California State Bill 201 - Raw Milk
Governor Arnold Schwarzenegger
Sacramento, CA 95814
RE: SB 201
I am writing to you because I have grave concerns with a bill which will soon be 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.
William D. Marler
- 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)
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