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Dairy Facts 2016

FDA Seeks Data on Raw Milk Cheese and Draft Risk Assessment

Aug 06, 2015

The Food and Drug Administration announced last Friday that it is seeking public comments, along with scientific data and information, to help the agency identify and evaluate ways to minimize the impact of harmful bacteria in cheeses made from unpasteurized milk. The comments and data will help FDA with its ongoing evaluation of the current 60-day aging requirements for raw milk cheeses.

In the notices, FDA said it recognizes that there is broad diversity in cheese manufacturing operations and knows that many factors go into ensuring the safety of the food. The agency wants to learn more about current practices used by a wide variety of producers, including the artisanal cheese manufacturing community.

FDA is taking this action in part based on findings from a joint quantitative risk assessment by the agency and Health Canada that also was released on Friday as a Final Notice. IDFA worked with FDA on this risk assessment, initially released in 2013, and submitted comments in support of its approach.

The assessment found that the risk of listeriosis from soft-ripened cheeses made with raw milk is estimated to be 50 to 160 times higher than that from soft-ripened cheese made with pasteurized milk. This finding is consistent with the fact that consuming raw milk and raw milk products generally poses a higher risk from pathogens than do pasteurized milk and its products.

The agencies aim to evaluate the effect of certain factors, such as the microbiological status of milk, cheese manufacturing steps and conditions during distribution and storage, on the overall risk of listeriosis to the consumer of soft-ripened cheese in the United States or Canada.

IDFA will work with the National Cheese Institute’s (NCI) Regulatory Committee to review the soft cheese risk assessment and request for data to determine what information the association can provide to help FDA with its safety evaluation.   

Members with questions may contact Cary Frye, IDFA vice president of scientific and regulatory affairs, at

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