date of importation, movement, or release; and port of importation or site of release. Additionally, detailed information is required, as appropriate, on the:

  • anticipated or actual expression of the altered genetic material in the regulated article and how it differs from the nonmodified parent organism;

  • molecular biology of the system;

  • locality where the donor, recipient, and vector were collected and produced;

  • experimental design at the release site;

  • facilities at the destination;

  • measures to ensure confinement; and

  • final disposition of the regulated article.

The permit application should be submitted to APHIS at least 120 days prior to intended release into the environment. APHIS conducts an initial review of the dossier (within 30 days) to determine if all necessary information is supplied. If not, the 120-day “clock” stops until the applicant provides the missing information. The permitting process allows APHIS to request monitoring and reporting of the results of small-scale releases.

Petition for Determination of Nonregulated Status (CFR 340.6)

APHIS has a procedure whereby an applicant can request that the agency determine that a particular transgenic plant is not a regulated article—that is, that it does not fall under the definition of a plant pest (BOX 3.1). This procedure is the sole route for commercialization of transgenic plants (e.g., sale of transgenic soybean seed) and the primary but not sole route to commercialization of transgenic plant products (e.g., when the plants are never sold but a product such as an industrial protein extracted from the plant is sold).

Once APHIS decides that a transgenic plant is not a regulated article, it cannot exercise any additional oversight on the plant or its descendants. Those descendants include all plants of the same species that receive the transgene through sexual reproduction. Therefore, separate deregulated lines can be mated with one another via conventional crossbreeding to bring together different transgenes in the same plant, and such plants are not subject to regulatory evaluation (see discussion of methods to create multitransgenic plants in Chapter 4).

Descendants may also include distantly related members of the same crop species. For example, after deregulation, a breeder could use cross-



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