December 5, 2003

The following article is excerpted from “American Shipper” on 5 December 2003.

The Food and Drug Administration will give food and feed importers until next summer to fully comply with new safety and security rules designed to prevents acts of bioterrorism that go into effect Dec. 12, ….

Food producers, carriers and distributors voiced concern this year that shipments would rot on the docks while they got paperwork in order to meet the FDA requirements. Those fears have subsided in recent weeks as the FDA made clear that shipments will only be held during the initial phase if they pose a health hazard, but McClellan's comments marked the first time the industry has been given a clear enforcement timetable.

"There will be a discretionary period of about six months, maybe longer," McClellan said during a press conference Wednesday to announce that Bureau of Customs and Border
Protection inspectors were given formal authority to enforce the interim FDA rules.

He said guidelines to assist with compliance would be issued in the days ahead.

The two agencies signed an agreement Wednesday that commissions Customs to conduct examinations and investigations to make sure importers have electronically given prior notice of an incoming food shipment and that foreign facilities involved in manufacturing, processing,
packing or storing the product have registered with the FDA. The rules were mandated by Congress last year under the Bioterrorism Act.

Many in industry and government credit Customs with tempering FDA's initial instinct for strict enforcement on Dec. 12. Customs officials say they learned a phased approach worked best when implementing similar advance notice requirements for inbound ocean container freight and other security regulations.

Customs "has found through the course of implementing security regimes that most legitimate traders want to comply. They need education," Deputy Commissioner Douglas Browning said. The agencies agreed in this case "that a period of transition would be appropriate"….

The commissioning serves as a force multiplier for FDA,  which only has about 900 agents and inspectors to cover 90 of the nation's 301 ports of entry. Customs has more than 18,000
inspectors along the border checking incoming travelers and cargo for compliance with U.S. laws. Customs helps enforce rules and regulations for some 40 U.S. agencies, including FDA.

The new agreement extends the food inspection duties already conducted on behalf of FDA to cover the bioterrorism advance notice and registration requirements at border ports where
FDA has limited personnel or no presence. Allowing Customs officers to act on FDA's behalf was a key factor in FDA's decision to reduce the length of the prior notice from at least 12 hours to between two and eight hours depending on mode of transport, according to officials at both agencies. Otherwise, shipments would have to be held until FDA officers
could review them, potentially clogging ports,…
 

The memorandum of understanding between the agencies provides for additional training and information sharing regarding imported foods. Browning said about 1,600 to 1,800 officers have been trained so far to understand and enforce the new rules. A minimum of two experts, stationed on-site or at a regional field office, will be responsible to help inspectors process food imports at every entry point. Ports that handle a high volume of food imports, like Miami and Los Angeles, will have as many as 20 technical experts who have been trained by FDA to train the rest of the Customs force,….

More than 100,000 companies, most of them foreign, have already registered with the FDA through its Web site. The agency estimates more than 400,000 domestic and foreign firms, many with multiple facilities, are covered by the registration requirement.

FDA also said it plans to finalize two other rules by the end of March to further implement Bioterrorism Act requirements. The proposals deal with the establishment and maintenance of records related to food and administrative detention for food shipments that could harm humans or animals. The FDA has the authority to hold food shipments and obtain records in cases where it determines a potential health threat exists while it drafts the final rules.