Food firms slow to register under new FDA security rules

Nov 25, 2003 (CIDRAP News) – With a Dec 12 deadline approaching, fewer than 20% of food establishments that must register with the Food and Drug Administration (FDA) under new regulations for protecting the US food supply have done so, FDA officials said yesterday.

About 71,000 facilities have registered so far, out of an estimated 400,000 that are subject to the registration rule, officials with the FDA's Center for Food Safety and Applied Nutrition (CFSAN) said at a briefing on the center's achievements in fiscal year 2003.

CFSAN spokesman Sebastian Cianci said the agency estimates that between 400,000 and 420,000 facilities need to register by the Dec 12 deadline. "Clearly we were hoping more would be registered by this time," he said. "We have a very robust computer system, but we won't be able to accommodate 300,000 [registrations] on December 11."

Under bioterrorism legislation passed in 2002, the FDA is requiring food facilities to register and to provide advance notice of imported food shipments. The regulations were proposed last January, and the agency announced the final rules Oct 9, with an effective date of Dec 12. The aim of the rules is to help the FDA find and notify firms affected by any food contamination and to help it monitor and inspect imported food.

Cianci said CFSAN has been working to notify food companies of the new requirements through satellite downlink meetings, direct meetings, Internet information, and various other means. "It's fully possible there may be some people who have not heard of this, and that's part of the reason that on December 12 we'll exercise enforcement discretion regarding what's coming into the country," Cianci said. FDA officials said earlier that for the first 4 months after the rules take effect, they would focus on making sure the food industry is fully aware of the rules before starting to enforce them.

In other items involving food safety and security, CFSAN Director Joseph Levitt said the agency inspected more than 78,000 imported food shipments in fiscal 2003, far exceeding its goal of 48,000 shipments. In fiscal 2001 only 12,000 shipments were inspected, he said, adding, "From 12,000 to 78,000 in 2 years I think is extraordinary work by our field force."

However, 78,000 shipments add up to a tiny fraction of all the shipments that arrive at US ports annually. In announcing the rule on advance notice of food shipments in October, the FDA estimated it would receive about 25,000 shipment notifications from food importers every day.

The FDA also conducted 7,363 inspections of US firms that produce "high-risk" foods in the past year, well over 95% of firms in that category, according to the CFSAN report. Another 147 inspections were conducted at foreign producers of high-risk foods. The number of foreign inspections was limited by travel restrictions related to world events, and many inspections scheduled in 2003 were postponed until 2004, the report says.

The CFSAN report also cites progress in working with the Mexican government on a certification program for Mexican firms that export cantaloupes to the United States. The FDA banned imports of Mexican cantaloupes in October 2002 after a series of Salmonella infection outbreaks associated with the products in 2000, 2001, and 2002. The report says CFSAN officials have reviewed "multiple drafts" of Mexico's certification program proposal since July and will continue negotiating on it.

In addition, four Mexican firms have been exempted from the cantaloupe import ban after review of documents and inspection of their operations, the report says. Petitions from several other Mexican firms are in various stages of review.

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