BIOTECHNOLOGY REGULATORY OVERVIEW
Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology. The three main Federal agencies responsible for regulating the safe use of genetically engineered organisms are APHIS, the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Health and Human Services' Food and Drug Administration (FDA).
FDA has primary responsibility for ensuring the safety of human food and animal feed, as well as proper labeling and safety of all plant-derived foods and feeds. EPA regulates pesticides, including plants with plant-incorporated protectants (pesticides intended to be produced and used in a living plant), to ensure public safety. That agency also regulates pesticide residue on food and animal feed. APHIS, through its Biotechnology Regulatory Services (BRS) program, regulates the introduction of certain organisms developed using genetic engineering that may pose a risk to plant health.
BRS REGULATORY AUTHORITY
BRS derives its authority to promulgate regulations from provisions of the Plant Protection Act, which is a part of the larger Agriculture Risk Protection Act of 2000. Congress authorizes various parts of USDA to regulate specified areas of U.S. Agriculture under these federal statutes.
Biotechnology Federal Regulations
The details of what items are regulated, such as organisms and processes, and how both may be regulated (time frames, permitting processes, penalties) are written by each Agency that has the appropriate authority. Federal regulations are published in the Federal Register and also in the Code of Federal Regulations, a large multivolume series. Those regulations for agriculture and the USDA comprise fifteen volumes and those governing biotechnology are found in Volume 7, Part 340 (7 CFR part 340).