§ 340.5 Petition to amend the list of organisms. ¹⁰

1. (a) General. Any person may submit to the Administrator a petition to amend the list of organisms in § 340.2 of this part by adding or deleting any genus, species, or subspecies. A petitioner may supplement, amend, or withdraw a petition in writing without prior approval of the Administrator and without prejudice to resubmission at any time until the Administrator rules on the petition. A petition to amend the list of organisms shall be submitted in accordance with the procedures and format specified by this section.

2. (b) Submission procedures and format. A person shall submit two copies of a petition to the Animal and Plant Health Inspection Service, Biotechnology and Scientific Services, PPQ, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737-1237. The petition should be dated, and structured as follows:

   Petition To Amend 7 CFR 340.2

   The undersigned submits this petition under 7 CFR 340.4 to request that the Administrator [add the following genus, species, or subspecies to the list of organisms in 7 CFR 340.2] or [to remove the following genus, species, or subspecies from the list of organisms in § 340.2].

   A. Statement of Grounds

   (A person must present a full statement explaining the factual grounds why the genus, species, or subspecies to be added to § 340.2 of this part is a plant pest or why there is reason to believe the genus, species, or subspecies is a plant pest or why the genus, species, or subspecies sought to be removed is not a plant pest or why there is reason to believe the genus, species, or subspecies is not a plant pest. The petition should include copies of scientific literature which the petitioner is relying upon, copies of unpublished studies, or data from tests performed. The petition should not include trade secret or confidential business information.

   A person should also include representative information known to the petitioner which would be unfavorable to a petition for listing or delisting. (If a person is not aware of any unfavorable information the petition should state, Unfavorable Information: NONE).

   B. Certification

   The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petitioner relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

   (Signature) ________________________

   (Name of petitioner) ________________

   (Mailing address) _________________

   (Telephone number) ______________

3. (c) Administrative action on a petition.

   1. (1) A petition to amend the list of organisms which meets the requirements of paragraph (b) of this section will be filed by the APHIS, stamped with the date of filing, and assigned a docket number. The docket number shall identify the file established for all submissions relating to the petition. APHIS, will promptly notify the petitioner in writing of the filing and docket number of a petition. If a petition does not meet the requirements of paragraph (b) of this section, the petitioner shall be sent a notice indicating how the petition is deficient.
   2. (2) After the filing of a petition to amend the list of organisms USDA shall publish a proposal in the Federal Register to amend § 340.2 and solicit comments thereon from the public. An interested person may submit written comments to the APHIS on a filed petition, which shall become part of the docket file.

   3. (3) The Administrator shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either:

      1. (i) Approve the petition in whole or in part in which case the Administrator shall concurrently take appropriate action (publication of a document in the Federal Register amending § 340.2 of this part); or
      2. (ii) deny the petition in whole or in part. The petitioner shall be notified in writing of the Administrator's decision. The decision shall be placed in the public docket file in the offices of APHIS, and in the form of a notice published in the Federal Register.

¹⁰ See footnote 5 in § 340.3.