On April 4, 2014, the Food and Drug Administration (“FDA”) issued a final rule adopting the interim final rule titled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.” The final rule is adopted pursuant to the Food Safety Modernization Act (“FSMA”). Prior to FSMA, the Federal Food, Drug, and Cosmetic Act (“FDCA”) provided the Secretary of the Department of Health and Human Services (“HHS”) with the ability to access food records that the FDA has reason to believe may be adulterated and present potential adverse health consequences, including death, to humans or animals.
The FSMA final rule broadens the FDA’s ability to access these records from just the specific article of food that may be at issue to any other piece of food that the FDA reasonably believes could be similarly affected. In addition, the final rule also provides the FDA with the authority to access records related to pieces of food for which the FDA believes there is a probability that using or exposing the food to humans or individuals could result in seriously adverse health consequences. This rule became effective as of April 4th.
At the same time as the FDA finalized its rule regarding record access requirements, the FDA also issued two pieces of guidance for industry. The first piece of guidance, the Small Entity Compliance Guide, serves as an update to the records guidance previously issued in December 2004. The document provides questions and answers to commonly asked questions regarding the following topics: (1) the establishment and maintenance of records, including the types of records that must be maintained by transporters and non-transporters of food; (2) the length of time that the records must be retained; and (3) which records must be made available and the process through which the FDA must follow before requesting access to the records.
The FDA also issued a second guidance document, entitled “FDA Records Access Authority Under Sections 414 and 704 of the FDCA.” The document revises similar guidance from the FDA issued in November 2005. The guidance document makes clear that the FDA’s records access authority applies to articles used for food or drink for humans or animals, chewing gum, and articles used to make any of those products. In addition, the FDA has authority to request records from both domestic and foreign persons, excluding restaurants and farms, that manufacture, pack, process, transport, distribute, import, receive, or hold articles of food that meet the circumstances set forth in § 414(a)(1) or (2) of the FDCA.
The second guidance document further describes the requirements from the final rule regarding records access that must be met for the FDA to be able to access and copy records. If the circumstances of the final rule are met, the FDA may access and copy records that will assist the FDA in determining whether the food is actually adulterated or whether there is a reasonable probability that using or exposing individuals or animals to the food could result in serious adverse health consequences. Furthermore, the guidance informs industry that the FDA will likely request access to records when it becomes aware of reportable food reports, product recalls, foodborne outbreaks, or consumer complaints. The document provides additional guidance regarding the types of records that the FDA may request and actions that the FDA may take when a firm refuses to permit access to records. Both guidance documents are non-binding and do not establish legally enforceable responsibilities.