On February 28 attorneys for Kelli and Anthony Estrella―owners of Estrella Family Creamery (Estrella) and the United States Department of Justice filed a motion in the Ninth Circuit Court of Appeals to voluntarily dismiss the Estrella’s appeal of a lower court ruling permanently enjoining Estrella from selling cheese and giving FDA authority to inspect the facility as well as empowering the agency to set the conditions on which Estrella could resume cheese sales. FDA had shut down Estrella in 2010 for positive pathogen tests at a time when the creamery was on its way to resolving whatever issues it had by working with the Washington State Department of Agriculture (WSDA). Estrella had been in negotiations with FDA since the court ruling over the terms enabling it to resume its cheese operation; Estrella was trying to limit FDA jurisdiction over it by doing business only in intrastate commerce. Financially strapped and frustrated over the FDA’s refusal to give specific answers on what the limits of the agency’s jurisdiction would be, Kelli and Anthony decided to move on, putting their farm up for sale and ending a long battle with FDA.
Tami Parr, a past president of the Oregon Cheese Guild, commented in an Oregon Live interview on November 5, 2012, that Kelli Estrella “made some of the best cheeses that the Pacific Northwest has seen in modern times.” Estrella won numerous domestic and international awards for the quality of its cheeses. Raw cheese consumers have suffered a major loss.
One of the greatest injustices ever perpetrated by the government against a raw dairy producer continued when a federal district court judge, Benjamin H. Settle, granted a motion for summary judgment filed by the United States on behalf of the U.S. Food and Drug Administration (FDA) against Estrella Family Creamery (“Estrella”) permanently enjoining Kelli and Anthony Estrella from selling cheese. The judge’s ruling gives FDA the authority to conduct inspections of the Estrellas’ facility and allows the creamery to resume cheese sales only if it meets numerous and burdensome requirements imposed by the agency.
In October 2010, when FDA executed a seizure order against Estrella, the agency embargoed all cheese stored at the creamery facility on the grounds that the cheese was adulterated since some of the cheese produced by Estrella had tested positive for listeria monocytogenes earlier in the year. While the Estrellas conceded the government was entitled to a judgment against the creamery for producing adulterated food based on the positive pathogen tests, they sought a remedy in which the creamery would only be subject to FDA’s jurisdiction if the creamery engaged in interstate commerce; therefore, if the creamery were to reopen for business, the Estrellas planned to sell only within the state of Washington and obtain all ingredients it used within the state.
In granting the government’s request to have free rein to inspect the Estrellas’ cheese business, Judge Steele held that “the inspection authority needed by the government to ensure that the Defendants are complying with the terms of the injunction should be more extensive than the statutory authority granted the Government to determine whether the Federal Food, Drug and Cosmetic Act . . . is, in fact, being violated.”
Adding insult to injury, the judge issued a condemnation order against the seized cheese and awarded FDA costs associated with the condemnation when the agency hadn’t spent a dime on the actual destruction of the seized cheese.
The Estrellas had already destroyed the cheese in the winter of 2011 after FDA did not respond to requests from their attorney to get rid of the product. At the time of its destruction, the cheese had long passed its shelf life and, therefore, was considered by the Estrellas to be a health threat.
Judge Settle’s decision means the Estrella Family Creamery will remain shut down, possibly permanently. Estrella has won numerous domestic and international awards for the quality of its cheeses and has never been accused of making anyone sick. The creamery does not have resources to comply with the requirements FDA will impose and wants nothing more to do with an agency that has single handedly put it out of business. The Estrellas are appealing the judge’s decision.
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.