A new law, inspired by terrorism, has changed how food companies are regulated, even when terrorism is not involved. Signed into law on June 12, 2002, the Public Health Security and Bioterrorism Response Act of 2002—less formally known as the bioterrorism legislation—has made sweeping changes in the powers of the Food and Drug Administration’s regulation of food companies.
A direct response to September 11, the bioterrorism law’s provisions have the flavor of a nation equipping itself for war, albeit a unique new type of war that directly and primarily threatens the health and safety of the civilian population. To safeguard the nation from attacks to its food, drug, and water supplies, this law adds new powers to a number of federal agencies, including FDA and the U.S. Dept. of Agriculture’s Food Safety and Inspection Service. It provides for stockpiling of vaccines; better coordination among federal agencies to provide health services in the event of a public health emergency; increased inspections; and new powers designed to help agencies prepare and respond.
FDA’s new powers include some it has wanted for decades, and their exercise is not restricted to terrorism contexts. One new power allows FDA to place articles of food under temporary detention—something FDA could not do before without a court order—if it believes the articles “present a threat of serious adverse health consequences or death to humans or animals” and has the approval of the Secretary of Health and Human Services or a designee. It can detain the food articles for up to 30 days.
The law also gives FDA another important power it never had before: the power to inspect and copy records at food plants, if it has a reasonable belief that the food is adulterated and would have serious health consequences to humans or animals. The new law requires that “each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such articles shall” permit FDA inspection of their records to allow FDA to determine whether the food is adulterated and whether such a threat to health exists. FDA is ordered to promulgate regulations implementing this requirement within 18 months. FDA’s review of records can involve two years of records showing “immediate previous sources and the immediate subsequent recipients of food, including its packaging.”
The bioterrorism law requires registration with FDA of every domestic and foreign food manufacturing, processing, packing, or holding facility. The law also:
• Allows FDA to debar food importers who commit repeated or serious food import violations.
• Requires importers to give prior notice of a food importation.
• Allows FDA to grant funds to states and other government entities, to essentially deputize them to make inspections and take other steps to assist in the enforcement efforts.
• Requires importers of components of drugs, medical devices, food additives, color additives, and dietary supplements that are to be processed and exported to maintain a chain of identification of those who will have possession of the article.
• Requires creation of a stockpile of drugs, vaccines, biological products, and medical devices to help the nation respond effectively to a bioterrorism attack or other health-related emergency.
Many of the new provisions target imported products in particular, in apparent recognition that imported goods are often a source of violative products. Because of the exceedingly low percentage of imports that are literally inspected now—approximately 1%—they represent a significant opportunity to introduce poisoned consumer goods into U.S. commerce.
Preceded by FDA’s guidances to the food industry on how to protect against bioterrorism, by similar steps by USDA, and by strategic planning by the new Office of Homeland Security, this law adds a massive and complex new set of measures designed to help the nation prevent, and quickly respond to, the type of attack many observers believe our enemies may try next. When he signed the bill, President Bush said, “Protecting our citizens against bioterrorism is an urgent duty of American government. We must develop the learning, the technology and the healthcare-delivery systems that will allow us to respond to attacks with state-of-the-art medical care throughout our entire country.”
The bioterrorism law contains the most significant changes to FDA’s enforcement powers over food since it received those powers in 1938, and it deepens FDA’s powers over other regulated products. As noted, the context of the law’s passage may have been defending against terrorism, but the powers are not limited to incidents of terrorism. These are permanent and important changes in how food companies will be regulated in the future.
by ERIC F. GREENBERG
Attorney at Law, Chicago, Ill.