The Food and Drug Administration has published two interim final rules in the Federal Register, regarding the FDA's administrative detention authority and advanced notice of rejected imports, connected to the Food Safety Modernization Act.
The first interim final rule relates to the FDA’s administrative detention authority. Currently, the FDA has the authority to detain products deemed to have “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” Under the FSMA, the criteria level has been modified to the more general definition “reason to believe that the article of food is adulterated or misbranded.” This change in administrative detention authority widens the FDA’s scope of products acceptable for detention to products that would normally be considered as part of a Class II recall.
The second interim final rule relates to importers giving advanced notice of imports that were refused entry into another country. Presently, importers must give the FDA advanced notice of imports electronically through a Customs and Border Protection or FDA system. This interim final rule implements an FSMA-mandated requirement that this prior notice include the identity of any country to which an article of food has been refused entry.
The requirements in both interim final rules will be effective July 3, 2011. Comments will be accepted on both interim final rules and reviewed by the American Feed Industry Association's FSMA work groups.