Jasper Hill: Letter to the FDA and call for action on raw milk cheese regulation
An important letter from the Vermont Delegation and Jasper Hill, to the FDA, and a call for action. If you’re a cheese professional (or just a cheese lover!), read this letter and contact your representative today, to ensure that we’ll be able to keep enjoying all cheeses, including soft-ripened raw milk cheeses, blues, and other styles that could be threatened (including the beloved Winnimere, pictured above) by proposed regulatory changes coming from the FDA. Via Mateo Kehler of Jasper Hill:
http://www.jasperhillfarm.com/fda
Read Representative Welch’s Bicameral Letter to the FDA: http://www.jasperhillfarm.com/s/Bicameral-Letter-to-FDA-regarding-E-Coli-Levels-in-Cheese.pdf
Read Jasper Hill's Comment To FDA Docket: http://www.jasperhillfarm.com/s/Jasper-Hill-FDA-Comment.pdf
Dear Friends in Cheese!
Many of you may remember the debacle of 2014 involving FDA’s flip-flopping position on the use of wooden shelving in the maturation of cheese in which a public outcry and a social media backlash forced FDA to withdraw its ludicrous and unscientific position on the matter. Well FDA has been at it again, this time by establishing microbiological criteria that make the production and sale of some raw-milk cheeses nearly impossible. FDA quietly changed the microbiological criteria for strains of non-toxigenic bacteria from 10,000 colony forming units (CFU) per gram to less than 10, effectively regulating many raw-milk cheeses out of the market. You may have noticed that Roquefort, Tomme D’Savoie and other special French and Italian cheeses have been missing from counters across the country (or have been replaced by pasteurized versions of themselves…). Well they are coming for domestic cheeses next.
The rub here is that there is no public health benefit to these new rules. Instead, many delicious cheeses that have long traditions and excellent food safety records may disappear from American cheese counters. This may seem like an esoteric issue, but it is a watershed moment for the future of artisan cheesemaking in the US. The rule making and regulations that are promulgated now will shape our industry for decades to come. WE NEED YOUR HELP….!
The Vermont Congressional Delegation has taken the lead in circulating a letter in both chambers of the US Congress as a first step in addressing the issue with FDA. Find linked below a draft that is making the rounds in Congress presently. Currently this letter has the following signatories on the House side:
The signed letter will be sent to Mike Taylor, Deputy Commissioner of Food and Veterinary Medicine at FDA after the Thanksgiving recess. It asks some pretty direct questions. We need some direct responses.
Have a minute? The DEADLINE IS MONDAY…. SO PLEASE consider writing or calling your congressman and senators. You can find your elected representatives by clicking on the following links:
http://www.house.gov/representatives/
http://www.senate.gov/senators/contact/
For additional background, I have linked below a document that Jasper Hill submitted to the Federal Docket with regards to FDA’s request for comments on raw-milk cheese and the 60-day aging rule.
Please feel free to reach out to me with any questions or additional background should you need it.
Thank you for your support of Raw Milk Cheese and for your support of cheesemakers at large.
FDA: Listeriosis in Raw Milk Soft-Ripened Cheese Assessment
Just published on the FDA site:
Joint FDA / Health Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Interpretive Summary
I’m awaiting a formal response from the American Cheese Society, and other better-informed sources, before I draw any firm conclusions on what this means, but at this time it certainly does raise some concerns as to what it could mean for American cheesemakers and consumers. from the conclusion:
“...the general conclusions, i.e., that the risk of listeriosis from consumption of soft-ripened cheese made from raw milk is substantially larger than that for consumption of soft-ripened cheese made from pasteurized milk, that the 60-day aging regulation actually increases the risk of listeriosis for consumption of raw-milk cheeses, that a 6 log reduction (or equivalent) of the contamination in milk is necessary to make raw-milk cheeses as safe from listeriosis as pasteurized-milk cheeses, and that most other strategies are not sufficient by themselves - apply to any soft-ripened cheese in or on which Listeria monocytogenes can grow substantially. Some additional data would decrease the uncertainty in the risk estimates.”
This seems to strongly suggest that the 60-day rule is likely to be removed as a requirement for raw milk, soft-ripened cheeses. However, it remains to be seen if this will result in raw milk soft-ripened cheeses being banned altogether, or if they will pursue a more nuanced approach. While there are not many soft-ripened, 60+ Day cheeses out there, a total ban could mean the end of some beloved cheeses in the U.S. market, many of which have been featured here.
Uplands Cancels Production of Rush Creek Reserve Due To Regulatory Uncertainty
If you've been wondering what impact recent FDA actions might have on American artisan cheesemaking, this morning brings some news that illustrates it in stark, and unfortunate, terms. The following letter was sent to cheesemongers and distributors by Andy Hatch, co-owner and head cheesemaker at Uplands Cheese Co., announcing that they will be canceling this season's production of their incredibly popular, and awarding winning, bark-wrapped, Vacherin-style cheese, Rush Creek Reserve:
From: Uplands Cheese
I'm writing to let you know that we will not be making any Rush Creek Reserve this year. It's disappointing news, I know, and we hope that it's not permanent. Food safety officials have been unpredictable, at best, in their recent treatment of soft, raw-milk cheeses, and until our industry is given clear and consistent guidance, we are forced to stop making these cheeses.
I'm sorry if this throws a wrench into your plans for the holidays - it certainly does on our end. It's not a decision we came to easily. Hopefully, our government officials will soon agree on how to treat traditional cheesemaking, and we can all return to the cheeses that are so important to us.
This will be a loss for mongers in the winter/holiday season, as the Rush Creek was always a cheese counter and wholesale favorite, but it also shows just what kind of impact the FDA's often hostile — and perhaps worse, unclear and shifting — regulatory approach to cheesemakers can have. Uplands Cheese, while small compared to the big cheese companies, is nonetheless a well-established, award-winning, commercially successful operation, and yet they don't feel they can keep making this particular cheese, in the present regulatory environment. Smaller and newer cheesemakers will have a hard time continuing their own cheeses that might fall afoul of the FDA's latest enforcement focus.
There will probably be other domestically-produced, Vacherin-style cheeses this winter (and hopefully imports of actual Vacherin and Mont d'Or won't be impacted, although given recent FDA holds on imports from France and Italy, I wouldn't assume it), but this is a big loss, and a potential sign of things to come. Stay tuned.
Update 08/15: I emailed with Andy Hatch, and he confirmed that this decision had not come in response to any FDA visit or letter, and that they'd never had problems during routine inspections, but "was a decision made slowly as I've watched the regulatory climate get more unpredictable over the year or so, with soft, raw-milk, farmstead cheese as the FDA's worst-case scenario."
He also added some advice for fellow cheesemakers: "all of us selling cheese these days - raw or not - should be testing every batch and tightening up our environmental control and monitoring. Each small problem just adds another arrow to the FDA's quiver."
(Emails quoted with permission from Uplands Cheese Co.)
Some eye-opening numbers to consider in the ongoing debate. #saveourcheese (the FDA has walked back their original position but it remains to be seen where this will end)
Game Changer: FDA Rules No Wooden Boards in Cheese Aging
This news has been ripping like wildfire through the cheese world for the last couple days. Its hard to exaggerate just how much of a financial and infrastructure hit this would be to cheesemakers, small producers in particular, who have been aging their cheeses on wood as standard practice for a very long time. From the smallest, newest caves to well-established producers with decades under their belts, cheese, particular longer-aging, larger format styles, are being aged on wood EVERYWHERE. In addition, the FDA has clarified that this position applies to imported cheeses as well. Say bye-bye to many of those amazing Swiss Alpines and French washed rinds.
This is huge. Hopefully the cheese world and their supporters won't take it quietly. Via Cheese Underground:
Game Changer: FDA Rules No Wooden Boards in Cheese Aging
A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community, as the federal Food and Drug Administration (FDA) this week announced it will not permit American cheesemakers to age cheese on wooden boards.
Recently, the FDA inspected several New York state cheesemakers and cited them for using wooden surfaces to age their cheeses. The New York State Department of Agriculture & Markets' Division of Milk Control and Dairy Services, which (like most every state in the U.S., including Wisconsin), has allowed this practice, reached out to FDA for clarification on the issue. A response was provided by Monica Metz, Branch Chief of FDA's Center for Food Safety and Applied Nutrition's (CFSAN) Dairy and Egg Branch.
In the response, Metz stated that the use of wood for cheese ripening or aging is considered an unsanitary practice by FDA, and a violation of FDA's current Current Good Manufacturing Practice (cGMP) regulations. Here's an excerpt:
"Microbial pathogens can be controlled if food facilities engage in good manufacturing practice. Proper cleaning and sanitation of equipment and facilities are absolutely necessary to ensure that pathogens do not find niches to reside and proliferate. Adequate cleaning and sanitation procedures are particularly important in facilities where persistent strains of pathogenic microorganisms like Listeria monocytogenes could be found. The use of wooden shelves, rough or otherwise, for cheese ripening does not conform to cGMP requirements, which require that "all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained." 21 CFR 110.40(a). Wooden shelves or boards cannot be adequately cleaned and sanitized. The porous structure of wood enables it to absorb and retain bacteria, therefore bacteria generally colonize not only the surface but also the inside layers of wood. The shelves or boards used for aging make direct contact with finished products; hence they could be a potential source of pathogenic microorganisms in the finished products."
In an email to industry professionals, Rob Ralyea, Senior Extension Associate in the Department of Food Science and the Pilot Plant Manager at Cornell University in New York, says: "According to the FDA this is merely proper enforcement of the policy that was already in place. While the FDA has had jurisdiction in all food plants, it deferred cheese inspections almost exclusively to the states. This has all obviously changed under FSMA."
Ah, FSMA. For those of you not in the know, the Food Safety Modernization Act is the most sweeping reform of American food safety laws in generations. It was signed into law by President Obama on January 4, 2011 and aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
While most cheesemakers have, perhaps, begrudgingly accepted most of what has been coming down the FSMA pike, including the requirement of HACCP plans and increased federal regulations and inspections, no one expected this giant regulation behemoth to virtually put a stop to innovation in the American artisanal cheese movement.
Many of the most awarded and well-respected American artisan cheeses are currently aged on wooden boards. American Cheese Society triple Best in Show winner Pleasant Ridge Reserve from Uplands Cheese in Wisconsin is cured on wooden boards. Likewise for award-winners Cabot Clothbound in Vermont, current U.S. Champion cheese Marieke Feonegreek, and 2013 Best in Show Runner-Up Bleu Mont Bandaged Cheddar.
Wisconsin cheesemaker Chris Roelli says the FDA's "clarified" stance on using wooden boards is a "potentially devastating development" for American cheesemakers. He and his family have spent the past eight years re-building Roelli Cheese into a next-generation American artisanal cheese factory. Just last year, he built what most would consider to be a state-of-the-art aging facility into the hillside behind his cheese plant. And Roelli, like hundreds of American artisanal cheesemaekrs, has developed his cheese recipes specifically to be aged on wooden boards.
"The very pillar that we built our niche business on is the ability to age our cheese on wood planks, an art that has been practiced in Europe for thousands of years," Roelli says. Not allowing American cheesemakers to use this practice puts them "at a global disadvantage because the flavor produced by aging on wood can not be duplicated. This is a major game changer for the dairy industry in Wisconsin, and many other states."
As if this weren't all bad enough, the FDA has also "clarified" - I'm really beginning to dislike that word - that in accordance with FSMA, a cheesemaker importing cheese to the United States is subject to the same rules and inspection procedures as American cheesemakers.
Therefore, Cornell University's Ralyea says, "It stands to reason that if an importer is using wood boards, the FDA would keep these cheeses from reaching our borders until the cheese maker is in compliance. The European Union authorizes and allows the use of wood boards. Further, the great majority of cheeses imported to this country are in fact aged on wooden boards and some are required to be aged on wood by their standard of identity (Comte, Beaufort and Reblochon, to name a few). Therefore, it will be interesting to see how these specific cheeses will be dealt with when it comes to importation into the United States."
Ralyea continues: "While most everyone agrees that Listeria is a major concern to the dairy industry, it appears that some food safety agencies interpret the science to show that wood boards can be maintained in a sanitary fashion to allow for their use for cheese aging, while others (e.g., the US FDA) believe that a general ban of any wooden materials in food processing facilities is the better approach to assure food safety. At this point, it seems highly unlikely that any new research data or interpretations will change the FDA policies in place."
In fact, many research papers do in fact conclude that wooden boards are safe. In 2013, the Wisconsin Center for Dairy Research published a paper on the subject, concluding: "Considering the beneficial effects of wood boards on cheese ripening and rind formation, the use of wood boards does not seem to present any danger of contamination by pathogenic bacteria as long as a thorough cleaning procedure is followed." You can read the whole report on pages 8-9 by clicking on this link.
Interesting side note: Health Canada does not currently have any regulations prohibiting aging and ripening cheese on wood, so apparently if we want to eat most American or European artisan cheeses, we'll need to drive across the border to do so.
So what's next? The American Cheese Society has mobilized its Regulatory & Academic Committee to learn more about this issue, and to ensure its members' interests are represented. The ACS promises to keep us apprised of developments. In the meantime, if you are a cheesemaker, and your operation is inspected and cited for the use of wooden surfaces, please contact the ACS office (720-328-2788 or [email protected]).
You might assume that wooden aging shelves are only used by smaller producers of artisan cheeses, but consider this: Under the FDA regulations, read literally, that cheese, pictured above, would be illegal for import to the US. It's name?
While the FDA may think this is enforcement of an existing policy, the test is not what they think, but what is objectively proven by the facts. Here, the facts show that the FDA for decades did not enforce any ban on wood aging surfaces. Thus, the FDA’s interpretation regarding wooden aging boards falls squarely in the new interpretation category, and must be subject to notice and comment rule-making. According to the Alaska Hunters Association doctrine articulated by the D.C. Circuit Court of Appeals:
Once an agency gives its regulation an interpretation, it can only change that interpretation as it would formally modify the regulation itself: through the process of notice and comment rulemaking…’Rule making,’ as defined in the APA, includes not only the agency’s process of formulating a rule, but also the agency’s process of modifying a rule.
In Alaska Hunters Association the D.C. Circuit analyzed whether the FAA could suddenly change its interpretation of a regulation, enforcing it against Alaskan businesses who for thirty years were either told the law didn’t apply to them or that the law would not be enforced against them. In the case, the D.C. Circuit quoted Oliver Wendell Holmes who once wrote “those regulated by an administrative agency are entitled to ‘know the rules by which the game will be played.’” In other words, agencies can’t change the rules on a whim, and bureaucrats can’t change the rules without notice, especially when people invested time, money, and labor in good faith reliance on existing interpretations of regulations.
Photo Credit Maira Kalman Open House NY’s Field Trip to Murray’s Cheese
I bet the White House Chef has served cheese aged on wood at some dinner since Obama signed FSMA — the bill that grants the FDA purview over cheesemaking...that used to be left up to the states.
So, “Cheese For Me But Not For Thee,” and "No Camembert For You!" Thanks, Obama!
This is devastating news for the artisanal and farmstead cheesemakers in the US, as well as a hand full of retailers aging cheese on wooden boards. It could also drastically change what kind of traditional European cheeses grace US counters, as wood is an aging medium more often than not. Like many big, sweeping FDA decisions, this one isn’t backed by substantial research and big ag stands to be untouched by this while small farmers and cheesemakers (and the palates of their supporting consumers) will suffer.
This changes my job and livelihood and my only comfort is knowing I won’t be alone in taking a stand against this “clarification” from the FDA.
