The Facts:

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.
 

  • Jennifer

    How about some real journalism. How about you be the first journalist who is not pro-raw milk to do some foundational research on listeria in pasteurized milk. After researching the numbers of infected dairies, correlate those numbers with how many dairies have had to recall, or close, and how many people were ill due to listeria. That would be refreshing.

  • Approx. 71% of foodborne illnesses which have been linked by laboratory to dairy products are linked to raw dairy. Considering that about 99% of dairy consumed in the US is pasteurized, I believe you get a pretty clear picture of the disproportionate contribution that raw dairy makes.

  • Andrew J Krueger

    It should be noted that Listeria is ubiquitous in the environment. If a microbiologist wished to “isolate” listeria, one could do so just from about anywhere one wished, including from pasteurized milk. Pasteurization (as defined by Grade A Pasteurized Milk Ordinance (PMO)) reduces numbers of listeria individuals but does not generally eliminate it. Isolation and culturing of listeria from a source doesn’t tell us much. It would be meaningful to have a figure of concentration, like individuals/mL, but isolation and culturing alone doesn’t tell us much about risk posed.
    It would be rather interesting indeed if the same stringent testing protocols were enforced for pasteurized dairies as for raw dairies. What incidence of listeria would we find, and at what concentrations?
    Now, please don’t group me in with raw milk zealots, or pasteurization zealots. I’m just saying that from a scientific perspective, being able to culture ANY listeria doesn’t tell us much about the potential risk in the foodstuff. And I would contend that it would be RARE to find a pasteurized milk product from which you could NOT isolate and culture listeria.

  • Doreen

    If you look into listeria m in any depth, you will find that there are at least 13 subtypes that have been serotyped and ONE of those makes people ill. The fear over listeria m may seem warranted, but in light of the fact that almost all Eurpoean countries allow 100 cfu’s in raw dairy and that there have been NO illnesses associated with close to 99% of listeria m recalls, I think the actual science behind the detection of listeria and the hype surrounding the detection of listeria are fear driven, superstition based, unscientific, control and destruction methods.
    Look over Marler’s listeria blog and find all the illness reports.
    Remember, the FDA who implemented the zero-tolerance for listeria m, took 30 years to figure out that vitamin C was helpful in fighting the common cold. They aren’t exactly quick to acknowledge that they don’t have the science on things ‘down to a science’.

  • Graham

    Jennifers statement does not make any since, this is not a pro-raw milk journalist and every person has the right to a safe product regardless if its raw milk or pasteurized. Estrella Family Creamery had know many times that there products had issues and they refused to do anything about it. If the firm had be responsible as they clam to be and cleaned up their act and made a recall this would not have been a problem. Other firms being irresponsible has nothing to do with Estrella Family Creamery, this journalist did their homework and is a great article. Estrella Family Creamery owner has still yet to take responsible for her actions and just post a pity me statment that people have the right to choose there own food. which is true if the firm was providing safe food, or at least warning customers that their food was unsafe. Estrella Family Creamery got exactly what they deserve….

  • “Pasteurization (as defined by Grade A Pasteurized Milk Ordinance (PMO)) reduces numbers of listeria individuals but does not generally eliminate it.”
    I believe the CDC would beg to differ. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001316.htm
    By inoculating raw milk with L. mono, and then pasteurizing the milk, numerous studies have found that pasteurization eliminates L. mono unless the level of inoculation is artificially high.
    “In another study in which investigators identified cows that had been naturally infected with L. monocytogenes, proper pasteurization was found to inactivate L. monocytogenes in milk contaminated through natural infection as well as in artificially inoculated milk.”
    The recent WHO conclusion? “…pasteurization is a safe process which reduces the number of L. monocytogenes occurring in raw milk to levels that do not pose an appreciable risk to human health”.

  • Andrew J Krueger

    Michael,
    Nowhere does that article mention that “pasteurization eliminates L. mono.” In fact, it is a summary of studies, and makes reference to assertions that pasteurization does not necessarily make milk safe from listeria, though the authors of the summary conclude this is not the case. The essence of my argument was that there is specificity lacking in the information provided as to concentration. If you wish to engage my logic directly, it would be appreciated.
    However, there certainly have been listeria infections from pasteurized milk. I don’t disagree that pasteurized milk is generally safe, but I would suggest that the FDA does not present a complete scientific basis on which to judge the safety of these milk products. Again, I would love to see some test results from a wide array of pasteurized and aged cheeses. I think the likelihood is that isolation would be possible from over 50%.
    Anyone with a lick of sense is aware that the FDA does not make judgments strictly on safety, but rather that industry influence is significant in their actions. This is true for most government regulation and legislation. Look at cannabis. Unsafe, right? Bullocks.

  • Andrew J Krueger

    Michael,
    One more thing. I agree that, as you state, raw milk contributes disproportionately to food illness. I would generally not buy raw milk, as there are simply too many ways for it to easily become contaminated. Mainly in handling, cooling, shipping, etc. I don’t feel that raw milk itself is unsafe, but rather that the likelihood that it becomes compromised (either due to the initial health of the animal or due to improper handling leading to bacterial bloom) is high. Mainly this is because most farmers attempting to sell raw milk are over-worked and underpaid, and dealing with marginal equipment and less than ideal circumstances generally. This is not aided by the regulation nor by other factors that generally stack the deck in favor of large farms over small.
    That said, I milk a goat and drink her milk, make cheese and yogurt from it, all raw. Her hairs fall in the milk and I strain them out. I’ve washed her with iodine so I’m not too worried.
    I’ve been to the Estrellas’ farm and seen them milk and make cheese. I’ve been in their cheese caves. A good friend and old neighbor of mine sold them one of their cows. Now, they’re not the best at caring for animals, but they are excellent at making cheese. Would I eat their cheese? Hell yes. I would not eat a lot of other raw dairy but I would happily eat theirs. Their sanitation is more than adequate and as I said before, we don’t really know the listeria count in their products, nor that in other pasteurized products. But you can look in any microbiology text and read that listeria is UBIQUITOUS. Like most bacteria, it takes a significant number to get you sick, unless you are already compromised. That is what is missing here: a scientific understanding of the microbial ecology around us, and the will to apply such to the subject at hand.
    Phew.

  • I’m going to keep it simple.
    Pasteurized milk can become contaminated after the pasteurization process. However, pasteurization reduces the number of Listeria mono. All L. mono can be eliminated if the levels of L. mono prior to pasteurization are not unusually high.
    The article I cited:
    “In one study using milk artificially inoculated with L. monocytogenes, investigators found that 0.9 seconds at 71.7 C is needed for each one log10 reduction in the number of L. monocytogenes organisms.”
    High-Temp Short Time pasteurization lasts 15 seconds. That’s 13.5 log10 reduction.
    “Since the concentration of L. monocytogenes likely to be present in contaminated raw milk is estimated to be approximately 10 organisms per mL, these data suggest that there is a substantial margin of safety in the HTST pasteurization process”
    The New England Journal of Medicine:
    “…a large inoculum would be necessary before survival of any organisms during pasteurization would be expected…”
    As far as the test results from a wide array of pasteurized products?
    The WHO reports on two studies conducted within the US involving pasteurized retail milk. The combined likelihood of this product containing L. mono was 0.0036%.
    In contrast, two USDA studies of raw milk in the Pacific Northwest found a L. mono presence in 4.9% and 7.0% of samples. Cornell University found the percentage of sampled raw milk tanks that contained Listeria to range between 2.73% and 4.6%.
    Whatever the number, 2.73 or 7.0, we can clearly see that pasteurization results in a much lower percentage of positive L. mono tests (0.0036%). About a 500% reduction in contaminated samples.
    http://books.google.com/books?id=090gYDBgqPEC&pg=PA92&lpg=PA92&dq=listeria+in+pasteurized+milk+prevalence&source=bl&ots=lTGMYt8T2g&sig=HGLT_tPgSGsDcFL6Vx4cXMIChKI&hl=en&ei=awTLTN3yIsKqlAfb59mgAQ&sa=X&oi=book_result&ct=result&resnum=1&ved=0CBMQ6AEwAA#v=onepage&q=listeria%20in%20pasteurized%20milk%20prevalence&f=false
    http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=143589
    foodscience.cornell.edu/…/RAW-MILK-MQIP-Position-Statement-01-09.doc
    As far as the specific counts for Estrella Creamery, I am not aware of the exact numbers.
    I would hope you would be appreciative of the risk Listeria poses to those members of your community who do have less hardy immune systems. Your own bravado in regards to Estrella Creamery’s contaminated facility does not justify putting the life of a child or any other individual at risk.

  • MJ Raichyk

    Kudos to the sparring efforts of Andrew and Michael for their entertaining displays of skill, but the key seems to be in Doreen’s hands as she points out that there’s ONLY ONE kind of this fabulous germ that causes damage and TWELVE OTHER FAMILY MEMBERS who seem quite sensible citizens with humans. And since there are no claims of damage to humans in this whole mess of fear-mongering, clearly the evil ‘twin’ is not in the cheesemakers’ operation AND SO THE FDA GESTAPO and their pawns SHOULD GO BACK TO THEIR ANXIETY CLOSET AND GIVE UP THEIR GUNS. And NOT be allowed to make these cheesemakers commit business suicide.

  • And yet, Estrella Creamery tested positive for a persistent strain of Listeria monocytogenes. This is the microorganism that is associated with listeriosis and “is more likely to cause death than other bacteria that cause food poisoning”.
    People can be carriers of this bacteria for a lengthy incubation period and suffer serious effects, pass it on, or suffer from only mild symptoms. It is not yet known whether any individuals became ill or will become ill because of Estrella Creamery’s L. mono. Everyone (including these cheesemakers) should be thankful if the problem was caught in time and no illnesses occur.
    Invoking imagery of Nazi Germany and referencing an organization guilty of systematic genocide is disrespectful to the millions of people who lost their lives in concentration camps and ghettos, as well as the lives of Americans who died opposing the Third Reich. You’d do well to have some grasp on the nature of Listeria monocytogenes and the context of the situation before wading into such heavy seas.