FDA Bioterrorism Act Compliance Checks

OGA has been notified by FMI that retailers are being asked by FDA to produce records demonstrating that they are in compliance with the Bioterrorism Act (P.L. 107-188), which requires documentation to trace the immediate previous sources and immediate subsequent recipients of foods (not including consumers).  As a reminder, FDA can only access these records if: (1) the agency believes that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals; and (2) the records are necessary to assist the agency in making such a determination (21 U.S.C. § 350, 21 CFR  § 1.361).  The law does not give FDA authority to conduct random audits of these records simply to assess compliance with the law.  FDA must have a belief that a food is adulterated and presents a threat.  If you have any requests for this information that you believe are improper, you may refer inspectors to the FDA guidance.

The Bioterrorism Act requires persons who manufacture, process, pack, transport, distribute, receive, hold or import food to maintain records of the food’s immediate previous source (IPS) and immediate subsequent recipient (ISR). The FDA’s implementing regulations are complex.

However, in an effort to clarify this as much as possible, there are some things that must be done in order to ensure compliance. For example: retain your invoices / bills of lading for two years and establish a filing / storage system that allows you to retrieve within 24 hours any invoice for a specific period of time.

Be aware – in order to be accurate and not oversimplify the compliance requirements, we strongly recommend that you review the Bioterrorism Act “quick sheet” for food retailers and distributors.