http://www.forbes.com/sites/gregorymcneal/2014/06/09/fda-may-destroy-american-artisan-cheese-industry/The Food and Drug Administration (FDA) has issued an executive decree banning the centuries old practice of aging cheese on wooden boards. One bureaucrat within the FDA, without surveying all of the scientific literature, and without public commentary, has rattled hundreds of small businesses across the United States. Consumers who eat any kind of aged cheese should prepare for a potentially catastrophic disruption in the market for artisan, non-processed cheese.
The FDA’s decision will not only harm American cheese makers, but may also bring a halt to the importation of artisan cheeses from abroad as Canadian and European Union regulators have not imposed such draconian measures and still allow for the use of wood boards to age cheese. Rob Ralyea of Cornell University’s Department of Food Science, commenting on the FDA’s action noted “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.â€
Corporate cheese makers like Leprino and Kraft will be able to weather this regulatory storm — they don’t make cheese, they manufacture cheese, and as such they do not follow the centuries old artisan techniques. But for small businesses and artisan cheese makers, wood boards are in fact essential to the making of cheese. As cheese expert Gordon Edgar writes, “wood creates a beneficial environment for cheese. After all, what is cheese but a great achievement of the microbe community?†Edgar notes that wood is essential to the flavor of artisanal cheeses, it distinguishes it from the large manufactured cheeses:
Over the last 30-40 years cheesemakers here in the states have been trying to use the best practices of traditional cheesemakers to give smaller scale production a taste/quality advantage over the larger (now almost completely automated) factories that dominate the market. These folks have sunk their livelihoods on practices and recipes that rely — in part — on wood aging. It could be devastating for some, not just for replacement costs, but also for the lack of the special difference in flavor and quality that allows them to sell their products at a price that — theoretically — allows them to survive as small players in an agribusiness world.
In sum, small businesses who specialize in artisan cheeses will likely be destroyed by this decision.
To make matters worse, the FDA is acting without legal authority.
The FDA’s decree came after the New York State Department of Agriculture asked the FDA for clarification as to whether wooden surfaces were acceptable for the aging of cheese. In response, Monica Metz, Branch Chief of the FDA’s Center for Food Safety and Applied Nutrition’s Dairy and Egg Branch (and a former employee of Leprino) wrote:
The use of wooden shelves, rough or otherwise, for cheese ripening does not conform to [Current Good Manufacturing Practices], 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.
To support her argument, Metz cited to 21 CFR 110.40(a), which in its entirety reads:
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. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.
The regulation does not ban wood, in fact it doesn’t even mention wood. It mentions surfaces that must be “adequately cleanable†and “properly maintained.†Of course, the FDA is entitled to argue, as Metz did, that wooden boards can never be clean enough to conform with the regulation. But, there are two problems with this argument. The first is science, the second is law.
With regard to science. It is not at all clear that the FDA has science on their side. At least one report by the Wisconsin Center for Dairy Research found that the benefits of wood aging for cheese outweigh the risks.
In this 1940 photo taken at the Tillamook cheese plant, Tillamook, Oregon, cheese ages on wooden surfaces. (Library of Congress archive photo)
The Center’s report evaluated nearly a dozen scientific articles that examined procedures for maintaining wood boards during the aging of cheese, and the report found:
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.
In fact, one study even suggested that wood boards presented fewer risks than plastic boards.
Now maybe the science is wrong. But that’s what notice and comment rule-making is for. Notice and comment rule-making is the process through which an agency like the FDA lets the public know they are planning on issuing a rule, and the public is then given an opportunity to comment on that rule. In that process the agency must justify their rule, and do so with science. Those impacted by the rule provide their own scientific arguments, then the agency adopts a final rule, providing reasons for why the final rule was adopted. (Here is an example of how the notice and comment process works).
In our democratic system of government, agencies can’t simply write rules without public input, rather they act with authority delegated to them by the Congress, pursuant to laws (specifically the Administrative Procedure Act or APA) that require agencies involve the public in the rule-making process. That’s how bureaucrats are held accountable.
Notice and comment rule-making is required in at least two circumstances. When an agency first issues a rule (like 21 CFR 110.40(a) which was last updated in April of 2013), and when an agency issues a new interpretation of a rule. According to the blog, Cheese Underground the FDA is trying to act like this is not a new rule:
The most interesting part of the FDA’s statement it that it does not consider this to be a new policy, but rather an enforcement of an existing policy. And worse yet, FDA has reiterated that it does not intend to change this policy.
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.
The Court continued, discussing the specific facts of the case, which seem to parallel those of the FDA’s enforcement decision against cheese makers (internal citations omitted):
Alaskan guide pilots and lodge operators relied on the advice FAA officials imparted to them—they opened lodges and built up businesses dependent on aircraft, believing their flights were subject to part 91′s requirements only. That advice became an authoritative departmental interpretation, an administrative common law applicable to Alaskan guide pilots. The FAA’s current doubts about the wisdom of the regulatory system followed in Alaska for more than thirty years does not justify disregarding the requisite procedures for changing that system. Throughout this period, guide pilots and lodge operators had no opportunity to participate in the development of regulations and to argue in favor of special rules for their operations. Air transportation regulations have evolved considerably since 1963 and part 135 has been the subject of numerous rule making proceedings. Had guides and lodge operators been able to comment on the resulting amendments and modifications to part 135, they could have suggested changes or exceptions hat would have accommodated the unique circumstances of Alaskan air carriage. As the FAA pointed out in its brief, the agency’s regulations have, in several respects, treated Alaska differently from the continental United States. There is no reason to suppose that with the participation of Alaskan guide pilots and lodge operators, the regulations in part 135 would not have been affected. If the FAA now wishes to apply those regulations to these individuals, it must give them an opportunity to comment before doing so.
This is strikingly similar to the FDA’s action against cheese makers. Consider this story in The Daily Caller, quoting one cheese maker who invested substantial amounts of time and money in developing his facility, a facility which he now must fear will be raided by the FDA:
Chris Roelli, a cheesemaker from Wisconsin, called the FDA’s clarified stance a “potentially devastating development†for U.S. cheesemakers, many of whom have invested years of labor and capital in the wood-aging process.
“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 told Cheese Underground. “This is a major game changer for the dairy industry in Wisconsin, and many other states,†he said, pointing out that prohibiting American cheesemakers from using the wood-aging technique will put them “at a global disadvantage,†especially against French producers.
Cheese maker Chris Roelli with a cheese wheel, standing in front of his wood aging boards. (Photo courtesy of Roellicheese.com)
kAccording to one report, Roelli “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 cheesemakers, has developed his cheese recipes specifically to be aged on wooden boards.â€
The FDA is not merely relying on the claim that they are only enforcing existing policy, they are also claiming that the 2011 Food Safety Modernization Act (FSMA) justifies their action. This too is a specious argument because the agency after passage of the FSMA did not issue new regulations and did not issue new interpretations of existing regulations. In fact, as late as October of 2012 (20 months after the passage of the FSMA), the agency was allowing cheese makers to use wooden boards, merely requiring that the boards be adequately cleaned.
The evidence is right here in a warning letter posted on the FDA’s own website. In the warning letter, addressed to a cheese maker, the FDA stated (emphasis mine):
On June 19, 2012, the FDA informed your firm of the environmental sampling results. Your firm indicated that you would stop production to clean and sanitize your facility. During the July 2012 inspection of your facility, an FDA investigator observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. You failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d). You failed to clean and sanitize all of the wooden boards used to hold your Gouda-style cheese in the large aging cave even after FDA informed you of positiveL. monocytogenes results found on one of these boards.
2. You failed to clean non-food contact surfaces of your facility as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d)(3). You failed to clean any of the metal racks in the large aging cave used to hold the wooden boards (used to hold cheese) even after FDA informed you of positive L. monocytogenes results found on one of these racks.
Cheese makers pay careful attention to these warning letters, just like anyone in a regulated industry would. They watch out for the types of things that get their competition in trouble with regulators so that they can ensure their practices are in compliance with the law. In fact, the very reason agencies post these warning letters is to deter others from committing similar violations. A natural reading of this warning letter is not that wooden boards are prohibited, rather it is that wooden boards should be cleaned and sanitized. If the agency conducting the inspection believed that wooden boards were prohibited, they would not have told the cheese maker to “clean and sanitize†the boards, they would have told the cheese maker to use a different surface.
The decades of cheese making and aging on wooden boards that preceded the FSMA, and the FDA’s record of enforcement after the FSMA clearly show that the FDA’s new interpretation is just that, new.
Before the FDA’s bureaucrats start shutting down the American cheese industry, they must subject their new interpretation to notice and comment rule-making and allow the voice of America’s small businesses to be heard. If not, it’s likely those small businesses will have a winning day in court that will force the FDA to listen.
Gregory S. McNeal is a professor specializing in law and public policy. You can follow him on Twitter @GregoryMcNeal or on Facebook.
UPDATE: The second line of the post was changed from “One bureaucrat within the FDA, without citing to any scientific study…†was changed to “One bureaucrat within the FDA, without surveying all of the scientific literature…†after I learned that the FDA did cite two inconclusive scientific studies.
You can spy on me, NSA. You can overtax me, IRS. You can assign arbitrary speed limits to issue me a fine, DOT.
But motherfucker FDA you ain't 'bout to take my got damn cheese.
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