Yesterday I hammered away on what seems to me to be Estrella Family Creamery’s inconsistent position between fetal death by abortion and the possibility of fetal death by Listeria. Some of the commentators see that as being unfair given that there are no reported fetal or other deaths linked to Estrella cheeses. True enough, but remember, the incubation period for Listeria can be as long as 70 days and most fetal deaths are simply left in the unknown category.
Other commentators felt that it was simply unfair to simply go after a small family farm run by nice people. I suppose that those would have liked my post of Sangar whose plant was shuttered after being linked to several illnesses and four to five deaths.
Bottom-line, I do not think big or small producers should get a free pass. Especially in the case where there is a Warrant and a Complaint. Below are some of the key points in the Affidavit against Estrella Family Creamery. When I get Sangar’s, I’ll post them too.
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.
- I am a Compliance Officer with the Food and Drug Administration (“FDA”), United States Department of Health and Human Services.
- 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.
- 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.
- Estrella Family Creamery, LLC (“Estrella”) is a small family dairy that manufactures and sells specialty aged cheeses made from raw cow and goat milk.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- On September 3, 2010, the agency requested that Estrella recall all cheese products. The firm declined.
- 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.
- 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.
- 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.