USDA, GMOs, Notification and Nonregulated Status

Another way USDA is said to regulate GMOs is through the notification process. The USDA provides a number of exemptions for articles that it has determined do not pose a plant pest risk.[i] One of such exemptions authorizes the introduction of certain regulated articles without a permit provided that USDA is notified in advance.[ii] To qualify for the notification process, a regulated article must be one of the plant species identified in the rule and must meet six eligibility criteria and six performance standards.[iii] The notification process replaces the permit process for importation, transportation or environmental release of a regulated article.[iv]

The six eligibility criteria cover characteristics of the regulated articles that are relevant to their risk profile as a plant pest, and require that:

  1. The plant species be a species APHIS has determined may be safely introduced;
  2. The introduced genetic material is stably integrated;
  3. The function of the introduced genetic material is known and its expression in the regulated article does not result in plant disease;
  4. The introduced genetic material does not produce an infectious entity, toxicants to nontarget organisms likely to feed or live on that plant species, or products intended for pharmaceutical use;
  5. The introduced genetic sequences derived from plant viruses do not pose a significant risk of the creation of any new plant virus; and,
  6. The plant has not been modified to contain certain genetic material derived from an animal or human pathogen. [v]

The notification performance standards govern how plants that are approved pursuant to the notification procedure should be shipped, stored, planted and field tested to ensure that regulated articles do not escape from containment or persist in the environment. More specifically, they are as follows:

  1. Shipment of viable plant or plant material must be in such a way that the material is unlikely to be disseminated while in transit and must be maintained at the destination facility in such a way that there is no release into the environment.
  2. When introduction is an environmental release, the planting of regulated articles must be done in such a way that they are not inadvertently mixed with non-regulated plants of any species which are not part of the environmental release.
  3. The plants and plant parts must be maintained in such a way that the identity of all material is known while it is in use, and the plant parts must be contained or devitalized when no longer in use.
  4. There must be no viable vector agent associated with the regulated article.
  5. The field trial must be conducted such that:
    1. The regulated article will not persist in the environment, and
    2. No offspring can be produced that could persist in the environment.
  6. Upon termination of the field test
    1. No viable material shall remain which is likely to volunteer in subsequent seasons, or
    2. Volunteers shall be managed to prevent persistence in the environment.[vi]

Once the USDA receives the notification it must either acknowledge that notification is appropriate for the designated introduction activity (import, interstate movement, or environmental release) or deny permission for introduction and require a permit.[vii]

Petition for Nonregulated Status

A party may apply for a “determination of nonregulated status,” from APHIS following the party’s planting experience and data collection under either a permit or a notification.[viii] Such a determination from APHIS means that a particular article, previously regulated as a potential plant pest, will no longer be regulated, on the basis of accumulated evidence that the article does not in fact pose a plant pest risk.

Nonregulated status permits the unrestricted transportation and planting of the crop, and is often sought for full commercialization, especially for commodity crops.[ix] A person may request that APHIS extend a previous determination of nonregulated status to other organisms, based upon information showing the similarity of the nonregulated organism and the regulated articles in question.[x]


[i] 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=146 (last visited on September 8, 2009).

[ii] Id.

[iii] See id.

[iv] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products, p. 11 (2001), available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf (last visited on September 12, 2009).

[v] See id. at p. 11 (citing 7 CFR §340.3(b)).

[vi] See 7 CFR §340.3(c)(1)-(6).

[vii] See BANR, supra note i at p. 146.

[viii] See Pew Initiative, supra note iv at pp. 11-12.

[ix] Id.

[x] Id.