Manufacturing News

Regulatory Watch

June 5, 2003
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Inspectors not up to snuff?

At least one industry trade group is raising objections to FDA’s new, stepped-up HACCP inspections. FDA implemented new inspection regulations two years ago to evaluate industry compliance after several illness outbreaks caused primarily by unpasteurized fruit juices.

The International Dairy Foods Association says some of its members report that the FDA inspectors don’t appear to have been adequately trained on the juice HACCP regulation and on dairy plants processing juice. IDFA says manufacturers are in a position of having to educate the government inspectors on the regulation, as well as on processing and pasteurization operations.

The problems reportedly include: requesting copies of records not required by the FDA HACCP regulation; lack of knowledge and experience with dairy and juice processing equipment; demanding validation of dairy pasteurization times and temperatures for juice beverages; expecting the plant’s HACCP program to list milk allergens, cleaning and sanitation of processing equipment; and incoming ingredient receiving as a critical control point.

IDFA said it will meet with FDA officials to discuss the field training inadequacies and provide some recommendations to streamline inspections.

Bioterrorism Act may cause undue burden

Food manufacturers have filed a formal response to FDA on some of the Agency’s proposed regulations under the 2002 Bioterrorism Act. The National Food Processors Association said any new regulations imposed under the act should not unnecessarily burden either the food industry or the government, but the proposals under consideration do in fact fall short of that objective.

“As proposed, FDA’s regulations for registration of food facilities and prior notice of imports go well beyond Congressional intent, and would pose a significant burden to industry in terms of both cost and operational practices,” said Rhona Applebaum, NFPA’s executive vice president and chief science officer.

“We believe that there are numerous ways that the regulations can and should be revised before they are finalized, both to lessen their negative impact and to ensure that they reflect the true purpose of the Bioterrorism Act, which is to prevent an incident or respond to a threat of bioterrorism involving the food supply,” she added.

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