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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 posi-
tive 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 Febru-
ary 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

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