USDA APHIS Requirements for Rookies Doug Grant, Ph.D. Chief, Western Compliance Assurance Branch

Transcription

1 USDA APHIS Requirements for Rookies Doug Grant, Ph.D. Chief, Western Compliance Assurance Branch National Alliance of Independent Crop Consultants Annual Meeting January 30, 2014

2 APHIS BRS For Rookies Outline Regulating Biotechnology Notifications and Permits Determinations of Non-regulated Status Confined Field Trials Inspection Basics Things to Avoid Sources of Information 1

3 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 2

4 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 3

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

6 Notifications Consist of 3 important documents: The application organism, phenotypes, constructs, locations (GPS), proposed dates Acknowledgment Letter approved dates for importation, interstate movement, or planting of field trials Outlines Performance Standards (7 CFR c) Design Protocols methods approved to be followed in order to meet the performance standards 5

7 Permits Consist of 1 important document, the Issued Permit: Based on the application organism, phenotypes, constructs, locations (GPS), proposed dates Includes Standard Permit Conditions (7 CFR f) Includes Supplemental Permit Conditions specific to the test organism and other parameters of the trial 6

8 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

9 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 8

10 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 9

11 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 10

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 11

13 Planting Reports Compliance Inbox epermits Hard Copy 12

14 Inspection Selection Planting Report Information: Notification or permit number Crop species Planting date Planting location (unique location IDs) Acreage 13

15 Planting Report - Example May 2,

16 Inspection Selection Majority of inspections occur during growing season Notifications Inspections randomly selected from planting reports Higher frequency in winter nursery locations (HI, PR) Permits At least one inspection per state per year Pharma-Industrial Permits for annuals, perennials at least yearly 15

17 Notifications FY 11 FY 12 FY13 # of Authorized Sites # of Actual Planted Sites % Planted % Inspected

18 Permits FY 11 FY 12 FY13 # of Authorized Sites # of Actual Planted Sites % Planted % Inspected

19 Inspection Goals Verify compliance with regulatory requirements (7 CFR 340) Using multiple methods of verification Keeping regulated material separate from non-regulated material Out of food and feed supply Prevent instances of low level presence (LLP) Safeguarding American Agriculture 18

20 What to Expect During an Inspection Inspector gathers names of all present Reviews documents and records Including an up-to-date map Asks questions about past activities and future plans Makes observations Takes measurements 19

21 Maps of Field Trial Locations Map obtained from cooperator preferred GPS coordinates can be used to make map Map notes locations of other regulated trials in vicinity Map should include points of reference (e.g. roads, buildings) Map required with each inspection report 20

22 Inspections Conducted in FY13 Biotech Inspections: Eastern U.S. 326 Western U.S. 351 Total

23 USDA Biotech Inspections Completed in FY 2013 (Total = 677) Hawaii: Inspections >50 30 to to to 10 1 to 4 Puerto Rico: US Virgin Islands: 0 22 Biotechnology Regulatory 97 Services 8

24 Avoid Compliance Issues Obtain authorization from BRS prior to importation, interstate movement, or environmental release Remember to submit planting reports Timeframes indicated on issued permit or acknowledgement letter Submit other reports and notices as required, such as field test data reports Maintain separation distance Prevent expected animal incursions Self-reporting is required for loss of confinement Plan for controlling volunteers following field trials 23

25 24

26 For More Information Unified website for U.S. Regulatory Agencies, Coordinated Framework: USDA APHIS BRS: General Inquiries: 25