October 10, 2003
"By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure," Secretary Thompson said. "These new requirements represent the latest steps in our ongoing efforts to respond to new threats and improve the safety of all the foods that we eat in this country."
The two new regulations will implement key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which provided FDA new authority to protect the nation's food supply against actual or threatened terrorist acts and other food-related emergencies.
"With input from the private sector, our partners in the federal government and the governments of our trading partners, we will use these regulations to work more effectively than ever to protect America's food supply, while maintaining the regular, free flow of commerce that is so vital to the well being of our citizens," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Coupled with other counter-terrorism initiatives, these regulations mark a new era of international collaboration, one that strengthens the free market and free trade even as we face new threats to our security. We will keep working to build on these important regulations to fulfill our mission of helping Americans get diverse, affordable food products that are as safe and secure as possible."
The first regulation requires food importers to provide the FDA with advance notice of human and animal food shipments imported or offered for import on or after Dec. 12, 2003. This will allow FDA to know, in advance, when specific food shipments will be arriving at U.S. ports of entry and what those shipments will contain. This advance information will allow the FDA, working with U.S. Customs and Border Protection (CBP), to more effectively target inspections and ensure the safety of imported foods. The FDA expects to receive about 25,000 notifications about incoming shipments each day.
The second regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the agency by Dec. 12, 2003. As a result, FDA will have for the first time a complete roster of foreign and domestic food facilities. The requirements will enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food. The FDA expects about 420,000 facilities to register under this requirement.
The FDA worked closely with CBP to ensure the new regulations promote a coordinated strategy for border protection.
"Using the electronic data required under these regulations and a sophisticated automated targeting system, CBP and the FDA will be working side-by-side to make joint decisions about food shipments that could pose a potential threat to the United States," said Commissioner Robert C. Bonner, U.S. Customs and Border Protection, Department of Homeland Security. "This integrated risk-management process will increase our security and facilitate the movement of legitimate commerce -- objectives shared by both agencies. We look forward to continuing our work with the FDA to implement the regulations in a manner that meets these shared objectives."
The regulations reflect comments from a broad array of law enforcement, national security, industry and other experts as the FDA worked to effectively improve food safety and security without adding unnecessary costs to domestic or international trade.
"We have listened carefully to what stakeholders said about the proposals, in order to develop rules that are both workable and feasible," said Dr. McClellan. "The rules we are announcing today [Thursday] are intended to fulfill our goal of making the food supply safer and more secure without hindering trade."
Under the prior notice regulation, prior notice of imported foods must be received and confirmed electronically by FDA no more than five days before its arrival and no fewer than:
In addition, for international mail shipments, notifications must be made before the shipment is mailed. Also, when an individual carries or otherwise transports foods subject to the new requirement, advance notice of two, four or eight hours is required -- depending on the mode of transportation. The food must also be accompanied by confirmation of receipt for FDA review.
The regulation's timeframes reflect the FDA's work, in collaboration with other agencies, to reduce substantially the required time for advance notice to minimize unnecessary costs. For example, the proposed rule issued earlier this year would have required that importers give notice by noon the day before the arrival of a shipment of food into the United States for all modes of transportation, including by land by road. The final regulation requires only two hours notice before arrival of food by land by road and could be reduced further in the future as part of FDA-CBP plan to coordinate border-management activities more efficiently.
The advance notice to the FDA may be submitted electronically in most circumstances using Customs' existing ABI/ACS system, making it easier for importers to comply with the new law. In addition, the FDA will operate a new Prior Notice System Interface that can receive such notifications.
The second regulation requires the owner, operator, or agent in charge of a domestic or foreign food facility to register with FDA, providing information about the name and address of each facility at which, and all trade names under which, the registrant conducts business, and information about certain categories of food the facility produces. For a foreign facility, the registration must include the name of the U.S. agent for the facility.
Registration is required for domestic facilities whether or not food from the facility enters interstate commerce. Domestic facilities are also required to provide emergency contact information. All changes to such information must be reported within 60 days. Except for specific exemptions, the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.
Registration would not be required for private residences of individuals; certain food transport vehicles; facilities that manufacture food contact substances and pesticides; farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; non-processing fishing vessels; and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Also exempt are foreign facilities if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S.
The registration may be submitted electronically, via the Internet, or by paper through surface mail or by fax. Registrations may also be submitted on CD-ROM by mail. The FDA will be able to accept electronic registration from anywhere in the world 24 hours a day, 7 days a week, beginning Oct. 16. Filling out registration online should take about 15 minutes if a facility has its paperwork ready. A registering facility will receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are filled in. There is no fee associated with registration.
The rules take effect Dec. 12, 2003, in accordance with the Bioterrorism Act. To assure that the regulations can be implemented efficiently and with minimal disruption, FDA intends to exercise broad enforcement discretion for the prior notice rule for the first four months after implementation. During this time, FDA and CBP will educate importers about how they can comply with the regulations, and will work with trade associations and foreign governments to make sure all importers are well informed of the new requirements. Thereafter, FDA will phase in full implementation of the prior notice requirements.
FDA has already conducted 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 full information about the rules. 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 http://www.fda.gov/OHRMS/DOCKETS/98fr/03-24921.htm.
Both the new regulations will be published as interim final rules in the Oct. 10 issue of the Federal Register. The FDA is requesting further public comment on the rules.
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