(a) Any person may submit a request or petition for a determination by the Administrator regarding other factors and conditions under which a food is considered a bioengineered food. A request or petition must be submitted in accordance with § 66.204.
(b) The request or petition may be supplemented, amended, or withdrawn in writing at any time without prior approval of the Administrator, and without affecting resubmission, except when the Administrator has responded to the request or petition.
(c) If the Administrator determines that the request or petition satisfies the standards for consideration in § 66.202, AMS will initiate a rulemaking that would amend the definition of “bioengineered food” in § 66.1 to include the requested factor or condition.
(d) The Administrator's determination that the request or petition does not satisfy the standards for consideration in § 66.202 constitutes final agency action for purposes of judicial review.
In evaluating a request or petition, the Administrator must apply the applicable standards described in this section.
(a) The requested factor or condition is within the scope of the definition of “bioengineering” in 7 U.S.C. 1639(1).
(b) The Administrator must evaluate the difficulty and cost of implementation and compliance related to the requested factor or condition.
(c) The Administrator may consider other relevant information, including whether the requested factor or condition is compatible with the food labeling requirements of other agencies or countries, as part of the evaluation.
(a) Submission procedures and format. A person must submit the request to the Agricultural Marketing Service in the form and manner established by AMS.
(b) Required information. The request or petition must include the information described in this paragraph (b).
(1) Description of the requested factor or condition.
(2) Analysis of why the requested factor or condition should be included in considering whether a food is a bioengineered food, including any relevant information, publications, and/or data. The analysis should include how the Administrator should apply the standards for consideration in § 66.202.
(3) If the request or petition contains Confidential Business Information (CBI), the submission must comply with the requirements of this paragraph (b)(3).
(i) The requester or petitioner must submit one copy that is marked as “CBI Copy” on the first page and on each page containing CBI.
(ii) The requester or petitioner must submit a second copy with the CBI deleted. This copy must be marked as “CBI Redacted” on the first page and on each page where the CBI was deleted.
(iii) The submission must include an explanation as to why the redacted information is CBI.