It is a violation of 7 U.S.C. 1639b for any person to knowingly fail to make a bioengineered food disclosure in accordance with this part.

(a) Any interested person who has knowledge of or information regarding a possible violation of this part may file a written statement or complaint with the Administrator.

(1) Written statements or complaints filed with the Administrator must include the following:

(i) Complete identifying information about the product in question;

(ii) A detailed explanation of the alleged regulatory violation; and

(iii) Name and contact information of the person filing the statement or complaint.

(2) Written statements or complaints should be addressed to Director, Food Disclosure and Labeling Division, AMS Fair Trade Practices Program, 1400 Independence Avenue SW, Washington, DC 20250; or submitted through the NBFDS Compliance Portal on the AMS website at https://www.ams.usda.gov/be.

(3) The Administrator will determine whether reasonable grounds exist for an investigation of such complaint.

(b) If the Administrator determines that further investigation of a complaint is warranted, an audit, examination, or similar activity may be conducted with respect to the records of the entity responsible for the disclosures.

(c) Notice regarding records audits or examinations or similar activities will be provided in accordance with § 66.304(a) and (b).

(d) At the conclusion of the audit or examination of records or similar activity, AMS will make the findings available to the entity that was the subject of the investigation.

(e) If the entity that is the subject of the audit or examination of records or similar activity objects to any findings, it may request a hearing in accordance with § 66.404.

(a) Within 30 days of receiving the results of an audit or examination of records or similar activity to which the entity that was the subject of the investigation objects, the entity may request a hearing by filing a request, along with the entity's response to the findings and any supporting documents, with AMS.

(b) The response to the findings of the audit or examination of records or similar activity must identify any objection to the findings and the basis for the objection.

(c) The AMS Administrator or designee will review the findings of the audit or examination of records or similar activity, the response, and any supporting documents, and may allow the entity that was the subject of the investigation to make an oral presentation.

(d) At the conclusion of the hearing, the AMS Administrator or designee may revise the findings of the audit or examination of records or similar activity.

(a) If the entity that was the subject of the audit or examination of records or similar activity does not request a hearing in accordance with § 66.404, or at the conclusion of a hearing, AMS will make public the summary of the final results of the investigation.

(b) AMS's decision to make public the summary of the final results constitutes final agency action for purposes of judicial review.