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Overview of Risk Assessment and Risk Management of PIPs in the U.S.

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Presentation on theme: "Overview of Risk Assessment and Risk Management of PIPs in the U.S."— Presentation transcript:

1 Overview of Risk Assessment and Risk Management of PIPs in the U.S.
BRAG PD Meeting Chris Wozniak, Ph.D. U.S. EPA, Office of Pesticide Programs Biopesticides and Pollution Prevention Division June 14, 2013

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3 Background The EPA Office of Pesticides regulates the sale, distribution, and use of all pesticides in the U.S. in order to protect human health and the environment. Including: GMOs such as GE Plant-Incorporated protectants (PIPs) and Microbial Pest Control Agents within the Biopesticides and Pollution Prevention Division (BPPD) and GEMs.

4 EPA’s Regulatory Role Federal Insecticide, Fungicide and Rodenticide Act – (FIFRA) pesticides Federal Food Drug and Cosmetic Act – (FFDCA) food and feed safety Food Quality Protection Act - (FQPA) amends FIFRA and FFDCA; sensitive groups Endangered Species Act - (ESA) any impact on threatened or endangered species

5 Microbial Biopesticides
Bacteriophage Viruses (baculoviruses) Bacteria Fungi Algae Protozoa Not entomopathogenic nematodes*, mites or other biocontrol organisms We do regulate paratransgenic insect symbionts such as Wolbachia in mosquitoes * if symbiont is engineered, then it is regulated

6 Experimental Use Permits - Microbials
If GE, need a Notification Permit at any size field release If non-GE, need an EUP at > 10A Need a FFDCA tolerance any time pesticide may enter food / feed supply We do regulate GE paratransgenic pesticidal products

7 What is a Plant-Incorporated Protectant (PIP)?
“ a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. “ It also includes any inert ingredient contained in the plant, or produce thereof.” (40 CFR Sec ) e.g., antibiotic or herbicide tolerance marker used in the selection of a PIP product.

8 Experimental Use Permits - PIPs
Cumulative acreage > 10 A (4 HA) per year per pest requires EPA approval Food / feed tolerance required (at any size) EUPs are all time limited and require reporting of results as well as any adverse events – [6(a)2 of FIFRA] Products of EUPs are not eligible for advertising or promotion EUPs may only be used to collect data required for FIFRA Section 3 registration

9 FIFRA Registration Typically follows an EUP
FIFRA is a licensing statute – pesticides require periodic review and annual maintenance fee for sale and distribution Adverse events require reporting to EPA for the life of the product

10 RISK Ecological Human Health (acute & chronic) (acute & chronic)
Aquatic Terrestrial Populations & Subpopulations Special protection for children

11 How EPA Characterizes PIPs
Characterization Product Molecular Expression Levels Protein Methods Analytical

12 How EPA Assesses Human Health Effects for PIPs
Assessment Human Health Acute Oral Toxicity Biochemical Properties Amino Acid Homology Sequence

13 How EPA Assesses Environmental Effects for PIPs
Assessment Environmental Non-target Effects Fate Gene Flow

14 Gene Flow Considerations
An assessment of the impacts of gene flow is needed for EPA registration of PIPs Potential for Invasiveness / Adverse effects Sexual compatibility to wild relatives for the crop Any NTO effects due to gene flow For EUPs: Any compatible sympatric species will require containment or mitigation measures or data for the field test

15 Food / Feed Tolerance Federal Food Drug and Cosmetic Act
Residue of pesticide on food or feed requires a tolerance or exemption Toxicity profiles are used to determine safety of pesticide residues FDA enforces tolerance violations

16 FFDCA - Tolerances Tolerance actions include inert ingredients (markers) Tolerances can be for all crops / commodities or more restricted Trade with unapproved PIPs in commerce can be problematic

17 RNAi Regulatory Considerations
Lack of novel protein production eliminates allergenicity assessment requirements Nucleic acids have an existing exemption from the requirement of a food tolerance (FFDCA) DNA / RNA part of human / animal diet RNAi (siRNA, miRNA) already exists in cells High sequence specificity required for activity? We do not have extensive genomics information on all the NTOs we would like to assess (i.e., how much similarity exists?) Can be delivered as plant, microbial or biochemical

18 PRIA Fees Regulatory actions are fee-based
Fees depend on the type of action and the requesting organization PRIA provides for date of response Food use vs non-food use, first use, EUP vs registration all affect fees

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20 U.S. Government Biotechnology – Principal Regulatory Websites
US EPA PIP Website US Department of Agriculture Biotech US Food and Drug Administration Biotech Assistance for national database creation

21 Useful Links Regulation of Biotechnology for Use in Pest Management – U.S. EPA Introduction to Biotechnology Regulation for Pesticides – U.S. EPA Regulating Biopesticides – U.S. EPA Bt-maize and scorpion toxin NPV case studies

22 Useful websites

23 Questions ?


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