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FDA Draft Compliance Guide Raises Questions for IDFA

Feb 11, 2010

IDFA submitted comments earlier this month to the Food and Drug Administration expressing concern about the agency's new draft guidelines on pathogen levels and testing. While supporting FDA's efforts to enhance consumer safety, IDFA raised questions about whether the agency's guidance levels are based on the latest scientific evidence and literature.

FDA plans to use the Compliance Policy Guide, when finalized, to set priorities for levels that would require regulatory action by field representatives. The draft guide covers two separate areas: microbial contaminants in dairy products and alkaline phosphatase as an indicator of inadequate pasteurization or post-pasteurization contamination of dairy products.

In the comments, IDFA encouraged the agency to conduct a thorough review of current scientific literature, as well as consult with academic and testing experts before finalizing the new levels.

"The information in this document appears to be an accumulation of older FDA positions and reference values for identifying the need for regulatory action on specific human pathogens and alkaline phosphatase values in foods," the comments stated. "We believe that reliance on this information . . . has led to incorrect and sometimes overly stringent levels."

IDFA is especially concerned that the guidance relating to alkaline phosphatase would cause false positives. This could trigger action from the field and possibly cause FDA to take inappropriate regulatory action, including asking state dairy regulators to issue unnecessary mandatory recalls. To support its position, IDFA consulted with industry experts and included extensive background on research demonstrating the flaws associated with using alkaline phosphatase to measure adulteration in cultured and other dairy products.

Read IDFA's comments here.

Read Federal Register notice here.

Members with questions may contact Allen Sayler, IDFA vice president of regulatory affairs and international standards, at





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