1. Biotechnology Regulatory Services Program Update National Plant Board Michael Gregoire Deputy Administrator July 27, 2010

2. Outline  State Partnership Initiatives  State inspection program  Petition Status  Budget Proposal  Current Litigation  RR Alfalfa  RR Sugar beet  GE Eucalyptus  Program Initiatives

3.  2010 Participants: Kansas, Arkansas, Florida, and North Carolina  MOU between APHIS BRS and participant States  Inspections ongoing  2009: 38  2010: 33 (to date) State Inspection Program

4. GE Crop Statistics Source: USDA National Agricultural Statistics Service and Sugarbeet Growers Association Most Prevalent GE Crops in the U.S. 2000-2009 Percentage of Crop that is GE

5. Pending Petitions for Deregulation CropTraits SoybeanHerbicide Tolerant Lepidopteran resistant Altered Acid Profile CornHerbicide Tolerant Drought Tolerant EucalyptusFreeze Tolerant CottonHerbicide Tolerant Lepidopteran resistant AlfalfaHerbicide Tolerant Creeping BentgrassHerbicide Tolerant AppleNon-browning PeanutSclerotinia blight resistant RoseModified Flower Color

6. Petitions for Nonregulated Status Recent Approvals  Herbicide Tolerant Cotton – May, 2009  Virus Resistant Papaya – Sept, 2009  Herbicide Tolerant Corn – Dec, 2009  Insect Resistant Corn – April, 2010  High Oleic Soybean – June, 2010

7. FY 2011 Budget Proposal  A total of $18.7 million for biotechnology regulation – an increase of $5.7 million from the FY 2010 budget of $13 million.  Increase is targeted for three critical areas:  expanding workload  evaluating new applications of the technology  strengthening the safeguarding system  User Fee Proposal

8. Current Litigation  Geertson Seed Farms, Inc. v. USDA (RR Alfalfa)  Center for Food Safety v. Connor (RR Sugar Beets)  Center for Biological Diversity v. APHIS USDA (GE Eucalyptus)

9. Round Up (RR) Alfalfa  Deregulated in 2005  Lawsuit filed  Ordered to prepare an EIS for RR Alfalfa in 2007  Injunction since March 30, 2007  Draft EIS published in December 2009  June 21, 2010 Supreme Court Decision

10. Draft EISPublic Comment Final EIS Public ReviewRecord of Decision Final Alfalfa EIS Process

11. Round up Ready (RR) Sugar Beets  Deregulated in 2005  Lawsuit filed in 2008  Ordered to prepare an EIS for RR Sugarbeet in Sept 2009  NOI published on May 28, 2010  Remedies hearing scheduled August 13, 2010

12. GE Eucalyptus  Lawsuit filed June 20, 2010  US District Court, Eleventh Circuit  Southern District of Florida  Hearings have not been set

13. Biotechnology Quality Management System (BQMS)  Compliance assistance program  Conducted Pilot in 2009  4 Companies  1 University  On the horizon (2010):  Issue final audit standard and guidelines  Enroll additional entities

14. Biotechnology Regulation  Register to become a BRS stakeholder to receive the latest news and information  http://www.aphis.usda.gov/biotechnology/ brs_main.shtml  Click on Register as a BRS Stakeholder on the right-hand navigation  Questions and Answers