In the aftermath of September 11, 2001, Americans recognized the need to protect the nation’s food supply from bioterrorist attacks. Last year, news reports indicated that Al Qaeda operatives had the ability to manufacture Salmonella and botulinum, and may have intended to poison the food supply of American troops in Afghanistan. A bioterrorist attack on fruits and vegetables, because they are consumed directly, or ingredients, because they are added to many other foods, could have particularly serious health and economic consequences. An attack of the U.S. food supply is not a mere possibility; in 1984, a cult in Oregon contaminated salad bars with Salmonella, sickening 751 people.

In response to the threat of bioterrorism, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The Bioterrorism Act protects the nation’s food supply by providing for: (1) administrative detention of suspect foods; (2) prior notice of food imports; (3) registration of food facilities; and (4) establishment and maintenance of records. The U.S. Food and Drug Administration (FDA) is responsible for implementing these provisions and, to that end, has issued three final rules and a proposed rule. This update will address the FDA’s most recent final rule regarding administrative detention of suspect foods, as well as summarize the FDA’s earlier-issued rules implementing the other provisions of the Bioterrorism Act.

Administrative Detention Of Suspect Foods

As part of a continuing effort to ensure the security of the nation’s food supply, the FDA announced on May 27, 2004 a final rule establishing procedures for detaining food under the authority of the Bioterrorism Act. This new addition to the Act allows the FDA to detain food if there is evidence that shows the food presents a threat of serious illness or death to humans or animals. The rule clarifies the procedures the FDA must follow to detain food, outlines the process for appealing a detention order, and establishes special procedures for perishable foods.

Although the FDA stands behind the new rule as a significant advance in the war against terrorism, critics have denounced the rule because it does nothing to prevent a terrorist attack. Other critics claim that the rule’s procedures for responding to a terrorist attack are unnecessary. The food industry, without the FDA’s involvement, voluntarily detains food that presents a threat of illness or death. However, supporters tout the new rule as an essential government tool for responding quickly to an attack. In any event, food manufacturers, processors, distributors, and retailers should understand the broad range of the FDA’s authority under the new rule and the impact it could have on their operations.

The rule spells out procedures the FDA must follow to detain food. After determining that the food presents a threat of serious illness or death, the FDA must issue a written detention order. The owner of the food must receive a copy of the order. At the time of detention, if the food is being transported or processed by someone other than the owner, the transporter or processor receives a copy as well. The FDA cannot detain food for longer than twenty calendar days under an original detention order. If an extension is necessary, the FDA may detain the food for an additional ten calendar days.

Appealing a detention order is an option available to anyone with a sufficient interest in or claim against the detained food under federal law. Because detention especially endangers perishable foods, procedures are different for perishable and non-perishable foods. For perishable foods, an appeal must be filed within 2 calendar days of receiving the detention order. The appeal for non-perishable foods does not need to be filed as quickly. A notice of intent to file an appeal and request a hearing must be filed within 4 calendar days of receiving the detention order, and the appeal itself must be filed within 10 calendar days of receiving the order. In most cases, the FDA must make a decision on the appeal within 5 calendar days after the appeal is filed, or the food must be released.

The FDA expects to apply the new rule mainly to domestic as opposed to imported foods. Under existing law, the FDA may refuse to admit imported food into the country on the basis of improper labeling or unsafe production and packaging. The FDA will continue to use its existing authority to refuse to admit imported foods, but if necessary, it can detain both domestic and imported food under the new rule.

Earlier-Issued Rules Implementing The Bioterrorism Act

Prior Notice of Food Imports

On October 10, 2003, the FDA issued a final rule implementing the provision of the Bioterrorism Act regarding prior notice of food imports. A previous Food Industry Update addressed the prior notice rule in detail. Generally, the prior notice rule requires certain importers to notify the FDA before importing food into the United States. As of December 12, 2003, importers must give the FDA prior notice of food shipments via one of several electronic systems. Failure to comply can result in detention of food at the port, refusal of entry into the United States, or a potential government lawsuit.

Registration of Food Facilities

Also on October 10, 2003, the FDA issued a final rule implementing the registration of food facilities provision of the Bioterrorism Act. A previous Food Industry Update addressed the registration rule in detail. In general, the registration rule required certain facilities to register with the FDA prior to December 12, 2003. The rule applies to all domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States by humans or animals, unless certain exemptions apply. Failure to register a facility can lead to refusal of imported food into the United States, or a potential government enforcement action. Facilities subject to these requirements can still register by completing the FDA’s electronic registration process.

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