GMA: FDA's Bioterrorism Regs Good But Need Improvement

WASHINGTON - Although the Food and Drug Administration has made many improvements to the proposed bioterrorism regulations, "there is still room for more, especially with concern to prior notice and record-keeping," Susan Stout, v.p. of federal affairs for the Grocery Manufacturers of America, said in testimony before the Health Subcommittee of the House Energy and Commerce Committee late last week.

Noting that the FDA is to be commended for its willingness to work with all stakeholders to make the bioterrorism regulations workable, Stout's testimony highlighted two requirements that place what GMA terms an undue burden on the food industry, without any improvement to the security of the food supply.

Specicially, Stout relayed GMA's recommendations, which include revising prior-notice requirements to create a separate category for the importation of sample products that are not for human consumption or retail sale, thereby allowing companies to continue routine testing practices while allowing the FDA to direct its resources to higher risk areas; and eliminating the requirement that food and beverage companies maintain records of lot or production codes for every individual product to the retail level. In the event of a threat to the food supply, companies and retailers remove all suspect products -- not just certain items by lot or production code -- making this requirement redundant.

The FDA is currently conducting an educational phase to give government and industry time to come into compliance with the regulations. However, the agency has provided little, if any, feedback on compliance so far, according to GMA, which says more than one-third of prior notices submitted as recently as April were deemed "incomplete," with no further explanation. The educational phase is scheduled to end in mid-August, when full enforcement begins.

"Without feedback from the FDA on why these prior notices are incomplete, we are concerned that products will be denied entry at the borders unnecessarily, once enforcement begins," Stout concluded.

In a related development, the FDA next month will launch a high-tech food-screening program designed to thwart terrorists from poisoning the U.S. food supply. The move is part of a bioterrorism law, which since December 2003 has required all food import shipments to be registered in advance with the FDA.

After Aug. 12, the program will expand to include a computerized risk assessment of each shipment before it reaches U.S. soil, and allow the FDA to detain any package it deems potentially harmful.

"Electronic screening allows FDA to concentrate its limited inspection resources on high-risk shipment," FDA acting commissioner Lester Crawford told the House Energy and Commerce Health Subcommittee last Friday.
This ad will auto-close in 10 seconds