The Bioterrorism Act: Essential Facts

September 2, 2004
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The Food and Drug Administration (FDA) is responsible for carrying out certain provisions of the Bioterrorism Act, particularly Title III, Subtitle A. This title of the law requires the FDA to promulgate regulations affecting an estimated 420,000 US and foreign food and beverage facilities. It covers all FDA regulated food and food ingredients intended for human or animal consumption, as defined in the Food, Drug, and Cosmetic Act Section 201f. This includes food and food additives for man or animal, dietary supplements and their ingredients, infant formula, pet food, animal feeds, fish and seafood, alcoholic and non-alcoholic beverages, bottled water, fruits and vegetables, dairy products, shell eggs, raw agricultural commodities, canned and frozen foods, live food animals, bakery products, snacks, and candy.

The intent of Title III Subtitle A is to provide a rapid response forward and backward traceability records program to better protect FDA regulated food supplies from bioterrorism and any other potential food hazard caused by negligence. Under the law, FDA was required to publish requirements to support the implementation and enforcement of this Bioterrorism Act in the Code of Federal Regulations no later than December 12, 2003. Following publication, companies with 500 or more employees have six months to comply. Companies with between 11 and 499 employees have 12 months. Companies with 10 or less employees have 18 months to comply.

The FDA is promulgating regulations for four sections of the law. They are Sections 305 Registration of Food Facilities, Section 306 Establishment & Maintenance of Records, Section 307 Prior Notice of Imported Food Shipments, and Section 308 Administrative Detention Authority. Other FDA and government initiatives designed to implement the intent of the law impact the food industry, including an FDA guidance entitled "Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance" and the US CBP Customs Trade Partnership Against Terrorism (C-TPAT) program. Current information on FDA actions supporting this bioterrorism legislation can be found at www.fda.gov/oc/bioterrorism/bioact.html.

On March 21, 2003 FDA released a security guidance for industry entitled "Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance." This represents the FDA's current thinking on the measures food establishments may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. The FDA states that it is relevant to all sectors of the food system, including farms, aquaculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, and warehouses. These and other documents relevant to food safety and terrorism are located at the FDA/Center for Food Safety and Applied Nutrition web site www.cfsan.fda.gov/~dms/fsterr.html

On May 27, 2003 the FDA and Bureau of Customs and Border Protection (CBP) announced their joint initiative to streamline the implementation of the prior notice requirements by allowing food importers to provide required information on food imports to either agency using an integrated process. Then in October 2003 the FDA and CBP issued their first Interim Final Rulings on Registration of Food Facilities and Prior Notice of Imported Food Shipments.

The Interim Final Ruling (IFR) on Registration of Food Facilities requires owners, operators, or agents in charge of domestic facilities that manufacture, process, pack, or hold, transport, distribute, receive, or import food for human or animal consumption in the United States and foreign facilities that last manufacture, process, pack, or hold prior to shipment to register with the FDA. Under this ruling, all affected facilities were required to register by December 12, 2003. Failure to comply is prohibited and can result in civil or criminal penalties.

The FDA's current policy is to focus enforcement on two situations. The first is a continuing failure to register a facility following issuance of an FDA warning letter. The second is if agency inspection of an unregistered facility documents serious violations of other provisions of the Food, Drug, and Cosmetics Act. If a foreign facility fails to register and attempts to import food into the US, that food will be held at the port of entry. Registration requirements are being enforced through a prior notice system.

Registration must be completed on Form 3537. The FDA website for registration and additional information is located at www.cfsan.fda.gov/~furls/ovffreg.html. By May 19, 2004, the FDA had received 202,024 registrations out of an estimated 420,000. Foreign registrations numbered 105,193 and 96,831 were domestic.

The October 2003 Interim Final Ruling on Prior Notice of Imported Food Shipments drastically altered the original 24-hour time requirement. The Interim Ruling states that prior notice can be received no earlier than five days before arrival of the product and no later than two hours if by land, four hours if by air or rail, and eight hours if by sea. If by mail, it must be received before mailing and with the confirmation number. On December 5, 2003, CBP issued the Required Advance Electronic Presentation of Cargo Information Final Rule that further modified the prior notice timeframes. Under this ruling, arrival by land by road is one hour before arrival or 30 minutes for participants in the FAST/C-TPAT program. By land by rail is two hours before arrival. For flights originating north of the equator in North and Central America, South America, the Caribbean and Bermuda, it is by "wheels up." For all other arrival by air, it is four hours before arrival.

The CBP C-TPAT, a joint government-business initiative, offers approved importers fast track, preferential treatment at border crossings in return for meeting the requirements of the program. These include security recommendations for importers, brokers, carriers, consolidators, marine port authority operators, and foreign manufacturers, as well as a validation process. In addition, C-TPAT partners are required to use C-TPAT approved suppliers, carriers, and warehouse operators.

On April 14, 2004 the FDA and CBP published their Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes. The plan has four phases. The first is to assess existing procedures and staffing needed to receive, review, and respond to the prior notices submitted in accordance with the Prior Notice IFR from August 12, 2004 to October 12, 2004. The second, from October 13, 2004 to November 12, 2004, calls for identifying what changes to work practices and staffing would be necessary for the FDA to continue to receive, review, and respond to all prior notice submissions with reduced timeframes. The third, from November 13, 2004 to February 12, 2005, calls for implementing changes to ensure they can receive, review, and respond to all prior notice submissions with reduced timeframes. Finally in June 2005 (revised from March 2005), FDA and CBP intend to issue the prior notice final ruling.

On April 2, 2004 the FDA issued a report on compliance with prior notice of imported foods, updated in May 2004. It shows that more than 80 percent of prior notice submissions were submitted through the CBP's Automated Commercial System (ACS) and about 12 percent came through the FDA's new web-based Prior Notice System Interface (PNSI) vm.cfsan.fda.gov/~pn/pnoview.html. The report further shows that many submissions to both systems lacked some of the specific data elements required for prior notice. In both cases compliance for imports via land, which is largely trucks, lagged behind that for other modes of transportation.

In December 2003 the FDA and CBP issued the Transitional Compliance Policy on facilities registration and prior notice, revised in August 2004. This compliance guideline makes clear that during the eight months ending August 12, 2004, the two agencies will rely primarily on educating the affected firms and individuals. As of August 12, 2004 the FDA and CBP focus is on enforcement for major violations and education for minor violations, as noted in the August 2004 revisions, with still only half of the estimated number of facilities registered.

On May 27, 2004 the Final Ruling on Administrative Detention of Suspected Foods was issued. Under this final ruling, the FDA may detain an article of food on the strength of credible evidence or information resulting from an inspection, examination, or investigation. This provides the FDA with new authority for detaining domestic or imported food within the US in intrastate or interstate commerce.

While the FDA states that Bioterrorism Act records are exempt from 21 CFR Part 11 requirements unless these records are covered under another regulation with Part 11 requirements, the FDA has yet to issue any ruling on establishment and maintenance of records. This ruling on records is expected to define how granular these records must be to ensure rapid response tracking and tracing.

Past FDA overviews on records and administrative detention have stated that non-transporter records must include all information reasonably available to the non-transporter to identify the specific source of each ingredient that was used to make every lot of finished product. These records must also be available within four hours if requested between 8:00 am and 5:00 pm, Monday through Friday or within eight hours if requested any other time. This yet to be promulgated ruling is of great concern to the industry because it is expected to have the greatest impact. The food industry believes that this anticipated ruling is unlike the other rulings in that no single method best suits everyone due to the diversity of manufacturing processes. In this case, over-mandating could hinder achieving and maintaining the intent of the Bioterrorism Act.

For more information:

The FDA's Bioterrorism Act website (www.fda.gov/oc/bioterrorism/bioact.html) and the Center for Food Safety and Applied Nutrition website (www.cfsan.fda.gov/list.html) provide a rich source of updated information on FDA activities.

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