Feedmills can now register online to meet FDA bioterrorism ruling

FDA has announced that electronic registration for foreign and domestic food and feed facilities is now live - more than 40,000 facilities can register in minutes
October 22, 2003

The Food and Drug Administration has announced that its new electronic registration system for food facilities, foreign and domestic, would be “live” this week. This registration system is available online at FDA says it is designed to bolster the safety and security of America's food supply and will help with quick identification and notification of food processors and other facilities involved in any deliberate or accidental contamination of food.

FDA’s registration system, one of the key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), is part of an interim final rule announced by Secretary of Health and Human Services Tommy G. Thompson October 9 and published on October 10 that requires domestic and foreign food facilities to register with the agency by December 12, 2003. As a result, FDA will have for the first time an official roster of foreign and domestic food facilities, allowing timely notification and response in the event of a food safety threat.

“FDA is committed to developing new, more efficient ways to enhance food security, and the new electronic registration system reflects that commitment,” said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. “Registering online will be fast and simple. Our site will be open 24 hours a day, seven days a week, available to anyone in the world with access to the internet. This new system will permit 400,000 facilities to register worldwide in 60 days, and will give FDA new capabilities to work with everyone involved in our food supply to keep it safe and secure.”

FDA is encouraging electronic registration because it is faster and more efficient than paper registration. Each firm registering online will instantly receive its unique registration number, which will be required for doing business in the U.S. beginning December 12. (Paper registration may be submitted via regular mail or fax.) Facilities will not be charged for registration, which is a one-time procedure.

Advance notice of shipments of food and feed for import into the U.S.
In addition to the registration rule, FDA last week published a second interim final regulation to enhance the safety and security of the food supply. That rule requires that FDA be provided advance notice of shipments of human and animal food being imported or offered for import into the U.S, also effective as of December 12, 2003.

In arriving at the interim final rule, the FDA worked closely with the Bureau of Customs and Border Protection (CBP) to ensure the new regulations promote a coordinated strategy for border protection. FDA and CBP continue to collaborate intensely on making the new safeguard of prior notice as efficient and effective as possible.

For example, FDA and CBP have worked together so that most notices can come in through the existing CBP system. In addition, FDA and CPB have signed a Memorandum of Understanding to commission CBP employees to serve on FDA’s behalf at ports where FDA may not currently have staff or to augment FDA staff in the enforcement of FDA’s prior notice regulation. FDA plans to co-locate its Prior Notice Review Center and staff at CBP’s National Targeting Center. This will ensure that the agencies maximize their joint assets and provide consistent enforcement. It further engenders a common bond, so that the two agencies most responsible for protecting the nation’s imported food supply can interact in person.

FDA and CBP are also working together to develop enhanced information systems and programs to keep food imports secure without imposing unnecessary costs or delays. FDA and other federal agencies continue to contribute to the development of CBP’s state-of-the-art automated commercial environment system to screen products and to support FDA’s public health mission.

“Not only have FDA and the Bureau of Customs and Border Protection forged a stronger working relationship, but we have also listened carefully to stakeholders across the board to provide an unprecedented level of food security as efficiently as possible,” said Dr. McClellan. "We will continue to work with all affected parties to help them understand how to do their part in assuring food safety at the lowest possible cost.”

FDA has already begun an extensive domestic and international outreach and education about the new rules. In the coming weeks, FDA will conduct national and international meetings and other programs to provide a comprehensive picture of the rules. As part of this effort, FDA also will hold a satellite downlink public meeting on Oct. 28 to discuss the two regulations. Information about this meeting, including domestic and international viewing opportunities and registration, is available at