ABSTRACT

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act: PL107-188) signed into law on June 12, 2002, has a direct and substantial impact on the entire U.S. food1 industry, particularly upon the imported segment,2 and will have far-reaching international trade ramifications. Food is broadly defined under the act and includes food and animal feed, nutritional supplements, food contact materials, live animals, bottled water, and alcoholic beverages (69 Federal Register (FR) 31670). congressional intent and the key provisions of this bill were to provide a coordinated national preparedness program for bioterrorism with an emphasis on public health and health services, including pediatric care, controls on dangerous biological agents, and improved protection for the food and water supplies. Unfortunately, in the resultant regulations, this focus appears to have been lost,3 at least in the segments of the bill intended to increase protection of the food supply. Instead, it may well be that the U.S. Food and Drug Administration (FDA) has used this act as an opportunity to exploit

public and congressional concern over the threat of bioterrorist acts to expand the agency’s jurisdiction and control over the U.S. food supply and its distribution system. Unfortunately, these regulations come at a substantial cost and may do little to improve the safety and security of the food supply.