Food import rules will have 8-month phase-in, FDA says

Dec 12, 2003 (CIDRAP News) – New federal rules intended to prevent the use of food as a bioterrorism weapon take effect today, but it will be 8 months before the rules are fully enforced, according to the Food and Drug Admnistration (FDA).

To facilitate FDA inspections of food imports, the rules say the FDA must be notified in advance of all food shipments entering the United States. Also, all domestic and foreign businesses and facilities handling food for the US market must register with the FDA.

The FDA and the Bureau of Customs and Border Protection (CBP) will jointly enforce the new rules. A compliance policy guide issued by the agencies yesterday "makes clear that during the next 8 months, the two agencies will primarily rely on educating the affected firms and individuals," the FDA said in a news release. "During this period, the agencies will utilize communication and education initiatives, escalating imposition of civil monetary penalties, and ultimately refusal of shipments. The phase-in period will end on August 12, 2004."

During this period, "FDA and CBP will generally use civil penalties and refusals only in response to repetitive, flagrant and other serious violations," the statement adds.

As of last night, 141,000 food facilities, including 69,000 domestic and 72,000 foreign firms, had registered with the FDA, agency spokesman Sebastian Cianci told CIDRAP News. The FDA estimates that roughly 400,000 facilities are subject to the registration requirement.

During the phase-in period, the FDA and CBP will continue their normal inspections of imports, officials said. "If we see something screwy in a shipment, we'll pull it aside and take a look at it," said Cianci. "We're not going to be doing anything less than we're doing now."

The new rules were developed under a wide-ranging counter-bioterrorism law passed in 2002. FDA Commmissioner Mark B. McClellan, MD, PhD, stated, "Our intention all along has been to implement the Bioterrorism Act in a way that would protect consumers without obstructing food imports, on which we depend for 20 percent of all fresh produce and up to 60 percent of all the seafood consumed in the U.S."

For food imports, the rules require 2 hours' advance notice for shipments entering the country by truck, 4 hours for air and rail shipments, and 8 hours for those on ships. The requirement also covers food packages mailed to the United States or carried in by individuals. But the FDA said it will not block the entry of mailed or hand-carried packages for lack of notification until Aug 12, 2004.

Cianci said the FDA has about 650 food inspectors at ports of entry. The CBP has about 1,600 inspectors who have been trained and are eligible to inspect imported food on behalf of the FDA, he reported.

During the transition period, the two agencies will provide industry and the public with information about the level of compliance with the prior notice rules, including the types of errors in submitted notices, officials said. Summary information will be posted on the FDA Web site.

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