FDA reports growing compliance with food security rules

Jun 30 (CIDRAP News) – As federal agencies near the Aug 12 deadline for full enforcement of the food security provisions of the 2002 Bioterrorism Act, authorities say the food industry is getting better at following the new rules.

Importers must register with the Food and Drug Administration (FDA) and provide 2 to 8 hours' notice of food shipments. The FDA has been receiving advance notice of about 150,000 shipments each week, according to the agency's compliance summary information. About 99.3% of those notices are completed on time, a marked improvement from earlier this year, Michael Herndon, a public affairs specialist with the FDA's Center for Food Safety and Applied Nutrition, told CIDRAP News yesterday.

But as with a student's homework assignment, filling in the blanks doesn't always mean giving a right answer. Although most notices are complete, the information isn't always accurate.

"We're going back now and examining to make sure the prior-notice information is accurate," Herndon added.

The notices allow agency officials to judge which shipments need inspection. The food security rules are jointly enforced by the FDA and the Bureau of Customs and Border Protection.

The new system has led to more targeted inspections and prompted some criticism from the food industry.

Historically, the FDA inspected less than 1% of imports. That percentage has doubled. FDA inspectors conducted 78,659 examinations of imported food shipments in fiscal year 2003, according to Herndon. The number far exceeded the agency's goal of 48,000 field inspections for the year and was more than six times the 12,000 inspections conducted in fiscal 2001.

Inspectors also have more sophisticated tools to target suspect imports. When companies notify the FDA that a shipment is arriving, agency employees can run that information through up to 100 checks, looking for red flags such as easily contaminated foods, specific countries of origin, or a product that matches other intelligence information, an FDA spokesman said.

The FDA went gently into the new rules by emphasizing education. Now regulators are moving toward the enforcement end of the spectrum.

Despite increased inspections, few shipments have been detained. Since the prior-notice law took effect in December 2003, FDA and customs inspectors have detained 12 shipments because of concerns about food contamination or filth. None of the shipments was found to be a threat to people or animals, Herndon said.

Registration remains a stumbling block. By Jun 24, only 208,277 foreign and domestic companies had registered with the FDA. By some FDA estimates, twice that many businesses need to register; others say the estimates have been adjusted.

"What we initially thought was 450,000, we're thinking is more likely 250,000," Herndon said. It's also likely that some companies aren't aware they need to register or that they don't believe the rules apply to them.

Food importers give the new rules mixed reviews.

"While FDA made many improvements to the proposed regulations, there is still room for more, especially with concern to prior notice and record keeping," said Susan Stout, vice president of federal affairs for the Grocery Manufacturers of America, in congressional testimony Jun 25. Addressing the Health Subcommittee of the House Energy and Commerce Committee, she requested that the FDA provide feedback on incomplete notices.

Stout also asked that the FDA eliminate requirements that food and beverage companies track lot or production codes for each retail product. If the food supply is threatened, Stout said, companies and retailers remove all the suspect products from shelves.

The FDA has extended the public comment period on the prior notice interim final rule through July 13, Dr. Lester M. Crawford, acting FDA commissioner, told the health subcommittee Jun 25. The final rule will be published in March 2005.

Herndon said Jun 29 that the FDA continues to work with importers to educate them about registration and completing the prior-notice forms.

"Even though the bigger picture is to protect Americans from bioterrorism, we're still not in the business of impeding commerce," he said.

Amy Becker is a full-time reporter at the St. Paul Pioneer Press and a freelance reporter for CIDRAP. She will enter the University of Minnesota's graduate program in public health administration and policy in fall 2004.

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