United States
Regulatory Oversight in Biotechnology
Responsible Agencies - Overview

The Agencies primarily responsible for regulating biotechnology in the United States are the US Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Products are regulated according to their intended use, with some products being regulated under more than one agency.

Agency Products Regulated Additional Info.
U.S. Department of Agriculture
plant pests, plants, veterinary biologics
USDA Contacts
Laws, Regs., Rules
Environmental Protection Agency
microbial/plant pesticides, new uses of existing pesticides, novel microorganisms
EPA Contacts
Laws, Regs., Rules
Food and Drug Administration
food, feed, food additives, veterinary drugs,
human drugs and medical devices
FDA Contacts
Laws, Regs., Rules

Before commercialization, genetically engineered plants/organisms must conform with standards set by State and Federal marketing statutes such as State seed certification laws, the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Federal Plant Pest Act. There are no national requirements for varietal registration of new crops.

EXAMPLES:

New Trait/Organism Regulatory Review Conducted by: Reviewed for:
Viral Resistance
in food crop
USDA
EPA
FDA
Safe to grow
Safe for the environment
Safe to eat
Herbicide Tolerance
in food crop
USDA
EPA
FDA
Safe to grow
New use of companion herbicide
Safe to eat
Herbicide Tolerance
in ornamental crop
USDA
EPA
Safe to grow
New use of companion herbicide
Modified Oil content
in food crop
USDA
FDA
Safe to grow
Safe to eat
Modified flower color
ornamental crop
USDA
Safe to grow
Modified soil bacteria
degrades pollutants
EPA
Safe for the environment

Agency Information

U.S. Department of Agriculture - USDA

Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting US agriculture from pests and diseases. Under the authority of the Federal Plant Pest Act, APHIS regulations provide procedures for obtaining a permit or for providing notification, prior to "introducing" a regulated article in the United States. Regulated articles are considered to be organisms and products altered or produced through genetic engineering that are plant pests of that there is reason to believe are plant pests. The act of introducing includes any movement into (import) or through (interstate) the United States, or release into the environment outside an area of physical confinement. The regulations also provide for a petition process for the determination of nonregulated status. Once a determination of nonregulated status has been made, the product (and its offspring) no longer requires APHIS review for movement or release in the US.

FIELD TRIAL APPROVALS: Available at APHIS Cooperator Web site

PRODUCT APPROVALS: Available at APHIS Web site

CONTACTS: Biotechnology Staff

Address: Biotechnology Evaluation
USDA-APHIS-PPQ
4700 River Road, Unit 133
Riverdale, MD 20737-1236

Name Title Phone/Fax
Number
Dr. Sally McCammon
Science Advisor, APHIS
301-734-5761
301-734-8724
Dr. James White
Senior Operations Officer, Biotechnology
301-734-5940
301-734-8669

Environmental Protection Agency - EPA

EPA ensures the safety of pesticides, both chemical and those that are produced biologically. The BioPesticides and Pollution Prevention Division of the Office of Pesticide Programs (OPP) uses the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate the distribution, sale, use and testing of plants and microbes producing pesticidal substances. Under the Federal Food, Drug and Cosmetic Act (FFDCA) EPA sets tolerance limits for substances used as pesticides on and in food and feed, or establishes an exemption from the requirement of a tolerance.

EPA also establishes tolerances for residues of herbicides used on novel herbicide-tolerant crops.

Under the authority of the Toxic Substances Control Act (TSCA), EPA's TSCA Biotechnology Program regulates microorganisms intended for commercial use that contain or express new combinations of traits. This includes "intergeneric microorganisms" formed by deliberate combinations of genetic material from different taxonomic genera.

FIELD TRIAL APPROVALS - PLANTS: Available from Contacts listed below

FIELD TRIAL APPROVALS - MICROBES: Available at EPA-TSCA Web site

PRODUCT APPROVALS AND TOLERANCE EXEMPTIONS

CONTACTS:

Office of Prevention, Pesticides and Toxic Substances, Biotechnology Staff

Name Title Phone/Fax
Number 		Address
Dr. Elizabeth Milewski
Advisor
202-260-6900
202-260-0949
401 M Street, S.W. (7101)
Washington, DC 20460

Office of Pollution Prevention and Toxics TSCA Biotechnology Program

Name Title Phone/Fax
Number 		Address
David Giamporcaro
Chief, Biotech. Rules Program
202-260-6362
202-260-0118
401 M Street, S.W.
Washington, DC 20460

BioPesticides and Pollution Prevention Division (BPPD) - Office of Pesticide Programs

Address: U.S. Environmental Protection Agency
BPPD - Office of Pesticide Programs (7501W)
401 M Street, S.W.
Washington, DC 20460

Name Title Phone/Fax
Number
Dr. Janet L. Andersen
Director, BPPD
703-308-8712
703-308-7026
Dr. Phil Hutton
Branch Chief, Microbial and Plant Pesticides
703/308-8260
703-308-7026
Dr. William Schneider
Biotech Notifications:Small Scale Field Testing
703/308-8683
703-308-7026

Food and Drug Administration - FDA

As a part of the Department of Health and Human Services, FDA regulates foods and feed derived from new plant varieties under the authority of the Federal Food, Drug, and Cosmetic Act. FDA policy is based on existing food law, and requires that genetically engineered foods meet the same rigorous safety standards as is required of all other foods. FDA's biotechnology policy treats substances intentionally added to food through genetic engineering as food additives if they are significantly different in structure, function, or amount than substances currently found in food. Many of the food crops currently being developed using biotechnology do not contain substances that are significantly different from those already in the diet and thus do not require pre-market approval. Consistent with its 1992 policy, FDA expects developers to consult with the agency on safety and regulatory questions.

FINAL CONSULTATIONS: Available at FDA Web site

CONTACTS: Center for Food Safety and Applied Nutrition (CFSAN)

Name Title Phone/Fax
Number 		Address
Dr. James Maryanski
Biotechnology Strategic Manager
202-205-4359
202-401-2893
200 C Street, S.W.
Washington DC 20204
Dr. Eric Flamm
Microbiologist
301-827-0591
301-443-6906
5600 Fishers Lane
Rockville, MD 20857

Relevant Laws - Regulations - Rules

USDA

LAWS

REGULATIONS

EPA

LAWS

REGULATIONS

FDA

LAWS

REGULATIONS