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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
|
Another perspective of the Federal system for evaluating products developed using modern biotechnology is presented by United States Regulatory Agencies at the United Biotechnology Website.
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
| Name |
Title |
Phone |
Address |
| Dr. Neil Hoffman |
Director, Regulatory Division
|
301-734-6331
|
4700 River Rd
Riverdale, MD 20737
|
| Dr. John Turner |
Director, Policy Coordination Division
|
301-734-8365
|
4700 River Rd
Riverdale, MD 20737
|
Under the Virus, Serum, Toxin Act, USDA-APHIS Veterinary Services inspects biologics production establishments and licenses veternary biological substances, including animal vaccines, that are products of biotechnology.
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 |
Address |
| Dr. Elizabeth Milewski |
Advisor
|
202-564-8492
|
1200 Pennsylvania Ave NW
Washington DC 20260
|
Office of Pollution Prevention and Toxics TSCA Biotechnology Program
(Microbial Products of Biotechnology)
| Name |
Title |
Phone |
Address |
| David Giamporcaro |
Chief, Biotech. Rules Program
|
202-564-8127
|
1200 Pennsylvania Ave NW
Washington, DC 20460
|
BioPesticides and Pollution Prevention Division (BPPD)
- Office of Pesticide Programs
| Name |
Title |
Phone |
Address |
| Dr. Janet L. Andersen |
Director, BPPD
|
703-308-8712
|
1200 Pennsylvania Ave NW
Washington, DC 20460
|
| Mike Mendelsohn |
Senior Regulatory Specialist
|
703-308-8715
|
1200 Pennsylvania Ave NW
Washington, DC 20460
|
| Dr. William Schneider |
Biotech Notifications:Small Scale Field Testing
|
703-308-8683
|
1200 Pennsylvania Ave NW
Washington, DC 20460
|
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 |
Address |
| Mary Ditto |
Consumer Safety Officer
|
301-436-1165
|
5100 Paint Branch Pkwy
College Park, MD 20740
|
| Dr. Eric Flamm |
Microbiologist
|
202-418-3053
|
5600 Fishers Lane
Rockville, MD 20857
|
Joint United States Federal Agencies Unfied Website
For a list of Decision documents for all Federal Agencies:
- United States Regulatory Agencies Unified Biotechnology Website
Relevant Laws - Regulations - Rules
USDA
LAWS
REGULATIONS
EPA
LAWS
REGULATIONS
Regulations under FIFRA/FFDCA
40 CFR Parts 152, 172, 174, 180
- Plant-Pesticides, Supplemental Notice; Proposed Rule
Federal Register: May 16, 1997 (Volume 62, Number 95)
- Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act; Proposed Rule
Federal Register: November 23, 1994 (Volume 59, Number 225)
- Microbial Pesticides: Experimental Use Permits and Notifications
Federal Register: September 1, 1994 (Volume 59, Number 169)
- Statement of Policy; Microbial Products Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances Control Act
Federal Register: June 26, 1986 (Volume 51, Number 123)
Regulations under TSCA
40 CFR Part 725 - Reporting Requirements and Review Processes for Microorganisms
- Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act
Federal Register: April 11, 1997 (Volume 62, Number 70)
FDA
LAWS
REGULATIONS
BIOTECHNOLOGY REGULATORY HISTORY
