Colorado State University Extension
SafeFood Rapid Response Network
Go to Table of Contents for this issue
FDA Proposed Regulations for Implementing the Bioterrorism Act
Edited by: Mary Schroeder, M.S., R.D. & Pat Kendall, Ph.D., R.D., Colorado State - Summer 2003
As a result of the recently passed Bioterrorism Act, four regulations, all designed to protect our food supply from possible terrorist activities, are being finalized by the U.S. Food and Drug Administration (FDA). All are expected to be in place by December 12, 2003. The new regulations include:
Registration of Food Facilities:
This regulation will require all owners, operators or agents in charge of domestic or foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the United States to register with the FDA. The proposal exempts farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for, or served directly to, the consumer, fishing vessels, and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Those who manufacture or process a food ingredient that is further manufactured/processed outside the U.S. are also considered exempt, although some "mixed type" facilities may be subject to registration for some of their activities. Registration must occur by December 12, 2003.Prior Notice of Imported Food Shipments:
The Bioterrorism Act also requires that the FDA receive prior notice of food imported or offered for import into the U.S., beginning December 12, 2003. The prior notice must include the identity of the article, manufacturer and shipper, grower (if known), originating country, the country from which it was shipped and the anticipated port of arrival. Those items not subject to these proposed requirements include meat, poultry and egg products that at the time of importation are subject to USDA's exclusive jurisdiction. If adequate notice is not given, articles will be refused admission and held until proper notice is provided.Administrative Detention:
The Act also spells out how the FDA can detain food from facilities that are not registered or did not give prior notice of shipments. Further, the FDA is authorized to detain any food if there is credible evidence or information indicating the food may pose a serious health threat to humans or animals.
Records Maintenance:
Finally, the proposed rule will require all manufacturers, processors, packers, distributors, receivers, holders and importers of food to keep records identifying the immediate source from which they received the food. Records will also be required regarding the immediate subsequent recipient to whom they sent the product. This recordkeeping proposal is designed to help the FDA track foods implicated in future emergencies, such as terrorism-related contamination. Current information on the FDA's efforts, including fact sheets on each of the proposed regulations can be obtained at: www.fda.gov under Bioterrorism Act.
Source:
U.S. Department of Agriculture/Center for Food Safety & Applied Nutrition (CFSAN). Protecting the Food Supply: FDA Actions on New Bioterrorism Legislation. May 2003.
