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Version- September 22, 2006

 

 

The US regulatory system operates in a coordinated framework involving three government agencies as given in Table below:

 

Table: US regulatory authorities for crop biotechnology products

 

Agency

Jurisdiction

Laws

USDA

Plant pests, plants, veterinary biologics

Federal Plant Pest Act (FPPA)

FDA

Food, feed, food additives, veterinary drugs, human drugs, medical devices

Federal Food, Drug and Cosmetic Act (FFDCA)

EPA

Microbial and plant pesticides, new uses of existing pesticides, novel microorganisms

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); FFDCA; Toxic Substances Control Act (TSCA)

 

The USDA’s Animal and Plant Health Inspection Services (APHIS) is the lead agency for the regulation of genetically engineered plants including the experimental evaluation of these products in confined field trials.  The Environmental Protection Agency (EPA) is responsible for assuring the human and environmental safety of pesticidal substances engineered into plants, and the Food and Drug Administration (FDA) is responsible for assuring that foods and drugs derived from genetic engineered are as safe as their traditional counterparts.  Products are generally regulated according to their intended use, with some products being regulated under more than one agency e.g. pesticidal plants.

 

Regarding research and development activities, the National Institutes of Health (NIH) have developed guidelines to describe facilities and practices intended to prevent unintended release or inadvertent exposure to GMOs or products thereof. Compliance with NIH guidelines is mandatory for working with GMOs for all scientists receiving federal funding or working for federal agencies.

 

            The list of the relevant laws is as follows:

 

 

USDA

LAWS

 

REGULATIONS


EPA

LAWS

REGULATIONS

Regulations under FIFRA/FFDCA

40 CFR Parts 152, 172, 174, 180

Regulations under TSCA

40 CFR Part 725 - Reporting Requirements and Review Processes for Microorganisms


FDA

LAWS

Federal Food, Drug, and Cosmetic Act 1938

  • Pre-market safety approval of all new drugs
  • Prohibited false therapeutic claims for drugs
  • Drugs labeled with adequate directions for safe use
  • Food standards "in the interests of consumers"
  • Cosmetics and medical devices under FDA's jurisdiction

 

REGULATIONS

BIOTECHNOLOGY REGULATORY HISTORY

Cronological History of Biotechnology Regulation