The United States Department of Agriculture (“USDA” or “Agency”) requires that anyone desiring to import, transport interstate, or plant a regulated article must apply for a permit or make a notification to the Agency’s Animal and Plant Health Inspection Service (“APHIS”) that an introduction will be made.[i] A regulated article is any organism which has been altered or produced through genetic engineering which USDA determines is also a plant pest or has reason to believe is a plant pest.”[ii]
If a permit for environmental release is sought, the applicant must submit an application with information including, inter alia:
- the donor organism(s);
- the recipient organism(s);
- the vector or vector agent(s);
- a description of the molecular biological mechanisms involved in the production of the regulated article;
- a description of the activity of the modified genetic material in the regulated article and a comparison to an unmodified organism;
- a description of the purpose of the introduction; and
- steps to control the article and associated biological materials.[iii]
According to APHIS, it reviews the submitted data to evaluate a number of potential risks, including whether the transgenic plant might: (1) expose other plants to pathogens; (2) harm other organisms, including agriculturally beneficial organisms, threatened and endangered species, and, in the case of plants that produce pesticides, organisms that are not the intended target of the pesticide (non-target organisms); (3) increase weediness in another species with which it might cross; (4) have an adverse effect on the handling, processing or storage of commodities; or (5) threaten biodiversity.[iv]
Other types of permits are also available. For example, an applicant may seek a limited permit for interstate movement or a limited permit for importation. The information an applicant seeking a limited permit is to provide is less detailed than one seeking a regular permit.[v]
Before issuing a permit for the release of a regulated article into the environment, USDA must follow the requirements of the National Environmental Policy Act (“NEPA”) by preparing a publicly available environmental assessment and if necessary, an environmental impact statement.[vi] Also, before issuing a permit for an environmental release, USDA must coordinate with the state where the release is planned, submitting a copy of the application or notification to the state department of agriculture for review.[vii]
[i] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products, p. 9-10 (2001), available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf (last visited on September 7, 2009).
[ii] Id., citing 7 CFR §340.1.
[iii] Id. citing 7 CFR §340.4.
[v] See 7 CFR §340.4(b) and compare with 7 CFR §340.4(c)(1) and (2).
[vi] Board on Agriculture and Natural Resources, Genetically Modified Pest-Protected Plants: Science and Regulation, p. 147 (2000), available at http://books.nap.edu/openbook.php?record_id=9795&page=147 (last visited on September 8, 2009).