This subpart applies to records regarding mandatory and voluntary disclosures under this part for foods offered for retail sale in the United States.

(a) General. (1) Regulated entities must maintain records that are customary or reasonable to demonstrate compliance with the disclosure requirements of this part.

(2) The records must be in electronic or paper formats and must contain sufficient detail as to be readily understood and audited by AMS.

(3) Records must be maintained for at least two years beyond the date the food or food product is sold or distributed for retail sale.

(4) Examples of customary or reasonable records that could be used to demonstrate compliance with the disclosure requirements of this part include, but are not limited to: Supply chain records, bills of lading, invoices, supplier attestations, labels, contracts, brokers' statements, third party certifications, laboratory testing results, validated process verifications, and other records generated or maintained by the regulated entity in the normal course of business.

(b) Recordkeeping requirements. (1) If a food (including an ingredient produced from such food) is on the List of Bioengineered Foods, the regulated entity must maintain records regarding that food or food ingredient.

(2) If a food (including an ingredient produced from such food) bears a bioengineered food disclosure based on actual knowledge and is not on the List of Bioengineered Foods, regulated entities must maintain records for such food or food ingredient.

(a) Request for records. When AMS makes a request for records, the entity must provide the records to AMS within five (5) business days, unless AMS extends the deadline.

(b) On-site access. If AMS needs to access the records at the entity's place of business, AMS will provide prior notice of at least three (3) business days. AMS will examine the records during normal business hours, and the records will be made available during those times. Access to any necessary facilities for an examination of the records must be extended to AMS.

(c) Failure to provide access. If the entity fails to provide access to the records as required under this section, the result of the audit or examination of records will be that the entity did not comply with the requirement to provide access to records and that AMS could not confirm whether the entity is in compliance with the bioengineered food disclosure standard for purposes of § 66.402.