There's a collegial, celebratory, almost giddy spirit at the annual American Cheese Society conference. No wonder many regulars refer to the gathering as "cheese camp." But the mood was noticeably more subdued at this summer’s summit in Providence, courtesy of the FDA.
The agency is currently reviewing its regulations for raw-milk cheese. Are the existing rules keeping us safe? To evaluate that, inspectors collected almost 1,500 samples of raw-milk cheese, imported and domestic, and tested them. They tested for pathogens like Listeria, Salmonella and E. coli 0157:H7. And they tested for a marker bacterium—non-toxigenic E. coli —that they consider their “canary in the coal mine,” an indication of a creamery that isn’t sufficiently clean.
Dr. Susan Mayne, newly appointed head of the FDA’s Center for Food Safety and Applied Nutrition, spoke at a conference lunch. Her presence reflected how diligently ACS leaders have worked to develop relationships within FDA and to engage policy makers in non-combative dialogue. And it signified, at least to me, how much ACS has grown, maturing from a gathering of back-to-the-land cheesemakers 30 years ago into a trade association with a powerful voice, strong leadership and serious issues.
Despite Dr. Mayne’s conciliatory tone and repeated assurances that the FDA wants to collaborate, not dictate, her remarks did little to assuage cheesemaker concerns. Here—paraphrased of course—is what many cheese makers are saying:
FDA is regulating the wrong thing.
Non-toxigenic E. coli (NTEC) are all around us: on produce, in our own gut and definitely in raw milk. This bacterium is not a pathogen, yet the FDA’s threshold for it is so low that few if any raw-milk cheeses can consistently clear the bar. Europeans don’t even measure NTEC in cheese. “It’s a meaningless microbiological standard,” says Catherine Donnelly, a professor of food science at the University of Vermont and an expert on the microbiological safety of food.
As Mayne pointed out, FDA has relaxed the NTEC standard. A cheese fails now if two samples don’t pass; formerly, one result over the limit would doom it. But the root problem remains, says Mateo Kehler, co-owner of Vermont’s Jasper Hill Farm. “There’s no correlation between non-toxigenic E. coli and pathogenicity,” insists the cheesemaker. “The standard sets the bar at such a low level that you need to be perfect, and with no benefit to public health.”
FDA laboratories and methodology are antiquated.
Many European labs and private U.S. labs have more sophisticated testing equipment that produces more accurate results, cheesemakers say. But the FDA doesn’t accept these results. It relies on an old approach known as MPN (“most probable number”) that generates more false positives. “Louis Pasteur probably used that technique,” joked Donnelly in one session.
European and domestic cheesemakers are understandably upset when state-of-the-art laboratories clear their products, but the FDA lab finds violations.
FDA inspectors are inadequately trained. The same agents inspect cosmetic manufacturers and pharmaceutical plants. They don’t understand cheese processing.
Mayne acknowledged this problem and said FDA is working on training field personnel with more specialized expertise.
European cheesemakers and importers are suffering big losses when cheese is held so long for FDA testing that it’s ultimately not sellable.
The FDA is working on faster testing, said Mayne. In the meantime, some European cheesemakers have declined to ship product, deciding that the benefit is not worth the risk.
The FDA has a huge task as public-health watchdog, but when its policies are so out-of-line with international standards, it creates havoc with our trading partners.
Bottom line: The FDA has just posted a request for input on how to reduce the risk of illness from raw-milk cheese. Cheesemakers, consultants and others who understand how to make such cheeses safely are invited to share their practices and suggest proactive policies here.
If the agency persists with its stringent NTEC benchmarks, raw-milk cheesemakers will face some tough decisions. Andy Hatch of Wisconsin’s Uplands Cheese Company made no Rush Creek Reserve last fall, concerned that this popular raw-milk cheese might fall victim; this fall, he told me, he intends to make some.
For his part, Kehler remains deeply troubled about the future of Jasper Hill’s raw-milk cheeses. If the regulations don’t change, he says, “Winnimere? Bayley Hazen? Bye bye.”