Wednesday, June 11, 2014

FDA vs Artisan Cheese Makers - Wooden Shelves Issue

As you may have heard, the FDA recently cited cheese makers in New York State for violating their "Good Manufacturing Practices." because they were aging their cheeses on wooden shelves. They issued a position statement proclaiming that wooden shelves are unsanitary for aging cheese.*

We, at New England Cheesemaking Supply Company are opposed to the FDA's position.  The main reason:  It is illegal.  

The FDA is required by law to follow certain basic practices.  Here is the ruling:

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.

The FDA's position statement* is a new interpretation of an old regulation.  ("Adequately cleanable" and "properly maintained" have allowed wooden shelving for decades in this country.)  When a regulation is reinterpreted, the agency, by law, has to announce the change to the public and the public has to be given the opportunity to comment.

The FDA is claiming this is not a new interpretation.  So, now, after artisan cheese makers all over the country have made huge investments in aging rooms with state of the art equipment, including wooden shelves, the FDA is just going ahead and changing the rules.  No notice to anyone!  It is incredible that they can say this is not a re-interpretation when they themselves have issued warnings (in writing!) for years to cheese makers for not adequately cleaning their wooden shelves.

Here are the rest of the reasons we are opposed to this new interpretation of the rules:

1.  They claim they are doing this to protect us from Listeria.  However, there are hardly any cases of Listeria caused by cheese in this country.  It is not a problem.

2.  Artisan cheese makers all over the world have been aging their cheeses on wood for centuries because wood is the best surface to encourage the growth of good bacteria.  Wood is one of the reasons artisan cheeses taste better than "manufactured" cheeses.

3.  Many artisan cheese makers will go out of business if their cheese does not taste good enough to command the prices they need to survive.

4.  Many artisan cheese makers will go out of business if they have to completely re-build their aging rooms.

5.  Most European imported cheese is aged on wood.  (In fact, many protected cheese are required by law to be aged on wood.  (Examples:  Comte, Beaufort and Reblochon)  Will all of these fabulous cheeses now be banned from the US?  What about wine barrels and wooden pizza paddles?

There is a petition you can sign if you feel as we do about this issue - click here

*FDA Official Statement
Composed by Monica Metz, Branch Chief for FDA’s Center for Food Safety.  She is, incidentally, a former quality control manager for Leprino Foods (which calls itself the “world’s largest mozzarella cheese manufacturer”).

Use of wooden shelves for cheese aging

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.

Recent publications by Zangerl et al. in 2010 showed that L. monocytogenes survived cleaning and sanitation on wooden shelves used for cheese ripening. [Zangerl, P., Matlschweiger, C., Dillinger, K.,& Eliskases - Lechner, F. (2010). Survival of Listeria monocytogenes after cleaning and sanitation of wooden shelves used for cheese ripening.  European Journal of Wood and Wood Products, 68(4), 415-419].  Another scientific paper by Mariana et al., 2011, does not suffice to overcome the cGMP violation.  Mariani, C., Oulahal, N., Chamba, J.F., Dubois-Brissonnet, F., Notz, E., Briandet, R. (2011).  Inhibition of Listeria monocytogenes by resident biofilms present on wooden shelves used for cheese ripening.  Food Control 22, 1357–1362].  More importantly, the data in the Mariani, et al., study showed that despite the use of unclean and clean native woods, L. monocytogenes strains were not completely inactivated or eradicated on the woods.  The mere fact that L. monocytogenes survived in any wood sample studied should be of concern. A single surviving L. monocytogenes cell may grow and multiply and thus serve to contaminate cheese.  Noteworthy is the fact that the authors suggested that further studies are required in order to establish the mechanism of inhibition by the bacteria described in the paper, which,for now, is only speculative. Thus the paper does not support the proposition for which it was offered, viz. that wooden shelves prevent contamination of cheeses with L. monocytogenes.

The primary concern for cheeses manufacturers should be prevention of cheese contamination with pathogens. Pathogenic microorganisms are not inherent natural contaminants of cheeses, therefore the sanitation of a cheese processing plant’s equipment and environment play an important role in preventing pathogen contamination.


JJ said...

This is ridiculous, of course. If the FDA is so concerned about the public's health, let us ask the FDA why tobacco continues to be sold in this country. I can't take seriously any absurd regulations such as the wood shelves issue as long as tobacco is still sold ( and the farmers subsidized) .

Jeri said...

Good point, JJ. Since I wrote this article, the FDA seems to have backed down (for now).