Principles of Plant Genetics and Breeding

Overview of the regulation of the US
biotechnology industry
The rationale for regulation of biotechnology is to protect
consumers from product risk, and to promote and
retain their confidence in biotechnology products, as
well as to promote trade. The agencies with regulatory
oversight in biotechnology in the USA are the US
Department of Agriculture (USDA), Food and Drug
Administration (FDA), and Environmental Protection
Agency (EPA). The products they regulate are summarized
in Table 15.1. Manufacturers and developers of
biotech products are required to meet certain minimum
product standards stipulated in state and federal marketing
statutes. These include state seed certification laws –
the Federal Food and Drug and Cosmetic Act (FFDCA),
Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), Toxic Substances Control Act (TSCA), Plant
ISSUES IN THE APPLICATION OF BIOTECHNOLOGY IN PLANT BREEDING 269
These results are consistent with the notion that the EPA’s high dose/structured refuge plans are effective, but scientists caution
that it may be too soon to tell whether or not resistance would have developed by this time without the implementation of IRM.
Conclusion
Through the oversight provided by USDA-APHIS, EPA, and FDA, GE plants have been more heavily scrutinized than any other
comparable agricultural product. While it is not possible to conclusively demonstrate that an agricultural product (GE or not) will
have no environmental or human health impact, there has been no documented case of a negative impact on human health or an
observed effect on the environment after a decade of growing GE plants.
However, new GE products currently under development, such as plants engineered to tolerate abiotic stress or to produce
pharmaceuticals or industrial compounds, may have significant impacts on (and benefits for) humans or the environment.
Regulators may need to continue to creatively use their legal authorities to accomplish the goal of improving agriculture, the
environment, and health as they are faced with increasingly complex risk assessments. It will also be the responsibility of regulatory
agencies to continue supporting research to assess the potential for these risks to occur, the means to mitigate them, and to
continue monitoring GE crops to ensure that no significant unexpected effects arise from their use.
References
Ellstrand, N.C. 2003. Dangerous liaisons? When cultivated crops mate with their wild relatives. Johns Hopkins University Press,
Baltimore, MD.
EPA. 2001. Regulations under the Federal Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated Protectants. Code of
Federal Regulations, Section 40, Parts 152 and 174. (Available at: http://www.epa.gov/pesticides/biopesticides/pips/pip_rule.pdf.)
FDA. 1992. Statement of policy: Foods derived from new plant varieties. Fed. Reg. 57:22984–23005.
Feyereisen, R. 1995. Molecular biology of insecticide resistance. Toxicol. Lett. 82/83:83–90.
National Research Council. 2002. Environmental effects of transgenic plants: The scope and adequacy of regulation. National
Academy Press, Washington, DC.
Tabashnik, B., Y. Carrière, T. Dennehy, S. Morin, A. Sisterson, and J.-Z. Zhao. 2003. Insect resistance to transgenic Bt crops:
Lessons from the laboratory and field. J. Econ. Entomol. 96:1031–1038.
US Congress. 2000. The Plant Protection Act (Public Law 106–224). (Available at: http://www.aphis.usda.gov/brs/pdf/
PlantProtAct2000.pdf.)
USDA-APHIS. 1997. Introduction of organisms and products altered or produced through genetic engineering which are plant
pests or which there is reason to believe are plant pests. Code of Federal Regulations, Section 7, Part 340. (Available at:
http://www.aphis.usda.gov/brs/7cfr340.html.)
USDA-APHIS. 2004. Environmental impact statement: Introduction of genetically engineered organisms. Fed. Reg. 69:3271–3272.
Table 15.1 US agencies and the biotechnology they
regulate.
Agency
US Department of
Agriculture
Environmental
Protection Agency
Food and Drug
Administration
Source: USDA.
Products regulated
Plant pests, plants, veterinary biologics
Microbial/plant pesticides, new uses of
exisiting pesticides, novel microorganisms
Food, feed, food additives, veterinary
drugs, human drugs, medical devices
Protection Act, and National Environmental Policy Act
(NEPA). Depending upon the product, an agency may
review it for its safety to grow, safety to eat, or safety
to the environment. The Animal and Plant Health