by Paul D. Rubin
In the aftermath of the events of September 11, 2001, Congress recognized the need to enhance the security of the U.S. food supply. On June 12, 2002, President Bush signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)1 which provides the U.S. Food and Drug Administration (FDA or Agency) with substantial new powers to regulate and review foods and dietary supplements imported into the United States. In addition, as part of Operation Liberty Shield, FDA has hired 800 new inspectors and increased the monitoring of imported foods in order to protect the U.S. food supply.
Among the new powers authorized in the Bioterrorism Act are the following:
1. Registration of food facilities, including foreign facilities;
2. Prior notice of food and dietary supplements imported into the United States;
3. Recordkeeping requirements that will enable FDA to identify the previous sources and the subsequent recipients of food; and
4. FDA administrative detention authority over food and dietary supplements that present a threat of serious adverse health consequences or death to humans or animals.
In addition to the above major rules, the Bioterrorism Act also contains other substantive provisions for which FDA is currently considering issuance of guidance documents to further explain and clarify its interpretation of these legal requirements. FDA has summarized some of these provisions as follows:
1. Debarment This authorizes FDA to debar (prohibit from importing food) persons who have been convicted of a felony relating to the importation of any food or who have engaged in a pattern of importing adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.
2. Marking The Secretary of the Department of Health and Human Services may require marking (labeling) of foods refused admission into the United States at the owners or consignees expense.
3. Port Shopping Food that has been refused admission into the United States will be considered adulterated if it is offered again for import, unless the person importing the food or offering it for import demonstrates that the food is now in compliance with FDA standards.
In order to expedite implementation of the Bioterrorism Act, Congress established strict deadlines for FDA to issue and enforce new regulations. Specifically, the Bioterrorism Act requires the Agency to ensure that final regulations are issued and in effect by December 12, 2003, for the registration and prior notice provisions of the Act. In addition, final regulations must be issued by December 12, 2003, for the recordkeeping requirements associated with the new provisions. With regard to FDA detention authority, the Bioterorrism Act requires FDA to issue regulations, but does not specify a deadline.
As of the writing of this article (March 2003), FDA has already issued the proposed rules for the registration and prior notice provisions of the Bioterrorism Act. Comments in response to these proposed rules had to be submitted to the Agency by April 4, 2003. By October 12, 2003, the Agency expects to issue final regulations and have its information technology systems operational in anticipation of the December 12, 2003, implementation date. Proposed rules for the recordkeeping and administration detention authority provisions were provided to the Office of Management and Budget on February 14, 2003; and FDA expected the proposed rules to be released to the public by March 31, 2003.
Except for specified exemptions, FDAs new regulations will apply to all facilities for all foods and animal feed products regulated by FDA, including herbs and other dietary supplements, infant formula, beverages (including alcoholic beverages), and food additives. As explained below, the prior notice requirement for imported foods is expected to be most problematic for the Agency and regulated industry. Accordingly, this article focuses primarily on the prior notice proposed requirements.