Biopesticides in the U.S. Risk Assessment/Risk Management Regulatory Processes & Emerging Technologies

Transcription

1 SLR/CLC Meeting Fort Collins, CO, April 2017 Biopesticides in the U.S. Risk Assessment/Risk Management Regulatory Processes & Emerging Technologies Russell S. Jones, Ph.D. Senior Scientist Risk Assessment Branch Biopesticides & Pollution Prevention Division Office of Pesticide Programs U. S. Environmental Protection Agency

2 Presentation Outline EPA Organization Pesticide Regulation Summary Overview of Biopesticides Biochemicals Microbials Plant Incorporated Protectants (PIPs) Registration and Data Requirements Emerging Technologies

3 Environmental Protection Agency Office of the Administrator Office of Air and Radiation Office of Chemical Safety and Pollution Prevention Office of Water Office of Research and Development Office of Land and Emergency Management Office of Enforcement and Compliance Assurance Office of Environmental Information Office of International and Tribal Affairs Office of General Counsel Office of the Inspector General Office of Administration & Resources Management Office of the Chief Financial Officer Ten Regional Offices Region 8/Denver CO, MT, ND, SD, UT, and WY 3

4 Office of Chemical Safety and Pollution Prevention (OCSPP) Immediate Office Office of Pesticide Programs Office of Pollution Prevention and Toxics Office of Science Coordination and Policy 4

5 Office of Pesticide Programs (OPP) Immediate Office Antimicrobial Division Biopesticides and Pollution Prevention Division Registration Division Health Effects Division Environmental Fate and Effects Division Biological and Economic Analysis Division Pesticide Re-evaluation Division Field and External Affairs Division IT & Resources Managment Division

6 Biopesticides & Pollution Prevention Division (BPPD) Immediate Office Biochemical Pesticides Branch Microbial Pesticides Branch Risk Assessment Branch Emerging Technologies Branch Environmental Stewardship Branch 6

7 Biopesticides And Pollution Prevention Division (BPPD) Established in 1994 to streamline registrations Reduced Regulatory Burden Bring safer pesticide products to market place Encourage uses in IPM strategic IPM programs

8 Pesticide Regulation Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Federal Food, Drug, and Cosmetic Act (FFDCA) Food Quality Protection Act (FQPA) Pesticide Registration Improvement Act (PRIA) Other Statutes: Endangered Species Act Migratory Bird Treaty Act Clean Water Act

9 Pesticide Registration Improvement Act (PRIA) Result of support from a coalition of industry, growers, environmental groups, and farm worker advocates. PRIA 1 (2004) established a registration fee-for-service system with specific fees and decision times by type of action PRIA 2 (2007) revised fee payment process and increased registration categories from 90 to 140 PRIA 3 (2012) Registration categories expanded from 140 to 189 Changes in Maintenance Fees Includes fee reductions and waivers IT set-aside: Improve tracking and databases 45/90 Day Technical Screen 9

10 Pesticide Registration Improvement Act (PRIA) PRIA 4 (proposed 2017?): Highlights* Seven-year extension (FY 2017 through FY 2023) Increases fee categories from 189 to New pest categories requiring efficacy data - New EUP categories and PIP categories Eliminates IT set-aside; creates GLP inspection set-aside Creates a set-aside to support efficacy guideline development and rule-making for public health pests. Incentives for new reduced-risk actives by higher fees on new conventional actives * May not reflect final language of Bill

11 Pesticide Registration Improvement Act (PRIA 4) House Agriculture Committee passed PRIA 4 (HR 1029) in February 2017 House Re-authorization passed on March 20, 2017 Full text of HR 1029 at:

12 Overview of Biopesticides 12

13 Characteristics of Biopesticides Substances, Organisms Found in Nature Or Structurally-similar synthetic substances Unique Modes Of Action Typically Low Use Rates Typically Reduced Risk

14 Characteristics of Biopesticides Inherently less toxic, or non-toxic, when compared to conventional pesticides. Many biopesticides affect only the target pest and closely related organisms Some are broad spectrum. Typically have low use rates and rapidly degrade in the environment Lower exposures to non-target organisms.

15 Benefits of Biopesticides Useful tools in IPM programs to decrease the use of conventional pesticides and reduce likelihood of pesticide resistance Often: Exempt from requirement for tolerances Have no PHI Have substantially shorter REIs 15

16 Biopesticide Categories Biochemicals Microbials Plant-incorporated Protectants (PIPS) OTHER BIOTECHNOLOGY PRODUCTS 16

17 Biochemical Pesticides Naturally-Occurring Substances Non-Toxic Mode of Action to Target Pest(s) History of Exposure to Humans and Environment with Minimal Toxicity US CRITERIA 40 CFR (a)(1)(i), (ii), & (iii)

18 Examples of Non-Toxic Modes of Action Growth and developmental changes e.g. Plant regulators, insect growth regulators Attractants, Repellents, Anti-feedants e.g. Pheromones Suffocation Desiccation Coatings (Irritants & Barriers)

19 Semiochemicals Pheromones Mating Disruptants Pheromone Traps

20 Non-Toxic Desiccants - Herbicides Acetic Acid (Vinegar) 20

21 Non-Toxic Coatings Kaolin clay - barrier & irritant 21

22 Naturally-occurring does not presume a non-toxic mode of action

23 Non-toxic substances can be lethal Physical Action Dissolving Action Suffocation

24 Biochemical Pesticides Other Uses May Include: Herbicides Insecticides Fungicides Nematicides Molluscicides

25 Microbial Pesticides Naturally Occurring and Geneticallymodified Microorganisms used as Pesticides: bacteria, fungi, viruses, and bacteriophages Uses may include: Herbicides, fungicides, insecticides, nematicides molluscicides US CRITERIA 40 CFR (b)(1)(2) & (3)

26 Microbial Pesticides Characteristics (May) Survive, reproduce in the environment Modes of action can include Competition Inhibition Use of pest as a growth substrate Toxicity Typically Low mammalian toxicity Target specificity Low use rates

27 Microbial Pesticides Mycoinsecticides Pathogenicity Mycotoxins

28 Microbial Pesticides Mycoherbicides Hemp sesbania control with Colletotrichum truncatum 28

29 Plant Incorporated Protectants (PIPs) Overview Key Features of PIPs 29

30 Plant-Incorporated Protectants (PIPs) Pesticidal substance (e.g., a protein) produced by a genetically altered plant and the genetic material needed to produce the substance To date, primarily Bacillus thuringiensis (Bt) transgenic crops to control insects Also, plant virus-resistant crops PIP Overview

31 Plant-Incorporated Protectants (PIPs) Products Derived from Biotechnology are Regulated in accordance with the Coordinated Framework for Biotechnology PIPs are regulated in coordination with USDA and FDA 2017 Update:

32 U.S. Oversight of Genetically-Engineered Plants 32

33 To be registered as a Biopesticide... Must contain a Biochemical, Microbial, or PIP active ingredient (or other biotech product) Must contain only approved inerts CANNOT contain a Conventional Chemical a.i. 33

34 Ingredients of Biopesticides General information on inerts Inerts that can be used in 25b products

35 New Biopesticide Registration Process Pre-Submission Meeting Submission of Application under PRIA Scientific Review of Data Label Review Decision Document (BRAD) for public comment (30 days) 35

36 Data Requirements Overview OCSPP Series Guideline study protocols Grouped according to intended uses and type of biopesticide Major disciplines of product characterization, mammalian toxicity, and ecological effects are tiered Information used in support of risk assessments Significantly reduced compared to conventional pesticides

37 DATA REQUIREMENTS Biochemical pesticides: Tables under 40 CFR Microbial pesticides: Tables under 40 CFR Plant Incorporated Protectants: 40 CFR 174

38 Biopesticide Data Requirements Product Chemistry, Product Analysis, Product Characterization Mammalian Tests Tier I Acute & subchronic toxicity, mutagenicity, developmental; pathogenicity (M only) Mammalian Tests Tier II Mutagenicity, developmental, immunotoxicity, applicator exposure; pathogenicity (M only) Non-Target Organisms Tier I Acute toxicity; pathogenicity (M only) Non-Target Organisms Tier II Environmental fate/expression Non-Target Organisms Tier III Chronic, Life Cycle, & Field Testing; Mesocosm Studies (M only) Mammalian Tests Tier III Chronic, longer term toxicity, carcinogenicity; infectivity analysis (M only) Non-Target Organisms: Tier IV Simulated or Actual Field tests (M only)

39 Biopesticide Data Requirements Initial Submission Product Chemistry, Product Analysis, Product Characterization Mammalian Tests Tier I Acute & subchronic toxicity, mutagenicity, developmental; pathogenicity (M only) Non-Target Organisms Tier I Acute toxicity; pathogenicity (M only) Product Performance (Efficacy): Public Health Pests Only

40 Exemptions from FIFRA Pheromones used in pheromone traps Foods used to attract pests Natural cedar chips, panels, etc Devices Minimum Risk Pesticides *(aka 25b list) *Not necessarily exempt FFDCA

41 Emerging Technologies Plant Biostimulants RNAi CRISPR

42 Plant Biostimulants Mixtures of naturally-occurring substances and/or microbes intended to: In small quantities, enhance plant growth/development/vigor Improve resistance to abiotic stress Increase nutrient and water use efficiency Improve soil characteristics Support growth/activity of beneficial microbes

43 Plant Biostimulants May consist of one or more of the following: Beneficial fungi or bacteria Seaweed extracts/other plant extracts Humates, organic acids, amino acids, oligosaccharides Hydrolyzed proteins, polypeptides Other similar inorganic/organic substances Plant hormones and other naturally-occurring plant growth substances

44 Plant Biostimulants Do not provide nutritionally-relevant fertilizer benefit to plants. Are not intended for use in the control of pests. Are they pesticides?

45 Plant Biostimulants FIFRA Section 2(u) includes Plant Regulators as substances considered to be Pesticides Are Plant Biostimulants = Plant Regulators? Plant Regulator = Pesticide Plant Regulator Claim = Pesticidal Claim No Federal statutory or regulatory definition for a Plant Biostimulant

46 Plant Biostimulants FIFRA Section 2(v) defines a Plant Regulators as: Through physiological action, does the substance or mixture of substances: Accelerate or retarding the rate of growth? Accelerate or retard the rate of maturation? Alter the behavior of plants or the produce thereof?

47 Regulatory Exclusions from the Plant Regulator Definition Plant nutrients & trace elements (e.g. fertilizers) Nutritional chemicals (not defined in FIFRA) Plant inoculants Soil amendments Vitamin-hormone horticultural products 47

48 Plant Biostimulant Guidance EPA has developed guidance for Plant Biostimulant (PBS) products and associated label claims that may be included in, or excluded from regulation under FIFRA Exclusions based on Substances Excluded from Regulation by FIFRA under 40 CFR (f)(1) & (2) and (g)(1), (2) & (3) and FIFRA Section 2(u): Includes guidance on Generic Product Label Claims for Products Not Covered by the Exclusions from the FIFRA Section 2(u) Definition of a Plant Regulator. 48

49 Ribonucleic Acid Interference (RNAi) Natural biological process Process identified in nematodes in 1998 Fire and Mellow win Nobel Prize in 2006 dsrna molecules used to inhibit gene expression Typically suppress production of protein necessary for a biological process

50 RNAi (Ribonucleic Acid Interference) Possible Pesticidal Applications Direct pest control Increase plant resistance to pests Decrease plant (weed) resistance to pests Suppress resistance to chemical pesticides May be PIPs May be spray-applied microbials/biochemicals

51 Clustered Regularly-interspersed Short Palindromic Repeats (CRISPR) A gene editing technique (CRISPR-Cas9) Natural process in bacteria virus resistance May be used to develop pathogen resistant crops -Rice resistant to bacterial blight and rice blast (Iowa State) -Blight-resistant potatoes (Penn State) -Wheat resistant to powdery mildew (China Academy of Sciences) Is it pesticidal?

52 EPA recognizes: Overall The value and benefits of biopesticides Continual advances in the science of biopesticide technology The ever-changing nature of the business. EPA is committed to: Approval of safer pesticides in accordance with PRIA timeframes; and Transparent, predictable processes.

53 For More Information To search for information on biopesticide active ingredients... To search for product labels using the Pesticide Product Label System (PPLS)...

54 For More Information Contact Cara Finn, BPPD Ombudsman Visit Us on the Web