FDA, Washington, D.C., has made available interim final rules for two sections of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which were published in the Federal Register October 10th. The two interim final rules are related to the sections of the Bioterrorism Act that address registration of food facilities and prior notice of imported food shipments. With some specific exemptions, according to the American Herbal Products Association (AHPA), Silver Spring, MD, companies that sell food, including dietary supplements, in the U.S. are required to be registered no later than December 12, 2003. Registration by this date in conformity with the final rule is required for both foreign and domestic firms. Exemptions to registration are established for retail facilities; for farms (except for “mixed-type facilities” that also, for example, process food for consumption off of the farm); for restaurants and nonprofit facilities that prepare and serve food directly to consumers and for foreign companies that produce only food that undergoes substantial additional processing prior to import. There are also exemptions for fishing vessels and for firms that are fully regulated by United States Department of Agriculture (USDA) under existing meat, poultry or egg inspection regulations. In addition to this facility registration requirement, all food and food ingredients—again, including dietary supplements and their ingredients—will be subject to new notification requirements prior to import on all shipments imported on or after December 12th and all such notifications will need to be in accordance with the interim final rule. FDA has communicated its intention to exercise its enforcement discretion in the early stages of implementation, rather than holding up imports due to technical errors in a required prior notice.

FDA published proposed rules for both of these new laws on February 3, 2003 and AHPA, as well as other organizations, provided substantive comments to these proposals. FDA has made numerous modifications to its proposed rules that were requested in AHPA’s comments, including:

• The registration exemption for retailers will be extended to distributors in the direct-selling channel of trade;
• Registration for co-owned facilities will be streamlined to allow multiple simultaneous registrations, under some circumstances the requirement for identification of a facility’s “trade names” was clarified as not including “brand names” associated with products;
• Prior notice requirements will generally be allowed to be submitted through the existing U.S. Customs system (the Automated Broker Interface of the Automated Commercial System, or ABI/ACS);
• The proposed limitation to allow only the importer or their agent to file prior notice has been modified to allow “any person with knowledge of the required information” to submit the prior notice; and
• The specific timeframes in which prior notice is required have been significantly modified, such that notice is required two hours in advance of imports via land; 4 hours in advance of imports via rail or air; eight hours in advance of imports via water and prior to mailing for any goods imported by mail.

Although these rules will become final on December 12th, FDA will be accepting comments until December 24th. In addition, FDA’s website for registration of food facilities, which became operational on October 16th, can be accessed at www.cfsan.fda.gov/~furls/ovffreg.html. (For more information, see this month’s Capitol Comments column on page 26.)