The U.S. Food and Drug Administration (FDA) has issued a final rule adopting  the interim final rule titled “establishment, Maintenance, and Availability of  Records: Amendment to Record Availability Requirements” for recordkeeping  regulations under the Food Safety Modernization Act (FSMA). The amendments made under FsMA allow FDA access to records beyond those relating  to specific suspect food articles if the agency believes that other food articles  are likely to be affected in a similar manner. The amendments also permit FDA  to access records relating to articles of food “for which there is a reasonable  probability that the use of, or exposure to, the article of food will cause serious  adverse health consequences or death to humans or animals.” The expanded  records-access authority is intended to improve FDA’s ability to respond to  and contain safety problems with the food supply for humans and animals. 

FDA has also issued two guidance documents, “FDA Records Access  Authority under Sections 414 and 704 of the Federal Food, Drug, &  Cosmetic Act” and “What You Need to Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide,” which  update previous versions. Comments on the guidance documents will be  accepted at any time. See Federal Register, April 4, 2014.