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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.
98 Wise Traditions SPRING 2020