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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