BRATTLEBORO — In July, the U.S. Food and Drug Administration (FDA) issued a change in raw-milk cheesemaking standards that places more than two-thirds of cheesemakers in the state at risk of being put out of business.
Of the 48 members of the Vermont Cheese Council (vtcheese.com), 34 make at least one cheese using raw milk.
According to industry insiders - cheesemakers, microbiologists, and even an authorized FDA agent - the agency's change in raw-milk cheese standards is not based in science. They say the regulations do nothing to protect the public and might even prevent cheesemakers from focusing on practices that do.
These new standards are now enforceable by the FDA, which means your favorite raw-milk Vermont cheddar could disappear at any moment.
With that loss, scores of jobs in Vermont associated with the production of your beloved cheese could also go with it, from the employment of the farmer who supplies the milk to the job of the cheesemonger who serves you.
As Mateo Kehler, co-owner of Greensboro cheesemaker The Cellars at Jasper Hill, wrote in an alert on his company's website, these new regulations will “make the production and sale of some raw-milk cheeses nearly impossible.”
Domestic producers of artisan-made, raw milk cheese such as Jasper Hill are in imminent danger, Kehler told The Commons, and some have already experienced the results of the new regulations.
Kehler believes the FDA “is not working to support artisan cheesemakers towards better regulation,” Kehler said. “They're working to destroy our little niche” and might be “regulating raw-milk cheeses and artisan cheesemakers out of the market.”
In a state that relies heavily on agriculture and tourism for its economy, the real possibility of losing an integral component of Vermont's financial survival is cause for alarm.
So the state's legislative delegation got involved.
'We can speak up'
Vermont's federal lawmakers are leading the charge to draw attention to, and try to reverse, the FDA's decision.
In late-November, U.S. Rep. Peter Welch and U.S. senators Patrick Leahy and Bernie Sanders reached out to their colleagues in Congress to sign a letter denouncing the FDA's new raw milk cheese regulations. In an act of bi-partisan, bi-cameral support, 21 members of Congress signed the letter.
On Dec. 3, they sent the letter to the FDA's deputy commissioner for foods and veterinary medicine, Michael Taylor. (As of early January, none of the Vermont delegation had received a response.)
In an interview with The Commons, Rep. Welch said, “Our goal is to make sure the [FDA] regulations are science-based.”
“The FDA shouldn't overreach,” Welch said. Otherwise, they “become destructive to the artisanal cheese industry.”
He urged the FDA to “interact with cheesemakers to understand their process” before creating regulations that work against them, and the stringent sanitation standards they already have in place.
When asked what power Congress has over the FDA, Welch said, “we can speak up and get attention for the cheesemakers.”
Welch also noted, “Congress has power over the FDA's budget.”
The science doesn't support it
The new regulations the FDA issued limit the presence of strains of non-toxigenic E. coli bacteria from 10,000 MPN (most probable number) per gram to less than 10 MPN/g in a sample of raw-milk cheese. The FDA's compliance officers collect the raw-milk cheese from a variety of sources, including retail stores, for testing.
While most people see mention of E. coli and immediately envision a trip to the hospital, Kehler explained the difference.
Not all E. coli will make you sick, he said. Like other bacteria, most strains of E. coli are part of a natural, healthy flora in our intestines - and in raw milk and raw-milk cheese.
“Only a small percentage of E. coli is pathogenic,” he said.
“The science doesn't support a correlation between non-toxigenic E. coli levels and pathogens in cheese,” Kehler said.
Thus, the presence of certain levels of non-toxigenic bacteria in raw-milk cheese is normal. It does not indicate a breach in sanitation in a cheesemaking facility or that a food item is dangerous.
But it seems like the FDA is unable to make this distinction.
“We're all concerned with food safety,” Kelher said, “but we need good regulations. These are not science-based rules.”
Although the non-toxigenic E. coli is not caused by or producing a poison, Kehler said that during an inspection, “the FDA shows up looking for the source of 'the filth.'”
He believes the FDA's approach to non-toxigenic E. coli points to “a fundamental lack of understanding of raw-milk cheeses.”
Dr. Catherine W. Donnelly, professor of nutrition and food science at the University of Vermont, told The Commons that “the FDA is concerned about E. coli O157:H7” - the strain of the bacteria that causes serious illness.
But “when surveys have been conducted on incidence of this pathogen in raw milk destined for use in artisan cheese making, it rarely if ever is found,” she noted.
Donnelly, a microbiologist who works with the raw-milk cheese industry, was the co-director of the Vermont Institute for Artisan Cheese for 10 years and has “specialized in listeria since 1983.” She said there is another problem with the FDA's methodology.
“The FDA is using the [most probable number] test,” Donnelly said. The problem with the MPN test, she said, is that “many non-specific organisms can register as E. coli but aren't.”
So the question remains: What exactly is the FDA testing?
'They do not recommend it. Period.'
The Commons sent the FDA a series of questions, most of them based on the same questions included in the Vermont legislative delegation's Dec. 3 letter. The responses came from FDA spokesperson Catherine McDermott.
One of the questions was, “Did the FDA utilize the microbiological guidance established by the International Commission on Microbiological Specifications for Foods [ICMSF]? If so, please explain how the ICMSF's information is consistent with the FDA's change in raw milk standards. If not, please explain why this guidance was not used.”
McDermott's response: “Yes. FDA's criteria is fully consistent with the advice provide by the ICMSF in its publications.”
She also quoted the ICMSF in her answer: “'... every effort should be made to adhere to manufacturing practices that will prevent coliform, especially E. coli contamination and subsequent growth.' ICMSF also states 'Certainly, the application of guidelines for E. coli at critical control points of cheese manufacture is advisable and industry should be encouraged to establish and use them as part of an internal microbiological safety and quality assurance system.'”
Donnelly countered that McDermott failed to provide the complete quote in the agency's response. She shared the paragraph from the ICMSF Book 2, which subsequently says:
“In several types of cheese E. coli can even be considered characteristic. With the exception of some strains of E. coli high populations of coliforms are unlikely to present a health hazard[...]. However, in view of the scarcity of evidence of recurring outbreaks due to [pathogenic E. coli] in cheese and the high cost of routine testing, it is doubtful that establishment of end-product criteria for either coliforms or E. coli would be justified. Accordingly, no sampling plan is proposed.”
Thus, the FDA chose to ignore the recommendations of the very same organization whose publications they quote in their response.
“They do not recommend it. Period,” Donnelly emphatically said, adding that with the FDA, “there's a disconnect to what the ICMSF is recommending."
Donnelly said the FDA also “chose to implement standards which are inconsistent with [European Union] regulations.”
“EU microbiological criteria for cheese are risk-based and differ depending upon whether cheese has been made from heat-treated [pasteurized or thermalized] versus raw milk,” she said, adding, “It is notable that no limits were established for E. coli in raw milk cheese.”
So, what's the risk?
The “drastic step” of applying such stringent standards to raw-milk cheese, “would only be justified were these cheeses presenting a demonstrable public health risk, which, to date, we have not seen evidence of,” the Vermont legislative delegation wrote to the FDA in December.
“Why did the FDA feel a more stringent E. coli standard for raw milk cheese was warranted?” they asked.
And, they asked, “What evidence exists to demonstrate that raw-milk cheeses produced under current practices place public health at risk?”
When The Commons submitted these same questions to the FDA, McDermott answered by describing a “food sampling pilot program” where the agency hopes to learn “more about how often select foods, such as raw milk cheese, become contaminated with food-borne pathogens and what patterns, if any, may help predict potential contamination in the future.”
She said the FDA “analyzed 1,600 samples of raw-milk cheese from a combination of domestic and internationally manufactured cheese to produce a statistically significant data set” to identify potential vulnerabilities and inform a risk profile.
The FDA is “conducting an analysis of that data and intends to share a report on our findings and analysis,” McDermott said.
Kehler's response to McDermott's answer: “Pretty sure their data will show very low levels of pathogenicity, which begs the question, why all the fuss?"
One could argue that the FDA is wasting time and taxpayers' money collecting raw-milk cheese samples and testing them for the presence of bacteria that will make no one sick, especially because that data is already out there.
In comments to the FDA over the rules, the Weston A. Price Foundation (WAPF) provided an extensive review of the scientific literature on raw milk cheeses, including comparisons between the safety of raw milk cheeses and pasteurized milk cheeses.
In its 44-page comment to the FDA, the foundation urged the FDA not to place unnecessary burdens on raw-milk cheesemakers. Most of the data the WAPF included comes from another federal agency, the Centers for Disease Control (CDC).
“Unfortunately, the FDA is starting with an incorrect assumption, namely that more regulations would benefit consumers of raw milk cheeses,” stated the foundation's president, Sally Fallon Morell, herself a cheesemaker, in the WAPF's Nov. 30 press release.
“Cheese, including cheese produced from unpasteurized milk, is a low-risk product,” the WAPF said in the summary of its comment, noting, “the CDC data for the 16-year period from 1998 to 2013 show that, given the amount of cheese produced and consumed in the United States, there are relatively few outbreaks.”
In the 16-year period, the data show no more than seven outbreaks of food-borne illness involving raw-milk cheeses, and “based on the information online, it is not possible to confirm whether all seven outbreaks were in fact from aged cheeses.”
Most raw-milk cheeses causing illness have historically been illegally-made, fresh cheeses, which industry insiders call “bathtub cheese.” Current regulations state that all raw-milk cheeses sold in this country, regardless of where they are made, must be aged for 60 days or more.
“The track record of aged raw-milk cheese safety in this country is excellent,” the WPFA wrote.
“The FDA's analyses to date have ignored the extensive scientific literature on the safety of aged, hard raw-milk cheeses, which are the majority of raw-milk cheeses produced in this country.”
“Cheese in general is a relatively low-risk product, and the majority of the food-borne illness outbreaks that do occur are caused by post-process contamination,” explained Fallon Morell in the press release. “The scientific studies show that the diverse community of microorganisms in raw milk cheese effectively limits the growth of pathogenic organisms, and thus post-process contamination is actually a greater risk in cheeses made from pasteurized milk.”
“American raw-milk cheese makers already comply with extensive regulations in order to produce this product,” Fallon Morell said, adding, “the science and CDC data are consistent with millennia of human experience: aged raw milk cheese is a safe, delicious, nutrient-dense food.”
Meanwhile, with the published raw-milk cheese standards, the FDA still has the authority to inspect and possibly shut down Vermont cheesemakers - all based on this shoddy science.
A dangerous distraction?
These new FDA regulations are “causing a disruption in trade,” Donnelly said, and they are “distracting the cheesemakers from doing the tests they should be doing.”
Cheesemakers have a finite amount of time and money, and Donnelly argues in favor of them using their resources to test for bacteria that could actually make people sick: listeria and Staphylococcus aureus.
She said a more accurate indication of safety and sanitation in raw-milk cheeses is the presence of listeria, and “a better way to test for listeria is in the production environment,” not in the finished cheese.
“No one is arguing against making raw-milk cheese safe,” Donnelly told The Commons, but “E. Coli standards are antithetical” to those efforts.
The FDA's actions, Kehler said, are “not sustainable.”
Ralph Ichter had stronger words to describe the FDA's actions.
When asked about the FDA's change in raw-milk standards, Ichter said, “It is stupid.”
Ichter, based in Washington, D.C., represents the French dairy industry in the United States, and he follows trade policies and FDA issues. He is the owner and CEO of a consulting firm, Euroconsultants, Inc., that works to negotiate trade in European foods and wines.
One of his company's specialities is French food and wine, and in his role as an authorized FDA agent under the Bioterrorism Act, he helps small- and medium-sized food and wine companies comply with FDA regulations.
Although Ichter's focus is on French cheeses imported into the U.S., his concerns are the same as Vermont cheesemakers' - and those of anyone who loves Vermont cheese.
Ichter said he believes “the big guys” - the super-sized, “agribusiness” industrial cheesemakers - pressured the FDA to change the raw-milk cheese standards, bringing them in line with those standards regulating pasteurized cheese.
He forwarded to The Commons a “Member Update” document from the American Cheese Society (ACS), dated Nov. 6, 2014.
In that account, the ACS summarized correspondence between its officers and William Correll, director of the Office of Compliance for the FDA's Center for Food Safety and Applied Nutrition.
In it, the ACS addresses changes in the FDA's Compliance Policy Guide, between the 2009 and the 2010 editions.
“After issuing its draft 2009 CPG, which proposed different permissible levels of nontoxigenic E. coli in raw milk and pasteurized milk cheeses, FDA received four comments from industry organizations, including the International Dairy Foods Association and the American Dairy Products Institute questioning why raw milk and pasteurized milk cheeses were treated differently,” the ACS document said.
It went on to detail how the industry organizations “called for a uniform level of non-toxigenic E. coli,” regardless of whether the cheese was made from raw or pasteurized milk. Rather than explain to the big guys the difference, the FDA seems to have capitulated and decided to change the standards to those of pasteurized cheese, Ichter suggested.
Ichter thinks the underlying goal of the FDA, and that of the industrial cheesemakers who are leaning on the agency, is “to kill the raw-milk cheese industry,” and these new non-toxigenic E. Coli standards are “a back-door way” to achieve that mission.
He said a number of smaller French cheesemakers have ceased exporting to this country. “They say, 'It's too much aggravation. We're not going to deal with this anymore,'” he said.
The lost trade is not the French cheesemakers' only concern, Ichter said. The public perception of the product as unsafe - despite the lack of scientific studies to substantiate that premise - is another problem, one shared by Vermont cheesemakers as well.
The FDA's change in raw-milk cheese standards is “contrary to all international standards,” Ichter said.
“The Ayatollah is the FDA,” he said.
'Wasteful and opaque'
Both Donnelly and Kehler noted the “contradiction” and “working at cross-purposes” between the FDA's actions and those of the U.S. Department of Agriculture.
They mentioned the immense support the USDA has given the Vermont artisan cheese industry, in the form of millions of dollars in grants and loans, as well as educational and technical support.
“Why would the FDA not help the USDA help artisan cheese-making along?” Donnelly asked.
“The USDA is trying to create these rural economies, and the FDA is trying to crush them,” Kehler said.
From a taxpayer's perspective, he said, it seems wasteful and opaque.
“It would be one thing if there was a public health benefit” to these regulations, Kehler said, “but there's not. We're asking for a transparent process and solid science.”
Raw-milk cheese is “an economic engine in this country. It's food people want to eat and will pay a lot of money for,” Donnelly said. She noted the recent White House dinner where French President François Hollande was a guest of honor. Jasper Hill's Bayley Hazen Blue - a raw-milk cheese - was served.
“At a time when there couldn't be more growth or demand for these products,” Donnelly said, “the sum of the parts all add up to the same thing: goodbye, raw-milk cheese, whether domestic or imported.”
“The FDA is a science-based agency, and they have an obligation to put their science on the table,” she said.
“We're going to try to hold [the FDA] accountable. As taxpayers and consumers, we deserve that,” Kehler said.
“That type of authority needs to have checks-and-balances in place,” Donnelly said.
“This is democracy in action,” Kehler added. “Vermont is on the right side of the issue."
At the very least, the FDA “should put all the compliance people” who decide the fate of imported and domestic raw-milk cheeses “in front of the cheesemakers to answer their questions,” Donnelly said.
“It doesn't serve the FDA well to engage with the industry in this manner,” she added.
Next moves
On the morning of Dec. 13, FDA Deputy Commissioner Michael Taylor met with a number of Vermont cheesemakers at the Latchis Theatre in Brattleboro, including Kehler, prior to Taylor's participation in the FDA's public meeting on the Food Modernization Safety Act.
Kehler told The Commons, “we spent some time talking about building trust,” and said that Taylor told the cheesemakers, “these [standards] are on the table.”
What Kehler wondered was, why get the congressional delegation “all worked up?” And, he said, “instead of being arbitrary,” why didn't the FDA “engage with the industry to find out the real issues” they face, especially “if the ultimate goal is to have a working relationship where policy development is transparent?”
A more local response to the FDA's attempt to regulate raw-milk cheese out of existence came from John Ferrara, manager of the Brattleboro Food Co-op Cheese Department.
“If they do it to Vermont cheese, it might be time to retire,” he said.