May 28, 2004

Final Rule on Administrative Detention On Display in Federal Register

On May 27, FDA announced its final regulation on Administrative Detention, which went on advanced display in the Federal Register the same day. This rule was established in response to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which authorized FDA to administratively detain suspect food as soon as it was enacted. The final regulation clarifies the agency's administrative detention procedures and the process for appealing the detention order. This new authority applies to food for which the agency has credible evidence or information that it presents a threat of serious adverse health consequences or death to humans or animals. The final rule can be found at http://www.cfsan.fda.gov/~lrd/fr040604.html. The press release announcing the publication is on FDA's website at http://www.cfsan.fda.gov/~lrd/fpbtact7.html.

Updated Compliance Information on Registration of Food Facilities

FDA's interim final rule on Registration of Food Facilities requires domestic and foreign facilities to register with FDA by December 12, 2003, if they manufacture, process, pack, or hold food for human or animal consumption in the U.S. FDA issued a Compliance Policy Guide (CPG) in December 2003 to provide guidance on the agency's strategy for enforcing and achieving compliance with the registration interim final rule. The CPG states that for both domestic and foreign facilities, FDA intends to focus its initial efforts on educating industry on how to comply with the rule.

FDA estimates that the total number of food facilities that must register is approximately 420,000, approximately half of which are domestic. As of May 19, 2004, FDA had received 202,024 registrations, of which 105,193 are foreign and 96,831 are domestic. The following FDA website provides additional registration compliance information, including the number of registrations per country and shows the registration rate by date: http://www.cfsan.fda.gov/~furls/ffregsum.html.