On October 10, 2003 the U.S. Food & Drug Administration (FDA) and the U.S. Bureau of Customs and Border Protection (CBP) jointly issued two interim final rules (IFR's) to implement provisions in the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act).
To the Editor:
On October 10, 2003 the U.S. Food & Drug Administration (FDA) and the U.S. Bureau of Customs and Border Protection (CBP) jointly issued two interim final rules (IFR's) to implement provisions in the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act): Registration of Food Facilities and Prior Notice of Imported Food." Both rules are intended to enhance the safety and security of the U.S. food supply and took effect on December 12, 2003.
* Registration of all domestic and foreign facilities that manufacturer, process, pack or hold food for consumption by humans or animals in the U.S.: An online registration system is available 24/7 once FDA publishes the final rule. Registration can also be done by mail or fax.
* Prior notice to FDA of each article of food imported or offered for import into the U.S. before the food arrives at the port of entry: Importers, in most circumstances, are able to provide the required information to FDA using CBP's Automated Commercial System. In addition, anyone may file prior notice over the Internet using FDA's Prior Notice System Interface.
Of the food facilities FDA estimated would have to register, only about half have done so and food shipments are arriving at U.S. ports without the requisite submission of prior notice to FDA. The agency is especially concerned about the relatively slow pace of registrations, which drastically declined once compliance policy guidelines (CPG's) were issued, stating that in the initial months of implementation of the two rules, the agencies would emphasize educating affected parties. Both CPG's clearly stated, however, that the agencies expect a good faith effort at compliance, as the requirements of the IFR's are in effect.
During the initial stages of implementation of the IFR's, FDA and CBP continue to work with the food and animal feed industries, and persons who import food into the U.S. to help them comply with the new rules. The Bioterrorism Act does, however, provide FDA with significant new enforcement tools. The Act makes failure to register a prohibited act under the Federal Food, Drug and Cosmetic Act (FD & C Act). In addition, the Bioterrorism Act adds a new section to the FD & C Act, which provides that if an article of food from an unregistered facility that is imported or offered for import into the U.S. is subject to a hold until the facility is registered. Similarly, the Bioterrorism Act provides that an article of food that is imported or offered for import without adequate prior notice is subject to refusal until adequate notice is submitted and the FDA has reviewed the notice and determined its response. If refused, such an article of food may not be delivered to the owner, importer or consignee under bond until the prior notice requirements have been satisfied.
Department of Health & Human Services (HHS)
The Food and Drug Administration (FDA)
The Center for Food Safety and Applied Nutrition (CFSAN)
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|Title Annotation:||Industry News|
|Date:||May 1, 2004|
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