Which U.S. Agencies Have Regulatory Authority Over Genetically Engineered and Classically Bred Crops?
In the early 1980s, the U.S. established a formal regulatory structure for GE organisms by expanding existing legislation to accommodate products created by rDNA. This approach was outlined in an Office of Science andTechnology Policy document entitled Coordinated Framework for Regulation of Biotechnology (1), which established the concept that GE foods would be regulated on the basis of product, not process, and on a case-by-case basis.
GE foods and products made from them are under regulatory control of three federal agencies: the FDA, the Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) (see 2 for a review). The FDA is responsible for the safety and labeling of foods and animal feeds from all crops, including those that are GE. The FDA requires full evaluations of GE foods containing uncharacterized DNA sequences, significantly altered nutrient levels, different composition relative to existing foods, potentially allergenic or toxic proteins, and/or new selection marker genes. The EPA evaluates food safety and environmental issues associated with new pesticides and pesticidal products. Bt corn (Bacillus thuringiensis; Zea mays) and the pesticidal Bt product it contains, used to control the European corn borer, for example, fall under its jurisdiction. The EPA’s control also encompasses GE plants in which a small part of a pest, such as a viral regulatory sequence (e.g., 35S promoter), is used to develop the GE crop. A division of the USDA, the Animal and Plant Health Inspection Service (APHIS), oversees environmental consequences and safety of planting and field-testing GE plants; their role is to ensure that field tests of GE crops are conducted under controlled conditions and that any unusual occurrences are reported. Every GE crop will not be overseen by all three agencies; however, all three agencies have the legal power to ask for immediate removal from the market of any product, if valid scientific data show a safety concern for consumers or the environment.
The federal government considers each GE plant with a specific DNA segment introduced via rDNA methods to be a “regulated article” and each gene transfer is defined as an event. Creating a second transformed plant with an identical DNA construct inserted in a different location is considered to be a separate event, a regulated article requiring oversight, even if the first event received regulatory approval and attained nonregulated status. As of November 2011, 138 petitions have been received at APHIS; 86 petitions have received nonregulation status and no longer require APHIS review for movement or release in the U.S. (3).
In 2005, an audit by the USDA Inspector General (4) indicated the USDA lacked basic information about where GE crops were grown and their fate after harvest, raising concerns particularly about the fate of crops engineered to produce pharmaceuticals (See “Can Genetically Engineered Food Crops Be Used to Make Pharmaceuticals? Could They Contaminate the Food Supply?”). Two additional concerns were raised in 2007. First, a U.S. federal court ordered the USDA to conduct more detailed reviews of applications for experimental plots of GE bent grass when pollen was found to have spread 13 miles from the original cultivation site (61). Second, in early 2007 questions were raised about the approval of deregulation status for Roundup Ready® alfalfa when a U.S. District Court Judge ruled that the USDA had erred in approving deregulation without a proper environmental impact statement (EIS). Roundup Ready® alfalfa was returned to regulated status, pending submission and review of an appropriate EIS (5).
1. Off. Sci. Technol. 1984. Proposal for a coordinated framework for regulation of biotechnology. Fed. Regist. 49:50
2. McHughen A. 2006. Plant Genetic Engineering and Regulation in the U.S. Univ. Calif. Agric. Nat. Resour., Agric. Biotechnol. Calif. Ser., Publ. 8179
3. ISB (Inf. Syst. Biotechnol.). 2007. Petitions of nonregulated status granted or pending by APHIS. http://www.nbiap.vt.edu/data.aspx. Last accessed 2011-11-25. PDF
4. Insp. Gen. USDA. 2005. Audit Report: Animal Plant Health Inspect. Serv. Controls over Issuance of Genet. Eng. Organism Release Permits. Audit 50601–8-Te
5. Animal Plant Health Insp. Serv., USDA. 2007. Return to regulated status of alfalfa genetically engineered for tolerance to the herbicide glyphosate. Fed. Regist. 72:56