Updates, Winter 2010
by Pete Kennedy, Esq.
President, The Farm-to-Consumer Legal Defense Fund
FDA, the center of the opposition to raw milk in this country, is now taking aim at raw cheese. The agency is involved in two enforcement actions against raw cheesemakers, which threaten to reduce significantly the availability of raw artisanal cheese in the US. The FDA has long wanted to extend the aging requirement for raw cheese from sixty to ninety days (a number of European countries have no aging requirement for raw cheese), but its actions in the case of Morningland Dairy of Mountain View, Missouri and Estrella Family Creamery of Montesano, Washington are an indication the agency has the potential to make it difficult for any artisanal cheesemaker to remain in business. Resolution of the Morningland and Estrella cases will impact freedom of food choice everywhere in this country.
Morningland Dairy cheese was seized by both FDA and the California Department of Food and Agriculture (CDFA) in the June 30, 2010 raid on the Rawesome food store in Venice (see Wise Traditions Fall 2010 issue for background on the raid). In August, CDFA informed the Missouri State Milk Board that samples of Morningland cheese had tested positive for Listeria monocytogenes and Staphyloccocus aureus. It should be noted that L. mono is widespread in the environment and many subtypes of this bacteria have not been implicated in human illness. Staph. aureus is present normally on everybody’s skin and is considered protective. Most subtypes of this organism do not produce the toxin, although some subtypes can occasionally cause vomiting. Gastrointestinal illness from Staph. aureus is self limiting, meaning medical treatment is not necessary.
The evidence is that the procedures the agency used in taking the cheese from Rawesome and recording the test results were sloppy at best.
On August 26, the Milk Board issued Morningland orders not to ship any cheese at the facility and to cease all production. On August 27, Morningland sent cheese samples off for testing. Unfortunately, as in California, proper protocols were not followed in taking the samples. A number of the samples came back positive for L. mono and Staph. aureus.
On August 31, Joe and Denise Dixon, owners of Morningland, issued a voluntary recall asking their customers to either destroy or return over sixty thousand pounds of cheese produced from January 1, 2010 onward. (On August 27 FDA had sent out a press release as the Dixons had not yet decided whether to issue a recall.) From August 30 through September 1, FDA conducted an inspection of the Morningland facility, taking one hundred environmental swabs, all of which tested negative for pathogens.
On September 24, the Milk Board verbally requested that Morningland destroy the entire cheese inventory; the Dixons asked that the request be put in writing, which was done on October 1. Morningland responded by objecting to the destruction order and proposing that each batch at the facility be tested, allowing the sale of only those batches of cheese testing negative for contamination.
The next day, the Milk Board rejected the Dixons’ proposal, petitioning the Howell County Court to order destruction of the entire inventory; the hearing was scheduled for October 8, giving the Dixons almost no time to prepare a defense, and was only cancelled when a scheduled state witness was not able to attend. On October 22 the Milk Board again filed a petition for a condemnation order; a hearing on the petition has been scheduled for January 11. If the Court issues the condemnation order, Morningland would be required to destroy fifty thousand pounds of cheese (market value of about two hundred fifty thousand dollars) located at Morningland’s cheesemaking facility.
There have been no reported illnesses from the consumption of cheese produced by Morningland. In fact, there have not been any cases of illness attributed to Morningland products in the thirty years of its existence. The Dixons have a loyal following and sell to hundreds of retail stores across the country as well as direct to consumers through their mail order business. As of the beginning of December, Morningland had not produced any cheese in over two months.
What is unjust about the actions taken against Morningland is that there has not been an adequate level of proof shown to establish that the bacteria found in the cheese are actually harmful to human health. There are many subtypes of L. mono and Staph. aureus; as mentioned above, many of these subtypes have not been found to cause illness in humans. The agencies have the capability to determine the subtype of a pathogen found and to determine whether that particular subtype is on record as having caused human illness; if the subtype has not, then there is no adulteration and no need to destroy the product.
The Milk Board, which is working at the direction of FDA, has not conducted any testing to determine the subtype. Once the agency had the initial positive tests from CDFA and the Dixons, it should have done subsequent testing for the subtype. Even if the subtype is known to cause illness in humans, it still needs to be determined whether the amount of bacteria in the food is enough to actually do so. FDA has a zero tolerance policy for L. mono, a standard widely rejected by the scientific community throughout the world. The zero tolerance policy, in fact, reduces the incentive to test for L. mono., thus potentially making our food supply less safe.
Washington--Estrella Family Creamery
In February 2010, Estrella Family Creamery received a call from the Washington State Department of Agriculture (WSDA) informing them that a wheel of Estrella cheese purchased at a retail outlet tested positive for L. mono. After a follow-up visit to the Estrella facility by WSDA inspectors turned up more positive results for L. mono in sampled cheeses and in the environment, the owners, Anthony and Kelli Estrella, issued a voluntary recall for several different cheeses. They also threw out thousands of dollars in cheese inventory. They then took about a month off from making cheese to work on a physical upgrade to the facility. After the dairy resumed production, WSDA returned to the facility and took thirty environmental swabs with one of them testing positive for L. mono. The inspectors were not concerned about the positive test, telling the Estrellas, “Listeria is everywhere, you will never totally eradicate it but you have to control it.”
From the time Estrella reopened until August, no cheese, produced post-recall, tested positive for any pathogen. Then FDA stepped into the picture; on August 2, FDA officials showed up to conduct a three-day inspection. They took 151 environmental swabs, four of which tested positive for L. mono (including one on a ceiling switch far from any cheese and another outside the cheese room on a slider door track). After the inspection, the FDA inspectors discussed the results with the Estrellas; they did not indicate that the swabbing or inspection results were unacceptable nor did they use language describing the facility as filthy or unsanitary. They only suggested some minor changes to be made in the facility’s operation.
During a subsequent visit on August 16, an FDA investigator collected a sample of cheese that was also found to be positive for L. mono. The sample came from Cave Three (Estrella has four cheese caves) which was the area where the dairy had the most problems in February. FDA claimed their testing showed that the strain of L. mono found in February at the facility and the strain found in the testing conducted there in August were “indistinguishable”. On August 30 Estrella took cheese samples for testing, four of which came back positive for L. mono; all four were from Cave Three. On September 3, the agency requested that Estrella recall all cheese products. The Estrellas declined the request; however, the company destroyed all cheese located in Cave Three.
On September 4, FDA issued a press release advising consumers that “consumption of all Estrella Creamery cheeses puts them at risk for L. mono related illnesses.” On October 21 the U.S. Marshall Service executed the seizure order issued by a federal district court against the entire inventory of raw cheese located at the creamery; the order was issued on the grounds that the cheese was adulterated since it had “been prepared, packed, and held under unsanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health” in violation of the Federal Food, Drug and Cosmetic Act. As much as 80 percent of the “seized” inventory consisted of long-aged cheeses (such as gruyere and cheddar) that do not support the growth of L. mono. None of these long-aged cheeses at the facility had ever tested positive for L. mono. A court hearing will be held to determine whether the cheese should be destroyed.
There have never been any reported illnesses from the consumption of cheese produced by Estrella in its seven years of operation. Anthony and Kelli Estrella have won numerous awards domestically and internationally for the quality of the cheese they produce. Estrella had halted all cheese production since mid-August. None of the environmental or cheese samples that tested positive for L. mono. has been tested to determine the subtype.
Under the Federal Food, Drug and Cosmetic Act, if a food contains a subtype of L. mono (or of any other pathogen) that is not found to have been harmful to human health, then the food is not “adulterated”; if the subtype of L. mono found in an environmental swab is one that has not been shown to cause illness in humans, then there should be no finding of adulteration. If the cheese can be destroyed just on the basis of an initial positive test for L. mono, then Estrella, like Morningland, is being denied due process.
Catherine Donnelly, co-director of the Vermont Institute for Artisan Cheese of the University of Vermont, commented, “If the FDA wanted to shut down the U.S. artisan industry, all they’d have to do is this environmental surveillance (testing for Listeria in cheese plants) and the odds of finding a pathogen would be pretty great. Is our role to shut these places down or help them?” (William Neuman, “Small Cheesemaker Defies F.D.A. over Recall”, New York Times, November 19, 2010)
For small food producers, one recall or destruction order can put them out of business. Due process of law needs to be upheld to protect producers from the reign of terror FDA is waging against farmstead cheese operations; otherwise, FDA will continue to go unchecked after raw dairy producers who have harmed no one with their products—working toward the agency’s eventual goal of eliminating access to raw dairy.
On September 17, U.S. District Court Judge Mark W. Bennett issued an order staying any judicial proceedings in the lawsuit challenging the interstate ban on raw milk for human consumption (see Wise Traditions Spring, Summer and Fall 2010 issues for background on the case). Under the order, proceedings were stayed until FDA answered several questions referred to it by the judge. The questions were, “whether § 1240.61 (the federal regulation banning raw milk for human consumption in interstate commerce) applies to and proscribes the conduct of the following situations:
- persons who travel from one state, where it is not legal to purchase raw milk, to another state, where it is legal to purchase raw milk, legally purchase raw milk, then return to the original state where they consume the raw milk themselves or give it to their friends or family members; or
- a principal and agent who agrees that the agent will obtain raw milk out-of-state, where it is legal to do so, and deliver it to the principal in the principal’s home state, where sales of raw milk are not permitted, where the principal then consumes the raw milk or gives it to their friends or family members; or
- a producer of raw milk who sells raw milk in a state where it is legal to do so in an intrastate transaction to persons that he knows are from out of state.”
All of the individually named plaintiffs in the lawsuit fit into one of the three scenarios described above. FDA has until March 17, 2011 to file its answers to the judge’s questions.
Good news from Pennsylvania! On October 7, the Pennsylvania Independent Regulatory Review Commission (IRRC) met to vote on whether to approve dairy regulations proposed by the Pennsylvania Department of Agriculture (PDA). The proposed regulations contained burdensome requirements for raw milk producers including two particularly onerous provisions. First, the regulations would require a mechanical bottling machine for producers; with a limited exception, handcapping would be prohibited.
Second, bottling, single-service container storage, and bottle washing would need to be done in rooms other than the milk room; currently, many raw milk producers in Pennsylvania bottle and handcap in the milk room and would have needed to incur the expense of constructing a separate room. Moreover, bottle washing would not be allowed in the room devoted to bottling and storage.
Often, bodies such as the IRRC simply rubber-stamp proposed regulations into law with minimal debate. Not this time. Tom Maurer, president of CARE (Communities Alliance for Responsible Eco-agriculture), and Bryan Snyder, the Executive Director of PASA (Pennsylvania Association for Sustainable Agriculture), rallied their respective members against the proposed regulations. At the October 7 meeting, Snyder did a great job in explaining to the IRRC how PDA was misleading them when describing the effect the new regulations would have on raw milk producers. The committee chair for the IRRC pointed out that raw milk regulations should not be combined with Pennsylvania’s adoption of the Pasteurized Milk Ordinance (also known as the PMO), which is mainly what the proposed regulations had to do with. The IRRC voted three to two to reject the proposed regulations.
On November 22, PDA submitted a revised version of the disapproved regulations to the IRRC. Although mechanical bottling and capping would not be required for milk sold on the farm, this would still be required for raw milk sold in retail stores. The revised regs still require that the washing of returnable bottles occur in a room separate from the milk room. Another provision that requires the raw milk producer be responsible for the costs of all pathogen testing (currently the testing is paid for by PDA) remains in the latest version of the regs. IRRC was scheduled to meet on December 16 to vote on whether to approve the revised regulations.
On November 8, raw milk farmer Michael Schmidt issued the “Edmonton Declaration” on the steps of the Alberta Legislature. The declaration is a call to arms for the raw milk movement in Canada. It states, “I [Schmidt] am here to mark this day as a turning point. A turning point because we the farmers, we the consumers, we as concerned people of Canada, are officially rejecting those who pass regulations without respecting our fundamental rights, our fundamental freedom to be and act as responsible individuals. We openly challenge and reject those who blindly enforce unjust laws . . . We reject the assault on small farmers under the pretense of food safety threats. We reject Government protection in regards to our individual food choices and our individual health treatment choices. We reject the criminalization of those who make informed decisions. . . I am calling on farmers and consumers alike to join in to openly challenge our bureaucrats and put our elected officials to task.”
In the declaration, Schmidt mentioned Cow Share Canada, an organization founded by him with a mission to develop raw milk standards, train and accredit raw milk farmers and protect those farmers from government attacks. Schmidt vowed that if any Province “engages in new court actions or physical attacks against cow share operators without any respect for the individuals’ choice of food and due legal process, I will once again enter into a hungerstrike to activate and encourage more and more people to openly join this battle for our fundamental rights and freedom to choose our food and our health.”
Schmidt went to the province of Alberta to support the cow share program, Beulah Novelty Food Coop. On October 26, Judith Johnson, the operator of Beulah, had been assaulted in an Edmonton church parking lot by an inspector from the Alberta Department of Agriculture and Rural Development who physically tried to force his way into Johnson’s van. The inspector was unsuccessful but Johnson subsequently let him and other government officials search the van after being told by them, “We will break your windows or seize your vehicle if you do not open the door.” The officials found and seized raw milk intended for Beulah’s shareholders, with the inspector telling Johnson that she would be getting nothing back and that they would be going out to her farm to charge her with violating the law. The night of the incident, Johnson was hospitalized.
Shortly after the raid, Alberta Health Operations ordered Johnson and her business partner, Henry Pudlow, to cease operations, claiming the milk seized had high bacteria counts and was unsafe for human consumption. Schmidt initially supported Beulah but withdrew his support on November 10 after visiting to inspect the cow share program and finding violations of standards set by Cow Share Canada. Johnson and Pudlow said they plan to restructure their operation to comply with the organization’s standards.
Earlier in the year, Schmidt on behalf of Cow Share Canada had taken over management of the Home on the Range cow share program in British Columbia after the herd manager, Alice Jongwarden, had been found in contempt of a court order prohibiting the distribution of raw milk for human consumption. After the order, Jongwarden had continued to distribute raw milk to the shareholders, with each jar of milk carrying a sticker with the words, “Not for Human Consumption.” On December 2, the Supreme Court of British Columbia upheld the contempt ruling but did not penalize Jongwarden, finding that since she had stopped her production and distribution of raw milk products (Schmidt had taken over management), she had “purged her contempt” and a penalty was not necessary. The Home on the Range cow share program is still continuing under Schmidt’s management.
For the latest developments on raw milk issues, go to www.farmtoconsumer.org
Those who have not joined the Farm-to-Consumer Legal Defense Fund are encouraged to do so. Membership applications are available online at www.farmtoconsumer.org or by calling (703) 208-FARM (3276); the mailing address is 8116 Arlington Blvd, Suite 263, Falls Church, VA 22042.
Pete Kennedy is an attorney from Sarasota, Florida and president of the Farm-to-Consumer Legal Defense Fund (www.farmtoconsumer.org). He compiled the state milk laws posted at realmilk.com. He advises many farmers and members about legal issues surrounding raw milk.
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