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Is 60-Day Rule Still Valid for Raw-Milk Cheese?

Recent recalls of raw-milk cheese have drawn increased attention to the U.S. Food and Drug Administration (FDA) rule that requires cheese made from unpasteurized milk to age for a minimum of 60 days before sale. For more than a decade, both the FDA and numerous food research groups have been working to answer the question: Is the “60-day rule” effective at eliminating harmful pathogens from raw-milk cheese?

The short answer seems to be, “Not completely.” The FDA is considering a possible change to the rule.

When the FDA first enacted the 60-day rule in 1949, no known disease-causing pathogens could survive the acidifying process of aging for more than a portion of the two-month process, and the 60-day time frame was selected to include an additional margin of safety.

Half a century later, however, modern studies and illness outbreaks have shown that some harmful pathogens survive in raw-milk cheese for longer than 60 days. A study published in the December 2010 Journal of Food Protection found that a strain of E. coli O157:H7 survived at viable numbers for approximately 100 days in Gouda and cheddar cheese, while researchers detected trace amounts after more than 270 days.

In November, an E. coli outbreak that sickened 38 people in five states was traced to Bravo Farms’ Gouda cheese made from raw milk and aged for at least 60 days. In December, gourmet raw-milk cheese from Sally Jackson in Washington state was the source of eight E. coli infections.

“We didn’t have this problem 50 years ago,” said Kathy Glass, Ph.D., associate director of the University of Wisconsin-Madison’s Food Research Institute. “At the time, the 60-day rule made sense, but now we have new enemies in front of us and we need to have a different tactic.”

The FDA has had the regulation under review for more than a decade. According to FDA spokesperson Sebastian Cianci, research questioning the effectiveness of the 60-day timeline first came to the agency’s attention in the late 1990s, but regulatory resources were focused on other matters in subsequent years.

 

The agency has since completed the initial draft of its review of the rule, although Cianci could not specify a timeframe for any decisions regarding it. He said the rule has been under review “in earnest” for the past year and he called the delay helpful in allowing time for more researchers to investigate the issue.

Researchers and cheese makers alike now speculate over what a revision to the law might entail. Glass suspects that the 60-day rule could become the “90-day rule” or the “120-day rule”.

“The holding time works because of a combination of acidification and not having enough moisture. There’s definitely a science behind it,” she said. “E. coli is very acid-resistant and has a low infectious dose, but if you give it enough time it will still die off under otherwise good conditions.”

Julie Steil, owner of River Valley Cheese in Fall City, WA, produces and sells a variety of cheeses made from both raw and pasteurized milk. She designs her raw-milk cheeses around the 60-day rule and said an extension of the minimum aging time would immediately impact her cash-flow and cheese-making process.

“I make a raw-milk Tomme-style cheese and have perfected my recipes so the cheese peaks at 75 to 90 days,” she said. “If the cheese sits on the shelf aging longer than that, it will be ruined.”

Aging extensions would reduce the shelf life of cheeses and increase the cost of holding inventory while it ages, Steil said. Her customers actively seek out River Valley’s raw-milk cheese for what she described as its “less processed” flavor.

Others question whether the emphasis on aging time is the best approach to controlling harmful pathogens in raw milk products. In countries such as France, Germany and England, sale of raw-milk cheese requires no minimum aging time. Instead, safety measures focus on animal health requirements, hygienic milk collection and storage, fast cooling, and microbiological criteria (a maximum acceptable concentration of coliform bacteria). As with raw milk products sold in the U.S., those sold in these countries carry a specific label that usually explains the health risks associated with consumption.

Of the 28 U.S. states that do not prohibit raw milk sales, many–including Washington, Idaho and California–have implemented microbiological criteria similar to regulations in Europe. Still, public health authorities such as the Centers for Disease Control and Prevention and food research professionals such as Glass stress caution when consuming raw milk products, even those aged to 60 days.

“When I teach dairy safety classes, I’m quite clear to people that even though the regulations say ’60 days’, there are some cheeses that just might not be safe to make with raw milk–they’re going to need heat treatment,” Glass said. “But when you get the right cheese, like a two-year-old Parmesan made from raw milk, it’s so good. I do the necessary tests and know a bug won’t stand a chance in something like that.”

© Food Safety News
  • Doc Mudd

    “In countries such as France, Germany and England, sale of raw-milk cheese requires no minimum aging time. Instead, safety measures focus on animal health requirements, hygienic milk collection and storage, fast cooling, and microbiological criteria (a maximum acceptable concentration of coliform bacteria). As with raw milk products sold in the U.S., those sold in these countries carry a specific label that usually explains the health risks associated with consumption.”
    OK, so why not adopt the best parts of this approach in the U.S.? This seems to make perfect sense; effective modern equipment, intensive hygiene all along the chain from source to end product, intensive safety measures (inspected & enforced to help keep the honest producers honest) and clear labeling to alert the consumer to specifics of known health risks.
    So, why not in the U.S.?
    Simply because our precious ‘small local producers’ cannot and will not take food safety and consumer welfare seriously if it involves any cost or inconvenience.
    Instead, these producers invest their profit, energy and talent in organizing activist groups who relentlessly lobby legislators and disseminate ridiculous propaganda to convince us the earth is flat and grubby, contaminated product is ‘natural’, a necessary feature of ‘sustainable’ production. Always vigilant to obfuscate any informed thought that might eventually cause small producers to become accountable for consumer safety.
    We’re getting to ‘know our farmer’ and beginning to realize we’re being quite professionally misled and fleeced.

  • Bill Anderson

    Please ignore Doc Mudd. Most small producers want to produce safe high quality food, they just sometimes lack the resources to fund the scientific research to validate and refine their practices.
    There all sorts of sham studies out there, funded by huge milk marketing boards, trying to bash the supposed safety of raw milk cheese. Studies that have nothing to do with the actual practices used to produce most raw milk cheese.
    If the FDA would actually put its resources towards helping small producers rather than trying to prosecute them, this wouldn’t be a problem.

  • http://www.marlerblog.com bill marler

    See my five part series on raw milk and the “60 day rule” – Part 1, Part 2, Part 3, Part 4 and Part 5, as well as Outbreaks, illnesses and recalls linked to raw (unpasteurized) and pasteurized dairy products, United States, 2010.
    http://www.marlerblog.com/legal-cases/carpe-cheese—bravos-raw-milk-cheese-seized-by-the-fda/

  • Nell Hanssen

    I’d like to know whether E. Coli 0157:H7 is ever found in raw cheese (or other raw products) from cows that are entirely grass-fed. My understanding is that this bacteria has evolved to be extremely acid tolerant due to the (unnaturally) acidic conditions in a cow’s stomach caused by a diet high in grain.
    I also feel that taking aim at the small producers is a little off-base, in general. Seems like most of our disease outbreaks did not originate from our smaller producers. The more animals you cram into one area, the more likely you’ll get rapidly spreading diseases and unsanitary conditions. It’s just a lot harder to clean up after several thousand animals than, say, 50. And just like us, if you feed animals healthy foods, they are less likely to get sick.
    I think Europe is right on in their focus on prevention, and the US is being its typical self in its treating of the symptoms. And, I’ve worked with small local producers all over the country, and it seems to me that if we provided a framework of standards for how our livestock is raised (provided the creation of this framework wasn’t influenced by Big Ag lobbiests, and focused on the establishment of a healthy diet and pasture-based systems) most local producers would have relatively few changes to make, while the CAFOs would have to make some serious adjustments.

  • mrothschild

    Nell: Yes, E. coli O157:H7 in raw milk products can come from cows that are entirely grass fed or grain fed, and outbreaks involving O157:H7 have come from small and large producers alike. Animals that carry the bacteria are not sick, they shed the bacteria in their feces. Preventing E. coli in raw milk or other foods, as you suggest, means making sure that the food does not become contaminated with fecal matter. That’s the aim of the U.S. food safety laws.

  • Doc Mudd

    Hi Nell. Here’s your answer:
    http://www.slate.com/id/2242290/
    I think Bill Marler once wrote a factual literature review, as well. Maybe someone has the link?
    The gist; nope, e coli doesn’t discriminate among cows, what they prefer to eat, what color they are, or the political leanings of their caretakers.
    E coli isn’t very discerning, but you and I need to be when it comes to information and ‘things that everyone knows’ that we might encounter on the internet. Turns out your generic worries about CAFOs and herd size are basically Kool-Aid induced hallucinations, too. I will admit, the internet echo chambers sound remarkably convincing and strident, especially considering they eminate from ignorant duffers who are stuffed so full of silly poop they can’t think straight.

  • http://www.marlerblog.com bill marler

    Here is the original article:
    http://www.marlerblog.com/lawyer-oped/grass-fed-vs-grain-fed-beef-and-the-holy-grail-a-literature-review/
    I am in the process of updating it and in exploring the common belief that E. coli O157:H7 came from CAFOs.
    Tune in.

  • Doc Mudd

    Exhaustive laboratory studies since the mid 1990s indicate E. coli O157:H7 evolved from an ancestor coliform responsible for human infantile diarrhea. Along the way it has populated livestock; cattle have become an important reservoir and a common source of human exposure owing to the prominence of cattle in our food chain.
    One can directly associate E.coli O157:H7 with livestock and can also, of course, directly associate livestock with CAFOs, but any association of E. coli O157:H7 with CAFOs would be indirect, at best. To conclude that “CAFOs caused E.coli O157:H7″ would be incorrect – such a conclusion would amount to irresponsible junk science.

  • Mary Rothschild

    Nell: Yes, E. coli O157:H7 in raw milk products can come from cows that are entirely grass fed or grain fed, and outbreaks involving O157:H7 have come from small and large producers alike. Animals that carry the bacteria are not sick, they shed the bacteria in their feces. Preventing E. coli in raw milk or other foods, as you suggest, means making sure that the food does not become contaminated with fecal matter. That’s the aim of the U.S. food safety laws.

  • Allison Hamlin

    The 60-day aging minimum for raw milk cheese presents problems for stakeholders on both sides of the fence. Clearly, it doesn’t satisfy the “reasonable certainty” test required of die-hard safety advocates, and producers continue to chafe at the arbitrary restriction, particularly in light of recent FDA murmurings about increasing the aging time. It’s not simply a question of aging practices that would reduce the instance of foodborne pathogens, but rather a reevaluation of the cheesemaking process as a whole and assessing hazard points along the way. (See Bill Marler’s piece for a comprehensive overview of the literature and history associated with raw milk cheesemaking: http://www.marlerblog.com/uploads/image/cheese%20piece%20Final%20updated%2012_18_10.pdf ) As HACCP plans, safety education, herd management, environmental testing, record keeping, third party certification and active relationships with regulators and researchers is currently the approach of many cheesemakers producing raw milk cheeses (the American Cheese Society estimates that 63% of their members voluntarily follow these best practices http://www.cheesesociety.org/wp-content/uploads/2011/02/ACS-Statement-on-Safe-Cheesemaking-for-Web.pdf ), perhaps it would be best to transition these guidelines into enforceable policy, supplanting the 60-day regulation with a more targeted system of controls.
    While I agree that the EU’s food system, and thus, approach to food safety differs from the model in the US, it does seem valid to take a comparative approach in order to assess potential ways in which to tailor any potential policy to supplant the aging minimum. (See the DBIC’s helpful comparative evaluation of international requirements for raw milk cheeses here http://www.dbicusa.org/documents/Raw%20Milk%20Cheese%20Legislation%20PDF.pdf ). From these regulatory trends, there are ample levels of risk-management to choose one adequate for the scale and concerns of our industry and consumers.
    The raw milk dilemma is here to stay. Consumers are intrigued by the minimal amount of processing (perhaps as a result of a sense that large-scale processed food is of increasingly questionable safety), and are looking for “authentic” sensory experiences. Dairy producers see the non-commodity pricing of raw milk as a way to add value to a profession with high overheads and low rates of return. Cheesemakers see these cheeses as expressions of the product and the process, and many have won national and international awards doing so. Perhaps a thoughtful evaluation of the intent of 21CFR133 (especially under the “proactive” and “preventative” provisions of the new Federal Safety Modernization Act of last year) is merited in order to move forward with legislation that is current, effective and appropriately tailored to the problem.