On October 21, 2010, the US Government filed a complaint for forfeiture in rem (meaning, a legal action to seize and condemn violative products) of raw milk-based cheese products manufactured by Estrella Family Creamery in Montesano, Washington. The government’s complaint identifies Estrella cheese products as having the potential to be contaminated by Listeria monocytogenes, a bacteria that can cause severe illness in human beings, including death in unborn children, the elderly, or people with compromised immune systems. Finally, the government’s complaint was filed only after the FDA requested that Estrella recall all of its cheese products, which Estrella declined to do.
Post complaint is where the facts end and opinions and rhetoric begin. Some comments are important, in some senses, and obviously true, like that the Estrellas are good people who do not want or intend their products to cause illness or death, which would be both bad for business and contrary to the principles by which the Estrella family obviously live their lives. Many other comments from various corners, including the Estrellas themselves, are totally Irrelevant and only serve to perpetuate the view that certain raw milk devotees, including many producers whose products have sickened and killed people, can’t see the forest for the trees. We are only a few months removed from the Hartmann debacle, where a Minnesota raw milk farmer fought the good fight, in his view, against indisputable evidence gathered by arguably the most competent health agency in the world. These attempts to control the moral and scientific high-ground are as pathetic, in the face of competently gathered evidence, as they are, ultimately, totally misguided and wrong.
So where is the reason in the debate over the current raw milk-based debacle in Montesano? One place it doesn’t seem to be is in all the post-complaint rhetoric. Neither God, nor guns, nor local versus monolithic agriculture really matter at all. Each producer of food must be judged only by the quality of his products.
Again, The Facts:
The affidavit (see full affidavit below) filed in support of the government’s complaint against Estrella states that, in February and March 2010, listeria monocytogenes was isolated from finished cheese samples, salt brine used in the production process, and "throughout the production and storage areas." On August 2, the FDA lab isolated listeria monocytogenes from processing and aging rooms at Estrella, including one room where cheese was being actively cut and wrapped for sale to consumers. On August 16, a sample of "Caldwell Crick Chevrette" tested positive for listeria monocytogenes. Notably, the August 16 positive test was generated from cheese produced on April 27, and was ready for sale and consumption in August. Finally, FDA’s PFGE analysis showed that the February and August samples contained identical strains of listeria monocytogenes.
The gist of the evidence is that Estrella had a problem that went uncorrected and thus posed a continuing threat to consumer health. This was not a facility that produces a product with a very finite shelf life. Some cheeses are aged for two months, and some, evidently, for up to six months. Notably, we are only a little more than two months removed from the last positive test in Estrella products and, again notably, the August and February tests were positive for an identical strain of listeria monocytogenes. Estrella had a problem in its production processes that it did not, or could not, control.
In this situation, reason lies only in the facts. The FDA has a public health mandate, and it must act to protect the public health (whether it does so indiscriminately is another matter altogether). Fortunately for Estrella, it is now in an adversarial process where it will have the opportunity, in court, to prove that seizure and forfeiture of its products is unwarranted, and that the government is, in fact, incorrect.
AFFIDAVIT OF LISA ELRAND
IN SUPPORT OF VERIFIED COMPLAINT FOR FORFEITURE IN REM
I, Lisa Elrand, hereby verify and declare under penalty of perjury that the following is true and correct to the best of my knowledge.
1. I am a Compliance Officer with the Food and Drug Administration (“FDA”), United States Department of Health and Human Services.
2. I have read the foregoing verified Complaint for Forfeiture In Rem and know the contents thereof; the information contained in the Complaint has been furnished by official government sources; and, based on information and belief, the allegations contained in the Complaint are true.
3. The sources of my knowledge and information and the grounds of my belief are the official files and records of the United States, as well as my investigation of this case, together with others, as a Compliance Officer with FDA.
4. Estrella Family Creamery, LLC (“Estrella”) is a small family dairy that manufactures and sells specialty aged cheeses made from raw cow and goat milk.
5. On February 1, 9, and March 1, 2010, the Washington State Department of Agriculture (“WADA”) collected finished cheese products, salt brine solution, rennet and environmental samples at Estrella. FDA has since determined that Estrella purchases rennet, which is a component of all Estrella cheese products, from a company located in Madison, Wisconsin. The state’s laboratory analyses of the samples collected from Estrella revealed the presence of Listeria monocytogenes (“L. mono”) in the finished cheese, in the salt brine solution, and throughout the production and storage areas. L. mono is an opportunistic pathogen capable of causing the illness listeriosis, which can result in death, especially in aged, infirm, very young, or immunocompromised individuals. As a result of the WADA’s discovery of L. mono, Estrella initiated recalls of several cheese products on February 10, February 15, and March 5, 2010.
6. On August 2, 2010, FDA initiated an inspection of Estrella and collected several environmental samples and finished cheese products. FDA laboratory analyses of these samples revealed the presence of L. mono in the processing areas and aging rooms, particularly Cave 3. Investigators observed finished product being cut and wrapped in the cheese room where L. mono had been detected.
7. During this inspection, the firm disclosed that it tested its products for Listeria between March 2010 and May 2010, and that a sample collected on March 2010 tested positive for L. mono.
8. During an August 16, 2010, visit, an FDA investigator collected a sample of “Caldwell Crik Chevrette” cheese that was made on April 27, 2010. One of the owners of Estrella told the FDA investigator that the product was part of Estrella’s commercial inventory of product, ready to be distributed. FDA laboratory analysis revealed that the sample tested positive for L. mono.
9. FDA analysis using Pulsed Field Gel Electrophoresis (“PFGE”) revealed that L. mono isolates obtained from FDA environmental samples collected on August 2-3, 2010, an FDA finished product sample collected on August 16, 2010, and finished product samples collected by the WADA in February 20 I0 were indistinguishable both by a primary and secondary enzyme. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source (i.e., from the facility and the products therein), it is highly likely that the two isolates are the same strain of L. mono, and that L. mono may have been transported throughout the facility and established niche areas. The presence of a persistent strain of L. mono in the facility over time is significant in that it demonstrates that sanitation efforts were inadequate to remove this pathogenic organism.
10. On September 1, 2010, the FDA and the WADA initiated the most recent inspection of Estrella. During this inspection, Estrella provided laboratory reports that revealed product it sampled on May 28, June 15, June 26, June 29, July 8, and August 30, 2010, had tested positive for L. mono. Investigators also found three paper-wrapped cheeses labeled “FDA sample, do not sell” stacked together on an aging shelf that appeared to be the three remaining cheeses from the lot that was sampled by FDA on August 16, 2010 and tested positive for L. mono. Estrella had previously informed FDA that cheese had been destroyed. The presence of the contaminated cheese presents an additional potential source of contamination.
11. Also during the September 1, 2010, inspection, FDA investigators observed that employees did not take necessary precautions to protect against contamination of food contact surfaces. Most significantly, the owner was observed tasting the cheese and placing the uneaten portion back into the cheese wheel. Conditions similar to those observed during the previous August 2010 inspections were also observed during this inspection.
12. On September 3, 2010, the agency requested that Estrella recall all cheese products. The firm declined.
13. On September 4, 2010, FDA issued an FDA News Release advising consumers that consumption of all Estrella Creamery cheeses put them at risk for L. mono related illnesses.
14. During FDA’s inspections of Estrella, FDA investigators also observed insanitary conditions in the production areas including tape and peeling paint on cheese press handles; flying insects and spiders on the walls and ceiling of the milk room vestibule and in the cheese processing room; and uncovered whey collection tank located against the exterior wall of the processing facility; milk residue build-up on the whey discharge sink, and rough bare wood shelving covered with cheese product residue in the cheese aging areas.
15. In short, the persistent presence of L. mono in both product and environmental samples from Estrella and the insanitary conditions repeatedly observed by FDA investigators causes all food articles held at Estrella to be adulterated.