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FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes 'Live', Allowing More Than 400,000 Facilities to Register in Minutes

FDA Reports on Progress in Developing Rapid Tests of Food Contamination

The Food and Drug Administration today announced further steps to use modern technology to provide new protections for America’s food supply. First, FDA announced that its new electronic registration system for food facilities, foreign and domestic, is “live” today. This registration system, available online at and designed to bolster the safety and security of America's food supply, will help with quick identification and notification of food processors and other facilities involved in any deliberate or accidental contamination of food. Second, FDA issued a report to Congress on its progress toward developing more rapid, easier, and less costly tests to detect food contamination.

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 we are inaugurating today 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.

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

In another step to improve the technologies available to keep the nation’s food supply safe and secure, FDA today sent to Congress a report detailing progress it has made in research to develop rapid tests and sampling methods to improve the agency’s ability to identify contamination of food.

The report, entitled “Testing For Rapid Detection of Adulteration Of Food,” responds to provisions in Section 302(d) of the Bioterrorism Act. That section charged FDA with developing faster methods to detect adulterated foods and animal feed at U.S. ports of entry so as not to delay unduly the flow of food to domestic markets. This is the first annual report to Congress as required under the Bioterrorism Act.

“Improving FDA’s inspection, detection and monitoring capabilities of food imports is a top priority,” said Dr. McClellan. “With our research partners in private industry, other government agencies, academia, trade associations, and others, FDA is conducting a considerable amount of research intended to develop new test methods and innovative test kits. Our goal is to make them faster, more economical, and more accurate, so that we can be better prepared at a lower cost.”

According to the report, FDA currently has over 90 different active research projects involving test and sampling methodology development. This is an FDA-wide effort and involves many FDA scientific experts and partners in academia and consortia to achieve this important and strategic research goal. Some of the research highlights are provided below:

Center for Food Safety and Applied Nutrition
Developing and validating effectiveness of rapid testing technology and methods for detecting potential biological, chemical and radiological threat agents in foods
Developing and assessing processing technologies and systems that may mitigate or eliminate potential biological and chemical threats to the food supply

Center for Veterinary Medicine
Successfully validated an analytical method using polymerase chain reaction (PCR) tests to detect bovine-derived materials in animal feeds to ensure compliance with FDA’s regulation designed to protect the U.S. against bovine spongiform encephalopathy (BSE, or “mad cow disease)
Worked to expand the number of species that the current PCR method is capable of detecting from bovine to include other ruminant species.

Office of Regulatory Affairs
Developed an immunoassay method for detection of botulism toxin in food.
Developed a mass spectrometry-based method for detecting a wide variety of chemical toxins in food.

National Center for Toxicological Research
Developed a novel approach to rapidly identify biomarkers of toxicity using a mass spectrometry-based method for detecting microorganisms that could be introduced into otherwise harmless organisms to cause intentional adulteration.

“The one-time allocation of $5 million provided last July by the Office of Management and Budget is allowing FDA to strengthen this research program,” said Dr. McClellan. “Because testing select agents in food represents a new field of scientific inquiry, the research needs are quite substantial and will need to be sustained over several years.”

FDA’s report to Congress is available on the web at


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