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Proposed Permit Data Requirements

DISCLAIMER:  This information maintained on, referenced to, or linked to from this website is preliminary or provisional and is subject to revision. It is provided as a public service and is intended solely to enhance transparency and understanding of the proposed revisions to the regulations at 7 CFR part 340.  This information has not received final approval, nor is any language contained herein promulgated by the U.S. Department of Agriculture (USDA), and is provided on the condition that neither the USDA nor the U.S. Government shall be held liable for any damages resulting from its authorized or unauthorized use.  The Federal Register and the Code of Federal Regulations remain the official sources for regulatory information published by the USDA.

General permit application requirements. 

Each permit application must include all of the following information:

  1. The name, title, and contact information (e.g., mailing address, email, telephone and fax numbers) of the responsible person and agent, if applicable;

  2. Country and locality where collected, developed, manufactured, reared, cultivated or cultured;

  3. If the organism has undergone a regulatory status inquiry, the ID number;

  4. The intended activity (importation, interstate movement, and/or environmental release) for the regulated organism; and

  5. Information necessary to identify and characterize the regulated organism(s) for which a permit is sought, including:

    1. The scientific names of all donor and recipient organisms plus any designations used for the regulated organism(s) (e.g., strain, line, variety);

    2. The form of the regulated organism (e.g., seeds, rootstocks, tubers, spores, larvae, eggs), the amount (e.g., numbers, total weight or volume), and a description of any biological material accompanying the regulated organism under permit (e.g., culture medium, or host organisms, etc.);

    3. Information about the gene modification, including the name, function, and source of the gene introduced, modified, or deleted.  For insertions, all accompanying elements (i.e. regulatory sequences, enhancers, etc.) must be provided along with a description of the purpose of the addition, deletion, or modification of the nucleic acids; and

    4. The anticipated phenotype of the regulated organism.

  6. A detailed description of the ultimate disposition of the regulated organism after the termination of the movement (e.g., destruction, devitalization, storage, research in laboratories or greenhouses, culturing, propagation, breeding, processing for analysis or manufacture);

  7. How the regulated organism will be handled and maintained so that its identity is maintained (e.g., marked, labeled) during the movement;

  8. The time frame (estimated start and duration) within which the movement(s) will occur; and

  9. A statement signed by the responsible person that certifies that the application information is accurate and complete.

    Additional information required for all permit applications involving importation and/or interstate movement.

  1. The origin and destination of the regulated organism, including information on the addresses and contact details of the sender and recipient, if different from the responsible person.

  2. The method of secure shipment to be used in the importation, via any means of conveyance, from outside the United States into contained facilities within the United States or the interstate movement, via any means of conveyance, from a contained facility in any State into or through any other State to another contained facility.

  3. The manner in which packaging material, shipping containers, and any other material accompanying the regulated organism will be disposed.

Additional information required for all permit applications involving environmental release

Information for permit applications for environmental release must address the spread, persistence risk, and potential harm of the regulated organism in the environment, including but not limited to:

  1. A description of how the phenotype of the regulated organism differs from the phenotype of the recipient organism, particularly with respect to potential interactions with, and its likelihood of spread and/or persistence in the environment.

  2. The location and size of all proposed environmental release sites, including area, geographic coordinates, addresses, land use history of the site and adjacent areas, and name and contact information of a person at each environmental release site, if different from the responsible person. 

  3. Information about the ecology, agronomy, and local climatic or geologic conditions that could result in floods, fires, tornadoes, earthquakes, etc. at each site that could impact the integrity of the environmental release site.

  4. The site management practices and control procedures designed to make it unlikely that there will be an unauthorized release of the regulated organism beyond the described environmental release site(s) and the permit time frame of the environmental release.  Each of the descriptions must include:

    1. Description of the methods and stages of transport of the regulated organism from a contained facility to the environmental release site, and any storage methods used at the site;

    2. Description of the methods of planting, inoculation, or environmental release; any reproductive or cultural controls; methods of treatment and harvest used for the regulated organism; and a plan for monitoring the site for pests, diseases, and effects on other organisms during the time the regulated organism is released;

    3. Description of the methods and stages of transport of the regulated organism from environmental release site back into contained facilities, or methods of devitalization at the site(s) of the environmental release;

    4. Description of the cleaning, disinfection, or other methods used to make it unlikely that unauthorized release or dissemination of the regulated organism into the environment could occur via means of conveyance and other articles (e.g., planters, harvesters, containers); and

    5. Description of any post-release land use practices, including any monitoring plans to ensure that the regulated organism or its progeny are unlikely to reproduce and disseminate in the environment after the termination of the environmental release (e.g., managing volunteer plants).

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