Revised Bioterrorism Regulations Seen as 'More Workable'

WASHINGTON - The interim final bioterrorism regulations released Thursday by the U.S. Food and Drug Administration were viewed positively by the Food Marketing Institute and other food industry trade groups. While the guidelines don't directly apply to food retailers, they will have an impact on companies that process, ship and store food.

The interim final regulations are the first two of four FDA regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). They involve prior notice of shipment and registration for domestic facilities that manufacture, process, pack, distribute, receive or hold foods for human or animal consumption. The interim regulations are effective beginning Dec. 12.

"The bioterrorism regulations issued today strike a good balance between strengthening food security and enabling food retailers and wholesalers to provide consumers the fresh and healthful products they demand," said Food Marketing Institute (FMI) President and CEO Tim Hammonds.

"We applaud the agency for the flexibility allowed when importing perishable products. The shorter prior-notice requirements (two to eight hours) will help ensure that these foods have ample shelf life. And the revised registration requirements ease the need for copious and duplicate records that already exist in state and local government offices.

Hammonds added that the food security strategy must continue to emphasize action over paperwork.

Other groups commenting on the new regulations included the Grocery Manufacturers of America. "GMA and its member companies are pleased that FDA appears to have given a great deal of consideration to making the bioterrorism regulations workable," said GMA VP of federal affairs Susan Stout.

Donna Garren, VP of scientific and technical affairs for the United Fresh Fruit and Vegetable Association, said her group is pleased that the new rules include positive changes reflected from United's comments submitted to FDA.

FDA is continuing to accept comments from interested persons. In March 2004, the agency will reopen the comment period on the regulations for an additional 30 days and then issue final regulations. During this time, FDA has said it intends to emphasize education about the new requirements.

To help educate the industry on the requirements, the Food Institute, a non-profit trade association, is holding several seminars. An East Coast seminar, to be held in Newark, N.J. on Nov. 5, is sold out, but a West Coast seminar has been added. It will be held Nov. 12 in San Francisco. The Food Institute is based in Elmwood Park, N.J.
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