The following news release was issued today by the US Department of Justice, US Attorney's Office for the Western District of Washington
FOR IMMEDIATE RELEASE
October 25, 2010
FEDS SEIZE PRODUCT FROM MONTESANO DAIRY ADULTERATED DUE TO THE PRESENCE OF A DANGEROUS PATHOGEN
District Court Judge Approves Seizure after Repeated Tests Show Listeria Monocytogenes
The U.S. Marshal’s Service seized all cheese products at Estrella Family Creamery (Estrella) in Montesano, Washington, Thursday, October 21, 2010, after repeated tests by the U.S. Food and Drug Administration (FDA) and Washington State Department of Agriculture (WADA) over the last several months showed the persistent presence of a pathogen, Listeria monocytogenes, in Estrella’s cheese products and facilities. The pathogen can cause the illness listeriosis which can be life threatening for the aged, infirm, very young or immune compromised individuals. The pathogen can be especially dangerous for pregnant women. U.S. District Court Judge Benjamin Settle authorized the seizure.
According to the FDA affidavit filed in U.S. District Court in Tacoma, the WADA collected samples of cheese and cheese ingredients from production areas at the farm on February 1st, 9th, and March 1, 2010. Testing revealed the presence of Listeria monocytogenes in the cheese, in the salt brine used in processing the cheese, and in production and storage areas throughout the farm. Estrella recalled a variety of cheeses in February and March 2010 following the test results.
In August, the FDA inspected the farm, collecting a new set of samples. The samples revealed the presence of Listeria monocytogenes in the production space and aging rooms. Further, Estrella’s owners revealed that their own tests between March and May 2010, showed the presence of Listeria monocytogenes in certain cheese products. On August 16, 2010, an FDA sample of “Caldwell Crik Chevrette,” that was ready to be shipped to customers, tested positive for Listeria monocytogenes. FDA testing revealed the Listeria monocytogenes pathogen found in August was indistinguishable from the pathogen found in March, indicating Estrella had not remedied the insanitary conditions found by the WADA in February and March 2010.
On September 3, 2010, the FDA asked Estrella to recall all cheese products. The company refused. The FDA issued a warning to consumers regarding the potential presence of Listeria monocytogenes in Estrella cheese on September 4, 2010.
Under the warrant signed last week, Estrella’s cheese products were seized to prevent the sale and dissemination of adulterated and potentially contaminated food.
The seizure is a civil action undertaken by the FDA. Assistant United States Attorneys David East and Kerry Keefe are handling the matter for the U.S. Attorney’s Office.
What prompted FDA to take this drastic action?
- Estrella has an embedded Listeria monocytogenes contamination that it could not (I won't say "would not") eliminate.
- In August, FDA found Listeria monocytogenes in a sample of cheese that was ready to be shipped to customers.
- The Listeria monocytogenes strain found in August by FDA was identical to the strain that the FDA and the Washington State Department of Agriculture found six months earlier – in February of this year – further indicating that Estrella had not solved its contamination problem.
- Estrella refused FDA's request to recall its products after the August detection of Listeria monocytogenes.
- Listeria monocytogenes infections can be deadly for susceptible members of the population, including the elderly and the very young.
Contrast this situation with the recent swift action that the Texas Department of State Health Services (DSHS) was able to take when confronted with a Listeria monocytogenes outbreak. The state agency had the power to mandate the closure of the chopped celery producer that was linked to the illnesses, and to insist upon the recall of potentially contaminated food.
FDA is not infallible, and I don't always agree with its actions. But an agency that is charged with protecting the health of 310+ million people must err on the side of public safety. Due to the lack of mandatory recall authority, FDA's hands were tied for six weeks, while the Department of Justice petitioned the US District Court for permission to seize the "...adulterated and potentially contaminated food." During those six weeks, Estrella's customers were at risk of contracting an infection with Listeria monocytogenes – one with potentially deadly consequences.
Mandatory recall authority for FDA is long overdue. It can – and must – be enacted during the fall "lame duck" session of Congress.
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I totally agree, Phyllis. It's long overdue -
ReplyDeleteThank you for this article and the many others.
Let's see... in Texas, there were serious ILLNESSES that proved the testing was accurate and sampling done right. In Estrella, the current FDA testing and sampling showed this "danger" existed for NINE MONTHS BUT NO ILLNESSES! Not even minor?
ReplyDeleteThat says that the FDA's case is SUSPICIOUS. This is quite clearly a case of something else going on.
@Dectiri.-Let me get this straight. Are you suggesting that it takes an outbreak of "serious illnesses" to prove that a food is contaminated? What about prevention?
ReplyDeleteListeria monocytogenes is a two-faced pathogen. It causes very mild gastrointestinal symptoms in the average, healthy individual. It causes serious illnesses, and a relatively high death rate (compared, for example, to Salmonella) in the elderly, young children, pregnant women and other people with compromised immune systems. The contaminated celery in Texas was supplied to schools and to nursing homes. Ten illnesses were confirmed during an eight month period. Five people died.
Had the Estrella cheeses been supplied to a similar population group rather than being sold at farmers markets, I would suggest to you that there would have been a similar pattern of illnesses.
BTW, time after time, it has been demonstrated (usually by population interviews during outbreak investigations) that most minor foodborne illnesses go unreported.
I prefer preventing outbreaks, rather than using them to confirm the existence of a food contamination problem.
Phyllis
Might it be possible that there is another side to this story? The Estrellas did earlier voluntarily recall cheeses that tested positive. The fact that contradictory professional laboratory test results exist indicating the cheese was safe was sadly not mentioned anywhere in either your post or this press release.
ReplyDeleteFDA currently is shutting down many small dairies and artisan cheesemakers nationwide without openly sharing their testing information. It is a gross oversimplification to believe that enabling the FDA to have manditory recall authority will achieve anything positive for food safety.
And, should the Estrella family demonstrate their cheese is without contaminants, there will be no repair of their reputation offered by the FDA or the press and no compensation for the loss of income should the cheese be ruined or not returned.
This is not as simple a matter as your post makes it seem....
I agree with auburnmeadowfarm. We all know that honey should not be given to infants, yet it continues to be sold. Why not label raw milk, aged cheese as a food to be avoided by certain people and let me take my risks and enjoy cheese with flavor? P.E., you want "food as safe as we can make it?" Sterilize it all? Do you have any information about LM deaths in France and/or their testing/monitoring protocols? I think it would add much to this discussion. Barb Schoos, still eating my EFC stash.
ReplyDelete@Barb.- It's not about whether or not the cheese was made using raw milk. It's about lack of sanitation and the potential for contamination of the cheese during handling and storage. Please read my follow-up article, posted yesterday evening.
ReplyDeletehttp://efoodalert.blogspot.com/2010/10/estrella-cheese-raid-its-not-about-raw.html
I agree that information from France (and from other countries and regions) would add to the discussion. I am hoping to post an additional follow-up in the next few days. I am aware, for example, of a lethal outbreak of Listeria monocytogenes in 2008 that was linked to the consumption of cheese in the province of Quebec (Canada).
Phyllis
Phyllis
ReplyDeleteThanks for your blog. Your article and comments are sane and fair. It would seem that people are very protective of small producers which I appreciate, being one myself. Perhaps Supporters of Estrella should volunteer to help them clean up their facility. That would go a lot farther than complaining about the regulations in place.
As a producer of raw milk products I must have extremely high standards for cleanliness and be diligent with milk testing, facility sanitation, and aging room cleanliness. It seems our goal as producers should be to create safe products not to attempt to disprove regulatory findings.
@Anonymous.-Thank you for offering my readers the perspective of a raw milk product producer who strives for high standards. I wish that all producers, both large and small, shared your goal.
ReplyDeleteBest wishes,
Phyllis