Biotechnology Regulatory ServicesProgram Update

National Plant Board

Michael Gregoire

Deputy Administrator

July 27, 2010

Outline

State Partnership InitiativesState inspection program

Petition Status Budget Proposal Current Litigation

RR AlfalfaRR Sugar beetGE Eucalyptus

Program Initiatives

2010 Participants: Kansas, Arkansas, Florida, and North Carolina

MOU between APHIS BRS and participant States

Inspections ongoing2009: 38

2010: 33 (to date)

State Inspection Program

GE Crop Statistics

Source: USDA National Agricultural Statistics Service and Sugarbeet Growers Association

Most Prevalent GE Crops in the U.S. 2000-2009

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Pending Petitions for Deregulation

Crop Traits

Soybean Herbicide Tolerant

Lepidopteran resistant

Altered Acid Profile

Corn Herbicide Tolerant

Drought Tolerant

Eucalyptus Freeze Tolerant

Cotton Herbicide Tolerant

Lepidopteran resistant

Alfalfa Herbicide Tolerant

Creeping Bentgrass Herbicide Tolerant

Apple Non-browning

Peanut Sclerotinia blight resistant

Rose Modified Flower Color

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

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 workloadevaluating new applications of the technologystrengthening the safeguarding system

User Fee Proposal

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)

Round Up (RR) Alfalfa

Deregulated in 2005 Lawsuit filed Ordered to prepare an EIS for RR Alfalfa

in 2007Injunction since March 30, 2007

Draft EIS published in December 2009 June 21, 2010 Supreme Court Decision

Draft EIS Public Comment

Final EIS

Public Review Record of Decision

Final Alfalfa EIS Process

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

GE Eucalyptus

Lawsuit filed June 20, 2010

US District Court, Eleventh CircuitSouthern District of Florida

Hearings have not been set

Biotechnology Quality Management System (BQMS)

Compliance assistance program Conducted Pilot in 2009

4 Companies1 University

On the horizon (2010):Issue final audit standard and guidelinesEnroll additional entities

Biotechnology Regulation

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Questions and Answers