FDA Hones in on Limited Raw Milk Cheese Despite Absence of a Single Documented Case in 23 Years

I have spent much of the last week reading a 189-page report issued jointly by the U.S. Food and Drug Administration and Health Canada, with the dry title, “Joint FDA/Health Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada”. The reading is as dry as the title suggests. It’s full of technical statistical and research terminology, terms like “risk characterization,” “sensitivity analysis,” “mitigation,” “rank correlation,” and on and on. What that meant was that I had to read everything two, three, and four times before I could begin to make sense of it. But the more I read, the more upset I became, because I realized this is a very important document, one that could have a huge effect on food availability. If the authors of this report are successful in accomplishing what they want to accomplish with brie and camembert cheeses, you can be sure they will continue on to other kinds of cheese, and then other entire categories of food products, in their endless search for supposedly serious pathogen dangers. Equally troubling, the FDA considers this report ”science based and transparent,” when it is anything but. I wrote the following analysis to try to get my thoughts down in an orderly way. I encourage you, after you’ve read my assessment, to try your own hand at reading the report, or at least the summary, and then to take the opportunity the FDA is offering to provide comments, and let the agency know in no uncertain terms what you think about this particular piece of literature. )

Nearly 15 years ago, a business book came out with the strange title, Who Moved My Cheese?

It was the story of mice in search of cheese that had disappeared, a parable about how people need to prepare for change, in their business and personal lives, and it became a huge best seller.

The parable may be playing out literally in real life before too long for raw milk soft cheese, if regulators in the U.S. and Canada have their way. A newly released 189-page report from the U.S. Food and Drug Administration and Health Canada concludes that there is “a 50- to 160-fold increase in the risk of listeriosis from a serving of soft-ripened raw-milk cheese, compared with cheese made from pasteurized milk.” As a result, the regulators suggest they want to see raw milk cheeses like camembert and brie either subject to unprecedented testing, processing similar to pasteurization, or else banned completely. I should note they also offer the option of doing away with the 60-day aging requirement for cheese, as a possible way to reduce the time pathogens have to multiply in the cheese, but it’s offered as kind of a straw man, since it “does not consider the effect of removing the regulation on the risk of illness from other pathogens…” (That risk assessment should be worth another few lengthy reports.)

The risk certainly sounds serious…until you read closely the full 189-page report and learn that the FDA-Health Canada conclusion about “a 50- to 160-fold increase in the risk” is based entirely on estimates and mathematical predictions, rather than real-life data on illnesses from the soft raw milk cheeses.

Even more remarkable, the actual real-life data presented in the report of illnesses worldwide from listeriosis in soft cheese over a 23-year period between 1986 and 2008 show not a single documented illness in the U.S. from listeriosis due to tainted brie or camembert. That data, in a table on page 17, documents four outbreaks of listeriosis in cheese in the U.S. over the 23-year period, but all four are from raw milk queso fresco cheese, a soft cheese served fresh, without being aged the required 60 days, and thus illegal in the U.S. (It gets made illegally, often in the Hispanic community, sometimes even mixed in bathtubs, which has earned it the nickname “bathtub cheese.”)

In Canada, two cheese-related outbreaks, which sickened 58 people, are attributable to “multiple types” of cheese.

Indeed, the researchers were only able to document 20 outbreaks of illness from listeria in all cheesesfrom all kinds of milk worldwide over the same 23-year period—less than one per year…and, according to the report, “half involved cheese made from unpasteurized milk.”

So in actuality, we’re talking about ten listeriosis outbreaks worldwide from raw milk cheeses over a 23-year period—a tiny number by any stretch of the imagination.

By way of comparison, the U.S. Centers for Disease Control documents more than 1,000 outbreaks, resulting in between 15,000 and 30,000 illnesses, from all foods each year in the U.S.

So, given the absence of a single documented illness from 60-day-aged soft raw milk cheeses over 23 years in the U.S., and just the possibility of a few dozen illnesses in Canada, how do the FDA and Health Canada come to their conclusion that such cheeses are up to 160 times more risky than pasteurized soft cheeses? As I recall my grade school math, zero times any number equals zero. The regulators do it via “mathematical / probabilistic modeling… to estimate the risk per serving of Camembert-like cheese in both countries,” according to the report.

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Tags: FDA, cheese, food, raw-milk, safety

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