FMI SUGGESTS CHANGES IN BIOTERRORISM ACT REGULATIONS

WASHINGTON -- The Food Marketing Institute here recently filed comments with the U.S. Food and Drug Administration advising the agency on how best to implement the FDA's new authorities to enhance food security while minimizing disruption to the food supply.be crafted carefully not to disrupt commerce with duplicative or overly broad requirements."FMI filed three sets of comments to the FDA concerning

WASHINGTON -- The Food Marketing Institute here recently filed comments with the U.S. Food and Drug Administration advising the agency on how best to implement the FDA's new authorities to enhance food security while minimizing disruption to the food supply.

be crafted carefully not to disrupt commerce with duplicative or overly broad requirements."

FMI filed three sets of comments to the FDA concerning the act, focusing on registration, record keeping and import notification -- sections 305, 306 and 307, respectively.

In terms of registration, FMI encouraged the FDA to focus the scope of facilities required to register. Section 305 requires facilities to register with the FDA if they "engage in manufacturing, processing, packing or holding food intended for consumption in the United States."

FMI cited the statutory language and legislative history that exempt retail establishments providing food directly to retail customers. FMI further argued that the legislative history clearly intends to exempt warehouses and central kitchens serving food retailers under the "same ownership or management," said Hammonds. "This should specifically include cooperative wholesale distribution centers as part of the exemption."

FMI also argued that current retail record-keeping practices serve biosecurity goals. Much of the information that the FDA could gather under the section of the act related to record keeping is already held by the industry and is routinely used to conduct efficient product recalls, according to the association.

FMI provided examples to make the point that "FDA's regulations should utilize the existing system, rather than require the food industry to develop new records specifically for purposes of this regulation."

Retailers currently keep records relating to their food products in accordance with the existing Federal Food, Drug, and Cosmetic Act. FMI suggested that retailers only be required to keep names and addresses of their food suppliers, and that they not keep customer records.

FMI also requested that separate, minimum import notification periods be established for different modes of transportation, such as truck, air, ship or rail. The act would require that importers give advance notice about food products crossing the border into the U.S. to allow scheduling of customs inspections.

The association argued that requiring more than eight hours of notice before food products can be imported from Canada and Mexico "would disrupt the cross-border flow of fresh produce."

In addition, the notice requires identification of the grower. FMI argued that in many cases the specific identity of the grower will not be known and that the importer should be able to declare "unknown" in the notification without deterring entry of the product into the U.S.

"The food industry is taking every step possible to improve biosecurity," Hammonds said. "It is critical, however, that industry and government use our resources in a timely, cooperative and efficient manner. Our strategy must emphasize action over paperwork -- especially when the information requested is already available."

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