Grain and Feed Associations voice opposition to FDA food import rules

Food & Drink Weekly, August 25, 2003

The National Grain and Feed Association (NGFA) and the North American Export Grain Association (NAEGA) said they are hopeful that the Food and Drug Administration (FDA) will make major changes to its proposed regulations implementing the bioterrorism-preparedness law passed by Congress in 2002.

FDA earlier this spring issued proposed regulations that will require, effective December 12, that all U.S. and foreign facilities--encompassing grain elevators, feed mills and processing plants--that manufacture, process, pack or "hold" food for human or animal consumption in the U.S. register with the agency.

FDA proposed to apply the registration requirement to both stationary and "mobile" facilities. In a second set of regulations, FDA proposed that importers, starting on December 12, provide prior notice concerning shipments of food, feed or feed ingredients destined for the U.S.. And in a third rulemaking, the agency proposed that food and feed facilities, as well as transporters, maintain records sufficient to identify the immediate previous domestic or foreign sources, as well as the immediate subsequent recipients, of such shipments.

The groups commended FDA for developing a system whereby facilities could register electronically, as well as by paper, for free. But the agency was encouraged to make the registration process less time-consuming for companies with multiple facilities, rather than requiring data entry by each facility individually. NGFA and NAEGA also urged FDA to redesign its registration form to more clearly specify which sections are optional, and to clarify that failure to update optional information is not subject to civil or criminal penalties.

NGFA and NAEGA also termed "inappropriate" FDA's proposal to hold importers financially and criminally liable for the failure of foreign facilities to properly register with the agency. Under the proposed rules, imports from foreign facilities that fail to properly register would be denied entry into the United States, with the importer assessed charges for holding the product at an FDA-approved bonded warehouse until the foreign facility is registered.

NGFA and NAEGA voiced major concerns over FDA's proposed regulations to require prior notice of food, feed and feed ingredient imports. They cited what was termed the "excessive, burdensome and unworkable" information that FDA proposed to have importers collect, including the identity and location of the grower of the agricultural product, if known. The NGFA and NAEGA warned that the prior notification requirements could be viewed by foreign countries as a non-tariff trade barrier that could subject the U.S. to challenge before the WTO.

NGFA and NAEGA also submitted comments on FDA's proposed regulations that would require U.S. and foreign facilities that "manufacture, process, pack, distribute, receive, hold or import" food or feed into the U.S. to maintain records and make those records available to FDA if the agency receives a "credible threat of serious adverse health consequences or death" to humans or animals. NGFA and NAEGA urged FDA to clarify that facilities that receive, handle, manufacture or ship raw commodities, ingredients or finished products on a commingled basis are exempt from the requirement to identify specific sources of ingredients, unless the products are segregated or identity-preserved for commercial reasons. The associations also cautioned that attempting to impose recordkeeping requirements on foreign facilities could pose WTO trade challenges.