Regulatory Issues: FDA begins bioterrorism enforcement

Facility registration and import notification have been required since Dec. 12, 2003, but FDA and Customs have been focusing on education.

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The grace period is over. This month, the Food and Drug Administration and Bureau of Customs and Border Protection will begin to more strictly enforce the import notification requirements of the Bioterrorism Act. Food processors can expect delays and possibly more serious consequences if incoming shipments are found to be in violation.

Particularly for those who have not yet thought about these requirements, now would be a great time to review them. Facility registration and import notification both have been required since Dec. 12, 2003. Briefly, the act requires registration of every facility that manufactures, processes, packages or holds food for consumption in the United States.

The act also requires that purchasers, importers, or agents notify FDA before a shipment of imported food reaches the U.S. FDA issued a regulation to implement the import notification requirement in October 2003, with a December 12, 2003, deadline for compliance.

Many months ago, FDA announced a phased-in approach to enforcement of the import notification requirements. Specifically, a Compliance Policy Guide, issued in December 2003 and updated in June 2004, stated that FDA and Customs planned to focus their enforcement resources on education during the first eight months of the rule. This eight-month "grace period" ends on August 12.

FDA’s Compliance Policy Guide classifies the various types of violations that are likely to occur. Inadequate prior notice would include cases where no prior notice was filed or an inaccurate or untimely prior notice was filed. There will also be cases where the article of imported food comes from a facility overseas that is not properly registered with FDA.

Prior to August 12, FDA and Customs responded to many Prior Notice violations with a warning aimed at educating the individuals responsible for the shipments. After August 12, Customs and FDA will choose between two responses: entry refusal and/or assessment of civil monetary penalties under the Tariff Act.

Civil penalties will most likely be reserved for more significant instances of non-compliance, such as situations in which the imported article of food presents a threat of adverse health consequences or situations in which the violation reflects a history of repeated conduct or appears to be intentional.

For most responsible operators in the food industry, the possibility of a refusal of entry or a delayed entry will provide adequate incentive to comply with the law.

FDA also issued a Compliance Policy Guide regarding registration of food facilities under the Bioterrorism Act. FDA is likely to discover in the course of routine inspections some domestic facilities are not properly registered. Failure to register a facility can be corrected easily by online registration through FDA’s web site. In some cases, FDA may respond with issuance of an "Untitled Letter" in which the owner, operator, or agent-in-charge of the facility is requested to register within 30 working days. If the facility does not come into compliance within 30 days, FDA will most likely issue a "Warning Letter."

The difference between a Warning Letter and an Untitled Letter is that a Warning Letter comes with an implicit commitment that FDA will take further enforcement action if necessary to resolve the matter. Food is not automatically adulterated or misbranded because it passes through an unregistered facility, but failure to register is a "prohibited act" under the Food, Drug, and Cosmetic Act, and injunctive relief would be available to FDA if a facility for some reason refuses to register after having received a Warning Letter.

By way of review, at the time of this writing, FDA has not yet issued its final rule on recordkeeping under the Bioterrorism Act. As you may recall, this rule will require food processors to keep "one up, one down" records to indicate the immediate previous source and immediate subsequent recipient of food and food ingredients handled by each facility. These final regulations should be issued shortly.

Earlier this year, FDA issued its final rule regarding the agency’s administrative detention authority under the Bioterrorism Act. Unlike the other rulemakings under the Bioterrorism Act, the administrative detention rule does not require much in the way of a compliance program. It explains FDA’s detention authority and establishes procedures to be followed when FDA invokes this authority.

David Joy is a partner at the Washington, D.C., law firm of Keller and Heckman LLP. He specializes in food and drug law, is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information, visit the Keller and Heckman web site at www.khlaw.com.

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