Food processors face rigors of Bioterrorism Act
Dan Sussman, contributing editor -- Manufacturing Business Technology, 12/1/2003 7:00:00 AM
Business as usual for food & beverage processors is about to undergo a major change that some—but certainly not all—companies are ready for.
Under newly published Food & Drug Administration (FDA) regulations driven by the new federal Bioterrorism Act, all companies—both domestic and foreign—that manufacture, process, pack, or hold food for human or animal consumption must register with the FDA.
Other new FDA regulations created under the act include:
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define the maintenance of records regarding a company's receipt, processing, and delivery of products;
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require that U.S. food companies notify the FDA of imported food shipments 24 hours before shipment from abroad; and
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grant the FDA authority to seize food products transported within the U.S.
FDA scrutiny is a new situation for the majority of food companies, says John Blanchard, an analyst with Dedham, Mass.-based ARC Advisory Group. While the pharmaceuticals industry has been under intense pressure for the past few years to develop and implement tracking and traceability systems, and electronic recordkeeping procedures under the FDA's 21CFR Part 11 regulation, the agency has not applied the same kind of pressure in the food industry.
"Food and beverage companies never have treaded water on this kind of thing like the pharmaceuticals industry, and they've never been pushed underwater by the regulators, so their sensitivities are a little lower," says Blanchard. "But they're absolutely preparing now for all of the requirements on the industry; the big companies see it coming fast."
In meeting the Bioterrorism Act regulations, food & beverage processors likely will find that some of their manufacturing systems may be deemed "high risk," and thus be subject to more scrutiny. "Food processors have to look to the pharmaceutical industry to determine what the high-risk and low-risk definitions are," says Blanchard. "For example, a high-risk process might be a retort [i.e., a vessel used to kill micro-organisms] in a canning operation. Another high-risk area would be blending. A low-risk process might be one that involves labeling."
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