FDA Issues New Rule to Help Federal Officials Track Food Supply

FDA on Monday issued a new food safety regulation that will establish new requirements for food companies "to help disease detectives track the source and destination of food," as federal officials "sought to reassure" the nation that the U.S. food supply is safe from a bioterrorism attack, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 12/7). At a news conference on Friday to announce his resignation, HHS Secretary Tommy 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 added, "We are importing a lot of food from the Middle East, and it would be easy to tamper with that." Thompson said that although U.S. inspections of imported food have increased over the past four years, they remain inadequate (California Healthline, 12/6).

FDA has increased food inspections from 12,000 annually before the Sept. 11 terrorist attacks to about 97,000 annually today, according to the Bush administration. HHS in 2005 expects to spend $150 million to protect the U.S. food supply, compared with $800,000 in 2001 (Los Angeles Times, 12/7). The new rule is the last of four food safety regulations required under the 2002 Bioterrorism Act (Meckler, AP/Boston Globe, 12/7). The three previous rules require registration of food companies with FDA, prior notice before food is imported and the impoundment of food that manufacturers or importers consider dangerous (Weise, USA Today, 12/7).

The new regulation affects "persons who manufacture, process, pack, transport, distribute, receive, hold or import food," according to FDA (CQ HealthBeat News, 12/6). The rule -- which exempts farms, restaurants, food banks and individuals who prepare food at home -- requires food companies to maintain records on where food was obtained and shipped (USA Today, 12/7). Federal officials would have access to the records in the event of a food-poisoning outbreak or terrorist attack (Los Angeles Times, 12/7). Under the regulation, food companies must maintain records on human food products for between six months and two years and records on animal food for one year. According to the Wall Street Journal, "many food companies already keep detailed records," but the rule will help standardize the practices that companies use to maintain records, FDA officials said (Schaefer Munoz, Wall Street Journal, 12/7).

FDA officials said that the regulation "eases burdens on food manufacturers by allowing the records to be kept in paper or electronic form," CQ Today reports (CQ HealthBeat News, 12/6). The rule, which will affect about 700,000 food companies, will cost about $1.4 billion to implement and as much as $123 million annually. Food companies with more than 500 employees must begin to comply with the regulation by Dec. 9, 2005. Food companies with between 11 and 500 employees must begin to comply with the rule by May 9, 2006, and those with fewer than 11 employees must comply by Dec. 9, 2006 (Wall Street Journal, 12/7).

"I believe firmly that we have a good handle on food importation, and also on the production of food ... with respect to intentional or accidental adulteration," FDA acting Commissioner Lester Crawford said, adding, "We have to continue to improve and be as fail-safe as we can be, (but) we are far better off than we were three years ago" (Los Angeles Times, 12/7). He said, "These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists" (Hudson, Washington Times, 12/7). Crawford said, "We have a long, long border that is not wired and not fenced" but added that the United States does not "need and can't inspect every article of food" (AP/Boston Globe, 12/7).

Thompson on Monday also released a statement that "softened his comments" from the news conference on Friday. Thompson, who praised the new rule in the statement, wrote, "There is more work to do yet, but our nation is now more prepared than ever before to protect the public against threats to the food supply" (Los Angeles Times, 12/7). He added, "Publication of this record-keeping rule represents a milestone in U.S. food safety and security" (Washington Times, 12/7).

"The FDA's new record-keeping requirement is a modest improvement, but nothing to breathe a sigh of relief over," Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, said, adding that FDA must inspect more food imports and should have the authority to inspect foreign food production facilities (Los Angeles Times, 12/7). DeWaal also said that despite increased funds for food inspection, the United States today only inspects 2% of all imported foods (AP/Boston Globe, 12/7). She also called for the establishment of a single agency responsible for food safety.

FDA and the U.S. Department of Agriculture -- which inspects about 20% of imported meat, inspects foreign food production facilities and evaluates foreign food safety systems -- currently share responsibility for food safety. "The FDA is dramatically short-staffed and underfunded when it comes to managing its mandate to ensure food safety," DeWaal said, adding, "The U.S. is falling behind the rest of the world when it comes to our food-safety structure" (Los Angeles Times, 12/7). She added that the food industry must implement security measures similar to those taken at airports and that the federal government should serve as "a deterrent to using food as a target."

The Grocery Manufacturers of America and the National Food Processors Association both released statements that promised to help maintain the safety of the food supply and praised FDA "for making its regulations manageable," USA Today reports (USA Today, 12/7). Richard Jarman, vice president of food and environmental policy for NFPA, said, "Understanding and interpreting these requirements will be a top priority for the food industry" (Wall Street Journal, 12/7).

CNN's "Paula Zahn Now" on Monday included a discussion on the safety of the U.S. food supply. Guests on the program included Sanjay Gupta, CNN senior medical correspondent; Marion Nestle, professor of nutrition, food studies and public health at New York University; and Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota (Zahn, "Paula Zahn Now," CNN, 12/6). The complete transcript is available online.