1. USDA-APHIS Plant Pest Risk Assessments Science Issues and Research Needs Biotechnology Risk Assessment Grants Program 2015 Project Director’s Meeting

2. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service  Department of Agriculture (USDA-APHIS-BRS) PPA: Protecting against damage from plant pests and noxious weeds  Environmental Protection Agency (EPA) FIFRA: Regulating the safe use of pesticides FFDCA: Setting allowable levels of pesticides in food TSCA: Regulating toxic substances  Food and Drug Administration (FDA) FFDCA: Regulating safety of food, drugs, and cosmetics Regulation under the Coordinated Framework – 1986, OSTP

3. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Regulation Under the Coordinated Framework New Trait/CropAgencyReview Insect resistance in food crop (Bt corn) USDA EPA FDA Risks to plant health Environmental, food/feed safety of pesticide Food/feed safety Herbicide tolerance in food crop (glyphosate tolerant soybeans) USDA EPA FDA Risks to plant health New herbicide use Food/feed safety Herbicide tolerance in ornamental crop (glufosinate tolerant tulips) USDA EPA Risks to plant health New herbicide use Modified oil in food crop (high oleic acid soybeans) USDA FDA Risks to plant health Food/feed safety Modified flower color (blue poinsettias) USDARisks to plant health

4. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Regulation of GE products at USDA Law: Plant Protection Act Regulation: 7 CFR 340 We regulate if:  The organism has been altered or produced through genetic engineering (recombinant DNA techniques), and  The organism is produced using plant pests, or  There is otherwise a reason to believe that the organism is a plant pest.

5. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Regulation of GE Organisms at USDA  Not all GE plants are regulated by APHIS – there must be a plant pest component.  List of organisms we consider to be plant pests is in the regulations at 7 CFR 340.2  We have a formal process by which a developer can inquire and receive and answer as to whether a given GE plant is within the scope of regulations at 7 CFR 340.

6. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Regulation of GE Organisms at USDA  To date we have answered 28 letters of inquiry for plants.  Those completed since we initiated a formal process in 2010 are on our website.  Response times have ranged from 3 months to over a year and have averaged 6 months for the last six completed.

7. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Regulated Activities  If a GE organism is regulated, a Permit or Notification is required for the following activities: Importation Interstate movement Field test (confined release)

8. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Confined Field Tests  Field testing focuses primarily on confinement; a full data package on the GE trait is not needed.  Risk assessment relies on familiarity with the plant, the trait, and the environment.  Characteristics of the plant are often key: Is it outcrossing of self-pollinating? Is it weedy or invasive? Are there wild relatives? Can the plant or offspring persist after the test is over? Would the trait be expected to change the plants weediness, invasiveness, or reproductive biology?

9. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Petition Process for Nonregulated Status  After safety has been established through field testing and other research activities, a developer may petition APHIS to grant “nonregulated status” No longer a regulated article Free to be moved and planted without permits or further APHIS oversight.

10. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Petition Process for Nonregulated Status  Petition Evaluation Comprehensive scientific review – Team of scientists Crop biology and taxonomy Any genotypic differences Any phenotypic differences Field test reports for all releases conducted in the U.S. Relevant experimental data, publications and other data upon which to base a determination

11. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Petition Procedure for Nonregulated Status  APHIS BRS conducts two evaluations:  Plant Pest Risk Assessment to determine if the GE organism poses a risk as a plant pest (Plant Protection Act)  Environmental Assessment or Environmental Impact Statement to broader evaluate environmental impacts of APHIS-BRS decision (National Environmental Policy Act; NEPA)

12. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Petition Process for Nonregulated Status  Components of a Plant Pest Risk Assessment: Create pest or disease problems for agriculture. Become a weed. Increase the weediness of sexually compatible plants. Harm non-target organisms (beneficial, endangered). Affect agricultural practices in a way which could create disease and pest problems. Transmit the genes to organisms with which it does not normally interbreed.

13. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Corn – HT, IR, AP Soybean – HT, PQ, AP Cotton – HT, IR Canola - HT, AP, PQ Papaya – VR Squash – VR Tobacco – PQ Sugar beet – HT Alfalfa – HT, PQ Rose – PQ  Tomato – PQ  Chicory – AP  Potato - IR, VR, PQ  Rice – HT  Flax – HT  Plum – VR HT – herbicide tolerance IR – insect resistance AP – agronomic properties VR – virus resistance PQ – product quality GE Plants with Nonregulated Status Over 100 Petitions Approved

14. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Categories of Products  Reviewed many times over past 20 years Corn, cotton, soy, canola Herbicide resistance (mainly via EPSPS and PAT) and insecticide resistance (Bt) Highly familiar  The future New types of plants – Eucalyptus, American Chestnut, Citrus New traits - Disease resistance, cold tolerance, yield increased, drought tolerance, new groups of herbicides, non-browning fruit, low acrylamide in cooked products. GE insects including plant pests New mechanisms

15. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Research Needs  Dormancy. Information on dormancy of small grains (i.e. wheat, barley, rice and canola), particularly variety x environment effects. This would include dormancy of crop, sexually compatible weedy species, and hybrids of the crop and weedy relatives.  Fitness traits in wild populations. How can we assess potential impact of fitness traits in wild populations?  Off target and non-target effects of genome editing technologies and RNAi. Risk assessments focus on phenotypes regardless of process, but it would be helpful to understand for the new technologies the likelihood of unintended phenotypes occurring. Quantification and comparison of off-target effects using Zinc Finger Nucleases, TALENS, and CRISPRs. For RNAi, it would be useful to fully understand the risks of off target and nontarget effects for cases where the target sequences are native plant genes vs pest genes. Are there different risk tiers?  Whole genome sequencing for molecular genetic characterization of plants

16. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Priority Research Areas (currently in BRAG RFA) Unintended Effects. Comparison between Transformation-associated Genomic Variation and Genomic Variation Introduced by Non-genetic Engineering Approaches in Plants Risk assessment framework at the landscape level for perennial crops (e.g. trees, grasses). Development of a Risk Assessment Framework for the Environmental Impacts of GE crops at the Landscape Level

17. United States Department of Agriculture Biotechnology Regulatory Services Animal and Plant Health Inspection Service Thank you! Questions?