Following the don’t-age-on-wood-boards-uh-just-kidding incident earlier this year, the U.S. FDA are again raising the hackles of cheese purveyors. This time over an import alert.
According to Janet Fletcher of the L.A. Times Daily Dish, an FDA-issued alert on certain manufacturers of raw milk cheeses due to presumed insanitary conditions is keeping some top-selling cheeses off of baguettes.
In early August, these cheeses and many more landed on an FDA Import Alert because the agency found bacterial counts that exceeded its tolerance level. Cheeses on Import Alert can’t be sold in the U.S. until the producer documents corrective action and five samples test clean, a process that can take months.
Of course, French creameries haven’t changed their recipes for any of these classic cheeses. But their wheels are flunking now because the FDA has drastically cut allowances for a typically harmless bacterium by a factor of 10.
The limits for nontoxigenic E. coli were cut from 100 MPN (most probable number) per gram to 10 MPN. These are bacteria that live in every human gut; they are typically harmless and we coexist happily. But the FDA considers them a marker for sanitation: If a cheese shows even modest levels of nontoxigenic E. coli, the facility that produced it must be insufficiently clean.
Dennis D’Amico, an assistant professor at the University of Connecticut whose specialty is dairy microbiology, says this premise is flawed.
“There was no health risk in all the years we operated at 100 MPN,” says David Gremmels of Oregon’s Rogue Creamery, which produces several raw-milk blues. “We look at this as an arbitrary change.”
Gremmels and others say they felt blindsided by the revised FDA guidelines, learning about them only when European cheeses began being held. The agency hasn’t offered any scientific support for the altered E. coli allowance, prompting unease about its decision making.
The stepped-up testing creates headaches for companies like Gourmet Imports, a Los Angeles cheese importer and distributor.
“In the past year, we’ve had delays on things you never would have imagined would be held before,” reports general manager Alex Brown. Even Parmigiano-Reggiano, a well-aged, low-moisture cheese unlikely to have microbial issues, was recently held for testing.
“It’s the safest cheese on the planet,” Brown says.
An import alert allows FDA to ask for more data (micro or inspection from an exporting country) and according to the Alert page, This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.
After a bit of digging I found a 2009 FDA Staff Compliance Policy Guide Sec. 527.300 Dairy Products – Microbial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) that states:
The presence of Escherichia coli in a cheese and cheese product made from raw milk at a level greater than 100 MPN/g (Most Probable Number per gram) indicates insanitary conditions relating to contact with fecal matter, including poor employee hygiene practices, improperly sanitized utensils and equipment, or contaminated raw materials. The presence of Escherichia coli at levels greater than 10 MPN/g in a dairy product, other than a cheese or cheese product made from raw milk, also indicates insanitary conditions. The presence of Escherichia coli at levels greater than 10 MPN/g in a dairy product made from pasteurized milk indicates that contamination occurred after pasteurization.
Any government agency needs to clearly and effectively communicate risk-based decisions, (especially changes) and provide the evidence to back a particular decision.