Bioterrorism rules need fixing: GMA official

June 25, 2004
In testimony before the Health Subcommittee of the House Energy and Commerce Committee, Susan Stout, vice-president of federal affairs for the Grocery Manufacturers of America (GMA), explained how implementation of the Bioterrorism Act of 2002 could be improved.

In testimony before the Health Subcommittee of the House Energy and Commerce Committee, Susan Stout, vice-president of federal affairs for the Grocery Manufacturers of America (GMA), explained how implementation of the Bioterrorism Act of 2002 could be improved.

Stout’s testimony highlighted two requirements that place undue burden on the food industry without any improvement to food supply security. She recommended that Food and Drug Administration (FDA):

•Revise prior-notice requirements to create a separate category for importation of sample products not for human consumption or retail sale. This would allow companies to continue this routine testing practice and allow FDA to direct its resources to higher-risk areas.

•Eliminate the requirement that food and beverage companies maintain records of lot or production codes for every individual product to the retail level. In case 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 unnecessary.

FDA is conducting an “educational” phase to give government and industry time to comply with the regulations. However, FDA has provided little, if any, feedback on compliance so far. In fact, according to FDA data, more than one-third of prior notices submitted as recently as April were deemed “incomplete,” but companies could only guess why. 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 said.

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