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FDA Suspends Testing for Generic E. coli in Cheese

Feb 10, 2016

The Food and Drug Administration announced this week that it “is in the process of pausing” its testing program for generic Escherichia coli (“E. coli”) in cheese. The agency made the decision based on concerns raised by raw milk cheesemakers and legislators who claim the testing criteria would limit the production of raw milk cheeses without evidence that testing for this organism yields any benefit to public health.

A Dec. 3 letter to FDA, spearheaded by Vermont’s congressional delegation, questioned whether the standard’s thousand-fold decrease in allowable levels of generic E. coli in raw milk cheeses would benefit public health and questioned whether the standards were scientifically sound.  

IDFA shared those concerns and is reaching out to officials at FDA to try to resolve the issues, said John Allan, IDFA vice president of regulatory affairs and international standards.

The FDA standard limits the level of generic E. coli found in raw milk cheeses from 10,000 most probable number (MPN) per gram to 10 MPN per gram. The standard was included in the latest edition of the FDA Compliance Program Guidance Manual and a Compliance Policy Guide, which FDA will also consider updating.

The agency plans to re-evaluate the criteria in the context of the Food Safety Modernization Act and the Preventive Controls for Human Food rule, which became final in September. The rule requires food producers to identify hazards that might occur in their products and operations and put controls in place to prevent or minimize those hazards.

Although FDA didn’t provide next steps or a timeframe for the re-evaluation process, the agency said it will continue to inspect cheese-making facilities and test for pathogens in domestic and imported cheese.

For more information, contact John Allan, vice president of regulatory affairs and international standards for IDFA, at

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