Assessment of the IR-4 Organization (AIR4O) An Overview of

Transcription

1 Assessment of the IR-4 Organization (AIR4O) An Overview of

2 Contents Mission and Overview... 3 Organization Assessment Charge... 4 IR-4 Background, Objectives, Deliverables and Impact... 4 The Funding Situation... 9 The Budget Situation - Challenging Budgetary Environment in the Land Grant Institutions The Budget Situation -Expanding Need for IR-4 Under the Changing Regulatory Environment Regulatory Study Needs, Other than Residue Other Regulatory Challenges The Budget Situation - Infrastructure Change Options The Budget Situation-Options - Potential Infrastructure Modification Examples Common Acronyms and/or Definitions Used in IR-4 Documents Attachment 1 -The IR-4 Organization-Summary Attachment 2-The IR-4 Organization-Northeast Region Attachment 3 -The IR-4 Organization-Northcentral Region Attachment 4 - The IR-4 Organization-Southern Region Attachment 5 - The IR-4 Organization-Western Region Attachment 6 -The IR-4 Organization-Project Headquarters Attachment 7 - The IR-4 Organization-USDA-ARS Minor Use Attachment 8 - The IR-4 Process Food Program Ornamental Horticulture Program Biopesticide and Organic Support Program (BOS) Attachment IR-4 Annual Report Attachment 10 IR-4 Strategic Plan: Vision Attachment 11 National Economic Impact of the IR-4 Project (2012 update) Attachment 12- IR-4 history Attachment 13 NRSP-4 (IR4) Specialty Crops and Specialty Uses Review Summary

3 Mission and Overview The mission of the IR-4 program is to ensure that safe and effective pest management tools are available for growers of specialty crops, including ornamental horticulture crops, and for minor uses on major crops through the generation of high quality field and laboratory data required for EPA registrations. The IR-4 Project operates as a unique partnership between USDA s National Institute of Food and Agriculture (NIFA) and Agricultural Research Service (ARS), the Land Grant Universities / State Agricultural Experiment Stations (SAES), the US Environmental Protection Agency (EPA), the agrochemical industry, commodity groups and specialty crop growers. It is understood, that the success of the program depends on cooperation of all major partners in this effort. The USDA provides the majority of the project funding, the EPA exempts IR-4 from paying submission fees, the Land Grant Universities (and SAES) offer the services of faculty and facilities, and the crop protection companies agree to support the registration of compounds for specialty crops that would otherwise not be economically viable to them. IR-4 is at a critical juncture and IR-4 s Project Management Committee strongly believes it must rethink how to respond to multiple years of flat funding, the challenging budgetary environment in the Land Grant institutions, changing regulatory requirements and evolving needs of specialty crop growers. The organizational structure of the IR-4 Project has varied little since 1975/1976 when the US Congress provided funds to establish regional centers at Cornell University, University of Florida, Michigan State University and University of California-Davis to supplement the activities at IR-4 Project Headquarters - Rutgers University. These monies established the IR-4 Project Regional Center and analytical laboratories to conduct necessary research needed at the Land Grant Universities/SAES in support of IR-4 s mission. About this same time, the USDA-ARS Administrator directed ARS researchers, at strategic locations, to assist in the IR-4 Project data development activities. Under this structure, the IR- 4 Project is essentially six independently-funded operational units cooperating together in generating data to address grower needs. Much of the time, the culture of good will and collaboration has contributed to the successful completion of the IR-4 Project mission. However, there are intervals when potential efficiencies might be lost because of this existing independent organizational structure. Over time, the type and amount of data collected by IR-4 operational units has changed. The 1989 modifications of EPA Good Laboratory Practice Regulations (GLPs-Chapter 40-Code of Federal Regulations; Part 160) remains the key influence in the current structure and function of the IR-4 units. IR-4 Headquarters serves the required role of Sponsor/Testing Facility Management and houses all the Study Directors while the regional centers generate the research data. The details of this structure is explained in the Operational Handbook to Fulfill the Requirements of EPA for Good Laboratory Practices-Version 7.0. IR-4 has witnessed shifts in development of new conventional pesticides; where fewer new active ingredients are being developed and companies are doing some of the work on specialty crops. This trend is expected to continue with EPA s latest concerns over pollinator protection, endangered species, cumulative risk of pesticides, modeling of pesticides in water, worker protection as well as the consolidation of companies that develop and register new pesticides. At the same time, the amount of data required for a new pesticide registration continues to increase, both in terms of residue exposure and product performance. Additionally, IR-4 funding has been flat while operational costs have risen, reducing the capacity of the program to complete its mission. Thus, the PMC and stakeholders through IR-4s most recent strategic plan requested that an organizational assessment be executed on the program. 3

4 Organization Assessment Charge The purpose of the IR-4 Organization Assessment Committee (OAC) is to review the IR-4 Project s existing organizational structure and its operational efficiencies within the organization: Specific Tasks for the OAC: 1. To evaluate the organizational structure of the regional centers, their field research centers/field research cooperators and dedicated IR-4 analytical laboratories, and the coordinating operations of IR-4 Project Headquarters. 2. To determine based on the various impacts on the IR-4 Project if the present organizational structure is appropriate to meet the current and future needs of the specialty crop producers, processors and consumers. 3. To examine how ARS operates within the IR-4 process and what role it has in future reorganizational models. Note: the goal is not to evaluate the ARS organization but how it fits into the IR-4 process. 4. To collect this information and appraise if operational efficiencies and/or savings can be achieved through reorganization of IR-4 s units while maintaining IR-4 s ability to meet its mission 5. To propose to the IR-4 Project Management Committee (PMC) any changes to the current organizational structure as well as operational efficiencies/savings that can be achieved through reorganization by recommending models, along with the positive/negative impacts of such changes. The OAC will consist of a Chair and four additional panel members. The Chair and panel members will represent different stakeholder sectors and expertise with a representative from: specialty crop commodity groups, SAES/USDA-ARS, crop protection industry, federal government (Office of Pest Management and Policy or EPA) and an organization assessment expert. Dr. Marty Marshall, former IR-4 Southern Region Director from University of Florida will provide technical assistance and staff support for the OAC. IR-4 Background, Objectives, Deliverables and Impact Annual crop losses of food, fiber, nursery, forestry, landscape and floral crops from insects, plant diseases, nematodes, and weeds are sizable. Conservative estimates indicate that total losses, even when the best pest management technology is applied, are in the range of 15 to 30 percent of total production. Many of these crops are termed minor or specialty crops 1 because they are high in value but grown on small acreage. The crop protection industry has little economic incentive in providing research and development dollars for these crops because of their small market and sales potential. Thus the IR-4 Project concept began in 1960 when the University of California proposed to the National Agricultural Chemical Association, now named CropLife America (CLA), the need for registration of pesticides for pest management in minor crops. CLA supported this suggestion and asked the California Agricultural Experiment Station to determine if the SAES could participate in this type of work. The Western SAES Directors approved this idea and solicited cooperation from other regional associations. The Experiment Station Committee on Organization and Policy (ESCOP) agreed in principle to the program and requested a feasibility study. The study indicated that most states had similar problems and that not only was the project feasible, but highly necessary to meet a host of needs. The SAES Directors established Interregional Research Project-4 (IR-4 or IR-4 Project) effective July IR-4 has been revised throughout its 53-year history and presently was extended as National Research Support Project (NRSP- 4) through IR-4 continues to facilitate the approval of registrations for crop protection products through the development and submission of appropriate data to US Environmental Protection Agency (EPA) and/or the crop protection industry. Historically, IR-4 focused efforts in the development of Magnitude of Residue data that determines how much pesticide remains in or on the crop at harvest. More recently, the 1 Fruits, vegetables, nuts, and herbs/spices 4

5 IR-4 Project has been providing additional efficacy data or crop safety data to show that the proposed chemical is safe on the crop and effective in managing the target pest(s). Traditionally, IR-4 had relied on the crop protection industry and university scientists to develop this data showing that pesticide use is safe and effective. As resources become limiting at universities, less of this work is done and more responsibility is falling on IR-4 to complete the data requirements to support registrations. In 1977, IR-4 added a second objective of registering pest control products on nursery, floral, forestry and Christmas trees known today as the IR-4 Ornamental Horticulture Program. Because of the large number of ornamental plant species, plant production systems and pests only a small number of registrations were being pursued by the crop protection industry. Companies holding the registrations of pesticide products for ornamental horticulture crops typically need product performance (efficacy and crop safety) data to add specific new plant and/or specific new pests to product registrations. IR-4 traditionally develops product performance data and submits such data to the crop protection industry to expand the list of crops and/or pests on their ornamental horticulture registrations. Historically, IR-4 focused on the development of plant safety data for herbicides and fungicides, and to a lesser degree, plant safety data with insecticides. Data showing when a pesticide is safe or when a pesticide caused injury are equally valuable. Starting in 2004, IR-4 placed more emphasis on directed research for product efficacy; data showing that the pesticide manages the target pest. Efficacy data is mostly developed on difficult to control pests and any active ingredient type is screened including microbials, natural chemicals and conventional chemicals. An additional aspect under the IR-4 Ornamental Horticulture Program includes invasive species; research on exotic pathogens and arthropods impacting ornamental horticulture crops. In collaboration with the green industry, projects were identified and suggestions submitted to USDA-APHIS. Since 2010, Farm Bill funding for IR-4 coordinated research on invasive species totaled $5,155,465. Projects include: Gladiolus Rust ( ); Management of Invasive Arthropods during Shipping ( ); Chrysanthemum White Rust ( ); Boxwood Blight ( ); and Impatiens Downy Mildew ( ). IR-4 added a third objective in 1982, Biopesticides. This objective s goal is to facilitate the registration of crop protection products classified by EPA's Biopesticide and Pollution Prevention Divisions (BPPD) as biopesticides. The program performs research to support registration of microbials such as fungi, bacteria, and viruses, low toxicity biochemicals, pheromones, plant growth regulators, and genetically modified organisms. Biologicals, such as arthropod (insect) parasites and predators or predacious nematodes, are not regulated under FIFRA, and do not fall under the IR-4 program. It should be noted that IR-4 s involvement with biopesticides actually started in the 1970s with the registrations of Bacillus thuringensis. In 2005, the IR-4 Biopesticide Program was renamed the Biopesticide and Organic Support Program (BOSP) providing efforts and activities that facilitate approval for biopesticide uses in USDA certified organic production systems. The IR-4 BOSP has two major functions; a regulatory support program to assist public sector scientists and small biopesticide companies with regulatory advice and petition preparation assistance, and a grants program. The competitive grants program began in 1995 and provided funding to the most promising technology to assist in the development of performance data. Potential proposals were broken into one of three categories, Early Stage, Advance Stage and Demonstration. The IR-4 Project s Biopesticide Program was further expanded in 2004 with the establishment of a jointly funded project with EPA s Biopesticide and Pollution Prevention Division (BPPD) to support large scale demonstration studies to convince growers that biopesticides can be effective when the products are used correctly in IPM programs. In 2014, the Biopesticide competitive grants program process changed. IR-4, in an effort to improve service to stakeholders and provide more support for IPM systems has recently modified its BOSP to 5

6 function similar to the Food and Ornamental Horticulture Programs by sponsoring a workshop. In association with this change, IR-4 has received over 160 requests for efficacy needs involving biopesticides. The focus of the program continues to support integration of biopesticides in conventional systems. This provides better management of pest resistance to pesticides, pesticide residues at harvest, and further reduces the risk associated with pesticide use to man and the environment. In addition, it also has a specific category devoted to the needs of organic producers. A sampling of these requests for assistance include: Spotted Wing Drosophila control on fruit; Fire Blight management on organic apple; residue mitigation/export crops; Varroa mite/honeybees; and weed control in nursery crops and sweet potato. The Public Health Pesticides (PHP) Program is IR-4 s newest initiative and started in This part of IR-4 is not considered as part of the primary program area, plant health. The goal of this program is to assists in the registration of pesticides to manage mosquitoes, ticks, fleas and other arthropod pests that transmit disease such as Zika virus, malaria, Dengue fever, Lyme disease, West Nile virus, etc. IR-4 s activities are an integral element of a larger cooperative agreement between USDA-ARS and the Department of Defense (DoD) - the Deployed Warfighter Protection Research Program (DWFP). The specific expertise and contribution of IR-4 in this effort is broadly defined as regulatory support, and is intended to help transition entomological and chemical research into useful products for EPA registration. The activities and products pursued by the IR-4 PHP Program have been primarily determined by the explicit objectives in the cooperative agreement between the federal agencies and IR-4: IR-4 will attempt to find active ingredients that have registrations for other uses or that are registered abroad and evaluate their utility for public health applications (i.e. identification of materials underutilized vs. public health pests); IR-4 will communicate with industry and the U.S. Environmental Protection Agency (EPA) in order to determine what steps are necessary to get a registration; IR-4 will also participate in managing the registration activities of some of the new, unregistered compounds discovered by USDA ARS and the DoD s DWFP. Since the agreement was formalized, staff members from IR-4, ARS, DWFP, and other collaborating institutions have participated in several formal reviews and other forums, and have identified additional sub-objectives that are critical to the overall objective and that can be realized, at least in part by IR-4, and these have become fully integrated into the IR-4 PHP Program scope of work: Creation and maintenance of a comprehensive inventory and database of materials that can serve as public health pesticides, including information on their identification and specification, chemistry, efficacy, risk profile, regulatory status, intellectual property status, and use patterns; Consultation and representation of researchers and product developers, and other facilitation and assistance in the registration of potential PHP materials; Assistance in efforts to support continuing registration of existing PHPs facing new data requirements; Evaluation and assistance in efforts to improve, harmonize, and streamline the PHP registration processes, both nationally and internationally; and Identification of and collaboration with other efforts to discover, develop, or register PHPs, to help ensure the most efficient use of resources. IR-4 has moved into other areas to assist specialty crop growers with their pest management challenges. For example, export markets for specialty crops continue to expand with U.S. exports of horticultural products approaching $20 billion in This continued expansion of specialty crop exports will be very much dependent on U.S. growers having the latest generation of legally registered "reduced risk" pesticides to protect their crops while at the same time, trading partners must be willing to establish corresponding maximum residue level (MRLs) to 6

7 allow residues of the pesticides in the imported crops. Without internationally recognized, science based MRL s, pesticide use in the United States becomes a fundamental technical barrier to trade. Canada is the United States largest trading partner. IR-4 works closely with its Canadian counterpart to prevent trade issues on both sides of the border. Agriculture Canada s Pest Management Centre (CN- PMC) has been collaborating with IR-4 for many years. Both organizations conduct research of mutual interest to specialty crop growers. In some cases, growers have farms on both sides of the border. Through cooperative research planning, CN-PMC conducts research which saves IR-4 as many as 20 studies and field trials with the data simultaneously submitted to EPA and Canadian regulation agencies. This cooperation saves U.S. tax payers around $500,000 annually as well as gives growers from both nations access to each other s markets. IR-4 has progressed on numerous activities to remove pesticide residues as trade barriers. Cooperating with USDA-Foreign Agriculture Service (FAS), IR-4 has: Repurposed existing IR-4 residue data - reformat and submit the data to trading partners to establish the necessary MRLs to support U.S. grower exports. Provided training to international partners in conduct of supervised field trials that can be used to set MRLs. It is the hope that like the collaboration between the U.S. and Canada, other international partners will be able to cooperate with IR-4 in the future when priorities within their countries match the priorities within the U.S. Led international discussions on how the minor use problem may be solved. Some specific examples are IR-4 s involvement in the first and second Global Minor Use Summits that IR-4 managed in association with the United Nations Food and Agriculture Organization (FAO) in Rome, Italy. IR-4 has been very active in the development of crop groups that have helped to improve the efficiency in gaining new registrations for specialty crops. Regulatory crop groupings are one of the best avenues to extend research funds while still providing the necessary data to establish pesticide tolerances for groups of related crops. Instead of developing residue data on every food or feed crop for every chemical use, data could be developed on a smaller set of representative crops and then extrapolated to a larger number of related crops. In 2002, IR-4 sponsored the International Crop Grouping Symposium for the propose of expanding crop groups to include many orphan minor crops and to propose new crop groups. Subsequently an International Crop Grouping Consulting Committee (ICGCC) was established by IR-4 consisting of over 200 crop, agrichemical and regulatory experts representing more than 60 countries. IR-4 is leading an effort domestically and internationally to update and enhance the crop groups. In March 2016, IR-4 submitted the last of the proposed modifications for crop groups to EPA. In the international area, the Codex Committee on Pesticide Registrations (CCPR) approved work on a revision of the Codex Classification of Foods and Animal Feeds. In 2007, IR-4, along with associates from The Netherlands, prepared and submitted a proposal for the classification of food and feed crops. The CCPR also agreed that the document on the principles and guidelines for the selection of representative commodities would be developed separately from the revision of the Classification of Food and Animal Feeds. Since that time CCPR has accepted major changes to the fruit types of crop groups. This was a major milestone in the harmonization of international pesticide standards and updates to the other plant types are expected to follow. Going forward, research on invasive pests, resistance management, protection tools for new crops and pollinator safeguards will continue to influence IR-4 s work plan. New pests continue to impact specialty crop growers such as Citrus Greening, Spotted Wing Drosophilia, Brown Marmorated Stink Bug, etc. Traditional chemistries are not always effective and new technologies are needed to manage these pest problems. Resistance to pesticide use 7

8 remains a leading issue as new technologies are required to replace pesticides ineffective in managing the evolution of pests. Over its 53-years in serving U.S. agriculture, the IR-4 Project s data has been used to produce 17,362 food crop registrations. For ornamental horticulture, it has produced more than 189 registrations which impact 36,000 ornamental crop uses. Below are two tables that the show the Summary of Deliverables for the IR-4 Food and Ornamental Horticulture Programs for the past five years. There are up and down trends in the measurements that reflect the complex, multiyear, multifunctional nature of IR-4 s research work. It should be noted that in 2015, IR-4 Food Program success, as measured by registrations was a record high of 1,175. Summary of Deliverables Food Program Statistics year mean Submissions Tolerances Registrations Ornamental Horticulture Program Statistics year mean Registrations Crops Impacted 2, ,535 5, Data Summaries Over the past five years, IR-4 funded 147 projects/proposals to supported biopesticide innovation, increased registrations or grower use. Titles of funded proposals are below with summaries of the results at the IR-4 Project website; IR-4 also assisted by providing regulatory support for potential products developed in the public sector and/or small business. Some of these are registered and others are still in the regulatory process awaiting completion of EPA s risk assessment. Yearly IR-4 achievements are captured and summarized in the program s Annual Reports and Year End Summaries. See the IR-4 website 2 for a comprehensive library of these reporting documents. Additional impacts of IR-4 s efforts on providing pest control tools for food crops have been measured. For the last 18 years, IR-4 has monitored the amount of loss avoidance of a pesticide use for which state(s) have included in Section 18 emergency exemptions submitted and approved by EPA. During this period, growers in states with approved Section 18s that were being supported by IR-4 data avoided a total loss of $22.7 billion or an average of $1.3 billion annually. Dr. Rich Bonanno, Past Chair of the IR-4 Commodity Liaison Committee wrote to Congress We believe the IR-4 Project has become one of the most efficient, indispensable and reliable government programs ever developed. Simply put, specialty crops cannot economically survive without the IR-4 Project. A 2012 update to a study from Michigan State s Center for Economic Analysis concluded that IR-4 contributes an estimated annual $7.2 billion to U.S. Gross Domestic Product and the program supports nearly 104,600 jobs (see page 239 in this document). The report noted growers benefit in higher yields with higher quality output, consumers benefit with new varieties and lower costs of food and ornamental crops. Without IR-4 intervention, it is anticipated that many specialty crops would enter the 2 8

9 food supply with illegal pesticide residues and in many crops there would be significant crop losses which would make these healthy foods extremely expensive and in some cases, unavailable for consumers. The IR-4 Program has existed for over 50 years and although its vision and mission have been refreshed over these years, its core mission has not differed greatly from when it was founded in As noted in the July 2014 IR-4 Project Strategic Plan, Vision 2020: The IR-4 Project aspires to remain a responsive and efficient organization that supports the farmer/growers, food processors and consumers of specialty crops (e. g. fruits, vegetables, nuts, herbs, trees, shrubs flowers, etc.) by facilitating the U.S. regulatory approval and international acceptance of chemical and biologically-based pest management technologies. This allows producers/processors to provide a consistent supply of nutritious foods essential to good health as well as aiding in the production of ornamental horticulture crops that enhance the environment. IR-4 activities also assist in agriculture profitability. The IR-4 Project effectively and efficiently assists with obtaining regulatory approvals for small market uses of pest management technology, such as specialty uses of pesticide products on major crops (e.g., corn, soybean, cotton, grains). Other specialty uses include the management of invasive species; approval of biotechnology for specialty crops and use of pest management technology to manage arthropod pests that pose a public health risk. IR-4 concentrates its efforts in the cooperative registration process of pest management technology that respects human health and the environment when the need for such regulatory approval is in the public interest. The IR-4 Project s current Mission Statement is to Facilitate regulatory approval of sustainable pest management technology for specialty crops and specialty uses to promote public wellbeing. The Funding Situation In federal fiscal year 2010, the US Congress approved $12.18 million for the Minor Crop Pest Management (IR-4) Special Research Grant line in Agriculture Appropriations law. Also that year, SAES continued to provide $481,152 for IR-4 Headquarters under NRSP-4 multi-state research funds. These NRSP-4 dollars are used for IR-4 HQ management (Executive, Associate and Assistant Directors). ARS administration provided approximately $4.0 million to its facilities to perform IR-4 research. These three sources of government funds for IR-4 s Plant Health efforts totaled $ million. Six years later, in fiscal year 2016, funding from these three sources has dropped to $ million, a reduction of $1.067 million or 7% while the cost of doing business continues to increase. Specific funds in FY 2016 were $ for Minor Crop Pest Management (IR-4) Special Research Grant, $481,182 for NRSP-4 and approximately $3.2 million from ARS administration for cooperative IR-4 efforts. 9

10 Plant Health Program Funding for IR-4, (x $1000) $18,000 $16,000 $14,000 $12,000 $10,000 $8,000 $6,000 $4,000 $2,000 $ NIFA ARS NRSP-4 Although funding for the three Plant Health programs has been slightly reduced over these seven years, the costs for developing the research data continue to rise. Consumer inflation has remained relatively low; however, inflation in the Higher Education segment has risen. During the period of 2011 to 2015, higher education inflation averaged 2.14% a year or a total of 10.7% 3. The impact of multiple years of flat funding and escalating costs is now affecting IR-4 s ability to maintain research levels needed to address grower demands. Specifically, in 2010, the IR-4 Project conducted 551 field trials to collect Food Program residue samples in the United States. In 2016, there were only 486 field trials collecting residue samples. A similar decline was observed in the ornamental horticulture program; in 2010, IR-4 funded 1,473 ornamental horticulture trials and by 2015, this number dropped to 673. Biopesticide research was also impacted: 36 projects in 2010 and 12 in IR-4 s expenses can be broken down into two main categories, core and program (field) research. The majority of core cost at the Regional Centers includes the funds needed to analyze the residue samples in the dedicated IR-4 analytical laboratories including salary/fringe for analytical chemists/support staff, required equipment 4 and supplies. Other Regional core expenses include the field research coordination, quality (control and assurance), sample shipping, State Liaison support, travel and other necessary direct costs. For IR-4 Project Headquarters, the majority of the core costs are salary/fringe for Study Directors, Quality Assurance Unit Team and IR-4 Project leadership. These are responsibilities specifically mandated in the Good Laboratory Practice regulations that have been assigned to IR-4 Headquarters by the IR-4 Project Management Committee. Other IR-4 Project Headquarters core costs include salary/fringe for Project Managers (Food, Ornamental Horticulture, Biopesticide & Organic Support, Public Health Pesticide and Outreach/communication), data management and other information technology costs, and administrative support. IR-4 Project Headquarters is also responsible for other IR-4 wide costs such as hosting priority setting workshops, managing IR-4 Project website/outreach, travel and office rental Commonfund Higher Education Price Index report. 4 Typical modern analytical instrument, LC/MS/MS cost $250,000 with a life cycle of 3-5 years 10

11 Funds to conduct field research are provided to state research cooperators through sub-awards from the Regional Centers. The Food Program uses a fee-for-service process to pay for field trials. A trial is designated by the EPA s requirement for the data to be generated on a specific commodity in multiple regions of the EPA s thirteen regional growing zones. On average, there are approximately six to seven field trials per study. The costs IR-4 Pays to state research cooperators to conduct these trials have increased from $4,750 per trial in 2010 to $6,000 per trial in It should also be noted that at many locations, the field research cooperators must pay for all their expenses with their IR-4 allocation. As IR-4 funds have become limited and the number of funded field trials decrease, there has been increased competition between sites for trials to fund operations. Many sites are receiving barely enough work to sustain their Centers. USDA-ARS provides fixed funding for each ARS field site and analytical lab doing IR-4 cooperative research; they receive standard funding regardless of their workload. Because of the increased competition for field research by state research cooperators, many of the sites involved in the ARS field program operate at reduced capacity. In the Product Performance, Ornamental Horticulture and Biopesticide & Organic Support Programs, field trials conducted at state locations are assigned a specific value and IR-4 develops a sub-award amount to pay for the work. Costs have increased for ornamental horticulture research as well. In 2010, the guideline for crop safety trials was $750 per trial and in 2016 it is $1,000 per trial; similar increases have occurred for efficacy with a change from $1,000 to $1,250 per trial. Below is the distribution of funding within the IR-4 Project programs and units for FY2016 Northeast Core 5 $370,534 North Central Core $1,284,599 South Core $1,290,885 West Core 6 $1,771,600 HQ $2,824,308 Food Program Field Trials $2,382,600 Ornamental Horticulture $518,000 Biopesticide $400,000 Supplemental 7 $250,860 NIFA Holdback 8 $819,614 TOTAL $11,913,000 Though there is significantly less research in the field, the amount IR-4 funds for field research has remained relatively stable. In 2010, IR-4 allocated $3.325 million for food, ornamental and biopesticide field research. In 2016, the amount allocated dropped to $3.300 million. Looking at allocations by percentage, in 2010, IR-4 allocated 27.3% of Special Research Grant (NIFA) funds to field research. In 2016, IR-4 allocated almost 27.8%. 5 In 2008, the Northeast Region Analytical laboratory was phased out, significantly reducing the region s core cost 6 PMC approved resolution that HQ, North Central and Southern region reduce core by $30,000 each and those funds be directed to Western Region 7 $240,000 of Supplement goes to analytical labs to cover lease payment for analytical instruments. 8 Congress allows NIFA to withhold approx. 7% of the grant to cover NIFA operations and Small Business grants 11

12 During this period of static funding, IR-4 has increased the funding for field research to better reflect true direct costs at the research farms and research centers. As noted, IR-4 currently funds field trials that collect residue samples at the rate of $6,000/trial. In 2010, this rate was $4,750. Though the field researchers are getting more funds per trial, for most, the actual trial assigned per site has decreased, leaving many with significant fiscal challenges. To minimize the issue, IR-4 has attempted to close redundant sites and reduce the size of certain field research centers. The Western Region has closed the El Centro Center in Southern California. The Northeast and Southern Regions have downsized research centers in Maryland and North Carolina by approx. 50%. Unless additional funds are allocated to field research, IR-4 has reached a point where there are not enough funds to adequately operate all existing field research centers. There are multiple options in dealing with this issue, including closing down some or all of the field research centers and transferring the work to USDA-ARS sites (some cooperating ARS centers that have excess capacity) and/or using private contract researchers to conduct this phase of the IR-4 studies. Any actions IR-4 takes must recognize that EPA has very specific regulations on the number and locations of field trials. Furthermore, there are specific guidelines for distinction of field trials performed at nearby locations. Some of these distinctions are not always easy to perform and hiring private contractors at a different site may be a better option. The reductions in IR-4 funding has already been absorbed by the core functions including closing an analytical laboratory, laying off some Study Directors and Quality Assurance personnel and research coordinators/managers, and reducing travel and supply purchases. In 2010, $8.03 million was allocated to the above functions, in 2016 that had dropped to $7.79 million. The cutbacks in federal funding have been buffered by some new and expanding sources of funding. For example, in 2015, IR-4 Headquarters raised $1.5 million in unrestricted funding from the crop protection industry. In 2010, funds from this source were $1.04 million. The funds are used to supplement research including additional field trials, help with purchasing necessary research equipment, cover projects with higher than normal costs, processing of raw commodities into appropriate products, etc. The industry funds also sponsor the IR-4 priority setting workshops, rent and other operations at IR-4 Headquarters. The Budget Situation - Challenging Budgetary Environment in the Land Grant Institutions Land Grant Universities have historically received significant appropriations of state and federal funds to support infrastructure and fulfill their mission to agriculture, both in terms of research and extension activities. In more recent decades, as public funds declined, universities needed to increase competitive grants to meet their mission and to recover the costs associated with maintaining facilities where research is conducted. The direct costs of research include salaries of personnel (staff and graduate students), travel, and materials and supplies associated with the proposed research project. Indirect (also referred to as Facilities and Administration) costs of research are part of the behind the scenes operations, infrastructure and facility maintenance that the university provides for faculty and staff to accomplish their work. These include equipment and facilities, electricity and water, campus security, information technology services and a variety of human resources on the university campus and research centers. Universities have regular negotiations with the US Government to establish allowable indirect cost (IDC) rates that can be included in research grant proposals. While all universities calculate the full cost of research facilities and administration, many funding agencies cap the rates that they will allow for grants that they fund. On the extreme, there are some funding programs, like IR-4, which under legacy federal funding authorization do not allow grants to charge these administrative costs. When the funding source does not allow for full F&A, it is up to the institution to determine whether or not they are willing to accept a grant that does not cover the full cost of research to the university. 12

13 As universities have become increasingly dependent on competitive funding (and IDC) to operate, some institutions are moving to restrict access to faculty who are carrying grants without full indirect cost recovery. In a recent case, Cornell University made a policy decision that it would no longer subsidize those programs that do not generate sufficient IDC to cover the costs of centrally-provided services. This resulted in the departure of IR-4 s Northeast Regional administrative and research functions from Cornell. The IR-4 Project Management Committee (PMC) believes it is inevitable that additional institutions will follow the path of Cornell, which, depending on location, could be catastrophic to the research infrastructure of the IR-4 Project. The PMC has discussed this issue with NIFA. NIFA believes that they can convert IR-4 funding from a Special Research Grant into a Cooperative Agreement. Cooperative Agreements allow for payment of 10% IDC. While below the full rate at many institutions, it shows a good faith effort by IR-4 to recognize the fiscal realities at the Land Grant institutions. Furthermore, the IR-4 Administrative Advisors believe that the allowable 10% IDC will greatly enhance their ability to defend IR-4 to university administrators well into the future. The Budget Situation -Expanding Need for IR-4 Under the Changing Regulatory Environment The regulatory requirements for crop protection product registration continue to evolve as a means to ensure that consumers, workers and the environment are protected to the greatest extent possible. These requirements not only apply to registration of new pest control products coming to market, but also for products already on the market, through the Registration Review process. IR-4 continues to adapt to the changing regulatory environment. The 1988 Amendments to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA 88) was a considerable challenge for IR-4. During the period from 1989 to 1994, the majority of IR-4 resources were being used to specifically defend products going through the FIFRA 88 reregistration process. As IR-4 was concluding its efforts in reregistration, the Food Quality Protection Act was passed and ushered in a new, higher standard of product safety which applies to products today. There are a number of areas that often directly impact IR-4 s submissions or may impact IR-4 in the next few years. Examples include Endangered Species Protection, Pollinator Protection, Cumulative Risk Assessment, Modeling of Pesticides in Water, and Worker Protection Standards. In some cases, there will be a need for additional studies, such as metabolism, immunotoxicity, etc., and there may also be an increased use of other data in the future, such as epidemiological data and other public data to make regulatory decisions. Regulatory Study Needs, Other than Residue Metabolism studies may be an uncertainty that can arise as a consideration of cost to register products for specialty crops. Over the past 20 years, there have been a few occasions (clopyralid for Brassica crops and quinclorac for berry crops) where there was outstanding metabolism data needed to support specialty crop uses. In one case, the manufacturer eventually agreed to conduct the metabolism study and in the other case, the grower group was able to obtain funds from USDA to have a metabolism study conducted. Metabolism studies can cost more than $250,000. IR-4 did one foliar dislodgeable residue study in These studies have not generally been an obstacle to additional minor use registrations since EPA does rather broad extrapolations from major crops to other crops. The Canadian minor use program has been conducting as many as 1-2 dislodgeable residue studies (at an average cost of $100,000) a year to support their minor uses. Although there may be insufficient data to set defaults in Canada (as is done in the US), this may be a larger issue with greenhouse grown vegetables, high tunnel agriculture production and ornamental horticulture crops. 13

14 The EPA mandated the Endocrine Disrupter Screening program and recently completed review of the List 1 chemicals that completed their tier 1 studies. While many of the chemicals passed without further data requirements, 18 of the chemicals will proceed with tier 2 testing and the List 2 chemicals will begin tier 1 testing. The tier 1 studies have been expensive for companies to undertake; however, with recent advances in this testing, EPA will adopt a high throughput methodology that will considerably reduce the time and cost for such studies. In the coming years, the registrations and use of neonicotinoid insecticides and other pesticides will likely become considerably more restrictive due to perceived impacts on pollinators and on the environment. IR-4 was impacted in April 2014 when EPA made IR-4 withdraw a spirodiclofen/blueberry petition as a result of the registrant not willing to include/add language on their Section 3 label to mitigate concerns for pollinators. The registrant balked on these changes because the utility of the product would be lost. In some cases, the manufacturers are being asked to do additional pollinator studies to determine the product exposure to bees. In the past year, IR-4 has withdrawn or delayed submission of a number of neonicotinoid insecticides pending EPAs decision/policy on pollinators. While registrants are proceeding with certain studies to defend some crops, it may be likely that for some specialty crops (e.g. strawberries) there may be a need for IR-4 to conduct pollen, nectar, or other studies to defend such uses. Needless to say it is expected that there will be limits placed on the use of these products, which will reduce the spectrum of products available for specialty crop growers. Challenge for IR-4: When additional data requirements are established or additional studies are needed for registration, the expertise and resources to resolve or fund the studies must be available in order for IR-4 to move forward and successfully register the chemical/crop combination. The challenge includes not only the cost of the study, but manpower to work with registrants, grant agencies, etc. to determine how the data gap will be met. Other Regulatory Challenges EPA s recent Organophosphate risk assessment (September 2015 comment period commenced) included the use of epidemiological data (public literature) to address uncertainty regarding dose responses to neurodevelopment effects. Based in part on these data, EPA retained a 10x safety factor for the OP cumulative health risk assessment, resulting in little room for crop uses. The likely impact on minor uses could be significant, and it leaves the manufacture and IR-4 in a difficult position to rebut such issues and unsure if this will become a new process or policy within EPA for other products. The registrant may not be willing to invest the time or manpower to work on rebuttals, if the market is not large enough to be deemed economically important to the registrant. Challenge for IR-4: Manpower and technical support to review data and prepare/defend rebuttals for active ingredients used on specialty crops. Data Needs to Access International Markets IR-4 stakeholders increasingly want access to international markets. As a result, the residue studies continue to increase in size and complexity to meet domestic regulatory requirements as well as international standards. These requirements often result in an increased need for data showing decline in residues over time from multiple locations and broader geographic locations to meet stricter field trial separation standards. Data requirements are often stricter in other areas as well, such as a greater number of guideline storage stability studies. Overall, regulatory studies are becoming more complex than in the past. 14

15 Challenge for IR-4: Residue studies may require more trials and more samples in order to register pesticides in the U.S. and to have access to export markets. In some cases, the international regulatory authorities may want analysis of additional or different metabolites of the chemical. These requirements result in added expense for carrying out additional trials, and in added expense to analyze additional trials, prepare the final report and QA the data. Analytical Chemistry While IR-4 may be gaining efficiencies by working with other countries to collect field samples, analytical challenges have increased. The newer chemistries tend to be more complex molecules and can be more challenging to analyze in these specialty crop matrices. There are often more metabolites of concern for new active ingredients further compounding the issue. The analysis also requires the latest instrumentation, which is expensive and often becomes antiquated quickly (within 3-5 years). Challenge for IR-4: Increasingly complex analyses take more time and analytical effort to develop adequate analytical methods on specialty crops. Technology continues to change and instrumentation is outdated quickly. The resources must be available to upgrade instruments to keep pace with regulatory requirements. Performance and Crop Safety Data Traditionally, much of the crop safety and product performance testing has been conducted by public sector scientists associated with Land Grant universities. Many of those scientists have retired in recent years and this traditional science is being eliminated as these positions are refilled with faculty with expectations to conduct more basic research. At the same time, crop protection companies are increasing requirements for having adequate efficacy and crop safety data to address liability concerns and EPA is using product performance data to bolster their Public Interest Findings. The gap between the need for data and the ability to conduct the necessary research is increasing rapidly. In 2015, IR-4 converted $250,000 of its core budget to address this area of research and to fill this gap by sponsoring additional efficacy and crop safety trials on food crops, serving as the critical source of impartial product performance data. It is expected that this need will continue to increase in the coming years across specialty crops. Challenge for IR-4: Performance data is needed by both registrants and EPA to register chemical/crop combinations. IR-4 has increased its food crop performance testing, often at the expense of the food residue program to address this need. Since data are not available elsewhere, these resources will continue to be needed. Other Challenges and Considerations Working with generic or smaller registrants to address a specialty crop pest management need has a unique set of challenges for IR-4. Obtaining GLP analyzed test and reference substances, submission documents, etc., require more time and effort with these companies. When IR-4 seeks other opportunities within the scope of the IR-4 mission (such as public health, international activities, sponsored projects and invasive species), these can also present challenges. There is initial work in establishing these programs, especially in advance of receiving grants as well as in the process of coordinating and submitting proposals. While they have been successful and have contributed to the program s success, they do carry a cost. The overall landscape of the crop protection industry has changed with fewer new synthetic chemistries being developed and a significant increase in biopesticides. While there has also been a shift to some of the major crop protection companies developing biopesticide programs, a vast majority of the companies developing biopesticides are very small companies. The number of new biopesticides, biotechnology 15

16 related products and small biopesticide companies have increased dramatically and these smaller companies also lack the ability to support regulatory research and efficacy studies. At this point, it is unclear if endangered species protection, modeling of pesticides in water, projected climate change impact on new/expanded territory of pests or other emerging regulatory activities will trigger additional data requirements in association with IR-4 actions on specialty crops. More than likely the regulatory activities will trigger data for all uses of an active ingredient. However, there may be some instances where the other regulatory activities will single out specialty crops and IR-4 may be asked to assist in solving the problem. Finally, as science and regulatory knowledge advances, it is anticipated that new issues will continue to emerge that will require IR-4 s attention and assistance. In the several cases noted above, all have required IR-4 to reallocate funds and resources to address issues. In some cases, such as FIFRA 88, the investment was considerable while in other cases assistance from the basic manufacture has allowed IR-4 to be successful. It is difficult to predict the future and determine which issues requiring data (over and above residue) may arise and which issues may limit registrations on certain specialty crops and specialty uses. IR-4 will need to weigh the cost and benefits of diverting resources if or when such needs arise or consider registration of alternative pest management tools and technologies to resolve stakeholder needs. These and future challenges will continue to place stress on the existing IR-4 budget and resources. The Budget Situation - Infrastructure Change Options Since the establishment of IR-4 in the 1960 s, IR-4 has predominately relied on direct funds from the federal government including the Minor Crop Pest Management (IR-4) grant administrated through USDA-NIFA, funds from USDA-ARS directed to some of their facilities to do cooperative research with IR-4, off-the top funding from the Multistate Research (Hatch) Funds provided by the Directors of the State Agriculture Experimental Stations and other ad-hoc sources of federal grant funds. There are other sources, including unrestricted contributions from the crop protection companies, as well as significant inkind contributions from the state Land Grant institutions that host IR-4 research, EPA, and even the Canadian government. Ideally, the US Congress would provide new resources to rectify the funding shortfalls for IR-4. IR-4 has attempted to outline specific funding needs and impacts in the July 2014 IR-4 Strategic Plan; Vision Every year the IR-4 Commodity Liaison Committee (CLC), a group of stakeholders representing specialty crop growers, commodity associations, food processors and the crop protection industry, arrange visits on Capitol Hill and home district offices in an attempt to encourage the US Congress to provide IR- 4 with adequate funding. They often utilize the summary information from Vision 2020 in making their request, see below. Though Congress seems sympathetic to the funding shortfalls IR-4 is facing, the federal deficit realities have limited any new funding for IR-4. Table 1. Financial resources needed to achieve benchmarks associated with IR-4 s core objectives (X $1,000) USDA-NIFA USDA-ARS Development Total Purpose $ $ $ $ Existing Plant Health Program Funding $11,916 $3,200 $1,250 $16,766 Additional Funding Needed for Plant Health Programs Restore Program Capacity $900 $1,000 $1,250 $3, (see page 172 in this document) 16

17 Expanded Efficacy/Crop Safety Testing $1,500 $ $1,900 Enhanced State-Based priority setting $ $100 Funds for Indirect Costs $1, $1,442 Existing Human/Animal Vector Management Funding 10 $252 $252 Additional Funding Needed for Human/Animal Vector Management Enhanced Data Management Capabilities ---- $ $75 TOTAL (Existing and New) $15,858 $4,927 $2,500 $23,285 As mentioned earlier, the crop protection industry provides direct fiscal support; on average $1.25 million annually through unrestricted grants. These resources have been used to supplement public funding to accomplish IR-4 s mission in all existing program areas. Industry funds have been used to pay for additional research, including: field trials, analytical analysis, required processing of apples, grapes, tomatoes, citrus, oil seeds and other commodities into specific crop fractions, and is used in funding biopesticide grants. Industry funds also cover the costs of the priority setting workshops for IR-4 s Food, Ornamental Horticulture and Biopesticide and Organic Support programs. Repair/replacement of critically important research equipment, incidentals and shortfalls in IR-4 Headquarters operational expenses such as maintaining the data archives, travel and updating computers are additionally supported by these resources. In Vision 2020, IR-4 established a goal to double the unrestricted grants and gifts to $2.5 million annually by Development funds will be targeted from a variety of sources, including the crop protection industry, grower groups, commodity associations and other philanthropic organizations. These new funds will be used in a variety of ways most importantly in efforts to restore IR-4 research capacity and infrastructure. IR-4 has attempted to diversify its funding by securing funds from other sources including resources for international activities through USDA-Foreign Agriculture Service, invasive species research through funds from USDA-APHIS and public health pesticide activities through cooperative funding from Department of Defense/USDA-ARS. IR-4 has two large (>$1.0 million) grant applications under review within USDA-NIFA from the Specialty Crop Research Initiative and Organic Research. Though these diversified funds are very much appreciated and it allows IR-4 to conduct value added research that is closely aligned with the IR-4 Project s core mission, IR-4 cannot depend on these grants to sustain the core programs. They are not the long term answer to IR-4 s fiscal needs. If additional funding for IR-4 cannot be appropriated through the US Congress, some alternative funding mechanisms should be considered to offset funding shortfalls. Some proposed ideas include: Funds from Pesticide Registration Improvement (PRIA) Act Congress has passed and has reauthorized PRIA that essentially charges the pesticide (chemical, biopesticide & biotechnology) industry fees for their review of data submissions into EPA. The majority of the resources go to offset the cost of review of the data submissions. However, precedence has been set where PRIA funds have been set aside for special projects or special purposes. What is being suggested is that, Congress, during their next reauthorization of PRIA, raise the fees to accommodate some new revenue for IR-4. This way, all registrants will pay at least a part of IR-4 activities. One point of caution; the PRIA fees must be raised high enough to potentially offset the current contribution of $1.25 million from industry. It could be possible then that some companies would reduce or eliminate their voluntarily contribution if they are forced to support IR-4 through larger PRIA fees. 10 USDA-ARS provides funds through a cooperative program in associations with Armed Forces Pest Management Board, Department of Defense 17

18 Mandatory Cost Sharing - Mandatory cost sharing of agriculture research is an accepted practice in many developed countries. The cost sharing/self-funding model is currently in place with several international minor use programs in developed countries including Australia, Germany, France, and United Kingdom. Mandatory cost sharing involves some individual or organizations outside of the federal government co-funding the cost of the research. Simply, if cost share funds are not available, the research does not get done. Under the cost sharing model, not only would a potential study require a high priority at the IR-4 workshop, but some group(s), including growers, commodity associations, food processors, crop protection industry, etc. would have to provide the appropriate cost share. IR-4 currently estimates that each residue study it performs costs on average $175,000. Residue studies on ultra-minor crops (<300,000 acres) cost less while residue studies on large acreage specialty crops (e.g. apple, potato, citrus) cost more. On average, each product performance field trial costs $6,000. There are downsides to this model. Though the cost sharing model would give IR-4 more operational funds, it would adversarial impact small commodities that often are not organized and many times cannot easily finance the cost share. For example, it would be extremely difficult for the wasabi growers, a crop grown on a few acres in the US, to come up with any substantial funds necessary for a crop share. The Budget Situation-Options - Potential Infrastructure Modification Examples Many believe it will be virtually impossible to maintain IR-4 on the current path forward without an influx of new resources and/or fundamental restructuring to reduce core expenses. This is especially true if the IR-4 current Special Research Grant is converted into a Cooperative Agreement that allows the host institutions to recoup a minimum amount (10%) of their indirect costs. Current and future inflation must also be considered. Today, IR-4 operates with a net funding of $ million from NIFA administrated Special Research Grant-Minor Crop Pest Management (IR-4), $481,182 from NRSP-4 through the Hatch Multistate Research Fund, and $3.2 million for cooperative research from ARS. It is highly likely that research expenses will increase at a rate higher than consumer inflation. It is also probable that IR-4 will have to hold back approximately $1.2 million for payment of indirect costs. By 2019, IR-4 could be operating on $10.7 million from NIFA, $481,182 from Hatch Multistate funding, and $3.2 million in cooperative ARS research. With these budget realities, plus an uncertain increase in expenses, how can IR-4 survive and still deliver critically needed services to the specialty crop community? Simply put, if you were establishing IR-4 today with $1.2 million dollars less than currently available, how would the program be best structured to be most efficient and responsive to the needs of its stakeholders? As a starting point, below are the current cores and field research allocations for the program: FY 2016 Northeast Region Core $375,000 North Central Region Core $1,400,000 Southern Region Core $1,400,000 Western Region Core $1,750,000 HQ Core $2,855,000 Food Program Field Research including Product Performance $2,400,000 Ornamental Program Research $520,000 18

19 Biopesticide Program Research $400,000 TOTAL $11,100,000 There are multitudes of ways to model the reductions to achieve the minimum reduction of $1.2 million. To assist the Organization Assessment Committee, IR-4 Project Management Committee developed and discussed some options with pro s and con s below. Other options can be considered. Across the Board Reduction - All units and programs within IR-4 would be given an equal reduction in operational funds to offset the reduction of $1.2 million. The upside of this model, it is simple and will allow the respective unit leaders and program managers to determine how best to absorb this loss in funds. For example, IR-4 HQ, whose existing funds support significant employee salary/benefits costs, would have limited choices but to reduce personnel. The regions would likely use multiple reductions in workforce, equipment and other costs. The programs (Food, Ornamental Horticulture, and Biopesticide/Organic Support) would absorb cuts by further reducing research. The main downside of this model is that it is not a strategic way to deal with an issue of this magnitude while trying to maintain IR-4 s high level of service to its stakeholders. This model also assumes that everything is of equal importance. Across the Board Reduction with Aggregate Field Research This is a variation of Across the Board Reduction. Funds from the field research programs (Food, Biopesticide/Organic Support, and Ornamental Horticulture) which are currently budgeted at $3,330,000 would be aggregated and reduced by the appropriate amount. The exact distribution of field program cuts could be decided at a later date based on grower needs and availability of solutions. Maintain Field Program at Currently levels, Across the Board Reductions to Core - This model has the same upsides/downsides of the full across the board cuts outlined in Across the Board Reductions except that the field programs are not impacted. The full blunt of the cuts would be in the analytical laboratories, the regional offices and IR-4 Headquarters. Each unit experiencing cuts would determine how to reduce the negative impact. Maintain Field Program, Outsource All Residue Analysis, and Combine Northeast and North Central Regions This is the most dynamic and drastic example. This model is designed to offset some of the across the board cuts in the units by combining the Northeast and North Central Regions into the new North Region and the elimination of the three IR-4 analytical laboratories. All residue sample analysis would be fully outsourced. It is anticipated that there will be over a $1.96-million-dollar savings by eliminating the three IR-4 Analytical Laboratories and combining the Northeast and North Central Regions into the new Northern Region. IR-4 HQ funding would remain fixed due to the expanded analytical responsibility of the study directors to develop the contracts with the Contract Research Organizations handling the residue analysis. There are some obvious downsides of this model, including the elimination of the workforce from the IR-4 analytical laboratories. IR-4 would lose much of its residue expertise and its ability to directly manage and oversee activities in the laboratory. IR-4 would become dependent on contract research organizations. This outsourcing of residue analysis would bring uncertainty in residue analysis cost; with reasonable costs in slow years and more expensive cost in years when the laboratories have a heavy load from industry. There also has been considerable IR-4 investment in existing analyst training and analytical equipment. Specifically, the LC-MS/MS and other analytical instruments 19

20 would be lost with the owed/leased equipment remaining with their host institutions. The host institutions would also lose IR-4 expertise in core university missions such as teaching, graduate training and collaborations. University of Florida and University of California, Davis would be able to recoup the existing space which houses the IR-4 residue labs and repurpose the sought-after and desirable laboratory space for other priority research programs. There are some upsides, it is anticipated that analysis timelines could be reduced allowing IR-4 more opportunity to meet submission schedules. The attention to timelines by the contract research analytical laboratories could also eliminate the need and the associated cost for IR-4 to develop guideline storage stability data in many cases. IR-4 would not have to continue to re-invest in new analytical equipment. Maintain Field Program and Consolidate into Two Regions with Laboratories -This example involves maintaining existing field research in the Food, Biopesticide/Organic Support and Ornamental Horticulture programs, reducing IR-4 HQ allocation by 5% and combining the regional structure into two regions, both with an analytical laboratory. This model has some of the same downsides as pointed out in Maintain Field Program, Outsource All Residue Analysis, and Combine Northeast and North Central Regions example though tempered, including less reduction in workforce, more control of laboratory analysis and the assumed benefit of having more stability in analytical costs. In closing one laboratory, IR-4 would lose that capacity but that could be made up with increased budget in the remaining laboratories or look to outsource some of the additional analytical workload. The field office responsibilities would be split into two regions; this would require realignment with one scenario to include all states west of the Mississippi river in the Western Region and states east in the Eastern Region. Another scenario may be to place states in each region by USEPA growing zones. Maintain Field Program, consolidate into two Regions, and maintain one analytical laboratory with outsourcing of some chemical analysis - This model involves a hybrid of some of the other models. Again, IR-4 will downsize the Regional Field offices to two. IR-4 would maintain one analytical laboratory that would be budgeted significant funds and be given the latitude to analyze samples internally or outsource sample analysis. IR-4 Headquarters funds would be reduced. This example is similar in model that many of the agricultural chemical industries have used to cut costs. Most companies have eliminated their internal ability to analyze residue samples; maintaining a lean chemistry staff to develop analytical methodology, contracts and oversee activities at contract research analytical laboratories. Some companies have maintained some resources to analyze priority studies, often with new chemicals. This model offers a balanced approach that allows IR-4 to transition in paying indirect costs with the ability to scale up if additional resources are allocated. As noted previously, there are many ways to model the reductions; these are just a few scenarios for the Organizational Assessment Committee to begin discussion. Except for the across the board reductions, the field research program was protected from cuts. IR-4 can slightly reduce the impacts to the IR-4 management infrastructure and/or laboratory in any one of the other scenarios with a reduction in funds allocated to the field research programs. Cuts in the field research program come with a high impact; a much greater reduction by IR-4 to deliver registrations to stakeholders. In addition to the above, we may also want to consider the opportunity to outsource food program field research to private contractors. In most locations of the country, there are numerous contractors available to conduct this type of research; some at competitive prices. 20

21 Common Acronyms and/or Definitions Used in IR-4 Documents AFPMB Department of Defense s Armed Forces Pest Management Board ARS or USDA-ARS USDA Agricultural Research Service APHIS or USDA-APHIS USDA Animal Plant Health Inspection Service ASR Analytical Summary Report CCPR Codes Committee of Pesticide Residues CDPR California Department of Pesticide Registration CLC Commodity Liaison Committee CN-PMC Canadian Pest Management Centre DoD Department of Defense DWFP Deployed Warfighter Protection Program of AFPMB EPA United States Environmental Protection Agency ESCOP Experiment Station Committee on Organization and Policy FAS or USDA-FAS USDA Foreign Agricultural Service FDB Field Data Book FRD Field Research Director GLPs Good Laboratory Practice Regulations IPM Integrated Pest Management IR-4 HQ IR-4 Project Headquarters, Rutgers University, Princeton NJ IR-4 Management Team Executive Director, Associate Director and Assistant Directors LGU Land Grant Universities NAFTA North American Free Trade Agreement NIFA National Institute of Food and Agriculture NRSP-4 National Research Support Project Number 4 OPMP Office of Pest Management Policy PCR Project Clearance Request PHI Pre-Harvest Interval PHP Public Health Pesticide PMC IR-4 Project Management Committee PRIA Pesticide Registration Improvement Act QA Quality Assurance RFC IR-4 Regional Field Coordinator RIPM Regional Integrated Pest Management Centers RLC IR-4 Regional Laboratory Coordinator RQAC IR-4 Regional Quality Assurance Coordinators SAES State Agricultural Experiment Stations SLR IR-4 State Liaison Representatives SOPs Standard Operating Procedures STDF World Bank s Standard Trade Development Facilities grant program USDA United States Department of Agriculture 21

22 Attachment 1 -The IR-4 Organization-Summary IR-4 Project organization and infrastructure consists of multiple, independent units cooperating together to accomplish the goals and priorities articulated by stakeholders. The IR-4 Project operates as a partnership between the State Agricultural Experiment Stations, USDA-Agriculture Research Service (ARS) and NIFA (National Institute of Food and Agriculture) to accomplish its mission and objectives. The IR-4 Program currently employees around 125 full-time equivalent staff, which includes ARS scientists. The six units operate collaboratively with national integration of activities generally supplied through IR-4 Project Headquarters (IR-4 HQ). Long-term policy, coordination, integration and management are provided by the 13-member IR-4 Project Management Committee (PMC). The IR-4 PMC comprises the IR-4 Project Executive Director, the four Regional Directors, the ARS National Director, the five Administrative Advisers (1 from the four regions, and ARS), the NIFA National Program Leader for IR-4, and the Chair of the Commodity Liaison Committee (CLC). The five Administrative Advisors and the NIFA Program Leader are nonvoting members on the PMC. The PMC meets three times a year to review the status of ongoing programs, develop policy and procedures, set operational budgets, develop strategic plans, and ensure that the program s overall goals are being met. From a business model, PMC serves as the Board of Directors while the IR-4 Project Executive Director serves as the Chief Executive Officer and spokesperson for the organization. IR-4 HQ, the four Regional Offices and USDA-ARS Office of Minor Use Pesticides are responsible for the day to day management of the program. The organization chart (end of Attachment 1) shows the IR-4 organization with the regional centers. Three of the regions are relatively similar in structure and function. The North Central Region at Michigan State University, East Lansing, the Southern Region at University of Florida, Gainesville and the Western Region at University of California, Davis maintain a field office, analytical laboratory and quality assurance unit personnel. Middle management positions include the Regional Field Coordinator (RFC), Regional Laboratory Coordinator (RLC) and the Regional Quality Assurance Coordinator (RQAC). The RFC is responsible for helping stakeholders identify needs as well as assigning field work to the regions field centers. The RLC oversees the analytical laboratory and the personnel responsible for running the residue analyses. Finally, the RQAC has the responsibility to management that all food field and laboratory studies are performed under Good Laboratory Practices (GLP) as defined by US EPA. The Northeast Region does not have an analytical laboratory like the other three regions. In 2008, the PMC decided to close one laboratory because the IR-4 s capacity to analyze residue samples far exceeded the funding available to produce residue samples. The monies were reinvested within other aspects of research including upgrading capacity and laboratory equipment for the remaining laboratories. Additionally, the Northeast Region is currently a partnership between Rutgers University in NJ which handles the administrative management and University of Maryland which handles the technical management and hosts the RFC. Although not supported by NIFA dollars, the ARS program is a vital part of the projects performance and outcomes. The ARS contribution to the IR-4 Project is approximately $3.2 million. The ARS component functions similar to the four regional centers. It has a Director, the Minor Use Officer, who assigns the projects and funding for the various field sites and analytical labs in ARS (chart at end of Attachment 1). A main difference between the regional structure of IR-4 and ARS is that the various ARS field and analytical sites are located throughout the U.S. and not managed regionally. IR-4 RQAC is responsible for the quality assurance activities at most ARS sites. IR-4 HQ at Rutgers University oversees the national program in all program areas. The staff at IR-4 HQ is composed of scientists involved in pest management, analytical chemistry or horticulture, and they manage each study for the various programs (Food, Ornamental, Biopesticide and Organic Support and 22

23 Public Health). In addition, there is a staff that coordinates the Quality Assurance for the national program. A significant amount of the operations and associated expenses at IR-4 Headquarters are to ensure compliance with Federal regulations. This includes compliance to the Good Laboratory Practice (GLPs) regulations found in Chapter 40, Code of Federal Regulations, Part 160, EPA Guidelines for Conduct of Magnitude of the Residue Studies (EPA-860 s) as well as regulations/guidelines mandated by funding authorities. IR-4 s unique infrastructure also includes strategically located field research centers/major research sites, with highly trained and experienced staff that develops and submits IR-4 research data through the complex regulatory process. The majority of IR-4 field trials are conducted at the field sites/centers associated with SAES or ARS. When necessary, Contract Research Organizations are utilized to conduct research. The major internal field sites are in the following locations: Northeast Region: MA, ME, MD, NJ (2), NY 11 North Central Region: MI (2), ND, OH*, WI Southern Region: AR, FL (2), GA*, NC, PR, SC*, TX Western Region: CA (2), CA*, HI, NM, OR, WA* *ARS funded facility In addition to the above, IR-4 will utilize scientific expertise of the Land Grant university system in conducting product performance in the Food, Ornamental Horticulture and Biopesticide/Organic Support Programs. Though, not formally part of the IR-4, there is close cooperation with Agriculture and Ag-Food Canada s Pest Management Centre. Cooperative research is conducted within Canada under a Memorandum of Understanding where data is mutually developed and shared with the goal to harmonize registration in both countries. Another group of individuals involved in the IR-4 Project are the State and Federal Liaison Representatives (SLR). In each state, the Director of the State Agricultural Experiment Station appoints a representative to interact with IR-4. There are also ARS Regional Liaisons, who serve a similar role to that of the IR-4 State Liaison Representatives. The fundamental role of the IR-4 SLR is to communicate the needs of specialty crop growers and advocate for IR-4 to work on research projects important for their state. Some IR-4 SLRs work diligently to understand the particular pesticide needs of the stakeholders in their states by conducting state wide workshops. Others collect information during their normal day to day activities. There is a large continuum of involvement and activities between individual State Liaison representatives; IR-4 SLR from states where major crops are predominately grown generally have less involvement. Certain states have identified a second SLR for Ornamental crops acknowledging the importance of IR-4 in the production of this crop for their local economy. It should be noted that IR-4 only provides a small amount of resources for its State Liaison activities. Stakeholder involvement is critical to the success of the IR-4 Program. IR-4 recognizes the farmers, growers and processers of domestically produced specialty crops/specialty uses as the primary stakeholders of IR-4 Project research and regulatory activities. The primary stakeholders and other partners have significant involvement in directing IR-4 s policies. As noted above in the discussion on the IR-4 Project Management Committee, IR-4 has a Commodity Liaison Committee (CLC) and the Chair of this committee is a voting member of the IR-4 PMC. Members of the CLC represent commodity associations, grower groups, food processors, the crop protection industry or individual farms. The CLC 11 NY Research Center in Ithaca, NY is being phased out and shut down effective end of the

24 serves as a conduit between IR-4 activities and interests of the specialty crop growers and food processors. They are stakeholders who provide guidance and advice to ensure the program continues to focus on significant pest management problems and meets the needs of specialty crop growers. They also support federal IR-4 funding and budget initiatives and assists in securing other sources of extramural funding. The CLC and other specialty crop stakeholders are significantly involved in setting IR-4 Project research priorities. This will be discussed in greater detail below. IR-4 anticipates that stakeholder involvement and interest with IR-4 will continue to increase as pest management issues escalate. IR-4 national and regional personnel continue to receive numerous invitations to formally address stakeholders at conferences, meetings and workshops to discuss the program and its ability to provide service. Finally, IR-4 collaborates with numerous organizations, and federal and international agencies. Besides those partners (USDA-NIFA, SAES and USDA-ARS) directly involved with the grant, IR-4 works jointly with the Crop Protection Industry, Agriculture and Agri-Food Canada Pest Management Centre (CN- PMC), USDA-FAS, USDA-APHIS and DOD-Armed Forces Pest Management Board (AFPMB). The crop protection industry provides access and information to their chemistries, biopesticides and plant incorporated protectants. This information is vital in the selection of tools for specialty crop and use stakeholders. All of these collaborations enhance the sustainability, viability and economic profitability of U.S. food and agriculture well enhancing human health and wellness to U.S. consumers. Many view the IR-4 Project as a model government funded program. With IR-4 there is a unique partnership formed between the USDA (NIFA and ARS), the IR-4 Headquarters and Regional Office and Laboratory staff, the State Agricultural Experiment Station/Land Grant University system, the crop protection industry, commodity and grower groups and the Environmental Protection Agency to facilitate registration of reduced risk pesticides and biopesticides for specialty crop growers and specialty use needs. 24

25 Commodity Liaison Commitee Rich Bonanno/Chair Project Management Committee John Wise/Chair Headquarters Rutgers University Jerry Baron/ Exec. Director USDA-ARS Beltsville, MD Paul Schwartz/Minor Use Officer North Central Region Michigan State University East Lansing, MI John Wise/Director Southern Region University of Florida Gainesville, FL Liwei Gu/Director Western Region University of California Davis, CA Matt Hengel/Director Northeastern Region Rutgers University Princeton, NJ Dan Rossi/Director Study Directors Quality Assurance Field Research Centers Field Coordinator Analytical Laboratories Three Regional Centers Field Coordinator Laboratory Coordinator Qualtity Assurance Coordinator Field Research Centers located in various states within the region Analytical Laboratory IR-4 Organizational Chart - The Project Management Committee is the managing body for the program developing policy, approving overall funding and coordinating national IR-4 program issues. This committee is made up of seven members, the four regional directors, the ARS Minor Use Officer, the Executive Director and the chair of the Commodity Liaison Committee. The organizational model for the regions having an Analytical Laboratory is shown in the dashed box. The Northeast Region only does field work and shares Quality Assurance responsibility with headquarters (dashed line). 25

26 Attachment 2-The IR-4 Organization-Northeast Region I. REGIONAL OVERVIEW The Northeastern Region (NER) of the IR-4 Project comprises 11 states: Connecticut, Delaware, Maine, Maryland, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont and West Virginia as well as the District of Columbia. Like other parts of the United States, specialty crop agriculture is critically important and is an important economic driver in several Northeastern states. With the rapidly increasing trend of buying food that is grown locally, the specialty crop producers in the Northeast Region have huge market and economic growth opportunities to provide food for the large population centers in/around cities such as Boston, New York, Philadelphia and Washington, DC. The IR-4 Northeast Region has been a region of considerable change over the past 10 years. Prior to 2009, the NER consisted of field research centers, field operations office, and an analytical laboratory. Within this infrastructure, there was personnel who performed field research trials, provided quality assurance/quality control oversight, coordinated field research activates, liaised with regional research community, commodity associations and other stakeholders, and analyzed residue samples. Due to budget realities the fact that IR-4 Project s capacity to analyze residue samples far out weighted IR-4 s resources to produce residue samples, the IR-4 Project Management Committee made a difficult decision to close one regional analytical laboratory. After much debate and study, the decision was made to phase out the Northeast Region Laboratory at Cornell University/NY State Agriculture Experimental Station-Geneva (NYAES-Geneva) by This site was chosen because of 18% internal fee that Cornell University charged all units for any grants received that did not allow indirect costs. Because IR-4 s grants from USDA did not allow indirect or overhead costs, the College of Agriculture and Life Sciences (CALS) paid this fee to Cornell University on behalf of the IR-4 unit at Geneva Agriculture Research Station. Also influencing the decision was the condition of existing facilities and analytical equipment. During this time, the regional organization and supporting budget was significantly reduced. The savings were reinvested in limited expansion along with new equipment for the remaining analytical laboratories. Some funds were reinvested in field research. In 2013, the NER experienced another major transition. IR-4 was informed by CALS that they could no longer cover the cost of the Cornell fee on the IR-4 grant and therefore could no longer host the Northeast Regional IR-4 Center. At this point, IR-4 had no other choice but to develop transition plans to move the operations away from Cornell. After study and dialogue, a decision was made by the IR-4 Project Management Committee to move the Northeast Region to Rutgers University. The unit would remain separate from IR-4 Headquarters but many of the functions of the new NER would be performed by staff from IR-4 Headquarters. Rutgers University submitted the fiscal year 2015 grant application to USDA for the IR-4 Northeast Region. Funds were provided to IR-4 Headquarters to perform most administrative and quality assurance functions. A sub-award was established with University of Maryland to perform the technical functions of the Regional Field Coordinator. During this transition, nearly $75,000 were redeployed into the IR-4 activities throughout the United States from savings experienced with shared services with IR-4 Headquarters. Before, during and after this transition, the IR-4 Project Northeast Region team remains committed to the goal of supporting specialty crop growers/minor use stakeholders in the Northeast region by providing legal access to safe and effective pest management technology. II. PERSONNEL AND INFRASTURTURE 26

27 The IR-4 Project s NER Director is currently Dr. Daniel Rossi of Rutgers University. Dan is also Executive Director of Northeast Association of Directors of State Agriculture Experiment Stations. Prior to taking on the NER Directors role in July 2015, Dan was the Administrative Advisor for the IR-4 Project representing Northeast states. Dr. Bradley Hillman, Director of New Jersey Agriculture Experiment Station, replaced Rossi as Administrative Advisor. In his capacity as IR-4 Project s NER Director, Rossi is the Principal Investigator (PI) on the USDA grant and as the representative on the Project Management Committee. Working with Rossi is IR-4 Executive Director, Dr. Jerry Baron who is co-principal Investigator on the USDA grant. Technical and administrative functions of the NER are managed through a partnership between Rutgers University and University of Maryland. The key participants are: Ms. Marylee Ross, University of Maryland She serves as Regional Field Coordinator (RFC). In addition to the responsibilities of RFC, she also has the responsibilities of management of the scaled back IR-4 Field Research Center in Salisbury, MD at University of Maryland s Lower Eastern Shore Research and Education Center. The University of Maryland is currently proceeding in hiring a research associate to assist Ms. Ross with expanded responsibilities. Some specifics of Ross s RFC responsibilities include: o Soliciting stakeholder input with regard to the specialty crop pest and disease management needs of NER specialty crop growers and commodity groups; o Interacting with IR-4 Project Headquarters Study Directors, Program managers (Food, Biopesticide/Organic Support and Ornamental Horticulture as appropriate to identify needs, develop protocols, processes and methods and bring projects to successful fruition; o Managing all field aspects of the food use program (under USEPA GLPs), as well as the biopesticide and ornamental programs; o Conducting quality control review of all data submitted from NER research; o Articulating and championing NER pest management priorities within IR-4 priority setting process. Ms. Jane Forder, IR-4 Project Headquarters/Rutgers University She serves as Regional Quality Assurance Coordinator (RQAC) responsible for the quality assurance responsibilities for all IR-4 field work in the Northeast states. This responsibility requires approximately 50% of her time. During the other 50% of her time she assists IR-4 Project Headquarters and the rest of the IR-4 Project through conducting high priority audits of data. Ms. Sherri Nagahiro, IR-4 Project Headquarters/Rutgers University - She manages administrative operations for the NER. This is approximately 20% of her functions. The other 80% are duties associated with the administrative functions of IR-4 Project Headquarters. Specific responsibilities and functions involving the NER include: o Drafting grant application for PI/Co-PI approval; o o o o Manage NER awards/funding sources from submission to close out; Interact with government agencies, university collaborators, researchers and consultants to negotiate agreement terms and conditions for subawards and cooperative agreements; Ensure IR-4 Northeast Region compliance to all terms and conditions of awards and agreements including developing project initiation and drafting annual reports, fiscal oversight of researchers that expend funds within their budgets; Reduce the burden of IR-4 NER activities on Rutgers University s Office of Research and Sponsored Projects; 27

28 o Manage Business Assistant to ensure NER purchasing issues are addressed; o Provide guidance to NER RFC in matters concerning Rutgers University policies, address financial or agreement matters, queries and/or concerns; o Collaborate with IR-4 Project Headquarters Program Managers in matters concerning their Northeast region research and projects to review and prepare budgets and ensure subaward agreements are executed; Other IR-4 Headquarters personnel involved include Ms. Uta Burke, Business Assistant, Ms. Juliet Thompson, Administrative Assistant-Quality Assurance, Ms. Sherrilynn Novack, Communications As noted above, Rutgers University/IR-4 Project Headquarters and University of Maryland provide support for NER activities. Both Universities provide institutional support with no indirect cost recovery. IR-4 Headquarters and NER activities that are imbedded within IR-4 Headquarters attempt to make up this lack of indirect cost by covering some expenses. For example, rent and utilities for office space is paid out of the grant. University of Maryland provides field and office space for the NER. Table 1: Northeastern Region IR-4 program organizational chart: 28

29 III. REGIONAL PROGRAMS FIELD RESEARCH PROGRAM - FOOD The total capacity of IR-4 Field Research Centers/key sites in NER is between 65 to 70 field trials per year. The Field Research Centers established to conduct field residue trials are outlined below in Table 2. Table 2: Northeastern region field research centers Field Research Center - Field Research Director Location EPA Region Cranberry Research Center-UMASS Homer Research Farm 12 Cornell University Lower Eastern Shore Research and Education Center Univ. of MD Rogers Farm Rutgers Tree Fruit Research and Education Center Rutgers Snyder Research and Education Farm Marty Sylvia/Hilary E. Warham, MA 1 1/3 Sandler Zvonko Jacimovski Ithaca, NY 1 16/21 Marylee Ross Salisbury, MD 2 10/26 Frank Drummond/David Orono, ME 1 2/4 Yarbrough Tom Freiberger Cream Ridge, NJ 1 or 2 16/20 Jennifer Fisher Pittstown, NJ 1 3/15 Approximate number of trials per year/max capacity FIELD RESEARCH PROGRAM ORNAMENTALS The Ornamental Horticultural program is similar to the Food Use Program in process but much smaller in resource allocation. The national program is managed by the Ornamental Horticulture Manager at IR-4 HQ. The NER RFC will identify qualified researchers, provide guidance as to research requirements, monitor and track trial progress, allocate funding and provide final reports to the Ornamental Horticulture Manager. Researchers are selected based on the target pest of interest and the researcher s expertise. The RFC notifies the researchers of their funding and provides access to the agreed upon protocols. These protocols are designed at the national level for a coordinated research effort. The RFC will also provide assistance to the researchers conducting work in the region as questions regarding the projects arise. The research cooperators involved in Ornamental Horticulture are in Table Until December

30 Table 3: Cooperating ornamental researchers, Institution Researcher Discipline Connecticut Agricultural Experiment Station Cornell Cooperative Extension of Suffolk County Jatinder Aulakh Weed Science Pre-emergent Herbicide Crop Safety James LaMondia Pre-emergent Herbicide Crop Safety Plant Pathology -- Nematode Efficacy Nora Catlin Plant Pathology Botrytis Efficacy Botrytis Efficacy: Field In Ground Seedlings New Disease Products Crop Safety Dan Gilrein Entomology Thrips Efficacy Foliar Feeding Beetle Efficacy New Insecticide/Miticide Crop Safety New Pest Products Crop Safety Andy Senesac Weed Science Pre-emergent Herbicide Crop Safety Pre-emergent Herbicide Crop Safety Ornamental Grasses Herbicide Crop Safety Ornamental Grasses Herbicide Crop Safety Rutgers Cream Ridge Research Center Dave Bodine Plant Pathology New Disease Products Crop Safety -- Rutgers University Carrie Mansue Weed Science Pre-emergent Herbicide Crop Safety Pre-emergent Herbicide Crop Safety TM Agricultural and Ecological Services Todd Mervosh (Consultant) Weed Science Pre-emergent Herbicide Crop Safety Pre-emergent Herbicide Crop Safety Ornamental Grasses Herbicide Crop Safety University of Delaware University of Maryland Brian Kunkel Entomology Scale Efficacy in Container -- Ed Beste Weed Science V Crop Safety -- University of Massachusetts Nick Brazee Plant Pathology New Disease Products Crop Safety -- Rob Wick Plant Pathology New Disease Products Crop Safety -- FIELD RESEARCH PROGRAM BIOPESTICIDE & ORGANIC SUPPORT (BOSP) 30

31 The goal is to support research that enhances the development and registration of biopesticides for use in conventional and organic food and non-food pest management programs. This program also has a workshop which is usually directly after the Food Use Workshop. The IR-4 BOSP selects priorities by stakeholders and is a defined research program with fee-for-service determined by the complexity and treatments required in each protocol. See Table 4, below, for the listing of cooperators and research IR- 4 funded in 2015/2016. Table 4: Cooperators and research projects for the BOSP 2015/2016 Project Year Researchers Institution Spotted Wing Cesar Rodriguez- 2015/2016 Drosophila Saona Rutgers University Spotted Wing Frank 2015 Drosophila Drummond University of Maine RNAi Technologies 2015 Anthony Shelton Cornell University Chestnut Blight 2015/2016 William Powell Syracuse Univ. (SUNY-ESF) Bacteria Speck/Spot 2015/2016 Meg McGrath Cornell University Striped Cucumber Beetle-Organic 2016 Abby Seaman Cornell University Striped Cucumber Beetle-Organic 2016 Brian Nault Cornell University Downy Mildew on Organic Basil 2015 Meg McGrath Cornell University Fire Blight on Organic Apple 2015/2016 Kari Peter Penn State ANALYTICAL LABORATORY As noted previously, the NER grant no longer supports an analytical laboratory. The residue samples produced in the NER are shipped to other IR-4 analytical laboratories for analysis. QUALITY ASSURANCE The NER IR-4 Quality Assurance Unit (QAU) currently consists of one regulatory scientist who is embedded within the QAU at IR-4 Headquarters. This individual s primary responsibility is auditing and providing reports to the study director and testing facility management (IR-4 Executive Director/designee) on the status of compliance to Good Laboratory Practices regulations. This is accomplished through facility inspections and in-life audits of field trials. The NER QA also assists field researchers with EPA inspections. Typically, during a single year, the NER IR-4 Center QAU will assist with 1-2 US EPA inspections. Because the workload of the NER Quality Assurance Unit is light, the auditor is expected to assist other regions and IR-4 Headquarters with their workload. This person s efforts are deployed by the IR-4 Quality Assurance Manager as needed to help expedite completion of report auditing. FIELD RESEARCH PROGRAM - PROGRESS 31

32 Northeastern region activity from 2012 to 2016 is presented in Table 5 for Field and Quality Assurance. In the field program, there are three types of research conducted. The Food Use program performs GLP controlled food residue studies to establish a registration/tolerance. The Food Efficacy/Performance program is to help fill in data gaps that can support a registration and does not require GLP inspection. This program is an easier path to a registration and offers a bigger return on the program s investment. The Ornamental and Biopesticide programs are also efficacy/performance programs to expand the uses for ornamental as well as food crops (biopesticide). The region averages around 91 food trials over the past five years which is well below the capacity of the regions field centers. Table 5: NER IR-4 activity from 2012 to Northeastern Discipline/Representative Crops Region Field Trials Centers Cranberry Research All types of pesticides on cranberry Center-UMASS Homer Research Farm 13 Cornell All types of pesticides on vegetables and tree fruit University Lower Eastern All types of pesticides on vegetables, small fruit, and mushroom Shore Research and Education Center Univ. of MD Rogers Farm, All types of pesticides on blueberry and potato University of Maine Rutgers Tree Fruit Research and All types of pesticides on tree fruit and small fruit Education Center Rutgers Snyder Research and Education Farm Food Efficacy Ornamentals Quality Assurance Facility In-Life, Field IV. STATE LIAISON REPRESENTATIVES 13 Until December

33 The State Agricultural Experiment Station Director in each state of the NER nominates a State Liaison Representative (SLR) to serve as a collaborator and advisor for the IR-4 program. See Table 6 for the listing of the NER State Liaison Representatives. Many of these SLRs have many years of experience in pest management practices and are actively involved in Integrated Pest Management (IPM) research and extension in their states. Communication is most often via but once a year, generally in the summer, the IR-4 NER holds a meeting with the Regional Director, RFC, SLRs and others to discuss potential pesticide needs in the region as well as identify common areas of future collaboration. Table 6: IR-4 Project Northeast Region State Liaison Representatives State Liaison Representative Connecticut T. Mervosh Delaware B. Kunkel Maryland E. Beste Massachusetts R. Wick Maine D. Yarborough New Jersey D. Polk New Hampshire C. Smith New York B. Nault Rhode Island H. Faibert Pennsylvania G. Krawczyk Vermont A Hacelrigg West Virginia D. Frank IV. BUDGET The budget outline in Table 7 is from 2012 to Though there is missing significant details for , the important information is the amount associated with the core functions. Research grants can vary year to year depending on research projects chosen at IR-4 Priority Setting Workshops and distribution of research with other regions, USDA-ARS and Canada. With the synergies gained by combining IR-4 NER administrative and quality assurance operations with that of IR-4 Headquarters, IR-4 was able to recoup over $50,000. Table 8 is the budget breakdown from the Subaward provided to University of Maryland to cover the cost of Regional Field Coordinator and assistant. The equipment item in this year s budget was to cover the cost of purchasing a van. Some additional notes on the Rutgers, University of Maryland and other subawards budget items are below. SALARY AND BENEFITS - Key Personnel - The majority (95%) of the Dan Rossi s (PI) salary is funded/associated with his duties as Executive Director of Northeast Region Association of State Agriculture Experiment Station Directors. Ninety-five percent of Jerry Baron s (Co-PI) salary is funded from his duties as Executive Director of the IR-4 Project through other funding sources. Quality Assurance The NER NIFA grant pays 100% of a Quality Assurance Specialist who is located in the HQ office. In 2015, the salary amount was less than 100%, with the remaining salary being covered from some carryforward funds from Cornell. Administration and Operations Functions are performed primarily by four members of IR-4 Project HQ staff. The majority of their salaries are funded from NIFA HQ grant with a fractional amount coming from the NER NIFA grant. TRAVEL -Expected travel includes: 33

34 Principal Investigator - travel to the IR-4 Project Management Committee (PMC) meetings to discuss long-term policy, coordination of the Northeast Region and the national program Quality Assurance Travel - In association with the Federal Good Laboratory Practice Regulations Quality Assurance Unit personnel "shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the regulations". To meet this requirement, the QA Unit personnel must travel multiple times annually to each field site to inspect facilities and observe critical phase of research. Workshop Travel Reimbursement - National priorities for IR-4 are established at Priority Setting Workshops. The NER Regional Field Coordinator, PI and Co-PI will select ten scientists from the NER to attend and participate in the workshops and reimburse expenses. State Liaison Representatives - The State Liaison Representatives (SLRs) are encouraged to attend the annual regional meeting; funds are provided to cover travel expenses. REGIONAL FIELD COORDINATOR OPERATIONS-Funds for the Regional Field Coordinator operations comes from two distinct and separate budget categories. Rutgers has established a Subaward with University of Maryland to fund the Regional Field Coordinator activities (see Table 8). Additionally, the Regional Field Coordinator/staff directly conduct research work at their site, approximately 12 field trials annually. These funds are transferred in a Fee for Service agreement. Total funds for this site exceed $225,000. Table 7: Northeastern Region budgets CORE ACTIVITIES Salaries and Wages PI $5,347 $9,090 Co-PI $9,189 $9,560 QA $60,000 $83,231 Administrative $34,182 $35,036 Fringe Benefits $43,998 $55,355 Total Salary + Fringe $152,716 $192,272 Travel $47,500 $19,169 Other Core Cost Sample shipping $22,000 $15,224 Subaward Univ. of MD (RFC) $150,869 $150,869 $172,869 $166,093 Total Core $450,000 $493,365 $430,711 $373,085 $377,534 Research Grants $481,941 $394,342 $387,500 $407,000 Total Regional Funds $975,306 $825,053 $760,585 $784,534 Table 8: Breakdown of expenses of Regional Field Coordinator operations at University of Maryland

35 35

36 Attachment 3 -The IR-4 Organization-Northcentral Region I. REGIONAL OVERVIEW The North Central Region (NCR) of the IR-4 Project comprises 12 states: IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD and WI and has been centered at Michigan State University (MSU) since the inception of the regional programs in The NCR program, while located at MSU, has developed a network of field research centers and cooperators around the region, established a highly capable laboratory unit at MSU, and, in response to the Good Laboratory Practice (GLP) requirements of United States Environmental Protection Agency (USEPA), has developed a cooperative group of Quality Assurance personnel to serve the region. According to USDA s 2007 Census of Agriculture, specialty crops accounted for well over $50 billion dollars in annual sales or 34% of the total crop sales for the US. In the NCR, the total value of these crops is $4.86 billion, of which approximately half is attributable to ornamental crops. Processors and consumers set stringent standards for high quality, pest-free produce to be provided at a low cost and on a reliable basis. In turn this establishes the need for highly effective pest management programs. Despite the high value of specialty crops, plant protection companies often consider the high cost of personnel time, product development, research testing, and registration too large an investment to register IPM tools for these crops. Liability issues for injury to, and loss of, such high value crops can also discourage the plant protection industry from investing in this market. To maximize the return on investment, most pest management products are targeted on major crop markets where there is a potential for better profits. As a result, specialty crops often end up with few pest control tools and, in the past, these have often been older ones, subject to loss from pest resistance, and with less desirable toxicological and environmental profiles. Major crops may also, on occasion, have uncommon or regionally limited pests that are given low priority by the plant protection industry, and therefore are appropriate for intervention by IR-4. This lack of modern pest management chemicals for specialty crops and minor uses is a vexing world-wide problem in countries with advanced regulatory systems. The mission of the NC Region IR-4 program is to ensure that safe, effective and economical pest management solutions are available for growers of specialty crops, including ornamentals, and for minor uses on major crops, both for the NC region, and as a key partner in the national IR-4 program. The goals of the program are to identify pest management needs for these crops in the region, to participate in the stakeholder prioritization of solutions at the national level, to conduct field research and analytical studies that develop the information to obtain clearances and label additions from EPA and the registrant to meet these needs, and, finally, to make information available on the status and progress of these studies and their final outcome to growers and other stakeholders. The IR-4 Project s continued success can be measured by the large number of specialty crop pest control clearances established or retained as a result of its efforts. A high priority is placed on those uses of products classified as Reduced Risk by EPA or otherwise deemed as lower risk alternatives to current uses. Additionally, priorities are also assigned to products that can be used in IPM programs. Since the program s inception in 1963, IR-4 has been granted over 13,000 food use clearances. As part of this process, IR-4 has been able to bring many new and safer pesticide active ingredients to minor crop 36

37 growers at the same time as their initial registration for use on major crops. According to EPA, IR-4 data supports approximately 50 percent of all EPA new uses for existing chemical registrations on food crops. For ornamental crops, in the IR-4 Project have conducted over 700 research trials that led to the registrations of uses of chemical and biopesticide agents on nursery stock, flowers, Christmas tree and turf grass. This resulted in new or amended registrations of compounds impacting approximately 1,500 ornamental crops. The ornamentals industry accounts for $15 billion (30%), of the total specialty crop value in the US. According to a recent report (The U.S. Economic Impact of the IR-4 Ornamental Horticultural Program. S. Miller, and A. Abdulkadri MSU Center for Economic Analysis, Dec. 2008) several states in the NC region are leaders in the production of ornamental crops (e.g. Michigan at no 6 and Ohio at no. 7, both with receipts well over $0.5 billion/year). Overall IR-4 contributes over $1 billion annually to the U.S. GDP through its ornamental program which supports almost 17,000 jobs in the ornamentals industry. Biopesticides have been an important IR-4 focus since 1982 and EPA has granted over 300 biopesticide clearances since the biopesticide research objective began with a total economic impact in 2011 of almost $155 million (Economic Impacts of the IR-4 Project and IR-4 Project Progams, S. Miller and A Leschewski, MSU Center for Economic Analysis, Dec. 2011).. II. PERSONNEL AND INFRASTURTURE The personnel who work to accomplish the goals of the NCR IR-4 Center are: Center Director. Dr. John Wise is the Center Director and is responsible for the overall conduct of the IR-4 program in the North Central region, and, as a voting member of the Project Management Committee (PMC), for assisting in the planning and conduct of the IR-4 Program nationally. He currently is the chair of the PMC, for which he will serve a three-year term ending in Laboratory Director: Dr. Susan Erhardt. Dr. Erhardt is currently in charge of the analytical unit. She is responsible for the operations of the IR-4 analytical laboratory at Michigan State University and for liaison with laboratory coordinators in other regions and the USDA-ARS IR-4 program and with Study Directors at IR-4 Headquarters. The Coordinator is specifically responsible for the conduct of analytical studies, the preparation of analytical summary reports (ASRs) and the observance of GLP in the lab. She and the Associate Director, Dr. Jiang, currently supervise four full-time and one part- time analytical chemists/lab assistants. In addition, there is one full time temporary lab staff, R. Chinnery, and two part-time student laborers used in the lab. She also acts as the Center s Archivist as required under GLP. Several part time/on-call personnel are also involved in the laboratory program as needed for such tasks as sample preparation and lab clean-up. Field Research Director: Dr. Satoru Miyazaki. Dr Miyazaki is responsible for liaison and communication with field researchers throughout the NCR and for communication with field research coordinators in other regions and with Study Directors at HQ regarding the conduct of the field portion of the NCR program. The Regional Field Research Director (RFRD) maintains EPA Good Laboratory Practice in all Regional fieldwork. He also acts as the liaison with the IR-4 state liaison representatives in each state 37

38 and is responsible for the timely submission and initial QA review of field data notebooks. He has one part-time assistant, N. Schroeder, at MSU Quality Assurance Unit Director: Dr. Zhongxiao Chen. Dr Chen is responsible for the Regional Quality Assurance Unit (QAU) and through this for the observance of EPA Good laboratory Practice across the NC Region including required facilities inspections, in-life study inspections, and the review of field and laboratory reports and final reports. He works in conjunction with the QA Director at IR-4 HQ. He also is responsible for QA operations at the UDA-ARS IR-4 unit at Wooster, OH under subcontract from USDA- ARS. Dr. Chen is assisted by Mrs. Lisa Latham as a full-time QA Associate at MSU. As a response to the need to conduct all food use studies under the exacting rules of GLP, the NCR IR- 4 program has developed a series of field research centers within the region. This consolidation of most of the fieldwork into a few specialized locations is essential because of the training and experience needed to conduct such studies and the availability of equipment and ancillary facilities such as pesticide storage units, freezers etc. to support the IR-4 studies, some of which have been funded by IR- 4 in order to develop these sites. The consolidation also leads to significant economies in QA costs since each facility performing IR-4 food use studies must be reviewed regularly for GLP compliance and each project must be visited at least once while the studies are in progress. These regional centers are: Michigan State University Field Research Center at East Lansing. Field Research Director: Dr. Bernard Zandstra, Department of Horticulture. This center performs food use field trials on vegetable, small fruit and tree fruit crops, specializing in herbicide applications. It typically conducts about 20 trials each year. One full time and one part-time assistant are committed to IR-4 projects. Michigan State University Field Research Center at Fennville. Field Research Director, Mr. Anthony VanWoerkom, Department of Entomology. The center at Fennville performs food use field trials primarily on small fruits and tree fruits. It typically conducts trials annually. University of Wisconsin Field Research Center at Arlington. Field Research Directors, Dr. Dan Heider (Department of Horticulture) and Scott Chapman (Department of Entomology). This center performs food use field trials on vegetables, field crops, mint and cranberry. It typically conducts trials annually and two positions are devoted, part-time, to IR-4 projects. In addition, for crops not grown at the Field Research Centers, projects are conducted, according to annual need, by other university cooperators with appropriate GLP training and oversight. These are conducted at several locations in the NC region, particularly in North and South Dakota and Nebraska. On occasion, private contractors are used if appropriate university cooperators are unavailable. In 2015/16 we intend to retain Dr. Derek Killilea (Killilea Consulting, ND) for QA assistance in the northwest states of the region, and E. Nelson in Wisconsin. 38

39 Fig. 1: Organizational Structure of the IR-4 NC Regional Center at MSU NCR Administrative Advisor: D. Buhler Michigan ABR NC Region Center Director: J. Wise North Central Regional Advisory Committee Bookkeeping, Secretarial and IT Support: L. Gallagher C. Devereaux J. Eschbach Regional Field Research: S. Miyazaki (Director) N. Schroeder (Asst.) Regional Analytical Lab: S. Erhardt (Director) W. Jiang (Assoc. Director) Regional Quality Assurance Unit: Z. Chen (Director) L. Latham (Asst.) IR-4 Field Research Centers: (MI, WI) Cooperating Field Sites: State AES (IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI) Contract Quality Assurance Services: D. Killilea E. Nelson L. Geissel Res. Asst. S. Kumar Res. Asst. E. Abouzied Res. Asst. R. Fader Res. Tech. R. Othoudt Lab. Asst. 39

40 Management of IR-4 resources The NCR program has developed and operates its own database (responsibility of Dr. Jiang) to track the scheduling and progress of all projects in both the field and laboratory phases. A new component to track projects as they proceed through Quality Assurance was added last year so that all phases of the projects assigned to the region can be readily monitored. Meetings between the Regional Director and the staff responsible for the lab, field, and QA units are held monthly (or more often if required) to review progress, plan and coordinate future activities, and resolve any problems or deviations from schedule. There are frequent conference calls, particularly nationally between the members of the IR-4 analytical program, the RFRD, and IR-4 HQ, to ensure that progress is satisfactorily maintained and to address any problems on a group basis. Accountability in following GLP is also verified by the regular on-site audits by the EPA s Office of Compliance Monitoring. There were five EPA compliance inspections conducted in the NC Region in 2015, and all were closed without adverse findings. This illustrates the continuing effectiveness of our region s FRDs, Laboratory and Quality Assurance personnel. Administrative management at MSU. The NCR IR-4 key personnel and laboratory staff are employees of Michigan State University and as such follow established University policy and procedure for operations including employee affairs, purchasing, and travel. The Senior Assoc. Dean of the College of Agriculture & Natural Resources at MSU and Director of AgBioResearch (Dr. Douglas Buhler) is the Administrative Advisor to the IR-4 program for the NCR and provides linkages to Michigan Agricultural Experiment Station (AgBioResearch) and MSU Extension and to the higher administration at MSU. He also represents the program to the NC Region State Agricultural Experiment Station (SAES) Directors. Since there are no indirect costs allowed on this grant, and in recognition of the value of the program to the state and region, MSU provides many services to IR-4. These MSU contributions include significant salary contributions for the several MSU extension specialist faculty who conduct our field research activities, oversight and financial management by the MSU Office of Sponsored Programs, and other support services such as waste management and personnel administration that would normally be funded by the indirect costs attributable to an external grant of this size. The financial accountability for the NCR grant will continue to be monitored and assured by the MSU Office of Sponsored Programs in full conformity with all federal regulations. The NCR program and personnel are affiliated with the Department of Entomology at MSU. The Department provides very effective administrative program support in the form of secretarial and book-keeping resources and representation to the University administration. III. REGIONAL PROGRAMS The NC Region IR-4 unit currently operates (on an annual lease basis) from a suite of facilities located in the Michigan Biotechnology Institute building located on the southern edge of the Michigan State University campus. This building contains excellent modern laboratory, office and meeting space and is connected to the campus computing network by a Fast Ethernet (100 Mb/s) system. The program 40

41 occupies a total of 4,636 ft 2 with three major laboratories of about 650 ft 2 each equipped with multiple fume hoods. Three smaller laboratories ( ft 2 ) are used for sample preparation and mass spectroscopy. A large walk-in freezer is fully devoted to IR-4 use with emergency power back-up in case of power failures and emergency call out in case of catastrophic failure. An additional large walk-in freezer is located in the CIPS building on the MSU campus which is used for long term sample storage. Eight offices ( ft 2 ) are available for the three Coordinators, the QA Assistant and the five analytical technicians. A further office facility is used for the secure data storage and archiving required under GLP, and a small storage area is used to store field research and other supplies. Three open cubicles adjacent to the office complex are available for a secretary, students and other assistants. All areas have high-speed data connections. We have an active lease agreement for this space, which is renewed annually based on our funding. Secretarial, book-keeping and IT services are provided by the Department of Entomology at MSU. Chemical and Radiological safety and training, including chemical waste disposal, are provided by the MSU Environmental Health and Safety Office. FIELD RESEARCH PROGRAMS Food Use Projects. These projects represent the major part of IR-4 s activities. Because of the stringent requirements of GLP, it is IR-4 policy project-wide to attempt to place as many studies as possible at specific IR-4 Field Research Centers where the personnel are trained and experienced in conducting such studies. As noted, we c urrently we have three such Field Research Centers in the NC region. If these Centers cannot handle a specific trial for some reason, we then go to additional established cooperators with the capability to conduct such as study and who are experienced in GLP. For the NC region these are often located in the Dakotas or Nebraska where crops such as sunflowers or flax are grown. Highly specialized crops such as wild rice (Minnesota) or ginseng (Wisconsin) again require the location of cooperators outside the Research Centers. Commercial contractors are often used in such situations if no experienced university personnel are available to conduct the study. Assignments outside the Research Centers are determined by the RFRD in consultation with the appropriate State Liaison Representative and IR-4 HQ. For 2016 there are 63 food use residue (GLP) projects and 9 performance (efficacy and crop safety) projects. The cost of a GLP food use residue field trial is typically about $6,000, but may be somewhat higher depending on complexity and travel costs. The cost of a combined crop safety and efficacy studies (non-glp) is typically $3,000. Biopesticides and Organic Support Program. Proposals are solicited widely as previously described. After the proposals are reviewed nationally by a team of experts including the RFRD, the role of the NC region is to distribute funds, to track progress on projects conducted by researchers in the NCR, to answer inquiries regarding the program, and to ensure the timely delivery of project reports to the program manager at IR-4 HQ. This is primarily the responsibility of the RFRD. Ornamental Horticulture Program. Projects are prioritized nationally with regional input, with some special attention to regional needs as already described. After award, the regional projects are monitored by the RFRD who also ensures the timely delivery of the project reports to HQ. Any problems are resolved by consultations between the researcher, the RFRD and the Ornamental Horticulture Manager at IR-4 HQ. 41

42 When annual funding is received by the region it is made available to the individual collaborators through sub-award agreements that are developed and administered by the MSU Office of Sponsored Programs which is responsible for financial oversight and reporting. International Activities: International activities have been primarily in the form of capacity building and invited lectures, Dr. Jiang has traveled to Egypt and Morocco to work with international laboratories and the IR4 headquarters building international laboratory capacity for residue analysis. He also contributed to the previous capacity building efforts with ASEAN countries. Dr. Jiang s effort in international activities have been covered by FAS funding, separate from the IR-4 NIFA grant. NCR State Researchers Participating in the IR-4 Program ILLINOIS MICHIGAN MINNESOTA OHIO WISCONSIN D. Williams S. Miyazaki V. Krischik D. Doohan D. Heider T. Davis F. Hand S. Chapman M. Hausbeck NEBRASKA A. Persad R. Groves INDIANA J. Wise S. Kamble J. Siefer D. Egel A. VanWoerkom S. Miller C. Sadof B. Zandstra SOUTH DAKOTA W. Kirk NORTH DAKOTA S. Clay IOWA G. Sundin R. Zollinger R. Hartzler R. Issacs M. Ciernia D. Cochran M. Grieshop B. Jenks KANSAS MISOURI R. Cloyd Open ANALYTICAL LABORATORY Laboratory Performance: The IR-4 laboratories at MSU have a comprehensive and modern collection of highly automated equipment needed to prepare, extract, clean up, separate, identify and quantify trace amount of pesticide in plant and food samples. This includes multiple gas and liquid chromatographs with flame photometric, electron capture, nitrogen/phosphorous (thermal ionic), fluorescence and UV detectors, integrators, UV/Vis spectrometers, and four mass spectrometers (one GC-MSD and three triple quadrupole LC-MS/MS instruments). This equipment has been purchased on previous IR-4 grants and is fully devoted to this project. Service contracts are essential on the larger pieces of equipment, particularly the workhorse LC/MS/MS units. A list of the major existing items of equipment is provided below (Table 1). In addition, the laboratory has adequate smaller, general laboratory equipment, sample grinders, small freezers, and computers including its own server. Two large walk-in freezers with independent power back-ups are available for sample storage prior to analysis. Critical instruments are also backed up by uninterruptable power supplies. Due to its age and increasing unreliability, a replacement instrument for the Thermo-Finnegan LC/MS/MS is requested as a new equipment lease. 42

43 Table 1: List of Major Equipment in the NCR IR-4 Laboratory Vendor Instrument Detector Year bought Agilent 6460 LC/MS/MS with series 1200 HPLC MS/MS 2010 DAD Waters UPLC/Quatro Micro MS/MS (ESI and APCI) MS/MS 2007 DAD Agilent 6890/5973N GC/MSD MSD 2005 Thermo TSQ Quantum LC/MS/MS with ESI, API and APCI sources MS/MS 2002 Finnegan DAD Waters 2690 Alliance/Millennium HPLC, with UV and fluorescence UV 1999 detectors fluores. Agilent Agilent 6890 GC, with EC, NP detectors ECD 1999 NPD Agilent Agilent 6890 GC, with NP, and FP detectors NPD 1998 FPD Robot RSI 10B sample processor None 2010 Coupe Dionex Dionex ASE-200, Automated Solvent Extraction System None 1998 The regional program also depends on the availability of adequate well-maintained equipment for pesticide application, crop cultural operations, and cold storage of materials and samples at the research stations that conduct our field trials. This is generally available as part of the collection of equipment provided by the universities in question and used for operating these stations for a range of projects. Quality Assurance Program The Quality Assurance Unit (QAU) monitors field trials and laboratory analytical trials that were conducted in the region including the USDA ARS facility at Wooster, OH. QAU conducts periodic in-life inspections of the GLP studies to assure the management that the study protocol and appropriate Standard Operation Procedures (SOPs) are followed in compliance with the EPA GLP standards (40 CFR 160), and audits the field data books, analytical raw data, analytical summary report, and draft final report of each study to assure the data quality and integrity for GLP compliance. As part of the GLP requirements, QAU also conducts facility inspections to assure that the personnel, equipment, and test facilities are properly set up and adequate for conducting the requested GLP studies (Table 2). The personnel in the QAU that were involved in NCR studies are: Quality Assurance Officers Dr. Zhongxiao Michael Chen Ms. Lisa Latham Area of Responsibility Regional QAU management, inspections, and audits Inspections and audits 43

44 Dr. Derek Killilea ND/SD Field Sites Dr. Bryan Jensen UW-Madison IR-4 Research Center (retired in 2015) Ms. Eileen Nelson UW-Madison IR-4 Research Center (Since December 2015) Table 2: NCR IR-4 activity from 2012 to North Central Discipline/Representative Crops Region Field Trials Total Centers MSU-East Lansing Weed Sci, Plant Path/CG 1-9, 11-13, 19 MSU-Fennville Entomology/CG U of Wisconsin Entomology, Weed Sci/CG 1-9,13,15,16,19 NDSU-Fargo Weed Sci/CG 1,2,6,7,15,16,18,20 NDSU-Minot Weed Sci/CG 1,2,6,7,15,16,18,20 Ohio State University Weed Sci,Plant Path/CG 1-9,13 SDSU Weed Sci/CG 1,2,6,7,15,16,18,20 Weed Sci, Plant Path/CG 1-9, 11-13, 19 Food Efficacy Ornamentals Analytical Projects Regional Laboratory Quality Assurance Facility In-Life, Field/Lab Field Data Book ASR Petition IV. STATE LIAISON REPRESENTATIVES Each state in the NCR, through their State Agricultural Experiment Stations, is encouraged to appoint a State Liaison Representative (SLR) to the NC Region Advisory Committee. Currently all the states but Missouri have appointed at least one such representative. The SLRs have the responsibility to explore and communicate high priority pest management needs in their states to the IR-4 Field Research Coordinator, act in an advisory capacity for the NCR program, and help to communicate the goals and achievements of the program to the stakeholders in their states. Commodity Liaison Committee (CLC). Operating at the national level, the CLC consists of specialty crop growers, and commodity group and food processor representatives. The members are nominated 44

45 by the CLC and approved by the Project Management Committee. The CLC is regionally-balanced and NCR members frequently take an active role at the regional level by serving on the NCR Advisory Committee. The chair of the CLC is a member of the Project Management Committee and the PMC schedules a half-day meeting with the entire CLC at least once a year. The structure and operations of the CLC are described in more depth in the companion Rutgers University proposal to house the IR-4 HQ. The IR-4 program has frequent communication with and receives input from stakeholders regarding program needs, operations, priorities and outcomes at the national and regional levels through both formal and informal mechanisms. Nomination and prioritization of the researchable projects begins at the NC Regional Advisory Meeting in late summer. State Liaisons Representatives, grower groups, IR-4 cooperators, the NCR IPM Center representative, Field Research Center Directors and other university specialists are invited to attend. Those not able to attend can participate via teleconferencing. Here the projects of special interest to the NC Region are discussed and those of the highest priority are nominated for prioritization at the annual Food Use Workshop (FUW). Progress and updates on the program are presented, future research needs are assessed and prioritized, and potential cooperators in conducting these projects are identified. NCR State Liaison Representative in the NCR ILLINOIS D. Williams INDIANA D.Egel IOWA R. Hartzler KANSAS R. Cloyd MICHIGAN S. Miyazaki MINNESOTA V. Krisckik MISSOURI Open NEBRASKA S. Kamble N. DAKOTA R. Zollinger OHIO D. Doohan S. DAKOTA S. Clay WISCONSIN D. Heider Communication with Stakeholders- Information Networks. Communication with stakeholders occurs though a number of formal and informal mechanisms at both the national and regional levels. A major vehicle for communication and input of project requests is the IR-4 website ( This interactive site allows anyone to check on the current status of projects and to submit the information to initiate new ones. The annual report for the program and many other types of information and links are also located there including a monthly activity report and a widely used New Products listing that describes new and pending chemicals and biopesticides that could provide solutions to specific pest management problems. The project has a full time Outreach Communications Coordinator who, among a variety of activities, publishes a newsletter every 3 months and, with regional assistance, provides state-level report cards to describe progress and contributions to the specialty crop agriculture of specific states. The several regional and national research planning 45

46 meetings are a further means whereby interactions and communication with collaborators, growers and the plant protection industry are facilitated. Activities Specific to the Region. The State Liaison Representatives are charged with communicating program activities and achievements to growers and other stakeholders in their states and also with bringing back to IR-4 the needs and responses of these stakeholders. The NC Region IR-4 director also holds an annual meeting with NC commodity liaisons in concert with the Great Lakes Fruit and Vegetable Expo in December each year. State level IR-4 meetings are also held from time to time to communicate with stakeholders in Michigan. An annual report of regional activities and achievements is prepared and distributed to the land grant universities in the NC region. Informally, the regional RFRD is in frequent communication with field researchers, commodity group and food processing representative, and project requestors to monitor and convey progress in attaining necessary registrations and determine the need for additional IPM materials. The RFRD attends research field days and, during the growing season, participates in some of the weekly Michigan Crop Advisory Team Alerts which communicate current events in crop production and pest management to extension personnel and growers in the field. Additional input in projects, prioritization and communication occurs through program integration with the NC IPM Center. This Center is co-located at MSU and the University of Illinois. The joint location with IR-4 at MSU facilitates collaboration between the two programs. Interactions between these programs include the participation of IR-4 personnel in the development of Pest Management Strategic Plans. In turn the NC IPM Center leadership is invited to participate in, and regularly attends, the annual regional IR-4 Advisory meeting. At the national level, the IPM Centers appoint a representative to liaise with the IR-4 Project Management Committee regarding pest management needs and priorities for specialty crops. Lynnae Jess, a co-director of the NC IPM Center stationed at MSU, has recently been appointed as this national liaison. IR-4 personnel actively engage university specialty crop scientists to better understand emerging pest management problems, and to inform research groups how IR-4 can contribute to successful solutions. For example, in several of the multi-state research teams working with Federal grants to address invasive species problems, IR-4 personnel have served on grant advisory committees or as collaborators. In several cases, optimized pest control solutions included new pesticide registrations, reducing pesticide pre-harvest intervals or attaining section 18 exemptions, all of which were accomplished through direct involvement with IR-4. IV. BUDGET Table 3 is a comparison and general breakdown of the regions budget from 2012 to 2016, with example budget description from 2016 NIFA grant below. 46

47 BUDGET JUSTIFICATION 2016 A. Senior IR-4 Personnel: 2016: $298,965 (Salaries) + $98,255 (Fringe Benefits) = $ 397,220 Name FTE Position John Wise 25% NCR IR-4 Center Director Satoru Miyazaki 100% Regional Field Research Director Susan Erhardt 100% Regional Laboratory Director Zhongxiao Chen 100% Regional Quality Assurance Unit Director Dr. Wise is the NCR Director. As such he is responsible for the overall conduct of the IR-4 program in the NC region including liaison with the other regions and co-planning of the national program as a member of the Project Management Committee. Dr. Miyazaki is in charge of the planning, execution and reporting of all the field research activities for the project in the North Central Region and for liaison with the NCR Advisory Committee. Dr. Erhardt is responsible for the operations of the NC Region analytical laboratory including liaison and cooperation with the other laboratories in the IR-4 system and with Study Directors in IR-4 HQ at Rutgers University. The Lab Director is also responsible for the development of the final Analytical Summary Reports that are submitted to IR-4 Headquarters. Dr. Chen is responsible for all Quality Assurance activities as required by EPA's code of GLP, including facility audits, in-life inspections of field and laboratory projects, and the review of all reports for adherence to GLP. He is also responsible for the planning and coordination of QA activities with IR-4 Headquarters and other regions B Other IR-4 Personnel: Personnel associated with the core operations of the IR-4 Center at MSU: Professional staff: 2016: $361,840 (Salaries) + $146,451 (Fringe Benefits) = $ 508,291 Clerical & IT staff: 2016: $24,493 (Salaries) + $11,020 (Fringe Benefits) = $ 35,513 Temporary labor: 47

48 2016: $24,480 (Salaries) + $5,626 (Fringe Benefits) = $ 30,106 Undergraduate students: 2016: $5,000 (Salaries) + $96 (Fringe Benefits) = $ 5,096 Wayne Jiang 60% Regional Laboratory Associate Director Lester Geissel 100% Lab. Research Assistant Eina Abouzied 100% Lab. Research Assistant Sima Kumar 100% Lab. Research Assistant Royal Fader 100% Lab Research Technologist Lisa Latham 100% QA Assistant (Research Assistant) Nicole Schroeder 50% Field Research Assistant Administrative assistant 50% Secretary/Book-keeper/IT specialist Undergraduate labor 500 hr x $10 Laboratory clean-up and sample preparation Dr. Erhardt is assisted as Lab Director by Dr. Jiang as Associate Director who conducts analytical research, advises the Director, and can act as Director in her absence. He is also active in computer and software maintenance and upgrades for the group. The Laboratory Research Assistants listed are all analytical chemists who conduct the laboratory analyses for pesticide residues under the overall direction of the Regional Laboratory Director and the Associate Director. The Lab. Research Technologist handles the storage, inventory, and preparation for analysis of crop samples in the Laboratory and maintains a clean laboratory environment, assisted by part time student labor. Dr. Chen is assisted in his QA functions by Ms. Lisa Latham, a Research Assistant who conducts some of the necessary inspections of research sites and reviews research reports under Dr. Chen s supervision. The Field Research Assistant is responsible for assisting Dr. Miyazaki in inventorying and reviewing the Field Data Notebooks received from field researchers. Concerning the secretary/book-keeper/it position, the Department of Entomology provides general secretarial and IT support for the four senior staff of the IR- 4 program at MSU, including such items as correspondence, IT maintenance, travel reimbursement, and meeting scheduling. They also handle the extensive book-keeping activities associated with this grant and help to maintain the computer systems and networks used by the program at MSU. C. Nonexpendable Equipment. $74,000/yr. Lease of a new LC/MS/MS instrument. The oldest of our three LC/MS/MS instruments is now well over 10 years old and becoming unreliable. These instruments 48

49 are critical. We will lease a new instrument rather than buy one because of their high cost with a $1 buy out the instrument at the end of the five year lease agreement. D. Travel. The senior staff members are required to attend several meetings around the nation each year for project planning and coordination, and for training purposes. As a member of the Project Management Committee, which oversees the project nationally, Dr. Wise will need to travel to PMC meetings plus several other IR-4 sites and meetings during the course of the year. We are also responsible for the IR-4 program in the 12 North Central Region states and typically have field projects running in several of these states. It is required under Good Laboratory Practice that in-life audits be conducted at these locations, which requires a large amount of travel, particularly by our Quality Assurance coordinators. Additionally, we help support travel costs for regional stakeholders to attend the NCR Advisory Committee meeting and the annual Food Use Workshop where future projects are discussed and prioritized. The specific nature and costs of many of these travel requirements are not predictable a year ahead, so the travel budget is based on our past experience of the general amount necessary to meet these obligations as itemized below: 2016: total $43,000 $19,000 Travel to IR-4 project meetings including NCR Advisory Committee $23,000 Travel for quality assurance site inspections $1,000 International travel to attend Canadian Prioritization Workshop E. Participant/Trainee Support: None F. Other Direct Cost. 2016: $793, Materials and Supplies. $64,784/yr For the MSU analytical laboratory, as itemized below: $28,000 Solvents $6,500 Compressed gasses $5,000 Glassware $7,000 Reagents and chemicals $2,000 Dry ice $7,000 Computers & parts. Replacement software for older analytical equip. $8,500 Chromatography supplies General office/miscellaneous supplies $784 49

50 2. Publication Costs: None 3. Consultant Services: $7,000/yr Satellite field QA in North Dakota by Dr. D. Killilea. 4. ADPE/Computer Services None 5. Contractual Services. $618,750/yr Fee-for-service: In the fee for service categories below, the standard awards are: Food use residue field trial (GLP): $6,000. In a few cases the payment is higher to allow for unusual travel costs to research sites and other complexities of the specific project. Food use combined efficacy/crop safety trial: $3,000 (sometimes the above complexity rule also applies.) Ornamental crop safety trial: $1,000 Ornamental crop efficacy trial: $10,000 (or approx. $2,000 per treatment) In a few cases the payment is higher due to complexities of the specific project. Biopesticide research projects: each project is funded based on the number of treatments required at approximately $1500 per treatment. In a few cases the payment is higher due to complexities of the specific project. Michigan State University: Food use residue trials (30) $187,500 Food use efficacy trails (6) $28,500 Biopesticide projects (4) $60,000 Ornamental crop efficacy trials (2) $22,500 Ornamental crop safety trials (12) $12,000 Other NC Region Cooperators: Food use residue trials (33) $205,000 Food use efficacy trails (3) $16,000 50

51 Biopesticide project (1) $18,000 Ornamental crop efficacy trials (2) $21,250 Ornamental crop safety trials (48) $48,000 Total $618, Facility Rental. $140,771/yr The IR-4 program s research facility requires rental fees for laboratory and office space in the Michigan Biotechnology Institute building. This consists of 2,640 sf of laboratory space with fume hoods at $33.44 per sf (total of $81,459), 1159 sf of general lab space ranging from $26.93 $29.84 per sf (total of $32,128), and 920 sf of office space at $ per sf. (total of $27,183). 7. Alterations/Renovations None 8. Grad. Asst. Tuition & Fees None 9. Other Communications: 2016: total: $5,343 $2,000 Telephone/fax/teleconferencing $2,343 Postage and express mail $1,000 Photocopy including supplies 10/11. Other Miscellaneous: $60,000 total/yr $2,000 Gas cylinder rental: 20 cylinders at $8.33/month x 12 months. $52,000 Instrument maintenance. Service maintenance costs are budgeted for the two most modern LC/MS/MS instruments. These instruments are 100% committed for IR-4 use. Service/maintenance contracts ($22,000 for the Waters instrument, $25,000 for the Agilent instrument) are critical to obtain rapid service and preventative maintenance to avoid expensive down-time and project delays. Other equipment maintenance and repair, $5,000. $6,000. Residue sample shipping: These refrigerated shipping costs vary depending on the distance of the shipment and its weight, which is not predictable in advance. However, the budget figure is an estimate based on past experience with an average shipping charge. TOTAL REQUESTED: 2016: $1,989,874 51

52 Table 3. NCR budget comparison Other Funding Sources (Total) Section A, Senior/Key Personnel: NIFA Funds NIFA Funds NIFA Funds NIFA Funds NIFA Funds Director $16,710 $16,683 $42,238 $26,128 $27,428 Coordinators/Managers $226,952 $255,030 $261,420 $266,212 $271,537 Total $243,662 $271,713 $303,658 $292,340 $298,965 Section B, Other Personnel Professional/QA/QC $0 $0 $0 $0 $0 Lab Analyst/Chemist $386,998 $371,600 $369,517 $381,630 $361,840 Secretarial/Clerical $36,991 $31,382 $35,356 $19,749 $24,493 Student $24,000 $24,000 $0 $0 $5,000 Part-time FTE) $18,269 $18,000 $42,000 $29,000 $24,480 FRINGE $277,426 $259,568 $270,852 $261,614 $261,448 Total $743,684 $704,550 $717,725 $691,993 $677,261 Total Salary, Wages and Fringe Benefits $987,346 $976,263 $1,021,383 $984,333 $976,226 Sectioin C, Equipment $0 $60,000 $55,000 $74,000 $74,000 Sectioin D, Travel Domestic $117,989 $62,000 $70,000 $58,000 $43,000 International $0 $0 $0 $0 Section E, Participant/Trainee Support Costs $0 $0 $0 $0 $0 Section F, Other Direct Costs Totals Totals Totals Totals Totals Regional Center Materials and Supplies $83,823 $62,000 $69,606 $64,784 $64,784 Publication Costs $0 $0 $0 $0 $0 Service Contracts & Sample Shipping $75,400 $75,000 $72,200 $60,000 $60,000 Postal $1,424 $3,299 $0 $0 $0 Phone $8,500 $5,500 $9,000 $6,788 $5,343 Consultations $12,000 $12,000 $12,000 $10,000 $7,000 Facility rent $124,550 $128,283 $132,258 $136,694 $140,771 Totals $305,697 $286,082 $295,064 $278,266 $277,898 Field Program Food Use/Performance $339,000 $504,496 $384,000 $405,500 $437,000 Ornamentals $61,629 $121,750 $101,000 $116,000 $103,750 Biopesticide/Organic Support $94,750 $90,622 $31,059 $0 $78,000 Totals $495,379 $716,868 $516,059 $521,500 $618,750 Section G, Direct Costs (A thru F) $1,906,411 $2,101,213 $1,957,506 $1,916,099 $1,989,874 52

53 Attachment 4 - The IR-4 Organization-Southern Region I. REGIONAL OVERVIEW The Southern Region (SR) of the IR-4 Project comprises 13 states: AL, AR, FL, GA, KY, LA, MS, NC, OK, SC, TN, TX and VA as well as the territory of Puerto Rico (PR). In the south, specialty crop agriculture is critically important and this is demonstrated by the fact that several southern states are recognized as top 20 producers nationally. For example, FL ranks number 1 nationally in acreage dedicated to orange production and number 2 nationally for vegetables, melons, potatoes, sweet potatoes, fruits, tree nuts and berries per value of sales by commodity group. Additionally, GA ranks second nationally for production of fresh market cucumbers, and spring onions; the state also receives a top 5 ranking for its production of several specialty crop commodities including bell peppers, cantaloupes, peaches, fresh market snap beans watermelons and squash. GA recently became the number one producer of blueberries nationally (Ref 1). The SR goal is to support our regional specialty growers in achieving economic sustainability. This is done by providing management tools to growers to ensure that pest populations remain below the economic damage threshold. In the SR, specialty crops provide major economic value to its 13 states and PR with an estimated value of over $30 billion dollars (Ref 2). Specialty crops provide over $3 billion dollars in revenue for eight of these states with TX>FL, AR>GA, NC>KY, LA, MS. When considered on a national basis, specialty crops account for over 50% of the total agricultural value for six of these states: AL (51%), GA (57%), KY (57%), SC (53%) and VA (77%), with specialty crops dominating FL s (98%) agriculture. Florida and PR s unique climate affords multiple growing seasons and an abundance of unique crops in tropical and subtropical fruits and vegetables (avocado, lychee, papaya, mango, banana, star fruit, etc.). Additionally, FL and other coastal southern states are major ports for plant and animal entry into the U.S. and this is a major concern for invasive species entering the country. An important goal for the SR and IR-4 is to work on preventing these from becoming problems for our specialty crop growers. Ornamentals also provide major economic value for our southern states. Total receipts for ornamentals including greenhouse and nursery crops were $16 billion dollars (Ref 3, 2007). The south ranks 1 st in grower sales receipts for greenhouse crops, 1 st in wholesale average sales for floriculture crops, 1 st in cash sales for bedding plants and annuals and 2 nd for potted plants. California, FL and TX are the top three states in sales of these crops. Cash sales for the major 18 producing states for nursery crops include eight states (AL, FL, GA, NC, SC, TN, TX, and VA) from the SR. With the importance of specialty crops to the SR, and FL in particular, and the potential threat of invasives crossing U.S. borders through its southern states ports, the SR IR-4 Program, through its partnership with the other components of IR-4, is providing the critical science and information to assist specialty crop growers with pest management tools. The S R IR-4 Center focuses on the grower needs for the Southern states guided by its constituents and works very closely in collaboration with the IR-4 Headquarters at Rutgers University. The goals of the SR IR4 program are to serve the specialty crop needs of the 13 states and territory. The S R is headed by a Director who serves as Principal Investigator on the grant and as the SR representative on the Project Management Committee. The region has three key middle managers under the Director: the Regional Field Coordinator (RFC), the Regional Laboratory Coordinator (RLC) and the 53

54 Regional Quality Assurance Coordinator (RQAC) responsible for the field, laboratory and quality assurance aspects of the food use program, respectively. Dr. Jackie Burns, Dean for Research, IFAS, Gainesville, FL, and the SR Administrative Adviser, provides guidance on issues and policy that may affect the region and national program. The RFC is responsible for soliciting and coordinating stakeholder input with regard to the specialty crop pest and disease management needs of SR specialty crop growers and commodity groups. The RFC is charged with managing all field aspects of the food use program (under USEPA GLPs), as well as the biopesticide and ornamental programs. The RLC is responsible for conducting chemical analysis and generating the residue data under GLPs for the Food Use Program. The RQAC is responsible for assuring GLP compliance in both the field and analytical portions of the Food Use Program. These individuals interact on a regular basis with IR-4 HQ personnel, primarily the Study Directors but also the Directors, Assistant Directors, Biopesticide and Ornamental Managers as appropriate to identify needs, develop protocols, processes and methods and bring projects to successful fruition. IR-4 has three distinct research programs, Food Use, Biopesticide and Organic Support and Ornamentals. In all of these programs, IR-4 HQ serves as the national coordinator and regional staff insures that regional needs are met. II. PERSONNEL AND INFRASTURTURE The personnel who work to accomplish the goals of the SR IR-4 Center are: Administrative o Jackie Burns, Administrative Advisor o Liwei Gu, Southern Region Director o Robin Federline, Financial Support Staff, Quality Control (QC) Staff o Amanda Hogle, Program Assistant, Clerical/Travel, Quality Control (QC) Staff Laboratory o Wlodzimierz Borejsza-Wysocki, Regional Laboratory Coordinator/Associate Regional Director o Gail Mahnken, Scientific Laboratory Manager o Vic Bauder, Chemist 4 o Carolyn Turlington, Chemist 4 o Tish Adams-Waters, Chemist 3 o David Guderian, Chemist 2 o Zheng (James) Li, Chemist o Susan Estevez, Assistant Sample Control Officer o Evan Duncan, Laboratory Assistant/Sample Preparation Field o Michelle Samuel-Foo, Regional Field Coordinator Quality Assurance o Kathleen Knight, Regional Quality Assurance Coordinator o Yavuz Yagiz, Assistant Regional Quality Assurance Coordinator All personnel are full time with the following exceptions: Yavuz Yagiz (50%), Susan Estevez (50%), Evan Duncan (50%). Their relationships to the organization are provided by the organizational chart Table 1. University of Florida is the host institution and there are no specific cost sharing arrangements. UF provides strong institutional support by providing office, laboratory and field space to meet the needs of the SR IR-4 Center. The host institution strongly supports the program by supplying infrastructure and support with no indirect cost recovery. UF Agricultural Experiment Station also is committed to 54

55 Integrated Pest Management (IPM) to develop integrated and ecologically sound pest management practices. The S R RFC works closely with many of the research and extension faculty and agents involved in the U F IPM program as well as the USDA S R IPM Center, located at NC State University, Raleigh, NC to solicit their guidance with regard to new pest control options and solutions. Table 1: Southern region IR-4 program organizational chart Administrative Advisor Jackie Burns Regional Director/ PMC Member Liwei Gu Support Staff Financial Robin Federline Support Staff Travel/Clerical Amanda Hogle Quality Assurance Coordinator Kathleen Knight Regional Laboratory Coordinator Wlodzimierz Borejsza- Wysocki Regional Field Coordinator Michelle Samuel-Foo Assistant Regional Quality Assurance Coordinator Yavuz Yagiz Assistant Coordinator/Chemist Gail Mahnken Quality Control Assistants Amanda Hogle Robin Federline Analytical Staff Victor Bauder David Guderian Zheng Li Carolyn Turlington Tish Adams-Waters Susan Estevez Evan Duncan Field Research Centers University of Florida - Citra University of Florida - Homestead North Carolina State University University of Arkansas Texas A&M University University of Puerto Rico FL Ag Research (Contract) South TX Ag Research (Contract) III. REGIONAL PROGRAMS FIELD RESEARCH PROGRAM - FOOD The total capacity of IR-4 Field Research Centers is between field trials per year. The Field Research Centers established to conduct field residue trials are located at: North Carolina State University (EPA Region 2), University of Florida - Citra (EPA Region 3), University of Florida Homestead and University of Puerto Rico (EPA Region 13), University of Arkansas (EPA Region 4), and TX A&M University (EPA Region 6) (Table 2). 55

56 Table 2: Southern region field research centers Field Research Center - Affiliation Field Research Director Location EPA Region Approximate number of trials per year University of Arkansas Jun Estorninos Fayetteville, AR 4 10 TX A&M Univ Cristina Marconi Weslaco, TX 6 15 & 4 1 Univ of FL Citra Peter Dittmar Citra, FL 3 25 Univ of FL TREC Rebecca Tannenbaum Homestead, FL University of Puerto Rico Wilfredo Robles Corozal, PR North Carolina State University Roger Batts Raleigh, NC 2 14 Florida Ag Research 2 Stephanie Yates Thonotosassa, FL 3 4 South TX Ag Research 2 Mike Phillips Uvalde, TX Trials done at the TX A&M Univ. Citrus Center 2 Contract research facility conducting GLP trials FIELD RESEARCH PROGRAM ORNAMENTALS The Ornamental Horticultural program is similar to the Food Use Program in process but much smaller in resource allocation. The national program is managed by the Ornamental Horticulture Manager at IR-4 HQ. The S R IR-4 Center, RFC will identify qualified researchers, provide guidance as to research requirements, monitor and track trial progress, allocate funding and provide final reports to the Ornamental Horticulture Manager. Researchers are selected based on the target pest of interest and the researcher s expertise. The RFC notifies the researchers of their funding and provide access to the agreed upon protocols. These protocols are designed at the national level for a coordinated research effort. The RFC will also provide assistance to the researchers conducting work in the region as questions regarding the projects arise. Because of the diverse nature of the ornamental projects and the specific skills required, we do not have Ornamental Research Centers per se, but seek out the appropriate research expertise as needed within the region. These can be university, extension or private researchers (Table 3). Table 3: Cooperating ornamental researchers Institution Research Discipline Project University of Tennessee Karla Adesso Entomology Thrips Efficacy Baysal-Guerl Plant Pathology New Disease Product CS Alan Witcher Weed Science Ornamental Grass Clemson University J. C. Chong Entomology Thrips Efficacy LSU Ag Center Yan Chen Entomology Thrips Efficacy Crepe Myrtle Bark Scale University of Florida Adam Dale Entomology Foliar Feeding Beetle Efficacy Stephen Marble Weed Science Ornamental Grass David Norman Plant Pathology Bacterial Efficacy Aaron Palmateer Plant Pathology Bacterial Efficacy Virginia Tech Jeff Derr Weed Science Ornamental Grass North Carolina State University Joe Neal Weed Science Ornamental Grass Steve Frank Entomology Foliar Feeding Beetle Efficacy Auburn University Charles Gilliam Weed Science Ornamental Grass TX A&M University Mengmeng Gu Crop Safety Basil Downy Mildew 56

57 Kevin Ong Plant Pathology Bacterial Efficacy FIELD RESEARCH PROGRAM BIOPESTICIDE & ORGANIC SUPPORT (BOSP) The goal is to support research that enhances the development and registration of biopesticides for use in conventional and organic food and non-food pest management programs. This program also has a workshop which is usually directly after the Food Use Workshop. The IR-4 BOSP selects priorities by stakeholders and is a defined research program with fee-for-service determined by the complexity and treatments required in each protocol (Table 4). Table 4: Cooperators and research projects for the BOSP Project No. of Treatments Amount Researchers Institution Spotted Wing Drosophila 10 15,000 Oscar Liburd University of Florida Bacterial-Clavibacter 12 18,000 Frank Louws North Carolina State Bacterial tomato spot and spec 11 16,000 Gary Vallad Whitefly- GH tomato 12 18,000 Hugh Smith University of Florida, Gulf Coast Research & Education Center University of Florida, Gulf Coast Research & Education Center Whitefly- GH tomato 12 15,000 Babu Srinavasan University of Georgia Weed-sweet potato 10 15,000 Katie Jennings North Carolina State University Weeds-ornamentals 10 15,000 Joe Neal North Carolina State University Varroa Mite 7 10,500 Lambert Kanga FL A&M University ANALYTICAL LABORATORY The Regional Analytical Coordinator is responsible for the operation of the SR analytical laboratory. The laboratory is staffed by 6 residue chemists (including an Assistant Regional Coordinator/Chemist), 1 sample control officer and 1 laboratory assistant/assistant sampler. The expertise of the staff covers sample processing, residue analysis, laboratory automation, and analytical instrumentation. There are over 115 years of analytical experience between the chemists. The laboratory houses a wide variety of analytical instrumentation that allows for the analysis of the majority of compounds evaluated within the IR-4 program. The laboratory is assigned projects based on chemistry to take advantage of particular analytical as well as matrix expertise. There is the capacity to analyze samples from field trials per year. The laboratory work starts with sample receipt. The laboratory has a trained technician for sample handling and receipt, as well as back up expertise. This individual is trained in the critical nature of his/her work with regard to study conduct as well as proper GLP procedures and documentation. Samples are received at the laboratory, in a frozen state, from ACDS, FedEx, or other courier and are logged into the laboratory database system which assigns a unique laboratory sample ID. Once logged in, the samples are processed into a homogeneous mixture suitable for pesticide residue analysis. When ready, samples are transferred to a specific analyst for residue determination according to protocol and validated analytical methods. There is 1 IR-4 laboratory on the UF campus carrying out IR-4 residue analysis under the supervision of the Regional Laboratory Coordinator. The Food and Environmental Toxicology Laboratory (FETL), Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences is housed in a one story building of approximately 7000 square feet and in parts of adjacent smaller buildings. The IR-4 Project utilizes 80% of the General Analytical Lab, all of the Sample Preparation Room, Instrument 57

58 Rooms and two offices. The Quality Assurance Officer is housed in an adjacent building (Bldg 833, Office 9). The Southern Region Director occupies Office 1, the Laboratory Coordinator occupies Office 5 and the Regional Field Coordinator occupies Office 15 of FETL. The Program Assistants are housed in the administrative office of FETL. Clerical, fiscal and related project activities are performed at FETL while all personnel activities are executed at the Departmental office. Frozen storage facilities are located in other small buildings adjacent to FETL. Currently IR-4 occupies two 10ft x 10ft x 10ft freezers and several smaller units, all monitored by an outside company and on backup generators. The Southern Region Laboratory has performed residue analysis for the IR-4 Project since its inception, and has all equipment necessary for extraction, isolation, clean up and detection of pesticides for residue analysis. The major equipment used and maintained by the project consists of gas chromatographs (GC) with various detectors, two gas chromatographs with mass spectrometry (MS) detectors (GC/MS), two high performance liquid chromatographs (HPLC) with uv and fluorescence detectors, and high performance liquid chromatographs with tandem mass spectrometers HPLC/MS/MS). Table 5 lists the dedicated analytical equipment used by the SR-IR-4 Program. Table 5: Major analytical instrumentation dedicated to the SR-IR-4 project. Instrument Number of Number of Instrument Instruments Instruments GC/NPD/ECD 3 GC/ECD 1 GC/NPD/FPD 1 GC/MS 2 HPLC/UV 1 LC/MS/MS 4 HPLC/Fluorescence/UV 1 QUALITY ASSURANCE The S R IR-4 QAU is headed by the RQAC and assisted by the Assistant Regional Quality Assurance Coordinator. The RQAU insures both the field and laboratory operations in the SR function under GLPs. The QAU also assists field and lab researchers with EPA inspections. Typically, during a single year, the SR IR-4 Center QAU will assist with 2-3 US EPA inspections. Although the USEPA does not endorse or establish formal approval of sites that successfully undergo an EPA inspection, a successful inspection does establish that the facility can conduct research and produce data that is acceptable to USEPA. It also demonstrates that the SR QAU audit and inspection program is effective, and that IR-4's GLP and technical training programs are having the desired effect. The QAU conducts in-life inspections of field trials, lab analyses, and the processing of samples. They also audit study, field, and laboratory final reports. Finally there are periodic inspections of processing, field, and laboratory sites for GLP compliance. These activities are done for both S R and ARS sites. The SR IR-4 QAU audits approximately 8 final petitions, field data books and 13 analytical summary reports, and conducts 7 0 Critical Phase inspections and 7 Facility inspections in a typical year. The QAU also participates in instruction during the IR-4 National and Regional training events. FIELD RESEARCH PROGRAM - PROGRESS Southern region activity from 2012 to 2016 is presented in Table 6 for all three program areas: Field, Laboratory and Quality Assurance. In the field program there are three types of research conducted. The Food Use program performs GLP controlled food residue studies to establish a registration/tolerance. The Food Efficacy/Performance program is to help fill in data gaps that can support a registration and does not require GLP inspection. This program is an easier path to a registration and offers a bigger return on the programs investment. The Ornamental and Biopesticide programs are also efficacy/performance programs to expand the uses for ornamental as well as food crops (biopesticide). The region averages 58

59 around 86 food trials over the present five years which is well below the capacity of the regions field centers. Table 6: SR IR-4 activity from 2012 to REGION Field Trials Food Residue Food Efficacy Ornamental Analytical Projects Regional Laboratory Quality Assurance Audits Facility Field and Lab In-Life Field Data Book Analytical Summary Report Petition The laboratory averages around 112 trials per year. The laboratory is capable of performing any crop/pesticide combination. The Quality Assurance unit activities are presented in Table 6. The unit inspects five areas for GLP compliance: facility, field and lab in life, field notebooks, analytical summary reports, and final petitions. IV. STATE LIAISON REPRESENTATIVES The Land Grant Institutions and Agricultural Experiment Station in each state of the SR nominate a State Liaison Representative (SLR) to serve as a collaborator and advisor for the IR-4 program. These SLRs have many years of experience in pest management practices and are actively involved in Integrated Pest Management (IPM) in their states. Communication is most often via but once a year generally in August/September, the SLRs meet with the RFC to discuss potential pesticide needs in the region as well as identify common areas of future collaboration. State Institution Researcher/Extension Personnel Alabama Auburn University Charles Gilliam Arkansas University of Arkansas Nilda Burgos Georgia University of Georgia Stanley Culpepper Kentucky University of Kentucky Ric Bessin Louisiana LSU Melanie Ivey Mississippi Mississippi State University Alan Henn North Carolina NC State University David Monks Oklahoma Oklahoma State University Charles Luper Puerto Rico University of Puerto Rico Wilfredo Robles South Carolina TBD TBD Tennessee University of Tennessee Amy Fulcher Texas TX A&M University Mark Matocha Virginia Virginia Tech Michael Weaver 59

60 IV. BUDGET The 2016 budget is presented in Table 7 while Table 8 is a comparison and general breakdown of the regions budget from 2012 to An explanation of the various expenses is presented below. SALARY AND BENEFITS The Director and Principal Investigator for the IR-4 SR Center is Liwei Gu, PhD. He is an Associate Professor in the Department of Food Science and Human Nutrition. H e serves on the IR-4 Project Management Committee (PMC) whose purpose is coordination and management of the National program. Wlodzimierz Borejsza-Wysocki, PhD serves as Co-Principal Investigator for the grant and as the SR IR-4 Regional Laboratory Coordinator (RLC) at 100% time (12-month calendar effort). He also serves as Assistant Director when the director is away. He has a Doctorate Degree in Plant Pathology/Biochemistry with extensive experience in analytical residue analysis and method development. The RLC is responsible for conducting chemical analysis and generating the residue data under GLPs for the Food Use Program. Michelle Samuel-Foo, PhD also serves as Co-Principal Investigator for the grant and is employed as the Regional Field Coordinator (RFC) at 100% time (12-month calendar effort). She has a PhD degree in Entomology and over 6 years experience in agriculture, pesticides and regulatory science. Kathleen Knight, BS serves as Regional Quality Assurance Coordinator (RQAC) at 100% time (12 months calendar effort). She has over 30 years experience in chemistry, laboratory managing and Good Laboratory Practices (GLP). She has approximately 15 years experience working in Quality Assurance and GLP. Jackie Burns, PhD Dean of Agricultural Sciences, UF serves as the SR IR-4 Administrative Adviser. She also serves in an advisory capacity on the IR-4 PMC and participates in program policy and coordination. She receives no salary or benefit compensation. The laboratory is staffed by 6 residue chemists; one (Gail Mahnken, PhD serving as Assistant RLC). The expertise of the staff covers sample processing, residue analysis, laboratory automation, and analytical instrumentation. There are over 100 years of analytical experience between these chemists. The laboratory is supported by 1 sample control officer and 1 laboratory student assistant. They support the analytical staff in sample processing, residue analysis, laboratory automation, and analytical instrumentation. The Assistant Quality Assurance Coordinator s role is to assist the RQAC in QA responsibilities. Yavuz Yagiz, PhD in Food Science and Human Nutrition is primarily responsible for GLP responsibilities of the regional laboratory, as well as some field inspections. He has extensive experience and published in food analysis and several years experience in Good Laboratory Practice. The two support staff supports the program with responsibilities for financial oversight, travel, documentation preparation, record keeping and data tracking, and meeting/ event coordination for the regions priority setting workshop and training workshops. In addition, both staff supports the field program by serving as Quality Control staff reviewing books, preparing and sending reports, and tracking findings are corrected. TRAVEL 60

61 Travel is mostly domestic with an occasional international travel by invitation for the Director or RFC. The field staff travels to regional, state and national meetings, and IR-4 events such as planning meetings and the national priority setting workshops, as well as make field site visits for monitoring and training. The field staff also makes several trips per year in an outreach capacity. The RLC travels primarily for regional and national meetings as well as training. The chemists are given travel monies to attend one national meeting for residue analysis at the discretion of the RLC. The quality assurance unit travels for regional and national meetings, training and site audits. A significant portion of our travel budget is used to support travel stipends for field research directors' training, state liaison representatives meetings, as well as the Food Use and Ornamental Workshops. We support the travel of approximately 30 to these various events. MATERIALS AND SUPPLIES The field office incurs expenses related to communication items: printing, office supplies, facility, copier/ scanner, computer equipment and technical support averages about $10K per year. Shipping for tracking of original documents as well as field samples sent to the lab, and service contract (6-8 instruments) expenses averages about $ K per year. The laboratory spends about $120K per year in chemicals, laboratory glassware, compressed gas/cylinder demurrage, and misc. laboratory supplies. They also incur expenses for office supplies, communication, shipping, computer equipment and technical. FIELD RESEARCH PROGRAM The monies for the research program are directly passed to all cooperators (field center scientists, and ornamental and biopesticide scientists) as Fee-for-Service. For the total research program in the SR, it amounts to around $900K per year. The Food Use is the largest expense within the program at $630K per year, followed by the ornamental at $180K per year, and biopesticide at $113K per year. 61

62 Table 7: Southern region 2016 budget. REGION: Southern Section A, Senior/Key Personnel: Section B, Other Personnel Full Time Equivalency (FTE) 1 NIFA 2016 Funding Base Salary Fringe Total Salary Director 0.2 $12,828 $693 $13,521 Coordinators/Managers 2 $177,208 $52,962 $230,170 Total 2.2 $243,691 Professional/QA/QC 4 $226,796 $75,522 $302,318 Lab Analyst/Chemist 5 $223,286 $74,354 $297,640 Secretarial/Clerical 1 $45,818 $19,656 $65,474 Student Part-time (2@0.5 FTE) 1 $45,872 $2,477 $48,349 Total 11 $713,781 Total Salary, Wages and Fringe Benefits $957,472 Sectioin C, Equipment $88,259 Other Funding Sources Sectioin D, Travel Domestic $98,500 International $0 Section E, Participant/Trainee Support Costs $0 Section F, Other Direct Costs Totals Regional Center Materials and Supplies $94,299 Publication Costs $2,000 Service Contracts & Sample Shipping $118,355 Postal $2,500 Phone $1,500 Consultations $0 Totals $218,654 Field Program Food Use/Performance $644,250 Ornamentals $167,250 Biopesticide/Organic Support $122,500 Totals $934,000 Section G, Direct Costs (A thru F) $2,296, FTE = 40 h/week 62

63 Table 8: General breakdown and comparison of SR budget from Other Funding Sources (Total) $17,500 $17,500 $17,000 $29,749 TBD Section A, Senior/Key Personnel: NIFA Funds NIFA Funds NIFA Funds NIFA Funds NIFA Funds Director $0 $0 $0 $0 $13,521 Coordinators/Managers $226,952 $226,952 $234,463 $240,135 $230,170 Total $226,952 $226,952 $234,463 $240,135 $243,691 Section B, Other Personnel Professional/QA/QC $0 $0 $0 $0 $302,318 Lab Analyst/Chemist $312,805 $315,349 $348,193 $382,519 $297,640 Secretarial/Clerical $93,941 $93,212 $92,171 $98,808 $65,474 Student $0 $0 $0 $0 $0 Part-time FTE) $0 $0 $0 $0 $48,349 FRINGE $196,716 $196,171 $228,797 $221,961 Total $603,462 $604,732 $669,161 $703,288 $713,781 Total Salary, Wages and Fringe Benefits $830,414 $831,684 $903,624 $943,423 $957,472 Sectioin C, Equipment $0 $0 $87,000 $88,259 $88,259 Sectioin D, Travel Domestic $135,385 $149,000 $133,500 $121,000 $98,500 International $7,000 $8,000 $6,000 $0 $0 Section E, Participant/Trainee Support Costs $0 $0 $0 $0 $0 Section F, Other Direct Costs Totals Totals Totals Totals Totals Regional Center Materials and Supplies $136,150 $174,776 $134,047 $118,196 $94,299 Publication Costs $9,000 $14,000 $5,312 $5,000 $2,000 Service Contracts & Sample Shipping $125,000 $135,000 $125,000 $123,090 $118,355 Postal $3,000 $3,500 $2,500 $2,500 $2,500 Phone $2,311 $3,000 $2,500 $2,500 $1,500 Consultations $0 $0 $0 $0 $0 Totals $275,461 $330,276 $269,359 $251,286 $218,654 Field Program Food Use/Performance $742,000 $663,000 $523,167 $597,667 $644,250 Ornamentals $201,250 $164,750 $191,250 $191,250 $167,250 Biopesticide/Organic Support $68,585 $74,341 $139,272 $0 $122,500 Totals $1,011,835 $902,091 $853,689 $788,917 $934,000 Section G, Direct Costs (A thru F) $2,260,095 $2,221,051 $2,253,172 $2,192,885 $2,296,885 63

64 Attachment 5 - The IR-4 Organization-Western Region I. REGIONAL OVERVIEW The Western Region (WR) of the IR-4 Project comprises 13 states: AK, AZ, CA, CO, HI, ID, MT, NV, NM, OR, UT, WA and WY as well as the territories and protectorates of American Samoa, Federal States of Micronesia, Guam and the Northern Marianas. In California, specialty crops dominate. California is the sole producer (99% or more) of a large number of specialty crops including almonds, clingstone peaches, figs, persimmons, raisins, sweet rice (a special short-grain Asian rice that becomes especially sticky when cooked), artichokes, dried plums, olives, pomegranates, and walnuts. In 2014, California farms produced $54 billion in gross cash receipts. Over 67% of the US grown fruits, nuts and vegetables are produced in California. (California Agricultural Statistics, 2015 crop year, USDA, NASS, California Field Office; website In the entire WR, fruits and nuts represent 85% of the US crop value and commercial vegetables represent 73%. (Crop Values 2015 Summary, February 2016, Agricultural Statistics Board, NASS, USDA). Of California top-ten valued commodities from 2014, seven of the ten are specialty crops (almonds, grapes, strawberries, lettuce, walnuts, tomatoes and pistachios). The ornamental horticulture industry is also significant in the WR. In 2006, 36% of the US grower cash receipts in greenhouse and nursery crops came from Western states (Floriculture and Nursery Crop Yearbook, FLO-2007, September 2007, Economic Research Service, USDA). Clearly, specialty crops are a very important component of WR agriculture. The WR IR-4 Center focuses on the grower needs for the Western states guided by its constituents and working in collaboration with the IR-4 Headquarters. The goals of the WR IR-4 program are to serve the specialty crop needs of the 13 states and Pacific Island territories in the WR. The WR is led by a Director who will serve as Principal Investigator on this grant and as the WR representative on the Project Management Committee (PMC). The Director also serves as the Regional Laboratory Coordinator (RLC) responsible for the laboratory aspect of the food use program. The region has two additional key personnel working with the Director/Laboratory Coordinator: The Regional Field Coordinator (RFC) and the Regional Quality Assurance Coordinator (RQAC) responsible for the field and quality assurance aspects of the food use program, respectively. This group comprises the WR Management Team and along with Ron Tjeerdema, Associate Dean of Environmental Sciences, College of Agricultural and Environmental Sciences, UC Davis, (WR Administrative Adviser). The Director/RLC, RFC and RQAC meet on a monthly basis. The Director meets as needed with the Administrative Adviser to discuss and decide on WR issues and policy. The RFC is responsible for soliciting stakeholder input with regard to the needs of WR specialty crop growers and managing the field aspects of the food use (under GLPs), biopesticide and organics support and ornamental horticulture programs. The RLC is responsible for conducting chemical analysis and generating the residue data under GLPs for the Food Use Program. The RQAC is responsible for assuring GLP compliance in both the field and analytical portions of the Food Use Program. The regional coordinators interact on a regular basis with IR-4 HQ personnel, primarily the Study Directors but also the Directors, Assistant Directors, Biopesticide and Organic Support Program and Ornamental Horticulture Managers. The regional staff works with the HQ staff as appropriate to identify needs, develop protocols, processes and methods and bring projects to successful fruition. In all of the IR-4 64

65 programs, IR-4 HQ serves as the national coordinator and regional staff ensures that regional needs are considered. II. PERSONNEL AND INFRASTRUCTURE The personnel who work to accomplish the goals of the WR IR-4 Center are: Administrative o Ronald S. Tjeerdema, Administrative Adviser o Matt Hengel, Western Region Director o V.Ana Balogh, Financial Manager o Jaqueline Hale, Office Manager Field o Rebecca Sisco, Regional Field Coordinator o Stephen Flanagan, Assistant Regional Field Coordinator o Mika Tolson, Assistant Regional Field Coordinator Laboratory o Matt Hengel, Regional Laboratory Coordinator/Regional Director o Bronson Hung, Analyst and Sample Control Officer o Paul Kuzmicky, Analyst o Tey Montalvo, Archivist/Laboratory Assistant o Riza Punongbayan, Analyst o Salvador Torres, Assistant Sample Control Officer o Fabiola Zuno, Analyst Quality Assurance o Martin Beran, Regional Quality Assurance Coordinator o Sherita Normington, Assistant Regional Quality Assurance Coordinator All personnel are full time with the following exceptions: V. Ana Balogh (50%), Paul Kuzmicky (60%), Riza Punongbayan (90%). Their relationships to the organization are provided by the organizational chart Figure 1. University of California, Davis is the host institution for the WR IR-4 Center and there are no specific cost sharing arrangements. UC Davis and the Department of Environmental Toxicology support the program by providing office, laboratory and field space to meet the needs of the WR IR-4 Center. This grant stipulates that no indirect costs can be charged. The host institution also provides organizational and administrative infrastructure with no indirect cost recovery. This effort is the equivalent of approximately $817,000. The UC Agricultural Experiment Station has a strong commitment to Integrated Pest Management (IPM). In 1979, a Statewide Integrated Pest Management Program (UC IPM) was established to develop and promote the use of integrated and ecologically sound pest management programs in California. The WR RFC works closely with many of the research and extension personnel involved in the UC IPM program and the USDA Western IPM Center to solicit guidance with regard to new pest control options. While the IR-4 program is not an extension program, it collaborates with extension personnel to identify pest management needs as well as incorporate newly available tools into their IPM programs. The WR IR-4 Center utilizes the expertise of personnel in various campus departments including Entomology, Plant Sciences, Plant Pathology and Pomology as well as University of California, Division of Agriculture and Natural Resources (UC Cooperative Extension/Agricultural Experiment Station). Figure 1: Western Region IR-4 Program Organizational Chart 65

66 USDA Western Region IR-4 Program Housed in the Department of Environmental Toxicology Detailed Organizational Chart for the WR IR-4 Center Administrative Adviser Ronald S. Tjeerdema Associate Dean for Environmental Sciences College of Agriculture and Environmental Sciences UC Davis Robert Rice Professor and Chair, Department of Environmental Toxicology UC Davis WR Director Matt Hengel Quality Assurance Unit Financial and Administrative Manager Analytical Laboratory Martin Beran V. Ana Balogh Field Program Matt Hengel Regional Quality Assurance Coordinator Rebecca Sisco Regional Laboratory Coordinator Sherita Normington Assistant Quality Assurance Coordinator Regional Field Coordinator Field Program IR-4 Office Jackie Hale Office Manager Stephen Flanagan Assistant Regional Field Coordinator Mika Tolson Assistant Regional Field Coordinator Tey Montalvo - Office Assistant Analytical Laboratory Bronson Hung-Analyst Fabiola Zuno - Analyst Riza Punongbayan - Analyst Paul Kuzmicky - Analyst Tey Montalvo - Technician Chava Torres - Technician Field Research Directors at various insitutions University of Hawaii Oregon State University Washington State University University of Idaho New Mexico State University UC Davis UC Riverside UCANR KARE Private Consultants Coastal Research Compass AgriTech Del Rio Research Turner Ag Research III. REGIONAL PROGRAMS 66

67 FIELD RESEARCH PROGRAM - FOOD The total capacity of IR-4 Field Research Centers (FRC) in the WR is between trials per year. The FRCs established to conduct field residue trials are located at: New Mexico State University (EPA Crop Production regions 8, 9, and/or 10), University of California, Kearney Research and Extension Center (EPA Crop Production region 10), University of California, Davis (EPA Crop Production region 10), University of California, Riverside (EPA Crop Production region 10), University of Hawaii, Manoa (EPA Crop Production region 13), Oregon State University (EPA Crop Production region 12, but can also serve part of region 11), Washington State University (EPA Crop Production region 11), and University of Idaho (EPA Crop Production region 11). See Table 1 for details with regard to WR IR-4 FRC including Principal Investigators, staff and locations. Table 1: Western Region Field Research Centers Approximate Field Research Center Field Research Director(s) Principal Investigator Affiliation Location EPA Crop Production Region Number of Trials per year Irrigated Agriculture Research & Dan Groenendale Doug Walsh Washington State University Prosser, 11 Education Center Washington 15 Kimberely Research & Education Will Meeks Ronda Hirnyck University of Idaho Twin Falls, 11 Center Idaho 15 Leyendecker Research Center Cary Hamilton Cary Hamilton New Mexico State University Las Cruces, 8,9,10 New Mexico 15 OSU Northwest Research & Peter Sturman Joe DeFrancesco Oregon State University Aurora, 11,12 Extension Center Oregon 15 OSU Northwest Research & Gina Koskela Joe DeFrancesco Oregon State University Aurora, 11,12 Extension Center Oregon 15 UC Davis Field Research Center Guy Kyser Bradley Hanson University of California, Davis Davis, 10 California 12 UC Davis Field Research Center Seth Watkins Bradley Hanson University of California, Davis Davis, 10 California 12 UC Kearney Agricultural Research David Ennes Jeff Dahlberg University of California, KARE Parlier, 10 and Extension Center California 24 UC Kearney Agricultural Research Keri Skiles Jeff Dahlberg University of California, KARE Parlier, 10 and Extension Center California 24 UC Riverside Field Research Nathan Leach Peggy Mauk University of California, Riverside Riverside, 10 Center California 20 UH Field Research Center Julie Coughlin Michael Kawate University of Hawaii Honolulu, 13 Hawaii 6 UH Field Research Center James Kam Michael Kawate University of Hawaii Honolulu, 13 Hawaii 6 Compass AgriTech Clark Oman Clark Oman PRIVATE contract GLP facility Montrose, CO 9 3 PRIVATE contract GLP facility Paso Robles, Coastal Ag Research Michelle Mitchell Michelle Mitchell CA 10 3 Del Rio Research Bob Viales Bob Viales PRIVATE contract GLP facility Salinas, CA 10 5 Turner Ag Research Blaine Turner Blaine Turner PRIVATE contract GLP facility Woodland, CA 10 5 FIELD RESEARCH PROGRAM ORNAMENTALS The Ornamental Horticultural program is similar to the Food Use Program in process but much smaller in resource allocation. The national program is managed by the Ornamental Horticulture Manager at IR-4 HQ. The W R IR-4 Center, RFC will identify qualified researchers, provide guidance as to research requirements, monitor and track trial progress, allocate funding and provide final reports to the Ornamental Horticulture Manager. Researchers are selected based on the target pest of interest, plant species and the researcher s expertise. The RFC notifies the researchers of their funding and provides access to the agreed upon protocols. These protocols are designed at the national level 67

68 for a coordinated research effort. The RFC will also provide assistance to the researchers conducting work in the region as questions regarding the projects arise. Because of the diverse nature of the ornamental projects and the specific skills required, we do not have Ornamental Research Centers per se, but seek out the appropriate research expertise as needed within the region. These can be university, extension or private researchers (Table 2). Table 2: Cooperating Ornamental Researchers Institution Researcher Discipline Project Description WASHINGTON STATE UNIVERSITY, PUYALLUP CHASTAGNER Plant Pathology Botrytis Efficacy (field in ground conifers) CHASTAGNER Plant Pathology Botrytis Efficacy (peonies) OREGON STATE UNIVERSITY DEFRANCESCO Plant Pathology New Disease Products Crop Safety - Foliar applications DEFRANCESCO Plant Pathology New Disease Products Crop Safety - Soil applications DEFRANCESCO Weed Science Pre-emergent Herbicide Crop Safety COLORADO STATE UNIVERSITY KLETT Weed Science Pre-emergent Herbicide Crop Safety KLETT Plant Pathology New Disease Products Crop Safety - Soil applications KLETT Plant Pathology New Disease Products Crop Safety - Foliar applications KLETT Entomology New Insecticide Products Crop Safety Foliar applications WASHINGTON STATE UNIVERSITY MILLER Weed Science Pre-emergent Herbicide Crop Safety MILLER Weed Science Herbicide Crop Safety for Bulb Flowers UNIVERSITY OF CALIFORNIA, DAVIS NANSEN Entomology Thrips Efficacy UNIVERSITY OF CALIFORNIA, DAVIS JIANG Plant Pathology Botrytis Efficacy (Greenhouse Bedding Plants) BBS Ag Research and Consultants KOIVUNEN Weed Science Pre-emergent Herbicide Crop Safety KOIVUNEN Weed Science Ornamental Grass Herbicide Crop Safety KOIVUNEN Entomology New Insecticide Products Crop Safety Foliar applications KOIVUNEN Plant Pathology New Disease Products Crop Safety - Foliar applications CROP INSPECTION SERVICE, VALLEY CENTER, CA UBER Entomology Weed Science Plant Pathology New Insecticide Products Crop Safety Foliar Applications Pre-Emergent Herbicide Crop Safety New Disease Products Crop Safety - Foliar applications CENTER FOR APPLIED HORTICULTURAL RESEARCH MEADOR Weed Science Ornamental Grass Herbicide Crop Safety MEADOR Weed Science Herbicide Crop Safety for Bulb Flowers MEADOR Entomology New Entomology Products Crop Safety Foliar applications MEADOR Plant Pathology Botrytis Efficacy (Greenhouse Bedding Plants) UNIVERSITY OF CALIFORNIA, WILEN COOPERATIVE EXTENSION ANR Weed Science Pre-Emergent Herbicide Crop Safety Weed Science Ornamental Grass Herbicide Crop Safety 68

69 FIELD RESEARCH PROGRAM BIOPESTICIDE & ORGANIC SUPPORT (BIOP) This program is operated as a defined research program based on priorities set at the Biopesticide and Organic Support Workshop. Funding is provided annually and distributed through the WR IR-4 Center to researchers in the region. The WR is responsible for tracking progress on research conducted by researchers at institutions in the WR. The program is managed at the national level by the Biopesticides and Organic Program Manager at IR-4 HQ. The regional role is to monitor, distribute funds, support inquiries regarding the program and ensure delivery of project reports back to HQ. The trials and protocols planned to be conducted in the WR in 2016 can be found in Table 3. They include assessment for biopesticide and organic materials to manage: Spotted Wing Drosophila in caneberries and blueberries, Fireblight in pome fruit, Varroa mites in honeybees, weeds in ornamental plants, and a regional interest to address Downy Mildew in spinach. Table 3: Cooperators and Research Projects for the BIOP INSTITUTION RESEARCHER BIOPESTICIDE PROTOCOL TITLE University of California, Division of Agriculture and Natural Resources, Cooperative Extension Santa Cruz County Ag Development Group, Inc. Bolda, Mark Schreiber, Alan Efficacy and Phytotoxicity of Biopesticides for management of Spotted Wing Drosophila (SWD) in blueberries and caneberries (Caneberries) Efficacy and Phytotoxicity of Biopesticides for management of Spotted Wing Drosophila (SWD) in blueberries and caneberries (Blueberries) University of California, Agriculture and Natural Resources, Cooperative Extension San Diego, Orange and LA Counties Wilen, Cheryl Weed Management - Ornamentals Oregon State University, Corvallis, OR Johnson, Ken Efficacy and Phytotoxicity of Biopesticides on Apple for the Control of Fireblight Efficacy and Phytotoxicity of Biopesticides on Apple for the Control of Fireblight Brigham Young University, Provo UT Grose, Julianne Providing product with UV protectors University of California, Davis Nino, Elina L. Efficacy and product safety of biopesticides for varroa mite management of honey bees. University of California, Davis McRoberts, Neil Biopesticides to Control Spinach Downy Mildew ANALYTICAL LABORATORY The Regional Laboratory Coordinator is responsible for the operation of the WR analytical laboratory. The laboratory is staffed by five residue chemists (including the Regional Coordinator), one sample control officer/residue chemist, one assistant sample control officer and one laboratory assistant/archivist. The expertise of the staff covers sample processing, residue analysis, laboratory automation, and analytical instrumentation. There are over 75 years of analytical experience between the five chemists. The laboratory houses a wide variety of analytical instrumentation that allows for the analysis of the majority of compounds evaluated within the IR-4 program. The laboratory is assigned projects based on chemistry to take advantage of particular analytical as well as matrix expertise. There is the capacity to 69

70 analyze samples from field trials per year. The list of planned trial analyses for 2016/17 can be found in Table 4. Table 4: Analytical Projects for 2016/17 PR# Compound Commodity Trials PROPAMOCARB-HCL BROCCOLI PROPAMOCARB-HCL CABBAGE QUIZALOFOP PEAR CYFLUMETOFEN CHERRY CYFLUMETOFEN PEACH CYFLUMETOFEN PLUM CHLOROTHALONIL CRANBERRY ACEQUINOCYL BANANA INDOXACARB COFFEE SAFLUFENACIL FIG INDOXACARB COFFEE CLOFENTEZINE HOPS ISOXABEN HOPS OXATHIAPIPROLIN HOPS OXYTETRACYCLINE OLIVE FAMOXADONE+CYMOXANIL PAPAYA FLUXAPYROXAD+PYRACLOSTROBIN POMEGRANATE 5 Total 95 The laboratory work starts with sample receipt. The laboratory has a trained technician for sample handling and receipt, as well as back up expertise. This individual is trained in the critical nature of the work with regard to study conduct as well as proper GLP procedures and documentation. Samples are received at the laboratory, in a frozen state, from ACDS (a private shipping company that specializes in frozen residue samples), FedEx, or other courier. Samples are logged into the laboratory database system which assigns a unique laboratory sample ID. Once logged in, samples are processed into a homogeneous mixture suitable for pesticide residue analysis. When ready, samples are transferred to a 70

71 specific analyst for residue determination according to protocol and validated analytical methods. An analytical report is then prepared summarizing the results of the analyses. This report is sent to the Study Director at IR-4 HQ for inclusion in the final report and petition to EPA. The RLC is the expert in particular chemistries and matrices (various raw agricultural commodities). The Study Directors/Discipline Coordinators at IR-4 HQ are dependent on the expertise of the RLC to deliver quality residue data for inclusion in EPA petitions. Table 5 lists the dedicated analytical equipment used by the WR-IR-4 Program. Table 5: Major Analytical Instrumentation dedicated to the WR IR-4 Project. Instrument Date Purchased Time Usage (%) Replacement Cost ($) GC/MS $80,000 GC/MS $80,000 LC-MS/MS $240,000 LC-MS/MS $220,000 LC-MS/MS $266,000 LC-MS/MS $350,000 QUALITY ASSURANCE The W R IR-4 QAU is headed by the RQAC and assisted by the Assistant Regional Quality Assurance Coordinator. The RQAU insures both the field and laboratory operations in the WR function under GLPs. The QAU also assists field and lab researchers with EPA inspections. Typically, during a single year, the WR IR-4 Center QAU will assist with 1-3 US EPA inspections. Although the USEPA does not endorse or establish formal approval of sites that successfully undergo an EPA inspection, a successful inspection does establish that the facility can conduct research and produce data that is acceptable to USEPA. It also demonstrates that the WR QAU audit and inspection program is very effective, and that IR-4's GLP and technical training programs are having the desired effect of producing high quality scientific data. The QAU conducts in-life inspections of field trials, lab analyses, and the processing of samples. They also audit study, field, and laboratory final reports. Finally, there are periodic inspections of processing, field, and laboratory sites for GLP compliance. These activities are done for both W R and ARS sites in the Western Region. The WR IR-4 QAU audits approximately 20 final petitions, field data books and 20 analytical summary reports, and conducts 110 Critical Phase inspections and 10 Facility inspections in a typical year. The QAU also participates in instruction during the IR-4 National and Regional training events. 71

72 HOST FACILITIES The Western Region IR-4 Center is located in the Department of Environmental Toxicology in Meyer Hall, on the UC Davis campus. Office - Within the department, IR-4 has 940 square feet of office space which provides individual offices for the WR Field Office Staff. This includes an individual office for the Regional Field coordinator, a shared office area for the Assistant Regional Field coordinators, and a work area and desk for the Office Manager and Assistants. The Quality Assurance Coordinator and Assistant Quality Assurance Officer have a shared space as well. The Department of Environmental Toxicology is a fully functioning academic department within UC Davis, College of Agriculture and Environmental Science, with a full complement of faculty, students and comprehensive staff support to supply administrative needs for personnel, purchasing and information technology. All budgetary matters are handled through the IR-4 Accounts Manager. Information Technology support from department personnel ensures the maintenance and security of an extension computer system that interfaces from multiple locations to a single server. Laboratory There are 2 IR-4 laboratories on the Davis campus that carry out residue analyses under the overall supervision of the Regional Laboratory Coordinator. There are 2,200 square feet of laboratory space in the Department of Environmental Toxicology in Meyer Hall. In addition, a second IR-4 laboratory facility (800 square feet) is located in a separate building at the Center for Health and the Environment (CHE) where the Sample Control Officer the work of the Assistant Sample Control Officer and the Archivist/Laboratory Assistant. In the Meyer Hall facility, the Regional Laboratory Coordinator supervises three Analysts and is supervisor to the personnel at the CHE Laboratory. The Environmental Toxicology Department has one central instrument room, a walk-in cold room, and two walk-in freezers, in addition to its 12 faculty research laboratories. Specifically, for IR-4 Laboratory use, there are three walk-in freezers (~700 ft 2 ) which are continuously monitored. The two largest walk-in freezers are on backup generators to protect against power failure. Specialized equipment utilized for IR-4 analyses includes, two Agilent GC-mass spectrometers, and one Applied Biosystem API-2000 LC/MS/MS systems, one Agilent 6410 LC-MS/MS, one Agilent 6430 LC-MS/MS and one Agilent 6460 LC-MS/MS. The Department and the Campus provide excellent library facilities in the areas of analytical methodology, biochemistry, chemistry, instrumentation, pharmacology, toxicology, environmental pollution, and pesticides. University of California Field Resources. The University of California maintains facilities for field work through its Division of Agriculture and Natural Resources and the Agricultural Experiment Station. The Kearney Research and Extension Center (Parlier), UC Davis and UC Riverside are particularly heavily engaged in IR-4 research. Western Region California Field Resources. There are 8 field research centers throughout the Western Region. All Field Research Centers have a history of conducting residue field trials and are well equipped to carry out IR-4 research. 72

73 FIELD RESEARCH PROGRAM - PROGRESS Western region activity from 2012 to 2016 is presented in Table 6 for all three program areas: Field, Laboratory and Quality Assurance. In the field program there are three types of research conducted. The Food Use program performs GLP controlled food residue studies to establish a registration/tolerance. The Food Efficacy/Performance program is to help fill in data gaps that can support a registration and does not require GLP inspection. This program supports the GLP food use residue program by providing data to help limit the registrants liability and subsequently label the use. The Ornamental Horticulture and Biopesticide and Organic programs are also efficacy/performance programs that serve to expand the labeled uses of conventional and biopesticide pest management tools for specialty crops. The region averages around 174 food trials over the past five years, well below the current capacity of the regions field centers at approximately trials per year. Table 6: WR IR-4 activity from 2012 to Western Region Discipline/Representative Crops 2 Field Trials Total Centers UC ANR, Desert Reasearch and Extension Center UC ANR, Kearney Agricultural Research and Extension New Mexico State University Oregon State University UC, Davis UC, Riverside University of Hawaii University of Idaho Washington State University Total Private Food Efficacy Ornamentals (15) (19) (17) (24) (25) Biopesticide Number of Trials (number of protocol/research combinations) Analytical Projects Regional Laboratory Quality Assurance Facility In-Life, Field/Lab Field Data Book Analytical Summary Reports Petition Numbers to date. 2 See attachments A and B for crop expertise across the WR Field Research Centers. The laboratory averages around 138 trials per year. The laboratory houses a wide variety of analytical instrumentation that allows for the analysis of the majority of compounds evaluated within the IR-4 program. The laboratory is assigned projects based on chemistry to take advantage of particular analytical as well as matrix expertise. There is the capacity to analyze samples from field trials per year. 73

74 The Quality Assurance unit activities are presented in Table 6. The unit inspects six areas for GLP compliance: facility, field in life, lab in life, field notebook data, analytical summary reports, and final petitions. IV. STATE LIAISON REPRESENTATIVES The Land Grant Institutions and Agricultural Experiment Station in each state of the WR nominate a State Liaison Representative (SLR) to serve as a collaborator and advisor for the IR-4 program. These SLRs have many years of experience in pest management practices and are actively involved in Integrated Pest Management (IPM) in their states. Communication is most often via but once a year generally in March or April, the SLRs meet with the RFC to discuss potential pesticide needs in the region as well as identify common areas of future collaboration. Table 7: State Liaison Representatives State Institution Researcher/Extension Personnel Alaska University of Alaska, Fairbanks Phillip Kaspari Cooperative Extension Service Arizona The University of Arizona, Yuma John Palumbo California University of California, Davis Rebecca Sisco Colorado Colorado State University Scott Nissen Hawaii University of Hawaii, Manoa Mike Kawate Idaho University of Idaho, Boise Ronda Hirnyck Montana Montana State University Mary Burrows New Mexico New Mexico State University Cary Hamilton Nevada University of Nevada, Reno Jay Davison Cooperative Extension Oregon Oregon State University Joe DeFrancesco Utah Utah State University Corey Ransom Washington Washington State University Doug Walsh Wyoming Currently Vacant V. BUDGET The 2016 budget is presented in Table 8 while Table 9 is a comparison and general breakdown of the regions budget from 2012 to An explanation of the various expenses is presented below. SALARY AND BENEFITS The Director and Principal Investigator (PI) for the IR-4 Western Region (WR) Center is Matt Hengel, PhD. He is an Associate Adjunct Professor in the Department of Environmental Toxicology at UC Davis. He is financially compensated 12 months of salary and benefits from the grant for his IR-4 program management and Regional Laboratory Coordinator (RLC) responsibilities. He has a Doctorate Degree in Agricultural and Environmental Chemistry with extensive experience and publications in analytical method development. Rebecca Sisco, MS, serves as Co-PI and Regional Field Coordinator (RFC) at 100% time (12 month calendar effort). She has a Master's degree in Integrated Pest Management and over 30 years experience in agriculture, pesticides and regulatory science. Martin Beran, BS, serves as Regional Quality Assurance Coordinator (RQAC) at ~92% time (11 month calendar effort). He has a Bachelor's degree in Entomology with over 20 years experience in entomology, crop residue field trials, analyses and GLP. He has approximately 20 years experience working in Quality Assurance (QA) as governed by GLP. 74

75 Ron Tjeerdema, PhD Associate Dean, College of Agricultural and Environmental Sciences, UC Davis, serves as WR Administrative Adviser. He also serves in an advisory capacity on the IR-4 PMC and participates in program policy and coordination. There is no salary and benefits compensation for this position, the WR IR-4 program does pay for travel to PMC meetings. The laboratory is currently staffed by 6 staff researchers in addition to the RLC. The expertise of the staff covers sample processing, residue analysis, laboratory automation, and analytical instrumentation. There are over 75 years of analytical experience among the chemists. There are two Assistant Regional Field Coordinators and an Assistant Quality Assurance Coordinator. Their roles are to assist the Regional Field Coordinator and Quality Assurance Coordinator in their respective roles. One Assistant Regional Field Coordinator has extensive experience in Western Region Agricultural Production. The other Assistant Regional Field Coordinator has extensive experience in project management and information technology. The Assistant Quality Assurance Coordinator has a biology degree and more than 25 years of experience in auditing and working in Good Laboratory Practice environments. The support staff assists (1.9 FTE) the program in the documentation, budgeting, record keeping and data tracking, along with meeting/event coordination that is required by a program of this size and focus. All tasks conducted by this staff are integral and specific to the IR-4 project. There are no costs also recovered as indirect costs. TRAVEL Travel is domestic with an occasional international travel by invitation for the Director. The field staff travels to regional, state and national meetings, and IR-4 events such as planning meetings and the national priority setting workshops, as well as make field site visits for monitoring and training. The RFC also makes several trips per year in an outreach capacity. The RLC travels primarily for regional and national meetings as well as training. The chemists are supported to travel to attend meeting for residue analysis at the discretion of the RLC. The quality assurance unit travels for regional and national meetings, training and site audits. Approximately 40% of our travel budget is used to support travel stipends for field research directors' training, state liaison representatives meetings, as well as the Food Use and Ornamental Workshops. We support the travel for approximately 56 trips to these various events. MATERIALS AND SUPPLIES The field office incurs expenses related to communication items: printing, office supplies, facility, copier/ scanner, computer equipment and technical support averages about $40K per year. Shipping for tracking of original documents as well as field samples sent to the lab, and service contract (4 instruments) expenses averages about $167K per year. The laboratory spends about $52K per year in chemicals, laboratory glassware, compressed gas/cylinder demurrage, and misc. laboratory supplies. They also incur expenses for office supplies, communication, shipping, computer equipment and technical. FIELD RESEARCH PROGRAM The monies for the research program are directly passed to all cooperators (field center scientists, and ornamental and biopesticide scientists) as Fixed Price Agreements. For the total research program in the 75

76 WR, it is approximately $1.394M per year. The Food Use is the largest expense within the program at $1.135M per year, followed by the ornamental at $165K per year, and biopesticide at $93.5K per year. 76

77 Table 8: Western Region 2016 budget. REGION: Western Section A, Senior/Key Personnel: Full Time Equivalency (FTE) 1 NIFA 2016 Funding Base Salary Fringe Total Salary Director/Lab Coordinator 1 $129,173 $49,473 $178,646 Coordinators/Managers 1.9 $201,039 $86,700 $287,739 Other Funding Sources Section B, Other Personnel Total 2.9 $466,385 Professional/QA/QC 3 $245,837 $127,343 $373,180 Lab Analyst/Chemist 5.5 $347,906 $180,216 $528,122 Support Staff 1.5 $99,435 $51,963 $151,398 Student Total 10 $1,052,700 Total Salary, Wages and Fringe Benefits $1,519,085 Sectioin C, Equipment $0 Sectioin D, Travel Domestic $77,000 International $0 Section E, Participant/Trainee Support Costs $27,000 Section F, Other Direct Costs Totals Regional Center Materials and Supplies $92,464 Publication Costs $0 Service Contracts & Sample Shipping $166,601 Postal $0 Phone $0 Consultations $18,000 Totals $277,065 Field Program Food Use/Performance $1,134,600 Ornamentals $165,000 Biopesticide/Organic Support $93,500 Totals $1,393,100 Section G, Direct Costs (A thru F) $3,293, FTE = 40 h/week Notes: Material and Supplies include postal charges (other than sample shipping) and communications (phone, computers, internet etc.) 77

78 Table 9: General breakdown and comparison of WR budget from Other Funding Sources (Total) $15,168 $15,168 $44,268 $94,268 $78,368 Section A, Senior/Key Personnel: NIFA Funds NIFA Funds NIFA Funds NIFA Funds NIFA Funds Director $13,596 $13,596 $15,005 $0 $0 Coordinators/Managers $252,844 $282,372 $288,944 $300,772 $330,212 Total $266,440 $295,968 $303,949 $300,772 $330,212 Section B, Other Personnel Professional/QA/QC $266,766 $213,730 $228,419 $238,671 $245,837 Lab Analyst/Chemist $304,455 $342,530 $349,339 $331,648 $347,906 Support Staff $179,887 $67,891 $104,558 $95,995 $99,734 $0 $0 $0 $0 $0 Part-time FTE) $0 $0 $0 $0 $0 FRINGE $398,982 $404,064 $477,534 $469,260 $495,396 Total $1,150,090 $1,028,215 $1,159,850 $1,135,574 $1,188,873 Total Salary, Wages and Fringe Benefits $1,416,530 $1,324,183 $1,463,799 $1,436,346 $1,519,085 Sectioin C, Equipment $0 $0 $0 $0 $0 Sectioin D, Travel Domestic $100,500 $81,383 $87,972 $57,000 $77,000 International $0 $0 $0 $0 $0 Section E, Participant/Trainee Support Costs $23,000 $15,000 $18,848 $22,000 $27,000 Section F, Other Direct Costs Totals Totals Totals Totals Totals Regional Center Materials and Supplies $220,000 $128,000 $126,556 $64,553 $92,464 Publication Costs $0 $0 $0 $0 $0 Service Contracts & Sample Shipping $0 $15,505 $111,896 $126,801 $166,601 Postal $0 $0 $0 $0 $0 Phone $0 $0 $0 $0 $0 Consultations $19,117 $0 $23,200 $20,000 $18,000 Lab Subcontract $70,000 $60,325 $91,000 $96,000 $0 Totals $309,117 $203,830 $352,652 $307,354 $277,065 Field Program Food Use/Performance $1,001,500 $974,928 $967,400 $1,077,000 $1,134,600 Ornamentals $151,250 $172,250 $159,950 $159,500 $165,000 Biopesticide/Organic Support $61,738 $164,252 $116,436 $0 $93,500 Totals $1,214,488 $1,311,430 $1,243,786 $1,236,500 $1,393,100 Section G, Direct Costs (A thru F) $3,063,635 $2,935,826 $3,167,057 $3,059,200 $3,293,250 Notes: Material and Supplies include postal charges (other than sample shipping) and communications (phone, computers, internet etc.). In 2012 Materials and Supplies included service contracts and sample shipping as well. Other funding sources are funds for additional work above and beyond USDA NIFA grant. Attachment A: WR Field Research Centers - Crop Expertise (California) 78

79 Crop Boutwell (Holtville) Skiles (KARE) Ennes (KARE) Kyser (Davis) Watkins (Davis) Leach (Riverside) ALFALFA X X X X X ALMOND X X X X APPLE X X X X ARTICHOKE ASPARAGUS X X X X X AVOCADO X X X BARLEY X X BASIL X X X X X X BEANS X X X X X X BEET (GARDEN & SUGAR) X X X X BLUEBERRY X X BROCCOLI X X X X X X CABBAGE X X X X X X CANEBERRY X X CANOLA X X CANTALOUPE X X X X X X CARROT X X X X CELERY X X X CHERRY X X X X CHICORY (ROOTS) X CILANTRO X X X X X X CITRUS X X X COFFEE CORN (FIELD & SWEET) X X X X X X CRANBERRY CUCUMBER X X X X X X CUCUMBER DATES X DILL (SEED) X X X FIG X X X X GARLIC X X GRAPE X X X X X GRAPEFRUIT X X X GRASSES X X X X X GREENS (MUSTARD) X X X X X X GUAVA X HOPS KIWIFRUIT X X X X LEMON X X X LENTIL LETTUCE (HEAD & LEAF) X X X X X X LYCHEE MINT X X 79

80 Crop Boutwell (Holtville) Skiles (KARE) Ennes (KARE) Kyser (Davis) Watkins (Davis) Leach (Riverside) MUSHROOM X X ONION (DRY & GREEN) X X X X X X ORANGE X X X PEA (DRY, PODDED & SUCCULENT) X X X X X X PEACH X X X X PEANUT PEAR X X X X PECAN PEPPER (BELL & NON- PERSIMMON X X PISTACHIO X X X X PLUM X X X X POTATO X X X X POMEGRANATE X X X X RADISH X X X X X X RAMBUTAN RHUBARB SAFFLOWER X X X X SESAME X X SMALL GRAINS X X SPINACH X X X X X X SQUASH (SUMMER & WINTER) X X X X X X STEVIA X X X X STONE FRUITS X X X X STRAWBERRY (GH & FIELD) X X X SUNFLOWER X X X SWEETPOTATO X X SWISS CHARD X X X X X X TARO (WETLAND) TOMATO X X X X X X TROPICAL FRUITS TURNIP (ROOTS & TOPS) X X X X X WALNUT X X X X WATERCRESS WATERMELON X X X X X X WHEAT X X X 80

81 Crop Attachment B: WR Field Research Centers - Crop Expertise (Outside of California) Hamilton (NM) Coughlin (HI) Kam (HI) Sturman (OR) Koskela (OR) Meeks (ID) Groenendale (WA) ALFALFA X X X X ALMOND APPLE X X X ARTICHOKE ASPARAGUS X X AVOCADO BANANA X X BARLEY X X BASIL X X BEANS X X X X X BEET (GARDEN & SUGAR) X X X X X BLUEBERRY X X BROCCOLI X X X CABBAGE X X CANEBERRY X X X CANOLA X X X CANTALOUPE X CARROT X X CELERY CHERRY X X X X CHICORY (ROOTS) X CHIVES CILANTRO X X X CITRUS CLOVER (FOR SEED) X X X X COFFEE X X CORN (FIELD & SWEET) X X X X CORN (FOR SEED) X X CRANBERRY X X CUCUMBER X X X DILL (SEED) X X FIG GARLIC X GRAPE X X X X GRAPEFRUIT GRASSES X X X X GREENS (MUSTARD) X X X GUAVA X X HOPS X X X X KIWIFRUIT X LEMON LENTIL X X 81

82 Crop Hamilton (NM) Coughlin (HI) Kam (HI) Sturman (OR) Koskela (OR) Meeks (ID) Groenendale (WA) LYCHEE X X MINT X X X X MUSHROOM ONION (DRY & GREEN) X X X X X ORANGE PAPAYA X X PEA (DRY, PODDED & SUCCULENT) X X X X PEACH PEANUT PEAR X X X PECAN PEPPER X PERSIMMON X X X PLUM X X X POMEGRANATE POTATO X X X RADISH X X RAMBUTAN RHUBARB ROSEMARY SAFFLOWER SESAME X X X SMALL GRAINS X X X X SORGHUM X SPINACH X X SQUASH X X X X STEVIA STONE FRUITS X X X X STRAWBERRY (GH & X X SUNFLOWER SWEETPOTATO X SWISS CHARD X X X X TARO (WETLAND) X X TOMATO TROPICAL FRUITS X X X TURNIP (ROOTS & TOPS) X X WALNUT WASABI X X X WATERCRESS X X WATERMELON X WHEAT X X X X X 82

83 Attachment 6 -The IR-4 Organization-Project Headquarters As one of the six partner units that makeup the IR-4 Project, IR-4 Project Headquarters (HQ) provides leadership and direction to all the units by coordinating the multiple year life cycle of every regulatory research project from submission of a request for assistance through registration of the technology. HQ coordinates and/or manages national and international research and regulatory activities on food crops with conventional chemical pesticides and biopesticides as well as national research with all types of pesticides on non-food ornamental crops. HQ accomplishes its tasks through close coordination with the specialty crop community (growers, commodity associations, food processors) and other specialty use stakeholders, state/federal research and extension scientists, pest management industry (chemical and biopesticide companies), EPA and other regulatory authorities, USDA (including NIFA, ARS, FAS, APHIS), Land Grant Universities/State Agriculture Experimental Stations, Department of Defense, international partners (e.g. Australia, Brazil, Canada, China, Colombia, Costa Rico, European Union, Kenya, New Zealand, Thailand)/regulatory authorities, and most importantly, other IR-4 units. HQ was the first functional operational unit of IR-4 when Interregional Research Project Number Four was formally established by USDA/SAES in The roles and responsibilities of HQ have expanded with the extension of IR-4 s mission as well as the need to manage new pesticide laws or regulations. Specifically, HQ expanded when the Regional Centers with laboratories were established and ARS started cooperative research in the mid-1970s. In 1989, new scientists were added when IR-4 received significant new Congressional funding to maintain minor uses in association with the 1988 Amendments to the Federal Insecticide, Fungicide and Rodenticide Act. Expansion also occurred by adding the Ornamental Horticulture, Biopesticide and Organic Support and Public Health Pesticide objectives. Much of the structure and responsibilities of HQ is to operate an efficient national/international multidiscipline research organization while ensuring the Project s compliance to EPA Good Laboratory Practice Regulations (GLP see Chapter 40 Code of Federal Regulations, Part 160). These regulations require any public or private organization that develops data of a regulatory nature submitted to EPA to put certain process into place that ensures the quality and integrity of the data. The IR-4 Project Management Committee has delegated GLP compliance to HQ. To ensure compliance, HQ houses the personnel required under the GLPs including the Testing Facility Management/Sponsor, Study Directors, and Quality Assurance Unit management. IR-4 followed the compliance model used by the crop protection industry when GLP regulations were extended to Magnitude of Residue studies in HQ s role was further expanded in 2015 when the IR-4 Northeast Region (NER) transferred from Cornell University to Rutgers University. The NER functions under the leadership of Dan Rossi. The NER grant provides resources to HQ to manage administrative operations for the region. The NER Quality Assurance officer is physically located at IR-4 HQ. HQ responsibilities include but are not limited to: Receive all new requests for assistance from growers, commodity organizations, research scientists and extension personnel; evaluate requests for registration status and duplication. 83

84 Maintain multiple databases (Food, Biopesticide/Organic Support, Ornamental Horticulture) that track the status of all requests for assistance. New, valid requests are entered into the appropriate IR-4 tracking database and status maintained until use is registered. Work with pesticide (chemical and biopesticide) registrants, USDA Regional Integrated Pest Management Centers, and EPA to determine the feasibility of potential projects for research and registration. Focus on factors that encourage IPM or regulatory situations that would prevent registrations. Plan, organize and facilitate open and transparent workshops with stakeholders to establish research priorities. Work closely with IR-4 regional personnel to develop a research plan and assign research sites. Draft, modify and finalize research protocols for IR-4 sponsored studies. For food crops, protocols must be in accordance with EPA guidelines for Good Laboratory Practices (GLP) requirements, required data sites and fractions. Authorize protocols as Study Director and Sponsor. Approve changes to protocol when needed. HQ Study Director required to serve as single point of study control. Work with Field Research Directors, Regional Field Coordinators (RFC) and Regional Laboratory Coordinators (RLC) to manage research. Review all quality control and quality assurance reports of the field and laboratory data. Request additional information to clarify issues when needed. Draft submission documents to include data and other required information. Coordinate GLP critical phase audits of field and laboratory research; facility audits of all research sites and phase/final report audits. Work with respective companies to coordinate the final pre-submission review of data/data report; obtain necessary submission documents. Submit data to pesticide registrants/epa to facilitate registration and respond to any questions from EPA. Notify stakeholders when pesticide tolerances and registrations are established. Reformat and submit data to international authorities to facilitate establishment of international maximum residue levels. Develop product performance and crop safety trials when needed to assist with the registration. Manage product performance research at nearby Rutgers Tree Fruit Research and Educational Center in Cream Ridge, NJ on ornamental crops. Provides assistance and guidance to public sector scientists, government programs and small companies regarding: 1) how to successfully navigate through a registration process within EPA s Registration Division and/or Biopesticide and Pollution Prevention Division. Provide regulatory support involving the deregulation and findings of substantial equivalence of genetically modified organisms for the registration and/or approval of plant incorporated protectants (PIPs). Provide assistance to certified organic growers about pest management options by facilitating registrations of pesticides that can be added to the National Organic Program s National List of substances approved for use in organic production. Issue subaward agreements and coordinate payments to the Northeast Region researchers; when deemed necessary, issue subaward agreements and coordinate payments to all biopesticide researchers. 84

85 Produce and provide public relations materials for the IR-4 National Program, CLC and PMC; produce IR-4 Newsletter 3 times/year; maintain website and other social media communications. Facilitate Project Management Committee meetings to discuss long-term policy, coordination and integration for the IR-4 National Program. Work with the IR-4 Commodity Liaison Committee to provide stakeholder direction for IR-4. Represent IR-4 at regional, national and international conferences, symposiums and workshops. PERSONNEL Multiple funding sources (NIFA Special Research Grant for HQ and NER, NRSP-4 grant, ARS Cooperative Agreements, FAS funds, unrestricted grants, etc.) support a total of 28.6 full time equivalents (FTE) including 19 with advanced degrees (9 Ph.D. and 10 Master s Degrees) and having the following assignments: Administrative/Cross Programs (6.8 FTEs) Jerry J. Baron, Ph.D., Executive Director (95%) Susan Bierbrunner, Database Manager Uta Burke, Business Assistant (90%) Cheryl Ferrazoli, Travel & Meeting Coordinator Shiayi Huang, M.A., Application Developer, Sherri Nagahiro, B.S., HQ & NER Financial, Grant & Business Manager (80%) Sherrilynn Novack, M.S., Public Relations and Communications Manager (95%) Karl Lindauer, SEBS Information Technology Consultant (20%) Biopesticide and Organic Support Program (2.5 FTEs) William Barney, M.S., Crop Grouping Manager (50%) Michael P. Braverman, Ph.D., Biopesticide and Organic Support Program Manager Krista Coleman, M.S., Research Assistant Food Program (11.5 FTEs) Marija Arsenovic, Ph.D. Weed Science Program Manager William Barney, M.S., Crop Grouping Manager (50%) Deborah Carpenter, Ph.D., Food Program Assistant Director, Registrations Keith Dorschner, Ph.D., Entomology Program Manager Kathryn Homa, M.S., Plant Pathology Manager Carolyn Jolly, M.S., Study Director, Interdisciplinary Daniel L. Kunkel, Ph.D., Associate Director, Food and International Programs Grace Lennon, M.S., Study Director, Interdisciplinary Raymond Leonard, B.A., Study Director, Interdisciplinary Kenneth Samoil, M.S., Interdisciplinary Karen Sims, B.S., Food Program Administrative Assistant Van Starner, Ph.D., Food Program Assistant Director, Research Planning & Outreach Northeast Region Administration (1.4 FTEs) Jerry J. Baron, Ph.D., Executive Director (5%) Uta Burke, Business Assistant (10%) Jane Forder, B.A., NER Quality Assurance Specialist 85

86 Sherri Nagahiro, B.S., HQ & NER Financial, Grant & Business Manager (20%) Sherrilynn Novack, M.S., Public Relations and Communications Manager (5%) Ornamental Horticulture Program (2.2 FTEs) David Bodine, Cream Ridge Research Assistant: (50%) Thomas Freiberger, Cream Ridge Researcher: (20%) Cristi L. Palmer, Ph.D., Ornamental Horticulture Program Manager Elymar Vea, Part-time Ornamental Horticulture Program Assistant (50%) Public Health Pesticides (1.2 FTEs) Yu-Han Lan, Student Assistant, Public Health Program (20%) Karl Malamud-Roam, Ph.D., Public Health Pesticides Program Manager Quality Assurance (HQ) (3 FTEs) Tammy White Barkalow, M.S. Food Program Assistant Director, Quality Assurance Diane D Angelo, M.S, Quality Assurance Specialist Juliet Thompson, Quality Assurance Administrative Assistant INFRASTRUCTURE HQ operations and NER administrative functions are part of the New Jersey Agriculture Experimental Station and School of Environmental & Biological Sciences (SEBS) within the Land Grant university, Rutgers, The State University of New Jersey. SEBS does not have available space on campus to house HQ. HQ leases office space in a commercial office building. The space is 16,540 square feet and consists of: 30 offices; 5 cubicles; a large conference room; a small conference room; two file rooms equipped with fire suppression systems (as required by the GLPs, one for active files and the other for archives), kitchenette, mail room; copy area large enough to accommodate two large capacity copier/scanners and a small reception area. This office provides the work area needed for IR-4 HQ scientists, staff and management to perform their required duties and a secure location for research documents. FISCAL CHALLENGES AND CONCERNS UNIQUE TO HQ Every IR-4 Unit has experienced flat or lower funding while expenses continue to rise. In most of the units, the reduced funds have been made up through the scaling back of research. Unfortunately for HQ, so much of its annual funding is tied up in fixed expenses: salary, fringe benefit cost, building rental, computer services, etc. There is often little predictability in salary/fringe categories, where HQ has experienced significant increases to fringe rate RETROACTIVELY for 8-10 months. In fact, IR-4 has had to lay off employees because of very high retroactive fringe increases. Only travel and a few other smaller expenses can be adjusted during leaner fiscal times. As noted the majority of the HQ (and NER) funds received do not allow indirect costs. HQ has been working behind the screens to minimize the indirect cost issue with HQ host institution, Rutgers. For over 15 years, HQ has been off campus and directly paying rent, computer support utilities, janitorial services and even campus mail delivery service for the 15-mile distance between campus and HQ office building. In addition to covering these expenses, HQ has been empowered by the Rutgers Office of Research and Sponsored Programs to develop and manage subaward agreements with cooperating 86

87 universities. We estimate that HQ is covering over $550, of expenses that are normally covered by institutions like Rutgers. This is approximately 10% of the entire HQ budget. In addition to the above, IR-4 has been very aggressive in soliciting grant funds from sources that do allow indirect funds. Rutgers receives some overhead funds from grants/cooperative agreements with FAS and APHIS. These grant sources allow 10% IDC. It seems inevitable that host universities will take the same path as Cornell University and require a minimum percent for indirect cost from its funding sources. When/if this becomes a requirement at Rutgers, the impact on HQ will be compounded because there is limited ways, outside of reduction in force to make substantial funding cuts. We sincerely hope that Rutgers central administration will be willing to negotiate some relief from HQ paying expenses normally covered by the host institution or agree to a lower indirect cost rate recognizing that there are already legitimate contributions. The budget struggles of the federal government continue to trickle down to programs that support agriculture. Therefore, HQ pursues financial support from other agencies and industry. In addition to the Special Research Grant (SRG) from NIFA, HQ currently receives funds from NRSP, APHIS, ARS, FAS, international organizations and the agrichemical industry. The combination of non-srg funds make up about 50% of the total funding for HQ. The challenge is to maintain or increase these types of funding. First, many believe that the NRSP funds are vulnerable as they come from the State Agriculture Experiments Station Directors who are fighting their own budgetary battles. The APHIS, ARS, FAS and international organization funds are project driven. The agrichemical industry is shrinking as large companies merge (i.e. DuPont and Dow) and/or consolidate their operations. In spite of the above, HQ has established a goal to increase grants from industry from $1.5 million to $3.0 million annually by This will be accomplished by developing new funding sources from the food processing industry, commodity associations and other miscellaneous organizations. In late 2015, IR-4 received the first two check totally $550,000 for support of the Global Minor Use fund/foundation. To better understand the operations of HQ, below is a detailed budget description from HQ Special Research Grant for fiscal year 2016 Sections A & B: Salaries: IR-4 Project HQ manages all aspects involving the receipt of Requests for Assistance, prioritization of potential research projects, establishment of research, development of data, review of data, ensuring regulatory compliance and submission of reports to regulatory authorities. Some of these activities involve planning and facilitating workshops to establish research priorities; coordinating and collaborating with field research centers, laboratories and regional personnel during all phases of the research project and managing all aspects of IR-4 submissions to industry and regulatory authorities. Salaries are adjusted for an anticipated increase of 3% effective July 1, Fringe benefits for all positions are calculated at 40.43% for the proposed budget period. 14 Rent ($425,000), IT Support ($50,000), 0.5 FTE to manage subawards ($60,000), campus mail delivery ($10,000) 87

88 PI and Co-PI: much of their salaries are funded from NRSP-4 funds, 39.7% of Executive Director s salary and 49.2% of Associate Director s salary $158,001 3 Food Program Managers: the majority of their salaries are funded from NRSP-4 funds. 48.9% of Assistant Director, Registrations; 5% of Assistant Director, Quality Assurance and 5% of Assistant Director, Research Planning & Outreach $74,054 2 Other Program Managers: some of their salaries are funded from FAS or APHIS 65% of Biopesticide/Organic Support Manager and 95% of Ornamental Horticulture. $ 201,390 Study Directors: 100% of Weed Science Program Manager; 95% of Crop Grouping Manager; 95% of Entomology Program Manager; 100% of Plant Pathology Manager; 100% of 4 Interdisciplinary Study Directors $ 816,743 Quality Assurance: 100% of Quality Assurance Specialist $71,204 Administration and Operations staff: 100% of Database Manager; 65% of Business Assistant; 100% of Research Assistant; 100% of Travel & Meeting Coordinator; 100% of Database & Application Developer; 65% of Business Manager; 90% of Public Relations & Communications Manager; 100% of Food Program Administrative Assistant; 100% of QA Administrative Assistant $ 520,428 Total salaries $1,841, % fringe $ 744,652 Total Salaries and Fringe benefits $2,586,482 Section C. Nonexpendable Equipment. No funds requested Section D. Travel: Project Management Committee (PMC) meetings are held spring, summer and fall and provide a forum to discuss: long-term policy, coordination and integration of the national program. Travel to the spring meeting will include the Executive Director; Associate Director, Food & International Programs; Assistant Director, Research Planning & Outreach; Assistant Director, Registrations; Assistant Director, Quality Assurance; Public Relations Specialist; Biopesticide and Organic Support and Ornamental Horticulture Program Manager $20,000 Section E: Participant/Trainee Support Costs No funds requested Section F: Other Direct Costs 1. Materials and Supplies daily necessities (pens, paper clips, staples, etc.), paper, folders, hanging files, report covers, ink cartridges for printer, fax and copy machines, CDs, stationary, envelopes, etc. are purchased on a routine or as needed basis. With the increased reliance on computers and the movement toward on line processes, computers contain the research data and information vital to the IR-4 Program. Given the life span of a computer is 4-5 years, it is necessary to replace approximately 5 antiquated computers (Dell laptops and/or desktops or equivalent). Each replacement computer will cost approximately $1,500 each, with this estimated budgetary figure also including any necessary drives, cards and updated software/licenses. These computers will be utilized solely for this program. If needed and for cost efficiency, HQ orders the sample bags stamped IR-4 with markable tabs to identify field research information on behalf of the National Program. Total Supplies $ 17, Publication Costs No funds requested 3. Consulting Services No funds requested 88

89 4. ADP/Computer Services Rutgers University, School of Environmental and Biological Sciences (SEBS) Information Technology Services provides computer and technical support. Services include: desktop support, telephone/fax/internet support, problem elevation, server administration, website maintenance and network support. Total Computer Services $ 54, Subawards/Consortium/ Contractual Costs No funds requested 6. Equipment or Facility Rental/User Fee in an effort to reduce costs, production of many publications and the photocopying/scanning of research documents and protocols that are distributed to field research directors, laboratory research directors and regional coordinators; petitions sent to the Environmental Protection Agency and raw data for reports under audit are done in-house. The machines are leased through a reduced rate State contract negotiated by Rutgers University. IR-4 strategy to lease rather than purchase is to take advantage of the technology improvements and upgrades as well as the reduced cost afforded by the state contract. Each lease includes a maximum copy amount per month; any overages are charged extra copy fees per page. Total Equipment Rental $25, Alterations and Renovations No funds requested 8. Telephone local and long distance phone calls; conference and webinar meeting calls; business travel calls and Rutgers charges for SES fiber network connection supporting internet traffic, phones, and the IR-4 website. Internet IR-4 HQ is located off campus; therefore, internet service is provided by Comcast. Total Telephone/Internet $ 10, Cell phones - monthly service for 4 cell phones belonging to the Executive Director; Associate Director, Food & International Programs; Assistant Director, Research Planning & Outreach and Assistant Director, Registration (note: any expenses beyond the negotiated monthly charges for phone service and minutes will be paid by the phone user. Total Cell Phone $ 3, Postage first class and express mail service of correspondences, research and meeting materials; ground shipments of research supplies and samples. Total Postage $12,000 Total Other Direct Costs $122,361, TOTAL DIRECT COSTS $2,728,843 89

90 The table below compares the revenue HQ receives and expenses annually between 2014 and anticipated in IR-4 HQ REVENUE & EXPENDITURES Revenue APHIS $461,996 $453,977 $150,000 ARS Cooperative Agreement for QA & Ornamentals $80,089 $99,448 $80,000 ARS Cooperative Agreement for Public Health $250,000 $225,000 $225,000 FAS $11,006 $15,000 $50,000 Industry $1,534,713 $1,153,665 $1,100,000 International Organizations $0 $161,500 $75,000 NRSP $481,182 $481,182 $481,182 Special Research Grant $2,912,570 $3,171,656 $2,728,843 Subaward Agreements $0 $132,250 $0 Registrations $33,788 $68,017 $35,000 Rental Income $32,126 $38,551 $40,000 other TOTAL REVENUE $5,797,470 $6,000,245 $4,965,025 Expenses January to December Salary/fringe (fringe differential) $3,821,275 $3,494,420 $3,669,141 Travel (domestic + foreign + registrations) $170,654 $197,664 $195,000 Rent $362,775 $404,373 $424,592 Communications (marketing + memberships + subscriptions + postage + telephone) $73,854 $72,875 $75,000 Materials and supplies (operating) $50,130 $27,737 $40,000 Capital Equipment (computers/copier leases/sebs IT) $114,718 $86,148 $100,000 Subawards Miscellaneous $82,898 $116,295 $100,000 Biopesticide & Organic Support $44,334 $60,375 $20,000 Ornamental Horticulture $350,298 $321,170 $50,000 Quality Assurance $36,340 $55,572 $35,000 Etofenprox $30,800 $59,590 $0 Processing Studies/MOR/Analysis $110,119 $84,406 $90,000 Workshops/Training/Conferences/Meetings (bus) $101,082 $249,528 $100,000 Report Writing $6,350 $0 $0 Professional Service Providers $38,403 $22,751 $30,000 Funds for cost share accounts $4,721 $33,146 $20,000 Indirect Costs $68,513 $42,398 $40,000 Additional expected expenses $400, TOTAL EXPENSES $5,467,262 $5,328,448 $4,988,733 REVENUE MINUS EXPENSES $330,209 $271,797 -$23, Some of the funds came late in the calendar year and HQ has not yet expensed these funds 90

91 91

92 92

93 Attachment 7 - The IR-4 Organization-USDA-ARS Minor Use I. REGIONAL OVERVIEW The ARS part of the IR-4 Project comprises 7 states scattered around the country: CA, GA, OH, MD, OR, SC, and WA. ARS has 2 residue laboratories devoted to the IR-4 program. They are located at Tifton, GA and Wapato, WA and accept samples from any of the IR-4 field locations. Field Research Directors are located in CA, GA, OH, SC and WA where vegetable field plots are established. Some small fruit work is done at GA and some tree fruit work is conducted at WA along with vegetables. ARS also conducts ornamental trials along with food trials at GA, OH, SC and WA. OR only conducts ornamental trials and CA only conducts food trials. All the ARS locations cooperating with the IR-4 program are funded on a recurring basis and the funding levels do not change unless there is an increase or reduction in the ARS funds for the ARS minor use pesticide program. The ARS goal is to cooperate with the IR-4 program and support specialty growers in achieving economic sustainability and assist the program in reducing the backlog of high priority pesticide clearance requests. This is done by providing management tools to growers to ensure that pest populations remain below the economic damage threshold. While the ARS IR-4 program recognizes the need for non-chemical control technologies, the ARS funds have been primarily confined to supporting chemical technologies for specialty crops. The ARS IR-4 Pro gram focuses on the grower needs and works very closely in collaboration with the IR-4 Headquarters at Rutgers University. The goals of the ARS IR-4 program are to serve the specialty crop needs of growers. The ARS IR-4 Program has a Regional Director located in Beltsville, MD who also serves as the Regional Field Coordinator (RFC), coordinates the ARS-IR-4 residue laboratories and represents ARS on the PMC. Quality Assurance services are provided by the regions and are reimbursed for their travel and services. The ARS Administrative Adviser is a member of the National Program Staff and provides guidance on issues and policy that may affect the region and national program. The RFC is charged with managing all field aspects of the food use program (under USEPA GLPs), and ornamental programs. The ARS IR-4 program has a LC who is responsible for conducting chemical analysis and generating the residue data under GLPs for the Food Use Program at each of the 2 ARS residue laboratories. These individuals interact on a regular basis with IR-4 HQ personnel, primarily the Study Directors but also the Directors, Assistant Directors, Biopesticide and Ornamental Managers as appropriate to identify needs, develop protocols, processes and methods and bring projects to successful fruition. IR-4 has three distinct research programs, Food Use, Biopesticide and Organic Support and 93

94 Ornamentals. In all of these programs, IR-4 HQ serves as the national coordinator and regional staff insures that regional needs are met. II. PERSONNEL AND INFRASTURTURE The personnel who work to accomplish the goals of the ARS IR-4 program are: Administrative Rose Hammond, Acting Administrative Advisor Paul Schwartz, ARS Region Director Cheryl Campbell, Office Automation Assistant, Administrative/Clerical support Laboratory Thomas Hendricks Laboratory Coordinator, Tifton, GA Todd Wixson Laboratory Coordinator-Wapato, WA All personnel are full time except Cheryl Campbell who assists Dr. Schwartz one day a week. ARS is the host institution and charges a 12% over-head to all the locations within ARS. Each ARS location also charges an over head of about 20% to all the programs at the location. III. REGIONAL PROGRAMS FIELD RESEARCH PROGRAM - FOOD The total capacity of the ARS Field Research Centers is between field trials per year. The Field Research Centers established to conduct field residue trials are located at: Tifton, GA and Charleston, SC (EPA Region 2), Tifton, GA (EPA Region 3), Wooster, OH (EPA Region 5), Salinas, CA (EPA Region 10), and Wapato, WA (EPA Region 11) (Table 1). 94

95 Table 1: ARS field research centers Field Research Center - Affiliation Crop Protection and Management Research Unit U.S. Vegetable Laboratory Application Technology Research Crop Improvement and Protection Research Temperate tree, fruit and vegetable research Field Research Director Location EPA Region Benjamin Fraelich Tifton, GA 2, 3 16 Paul Wade Charleston, 2 13 SC Leona Horst Wooster, OH 5 21 Sharon Benzen Salinas, CA John Harvey Wapato, WA Approximate number of trials per year FIELD RESEARCH PROGRAM ORNAMENTALS The Ornamental Horticultural program is similar to the Food Use Program in process but smaller in resource allocation. The national program is managed by the Ornamental Horticulture Manager at IR-4 HQ. The RFC will monitor and track trial progress, and provide final reports to the Ornamental Horticulture Manager. Protocols designed at the national level for a coordinated research effort are provided to the ARS cooperators. (Table 2). Table 2: ARS ornamental researchers Location Researcher Discipline Project Tifton, GA Benjamin Fraelich Entomology Crop Safety Charleston, SC Paul Wade Horticulture Crop Safety Wooster, OH Michael Reding Entomology Efficacy, Crop Safety Corvallis, OR Nik Grunwald Plant Pathology Efficacy Wapato, WA John Harvey Horticulture Crop Safety 95

96 ANALYTICAL LABORATORY-Tifton A Research chemist is responsible for the operation of the USDA-ARS Tifton, Georgia analytical laboratory. The laboratory is staffed by 2 chemists and 2 physical science technicians. The expertise of the staff covers sample processing, residue analysis, laboratory automation, and analytical instrumentation. There are over 75 years of analytical experience between the staff members. The laboratory houses a wide variety of analytical instrumentation that allows for the analysis of the majority of compounds evaluated within the IR-4 program. The laboratory is assigned projects based on chemistry to take advantage of particular analytical as well as matrix expertise. There is the capacity to analyze samples from field trials per year. The laboratory work starts with sample receipt. Samples are received at the laboratory in a frozen state from ACDS, FedEx, or other courier, assigned unique laboratory sample IDs, and logged into the laboratory database system. Once logged in, the samples are processed into a homogeneous mixture suitable for pesticide residue analysis. When ready, samples are analyzed for residues according to protocol and validated analytical methods. The Tifton IR-4 laboratory is part of the USDA-ARS Crop Protection and Management Research Unit (CPMRU). The laboratory utilizes four laboratories (one used primarily for sample processing that has several chest and upright freezers, two wet labs, and one instrument lab) and two offices in a one story building occupied by CPMRU. Two 10ft x 10ft walk-in frozen storage facilities are located near the main CPMRU building. All sample storage units are monitored by a temperature monitoring/recording/alarming software/hardware system and are on backup natural gas generators. The Tifton laboratory has performed residue analysis for the IR-4 Project since 1979, and has all equipment necessary for extraction, isolation, clean up and detection of pesticides for residue analysis. The major equipment used and maintained by the project consists of a gas chromatograph (GC-NPD) with a nitrogen-phosphorus detector (NPD), a gas chromatograph with a mass selective detector (GC-MSD), and one high performance liquid chromatograph with tandem mass spectrometers (HPLC-MS/MS). Table 3 lists the dedicated analytical equipment used by the Tifton IR-4 Laboratory. Instrument Make Model Detector Liquid Chromatograph Thermo Scientific TSQ Quantum Ultra Tandem Mass Spectrometers Gas Chromatograph Agilent Technologies 6890 Series Mass Spectrometer Gas Chromatograph Agilent Technologies 6890 Series Nitrogen-Phosphorus Table 1 96

97 ANALYTICAL LABORATORY-Wapato A Research chemist (Laboratory Research Director or LRD) is responsible for the operation of the USDA-ARS Wapato, Washington analytical laboratory. Including the LRD the laboratory is staffed by 1 chemist and 3 science technicians, one of whom is an analytical chemist by training. The expertise of the staff covers sample processing, residue analysis, laboratory automation, and analytical instrumentation. Staff members combine for approximately 70 years of analytical experience. The laboratory houses a variety of analytical instrumentation that allows for the analysis of the majority of compounds evaluated within the IR-4 program. The laboratory is assigned projects based on chemistry to take advantage of particular analytical instrumentation as well as by matrix expertise. There is the capacity to analyze samples from field trials per year. The laboratory work starts with sample receipt and all location IR-4 personnel are trained for check-in and processing. Samples are received at the laboratory in a frozen state from ACDS or FedEx, assigned unique laboratory sample IDs, and logged into the laboratory database system. Once logged in, the samples are processed into a homogeneous mixture suitable for pesticide residue analysis. I f c a l l e d f o r b y the protocol storage stability samples are then prepared. When ready, samples are analyzed for residues according to protocol and validated analytical methods. The Wapato IR-4 laboratory is part of the USDA-ARS Yakima Agricultural Research Laboratory (YARL). The laboratory utilizes two laboratories, one used primarily for sample processing, and one office in a one story building occupied by YARL. Two 8ft x 10ft walk-in frozen storage facilities are located in the building, one within the main analytical laboratory and one adjacent to the processing laboratory. There are two reach-in refrigerator/freezer units in the main laboratory. These sample storage units are monitored by a temperature monitoring/recording/alarming software/hardware system and are on the facility s backup oil generator. There is also a 10ft x 20ft emergency walk-in freezer located in the facility s courtyard. The emergency freezer is not part of the monitoring network and is used only when one or both of the walk-ins are down for an extended time. The Wapato laboratory has all equipment necessary for extraction, isolation, clean up and detection of pesticides for residue analysis. The major equipment used and maintained by the project consists of a gas chromatograph with a nitrogen-phosphorus detector (NPD) and a flame photometric detector (FPD), a gas chromatograph with a mass selective detector (GC-MSD), and one high performance liquid chromatograph with UV and tandem mass spectrometers (HPLC-MS/MS). 97

98 Table 4 lists the dedicated analytical equipment used by the Wapato IR-4 Laboratory. Instrument Make Model Detector Liquid Chromatograph Agilent Technologies 1260 Infinity UV/Tandem Mass Spectrometer (Model 6460) Gas Chromatograph Agilent 7890 Series Mass Spectrometer (Model 5973) Technologies Gas Chromatograph Agilent Technologies 6890 Series Nitrogen-Phosphorus/Flame Photometric FIELD RESEARCH PROGRAM - PROGRESS ARS IR-4 activity from 2012 to 2016 is presented in Table 5 for program areas: Field and Laboratory. In the field program there are three types of research conducted. The Food Use program performs GLP controlled food residue studies to establish a registration/tolerance. The Food Efficacy/Performance program is to help fill in data gaps that can support a registration and does not require GLP inspection. This program is an easier path to a registration and offers a bigger return on the programs investment. The Ornamental program is also efficacy/performance program to expand the uses for ornamentals. The region averages around 63 food trials over the present five years which is well below the capacity of the regions field centers. Table 5: ARS IR-4 activity from 2012 to REGION Field Trials Food Residue Food Efficacy Ornamental Analytical Projects Tifton Laboratory Wapato Laboratory The laboratories average around 63 trials per year. The laboratories are capable of performing any crop/pesticide combination. ARS has no Quality Assurance unit. These activities are done by the regions and are reimbursed by ARS. 98

99 IV. FEDERAL LIAISON REPRESENTATIVES The Land Grant Institutions and Agricultural Experiment Station in each state of the SR nominate a State Liaison Representative (SLR) to serve as a collaborator and advisor for the IR-4 program. ARS has a liaison representative representing the 3 major pesticide disciplines in each of the 4 USDA regions These LRs have many years of experience in pest management practices and are actively involved in Integrated Pest Management (IPM) and other areas of pest control research. Communication is most often via but once a year generally in September/October, the LRs meet with the RFC to discuss potential pesticide needs and potential workloads for the ARS FRDs. ARS LRs have not met as a group for several years due to Agency travel restrictions but have met using webinars. Region Discipline Researcher North Central Fungicides Charles Krause, Wooster, OH North Central Herbicides Martin Williams, Urbana, IL North Central Insecticides Michael Reding, Wooster, OH North East ARS has no active IR-4 sites in the NE Southern Fungicides Richard Davis, Tifton, GA Southern Herbicides Vacant Southern Insecticides Alvin Simmons, Charleston, SC Western Fungicides Niklaus Grunwald, Corvallis, OR Western Herbicides Rick Boydston, Prosser, WA Western Insecticides Joseph Munyaneza, Wapato, WA IV. BUDGET The monies for the research programs are allocated on a recurring basis to the ARS locations conducting research for the IR-4 program. Funds are utilized by FRDs, the residue laboratories and ornamental scientists to conduct trials for IR-4. For the total research program in ARS, it amounts to around $2.5 million per year. The residue laboratories are the largest expense within the program at $1.2 million per year. 99

100 The 2016 budget is presented in Table Other Funding Sources (Total) $0 Section A, Senior/Key Personnel: ARS Funds Director $202,824 Director is also coordinator and manager Research Leaders $80,434 Total $283,258 Section B, Other Personnel Professional/QA/QC $0 Lab Analyst/Chemist and staff $697,721 included in Secretarial/Clerical staff Field research directors and staff $526,542 Ornamental Research Director and staff $79,144 FRINGE Total $1,303,407 Total Salary, Wages and Fringe Benefits $1,586,665 Section C, Equipment $2,654 Section D, Travel Domestic $23,195 International $0 Section E, Participant/Trainee Support Costs $0 Section F, Other Direct Costs Totals Regional Center Materials and Supplies $286,293 Service Contracts $113,540 Repair and Maintenance $4,000 Rent $600 Research Support agreement $21,344 Indirect research costs $404,865 Shared research costs $14,755 Totals $845,397 Field Program Food Use/Performance Ornamentals Biopesticide/Organic Support 100

101 Totals $0 Section G, Direct Costs (A thru F) $2,457,911 Salary and benefits The ARS Director is Paul H. Schwartz, PhD. He is located at Beltsville, MD, and has a PhD in Entomology H e has served on the IR-4 Project Management Committee (PMC) whose purpose is coordination and management of the National program since He also is the Regional Field Coordinator (RFC) and coordinates the 2 ARS IR-4 residue laboratories. Rose Hammond, PhD (Research Plant Pathologist) is the ARS IR-4 Administrative Adviser while she is the Acting NPL for Plant Health USDA ARS ONP Crop Production and Protection. The last person hired as an FRD was Paul Wade in 2007; Sharon Benzen has been with the program since The two laboratory coordinators have been with the program since 1992 and There is stability in the ARS IR-4 program personnel. 101

102 Attachment 8 - The IR-4 Process Food Program The research planning process involves input from its many stakeholders. Most proposals for IR-4 assistance are transmitted from growers through federal and state research and extension scientists involved in pest management research on high-value specialty crops. IR-4 also receives requests for assistance directly from growers and/or organizations representing specific commodities. The crop protection industry is prohibited from submitting requests for assistance. These requests for assistance, called Project Clearance Request (PCR s), can be submitted electronically via the IR-4 web site ( PCRs requests basic information, such as the crop, the proposed pest management tactic, the target pest(s) in question, the proposed use of the pest management tool including the application rate and timing, the interval from last treatment to harvest and why the pest control material is needed, and inquires if preliminary data are available. Preliminary data are very important to convince agricultural chemical companies that the proposed use is safe when used on the crop and it effectively controls the target pests. Upon receipt of the completed PCR, the proposed use is screened by IR-4 for validity. IR-4 transmits a formal questionnaire to the appropriate crop protection company to determine if they are willing to expand the registration to include the proposed use if IR-4 develops the appropriate data. If so, the proposed use is regarded as Researchable and is considered in the research project prioritization procedures. IR-4 does not have enough resources to work on all pending researchable requests. In fact, IR-4 can only work on about 25% of potential researchable projects in a given year. In order to identify the most important projects, IR-4 has a detailed open and transparent priority setting process. Regional input by stakeholders is a key component in establishing priorities, including an on-line nomination step, a face-to-face regional meeting and a national Food Use Workshop with about 185 participants representing commodity organizations, and federal and state research/extension scientists and regulatory authorities. At the workshops, the nominated projects are discussed in detail and its importance is considered on the basis of factors such as the availability and efficacy of alternatives, pest damage potential, performance of the proposed chemical, and its compatibility with integrated pest management programs. As a safety net, IR-4 has established a procedure that holds back some resources after the workshop to respond to projects of regional importance or important projects that will not be scheduled for various reasons. This upgrade process requires a stakeholder to be a Champion and write a brief proposal outlining the pest problem/need while providing supporting efficacy and crop safety data. Following the Workshop, a National Research Planning Meeting is held to assign field and laboratory sites for the highest priority research projects to be conducted in the upcoming year. About 60 food use residue projects (crop-chemical combinations) involving 500 field trials are undertaken annually, some in close cooperation and coordination with Canada s Pest Management Centre of Agriculture and Agri-Food Canada. Once projects are chosen and assigned, research protocols are drafted by the Study Director at IR-4 HQ. Protocols define the proposed pattern of use, the number and location of field trials, and instructions for analysis of the chemical and metabolites in the commodity as specified by EPA. The protocol also contains directions for the receipt and handling of the test chemical, the application of the test chemical on the target crop, the appropriate time and harvesting of the mature crop, the collection of representative crop samples and handling of these samples after harvest, the transfer of the crop samples to the analytical laboratory, and the analysis of crop and other supporting residue samples. 102

103 The EPA requires that this research be conducted and documented following exacting procedures outlined in the Good Laboratory Practice regulations. The GLP s require the assigning of a Study Director who serves as the single point of control for the research at the field and laboratory sites. The GLP s also require that all research work is monitored by an independent Quality Assurance Unit which is specifically required to notify the Study Director and IR-4 management when there are perceived noncompliance issues. EPA has also published specific guidelines on conducting magnitude of residue research studies, which requires a specific number of field trials be conducted in specific geographic regions. These guidelines are based on the acreage of the crop along with the potential of dietary exposure, plus the major production regions for the crop. IR-4 has established the field research centers/major research sites at strategic locations throughout the US. At these Field Research Centers, the crop is grown, the pesticide chemical is applied per protocol directions and the appropriate fractions of the crop are harvested when mature. The samples are shipped to one of the IR-4 analytical laboratories or a cooperating laboratory. These laboratories have state of the art analytical equipment that measure the amount of target chemical and its metabolites remaining in or on the crop. All data from IR-4 studies are transferred from field sites and analytical laboratories to IR-4 Headquarters, where Study Directors critically review the data and incorporate it into the required petition format for submission to EPA. Before the data are transferred, it is subjected to both quality control and quality assurance audits. These quality checks have helped ensure that IR-4 continues to achieve some of the lowest number of review cycles of any data submitter. The data are reviewed by the cooperating chemical company. Additionally, the IR-4 Quality Assurance Unit is responsible to review the data and the final report, and report to management that the final report reflects the raw data. The QAU also notifies the Study Director and Management if other issues occurred during the study that might result in GLP non-compliance. When the data package(s) and tolerance petition are complete they are submitted to EPA. Scientists in the EPA s Health Effects Division conduct a comprehensive review of the IR-4 residue and supporting registrant toxicology data. If the data show that the use would not expose consumers or the environment to unreasonable adverse effects, the EPA publishes a pesticide tolerance or maximum residue limit (MRL) as a Final Rule in the Federal Register. The MRL is the amount of the agricultural chemical in or on the crop that is considered safe and legally acceptable. Below is a summary diagram of the Food Use Program Process. 103

104 Depending on when the request for assistance is received, the use is prioritized as High Priority, the entire processs takes about 5 years. This time frame includes a 16 month review of the data/processsing the registration by EPA. The IR-4 research is under a 30 month timeline. See Figue (below) for a detail graphic of the IR-4 timelines. 104

105 Flow diagram of the IR-4 process. The diagram is primarily for the Food Use Program, as it is the largest program and to establish a residue tolerance on food requires the work be performed under Good Laboratory Practices (GLP). The Ornamental and Biopesticide Programs are primarily designed for evaluating crop safety and efficacy of the proposed crop protection tools being evaluated. Ornamental Horticulture Program The process within the Ornamental Horticulture Program is similar to the food crops program with some notable exceptions. Though stakeholders can submit specific requests of a pesticide for assistance on a particular plant species through the IR-4 website, most research activities in the ornamental horticulture area are considered broad research projects and are submitted for stakeholder consideration before or at the IR-4 Ornamental Horticulture Workshops Projects are discussed thoroughly for positive and negative aspects including whether non-registered active ingredients are available for screening and the geographical scope of the problem, and then workshop attendees rank these projects by voting The projects with the highest number of votes become priority research projects. For non-edible crops, the research and registration process is much simpler because GLP residue studies and pesticide tolerances are not required. The cooperating registrant can add the ornamental horticulture crop(s) and/or pest species to their registration when they feel comfortable that the use is safe to the crops and the active ingredient is effective against the target pests. Many pesticide products on ornamentals have open registrations that specifically allow growers the opportunity to use the product on unspecified plants as long as it is first tested under the grower s conditions. Since this objective was added, IR-4 data has supported over 36,000 use expansions. Biopesticide and Organic Support Program (BOS) Since its inception in 1982, the IR-4 biopesticide research program has provided competitive grant funding of projects, amounting to over $7.6 million in grants to researchers. In 2014, IR-4 decided to transition its biopesticide from a Request for Application, program that supports Early, Advanced and 105

106 Demonstration stage research to a priority setting workshop that actively engages stakeholders who chose the most critical needs for biopesticides and IR-4 responds by directing research to these priorities. IR-4 held its first Biopesticide Workshop in September 2014 in association with the Food Use Workshop in Atlanta, GA. Based on the priorities established at the workshop, IR-4 funded 12 studies with 29 different researchers. These studies were conducted by different universities on fruits and vegetables, tropical crops, honeybees, and ornamentals. Among the high profile invasive pests, the biopesticide program has supported projects involving spotted wing drosophila, and fireblight management in organic apples. IR-4 held the second Biopesticide Workshop in September 2015 in association with the Food Use Workshop in Chicago, IL. The priority setting workshop was held to actively engage stakeholders and encourage submission of known pest management voids that can potentially be answered by biopesticide technology. 106

107 Eliminating Pesticides as a Trade Barrier Managing Pesticide Resistance Enhancing our Safe Food Supply Combating Vector Borne Diseases!MAKING A DIFFERENCE Researching Bee Safe Products Facilitating Capacity Building Protecting Pollinators Expanding Crop Groups Leading Global Collaboration Combating Invasive Species YEAR END SUMMARY 2015

108 ! Dear Friends, I am pleased to present this 2015 IR-4 Year End Summary (YES) saluting IR-4 s accomplishments. The IR-4 Process starts with growers and processors of fruits, vegetables, herbs, ornamentals and other specialty crops who have pest management problems requesting assistance from IR-4. Those growers who have specialty use problems on larger crops may also request assistance from IR-4. An example of a specialty use request on a major crop was a recent success for rice growers needing a new bird repellent (see pg 7). Through the efforts of many, the IR-4 process ends with a new product to manage pests. IR-4 is Making a Difference for agriculture, as well as consumer access to reasonably priced, healthy food. Recognition is due to the large network of university researchers, extension personnel, government employees and industry colleagues who participate in the process. This includes over 200 dedicated IR-4 employees and research cooperators who Make a Difference every day in their IR-4 research. It also includes our friends at USDA s National Institute of Food and Agriculture, Agriculture Research Service and Foreign Agriculture Service (FAS) who help provide resources to do this work, and the team at the US Environmental Protection Agency (EPA) who review IR-4 data submissions, as well as partners from Canada and other international cooperators who are actively involved in joint data development projects. This is how IR-4 Made a Difference in IR-4 data supported 1,175 chemical clearances on food crops. This is the highest number of annual clearances/registrations achieved in the 53-year history of IR-4. Most of these clearances were with reduced risk chemicals and uses important for integrated pest management systems. The majority of IR-4 supported uses are expected to be added to product registrations in time for the 2016 growing season. The IR-4 Ornamental Horticulture Program continues to provide significant deliverables to its stakeholders. In 2015, IR-4 data were used to amend two herbicide labels (Freehand, Tower) to include additional crops, and two new fungicides (Mural, Segovis) were approved, allowing for more disease management options. IR-4 also achieved success in the Biopesticide and Organic Support Program. In 2015, IR-4 successfully implemented its new Biopesticide grants process where stakeholders select high priority projects for research at the IR-4 Biopesticide Workshop. One notable accomplishment in this program includes the EPA approval of HopGuard II (potassium salts of hops beta acids) to manage Varroa mites in bee hives. IR-4 staff wrote the registration package and developed the science literature reviews that were utilized in the EPA risk assessment process, which directly led to this registration. The Public Health Pesticide Program achieved some key milestones in 2015, including supporting pre-registration activities, efficacy testing, and obtaining Experimental Use Permits, for new insecticide-treated fabrics, mosquito traps, and molecular biocontrol agents. Del Monte vegetables have been able to secure registrations for all of our primary herbicides, insecticides and fungicides either directly working with IR-4 or in cooperative collaborative efforts with IR-4 and the agrichemical industry. We reflected the value in our book Vegetable Insect Management by Foster and Flood. Brian R. Flood, Ph.D. Research Fellow / Pest Management Vegetables Del Monte Foods

109 Everyone who eats has an interest in the IR-4 Project whether they know it or not. The IR-4 Project is a vital part of the country s food security system and should be considered a national strategic imperative! Bob Simerly, CPAg Agronomist, McCain Foods USA, Inc. IR-4 is Making a Difference throughout the world. In September, IR-4 successfully hosted the first Global Minor Use Priority Setting Workshop, where over 170 participants from 30 countries decided upon three primary and six secondary research priorities. The international research for these priorities will begin in Many countries have committed to conducting this research, allowing for global product acceptance and free trade among countries. Recently, the UN-Food and Agriculture Organization called on nations to reduce food waste, which is defined as the decrease of food in subsequent stages of the food supply chain intended for human consumption. Food is lost or wasted throughout the supply chain, from initial production down to the final stop, household consumption ( IR-4 is Making a Difference in reducing food waste by providing farmers everywhere with the safest and most current pest management technology that reduces the loss of food due to pest damage. The Directors of the State Agricultural Experiment Stations and USDA realize IR-4 is Making a Difference and voted 49 to 1 to reauthorized IR-4 for five more years. Making a Difference is difficult when IR-4 continues to face the challenge of securing adequate financial resources to sustain productive research. The impact of multiple years of flat funding and escalating costs is affecting IR-4 s ability to establish new research to answer grower needs. Specifically, IR-4 conducted fewer new food use studies in 2015 (62) than it did in 2011 (85); a similar decline was observed in the ornamental horticulture program which declined from 1316 to 673 trials. Many of IR-4 s partners are facing similar fiscal challenges and again, inadequate funding has had an impact. Cornell University s College of Agriculture and Life Sciences could no longer afford to cover overhead costs associated with IR-4 activities in New York State and ceased IR-4 operations at the university. Fortunately, Rutgers University and the University of Maryland were able to assume Cornell s role. IR-4 continues to rely on the generous contributions of time and effort by members of the IR-4 Commodity Liaison Committee (CLC), Minor Crop Farmers Alliance (MCFA) and the specialty crop community to articulate the value IR-4 brings to American agriculture and food safety, as well as its contribution to economic growth. On behalf of the IR-4 Project Management Committee, I want to express heartfelt thanks to IR-4 stakeholders for their commitment and support, and guidance provided by these individuals and groups to ensure that IR-4 and the need for specialty crop/ specialty use pest management technology remains a national strategic imperative!! All the best Jerry 3

110 ! Making a Difference for Leaf Lettuce Growers IR-4 Made a Difference by supporting the renewal of the registration for the herbicide pronamide (pyzamide/trade name KERB ). In 2007, EPA modified the pronamide tolerances forcing the removal of the use on leaf lettuce from the registration. The loss of KERB on the leaf lettuce registration created a huge weed management void for growers in the production of many types of leaf lettuce. Hand weeding was often the only option for leaf lettuce growers. DowAgrosciences, submitted new data allowing EPA to reassess and reclassify pronamide to better defined the human health risk assessment. This then opened the door for adding leaf lettuce back to the label. In 2014, DowAgrosciences submitted IR-4 developed residue data, which was used to successfully establish a new tolerance for leaf lettuce. To the delight of growers, this much needed herbicide was approved just in time for the 2016 growing season. The US Greenhouse Hydroponic vegetable industry has developed in the last 25 years. We would not exist today without the IR-4 Program. Making a Difference for Prickly Pear Cactus Growers! Mike Bledsoe Senior Vice President Food Safety & Regulatory Affairs Village Farms IR-4 has been receiving requests to help Prickly Pear Cactus growers for years. This is the only commercial crop in continental US that has the Crassulacean Acid Metabolism photosynthetic pathway, which is 2-3 times more efficient in converting water to dry matter than C4 grass crops like sorghum and corn. Given climate change and drought concerns, cactus could be a useful crop for the future in areas such as livestock forage and Photo by Peter Felker bioenergy. However, even an unusual crop like this has pest issues. Prior to 2015, the cactus crop in the US had only one insecticide registered (carbaryl) and the use was limited to 3 applications per year. This was entirely inadequate for a crop that has a yearlong frost free growing season and is attacked by two major pests, the wild cochineal insect (that produces a colorfast red dye) and a stunting disease tentatively identified as being caused by an aphid-transmitted umbravirus. IR-4 is Making a Difference for growers of Prickly Pear Cactus by its work in developing and advancing the new insecticide, Sivanto (flupyradifurone), which has low toxicity to honey bees. This product provides excellent control of these cactus pests. Thanks to cooperative research efforts of IR-4 and Bayer CropScience, an EPA registration was obtained for Sivanto on cactus and many other crops in early However, before Bayer would fully register the product on cactus, an additional study was needed to measure the effects of Sivanto on cactus bees. Bayer came up with a novel approach of using a California Experimental Use Permit, which facilitated further study while also allowing growers to market their treated crops. This unique collaboration with Bayer, the growers, and scientists will help to refine the label and ensure that cactus bees will not be adversely affected by this use, and growers will be able to manage pests. 4

111 Making a Difference in Bee Health IR-4 is Making a Difference with its latest Biopesticide & Organic Support Program success, the registration of HopGuard II. The active ingredient (potassium salts of hop beta acids) is derived from the hop plant and is the same ingredient used in flavoring beer. By formulating the acid onto strips and placing them in beehives, the acid helps to manage the parasite known as Varroa mite, which has been implicated in colony collapse disorder. Some of the early research on this product was facilitated through US Department of Agriculture - Agricultural Research Service (USDA-ARS). The data from USDA- ARS along with information about hops in the scientific literature was submitted to EPA by IR-4 to support its I do not know how we would survive raising vegetables without IR-4! IR-4 has been able to get us new chemicals labeled, along with better use rates and lower PHIs that we needed to keep our vegetables weed free, and insect free while keeping our bees safe, and our diseases under control. Bruce Buurma Buurma Farms registration. IR-4 also funded efficacy studies, and helped maintain the Section 18 (emergency use permits) in many states. Because this is a food grade product, it enables beekeepers to manage Varroa mite even during honey flow, when conventional pesticides are not allowed. In addition to controlling Varroa mite, HopGuard II helps to provide a new market for hops products in the Pacific North West. Arrow is pointing to the Varroa Mite on the bee. Photo by entomology.ifas.ufl.edu!

112 ! Downy Mildew has been a major problem for agriculture for centuries. The disease is caused by various species of fungi including members of the genera Pseudoperonospora, Bremia and Peronospora. All are classified as oomycetes or water molds. These diseases have devastating effects on many plants including cucurbits (cucumber, melon, squash, pumpkin, etc.), Brassica (cabbage, broccoli, etc.), basil, onion, grapes, and numerous environmental horticulture plants including impatiens, roses, and viburnum. And some downy mildews infect both edible and non-edible related crops, such as sunflower/black-eyed susan. Making a Difference in Downy Mildew Control! IR-4 is Making a Difference for specialty crop growers with residue, efficacy and crop safety screening for new pesticides and biopesticides for downy mildew in edible and non-edible crops. Basil crops have been totally decimated by basil downy mildew, effecting both basil grown for culinary and ornamental purposes. For basil downy mildew, IR-4 has conducted broad efficacy testing of biopesticides alone and in combination with conventional pesticides. Some of IR-4 s field trials included products that would be allowed to be used for organic basil production. In August 2015, EPA approved the registration of a new active ingredient oxathiapiprolin. IR-4 provided supporting residue and efficacy data for this new tool used to fight downy mildews for which specialty crop growers are very excited. This new chemical was developed by DuPont but has been licensed to Syngenta. Syngenta has exclusive rights to foliar and soil uses on all edible and non-edible crops in North America. Oxathiapiprolin has been proven in many field trials to provide outstanding efficacy for downy mildew control, both as a preventative and through residual activity. This registration provides growers with a new mode of action fungicide. It has been shown to be highly effective at very low use rates and exhibits no cross resistance to other products. IR-4 residue data on edible crops such as legumes, leafy vegetables, fruiting vegetables, cucurbit vegetables and ginseng were included as part of the initial submission and are now registered. There are still more registrations in the works. In December 2015, IR-4 submitted data for other Brassica leafy vegetables, raspberry, blackberry and basil. Once registered, oxathiapiprolin will be an important and foundation tool for basil growers to protect their crop. Impatiens Downy Mildew (Peronospora obduscens) Photo by Cristi Palmer Wyenandt et al Basil Downy Mildew (Peronospora belbahrii): Discoveries and Challenges Relative to Its Control. Phytopathology 105 (7): IR-4 efficacy data on non-edible crops contributed to the first registration of oxathiapiprolin for ornamental horticulture plants grown in greenhouses, nurseries, and landscapes. Impatiens downy mildew was completely controlled with soil treatments prior to the start of symptoms. Additional crop safety studies are planned so growers can be assured of no injury across a wide variety of plants. IR-4 is Making a Difference in studying new and emerging downy mildew diseases. In addition to studying efficacy for impatiens downy mildew, IR-4 had facilitated collaborations with a team of scientists to examine how cucurbit and impatiens downy mildew overwinter. How do they survive? Do they move to alternate non-crop plants? This team has also studied the genome of downy mildews to better understand population dynamics, develop new diagnostic tools, and determine how impatiens downy mildew could have become so devastating in a few short years.

113 Making a Difference in Resistance Management in Fruit and Nut Crops In 2015, the IR-4 Biopesticide and Organic Support Program shifted its emphasis to a grower need based prioritization system. This approach has produced several encouraging results in critical pest management issues. Fireblight is a serious bacterial disease of apples and pears. The restriction against the use of antibiotics in organic production has made this problem more acute. A combination of Blossom Protect plus Buffer Protect followed by an application of FireQuencher was as effective as an antibiotic treatment. In the management of spotted wing Spotted Wing Drosophila monitoring trap in blackberry (Photo by Oscar Liburd, University of Florida) drosophila in organic blueberry and blackberry, Veretran D and Grandevo were effective in rotation with Entrust. Promising technologies are under development for walnut and chestnut too. Making a Difference in Securing New Bird Repellent IR-4 is Making a Difference by supporting minor uses on major crops. The US Environmental Protection Agency recently approved the use of anthraquinone (AV-1011) as a bird repellent to protect rice seedlings. When applied to rice seed prior to planting, it is scientifically designed to deter birds from eating rice seed before and during emergence. Photo by Mike Brinkley, Arkion Anthraquinone is a natural product found in some plants such as rhubarb. It is nontoxic, nonsystemic and is effective through plant emergence, which eliminates the need for replanting lost acres due to bird predation of planted rice seed. Birds develop a negative association between the material, light shift, and the crop, thereby safely repelling the birds. The label for AV-1011 will be extremely valuable for Louisiana rice producers as well as producers in all other southern US rice producing states. Bird depredation on seeded rice is a major problem in certain areas of all of these rice producing states. The use of AV-1011 helps establish a uniform rice stand, which facilitates many production practices including fertilization, weed and insect control, as well as timely flood establishment. All of these will help achieve maximum yields which are critical for sustainable rice production. Steven Linscombe Director LSU AgCenter Rice Research Station!

114 ! IR-4 has shown outstanding leadership to minor use growers internationally and has been instrumental in the setup of several programmes. Relationships with IR-4 have been critical to the setup of a minor use project in New Zealand. In addition to advice on project development, the opportunity to learn about priorities and new agrichemical control options in the US, has assisted the establishment of projects in New Zealand. IR-4 has also provided invaluable leadership to international discussions and the establishment of policy on minor use, particularly at Codex. It is due largely to the commitment of IR4 that a Global Priority Setting Workshop was able to be held this year. I hope that IR4 will be able to maintain its commitment to Minor Use internationally as there is more work to be done. Nikki Johnson Project Leader Registration of Sustainable Agrichemicals for Minor Crops Project New Zealand

115 Making a Difference Toward Global Cooperation! In September 2015, IR-4 (along with USDA, Australia, Canada, the EU and others) Made a Difference by sponsoring the first Global Minor Use Workshop. The workshop was a first step in global research approaches to identifying solutions to solve minor use needs on fruits, vegetables and other specialty crops. From there the participants developed plans for cooperative research or data sharing. Prior to the Workshop, a database was created through a worldwide survey, where countries shared information about their specialty crop pest issues. The database is widely available for the minor use community and registrants. Forty countries shared information about their needs for solutions to their specialty crop pest management voids. The research projects will focus on: fruit flies on inedible peel tropical crops; downy mildew on leafy vegetables (lettuce, spinach, greens) in temperate growing climates; and aphids on lettuce grown in the greenhouse. The US IR-4 program agreed to be the lead country, for the tropical project and will provide the oversight and direction for the project. A lead country is still being identified for the temperate and the greenhouse crop projects. In order to coordinate and support this global research, the USDA-FAS initiated a Global Minor Use Fund with a contribution of $500,000 and encouraged other countries and industry partners to follow suit. More information regarding the meeting can be found on the global minor use portal website at: Making a Difference in Capacity Building IR-4 continues to Make a Difference by developing potential partners in global residue studies through the Tropical Residue Study and Capacity Development Program sponsored by USDA-FAS. In 2015, a project update meeting was held in Cambodia to develop timelines for completion of studies intended for submission to the World Health Organization s Joint Meeting on Pesticide Residues (JMPR). Field residue research training included papaya studies in Brunei and lychee in Thailand. Studies Mango harvest during residue study in Thailand. are also ongoing in several Asian countries. In Latin America, studies are proceeding with pyriproxyfen and spinetoram on a variety of crops such as banana and pineapple. These projects are expected to be complete in The project has expanded to Africa and efficacy trials are planned in Kenya, Uganda, Tanzania, Ghana and Senegal. IR-4 is Making a Difference by continuing its work in Egypt and Morocco.!

116 ! Making a Difference for Ornamental Horticulture Growers Growing Ornamental Horticulture crops is an art and these beautiful plants require careful management. Often, growers group these crops in ways to achieve production efficiencies. In a greenhouse, growers might group crops that need the same light exposure or fertilizer needs; in outdoor crops, growers might group crops for more efficient water or pest management practices. IR-4 is Making a Difference for nursery growers by providing research data that allows for new crops to be added to herbicide product labels, which allows growers more flexibility in grouping their crops for weed management practices. Nursery growers typically apply herbicides to manage weeds prior to emergence early in the annual production cycle. Pre-emergent herbicides reduce the labor costs of hand weeding and lessen the application of post-emergent herbicides, which might cause injury to crops with accidental overspray. For several years, IR-4 has screened pre-emergent herbicides for crop safety when they are applied over crops as they are breaking dormancy and then again 6 weeks later. This is when the crops are tender and most susceptible to injury. If no injury is observed with this timing, there is less risk of injury when plants are hardier later in the season. This project has consistently provided information for new and updated labels, such as the two herbicides Freehand (pendimethalin + dimethenamid-p) and Tower (dimethenamid-p) which were amended for new crops in IR-4 has been and continues to be integral in helping to provide guidance in pest management options to the greenhouse, nursery, and landscape industries. Through IR-4 s focus on product registration, our industry has greater options for pest management tools that are safe for plants and pesticide resistance management. Jill Calabro, Ph.D. Science & Research Programs Director AmericanHort/Horticultural Research Institute Photo by Cristi Palmer IR-4 is Making a Difference in managing plant diseases of ornamental horticulture crops. Foliar diseases mar the beauty of ornamental horticulture plants. Diseases such as botrytis gray mold and leaf spot reduce plant quality. Over the last couple years, these two disease groups were ranked as high priority projects, and IR-4 screened several new tools for efficacy. Dovetailing with registrant research activities, IR-4 efficacy and crop safety data supported the registration of Mural (azoxystrobin + benzovindiflupyr) for botrytis, powdery mildew, and leaf spot diseases. Downy mildew diseases are problematic and can cause loss of entire crops; and they have ranked highly in the IR-4 Grower & Extension Survey. As mentioned previously, Segovis (oxathiapiprolin) was screened by IR-4 for crop safety and impatiens downy mildew management. This information assisted in label development, allowing growers to manage downy mildews and other water mold diseases on a variety of crops. 10

117 Making a Difference in Combating Invasive Pests IR-4 is Making a Difference by studying ways to prevent new insect and mite pests from coming into the US when receiving young plants grown overseas. With international production and shipment of plants, preventing potentially Arrow points to stem damage (girdling) due to feeding by larvae of the European pepper moth, Duponchelia fovealis (Zeller). Photograph by Jim Bethke, Department of Entomology, University of California, Riverside. invasive pest species from entering and establishing in the US is a challenge. One example of international hitchhikers is the European Pepper Moth (EPM). In 2004, this pest was first discovered on begonia in San Diego County, CA. Thinking the pest was under control, growers were no longer aware of its presence. However, in 2010 the pest was found in 15 other counties in CA and many other states. This pest feeds on many ornamental horticulture and edible plants, leaving damage on roots, leaves, flowers, buds, fruits, and stems. It can survive just by feeding on decaying plant debris. It can hide in pots near the drainage openings and can easily be moved unnoticed from infested areas. IR-4 was part of a cooperative project with APHIS which studied the biology of EPM and potential ways to prevent movement of this pest and others on cuttings within the US and to provide guidance to offshore producers to prevent future exotic hitchhikers with pre-shipment treatments. Research was conducted on several pests (thrips, mites, mealybugs) with biopesticides, natural chemistries and hot water as treatments used immediately before shipping. While several pests and products were screened with variable success, the best outcome occurred with citrus mealybug where BotaniGard (Beauveria bassiana) compared favorably with Safari (dinotefuran) for reducing populations completely through 2 weeks after dipping infested chrysanthemum cuttings. This project has Made a Difference by highlighting a potential avenue for managing exotic pests during shipping and highlights where new biopesticides and natural products will need to be developed for optimal and consistent efficacy. Making a Difference in Aedes Mosquito Control! News articles have been filled by scary stories of the Zika, Dengue and Chikungunya viruses. One known vector of these viruses is mosquitoes. IR-4 is Making a Difference by providing pest control solutions for these assailants. Aedes aegypti (the Yellow Fever Mosquito) and Aedes albopictus (the Asian Tiger Mosquito) are the primary vectors of a wide swath of deadly or debilitating viruses. They are wide-spread in the US, and they are notoriously hard to control. Biting primarily during the day, they are not stopped by bed nets. They lay eggs in multiple batches in small, inconspicuous water bodies, and then live largely indoors, so they are very hard to target with either larvicides or adulticides. But a new suite of control tools are coming, and the IR-4 Public Health Pesticides Program is helping move them from the lab to the market. Since 2009, IR-4 has provided registration support for Lethal Ovitraps an attract-and-kill device recently registered by EPA. This device kills females Aedes when they enter it to lay eggs. The IR-4 PHP was also part of the Rutgers University team that developed similar devices that induce female Aedes to carry the pesticides on their feet and poison their own offspring. IR-4 has been the registration advisor for Attractive Toxic Sugar Bait, which kills mosquitoes when they feed on it. In 2015, the Biopesticide and Organic Green stain showing presence of Wolbachia in mosquito. (Photo courtesy of Stephen Dobson, University of Kentucky) Support Program funded efficacy studies with,a bacteria which inhibits reproduction of mosquitoes carrying the Zika virus.! Finally, IR-4 is assisting with registration of a mosquito larvicide for drinking water and of a Wolbachia intracellular biocontrol product for use against Aedes albopictus. 117

118 ! IR-4 Headquarters Rutgers University 500 College Rd. E. Suite 201 W. Princeton, NJ Fax: IR-4 Executive Director Dr. Jerry Baron x 4605 Cell: jbaron@aesop.rutgers.edu Food Use & International Programs Associate Director Dr. Dan Kunkel x 4616 kunkel@aesop.rutgers.edu Biopesticides and Organic Support Program Manager Dr. Michael Braverman x 4610 braverman@aesop.rutgers.edu Ornamental Horticulture Manager Dr. Cristi Palmer x 4629 palmer@aesop.rutgers.edu Public Health Pesticides Manager Dr. Karl Malamud-Roam x 4628 kmr@aesop.rutgers.edu Who to Contact to Make a Difference? Northeast Regional Field Coordinator (CT, DC, DE, MA, MD, ME, NH, NJ, NY, PA, RI, WV, VT) Ms. Marylee Ross Univ. of MD/LESREC Nanticoke Rd. Salisbury, MD, Phone: ext. 310 Fax: mross@umd.edu North Central Regional Field Coordinator (IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI) Dr. Satoru Miyazaki Michigan State University IR-4 North Central Reg. Res. Ctr Technology Boulevard, Suite 1031B Lansing, MI Fax: ncrir4@msu.edu Southern Regional Field Coordinator (AL, AR, FL, GA, KY, LA, MS, NC, OK, PR, SC, TN, TX, VA) Dr. Michelle Samuel-Foo University of Florida P.O. Box SW 23rd Drive, Bldg. 685 Gainesville, FL Fax: Cell: mfoo@ufl.edu Western Regional Field Coordinator (AK, American Samoa, AZ, CA, CO, Federated States of Micronesia, Guam, HI, ID, MT, NV, NM, Northern Marianas, OR, UT, WA, WY) Ms. Rebecca Sisco Univ. of CA; Dept of Env. Toxicol. Meyer Hall, Rm One Shields Avenue Davis, CA Fax: Cell: rsisco@ucdavis.edu USDA-ARS Dr. Paul H. Schwartz Jr. USDA/ARS/Off. of Minor Use Pesticides Rm. 119, Bldg. 308, BARC-E Baltimore Avenue Beltsville, MD Fax: paul.schwartz@ars.usda.gov This material is based upon work that is supported by the National Institute of Food and Agriculture, U.S. Department of Agriculture, under award number with substantial cooperation and support from the State Agricultural Experiment Stations, USDA-ARS, and USDA-FAS. IR-4 has been successful due to its unique ability to foster cooperation among stakeholders, make decisions, and carry out its core mission to provide growers of specialty crops access to pest management products. Without IR-4, the blueberry industry would have a much smaller pest control toolbox. Dave Trinka Director of Research Michigan Blueberry Growers Association!

119 Eliminating Pesticides as a Trade Barrier Managing Pesticide Resistance Enhancing our Safe Food Supply Combating Vector Borne Diseases MAKING A DIFFERENCE Researching Bee Safe Products Leading Global Collaboration Facilitating Capacity Building Combating Invasive Species Protecting Pollinators Expanding Crop Groups Annual Report 2015

120 Pest Management Solutions for Specialty Crops and Minor Uses IR-4 Headquarters Center for Specialty Crop Pest Management Rutgers, The State University of New Jersey 500 College Road East, Suite 201 W Princeton, NJ fax: February 29, 2016 Dear Friends, I am pleased to present the 2015 IR-4 Annual Report documenting IR-4 s accomplishments in calendar year The details of IR-4 s research efforts, accomplishments, challenges and future plans are found on the following pages. Calendar year 2015 was a record breaking year for the Food Program and with significant and notable accomplishments in the other program areas as well. Specifically: Food Program-EPA approved IR-4 data submissions supporting 1175 registrations or clearances on fruits, vegetables, herbs, other specialty food crops and specialty uses on major food crops. This is the highest number of registrations achieved in a single calendar year and breaks the previous record of 1085 achieved in Ornamental Horticulture Program-This Program continues to provide significant deliverables to its stakeholders. In 2015, IR-4 data was used to amend two herbicides (Freehand, Tower) with additional crops. The registration of two new fungicides (Mural, Segovis) improved disease management options. Biopesticide and Organic Support Program - The biggest highlight and most impactful registration under this Program was EPA approval of the registration of HopGuard II (Potassium salts of hops beta acids) to manage Varroa mites in bee hives. Varroa mites are known to be a critical pest causing significant damage to pollinators. IR-4 staff wrote the registration package and developed science literature reviews utilized in the EPA risk assessment process which directly lead to the registration action. Public Health Pesticide Program- IR-4 s efforts in this area remains relevant and absolutely necessary to protect the public from diseases (such as Zika virus, Dengue fever, malaria, Lyme disease) that are transmitted by mosquitos and ticks. The Program achieved some milestones in 2015, including supporting pre-registration activities, efficacy testing and obtaining Experimental Use Permits for new insecticide-treated fabrics, mosquito traps and molecular biocontrol agents. In addition to the above, in September 2015 IR-4 successfully managed the first Global Minor Use Priority Setting Workshop. Over 170 participants from 30 countries attended, and through consensus agreement, the participants chose three primary and six secondary research priorities. Research efforts will begin in 2016 on these priorities with multiple international partners. Major funding for IR-4 is provided by Special Research Grants and Hatch Act Funds from USDA-NIFA, in cooperation with the State Agricultural Experimental Stations and USDA-ARS.

121 The Directors of the State Agricultural Experiment Stations, recognizing the importance of IR-4 to specialty crop agriculture, approved the 5-year reauthorization of IR-4 Project, through the approval of the NRSP-4 Project Statement. This allows funding of IR-4 through Hatch Act/Multistate Research Funds. IR-4 s deliverables are realized through the collective efforts of many; beginning with farmers, producers and growers who need safe and effective technology to manage destructive pests and ending with industry registering this technology with regulatory authorities thereby allowing legal use. Along the way, many individuals and groups are engaged in The IR-4 Process, including the large network of university researcher s/extension personnel and USDA employees who do the day to day work. Industry contributes through allowing access to their pest management technology, technical support and additional resources. Significant appreciation to our friends at USDA s National Institute of Food and Agriculture, Agriculture Research Service and Foreign Agriculture Service who help provide resources and the dedicated team at US Environmental Protection Agency who review IR-4 data submissions. Also participating are government personnel from Canada and other international partners who are actively involved in joint data development projects. IR-4 continues to face the challenge of securing adequate financial resources to sustain productive research. The impact of multiple years of flat funding and escalating costs is affecting IR-4 s ability to establish new research to answer grower needs. Specifically, IR-4 conducted 62 new studies in 2015 which was 23 less than the 85 new studies conducted in A similar decline was observed in the Ornamental Horticulture program which field trial numbers were reduced from 1316 to 673 during the same time period. Many of IR-4 s partners are facing similar fiscal challenges. Inadequate funding has had a negative impact. For example, Cornell University was forced to cease involvement with most IR-4 activities in 2015/2016 because they could no longer afford to cover overhead costs associated with IR-4 activities in New York State. Fortunately, Rutgers University and the University of Maryland were able to take over Cornell s role. The challenge of allowable overhead and IR-4 funds is becoming a larger issue with other universities that support IR-4 research. IR-4 continues to rely on the generous contribution of time and effort by the members the IR-4 Commodity Liaison Committee (CLC), Minor Crop Farmers Alliance (MCFA) and other specialty use stakeholders to articulate the value of IR-4 to American agriculture, food safety and economic growth. We sincerely appreciate the support and guidance provided by these individuals and groups to ensure that IR-4 and the need for specialty crop/specialty use pest management technology remains on the front burner. In closing, it is safe to say, IR-4 s accomplishments and how we help farmers and producers grow their healthy food and ornamental crops with limited pest damage and/or reduced food waste makes a difference. Commodity Liaison Committee member Bob Simerly said it best Everyone who eats has an interest in the IR-4 Project whether they know it or not. The IR-4 Project is a vital part of the country s food security system and should be considered a national strategic imperative. All the best,

122 ANNUAL REPORT OF THE IR-4 PROJECT (NRSP-4) January 1, December 31, 2015 *National Research Service Program No. 4 - Specialty Crop Pest Management Background In 1963, the Directors of the State Agricultural Experiment Stations (SAES) and the United States Department of Agriculture (USDA) established the IR-4 Project (IR-4). IR-4 was needed because the registrants of pesticides focus their product development efforts on large acreage crops (major crops such as corn, soybeans, wheat, etc.) where the potential sales are significant. Fruits, vegetables, nuts herbs, and other small acreage crops (collectively called specialty crops) are considered minor markets and the development of pest management technology for pest control and reducing food waste in the production specialty crops are not usually the objective of the private sector. As a result, there are often many pest management voids in specialty crops. This is called the Minor Use Problem. The Minor Use Problem also applies to small or specialty uses on major acreage crops. IR-4 fills the void by developing the magnitude of the residue and/or product performance data needed by the US Environmental Protection Agency (EPA), the crop protection industry and/or other regulatory authorities to allow registrations on the specialty crops. The principal objective of IR-4 is to provide farmers legal access to essential pest management products that protect specialty crops from destructive pests while reducing food waste. Without safe and effective pest management products, which have been approved by regulatory authorities, crops would suffer significant yield and quality losses. The minor use problem is not unique to low acreage specialty crops. In 1977, IR-4 expanded its core objectives to include registration of pesticides for the protection of nursery/floral crops and Christmas trees. In 1982, IR-4 s mission was enhanced to include support for microbial and biochemical pesticide products. In 2009, regulatory support for minor use pesticides that manage arthropod pests which transmit disease to humans was added as a fourth IR-4 Project objective. In all four IR-4 Project areas, national coordination, technical guidance and funding are provided to develop the appropriate data and/or support registrations. The Minor Use Problem is broad, affecting every state, every US territory and essentially every country. IR-4 has been successful; the research performed by the IR-4 Project over its history has facilitated over 47,000 registrations of conventional pesticides and biopesticides on specialty food crops and ornamental horticulture crops. Since the mid-1990 s, IR-4 has given priority to facilitate registration of EPA defined as Reduced-Risk chemicals and biopesticides to fill pest management voids. IR-4 also focuses its efforts on products that are compatible with Integrated Pest Management Systems (IPM). All states/territories benefit from the efforts of the IR-4 Project because registrations of pest management products are often national in scope. The general public also benefits because of the broad availability of healthy foods at reasonable prices. IR-4 has achieved this success because it works in close cooperation with many groups and associations to accomplish its mission. Resources are leveraged to their fullest potential. Some of the major partners/cooperators include specialty crop growers/commodity organizations, the SAES, the crop protection industry, the USDA units (including Agriculture Research Service-ARS; Foreign Agriculture Service-FAS; National Institute of Food and Agriculture-NIFA; Animal and Plant Health Inspection Service-APHIS), EPA, the Department of Defense-Deployed Warfighter Protection Program (DWFP), California's Department of Pesticide Regulation (CA-DPR), Canada s Pest Management Regulatory Agency (PMRA) and the Pest Management Centre in Agriculture and Agri-Food Canada (CN-PMC). These and other Cooperating Agencies, principal leaders of the project, technical managers and IR-4 State and Federal Liaison Representatives are shown in Attachment 1. Further details about the IR-4 Project can be found on the IR-4 Project s website: 1

123 Food Program The IR-4 Project remains committed to its original objective to provide regulatory approval of safe and effective plant protection products to assist in the production of food crops and give specialty crop growers the tools they need to grow a healthy crop and be successful and competitive in local, regional, national and international markets. Research Activities Food Residue Since 1963, IR-4 stakeholders have submitted 11,857 requests for assistance to the IR-4 Food Program. Of these, 390 are currently considered researchable projects that remain as documented needs of specialty crop growers. The others have been addressed through previous research and regulatory submissions or cannot be registered at this time. In 2015, a total of 173 new project requests were submitted to IR-4. IR-4 staff added 66 requests to the IR-4 database to track the new crop group updates that will be bundled into future submissions to EPA. The total number of new requests added to the IR-4 tracking system during 2015 was 239 project requests. IR-4 s research priorities for 2015 were determined by IR-4 stakeholders during the September, 2014 IR-4 Food Use Workshop, in Atlanta, GA. Based on the outcome of that workshop and other priority setting mechanisms such as upgrading to answer regional needs, IR-4 scheduled 62 new studies in An additional 26 studies were carried over from the previous year for a total of 88 research projects. In most studies, the test chemical is applied in the field in a manner that simulates proposed grower use of the pesticide on the target crop. When the crop is at the appropriate stage, samples of the crop are collected and shipped to the analytical laboratory where the amount of test chemical remaining in or on the crop is determined. Field and laboratory data from this research are compiled in a regulatory package and utilized to request a pesticide tolerance or to set a maximum residue limit (MRL). The 2015 food residue research program consisted of 379 IR-4 State, 69 USDA-ARS field trials and 36 trials from our Canadian (CN-PMC) partners for a grand total of 484 field trials. Canada also served as Sponsor and Study Director for 3 of these studies. The specific studies for 2015, including test chemical and crop, are shown in Attachment 2. The majority of field trials are assigned to IR-4 or CN-PMC/Field Research Centers and sample analyses to the IR-4 Analytical Laboratories. When necessary, other cooperating facilities or contractors are utilized to ensure projects are completed in a timely manner. Research Activities - Efficacy and Crop Safety (E/CS) The need for IR-4 to develop product performance and crop safety data to support labeling of new uses for specialty crop pest management has become a more important priority in the IR-4 research plan in recent years, and in many cases the data are required by registrants prior to actively marketing the new uses. For 2015 IR-4 planned trials, requiring $191,000 in funding, to support E/CS trials in four research areas: for projects where these data are needed to support past residue research, but more E/CS data are needed before registration; supporting on-going residue research; for highest priority regional E/CS needs; and supporting projects to identify possible products to control pests where tools currently are not available [Pest Problem Without Solution, or PPWS ]. This funding supported research to address needs for 29 projects, including 68 state university trials and an additional 5 trials by ARS. In addition, Canada-PMC planned to conduct 6 E/CS trials, impacting 4 IR-4 projects. All of these E/CS trials will be used to support new uses in the U.S. which will benefit specialty crop stakeholders (see Attachment Efficacy/Crop Safety (E/CS) Research Program for full details). Submissions and Success Submissions. In 2015, IR-4 submitted data to EPA or to the cooperating registrant for 22 chemicals, addressing 97 specific IR-4 requests for assistance that were submitted by IR-4 stakeholders. Additionally, IR-4 submitted one petition to EPA that proposed to add new crops to the existing crop groups for the Cereal Grains Crop Group 15; Forage, Fodder and Straw of Cereal Grains Crop Group 16 and the Grass Forage, Fodder, and Hay Crop Group

124 12Included in these pesticide submissions are packages that were submitted to cooperating registrants, where they submit IR-4 data with their submissions for new uses, label amendments, to address conditional registrations (data call-in), or to address registration review (re-registration) requirements to maintain the use of a product. This was another productive year for IR-4 submissions. See Attachment 4 for a comprehensive listing of data submitted in While this number is lower than the record numbers from 2014, it reflects the fluctuation of study completions and submission that are often dependent on several factors, such as receiving documents from the cooperating registrant, etc. There are another 111 reports signed and ready for submission but are awaiting final documents or are being bundled with other studies before making the submission to EPA. The IR-4 Food Use Program continuously strives to work smarter and more efficiently to deliver new plant protection products for specialty crop growers. In 2015, EPA provided IR-4 with specific training for making submissions through their portal and IR-4 followed by immediately utilizing this advanced process. This change will enable EPA to process and review IR-4 submissions more efficiently as well as enabling them to work smarter with their review partners, such as the PMRA in Canada. Other efficiencies IR-4 takes advantage of is that nearly every submission made by IR-4 includes an update to at least one of the new crop groups, which add even more new uses to product labels and supports new crop markets for growers. For example, there were a number of tree nut crop group updates made in 2015, and each one of those new tolerances now includes pistachio as well as a number of other new tree crops. Successes. New uses resulting from IR-4 submissions returned to a record high in 2015, with 1175 new uses from 187 tolerances that EPA established based on IR-4 data. As noted in our 2014 report, there are normal ebb and flow of IR-4 submissions and reviews by EPA and as show here by the high numbers in 2015, EPA continues to support IR-4 in reviewing IR-4 data as it is submitted. IR-4 continues to average 700 new uses each year. The 1173 new uses in 2015 bring the IR-4 52-year total of clearances to 17,362. A complete list of these new uses along with the new crop groups can be found in Attachment 5. In total, EPA reviewed 28 chemistries for IR-4 in 2015, which further demonstrates EPA s support for IR-4 and their commitment to address grower needs. It is important to note that the successes IR-4 achieved in 2015 were realized in a climate where EPA has placed crop protection products under increased scrutiny to protect consumers, farm workers and the environment, with particular attention being paid to protecting children, pollinators, endangered species, etc. EPA s increased scrutiny of pesticide hazard/risk has required IR-4 to withdraw a number of petitions from EPA, such as clothianidin, and delaying submissions of other products, until further assessments can be made. These types of actions often contribute to the ebb and flow of reviews at EPA. IR-4 continues to evaluate labels to determine if the new uses approved by EPA are indeed available to growers through labels registered in each state. In 2015, of the 1173 possible new uses it has been determined that 266 uses now appear on product labels, nearly 25% of the total possible uses. IR-4 has contacted each of the registrants to encourage them to continue adding all possible uses to their marketing labels. It should be noted that some of the crops not counted were for new crop group conversions; therefore, some of the crops may be listed on product labels, just not the newly listed crops that were recently added to crop groups. It is expected that many of those uses will be added at a later date. IR-4 will continue to track these new uses with the registrants. IR-4 also re-reviewed the labeling success of 2014 approvals and it is reported that over 70% of those uses now appear on product labels. A listing of IR-4 projects in the queue for future submission to EPA that include data from 152 studies that will address over 243 IR-4 project requests, are provided on Attachment 6 or can be viewed on the IR-4 website at: EPA posts their Multi-Year work plan, which includes IR-4 submissions pending at EPA, at: IR-4 submissions are generally reviewed by EPA and a tolerance established within a 15-month review timeline. IR-4 continues to support EPA s goal of encouraging the use of pesticides that pose less risk to human health and the environment compared to existing alternatives. Where possible, IR-4 continues to make requests of EPA for many of our submissions to be classified as Reduced Risk. Regulatory Compliance Good Laboratory Practice Standards (GLP s as noted in Chapter 40, Code of Federal Regulations, Part 160) compliance is paramount to the success of the IR-4 Project s Food Program. Key components of compliance are the

125 125activities of the IR-4 Project s Quality Assurance Unit (QAU). The QAU continues to provide monitoring and support to cooperating scientists throughout the U.S. Audits of facilities and ongoing field and laboratory procedures provide assurance that IR-4 s data are of the highest quality and will be accepted by the crop protection industry and EPA. The Annual QA Planning Meeting was held in Gainesville, FL on March 12-13, At this meeting, the audit plan for 2015 was created. For calendar year 2015, regular inspections included 25 facilities, 182 in-life audits of field trials, 74 in-life of residue analytical laboratory activities, 57 analytical summary report/data audits and 275 field data book audits. During the 2015 calendar year, 68 final reports and amended reports were audited. In 2015 the US EPA notified IR-4 of 8 inspections for GLP compliance and data integrity. A total of 151 EPA GLP facility inspections have occurred at IR-4 related sites since April 27, IR-4 facilities continue to maintain high standards and fully meet the GLP requirements. IR-4 continues to use the novel eqa reporting system to improve efficiencies and enhanced communications. Over 800 inspection and audit reports have been processed using the web-based system. The system is due for a major upgrade. Training webinars will be offed in early 2016 to familiarize users to the system changes. Crop Grouping Initiative IR-4 continues to expand and enhance crop groups and sub-groups. The revised Cereal Grains Crop Group 15; Forage, Fodder and Straw of Cereal Grains Crop Group 16 and Grass Forage, Fodder, and Hay Crop Group 17 were submitted to the EPA over the past year. The revised Nongrass Animal Feeds (Forage, Fodder, Straw and Hay) Crop Group 18 will be submitted in The final rule for Leafy Vegetables (except Brassica) and Brassica Vegetables and the new crop groups for Stalk, Stem, and Leaf Petiole; Tropical and Sub-tropical fruit, edible peel and Tropical and Sub-tropical fruit inedible peel is expected to be published in The effort to update crop groups continues with the Codex Committee of Pesticide Residues as well and the Vegetable types are expected to be completed during the 2016 Codex Committee of Pesticide Residues meeting. International Activities: IR-4 remains committed to assisting US specialty crop growers with their desire to export fruits and vegetables to international markets through harmonizing pesticide residues standards in specialty crops, thus reducing the use of MRLs as a technical phytosanitary trade barrier. In North America, IR-4 s cooperation with CN-PMC continues to be fruitful considering that they contributed 36 field trials to our joint program in Of the 88 studies conducted by IR-4 in 2015, three were managed by CN- PMC, with them serving as Study Director and Sponsor, and they utilized a number of IR-4 field research centers to complete the NAFTA data requirements. In addition, the CN-PMC program continues to provide significant contributions to IR-4 efficacy and crop safety research and shares ornamental efficacy and crop safety with IR-4. There also continues to be a good exchange of personnel, with CN-PMC participating in various IR-4 meetings and vice versa. In total the research benefit of working with CN-PMC saves IR-4 an estimated $500,000 per year. The joint review process by EPA and Canada s Pest Management Regulatory Agency also benefits IR-4 stakeholders by saving resources on both sides of the border; only one agency is responsible for reviewing the residue data. More importantly, both agencies are establishing MRLs at the same level, at the same time. This prevents trade irritants before they happen. EPA and PMRA completed two joint reviews on IR-4/CN-PMC submissions in 2015 for the active ingredient novaluron and pyrimethanil. IR-4 sponsored the first Global Minor Use Workshop, which took place on September 20-22, 2015 in Chicago, Illinois, and over 170 people from more than 30 countries attended. The workshop was held in association with IR- 4 s annual research priority setting workshops for specialty food crops with pesticides and biopesticides. The goal of the Global Minor Use Workshop was to prioritize common critical pest management voids on fruits, vegetables and other specialty crops and to identify solutions to problems and then to develop plans for cooperative research targeting one study each of three areas: tropical, temperate growing climates and in greenhouse situations. The primary priorities are greenhouse/protected crops-aphids on lettuce; temperate crops-downy mildew on leafy vegetables; and tropical crops-fruit flies on inedible peal crops.

126 1Activities at the Global Minor Use Workshop concentrated on reviewing a newly developed database of priority global minor use pest management needs. This database was created through a worldwide survey conducted months before the workshop. Forty countries shared information about their specialty crop pest management voids and needs for solutions. Information from the database was used as the first filter to determine what the most important pest needs were and to seek possible solutions for joint research. As needs were discussed, many countries responded by offering existing data to assist in solving pest management problems. The IR-4 Project agreed to be the lead country, for the tropical project and will provide the oversight and direction for the project. The newly established European Union Minor Use Coordinator Facility is expected to be lead the project on temperate crops. A lead country is still being identified for the greenhouse crop projects. During the Global Minor Use Workshop, USDA-Foreign Agriculture Service (USDA-FAS) announced that they funded $500,000 to IR-4 to start a Global Minor Use Fund. The Fund is intended to serve as seed money in a larger fundraising effort to support future cooperative global work with pesticide registration harmonization. IR-4 s Global Capacity Development, Residue Data Generation Project made good progress in Coordinated by USDA-FAS, this project s objective is to enhance capacity of participating nations in Asia, Africa and Latin America to meet pesticide-related requirements based on international (Codex) standards. This goal is being achieved by collaborative residue data generation projects on low risk products, such as pyriproxyfen and spinetram on tropical fruits, that incorporate all technical aspects of these studies and is expected to provide broader national residue monitoring as well. The focus of IR-4 s contributions has been on developing the expertise to conduct field and laboratory pesticide residue studies under Good Laboratory Practices and to eventually provide data to local authorities and Codex for product registration. All three of the regions participating in this project have received Standards Trade Development Facility (STDF) and USDA-FAS funding, which also provides support for IR-4 s contributions to the project. Work in the three regions is progressing and is in various stages, with a commitment to start making submissions to a Joint Meeting on Pesticide Residues (JMPR) in The Asia region has made the most progress with several reports being completed in time for the 2016 submission date. In Latin America several projects are under way and sample analysis is taking place as well. In the Africa region, training is concluding and projects should initiate in Please see IR-4 newsletter article on the subject at: It is IR-4 s vision that at the end of this work, there will be a global network of capable minor use programs that can partner, when appropriate, with IR-4 to addressing domestic and international grower needs as noted from the Global Minor Use Workshop. At the request of EPA, IR-4 personnel continue to be included as part of the US delegations to both the CCPR and Organization for Economic Co-operation and Development (OECD) as well as the Working Group on Pesticides and the NAFTA Technical Working Group on Pesticides. IR-4 plays a key role on the OECD Expert Group on Minor Uses, where a number of guidance documents have been prepared and released over the past few years with regard to minor use issues. IR-4 also assists other countries, both developed and developing, as they begin to establish minor use programs, especially with New Zealand, Brazil, Costa Rica and Colombia. The knowledge and expertise of IR-4 is often sought and is highly valuable to these countries as their minor use programs evolve. IR-4 continued to support submissions to the JMPR, where IR-4 supported a number of submissions by registrants. While IR-4 has nominated a number of chemicals for JMPR review in the future, there were no chemistries that IR-4 could dovetail to the 2016 JMPR work plan, since the registrants included IR-4 in their submissions. Ornamental Horticulture Program The Ornamental Horticulture Program continues to support an industry valued at nearly $12 billion in annual sales (Horticulture Census, 2009, NASS). This industry is quite complex because growers cover many diverse markets including flowers, bulbs, houseplants, perennials, trees, shrubs and more. These plants are grown and maintained in greenhouses, nurseries, commercial/residential landscapes, interiorscapes, Christmas tree farms and sod farms. Research Activities In 2015, IR-4 conducted 672 ornamental horticulture research trials to support registrations in the greenhouse, nursery, landscape, Christmas tree and forestry industries. Of these 147 were efficacy trials designed to compare different products to manage damaging insects, plant diseases and weeds and to measure the impact of growth regulators; the remaining trials were conducted to determine the level of phytotoxicity to crops with herbicides used

127 to manage common weeds in and around nurseries. Please see Table 1 for a summary of research activities and Attachment 7 for a complete listing of 2015 field cooperators and Attachment 8 for research activities listed by project. Table 1. Summary of IR-4 s 2015 and Revised 2014 Ornamental Horticulture Program Research Activities. Category 2015 Revised 2014 Efficacy Crop Total Efficacy Crop Total Safety Safety Number of Studies (PR Numbers) with Planned Trials Number of Trials Submissions and Successes During 2015, 22 data summaries were compiled based upon research reports submitted by researchers. See Attachment 9 for Abstracts from the individual reports. The summary reports include Acibenzolar Crop Safety, Ametoctradin + Dimethomorph Crop Safety, Aphid Efficacy Literature Review & Summary, Bacterial Disease Efficacy Summary, Benzovindiflupyr + Azoxystrobin Crop Safety , Cyflufenamid Crop Safety, Cyflumetofen Crop Safety, Dimethenamid-p Crop Safety, Dithiopyr Crop Safety, Gladiolus Rust APHIS Project Summary, Indaziflam Crop Safety, Isoxaben Crop Safety, Mesotrione Crop Safety, Metconazole Crop Safety, Pendimethalin + Dimethenamid-p Crop Safety, Pyrifluquinazon Crop Safety, Pythium Efficacy, Spirotetramat Crop Safety, Tebuconazole Crop Safety Summary, Thrips Efficacy Summary, Tolfenpyrad Crop Safety Summary, and Triticonazole Crop Safety. Data from 4,044 trials contributed to the writing of these reports. Table 2 lists the number of trials by IR-4 Region that were used in the data summaries. Table Ornamental Horticulture Program Research Summaries. Region Number of Trials North Central 480 North East 458 Southern 1057 Western 771 USDA-ARS 1278 Total 4,044 During 2015, US EPA approved 2 new labels based partially on the efficacy or crop safety IR-4 generated: Mural WDG (benzovindiflupyr + azoxystrobin), Segovis SC (oxathiapiprolin). US EPA approved 2 label amendments: Freehand G (pendimethalin + dimethenamid-p) and Tower (dimethenamid-p). Empress intrinsic Brand Fungicide (indaziflam) was registered in CA. Two numbered formulations were dropped from further development. After the 2014 annual report was finalized, it was discovered that the EPA registrations of Anderson s Golf Products Kansel Plus Fertilizer (oxadiazon + pendimethalin), F6875 4SC (sulfentrazone + prodiamine) occurred. See Table 3 for 2015 and revised 2014 information.

128 Table 3. Ornamental Horticulture Program Contributions to 2015 and Revised 2014 Registrations. Category 2015 Revised 2014 Efficacy Crop Total Efficacy Crop Total Safety Safety New US EPA Product Registrations a 2 0 f US EPA Label Amendments b State Registrations c International Not to be Registered Number of Trials Contributing to Registrations d North Central North East Southern Western USDA-ARS Number of Impacted Crops e , ,244 a New products for the ornamental horticulture industry based on data collected through IR-4 and submitted to manufacturers in previous years. b Label updates on existing products for the ornamental horticulture industry based on data collected through IR-4 and submitted to manufacturers in previous years. c State registrations and special local needs registrations on federally registered products for the ornamental horticulture industry based on data collected through IR-4 and submitted to manufacturers in previous years. d The total number of trials where data was utilized for registrations. e The number of impacted crops is an estimate of the total plant species grown commercially for ornamental uses impacted by the IR-4 data. f For some registrations, IR-4 contributed both efficacy and crop safety data. Priority Setting The Ornamental Horticulture Workshop was held outside Chicago in Schaumburg, IL in October 2015 to establish priorities for the 2016 to 2017 biennial research cycle. During the first morning of the workshop, registrant representatives presented new active ingredients and highlighted opportunities for existing products. Then the results of the Grower & Extension Survey were presented, and participants discussed the pro and cons for conducting efficacy or crop safety research on 34 current and potential new projects. To have these discussions flow smoothly, IR-4 staff updated Project Sheets which summarized the need, research and registrations to date, and 15 Product Lists outlining the key features of tools currently available for certain diseases and pests. After the relative merits of each project were captured and a Sticker Caucus was held so that workshop attendees could vote for the research projects. During the second morning of the workshop, the outcomes for each discipline were projected, and the research priorities were finalized after further conversations. Priorities from the 2015 Workshop include: Entomology Projects: Thrips Efficacy, Foliar Feeding Beetle Efficacy, New Product Crop Safety. Pathology Projects: Botrytis Efficacy, Bacterial Disease Efficacy, New Product Crop Safety. Weed Science: Pre-Emergent Herbicide Crop Safety will be focused on Tower EC and Dimension 2EW, while the Ornamental Grass Herbicide Crop Safety will screen Dimension 2EW, Gallery, and Pendulum 2G. Invasive Species Research Activities During 2015, the IR-4 Ornamental Horticulture Program continued to facilitate research activities for several invasive species impacting the Ornamental Horticulture Industry: Management of Invasive Arthropods during Shipping, Gladiolus Rust Biology and Management, Chrysanthemum White Rust Biology and Management, Boxwood Blight Biology and Management, and Impatiens Downy Mildew Biology and Management. Each project was funded under USDA-APHIS Farm Bill Section and encompassed key objectives to manage exotic invasive species by studying aspects of pathogen or pest biology and management tools (conventional or biopesticide

129 as appropriate to the target organism) on plants to enable growers to better implement mitigation strategies. The Gladiolus Rust Project finished and a final summary report of research results was posted to the IR-4 website. Key elements of each project are listed in Table 4 below. Table 4. Invasive Species Projects during 2015 Project Topic Collaborating Researchers Research Objectives Duration Management of Invasive Arthropods Gladiolus Rust Chrysanthemum White Rust Boxwood Blight Impatiens Downy Mildew Lance Osborne, University of Florida Cindy McKenzie, USDA-ARS, Fort Pierce Jim Bethke, University of California Arnold Hara, University of Hawai i James Buck, University of Georgia Alberto Valencia-Botin, University of Guadalajara Doug Luster, USDA-ARS Fort Detrick Mo Bonde, USDA-ARS Fort Detrick Steve Jeffers, Clemson University Doug Luster, USDA-ARS Fort Detrick Mo Bonde, USDA-ARS Fort Detrick Oney Smith, Hood College, Kurt Heungens, ILVO, Belgium Bas Brandwagt, Royal van Zanten, The Netherlands JoAnne Crouch, USDA-ARS, Beltsville Sharon Douglas, Connecticut Agriculture Experiment Station (CAES) Robert Marra, CAES Jim LaMondia, CAES Margery Daughtrey, Cornell University Nina Shishkoff, USDA-ARS- Fort Detrick JoAnne Crouch, USDA-ARS, Beltsville Mike Benson, NC State University Marc Cubeta, NC State University Kelly Ivors, NC State University Chuan Hong, Virgina Tech Anton Baudoin, Virginia Tech Norm Dart, Virgina Department of Ag. & Consumer Services Len Coop, Oregon State University Anne Gould, Rutgers University Brad Hillman, Rutgers University Margery Daughtrey, Cornell University Mary Hasubeck, Michigan State University Aaron Palmateer, University of Florida JoAnne Crouch, USDA-ARS, Beltsville Nina Shishkoff, USDA-ARS, Fort Detrick Lena Quesada, NC State University Ann Gould, Rutgers University Duponchelia fovealis biology and management tools (conventional, biopesticide, predators) Prevention of arthropod development during shipping with applications of biopesticides and biorational materials immediately before shipping Fungicide screening and rotational programs Screening for gladiolus cultivar resistance Overwintering/oversummering of Uromyces transversalis Development of serological and genetic assays Overwintering of Puccinia horiana Fungicide impact on sporulation Fungicide screening on whole plants Development of serological and genetic diagnostic tools Biology and development of P. horiana in chrysanthemum including systemic movement Fungicide screening and mitigation strategies Cultural control potentials including use of heat treatments Effect of sanitizers on conidia and mycelia Impact of fungicides on microsclerotium development Screening of potential biopesticides for microslerotium inactivation Development of isothermic LAMP detection assay Boxwood species and cultivar screen for resistance Calonectria pseudonaviculata host range (Pachysandra and Sarcoccoca) Development of infections under field conditions Calonectria pseudonaviculata population genetics Development of epidemiology model based on U.S. temperature and moisture conditions Overwintering of Plasmopora obducens oospores Fungicide screening and rotational strategies Sporangia and oospore development and epidemiology Plasmopora obducens population genetics Development of genetic tools for downy mildews including Impatiens Downy Mildew, Cucurbit Downy Mildew, Hops Downy Mildew, Basil Downy Mildew Biopesticide and Organic Support Program The IR-4 Biopesticide and Organic Support Program has the goal of facilitating the registration of crop protection products classified by EPA as Biopesticides. IR-4 also has a registration assistance program to provide university

130 and USDA researchers as well as small biopesticide companies with regulatory advice and petition preparation assistance. Research Activities Since its inception in 1982, the IR-4 biopesticide research program has provided competitive grant funding of projects, amounting to over $7.6 million in grants to researchers. In 2014, IR-4 decided to transition its biopesticide from a Request For Application, program that supports Early, Advanced and Demonstration stage research to a priority setting workshop with actively engage stakeholders who chose the most critical needs for biopesticides and IR-4 responds by directing research to these priorities. IR-4 held its first Biopesticide Workshop in September 2014 in association with the Food Use Workshop in Atlanta, GA. Based on the priorities established at the workshop, IR-4 funded 12 studies with 29 different researchers. These studies were conducted by different universities on fruits and vegetables, tropical crops, honeybees, and ornamentals. Among the high profile invasive pests, the biopesticide program has supported projects involving spotted wing drosophila, and fireblight management in organic apples. See Attachment 10 for the specific research projects and research cooperators. IR-4 held the second Biopesticide Workshop in September 2015 in association with the Food Use Workshop in Chicago, IL. The priority setting workshop was held to actively engage stakeholders and encourage submission of known pest management voids that can potentially be answered by biopesticide technology. Submissions and Successes In 2015, IR-4 submitted amended registration packages for Aspergillus flavus AF36, and a new registration for Psuedomonas fluorescens ACK55. EPA approved three registration of an IR-4 submission in response to IR-4 submissions. These include a new formulation and manufacturing process for Aspergillus flavus AF36, potassium salts of Hop Beta Acids, an extract of hop cones has been registered for use in managing Varroa mites in honeybees and the bird repellent AV-1011 in rice. The Public Health Pesticides Program The IR-4 Public Health Pesticide (PHP) Program focuses on expansion and maintenance of the tool box of pesticide products that protect the public from vector-borne diseases (e.g. Dengue fever, Zika virus, Lyme disease, malaria, etc.) and from the nuisance and economic costs caused by mosquitoes, ticks, and other arthropod pests. Vector control uses of pesticides are statutorily recognized as minor uses, and it is widely recognized that public support for their development and registration is in the public interest. Primary funding for the IR-4 PHP Program is provided by the Deployed Warfighter Protection Program (DWFP) of the U.S. Department of Defense (DoD), and by USDA-ARS. IR-4 serves as a regulatory consultant and representative for many of the new materials and methods developed by DWFP-funded researchers, as well as other military and USDA medical and veterinary entomology programs. In addition, the DoD and ARS have engaged IR-4 to help maintain and expand the vector control toolbox by identifying new or underutilized vector control tools, supporting the continued registration of existing useful vector control products, and providing regulatory support generally for military pest management. IR-4 remains a key player linking researchers, the vector control user community, commercial partners, and regulators in the development of a wide range of new chemical tools for vector control, including toxicants, repellents, attract-and-kill products, pesticide-treated fabrics, and novel biocontrol agents if they are regulated as pesticides. This collaborative approach has also been fruitful in efforts to retain existing tools facing new data requirements, and in the search for underutilized chemicals from other realms which might be repurposed for vector control or introduced into the U.S. market from abroad. During 2015, the IR-4 completed a research program on the drift and incidental deposition of mosquitocides on crops with completion of the final reports covering ground applications of the mosquito adulticide etofenprox on multiple crops. As the EPA submittal was bundled with a crop study and jointly submitted in January This study complements IR-4 s earlier work with aerial applications, which resulted in an all-crop tolerance for this new vector

131 control product and clarifies the range of residues seen with different application methods, as well as the cumulative load that can result after multiple applications in the same area over the course of a season. In 2015 we worked with pesticide users and regulators to evaluate the extent to which IR-4 models, methods, and data may help estimate incidental drift and deposition onto water, as well as onto crops, and we anticipate extensive use of this information in endangered species and other risk assessments during registration reviews. IR-4 was active in 2015 in support for other new uses for existing pesticide materials, including assistance in efficacy studies for two types of lethal ovitraps that target container-breeding mosquitoes. One product, originally developed by the U.S. Army and now commercially licensed, has recently received EPA registration with IR-4 but the label recommends a high density of traps, and operational success will likely require more evidence of effectiveness at low trap densities. Another product in development with support from IR-4 relies on dissemination of a reduced risk insect growth regulator insecticide by ovipositing female mosquitoes. Efficacy trials for these devices are ongoing, and IR-4 is expecting to assist with regulatory submittals in 2016; we also began protocol development in 2015 for large-scale comparative efficacy tests with these and other products potentially useful vs. the serious disease vectors Aedes aegypti and Ae. albopictus. A different approach to control of day-biting mosquitoes such as these would use volatile materials which reduce biting pressure without needing skin-applied repellents; a major 2015 success was the announcement by Bayer that they are submitting Transfluthrin and a transfluthrin-based spatial repellent to EPA for registration after five years of discussions with IR-4, the military, and other proponents of its need in the U.S.. Finally, clothing treated with permethrin helps protect from insect bites but faces limitations, including resistance and durability, and in 2015 we are made significant progress in this realm, defining EPA-acceptable protocols for doseresponse and efficacy trials, as well as skin irritancy and sensitization, for non-permethrin chemicals; and demonstrating the technical feasibility of non-destructive measurement of pyrethroids on clothing and nets using IR scanners and possibly other methods. IR-4 also provided substantial support to new materials and products for vector control this year, including three truly novel approaches. We are the primary regulatory consultants for Attractive Toxic/Targeted Sugar Baits (ATSB) for control of mosquitoes, sand flies, and possibly other vector species. With IR-4 assistance, a commercial EPA 25(b) ATSB product was introduced to the U.S. PCO market in 2014 and a household version was introduced and had great commercial success in 2015, resulting in the company s purchase and a major capital infusion, suggesting strong long-term market viability; we also helped secure major development and efficacy testing funding from the Gates Foundation and the Innovative Vector Control Consortium, and field trials are underway in several countries. We expect to assist with an EPA submittal for non-25(b) products in the next two years. IR-4 also continued to represent the ARS NPURU lab in EPA pre-registration negotiations for an entire new class of repellents and toxicants the Chromenes; and we hope that commercial viability will allow regulatory submittals in the future. We continued to evaluate a class of natural molecules which repel bees and possibly other pollinators, and which may be a valuable tool to minimize vector control and other pesticide impacts on these beneficial insects. Finally, we helped obtain Experimental Use Permits (EUP s) and funded work on the rearing and release of Aedes aegypti mosquitoes infected with the endosymbiotic bacteria Wolbachia as a new approach to the sterile male method; a previous EUP we supported for this work vs. Aedes albopictus led to an effective product and the EPA registration packet was submitted in January 2016, and will be shown in next year s list. Given the great diversity of actual and potential vector control tools, a major focus of the IR-4 PHP program has been the development and maintenance of a database of public health pesticides, and we particularly emphasize the identification of underutilized chemicals with significant potential utility for organized vector control programs. During 2015 the IR-4 PHP database ( was substantially revised and expanded, with the addition of 340 chemicals (AI s), 5601 chemical identifiers, 5234 chemical data records, 1057 products, and over 4000 product identifiers and data records, in addition to updates on thousands of additional records. We added new data on military use pesticides for purposes other than vector control, as a general service to a key stakeholder, and we introduced a Project Management module to assist military and other federal vector control researchers and funders. Finally, we developed several dozen queries to help track regulatory requirements for existing vector control materials, and to help ensure timely response to EPA usage data requests.

132 Impact The successes, accomplishments and deliverables of the IR-4 Project and it four main program areas are documented in the Program sections. The accomplishments are many. It is safe to say that without the existence of the IR-4 Project; only a limited number of safe and effective crop protection chemicals and biological alternatives would be available for use on food and ornamental specialty crops and minor uses. The IR-4 Project is a critically important organization in providing the US population a safe and plentiful supply of reasonably priced vegetables, fruits, herbs, and ornamental crops throughout the year. Specialty crop producers have provided antidotal evidence of importance. Here are some of their comments: Everyone who eats has an interest in the IR-4 Project whether they know it or not. The IR-4 Project is a vital part of the country s food safety security system and should be considered a national strategic imperative Bob Simerly, McCain Food USA, Inc. and representing the National Onion Association. Del Monte vegetables have been able to secure registrations for all of our primary herbicides, insecticides and fungicides either directly working with IR-4 or in cooperative collaborative efforts with IR-4 and the agrichemical industry. Brian Flood, Research Fellow, Del Monte Foods The US greenhouse hydroponic vegetable industry has developed in the last 25 years. We would not exist today without the IR-4 Program Mike Bledsoe Ph. D, Senior Vice President Food Safety and Regulatory Affairs, Village Farms. I do not know how we would survive raising vegetables without IR-4. IR-4 has been able to get us new chemicals labeled, along with better use rates and lower PHIs that we need to keep our vegetables weed free, insect free while keeping our bees safe and our diseases under control. Bruce Buurma, Buurma Farms, Willard Ohio. IR-4 has been and continues to be integral in helping to provide guidance in pest management options to the greenhouse, nursery and landscape industries. Through IR-4 s focus on product registrations, our industry has greater options for pest management tools that are safe for plants and pesticide resistance management. Jill Calabro, PhD. Science & Research Program Director, American Hort/Horticulture Research Institute. Everyone who eats has an interest in the IR-4 Project Michigan State University s Center of Economic Analysis conducted a study on the economic impact of IR-4 Project s activities in the Food, Ornamental Horticulture and Biopesticide and Organic Support programs. This report was updated in October According to the report, When well-established methods of measuring direct and secondary economic impacts are used to gauge the contributions of the IR-4 Project and its three primary programs, including the Food Crops, Ornamental, and Biological and Organic Support programs in terms of sales, employment and gross domestic product is significant. Each program posits real economic benefits to growers and the economy as a whole. Specifically, growers benefit in higher yields with higher quality output, consumers benefit by more varieties and lower costs of food and ornamental crops, and the industry benefits through better global competitiveness of US output. Including all secondary impacts, the IR-4 Project is anticipated to support research and industry sales sufficient to support 104,650 U.S. jobs and bumps annual gross domestic product by as much as $7.2 billion. Though the data is over three years old, it is highly likely that the economic impact of IR-4 s activity in 2015 is equal or better than the values reported in The powerful impact IR-4 has on these economic drivers is only half the story. The other half involves food safety, food security and public wellbeing. IR-4 assists in the registration of the latest generation of reduced risk and biopesticide pest management products. These products are compatible with Integrated Pest Management systems, and have little hazard or degrade rapidly after use. They allow farmers to maximize yields of quality fruits, vegetables and nuts; making products available to the public at an affordable price. With IR-4 s assistance, specialty crop growers provide the public a consistent supply of nutritious foods, essential to good health, as well as aid in the production of ornamentals that enhance the environment. Additionally, IR-4 helps provide tools to manage

133 pests like mosquitoes, ticks and fleas that transmit diseases to humans. The bottom line, what IR-4 delivers to society is extremely important and necessary Appropriations and other funding The IR-4 Project is funded by various groups within USDA in partnership with the SAES as well as others. Total direct funding for the IR-4 Project during calendar year 2015 was $18.1 million and was from the following sources: 2015 Direct Funding for IR-4 including sources and comments: Amount Source Comment $11.913,000 Congress via a Special Research Grant Administrated through NIFA. The Congressional appropriated funds managed through USDA-NIFA provide resources for IR-4 Project core operations within the Food, Ornamental Horticulture and Biopesticide and Organic Support programs. In 2015, approximately $7.541 million was distributed to the four IR-4 Regional offices and Headquarters for personnel, supplies, equipment, laboratory analysis and other core expenses. Over $2.5 million was allocated for field trials that produce the necessary residue samples and product performance data; $518,000 for ornamental trials; $400,000 for biopesticide/organic support grants and the remaining $811,075 was mandatory NIFA holdback $481,182 State Agriculture Experimental Station Directors $3,170,000 USDA-Agriculture Research Service $225,000 Department of Defense/USDA- Agricultural Research Service $600,000 USDA-Foreign Agriculture Service and other global partners $195,000 USDA-Animal and Plant Health Inspection Service Multi-State Research Funds/NRSP-4 grant. NRSP-4 funds directly pay salaries for IR-4 HQ management who provide overall leadership and coordination of the IR-4 Project s on-going research efforts. USDA-ARS provides funds supporting their personnel who work on cooperative projects that align with priorities and studies managed by IR-4. Participating ARS scientists are given specific research assignments that fully complement and do not duplicate the ongoing research at the SAES Cooperative agreement between IR-4 and USDA-ARS based on allocation through Deployed Warfighter Protection Program Funding is provided exclusively for the Public Health Pesticide Registration Support Program and pays for personnel costs, travel and subcontracts to research groups who conduct priority research projects. International activities to support specialty crop exports and global pesticide regulatory harmonization. This includes funds for capacity building training programs in Asia, Africa and Latin America and seed funds to be used for the establishment of the Global Minor Use fund. Management of selected invasive species both within the US within quarantine facilities as well as internationally where the invasive pest is native. Activities include efficacy testing of pest management products to studies to better understand the biology of the pest. $1,510,000 Industry support Unrestricted funds-the crop protection industry and some grower groups/commodity associations also contributes direct financial resources as well as significant in-kind resources. IR-4 used these resources to supplement USDA funds; $305,829 for additional research activities, $404,373 for office rent, $843,075 to support additional HQ operations and $253,164 for priority setting/research planning workshops, EPA training tour, and related meetings. $18,094,182 TOTAL DIRECT FUNDING IR-4 also receives a significant amount of in-kind contributions from multiple sources, including the substantial inkind contributions provided by SAES/land grant universities by hosting IR-4 field research centers, analytical laboratories and management offices throughout the United States (estimated >$5 million annually) EPA Pesticide Registration Improvement Act fee waivers ($4.417 million in Fiscal Year 2015) and the crop protection industry (their in-kind contributions are conservatively estimated to be a 1:1 match). The government of Canada also make significant in-kind contribution (>$750,000). The IR-4 Project remains prudent with the use of resources while it continues to search for opportunities to gain efficiencies in all aspects of its research and regulatory affairs. Over the last several years, there have been substantial process improvements which allow IR-4 to get the most out of the funding.

134 Future Directions IR-4 hosts a series of workshops to prioritize future research projects. These open workshops are designed to gain stakeholder input and feedback to determine what the most important research pest management needs are and where resources should be spent. In 2015, IR-4 hosted four workshops. Priorities for 2016 research were determined at the September 22-23, 2015 Food Use Workshop held in Chicago, IL. Prior to the workshop, IR-4 facilitates an internet based process where stakeholders identify and nominate projects for consideration at the workshop. Projects given at least one on-line A nomination are compiled into a project list utilized during face-to-face deliberations at the workshop. Approximately 200 participants (growers, commodity organizations, university research and extension specialists) develop consensus on the most important chemical/crop research projects for the next growing season. Assessment of project priorities are based on many criteria, including (but not limited to): (1) availability and efficacy of alternative pest management tools (including ongoing projects for the same need) (2) pest damage potential of target pest(s) (3) performance and crop safety of the chemical tool in managing the target pest(s) (4) compatibility of the proposed chemical candidate with Integrated Pest Management (5) uses currently covered by Section 18 emergency exemptions (6) harmonization implications due to lack of international MRLs. Following the workshop, a National Research Planning Meeting is held to assign field and laboratory locations for the research projects. If a project is also a priority in Canada, IR-4 will work in cooperation with CN-PMC on these studies of mutual interest. After finalizing field and lab assignments, Study Directors at HQ, draft protocols specific to the individual research study. These draft protocols are developed under federal guidelines as noted in EPAs Harmonized Test Guideline (OPPTS 860) and are distributed to stakeholders and Field Research directors for review and comment before being issued as the final research protocol. Based on priorities established at the IR-4 Food Use Workshop, in 2016, the current food residue plan includes 501 field trials. This trial plan includes: 411 trials to be conducted at IR-4 Field Research Centers/other University sites, 54 field trials at ARS sites and 36 trials conducted by Canadian partners (CN- PMC). The 2016 Food Use Workshop to identify 2017 research priorities will be held in September 22-23, 2016 in Orlando Florida. The Ornamental Horticulture Program will continue to address stakeholder needs by balancing crop safety and efficacy testing for new active ingredients and expanded current registrations for new and important pest species. Based on priorities established at the October 2015 IR-4 Ornamental Horticulture Workshop, IR-4 plans to conduct 532 trials in 2016 including efficacy testing work for thrips efficacy, foliar feeding beetle efficacy, botrytis efficacy, and bacterial disease efficacy. In addition, plant safety or phytotoxicity screening on a wide variety of ornamental crops with specific fungicides, insecticides and herbicides will be conducted. The Biopesticide and Organic Support priority setting workshop is held in combination with the annual IR-4 Food Use Workshop on September 24 in Chicago, IL. During the workshop, there were discussions concerning the outcome of the 2015 projects including: were any of the projects promising enough to fund for a 2nd year and did these projects fit the priorities set for It was determined that Spotted Wing Drosophila, fireblight on apple, Chestnut blight, Varroa mite on honeybee, bacterial management in tomato and whitefly on greenhouse tomato should be funded for a second year. The 2016 Biopesticide and Organic Support Workshop to identify 2017 research priorities will be held in September 21, 2016 in Orlando Florida. International research for these priorities will begin in Many countries committed to conducting the required research, allow for global product acceptance and free trade among countries.

135 IR-4 takes pride in these accomplishments; providing over 47,000 registrations for food and non-food crops over the 53-year history of the Project. However, there are many issues that remain unresolved. Specialty crop growers/minor use stakeholders still face challenges in managing critical pests that consume their crops and profits. It is often difficult to export certain specialty crops because standards of allowable pesticide residues (MRLs) vary across nations. IR-4 s international involvement plays a major role in harmonizing MRLs for allowable pesticide residues in specialty crops. Newly emerging invasive pests, such as Brown Marmorated Stink Bug, Spotted Winged Drosophila, Boxwood Blight, resistant weeds and other pests threaten agriculture and the environment. Recent outbreaks of Zika Virus, West Nile Virus and Dengue fever in the continental US highlight the need for solutions to manage public heath pests as well. IR-4 s existing strategic plan, VISION 2020, was completed and approved by the IR-4 Project Management Committee in July This plan details the IR-4 Project background, vision, mission, values, culture, objectives and funding needs and identifies strategic benchmarks and the goals in each program area. See the IR-4 website for details. The most noteworthy item under this plan include increased emphasis in helping harmonize global standards for pesticide residues in specialty crops to give domestic producers expedited access to lucrative international markets. Congress authorized this activity in the 2014 Farm Bill. Another ongoing change includes increased emphasis on supporting the strategic use of biopesticides not only to control key pests but to assist in the management of pest resistance to pesticides and reduction of chemical residues in food. Adequate funding remains the most critical current and future challenge for IR-4. In most program areas, IR-4 funding remains at or below levels experienced in The impact of multiple years of flat funding and escalating costs is affecting IR-4 s ability to maintain research levels needed to address grower demands. Specifically, IR-4 conducted 62 new food use studies in 2015 which was 23 less than in A similar decline was observed in the ornamental horticulture program which anticipates a decline from 1316 trials in 2011 to 673 in Many of IR-4 partners are facing funding challenges and some partners have withdrawn from IR-4 involvement due to these challenges. For example, the Cornell University administration did not submit a grant application to USDA- NIFA to support IR-4 s FY 2015 Northeast Region operations. This is mainly due to the Federal restriction not allowing Cornell to collect indirect costs on the IR-4 grant. IR-4 has relocated its Northeast Region operations to Rutgers University and University of Maryland. Recognizing that other partner research institutions may soon refuse to take grant money that does not allow indirect costs, IR-4 has established a Path Forward Working Group to develop a strategy, including evaluating the impacts and opportunities for transitioning from the current USDA-NIFA Special Research Grant funding to a Cooperative Agreement approach with allows 10% indirect costs. As part of the IR-4 Project Vision 2020 Strategic Plan, IR-4 is intending to conduct an Organizational Assessment to review IR-4 s existing organization structure and its operational efficiencies within the organization. Some of the specific tasks of the Organizational Assessment is to: 1. To evaluate the organizational structure of the regional centers, their field research centers/field researcher cooperators and dedicated IR-4 analytical laboratories, and the coordinating operations of IR-4 Project Headquarters. 2. To determine, based on the various impacts on the IR-4 Project, if the present organizational structure is still appropriate to meet the current and future needs of the specialty crop producers, processors and consumers. 3. To identify efficient and inefficient operational processes throughout the IR-4 Organization. 4. To examine how ARS operates within the IR-4 process and what role it has in any future reorganizational models. Note: the goal is not to evaluate the ARS organization but how it fits into the IR-4 process. 5. To collect this information and appraise if operational efficiencies and/or savings can be achieved through reorganization of IR-4 s units. 6. To propose to the IR-4 Project Management Committee (PMC) any changes to the current organizational structure as well as operational efficiencies/savings that can be achieved through reorganization by recommending models, along with the positive/negative impacts of such changes.

136 PUBLICATIONS/PRESENTATIONS Arsenovic, M, D. Kunkel, J. Baron, 2015: The IR-4 Project: Update on Weed Control Projects (Food Uses). 69 th Annual Meeting of the Northeastern Weed Science Society, Abstract. Bonde, M.R., S.E. Nester, D.G. Luster and C.L. Palmer Longevity of Uromyces transversalis, Causal Agent of Gladiolus Rust, under Various Environmental conditions. Plant Health Progress. April doi: /php-rs Bonde, M.R., Murphy, C.A., Bauchan, G.R., Luster, D.G., Palmer, C.L., Nester, S.E., Revell, J.M. and Berner, D.K Evidence for systemic infection by Puccinia horiana, causal agent of chrysanthemum white rust, in chrysanthemum. Phytopathology 105(1): htpp://dx.doi.org/ /phyto r. Braverman, M. P., D. L. Kunkel, J. J. Baron, B. Barney and K. Coleman The IR-4 Program for Registration, Efficacy testing and Development of Organic Products and Biopesticides. Abstract. American Chemical Society Meeting. Boston, MA, August 16, Abstract AGRO 102 Braverman, M.P Avoiding Pitfalls of Preparing Dossiers. Informa Crops and Chemicals Conference, Raleigh, NC July 22 Braverman, M.P Preparation of Pesticide Tolerance Exemption Petitions: As Easy as ABC. BPIA Registration Workshop Washington D.C. Sept 16, 20 Huesing, J., D. Andres, M.P. Braverman, A. Burns, A.S. Felsot, G.G. Harrigan, R.L. Hellmich, A. Reynolds, A.M. Shelton, W.Jansen van Rijssen, E. Jane Morris, and J.N. Eloff. In Press. Global Adoption of GM Crops: Status and Challenges. Journal of Agricultural and Food Chemistry Kunkel, D., M. Braverman, B. Barney and J. Baron Working Towards a Global Regulatory Program for Minor Uses Abstract. American Chemical Society Meeting. Boston, MA, August 16, Abstract # AGRO 57 Kunkel, D.L., Arsenovic, M., Baron, J.J., Braverman, M.P., Batts, R IR-4 Update and New Strategic Plan: Vision Weed Science Society of America, Lexington, KY, February 9-12, Abstract #236 Malamud-Roam, K The IR-4 Project and Public Health Pesticides: Lessons Learned from 50 Years of Support for Small Markets in Agriculture (Poster). Roll Back Malaria Vector Control Working Group Annual Meeting, Geneva, Switzerland, Jan Malamud-Roam, K Regulatory Status of the Vector Control Toolbox. Armed Forces Pest Management Board Triennial Workshop, Jacksonville, FL, March Malamud-Roam, K Regulatory Update. American Mosquito Control Association Annual Meeting, New Orleans, LA, March Malamud-Roam, K Endangered Species and Vector Control. American Mosquito Control Association Annual Meeting, New Orleans, LA, March Malamud-Roam, K Risk Mitigation and Label Revisions. American Mosquito Control Association Washington Meeting, DC, May Malamud-Roam, K Endangered Species and Vector Control. American Mosquito Control Association Washington Meeting, DC, May 2015.

137 Malamud-Roam, K The IR-4 Project and Public Health Pesticides: Lessons Learned from 50 Years of Support for Small Markets in Agriculture (Poster). Gates Foundation / IVCC Innovation to Impact Program Review, London, UK, July Malamud-Roam, K Regulatory Status of the Vector Control Toolbox. Armed Forces Pest Management Board Annual Fall Meeting, Silver Spring, MD, Nov Malamud-Roam, K Attract and Kill. IR-4 Newsletter, 46(2), p16. Spring Malamud-Roam, K Translating Innovation to Impact in Vector Control. IR-4 Newsletter, 46(3), p11. Summer Novack, S. IR-4 Newsletter. Volume 46 Number 1. New Jersey Agricultural Experiment Station Publication No. P Novack, S. IR-4 Newsletter. Volume 46 Number 2. New Jersey Agricultural Experiment Station Publication No. P Novack, S. IR-4 Newsletter. Volume 46 Number 3. New Jersey Agricultural Experiment Station Publication No. P Novack, S. IR-4 Newsletter. Volume 46 Number 4. New Jersey Agricultural Experiment Station Publication No. P Palmer, C.L., J. Baron, and E. Vea Role of IR-4 Ornamental Horticulture Program in Developing IPM Tools for Specialty Crops. Abstract International IPM Symposium. Salt Lake City, UT. March 23-27, Palmer, C.L., J. Baron, E. Vea and E. Lurvey Update on 2014 Weed Science Research in the IR-4 Ornamental Horticulture Program. Proceedings of the 69 th Northeastern Weed Science Society. January Palmer, C.L., IR-4 Collaborations addressing Pest Management in Greenhouses. Abstract. Entomology Society of America Annual Meeting. Minneapolis, MN. November 14-18, Palmer, C.L IR-4: Back to the Future for Pest, Disease & Weed Management. Presentation for SAF Pest & Production Management Conference, February, Palmer, C.L., M.R. Bonde, S.E. Nester, J.M. Revell and D.G. Luster Fungicide Impact on in vitro Germination of Basidiospores of Puccinia horiana, the Causal Agent of Chrysanthemum White Rust. Plant Health Progress. April doi: /php-rs Starner, V. and S. Novack, A Look at VA s Northern Shenandoah Valley Agriculture, IR-4/EPA/USDA Field Tour June 24, 2015 tour book. New Jersey Agricultural Experiment Station Publication No. P , 20 pp. Wyenandt, A, Simon, J.E., Pyne, R.M., Homa, K., McGrath, M., Zhang, S., Raid, R.N., Ma, L.J., Wick, R., Guo, L., Madeiras, A Basil downy mildew (Peronospora belbahrii): Discoveries and challenges relative to its control. Phytopathology. 105(7):

138 December 31, 2015 Approved by: J.J. Baron, Executive Director IR-4 Project, NJ Agricultural Experiment Station Rutgers, The State University of New Jersey John Wise, Chair, IR-4 Project Management Committee Michigan State University Douglas Buhler, Chair, IR-4 Administrative Advisers Michigan State University

139 ATTACHMENT 1 Participants in the Process Stakeholder Representatives These are the primary customers for IR-4 Project services. A concerted effort is always made to seek input from growers/commodity group representatives for establishing research priority setting policies. The IR-4 Commodity Liaison Committee (CLC) provides input to the IR-4 Project Management Committee on overall operations and program direction. They are often effective communicators to Congress on the importance of the IR-4 Project and its deliverables to specialty crop agriculture in the United States. Members include: Dr. Michael Aerts, Florida Fruit and Vegetable Association Mr. Mark Arney, Nat'l Watermelon Promotion Board Mr. Kirk Baumann, Ginseng Board of Wisconsin Dr. Lori Berger, Ag Business Resources Dr. Michael Bledsoe, Village Farms, L.P. Dr. A. Richard Bonanno, Pleasant Valley Farms and CLC Chair Mr. Bruce Buurma, Buurma Farms Inc. Mr. James R. Cranney, California Citrus Quality Council Mr. Alan DeYoung, Van Drunen Farms (partial year) Dr. Brian R. Flood, Del Monte USA Ms. Ann E. George, Washington Hop Commission Mr. Terry Humfeld, Cranberry Institute Mr. John Keeling, National Potato Council Mr. Phil Korson, Cherry Marketing Institute Mr. Eric Maurer, Engage Agro Mr. Armando Monterraso, Brooks Tropicals Mr. Dennis Nuxoll, Western Growers Association Mr. Ray Prewett, Texas Vegetable Association (partial year) Ms. Laura Phelps, American Mushroom Institute Mr. Keith Pitts, Marrone Bio Innovations (partial year) Mr. Ray Ratto, Ratto Brothers Mr. Steven Salisbury, Mint Industry Research Council Mr. Paul Schlegel, American Farm Bureau Federation Ms. Lin Schmale, Society of American Florists Mr. Todd Scholz, USA Dry Pea & Lentil Council Dr. Alan Schreiber, Agriculture Development Group, Inc. Mr. Bob Simerly, National Onion Association Mr. Berry Tanner, National Watermelon Association (alternative) Mr. Dave Trinka, MBG Marketing Mr. Dennis Tristao, J.G. Boswell Company Cooperating Government Departments and Agencies Agriculture and Agri Food Canada (CN-PMC) Health Canada State Agricultural Experiment Stations/Land Grant Universities (SAES) State of California Department of Pesticide Regulation (DPR) U.S. Department of Agriculture, National Institute of Food and Agriculture (NIFA) U.S. Department of Agriculture, Agricultural Research Service (ARS) U.S. Department of Agriculture, Foreign Agriculture Service (FAS) U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) U.S. Department of Defense, Deployed Warfighter Protection Program (DWFP) U.S. Environmental Protection Agency (EPA)

140 ATTACHMENT 1 Continued Crop Protection Industry ADAMA AgBio Development Inc. AgraQuest Inc. Agrimar AgroSource Inc. Albaugh, Inc. Amvac Chemical Corporation Arkion Life Sciences Arysta LifeScience North America Corp. BASF Corporation Bayer CropScience USA Bayer Environmental Science BetaTec BioBest Bio HumaNetics BioProdex BioSafe Systems Bioworks CAI Limited Certis USA Dow AgroSciences DuPont Agricultural Products Engage Agro FMC Corporation Gowan Company Hacco, Inc. Isagro, USA ISK Biosciences Janssen Pharmaceutica K-I Chemical USA Inc. MGK Landis International Lonza Inc. Luxembourg-Pamol, Inc. MacDermid Agricultural Solutions, Inc. Marrone BioInnovations, Inc. Monsanto Company Natural Industries Neudorff Nichino America, Inc. Nisso America, Inc. Novozymes, Inc. Nufarm Americas, Inc. OHP Pace 49, Inc. SePro Corporation Sipcam Advan Summerdale, Inc. Syngenta Crop Protection Inc. Syngenta Flowers TKI Novasource UPI Valent Biosciences Valent USA Corporation Willowood USA IR-4 PARTICIPANTS Project Management Committee (PMC): Dr. Jerry Baron, IR-4 Project Headquarters IR-4 Project Executive Director Dr. A. Richard Bonanno, Bonanno Farm Trust and CLC Chair Dr. Douglas Buhler, Michigan State University Administrative Advisor, North Central Region Dr. Jackie Burns, University of Florida Administrative Advisor, Southern Region (partial year) Dr. Mary Delany, University of California, Davis - Administrative Advisor, Western Region Dr. Mary Duryea, University of Florida - Administrative Advisor, Southern Region (partial year) Dr. Liwei Gu, University of Florida Regional Director, Southern Region (partial year) Dr. Rob Hedberg, USDA-NIFA- National Program Leader Dr. Matt Hengel, University of California, Davis - Regional Director, Western Region Dr. Bradley Hillman, Rutgers University Administrative Advisor, Northeast Region (partial year) Dr. Maurice Marshall, University of Florida - Regional Director, Southern Region (alternative) Dr. Daniel Rossi, Rutgers University - Administrative Advisor, Northeast Region Dr. Paul Schwartz, Jr. USDA-ARS Director Minor Use Program Dr. David Soderlund, Cornell University - Regional Director, Northeast Region & PMC Chair (partial year) Dr. John Wise, Michigan State University Regional Director, North Central Region, Chair (partial year)

141 ATTACHMENT 1 Continued IR-4 Project Headquarters (HQ) IR-4 Headquarters is located at the 500 College Road East, Suite 201W, Princeton, NJ 08540; (732) Dr. Marija Arsenovic Manager, Weed Science Activities/Study Director Ms. Tammy Barkalow Assistant Director, Quality Assurance Mr. Bill Barney Manager, Crop Grouping/Study Director Dr. Jerry Baron Executive Director Ms. Susan Bierbrunner Data Manager and Administrative Support Dr. Michael Braverman Manager, Biopesticides and Organic Support Program Ms. Uta Burke Administrative Support Dr. Debbie Carpenter Assistant Director, Registrations Ms. Krista Coleman Program Assistant: Organic Support, Food and Crop Grouping Ms. Diane D Angelo Quality Assurance Dr. Keith Dorschner Manager, Entomology Activities/Study Director Ms. Cheryl Ferrazoli Administrative Support Ms. Jane Forder Quality Assurance Ms. Kathryn Homa Study Director/Research Coordinator Ms. Shiayi Huang - Database Developer Ms. Carolyn Jolly Study Director/Research Coordinator Dr. Daniel Kunkel Associate Director, Food & International Programs Ms. Grace Lennon Study Director/Research Coordinator Mr. Raymond Leonard Study Director/Research Coordinator Dr. Karl Malamud-Roam Manager, Public Health Pesticides Program Ms. Sherri Nagahiro Business Manager Ms. Sherri Novack Manager, Communications and Outreach Dr. Cristi Palmer Manager, Ornamental Horticulture Program Mr. Kenneth Samoil Study Director/Research Coordinator Ms. Karen Sims Administrative Support Dr. Van Starner Assistant Director, Research Planning & Outreach Ms. Juliet Thompson Administrative Support Dr. Ely Vea Assistant, Ornamental Horticulture Program Field Coordinators (Regional and ARS) Ms. Edith Lurvey, Cornell University Northeast Region Dr. Satoru Miyazaki, Michigan State University North Central Region Dr. Michelle Samuel-Foo, University of Florida Southern Region Dr. Paul Schwartz Jr., USDA-ARS ARS Office of Minor Use Pesticides Ms. Rebecca Sisco, University of California, Davis Western Region Laboratory Coordinators (Regional and ARS) Dr. Wlodzimierz (Wlodek) Borejsza-Wysocki, University of Florida Southern Region Dr. Sue Erhardt, Michigan State University North Central Region Mr. Thomas Hendricks, USDA-ARS Tifton, GA Dr. Matt Hengel, University of California, Davis Western Region Mr. T. Todd Wixson, USDA-ARS Wapato, WA

142 ATTACHMENT 1 Continued Regional Quality Assurance Unit Coordinators Dr. Martin Beran, University of California, Davis Western Region Dr. Zhongxiao (Michael) Chen, Michigan State University North Central Region Ms. Jane Forder, Rutgers University Northeast Region (partial year) Ms. Michele Humiston, Cornell University Northeast Region (partial year) Ms. Kathleen Knight, University of Florida Southern Region Additional Technical Staff Ms. Robin Adkins Federline Quality Assurance, Southern Region Ms. Elizabeth Culbert IR-4 Satellite Laboratory, Washington State University Mr. Stephan Flanagan Assistant Regional Field Coordinator, Western Region Dr. Vince Hebert Manager, IR-4 Satellite Laboratory, Washington State University Ms. Regina Hornbuckle Quality Assurance USDA-ARS (partial year) Dr. Bryan Jensen Quality Assurance Participant, University of Wisconsin (partial year) Dr. Derek Killilea Quality Assurance Consultant Ms. Lisa Latham Quality Assurance, North Central Region (partial year) Ms. Mary Lynn Quality Assurance Consultant Ms. Eileen Nelson - Quality Assurance Participant, University of Wisconsin (partial year) Ms. Sherita Normington Associate Quality Assurance, Western Region Ms. Mika Pringle Tolson Field Program Assistant, Western Region Dr. Yavuz Yagiz Analytical Quality Assurance, Southern Region State and Federal IR-4 Liaisons Representatives Northcentral Region Dr. S. Clay SD Dr. R. Cloyd KS Dr. D. Doohan OH Dr. D. Egel IN Dr. R. Groves WI Dr. R. Hartzler IA Dr. D. Heider WI Dr. S. Kamble NE Dr. C. Krause USDA-ARS Dr. V. Krischik MN Dr. S. Miyazaki MI Dr. M. Reding USDA-ARS Dr. D. Williams IL Dr. M. Williams USDA-ARS Dr. R. Zollinger ND VACANT MO Northeast Region Dr. E. Beste MD Ms. H. Faubert RI Dr. D. Frank WV Dr. A. Hazelrigg VT Dr. G. Krawczyk PA Dr. B. Kunkel DE Ms. E. Lurvey NY Dr. T. Mervosh CT Dr. B. Nault NY Dr. D. Polk NJ Ms. C. Smith NH Dr. R. Wick MA Dr. D. Yarborough ME

143 ATTACHMENT 1 Continued Southern Region Dr. R. Bessin KY Dr. N. Burgos AR Dr. S. Culpepper GA Dr. R. Davis USDA-ARS Ms. A. Fulcher TN Dr. C. Gilliam AL Dr. A. Henn MS Dr. M. Lewis-Ivey LA Mr. C. Luper OK Mr. M. Matocha TX Dr. D. Monks NC Dr. W. Robles Vasquez PR Dr. M. Samuel-Foo FL Dr. A. Simmons USDA-ARS Dr. M. Weaver VA Mr. T. Webster USDA-ARS Western Region Dr. R. Boydston USDA-ARS Dr. M. Burrows MT Mr. J. Davison NV Mr. J. DeFrancesco OR Mr. C. Hamilton NM Dr. R. Hirnyck ID Dr. P. Kaspari AK Dr. M. Kawate HI Dr. J. Munyaneza USDA-ARS Dr. S. Nissen CO Dr. J. Palumbo AZ Dr. C. Ransom UT Ms. R. Sisco CA Dr. D. Walsh WA Northcentral Region J. Cardina OH S. Chapman WI M. Ciernia ND S. Clay SD D. Doohan OH M. Hausbeck MI D. Heider WI B. Jenks ND S. Miller OH T. Scholz MN A. Van Woerkom MI B. Zandstra MI Northeastern Region R. Bellinder NY J. Collins ME T. Freiberger NJ C. Hoepting NY Z. Jacimovski NY N. Lalancette NJ M. McGrath NY K. Peter PA Regional Field Research Directors

144 ATTACHMENT 1 Continued Northeastern Region (Continued) M. Ross MD C. Smart NY C. van den Berg DE M. VanGessel DE A. Wyenandt NJ D. Yarborough ME Southern Region D. Alfred FL R. Batts NC N. Boyd FL P. Bruno TX N. Burgos AR M. Campos TX D. Carrillo FL P. Dittmar FL L. Estorninos AR M. Gutierrez FL A. Henn MS M. Ivey LA K. Jennings NC O. Liburd FL C. Marconi TX J. Martin KY W. Mitchem NC A. Monterroso FL D. Odero FL M. Phillips TX W. Robles Vazquez PR R. Saldana TX H. Smith FL D. Sutherland FL R. Tannenbaum FL G. Vallad FL S. Yates FL S. Zhang FL Western Region J. Adaskaveg CA M. Bari CA B. Boutwell CA J. Coughlin HI J. DeFrancesco OR D. Ennes CA D. Groenendale WA C. Hamilton NM B. Hanson CA R. Hobbs CA J. Kam HI D. Keenan (Stoffel) CA G. Koskela OR G. Kyser CA N. Leach CA C. Mallory-Smith OR W. Meeks ID T. Miller WA M. Mitchell CA C. Oman CO

145 ATTACHMENT 1 Continued Western Region (Continued) E. Peachey OR S. Salisbury OR K. Skiles CA R. Smith CA P. Sturman OR B. Turner (Woodland) CA B. Viales CA D. Walsh WA S. Watkins CA ARS S. Benzen CA R. Boydston WA B. Fraelich GA J. Harvey WA L. Horst OH P. Wade SC Canada M. Clodius BC J. Dubuc QC D. Hanscomb NS D. Nield BC G. Riddle ON R. Wismer ON

146 ATTACHMENT Food Use Research Projects - Residue Trials Chemical Crop PR # Acetamiprid Avocado Acetochlor Bean & Pea (Succulent) B10214 Acifluorfen Bean (Lima) (Succulent & Dried Shelled) A6300 Acifluorfen Pea (Southern) A6301 Bentazon Pea (Dry) Bromoxynil Grasses (Seed Crop) Chlorfenapyr Tomato (GH) (Small) Chlorothalonil Sugar Apple A3721 Clofentezine Guava 9323 Clopyralid Caneberry A5147 Clopyralid Onion (Dry Bulb) Cyazofamid Ginseng Cyflumetofen Pepper (GH) Cyflumetofen Tomato (GH) Cyromazine Pea (Edible Podded & Succulent Shelled) Difenoconazole + Azoxystrobin Asparagus Difenoconazole + Azoxystrobin Bean & Pea (Edible & Podded) Difenoconazole + Azoxystrobin Dragon Fruit (Pitaya) Difenoconazole + Azoxystrobin Passion Fruit Dinotefuran Basil 8595 Diquat Avocado Fenpyroximate Bean (Succulent Shelled) Fenpyroximate Blueberry Fenpyroximate Squash (Summer) 9033 Fluazifop-P-Butyl Celery 2336 Fluazifop-P-Butyl Papaya Fluazinam Tomato Flumetsulam Clover (Seed Crop) Flumioxazin Edamame (Vegetable Soybean) 11132** Flumioxazin + Pyroxasulfone Grasses (Seed Crop) Flumioxazin + Pyroxasulfone Sweet Potato FTH 545 Strawberry 11159** Imidacloprid Corn (Seed Crop) Indaziflam Asparagus Indaziflam Blueberry (Lowbush) 11412** Indoxacarb Coffee Indoxacarb Grasses (Seed Crop) A9521 Isoxaben Caneberry Kasugamycin Almond Kasugamycin Olive Kasugamycin Peach 9888 Linuron Bean (Dried Shelled) Linuron + Diuron Sesame 11396

147 Chemical Crop PR # Mandipropamid Grapefruit Mandipropamid Lemon Mandipropamid Orange Mefenoxam Herbs (GH) Mefenoxam Tomato (GH) 1700** Nitrapyrin Broccoli A2188 Nitrapyrin Cabbage A2022 Nitrapyrin Celery A2024 Nitrapyrin Grapefruit Nitrapyrin Greens (Mustard) A2660 Nitrapyrin Lemon Nitrapyrin Lettuce (Head & Leaf) A2659 Nitrapyrin Orange Novaluron Sunflower Oxathiapiprolin Pomegranate Paraquat Sesame Penoxsulam + Oxyfluorfen Artichoke (Globe) Penthiopyrad Banana Permethrin Grapefruit 1953 Potassium Phosphite Almond Potassium Phosphite Pistachio Potassium Phosphite Walnut Propamocarb-HCL Guava 7171 Propamocarb-HCL Spinach 11499** Propiconazole Broccoli Propiconazole Cabbage Pyriofenone Cucumber (GH) Pyroxasulfone Celery 11324** Quizalofop Apple 10033** Quizalofop Cherry 10036** Quizalofop Peach 10034** Quizalofop Pear 10032** Quizalofop Plum 10035** Rimsulfuron Pomegranate Saflufenacil Fig Sethoxydim Basil A2063** S-Metolachlor/Metolachlor Rosemary Spinetoram Dragon Fruit (Pitaya) Spinetoram Grape Streptomycin Pepper (Bell & Nonbell) Sulfoxaflor Artichoke (Globe) Thiabendazole Clover (Seed Crop) Thiabendazole Greens (Mustard) (Seed Trt) Trifluralin Sesame Trinexapac-Ethyl Clover (Seed Crop) * *indicates joint studies with Canada PMC.

148 ATTACHMENT Efficacty/Crop Safety (E/CS) Research Program Research to complete E/CS needs for pre-2015 projects/residue studies: Chemical Crop PR# Comments ARS trials indaziflam high bush blueberry residue study; multi-year CS trials (need 3rd year observations) GA State university trials OR, NC, MI clomazone dill residue study -- CA clomazone cilantro residue study -- CA, CA, FL quizalofop grape nd year trial CA; 1 st year trial NY -- CA, NY fomesafen sweet potato residue study GA AR, NC, MD linuron sweet potato residue study GA AR, NC, MD fluazifop chives residue study -- AR, CA, FL, MI pendimethalin celery residue study -- CA, FL acifluorfen edamame residue study OH AR, MI, NY pyroxasulfone edamame residue study WA AR, MI, NY acifluorfen lima bean residue study -- CA, DE saflufenacil caneberry residue study -- NC, OH, OR, WA Totals 5 33 Research to complete E/CS needs for new 2015 residue studies: Chemical Crop PR# Comments ARS trials State university trials cyantraniliprole ginseng residue study WI, WI clopyralid dry bulb onion residue study FL, MI, NY, OH pyroxasulfone celery residue study CA, FL acifluorfen pea residue study AR, NC cyflumetofen GH tomato residue study FL cyflumetofen GH pepper residue study FL pyriofenone GH cucumber residue study FL, OH kasugamycin peach residue study CA, NJ, PA kasugamycin almond residue study CA indazaflam asparagus residue study CA, NC, NJ saflufenaxil fig residue study CA, CA acetamiprid avocado residue study FL rimsullfuron pomegranate residue study CA Totals 0 25 Research in 2015 for PPWS (Pest Problem Without Solution) studies: Chemical Crop PR# Comments ARS trials State university trials Insecticides dragon fruit chilli thrips control FL, FL Fungicides fruiting vegetables bacterial disease control FL, LA, MI, NY, OH Totals 0 7

149 Chemical Crop PR# Comments ARS trials pendimethalin fava bean 9959 valifenalate basil Research in 2015 for for high priority regional needs: need CS data to add fava bean to label need new tools for DM resistance management Totals State university trials CA NJ, NY 0 3

150 ATTACHMENT Submissions to EPA, Registrants, Codex, and State Departments of Agriculture Pest Control Agent Type* Date Commodity or Crop Group PR# Fluazinam F 2/2/2015 Squash/cucumber subgroup 9B Cabbage Mayhaw Vegetable, tuberous and corm, subgroup 1C Lettuce storage stability B6892 Cyazofamid F 2/10/2015 Herb subgroup 19A Tomato (greenhouse) Pepper (greenhouse) Anthraquinone B 4/20/2015 Rice 09687* Pyrethrins+PBO I 4/27/2015 Herbs and spices 10855* Pyridaben I 5/07/2015 Cucumber (greenhouse) Fruit, pome, group Nut, tree, group Fruit, stone, group Fruit, citrus, group Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F Berry, low growing, subgroup 13-07G, except cranberry FTH 545 F 5/2015 Cantaloupe 11158* F 5/2015 Squash (Summer) 11157* F 5/2015 Cucumber 11156* Chlorantraniliprole I 6/10/2015 Artichoke, globe Nut, tree, group Fruit, stone, group Hops Metaldehyde M 7/07/2015 Wheat Beet, garden, Rutabaga, and Turnip Hop Penflufen F 7/14/2015 Onion, bulb, subgroup 3-07A Onion, green, subgroup 3-07B Fluensulfone N 7/22/15 Vegetable, tuberous and corm, subgroup 1C Fomesafen H 7/24/2015 Berry, low growing, subgroup 13-07G, except cranberry Vegetable, tuberous and corm, subgroup 1C

151 Pest Control Agent Type* Date Commodity or Crop Group PR# Vegetable, legume, group Fenpyroximate I 7/28/2015 Watermelon 11182* Aspergillus flavus strain TC16F, TC35C, TC38B, and TC46G F 8/10/2015 Corn 1048B Flumioxazin H 8/18/2015 Clover A10605 Caneberry subgroup 13-07A Brassica, head and stem, subgroup 5A Fruit, citrus, group Vegetable, fruiting, group Fruit, pome, group Fruit, stone, group Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F Onion, bulb, subgroup 3-07A Berry, low growing, subgroup 13-07G Nut, tree, group Flupyradifurone I 8/2015 Caneberry 10860* Cucumber 10785* Pepper (Greenhouse) 11244* Pomegranate 10770* Tomato (Greenhouse) 10784* Clomazone H 9/01/2015 Edamame Asparagus Pseudomonas fluorescens strain ACK55 H 9/10/2015 All commodities (conservation of sage grouse habitat and reduction of wildfire risk) 0995B Halosulfuron H 10/08/2015 Cucumber 10891* Pyrethrins+PBO I 10/16/2015 Mushroom 05954* Acequinocyl I 11/11/2015 Avocado Bean (dry shelled) Vegetable, cucurbit, group Vegetable, fruiting, group Fruit, citrus, group Fruit, pome, group Cherry subgroup 12-12A Nut, tree, group Tea 11706

152 Pest Control Agent Type* Date Commodity or Crop Group PR# Vegetable, legume, edible podded, Flonicamid I 12/01/2015 subgroup 6A Pea and bean, succulent shelled, subgroup 6B Pea and bean, dry shelled, except soybean, subgroup 6C Vegetable, fruiting, group Fenamidone F 12/22/2015 Basil Proposed Vegetable, Brassica, head and stem, group Proposed Vegetable, leafy greens, subgroup 4-15A Proposed Vegetable, Brassica, leafy greens, subgroup 4-15B Proposed Vegetable, leaf petiole, subgroup 22B Kohlrabi Fennel, Florence Celtuce Cottonseed subgroup 20C Oxathiapiprolin F 12/24/2015 Proposed Vegetable, stalk and stem, subgroup 22A Basil Caneberry subgroup 13-07A Proposed Vegetable, leafy greens, subgroup 4-15A Proposed Vegetable, Brassica, leafy greens, subgroup 4-15B Proposed Vegetable, Brassica, head and stem, group Carbaryl I 12/11/2015 Cranberry 10789* *B=Bird repellent, F=fungicide, H=herbicide, I=insecticide/acaricide, M=molluscide, P= plant growth regulator, R = rodenticide *Completed Final Reports Submitted to Registrant or other regulatory body to support US growers

153 ATTACHMENT Tolerance Successes - Permanent Tolerances Published in the Federal Register Pest Control Agent Type* Date Commodity or Crop Group PR# No. of Uses No. of Tolerances Bushberry subgroup 13-07B, except Flupyradifurone I 1/23/2015 cranberry** Prickly pear cactus** Clover** Pendimethalin H 2/11/2015 Hop** Onion, bulb, subgroup 3-07A Onion, green, subgroup 3-07B Vegetable, fruiting, group Fruit, citrus, group Fruit, pome, group Fruit, stone, group Berry, low growing, subgroup 13-07G Sunflower subgroup 20B Metaldehyde M 3/4/2015 Vegetable, legume, edible podded, subgroup 6A** Vegetable, foliage of legume, except soybean, subgroup 7A** Pea and bean, succulent shelled, subgroup 6B** Clover (Pacific Northwest only)** Ginseng** Tomato subgroup 8-10A2** Fruit, citrus, group ** Boscalid F 3/18/2015 Dill, seed Herb subgroup 19A Fruit, stone, group Nut, tree, group Pyraclostrobin F 4/10/2015 Dill, seed Herb subgroup 19A Fruit, stone, group Nut, tree, group 14-12, except pistachio Metconazole F 5/29/2015 Pea and bean, dried shelled, except soybean, subgroup 6C** Sunflower subgroup 20B** Rapeseed subgroup 20A2** Fruit, stone, group ** Nut, tree, group ** Sethoxydim H 6/15/2015 Vegetable, bulb, group Vegetable, fruiting, group Fruit, citrus, group Fruit, pome, group Caneberry subgroup 13-07A

154 Pest Control Agent Type* Date Commodity or Crop Group PR# No. of Uses No. of Tolerances Bushberry subgroup 13-07B Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F Berry, low growing, except strawberry, subgroup 13-07H Rapeseed subgroup 20A Sunflower subgroup 20B Cottonseed subgroup 20C Borage, meal 6** Fescue** Prohexadione P 7/08/2015 Strawberry Watercress S-Metolachlor H 7/08/2015 Lettuce Vegetable, fruiting, group 8-10, except tabasco pepper Vegetable, cucurbit, group Berry, low growing, subgroup 13-07G, except cranberry Sunflower subgroup 20B Novaluron I 7/22/2015 Avocado Bean, succulent Vegetable, cucurbit, group 9 (addition of greenhouse-grown cucumber) Carrot Vegetable, fruiting, group Fruit, pome, group Cherry subgroup 12-12A Peach subgroup 12-12B and Plum subgroup 12-12C Fluazifop-p-butyl H 8/6/2015 Sweet potato 6** Fludioxonil F 8/14/2015 Carrot** Fruit, stone, group ** Difenoconazole F 8/26/2015 Artichoke, globe Ginseng Fruit, stone, group Nut, tree, group Oxathiapiprolin F 9/4/2015 Ginseng** Leafy greens subgroup 4A** Onion, bulb, subgroup 3-07A** Onion, green, subgroup 3-07B** Pea, succulent shelled** Vegetable, fruiting, group 8-10** Vegetable, cucurbit, group 9** Cyprodinil F 9/09/2015 Artichoke, globe Pomegranate Guava

155 Pest Control Agent Type* Date Commodity or Crop Group PR# No. of Uses No. of Tolerances Acerola 1 1 Feijoa 1 1 Jaboticaba 1 1 Passionfruit Starfruit 1 1 Wax jambu 1 1 Fruit, stone, group Halosulfuron-methyl H 9/17/2015 Fruit, pome, group A Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F (East of the Rockies only) A Pyrimethanil F 10/21/2015 Cucumber (greenhouse only) Tomato subgroup 8-10A Fruit, citrus, group Fruit, pome, group Fruit, stone, group Methoxyfenozide I 10/28/2015 Chive, fresh leaves Onion, green, subgroup 3-07B, except chive, fresh leaves Herb subgroup 19A, except chive, fresh leaves Nut, tree, group Fruit, stone, group 12-12, except plum, prune, fresh Rimsulfuron H 10/30/2015 Sorghum (grain) Acetamiprid I Clover (for regional registration in the 11/04/2015 Pacific Northwest only)** Nicosulfuron H 11/04/2015 Sorghum (grain) Saflufenacil H 11/25/2015 Pomegranate** Azoxystrobin F 12/9/2015 Ti palm Quinoa Fruit, stone, group Nut, tree, group 14-12, except pistachio NAA P 12/14/2015 Pomegranate Pendimethalin H 12/21/2015 Bushberry subgroup 13-07B Caneberry subgroup 13-07A Nut, tree, group Propiconazole F 12/23/2015 Brassica, leafy greens, subgroup 5B Dill Quinoa Radish Ti palm Watercress Fruit, stone, group 12-12, except plum Nut, tree, group Spinetoram I Berry, low growing, subgroup 13-07G, 12/24/2015 except cranberry Bushberry subgroup 13-07B

156 Pest Control Agent Type* Date Commodity or Crop Group PR# No. of Uses No. of Tolerances Caneberry subgroup 13-07A Coffee Cottonseed subgroup 20C Fruit, citrus, group Fruit, pome, group Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F Fruit, stone, group Nut, tree, group Onion, bulb, subgroup 3-07A Onion, green, subgroup 3-07B Vegetable, fruiting, group Quinoa Berry, low growing, subgroup 13-07G, Spinosad I 12/28/2015 except cranberry Bushberry subgroup 13-07B Caneberry subgroup 13-07A Coffee Cottonseed subgroup 20C Fruit, citrus, group Fruit, pome, group Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F Fruit, stone, group Nut, tree, group Onion, bulb, subgroup 3-07A Onion, green, subgroup 3-07B Vegetable, fruiting, group Quinoa Totals *F=fungicide, H=herbicide, I=insecticide/acaricide, M=molluscide, P=plant growth regulator, R=rodenticide 1 Update of established tolerance on old crop group or subgroup 2 Conversion of established tolerance(s) on representative commodities to a crop group or subgroup tolerance 3 Conversion of established tolerance(s) on representative commodities and submission of new data to complete the requirements for a crop group or subgroup 4 Response to EPA request for Codex harmonization 5 Tolerance for indirect or inadvertent residues 6 Revised tolerance

157 ATTACHMENT 6 Pending Food Program Submissions to EPA PR # Chemical Commodity (Full name) ,4-DB LENTIL ,4-DB GUAR BENZYLADENINE AVOCADO ACEQUINOCYL GUAVA ACETOCHLOR BEAN & PEA (SUCCULENT) ALL PESTICIDES CROP GROUP ATRAZINE SORGHUM (SWEET) AVG CHERRY AZOXYSTROBIN BLUEBERRY BENZOVINDIFLUPYR ONION (DRY BULB) BETA-CYFLUTHRIN FLAX BIFENAZATE BANANA BIFENAZATE CROP GROUP BIFENAZATE SUBGROUP 12-12A BIFENAZATE SUBGROUP 12-12B BIFENAZATE SUBGROUP 12-12C BIFENAZATE SUBGROUP 20C BIFENAZATE SUBGROUP 24A (TEMP) BIFENTHRIN CRANBERRY BIFENTHRIN LEMON BIFENTHRIN APPLE BIFENTHRIN GREENS (MUSTARD) BIFENTHRIN PEACH BIFENTHRIN POMEGRANATE BIFENTHRIN AVOCADO BIFENTHRIN CROP GROUP BIFENTHRIN CROP GROUP BIFENTHRIN SUBGROUP 08-10A BIFENTHRIN SUBGROUP 08-10B BIFENTHRIN SUBGROUP 13-07A BROMOXYNIL MILLET CHLORFENAPYR BASIL & CHIVES (GH) CHLORFENAPYR CUCUMBER (GH) CHLORFENAPYR CROP GROUP (GH) CHLORFENAPYR TEA CHLOROTHALONIL ALMOND CHLOROTHALONIL CHERRY, SOUR CHLOROTHALONIL GRAPEFRUIT CHLOROTHALONIL GREENS (MUSTARD) CHLOROTHALONIL LEMON CHLOROTHALONIL LETTUCE (HEAD & LEAF) CHLOROTHALONIL LYCHEE CHLOROTHALONIL ORANGE CHLOROTHALONIL RADISH CHLOROTHALONIL SPINACH

158 PR # Chemical Commodity (Full name) CHLOROTHALONIL GUAVA CLETHODIM ALMOND CLETHODIM OKRA CLOMAZONE DILL CLOMAZONE CANOLA CLOPYRALID PEAR CLOPYRALID RADISH CLOPYRALID STONE FRUITS CLOPYRALID SUBGROUP 13-07G CYANTRANILIPROLE (HGW86) CANEBERRY CYANTRANILIPROLE (HGW86) COFFEE CYANTRANILIPROLE (HGW86) STRAWBERRY CYANTRANILIPROLE (HGW86) LETTUCE (GH) DCPA CARROT DCPA PRICKLY PEAR CACTUS DCPA CROP GROUP DCPA SUBGROUP 13-07G DCPA SUBGROUP 09A DIFENOCONAZOLE GUAVA DIFENOCONAZOLE PAPAYA DIFENOCONAZOLE COTTONSEED DIFENOCONAZOLE CROP GROUP (TEMP) DIFENOCONAZOLE SUBGROUP 13-07F DIFENOCONAZOLE SUBGROUP 04-14B (TEMP) DIFENOCONAZOLE + AZOXYSTROBIN CRANBERRY DINOTEFURAN CUCUMBER (GH) DIQUAT GUAVA DIQUAT LYCHEE DIQUAT ONION (DRY BULB) DIQUAT WATERCRESS DIQUAT BANANA DIQUAT SUGAR APPLE DIQUAT PEPPER (BELL & NONBELL) DIQUAT TOMATO DIURON CHERRY DIURON PLUM EMAMECTIN BENZOATE ARTICHOKE (GLOBE) EMAMECTIN BENZOATE BASIL EMAMECTIN BENZOATE CHERRY ETHEPHON FIG ETHOFUMESATE (WILLOWOOD) BEET (SUGAR) ETHOPROP MINT ETHYLENE PINEAPPLE ETOXAZOLE CORN (SWEET) FAMOXADONE + CYMOXANIL BEAN, LIMA (SUCCULENT & DRIED SHELLED) FAMOXADONE + CYMOXANIL CARROT FAMOXADONE + CYMOXANIL GREENS (MUSTARD) FAMOXADONE + CYMOXANIL MANGO

159 PR # Chemical Commodity (Full name) FAMOXADONE + CYMOXANIL GINSENG FENHEXAMID KIWIFRUIT (PREHARVEST) FENHEXAMID ONION FENHEXAMID ONION (GH TRANSPLANT) FENHEXAMID SUBGROUP 13-07A FENHEXAMID SUBGROUP 13-07B FENHEXAMID SUBGROUP 13-07E FENHEXAMID SUBGROUP 13-07F FENHEXAMID SUBGROUP 13-07G FENPROPATHRIN GREENS (MUSTARD) FENPROPATHRIN SWEET POTATO FENPROPATHRIN TURNIP (ROOTS) FENPROPATHRIN CROP GROUP FENPROPATHRIN SUBGROUP 12-12A FENPROPATHRIN SUBGROUP 12-12B FENPROPATHRIN SUBGROUP 12-12C FENPYROXIMATE BANANA FENPYROXIMATE CELERY FENPYROXIMATE CANEBERRY FENPYROXIMATE CROP GROUP FLONICAMID ALFALFA, CLOVER FLUAZIFOP-P-BUTYL CROP GROUP FLUAZIFOP-P-BUTYL CROP GROUP FLUDIOXONIL CELERY (GH) FLUENSULFONE RADISH FLUMIOXAZIN GUAYULE FLUOPICOLIDE GRAPEFRUIT FLUOPICOLIDE LEMON FLUOPICOLIDE BASIL FLUOPICOLIDE BEAN (SNAP) FLUOPICOLIDE HOPS FLUOPICOLIDE ORANGE FLUOPICOLIDE BASIL FLUOPICOLIDE CROP GROUP FLUOPICOLIDE SUBGROUP 13-07F GLYPHOSATE PEPPER (CHILI) GLYPHOSATE ONION (DRY BULB) GLYPHOSATE CROP GROUP GLYPHOSATE CROP GROUP HEXAZINONE BLUEBERRY (HIGH BUSH) IMAZALIL MUSHROOM (WHITE BUTTON) INDAZIFLAM FIG INDAZIFLAM POMEGRANATE ISOXABEN APPLE ISOXABEN BLUEBERRY ISOXABEN SUBGROUP 13-07F ISOXABEN TREE NUTS KASUGAMYCIN APRICOT

160 PR # Chemical Commodity (Full name) LAMBDA-CYHALOTHRIN ASPARAGUS (FERN) LAMBDA-CYHALOTHRIN CARROT LAMBDA-CYHALOTHRIN GREENS (MUSTARD) LAMBDA-CYHALOTHRIN OKRA LAMBDA-CYHALOTHRIN RADISH LAMBDA-CYHALOTHRIN RICE, WILD LAMBDA-CYHALOTHRIN BULB VEGETABLES SUBGROUP 03-07A LAMBDA-CYHALOTHRIN BROCCOLI RAAB LAMBDA-CYHALOTHRIN MILLET, PEARL LAMBDA-CYHALOTHRIN RUTABAGA LAMBDA-CYHALOTHRIN TEA LAMBDA-CYHALOTHRIN TURNIP (ROOTS) LAMBDA-CYHALOTHRIN + THIAMETHOXA GUAVA LAMBDA-CYHALOTHRIN + THIAMETHOXA AVOCADO LINURON BASIL MANCOZEB BLUEBERRY MEFENOXAM CUCUMBER (GH) MESOTRIONE CROP GROUP METRIBUZIN PEA (EDIBLE PODDED & SUCCULENT SHELLED) METRIBUZIN POTATO NAA ALMOND NAA PLUM NAA WALNUT NOVALURON LYCHEE OXYFLUORFEN COFFEE OXYFLUORFEN ONION (GREEN) OXYFLUORFEN STRAWBERRY (TRANSPLANTS) OXYFLUORFEN TI PALM OXYFLUORFEN TOMATO OXYFLUORFEN CANEBERRY (RASPBERRY) OXYTETRACYCLINE CHERRY PENDIMETHALIN SAFFLOWER PENOXSULAM + OXYFLUORFEN ARTICHOKE (GLOBE) PENTHIOPYRAD BLUEBERRY (HIGH BUSH) PENTHIOPYRAD CANEBERRY (RASPBERRY) PENTHIOPYRAD LETTUCE (GH) PENTHIOPYRAD CILANTRO PERMETHRIN TEA PROMETRYN SESAME PROPICONAZOLE + CHLOROTHALONIL TOMATO (GH) PYMETROZINE LETTUCE (GH) PYRETHRINS + PBO CROP GROUP PYRIFLUQUINAZON CUCUMBER (GH) PYRIOFENONE PEPPER (GH) PYROXASULFONE SUNFLOWER 8295 QUINCLORAC ASPARAGUS QUINCLORAC BLUEBERRY QUINCLORAC CANEBERRY

161 PR # Chemical Commodity (Full name) QUINOXYFEN CUCUMBER QUINOXYFEN SQUASH (SUMMER) QUINOXYFEN CROP GROUP QUIZALOFOP GRAPE RIMSULFURON GRASSES (SEED CROP) RIMSULFURON CROP GROUP RIMSULFURON CROP GROUP RIMSULFURON CROP GROUP RIMSULFURON CROP GROUP RIMSULFURON SUBGROUP 08-10A RIMSULFURON SUBGROUP 13-07F RIMSULFURON TUBEROUS/CORM VEGETABLES RIMSULFURON (CRANBERRY) CRANBERRY S-METOLACHLOR/METOLACHLOR CHICORY (ROOTS & TOPS) S-METOLACHLOR/METOLACHLOR SWISS CHARD S-METOLACHLOR/METOLACHLOR CROP GROUP SPIRODICLOFEN BANANA SPIRODICLOFEN SUGAR APPLE SPIRODICLOFEN DATE SPIROMESIFEN CANTALOUPE SPIROMESIFEN CUCUMBER SPIROMESIFEN FRUITING VEGETABLES SPIROMESIFEN GRASSES SPIROMESIFEN OKRA SPIROMESIFEN SQUASH (SUMMER) SPIROMESIFEN WATERCRESS SPIROTETRAMAT CARROT SPIROTETRAMAT STONE FRUITS SPIROTETRAMAT TREE NUTS SULFENTRAZONE MINT SULFENTRAZONE CHIA SULFOXAFLOR QUINOA SULFUR DIOXIDE FIG TEBUCONAZOLE TOMATO (GH) TEBUCONAZOLE WATERCRESS TERBACIL PEACH TERBACIL STRAWBERRY (ANNUAL) TERBACIL OREGANO THIAMETHOXAM CANEBERRY THIOPHANATE METHYL BEAN (SNAP) THIOPHANATE METHYL PEPPER (FIELD & GH) TOLFENPYRAD AVOCADO TOLFENPYRAD BLUEBERRY TOLFENPYRAD ONION TOLFENPYRAD STRAWBERRY TOLFENPYRAD TOMATO (GH) TRIFLURALIN ROSEMARY TRIFLURALIN CROP GROUP 03-07

162 PR # Chemical Commodity (Full name) TRIFLURALIN CROP GROUP TRIFLURALIN CROP GROUP TRIFLURALIN CROP GROUP TRIFLURALIN CROP GROUP TRIFLURALIN SUBGROUP 13-07F ZINC PHOSPHIDE GRASSES (SEED CROP)

163 ATTACHMENT ORNAMENTAL HORTICULTURE PROGRAM FIELD COOPERATORS NORTHCENTRAL REGION Dr. Raymond Cloyd IL Dr. Diana Cochran IA Mr. Terry Davis MI Dr. Francesca Hand OH Dr. Mary Hausbeck MI Dr. William Kirk MI Dr. Hannah Mathers OH Dr. Anand Persad OH Dr. Cliff Sadof IL Dr. John Siefer OH NORTHEAST REGION Dr. Ed Beste MD Mr. Dave Bodine NJ Dr. Nicholas Brazee MA Dr. Nora Catlin NY Dr. Ray Frank MD Mr. Dan Gilrein NY Dr. Brian Kunkel DE Ms. Carrie Mansue NJ Dr. Todd Mervosh CT Dr. Andy Senesac NY Dr. Rob Wick MA SOUTHERN REGION Dr. Kris Braman GA Dr. Yan Chen LA Dr. JC Chong SC SOUTHERN REGION (continued) Dr. Jeffrey Derr VA Dr. Steve Frank NC Dr. Charles Gilliam AL Dr. Mengmeng Gu TX Dr. Chris Marble FL Dr. Joe Neal NC Dr. Dave Norman FL Dr. Kevin Ong TX Dr. Aaron Palmateer FL Dr. Dan Potter KY Dr. Erfan Vafaie TX WESTERN REGION Dr. Gary Chastagner WA Dr. Joe DeFrancesco OR Dr. James Klett CO Dr. Tim Miller WA Dr. Mike Parrella CA Dr. Jay Pscheidt OR Dr. Buzz Uber CA Dr. Cheryl Wilen CA USDA-ARS Mr. Ben Fraelich GA Mr. Tom Freiberger NJ Dr. Nik Grunwald OR Mr. John Harvey WA Dr. Mike Reding OH Mr. Paul Wade SC

164 ATTACHMENT ORNAMENTAL HORTICULTURE PROGRAM RESEARCH ACTIVITIES Discipline Project Researchers Crops Products Trials Entomology BAS 440I Crop Safety * BYI-2960 Crop Safety * Cyflumetofen Crop Safety * Leafminer Efficacy Mealybug Efficacy Pyrfluquinazon Crop Safety * Pyridalyl Crop Safety Scale Efficacy * Thrips Efficacy * Tolfenpyrad Crop Safety * Pathology A14658C Crop Safety Acibenzolar Crop Safety * Benzovindiflupyr + Azoxystrobin (A18126B) Crop Safety * Botrytis Efficacy * Cyflufenamid Crop Safety * Difenconazaole + Azoxystrobin (A13703G) Crop Safety * Downy Mildew Efficacy Fluxapyroxad + Pyraclostrobin * Fusarium Efficacy Leaf Spot & Anthracnose Efficacy * Mandestrobin Crop Safety * Metconazole Crop Safety * Oxathiapiprolin Crop Safety Phytophthora Efficacy Powdery Mildew Efficacy Pydiflumetofen + Azoxystrobin + Propiconazole Crop Safety Pydiflumetofen + Fludioxonil Crop Safety Pydiflumetofen Crop Safety Tebuconazole Crop Safety Triticonazole Crop Safety * Weed Science Crabgrass Efficacy Dimethenamid-p Crop Safety * Dithiopyr Crop Safety * Flumioxazin + Pyroxasulfone Crop Safety Indaziflam Crop Safety * Isoxaben Crop Safety * Mulberry Weed Efficacy Oxalis Efficacy Oxyfluorfen + Prodiamine Crop Safety * Pendimethalin + Dimethenamid-p Crop Safety * Pendimethalin Crop Safety * Phyllanthus Efficacy Spurge Efficacy Sulfentrazone + Prodiamine Crop Safety * * National Priority Projects For a detailed list of research activities visit ir4.rutgers.edu.

165 ATTACHMENT 9 SUMMARIES OF 2014 ORNAMENTAL HORTICULTURE RESEARCH Acibenzolar Crop Safety Acibenzolar is an active ingredient that stimulates plant defense systems. In 2002, IR-4 started testing Insimmo (acibenzolar) for safety on several ornamental horticulture crops. In 2008, IR-4 continued crop safety screening after a renewed interest in bringing this active ingredient to ornamental horticulture growers. From 2002 through 2014, the IR-4 Project completed 249 trials on 67 ornamental plant genera or species examining phytotoxicity related to foliar and/or drench applications of Insimmo. In these trials, 36 species or genera exhibited minimal or no injury after foliar applications. Based on this information, it is recommended that all but 2 of these crops be added to a list of tolerant plants when this active ingredient gains registration. While there was sufficient evidence of minimal or no injury for Dianthus sp. and Pelargonium x hortorum, a single trial for each crop did elicit moderate to severe injury. Further investigation on cultivar or species differences may be warranted. Ametoctradin + Dimethomorph Crop Safety Orvego, registered with EPA on May 21, 2012 is a combination of ametoctradin (FRAC 45) and dimethomorph (FRAC 40). In 2012, IR-4 started testing Orvego (ametoctradin + dimethomorph) for safety on several ornamental horticulture crops as part of the new fungicide and bactericide crop safety project. In 2013, BASF recommended only finishing ongoing research activities due to observations of very little injury across crops. From 2012 through 2014, the IR-4 Project completed 22 trials on 9 ornamental plant genera or species examining phytotoxicity related to primarily drench applications. No injury or grow reduction was observed for any tested crop. Aphid Efficacy In the past, IR-4 had conducted Ornamental Horticulture Surveys to poll growers, landscape care operators, researchers, extension personnel and others affiliated with the ornamental industry on needs and issues related to disease, insect, and weed management. In 2013, aphids were identified as one of the top five important insects of concern. This summary includes a review of experiments conducted from 1998 to 2013 on ornamental horticulture and food crops published in Arthropod Management Tests. During this time period, numerous products representing 35 active ingredients were tested as foliar or soil applications against several species of aphids known to attack ornamental crops. Although there were insufficient data for definitive conclusions, many of the older registered active ingredients, including, acephate, acetamiprid, bifenthrin, chlorpyrifos, dimethoate, flonicamid, imidacloprid, lambda-chyalothrin, malathion, pymetrozine, spirotetramat, and thiamethoxam generally provided effective control. Similarly, several relatively new products, including cyantraniliprole, pyrifluquinazon, sulfoxaflor, and tolfenpyrad were effective. Bacterial Disease Efficacy From 2008 to 2014, 54 products were tested through the IR-4 Program as drench or foliar applications against bacterial pathogens. In addition to research collected through the IR-4 program, this summary includes a review of experiments conducted from 2005 to 2014, mainly on tree crops. Species tested included: Agrobacterium tumefaciens, Erwinia amylovora, E. chrysanthemi, Pseudomonas chicorii, P. marginalis, P. syringae, Pseudomonas sp., Xanthomonas campestris and Xanthomonas spp. In general, all products, including the standard copper containing bactericides (Camelot, CuPRO, Cuprofix, Cuprofix MZ, Junction, Kocide, MasterCop, Phyton 27 and ReZist) and mancozebs (Dithane, Penncozeb, Protect) and biologicals (Cease, Regalia, Rhapsody and Serenade), provided variable efficacy on these bacterial pathogens. Several new products that are included in the IR-4 Bacterial efficacy project looked promising based on their efficacy relative to standards. These include Acibenzolar, CG100, Citrex, HM-0736, Kasumin, Regalia, Taegro, Tanos and ZeroTol. Further research is needed to obtain additional efficacy data to recommend actions to register or amend labels for these pests. Cyflufenamid Crop Safety Cyflufenamid is an active ingredient for managing foliar diseases including powdery mildew and botrytis. It is not yet registered by EPA for the ornamental horticulture industry. During 2012 and 2013, the IR-4 Project completed 39 trials on 15 ornamental plant genera or species. In these trials, 9 species or genera exhibited minimal or no injury after foliar applications. For the remaining 7 crops, sufficient information has not yet been generated. However, to date the tested crops are not sensitive to foliar applications up to 4X the proposed high label rate.

166 ATTACHMENT 9 Continued Cyflumetofen Crop Safety Sultan (cyflumetofen) was registered for use on greenhouse ornamental horticulture crops as foliar sprays in the United States on May 9, 2014 to manage mites. The label does not contain a list of crops tested for tolerance. During 2014, the IR-4 Project conducted 29 trials on 15 ornamental plant species examining phytotoxicity related to cyflumetofen applications. No tested crops exhibited significant injury or growth reduction during these experiments. Dimethenamid-p Crop Safety From 2007 to 2015, IR-4 completed 460 trials on Tower EC (dimethenamid-p). The data contained in this report was generated to register uses of dimethenamid-p on and around ornamental horticulture plants with over-the-top applications. The dimethenamid-p rates in the testing program were 0.97, 1.94 and 3.88 pounds active ingredient per acre (lb ai per A) as the 1X, 2X and 4X rates. Tower EC had been applied to 139 plant genera or species. Of these, 60 plant species exhibited no or minimal transient injury after application at all three rates. Nine crops exhibited no phytotoxicity at 0.97 and 1.94 lb ai per acre but did have some injury at 3.88 lb ai per acre. Seven crops Catharanthus roseus, Cladrastis, Echinacea, Epilobium canum, Muhlenbergia dubia, Teucrium chamaedrys and Viburnum opulus exhibited significant phytotoxicity at even the lowest rate. Dithiopyr Crop Safety Dimension was initially registered in 1992 for ornamental horticulture uses. This initial label contained an extensive list of ornamental horticulture plants in landscapes where Dimension could be used without causing phytotoxicity. In 2006, the new Dimension 2EW label contained registered uses for field container and in ground nursery production, the first dithiopyr product to have these use sites. Starting in 1992, IR-4 examined 83 crops to expand this label to other crops, including several different fern species grown in field containers. Of the researched crops and Dimension formulations, only one crop (Rosa sp.) can be added at this time based on the data provided here. It is recommended the trials conducted using emulsifiable concentrate formulations be repeated with Dimension 2EW. Gladiolus Rust APHIS Project Summary The project entitled Determining the impact of registered and non-registered fungicides and disinfestants on Uromyces transversalis, the causal agent of gladiolus rust, and their use as mitigation tools in combination with host plant resistance, had eight objectives with the primary goal of developing strategies to locally eradicate gladiolus rust, caused by Uromyces transversalis. Fungicides individually and in programs were evaluated and recommendations were included for Mexican growers and two growers in California. Four experiments were conducted screening gladiolus cultivars with more tolerant cultivars identified. In addition to examining survivability of urediniospores in the field, survival of spores under controlled environmental conditions has been examined. Polyclonal antibodies were developed from germinating urediniospores and based on antigens identified through development of cdna libraries. Indaziflam Crop Safety From 2011 through 2014 IR-4 has completed 102 trials evaluating indaziflam granular formulations for crop safety. The data contained in this report was generated to register the use of indaziflam on and around ornamental horticulture plants with over-the-top applications. The rates tested were 0.045, and pounds active ingredient per acre (lb ai per A) as the 1X, 2X and 4X rates. The indaziflam 0.03%G formulation was applied to 16 plant genera or species, the Marengo G formulation was applied to 28 crops. Of these crops, 7 exhibited no or minimal transient injury after application at all three rates including Berberis sp., Liriope sp., Ophiopogon japonicus, Rhododendron sp., Rosa sp., Taxus media and certain Viburnum species. The remaining crops evaluated have only been screened in 1 or two trials or exhibited minimal to significant injury. Further testing is required on many species before a conclusion can be made confirming crop safety.

167 ATTACHMENT 9 Continued Isoxaben Crop Safety Gallery 75DF (isoxaben) was initially registered in 1992 for ornamental horticulture uses. This initial label contained an extensive list of ornamental horticulture crops where Gallery could be used without causing phytotoxicity. It also included a short list of crops where Gallery applications were not recommended. Between 1992 and 2013, IR-4 examined 93 crops to expand this label to other crops, including several different fern species grown in field containers. Of these, 24 crop species exhibited no or minimal transient injury with 20 already placed on the Gallery label. Eight crops exhibited injury in this research: Astilbe sp., Athyrium filix-femina, Buddleia davidii, Dendranthema x morifolium, Digitalis purpurea, Echinacea purpurea, Stachys byzantine, and Thymus sp. A new formulation, Gallery SC, was tested in 2014 and 2015 to determine crop safety on 21 crops in 25 trials. Of these, one species, Chasmanthium latifolium, exhibited no or minimal transient injury; this species is already in the Gallery label. Mesotrione Crop Safety From 2007 to 2011, IR-4 completed 144 trials on Mesotrione SC. The data contained in this report was generated to register uses of mesotrione on and around ornamental horticulture plants with over-the-top applications. The mesotrione rates were 0.187, 0.25 and 0.37 pounds active ingredient per acre (lb ai per A) as the 1X, 1.5X and 2X rates. Mesotrione SC had been applied to 48 plant genera or species. Of these, nine exhibited no or minimal transient injury after application at all three rates. Twenty one crops exhibited significant phytotoxicity at even the lowest rate: Buddleia davidii, Cortaderia selloana, Dianthus gratianopolitanus, Echinacea purpurea, Hydrangea quercifolia, Ilex sp., Lagerstroemia indica, Liriope sp., Ophiopogon sp., Phlox paniculata, Phlox subulata, Picea sp., Pseudotsuga menziesii, Rosa sp., Salvia sylvestris, Spiraea sp., Taxus sp., Thuja occidentalis, Veronica sp., Viburnum sp., and Vinca sp. Metconazole Crop Safety Metconazole was registered as Tourney 50WDG in the United States in 2007 as a turf fungicide. In 2010, uses for ornamental horticulture plants in greenhouse, nurseries, and landscapes were added. The commercial label contains a list of 49 woody ornamental plants exhibiting no or minimal injury. However, because metconazole is in the triazole class it could cause symptoms similar to plant growth regulators and additional testing is warranted on additional herbaceous and woody ornamental species. Between 2010 and 2014, the IR-4 Project completed 144 trials on 38 ornamental plant species examining phytotoxicity related to foliar applications of Tourney. In these trials, 21 species or genera exhibited minimal or no injury after foliar applications. Of these, 14 are already on the Tourney label; Buxus sp., Calibrachoa sp., Hemerocallis sp., Hydrangea sp., Lantana sp., Liriope sp. and Verbena sp. are the seven crops not yet listed. Based on this information, it is recommended that these be added to the list of tolerant plants on the Tourney 50WDG label. Four crops exhibited stunting: Begonia, Impatiens, Pansy and Zinnia. Pendimethalin + Dimethenamid-p Crop Safety From 2007 to 2013, IR-4 completed 598 trials on Freehand G (BAS 649 G; dimethenamid-p + pendimethalin). The data contained in this report was generated to register uses of dimethenamid-p + pendimethalin on and around ornamental horticulture plants with broadcast applications, including over the top of established plants. The Freehand rates in this testing program were 2.64, 4.3 and 10.6 pounds active ingredient per acre (lb ai per A) as the 1X, 2X and 2X rates. Freehand G had been applied to 166 plant genera or species. Of these genera and species, 71 exhibited no or minimal transient injury after application at all three rates. Thirty three (33) crops exhibited little or no phytotoxicity at 2.64 lb ai per acre, but did have some injury at 4.3 and/or 10.6 lb ai per acre, or showed injury after the second application. Of the forty nine (49) crops that still need additional information, there are twelve (12) genera or species in which three or more trials do not show significant injury, but one or more additional trials shows some sort of notable injury, necessitating additional research. Additional trials are also indicated to establish species or cultivar sensitivities.

168 ATTACHMENT 9 Continued Pyrifluquinazone Crop Safety Pyrifluquinazon was registered for use on greenhouse ornamental horticulture crops as foliar sprays in the United States in 2013 to manage whiteflies, aphids, leafhoppers, chilli thrips, and mealybugs. The label contains a list of crops tested for tolerance. From 2010 to 2014, the IR-4 Project conducted 92 trials on 24 ornamental plant species examining phytotoxicity related to pyrifluquinazon applications. No tested crops exhibited significant injury or growth reduction during these experiments. It is recommended that Bacopa sp. be added to the list of tolerant crops. Pythium Efficacy At the IR-4 Ornamental Horticulture Program Workshop in 2009, Pythium Efficacy was selected as a high priority project to expand the knowledge and list of fungicides available to growers for these diseases. In addition to research collected through the IR-4 program, this summary includes a review of experiments conducted from 1999 to 2013 on ornamental horticulture and vegetable crops. During this time period, numerous products representing 40 active ingredients were tested as drench, foliar or soil applications against several Pythium species causing root rot and damping-off on ornamentals, and root rot, cottony leak, damping-off and cavity spot on vegetables. Pythium species tested included: P. aphanidermatum, P. irregulare, P. mamillatum, P. dissotocum, P. myriotylum,p. ultimum and P. vipa. Most trials were conducted on P. aphanidermatum and P. ultimum. Although there were insufficient data for definitive conclusions, several relatively new products that are included in the Pythium efficacy project looked promising. These were Adorn, Disarm, Fenstop, Heritage and Pageant. V also looked promising. The phosphorus acids/phosphorus acid generators (Agri-Fos, Alude, K-Phite, Magellan, Phostrol or Vital) provided mix results. Acibenzolar, BW240/Rootshield Plus and CG100 were generally ineffective. The established standards Subdue Maxx and Terrazole/Truban generally performed well. Conversely, the registered biological products Companion/QRD 713, PlantShield/RootShield and SoilGard generally looked ineffective. The data from these trials suggest that the effectiveness of some fungicides in controlling Pythium root rot may vary, depending on the species of Pythium or crop. Spirotetramat Crop Safety Spirotetramat was registered as Kontos for use on ornamentals applied foliar or drench in the United States in The label recommends use on ornamental horticulture plants except a few species or genera specified in the label. From 2007 to 2013, the IR-4 Project conducted 225 trials on 49 ornamental plant species examining phytotoxicity related to Kontos applications. In these trials, only 6 crops (Begonia sp, Coleus x hybridus, Petunia sp., Pelargonium sp., Vinca sp., and Viola sp.) exhibited noticeable, significant injury and that was a slight height reduction, leaf curling, bleaching of flowers or plant death at the 2X and 4X rates applied as drench. One species (Verbena hybrida) exhibited significant flower discoloration at all rates applied as drench in one trial. Based on this information, it is recommended that the label prohibits drench application on Begonia sp., Coleus x hybridus, Petunia sp., Pelargonium sp., Verbena hybrida, Vinca sp., and Viola sp. The current label does not recommend use of Kontos on Pelargonium spp. Foliar application on these species may be recommended with the precautionary statements in the CROP TOLERANCE section of the current Kontos label. Tebuconazole Crop Safety Tebuconazole was first registered in 1994 for peanut diseases. Since then its food use label has expanded to several other food crops. The first noncrop registration of Torque 3.6SC (tebuconazole) occurred in 2010 for ornamental horticulture growers, professional landscape managers and for golf course turf. Tebuconazole manages foliar ornamental horticulture diseases including powdery mildew and rusts. However, given that triazoles have a tendency to also exhibit impacts similar to growth regulators, the crop safety profile for Torque 3.6SC is not well known. From 2012 through 2014, the IR-4 Project completed 45 trials on 15 ornamental plant genera or species. In these trials, 9 species or genera exhibited minimal or no injury after foliar applications. Torque caused stunting in Pansy and Zinnia at the higher application rates. In one trial, Narcissus exhibited moderate injury after the third application; additional trials are warranted to determine whether number of applications or the crop cultivar might be the contributing factor for injury. For the remaining 2 crops, not sufficient information has been generated.

169 ATTACHMENT 9 Continued Thrips Efficacy Summary For the last 9 years, the IR-4 Ornamental Horticulture Workshop has ranked developing efficacy data on new products to manage thrips as a High Priority Project. Thrips remain an important threat for several reasons: 1) the damage thrips cause to ornamental horticulture plants, decreasing the value of the infested crops; 2) the tospoviruses (tomato spotted wilt, impatiens necrotic ringspot) they can vector; 3) the newly arrived invasive species which impact at least 250 different ornamental horticulture species; and 4) growers lack the ability to rotate among 3 to 4 different modes of actions to effectively manage resistance development in the thrips populations they must control to maintain economic viability. From 2005 through 2015, 81 products representing 53 different active ingredients were tested for thrips management. These products represented both biological and chemical tools. Some products were already registered but more data were needed particularly with the newly invasive thrips species or they were considered standards to measure the level of efficacy achieved with other materials. Other products were in development but have not yet been registered with the EPA. The five thrips species tested in the IR-4 program were Chilli Thrips (Scirtothrips dorsalis), Gladiolus Thrips (Thrips simplex), Privet Thrips (Dendothrips ornatus), Weeping Fig Thrips (Gynaikothrips uzeli), and Western Flower Thrips (Frankliniella occidentalis). Tolfenpyrad Crop Safety Tolfenpyrad was first registered as Hachi-Hachi 15 EC in the United States on July 28, 2010 for the control of aphids, leafhoppers, scales, thrips, whiteflies, and early instar lepidopteran larvae on ornamental horticulture crops grown in greenhouses. An expansion of this label for outdoor uses is planned. The IR-4 Project completed 160 trials on 24 ornamental plant species from 2010 through 2014 examining phytotoxicity related to foliar applications of Hachi-Hachi 15EC or Hachi-Hachi SC. In this report, 11 species or genera exhibited minimal or no injury after foliar treatments of Hachi-Hachi 15EC (tolfenpyrad) at 21, 48 and 84 fl oz per 100 gal. All can be added to the label as crops tested for tolerance: (Alyssum sp., Angelonia sp., Antirhinnum sp., Begonia sp., Chrysanthemum/Dendranthemum sp., Dahlia sp., Petunia sp,. Tagetes sp., Verbena sp., Viola sp. and Zinnia sp.). For Hachi-Hachi SC, 12 crops can be listed on the label as crops tested for tolerance (Alyssum sp., Angelonia sp., Antirhinnum sp., Bacopa sp., Begonia sp., Dahlia sp., Gerbera sp., Petunia sp., Tagetes sp., Verbena sp., Viola sp. and Zinnia sp.), and two crops should be included in listing of crops where treatments are not recommended: Impatiens sp. and Impatiens, New Guinea Hybrids. Triticonazole Crop Safety Triticonazole was registered as Trinity 2SC in the United States in 2007 as a turf fungicide. Since that time it has been under development to expand to ornamental horticulture diseases. Because triticonazole is in the triazole class, it could cause symptoms similar to plant growth regulators and testing is warranted on additional herbaceous and woody ornamental species. Between 2010 and 2014, the IR-4 Project completed 166 trials on 38 ornamental plant species examining phytotoxicity related to foliar applications of Trinity 2SC. In these trials, 24 species or genera exhibited minimal or no injury after foliar applications. Of these, five are not yet listed on the label: Alyssum sp, Buxus sp., Cornus sp., Lantana sp., and Osteospermum sp.

170 ATTACHMENT 10- Biopesticide and Organic Support Program 2015 Grant Awards Efficacy evaluations of biopesticides for management of Spotted Wing Drosophila. Efficacy evaluations of biopesticides for management of Fireblight apple in organic apple production. Efficacy evaluations of chestnut transformed with the OxO gene for management of chestnut blight. Development of hypovirulent strains of Chestnut Blight for topical applications in Chestnut. Efficacy evaluations of biopesticides for management of Varroa mite in Honeybees Development of Agrobacterium transformed Walnut for resistance to crown gall in walnut Efficacy evaluations of a modified sterile insect technique for management of diamondback moth in cabbage. Efficacy evaluations of biopesticides for management of Clavibacter in tomato Efficacy evaluations of biopesticides for management of Bacterial tomato spot and spec in tomato Efficacy evaluations of biopesticides for management of Downy mildew in organic basil. Efficacy evaluations of AF36 for management of aflatoxin producing fungi in figs Efficacy evaluations of biopesticides for management of Whitefly in GH tomato. Research Cooperators NORTHCENTRAL REGION Mary Hausbeck Rufus Issacs George Sundin Dennis Fulbright Sally Miller Matt Greishop NORTHEAST REGION Cesar Rodriguez-Saona Margaret Tuttle McGrath Frank Drummond Kari Peter Anthony Shelton William Powell MI MI MI MI OH MI NJ NY ME PA NY NY WESTERN REGION Julianne Grose Alan Schreiber Mark Bolda Ken Johnson Tim Smith Elina L. Nino Themis Michailides Abhaya Dandekar SOUTHERN REGION Oscar E. Liburd Shouan Zhang Keith Yoder Lambert Kanga Frank Louws Gary Vallad Richard Raid Hugh Smith Stephen Dobson UT WA CA OR WA CA CA CA FL FL VA FL NC FL FL FL KY Biopesticide Regulatory Support Package Approved in 2015 Product Crop PR Number TYPE Registration Type Uses 9,10 anthraquinone Rice Insecticide Section 3 1 Potassium salts Hop Beta Acids Honeybees 0432B Insecticide Section 3 2 Aspergillus flavus AF36 Cotton 0052B Fungicide Amendment 1 Aspergillus flavus AF36 Corn 0378B Fungicide Amendment 1 Aspergillus flavus AF36 Pistachio 0372B Fungicide Amendment 1

171 Who to Contact to Make a Difference? IR-4 Headquarters Rutgers University 500 College Rd. E. Suite 201 W. Princeton, NJ Fax: IR-4 Executive Director Dr. Jerry Baron x 4605 Cell: jbaron@aesop.rutgers.edu Food Use & International Programs Associate Director Dr. Dan Kunkel x 4616 kunkel@aesop.rutgers.edu Biopesticides and Organic Support Program Manager Dr. Michael Braverman x 4610 braverman@aesop.rutgers.edu Ornamental Horticulture Manager Dr. Cristi Palmer x 4629 palmer@aesop.rutgers.edu Public Health Pesticides Manager Dr. Karl Malamud-Roam x 4628 kmr@aesop.rutgers.edu Northeast Regional Field Coordinator (CT, DC, DE, MA, MD, ME, NH, NJ, NY, PA, RI, WV, VT) Ms. Marylee Ross Univ. of MD/LESREC Nanticoke Rd. Salisbury, MD, Phone: ext. 310 Fax: mross@umd.edu North Central Regional Field Coordinator (IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI) Dr. Satoru Miyazaki Michigan State University IR-4 North Central Reg. Res. Ctr Technology Boulevard, Suite 1031B Lansing, MI Fax: ncrir4@msu.edu Southern Regional Field Coordinator (AL, AR, FL, GA, KY, LA, MS, NC, OK, PR, SC, TN, TX, VA) Dr. Michelle Samuel-Foo University of Florida P.O. Box SW 23rd Drive, Bldg. 685 Gainesville, FL Fax: Cell: mfoo@ufl.edu Western Regional Field Coordinator (AK, American Samoa, AZ, CA, CO, Federated States of Micronesia, Guam, HI, ID, MT, NV, NM, Northern Marianas, OR, UT, WA, WY) Ms. Rebecca Sisco Univ. of CA; Dept of Env. Toxicol. Meyer Hall, Rm One Shields Avenue Davis, CA Fax: Cell: rsisco@ucdavis.edu USDA-ARS Dr. Paul H. Schwartz Jr. USDA/ARS/Off. of Minor Use Pesticides Rm. 119, Bldg. 308, BARC-E Baltimore Avenue Beltsville, MD Fax: paul.schwartz@ars.usda.gov This material is based upon work that is supported by the National Institute of Food and Agriculture, U.S. Department of Agriculture, under award number with substantial cooperation and support from the State Agricultural Experiment Stations, USDA-ARS, and USDA-FAS. Everyone who eats has an interest in the IR-4 Project whether they know it or not. The IR-4 Project is a vital part of the country s food security system and should be considered a national strategic imperative. Bob Simerly, CPAg Agronomist, McCain Foods USA, Inc.

172 IR-4 PROJECT: VISION 2020

173 BACKGROUND Since 1963, the IR-4 Project has been the primary resource for facilitating registrations of conventional chemical pesticides and biopesticides for specialty crops and other minor uses (specialty uses) in the United States. Using its unique ability to partner with government, industry and growers, IR-4 develops required data to support the registration of pest management products. IR-4 s commitment and service to the producers of fruits, vegetables, herbs, ornamentals and specialty uses is unsurpassed; the Project s research efforts have yielded over 45,000 use registrations in the past 50 plus years. The IR-4 Project is committed to remain relevant to its stakeholders. Through advisory boards, workshops and strategic planning, new programs and initiatives have been added to assist specialty crop growers with their pest management needs. Supporting all segments of specialty crop/specialty use agriculture including facilitating pest management products that can be used for organic growers as well as cutting edge biotechnology products. More recently, IR-4 expanded its mission to: Assist in exports of U.S. grown specialty crops by aiding in the harmonization of domestic tolerances with global Maximum Residue Levels (MRLs) and with standards of global trading partners; Conduct research to mitigate invasive pest species which cause economic and environmental hardships; and Support registration of new products to manage arthropod pests, such as mosquitoes, ticks, sand flea, which can vector diseases of human. IR-4 s evolution includes: Focusing research efforts on reduced risk pesticide registrations that are critically important to modern Integrated Pest Management Systems; Emphasizing the development of efficacy data to manage difficult to control pests in ornamental crop production; and VISION 2020

174 REFRESH THE VISION In order to capture stakeholder comments and advice as to the future pest management needs for specialty crops/specialty uses, IR-4 conducted an online strategic planning survey in late Over 550 individuals responded. Their comments, ideas and suggestions influenced the development of the IR-4 Project Vision The IR-4 Strategic Planning Survey asked participants a series of questions including, Do you believe the need for existing services provided by the IR-4 Project will increase, decrease or stay the same over the next five years? Over 65% of the replies associated with the Food Program indicated that the need will increase. Seventy-two percent of those responding to the Biopesticide section felt the need for the program will increase and 56% felt the need for the Ornamental program will increase. Survey participants were also asked to identify the transformational forces that are driving the increased need for IR-4. Responses included: New pest pressure, Pest resistance to pesticides, Increased need for product performance data, Residue studies becoming more complex, Internationalization of IR-4 data development, and Emerging science and regulatory issues.

175 IR-4 VISION The IR-4 Project aspires to remain a responsive and efficient organization that supports the farmer/growers, food processors and consumers of specialty crops/specialty uses by facilitating U.S. regulatory approval and international acceptance of chemical and biologically-based pest management technologies. This allows producers and food processors to provide a consistent supply of nutritious foods, essential to good health, as well as aid in the production of ornamental horticulture crops that enhance the environment. IR-4 activities also assist in agriculture profitability. The IR-4 Project effectively and efficiently assists with obtaining regulatory approvals for small market uses of pest management technology, such as specialty uses of pesticide products on major crops (corn, soybean, cotton, grains). Other specialty uses include the management of invasive species, approval of biotechnology for specialty crops and use of pest management technology to manage arthropod pests that pose a public health risk. The IR-4 Project concentrates its efforts in the cooperative registration process of pest management technology that respects human health and the environment. MISSION STATEMENT The mission of the IR-4 Project is to facilitate regulatory approval of sustainable pest management technology for specialty crops and specialty uses to promote public wellbeing. PROJECT VALUES & CULTURE Exceptional Service to Customers/Stakeholders Inclusiveness Effective collaboration Transparency, Accountability and Stewardship Highly Competent Staff

176 PLANT HEALTH OBJECTIVES FOOD PROGRAM Facilitate the domestic registration of conventional chemical pesticides to manage pests on specialty food crops as well as specialty uses on major food crops. Where appropriate, assist in the establishment of international Maximum Residue Levels (MRLs) of pesticides in specialty food crops to remove pesticide residues as a barrier of trade.

177 PLANT HEALTH OBJECTIVES ORNAMENTAL HORTICULTURE PROGRAM Develop data to support appropriate use of pest management technology (conventional chemistry, microbials, plant extracts) and cultural practices for managing pests on ornamental horticulture plants.

178 BIOPESTICIDE & ORGANIC SUPPORT Develop product performance (value) data and provide regulatory guidance to support new registrations of biopesticides for the management of pests in conventional and organic agriculture. HUMAN/ANIMAL VECTOR MANAGEMENT OBJECTIVE PUBLIC HEALTH PESTICIDES PROGRAM Provide assistance in the development and registration of biopesticides, conventional chemical pesticides and other pest management technology for use in controlling arthropod pests that transmit disease to humans and minor animal species.

179 TURNING IDEAS INTO ACTIONS IMPROVE EFFICIENCIES IR-4 will seek an independent examination of its organizational structure to determine where efforts can be consolidated or enhanced. ENHANCE GRASS ROOTS PRIORITY SETTING AND OUTREACH ENHANCE IR-4 S IR-4 State Liaison Representatives will be empowered to conduct state based workshops or collaborate in multi-state workshops to identify pest management voids and raise awareness of IR-4. HUMAN/ ANIMAL There is an acute need for information on pest management product/technology used to manage arthropod pests that vector disease. IR-4 will modify and expand our publically available Public Health Pesticide database to answer the data voids and make it more useful to stakeholders. VECTOR PROGRAM FUTURE DEVELOPMENT For IR-4 to continue to support specialty crop agriculture and other specialty minor uses in meeting pest management needs, an increased investment in funding for IR-4 is absolutely necessary. Its funding must be increased to $23.7 million. It is IR-4 s goal to double the unrestricted grants and gifts to $2.5 million annually by 2020.

180 GOALS/BENCHMARKS* Priority Setting/Outreach At least 25 IR-4 State Liaison Representatives will host or participate in local priority setting workshops, with information feeding into IR-4 s national workshops. Reach out to Integrated Pest Management and Organic agriculture communities to assist then in getting regulatory approval for technology necessary for successful pest management systems. Increase awareness of IR-4 to stakeholders and key influencers by expanding outreach and sharing of information via conventional print and electronic means as well as via social media. Research IR-4 will conduct/cooperate on: Food Crops Approximately 100 Magnitude of the Residue studies annually to answer grower critical pest management needs in modern integrated pest management systems. 50 to 60 field trials designed to collect efficacy and/or crop safety data annually. 30 studies with international research programs that lead to harmonized MRLs. Ornamental Horticulture At least six to eight research projects to screen options for the management of critical pests and to determine whether solutions impact plant quality. At least 200 field trials to determine potential phytotoxicity risk of pesticides on specific ornamental crops. Biopesticides studies with biopesticides alone, or in combination with conventional chemical pesticides to determine feasible solutions to manage critical pests and provide sustainable pesticide resistance management opportunities. Two to three support projects where IR-4 will provide knowledge and understanding of the regulatory process to facilitate the approval of biopesticide and biotechnology. One project to assist certified organic growers by facilitating approval of products that can be used in organic systems. Regulatory Submissions Submit to US EPA and/or industry: Approximately 100 final reports from Magnitude of the Residue studies. Six data packages proposing establishment or expansion of uses for ornamental crops. Three to four regulatory packages proposing new or expanded uses of biopesticides. Internal Processes Lessen the burden of IR-4 on the costs incurred by land grant universities in hosting IR-4 research units. Replace outdated analytical equipment at the IR-4 Analytical Laboratories. Replace key personnel lost through retirements and resignations. * For IR-4 to achieve these goals there must be an increased public/private investment in funding. It is estimated that total funding must be increased to $23.7 million.

181 FINANCIAL RESOURCES NEEDED TO ACHIEVE BENCHMARKS (X $1,000)

182 IR-4 SPONSORED RESEARCH Individual farmers, commodity associations and/or other organizations also provide funding to have their priority project added to IR-4 s research program. These programs include: Grower-Funded Research, Invasive Species Management, International (Global) Capacity Building, Import Tolerances, Pollinator Protection, and Other Studies as Needed.

183 Contacts IR-4 Headquarters Dr. Jerry Baron - IR-4 Executive Director, x 4605, jbaron@aesop.rutgers.edu Dr. Dan Kunkel - IR-4 Associate Director, Food and International Programs, x 4616, kunkel@aesop.rutgers.edu Dr. Michael Braverman - Manager, Biopesticide & Organic Support, x 4610, braverman@aesop.rutgers.edu Dr. Cristi Palmer - Manager, Ornamental Horticulture, x 4629, palmer@aesop.rutgers.edu Dr. Karl Malamud-Roam - Manager, Public Health Pesticides, x 4628, kmr@aesop.rutgers.edu Regional Field Coordinators & ARS Dr. Satoru Miyazaki - North Central, Michigan State University, , ncrir4@msu.edu Ms. Edith Lurvey - Northeast, Cornell University-NYSAES, , ell10@cornell.edu Dr. Michelle Samuel-Foo - Southern, University of Florida, , mfoo@ufl.edu Ms. Rebecca Sisco - Western, University of California, , rsisco@ucdavis.edu Dr. Paul Schwartz - USDA-ARS, , Paul.Schwartz@ars.usda.gov Major funding provided by Special Research Grants and Hatch Act Funds from USDA-NIFA, in cooperation with the State Agricultural Experiment Stations, and USDA-ARS. State Agricultural Experiment Stations provide in-kind support valued at over $10 million annually.

184 IR-4 PROJECT: VISION 2020

185 Table of Contents Page Introduction/Background 3 The Need for IR-4 5 IR-4 Project Vision 7 Mission Statement 7 Project Values & Culture 7 Plant Health Objectives 8 Human/Animal Vector Management Objective 10 Turning Ideas into Actions 10 Funding Needs Table 15 IR-4 Sponsored Programs 15 Appendix 1: Appendix 2: Appendix 3: Report of CSREES-USDA External Peer Review of National Research Support Project-4 & IR-4 Project s Response to the Report Accomplishments of the Strategic Plan Summary of IR-4 Strategic Planning Survey

186 IR-4 Project: Vision 2020 Introduction/Background Since 1963, the IR-4 Project (IR-4) has been the primary entity in the United States to facilitate registrations of conventional pesticides and biopesticides on specialty food crops (fruits, vegetables, nuts, herbs, spices) and non-food ornamental horticulture crops (greenhouse flowers, nursery, landscape plants, and Christmas trees). These registrations are necessary to prevent damage to the crops we eat or the plants that enhance our environment. The crop protection industry focuses their product development efforts on large acreage crops with significant sales and adequate return on investment. Specialty crops are low acreage and potential sales are limited, often not enough to provide an adequate return to the registrant. The IR-4 Project often serves as an intermediary between the crop protection industry and specialty crop farmers to facilitate the regulatory approvals that meet the pest management needs of these producers/farmers. In this capacity, IR-4 develops research data to support US Environmental Protection Agency (EPA) registrations and cooperates in the registration of pest management tools for minor uses on major crops. Additionally, IR-4 effectively and efficiently gains many added uses through extrapolation and crop grouping. The IR-4 Project operates as a unique partnership between the Federal government (USDA, EPA, and Department of Defense), the land-grant universities/state Agricultural Experiment Stations (SAES), farmers/commodity associations, food processors, the crop protection/pest management industry and international partners (e.g. Pest Management Centre of Agriculture and Agri-Food Canada). The IR-4 Commodity Liaison Committee (CLC) provides IR-4 with a direct link to specialty crop farmers/commodity associations. The CLC provides stakeholder guidance and suggestions on policy. See the IR-4 Project website ( for a detailed overview of the IR-4 Project. The IR-4 Project has made a substantial impact on U.S. agriculture over the past 50 years. Its research data has been used to garner nearly 16,000 food crop registrations and an additional 160 product registrations impacting nearly 31,000 ornamental crop uses. A recent study from Michigan State s Center for Economic Analysis concluded that IR-4 contributes an estimated $7.2 billion to U.S. Gross Domestic Product and the Program supports nearly 105,600 jobs 1. Without IR-4 intervention, it is anticipated that many specialty 1 Miller, S.R. and A. Leschewski (2011). Economic Impacts of the IR 4 Project and IR 4 Project Programs. East Lansing, MI: Michigan State University s Center for Economic Analysis. P 186

187 crops would enter the food supply with illegal pesticide residues and in many crops there would be significant crop losses which would make these healthy foods extremely expensive and in some cases, unavailable for consumers. To ensure that the IR-4 Project remains relevant to its stakeholders and worthy of a government funding, the IR-4 Project Management Committee conducts an extensive process that includes, updating of the Project s strategic plan, a formal review by outside experts to substantiate the value of IR-4 activities, and if appropriate, reauthorization of the Project by USDA/State Agricultural Experiment Station Directors. This process is conducted every five years; the last expert panel issued a report in 2009; a copy of the expert panel s report and IR-4 s response is in Appendix 1. The IR Strategic Plan expanded the Project s mission to become more actively involved in three areas: Assist U.S. specialty crop farmers to compete in international trade by aiding in the harmonization of pesticide use and country-specific Maximum Residue Levels (MRLs), which often differ between the US and its global trading partners. Research to mitigate invasive species which cause economic and environmental hardships as well as disrupts Integrated Pest Management (IPM) systems and strategies. Initiate a public health pesticide program to protect US Armed Forces and the public from arthropod pests that transmit disease to humans. See Appendix 2 for accomplishments under the IR Strategic Plan. Many acknowledge that with the rapidly expanding global population, climate changes and other major issues, the challenge of production and distribution of adequate food will become more acute. Not only must farmers produce more food, science is challenged to improve food quality, shelf life of products, and reduce storage losses to pests, including post-harvest diseases. IR-4 is a proven, publically funded, science based entity that can assist with these challenges now and in the future. As IR-4 moves into the next five-year strategic planning timeframe, a strategic planning survey was conducted from September to November 2013 to solicit input on future directions from the specialty crop/specialty use community. Over 550 stakeholders responded and their anonymous comments, ideas and suggestions influenced the development of this IR-4 Project Vision A summary of their survey responses is included in Appendix

188 The Need for IR-4 The IR-4 Strategic Planning Survey asked participants a series of questions including, Do you believe the need for existing services provided by the IR-4 Project will increase, decrease or stay the same over the next five years? The majority of respondents (65.5%) replied that the need for IR-4 will increase 2. Survey participants were asked to identify the transformational forces that are driving the increased need for IR-4. Factors resulting in increased need for IR-4; responses include: New pest pressure It is anticipated that crop damage from invasive species and emerging pests will become a greater challenge to crop production. New public health pests have also been introduced in the U.S. in recent years. Pest management technology, supported through IR-4 s efforts, is needed to manage these newly emerging pests. Pest Resistance to Pesticides There is a rapid increase in the number of weeds, insects and plant diseases that are becoming resistant to existing pesticide products. IR-4 is needed to secure new registrations for specialty crops and vector control with new technology that must be part of the strategy to maintain efficacy of existing products as well as replacing those products that are unable to manage resistant pests. Increased Need for Product Performance Data Traditionally much of the crop safety and product performance testing has been conducted by public sector scientists associated with the land-grant universities. Many of the scientists who conduct this research have retired and this traditional duty has been downplayed during the hiring of new scientists. At the same time, the crop protection companies have become increasingly cautious about supporting registrations without having adequate efficacy and crop safety data. Furthermore, EPA is using product performance data in the development of Public Interest Findings. The gap between the need for data and the ability to conduct the necessary research is increasing rapidly. Many are looking at the IR-4 Project to use its existing scientific expertise and infrastructure to fill this gap by sponsoring efficacy and crop safety trials on specialty crops and serving as the critical source of impartial Product Performance data. Residue Studies are becoming more complex - IR-4 residue studies continue to increase in size and complexity. As regulatory schemes evolve there is an increased need for data showing decline in residues over time from multiple locations. Additionally there are needs for data representing broader geographic locations to meet stricter field trial separation standards, the use of different types of adjuvants, and a broader array of delivery systems as well as analysis of multiple metabolites of the test pesticide. Internationalization of IR-4 Data Development Specialty crop producers want access to international markets but pesticide residues can be a barrier to trade. To help overcome this obstacle, IR-4 can design and conduct studies to meet both domestic and international standards. In many studies, IR-4 will need to establish additional field trials beyond the sites required by U.S. guidelines. 2 The response by program area was: Food Program (69%), Ornamental Horticulture Program (56%), Biopesticide and Organic Support Program (72%) and Public Health Pesticide Program (65%). 188

189 Emerging Science and Regulatory Issues - As science and regulatory knowledge advances, it is anticipated that new issues will emerge that will require IR-4 s assistance. The most recent example of this is the protection of European honeybees; the impact of pesticides on honeybees and other pollinators of specialty crops is of increasing concern. Some of the emerging issues will require crop-specific, and potentially cost prohibitive solutions and could limit registrations on certain specialty crops and specialty uses. Assistance from IR-4 to develop the required crop specific data or secure the registration of alternative pest management technologies is of critical importance. Other areas that respondents identified as forces to drive the future need for IR-4 included: More work is needed to develop insect and disease management programs that use combinations or rotations of multiple active ingredients, including biopesticides. Such programs have value for both resistance management and improved environmental health. The ongoing development of new and better technology, including biopesticides, biotechnology (e.g. genetically modified specialty crops, RNAi) will require IR-4 s assistance to complete registrations. Consumer demand for locally grown, pick your own or organically grown specialty crops is increasing. Farmers need IPM compatible, conventional chemical pesticides and/or biopesticides to manage pests in these production systems. The IR-4 Project has a long and proven record of developing required data that supports the EPA registrations for specialty crops and other minor use products. Ninety-two percent of the survey respondents noted that IR-4 delivers an indispensable service for specialty crop agriculture. The unique infrastructure within the IR-4 Project includes strategically located field research sites, fully capable analytical laboratories, and a highly trained and experienced staff that develops and submits IR-4 research data through the complex regulatory process. IR-4 seamlessly manages and coordinates research and regulatory affairs. With adequate funding, the IR-4 Project is fully capable of helping specialty crop growers and other minor use stakeholders in obtaining the best available pest management technology they need for them to manage pests and successfully grow high quality products. 189

190 IR-4 Project Vision The IR-4 Project aspires to remain a responsive and efficient organization that supports the farmer/growers, food processors and consumers of specialty crops (e. g. fruits, vegetables, nuts, herbs, trees, shrubs flowers, etc.) by facilitating the U.S. regulatory approval and international acceptance of chemical and biologically-based pest management technologies. This allows producers/processors to provide a consistent supply of nutritious foods essential to good health as well as aiding in the production of ornamental horticulture crops that enhance the environment. IR-4 activities also assist in agriculture profitability. The IR-4 Project effectively and efficiently assists with obtaining regulatory approvals for small market uses of pest management technology, such as specialty uses of pesticide products on major crops (e.g., corn, soybean, cotton, grains). Other specialty uses include the management of invasive species; approval of biotechnology for specialty crops and use of pest management technology to manage arthropod pests that pose a public health risk. IR-4 concentrates its efforts in the cooperative registration process of pest management technology that respects human health and the environment when the need for such regulatory approval is in the public interest. Mission Statement Facilitate regulatory approval of sustainable pest management technology for specialty crops and specialty uses to promote public wellbeing. Project Values & Culture Exceptional Service to Customers/Stakeholders Prompt and dependable response to all requests for assistance as well as providing deliverables in a reasonable time. Inclusiveness - Encourages the participation of all stakeholders in the identification of pest research needs and establishment of research priorities. Development of innovative solutions - including the creative development of strategies to bridge data gaps. Effective collaboration - Partner with numerous groups including commodity associations, land-grant universities, USDA, pest management industry, EPA, Canada s Pest Management Centre 3 (PMC) and other domestic and international government agencies to accomplish tasks. 3 IR-4 has expanded its infrastructure capability by partnering with the Agriculture and Ag-Food Pest Management Centre. For example, IR-4 has access to field and lab research sites associated with the Canadian minor use pesticide program to support joint projects in order to meet regulatory data requirements. 190

191 Transparency, Accountability and Stewardship - Share information with interested parties to enable a better understanding and trust that government funds appropriated to IR-4 are being used in a fiscally-sound and efficient manner. Maintain a Highly Competent Staff IR-4 will continue to hire, nurture and retain talented and hardworking team members to achieve its goals. Plant Health Objectives Food Program Facilitate the domestic registration of conventional chemical pesticides to manage pests on specialty food crops as well as specialty uses on major food crops. Steps A. Solicit new requests for assistance to help specialty crop farmers/specialty use stakeholders with their pest management needs, including uses of pesticide products in an integrated pest management program and/or pesticide resistance management systems. B. Manage an open and transparent research priority setting process. C. Screen potential pest management products for efficacy in managing priority pest problems, as well as tools in integrated pest management programs and/or pesticide resistance management systems. D. Conduct and submit to EPA Magnitude of the Residue Studies to facilitate registration of conventional chemicals. Conduct Magnitude of the Residue Studies with biopesticides and other pest management technology if required for registration. E. When appropriate, develop data documenting changes in pesticide residues on specialty crops through washing, handling and other activities after harvest. Data may to be used in refining the dietary exposure risk assessments. F. Perform product performance (crop safety and/or efficacy) field trials to provide specific data needed by the product registrants in making decisions to market their products on specialty crops and specialty uses. G. Develop specific extrapolation proposals and models (Crop Groups/Subgroups) that allow data developed on a few representative crops to be used to support registration on multiple crops within a group. H. Share program results through current and new outreach avenues. 191

192 Where appropriate, assist in the establishment of international Maximum Residue Levels (MRLs) of pesticides in specialty food crops to remove pesticide residues as a barrier of trade. Steps A. Provide existing IR-4 data to international regulatory authorities and other organizations to establish MRLs that facilitate U.S. exports of treated produce. B. When priorities align, work with domestic and international government/non-government programs on cooperative research projects. C. Develop residue data required by international regulatory authorities to establishing needed MRLs needed to export domestic specialty crops/uses. D. When appropriate, develop data documenting reductions in pesticide residues on specialty crops/uses through washing, handling and other activities after harvest. These decline data may to be used to develop models of potential pesticide residue in specialty crops targeted for export. E. Share program results through current and new outreach avenues. Ornamental Horticulture Program Develop data that supports appropriate use of pest management technology (conventional chemistry, microbials, plant extracts, etc.) and cultural practices to manage pests on ornamental horticulture plants. Steps A. Solicit, via a grower survey and/or other mechanisms, a comprehensive list of pest management voids for the ornamental horticulture industry. B. Manage an open and transparent research priority setting process. C. Perform efficacy and crop safety trials with pest management technologies that facilitate label development and registration and to support appropriate use. D. Share program results through current and new outreach avenues. Biopesticide and Organic Support Program Develop product performance/value data and provide regulatory guidance to support new registrations of biopesticides for the management of pests in conventional and organic agriculture. Steps A. Solicit, via a stakeholder survey and/or other mechanisms, a comprehensive list of pest management voids and potential biopesticide/organic products that could provide a biopesticide solution. B. Manage a recurring open and transparent research priority setting process on a regular basis. 192

193 C. Conduct Efficacy/Crop Safety research trials on the highest priority projects that include potential biopesticide/organic solutions alone and when appropriate, in combination with conventional chemical pesticides. D. Assist public sector scientists, institutions and small businesses with the EPA registration of biopesticides when IR-4 involvement is in the public interest. E. Assist public sector scientists, institutions and small businesses with the government approval of novel technology (e.g. plant incorporated protectants, RNAi) for pest management. F. Develop data to promote adoption of biopesticides. G. Share program results through current and new outreach avenues. Human/Animal Vector Management Objective Provide assistance in the development and registration of biopesticides, conventional chemical pesticides and other pest management technology for use in controlling arthropod pests that transmit disease to humans and minor animal species. Steps A. Solicit input and develop priorities from Department of Defense, Center for Disease Control and Prevention and other stakeholders on potential products that can manage arthropod pests that transmit diseases to human and minor animal species. B. Perform Efficacy/Crop Safety trials and other studies with biopesticides, conventional chemical pesticides and other pest management technology that provides necessary data and/or information for the registrants to make a specific decision on registering their products for managing pests that transmit disease to humans or minor animal species. C. Assist others with the registration of biopesticides, conventional chemical pesticides and other pest management technology when IR-4 involvement is in the public interest. D. Develop and maintain a comprehensive catalogue of existing and potential public health pesticides. E. Share program results through current and new outreach avenues. Turning Ideas into Actions Improving efficiencies The organizational structure of the IR-4 Program has been consistent over the last 50 years. There are four regional offices (Northeastern, North Central, Southern, and Western) and IR-4 Headquarters connected to State Agricultural Experimental Stations/land grant university system who receive funds to conduct field work, perform laboratory residue analysis or to manage studies. USDA-ARS has a complementary Minor Use Program which conducts similar research activities at several USDA-ARS research stations that are fully integrated with research performed at the land grant universities. Under this structure, the IR- 4 Project is essentially six independently-funded operational units cooperating together to address grower needs. Much of the time, the culture of good will and collaboration allow 193

194 successful completion of the mission. However, there are times when potential efficiencies are lost due to the existing organizational structure. In an effort to improve efficiency, IR-4 seeks an independent examination of its organizational structure, tactical approaches and document/data management systems by an expert panel. This panel will be asked to make recommendations on how IR-4 operational efficiencies can be improved and whether the Project should be restructured. If restructure is recommended, the panel is charged with making suggestion(s) on a structure to best meet the needs of specialty crop stakeholders. These recommendations will be submitted to the IR-4 Project Management Committee for full consideration. Enhancing Grass Roots Priority Setting and Outreach IR-4 has an existing network of State Liaison Representatives (SLR), one for each of the 50 states, Puerto Rico, Guam and the District of Columbia. In many states, the IR-4 SLR responsibilities are an added duty assignment to someone within that state s land-grant institution who is familiar with pest management of horticulture crops. Due to IR-4 s budget challenges and other responsibilities the SLR assets have not been fully utilized in many states/territories. Furthermore, many SLR s have not been given clear direction on IR-4 s expectations of their activities IR-4 SLRs will be asked to conduct/hold state based workshops or collaborate on multi-state workshops targeting specialty crop farmers, extension personnel, researchers and industry. The purpose of these workshops is to identify outstanding pest management voids in all program areas, update the stakeholders on IR-4 activities and build better communication links. The need for reinvestment in IR-4 s Plant Health Objective activities The federal investment from USDA (NIFA & ARS) and the SAES in the IR-4 Plant Health programs (Food, Ornamental Horticulture, and Biopesticides & Organic Support) has been reduced from $16.48 million in 2009 to $15.96 million in This financial reduction underscores the more substantial loss of buying power from five years of moderate inflation. The funding cuts and loss of buying power has forced IR-4 to reduce the number of Food, Ornamental Horticulture and Biopesticide research studies and not respond to important needs of specialty crop agriculture. In 2009, the Food Program funded research that responded to 109 priority Requests for Assistance (PR s) identified by stakeholders at the IR-4 priority setting workshop. By 2014, IR-4 only had resources to fund research for 75 new priority PR s. IR-4 is currently carrying a backlog of 362 unanswered pest control product needs in the Food Program. Of these, 131 were identified as high priority at IR-4 s September 2013 priority setting workshop. The funding challenges resulted in targeted reduction of in some Project positions and closure of several IR-4 analytical laboratories. Additionally the funding cuts resulted in a deferral in making purchases for replacing field and laboratory research equipment essential to IR-4 s Plant Health research. Much of the instruments and equipment in IR-4 s analytical laboratories is at or past their recommended replacement date, making it less reliable and 194

195 more prone to failure. In order for IR-4 to maintain state-of-the-art analytical laboratories, equipment must be replaced or upgraded in three to five year cycles. In addition to the above, the data requirements for residue studies continues to evolve and increase in complexity. Recent trends include the need to develop data on multiple chemical metabolites. There is an increasing need for data showing the decline or degradation of chemical residues over time, both pre-harvest and post-harvest. Sometimes this data is used by EPA if the proposed use meets the threshold for exposure in their risk assessment. In other cases, decline data can be used to help farmers export their specialty crops to other countries where the MRL is different from what EPA has established. Furthermore, EPA is expanding their need for efficacy and crop safety data in association with registration submissions. This data is used in the development of Public Interest Findings documenting the benefits of new registrations. The Ornamental Horticulture and Biopesticide and Organic Support Programs experienced similar reductions in research activities. In 2009 IR-4 conducted 1,212 ornamental field trials and funded 34 biopesticides research grants. By 2013, the numbers dropped to 715 ornamental horticulture field trials and 23 biopesticide grants. Another financial factor that IR-4 must address is indirect costs. Indirect costs are real expenses associated with managing a grant and housing a research program. Indirect cost rates are negotiated between universities and the federal government based on actual university expenditures in support of sponsored research. Most USDA grants allow landgrant universities to collect approximately 30% of a grant as indirect costs. The legislation authorizing support for IR-4 by USDA-NIFA explicitly prohibits the payment of indirect costs. The unrecovered indirect costs represent a significant contribution by the participating institutions, that some may not be able to sustain. Some of the land-grant universities hosting IR-4 research units have been innovative in recouping some of these costs. For example, some have transitioned certain indirect costs into allowable direct costs (e.g. IR-4 Headquarters pays rent for its office space). Others are instituting new policies which may limit further IR-4 involvement with that institution. These changes will divert funds from research resulting in even fewer research studies being conducted through IR-4. IR-4 has built its infrastructure of scientific expertise, facilities and research capacity over the last 50 years. This infrastructure is critical in allowing IR-4 to provide its stakeholders with deliverables that are in the public good. Financial resources are the limiting factor. For IR-4 to continue to support specialty crop agriculture and other specialty minor uses in meeting pest management needs, an increased investment in funding for IR-4 is absolutely necessary. Enhancement of IR-4 s Human/Animal Vector Management Objective IR-4 has developed and populated public health pesticide database. The purpose of this database was to provide a comprehensive listing of pesticides registered to manage arthropod pests that transmit disease to human/animals as well as a single source of information on potential new products that can be used in this niche. The database is population with regulatory information, product performance data and chemical 195

196 characteristics. There is an on-going effort to continue to expand the information captured in the database to make it more useful to stakeholders. Additional funds ($75 K) are needed annually to continue to augment and validate the information in the database. The funds will be used for enhanced collection of new product information/intelligence as well as convert the structure to allow for public access to the data via a web based application. This would eliminate the need for IR-4 staff to perform custom searches for stakeholders. Development The Crop Protection Industry generously provides IR-4 approximately $1.25 million dollars annually through unrestricted grants and gifts. These resources have been used to supplement public funding to accomplish IR-4 s mission in all existing program areas. Industry funds have been used to pay for additional research, including; field trials, analytical analysis, required processing of apples, grapes, tomatoes, citrus, oil seeds and other commodities into specific crop fractions, and is used in funding biopesticide grants. Industry funds also cover the costs of IR-4 s Food and Ornamental Priority Setting Workshops, repair/replacement of critically important research equipment, and shortfalls in IR-4 Headquarters operational expenses such as maintaining the data archives, travel and updating computers. It is IR-4 s goal to double the unrestricted grants and gifts to $2.5 million annually by Development funds will be targeted from a variety of sources, including the crop protection industry, grower groups, commodity associations and philanthropic organizations. These new funds will be used to restore IR-4 research capacity and infrastructure. Strategic Benchmarks for the Plant Health Objectives With appropriate funding IR-4 will be able to: Replace key personnel lost through retirements and resignations. IR-4 SLR will be supported with funds to conduct workshops targeting Cooperative Extension and grower participation that identify pest management voids, expand exposure, and measure impact of the program. Replace outdated analytical equipment at the three IR-4 Analytical Laboratories. Contribute up to 10% of grant funds to host institution as part of indirect cost recovery. Food Program o On an annual basis, IR-4 will hold a prioritization workshop that enables stakeholders to provide input on most important projects and select those projects as research priorities. o IR-4 will conduct up to six studies which includes conventional chemical pesticides, biopesticides, and combinations to determine the most promising product(s) to manage a most critical pest management void. o IR-4 will conduct approximately 100 Magnitude of the Residue studies annually and an equal number of studies will be submitted each year to EPA or regulatory authorities to support registrations. Leverage the partnership with Canada s PMC and cooperate with bilateral data generation for joint 196

197 submissions on common pest(s) identified by farmers/producers in the United States and Canada. When appropriate, IR-4 will conduct residue trials at enough sites to meet international standards. o IR-4 will conduct 50 to 60 field trials designed to collect efficacy and/or crop safety data annually. o IR-4 will complete the development and submission to EPA of the remaining crop grouping expansion proposals. Ornamental Horticulture Program o Once every two years, IR-4 will host a forum to allow stakeholders to provide input on the most important pest management voids and most important research priorities with decision criteria such as mitigation of resistance development, impact on beneficial organisms, and lack of available alternatives. o IR-4 will conduct at least six research projects to screen options for the management of critical pests and to determine whether solutions impact plant quality. Depending on research targets, efficacy protocols will incorporate tank mix combinations or rotations of multiple active ingredients, including conventional chemistry, microbials, plant extracts, and other pest management technology. o IR-4 will disseminate results through: project summary reports posted to the website, presentations at scientific and trade meetings, and communications via social media. IR-4 will explore additional digital media or other avenues for grower outreach. Biopesticide and Organic Support Program o IR-4 will actively engage stakeholders and encourage submission of known pest management voids that can potentially be answered by biopesticide technology and will empower appropriate IR-4 SLRs to conduct statewide workshops to encourage more Cooperative Extension and grower participation. o IR-4 will enable stakeholders to provide input on the most important projects and identify those most important projects as research priorities. o IR-4 will conduct up to 20 studies at multiple locations with biopesticides, conventional chemical pesticides and combinations will be tested to determine which program(s) exhibit potential to manage critical pests, provide pesticide resistance strategies, or are an important component of an integrated pest management system. o IR-4 will assist public sector associates on an as-needed basis, and provide guidance on how to develop data needed to successfully attain deregulation and findings of substantial equivalence of genetically modified organisms. o IR-4 will provide funds to conduct approximately five on-farm extension type Biopesticide Demonstration projects to help specialty crop farmers. 197

198 Financial resources needed to achieve benchmarks associated with IR-4 s Objectives (x $1,000) Purpose USDA- NIFA $ USDA- ARS $ Development $ Total $ Existing Plant Health Program Funding $11,916 $3,600 $1,250 $16,766 Additional Funding Needed for Plant Health Programs Restore Program Capacity $900 $1,000 $1,250 $3,150 Expanded Efficacy/Crop Safety Testing $1,500 $ $1,900 Enhanced State-Based priority setting $ $100 Funds for Indirect Costs $1, $1,442 Existing Human/Animal Vector Management $252 $252 Funding 4 Additional Funding Needed for Human/Animal Vector Management Enhanced Data Management Capabilities ---- $ $75 TOTAL (Existing and New) $15,858 $5,327 $2,500 $23,685 IR-4 SPONSORED PROGRAMS The IR-4 Sponsored Program objectives extend the scope and capabilities of the IR-4 Project to benefit the public interest and are often funded by grants and agreements written specifically to address a particular issue or problem. It is also a way for specialty crop farmers/producers and other specialty use stakeholders to gain access to the knowledge base and capabilities of IR-4 when regulatory research/regulatory assistance is not available from the registrant, and the data needs are beyond the scope of the core IR-4 budget or objectives. It is expected that sponsored program stakeholders will contribute full funding to cover requested data development and regulatory activities. Grower-Funded Research Due to funding limitations, IR-4 can only take on a limited number of research projects with food and ornamental crops annually. Individual farmers, commodity associations and/or others have volunteered supplemental funding to have their priority project added to IR-4 s research program. IR-4 will continue to accept funds to support these commodity driven projects, and develop data required by the registrants and EPA that support the registrations for these important needs. 4 USDA ARS provides funds through a cooperative program in associations with Armed Forces Pest Management Board, Department of Defense 198

199 Invasive Species Management IR-4 will provide leadership in the development of data and other relevant information with biopesticides and conventional chemical pesticides to manage invasive species. IR-4 will collaborate with USDA-APHIS, USDA s Office of Pest Management and Policy (OPMP), Regional Integrated Pest Management Centers and other stakeholders to identify voids in the availability of conventional chemical pesticide and biopesticide registrations for invasive species already present in or likely to establish themselves in the U.S. IR-4 will then facilitate cooperative research, which furthers the development of technologies to manage invasive species for use in integrated management or recovery plans. International (Global) Capacity Building IR-4 will conduct educational programs and outreach activities to train research and regulatory personnel in the processes used for the development of regulatory data, and to support the establishment of Maximum Residue Levels and registrations for biopesticides and conventional chemical pesticides. IR-4 will help with the establishment of publically-funded data producing programs through capacity building and cooperate on international data generation. IR-4 will continue to strengthen the partnership with PMC of AAFC to advance research priorities in order to support the Canada-United States Regulatory Cooperation Council initiative under regulatory coordination to harmonize, when possible, pesticide labels on crops grown in and traded between the United States and Canada. Import Tolerances IR-4 will assist U.S. based stakeholders that rely on imported specialty crops as their raw materials through assistance in the establishment of import pesticide tolerances. IR-4, working with U.S. based stakeholders, will utilize its existing priority list of pesticide products used on the relevant crops where an import tolerance is needed. IR-4 will then open dialogue with EPA, the crop protection industry and the representatives of the relevant crops to determine where field trials must be conducted and other information required in the research protocol. IR-4 will find and collaborate with qualified researchers at locations where the residue data must be gathered to perform Magnitude of the Residue studies with IR-4 then providing the residue data to cooperating registrants for submission to EPA for import MRLs. Pollinator Protection IR-4 will provide regulatory support and assistance with the registration of biopesticides, conventional chemical pesticides and other pest management technology to manage Varroa mites and other pests of managed honeybees and other pollinators. IR-4 will collaborate with USDA, EPA, the crop protection industry, commodity associations and other stakeholders to identify potential solutions to manage critical pests of pollinators. When necessary, IR-4 research cooperators will perform efficacy/crop safety trials with biopesticides, conventional chemical pesticides and other pest management technology to provide necessary information that allows the registrants to make a specific decision to register their product for a pollinator s 199

200 health use. If acceptable, IR-4 will facilitate cooperative research to further the development of technology to manage pests of pollinators. The resulting data will be used to assist with the registration of products to protect the pollinators, including assistance with registration. Other Studies When appropriate and if resources are available, IR-4 will conduct and/or manage other regulatory studies, required by EPA to support the registration of a priority use for a biopesticide, a conventional chemical pesticide or other pest management technology to manage a pest. 200

201 Appendix 1: Report of CSREES-USDA External Peer Review of National Research Support Project-4 (NRSP-4) IR-4: A National Agricultural Program to Provide Registration Assistance for Specialty Crop and Minor Use Pest Management IR-4 Headquarters, Princeton, New Jersey May 19-21, 2009 & The IR-4 Project s Response to Report 201

202 External Peer Review May 19 21, 2009 Pa 202

203 CONTENTS REVIEW PANEL MEMBERS...ii ACKNOWLEDGEMENT...1 INTRODUCTION... 1 PROJECT SUCCESSES AND KEY ACCOMPLISHMENTS..3 Productivity and Recognition....3 Customer/Stakeholder Relationships.4 Program Structure and Management.4 RECOMMENDATIONS...5 Administrative and Strategic Management...5 Personnel Management. 7 Program Management and Leadership..7 Stakeholder Considerations...9 Opportunities....9 International Opportunities..10 CONCLUSIONS...10 APPENDIX

204 IR-4 External Peer Review Panel Members IR-4 Headquarters, Princeton, New Jersey May 19-21, 2009 Laurence D. Chandler Team Leader (Member of 2003 Review Panel) Director, Midwest Area USDA-Agricultural Research Service 1815 North University St. Peoria, IL Phone: Fax: Wally Ewart Consultant to the California Citrus Growers 716 E. Promontory Road Shelton, WA Phone: Jerry Lee Human Resources and Environmental Services Manager Monrovia Growers P.O. Box 390 (Physical Address: 1579 GA Hwy. 111S) Cairo, GA Phone: Fax: Janis McFarland (Member of 2003 Review Panel) Head, Regulatory Affairs, NAFTA Syngenta Crop Protection, Inc. 410 S. Swing Road Greensboro, NC Phone: Fax:

205 Daniel J. Rosenblatt Chief, Risk Integration, Minor Use and Emergency Exemption Branch Registration Division Office of Pesticide Programs (750SP) U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, D.C Phone: Cheng-I Wei Dean, College of Agriculture and Natural Resources & Director of Agricultural Experiment Station and Maryland Cooperative Extension Service 1296 Symons Hall University of Maryland College Park, MD Phone: Fax:

206 External Peer Review of NRSP-4 (IR-4) IR-4 Headquarters, Princeton, New Jersey May 19-21, 2009 The External Peer Review Panel wishes to thank the Cooperative State Research, Education, and Extension Service and the leaders and staff of the IR-4 Project for their leadership and overall effort in preparing for this review. The following consensus report represents an opinion from the review panel of the current status and recommended future direction of the program. Acknowledgment The External Review Panel extends their appreciation to Dr. Jerry Baron, IR-4 Project Executive Director and the entire IR-4 HQ Staff for their efforts in preparing for the review and for their hospitality and graciousness in hosting the panel. Arrangements and accommodations were excellent. The panel appreciated the well developed Background Materials and Information Book, the well prepared and informative presentations, and the thoughtful and open dialogue in response to our numerous questions and discussion sessions. The panel also thanks Dr. Monte Johnson, USDA-CSREES, Dr. Mary Duryea, Administrative Advisor, and Dr. Sally Schneider, USDA-ARS for their guidance and comments regarding the charge and objectives for this review. We also extend our thanks to Dr. Marty Marshall, chair of the IR-4 Project Management Committee, for his attendance at the review and his contributions to the numerous discussions. Finally, appreciation is extended to the numerous internal and external stakeholders who participated in the review and provided useful commentary and ideas for the panel to consider. The obvious multi-agency, multi-disciplinary, and broad-based stakeholder support and cooperation is unique among Federal-funded R&D programs and is worthy of acknowledgment from the panel and other interested parties. Introduction The National Research Support Project (NRSP) system, and specifically this project (currently known as the IR-4 Project), was established 46 years ago by the directors of the State Agricultural Experiment Stations to facilitate registrations of pesticides on specialty food crops (fruits, vegetables, nuts, herbs/spices) and minor uses on major crops. Currently the national IR-4 Project (IR-4 Headquarters, the USDA-Agricultural Research Service (ARS) Office of Minor Use Pesticides, the four regional offices, the seven analytical laboratories and the 31 field research centers) employs about 125 fulltime staff. Fiscal year 2009 financial support includes: USDA-Cooperative State Research, Education, and Extension Service (CSREES) ($12 million), USDA-ARS ($4.01 million), State Agricultural Experiment Stations (SAES) ($481,182), USDA-FAS ($250,000) and industry ($1.66 million). Other funds are provided from an in-kind match (SAES and industry) at about a 1:1 ratio. This support is supplemented by in-kind support from the State Agricultural Experiment Stations which is conservatively estimated to be equal to the amount of direct federal support. USDA-ARS established a 206

207 companion program in 1976 to provide additional cooperation and program support to the IR-4 Project. The following information is taken directly from the comprehensive IR-4 Project Background Materials and Information Book provided to the Review Panel: The mission of the IR-4 Project is to facilitate registration of sustainable pest management technology for specialty crops and minor uses. The IR-4 Project focuses its efforts on providing value and exceptional service to the primary beneficiary of the Project, the growers of specialty crops, fruits, nuts, vegetables, herbs, ornamentals, and other horticultural crops. IR-4 s principal duty is to assist in the cooperative registration process of safe and effective pesticides and other pest management technology, supplementing the efforts of industry in markets where economic factors preclude full industry development. IR-4 concentrates its efforts on lower risk technology that respects humans and the environment. Additionally, IR-4 assists specialty crop growers in eliminating international trade barriers caused by pesticide residues in food crops. IR-4 will also assist other stakeholders by aiding in the cooperative registration of minor uses of pesticides, including: minor uses on major crops, invasive species management, approval of biotechnology for specialty crops and the minor use of pesticides to manage arthropod pests that transmit vector borne diseases posing a public health risk. IR-4 will supplement the efforts of industry and government in the development of these minor uses to ensure success. Benefitting from activities of IR-4 are growers, food processors and the general public. The general public benefits by having high quality food and ornamental crops available at reasonable prices. Specialty food crops provide essential nutrition for a balanced diet as well as health promoting activity recommended by nutritionists and health professionals. The nonfood ornamental crops enrich the environment and improve the quality of life. Also important are the efforts of IR-4 to provide safe and effective tools to manage medically important arthropods. Please also refer to Appendix 1, Relevant IR-4 Facts, provided by the IR-4 HQ staff which briefly summarizes the current status and accomplishments of the Project. The External Review Panel met at IR-4 National Headquarters in Princeton, NJ, on May 19-21, Their charge was to review the current status of the IR-4 Project and make recommendations for IR-4 staff consideration that would enhance their operations and effectively position the program to best fulfill their mission and identify future opportunities for the program. The panel examined past accomplishments and current organizational structure and operations. Additionally, it commented on future programmatic and management considerations. 207

208 Following are the consensus comments and recommendations of the External Peer Review Panel. IR-4 Project Successes and Key Accomplishments Since the last program review in 2003, the IR-4 Project has continued its remarkable record of progress in developing pest management solutions for the numerous customers and stakeholders involved in specialty crops and minor uses on major crops. The Review Panel commends IR-4 Project leaders, managers, and staff for continuing their pesticide registration efforts and for addressing program challenges in a manner necessary to optimize operational efficiencies. Specifically, the following commendations are provided: A. Productivity and Recognition The IR-4 Project has maintained high levels of overall productivity as evidenced by the 700+ food trials, ornamental trials, and the continued expansion of the biopesticide program. The number of new registrations that are supported by these trials and the related information developed on product residues (food safety), plant health, and pest efficacy are excellent indicators of continued program success. The panel noted that the average annual number of trials conducted has generally increased since IR-4 developed data supports approximately 50 percent of the new tolerances established by EPA in a given year which are used in facilitating registrations on food crops. The panel also noted the increased number of studies in support of EPA food tolerances developed by IR-4 data since The panel noted that the high number of tolerance petitions developed by IR-4 that led to registration has also led to the decreased need for Emergency Exemptions. The IR-4 Project received an increase in appropriated funding in FY The panel notes that during austere times, receipt of a funding increase is an exceptional indicator of program success. The panel commends the IR-4 Project for conducting the 2007 National Economic Impact of the IR-4 Project study. In particular, it is noted that the project efforts attributed an estimated $7,675 million in expected direct contributions to the U.S. gross domestic product, which is also expected to support over 113,000 U.S. jobs (2007 estimates). Additionally, the panel commends the IR-4 Project for conducting an economic impact study of the Ornamental Horticulture Project which was estimated to contribute $1.2 billion to the gross domestic product and approximately 17,000 jobs within the United States The IR-4 Project HQ Staff is well trained and dedicated. The staff is well informed and considered subject matter experts. They work well as a team and all are well versed in their disciplines and coordinate with one another when discussing the mission and objectives of the IR-4 Project. The panel noted that 208

209 they have excellent knowledge of agriculture, IPM, horticulture/ornamental production practices, residue chemistry, GLP, and the overall process necessary to test and register new pest management products. The panel was impressed with their can do attitude and their ability to work smart and efficiently. Their ability to leverage available data to seek solutions and efficiencies with cooperators ( push the envelope ) has been invaluable to the success of the project. Particularly impressive are the following examples: a) in collaboration with EPA, developed an expedited approach to extrapolate results of residue field trial data on certain commodities to a wide variety of crops for chemicals with extremely low mammalian toxicity, low application rates, and short half life in the environment (i.e., super crop groups); b) ability to think creatively to reposition the Tifton, GA, location to provide needed data to support Florida tolerance/registration needs. The IR-4 Project field staffs (regional offices, residue laboratories, and field research groups) have an excellent reputation and sustained productivity. IR-4 is a leader in globalization/international harmonization efforts. This process has been well received by both the national and international regulatory, marketing, and horticultural production communities. Substantial progress has been made in crop grouping. Canada has decided to model their minor use/specialty crop program after the IR- 4 Project. To date the Canada/U.S. IR-4 collaboration has resulted in 16 joint projects. B. Customer/Stakeholder Relationships The IR-4 Project Staff (both national and regional) is engaged with their customer and stakeholder base and interacts with them on a regular basis. The entire IR-4 Project has an open door relationship with industry, the regulatory community, and other partners which has led to numerous successful outcomes while striving for continuous improvement. IR-4 continues to maintain excellent cooperation with USDA-CSREES, USDA- ARS, U.S. Environmental Protection Agency (EPA), USDA-Foreign Agricultural Service (FAS), State Agricultural Experiment Stations (SAES), Universities, Canada Pest Management Regulatory Agency (PMRA) and Agriculture and Ag Food Canada (AAFC), registrants, producers, and others. The panel commends the IR-4 Project for their excellent communication efforts. The website, newsletter, and other communication tools have been substantially modified since the 2003 Review. All are well done and provide excellent information to IR-4 internal and external stakeholders. C. Program Structure and Management The panel acknowledges the IR-4 Project for addressing the majority of suggestions made in the 2003 Program Review. The panel commends the IR-4 Project for the process used to develop their current IR-4 Strategic Plan - - A Strategic Plan for the IR-4 Project ( ). 209

210 Input from a large group of stakeholders was a good initial step for developing a process to gather input in the future. The panel also commends the project for their strategic thinking in looking at future needs for the program. The panel commends the IR-4 Project for conducting a comprehensive review of the Ornamental Horticulture Program on June 3, 2008, which resulted in a unanimous decision to continue the program and to subcontract with an economist to define the economic impact of the work (completed in Dec. 2008). The panel commends IR-4 Project leadership for the difficult decision to downsize the number of regional laboratories from four to three. A good process was developed and followed that may result in more flexibility in utilization of future resources and continued evaluation and alignment with program mission. Recommendations A. IR-4 Project Administrative and Strategic Management the panel recognizes the difficulties in managing a national effort involving numerous institutions and commends the HQ staff and the Project Management Committee for their leadership. The following recommendations are made in an effort to provide guidance to staff to continue to work to position the IR-4 Project as the leader in the specialty crop and minor use pest management solutions arena. The panel recommends that the IR-4 Project develop an action plan based on the newly developed Strategic Plan for The action plan should provide a roadmap on how to accomplish the stated objectives of the project. The panel recommends that a business plan be developed as part of the overall action plan (see above). The business plan should consider development of a financial management strategy that would maintain the project during flat budget periods, as well as position the project to take advantage of growth opportunities. Once the business plan is developed, IR-4 leadership should periodically revisit the Strategic Plan to determine if mid-course corrections might be necessary. The panel believes it is important for the IR-4 Project to determine and prioritize the core business practices and program objectives that are most important to maintain during difficult financial times. Additionally, they should analyze potential growth areas (see next bullet) as part of the overall prioritization process. The panel urges IR-4 Project leadership to carefully evaluate Mission Creep in relation to their Strategic Plan and accompanying business plan. Program expansion should be based on a careful evaluation of potential growth areas and within the context of a business strategy. The project would benefit from staff and stakeholder sessions designed to develop the pros and cons for expansion of the project mission. These sessions could determine the benefits (e.g., science capacity and outcomes, knowledge development, enhanced funding, broader stakeholder support, and accomplishment of the core mission) that might result from potential expansions. 210

211 As part of the development of a business plan the panel recommends that IR-4 Project leadership continue to evaluate the capacity of the remaining regional residue laboratories and the ARS residue facilities. A cost/benefit study would be helpful to determine appropriate current and predicted needs for the IR-4 Project. The panel recommends that IR-4 Project leadership, both at HQ and at the regional level continue to evaluate field study site distribution needs and related capacity issues. They also recommend that close coordination with the ARS IR-4 program continue so as to optimize available resources. The panel noted the continuing difficulties the IR-4 Project has had in regards to timely distribution of appropriated funds. Receipt of funds occurring approximately 6 to 9 months after the start of the Federal Government fiscal year due to delays in appropriation bill passage has complicated maintenance of existing field and laboratory projects, as well as impeded the timely initiation of new projects. Although events surrounding the appropriation cycle are out of the control of IR-4 Project management, it remains necessary to seek alternative solutions to aid cooperating project coordinators. The panel suggests that IR-4 Project leadership in cooperation with USDA-CSREES leadership work together to seek solutions that could minimize some of the concerns. Solutions could include approving projects to receive funds for a minimum of two-years to eliminate carry over issues, or seek new authorizations to change the manner in which funds are received by the project (five-year authorization at an established funding level rather than single year appropriations). Close communication and continuing dialogue on possible resolutions between IR-4 and cooperating universities is also encouraged. Explanations of the above cited funding concerns are complicated and difficult for many stakeholders and interested parties to adequately understand. The panel suggests that IR-4 Project stakeholders (e.g., Commodity Liaison Committee) work closely with IR-4 leadership to develop a one-page summary document that describes the current funding process and suggests potential options for resolution of the problem. This document would be beneficial for stakeholder education and enhanced communication. The panel recommends that the IR-4 Project develop a transparent process to better track and analyze existing and potential uses of industry unrestricted funds. As part of the recommended Business Plan, these funds should be identified for possible uses including emergency/contingency needs and matches for special grants. The panel recommends the continued evaluation of the role of state liaisons within the IR-4 Project. It was noted that one state, Missouri, did not have a current liaison. Within the Southern Region, some states have separated their liaisons into separate positions for food crops and ornamentals. We encourage IR-4 to evaluate this concept and determine if it worthy of implementation in other key production states. 211

212 B. IR-4 Project Personnel Management the panel believes that the strength of any organization is based on the productivity and skills of their personnel. It is imperative that organizations properly evaluate their personnel needs and position themselves to address potential changes that might affect program delivery effectiveness. The following recommendations provide suggestions to address a critical program continuity need. The panel recommends that all organizational levels of the IR-4 Project review their current personnel structures and discuss and implement succession planning activities as appropriate. We also encourage establishment of career ladders as opportunities arise. Traditional succession planning may be difficult to achieve within the IR-4 Project structure. We encourage IR-4 staff to develop a mentoring program for early and mid-career staff to provide opportunities to better understand how the project functions as well as operational considerations at the host institutions of project employees. The project is also encouraged to conduct cross-training as appropriate. The panel recommends that the IR-4 Project employ summer interns as opportunities arise. The panel encourages IR-4 Project leadership to work closely with university department chairs and heads and related university administrators to seek professional status of IR-4 staff on their respective campuses. We would also encourage consideration of sabbatical opportunities. C. IR-4 Project Program Management and Leadership the panel is encouraged by the continued progress the project has made in developing data used to petition the EPA to establish tolerances for potential registrations and collaborations on specialty crop and minor use pest management solutions. Leadership in global harmonization efforts has positioned the IR-4 Project to play a key role in international activities. The following recommendations are made to provide IR-4 with ideas to maintain the high level of productivity and leadership in specialty crop and minor use pest management arenas. The panel concurs that the use of specialty crop and minor use pest management in its mission statement is appropriate. We recommend that the IR-4 Project evaluate their mission statement periodically as part of their strategic planning and program review process. The panel recommends that the IR-4 Project continue to evaluate how the project incorporates management of exotic and invasive pests into their program. Coordination with EPA, APHIS, and the state agricultural departments and experiment stations is encouraged. Global Harmonization (MRLs and crop grouping) is critical for production of specialty crops. The panel recommends that the IR-4 Project continue to support efforts and provide international leadership on MRL harmonization and crop grouping. 212

213 The panel heard from various stakeholders that lumping crops into crop groups has had, and will continue to have, export ramifications regarding receipt of labels from the registrant. We recommend that IR-4 Project staff provide advanced notification to affected stakeholders for timely assessment of possible registrations. We note the addition the IR-4 staff made to the Project Clearance Request (PCR) form (a tab to indicate if export is involved with a potential material) which will improve the process. The panel recommends that the IR-4 Project outline a process for broader vetting of use patterns with stakeholders during project protocol development (before anything enters into testing). This involves expanded and diligent consideration of proposed use patterns on a national basis. In some cases, this may also include planning for sufficient U.S. trials necessary to support the data requirements of an important international trading partner in the event that additional field trials are necessary to gain an MRL in the foreign market. We encourage the continued inclusion of the following (originally developed in the 2003 Review Report and slightly updated with this review) criteria to maximize the benefits of allocated resources and to ensure alignment with IR-4 s strategic objectives: o role in pesticide resistance management o severity of pest problem o crops, acreage affected and potential economic impact o multi-year Section 18 exemptions o awareness of potential risk issues communicate with EPA as part of the vetting process for projects o where possible, make priority selection for project support for a material that could be considered reduced risk and/or fully compatible with sustainable agriculture o regional input to prioritization prior to food use and ornamental workshops o status of potential trade barriers The panel encourages the continued evaluation, as appropriate, of the feasibility of including efficacy and crop safety components within work plans and prioritization activities. The panel recommends that IR-4 Project HQ staff develop a value-added metric for the biopesticide program. The panel recommends that IR-4 Project leadership develop a scope and related action plan for the Human Health pilot program (public health pest control). The program should be evaluated based on how it fits into the current IR-4 Project mission, as well as the value it adds to the project. We suggest that the program be evaluated prior to the end of the pilot to determine the feasibility of continuing as part of the IR-4 Project. In general, we believe this type of evaluation should be conducted for any new program enhancement or expansion of the existing core capacity of the project. The panel encourages the IR-4 Project to continue their active communication and coordination with potential registrants to address issues such as hazard and 213

214 risk cup characterization, timely notices of filing, labels, registration materials, etc. If necessary data/information cannot be provided by the registrant in a timely way, we believe it is proper for IR-4 to consider withdrawing its investment and energy toward developing field trial data for the project. D. IR-4 Project Stakeholder Considerations over the life of the IR-4 Project, stakeholders, customers, and partners have played a key role in the success and overall programmatic health of the project. Maintaining good relations with stakeholders is paramount to the future of these efforts. Expansion of the current stakeholder base is underway and will pay dividends in the future. The panel suggests that current metrics used by the IR-4 Project to measure programmatic success be reviewed and possibly refined to better reflect stakeholder needs. For example, registration of a use on a label is viewed as a key measure of success among growers but was not included in documentation reviewed by the panel. The number of specialty/minor uses included on a label should be included in future reports. Stakeholders would like to be better informed of issues, registration decisions, etc., involving genetically modified organisms (GMOs)/plant incorporated protectants (PIP) before moving forward on potential projects. The panel encourages IR-4 Project leadership to consider this recommendation and develop a protocol to include these discussions as part of the prioritization process. The panel encourages IR-4 Project leadership along with the Project Management Committee to evaluate the structure and review the current mission and charter of the Commodity Liaison Committee to ensure stakeholder equity. The panel encourages the IR-4 Project leadership, the Project Management Committee and the Commodity Liaison Committee to seek opportunities to broaden the existing stakeholder base. Interested stakeholders not currently associated with IR-4 should be identified and encouraged to become more involved in the project. The panel recommends that the IR-4 Project enhance cooperation with the Regional IPM Centers as appropriate. E. Opportunities Opportunities for program expansion, acquisition of additional funds, or hiring of personnel with innovative and unique skills can frequently occur, and sometimes without advance notification. The panel encourages the IR-4 Project to proactively address opportunities and continue leadership in specialty crops and minor use pest management activities and provides the following recommendations to assist this effort. The panel suggests that IR-4 Project leadership carefully evaluate their current and future role as the premier resource for specialty crop and minor use pest management and product registration. Is there a role for the IR-4 Project staff as national/international consultants and/or experts in this important field of work? 214

215 As mentioned in earlier recommendations, the panel encourages the IR-4 Project to evaluate and determine if other researchable areas could be included within the program. Opportunities are known to exist in application technology, beneficial organisms/biological control, biotechnology, and in development of innovative methodologies to estimate residue quantities with less testing involved. All opportunities should be evaluated in the context of the IR-4 Project business plan. The panel encourages the IR-4 Project to seek opportunities to obtain funds from sources other than traditional CSREES Federal appropriations as long as the funding source and project scope meets existing IR-4 Project goals and objectives. Sources could include Department of Defense (DOD), Department of Energy (DOE), Department of Health and Human Services (DHHS), and the National Science Foundation (NSF). F. International Opportunities Trade facilitation is a relatively recent and increasingly important aspect of IR-4 s activities. The work currently focuses on providing residue test results to other developed trading partners so that products exported by our growers are accepted. USAID or FAS may request IR-4 s assistance in establishing residue testing laboratories or minor use efficacy/phytotoxicity trials overseas to enhance food safety and regional/international trade. Conclusions: The IR-4 Project continues to be a very good program and is a leader within the specialty crop and minor uses communities for pest management. The project has made substantial strides in administrative and program management since the 2003 review. The current Review Panel applauds their continued success and encourages the needed development of action and business plans necessary to maintain their leadership role. The IR-4 Project has a bright future. 215

216 Appendix 1 Relevant IR-4 Facts For forty-six years, the IR-4 Project has been assisting in the registration of pesticides for fruits, vegetables, herb/spices, nuts, ornamentals and other specialty crops as well as minor uses on major crops. IR-4 is needed because the cost of the data required by US EPA for registrations far exceeds the potential profits to industry from sales in the low volume specialty crop/minor use markets. IR-4 provides the necessary data to facilitate industry s expansion of registrations. IR-4 maintains three core objective programs (Food Crops, Ornamental Horticulture, Biopesticide and Organic Support) plus a new cooperative project: Registration Support for Pesticides Managing Medically Important Arthropods. Under the Food Crops program, there is a task to support the expansion of current crop groups. The new Mission Statement of the IR-4 Project is to facilitate the registration of sustainable pest management technology for specialty crops and minor uses of pesticides. Under this new mission statement, the core objectives have been enhanced to include: o Product performance testing to identify pest management solutions to answer priority grower needs. o International harmonization of maximum residue levels to remove pesticides as trade barriers. o Invasive species management and registration assistance for products available for organic producers. Policy, funding distribution and strategic decisions are made by the IR-4 Project Management Committee. Day to day activities are managed by IR-4 Headquarters, the four regional offices and USDA-ARS Office of Minor Use Pesticides. IR-4 employs about 125 FTE who work at either IR-4 Headquarters, one of the four regional offices, USDA-ARS Office of Minor Use Pesticides, one of the seven analytical laboratories or at one of the 31 field research centers. Annually, IR-4 conducts about 700 food crop trials that support 100 Magnitude of the Residue Studies, 1,200 ornamental efficacy and/or crop safety trials and funds approximately 40 biopesticide proposals. This activity leads to approximately 1,000 tolerances for crop and chemical combinations on food crops and registrations that impact 3,000 plus ornamental crops annually. IR-4 has a presence within almost every state and United States territory through the assignment of State Liaison Representatives. Research priorities are established through a Workshop process for Food Crops and Ornamental Horticulture and through a Call for Proposal process in the Biopesticide and Organic Support Program. 216

217 Most work in the Food Crops Program is conducted following EPA established Good Laboratory Practice regulations. IR-4 has a fully functional Quality Assurance Unit that audits food crop data and reports. Fiscal year 2009 financial support includes: USDA CSREES ($12 million), USDA-ARS ($4.01 million), SAES ($481,182), USDA-FAS ($250,000) and industry ($1.66 million). Other funds from the in-kind match (SAES and industry) at about 1:1 ratio. IR-4 research and regulatory successes contribute $7.675 billion and $1.2 billion to the US gross domestic product annually in the food crops and ornamental horticulture areas, respectively. 217

218 IR-4 HeadQ..uarters Rutgers. The State Universi\}' of New lersey 500 College Road East. Suite 20I W Princeton, Nl fax: 609.SI lr4.rutgers.edu Dr. Meryl Broussard Deputy Administrator Plant and Animal Systems USDA-NIFA 1400 Independence Avenue SW Stop 2201 Washington, DC, October 29, 2009 Dear Dr. Broussard, On behalf of the IR-4 Project Management Committee, we submit to you our responses to the recommendations provided by CSREES-USDA External Peer Review of the National Research Support Project-4 (NRSP-4)/IR-4 which was held at IR-4 Project Headquarters,May 19-21, We thank Dr. Laurence Chandler, Team Leader of the Panel and the other Panel members for their efforts before, during and after the External Peer Review. They were extremely well prepared; they asked tough questions and provided excellent recommendations. The entire IR-4 Project gets great value out of having a panel like this review our activities and strategies. We believe it helps us maintain IR-4 as a successful government sponsored research project. Below are the Recommendations developed by the NRSP-4 External Review Panel. Immediately following each recommendation is the IR-4 Project's response to their proposal. A. IR-4 Project Administrative and Strategic Management The panel recommends that the IR-4 Project develop an action plan based on the newly developed Strategic Plan for The action plan should provide a roadmap on how to accomplish the stated objectives of the project. The panel recommends that a business plan be developed as part of the overall action plan. The business plan should consider development of a financial management strategy that would maintain the project during flat budget periods, as well as position the project to take advantage of growth opportunities. Once the business plan is developed, IR-4 leadership should periodically revisit the Strategic Plan to determine if midcourse corrections might be necessary. Response:IR-4 is in the process of developing an action plan and business plan. Much of this information is required for the proposal to renew NRSP-4 and will be a part of this document that will be submitted later this year to the Directors of the State Agriculture Experiment Stations. li Page Major funding for IR-4 is pr(lvided by Special Research Grants and Hatch Ad funds from USDA CSREES, in cooperati"!'_wirh rhe Sure Agriculwral bperimem Stations, and USDA ARS. I\!:ITGERS IM'I I t Aft U IYJ I IItf 0'....,,, 218

219 The panel believes it is important for the ffi-4 Project to determine a nd prioritize the core business practices and program objectives that are most important to maintain during difficult financial times. Additionally, they should analyze potential growth areas (see next bullet) as part of the overall prioritization process. Response: In difficult financial times IR-4 will protect the traditional functions of the core objectives, that is, Magnitude of the Residue studies on food crops to support pesticide tolerance ap plications, pesticide efficacy and phytotoxicity testing on ornamental crops and efficacy testing of biopesticides. The panel urges IR-4 Project leadership to carefully evaluate "Mission Creep" in relation to their Strategic Plan and accompanying business plan. Program expansion should be based on a careful evaluation of potential growth areas and within the context of a business strategy. The project would benefit from staff and stakeholder sessions designed to develop the pros and cons for expansion of the project mission. These sessions could determine the benefits (e.g., science capacity and outcomes, knowledge development, enhanced funding, broader stakeholder support, and accomplishment of the core mission) that might result from potential expansions. Response: IR-4 will consider this recommendation and conduct staff and stakeholder sessions w hen any potential program expansion or new opportunity is uncovered. As part of the development of a business plan the panel recommends that IR-4 Project leadership continue to evaluate the capacity of the remaining regional residue laboratories and the ARS residue facilities. A cost/benefit study would be helpful to determine appropriate current and predicted needs for the IR-4 Project. R esponse: IR-4 has eval uated analytical capacity previously, which resulted in phasi ng out one of its regional labor atories. IR-4 will continue to evaluate the capacity of its programs, especially the analytical capacity in the futur e. Because of the tr ansition with the phase out of the Northeast Region laboratory and the partial transfer of resources to enhance personnel and infrastructu re. IR-4 w ill conduct a r eassessment oflaboratory capacity in The panel recommends that IR-4 Project leadership, both at HQ and at the regional level contin ue to evaluate field study site distribution needs and related capacity issues. They also recommend that close coordination with the ARS IR-4 program continue so as to optimize available resources. R esponse: On an annual basis, IR-4 does an assessment of the field study site distri bution needs for State Agricultural Experiment Station and Agriculture R esearch Service sites. This occurs at the IR-4 National Research Planning meeting. IR-4 will continue to reevaluate the field site distribution needs and make strategic modifications w hen necessary. The panel noted the continuing difficulties the IR-4 Project has had in regards to timely distribution of appropriated funds. Receipt of funds occurring approximately 6 to 9 months after the start of the Federal Government fiscal year due to delays in appropriation bill passage has complicated m ainte nance of existing field and laboratory projects; as well as impeded the timely initiation of new projects. Although events surrounding the appropriation cycle are out of the control of IR-4 Project management, it remains necessary to seek alternative solutions to aid - 219

220 cooperating project coordinators. The panel suggests that IR-4 Project leadership in cooperation with USDA-CSREES leadership work together to seek solutions that could minimize some of the concerns. Solutions could include approving projects to receive funds for a minimum of two-years to eliminate carry over issues, or seek new authorizations to change the manner in which funds are received by the project (five-year authorization at an established funding level rather than single year appropriations). Close communication and continuing dialogue on possible resolutions between IR-4 and cooperating universities is also encouraged. Response: The IR-4 Executive Director has met with CSREESINIFA management in an attempt to expedite resource distribution to the program. As a result, a modified process will be initiated. This was implemented in fiscal year 2010 when the IR-4 Request for Applications (RFA) was released in mid-october The RFA review process will occur concurrently with the Federal Government's appropriation process. This change could potentially reduce the funding delays by at least 90 days. Other opportunities to minimize the problem are being explored. Explanations of the above cited funding concerns are complicated a nd difficult for many stakeholders and interested paj:ties to adequately understand. The panel suggests that IR-4 Project stakeholders (e.g., Commodity Liaison Committee) work closely with IR-4 leadership to develop a one-page summary document that describes the cuj:rent funding process and suggests potential options for resolution of the problem. This document would be beneficial for stakeholder education and enhanced communication. Response: This i s an excellent su ggestion and this task is being assigned to the IR-4 Communications Manager for follow-up. The panel recommends that the IR-4 Project develop a transparent process to better track and analyze existing and potential uses of industry unrestricted funds. As part of the recommended Business Plan, these funds should be identified for possible uses including emergency/contingency needs and matches for special grants. Response: An a nnual r eport on the income and expenditures of industry funds will be provided to the PMC, maintaining due respect for confidentiality w here the source of f undin g. The panel recommends the continued evaluation of the role of state liaisons within the IR-4 Project. It was noted that one state, Missouri, did not have a current liaison. Within the Southern Region, some states have separated their liaisons into separate positions for food crops and ornamentals. We encourage IR-4 to evaluate this concept and determine if it is worthy of implementation in other key production states. Response: Additional other states have established both a food crop a nd ornamental crop SLR. It is being proposed that an ad hoc panel be established to examine th e roles and r esponsibilities of the IR-4 State Liaison representatives (SLRs). The panel will be asked to develop recommendations on futur e duties of the SLRs. B. IR-4 Project Personnel Management The panel recommends that all organizational levels of the IR-4 Project review their current personnel structures and discuss and implement succession planning activities as appropriate. 220

221 We also encourage establishment of career ladders as opportunities arise. Response: IR-4 Project Headquarters has recently reorganized and opened up some advancement opportunities for staff. Other units are exploring this possibility. Traditional succession planning may be difficult to achieve within the IR-4 Project structure. We encourage IR-4 staff to develop a mentoring program for early and mid-career staff to provide opportunities to better understand how the project functions as well as operational considerations at the host institutions of project employees. The project is also encouraged to conduct cross-training as appropriate. Response: IR-4 Project Headquarters has provided mentors to recently hired junior scientists. With several r ecent hires at IR-4 Project Headquarters and at the Regions, it is appropriate that IR-4 explore opportunities to renew the past practice of cross training of staff between Headquarters and the Regions. The panel recommends that the IR-4 Project employ summer interns as opportunities arise. Response: IR-4 Project Headquarters continues to employ a stud ent intern. Some Regions hire undergraduates and participate in the graduate students and visiting scientists from overseas. Additional opportunities will be explored. The panel encourages IR- 4 Project leadership to work closely with university department chairs and heads and related university administrators to seek professional status of lr-4. staff on their respective campuses. We would also encourage consideration of sabbatical opportunities. Response: Several IR-4 Project Headquarters professionals are serving as instructors in Rutgers University courses. This is allowing for closer involvement of IR-4 and their faculty associates on the campus. One member has an adjunct appointment with the Rutgers University Center for Vector Biology. This is true at the North Central Region; all three of the pr oject coordinators are classified as Academic Staff and have the option of becoming non-tenur e track faculty in Entomology. C. IR-4 Project Program Managemen t and Leadership The panel concurs that the use of"specialty crop and minor use pest management" in its mission statement is appropriate. We recommend that the IR-4 Project evaluate their mission statement periodically as part of their strategic planning and program review process. Response: Will place this recommendation on an agenda of a future Project Management Committee meeting. The panel recommends that the IR-4 Project continue to evaluate how the project incorporates management of exotic and invasive pests into their program. Coordination with EPA, APIDS, and the state agricultural departments and experiment stations is encouraged. Response: As a first step, IR-4 Project Headquarters has opened dialogue with USDA- APHIS on IR-4's potential involvement in the management of invasive pests. 221

222 Global Harmonization (MRLs and crop grouping) is critical for production of specialty crops. The panel recommends that the IR-4 Project continue to support efforts and provide international leadership on MRL harmonization and crop grouping. Response: IR-4 Project Headquarters has reorganized and specifically assigned the Associate Director with the responsibility to lead IR-4's international activities. Additionally, IR- 4 Project Headquarters has submitted a grant application to USDA-Foreign Agriculture Service to obtain some additional resour ces to ex pand on IR-4 international leadership activities including expansion of submission ofir-4 data for Codex MRL's. The panel heard from various stakeholders that lumping crops into crop groups has had, and will continue to have, export ramifications regarding receipt oflabels from the registrant. We recommend that IR-4 Project staff provide advanced notification to affected stakeholders for timely assessment of possible registrations. We note the addition the IR-4 staff made to the Project Clearance Request (PCR) form (a tab to indicate if export is involved with a potential material) which will improve the process. Response: For many of the commodity organizations that are engaged with IR-4 (e.g. mint, hops, cranberry) an advanced notice process is being implemented. For commodity organizations that are not actively engaged with IR-4, specific active notification systems will have to be developed. The panel recommends that the IR-4 Project outline a process for broader vetting of use patterns with stakeholders during project protocol development (before anything enters into testing). This involves expanded and diligent consideration of proposed use patterns on a national basis. In some cases, this may also include planning for sufficient U.S. trials necessary to support the data requirements of an important international trading partner in the event that additional field trials are necessary to gain an MRL in the foreign market. Response: IR-4 currently posts proposed protocols on the IR-4 Website and solicits comments from stakeholders for approximately 14 days prior to finalization. IR-4 can increase communication and outreach on the availability of the draft protocols and comment period deadlines. Please note, though comments are received, there are instances when protocols ar e not modified in response to the comments. In many cases, EPA or company recommendations are forcing a specific use pattern. We encourage the continued inclusion of the following (originally developed in the 2003 Review Report and slightly updated with this review) criteria to maximize the benefits of allocated resources and to ensure alignment with IR-4's strategic objectives: o role in pesticide resistance management o severity of pest problem o crops, acreage affected and potential economic impact o multi-year Section 18 exemptions o awareness of potential risk issues - communicate with EPA as part of the vetting process for projects o where possible, make priority selection for project support for a material that could be considered reduced risk and/or fully compatible with sustainable agriculture 222

223 o regional input to prioritization prior to food use and ornamental workshops o status of potential trade barriers Response: Agreed The panel encourages the continued evaluation, as appropriate, of the feasibility of including efficacy and crop safety components within work plans and prioritization activities. Response: The Assistant Director, Research Planning and Outreach has been given the task to hone in on IR-4 Project efficacy and crop safety activities and d evelop specific recommendations for potential expansion. The panel recommends that IR-4 Project HQ staff develop a value-added metric for the biopesticide program. Response: Agr eed and IR-4 will open discussions with Michigan State University's Center for Economic Analysis on the feasibility of conducting a stu d y. The panel recommends that IR-4 Project leadership develop a scope and related action plan for the Human Health pilot program (public health pest control). The program should be evaluated based on how it fits into the current IR-4 Project mission, as well as the value it adds to the project. We suggest that the program be evaluated prior to the end of the pilot to determine the feasibility of continuing as part of the IR-4 Project. In general, we believe this type of evaluation should be conducted for any new program enhancement or expansion of the existing core capacity of the project. Response: The recommended assessment will be undertaken pr ior to the termin at ion date of the pilot project (July 2013). The panel encourages the IR-4 Project to continue their active com munication and coordination with potential registrants to address issues such as hazard and risk cup characterization, timely notices of filing, labels, registration materials, etc. If necessary data/information cannot be provided by the registrant in a timely way, we believe it is proper for IR-4 to consider withdrawing its investme nt and energy toward developing field trial data for the project. Response: Agr eed and for many companies, IR-4 is expanding its active communications from one annual meeting into multiple face to face meetings. D. IR-4 Project Stakeholder Considerations The panel suggests that current metrics used by the IR-4 Project to measure programmatic success be reviewed and possibly refined to better reflect stakeholder needs. For example, registration of a use on a "label" is viewed as a key measure of success among growers but was not included in documentation reviewed by the panel The number of specialty/minor uses included on a label should be included in future reports. Response: Agreed a nd IR-4 is developin g systems to better track registrations associated with IR-4 activities vs. the curr ent system of tracking tolerances. It is agreed that tolerances may not always be the ultimate measure of success. Stakeholders would like to be better informed of issues, registration decisions, etc., involving genetically modified organisms (GMOs)/plant incorporated protectants {PIP) before moving forward on potential projects. The panel encourages IR-4 Project leadership to consider this recommendation and develop a protocol to include these discussions as part of the prioritization 223

224 process. Response: IR-4 has a longstanding policy that was esta blished by the IR-4 Project Management Committee in consultation with the CLC that IR-4 will not initiate registration support involving Plant Incorporated Protectants unless the commodity organization involved with the PIP provides acknowledgement and agreement of the activity. However, many feel this policy needs modification to manage instances where one segment of the commodity is agreeable and another segment is not. The panel encourages IR-4 Project leadership along with the Project Management Committee to evaluate the structure and review the current mission and charter of the Commodity Liaison Committee to ensure stakeholder equity. Response: The PMC will evaluate structure and 1 eview the mission and charter ofthe Commodity Liaison Committee. The panel encourages the IR-4 Project leadership, the Project Management Committee and the Commodity Liaison Committee to seek opportunities to broaden the existing stakeholder base. Interested stakeholders not currently associated with IR-4 should be identified and encouraged to become more involved in the project. Response: The PMC will evaluate opportunities to broaden the Commod ity Liaison Committee. The panel recommends that the IR-4 Project enhance cooperation with the Regional IPM Centers as appropriate. Response: Agreed and the Executive Director will attempt to visit these centers to encourage cooperative activities. There is additional involvement between the IR-4 Regional Offices a nd the Regional IPM Centers. For example, the North Cen tral Region IR-4 office always invites the NC Regional IPM Center Director to our annual advisory meeting and solicits any ideas for collaboration and cooperation. E. Opportunities The panel suggests that IR-4 Project leadership carefully evaluate their current and future role as the premier resource for specialty crop and minor use pest management and product registration. Is there a role for the IR-4 Project staff as national/international consultants and/or experts in this important field of work? Response: IR-4 will continue to provide national and international leadership for specialty crop and minor use pest management and registration. The IR-4 will continue to evaluate these activities for relevance within their-4 overall mission, goals a nd objectives. As mentioned in earlier recommendations, the panel encourages the IR-4 Project to evaluate and determine if other researchable areas could be included within the program. Opportunities are known to exist in application technology, beneficial organisms/biological control, biotechnology, and in development of innovative methodologies to estimate residue quantities with less testing involved. All opportunities should be evaluated in the context of the IR-4 Project business plan. Response: As recommended by this panel, IR-4 should consider potential growth areas only after careful evaluation with staff and stakeholder sessions designed to d evelop the pros and cons for expansion of the project mission. 224

225 The panel encourages the IR-4 Project to seek opportunities to obtain funds from sources other than traditional CSREES Federal appropriations as long as the funding source and project scope meets existing ffi-4 Project goals and objectives. Sources could include Department of Defense (DOD), Department of Energy (DOE), Department of Health and Human Services (DHHS), and the National Science Foundation (NSF). Response: Agreed and grant applications are currently pending from sources outside the "traditional" CSREESINIFA source, which fit the overall goals and objectives of the program. F. International Opportunities Trade facilitation is a relatively recent and increasingly important aspect of IR-4's activities. The work currently focuses on providing residue test results to other developed trading partners so that products exported by our growers are accepted. USAID or FAS may request ffi-4's assistance in establishing residue testing laboratories or minor use efficacy/phytotoxicity trials overseas to enhance food safety and regional/international trade. Response: Agreed In closing we want to thank Dr. Monte Johnson of your team for facilitating the External Peer Review of the IR-4 Project. He did an excellent job. Please let me know if I you need additional information or have any questions. Cc: IR-4 Project Management Committee L. Chandler, USDA 225

226 Appendix 2: Accomplishments under the Strategic Plan Food Program - To identify and facilitate registrations/approvals which allow growers to use the newest generation and most effective pest management solutions for high-value specialty food crops and minor uses on a major food crop. Emphasis will be placed on using lower/reduced risk chemicals and encouraging uses compatible with Integrated Pest Management and Resistance Management programs. Performance measure: If requested funding is obtained, the specific goal is to develop data for submission to US EPA in support of grower needs. The target is data packets that support 1,000 potential new domestic registrations annually, with at least 80% of these registration focusing on lower/reduced risk technologies. Additionally, IR-4 will provide and/or submit 25 data packages to international bodies (eg Codex Committee of Pesticide Residues, European Union, Canada, Japan, Taiwan) annually to support US grower exports. Progress: Mean Registrations Petitions Submissions to EPA New Research (Field Trials) International Submissions Crop Group Modifications Approvals: (2010) Oilseed, Fruiting Vegetable, Citrus Fruit and Pome Fruit Groups. (2012) Stone and Tree Nut Groups Other: (2012) Global Minor Use Summit 2 Ornamental Horticulture Program - To identify and develop efficacy and phytotoxicity data to support reduced risk pest management solutions for ornamental horticulture crops, with an emphasis on the most effective biological and chemical solutions compatible with Integrated Pest Management and resistance management programs. Data developed will establish or expand the number of ornamental horticulture crops or pests on pesticide labels and enable growers to most effectively utilize these tools by assessing their impact on beneficial organisms and their ability to be used within resistance management programs Performance Measure: The specific goal is to provide product performance (efficacy and/or crop safety data) to the crop protection industry and to facilitate establishment or expansion of registrations 6 Not funded until

227 (new products, new crops and/or new pests) associated with ornamental crops. If requested funding is provided, the data developed by the IR-4 Project will contribute to at least 20 registrations and impact at least 5,000 ornamental species annually. Progress: Mean 8 Registrations Species Impacted 9 Data Summaries Submitted New Research (field trials) Invasive Species Research ( ) - Gladiolus Rust ( ) Management of Invasive Arthropods ( ) - Chrysanthemum White Rust ( ) Boxwood Blight ( ) Impatient Downy Mildew Biopesticide and Organic Support Program - To support research and provide regulatory support that enhances the development, registration and use of biopesticides in conventional specialty crop production systems and to facilitate the approval of pest management technology for use in certified organic production systems. Performance Measure: If requested funding is obtained, the specific goal is to fund at least 50 research projects annually that will evaluate and demonstrate the use of biopesticides as well as projects that develop data in support of pest management products for organic crop production. Progress: Mean 10 Registrations Proposals funded Registration Support for Pesticides Managing Medically Important Arthropods - To facilitate the registration of pest management products that control arthropod pests responsible for transmitting vector borne diseases and threatening human health. Progress: Not funded until

228 (2011) IR-4 submits data requesting an All Crops Tolerance for etofenprox. (2012) Published on-line inventory of over 600 available and potential pesticides for to manage arthropod pests that transmit diseases to humans and animals (2013) EPA establishment of crop tolerances to allow the an adult mosquitocide, etofenprox to manage mosquitoes near crops. (2013) Provided regulatory support for Attractive Toxic/Targeted Sugar Bait technology 228

229 Appendix 3 Summary of Responses from IR-4 s 2013 Strategic Planning Survey How familiar are you with the IR-4 Project? 550 responses 88% moderately or very familiar Which Program have you interacted? 329 w/food-residue 306 w/food-e/cs 171 w/ornamental-e/cs 128 w/biopesticide-grants 100 w/food-international 60 w/biopesticide-regulatory support 52 w/public Health Pesticide 50 w/ornamental-invasive What role do you interact with IR-4 Project? 35% are State/Federal Research/Extension 26% are Crop Protection Industry 16% are Grower/Commodity Group Representative 11% are Consultant 10% are IR-4 employee IR-4 Delivers Indispensable service for Specialty Crop Agriculture or other minor uses 69% Strongly Agree 23% Agree <4% Disagree/Strongly Disagree Assuming new unrestricted funds are available; please state how important it is for IR-4 to work in the following areas (highest to lowest) Increase the IR-4 Food Use Program Conduct research to fully integrate biopesticides with chemical pesticides Monitor and/or mitigate pest resistant to pesticides Increase support for IR-4 Biopesticide and Organic Support Program Develop data to assess exposure of pollinators to pesticides Develop data to answer the regulatory needs associated with FMSA Develop data to help satisfy regulatory requirements for Public Health Pesticides Increase Ornamental Horticulture program research Increase regulatory support for Biopesticide program Are there untapped opportunities for synergy between IR- and other government funded groups on pest management? 229

230 Work on strengthening ties with IPM. Start paying more attention to organic IR-4 should be an advocate for ag issues with other government programs USDA Office of Pest Management and Policy Sustainable ag groups IR-4 is communicating effectively using it website, social media, newsletter, and monthly reports. Please select your level of agreement. Agree 59% Strongly Agree 21% Neither Agree or Disagree - 18% Disagree/Strongly Disagree 2% How can IR-4 Communicate Better? Through direct contact. Our stakeholders are busy it is not sufficient to expect that they will voluntarily go to our website or read our newsletters Ensure that communication pieces are created/used are technically accurate and verbally/grammatically correct IR-4 should work more with State Extension Services Social media outreach should be more aggressive Attend grower meetings / interact more with commodity organizations use the telephone make the IR-4 website more friendly Implement tracking tool to notify stakeholder of milestones Use less jargon and language that growers understand Do you agree the benefits of face-to-face meetings with stakeholders outweigh their expense? 23% Strongly Agree 42% Agree 26% Neither agree or disagree 8% Disagree/Strongly Disagree How comfortable are you with video and voice conferencing technologies to replace IR-4 meetings? 36% Very Comfortable 36% Neither Comfortable nor Uncomfortable 17% Very Uncomfortable How important are the following in helping the talent and expertise of the IR-4 State Liaison Representatives? 78% of respondents felt it was important (Somewhat/Very/Extremely) for SLRs to hold state wide IR-4 workshops 67% of respondents felt it was important (Somewhat/Very/Extremely) for SLRs to produce a state newsletter 88% of respondents felt it was important (Somewhat/Very/Extremely) for SLRs to represent IR-4 at grower meetings Comments: o Maybe involve Extension Area Agents or specialists better to connect with growers o Establish statewide stakeholder boards: o obtain additional feedback from suppliers and consultants; closer to growers IR-4 s involvement with international harmonization of pesticides is important in facilitating increased exports of specialty crops 230

231 44% Strongly Agree 43% Agree 10% Neither agree or disagree <2% Disagree/Strongly Disagree Comment o There seems to be a disconnect between the people submitting petitions and the consideration of international MRL and IR-4 involvement with participating in all of these international activities. Some energy would be better spent working with staff on considering international markets when preparing protocols and petitions How do you see IR-4 participating in international activities in the future? 82% Yes 5% No 14% Unclear Assuming external funds are available, how important is it that IR-4 participate in training and mentoring international scientists and regulators to assist them in establishing their own minor use program? 15% Extremely important 42% Very important 31% Neither important or Unimportant 11% Unimportant The IR-4 Food Use Program has been successful in serving the needs of its stakeholders 50% Strongly Agree 44% Agree 6% Neither agree or disagree 0% Disagree/Strongly Disagree Do you believe the need for existing services provided by the IR-4 Food Use Program will increase, decrease or stay the same over the next five years 69 % - Increase 26% - Stay the same 5% - Decrease What are the greatest strengths of the IR-4 Food Use Program? Service to growers (55%) Facilitation cooperation/collaboration/inclusion (26%) Its people (19%) It has a valuable, well-defined product and its impact is readily measured. The culture of IR-4 is very healthy, and even contagious. Thus, as the projects interacts with other entities, nationally and internationally, the IR-4 GOODS will continue to be spread How can IR-4 build upon this strength? Secure multi-year funding so that every year the extensive energy/resources required to deal with budget issues could be more appropriately used Find ways to make sure the tolerances make it to the user label Continue to be the best you can be with customer focus as your trademark.. Customers being the growers 231

232 Keep focus on what IR-4 was designed to do, provide specialty crop tolerances and 24Cs Awareness of pesticide resistance issues and how to manage without new tools being developed I have witnessed that as good as IR-4 is, there remains those that do not understand their operation. Still need the simple explanation of what is tis and how effective it has been to share with many potential stakeholders and general public Help link USDA-ARS discoveries to commercial development entities The strength of the program is tethered to a softening source of funding. The Project has to now begin to move toward additional sources of funding Start developing a group of interns that are going to be able to continue the work as the core group retires Build stronger relationships at EPA Embrace IPM, no more lip service or pandering to fringe elements of their stakeholder base. Adopt progressive role in contracting resistance management monitoring services that represent another major gap between what manufactures cannot/will not provide and what stakeholders need to protect their valuable investment ins minor use programs Encourage IR-4 Regional coordinators to be active representatives of their regions What part of the IR-4 Food Program needs improvement? Priority setting (16%) Priority setting is still very much dependent on who is present/involved. Transparency of regional decision prior to annual FUW.There sometimes (ofter?) appear to be large discrepancies between commodity group needs and regional decision making None/Not sure (16%) Communication/Outreach (13%) Resource allocation (12%) Some restructuring to deal with decreased funding and overcapacity in certain regions Timelines to registration (11%) 30 month timeline for approval to submission is too long; should be closer to 20 months Funding (7%) there are often times when research centers are not adequately supported, perhaps IR-4 should consider consolidating regions Involvement with industry (4%) Mission Creep (2%) IR-4 HQ has to be careful in not expanding too far from its core mission Misc. (18%) Are there aspects of the Food Use Program that have outlived their utility? No (66%) Not sure (18%) Yes (16%) o Biopesticide Program could be tailed back (3) o National meeting not needed (2) o The current regional structure (2) o Too Much Administration (2) o The paper IR-4 Newsletter o Food Use Workshop o QA inspections & travel-use local consultants o Overcapacity in EPA Data Region 2 o Databases could be more user friendly What do you see is trending in pest management in specialty food crops that IR-4 can lead, or participate in, to better serve the needs of its stakeholders? 232

233 Biopesticides/GMOs (21%) International harmonization (17%) Resistance Management (13%) Invasive Species (12%) IPM (11%) Efficacy/Crop Safety data needs (10%) Pollinator Protection (9%) New Uses/New Crop (4%) Other (2) If Funding for IR-4 Food Program were to increase, which activities should be expanded or what new activities should be added? Intensify the process of running residue studies to get new products registered (29%) More Efficacy/Crop Safety Testing (18%) Make the generation of E/CS data more critical to IR-4 business as many registrants will not market uses until comfortable against liability claims is satisfied by proof of concept and/or proof of safety data International-Expand harmonization and international involvement (16%) Biopesticides/GMO s/organics (10%) o Interesting-this many added Biopesticide related comment to question that was specifically targeted to Food Program Other (7%) o Crop Groups/IPM/Seed Treatment/Animal Health/ More grower outreach (5%) Invasive/critical pests (5%) Resistance Management (4%) Replace equipment (3%) Pollinator Protection (3%) Other noteworthy comments: Investigate need of getting involved in the use of antimicrobial products in food preparation or processing areas As the number of applied scientists decrease, we need to increase our support for efficacy and crop safety research. However, if this area is increased, we need to develop a better system for selecting projects What are the threatening forces that will challenge the IR-4 Food Use Program? Funding (50%) Public Policy (21%) IR-4 Independence (6%) Available Technology (5%) Qualified Personnel (5%) Government Regulation (5%) Comments Dwindling support within the ARS system for the critical work IR-4 does Being isolated from other IPM Programs Major crops claiming minor status Top heavy in management, inefficient in comparison to private industry. Waste of taxpayer money GMO plants that do not require pesticides Success of Crop Grouping How can these threats be turned into opportunities? 233

234 Communication & Education Perhaps IR-4 can garner additional support from industry or Fee for Service Apply for more grant But take care that chasing dollars does not dilute the mission of IR-4 but rather compliments or improves the organization keep answering growers needs Budget cuts could push more cooperative efforts with other countries and make the whole process more efficient The annual funding issue could create an opportunity for IR-4 to consider a wholesale restructuring; the 4-region structure may have outlived its usefulness and could be adjusted to take advantage of the strengths of its human resources, possibly into 3 or even 2 regions, with maybe only 2 labs; the savings from significant restructuring could be substantial, making it a leaner/meaner program that continues to be the envy of, and example for, all other government entities. The IR-4 Ornamental Horticulture Program has been successful in serving the needs of its stakeholders Agree- 63% Strongly Agree-26% Disagree/Strongly Disagree <1% Do you believe the need for existing services provided by the IR-4 Ornamental Horticulture Program will increase, decrease or stay the same over the next five years Increase- 56% Stay the same 37% Decrease 7% What is the greatest strength of the IR-4 Ornamental Horticulture Program? Data development/expanded registrations- 48% Facilitating Collaboration 36% Research Funding 9% The people- 7% How can we build upon the strength over the next 5 years? Keeping up the momentum; increase interaction with Hort industry Increase funding for ornamental research More researchers participating, greater funds to distribute. Develop a truly integrative program by more research into conventional and biopesticide efficacy, rotation, and non-target impacts Exploration of new chemical molecules Promote regional programs difficult as faculty numbers fall Improve organization, management and efficiency of program. Also involve grower stakeholders more Continue the existing strategy Since the last strategic plan, the IR-4 Ornamental Horticulture Program has become involved in addressing exotic invasive species. How can IR-4 enhance service to growers related to invasive species? Facilitate cooperation between multiple parties- 53% Education/Communication 27% Fund research, develop data to support registrations- 20% Invasive species are a major threat to all areas of crop, animal and human health. Whole industries and populations are threatened. All efforts must be made to coordinate and build strategies across the Federal and State governments to limit the introduction. IR-4 must be the advocate for ag with other government agencies to educate about the seriousness of the threat and the importance of putting solutions in place prior to crisis 234

235 What part of the Ornamental Horticulture Program needs improvement? Getting people involved the grower so the surveys reflect the biggest need and not just what they see the most in their own operation. The efficacy part of the program has vastly improved the worth of the data that IR-4 generates. Being able to show that some products are more specific for pest/pathogen/weed control vs. another product so growers can see good rotation products in very important to help build meaningful platform of solutions for growers Getting the industry involved. Every national conference should have a presentation about the importance of IR-4 to the industry, OFA- July, CENTS- January, NEGrows- February, Farwest -August, etc. timing of funding-often research is almost completed when the research dollars arrive and getting more difficult to continue to do this Protocols need to be designed to assess efficacy in light of the pest biology rant than a one-size fits all protocol. Much more could be learned with more thoughtful protocols Are there aspects of the Ornamental Horticulture Program that have outlived their utility? No (91%) Yes (9%) What do you see is trending in pest management in ornamental crops that IR-4 can lead, or participate in, to better serve the needs of its stakeholders? Biopesticides/IPM/Systems approach to manage pests - 48% Managing tools for pesticide resistant pests 13% Development of efficacy data to help growers make good decisions on which product to use -13% Management of invasive species 13% New pests/new crops 10% Take an ornamental production chain approach to managing diseases, pests and environmental safety, starting at seed production and propagation through production, processing and sale. Inclusion of more biopesticides and use of combinations of available products/strategies in efficacy trials and priority projects. Best management or production practices can be developed piece by piece or crop group by crop group to best fulfill pest and disease management needs of the industry and environmental safety needs of the public If ornamental horticulture program funding were to increase what activities should be expanded? More efficacy research 40% Invasive species management 20% Biopesticide integration 16% Develop international partnerships 10% What are the threatening forces that will challenge the Ornamental Horticulture Program in the next five years? Funding 60% Invasive pests 13% Retirement of scientists 9% Downsizing of ornamental production industry 5% How can IR-4 convert the current and future threats into opportunities? Seek more funds Improve communication with stakeholders through the development of digital tools; request state liaisons and researchers identify IR-4 as funding source for research/data in extension/education program. Bring more industry businesses into the process to widen the support base 235

236 Exotic pests and phytosanitary issues pesticides are still essential for ornamentals. This may be a good approach to continue (or increase) government funding in an effort to both address these issues and maintain the traditional roles of the IR-4 ornamentals program. Establish priorities and continue doing what it has been doing: supporting accurate and objective research. Establish a work force with experts in different areas to advice on course to follow. The IR-4 Biopesticide and Organic Support Program has been successful in serving the needs of its stakeholders Agree- 48% Strongly Agree-13% Disagree/Strongly Disagree 13% Do you believe the need for existing services provided by the IR-4 Biopesticide and Organic Support Program will increase, decrease or stay the same over the next five years Increase- 72% Stay the same 19% Decrease 10% More biopesticides coming to market Need for effective, softer, more biological approaches to managing pests, diseases and weeds will only increase as resistance development and environmental pressures increase What is the greatest strength of the IR-4 Biopesticide and Organic Support Program? Furthering the registration of biopesticides through data development and/or regulatory support- 62% Facilitating collaboration between industry/research community and EPA 28% Much needed support for the Organic industry 9% How can we build upon the Biopesticide and Organic Support Program strength? There is a need of unbiased research data and for developing program approaches with other biopesticides to provide growers with sound options that actual work in defending their crops against pathogens Offer cleaner guidelines for the organic support program, build connections with OMRI and certifiers, get input on the needs of organic growers Continue to provide assistance to small companies or help provide linkages from ARS discoveries to commercialization entities. What part of the Biopesticide and Organic Support Program needs improvement? If you look at many of the projects that have been funded it seems most of them are for products that go nowhere. If you did a retrospective of funded projects and figured out who many products are being used significantly, I suspect you would find a few winners and a lot of products that just went away or are not being used. Many organic materials are labeled for various specialty crops, but have no efficacy data. If the funding was available, then IR-4 could help with some kind of improved efficacy screening program for organic materials The grant application process is quite laborious, it seems that there is repetition in the forms/information that is required & the format of Biopesticide proposal is highly dysfunctional. The format should fall in line with normal scientific writing format of competitive grants the granting program needs to be more transparent, regarding feedback into how priorities were set and award decisions were made Are there aspects of the Biopesticide and Organic Support Program that have outlived their utility? the database and other items on the web page should be reviewed 236

237 the biopesticide program should fund/address cutting edge innovations---not the same old tired options which keep getting recycled IR-4 is adequately meeting the needs of organic growers? Neither Agree nor Disagree 45% Agree- 31% Strongly Agree-4% Disagree/Strongly Disagree 19% What do you see is trending in biopesticides that IR-4 can lead, or participate in, to better serve the needs of its stakeholders? The desire on the part of more progressive grower to incorporate biopesticides in their IPM Programs Biopesticide industry is growing fast & more companies are involved with biopesticides and will need more service from IR-4 Integrating pesticides, biopesticides and biological control organisms into meaningful repeatable programs to reduce pesticide use and counter resistance Need for products with safety to pollinators Nanotechnology Need for efficacy data is great. Many products come on the market without good efficacy data. Growers are very interested and supplier eagerly promote these products but Extension has a difficult time know what to recommend so efficacy data is critical If funding for the IR-4 Biopesticide and Organic Support Program were to increase over the next five years, how important is it that the program be expanded in the following areas? (1 to 5 scale with 1= not important at all and 5 = extremely important) Biopesticide integration into conventional programs 4.24 Utilizing biopesticides for safety to pollinators 4.03 Use of biopesticides to reduce conventional pesticide residues on crop 3.76 Organic Agriculture Extend biotechnology program into APHIS deregulation

238 Contacts IR-4 Headquarters Dr. Jerry Baron - IR-4 Executive Director, x 4605, jbaron@aesop.rutgers.edu Dr. Dan Kunkel - IR-4 Associate Director, Food and International Programs, x 4616, kunkel@aesop.rutgers.edu Dr. Michael Braverman - Manager, Biopesticide & Organic Support, x 4610, braverman@aesop.rutgers.edu Dr. Cristi Palmer - Manager, Ornamental Horticulture, x 4629, palmer@aesop.rutgers.edu Dr. Karl Malamud-Roam - Manager, Public Health Pesticides, x 4628, kmr@aesop.rutgers.edu Regional Field Coordinators & ARS Dr. Satoru Miyazaki - North Central, Michigan State University, , ncrir4@msu.edu Ms. Edith Lurvey - Northeast, Cornell University-NYSAES, , ell10@cornell.edu Dr. Michelle Samuel-Foo - Southern, University of Florida, , mfoo@ufl.edu Ms. Rebecca Sisco - Western, University of California, , rsisco@ucdavis.edu Dr. Paul Schwartz - USDA-ARS, , Paul.Schwartz@ars.usda.gov Major funding provided by Special Research Grants and Hatch Act Funds from USDA-NIFA, in cooperation with the State Agricultural Experiment Stations, and USDA-ARS. State Agricultural Experiment Stations provide in-kind support valued at over $10 million annually. 238

239 Economic Impacts of the IR-4 Project and IR-4 Project Programs December 28, 2011 Steven R. Miller & Andrea Leschewski Center for Economic Analysis Michigan State University 88 Agriculture Hall East Lansing, MI

240 Executive Summary The Interregional Research Project Number 4 (IR-4 Project) has been a pivotal resource in providing U.S. residents a plentiful and low-cost array of vegetables, fruits, berries and tree nuts since 1963 by facilitating the registration of newer, lower-toxic pest control products with the EPA for application on specialty crops. Specialty crop growers often are at a disadvantage relative to program crop growers in having access to effective crop loss mitigation options against common agricultural pests. Specialty crops make up about 40 percent of the total value of U.S. crop production and include both food and ornamental crops that afford insufficient economic incentive for a pesticide companies to support initial or continuing registration of commercial pesticides. As all agricultural uses of pesticides are regulated by the EPA, each use must be registered or exempted before applied. Such registration is costly, making only registration for uses on any but large acreage crops unprofitable for pesticide companies. The IR-4 Project leverages resources to pursue registration for such uses. Along with supporting the use of reduced-toxicity pesticides, with its Biological and Organic Support program, the IR-4 Project is able to direct necessary resources to meet the U.S. goal of substantially decreasing the environmental and health impacts of agricultural pesticide use following the passage of the Food Quality Protection Act of This report assesses the economic impact of the IR-4 Project on the U.S. economy. The assessment assumes a long-run presence of the IR-4 Project, such that relevant decision makers recognize and plan for the continued efforts of the IR-4 Project. Because this report limits research to private transactions, and hence returns to expenditures, it does not purport to measure the true social costs of pesticide usages that include public health and environmental quality aspects. In addition, the report does not purport to measure the true cost of allocated public and private funds to IR-4 activities in terms of the value of foregone uses of such funding. Well-established methods of measuring direct and secondary economic impacts are used to gauge the contributions of the IR-4 Project and its three primary programs, including the Food Crops, Ornamental, and Biological and Organic Support programs in terms of sales, employment and gross domestic product. It should be noted that estimated economic impacts do not take into consideration health or environmental impacts, or associated economic outcomes of such impacts. Economic impact estimates do measure the direct and secondary effects of IR-4 registered pesticides contribution to increased agricultural output of minor use crops and associated impacts of IR-4 expenditures for research and pesticide registrations. The findings suggest that each program posits real economic benefits to growers and the economy as a whole. Specifically, growers benefit in higher yields with higher quality output, consumers benefit by higher varieties and lower costs to food and ornamental crops, and the industry benefits through better global competitiveness of U.S. output. Including all secondary impacts, the IR-4 Project is anticipated to support research and industry sales sufficient to support 104,650 U.S. jobs and bumps annual gross domestic product by $7.3 billion. The findings support public investment in the IR-4 Program in alleviating an economic market failure should the pesticide industry for minor-uses be left to its own devices under the regulation of the Food Quality Protection Act of

241 Table of Contents Introduction... 1 The IR-4 Project... 2 The IR-4 Ornamental Horticulture Program... 4 The IR-4 Biopesticides and Organic Support Program... 5 Estimating the Economic Impacts of the IR-4 Project... 7 Direct Effects... 9 Direct Expenditure Effects... 9 Industry Productivity Direct Effects Direct and Economics Impacts of the Biological and Organic Support Program Summary of Findings Appendix A: The IMPLAN Economic Impact Model Bibliography

242 Introduction The Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA) recognize that a variety of pest management tools are needed in order to maintain a safe and dependable supply of fruits and vegetables while allowing U.S. crop producers to compete in global markets. Access to such pesticide tools also enables the management of pest resistance, reduces the risk of pest-borne diseases and enables more effective integrated pest management practices. However, pesticide use poses risk to health and environment. To reduce risks, federal law requires that pesticides must be registered or exempted by the U.S. EPA to assure that prescribed uses pose no threat to human health and no unreasonable risk to the environment if used in accordance to label directions. As stipulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the EPA examines the ingredients of a pesticide; the site or crop on which it is to be used; the amount, frequency and timing of its use; and storage and disposal practices to ensure that it will not have unreasonable adverse effects on humans, the environment and non-target species before registering or exempting labeled pesticide applications. More than 140 different studies on a chemical's toxicology, crop residues and environmental effects may be required before the EPA determines the conditions by which the pesticide meets health and environmental safety guidelines (National Agricultural Chemicals Association 1993). Food and feed-grain applications require additional testing to ascertain whether chemical residues at harvest meet EPA-established tolerances (maximum pesticide residue levels). Through extensive testing, those applications that demonstrate compliance with all federal health and environmental safety restrictions will receive EPA clearance for prescribing such use on the pesticide label. Uses and rates not listed on the label are strictly prohibited without special exemption under Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act of 1947 (FIFRA). Pesticide labels specify directions for safe use, storage and disposal based on rigorous testing and off-label uses of pesticides are strictly illegal (USDA: National Agricultural Statistics Services 2007). The costs of research necessary to develop data to support labeled uses are generally borne by chemical companies. The registrant is responsible for providing the EPA field test studies conducted under strict EPA regulations. Such field testing is expensive and can require years of research. For large acreage crops such as corn, wheat and soybeans, the registrant generally assumes the costs of registration, as the cost is easily recovered through high sales volumes. However, agrichemical firms seldom assume the full expense of registering for minor-use crops, where the expected returns from sales will not cover the registration expense. For minor uses, the relative high cost of registration against limited sales potential and the potential liability provide an unfavorable risk-reward relationship for pursuing pesticide registrations for minor uses. Minor-use crops include both food and ornamental crops where total production is less than 300,000 acres, or those crops for which there exists insufficient economic incentive for a registrant to support initial or continuing registrations (USDA: National Agricultural Statistics Services 2007). 1 Such crops are generally high-value but occupy low acreage compared to program crops. They occupy multiple minor-use registrations in isolation but account for about 13.7 million acres of U.S. farmland, about $67 billion in sales and approximately 1 The easiest way to discern what is a specialty crop is by listing what is not a specialty crop. The following crops do not meet the acreage definition of a minor crop: almonds, apples, barley, beans (snap and dry), canola, corn (field, sweet and pop), cotton, grapes, hay (alfalfa and other), oats, oranges, peanuts, pecans, potatoes, rice, rye, sorghum, soybeans, sugar beets, sugarcane, sunflower, tobacco, tomatoes, turf and wheat. 242

243 40 percent of all U.S. crop sales according to the 2007 and 2002 Agriculture Censuses (USDA: National Agricultural Statistics Services 2002, 2007). While specialty crop production makes up a large component of total U.S. agricultural sales, such crops would be susceptible to prohibitive risk of economic loss from common agricultural pests without access to many of the same pesticides used by large acreage crop producers. If the market was left to its own devices, insufficient financial incentives for the agrichemical industry to invest in the research required to register pesticides for the plethora of minor uses would restrict consumer access to a wide spectrum of minor-use food crops that make up USDA guidelines to a healthy diet. The USDA and state agricultural experiment stations (SAES) recognized this problem in 1963 when they organized the Interregional Research Project Number 4 (IR-4 Project) to facilitate the registration of existing and newer pest control products. The IR-4 Project is the only program that conducts research and submits petitions to EPA to establish new tolerances and labeled uses for specialty crop growers. This report assesses the economic impact of the IR-4 Project on the U.S. economy. The assessment assumes a long-run presence of the IR-4 Project, such that relevant decision makers recognize and plan for the continued efforts of the IR-4 Project. With its rich history in supporting specialty crop growers, such an assumption is reflected in historical relationships used to model the fiscal impacts of the IR-4 Project. The structure of the report is as follows. First is an overview of the IR-4 Project, the Biological and Organic Support and the Ornamental Horticulture Programs. This is followed with a general overview of the methodology used to assess the economic impacts. Next is a section on empirical estimates of direct and total macroeconomic impacts. The report concludes with a summary of findings. The IR-4 Project The IR-4 Project was established in 1963 as a collaborative effort of the Agricultural Research Service (ARS) agency of the USDA, National Institute of Food and Agriculture (NIFA formally called the Cooperative State Research, Education, and Extension Service) and state Agricultural Experiment Stations (SAES) at Land Grant universities in coordination with the Environmental Protection Agency (EPA) to assist in the collection of residue and efficacy data in support of the registration or reregistration of minor use pesticides. With headquarters at Rutgers University, and regional state university offices at the University of California, Cornell University, University of Florida and Michigan State University, the ARS coordinating office in Beltsville, MD, and research laboratories and field research centers located in twenty-five states, the IR-4 Project conducts the research necessary to support a wide variety of specialty crop pesticide applications necessary to maintain a stable and safe food supply for the nation and to deliver a diversity of ornamental crops that brings value to U.S. households and neighborhoods. The IR-4 Project works with various stakeholders to establish priorities in pursuing ample pesticide options for specialty crop pest control. By leveraging its network of SAES and industry scientist, and through its correspondence with the EPA, the IR-4 Project provides the field trial and laboratory residue data necessary for EPA clearance of minor use tolerances. The IR-4 Project has provided the necessary field and residue 243

244 data to account for about 50 percent of EPA s annual work plan and new clearances in recent years. In this role, the IR-4 Project closes the gap in pest management options between specialty crop and program crop growers. Since its inception, the IR-4 Project has achieved over 10,000 pest control clearances on food crops (including biopesticide uses) and over 10,000 clearances on ornamental crops and is instrumental in curtailing substantial economic loss from pest-induced crop damage. In addition, the IR-4 Project preempted economic losses to the agricultural sector when stricter standards of food safety were imposed with the passage of the Food Quality Protection Act of 1996 (FQPA). FQPA imposed added protections from pesticide exposure on food, especially for infants and children, and forced several critical pesticides off the market or substantially restricted their use. The IR-4 Project reduced the potential impact of FQPA on specialty crop growers by proactively pursuing the registration of new and safer alternatives for minor use pest management prior to the passage of FQPA. More so, about 70 to over 80 percent of IR-4 Project s effort supports the registration of reduced-risk pesticides that substantially reduce the risk to human and environmental health relative to existing or recently de-registered products (Viray and Hollingworth 2009; U.S. Environmental Protection Agency 2001a). The IR-4 Project operates three distinct programs; the Food Program, the Ornamental Horticulture Program, and the Biological and Organic Support Program. Within each program area, the IR-4 Program operates several initiatives to further streamline the pesticide registration process that build on existing synergies across its network of scientists, crop protection industry, and national and international regulatory agencies. For example, following the passage of the Pesticide Registration Improvement Act of 2003 (PRIA), the IR-4 Project and the EPA have increased coordination efforts to streamline the EPA registration process and clear backlogs of IR-4 petitions (Kunkel 2008). The project also facilitates research and registration standards across national boundaries (Kunkel 2010) that not only expedite the registration process with international residue and tolerance data collaboration, but also facilitate international trade through adoption of global research standards and by aligning international maximum residue levels (MRLs). Further efforts have led to U.S. and international capacity building efforts like the launch of the IR-4 Project Global Minor Use Information Portal found at and classification schemes that increase the scope of field trials across similar crop applications. Through such efforts, the IR-4 Project has decreased the domestic and international research costs of collecting pesticide residual and efficacy data, increased agricultural trade opportunities and reduced the economic costs of pesticide registrations. Such synergistic outcomes are not likely to occur in the absence of the IR-4 should industry be left to its own devices for meeting minor-use growers needs. The IR-4 Project is funded by the USDA in partnership with the SAES. The majority of USDA funding for the IR-4 Project comes through the National Institute of Food and Agriculture (NIFAformerly called Cooperative State Research Education and Extension Service). The Agriculture Research Service (ARS) established a companion minor use program in 1976 to provide further program support. Recently, USDA-Foreign Agriculture Service (FAS) has provided IR-4 additional funding to coordinate the development of international standards that support specialty crop exports. The SAES contributes financial resources through Hatch Multi-State Research Funds and a significant amount of in-kind contributions by housing IR-4 Field Research Centers, analytical laboratories and management offices throughout the United States. The crop protection industry 244

245 also contributes direct financial resources as well as significant in-kind resources. There are three principal programs under the IR-4 Project: the Food Program, the Ornamental Horticulture Program and the Biopesticides and Organic Support Program. Each is discussed separately below. The IR-4 Ornamental Horticulture Program The IR-4 Ornamental Horticulture Project was founded in 1977 to provide agrichemical registration support for non-food, specialty crop growers that include ornamental horticulture plants grown in greenhouses and nurseries, landscape plantings, Christmas tree farms, sod farms and interiorscapes. This program directly contributes to the health of this industry by providing necessary research and EPA registration support for an industry that otherwise would have few resources to address agrichemical usage and research tools to form enlightened management decisions for controlling pests in an efficient and ecologically friendly manner. The ornamental crop industry makes up an important component of specialty crop agriculture. Ornamental crops exclude plants intended for commercial food production. They include floriculture and nursery crops, where floriculture crops include bedding and garden plants, cut flowers, potted flowering plants, indoor foliage plants, and cuttings and other prefinished plants generally sold to other growers for further growing. In the U.S., non-food specialty crops make up over 15 percent of the total value of sales of all production crops and 36 percent of the value of sales of all specialty crops (National Agricultural Statistics Services 2004). According to the 2007 Census of Agriculture, the U.S. total value of sales of non-food specialty crops were nearly $13.7 billion as shown in Table 1. As in indication to the total value of ornamental crops, Jarardo (2006) estimates that sales per U.S. Households are about $147 at wholesale based on 2005 estimates. Table 1: Value of Specialty, Non-Food Crops Sold: 2006 (1,000s) Crop Sales Aquatic Plants $ 35,193 Bulbs, corms, rhizomes and tubers-dry $ 90,304 cuttings, seedlings, liners and plugs $ 440,933 Floriculture crops $ 6,466,886 Flower seeds $ 35,995 Nursery stock $ 6,568,563 Other nursery crops $ 48,476 Total $ 13,686,350 Source: Table 37 of the 2007 Census of Agriculture Consumer desire for cosmetically unblemished ornamental plants demands substantial investment in agrichemical solutions. Presentation is a vital component in the value of ornamental crops. Consumer perception of the quality of ornamental crops rests wholly on external attributes, such as absence of defects, uniformity of size, and shape. Ornamental growers must contend with demand for blemish-free ornamentals. To address customer demand, growers have a small portfolio of options to support unblemished ornamental crop production that include integrated pest management approaches, environmental controls in greenhouses, pesticides, and growth regulators. However, regulatory oversight of pesticide usage and unfavorable agrichemical industry risk-reward 245

246 relationships for ornamental crop registration creates a market failure condition for ornamental crop growers; reducing access to agrichemicals available to other growers. This known issue was addressed in the creation of the IR-4 Ornamental Horticulture Project to coordinate and sponsor research for data generation required for registering floriculture uses. Over the Ornamental Horticulture Program s history, the primary focus has been to generate crop safety information and to add new crops to labels. This changed during the 2003 Annual Workshop where attendees established high priority projects to focus the research efforts on key issues in each discipline. At that workshop attendees selected Phytophthora Efficacy, Scale & Mealybug Efficacy, and Herbaceous Perennial Tolerance to Select Herbicides. Since then, the program has also conducted research on several high priority projects such as efficacy for Borers, Beetles, Pythium, Q biotype Whiteflies, Thrips, and White Grubs, and crop safety on a number of herbicides. The 2008/2009 research priorities include efficacy for Armored Scale, Downy Mildew, and Borers, and crop safety for Freehand, Tower, among other herbicides. High priority project selection starts with growers, landscape care professionals, extension agents or researchers identifying a need an area where current management tools are not registered, such as for a newly introduced pest or for crops where little phytotoxicity information is available. Research has been sponsored on most active ingredients registered for ornamental horticulture since The IR-4 Biopesticides and Organic Support Program The IR-4 Biological and Organic Support Program were initiated in 1982 to assists in the EPA registration of biopesticides for pest management systems for specialty crops or for minor uses on major crops. Two classes of biopesticides are biochemical (naturally occurring substances) and microbial (consisting of microorganisms). The EPA defines biopesticides as those chemicals that include naturally occurring substances that control pests (biochemical pesticides), microorganisms that control pests (microbial pesticides), and pesticidal substances produced by plants containing added genetic material (plant-incorporated protectants) or PIPs (U.S. Environmental Protection Agency 2001b). This definition excludes biologicals like arthropod parasites and predators or predacious nematodes (Braverman et al. 2006). Biopesticide use in the US has consistently grown since 1997 (Bailey, Boyetchko, and Längle 2010). While, their use has not reached the level of conventional pesticides making up only about one percent of the global pesticide market (Copping and Menn 2000) their growth in use exceeds that of chemical pesticides (Hall and Menn 1999). The biopesticide market is also diversifying products. While Bacillus thuringiensis comprised about 90 percent of total biopesticide applications in 1990s, its share of the biopesticide as dwindled to about 57 percent by 2007 (CPL Business Consultants 2010). According to the EPA there were 195 registered biopesticide active ingredients and 780 products at the end of 2001 (U.S. Environmental Protection Agency 2010). Biopesticides offer several advantages over conventional pesticides (Joshi 2006, pp. 12). They are generally considered safer and more environmentally friendly alternatives to highly toxic chemical pesticides and make up an important component of an integrated pest management (IPM) system (Copping and Menn 2000). Biopesticides generally offer much more targeted activity against a desired pest than conventional pesticides, which often affect a broad spectrum of pests including desirable, beneficials and human workers. Biopesticides often are effective in very small quantities; thereby offering lower exposure. They also decompose more quickly than conventional chemical pesticides and often supplement the conventional pesticides when used in integrated pest 246

247 management (IPM) programs for reducing pest resistance. Additionally, biopesticides are often consistent with certified organic food production, which has seen significant growth in the U.S. market (Dimitri and Greene 2002). But this is not to suggest that all biopesticides meet the National Organic Program guidelines. The popularity of biopesticides has increased substantially in recent years with enhancements in effectiveness and with consumer preferences toward healthier food products and elevated environmental concerns (Thakore 2006; Joshi 2006). Extensive research over the past 20 years has enhanced the effectiveness of biopesticide use, while techniques for mass production, storage, transport, and application of biopesticides have reduced production and operational costs of adopting biopesticides (Uri 1998). However their adoption is largely restricted to niche markets (Gaugler 1997) and most IR-4 Project registration assistance is sought for biopesticides produce by small businesses and individual scientists (Braverman et al. 2006). The EPA encourages the development and use of biopesticides. Because biopesticides are naturally occurring, they pose fewer risks than conventional pesticides, and the EPA generally requires much less data for registration. However, the EPA always conducts rigorous reviews of any pesticide, as mandated under FQPA to ensure that pesticides will not have adverse effects on human health or the environment. For the EPA to be sure that a biopesticide is safe, the agency requires that registrants submit the relevant data on the composition, toxicity, degradation, and other characteristics required of chemical pesticides. The IR-4 Biological and Organic Support Program provides assistance in meeting EPA data requirements for registering biopesticide solutions across most agricultural crops and advances the development and implementation of biological solutions. In addition, the IR-4 Biological and Organic Support Program, along with additional support from NIFA and Agricultural Research Service, encourage the development of biopesticide solutions through competitive grants for biopesticide research. The program also partners with the EPA to provide funding for demonstration projects using biopesticides. The awards are extremely competitive as only about 40 percent of requested funds are awarded each year (The IR-4 Project 2008). The IR-4 Food Program When established in 1963, the IR-4 project was established to include specialty crops on pesticide labels. At the time, there was no distinction between food and horticulture directives. In 1977, the IR-4 established a program that focuses on horticulture needs and one that focuses on food agriculture needs. The later became the IR-4 Food Program, where priorities and issues specific to minor-use food crops can be addressed. With this focus, the Food Program has evolved over time to keep pace with grower needs and facilitates the registration of and adoption of new, reduced-risk pesticides to replace older pesticides pulled from the market. According to the 2007 Census of Agriculture, vegetables, melons, fruits and tree nuts the largest component of minor-use food crops make up about 25 percent of total production of agricultural food crops, or about $33 billion annually. While the total value of sales is significant in the aggregate, many crops make up this category, such that any one crop makes up a small component of total sales. This limits the attractiveness of pesticide companies to pursue registration for each specialty crop. The Food Program works with growers to establish minor-use, food crop priorities that instruct the Food Program on which commodity-pesticide registration projects to pursue. 247

248 Despite the establishment of the Ornamental Horticulture and Biopesticides and Organic Support Programs, the Food Program makes up the largest component of the IR-4 annual operating budget. Of the total 2009 IR-4 budget, approximately 80 percent can be accounted for pursuing registration under the Food Program. However, the delineations across programs are not easy to make as field trials and laboratory work may be shared across food and horticulture programs and many efforts, such as IPM and educational projects, transcend program boundaries. Estimating the Economic Impacts of the IR-4 Project The economic impact estimates in this report follow well-established economic modeling practices for estimating all private transactions associated with IR-4 activities. Such transactions include all direct expenditures of the IR-4 Project, which also include in-kind industry and SAES expenditures for the administration and research around pesticide registration in pursuit of the program objectives. Additionally, estimated industry productivity impacts that arise through access to pesticide solutions that would logically be restricted in the absence of the IR-4 Project are estimated. Industry productivity impacts are limited to farm-level direct effects in terms of added output and revenues attributed to pesticide access. 2 Because this report limits research to private transactions, and hence returns to expenditures, it does not purport to measure the true social costs of pesticide usages that include public health and environmental quality aspects (Headley 1975). In addition, the report does not purport to measure the true cost of allocated public and private funds to IR-4 activities in terms of the value of foregone uses of such funding. Calculating the economic impact of the IR-4 Project follows a traditional expanded input-output (I- O) approach for impact assessment. I-O approaches of impact assessment have an enduring history in economic modeling since the 1930 s and is the subject of extensive economic research. The presentation below provides a cursory description of the I-O approach and limitations. Appendix A of this document provides a more complete description of the I-O approach and the model used to estimate economy-wide impacts. The I-O approach starts with a social accounting matrix (SAM), which represents a double-entry accounting system that tracks the transactions of industries and institutions within the study region. Industries represent productive activities defined along commodity types, institutions represent nonproducing sectors such as households and governments within and outside of the region, and the region is defined as the whole of a nation or any sub-part of the nation. Transactions include the purchases of goods and services across industries as intermediate inputs to production and the purchases of goods and services for final use by institutions. The SAM also records trade transactions with other regions as imports and exports. The SAM is a true representative model of the national economy reflecting the exchange of funds across all industry sectors and institutions. This framework tracks transactions across all sectors of the economy via linear mathematical equations. Therefore, an increase in economic activity in one sector will result in changes in economic activities of all associated industries and institutions in fixed proportions. The SAM used in this analysis is adopted from estimated Benchmark Input-Output Accounts reported by the Department of Commerce, Bureau of Economic Analysis (Bureau of Economic Analysis 2010; Minnesota IMPLAN Group Inc. 2004). 2 As noted below, the modeling framework explicitly assumes no price effect of added or restricted industry output. 248

249 Several implicit and explicit assumptions are inherent in the I-O framework. First, the I-O model employs strictly linear relationships across industries and institutions. While such linear relationships simplify the modeling design and solution, it implicitly assumes no externalities, constant returns to scale, and no capacity constraints. An externality occurs if benefits or costs are incurred by parties that are not directly engaged in direct or secondary transactions. Constant returns to scale imply fixed productivity of all sectors regardless of the change in scale of operations. It seems plausible that scale economies should exist in shared resources across IR-4 research projects. However, the loss of precision due to the assumption is likely to be minor. The last potentially restrictive assumption maintains that land, labor, capital, and intermediate inputs 3 are not constrained by availability that would otherwise result in price changes. However, for relatively small impacts, this assumption is generally not an issue. Other restrictive assumptions of this framework exist but do not necessarily pertain to the analysis at hand. For an introductory treatment of the assumptions of I-O modeled impacts, see Coughlin and Mandelbaum (1991). A more complete, textbook, treatment can be found in Richardson (1972). Total economic impacts are generally calculated as the sum of three components. The change being modeled itself is termed the direct effect. The direct effects set into motion a chain of secondary transactions across the economy including indirect and induced effects. Indirect effects are all the transactions necessary to supply the inputs to accommodate the new direct sales. Induced effects are new expenditures from income. These include consumer spending associated with increased wages and government expenditures from added tax revenues. The induced effects also lead to purchases that give rise to additional indirect effects, as households and government increase the demand for final goods and services sets off a second chain of transactions across. The total effect can be characterized by the following equation, Total Effect = Direct Effect + Indirect Effect + Induced Effect. Total effect is the total change in economic activity and can be measured in terms of income, employment, output or gross domestic product. Direct effect is the measure of the force of change postulated to cause the total change in economic activity. It represents an exogenous infusion to or drain on the economy. Indirect Effect is the measure of changes in inter-industry transactions resulting from the direct effect. Induced Effect is the measure of changes in transactions of households from changes in income resulting from the direct and induced effects. All effects are measured in terms of output (sales). However, more common measures of economic activity include the value of gross domestic product (the value of all final goods and services produced in an economy), employment and wages. A simple transformation converts output into other economic measures using baseline ratios to total output by industry. The IMPLAN Pro Version 2.0 (IMPLAN) software environment is used to provide the I-O economic impact modeling framework of the IR-4 Project research activities. The model is specified using economic and demographic measures from a host of government statistical reporting agencies including the Bureau of Economic Analysis, Bureau of Labor Statistics, and the U.S. 3 Purchases by businesses from businesses for the production of goods and services 249

250 Census Bureau (Minnesota IMPLAN Group Inc. 2004). The structure of the model relies on the social accounting matrix that is a restatement of the Annual Industry Accounts provided by the Bureau of Economic Analysis. This social accounting matrix is specified in terms of output which is the sum of all goods and services provided within the economy. The IMPLAN model provides the conversions from output to gross domestic product, employment and wages internally. IMPLAN Pro has 440 industry sectors at its most disaggregate level. Such industry detail affords detailed analysis but is too expansive for forming economic impacts. Hence, industry sectors are aggregated along functional lines replicating NAICS industry aggregates at the three-digit level except for NAICS (Environmental Consulting Services) and NAICS (Other Scientific and Technical Consulting Services), which were aggregated into a single category; Environmental Consulting. This special category is necessary to isolate the direct effect of the IR-4 Project. A second special category, Specialty Crops, is established for the specialty or minor-use sector by combining vegetable and melon farming (NAICS 1112), tree-nut farming (NAICS ), fruit farming (NAICS 11131, & exc ), and greenhouse and nursery production (NAICS 1114) sectors. A final special category, Pesticides, is isolated as NAICS (Pesticide and Other Agriculture Chemical Manufacturing) to measure pesticide inputs to minor crop production. Direct Effects The first task to estimating the macroeconomic impacts of the IR-4 Project is to define and estimate the direct effects. Direct effects are broken out into three distinct categories to isolate the impact of the Food, Ornamental Horticulture, and Biopesticides & Organic Support Programs. In addition to direct expenditures of the IR-4 Project, each program contributes to industry impacts through reductions in loses to pests, and increases in product value. These industry direct effects are estimated for each program and detailed below. The next sections discuss estimates of direct expenditure impacts, or effect, and then discuss direct industry impacts. These direct effects are then used to calculate economy-wide impacts using the IMPLAN economic impact model. Direct Expenditure Effects Direct effects of the IR-4 Project include all IR-4 direct expenditures, all budgeted and in-kind SAES expenditures for IR-4, and in-kind expenditures by industry and government and non-government agencies. Several funding sources contribute to the total IR-4 Project direct effects, where IR-4 Project administration estimates that every dollar they receive in direct funding supports an additional dollar of in-kind expenditures. The total fiscal budget of the IR-4 Project, including the IR-4 Ornamentals Program and the IR-4 Biopesticides and Organic Support Program, exceeded $19 million in the fiscal year The FY 2009 USDA appropriations from USDA-NIFA were $12.0 million plus $650 thousand for biological control, while the USDA-ARS contributed $4.0 million and the USDA-Foreign Agriculture Service provided $500,000. The Directors of the state agricultural experiment stations, through the Multistate Research Funds, provided the IR-4 Project with $481,182. The commodity and crop protection industries and other grant-generating activity collectively contributed an additional $1.36 million, while the EPA contributed $1.00 million. Direct funding is augmented with in-kind contributions at a ratio of 1:1 (The IR-4 Project 2009) that contribute over $18.75 million to total value. That is, SAES host institutions, the crop protection industry, and regulatory authorities leverage IR-4 funded research with in-kind contributions toward reaching mutually beneficial 250

251 outcomes. For example, SAES host institutions contribute indirect and direct costs of carrying out field testing and technical assistance, while commodity and crop protection industries provides nonpecuniary test substance and analytical and technical assistance to help in the registration of pesticides for minor use. When combining the IR-4 Project total funding and in-kind contributions to research, total direct economic activity toward registering pesticides exceeds $38 million dollars, as shown in Table 2. Table 2: IR-4 Project 2009 Basis of Direct Effects (000 s) Source Funding USDA, National Institute of Food and Agriculture (NIFA) $ 12, USDA, Agricultural Research Service (ARS) $ 4, USDA, Hatch Grants (SAES) $ USDA, Foreign Agricultural Service (FAS) $ 500 USDA, Animal and Plant Health Inspection Service $ 172 Industry and Other Grants $ 1, U.S. Environmental Protection Agency (EPA) $ 100 In-kind research expenditures $ 18, Total IR-4 expenditures $ 38, Includes the IR-4 Ornamentals Program and the IR-4 Biological and Organic Support Source: IR Annual Report The total fiscal budget of the IR-4 Project, including the IR-4 Ornamentals Program and the IR-4 Biopesticides and Organic Support Program, exceeded $19 million in the fiscal year The FY 2009 USDA appropriations from USDA-NIFA were $12.65 million, while the USDA-ARS contributed $4.0 million and the USDA-Foreign Agriculture Service provided $500,000. The Directors of the state agricultural experiment stations, through the Multi-state Research Funds, provided the IR-4 Project with $481,182. The commodity and crop protection industries and other grant-generating activity collectively contributed an additional $1.36 million, while the EPA contributed $1.00 million. Direct funding is augmented with in-kind contributions at a ratio of 1:1 (The IR-4 Project 2009) that contribute over $18.75 million to total value. That is, SAES host institutions, the crop protection industry, and regulatory authorities leverage IR-4 funded research with in-kind contributions toward reaching mutually beneficial outcomes. For example, SAES host institutions contribute indirect and direct costs of carrying out field testing and technical assistance, while commodity and crop protection industries provides non-pecuniary test substance and analytical and technical assistance to help in the registration of pesticides for minor use. When combining the IR-4 Project total funding and in-kind contributions to research, total direct economic activity toward registering pesticides exceeds $38 million dollars, as shown in Table 2. The total IR-4 Project expenditures shown in Table 2 can be broken down into expenditures on each of the following three IR-4 Programs: the Food Crop Program, the Ornamental Horticulture Program and the Biopesticides and Organic Support Program. Of the $38 million dollars in total IR-4 Project expenditures, 83 percent, or $31 million dollars, is allocated to the Food Crops Program. The Ornamental Horticulture Program s expenditures total over $5 million dollars and account for over 13 percent of total IR-4 Project Expenditures. The remaining 4 percent of total IR-4 Project Expenditures is accounted for by the Biopesticides and Organic Support Program, whose expenditures total $1.5 million dollars. Table 3 shows the IR-4 Project Expenditures by Program. 251

252 Table 3: IR-4 Project Expenditures by Program 2009 Basis of Direct Effects (000 s) Expenditure Program 2009 Food Crops Program 31, Ornamental Horticulture Program 5, Biopesticides & Organic Support Program 1, Total Direct Effects 38, Source: A Strategic Plan for the IR-4 Project ( ) Industry Productivity Direct Effects A review of the academic literature on the returns to cost of pesticides provides industry impacts that arise from productivity outcomes of access to pesticide solutions for specialty and biopesticide options. To keep the analysis manageable, the impact is measured in terms of production changes only; therefore avoiding the enumeration of price impacts. Shifting prices have the potential to transfer the impacts of greater productivity to various economic sectors including pesticide manufacturers, land owners, farmers, wholesalers, and consumers to name a few. Generally such distributional effects only establish the allocation of the aggregate impact, not the aggregate impact. 4 The productivity impact section of this study estimates the anticipated economic gains to crop producers as a result of IR-4 Project-assisted registrations. The IR-4 Project provides data to support new EPA clearances and/or new tolerances for specialty crops that either enhances the productivity of crop farmers or mitigates losses to crop farmers. In this effort, the IR-4 Project contributes to the availability of newer, less toxic, pesticide products for minor use that affords producers more effective ways of mitigating economic losses from pests and for managing pest resistance. Measuring productivity gains is complicated by the heterogeneous options for pest control, inconsistent growing environments across the U.S. variations of pest pressure, and the ability to assign proportional yield loss to various stresses. Such heterogeneity creates varying degrees of impacts across the spectrum of applications (Carpentier and Weaver 1996; Norwood and Marra 2003). Since the 1970s few researchers have attempted to measure the aggregate productivity gains afforded by pesticides. To circumvent this deficiency, a meta-approach is employed that utilizes estimates across commodities, and across researchers to provide an average, or expected impact of pesticide availability on production with no accounting for the type of crop, geography, pesticide, method of application, or combined pesticide/crop interaction. Despite this, there is sufficient evidence to suggest that pesticides play a significant role in securing U.S. supply of food, fiber and energy from agricultural production. The US National Research Council advocates that pesticides are irreplaceable in the production of agriculture (Anonymous 2000). In quantifying productivity growth of U.S. agriculture, Jorgenson and Gollop (1992) note significant declines in productivity growth following the recall of DDT (Gollop and Swinand 1998). Knutson et al., (1990) estimated that a total ban on pesticide use in the U.S. would likely result in a cost of $41 billion per year in higher food costs and lower quality crops and livestock. Fernandez- Cornejo et al. survey a number of pesticide impact studies finding a broad range of impacts (1998). 4 Some distributional impacts may result in slight distortions of aggregate impacts. However, within the I-O modeling framework, where prices are explicitly assumed constant, such distortionary effects are precluded from taking place. 252

253 Some authors attribute the variance in estimated productivity impacts to the econometric techniques employed across pesticide productivity studies (Carpentier and Weaver 1997; Saha, Shumway, and Havenner 1997). But no consensus has emerged as to the most appropriate econometric method for valuation. The question becomes more difficult to address in light of the heterogeneous production responses of plant/pesticide combinations, differences in active ingredients and approaches to measuring active ingredients and varying pesticide practices across regions and crops. A meta-analysis abstracts from such estimation issues by combining the empirics across a wide spectrum of research that, on average, is the best estimate of the potential impact of availability of a wide range of pesticide applications for specialty crops (Alston et al. 2000). In their survey, Fernandez-Cornejo et al. found that the return per dollar spent on pesticide applications ranged from $11.90 to $0.11 with a mean and median of $3.66 and $2.50, respectively. We opt to use the more conservative measure of the median return of $2.50 for two reasons. First, where data is skewed, the median is the preferred measure of the expected impact because the median is robust to unusually large outliers. Second, where two options exist and there exists insufficient reason to favor one over the other, the most conservative value should be favored. Hence, the more conservative median meta-value of $2.50 return per dollar spent on pesticide applications will be used as the rate of return per dollar invested in pesticide application. To apply the rate of return, and therefore identify the impact of the IR-4 Project on crop output, total expenditures for pesticides for use on specialty crops must be established. Market data of pesticide expenditures for minor uses are not tracked. Hence, an indirect method of estimation provides total minor-use pesticide expenditures. Using IMPLAN data, pesticide expenditures make up about seven percent of total value of specialty crop output, or $6.41 billion in This compares conservatively to a 2001 EPA estimate of agricultural pesticide expenditures as a share of total sales of crops, nurseries and greenhouses in the 2002 Census of Agriculture (USDA: National Agricultural Statistics Services 2002; Kiely, Donaldson, and Grube 2004), which suggests that pesticide expenditures make up approximately percent of total horticultural sales. The more conservative estimate that pesticides make up seven percent of total value of output in 2007 is used to estimate total pesticide purchases in Direct and Economic Impacts of the IR-4 Food Program The 2007 Census of Agriculture estimates the market value of specialty crops included under the IR- 4 Food Program to be $53.38 billion (USDA: National Agricultural Statistics Services 2009). If seven percent of this value comprises pesticide expenditures, then pesticide expenditures make up $3.73 billion. Using the benefit cost ratio of $2.5 reported by Fernandez-Cornejo et al., pesticides are estimated to contribute $9.34 billion dollars. A report by the EPA generally notes that the IR-4 Project has contributed to 50 percent of the total existing and new pesticide registrations for specialty crop applications (U.S. Environmental Protection Agency 2001a). Hence, only 50 percent of total industry expenditures on agrichemicals are attributed to the IR-4 Food Crop Program. The direct impact of food crops productivity through the IR-4 Food Crop Program is therefore $4.67 billion dollars. These productivity estimates for the Food Crop Program are summarized in Table 4 5 This is compared to 4.97 percent reported by the Bureau of Economic Analysis for the 1997 U.S. Input Output Account Benchmark (Bureau of Economic Analysis 1997). The USDA: NASS, places this value at 4.26 percent of all farm productive expenditures (USDA: National Agricultural Statistics Services 2004). However this also entails grain crops and other activities not tied to specialty crop production. Specialty crop production tends to support a higher concentration of pesticide applications. Total value of pesticide expenditures is valued in 2009 currency. 253

254 below. This is in contrast to a 2007 study (Miller 2007) that estimates industry impacts of $4.56 billion with industry sales of $60.02 billion. The relatively large industry impact from 2007 arises from two sources. First, the market value of specialty crops increased to more than $67 billion in 2007 a $7 billion increase since the prior report. Second, for the U.S., pesticide expenditures share of total specialty crops sales increased from five percent in 2004 to seven percent in Table 4: IR-4 Food Crops Program Direct and Total Output Effects Effects ($ Millions) Direct Indirect Induced Total Program Expenditures Food Crops Program Industry Productivity Food Crops Program 3, , , , Total 3, , , , Two studies help to validate the productivity impact calculated here. Whittaker, Lin, and Vasavada (1995) find that restricting pesticide expenditures from $30 per acre to $6 per acre results in 13.7, 9.8, and 15.6 percent decline in farm profits for small, medium, and large farms respectively. Similarly, Pimentel et al. (1993) find that reducing pesticide use by 50 percent over 40 different crop groups would generally result in more than a ten percent reduction in yields compared to existing pest management practices. The current estimate of direct productivity impacts of 6.97 percent of total crop sales falls within this range and suggests that pesticide availability for minor uses contributes nearly 7 percent to total sector output annually. Direct and Economic Impacts of the IR-4 Ornamental Horticulture Program Similar to the IR-4 Food Program, the 2007 Census of Agriculture estimates the market value of specialty crops included under the IR-4 Ornamental Horticulture Program to be $13.68 billion (USDA: National Agricultural Statistics Services 2009). Using the more conservative estimate that pesticide expenditures make up seven percent of the market value, we find that pesticide expenditures comprise $0.95 billion. Again using Fernandez-Cornejo et al. s benefit cost ratio of $2.5., we find pesticides are estimated to contribute $2.39 billion dollars. Taking into account that only 50 percent of total floriculture industry expenditures on pesticides are attributed to the IR-4 Ornamental Program, the direct impact of floriculture s productivity through the IR-4 Ornamental Horticulture Program is equivalent to $1.19 billion in floriculture sales annually over all U.S. producers. This increase in productivity manifests itself into measurable direct impacts through increased net revenue for producers, who in turn generate economy-wide impacts through transactions to expand production or expand household expenditures. Table 5 below includes the industry productivity estimate for the Ornamental Horticulture Program. 254

255 Table 5: IR-4 Ornamental Program Direct and Total Output Effects Effects ($ Millions) Direct Indirect Induced Total Program Expenditures Ornamental Program Industry Productivity Ornamental Program , Total , Direct and Economics Impacts of the Biological and Organic Support Program Like estimating the industry productivity impacts of the IR-4 Food and Ornamental Programs, estimating the productivity impacts of the Biological and Organic Support Program presents challenges. Biopesticides are often associated with integrated pest management practices, organic farming and specialty crops. However, their application is not limited to such segments (Cao, Park, and McSpadden Gardener 2010; Rodgers 1993; Copping and Menn 2000). This makes establishing a basis of productivity impact in terms of sector sales difficult, and there currently are no comprehensive cost/benefit studies of biopesticide use in agriculture. Therefore, limited means exists for quantifying the contribution of biopesticides impact on agricultural output. The approach used in this report is to assume an identical, aggregate benefit/cost ratio of biopesticides as that of conventional pesticides. Testing such an assumption is complex (Copping and Menn 2000; Gan-Mor and Matthews 2003) and is outside the scope of this study. Hence, we caution the reader to recognize such shortcomings of the estimated agricultural productivity impacts. Because a recent report provides U.S. estimates of the sales of microbial biopesticide market, the calculation of the expected direct productivity effects is relatively straightforward. CPL Business Consultants provides global and national market reports and recently estimated the U.S. sales of microbial biopesticide to be about $101 million in 2007 (CPL Business Consultants 2010). According to this report, the market for biopesticide is seen growing by as much as 20 percent per year, while conventional pesticide usage has been in decline. We apply the same productivity factor of $2.50 for every dollar to estimate the direct productivity impacts of biopesticide access; suggesting that biopesticides contributes about $298 million to total sector output annually. Table 5 summarizes the productivity estimates of the Biological and Organic Support Program. Table 6: IR-4 Biological and Organic Support Direct and Total Output Effects Effects ($ Millions) Direct Indirect Induced Total Program Expenditures Biological and Organic Support Industry Productivity Biological and Organic Support Total

256 Macroeconomic Impacts The direct effects specified above form the basis of the economic impact estimates. Total expenditure impacts represent the direct and industry productivity impacts of research and administrative expenditures of the IR-4 Project. Program expenditures are assumed to equal the total program budget of $38.01 million. This is separated into three components; the Food Crop Program, the Ornamental Horticulture Program, and the Biological and Organic Support Program. When taking account secondary impacts expenditures include indirect and induced effects, research expenditures from the Food Crops Program budget generates about $ million in sales to the economy, while the Ornamental Horticulture Program and Biological and Organic Support Program generate $17.53 million and $5.08 million in sales to the economy respectively. However, program expenditures make up a small share of the total impacts of the IR-4 Project. Larger impacts accrue to growers afforded better tools for mitigating pest damage. Adding industry direct and indirect impacts from increased yields and produce quality, the overall program contributions to output is $13.8 billion, $3.5 billion and $299 million for the Food Crops, Ornamental, and Biological and Organic Support programs, respectively. Total program impacts are reported in Table 7, which summarizes Tables 4, 5 and 6. Table 7: Aggregate Direct and Total Output Effects Program Aggregate Effects ($Millions) Direct Indirect Induced Total IR-4 Food Crops Program 4, , , , IR-4 Ornamental Program 1, , , IR-4 Biological and Organic Support Total 6, , , , When combining the research expenditure impacts and the agricultural productivity impacts across all three programs, the IR-4 Project generates over $17.57 billion in total U.S. output. This compares to $12.92 billion estimated in 2007 (Miller 2007) but takes into consideration recent increases in minor-use production and provides the first estimates of the impacts of the Biological and Organic Support Program. While total U.S. output provides an instructive gauge by which to measure the total impact of the IR-4 Project, output impacts can be misleading. Output represent the sales of not only the value of crop production, but also the value of seeds and other material that go into the production process, and the value-added transactions necessary to generate final goods and services for consumption. Other measures provide a more compelling assessment of the overall effect the IR-4 Project has on the U.S. economy. Tables 8 to 10 convert output sales into employment, earnings and gross domestic product (GDP) for each IR-4 Project programs. 6 The IR-4 Food Crops Program provides the largest impact in terms of output and, hence, should produce the largest impacts in employment and GDP terms. Table 8 shows associated employment, labor income and GDP impacts of the Food Crops Program, suggesting that program expenditures and contributions to grower productivity generates nearly 30,000 jobs directly. Once accounting for secondary impacts, the Crops Program generates economic activity sufficient to support 87,792 U.S. jobs with labor income exceeding $3.5 billion. The IR-4 Food Crop Program and associated research is estimated to add nearly $6.1 billion to annual GDP. 6 See Appendix A for methodology 256

257 Table 8: Economic Impacts of the IR-4 Food Crops Program Direct Indirect Induced Total Employment 29,595 24,862 33,335 87,792 Labor Income ($ mill) , , Gross Domestic Product ($ mill) 1, , , , Similarly, Table 9 shows employment, labor income, and GDP impacts of research expenditures and increased grower productivity impacts of the IR-4 Ornamental Horticulture Program. In total, this program generates a total of 14,501 full and part time jobs with wages of $582 million, and it is estimated to contribute $1.0 billion to annual GDP. Table 9: Economic Impacts of the IR-4 Ornamental Program Direct Indirect Induced Total Employment 4,888 4,106 5,506 14,501 Labor Income ($ mill) Gross Domestic Product ($ mill) , Table 10 reports employment, labor income, and GDP impacts of research expenditures and increased grower productivity impacts of the Biological and Organic Support Program. The estimated employment and GDP impacts reflect the relative size of this program relative to other programs. Regardless, the program is estimated to generate 2,358 jobs with annual earnings of $87 million. The program is also estimated to add just over $155 million to annual GDP. Table 10: Economic Impacts of the IR-4 Biological and Organic Support Direct Indirect Induced Total Employment ,358 Labor Income ($ mill) Gross Domestic Product ($ mill) Adding Tables 8, 9 and 10 provides estimated impacts of the IR-4 Project. Such estimated aggregate economic impacts are shown below in Table 11, where the IR-4 Project generates an estimated 104,650 jobs, with earnings just under $4.2 billion. In terms of gross domestic product, the IR-4 Projects is estimated to contribute $7.25 billion annually to GDP. Table 11: Aggregate Economic Impact Summary of the IR-4 Project Direct Indirect Induced Total Employment 35,371 29,609 39, ,650 Labor Income ($ mill) 1, , , , Gross Domestic Product ($ mill) 2, , , , Section 18 impacts are shared-out to Biological and Organic Support and All other IR-4 Project Programs based on 2009 successful Section 18 petitions. Summary of Findings Specialty crop growers are at a disadvantage relative to their large-acreage crop counterparts in gaining access to pesticides. Because of the relatively small acreage employed for each specialty crop 257

258 commodity, the added sales from pesticide registration for minor-use are often not sufficient to cover the cost of registering pesticides for such applications. The IR-4 Project supports growers and the pest control industry in developing the necessary data for registering minor-use application pesticides. As minor-use crops make up a substantial component of the USDA-recommended dietary intake, it is important that producers have sufficient pesticide resources for assuring low-cost access to such specialty food crops. Additionally, effective pest management of our food and fiber production demands sufficient access to an array of pest management options for mitigating pest resistance while reducing environmental and health impacts. As about 70 to over 80 percent of project-supported registrations are for reduced-risk pesticides, the IR-4 Project s efforts have been instrumental in meeting the Food Quality Protection Act of With the Biological and Organic Support Program, the IR-4 Project is able to direct necessary resources to meet the U.S. goal of substantially decreasing the environmental and health impacts of agricultural pesticide use on 13.7 million acres of agricultural land. This report documents the estimated economic impact of the IR-4 Project s Food Crop Program, Ornamental Horticulture Program and Biological and Organic Support Program. Well-established methods of measuring direct and secondary economic impacts are used to gauge the contributions of the IR-4 Food Crop Program, the Ornamental Horticulture Program and the Biological and Organic Support program in terms of sales, employment and gross domestic product. It should be noted that estimated economic impacts do not take into consideration health or environmental impacts, or associated economic outcomes of such impacts, but rather quantifies the measurable contribution to economic output from program expenditures and grower productivity. These direct effects materialize into larger macroeconomic impacts once accounting for multiplier effects. The findings suggest that the IR-4 Project and associated programs contribute $7.3 billion to annual gross domestic product. Such economic activity is sufficient to support over 104,000 U.S. jobs with annual earnings that top $4.2 billion The findings presented in this report illustrates the importance of the IR-4 Project in terms of contribution to U.S. specialty crop output that includes a multitude of food crops necessary for households to meet USDA dietary guidelines, and contribution towards reducing agriculture reliance on older, more toxic varieties of pesticides. Public investment in the IR-4 Project is small relative to its measurable economic returns. These returns are realized across agricultural producers in all 50 states from limited expenditures in correcting a market failure in the agricultural pesticide industry; thereby leveraging benefits across a $67 billion industry. In essence, there is strong evidence that public investment the IR-4 Project provides economic returns well in excess of program costs. 258

259 Appendix A: The IMPLAN Economic Impact Model The Minnesota IMPLAN Group Inc. model for economic impact evaluation, IMPLAN Pro. 2 (Minnesota IMPLAN Group Inc. 2004) is a general application economic impact evaluation model based on a common economic construct known as a social accounting matrix (SAM). The SAM is a comprehensive accounting system that identifies all the monetary transactions between the sectors in an economy. The SAM is comprises a square matrix (number of columns equals number of rows) that represent individual sectors as both buyers and sellers. Each row represents the revenue earned by the corresponding sector while each column represents its expenditures (Isard et al. 1998, pp. 283). This construct builds a closed system that represents transactions within and amongst all sectors: inter-industry transactions; transactions between industries and government; transaction between industries and households; transaction between households and government; and the purchases and sales between the state economic sectors and the rest of the world. IMPLAN provides industry detail to 440 different industry categories including agricultural, goodsproducing, and service-providing industries. Institutions are broken out into households by income group, federal, state and local government sectors, and by import and export markets. The SAM also provides household and government purchases of goods and services. Additional transactions are recorded within the SAM including transactions across households, government transfers to households and household transactions to government in the form of taxes and fees. Because the social accounting system examines all the aspects of a local economy, it provides a comprehensive snapshot of the economy and its spending patterns. The I-O framework was first described by Francois Quesnay in 1758 and developed by Wassily Leontief (1986). The structure supports demand-driven responses, where changes in output demand in one industry materializes in changes in the demand for production of other industries. For example, an increase in local demand for printing services will spur demand for feed paper, ink, printer repair services and other goods and services required by printing companies. The beneficiaries of these direct transactions will increase the demand for inputs used in their respective production processes. Households that enjoy enhanced employment opportunities earn and spend more on goods and services and taxes. Such household impacts generate additional direct and secondary transactions across the economy. The extent to which initial stimulus generates such secondary transactions is hindered by the degree of purchases made outside the modeled region. Industries that purchase inputs from local suppliers generate greater secondary transactions than industries that tend to purchase inputs produced outside the state, holding all else constant. I-O models have become staple economic impact models for regional analysis (Blakely and Bradshaw 1989). I-O models provide a systematic and intuitive approach to estimating economywide impacts of a change in the local economy. This approach uses linear relationships to reflect production processes that equate industry inputs and outputs. The linear transactions that define a SAM are generalized in a set of multipliers that capture the full extent of transactions associated with any changes in the level of production in an industry. To exemplify, within the I-O analysis, the total impact is specified in value of transactions as, = + + (1) The I-O model takes changes in demand called direct effect and relates them to overall economic impact called total effect through a set of mathematical equations described above. The indirect effect is the value of secondary inter-industry transactions in response to direct effects. The induced effect is the value of transactions resulting from changes in income in response to direct effects. 259

260 Because the relationships are linear, the direct, indirect and induced effects can be specified as multiples of the direct effect and equation (1) can be restated as, = 1 + +, (1.1) where k 1 and k 2 greater than or equal to zero. More simply, Equation (1.1) can be restated as, =, (2) where k = (1 + k 1 + k 2 ). Equation (2) says that the economy-wide impact, Total Effect, is some multiple of the direct effect, where the multiplier takes a positive value equal or greater than one. The minimum value the multiplier can take, one, reflects the intuitive result that if the economy s output of agricultural products for example expands by $1 million dollars, the economy will expand at least by $1 million dollars. However, if the indirect and induced effects are not equal to zero, this $1 million increase in output will spur other industries to expand output of goods and services and will generate household income that are applied to the purchase of goods and services in the economy; generating a total economic impact greater than the initial $1 million expansion. Generally, the economic multiplier is specified as a ratio of the total to direct effects. Rearranging equation (2) provides, =, (3) where the multiplier, k encompasses all the direct, indirect and induced effects for a given industry and denotes the impact of a change in direct effects on the total economic system. Each industry in a region is characterized by its own multiplier k. Industries with expansive localized production chains will tend to have higher multipliers than industries that rely on suppliers outside of the modeling region. When there is adequate supply within the state, the state has more potential to retain the total effects of the industry. However, when producers have to depend on supplies outside the state, leakage occurs and part of the total effect is lost. All effects are measured in terms of output (sales). However, more common measures of economic activity include the value of gross domestic product (the value of all final goods and services produced in an economy), employment and wages. A simple transformation converts output into other economic measures using baseline ratios to total output by industry. Sector values for gross domestic product, employment and labor wages per unit of output are derived using the following equations for industry i. =,, =,, =,, The subscript 0 denotes baseline values not subject to change. These baseline ratios for each industry sector are used in conjunction with the social accounting matrix to provide impact measures on gross domestic product, employment, and labor wages. The I-O impact evaluation model requires several restrictive assumptions. First, the model imposes constant returns to scale, such that a doubling of output requires a doubling of all inputs. Second, technology is fixed with no substitution. These two assumptions impose that an increase in industry 260

261 output requires an equal and proportionate increase in all inputs. Additionally, supply is assumed perfectly elastic such that there are no supply constraints. This final assumption also asserts that all prices are fixed, such that an increase in demand for any commodity will not result in a price change for that industry. I-O models have been criticized on the grounds that some of these assumptions are overly restrictive and the magnitude of the bias generated by these assumptions are greater the larger the industry direct effects are relative the overall size of the industry (Coughlin and Mandelbaum 1991). Despite this criticism, I-O models have become a standard by which economic impact assessments are generated. 261

262 Bibliography Alston, Julian M., Connie Chan-Kang, Michele C. Marra, Philip G. Pardey, and TJ Wyatt A Meta- Analysis of Rates of Return to Agricultural R&D. In IFPRI Research Reports. Washington D.C.: International Food Policy Research Institute. Anonymous The Future Role of Pesticides in US Agriculture, edited by US National Research Council. Washington, D.C.: National Academy Press. Bailey, K. L., S. M. Boyetchko, and T. Längle Social and economic drivers shaping the future of biological control: A Canadian perspective on the factors affecting the development and use of microbial biopesticides. Biological Control 52 (3): Blakely, E. J., and T. K. Bradshaw Planning local economic development: Sage. Braverman, M. P., D. L. Kunkel, J. J. Baron, and R. E. Holm The IR-4 Program for Registration and Development of Organic Products and Biopesticides. In Crop Protection Products for Organic Agriculture: American Chemical Society. Bureau of Economic Analysis Benchmark Input-Output Accounts 1997 [cited May ]. Available from Benchmark Input-Output Accounts 2010 [cited November ]. Available from Cao, Chunxue, Sunjeong Park, and Brian B. McSpadden Gardener Biopesticide Controls of Plant Diseases: Resources and Products for Organic Farmers in Ohio. In Fact Sheet. Columbus, OH: Ohio State University Extension. Carpentier, Alain, and Robert D. Weaver Intertemporal and Interfirm Heterogeneity: Implications for Pesticide Productivity. Canadian Journal of Agricultural Economics/Revue canadienne d'agroeconomie 44 (3): Damage Control Productivity: Why Econometrics Matters. Americn Journal of Agricultural Economics 79 (1): Copping, Leonard G., and Julius J. Menn Biopesticides: A Review of their Action, Applications and Efficacy. Pest Management Science 56 (8): Coughlin, C. C., and T. B. Mandelbaum A Consumer s Guide to Regional Economic Multipliers. Review-Federal Reserve Bank of St. Louis: CPL Business Consultants The 2010 Biopesticides Market in North America. Oxfordhire, UK: Market Publishers: Market Report Database. Dimitri, Carolyn., and Catherine. Greene Recent Growth Patterns in the US Organic Foods Market. In Agriculture Information Bulletin. Washington, D.C.: Economic Research Service. Fernandez-Cornejo, Jorge, Sharon Jans, and Mark Smith Issues in the Economics of Pesticide Use in Agriculture: A Review of the Empirical Evidence. Review of Agricultural Economics 20 (2): Gan-Mor, Samuel, and Graham A. Matthews Recent Developments in Sprayers for Application of Biopesticides--an Overview. Biosystems Engineering 84 (2): Gaugler, Randy Alternative paradigms for commercializing biopesticides. Phytoparasitica 25 (3): Gollop, Frank M., and Gregory P. Swinand From Total Factor to Total Resource Productivity: An Application to Agriculture. American Journal of Agricultural Economics 80 (3): Hall, Franklin R., and Julius J. Menn Biopesticides: Use and Delivery. Totowa, NJ: Humana Press Inc. Headley, J. C The Economics of Pest Management. In Introduction to Insect Pest Management, edited by R. L. Metcalf and W. H. Luckman. New York: John Wiley & Sons. 262

263 Isard, W., I. J. Azis, M. P. Drennan, R. E. Miller, S. Saltzman, and E. Thorbecke Methods of Interregional and Regional Analysis. Brookfield, VT: Ashgate. Jerardo, Andy Floriculture and Nursery Crops Yearbook: 2005, ed M. Evans. Place Published: Market and Trade Economics Division, Economic Research Service: USDA (accessed. Jorgenson, Dale W., and Frank M. Gollop Productivity Growth in U.S. Agriculture: A Postwar Perspective. American Journal of Agricultural Economics 74 (3): Joshi, S. R Biopesticides: A Biotechnological Approach. New Delhi: New Age International. Kiely, Timothy, David Donaldson, and Arthur Grube Pesticide Industry Sales and Usage: 2000 and 2001 Market Estimates. Washington DC: Office of Pesticide Programs: EPA. Knutson, Ronald D., C. Robert Taylor, John B. Penson, and Edward G. Smith Economic Impacts of Reduced Pesticide Use. Choices 5 (4): Kunkel, Dan IR-4 and EPA Registration Process: Reaching New Highs in IR-4 Project Newsletter 39 (4):2 & IR-4 International Activities. IR-4 Project Newsletter 41 (3):3 & 11. Leontief, W. W Input-Output Economics. New York: Oxford University Press, USA. Miller, S. R National Economic Impact of the IR-4 Project. East Lansing: Center for Economic Analysis. Minnesota IMPLAN Group Inc User's Guide: IMPLAN Pro. Version 2.0. Stillwater, MN. National Agricultural Chemicals Association From Lab to Label-The Research, Testing, and Registration of Agricultural Chemicals. Washington, D.C.,. National Agricultural Statistics Services Census of Agriculture: United States: Summary and State Data. Vol. Volume 1, Geographic Area Series Part 51. Washington D.C.: U.S. Department of Agriculture. Norwood, F. Bailey, and Michele C. Marra Pesticide Productivity: Of Bugs and Biases. Journal of Agricultural and Resource Economics 28 (3): Pimentel, David, Lori McLaughlin, Andrew Zepp, Benyamin Lakitan, Tamara Kraus, Peter Kleinman, Favius Vancini, W. John Roach, Ellen Graap, William S. Keeton, and Gabe Selig Environmental and Economic Impacts of Reducing U.S. Agricultural Pesticide Use. In The Pesticide Question, edited by D. Pimentel and H. Lehman. New York and London: Chapman & Hall. Richardson, Harry W Input-Output and Regional Economics. New York: John Wiley and Sons. Rodgers, Paul B Potential of Biopesticides in Agriculture. Pesticide Science 39 (2): Saha, Atanu, C. Richard Shumway, and Arthur Havenner The Economics and Econometrics of Damage Control. Americn Journal of Agricultural Economics 79 (3): Thakore, Yatin The Biopesticide Market for Global Agricultural Use. Industrial Biotechnology 2 (3): The IR-4 Project A Strategic Plan for the IR-4 Project ( ). Princeton, NJ: The IR-4 Project The IR-4 Project: 2009 Annual Report. Princeton, NJ: The IR-4 Project. U.S. Environmental Protection Agency New Approaches to Minor Uses 2001a [cited April ]. Available from Regulating Biopesticides 2001b [cited December ]. Available from Types of Pesticides, September 30, 2010 [cited December ]. Available from Uri, Noel D Development and Use of Biopesticides: Implications of Government Policy and Consumers' Preferences. Technological Forecasting and Social Change 59 (3): USDA: National Agricultural Statistics Services Census of Agriculture. Washington D.C.: United States Department of Agriculture. 263

264 Census of Agriculture. Washington D.C.: United States Department of Agriculture USDA-NASS Agricultural Statistics Place Published: U.S. Office of Printing. (accessed May 2007) Agricultural Chemical Usage: 2006 Nursery and Floriculture Summary. Washington D.C Census of Agriculture: Specialty Crops. Washington D.C.: United States Department of Agriculture. Viray, Faye Aquino, and Robert Hollingworth The Use and Benefits of Reduced Risk Pesticides Since the Passage of the Food Quality Protection Act. IR-4 Project Newsletter 40 (4):1 & Whittaker, Gerald, Biing-Hwan Lin, and Utpal Vasavada Restricting Pesticide Use: The Impact on Profitability by Farm Size. Journal of Agriculture and Applied Economics 27 (2):

265 The IR-4 Project 50 Years of Sustained Success Jerry Baron, Robert Holm, Daniel Kunkel, Paul H. Schwartz and George Markle 1 265

266 Table of Contents Introduction.. 4 The Early Years 5 Leadership & Organizational Structure.. 6 Funding 13 Strategic Planning 15 The Food Program. 17 Ornamental Horticulture Program. 27 Biopesticide and Organic Support 30 Animal Drug.. 31 Public Health Pesticide Program.. 31 Crop Protection Industry.. 32 The Process Value & Impact. 36 Hall of Fame/Other Awards.. 37 The Future. 38 Appendixes 40 Page 2 of

267 INTRODUCTION Celebrating a half century anniversary for any government funded program is a significant milestone, and for the IR-4 Project s its 50 th year anniversary is no exception. Since 1963, the IR-4 Project has been the major factor in facilitating the registration of crop protection tools for U.S. specialty crop growers. Specialty crops are grown on limited acreage and often have a high economic value; collectively estimated at $67 billion annually in 2011 (Clark). Almost all food crops we consume, e.g. fruits, vegetables, nuts, herbs, and spices as well as non-food crops such as landscape plants and flowers are considered specialty crops. The pests that damage crops do not discriminate between major crops (corn, soybean, cotton, wheat/small grains, etc.) and specialty crops. Crop protection technology is often needed to prevent significant damage to the quality and yields of crops. However, the agrochemical industry often lacks the financial incentives to expand registration for their products to the specialty crops. This is due to limited sales, high crop damage liability concerns and the significant expense to develop the data to support a registration of a specialty crop. The same situation exists for minor uses on major crops. The lack of crop protection products for specialty crops and minor uses on major crops is called the Minor Use Problem and the IR-4 Project was formed to solve this problem for US growers. The IR-4 Project operates as a unique partnership between the U.S. Department of Agriculture (USDA) both the National Institute of Food and Agriculture (NIFA) (formerly called the Cooperative State Research Education and Extension Service or CSREES), and the Agricultural Research Service (ARS), the State Agricultural Experiment Stations (SAES), the U.S. Environmental Protection Agency (EPA), the agrochemical industry, commodity groups, and growers. In recent years, additional partnerships have been formed with USDA- Foreign Agricultural Service (FAS) which supports international specialty crop export activities, Animal Plant Health Inspection Service (APHIS) to work on selected invasive species, and the Department of Defense s Deployed Warfighter Protection Program to provide regulatory support for public health pesticides. The Mission Statement for the IR-4 Project is simply to; Facilitate Registration of Sustainable Pest Management Technology for Specialty Crops and Minor Uses. Stakeholders gain numerous benefits from the IR-4 Project s efforts, including: Growers--pest management solutions for traditional and organic farmers to maintain productivity and competiveness; Food Processors--a dependable, safe and economic food source; Consumers--a safe, wholesome, affordable, varied, and nutritional food supply. 267

268 From a humble beginning in 1963 with only two staff members and a $25,000 budget to a staff of 125 full time equivalent members and a budget of over $37 million ($19 million direct support and $18 million indirect/in-kind support), the IR-4 Project has made a major impact on U.S. agriculture with over 26,000 specialty crop registrations. THE EARLY YEARS In the late 1950 s, as a national system for the registration of pesticides continued to develop, the SAES Directors, university extension agents, and USDA recognized the need to develop processes for registering agrochemicals for use on specialty crops and for minor uses on major crops. The project concept began in early 1960 when the University of California proposed to the National Agricultural Chemical Association (NACA) the need for registration of chemicals on minor crops. NACA supported this suggestion and asked the Director of the California Agricultural Experiment station to determine if the State Agricultural Experiment Stations could participate in this type of work (Markle, Baron and Holm 2002). The Western Agricultural Experiment Station Directors approved this idea and solicited the cooperation of other regional associations. The Experiment Station Committee on Policy (ESCOP) agreed with the principle of the program and requested a feasibility study. The study indicated that most states had a similar problem and that not only was the project feasible but highly necessary to meet a host of needs. In 1962, the SAES Directors became extremely concerned about the legal availability of specialty crop pest management tools. A list of 548 urgently needed pest control product uses was developed. The SAES Directors requested the USDA s help to solve this Minor Use Problem and as a result the IR-4 Project was established on July 1, 1963 as an Interregional Research Project with the title: Evaluation of Current Data and Needed Research to Determine Tolerance Limits of Chemicals for Minor Uses on Agricultural Products. Because of the interest and concern expressed by the State of New Jersey, the National Headquarters and overall program coordination were placed on the campus of Rutgers University, College of Agriculture (since renamed Rutgers University School of Environmental and Biological Sciences) in association with the New Jersey Agricultural Experiment Station (NJAES). The NJAES titled the project: The Clearance of Chemicals as a Public Service. There were synergies in placing the program in New Jersey because the NJAES was involved in other major agrochemical projects on the fate of these chemicals on the environment. Also, New Jersey, at that time, was the headquarters of many agrochemical companies. 268

269 Several government agencies and industry groups endorsed the principal of the IR-4 Project and expressed interest in cooperation. They included the Food and Drug Administration, (FDA), the USDA-ARS s Pesticide Regulation Division (the precursors to the EPA s Office of Pesticide Programs), and the National Agricultural Chemicals Association (now called CropLife America or CLA). The importance of the IR-4 Project was demonstrated early in its history when on April 13, 1966, USDA proposed to cancel all No-Residue/Zero Residue registrations within a five year period. IR-4 received numerous requests to help save the older agrochemical uses that were not being defended by registrants due to the expenses involved. IR-4 developed and facilitated a strategy with interested parties to defend uses on specialty crops where the chemical was already being defended by registrants on major crops. By the end of 1967, IR-4 obtained extensions for 38 pesticides on 129 crops. LEADERSHIP & ORGANIZATIONAL STRUCTURE Since its inception, the IR-4 Program has operated under the guidelines for regional research as developed by the Cooperative State Research Service (CSRS) and subsequent successors. The project leadership consisted of two committees: an Administrative Advisory Committee consisting of a member from each of the four USDA agricultural regions, and a Technical Committee consisting of a voting member representative from each participating region and appointed by the director of the SAES, an Administrative Advisor, and a CSRS representative. Subsequently, the IR-4 National Director and the Agricultural Research Service representative were added to the committee as voting members. The Technical Committee was abolished in 1997 and the Project Management Committee (PMC) was formed to take its place with similar responsibilities. Below is a Photo from the 1966 IR-4 Technical Committee Meeting at IR-4 Headquarters at Rutgers University. Markle Compton Freed Walker Swift 269

270 The Project Management Committee (PMC) serves as the Board of Directors for the IR-4 Project. The PMC meets three times a year to develop policies and procedures, to set operational budgets within funding limitation, to review the status of ongoing programs, and to insure the program s overall goals are being met. The PMC members consist of the IR-4 Project Executive Director (formally called National Director), the four Regional Directors, the ARS Minor Use Program Director, the IR-4 Administrative Advisors (one for each of the four regions, and the USDA/ARS Administrator and the USDA-NIFA Director), the USDA-NIFA IR-4 National Program Leader and the Commodity Liaison Committee (CLC) Chair. The IR-4 Executive Director, the four Regional Directors, ARS Minor Use Program Director and the CLC Chair are voting members. The Chair for the PMC is elected from the voting members. A full roster of PMC/Technical Committee members are documented in IR-4 Project Management Committee/Technical Committee Representatives table, below. IR-4 Project Management Committee/Technical Committee Representatives* Northeast Region Administrative Advisor: Dan Rossi, Mark Robson, Bruce Carlton, Rod Sharp, Darrell Lund, Roger Wyse, David Brown, R. M. Hermann, G.F. Walton, W.C. Kebbard, Ordway Starnes Regional Director: David Soderlund, Richard Durst, Terry Spittler, John Burke, B.R. Wilson, Baily Pepper North Central Region Administrative Advisor: Regional Director: Southern Region Administrative Advisor: Regional Director: Western Region Administrative Advisor: Regional Director: ARS Administrative Advisor: Program Director: Doug Buhler, Gary Lemme, Kirklyn Kerr, Eldon Ortman, Roger Wyse, John Mahlstede, J. Collenbach, Robert Hollingworth, F. Matsumura, R. Ruppel, R. J. Sauer, P.A. Daum. J.E. Fahey, R.L. Janes, P.H. Woodley Mary Duryea, Neal Thompson, Vernon Perry, Howard Wilkowske, Marty Marshall, Cheng Wei, Willis Wheeler, Neal Thompson William Eden, C.H. Van Middelem Mary Delany, Mike Parrella, Andre Lauchli, George Ware, I Thompson, L. Rasmusssen, W.M. Dugger, D. Rolston, K.W, Hill, A.M. Boyce Ron Tjeerdema, Marion Miller-Sears, T. Shibamoto, Jim Seiber, W.W. Kilgore, Virgil Freed Sally Schneider 1, Nancy Ragsdale 1,, Richard Parry 1,, Ralph Ross 1, E. Knipling, Terry Kinney, T.W. Edminister ( 1 represent ARS Administrator) Paul Schwartz, Kenneth Walker IR-4 Executive Director: Jerry Baron, Robert Holm, Richard Guest, George Markle, Robert Kupelian, Charles Compton NIFA/CSREES/CSRS: Rob Hedberg, Monte Johnson, James Parochetti, H. Teague, Kenneth Dorschner, Robert Riley, R. J. Sauer Commodity Liaison Committee Chair: Rich Bonanno, Rocky Lundy, Jere Downing, Larry Elworth *Incumbent listed first followed by most recent Five individuals have served as the uppermost administrative head of the IR-4 Project and are responsible to the PMC for overall coordination of the program. The Technical Committee chose Charles C. 270

271 Compton, a well-known entomologist with experience in the university system and the agrochemical industry as the first National Project Leader. The other beginning employee was George Markle, who served as Compton s assistant, who later became Associate Director and Co-Director. During the 1970 s IR-4 Project Headquarters expanded from the initial staff of two to a 10-person program by the end of the decade. Compton retired in 1977 and was one of the early recipients of the IR-4 Hall of Fame Award for his many contributions. Compton was replaced by Robert Kupelian, a chemist with experience in the agrochemical industry. Kupelian, who s tenure as the as the National Director spanned from 1978 to Kupelian was instrumental in the establishment of the National Animal Drug Program, which was initially dovetailed with the IR-4 program. For a period, Markle and Richard (Dick) Guest served as Co-Directors until Guest became sole National Director in He was instrumental in leading IR-4 s response to FIFRA 88 and developing a strategy to respond to new regulatory demands of the Food Quality Protection Act of 1996 (FQPA) and encouraged IR-4 s efforts to promote work with reduced risk pesticides. Guest retired in Both Dick Guest and George Markle have been inducted into the IR-4 Hall of Fame. Robert (Bob) Holm was hired in 1998 to assume the Executive Director position after a long career in research and development management roles in the crop protection industry. He was instrumental in forging many partnership initiatives with the EPA and the agrochemical companies. This allowed IR-4 many the new opportunities to pursue new chemistries on specialty crops as part of the reduced risk strategy. After serving as the national leader for IR-4 for eight years, Holm retired in 2006 as the Executive Director. Bob Holm received the Agrow Lifetime Achievement Award based on his many contributions to agriculture, especially his IR-4 contributions. He was also inducted into the IR-4 Hall of Fame in Following Holm as IR-4 Executive Director is Jerry Baron. Baron joined IR-4 in 1986 upon completing his degree from North Carolina State University and has worked in numerous roles within IR-4 during his 25+ year tenure. He was instrumental in expanding and supporting IR-4 s international activities and establishing IR-4 s Public Health Pesticide Registration objective. Below are Photos of IR-4 s National/Executive Directors; from left to right: Dr. Charles Compton, Dr. Robert Kupelian, Dr. Richard Guest, Dr. Robert Holm and Dr. Jerry Baron. 271

272 The IR-4 Project Headquarters staff provides overall program coordination with the four regions, the USDA-ARS, the EPA, the crop protection industry, Commodity Liaison Committee and numerous other internal and external partners. This group is part of Rutgers, The State University of New Jersey and the New Jersey Agricultural Experiment Station and has been housed in various locations both on and off the Rutgers University-Cook Campus. The IR-4 Project Regional offices and Regional Leader Laboratories were established in 1975 to provide IR-4 with field and laboratory research capacity. The US is divided into four regions with the IR-4 Regional Offices/Laboratories being located in and associated with the host Land-Grant Institutions. The locations are: Northeast Region New York State Agricultural Experiment Station; Geneva, NY North Central Region - Michigan State University; East Lansing, MI Southern Region - University of Florida; Gainesville, FL Western Region - University of California; Davis, CA All of these units operate independently, receiving separate portions of the IR-4 grant from USDA- NIFA and under the leadership of a Regional Director (PMC member). Each Regional Director is responsible for the staff budget, and programs in their region managed by Regional Field Coordinators (RFC), Regional Laboratory Coordinators (RLC), and Regional Quality Assurance Coordinators (RQAC). The rooster of key regional research coordinators since the IR-4 analytical laboratories and regional offices were opened are documented in IR-4 Historical Key Regional Research Coordination Personnel table, below. 272

273 Northeast Region Regional Field Coordinator: Regional Lab Coordinator: Regional QA: IR-4 Historical Key Regional Research Coordination Personnel (Incumbent listed first followed by most recent) Edith Lurvey, John Martini, Paul Baker, Chand Watve Wlodzimierz Borejsza-Wysocki, Chris Lam, Pim Larson-Kovach, Terry Spittler Michelle Humiston, Barbara Anderson, Denise Snook, North Central Region Regional Field Coordinator: Regional Lab Coordinator: Regional QA: Southern Region Regional Field Coordinator: Regional Lab Coordinator: Regional QA: Western Region Regional Field Coordinator: Regional Lab Coordinator: Regional QA: ARS GA Lab WA Lab MD Lab Satoru Miyazaki, T. Dudek Sue Enhardt, Wayne Jiang, Dick Leavitt Zhongxiao Chen, Chris Vandervoort Michelle Samuel-Foo, Charlie Meister Wlodzimierz Borejsza-Wysocki, Jau Yoh, Promode Bardalaye, Neal Thompson Kathleen Knight, Sam Fernando Rebecca Sisco, Margaret Reiff, Ron Hampton, Rick Melnicoe, Harold Alford Matt Hengel, Chuck Mourer, Jim Stokes, Tom Archer Martin Beran, Jim McFarland Tom Hendrick, Don Wauchope, William Rhode Todd Wixon, Ron Sell, Les McDonough Emile Pfeil, Al Herner, Ken Hill All regions have an analytical laboratory with the exception of the Northeast Region. In 2008, the PMC made a decision to shut down one laboratory because the capacity to analyze residue samples far exceeded the funds available and IR-4 s ability to produce new residue samples in its field trials. Savings from the laboratory phase-out would be reinvested in the upgrading of equipment at the remaining laboratories The RFCs are responsible for working with stakeholders to identify needs and for assigning field residue trials at the Field Research Centers located within their regions from the projects prioritized the previous year by stakeholders at the annual Food Use Workshop. The final residue trial locations are coordinated with IR-4 Headquarters staff to ensure the studies are conducted in the appropriate EPA geo-climatic zones according to EPA guidelines. The actual field residue trials are conducted by the Field Research Directors (FRD) at research farm locations. The USDA Agriculture Research Service (ARS) Minor Use Program has its own funding and it works in close coordination with the Headquarters and Regions to conduct specialty crop residue and product performance at its dedicated sites. USDA-ARS also cooperates with ornamental efficacy trials. The program has been led since 1976 by Dr. Paul Schwartz who has provided leadership and continuity not only to the ARS part of the program but also the entire program through his role in the IR-4 Technical Committee/Project Management Committee where he has served multiple terms as the Chair. 273

274 Figure 1: Diagram showing the locations of the IR-4 Food Program Infrastructure. The IR-4 network includes a State Liaison Representative (SLR) in every state and US territory. The SLRs are chosen by the state/territory SAES Director. This individual is asked to provide support for their state specialty crop growers by conveying their needs to the IR-4 Program. A key responsibility of SLR s is to encourage the submission of PCR s to document the pest management needs of their specialty crop growers. A key external stakeholder group, named the Commodity Liaison Committee or CLC, was formed in 1991 to provide the program with guidance on how to best serve the specialty crop growers they represented. The CLC serves as a bridge between the specialty crop growers it represents and IR-4 to assure that the program continues to focus on important pest management problems. The CLC serve as an important stakeholder group to provide guidance and advice on ways in which the program can best serve the needs of specialty crop growers. Additionally, the CLC encourages its members, other commodity organizations and specialty crop growers to submit Project Clearance Requests (PCR s) to define pest control problems needing IR-4 support. The CLC also communicates the IR-4 mission to the broad agriculture community and provides grower level visibility on specialty crop issues. Another important role of the CLC is to support federal IR-4 funding and budget support initiatives to maintain a viable research and registration program. The historical listing of IR-4 Commodity Liaison Committee members is found in below. 274

275 IR-4 Commodity Liaison Committee members, Aerts, M Florida Fresh Fruit and Vegetable Assoc Murphy, L Society of America Florists Ahrens. D Twin Gardens Farms Obenauf, G CA Prune, Raisin, Walnut Allman, G Mint Industry Research Council Olszack, R Grower Arney, M National Watermelon Board Pittsz, M Cranberry Institute Balling, S Del Monte Phelps, L American Mushroom Institute Baumann, K WI Ginseng 2008 Prewett, R TX Vegetable Assoc Burger, L California Specialty Crops Committee 2008 Ratto, R Grower Bledsoe, B Village Farms Rawlins, S Farm Bureau Bonanno. R Grower Regelbrugge, C American Nursery and Landscape Assoc Botts, D Florida Fresh Fruit and Vegetable Assoc Romang, R Buurma, B Grower Schmale, L Society of America Florists Cranney, J California Citrus Quality Schreiber, A Agriculture Development Group 2009 Davenport, T National Grape Cooperative Scholz, T USA Dry Pea & Lentil Downing, J Cranberry Institute Sharp, J CA Strawberry Elworth, L PA Apple Marketing Sorbello, M NY Potato Ewart, W CA Citrus Spencer, B AZ Citrus Flood, B Del Monte Teffeau, M American Nursery and Landscape Assoc Freeman, R Farm Bureau Traino, P NJ Vegetable George, A US Hops Trinka, D MBG Marketing Giclas, H Western Growers Zellers, R MI Vegetable Humfield, T Cranberry Institute Zuleger, D WI Potato & Vegetable Assoc Jewett, V United Fresh Fruit & Vegetable Wegmeyer, T American Farm Bureau Keeling, J National Potato Council 2006 Kesner, C Cherry Marketing Institute Kodet, T Bruce Church Korson, P Cherry Marketing Institute 1995 Kurtz, E CA Lettuce Lister, A MI Cherry Committee Lundy, R Mint Industry Research Council Maurer, E Crop Life America McCloud, S Almond Board 1991 Melban, K CA Pepper Montoian, R CA Grape & Tree Fruit 1991 The first Chair of the CLC was Larry Elworth who represented the Pennsylvania s apple industry. The next CLC Chair was Jere Downing of the Cranberry Institute followed by Rocky Lundy, Executive Director of the Mint Industry Research Council. Lundy was passionate in keeping IR-4 on the appropriate path to help specialty crop growers find solutions for their pest management problems. His efforts with the PMC helped facilitate unprecedented expansion within the IR-4 Project. Equally important, Rocky often led fierce budget battles like the one in FY 2005 that resulted in a $1.7 million increase after an unexpected 11 th hour cut of 1.1 million in the FY 2004 budget. In 2012, Rich Bonanno, a vegetable and flower grower from MA took over the 275

276 leadership of the CLC. Bonanno coordinated specialty crop grower s response to the USDA s proposed consolidation of IR-4 with five Integrated Pest Management programs to form a new program called Crop Protection. Through his efforts, many in the specialty crop community including CLC members, members of the Minor Crop Farmers Alliance, individual growers and allied industries contacted government officials and encouraged them to remove IR-4 from this consolidation plan. Below is a picture from Commodity Liaison Committee educational luncheon in Rayburn House Agriculture Building, February, 2011 with Rocky Lundy as the speaker. FUNDING Government funding and support for the IR-4 Project started with the initial investment of $25,000 by the SAES in The funding source for this investment was off the top funds from Hatch Act or Regional Research Funds (RRF) account. These resources were provided to Rutgers University to cover the salaries of Dr. Compton and Professor Markle. The culture of fully utilizing in-kind contributions and partnership was established at the very beginning of IR-4. Here, several USDA Projects provided data to assist IR-4 with its mission. The cooperating Project included: Northcentral Project 19 - Fundamental problems associated with the accumulation of pesticide chemicals in soil; 276

277 Northcentral Project 33 - Pesticide residues in or on food, feed, and forage crops; North East Project 36 - Pesticides in or on raw agricultural commodities; Southern Project 22 - Pesticide residues in plant and animal products and soils; Western Project 45 - Pesticide residues their nature, distribution, and persistence in plants, animals, and soils. Funding for IR-4 through RRF increased to over $100,000 annually by During this time, the Project had proven its value and realistic efforts were being made to expand resources. In 1975, Congress allocated funds under Public Law Special Research Grants (SRG) to support the establishment of Regional Leader Laboratories (Regional Offices) which provided, for the first time, the opportunity for IR-4 to directly develop residue data. Field Coordinators were hired to manage the field research and analytical laboratories were established to analyze crops for residues. John Mahelstede, Associate Director at Iowa State University and IR-4 Administrative Advisor from the Northcentral Region was instrumental in obtaining these dedicated funds for these research operations. These new Special Research Grant (SRG) funds were provided with the oversight of USDA- Cooperative State Research Service (later renamed Cooperative State Research, Extension and Education Service-CSREES and now known as the National Institute of Food and Agriculture-NIFA). Since this first appropriation, this group has provided grants to IR-4 totaling nearly $ million. In 1976 ARS allocated $410,000 from its budget to initiate a minor use pesticide program. These funds were obtained thru the efforts of Waldemar Klassen, Paul Schwartz and Warren Shaw of the ARS National Program Staff. The majority of funds were given to ARS personnel at field sites and chemists at analytical laboratories to participate in IR-4 managed residue studies. From 1975 until 1990 the SRG and RRF funding gradually increased until it reached just under $2 million. It increased to $3 million in 1991 and by 1995 it had nearly doubled to over $5 million. In 1998 it went to over $8 million and has remained around $10-12 million from 2002 to the present. ARS funds also increased during this period from about $2 million in the 1990 s to around $4 million. This decade between 1980 and 1990 was very financially challenging for IR-4. During certain years, the President, in his fiscal year budget proposal, did not any recommend funding for the IR-4 Project. The IR-4 Project was in a budget category with other programs that were considered non-essential. Fortunately, due to the efforts of certain commodity associations, Congress kept IR-4 funded during their appropriation deliberations. 277

278 The crop protection industry also provides unrestricted grants that IR-4 can use where most needed such as contracted field sites that often cost more than SAES sites, laboratory, and report writing efforts as well as funding for other key programs and workshops, IR-4 was able to use the external unrestricted funding from the crop protection industry to continue programs. Since 1988, the combined contributions from the companies have exceeded $19 million to support IR-4 activities. Starting in 2010, IR-4 has faced some significant challenges with respect to funding and governmental reorganization. Adequate funding remains the most critical current and future challenge for IR-4. Since 2011 there have been cuts in federal government funding with the potential for more cuts in the future. The most devastating cuts occurred in 2013 in association with Budget Control Act of 2012 or The Sequester, Here, IR-4 funds were reduced by 7.6% These cuts forced IR-4 to reduce the number of new research projects that solve grower problems. Additionally, completion of some research projects was delayed, essential travel was reduced, planned laboratory equipment purchases were delayed and some personnel positions were not replaced. Complicating the funding cuts were large increases in operating expenses. These drastic cuts were occurring the same time fixed operational expenses are rapidly increasing. In February 2012, USDA released a proposal to consolidate the IR-4 Project with several Integrated Pest Management (IPM) programs. The President s Fiscal Year 2013 funding plan called for the transfer of funds traditionally provided for IR-4 activities and five IPM programs to a new consolidated program called Crop Protection. Many specialty crop growers and others in the minor use community had critical concerns about the impact of including IR-4 in this IPM consolidation plan. Over the years, the CLC has come to IR-4 s rescue when Congress was considering cutting the annual budget. However, it was never more important than in 2012 when the CLC led by Chair, Rich Bonanno, led an initiative of nearly 100 commodity/stakeholder groups supporting the continued independence of IR-4. Broad grassroots support informed Congress and USDA of the need to keep IR-4 as a stand-alone program and fortunately, the President s proposal was not enacted. With the diversification of IR-4 s research activities, there are new sources of funding. The Department of Defense, under a cooperative agreement with USDA-ARS, funds the public health pesticide program at approximately $250,000 annually. The USDA-Foreign Agriculture Service has funded much of IR-4 s international efforts. More recently, the World Bank, through it Standards and Trade Development Facilities grants program, has provided resources for international capacity building activities. The newest funding source is USDA-APHIS which has provided resources to do research work on invasive pests. A comprehensive accounting of IR-4 funding since the beginning is found in the Total IR-4 Project Funding History 1963 to

279 Total IR-4 Project Funding History (x $1,000) 1 FY RRF SRG ARS Animal Drug Global APHIS PHP Industry Misc Total $ $105 $250 $ $110 $560 $410 $1, $135 $1,200 $910 $2, $135 $1,200 $910 $2, $150 $1,164 $910 $2, $158 $1,164 $910 $2, $176 $1,213 $910 $2, $200 $1,440 $910 $240 $35 $2, $227 $1,440 $1,100 $240 $70 $3, $254 $1,440 $1,100 $240 $58 $3, $289 $1,440 $1,100 $240 $70 $3, $320 $1,369 $1,100 $279 $2, $318 $1,369 $1,100 $229 $70 $3, $337 $1,369 $1,100 $229 $9 $35 $2, $352 $1,369 $1,100 $229 $35 $3, $347 $1,975 $1,100 $226 $10 $71 $3, $433 $3,000 $1,100 $450 $12 $40 $4, $456 $3,500 $2,100 $429 $92 $70 $6, $482 $3,500 $2,100 $429 $97 $6, $490 $6,373 $2,100 $291 $9, $490 $5,711 $2,100 $160 $50 $8, $482 $5,711 $2,100 $460 $10 $8, $514 $5,711 $2,100 $481 $10 $8, $482 $8,911 $2,100 $594 $12, $501 $8,990 $2,100 $303 $11, $482 $8,990 $2,100 $355 $60 $11, $482 $8,990 $3,100 $786 $288 $13, $481 $10,485 $3,600 $443 $63 $15, $481 $10,743 $3,800 $1,040 $94 $16, $481 $9,549 $4,000 $1,577 $189 $15, $481 $11,142 $4,000 $1,623 $244 $17, $481 $10,667 $4,000 $1,156 $359 $16, $481 $10,667 $4,000 $1,485 $257 $16, $481 $11,367 $4,000 $29 $1,618 $563 $18, $481 $12,000 $4,000 $241 $250 $1,453 $234 $18, $481 $12,180 $4,000 $331 $250 $1,022 $328 $108, $481 $12,180 $4,000 $409 $155 $250 $1,022 $365 $18, $481 $11,913 $3,900 $124 $567 $250 $1,149 $278 $18, $444 $11,006 $3,570 $242 $591 $250 $1.299 $180 $17,452 TOTAL $15,236 $222,439 $84,640 $445 $1,373 $1,313 $1,250 $18,509 $4,835 $444,971 1 RRF=Regional Research Funds/Hatch Funds; SRG=Minor Crop Pest Management (IR4) line under USDA-NIFA Improved Pest Control appropriations; ARS=Agriculture Research Service allocation complement IR-4 activities; Animal Drug; Global; funds mostly from USDA=Foreign Agriculture Service; APHIS-funds for invasive species research; PHP-funds for Public Health Pesticide activities through a joint grant from Department of Defense and ARS; industry- unrestricted funds to assist IR-4 in its research mission; MISC-other sources of funds 279

280 The above funding discussion refers to the direct funds IR-4 receives from government and other sources. There are significant additional contributions of in-kind contributions from many sources. It is estimated that for every direct dollar allocated to IR-4 there is AT-LEAST one additional dollar of in-kind support from contributions by SAES, US EPA, crop protection industry, Canada and commodity associations. STRATEGIC PLANNING The 1989 Strategic Plan was the IR-4 Project s first attempt to use the strategic planning process to address current challenges such as FIFRA 88 and longer term issues which included the expansion of both the Ornamentals and Biopesticide Programs. The Ornamentals Program received additional funding during this decade as did the Biopesticide Program. The plan also called for the establishment of strategically located field research centers to conduct food use residue trials according to Good Laboratory Practice (GLPs) regulations, as well as expanding the capacity of the existing SAES residue laboratories. The 1995 to 2002 Strategic Plan reinforced the 1989 Strategic Plan s major goals while it stressed a major shift in the program s emphasis from supporting the re-registration of uses to safer/reduced risk pest control products while expanding the Biopesticide Program at the same time. The 2001 to 2005 Strategic Plan continued to emphasize the importance of responding to the FQPA by targeting safer or reduced risk chemistries and biological pest control approaches. This was critical because specialty crop growers were faced with losing many of their older chemistries due to concerns about their acute and chronic toxicity especially to farm workers and pesticide applicators as well as environmental fate and impact on non-target organisms. The fourth IR-4 Strategic Plan covered the years of 2006 to 2008 it was limited to only three years to synchronize future strategic plans with the USDA Project Review Process. This strategic plan expanded the scope of the original three core programs (Food Use, Ornamentals and Biopesticides) to include an initiative to pursue global harmonization of specialty crop residue levels (Maximum Residue Levels or MRLs). This new initiative was deemed important because domestic growers of specialty crops were looking to enhance export markets. However, pesticide tolerances in the US were often different from international standards. These differing standards restricted export to many foreign countries and serve as a trade barrier. The fifth IR-4 Strategic Plan was developed largely by stakeholder suggestions during a 2008 Strategic Planning Conference. This plan put efforts into enhancing all three existing objectives. This included: 280

281 Facilitate Identification of Pest Management Solutions to Answer Priority Grower Needs (Food Program) Harmonization of Maximum Residue Levels to Remove Pesticides as a Trade Barrier (Food Program) Invasive Species Management (Food and Ornamental Horticulture Programs) Registration Assistance for Products for Organic Markets (Biopesticide and Organic Support Program) Besides reinforcing the initiatives in the previous strategic plans, the current strategic blueprint calls for a new initiative to facilitate the registration of chemistries that manage arthropod pests of medical concern which has grown into the current Public Health Pesticides (PHP) Program. In addition to the IR-4 Project s Strategic Plan, there have been some noteworthy reports issued by the Federal government on the minor use issue. In 1991, Cooper Evans, then Special Assistant to President for Agriculture drafted a paper call Loss of Safe Pesticides for Minor Crops: An Analysis. The Executive Summary including the following points: Production of fruits, vegetables and other specialty crops is in serious trouble. Consumer demand is strong. Yet US producers may lose this market opportunity unless policies are changed to assure availability of safe effective pesticides Minor use pesticides are endangered for economic, not safety reasons. Agrochemical companies cannot afford to develop or keep them on the market Clearly, funding of IR-4 has not been adequate to meet the needs of agriculture. The Council for Agricultural Science and Technology issued a report in 1992 entitled Pesticides: Minor Uses/Major Issues (Council for Agriculture Science and Technology Report 1992), The conclusion of this report stated Solution of existing and anticipated minor crop/use pesticide related issues will require concerted and cooperative efforts by all parties including federal and state legislators and regulators, research, extension and marketing specialists, growers, and processors, manufacturers and formulators, and commodity groups. Only through the efforts of these parties can the needs of US minor crop producers be adequately addressed. Without such cooperative efforts, minor use issues will continue to escalate to the detriment of US agriculture, minor crop growers, and consumers 281

282 FOOD PROGRAM Since its inception 50 years ago, the IR-4 Project s main emphasis has been to support the regulatory approval of crop protection chemicals for specialty food crops and minor use on major food crops. Here the IR- 4 Project has conducted residue studies and submitted over 3500 tolerance petitions to the government that have resulted in nearly 16,000 pest control clearances on specialty food crops. The pest control tools made available to U.S. specialty crop growers through IR-4 initiatives have helped growers avoid economic losses due to numerous pests and diseases. In addition, IR-4 has helped U.S. specialty crop growers produce the world s safest food with strict adherence to modern safety standards for humans and the environment. The modern era for IR-4 started in 1975, when the USDA allocated funds to support the establishment of Regional Leader Laboratories (Regional Offices) which provided for the first time the opportunity for IR-4 to directly develop residue data. Scientific staff was hired to manage the field research and conduct residue analysis in the cooperating laboratories.. The guidelines and requirements for the registrations of food use crop protection tools, IR-4 s primary mission, have changed dramatically over the past 50 years from a rather unsophisticated (by today s standards) one administered by the USDA to the current highly complex program administered by the EPA. Additionally, a number of US pesticide laws were passed over the last 50 years that have had a dramatic impact on the way the IR-4 Program conducts business. Up to 1973, IR-4 regulatory submissions were made to the USDA-ARS s Pesticide Registration Division. EPA was established to regulate all potential environmental pollutants in December of Under this new Federal Agency resides the Office of Pesticide Program (OPP). Within OPP, EPA has always allocated resources to specifically manage minor use submissions via the Minor Use Officer. Some of the Minor Use support personnel in the early years of EPA include, C.L. Smith, Wade Fowler, Henry Korp, Clinton Fletcher and Don Stubbs. To assist IR-4, EPA assigned one of their regulatory scientist, Drew Baker to IR-4 Headquarters in His duty was to provide advice to IR-4 research managers on studies and to do a prescreen of regulatory submissions to ensure that all necessary information was clearly available. In 1982, Hoyt Jamerson was selected as the EPA Minor Use Officer and his unwavering willingness to work with IR-4 to resolve regulatory issues facing petition submissions was valuable in obtaining regulatory clearances. Jamerson was presented with the IR-4 Hall of Fame Award when he retired as a result of his many contributions to the overall accomplishments to food use program. 282

283 The period after EPA s formation and until 1988 was rather uneventful. IR-4 submitted quality data, EPA reviewed the packages and in most cases new uses were approved. However, the 1988 Amendments to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA 88), triggered a significant need for IR-4 to defend critical older chemistries. FIFRA 88 required the accelerated development of agrochemical residue data and their submission to the EPA using current (at that time) state-of-the-art analytical equipment and procedures to support the continued registration of pest control tools that were originally registered before November, This law placed tremendous data development burdens on the agrochemical industry registrants. IR-4 grower and commodity group stakeholders feared that many specialty crop and minor uses would not be defended by the registrants through this process due to the cost of developing the required new data to meet the tougher new guidelines. Because of this concern, IR-4 developed a strategy to defend as many as 1,000 uses considered vulnerable to cancellation due to re-registration data requirements. The plan of action also received support from Congress in the form of additional resources to IR-4 to develop the necessary data. During the 10 year period after 1988, nearly two-thirds of IR-4 s resources were tied up in this critical stakeholder-driven effort. The final accomplishment was that IR-4 was able to maintain the registrations of 700 uses deemed vulnerable. Other uses were not defended because the chemical registrant decided to cancel the entire chemical registration. In 1989, EPA s Office of Compliance extended the Good Laboratory Practice (GLPs) regulations beyond laboratory toxicology studies to include field studies. IR-4 was now required to operate under the GLP regulations. This resulted in some fundamental changes in IR-4 research operations including having dedicated units for IR-4 research, standard processes in many aspects of research, the establishment of the Quality Assurance Unit (QAU), enhanced recordkeeping and identifiable study directors at IR-4 Headquarters who serve as single point of study control. At this point, IR-4 stepped up its involvement with the crop protection industry and the National Agriculture Chemicals Association (NACA-since renamed CropLife America or CLA). Because IR-4 was a key and significant data submitter and policies and procedures undertaken in response to GLPs and FIFRA88 critically affected IR-4. IR-4 was asked to participate and serve on industry wide workgroups to help shape research practices. In this aspect, IR-4 personnel Baron and Schwartz were the primary authors of the initial crop zone maps or data regions for the US and working with NACA members were instrumental in determining the number of trials needed per crop in each region to establish a tolerance. Dr. Baron also led in the development of a standardized Field Data Notebook that still is the template of data collected in magnitude of 283

284 the residue studies. IR-4 continues to maintain a presence on appropriate CropLife America committees and workgroups. In 1993, IR-4 upgraded its GLP process with the hiring of specialized QAU staff and the implementation of the expanded IR-4 Field Data Notebook. Much of the credit for the establishment of the IR- 4 QAU staff and GLP compliance measures goes to Tammy (White) Barkalow who was the first formal QAU employee and currently oversees the 12 member unit. Measures of the QAU program s successes included over 130 EPA inspections without any negative citations. In November 2002, IR-4 management convened a Review Group to examine IR-4 s GLPs and QA process. Specifically, the Review Group was charged to evaluate the structure and operations involving GLP compliance, and to offer recommendations for increased efficiencies and cost reductions. Seven recommendations were offered by the Review Group which have since been implemented and has improved the ability of IR-4. In the mid-1990 s IR-4 became aware of the crop protection industry s shift in research and discovery strategies to newer chemistries that had desirable characteristics for consumers and the environment such as low toxicity, short environmental life, and high specificity for the targeted pest with little impact on non-target plants and animals. Because of this exciting new trend, IR-4 started focusing its efforts on this lower risk approach which later became known as the IR-4 Reduced Risk Chemistry Initiative. In 1996, Congress passed Amendments to FIFRA and the Federal Food, Drug and Cosmetic Act. These Amendments were collectively called the Food Quality Protection Act. These Amendments set a completely new, and much higher, standard for the reregistration of older agrochemicals and registration of new crop protection tools. FQPA imposed an additional 10x safety factor for children, required aggregate risk assessment which combined exposures to a single pesticide from all sources including the diet, water, and household use. (vs. earlier assessments that concentrated on dietary risks only), and cumulative risks from compounds with the same toxicity mechanism (i.e. organophosphates/op s as a group). The Act required that nearly all of the 10,000 chemical tolerances in effect in 1996 be reassessed by In addition to the new safety standards, there were some incentives in the FQPA language to encourage specialty crop registrations. The FQPA extended the exclusive 10-year data protection period for a registrant under FIFRA when specialty crops were added to product labels. For every three minor uses registered (within seven years of the initial registration) up to one additional year could be added to data protection rights for a maximum of three additional years. This provision to extend the exclusive marketing period has been a huge 284

285 incentive for industry to register minor uses and to work with IR-4 to develop specialty crop uses for their new chemistries. Many registrants are now taking advantage of this incentive and it has also been written into Canadian law as well as European Union law. The early years of FQPA implementation were not easy for EPA or IR-4. IR-4 went from 82 food crop clearances in 1996 to only one food crop clearance in This was due to the Agency s efforts to interpret and implement the FQPA passed by Congress in In the fall of 1998, Mr. Jim Jones, then Director of the Registration Division attended the IR-4 Food Use Workshop and worked with Bob Holm, to form the EPA/IR-4 Technical Working Group (TWG) which started meeting in 1999 with Mr. Jamerson and Dr. Daniel Kunkel as Co-Chairs. Hoyt was instrumental in that role until his retirement in 2004 when Ms. Barbara Madden assumed this role as Minor Use Officer and TWG Co-Chair. Some of the initiatives implemented through these TWG meetings in associations with EPA s Chemical Scientific Advisory Committee (ChemSAC) included the following: Petition Summary templates for easier/quicker review by EPA, Super Crop Groups which saved IR-4 over $1 million in laboratory and field trial expenses for Reduced Risk products (spinosad and azoxystrobin) and resulted in hundreds of new uses without generating any additional residue data. Screen Potential Research where EPA has agreed to pre-screened potential chemicals prior to the workshop in an attempt to help IR-4 focus on the chemicals with the clearest path towards registration. Chemicals classified as Red Light are not considered in the workshop, while Yellow Light materials are given higher scrutiny and Green Lights proceed without concern. Petition Bundling: The EPA worked with IR-4 to bundle or submit as many petitions on an individual active ingredient as possible and feasible in order to most efficiently utilize the Agencies resources for risk assessments and crop grouping opportunities. Reduced Risk Classification for Minor Crops: The EPA streamlined a format which IR-4 could use to propose studies to the Agency in a Reduced Risk Classification for minor/specialty crop. Work Share Program with California: The California Department of Pesticide Regulation (CDPR) has its own state regulatory review process to insure crop protection chemistries meet the standards set by state mandated guidelines. IR-4 helped facilitate this Workshare Program between the EPA and CDPR in 2000 where CDPR does regulatory reviews of selected IR-4 petitions important to California specialty crop growers with EPA granting the Federal registration, thus saving EPA valuable resources. 285

286 Education tours for EPA scientists: IR-4 arranges a field tour of specialty crop agriculture for EPA staff each year to help them better understand how pesticides are used by growers and to make them more aware of how important these products are for production agriculture. IR-4 s Methyl Bromide Alternatives (MBA) initiative started in 1998 and lasted to This initiative was critically important to certain specialty crop stakeholders. Methyl bromide is/was widely used by tomato, strawberry, pepper, cucurbit crops and ornamental growers as a soil fumigant to control a broad spectrum of soil diseases, nematodes, soil insects and weeds. However, methyl bromide is considered a Class 1 ozone depleting substance and is being phased out. IR-4 research, which was managed by Jack Norton and funded primarily through contributions from cooperating agrochemical companies, entailed field evaluations of alternative systems for strawberry and tomato with testing done in CA and FL by leading university researchers. In 2003, the program was expanded to peppers, eggplant, cucurbit vegetables, cut flowers, turf and ornamental bulb crops. The data developed by IR-4 helped commodity groups obtain critical use exemptions (CUE s) to enable the continued use of methyl bromide until economical and technically viable alternatives could be registered and incorporated into grower practices. More importantly, IR-4 facilitated the support of an alternative product (dazomet) for the use on strawberries and tomatoes as a soil treatment and another product (propylene oxide/carbon dioxide) for postharvest use on stored spices, nutmeats, in-shell nuts, cocoa and cocoa beans. IR-4 helped in the registration process for a new product, MULTI GUARD PROTECT, for soil use and expanded the use of propylene oxide by label amendments to include dry fruits. Since 2000, 70 to 80% of IR-4 s research effort has involved new pest control technologies which are considered reduced risk. This shift from a defensive FIFRA 88 program to a proactive reduced risk strategy in a few short years was accomplished through a two pronged approach consisting of partnering with the crop protection industry and educating specialty crop stakeholders. IR-4 recognized that without access to the new technologies it could not help its specialty crop growers with their control problems when the older chemistries were being greatly restricted or removed from the market entirely. IR-4 worked closely with the crop protection industry on new product development strategies that included specialty crops in addition to their traditional major new crop focus. A key part of this strategy was using crop groups where studies on a few key representative crops allowed the product s use on many similar crops in the crop group. Also, it became clear with reduced staffing in the agrochemical industry due to mergers and reduced funding for federal and state research/extension scientists, that the public group did not always have an opportunity to test the new products. IR-4 also instituted a publication entitled New Pest Control Products/Transition Solution List ( to inform all stakeholders and the general public about 286

287 the options and virtues of the new technologies available to assist in the transition away from the FQPA vulnerable products. In January, 2004 Congress passed The Pesticide Registration Improvement Act (PRIA-Fee for Service). This law has been reauthorized three times, most recently in PRIA ushered in a number of new challenges not only for EPA but also for IR-4. There were many procedural changes that not only required the agricultural chemical industry to pay millions of dollars for EPA to review their submission, some of which had been backlogged at EPA for several years but also required significant alternations in the way IR-4 made submissions. To ensure that IR-4 s petitions were being properly handled, EPA requested that IR-4 follow new procedures that include fee waiver letters, as well as Notices of Filing and for registration packages to be submitted on behalf of the registrants. As a result IR-4 has realized significant benefits from PRIA with the main benefit being a more predictable timetable for EPA decisions. IR-4 is also provided with a PRIA fee exemption on all tolerance submissions. IR-4 s submissions fall under PRIA time lines; a 15 month EPA review period for most submissions in which a new uses is added to an existing registered pesticide. There is a 10-month timeline if the submission is considered by EPA to be a Reduced Risk use. Because of these time lines EPA has challenged IR-4 to increase efficiency by bundling as many uses as possible for each chemical, into a single petition and to routinely make no more than one submission for each active ingredient in a year. CROP GROUPING An early initiative for IR-4 which started in 1971 by Compton and Markle involved the concept of Crop Groups. This was the development of a model that allowed extrapolation of residue data from a few representative crops to many other crops in the same group. This allowed establishment of residue tolerances for the entire group of crops based on the residues in the key crops. This realty amplifies the impact of many IR-4 studies. The first edition of Food and Feed Crops of the United States (Magness, Markle and Compton 1971) has affectionately been termed the Greenbook and outlined the general grouping scheme with a focus on the type of edible plant parts (i.e. fruit, seed, roots, etc.) and their uses (vegetable, feed, etc.). The first edition included over 300 crops divided into large general groups; vegetables, tree fruits, tree nuts, oil crops, spices, grasses, non-grass feed, grains, etc. Within these large groups, the specific crops were subdivided or subgrouped by like parts such as root and tuber, fruit, leaves, pods, etc. The first edition was used as the basis for the 287

288 international FAO/WHO Codex Alimentarius crop groups classifications in 1978 and by the EPA in 1983 and again in 1995 for their early crop grouping scheme. The second edition of Food and Feed Crops of the United States by G.M. Markle, J.J. Baron and B.A. Schneider (Markle, Baron and Schneider 1998) continued to improve the regulatory processes with more standardization included in the scientific base. It serves as a complete source of food and feed information and the basis of a significant part of the current food safety regulatory guidelines with many specialty crops being grouped with larger consumption representative crop which are used for the crop grouping residue studies. The second edition contains over 1,000 scientific crop names along with their common and principal vernacular names and synonyms. This edition classified crops in 10 primary or large crop groups (i.e. vegetables, fruits, etc.) and 31 principal crop groups (i.e. root and tubers, citrus, berries, etc.). The last decade has seen dramatic changes in the crop grouping approach driven mainly by the rapid development of global food crop markets and import/export activities. In 2002, IR-4 sponsored an International Crop Grouping Symposium in Arlington, VA. The report of this Symposium (CGS) proposed an expansion of the scheme in place by adding a significant number of new crops and groupings. In 2003, the IR-4/EPA Crop Grouping Working Group, under the guidance of Dr. Hong Chen and more recently, Mr. William Barney, was formed to make the proposal part of federal regulation. To assist this effort and make it more global in nature, the International Crop Grouping Consulting Committee (ICGCC) was established in 2004, representing specialty crop, regulatory, and agrochemical experts from about 40 countries. This international effort has significantly helped to promote harmonization of the U.S., Canadian and Codex crop classification systems. The crop grouping activities have been the basis for many of IR-4 Program accomplishments over the past 50 year. Most recently, EPA and the Pest Management Regulatory Authority (PMRA) in Canada have approved nine new/enhanced crop groups. In 2007 EPA and PMRA codified changes in the Bulb Vegetables, Berries & Small Fruit groups. They also established a new Edible Fungi group. Three years later in 2010, the North American regulatory authorities modified the Fruiting Vegetables, Citrus Fruit, Pome Fruit groups and established the Oil Seed group to harmonize the two countries. Finally in 2012, there were publications of modifications to the Stone Fruit and Tree Nuts groups. In addition to the above, EPA and PMRA have accepted but not yet codified modifications to the Leafy Vegetables, Stalk, Stem & Leafy Petiole, Brassica Head & Stem groups. The formal approval is expected in the future. Without crop groupings and representative crops from each group for residue analyses, as was the reality during the first decade of IR-4 s existence, the old paradigm of conducting a residue study for each specialty 288

289 crop would still be in place. This would have resulted in less than 20% of the current specialty crop clearances over the past 40 years and probably only 10% with the new crop grouping initiatives. For each study IR-4 conducts, through crop grouping an additional 5-10 commodities can be added to product labels. In April 2012, the Codex Committee on Pesticide Residues accepted the North American based approach for the Fruit type crops. Not only did they accept the expansion of the groups but they approved the concept of representative crops and data extrapolation. The acceptance of representative crops is the critical component of the savings from using the crop groups. I n addition to the formal crop groups, IR-4, on a case-by-case situation proposed broader extrapolations of the crop group approach. IR-4 was able to take the leadership and propose to EPA that they extend the existing data supporting the reduced risk insecticide spinosad on key crops to multiple crops and crop groups. EPA agreed with IR-4 s proposal and when all the necessary data was reviewed the registration was used to support over 160 new uses. IR-4 has termed this innovative approach as Super Crop Grouping. This approach has since been successfully uses with the pesticides azoxystrobin, chlorantraniliprole, glyphosate, pyroproxfen, and spinetoram, INTERNATIONAL HARMONIZATION IR-4 s involvement with efforts to remove pesticide residues as a barrier of exports for US-grown specialty crops has been growing in importance over the last 20 years. Now it has become a common aspect of IR-4 s efforts that provide expanded use of the data generated by IR-4. In the mid-1990 s, Health Canada s Pest Management Regulatory Agency (PMRA) sent a representative, Douglas Rothwell, to attend IR-4 Food Use Workshops to explore opportunities for partnership projects. Canadian specialty crop growers were also represented by the Canadian Horticultural Council and were somewhat frustrated by not being able to use the new, reduced risk chemistries being made available to US specialty crop growers. This also led to significant trade barrier issues due to a lack of MRL s for the new crop protection tools in Canada, which restricted U.S. grower exports to Canada. To address these issues, PMRA and the Canadian Horticultural Council started conducting joint residue field programs with IR-4 in Over the next 5 years, a total of 6 joint residue trials had been conducted in Canada and the first joint U.S. and Canadian residue petition for fenhexamid on caneberries was submitted to PMRA by Johannes Corley in 2001 for a joint review with the EPA. 289

290 During the period from 2000 to 2002, Bob Holm, Jerry Baron and Dan Kunkel were invited to Canada on numerous occasions to consult with PMRA and Agriculture and Agri-Food Canada (AAFC and Canada s equivalent to the USDA) on setting up a minor crop support program similar to IR-4 s in Canada. The Canadian government made a major funding commitment in 2002 to its staff and resources and to AAFC to set up the Pest Management Centre (CN-PMC) along with 10 Field Research Centers to conduct the field portion of GLP residue trials and funds to conduct residue analysis. This allowed the CN-PMC Team to conduct 52 joint residue trials on 20 joint studies in 2003, compared to 6 trials during the entire period from 1996 to 2001, and resulted in much greater capacity for both the U.S. and Canadian efforts. This level of joint studies continues today and the partnership has only strengthened over the years. The recent agreement between the US President and the Canadian Prime Minister known at the Regulatory Cooperation Council, will likely further increase the amount of join research over the coming years. The Canadians hold their annual Minor Use Workshop prioritization meetings in the spring and attend the fall IR-4 Food Use Workshops and the National Research Planning Meetings. Joint projects are developed when CN-PMC projects match the ones selected at the IR-4 Food Use Workshop. IR-4 and the AAFC PMC management attend the NAFTA Technical Working Group Meetings and help facilitate joint project reviews between the EPA and PMRA, thus avoiding duplicate review costs. In 2004, the NAFTA Technical Working Group on Pesticides (TWG) approved the minor use joint review program that conducted joint reviews on seven chemicals in In 2007, CN-PMC started to assume the responsibilities for Study Director and Sponsor for some of the joint studies. By establishing a common MRL on a specialty crop from a particular crop protection products use, trade irritants between the two countries can be prevented before they have the potential to become a major problem for specialty crop growers on each side of the border. The U.S./Canadian specialty crop partnership has yielded valuable results for all stakeholders involved IR-4 has also been working with EPA and Canadian authorities to implement the pesticide related areas in President Obama s initiative with Canada s Prime Minister Harper known as the Regulatory Cooperation Council (RCC). Here IR-4 has been working with partners in Canada (Pest Management Centre of Agriculture and Ag-Food Canada) to develop even more harmonized processes and data generation that will allow the US and Canadian regulatory authorities to share resources to review data to further eliminate trade barriers and technology gaps between the two countries. 290

291 Much credit for the close coordination between the CN-PMC and IR-4 can be given to Shirley Archambault, who worked in that capacity for the Canadian Horticultural Council and for the past 10 years has served as the IR-4 Coordinator for the CN-PMC. Shirley also represents Canada at U.S. crop protection industry partnership meetings. In 2009, Manjeet Sethi joined the CN-PMC as Executive Director. Under his leadership, the programs have been expanded to include more work with IR-4 and the productivity of the organization has increased. IR-4 also regularly participates in global organizations that involve pesticide issues and commodities in trade and makes submissions to the Joint Meeting on Pesticide Residues (JMPR) which are used by the Codex Committee on Pesticide Residues to establish Codex Maximum Residue Levels for international trade. IR-4 provides support by assisting EPA, as part of the US delegations to both the CCPR and Organization for Economic Co-operation and Development (OECD) as well as the Working Group on Pesticides and the NAFTA Technical Working Group on Pesticides. IR-4 also plays a key role on the OECD Expert Group on Minor Uses, where a number of guidance documents have been prepared and released over the past year with regard to minor use issues. Additionally, IR-4 assists other countries, both developed and developing, as they begin to establish minor use programs and have signed MOUs with Canada, New Zealand and Brazil. The knowledge and expertise of IR-4 is occasionally sought and is highly valuable to these countries as their minor use programs evolve. IR-4 s international involvement is highlighted with the leadership role it played in the first and second Global Minor Use Summits. Both Summits were held at the United Nations Food and Agriculture Organization (FAO) Headquarters in Rome, Italy and co-organized by FAO, USDA, EPA, and IR-4. The first Summit was held in December 2007 and Chaired by Jerry Baron. The second Summit was held in February 2012 and Chaired by Dan Kunkel. Over 250 delegates attended the Summits representing over 50 industrialized and developing countries. The First Summit outcome was Five Action items and the second Summit resulted in a five year work plan that categorized items into short, medium and long term timeframes to support and address minor use issues. Starting in 2012, IR-4, in cooperation with USDA-Foreign Agriculture Service (FAS), has been conducting capacity building training programs in Southeast Asia, Africa and Central/South America. These programs cover all aspects of the conduct of Good Laboratory Practice in magnitude of the residue study including pesticide applications, laboratory analysis, data package development and Standard Operating Procedures. The goal of this work is develop research partners in this region who can cooperate on specific research studies when US priorities match the Asian priorities. Funds for these activities are being provided by the Standards Trade Development Facilities through the World Trade Organization. 291

292 ORNAMENTAL HORTICULTURE PROGRAM In the early to mid-1970, awareness was growing for the need to register materials for non-food uses (foliage and flowering plants in the greenhouse and out of doors; bedding plants; woody ornamentals; shade trees; and turf) because of the 1972 amendments to FIFRA. These specialty crops were also underserved, and growers and landscape maintenance personnel needed an adequate supply of registered tools to manage pests, diseases and weeds. The ornamentals industry approached T. W. Edminster (then Administrator of ARS) with the request that ARS assist with data development to register ornamental uses. He directed Dr. Schwartz to use $500,000 of the ARS Minor Use Pesticide funds and work with IR-4 to obtain ornamental registrations. To serve this segment of specialty crop agriculture, in 1977, the IR-4 Project added a new research objective that involved developing data to answer pest management voids in nursery and floral crops, forest seedlings, turf grass, and Christmas trees. This objective became what is now known as the Ornamentals Horticulture Program. This aspect of IR-4 involves the development and collection of crop safety and/or product performance/efficacy data to add new ornamental species and/or pests on registrations. The first IR-4 /USDA-ARS Ornamental Workshop was held in April 1977 in St Louis, MO. The needs of the industry were condensed into 5621 distinct project requests. The Second Workshop was held later that year in December in Dallas, TX and prioritized these requests. Ray Frank, Dick Lindquist and Chuck Powell led the prioritization with legendary marathon sessions lasting late in the evenings. Below is a photo of the four Founding Fathers of this objective. From left to right are Dr. Chuck Powell, Dr. Richard Lindquist, Mr. J. Ray Frank and Dr. Paul Schwartz. The first IR-4 supported registrations were for new uses of Banrot, Glyphosate, and Ronstar was approved in In 1981, a special project was initiated to determine which products were efficacious and should be labeled to control black vine weevil. Six products were tested on 20 ornamental species. The next 292