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FDA ‘pauses’ non-toxigenic E. coli tests for cheese, including raw milk cheese

The Food and Drug Administration has temporarily suspended its cheese testing program for non-toxigenic E. coli, partly in response to complaints from proponents of raw milk and related products.

“Recently, cheesemakers have raised concerns suggesting that the FDA is applying safety criteria that may, in effect, limit the production of raw milk cheese without demonstrably benefitting public health,” agency officials said in a news release earlier this week.

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Measuring non-toxigenic E. coli has long been used by FDA and other public health agencies in the U.S. and other countries to indicate fecal contamination.

“The FDA’s reason for testing cheese samples for non-toxigenic E. coli is that bacteria above a certain level could indicate unsanitary conditions in a processing plant. Our surveillance sampling shows that the vast majority of domestic and imported raw milk cheeses are meeting the established criteria.”

So, until further notice, the agency is backing off of non-toxigenic E. coli testing in cheese while it reviews new rules that were mandated by the Food Safety Modernization Act of 2011.

“The agency will continue to inspect cheese-making facilities and test for pathogens in domestic and imported cheese but, in the meantime, FDA is in the process of pausing its testing program for non-toxigenic E. coli in cheese,” according to the news release.

FDA officials acknowledged the work of artisan cheesemakers, voicing “appreciation for the great care that many take to produce raw milk cheeses safely.” Some of those cheesemakers have challenged the value of  FDA testing programs. They contend there is no scientific evidence that testing raw milk products — including cheeses — enhances public health.

“Specifically, the concerns include the application of the test results and scientific foundation of these criteria,” according to the FDA news release.

“… We understand the concerns expressed by some cheesemakers, as well as lawmakers, and intend to engage in a scientific dialogue on these issues.

“The agency’s role in this area, and with respect to food safety generally, is to work with the industry, consumers, government partners and experts to be sure the right science-based, prevention-oriented standards and safety criteria are in place and that there is widespread compliance in the interest of food safety and consumer confidence.”

The Preventive Controls for Human Food rule mandated by FSMA, which became final in September, requires that food producers identify hazards in their products and operations and put controls in place to prevent or minimize those hazards. The phrase usually used in reference to this practice is: Hazard Analysis and Critical Control Points (HACCP).

Looking ahead, with the FSMA preventive controls rule now final, the FDA will take another look at what role non-toxigenic E. coli should have in identifying and preventing insanitary conditions and food safety hazards for both domestic and foreign cheese producers.

The FDA will also consider and update, as appropriate, the 2010 Compliance Policy Guide, which outlines safety criteria.

That guide reduced by 90 percent the amount of non-toxigenic E. coli that can be in raw milk cheese. Previously it was acceptable to have a level of 100 MPN (most probable number) per gram in two or more of more five samples. The 2010 guide reduced that to 10 MPN per gram.

Corrected content: The original version of this story incorrectly stated the acceptable levels previous to the 2010 guide. Prior to 2010, it was acceptable to have 100 MPN (most probable number) per gram of non-toxigenic E. coli in two or more of more five samples. The FDA has not stopped testing for pathogens. It has stopped testing for non-toxigenic E. coli.

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