USDA APHIS Biotechnology Regulatory Services Update

Transcription

1 USDA APHIS Biotechnology Regulatory Services Update Doug Grant, Ph.D. Chief, Western Compliance Assurance Branch National Alliance of Independent Crop Consultants Annual Meeting January 24, 2013

2 Biotechnology Regulatory Services BRS Mission: To protect America s agriculture and the environment using a science-based regulatory framework that allows for the safe development of GE organisms Biotechnology Regulatory Services Animal Care Wildlife Services APHIS Plant Protection & Quarantine Veterinary Services International Services

3 Coordinated Framework USDA Safe for agriculture and the environment FDA Safe for use in food and feed EPA Safe for use as pesticide Most products are regulated by more than one agency

4 Biotechnology Regulation Regulated Status Interstate Movement, Importation, and Field Testing Permit Notification Nonregulated Status Removed from APHIS Oversight Petition

5 Determinations of Nonregulated Status

6 Petition Process Steps Review for Completeness 60-Day Comment On Petition Preparation of PPRA Preparation of EA 30-Day Comment on PPRA,EA Preliminary Decision, 30-day review Revise Docs, Respond to Comments Decision Final Final Docs, Decision 1 month 2 months 15 months total 3 months 2 months 7 months 1 month 13 months total

7 Petition Evaluation APHIS BRS conducts two evaluations: Plant Pest Risk Assessment (PPRA) To determine if the GE organism poses a risk as a plant pest (Plant Protection Act of 2000) Environmental Assessment (EA) or Environmental Impact Statement (EIS) To more broadly evaluate environmental impacts of the APHIS-BRS determination Required by the National Environmental Policy Act (NEPA) of 1969

8 Petitions: Data Submitted For petitions, applicants must provide information on: Crop biology and taxonomy Inserted gene New protein(s) produced and function in plant Field test reports Experimental data, publications and other data upon which to base a determination Any unfavorable data and information

9 GE Plants with Nonregulated Status Determinations of nonregulated status: over 90 petitions, representing 16 plant species Determination of nonregulated status extends to the GE plant and its offspring. Actual commercialization of GE plants with nonregulated status is determined by market demand, not the APHIS decision.

10 AC21 Advisory Committee on Biotechnology and 21st Century Agriculture USDA formed committee charged with examining issues about coexistence Diverse membership conventional and organic farmers and organizations, industry, biotech developers and users, State Departments of Agriculture Final report includes recommendations Check website for more info

11 Notifications and Permits BRS reviews the information submitted Shares non-cbi information with States and/or Tribes for review and comment Issues a permit or Acknowledges a notification Verifies compliance (site inspections, record audits, etc.) Reviews field test reports

12 Notifications and Permits Goal of notifications and permits: prevent the unintended release of the regulated article Regulatory requirements to minimize the possibility that the organism will: Persist in the environment Produce offspring that will persist Within crop species or wild relatives Significantly impact non-target organisms

13 Compliance Assistance Biotechnology Quality Management System (BQMS) Voluntary compliance assistance and outreach program. Complementary to BRS regulations. Draft audit standard published for public comment in 2009; final standard published in 2010.

14 Regulatory Workshops (FY12) Regulatory Permitting and Compliance Workshops aimed at academic and public researchers working with regulated GE organisms: March 29-30: Arizona State University - Tempe April 30 - May 1: University of Missouri Columbia May 10-11: University of Florida Gainesville July 10: NC A&T State University Greensboro July 16: State University of New York - Syracuse Plan to have at least four workshops in 2013

15 Field Release Authorizations 1400 Field Trial Notifications and Permits ( )

16 Confined Field Trials Applicant provides information on: reproductive biology of the organism environment and conditions of the release including: Measures to maintain physical isolation Measures to maintain reproductive isolation site security, monitoring, and inspection plans for termination, devitalization, disposal, post-harvest monitoring and land use

17 Inspection Goals Verify compliance with regulatory requirements (7 CFR 340) Using multiple methods of verification Keeping regulated material separate from nonregulated material Out of food and feed supply Prevent instances of low level presence (LLP) Safeguarding American Agriculture

18 Planting Reports Compliance Inbox epermits Hard Copy

19 Planting Report - Example Date: Dec. 2, 2012

20 Planting Reports Submitted Academics Industry epermits Compliance Inbox Mail

21 Notifications FY 11 FY 12 # of Authorized Sites # of Actual Planted Sites % Planted % Inspected

22 Permits FY 11 FY 12 # of Authorized Sites # of Actual Planted Sites % Planted % Inspected

23 Inspection Selection Planting Report Information: Notification or permit number Crop species Planting date Planting location (unique location IDs) Acreage

24 Inspection Selection Majority of inspections occur during growing season Notifications Inspections randomly selected from planting reports Higher frequency in winter nursery locations Permits At least one inspection per state per year Pharma-Industrial Permits for annuals, perennials at least yearly

25 Inspections Conducted in FY12 Biotech Inspections: Eastern U.S Western U.S Total - 679

26 Moving Forward Number of post-harvest inspections will increase in FY13 Look at post-harvest field operations Storage, shipping, handling of harvested material Volunteer monitoring Most inspections conducted by PPQ PPQ re-org won t impact biotech inspections BRS will continue to train biotech inspectors Total number of inspections similar to FY12 Improvements to inspection worksheets Worksheet questions to be made available to public

27 Avoid Compliance Issues Obtain authorization from BRS prior to importation, interstate movement, or environmental release Remember to submit planting reports In a timely manner, as indicated on the issued permit or acknowledgement letter Submit other reports and notices as required, such as field test data reports Prevent expected animal incursions Self-reporting is required for loss of confinement Remember to plan for controlling volunteers following field trials

28 Inspection Questions Contact Compliance Assurance Branch Chiefs Western Dr. Doug Grant Eastern (970) Dr. Wendy Jin (919)

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30 For More Information Unified website for U.S. Regulatory Agencies, Coordinated Framework: USDA APHIS BRS: General Inquiries: