I’ve been trying to get back in the swing of things after being away for a month–recovering from jet lag, unpacking, going through mail, paying overlooked bills, re-stocking the fridge and all that sort of thing. I haven’t felt like doing anything that required a lot of concentration, but then Henwhisperer, a blog reader, sent me a very intriguing document from your friends and mine at the U.S. Food and Drug Administration, and unfortunately, it requires serious concentration to understand, maybe because it’s a government document, written in bureaucratese.
But I think it’s important enough to expend the effort, and to post here, so others can provide interpretation and insight…and perhaps even provide input sought by the FDA.
Essentially, the document, just issued last week, is a “request for comments” from the FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Services, “requesting comments and scientific data and information that would assist the agencies in their plan to update a risk assessment on the relationship between foodborne Listeria monocytogenes in selected categories of ready-to-eat (RTE) foods and human health.”
Lo and behold, one of the 23 “RTE foods,” in addition to deli meats, sea food, ice cream, pasteurized milk, and veggies…is raw milk. Another is soft cheeses–not specified whether raw or pasteurized milk cheeses.
According to the document, “The purpose of the risk assessment is to incorporate newly available scientific data and information into the risk assessment in order to update estimates of the relative risk of illness and death associated with the consumption of different types of RTE foods that may be contaminated with L. monocytogenes…”
All this is highly relevant to producers and consumers of raw dairy, since L. monocytogenes has been a highly contentious issue in a number of regulatory and legal cases. In New York state, at least half a dozen raw dairies have been temporarily shut down at different times over the last five years because listeria has been found in their milk, yet there have been no illnesses. One farmer, Chuck Phippen, has been shut down at least eight times for the presence of listeria, and has filed suit against the state’s Department of Agriculture and Markets over the matter.
In Missouri and Washington, it was findings of listeria, once again without any illnesses, that have led to the shuttering of two raw cheese producers. The Missouri case, involving Morningland Dairy, wound up in court, where a judge accepted the state’s argument that the presence of listeria constituted a serious enough danger to warrant destroying $250,000 worth of inventory.
It’s impossible to know how much these cases might have inspired the FDA to re-examine its approach to listeria cases. But the request for comments touches on a number of issues raised in the New York and Missouri raw milk and raw cheese cases. For example, FDA says it seeks data on “The number of L. monocytogenes cells present per amount (unit volume or weight) of contaminated RTE food.” It also proposes to consider “The relationship between the dose of L. monocytogenes ingested with food and the frequency of listeriosis…”
In both the New York and Missouri cases, a big part of the argument in opposition to the regulators has been that the simple presence of L. monocytogenes isn’t necessarily a public health danger. This matter has been raised by scientists within the FDA and at other institutions, but the agency hasn’t seen fit to take the concerns seriously, until now…maybe.
One other intriguing aspect of the FDA’s upcoming re-evaluation of L. monocytongenes is that the agency is considering adjusting findings it came up with in 2003 on the same subject. In that assessment, the FDA ranked a number of foods in terms of the danger posed by L. monocytogenes.
Here’s where the whole matter becomes more complicated than I would have liked, especially while dealing with jet lag. What did the FDA find in its original report on L. monocytogenes? Turns out that “unpasteurized fluid milk” was labeled “high risk” on a “per serving basis,” along with hot dogs, deli meats, and smoked seafood. Interestingly, pasteurized milk was labeled “high risk” on a “per annum basis” (with deli meats considered “very high risk” on that basis).
But how, I wondered, did the FDA arrive at any kind of “per serving” assessment of raw milk? After all, it pretends that raw milk shouldn’t be consumed under any circumstances. How would it have any indication of how many servings of raw milk are made each day, or week, or year?
So I went deep into the 2003 report, where food number 14 is the “Unpasteurized fluid milk food category”. And there, it states, “Unpasteurized Fluid Milk consumption was estimated to be 0.5% of total milk…”
Now mind you, the U.S. Centers for Disease Control has done surveys indicating that as much as three per cent of milk consumption could be raw milk. Even if the actual number is two per cent, or even one per cent, it’s two times, or four times, or even possibly six times the figure the FDA was using in 2003. Might the FDA be making its estimate low enough to ensure the denominator of its “per serving” assessment is low enough that raw milk will come out as high risk.
What percentage will the FDA use in this new updated assessment? That should be just one of a few interesting results to come out of the upcoming study.
In the meantime, I guess I can credit the FDA for helping lift the fog of my jet lag. And I would encourage anyone with insights and data to answer the FDA’s request for comments. The deadline is July 6. ?