FDA To Implement The Bioterrorism Act

The new legislation will have far reaching implications to foreign and domestic companies.

By Todd Harrison & Todd Halpern

As discussed in the Capitol Comments column last September, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act”). The purpose of that legislation was “to improve the ability of the U.S. to prevent, prepare for and respond to bioterrorism and other public health emergencies.” Title III, Subtitle A of the Bioterrorism Act contains provisions intended to protect the U.S. food supply. In part, Subtitle A requires the U.S. Food and Drug Administration (FDA) to promulgate regulations that: (1) require any facility engaged in the manufacturing, processing, packing or holding of food for consumption in the U.S. to register with FDA; and (2) require the submission to FDA of prior notice of each article imported into the U.S. Because the Bioterrorism Act adopts the definition of “food” contained in the Federal Food, Drug and Cosmetic Act (the “FFDCA”), all of these requirements will apply to both dietary supplements and conventional foods.

On February 3, 2003, two FDA proposed rules were published in the Federal Register, implementing the registration and prior notice provisions of the Bioterrorism Act. According to FDA, both regulations will become final by October 12, 2003. Both proposals have far reaching ramifications for companies that import not only finished food and dietary supplement products but also individual food and dietary ingredients, including excipients found in dietary supplement products. At press time the deadline for comments had expired.

Registration

Unless exempt, all facilities, both domestic and foreign, that manufacture, process, pack or hold food consumed in the U.S. will have to be registered with FDA by December 12, 2003. A non-exempt company not registered by that date will not be permitted to distribute food in the U.S. until registered with FDA. Exempt facilities include: (1) farms; (2) retail facilities; (3) restaurants; (4) nonprofit food facilities in which food is prepared for, or served directly to, the consumer; (5) fishing vessels not engaged in processing; and (6) facilities regulated exclusively by USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act. If required, failing to register constitutes a prohibited act under the FFDCA, which means potentially being subjected to civil and/or criminal liability, an injunction and debarment.

The proposal lists several types of information that each registration will have to provide, including basic corporate identification and contact information, the contact information of a person designated as the “emergency contact” who may be reached in the event of suspected contamination, as well as other information related to the product(s) held by the company. All registrations will have to include a certification that the information contained in the registration is true and correct. If any information is false, fictitious, or fraudulent, the person completing the registration could be found to be in violation of 18 U.S.C. § 1001 and thereby subject to criminal penalties. Electronic registration will be “strongly encouraged,” but those with no means of electronic access that are reasonably available will have the option to send the registration application by mail. As proposed, the rule requires that all registrants update registrations within 30 calendar days of any change to any of the information previously submitted. Registration will not be permitted until the proposed rule becomes final, which FDA does not expect will occur before October 12, 2003.

Definition of “Facility”—Control by a Single Management

A “facility” is defined as “any establishment, structure or structures under one management at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs or holds food for consumption in the U.S.” The key is identifying what is under the control of a single management—not the physical buildings. For example, several buildings (at a general physical location) managed by one entity may constitute a single facility requiring only one registration. Conversely, multiple registrations may be required for a single building if it is under separate management. According to FDA, joint management is considered one management. FDA intends to give companies the option of filing registration forms on behalf of one or more of their facilities.

Considerations for Foreign Companies

A foreign facility may designate its U.S. agent as its agent in charge for purposes of registering the foreign facility. The U.S. agent of a foreign facility may be responsible for registering the foreign facility only if it has been designated as the “agent in charge.” Because the agent in charge has other responsibilities (e.g., handling all communications with FDA on behalf of the company), FDA strongly encourages executing a written agreement authorizing the U.S. agent to register the facility and specifying the U.S. agent’s other responsibilities. The company does not, however, have to supply the agreement to FDA. The U.S. agent must reside or maintain a business in the U.S. FDA will treat representations provided by the U.S. agent to FDA as those of the foreign facility, and will consider information FDA provides to the U.S. agent as the equivalent of providing the same information or documents directly to the foreign food facility.

Foreign facilities are exempt from registering if food from these facilities undergoes further processing or packaging by another facility outside the U.S. The facility is not exempt from registration if the processing or packaging activities of the subsequent facility are limited to the affixing of a label to a package or other de minimis activity. The facility that conducts the de minimis activity also must register.

Prior Notice

The purchaser or importer of the article of food (or their agent) who resides or maintains a place of business in the U.S. is generally responsible for submitting the notice. The notice must be submitted by noon of the calendar day before the day of arrival (12:00 p.m. in the time zone in which the FDA office with responsibility over the anticipated port of entry resides). The notice must be submitted electronically through the Prior Notice System (currently under development) unless the FDA system is not functioning. The system will be designed to provide an automatic electronic acknowledgment of receipt of a complete prior notice submission, with a time and date stamp. As proposed, the rule requires that the notice contain (among other things) various identification information about the im­porter, the article(s) being shipped, the country from which it came, the shipper, and the anticipated date of entry and port of entry. As with failing to register, failing to provide prior notice will constitute a “prohibited act” under the FFDCA, potentially subjecting one to all of the penalties previously described—both criminal and civil.

Amendments

Amendments of the notice relating to product identity will be allowed if complete information about product identity does not exist by the deadline for prior notice for the planned shipment. Information regarding identity of the article may be amended only once. Amendments may be submitted to revise quantity and must be submitted to the anticipated port of entry or the anticipated port of entry or time of arrival. They may not, however, be used to change the nature of the article of food. Any amendments must be submitted no later than two hours prior to arrival.NW