On June 12, 2002, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act, commonly referred to as the Bioterrorism Act. The Act gives broad new authorities to the Food and Drug Administration (FDA), which regulates about 80 percent of the U.S. food supply, to protect our food against intentional contamination or from other food-related emergencies. Lester Crawford, Deputy Commissioner of the FDA, in testimony before the Senate Governmental Affairs Committee, said the events of September 11, 2001 have challenged the government "to sharpen our focus on protecting Americans from those who could harm us through our food supply."

Registration
FDA and U.S. Customs and Border Protection signed a Memorandum of Agreement on December 03, 2003, authorizing CBP officers to do FDA inspections for the Bioterrorism Act. CBP officers have received training in the implementation of the Bioterrorism Act. They will assist in the enforcement of the registration provision of the Act, which will be phased in over the course of the next four months. The regulation became effective in December 2003 and requires owners and operators of foreign and domestic food facilities that manufacture, process, pack, or hold food intended for the U.S. market to register the name and address of their facility and the types of food processed there. Foreign facilities must also designate a U.S. agent who resides in and maintains a place of business in the U.S. as an emergency contact. FDA estimates that more than 400,000 facilities are required to register.

Prior notice - four if by air and eight if by sea
A second regulation, also effective in December, requires that FDA receive prior notice of imported food shipments before the food arrives at a U.S. port. Prior notice may be submitted electronically using Customs and Border Protection's Automated Broker Interface system or the new FDA prior notice system. FDA anticipates that there will be 25,000 notifications every day. Advance notice gives officers and analysts time to conduct a risk assessment of a shipment and decide the degree of scrutiny it will undergo. The notice must be received no more than five days before the arrival and no fewer than two hours if the shipment arrives by truck, four if arriving by air or rail, and eight hours before arrival by vessel. Notification of international mail shipments must be made before the shipment is mailed.

Prior notice is commodity specific and contains very detailed information about the product entering the U.S. CBP officers will conduct a document review and receive information through automated systems indicating whether a shipment has met the FDA requirements and can be released or should be held. In some cases they may pull a sample of containerized products such as canned goods, or they may hold the shipment until an FDA officer is called to do the inspection.

Cathy Sauceda, Director of Special Trade Enforcement, Office of Field Operations, sees the new law as a potent tool in protecting the U.S. food supply. "For the first time the FDA can receive advance information on food being shipped into the United States and can detain a shipment of food that presents a credible threat to humans or animals, " said Sauceda.

Manufacturers, processors, packers, importers, and others are also required to keep records that identify food sources and where it goes when it leaves their facilities. If food is contaminated this information could prove invaluable in tracking and tracing it back to its source.

What are we trying to prevent?
Food as a tool for terrorism is not a new concept. The World Health Organization warned that "the malicious contamination of food for terrorist purposes is a real and current threat." Food supplies are especially susceptible to tampering because there are so many points of vulnerability in the chain of food production and distribution, and there is ample precedent for it.

The U.S. Centers for Disease Control and Prevention (CDC) has identified and ranked several foodborne pathogens as agents for possible terrorist attacks. Anthrax and botulism, both of which are deadly pathogens and may contaminate food, were ranked among the high-priority agents. Other less virulent agents include salmonella, e coli, and ricin. Heavy metals such as arsenic, lead, and mercury, and pesticides, dioxins, furans, and polychlorinated biphenyls (PCBs) could also be used by terrorists to contaminate food.

picture of a produce section of a grocery market.

In 2002, nearly 40 people died and more than 200 were hospitalized near Nanjing, China when a fast food restaurant owner added rat poison to a competitor's food. And in 1978 a dozen children in Holland and West Germany were hospitalized after eating oranges imported from Israel. The Arab Revolutionary Council, in an attempt to hurt the Israeli economy, had deliberately contaminated the fruit with mercury.

And the U.S. is not exempt. In 1984, in an effort to disrupt a local election, members of a religious cult in Oregon deliberately contaminated salad bars with salmonella. The incident caused 751 cases of salmonellosis and resulted in the hospitalization of 45 of the victims. More recently a supermarket employee intentionally poisoned 200 pounds of ground beef with an insecticide containing nicotine, and 111 people got sick as a result.

While these incidents are not related to terrorism, the threat to our food supply is more than theoretical. In January 2003, several suspected militants were arrested in London for plotting to add a deadly poison called ricin to the food supply on a British military base. A CIA investigation raised the question of whether one of al Qaeda's leading experts on chemical and biological warfare was involved in the plot.

In September 2003, the U.S. Federal Bureau of Investigation (FBI) warned that terrorists might use two naturally occurring toxins, nicotine and solanine, to poison U.S. food or water supplies. Manuals and documents recovered in Afghanistan that refer to the use of these substances as poisons have fueled FBI concerns.

Impact on trade
New regulations will change the way that shippers and manufacturers do business. FDA and CBP are working to educate importers, foreign governments, and trade associations on what is necessary to comply with the new requirements. FDA plans to "exercise broad enforcement discretion" initially to provide maximum opportunity for compliance. The most difficult audience to reach with information are small foreign producers. Foreign "mom and pop" operations may face language barriers (the Internet registration is in English), lack access to computers, or be unfamiliar with electronic filing protocols.

Nevertheless, securing our food supplies from sabotage holds the highest priority and after August 13, 2004, full enforcement of the new U.S. regulations will begin. Violators risk having their merchandise embargoed, sent to a secure facility or returned to the exporting country. Perishable items will spoil if merchandise detained exceeds the capacity to store it. The FDA can also bring civil and criminal action against parties that are not registered, and these companies may be precluded from further trade activity if convicted of a felony violation of the act.

More than food is at stake
A terrorist attack on the food supply could have severe public health consequences and a substantial impact on the economy. More critically, it could erode public confidence. The Bioterrorim Act provides us with information that will keep our food supplies safe and secure, and equip CBP to respond to any suspect shipment of food. Protecting our food supply is synonymous with protecting our social infrastructures. So eat, drink, and be merry.