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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Raw Milk Debate Continues with SB201

Dear Senator,

I am writing to you because I have grave concerns with a bill currently before you – SB201. I urge that you vote against the bill as written.

Raw milk is at the center of a nationwide controversy over its potential value as a nutritional food versus the severe illnesses that can result from contaminated product. Pasteurization was developed to rid dairy products of pathogens like toxic E. coli as well as to assure a longer, safer shelf life (see attached History of Raw Milk). Raw milk tainted with E. coli O157:H7 has already sickened children in this state. Today a woman lies in a hospital in Northern California on a ventilator after consuming raw milk contaminated with Campylobacter. If a product as potentially dangerous as raw milk is to be legally sold to the consumer, regulation must be air-tight, and penalties for violations must be enforceable by regulators charged with protecting the public health.

SB 201 as currently written has the following fatal flaws:

1) HACCP – The bill proposes that raw milk be regulated by a HACCP protocol. HACCP—Hazard Analysis Critical Control Point—is a food safety and self-inspection system that describes procedures for producing potentially dangerous foods. There are national HACCP protocols in place for juice, meat, poultry, and seafood processing, but none for raw milk. Developing a HACCP protocol can take years, even when the industry being regulated agrees with the government assessments of risk. Companies will be free to produce raw milk under minimal regulation until the HACCP plan is ready. Further, the bill specifically precludes CDFA from taking action on high coliform counts even if coliform testing was determined to be part of the approved raw milk HACCP plan.

2) SSOP – HACCP plans do not necessarily include sanitation procedures and environmental monitoring. This is the purview of the SSOP (Sanitation Standard Operating Procedure), which is absent from SB201. Mandating HACCP without mandating SSOP is a half measure, at best.

3) Enforcement is not spelled out in the current version of the bill. Not what would happen to a producer who broke the HACCP protocols (when in place) nor to repeat violators.

4) Colostrum (Also called first milk, this is the milk produced in pregnancy and right after birth. It is high in carbohydrates, protein, and antibodies and low in fat.) The current bill does not even address this ‘growth area’ of raw products. Under the bill, unregulated colostrum could be sold and marketed as a stand-alone product, in a raw colostrum/milk mixture, or as an ingredient in other foods.  There is no scientific reason to treat colostrum differently from raw milk. Omitting colostrum from SB 201 would allow a producer to add a small amount of colostrum to raw milk, label the product as colostrum, and sidestep the intent of the new law. (At least one California raw milk company has already used this work-around to circumvent federal law prohibiting interstate shipment of raw milk to consumers. http://www.organicpastures.com/faq.html – item #14.)

5) Pathogen Regulation – the bill prevents CDFA from taking regulatory action on the detection of pathogens unless the amount is “sufficient to cause illness in humans.” This leaves the door wide open for argument about what level of verotoxigenic E. coli, Salmonella, Campylobacter or Listeria is necessary to cause disease.  Legislators must not tie the hands of CDPH and CDFA by limiting their enforcement powers to an undefined amount “sufficient to cause illness in humans.”

• The minimum infectious dose for many pathogens depends on several factors including (a) the infectivity and virulence of the specific strain, (b) the size, age, and immune-competent status of the victim, (c) foods ingested along with the pathogen, and (d) compounding factors such as the use of antacids.

• It is often technically difficult to detect the presence of a pathogen in a random sample of ‘finished product.’ Even in a fluid like raw milk, the pathogens are not likely to be uniformly distributed throughout a production lot. The probability that a certain level of pathogen will be found by product testing is very low—unless the contamination is very high. Rather than a vague standard of sufficient to cause illness in humans,” SB 201 should mandate a zero tolerance rule for any level of infectious bacterial pathogen.

6) Ban the sale of raw milk from cows with symptoms of clinical mastitis – Milk and colostrum are virtually bacteria free when they leave the udder, except in the case of an animal suffering from clinical or sub-clinical mastitis. Cows with mastitis shed bacteria—E. coli and Staphylococcus aureus, among others—into their colostrum and milk, and no raw milk should be sold from them. This is not addressed in SB201.

7) Standard plate count – SB 201 should not eliminate the mandated 15,000 per milliliter standard plate (or bacteria) count limit for grade A raw milk. The existing law, AB1735, mandates both coliform limit and a bacterial count limit for raw milk. SB201 not only offers a way for raw milk dairies to opt out of the total coliform limit, but in doing so, it emasculates the standard plate count provision of AB1735 by prohibiting the use of standard plate counts for enforcement purposes.

• Most pathogens –E. coli O157:H7 being a notable exception—are not coliforms, and most coliforms are not pathogens. At best, the coliform group of bacteria can be viewed as an indicator of possible environmental contamination or temperature mishandling of raw milk.

• Coliforms began their role as “indicator” bacteria as a stand-in for direct detection of pathogens in potable water. This test was chosen for convenience. When drinking water monitoring began, direct enumeration of E. coli – a surrogate for potential Salmonella contamination – was a long and costly process.

• Dairy microbiologists adopted coliforms – a group of microbes that are both prevalent in the environment and are heat-sensitive – as a convenient indicator of inadequate pasteurization and of post-process contamination. The ease, convenience, and low cost of coliform enumeration also added to the popularity of this test. Nevertheless, the presence of coliforms in pasteurized milk was not viewed as direct indicator of the presence of a pathogen; rather, an elevated coliform count was looked upon as an indicator of something having gone wrong in the manufacturing process.

• While a coliform standard makes sense in pasteurized milk, the decision to apply a coliform test to raw milk is questionable, at best. Many of the bacterial contaminants and most of the pathogens that have been reported in raw milk are non-coliforms. An elevated “total” bacterial count would be at least equally effective as an indicator of unsanitary practices or poor temperature control.

8) SB201 does not reiterate requirements carried forward from existing laws.

• SB201 does not provide guidance on what requirements must be met for retail raw milk and raw colostrum under the follow circumstances: (a) while a dairy’s HACCP plan is under development or under revision as the result of a suspension or revocation of approval, (b) while a dairy’s HACCP plan is under initial review by CDFA and/or CDPH, (c) in the event that CDFA and/or CDPH suspends or revokes its approval of a dairy’s HACCP plan, or (d) while a suspension or revocation of a dairy’s HACCP plan is under appeal. Under these circumstances, a dairy that has opted for the HACCP alternative might be considered to be exempt from the coliform rule even when an approved HACCP plan is not actively in place.

• SB201 should be amended to incorporate explicitly all of the provisions Sections 33527, 35783, 35783.1, 35861 and 35891 of the Food and Agricultural Code, and should state unequivocally that the standard plate count, somatic cell count and coliform count limits are enforceable unless an approved HACCP plan is in place and has been implemented by a dairy farm that produces and processes raw milk.

9) Unanswered questions – critically important issues which are either not addressed or not clearly spelled out:

a) What tests would be used? Screening, confirmatory, or both?

b) How sensitive and specific are the tests to be used?

c) Do the tests need to be approved by the AOAC or other equivalent certifying body?

d) Why only test bi-weekly for E. coli O157:H7? The last raw milk recalls were due to Campylobacter and Listeria contamination.

e) What happens if no quick test is approved to detect E. coli O157:H7 in raw milk?

f) Is the tested product held until the results are in? If not, why not?

g) What happens if a test is positive? Total product recall? What protocol?

Senator, I urge you to vote against this bill. It is vitally important to have regulation in California on raw milk, but approving this bill will set flawed and unfinished processes into law. We urge you to press for clarity, detail, and precision in a final version that will regulate the raw milk industry from the moment it is signed into law, rather than the current version, which only passes the difficult decisions into other, unknown hands.

Attachments:

•    Peer-reviewed literature – Pro
•    Peer-reviewed literature – Con
•    CDC list of outbreaks associated with unpasteurized milk or cheese, 1973-2007
•    History of Raw Milk
•    Escherichia coli O157:H7 Infections in Children Associated with Raw Milk and Raw Colostrum from Cows – California, 2006  (CDC-MMWR)

References:

1.    Barbano, D.M., Y. Ma, M.V. Santos. 2006. Influence of Raw Milk Quality on Fluid Milk Shelf Life. J. Dairy Sci. 89(E. Suppl.):E15-E19.

2.    Berriatua, E., I. Ziluaga, C. Miguel-Virto, P. Uribarren, R. Juste, S. Laevens, P. Vandamme, J.R.W. Govan. 2001. Outbreak of Subclinical Mastitis in a Flock of Dairy Sheep Associated with Burkholderia cepacia Complex Infection. J. Clin. Microbiol. 39:990-994.

3.    Christen, G.L., P.M. Davidson, J.S. McAllister, L.A. Roth. 1992. Chapter 7. Coliform and Other Indicator Bacteria. In: Standard Methods for the Examination of Dairy Products, 16th edition (R.T. Marshall, ed.). American Public Health Association, Washington, DC.

4.    Corlett, D.A., Jr. 1998. HACCP User’s Manual. Aspen Publishers, Inc., Gaithersburg, MD.

5.    Entis, P. 2007. Appendix A. A Microbial Who’s Who. In: Food Safety: Old Habits, New Perspectives. ASM Press, Washington, DC.

6.    Holm, C., L. Jepsen, M. Larsen, L. Jespersen. 2004. Predominant Microflora of Downgraded Danish Bulk Tank Milk. J. Dairy Sci. 87:1151-1157.

7.    Hutchison, M.L., D.J.I. Thomas, A. Moore, D.R. Jackson, I. Ohnstad. 2005. An Evaluation of Raw Milk Microorganisms as Markers of On-Farm Hygiene Practices Related to Milking. J. Food Prot. 68:764-772.

8.    International Commission on Microbiological Specifications for Foods. 1986. Microorganisms in Foods. 2. Sampling for Microbiological Analysis:Principles and Specific Applications, 2nd ed. University of Toronto Press, Toronto, Canada.

9.    Jay, J.M. 2000. Chapter 20. Indicators of Food Microbial Quality and Safety. In: Modern Food Microbiology, 6th ed. Aspen Publishers, Inc. Gaithersburg, MD.

10.    Jay, J.M. 2000. Chapter 25. Foodborne Listeriosis. In: Modern Food Microbiology, 6th ed. Aspen Publishers, Inc. Gaithersburg, MD.

11.    Jay, J.M. 2000. Chapter 28. Foodborne Gastroenteritis Caused by Vibrio, Yersinia, and Campylobacter Species. In: Modern Food Microbiology, 6th ed. Aspen Publishers, Inc. Gaithersburg, MD.

12.    Jayarao, B.M., and L. Wang. 1999. A Study on the Prevalence of Gram-Negative Bacteria in Bulk Tank Milk. J. Dairy Sci. 82:2620-2624.

13.    Kornacki, J.L., and J.L. Johnson. 2001. Chapter 8. Enterobacteriaceae, Coliforms, and Escherichia coli as Quality and Safety Indicators. In: Compendium of Methods for the Microbiological Examination of Foods, 4th edition (F.P. Downes & K. Ito, eds.). American Public Health Association, Washington, DC.

14.    Murphy, R.Y., and R.A. Seward. 2004. Process Control and Sampling for Escherichia coli O157:H7 in Beef Trimmings. J. Food Prot. 67:1755-1759.

15.    Stewart, S., S. Godden, R. Bey, P. Rapnicki, J. Fetrow, R. Farnsworth, M. Scanlon, Y. Arnold, L. Clow, K. Mueller, C. Ferrouillet. 2005. Preventing Bacterial Contamination and Proliferation During the Harvest, Storage, and Feeding of Fresh Bovine Colostrum. J. Dairy Sci. 88:2571-2578.

16.    Tamplin, M.L. 2005. Inactivation of Escherichia coli O157:H7 in Simulated Human Gastric Fluid. Appl. Env. Microbiol. 71:320-325.

  • mark mcafee

    Bill,
    SB 201 requires all of the pre January 2008 standards to apply including a low SPC.
    Under SB 201 all raw milk must have a lower SPC than the maximum allowed after proper pasteurization.
    In your critique you are mistaken. SPC is still a requirement and the state can and will degrade raw milk that is found to be out of compliance for SPC of more than 15000. This has been the law for years and years.
    When statign facts please be very careful to be accurate.
    Current law also allows milk intended to be used for pasteurization to be sold to a dairy that bottles raw milk and that raw milk can be sold as raw. This comingling is illegal under SB 201.
    SB 201 is good law, is needed to protect food safety, our raw milk consumers and the producers themselves.
    Mark McAfee

  • http://www.marlerblog.com Bill

    The provision for a SPC limit of 15,000 in final raw product was included in the 06/05/2008 version but had been deleted in the 06/16/2008 version.
    http://www.leginfo.ca.gov/cgi-bin/postquery?bill_number=sb_201&sess=CUR&house=B&author=florez

  • Amanda Rose

    Dear Mark,
    You mentioned to me a number of times in person that it is illegal to outsource raw milk under the Food and Ag Code (contrary to your posting here). My reading of the code seems to support your past statements, though I am not a legal expert. I assume this is why you have stated publicly (Apr 15) that outsourcing the cream in Sep 2007 was “illegal” and you made a mistake. Cream falls under the same code as raw milk in this regard.
    Butter does not appear to have the same restrictions which is why you continued to buy product for butter and bring it to your farm in the bulk tanks I saw last fall.
    Colostrum does not have the same restrictions because it is not even a dairy product.
    SB 201 addresses nothing but “raw milk,” just like current Food and Ag Code. There is no new protection in this bill against outsourcing for consumers.
    In any case, your bill has a lot of support and if it does pass, you can use this Marler letter as your cheat sheet for ideas to avoid regulation. If your milk gets degraded in the meantime, you could always add 5% colostrum to it and sell it as “super leche” for $2 more a gallon wholesale. Not bad.
    Amanda

  • LowCountry Gal

    This is not the first time (in the face of raw milk causing illness and death) that California has been divided on this issue.
    During the 1980s with Stouvie brothers & AltaDena someone was 158 times more likely to develop a Salmonella dublin infection if they were a raw milk drinker.
    http://www.cdc.gov/mmwr/preview/mmwrhtml/00000318.htm
    By way of background: Salmonella dublin is a host-adapted strain of the species which can be excreted directly in the milk with no apparent illness in the cow. In this respect AltaDena cows were similar to Mary Mallon (aka Typhoid Mary) the first person in the United States to be identified as a healthy carrier of typhoid fever (Salmonella enterica ). Over the course of her career Mary infected 47 people, three of whom died.
    If you compare the letters and testimony from the AltaDena era with the blogs of today, it’s like watching a play you saw years ago, with the same parts, the same lines, on the same stage.
    Mark McAffee is playing Stouvie’s role and FDA, CDC, raw milk consumers and the State Department of Ag are all reprising their roles.
    Unless you want to have this argument all over again two years from now it would be best to settle this now.
    Certainly your 10 coliform limit does offer some protection for susceptible population, but there remain loopholes in the proposed legislation that the state’s Governor could drive a Humvee through – which would keep raw milk a very, very dangerous product.
    There might be some willingness to compromise on the 10-coliform limit IF an adequate sanitation program (including verification testing) was approved in a true HACCP plan.
    It would, however, be the responsibility of the HACCP plan author to prove to the state regulatory agencies that whatever sanitation standards they are proposing are supported by science and industry experience in other food commodities.
    But based on the philosophical position exhibited by some raw milk producers throughout the country, I suspect it will take months or years before a raw dairy HACCP plan gets approved anywhere.
    Until that time California’s current sanitation standards are really the only thing you have protecting children.

  • Kyra

    Someone sent me this fascinating story by Nicholas Grube, reporter with the Triplicate.
    http://www.triplicate.com/news/story.cfm?story_no=9874
    He interviews people who in the face of an outbreak, continue to support consumption of raw milk for “health benefits.” The dairy voluntarily shut down a “cow share” program upon learning of the outbreak. An intriguing quote from his article: “She [raw milk consumer] is just one of many people in Del Norte County who are seeking alternative sources of raw, unpasteurized milk since the dairy voluntarily shut down its program due to an outbreak of the bacteria Campylobacter that may have infecting up to 15 people who drank the milk.
    Bill, what’s up? You cited a compelling report out of Stanford about risks to the milk supply (http://www.marlerblog.com/2008/08/articles/lawyer-oped/who-poisoned-our-peppers/) if a terrorist used botulinum toxin as a weapon in a recent twist on the “tainted pepper” story.
    Most agree that “poisoned milk” would cause great “terror,” and create havoc for public health officials, law enforcement, etc. Although botulism is considered a “class A” agent, the assumption is that even Salmonella, Campylobacter, E. coli O157, or other more prevalent disease causing agents would result potentially in huge panic by the public if intentionally introduced into our food supply.
    So…million dollar question…any ideas why individuals and communities in this growing movement to shun safeguards like pasteurization would intentionally seek out raw milk for themselves and their children that is known to be risky?
    .

  • Alicia

    All raw foods, meat, celery, lettuce have similar potential to carry these bacteria.
    Raw milk, fruits, sprouts and vegetables are important sources of ENZYMES that naturally aid digestion and metabolism. The process of pasteurization kills those beneficial enzymes. It’s not the same as beneficial bacteria, such as yogurt contains.
    All I needed to cure acidity was to limit the amount of cooked food in my diet. A glass of raw milk cures heartburn on the spot as well as IBS and obesity over time. When milk is heated the fat molecule breaks down differently in the body than raw milk fat does.
    I’d rather remove the true cause than treat the known results of an acidic, always cooked, diet with antacids.
    Nescience, not science is fueling the raw milk scare. We simply have to be as careful as we are supposed to be with fresh eggs, raw fish, etc, etc.
    It is already safe to buy, sell and drink raw milk. The intent of SB 201 is to increase that safety even more.

  • Lorin Partain

    Welcome to fascist America ! Where a diary farmer who sells a product that people want and are willing to buy is not allowed to because it threatens his larger competitors who offer an inferior product. So they hire their shyster lawyers, like this guy, to come after said dairy farmer, by means of the government to shut him down before he becomes too successful and the flood can’t be held back anymore, forcing them to change their practices. If you thought we lived in a Capitalist society, then you might need to think again. No free market here that I can see.

  • Daniel Rold

    This is a load of crap. All major food outbreaks of salmonella in recent times have been attributed to pasteurized milk. For every raw milk contributed disease there are a hundred for pasteurized milk. What about all the problems with digestibility, allergies, lactose intolerance, food sensitivities, and physical degeneration attributed to pasteurized milk? Pasteurization was enacted because in the early 19th century dairy producers where starting to change the process by which they raise dairy cows ($$) and the quality of the life of the animal declined as did the quality of the milk (of course its going to make you sick, moron). This was done to save money. You can’t get a healthy food from a sick animal. So the solution should have been to go back to healthy animals but instead you pasteurize the milk. That doesn’t clean it or make it healthy (saves $$). It just ensures that the negative effects are delayed and therefore cannot be conclusively scientifically validated due to the many contributing factors that limit the reliability of the pinpoint scientific process. Now if you think pasteurization is a solution just think…all those pathogenic bacteria that you were worried about are still in the milk. You haven’t cleaned them out. Instead, now their exploded bodies are strewn throughout that disgusting milk your drinking. And the low quality of the horrific conventional farms is still there with robine growth hormone (why your daughters are reach puberty earlier along with soy baby formula), antibiotics (no other way to keep them barely alive), unnatural food sources (cows have five stomach specifically evolved to eat grasses not corn), no sunlight (they live their whole lives inside small pens), and no movement (they don’t go outside or take a walk, imagine what you would look like, (or do look like)). Delicious! And you think you have an argument? No you have money and power. But the power is in the people and we recognize you for what you are: Your a piece of shit with no morals and no humanity.