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BRS History

History of Biotechnology and Regulatory Services (BRS)


August, The U.S. Department of Agriculture creates a new unit within the Animal and Plant Health Inspection Service called Biotechnology Regulatory Services (BRS) to focus on USDA's key role in regulating and facilitating biotechnology.

February, The National Academy of Sciences provides recommendations in its February 2002 report "Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation."


APHIS' establishes Biotechnology Policy Group in Program Planning and Development to coordinate biotechnology policy.

2001 Council on Environmental Quality (CEQ) of OSTP publishes Case Studies of Environmental Regulations for Biotechnology

2000 Plant Protection Act consolidates and extends USDA authority to regulate Plant Health - Title 7 Chapter 61, 104

May 2, USDA changes eligibility requirements for field testing under Notification -- Simplification of Requirements and Procedures for Genetically Engineered Organisms 7 CFR 340

APHIS's dissolves BBEP, and transfers biotechnology functions to APHIS PPQ

1995 EPA registers first pest protected plant—Monsanto's New Leaf potato

March 31, USDA publishes alternative requirements for field testing--Notification Procedures for the Introduction of Certain Regulated Articles 7CFR 340.3.

March 31, USDA publishes rules to allow determinations that certain plants are no longer Regulated Articles-- Petition for Nonregulated Status 7CFR 340.

1992 May 29, FDA publishes its "Statement of Policy: Foods Derived from New Plant Varieties (57 FR 22984)

October 19, USDA APHIS deregulates a product for the first time, Calgene's FLAVR SAVR tomato

First field test of a potential commercial product - Calgene plants Tobacco Mosaic Virus-resistant tomatoes.

October 1, USDA's establishes Biotechnology, Biologics and Environmental Protection (BBEP) to regulate biotechnology and other environmental programs


June 16, USDA publishes a rule for permitting field tests (7CFR 330 and 340) “Introduction of Genetically Engineered Organisms.”

November 25, USDA under 7CFR 340.3 authorizes first field test -- Calgene's Bromoxynil-Resistant Tobacco


May 30, USDA authorizes by means of an "Opinion Letter" the first release of genetically engineered organisms in the environment: Agracetus' crown-gall resistant tobacco.

June 26, Office of Science and Technology Policy (OSTP) publishes the “Coordinated Framework for Regulation of Biotechnology” that directs how existing laws and agencies including USDA, EPA and FDA should regulate biotechnology (51 Federal Register 23302)

1985 1985 January, Advanced Genetic Systems injects live genetically engineered “ice minus” bacteria into fruit trees in the open air on the roof of their building prefatory to filing an application for an EPA Experimental Use Permit (EUP) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
1983 NIH's Recombinant DNA Advisory Committee authorizes field tests of the genetically engineered “ice-minus” strains of Pseudomonas syringae and Erwinia herbicola 48 Federal Register 16459
1978 NIH's Recombinant DNA Advisory Committee implements Guidelines for Research with Genetically Engineered Organisms 43 Federal Register 60108

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