MONDAY, Dec. 6, 2004 (HealthDayNews) -- U.S. officials announced final regulations to further safeguard the nation's food supply on Monday, only three days after outgoing Health and Human Services Secretary Tommy Thompson said he was greatly worried that food was easy prey to a terrorist attack.
The new rule, the last in a series of four mandated under the Bioterrorist Act of 2002, requires manufacturers, distributors, and other links in the food-supply system to establish and keep records that would identify who had the food before them and who got it next.
"The records required by this are crucial for the FDA [Food and Drug Administration] to deal effectively with emergencies," acting FDA commissioner Dr. Lester Crawford said during a news teleconference. "The ability to trace back will enable us to get to the source of the contamination. It will also allow the FDA to trace forward from the identified source to remove all other similarly adulterated food that poses a similar health threat."
On Friday, in a news conference announcing his resignation, Thompson said, "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 he worried "every single night" about vulnerabilities in the food system.
His prepared remarks were more optimistic on Monday. "We have a lot of work yet to do, but our nation is now more prepared than ever before to protect the public against threats to the food supply," Thompson said in a statement.
In announcing the latest regulation, which was long expected, Crawford stated: "With respect to accidental and intentional adulteration, we have to continue to improve and be as close to fail-safe as we can possibly be without disrupting totally production and sourcing of food. We are far better off than we were three years ago, and each day we get better. But it will always be a source of concern for people who are in charge, and it should be."
The probability of food being contaminated is "very low indeed," he said, but added that "we're not comforted by that at all. We're trying to look out for every eventuality we can."
The Bioterrorism Act was designed to plug "gaps" in the food supply system to thwart acts of terrorism.
The first three rules, already in effect, deal with registration of foreign and domestic food facilities; prior notice of food shipments imported or offered for import into the United States; and administrative detention for food products that might pose a health threat.
The current rule, to be published Dec. 9 in the Federal Register, will take effect one year from now for large businesses (500 or more full-time employees), in 18 months for small businesses (11 to 499 full-time employees), and in two years for very small businesses (10 or fewer employees). All businesses must be in compliance by Dec. 9, 2006, said Leslye M. Fraser, director of the Office of Regulations and Policy at the FDA's Center for Food Safety and Applied Nutrition.
Companies will need to keep records on human foods for six months to two years, depending on the shelf life of the food in question, and on animal foods, including pet food, for one year. Farmers and restaurants are exempt from the regulation.
If the FDA believes that food has been contaminated or somehow poses a threat of "serious adverse health consequences or death" to humans or animals, records must be made available to the agency within 24 hours, the new rule states.
Crawford said about 2 percent of all food coming into the United States is inspected, although the FDA receives "notification" or written records on 100 percent of these foods. Those records help authorities determine which shipments to physically inspect, he said.
"If we have reason to inspect something, or have found a pattern of misbehavior, we will inspect more often," Fraser said. "If something is of considerable concern, we will inspect each and every shipment or we will use other authorities we have to cut off shipments entirely if we find a pattern of violation."
While acknowledging that the new rule can't prevent contamination, Fraser said "the duty to have safe food in the first place was already contained in the Food, Drug and Cosmetic Act [of 1906, which created the FDA]. It is the obligation of anyone who is producing and distributing food into commerce."
More information
For more on the Bioterrorism Act of 2002, visit the FDA.
