On Friday, CDC and FDA announced that E. coli O26:H11 in Graziers raw milk cheese from Sierra Nevada Cheese Company of Willows, California has sickened 13 people in nine states, put eight in the hospital and left three children in kidney failure. More than half of the sick are five years old or younger. The first illness began July 7. FDA contacted the company on September 24, eleven weeks later, and the company recalled every Graziers raw milk cheese the same day. The cheese was aged at least 60 days, which is what federal law requires of a raw milk cheese, and the label said exactly that. It said nothing else. I wrote about the outbreak on Saturday.
For several weeks I have been drafting a citizen petition to FDA under 21 CFR 10.30 asking the agency to require a warning statement on cheese made from unpasteurized milk. This outbreak is the reason to stop drafting and file. Before I do, I am posting the draft here and asking for comments. The full draft petition runs 22 pages with 47 footnotes, every one of them to a public source. I want to hear from cheesemakers, retailers, public health people, lawyers, parents, and from the people who are going to disagree with me. I would rather hear it now than read it in the docket after I file. Here is complete draft: https://www.marlerblog.com/files/2026/09/Raw-Milk-Cheese-Warning-Label-Citizen-Petition_WDM_9_27_26.pdf
What the 60-day rule is
Since 1987 FDA has prohibited unpasteurized milk in interstate commerce. The regulation carves out one exception, in its own words “alternative procedures to pasteurization,” meaning cheese cured at least 60 days at not less than 35 degrees under the federal standards of identity. The 60-day rule dates from the 1940s. It is the entire legal basis on which raw milk crosses state lines in a form people eat, and nothing in federal law requires the label to say what that means.
What FDA’s own science says about the rule
This is not my science. It is the agency’s. The joint FDA/Health Canada risk assessment, finalized in 2015, found that a serving of soft-ripened cheese made from raw milk carries roughly 50 to 160 times the listeriosis risk of the same cheese made from pasteurized milk, and that for those cheeses 60 days of aging can increase the risk rather than reduce it, because the pH rises as the cheese ripens and Listeria grows.
The same day it finalized the assessment, FDA published a request for comments on the 60-day rule. In it the agency wrote that the aging period had been presumed to control pathogens, that the available data raised questions about the safety of raw milk cheese even when aged, and that peer-reviewed studies showed E. coli O157:H7 surviving 60 days in cheddar. It cited a 1997 federal advisory committee memorandum saying the literature confirms pathogens survive the aging process. It asked whether a performance standard should replace the rule. Seventy-five comments were filed. Eleven years later there is no proposed rule, no completed reevaluation and no explanation.
FDA’s 2014 to 2016 sampling of 1,606 aged raw milk cheeses found pathogens in 14, including Salmonella, Listeria and a Shiga toxin-producing E. coli, and found generic E. coli, the agency’s indicator of unsanitary processing, in 5.4 percent. And a Cornell study FDA funded, published in Nature Medicine last October, found that 60 days of aging does not eliminate viable H5N1 bird flu virus in raw milk cheese. FDA began sampling aged raw milk cheese for the virus in December 2024, posted interim results in March 2025, promised final results that spring, and has not posted them.
Four outbreaks in 31 months, all in cheese that followed the rule
Each cheese was aged as the law requires. February 2024, Raw Farm raw cheddar, E. coli O157:H7: 11 sick in five states, five hospitalized, two with hemolytic uremic syndrome (HUS). October 2025, Twin Sisters Creamery aged raw milk cheese in Washington and Oregon, E. coli O103 and O26: 10 sick, one hospitalized, in cheese the state noted was “aged at least 60 days, as required by law.” I represent a claimant in that outbreak, and the petition says so. March 2026, Raw Farm raw cheddar and raw milk, E. coli O157:H7: nine sick, three hospitalized, one with HUS, more than half under five. September 2026, Graziers, E. coli O26:H11: 13 sick, eight hospitalized, three with HUS, more than half five or younger. Together, 43 people sick, 17 hospitalized and at least six children with kidney failure. Before that window, in 2017, a soft raw milk cheese from Vulto Creamery in New York was linked to a Listeria outbreak that hospitalized all eight of its victims and killed two.
Even California stops at the bottle
California has required a boxed WARNING on raw milk products since 1991. Its definition of a raw milk product expressly excludes cheese cured at least 60 days. Washington’s warning applies to containers of raw milk, not to cheese. Three of the four producers above are in those two states, and under state law none of their cheese had to carry a warning. Under federal law none of it did. The state exemption rests on the same assumption FDA’s own science has undermined: that 60 days of aging makes the warning unnecessary.
What the petition asks FDA to do
First, add a prescribed statement to 21 CFR 101.17, the regulation that has carried the unpasteurized juice warning since 1998 and the shell egg statement since 2000, modeled on the juice words: “WARNING: This product is made from unpasteurized (raw) milk and may contain harmful bacteria that can cause serious illness in children, older adults, pregnant women, and persons with weakened immune systems.” Capitalized, bold, boxed, on the package.
Second, reach the cheese that has no manufacturer’s label. A five-pound Graziers loaf cut and re-wrapped at a deli counter carries nothing. The petition asks that cut-to-order cheese may be covered by a placard at the point of sale, that imported cheese be treated the same as domestic, and that online sellers put the statement on the product page.
Third, exempt cheese made from pasteurized milk or from milk treated by a process validated to achieve an equivalent reduction in pathogens, and exempt cheese shipped for further processing, exactly as the juice rule does.
Fourth, finish the reevaluation of the 60-day rule that FDA announced in 2013 and took comments on in 2015. Within a year, publish either a proposed rule or a written explanation of why not.
Fifth, publish the raw milk cheese sampling data the agency already collects, at the sample level, including the 2025 bird flu results. And follow the juice model on timing: labels turn over in the ordinary course, with a placard permitted for the first year.
What it does not ask for
It does not ask FDA to ban raw milk cheese, to lengthen the aging period, or to restrict who may buy it. Adults who want cheese made from unpasteurized milk would remain free to buy it, with the same information the government already puts on a bottle of raw milk in California and on a carton of unpasteurized juice everywhere. It asks for a sentence.
Where I want your help
Tell me what is wrong with the draft, and be specific. Some questions I am weighing:
Is the wording right? FDA’s juice warning names children, the elderly and people with weakened immune systems. I added pregnant women, because of Listeria, and said “older adults.” Should the statement name the diseases, or is that too much for a label?
Is a counter placard workable for cut-to-order cheese, and who is responsible for it, the retailer or the cheesemaker?
What validated processes should qualify for the exemption, and who validates them?
Is one year of placards before labels must change too long for public health or too short for a small farmstead cheesemaker?
And if any fact in the draft is wrong, say so. Every count, date and quotation is footnoted, and I would rather fix it than file it.
Send comments to bmarler@marlerclark.com by [Friday, October 9]. I will read all of them, I will change the petition where you persuade me, and I may quote from comments in a follow-up post without names unless you tell me I can use yours. Once the petition is filed, FDA will assign it a docket number on regulations.gov, and anyone will be able to comment formally there. The agency is required to respond within 180 days.
Twenty-eight years ago FDA put a warning on unpasteurized juice after outbreaks that included a child’s death, and wrote that consumers were entitled to know a product they thought was healthful could carry pathogens. The parents in this outbreak were entitled to the same sentence. I want to make the case for it as well as it can be made, which is why I am asking you first.
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