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Guidelines require certain food facilities to register with agency

WASHINGTON, DC - The US Food and Drug Administration (FDA) is proposing that foreign and domestic facilities that manufacture, process, pack or hold food to be consumed by humans or animals in the US be required to register with the agency.

The FDA also wants to be given prior notice before food is imported or offered for import into the US.?

Beginning on December 12, 2003, the rules say, the FDA must receive advance notice of each article of food imported or offered for import into the US - regardless of whether the food will be consumed in the US.

The proposed rule would require notice to be submitted by noon the day before the food arrives at the port of entry.

Among other items, the notice must include a description of the food, the manufacturer and shipper, originating country, country from which the article is shipped, and anticipated port of entry.

The FDA and the Bureau of Customs and Border Protection (CBP) have said that importers, in most circumstances, will be able to provide the required prior notice information to FDA using the CBP's Automated Commercial System (ACS).

If prior notice is not submitted or is inadequate, the act provides that the food shall be held at the port of entry until adequate notice is provided.

The only exemption would be food brought into the US in a traveler's personal baggage.

The proposed rules, mandated by the Bioterrorism Act of 2002, are scheduled to go into effect December 12. The agency said it is currently reviewing public comments on the proposals.

Another rule would require specific records about a food's "immediate previous sources and immediate subsequent recipients" to be kept and retained, while a fourth would identify procedures the Secretary of Health and Human Services would take to stop foods "that present a serious health threat to humans or animals" from entering the US food system.

The agency is proposing that certain facilities - including restaurants, non-processing fishing vessels, and facilities regulated exclusively by the US Department of Agriculture - be exempted from the rules.

Businesses with 500 employees or more would have six months to comply with the final regulations after publication in the Federal Register. Smaller businesses would have 12 or 18 months to comply, depending on their size.

The FDA said it expects the final registration requirements will be published by mid-October to allow the food industry time to understand the new requirements and comply by December 12, the date specified by Congress.

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