FDA finalizes food bioterrorism rule

All domestic and foreign facilities that pack, store, manufacture or process food in the United States must register with the agency.

The Food and Drug Administration this week finalized a rule developed after the 2001 terrorist attacks to protect the food supply against bioterrorism.

The final rule requires all domestic and foreign facilities that pack, store, manufacture or process food in the United States to register with the agency. There are no significant changes between the final rule and the interim draft rule issued in 2003, according to the agency.

"This rule is one of our critical tools for safeguarding the American food supply," acting FDA Commissioner Andrew von Eschenbach said in a statement. "By finalizing this rule, we now have another important safeguard in our ongoing efforts to make sure that human and animal foods are protected from a deliberate or accidental act of contamination."

The rule covers facilities that deal with meat, poultry, processed eggs, animal feed, dietary supplements, beverages and food additives. So far, more than 260,000 domestic and foreign facilities have registered with the agency.

The agency said that the final rule would help it to quickly trace contaminated food back to any facility it passed through. This would allow FDA officials to determine if other food from the facility had been tainted.

This is the third FDA food bioterrorism rule drafted after the September 2001 terrorist attacks to be finalized. A rule allowing the agency to detain food for 30 days if it has credible evidence that the food poses a risk was finalized in June 2004. In December of last year, the agency finalized a rule requiring companies to retain records of food origins and destinations for six months to two years, depending on a product's shelf life. The agency has yet to finalize a rule requiring prior notice for imported food shipments.

Former Health and Human Services Secretary Tommy Thompson said last year that he was surprised that terrorists have not yet attempted to contaminate the supply.

The World Health Organization, in a 2002 report, said that while steps have been taken to prevent terrorist contamination of the food supply, food bioterrorism is perhaps a greater threat than a terrorist attack with a weapon of mass destruction.

"Food is also the most vulnerable to intentional contamination by debilitating or lethal agents," the report said. "The diversity of sources of foods, including the global market, makes prevention difficult, if not impossible. At the same time, many developing countries lack basic food safety infrastructures and are vulnerable to deliberate acts of sabotage."

Food bioterrorism has been used in the past, according to the World Health Organization. In 1984, a cult in the United States contaminated salad bars with salmonella, resulting in 751 illnesses. A disgruntled Texas laboratory worker in 1996 infected colleagues' food with dysentery.

One critic has charged that the new U.S. rules are not sufficient to counter the threat.

"FDA still lacks essential tools to manage the threat of bioterrorism," said Caroline Smith DeWaal, food safety director at the nutrition and health advocacy organization Center for Science in the Public Interest.

"FDA still doesn't do enough inspections of food at the border. FDA still does not have authority to inspect the plants where food is being processed outside the borders," she told Global Security Newswire. "We're relying on a weak safety net."

DeWaal said her group since 2001 has asked for increased funding for food safety programs. She is concerned that costs of the war in Iraq and the recovery from Hurricane Katrina will leave less money for food safety. The fiscal 2006 FDA budget request seeks $180 million for food safety and other counterterrorism activities.

"As the Bush administration considers budget cuts, food safety programs should be exempt from those kind of across the board budget cuts," DeWaal said. "The programs simply cannot afford to be cut."