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.
No comments:
Post a Comment