This document discusses the regulation of biotechnology products in the United States by three agencies: the FDA, USDA, and EPA. The FDA regulates food, drugs, and biologics. The USDA regulates meat, plants, and animal biologics. The EPA regulates pesticides, toxic substances, and microorganisms. Each agency has specific laws governing the areas they oversee. The regulation of genetically modified organisms depends on the product and its intended use.

1. ENVIRONMENTAL
PROTECTION LAW TO
BIOTECHNOLOGY
PRODUCTS
BINDU KSHTRIYA

2. BIO TECHNOLOGY
the exploitation of biological processes for industrial
and other purposes, especially the genetic
manipulation of microorganisms for the production
of antibiotics, hormones, etc

3. REGULATION OF
BIOTECHNOLOGY
Three agencies involved in regulation of
biotechnology.
1) FDA
2) USDA, Department of
Agricultural.
3) Environmental Protection Agency.

4. LAW INVOLVED UNDER
FDA
Food and Drug Administration (FDA), of the
Department of Health and Human Services
- FFDCA, 21 USC 321-397
- Public Health Service Act (PHSA), 42 USC
262, 264

5. LAW INVOLVED UNDER
USDA
The Plant Protection Act (PPA) (USDA);
The Meat Inspection Act (MIA)(USDA);
The Poultry Products Inspection Act (PPIA) (USDA);
The Egg Products Inspection Act (EPIA) (USDA);
The Virus Serum Toxin Act (VSTA) (USDA);

6. LAW INVOLVED UNDER
EPA
Environmental Protection Agency (EPA): 1) Federal
Food, Drug, and Cosmetic Act (FFDCA), 21
USC 321, 246a et seq., as amended by the Food Quality Protection
Act (FQPA) Pub Law 104-170 (1996)
2)Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 USC
136-136y, as amended by FQPA, supra.,
3) Toxic Substances Control Act (TSCA), 15 USC 2601-2692

7. REGULATION OF
BIOTECHNOLOGY
FDA has responsibility for the safety of food and animal feed,
and for the safety and efficacy of human drugs and biologics,
and animal drugs. Within the FDA, there are four centers with
responsibilities for biotechnology products: the Center for Food
Safety and Applied Nutrition (CFSAN); the Center for
Veterinary Medicine (CVM); the Center for drug Evaluation and
Research (CDER), and the Center for Biologics Evaluation and
Research (CBER).

8. USDA
USDA has responsibility for the safety of meat, poultry and
egg products; for regulating potential agricultural plant
pests and noxious weeds; and for the safety and efficacy
of animal biologics. Within USDA, the Animal and Plant
Health Inspection Service (APHIS) has the major
responsibility for biotechnology regulation, with additional
possible responsibilities for the Food Safety and
Inspection Service (FSIS).

9. ENVIRONMENTAL
PROTECTION AGENCY
EPA has responsibility for the use of pesticides
and setting allowable levels (tolerances) of
pesticide residues in food, and for the regulation
of non-pesticidal toxic substances, including
microorganisms.

10. REGULATION OF GENETICALLY
MODIFIED ORGANISMS:
Genetically Modified
Products
AGENCY LAW
Plants
Plant Pests USDA-APHIS PPA
Plant incorporated
protectants
EPA FIFRA
Plants producing toxic
substances
EPA TSCA
Animals
Animals FDA FFDCA
Animals producing toxic
substances
EPA TSCA
Microorganisms

11. ANIMALS
New
Animal
Drug
Tx Construct
Tx Animal
Animal
derived
products
FDA

12. MICROORGANISM
TSCA provides EPA with authority to regulate chemical substances which may
present an unreasonable risk of injury to health or the environment during
manufacture, processing, distribution in commerce, use, or disposal.
TSCA applies to uses of substances that are not specifically covered by another
statute (e.g., pesticides regulated under FIFRA, or drugs regulated under FFDCA).
EPA reviews the microorganisms for their potential to cause unreasonable risks to
human health and the environment.
The TSCA biotechnology regulations also address intergeneric microorganisms
used in research and development for commercial purposes and create a vehicle
for reporting on testing of new microorganisms in the environment—the TSCA
Experimental Release Application (TERA).

13. Genetically Modified Product Agency Law
Human Food
Whole food
Plants (i.e., vegetables,
fruits)
FDA – CFSAN FFDCA
Meat, poultry and eggs USDA – FSIS
MIA; PPIA;
EPIA
Food Articles
Food Additives FDA – CFSAN FFDCA
Dietary Supplements FDA - CFSAN DSHEA
Animal Feed FDA - CVM FFDCA
Drugs and Biologics
Human Drugs FDA - CDER FFDCA

14. Genetically modified
products
Agency Law
High value products
Cosmetics FDA - CFSAN FFDCA
Pesticides EPA FIFRA
Other substances if toxic EPA TSCA

15. Pesticides
Purpose: To create a basis for people to understand what pesticides
are and their application.
Example definition from the EPA
A pesticide is any substance or mixture of substances intended for:
preventing,
destroying,
repelling, or
mitigating any pest.

16. How the EPA Regulates
Pesticides
Purpose: To explain the how the EPA regulates pesticides.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Federal Registration Actions
Experimental Use Permits (EUP’s)
Emergency Exemptions
State-Specific Registration
Federal Food, Drug, and Cosmetic Act (FFDCA)
Food Quality Protection Act of 1996

17. Pesticide Registration

18. Registration Process
Purpose: To describe what happens before a pesticide is allowed to be
distributed, sold, or used in the United States.
EPA Considerations
EPA Concerns for Human Health and Environmental Effects
Acute toxicity tests
Chronic toxicity tests
Length of Registration

19. Introduction to TSCA
Authority
Approve new chemicals
Review & Manage existing chemicals
Gather & Apply chemical hazard info.
Enforce regulations

20. Introduction to TSCA
New vs. Existing Chemicals
New chemicals are those that are not listed on
the TSCA Chemical Inventory
Existing chemicals are those that are listed on
the TSCA Chemical Inventory

21. THANKYOU
BINDU KSHTRIYA