The United States Department of Agriculture (USDA) is charged with regulating the various activities in the United States that relate to agriculture. The main authority for the involvement of the USDA in approval of agricultural biotechnology stems from the Plant Protection Act with directly addresses the agricultural secretary:

"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 the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination of a plant pest or noxious weed within the United States." Public Law No. 106-224, Section 411.

Biotechnology in particular is regulated by the USDA's branch APHIS (Animal and Plant Health Ispection Service). USDA-APHIS oversees "regulated articles" which for biotechnology purposes are those that have been modified with genetic engineering that have the potential for being plant pests. Many times,biotechnology products are considered regulated as a result of the use of plant pests during their creation, such as when Agrobacterium tumifaciens is the method of DNA insertion. When a product is "regulated" any use and movement of the product must be approved by USDA-APHIS. In order to be released commercially, products can not be regulated, therefore companies may petition for non-regulated status.

As of 1997, most new plants do not require a full permit in order to be planted, but only a formal notification of creation to the USDA. According to "US Regulation of Agricultural Biotechnology: An Overview" in AgBioForum by Neil Benson, located here , there are six requirements in order to only need to file a notification:

  • The species may neither be a noxious weed under USDA regulations nor considered by the Agency to be a weed in the area where it will be released.
  • The introduced genetic material must be stably integrated into the plant genome.
  • The function of the introduced genetic material must be known, and its expression in the regulated article must not cause plant disease.
  • The introduced genetic material must not cause production of an infectious entity, encode substances known or likely to be toxic to non-target organisms, which are likely to feed or live on the plant species, or encode products intended for pharmaceutical use.
  • The introduced genetic sequences derived from plant viruses must not pose a significant risk of creating new plant viruses.
  • The plant must not have been modified to contain genetic material derived from human or animal pathogens (7 C.F.R. §340.3(b)).

Upon the creation of an genetically modified organism that will be introduced to the environment, transported, or imported, the USDA must be notified or in some cases, a permit obtained. The permit will then allow the product to be planted, but is regulated and any movement of the product is strictly monitored. The act of registering for a permit requires the submission of all details surrounding the product such as the donor organism, steps performed, and the final desired purpose of the product. The notifications are good for a one year term, however are allowed to be renewed with additional notification.

Petitioning for non-regulated status is a lengthy and rigorous process for the applicant. Any aspects of the article in question must be presented clearly, with experimental data and studies which verify any conclusions shown. While the USDA does not perform these experiments itself, it has set out many guidlines which it requires of the experimental results submitted. These experiments may be monitored by USDA-APHIS at any point, as agreed upon when the product was initially categorized as a "regulated article". Additional information on requirements for this petition can be found on the USDA-APHIS website . Part of the review process for the petitions by the USDA-APHIS included as public comment period. This period allows the general public a viewing of the petition and for any concerns to be voiced to the agency. The agency is then required to address any concerns that are expressed before approval can be granted. As of 2012, the APHIS budget has been increased, with the desired result being an expedition of the approval of these petitions. One aspect that is hoped to be improved is an earlier comment period, granting the agency a longer period for review of these comments. Once a product has been granted non-regulated status, the product and any progeny derived from it are considered non-regulated and can be released into the US freely, provided it has been approved by other regulatory agencies.

The USDA is also in charge of the movement of regulated articles, whether this be interstate travel, or travel into or out of the country. This travel must follow standards set out by the USDA, in addition to gaining prior approval from the agency.