Charter Challenge to Canada’s Raw Milk BanJune 17, 2020
FDA Denies Raw Butter PetitionJune 29, 2020
By Pete Kennedy, Esq.
With all the laws on the books today favoring industrial food under the guise of protecting the public health, one that stands out is the federal prohibition on fresh cheese (raw cheese aged less than sixty days). The cheeses whose producers are hurt by the sixty-day aging requirement are the soft-ripened and semi-soft cheeses defined in regulation by FDA in the Code of Federal Regulations, 21 CFR 133.182 and 21 CFR 133.187.
The production and sale of fresh cheese has been legal in Europe for centuries, with an excellent overall track record for safety. Moreover, the legal shelf life of a raw cheese like camembert in Europe is only fifty-five days, mainly due to the increased chance of the growth of listeria after that time; so in the U.S., artisan cheesemakers producing camembert or a similar cheese must wait longer than they should have to in order to get paid while being forced into selling a product that has a higher risk of contamination. Each type of cheese has its own pH and moisture level, two among other factors that need to be taken into account before determining the proper aging time for the cheese.
The FDA has no intention of changing its one-size-fits-all aging requirement for cheese, but a recently published book, titled Ending the War on Artisan Cheese, should help any effort to go in that direction. The book, written by Catherine Donnelly who is a professor of food science and nutrition at the University of Vermont, covers in extensive detail how the FDA’s policies on raw cheese aren’t based on science but rather on creating a climate of fear and intimidation against artisan producers to protect and expand the market share of industrial cheese makers.
The FDA actions Donnelly lists against artisan producers include:
- Inspections, along with product detentions during each inspection, of every cheesemaker (as well as two Whole Foods stores) who attended a 2013 workshop in Georgia titled “Food Safety and Hygiene in Artisan/ Farmstead Cheesemaking” that was cosponsored by the Georgia Department of Agriculture, the Innovation Center for U.S. Dairy and Whole Foods.1 The workshop was designed for small-scale cheesemakers and also included invitations to federal and state inspectors, the thought being that many of the inspectors were “not always knowledgeable about artisan cheesemaking.”2 The inspections and detentions occurred the day after the workshop. As Donnelly states, “the notion that attendance at, or sponsorship of, an educational workshop could subject an artisan cheesemaker or cheesemonger to regulatory scrutiny defeated the very purpose for which these workshops were intended.”3
- The American Cheese Society (ACS) is the leading organization in the U.S. supporting the promotion of artisan, farmstead and specialty cheeses. As Donnelly explains it, “Attendees at the American Cheese Society began to notice some interesting connections between the dates when the annual ACS meetings were occurring and the timing of FDA recall announcements and unannounced visits to their establishments. Cheesemakers would lament that they were unable to bring the quality assurance members of their organization to the ACS annual meetings because it becomes a matter of routine that unannounced inspections from the FDA occur during the ACS meeting.”4
- FDA officers would take cheese from producers for “microbiological compliance sampling,” which then requires cheesemakers to “withhold the production lots being tested from distribution into commerce until results of the FDA’s analysis were returned. Affected companies noticed a pattern: Many times results were released only after the products had reached the end of their sell-by dates. And in most cases, the tested products met compliance criteria: They were salable products that fully complied with regulations, but they could not be sold, because of regulatory targeting and testing of these goods.”5
- In 2009-2010 FDA changed the tolerance level of generic E. coli in raw milk cheese from ten thousand colony-forming units per gram of cheese (cfu/g) and lowered it to ten Most Probable Number (MPN) per gram in “two or more subsamples or greater than one hundred MPN per gram in one or more subsamples.”6 The European Union hasn’t established a generic E. coli tolerance level for raw cheese, only pasteurized cheese. The new tolerance levels effectively prohibited artisans from being able to release significant amounts of their product into commerce. Extensive sampling by FDA from 2004-2006 before the new requirements went into effect showed that about 70 percent of the cheese tested then would not have met the new standard.7 This standard especially created trouble for producers of raw milk soft and semi-soft cheeses; the long acidification times often involved in the production of those cheeses can easily lead to levels above ten MPN. There is no scientific evidence that these new standards lead to safer cheese. Thanks to political pressure, FDA finally halted using the one hundred-to-ten MPN standards in 2016.8
During most of the time FDA actions against artisan cheesemakers were occurring under the aegis of the Center for Food Safety and Applied Nutrition (CFSAN), John Sheehan was the director of FDA-CFSAN’s Division of Dairy, Egg and Meat Products. Monica Metz was the chief for FDA-CFSAN’s Milk and Milk Products Branch; both Sheehan and Metz were former employees of industrial cheesemaker Leprino Foods.9
FDA established the 60-day aging rule in 1950. Donnelly shows that: the regulations were formulated around the behavior of bacterial pathogens such as Salmonella typhi and brucella in Cheddar cheese, the predominant cheese variety produced in the United States in 1950. Cheddar cheese has a low moisture content, high salt content and low pH/high acidity, and these parameters interact to create an environment that is inhospitable to bacterial pathogens, so they die off as cheese ages over the course of sixty days or longer. Not all cheeses share these characteristics, however, and the regulations currently upheld in the CFR have been broadly applied to a number of specified cheese varieties despite scientific evidence that suggests such regulations are inappropriate for certain cheeses, such as soft-ripened varieties like Brie and Camembert.10
For reasons of food safety and quality, soft and semi-soft cheeses should have shorter aging requirements. While it’s true that soft and semisoft cheese have been responsible for more foodborne illness outbreaks than hard cheeses, there is plenty of evidence that these cheeses can be produced safely.
Donnelly herself has been part of a successful effort to produce safe raw cheese through her work with the Vermont Institute for Artisan Cheese (VIAC), which has developed risk reduction protocols and process control measures for Vermont artisan cheesemakers that have resulted in more sanitary facilities. When FDA conducted nationwide environmental sampling for listeria at soft cheese firms, not a single Vermont cheese facility tested had a positive test for listeria out of one hundred to three hundred environmental swabs taken at each facility.11
FDA has more than shown it is interested only in destroying artisan cheesemakers, but the legislative process is a vehicle to lower and/or eliminate aging requirements to allow the sale of fresh cheese. There is no prohibition against the sale of unaged raw cheese in intrastate commerce; Wyoming, Kansas and some seventy to eighty towns in Maine currently allow the direct producer-to-consumer sale of fresh raw cheese. Fresh cheese is a great opportunity for small farmers and local artisans to produce a safe, nutritious product. The demand and the safety protocols are in place to make that happen.
- Catherine W. Donnelly, Ending the War on Artisan Cheese: The Inside Story of Government Overreach and the Struggle to Save Traditional Raw Milk Cheesemakers. White River Junction, Vermont: Chelsea Green Publishing, 2019. Paperback, p. 94.
- Ibid., p. 127.
- Ibid., pp. 57-58 citing from “Compliance Policy Guide Sec. 527.300 Dairy Products—Microbial Contaminants and Alkaline Phosphatase Activity,” Federal Register notice of availability, December 23, 2010.
- Ibid., p. 67.
- Ibid., pp. 69-70 referring to an FDA press release, “Constituent Update,” February 8, 2016; accessible 3/11/2020 at https://www.fda.gov/food/cfsan-constituent-updates/fda-taking-new-look-criteria-raw-milk-cheese.
- Ibid., p. 106 citing about Monica Metz from Barbara Boland, “Former employee of ‘big cheese’ wrote FDA letter that put NY artisan cheese makers out of work”, CNSNews, June 13, 2014. Accessed 3/11/2020 at https://www.cnsnews.com/mrctv-blog/barbara-boland/formeremployee-big-cheese-wrote-fda-letter-put-ny-artisancheese-makers. [Note: Confirmed from “Experience” listed on LinkedIn for John Sheehan as quality control manager for Leprino 1988-2000; accessed 3/11/2020 at https://www.linkedin.com/in/john-sheehan-94a0588]
- Ibid., p. 21.
- Ibid., p. 92-93.
This article was first published in the Spring 2020 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.