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•   FDA officers would take cheese from producers for “microbiological  than hard cheeses, there is plenty of evidence
            compliance sampling,” which then requires cheesemakers to “with-  that these cheeses can be produced safely.
            hold the production lots being tested from distribution into commerce     Donnelly herself has been part of a success-
            until results of the FDA’s analysis were returned. Affected companies  ful effort to produce safe raw cheese through
            noticed a pattern: Many times results were released only after the  her work with the Vermont Institute for Artisan
            products had reached the end of their sell-by dates. And in most  Cheese (VIAC), which has developed risk re-
            cases, the tested products met compliance criteria: They were salable  duction protocols and process control measures
            products that fully complied with regulations, but they could not be  for Vermont artisan cheesemakers that have
            sold, because of regulatory targeting and testing of these goods.” 5  resulted in more sanitary facilities. When FDA
                                                                       conducted nationwide environmental sampling
         •   In 2009-2010 FDA changed the tolerance level of generic E. coli in   for listeria at soft cheese firms, not a single
            raw milk cheese from ten thousand colony-forming units per gram   Vermont cheese facility tested had a positive test
            of cheese (cfu/g) and lowered it to ten Most Probable Number (MPN)   for listeria out of one hundred to three hundred
            per gram in “two or more subsamples or greater than one hundred   environmental swabs taken at each facility. 11
                                                  6
            MPN per gram in one or more subsamples.”  The European Union      FDA has more than shown it is interested
            hasn’t established a generic E. coli tolerance level for raw cheese,   only in destroying artisan cheesemakers, but the
            only pasteurized cheese. The new tolerance levels effectively pro-  legislative process is a vehicle to lower and/or
            hibited artisans from being able to release significant amounts of   eliminate aging requirements to allow the sale
            their product into commerce. Extensive sampling by FDA from   of fresh cheese. There is no prohibition against
            2004-2006 before the new requirements went into effect showed that   the sale of unaged raw cheese in intrastate com-
            about 70 percent of the cheese tested then would not have met the   merce; Wyoming, Kansas and some seventy to
            new standard.  This standard especially created trouble for producers   eighty towns in Maine currently allow the direct
                        7
            of raw milk soft and semi-soft cheeses; the long acidification times   producer-to-consumer sale of fresh raw cheese.
            often involved in the production of those cheeses can easily lead to   Fresh cheese is a great opportunity for small
            levels above ten MPN. There is no scientific evidence that these new   farmers and local artisans to produce a safe,
                                                                       nutritious product. The demand and the safety
            standards lead to safer cheese. Thanks to political pressure, FDA
            finally halted using the one hundred-to-ten MPN standards in 2016. 8  protocols are in place to make that happen.
                                                                       REFERENCES
             During most of the time FDA actions against artisan cheesemakers   1.    Catherine W. Donnelly, Ending the War on Artisan
                                                                           Cheese: The Inside Story of Government Overreach and
         were occurring under the aegis of the Center for Food Safety and Applied   the Struggle to Save Traditional Raw Milk Cheesemak-
         Nutrition (CFSAN), John Sheehan was the director of FDA-CFSAN’s   ers. White River Junction, Vermont: Chelsea Green
                                                                           Publishing, 2019. Paperback, p. 94.
         Division of Dairy, Egg and Meat Products. Monica Metz was the chief   2.   Ibid.
         for FDA-CFSAN’s Milk and Milk Products Branch; both Sheehan and   3.    Ibid.
         Metz were former employees of industrial cheesemaker Leprino Foods. 9  4.    Ibid., p. 127.
                                                                           Ibid.
                                                                       5.
             FDA established the 60-day aging rule in 1950. Donnelly shows that:  6.   Ibid., pp. 57-58 citing from “Compliance Policy Guide
         the regulations were formulated around the behavior of bacterial patho-  Sec. 527.300 Dairy Products—Microbial Contaminants
                                                                           and Alkaline Phosphatase Activity,” Federal Register
         gens such as Salmonella typhi and brucella in Cheddar cheese, the pre-  notice of availability, December 23, 2010.
         dominant cheese variety produced in the United States in 1950. Cheddar   7.    Ibid., p. 67.
         cheese has a low moisture content, high salt content and low pH/high   8.   Ibid., pp. 69-70 referring to an FDA press release, “Con-
                                                                           stituent Update,” February 8, 2016; accessible 3/11/2020
         acidity, and these parameters interact to create an environment that is   at https://www.fda.gov/food/cfsan-constituent-updates/
         inhospitable to bacterial pathogens, so they die off as cheese ages over   9.    fda-taking-new-look-criteria-raw-milk-cheese.
                                                                           Ibid., p. 106 citing about Monica Metz from Barbara
         the course of sixty days or longer. Not all cheeses share these charac-  Boland, “Former employee of ‘big cheese’ wrote FDA
         teristics, however, and the regulations currently upheld in the CFR have   letter that put NY artisan cheese makers out of work”,
                                                                           CNSNews, June 13, 2014. Accessed 3/11/2020 at https://
         been broadly applied to a number of specified cheese varieties despite   www.cnsnews.com/mrctv-blog/barbara-boland/former-
         scientific evidence that suggests such regulations are inappropriate for   employee-big-cheese-wrote-fda-letter-put-ny-artisan-
         certain cheeses, such as soft-ripened varieties like Brie and Camembert. 10  cheese-makers. [Note: Confirmed from “Experience”
                                                                           listed on LinkedIn for John Sheehan as quality control
             For reasons of food safety and quality, soft and semi-soft cheeses   manager for Leprino 1988-2000; accessed 3/11/2020 at
                                                                           https://www.linkedin.com/in/john-sheehan-94a0588]
         should have shorter aging requirements. While it’s true that soft and semi-  10. Ibid., p. 21.
         soft cheese have been responsible for more foodborne illness outbreaks   11. Ibid., p. 92-93.
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