On February 23, 2012, the U.S. Food and Drug Administration (FDA) published an Interim Final Rule expanding record-keeping requirements for food establishments as authorized under the FDA Food Safety Modernization Act (FSMA). These regulatory changes in record keeping are intended to improve FDA's ability to respond to and contain food-related safety problems. Under the new regulation, FDA can request records not only for foods the Agency believes are adulterated and present a threat of adverse health consequences, but also for foods that FDA reasonably believes are likely to be affected in a similar manner as the adulterated food (e.g., a similar food product prone to the same type of contamination or a food product held in the same facility where a different food was contaminated during storage) and also have the potential to cause serious adverse health consequences or death to humans or animals. Records and information requested under this regulation must be made available to FDA for inspection and photocopying or other means of reproduction within 24 hours from the time of receipt of an official request by FDA. The record keeping requirements apply to persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Comments on the Interim Final Rule should be submitted to FDA by May 23, 2012. The Interim Final Rule is effective March 1, 2012.

In conjunction with issuance of the Interim Final Rule, FDA published two guidance documents, “Draft Guidance to Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act”, and “Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)”.

The guidance provides industry with additional information on complying with the noted record-keeping requirements. For further information, please contact Georgia C. Ravitz, Brian P. Waldman or James Hartten.

To view the Interim Final Rule, click here.