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New U.S. FDA Rules under the Bioterrorism Act will require Action by Many in the Food Industry

September 5, 2003

Many facilities and individuals engaged in the production, Importation and distribution of food in the United States will have to meet new requirements from the United States Drug and Food Administration (FDA) beginning December 12, 2003, mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act).

One of these new regulations would require registration of domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S.

Another would require prior notice to FDA of food imported or offered for import into the U.S.

A third regulation would specify information that must be included and retained in records that would identify the immediate previous sources and immediate subsequent recipients of food.

Lastly a fourth regulation identifies procedures under which FDA would administratively detain food that presents a serious health threat to humans or animals.

Following the events of September 11, 2001, the U.S. Congress passed the Bioterrorism Act to strengthen U.S. security against bioterrorism. The act provides several new tools that enable FDA to act quickly in responding to threatened or actual terrorist attacks on the u.s. food supply or other food-related emergencies by providing the agency with better information than is now available to the agency about the production and distribution of food consumed in, or entering, the U.S. FDA published the new regulations as proposals for comment and currently is evaluating the comments it received. FDA plans to publish the final registration and prior notice regulations by mid-October 2003, to allow the food industry time to understand the new requirements and be in compliance by the date the U.S. Congress specified in the Bioterrorism Act, December 12, 2003. The FDA plans to publish the final record-keeping and administrative detention rules by December 12, 2003.

Note: this information reflects the new regulations as they were proposed for public comment. The comments FDA received likely will alter some details in the final regulations, which will contain the requirements with which affected industry must comply.

Registration of food facilities

Domestic or foreign facilities that manufacture, process, pack or hold food for consumption by humans or animals in the u.s. will have to register with FDA no later than December 12, 2003. Registrations will not be accepted until the final regulation is published. At that time, the owner, operator, or agent in charge of a domestic or foreign facility will be able to register via the internet to submit required information--e.g., the name and address of each facility at which the registrant conducts business and the categories of food the facility handles - and receive from FDA an instantaneous confirmation of Registration and the facility's registration number.

Registrations by mail also will be accepted, but that will be a much slower process. There is no fee associated with registration. Imported food from foreign facilities that are required to register but have not will be held at the port of entry until the facility is registered. In addition, it is a prohibited act to fail to register if required to do so, which could subject the owner, operator, or agent-in-charge of the facility to criminal or civil penalties.

Except for the exemptions below, the new requirement would apply to all affected facilities for all foods and animal feed products regulated by FDA, including dietary supplements, infant formula, beverages (including alcoholic beverages), and food additives.

Exemptions: farms, restaurants, retail food establishments, non-profit establishments that prepare or serve food, fishing vessels not engaged in processing, facilities regulated exclusively by the U.S. Department of Agriculture, and foreign facilities, if the food from the facility undergoes significant further processing or packaging by another facility outside the U.S.

Prior notice of imported food

Beginning on December 12, 2003, FDA must receive advance notice of each article of food imported or offered for import into the U.S. -- regardless of whether the food will be consumed in the U.S. Among other items, the notice must include a description of the food, the manufacturer and shipper, originating country, country from which the article is shipped, and anticipated port of entry. FDA and the Bureau of Customs and Border Protection (CBP) have announced that importers, in most circumstances, will be able to provide the required prior notice information to FDA using CBP’s automated commercial system, which currently is used to provide import information to customs, making it easier for them to comply with the new law. If prior notice is not submitted or is inadequate, the act provides that the food shall be held at the port of entry until adequate notice is provided.

Exemptions: food brought into the U.S. in a traveler's personal baggage.

Establishment and maintenance of records

Domestic persons that manufacture, process, pack, transport, distribute, receive, hold, or import food for consumption in the U.S. will be required to create and

Maintain records that are necessary to identify the immediate previous sources and the immediate subsequent recipients of food (i.e., where it came from and where it went). This requirement also applies to foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. The information will allow FDA to follow up on credible threats of serious illness or death to humans or animals by tracing the food back to its source, and tracing the food forward to all recipients to remove it from commerce as necessary.

Larger businesses (more than 500 employees) would have to comply with the final regulation within 6 months from its publication in the federal register. Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months from publication, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from publication.

Exemptions: farms, restaurants, certain pet food entities, retail food establishments, non-profit establishments that prepare or serve food, fishing vessels not engaged in processing, facilities regulated exclusively by the U.S.

Department of agriculture, and foreign facilities, if the food from the facility undergoes significant further processing or packaging by another facility outside of the U.S. retail food operations also are exempted from maintaining records on immediate subsequent recipients when food is sold directly to consumers.

Please refer to FDA's web page on the Bioterrorism Act. It includes the Act itself, the provisions related to FDA, and the agency's regulatory proposals and activities to implement these provisions.

Please find it at: Http://www/fda.gov/oc/bioterrorism/bioact.html