Biotechnology Regulatory Services Program Update and Hot Topics. National Plant Board

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1 Biotechnology Regulatory Services Program Update and Hot Topics National Plant Board Doug Grant Chief, WR Compliance Assurance Branch Denver, CO August 9, 2011

2 Outline Program Update RR Sugarbeet Partial Deregulation Implementation Inspections and Compliance Activities Current Hot Topics Litigation Recent Regulatory Activity Program Improvement Initiatives

3 RRSB History Event H7-1 SB was grown under notification from 1998 to In 2003, APHIS received a petition for nonregulated status to Event H7-1 SB. BRS prepared an EA and in 2005, APHIS announced that H7-1 SB did not pose a plant pest risk and was no longer considered a regulated article.

4 RRSB History RRSB Notifications 2005: Deregulation 1/232008: Lawsuit filed 9/21/2009: Court Ordered EIS 8/13/2010: Court vacated deregulation 8/9/2010: Petition for Partial deregulation 11/4/2010: Draft EA (partial) 2/4/2011: Partial Deregulation

5 RRSB History Feb 2011, APHIS published an EA for the partial deregulation in which APHIS would: Authorize the environmental release and movement of H7-1 SB seed production activities under APHIS permits and notifications and root crop production activities under compliance agreements

6 RRSB Compliance Agreements Formal, written, signed agreement between APHIS and any person who wants to import, move, and/or conduct an environmental release in conjunction with the H7-1 SB root crop. The CA includes requirements and mandatory conditions. To-date, APHIS-BRS has issued 15 CAs.

7 Sugar Beet Root Crop Compliance Agreement Categories for Conditions/Requirements Shipping/packing requirements for seed to be planted Maintaining shipments and monitoring records Training of personnel Reporting non-compliance issues to BRS Monitoring for bolting plants and volunteers Removal of bolters before flowering and volunteers Reporting of bolters to BRS Post-harvest land-use restrictions Tracking of harvested beets Trucks loaded to minimize loss

8 RR Sugar Beets Partial Deregulation Sugar beet seed crop: Permits (5) Mandatory conditions and restrictions WA, OR, ID, MI, ND, MN, IA, WY, AZ, MT,and NE Sugar beet root crop: Compliance Agreements (15) Mandatory conditions and restrictions AZ, CO, ID, MI, MN, MT, NE, ND, OR, WA, and WY Third Party Audits and Inspections Valid until Dec

9 Third-party Audits and Inspections 90 auditors and inspectors APHIS training is required Reports submitted to BRS for review and approval APHIS inspections RR Sugar Beets Partial Deregulation At least one inspection per State RRSB root crop inspection and audit worksheets

10 Inspection Improvements FY10/11 Inspections initiated, submitted electronically via epermits Inspection selection process done in Regions Questions tailored by inspection type Revised inspection questions, revised inspection manual (2010) New inspection worksheets for tree trials, microbes, and arthropods State Department of Agriculture Inspection Program continuing in 4 states (AR, KS, FL, NC)

11 Guidance on Notification & Permit Inspections

12 Average Number of Inspections from FY08 FY NJ: 2 DE: 1 MD: 2 42 Virgin Islands: 5 Map created by M. Dexter on

13 Planting Report Information FY10 Plantings Under Notification CA IA KS MO OR WA HI/PR Cont. US US Total Notifications Planted Unique Plantings Unique Sites Planted* *Unique sites planted based on unique location ID, not based on GPS coordinates.

14 Planting Report Information FY 10 Plantings Under Release Permit (Trad l) CA IA KS MO OR WA HI/PR Cont. US US Total Permits Planted Unique Plantings Unique Sites Planted* *Unique sites planted based on unique location ID, not based on GPS coordinates.

15 Inspections Requested FY10 vs. FY11* Inspection Type FY10 FY11 % Increase Notification % Pharma/Industrial Permits % Other Permits % Total % In AR, FL, KS, NC % * So far, through Aug 8, 2011.

16 Deregulations Final Recent Regulatory Activity Pioneer SPT Corn Amalyse Corn RR Alfalfa Drafts open for public comment GE Kentucky Bluegrass

17 Ongoing Litigation RRSB III: Sugar beet industry Challenges that conditions imposed by APHIS decision are beyond the Agency s authority under the PPA Seeks a declaratory judgment that the EA and other APHIS administrative actions comply with NEPA RRSB IV: Center for Food Safety and others Challenges APHIS' issuance of permits for RR sugar beet seed crop and partial deregulation of RR sugar beet root crop Alfalfa II: Center for Food Safety and others Challenges the adequacy of the RR Alfalfa EIS Eucalyptus Permits Suit: Center for Food safety and other environmental groups Challenges the adequacy of APHIS environmental documentation

18 NEPA Pilot Program Improvement Initiatives Enhance NEPA compliance and timeliness of environmental documents Provide environmental reports Third party contracts to develop environmental documentation Petition Improvement Project Improve the speed and predictability of the deregulation process