USDA's Procedure For Regulating Transgenic Organisms

As previously discussed, the United States Department of Agriculture (“USDA”) has regulatory jurisdiction over transgenic crops through its Animal and Plant Health Inspection Service (“APHIS”).[i]

Under the Plant Protection Act (“PPA”) USDA requires that anyone desiring to import, transport interstate, or plant a “regulated article” must apply for a permit or make a notification to APHIS that an introduction will be made.[ii] Under USDA regulations “regulated articles” are defined as “any organism which has been altered or produced through genetic engineering … which USDA determines is a plant pest or has reason to believe is a plant pest.”[iii]

A permit imposes restrictions on transportation or planting to prevent the escape of plant material that may pose a pest risk to the environment.[iv] On what the USDA calls “the basis of its experience with the permit program,” USDA has provided a number of exemptions for articles that it has determined do not pose a plant pest risk. Those articles can be introduced without a permit provided that the USDA is notified in advance.[v] The notification procedure thus allows for the introduction of plant material that may actually pose a plant pest risk, without a permit, but that introduction can occur only in accordance with specific criteria governing the type of material that is introduced and the steps that must be taken to ensure that it is environmentally contained.[vi] Obtaining a permit for field testing, or making a notification that testing will take place, is a typical step in the development of a commercial product. [vii]

After permit for field testing of a regulated article is obtained, a petition for nonregulated status may be submitted. [viii] According to APHIS, nonregulated status petition will be granted only after the studies and data submitted in support of the petition, including the results of the field trials, demonstrate that there will in fact be no significant plant pest risk from widespread planting.[ix]

Petitioning APHIS for a determination of nonregulated status is a typical route to commercialization of a transgenic plant that will be widely planted, such as a commodity crop, since it allows planting and transportation without conditions that might be imposed by a permit.[x] However, nonregulated status is not a precondition for commercialization.[xi] A product may also be commercialized under permit.[xii]

The next article will evaluate the type of information that must be submitted by a party seeking a permit for environmental release.


[i] APHIS regulates the importation, exportation and transport of plants. However, another USDA agency is implicated in the regulation of transgenic organisms – Food Safety and Inspection Services (“FSIS”) – which regulates the importation and exportation and transport of meat, poultry and egg products. See US Department of Agriculture, Office of Inspector General Southwest Regions, Audit Report: United States Department of Agriculture Controls Over the Importation of Transgenic Plants and Animals, p. i (2008), available at http://www.usda.gov/oig/webdocs/50601-17-TE.pdf (last visited on September 5, 2009).

[ii] 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 5, 2009).

[iii] Id., citing 7 CFR §340.1; see my previous post, defining “plant pest.”

[iv] See, Pew Initiative, supra note ii at 9-10; see also Board on Agriculture and Natural Resources, Genetically Modified Pest-Protected Plants: Science and Regulation, p. 146 (2000), available at http://books.nap.edu/openbook.php?record_id=9795&page=147 (last visited on August 23, 2009), stating that:

a permit is required for (1) any organism altered or produced through genetic engineering if the donor or recipient organism either (a) belongs to a group of plant pests listed in 7 C.F.R. § 340.2 or (b) is an unclassified organism and/or an organism whose classification is unknown, (2) any product that contains a listed plant pest or unknown/unclassified organism, or (3) any other organism or product altered or produced through genetic engineering that USDA determines to be or has reason to believe is a plant pest (as defined by 7 C.F.R. § 340.1). The rules define genetic engineering as genetic modification of organisms by rDNA techniques. The rules do not regulate research with genetically modified organisms in a laboratory or contained greenhouse but come into play only when a person seeks to introduce genetically modified organisms into the environment or interstate commerce.

[v] See BANR, supra note iv at 146.

[vi] See Pew Initiative, supra note ii at 9.

[vii] Id.

[viii] Id. at 10.

[ix] Id.

[x] Id.

[xi] Id.

[xii] Id.