Introduction to The Regulation of Genetically Modified Organisms by the USDA

United States Department of Agriculture

United States Department of Agriculture

The United States Department of Agriculture (“USDA” or “Agency) shares significant regulatory authority over GM crops with FDA and EPA.[i] Transgenic, or genetically modified, plants are regulated by USDA’s Animal and Plant Health Inspection Service (“APHIS”) under the Plant Protection Act (“PPA”).[ii]

USDA’s Jurisdiction Over Plants and Other Organisms

Under the PPA, the Secretary of Agriculture may “prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of any plant, plant product, biological control organism, noxious weed, article, or means of conveyance, …,” if the Secretary determines that such restriction is necessary to prevent the introduction or dissemination of plant pests in the Unites States.[iii] In the regulation implementing the PPA, “plant pest” is defined as “[a]ny living stage of [organism] … which can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants.”[iv] Thus, for example, if a gene from a group of organisms that are considered to be plant pests is introduced into a plant that is not considered a plant pest, APHIS would regulate the resulting plant as a potential plant pest.[v]

USDA’s Jurisdiction Over GMOs

Genetically modified products that would be subject to the PPA regulations would be those that had been “altered or produced through genetic engineering, if the donor organism, recipient organisms, or vector agent belongs to any genera or tax designated in 340.2 and meets the definition of plant pest.”[vi] In other words, in order to trigger USDA oversight, genetic engineering must be involved and the donor, recipient or vector must be a plant pest.

The next article will evaluate the details of APHIS oversight of GMOs.

[i] See Emily Marden, Risk and Regulation: U.S. Regulatory Policy On Genetically Modified Food and Agriculture, 44 B.C.L.R., 733, 767 (2003).

[ii] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products, p. 9 (2001), available at (last visited on August 31, 2009); see 7 U.S.C. §7701 et seq. (formerly 7 U.S.C. §§150aa-jj (repealed 2000)).

[iii] Pew Initiative, supra note ii at p.9.

[iv] See 7 C.F.R. §340.1. The full definition of a plant pest is: “any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses; or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause disease in or damage to any plants or parts thereof; or any processed, manufactured, or other products of plants.” Id.

[v] Richard Caplan and Skip Spitzer, Regulation of Genetically Engineered Crops and Foods in the United States, p. 7 (2001), available at (last visited on September 18, 2009)

[vi] Marden, surpa note i at 768-69.