International Agricultural Training and Regulatory Services: A Small Business Perspective

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1 International Agricultural Training and Regulatory Services: A Small Business Perspective Dr. Sue Cohen President Center for Regulatory Research, LLC

2 Woman Owned Small Business Business Activities Contractor and Subcontractor Roles Industry Contracts Government Contracts University Contracts Overview Center for Regulatory Research, LLC

3 Company Center for Regulatory Research, LLC Woman Owned Small Business Limited Liability Company A Limited Liability Company (LLC) is a business structure allowed by state statute. LLCs are popular because, similar to a corporation, owners have limited personal liability for the debts and actions of the LLC. Other features of LLCs are more like a partnership, providing management flexibility and the benefit of pass-through taxation. Registered in Minnesota in 2005 Registered as a Government Contractor Central Contractor Registrant Database

4 Business Activities Regulatory Services Risk Assessment Research Training Company Activities Center for Regulatory Research, LLC

5 Regulatory Services Center for Regulatory Research, LLC assists biotechnology and beneficial insect and biopesticide companies with import/export permit applications. Permits require scientific literature reviews, knowledge of production processes and knowledge of modes of transportation Evaluation of containment facilities and development of standard operating procedures New product development, commercial feasibility and potential for product export Beneficial Insect: Cryptolaemus montrouzieri that feeds on mealybugs Biopesticide: Beauveria bassiana fungus controls whitefly GMO specialty crops

6 Risk Assessment Research 1) Risk Concepts 2) Species Distribution and Establishment 3) Climate Mapping and Analysis

7 Risk Concepts Risk = the likelihood and magnitude of an adverse event Risk Assessment = the estimation of risk Risk Management = the pragmatic decision making process concerned with what to do about the risk Risk Communication = the act or process of exchanging information concerning risk Risk Analysis = the process that includes risk assessment and risk management Pest = An organism whose undesired effects outweigh its beneficial effects as it relates to a specific time or place. (FAO definition) = Any species, strain or biotype of plant, animal or pathogen agent injurious to plants or plant products Source: Orr, R.L., Cohen, S.D., and Griffin, RL Generic non-indigenous pest risk assessment process. USDA-APHIS report, November 22, 1993, 40 pp.

8 Structure of Risk Analysis Risk assessment -Hazard identification -Hazard characterization -Exposure assessment -Risk characterization Risk management -Risk evaluation -Option assessment -Option implementation -Monitoring and review Risk communication

9 Pest Risk Assessment Model Standard Risk Formula Risk = Probability of Establishment X Consequence of Establishment Elements of the Model Risk = Pest with Host (Origin) X Entry Potential X Colonization Potential X Spread Potential Economic Damage Potential + Environmental Damage Potential + Perceived Damage (Social and Political) Source: Orr, R. L., Cohen, S. D. and Griffin, R. L Generic non-indigenous pest risk assessment process. USDA-APHIS Report, 40 pp, November 22, 1993.

10 Risk Management Hazard ID Risk Characterization Strategic and Operational Considerations Operational and Economic Feasibility Risk Reduction and Mitigation Monitoring

11 RISK MATRIX FOR DECISION-MAKING Impact Significant Moderate Considerable management required Risks may be worth Accepting with monitoring Risk Management Actions Must manage and monitor risks Management effort worthwhile Minor Accept risks Accept but monitor risks Extensive management essential Management effort required Manage and monitor risks Low Medium High Likelihood

12 Risk Assessment Guidelines 1) Ecological Risk Assessment: The process that evaluates the likelihood that adverse ecological effects may occur or are occurring as a result of exposure to one or more stressors. [US Environmental Protection Agency Guidelines] 2) Microbial Risk Assessment: A process that evaluates the likelihood Of human health effects occurring after exposure to a pathogenic Microorganism or to a medium in which pathogens exist. [ILSI, Revised Framework for Microbial Risk Assessment] 3) Pest Risk Assessment: Evaluation of the probability the introduction And spread of a pest and the magnitude of the associated potential Economic consequences. [FAO, IPPC, ISPM #5, 2010]

13 Risk Assessment Research Climatic Mapping and Analysis are useful for risk and environmental assessment processes Species distributions and establishment predicted by physiological responses of growth and development to climate variables of temperature, rainfall, soil moisture, dry conditions, and pest - host interactions. Biome Analysis: Based on the presence or absence of species in an ecological habitat described by climate and land type Climate Matching: Presence or absence of species in one climate area of the world is compared to other areas for eco-climatic similarity Climate Analysis: One or more species physiological requirements based on laboratory and/or field data are matched with existing monthly weather data

14 Biome Analysis: Risk Assessment Research

15 Climate Analysis: Risk Assessment Research

16 International Agriculture Training Center for Regulatory Research, LLC offers training to USDA Foreign Agriculture Service programs through the company or will jointly provide programs with university partners. The company has offered training courses since 2006 and has hosted participants from Ethiopia, Nigeria, Senegal, South Africa, Uganda, Yemen, Egypt, Oman, Jordan, Peru, Viet Nam, Thailand, Philippines, and Indonesia. Training courses on such topics as risk assessment, plant biotechnology, food safety, animal health, SPS issues, plant quarantine, and plant inspection have been offered by the company.

17 International Agriculture Training International Agricultural Training Programs USDA Borlaug Program: a semester program to take a course or learn research skills USDA Cochran Fellows Program: 1-3 week program with lectures and field trips USDA Faculty Exchange Program: a semester program designed for developing a course and/or research skills U.S. Agency of International Development: 1-5 year programs with company and/or university partners

18 International Agricultural Training Center for Regulatory Research, LLC International Agricultural Training USDA Cochran Fellows Program Senegal: USA Market Access

19 International Agricultural Training USDA Cochran Fellowship Program In 1984, Senator Cochran (Mississippi) had a vision for a new exchange program to help developing countries improve their agricultural systems and enhance trade links with the United States. He worked with the U.S. Congress and the U.S. Department of Agriculture to implement this goal, culminating in the creation of the Cochran Fellowship Program (CFP). Source:

20 International Agricultural Training USDA Cochran Fellows Program Since 1984, the U.S. Congress has made funds available to the CFP for training agriculturalists from middle-income countries, emerging markets and emerging democracies. Training opportunities are for senior and mid-level specialists and administrators working in agricultural trade, agribusiness development, management, policy and marketing from the public and private sectors. Source:

21 International Agricultural Training USDA Cochran Fellows Program Since its inception in 1984, the Cochran Fellowship Program has provided U.S.-based training for over 14,300 international participants from 123 countries worldwide. Source:

22 International Agricultural Training USDA Cochran Fellows Program (1) Assist eligible countries to develop agricultural systems necessary to meet the food and fiber needs of their domestic populations; and (2) Strengthen and enhance trade linkages between eligible countries and agricultural interests in the United States. Source:

23 International Agricultural Training Center for Regulatory Research, LLC Training Programs

24 International Agricultural Training Cochran Fellows Program: Market Access for Senegal Trainers/Consultants: Steve Clarke, Sue Cohen, David Ragsdale, Cindy Tong, Rob Venette Program Focus: Export of Asparagus and Melons to the USA Fellows: Minister of Agriculture, Plant Pathologist, Chief of Plant Quarantine, Farm Producers

25 Senegal: Market Access

26 Senegal produces peanuts, millet, rice, corn, sugarcane and fruits and vegetables for domestic consumption. Green beans, cherry tomatoes, mango and melons are exported to the European Union. Senegal: Market Access

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28 Introduction Senegal asked to be authorized to export asparagus to the US. This presentation shows the procedure outlined by APHIS for a pest risk assessment.

29 Stage 1: Initiation In the outline: Step 1: Document the Initiating Event(s) for the PRA In the Asparagus PRA: The PRA explains that Senegal requested authorization to export Asparagus

30 Stage 2: Assessment In the outline: Step 2: Assess Weediness Potential In the Asparagus PRA: Weediness Potential? YES Could it become a new weed in US? NO (already grows in US)

31 In the outline: Step 3: Identify and Cite Previous Risk Assessments In the Asparagus PRA: Several PRAs from countries denying or permitting importation are cited

32 In the outline: Step 4a: Pest Categorization List potential quarantine pests occuring in export region In the Asparagus PRA: Pest PRA presents a table with all potential quarantine pests Arthropods Geographic Distribution Acari: Tetranychidae Tetranychus urticae Koch Coleoptera: Chrysomelidae Crioceris asparagi (L.) Plant Part Affected Quarant ine Pest Follow Pathway References Senegal, U.S. Leaves No No (Bolland et al., 1998; CABI, 2004) Senegal, U.S. Leaves and shoot No Yes (NCSU, 1997b; Touré-Dieng, 1999) Table from Guidelines for Pathway-Initiated Pest Risk Assessments, 2007

33 In the outline: Step 4b: Identify Quarantine Pests Likely to Follow the Pathway Pests likely to follow pathway? Yes No Proceed to Step Five STOP In the Asparagus PRA: Seven pests need further analysis due to association with asparagus shoots, the part of the plant to be imported

34 In the outline: Step 5: Assess Consequences of Introduction Climatehost interaction Host range Dispersal pontential Risk Elements Economic impact Environmental impact In the Asparagus PRA: Pests pose little economic risk to asparagus, but most have high dispersal risk Elements from Guidelines for Pathway-Initiated Pest Risk Assessments, 2007

35 In the outline: Step 6: Assess Introduction Potential Quantity imported annually Not detected at port of entry Survive Postharvest Treatment? Risk Elements In contact with host material suitable for reproduction In the Asparagus PRA: Pests all score medium to high for introduction potential Survive shipment? Moved to area with environment suitable for survival Elements from Guidelines for Pathway-Initiated Pest Risk Assessments, 2007

36 In the outline: Step 7: Conclusion and Pest Risk Potential The PRA can comment on management options, but full analysis is reserved for other documents (A) Consequences of Introduction Summary (B) Likelihood of Introduction Pest Risk Potential (A)+(B) In the Asparagus PRA: The PRA concludes that the current pest risk is too high to import Asparagus and briefly discusses management options. Elements from Guidelines for Pathway-Initiated Pest Risk Assessments, 2007

37 Step 7: Conclusion and Pest Risk Potential (cont.) In the Asparagus PRA: The PRA includes a Pest Risk Potential table, showing scores of the potential pests Pest Consequences of Introduction (Cumulative Risk Rating) Likelihood of Introduction (Cumulative Risk Rating) Pest Risk Potential C. pallescens Medium (12) Medium (13) Medium (25) H. High (15) High (17) High (32) armigera I. aegyptiaca Medium (10) Medium (13) Medium (23) L. villosa Medium (10) Medium (13) Medium (23) M. hirsutus High (14) Medium (14) High (28) N. viridis High (14) Medium (14) High (28) S. aurantii Medium (11) High (16) High (27) S. dorsalis High (14) High (16) High (30) S. littoralis High (14) High (16) High (30) Example: C. Pallescens scores 12 for Consequences and 13 for Likelihood. Its risk potential: = 25 (Medium) Table from Importation of Fresh Asparagus, 2007

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39 Introduction Senegal asked to be authorized to export asparagus to the US. APHIS denied the request and gave suggestions for risk management that could allow future importation.

40 Options available for Risk Managment APHIS suggested the following types of management for Asparagus Control Program Pest-Free Areas Options for Management Monitoring Certification Inspections White Asparagus Mitigation Options

41 Some Options Previously Detailed Pest-Free Area Control Program Using chemical or mechanical means Certification Inspections

42 Mitigation Options Post-harvest and Prior to Shipping Pest-free packing house Wash Inspection Options Certification Inspections Pest-Free crates

43 Mitigation Options Post-harvest and Prior to Shipping Sampling and inspection Limits on Distribution and Transit Quarantine Treatments Options Intact Packing Safeguards Upon Arrival Pest-Free crates

44 Monitoring Pre-shipment Program Options Shipments Traceable to Origin To identify shortcomings or opportunities from improvement To be conducted under supervision of APHIS and Senegal NPPO personnel. Field Survey And Tracking Includes commodity cutting and trapping Regular surveys to determine presence of pests Growers receive certification based on results Stems must be packed in containers with identification labels indicating origin

45 White Asparagus Characteristics Grown under dirt so many pests avoided Admissible from Several countries Higher market Price Pests easy to distinguish on flesh If white asparagus is exported to US, APHIS will require the following: All stems show no green Certificate signed by Senegalese NPPO declaring stems free of quarantine pests

46 Senegal: Market Access USDA APHIS approved permit application and systems management procedures for production of white asparagus and shipment of white asparagus to the continental US on December 18, Originally, a timeframe of 4 years was projected for final approval but It took 9 years for regulatory approval.

47 International Agricultural Training Lessons Learned from Training: 1) Ask participants to fill out a form with special needs and interests 1) Interviewers who select participants some times do not have the background to determine what participants need in the way of training topics 2) Non-native speakers grasp information quicker with visual illustrations, field trips and hands-on exercises 3) A mix of oral presentations and interactive computer exercises reduce the fatigue of long hours working in a non-native language 4) Participants should fill out a one page evaluation form with numerical ratings. The ratings system on the form should be stated clearly to avoid misunderstandings.