Coordinated Framework for the Regulation of Biotechnology
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).
For a complete list of U.S. laws and regulations pertaining to biotechnology under the Coordinated Framework, click here.
BRS derives its authority to write 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 US Agriculture under these Federal Statutes.
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. All formal 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 as overseen by APHIS-BRS are found in Volume 7, Section 340.
Last Modified: April 29, 2013