Food Supply Called 'Easy' Target for Terrorists - December 14, 2004 Vol.5, No.25

December 14, 2004 Vol.5, No.25:

Published: 12/13/2004

Printable Version
Email to a Friend

Bioterrorism Act Provision to Protect the Food Supply

Section 303 (Administrative Detention) authorizes the Secretary of Health and Human Services, through FDA, to order the detention of food if an officer or qualified employee has credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals. The Act requires the Secretary, through FDA, to issue final regulations to expedite enforcement actions on perishable foods. No time frame is specified.

Section 305 (Registration of Food Facilities) requires the owner, operator, or agent in charge of a domestic or foreign facility to register with FDA no later than Dec. 12, 2003. Facilities are defined as any factory, warehouse, or establishment, including importers. While FDA expects to issue regulations by this date, food facilities must register by this date even if regulations have not been issued.

Section 306 (Establishment and Maintenance of Records) requires the Secretary of Health and Human Services to establish requirements by Dec. 12, 2003 for the creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food (that is, one up, one down). Such records are to allow FDA to address credible threats of serious adverse health consequences or death to humans or animals. Entities subject to these provisions are those that manufacture, process, pack, transport, distribute, receive, hold or import food. Farms and restaurants are exempt from these requirements.

Section 307 (Prior Notice of Imported Food Shipments) requires that prior notice of imported food shipments be given to FDA. The notice must include a description of the article, the manufacturer and shipper, the grower (if known), the country of origin, the country from which the article is shipped, and the anticipated port of entry. The Secretary of Health and Human Services, through FDA, must issue final regulations by Dec. 12, 2003. While FDA fully expects regulations to be issued by this date, if such regulations are not issued, the statute still requires importers to provide no less than eight hours and no more than five days notice to FDA until the regulation takes effect.

Further Information

Text of the Bioterrorism Act
Information on FDA’s Bioterrorism Regulations

Food Supply Called 'Easy' Target for Terrorists

The Food and Drug Administration’s response to bioterrorism has done little to protect our food supply, prompting even the outgoing Secretary of Health and Human Services to show concern.

In his resignation remarks last week, Tommy Thompson told press that he believed that it would be “easy” for terrorists to contaminate our food supply. “For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do,” he said, adding that he “worried every single night” about terrorist threats to the nation’s food supply.

Four provisions of the bioterrorism act required FDA to develop new regulations to protect our food supply. FDA’s latest bioterrorism regulation on the establishment and maintenance of records represents the fourth regulation promulgated by FDA in response to the act. The regulation requires that food suppliers establish and maintain records of where their food shipments came from and where they go next. In the case of an attack on our food supply, these records will assist government officials in discovering the source of the attack, although they will do little to protect our food supply from an actual bioterrorism threat.

FDA’s three previous rules require registration of foreign and domestic food facilities, necessitate prior notice of food shipments imported or offered for import in the US, and authorize the use of administrative detention so that food products that might pose a threat of serious adverse health consequences or death may be detained.

Administrative detention is only effective once the adverse threat has been found, but, as Thompson pointed out, only a very small percentage of food supply is ever inspected. If the food threats are not discovered, administrative detention can do little to protect the food supply. The registration of facilities will, like the new record-keeping regulation, assist FDA in tracking any attacks once they occur, but it will do little to find potential threats.

The prior notice of shipment could have been a real effort to block the entry of contaminated food into our food supply, but the rules were significantly weakened during review with OMB. The original proposal, issued in February 2003, required importers to notify the FDA by noon the day before the shipment was to arrive. The final standards, however, required just eight hours notice for shipments arriving by sea, four hours for those transported by air or rail, and only two hours for shipments coming by land — hardly enough time to investigate a potential bioterrorism threat.

According to a statement by the Center for Science in the Public Interest Food Safety Director Caroline Smith DeWaal, our food supply will remain an easy target for terrorism unless FDA is given the authority necessary “to visit foreign factories and farms that want to ship food to the U.S., and authority to mandate recall and traceability all along the food supply. Ultimately, the food laws should be comprehensively modernized and food-safety functions combined into a unified food-safety agency, rather than the hodgepodge we have today.”

With Thompson set to depart, Bush has nominated Mike Leavitt, currently the administrator of EPA, to head HHS. It is unknown how or to what extent Leavitt will work to strengthen food safety safeguards. Generally while at EPA, Leavitt, a former governor of Utah, favored the regulated community, promoting minimal regulation and voluntary standards in lieu of requirements.