Can Federal Regulatory Agencies Stop Planting of Genetically Engineered Crops That Pose Environmental Risks?

The United States created a formal regulatory structure for GE organisms establishing the concept that GE foods would be regulated on the basis of product, not process, and would be regulated on a case-by-case basis (1) [see "Which U.S. Agencies Have Regulatory Authority Over Genetically Engineered and Classically Bred Crops?”, (2)]. GE crops and products made from them are under regulatory control of three federal agencies: the Food and Drug Administration (FDA), the EPA, and the USDA (for a review, see Reference 3). The FDA is responsible for food safety and labeling of foods and animal feeds from conventional and GE crops. The EPA evaluates food safety and environmental issues associated with new pesticides and pesticidal products, such as Bt corn and the pesticidal Bt product it contains. The EPA’s charge also includes GE plants in which a small part of a pest, such as a viral regulatory sequence (e.g., 35S promoter), is used. A division of the USDA, APHIS, oversees environmental safety of planting and field-testing GE plants to ensure GE crop field tests are performed under specified conditions and any unusual occurrences are reported. All three agencies do not oversee each GE crop; however, all have legal rights to demand immediate market removal of any product if valid scientific data show safety concerns for consumers or the environment.

A plant with an rDNA fragment inserted into the plant genome is considered a regulated article by USDA APHIS, and each time a specific fragment is inserted it is considered a new event [see "Which U.S. Agencies Have Regulatory Authority Over Genetically Engineered and Classically Bred Crops?”, (2)]. Each event must go through regulatory approval, even if a first event with the same fragment received approval. Regulated articles are evaluated for impact on the environment and on agriculture, e.g., will the gene move to a native plant and perturb the ecosystem or become a weed in a cultivated setting? Small-scale field trials are used to make preliminary EI assessments. In the United States, the GE plant is a regulated article until APHIS deregulates it [see "Which U.S. Agencies Have Regulatory Authority Over Genetically Engineered and Classically Bred Crops?”, (2)], To gain nonregulated status, molecular, biochemical, and cellular analyses are done on the GE plant, and data are collected on the life cycle, reproductive characteristics, and expected and unexpected changes versus a nonengineered plant. A petition for nonregulated status containing these data is formulated by the event’s creator and reviewed by APHIS, after which an Environmental Assessment can be issued and determination of nonregulated status granted. From June 1992 to January 2009, 117 petitions for nonregulation were received at APHIS. Twenty-nine were withdrawn or are incomplete; 13 are pending; 75 petitions have received nonregulated status (4), including GE varieties of chicory, corn, cotton, flax, papaya, plum, potato, rapeseed, rice, soybean, squash, sugar beet, tobacco, and tomato. Information on status, requesting institution, genes introduced, phenotype of GE plants, field test data, and environmental assessments of deregulated articles is publicly available (4). Deregulation does not mean the GE crop has been commercialized, only that it no longer requires APHIS review for movement or release (5).

In 2005, the USDA Inspector General conducted an audit that indicated the USDA lacked basic information about where GE crops were grown and their fate after harvest (6). This finding raised concerns, particularly about crops that produce pharmaceuticals. Although all three federal agencies can legally request removal of a product from the market, it was the court system that made inquiries regarding the EI of two GE crops, one which had nonregulated status and one which had not yet requested such status. In the first instance, a U.S. federal court ordered the USDA to conduct more detailed reviews of applications for experimental plots of GE bentgrass after it was shown that pollen had spread thirteen miles from the original cultivation site (7) (see “What Happens When Pollen Moves From Genetically Engineered Crops to Wild Relatives or Non-Genetically Engineered Varieties? In Areas of Genetic Diversity“). The second instance involved Roundup Ready® alfalfa. In 2005 APHIS concluded that this GE variety was safe for animal feed on the basis of substantial equivalence; ∼320,000 acres (129,500 hectares) were subsequently planted in the United States. A U.S. District Court Judge for the Northern District of California, however, ruled that the USDA had erred in approving deregulation (8) and that nonregulation (see “What Happens When Pollen Moves From Genetically Engineered Crops to Wild Relatives or Non-Genetically Engineered Varieties? In Areas of Genetic Diversity“) might have significant EI that required preparation of an environmental impact statement (EIS). The court further stated that theUSDAviolated the National Environmental Policy Act by preparing an environmental assessment (EA) instead of an EIS (9). After the court ruling in March 2007, further plantings of HT alfalfa were prohibited and restrictions were put on its production. Roundup Ready® alfalfa returned to regulated status, pending submission and review of an EIS (9, 10).

References:

1. Off. Sci. Technol. 1984. Proposal for a coordinated framework for regulation of biotechnology. Fed. Regist. 49:50

2. Lemaux PG. 2008. Genetically engineered plants and foods: a scientist’s analysis of the issues (Part I). Annu. Rev. Plant Biol. 59:771–812

3. McHughen A. 2006. Plant Genetic Engineering and Regulation in the U.S. Univ. Calif. Agric. Nat. Resourc. Agric. Biotechnol. Calif. Ser. Publ. 8179

4. ISB (Inf. Syst. Biotechnol.). 2011. Results of search: Crops no longer regulated by USDA. http://www.nbiap.vt.edu/search-petition-data.aspx. Last accessed 2011-11-26. PDF

5. ISB (Inf. Syst. Biotechnol.) 2011. APHIS petitions of nonregulated status approved or pending. http://www.nbiap.vt.edu/data.aspx. Last accessed 2011-11-25. PDF

6. Inspector Gen. USDA. 2005. Audit Report: Animal and Plant Health Inspection Service Controls over Issuance of Genetically Engineered Organism Release Permits. Audit 50601-8-Te

7. Watrud LS, Lee EH, Fairbrother A, Burdick C, Reichman JR, et al. 2004. Evidence for landscape-level, pollen-mediated gene flow from genetically modified creeping bentgrass with CP4 EPSPS as a marker. Proc. Natl. Acad. Sci. USA 101:14533–38

8. Anim. Plant Health Insp. Serv. USDA. 2005. Monsanto Co. and Forage Genetics International; availability determination of nonregulated status for alfalfa genetically engineered for tolerance to glyphosate. Fed. Reg. 70:36917–19

9. Anim. Plant Health Insp. Serv., USDA. 2007. Return to regulated status of alfalfa genetically engineered for tolerance to the herbicide glyphosate. Fed. Regist. 72:56

10. Anim. Plant Health Insp. Serv., USDA. 2008. Environmental impact statement; determination of regulated status of alfalfa genetically engineered for tolerance to the herbicide glyphosate. Fed. Regist. 73:4. Docket No. APHIS-2007-0044

Updated 2/16/12