BILL ANALYSIS
SB 201
Page 1
Date of Hearing: June 24, 2008
ASSEMBLY COMMITTEE ON HEALTH
Mervyn M. Dymally, Chair
SB 201 (Florez) - As Amended: June 18, 2008
SENATE VOTE : Not relevant
SUBJECT : Dairy farms: raw milk: testing: standards.
SUMMARY : Establishes the Fresh Raw Milk Act of 2008 to require
raw milk dairy farms that choose to comply with the requirements
of this bill to develop and maintain an individualized Hazard
Analysis Critical Control Point (HACCP) plan, as specified.
Specifically, this bill :
1)Requires a dairy farm that produces and processes raw milk to
develop and maintain an individualized HACCP plan for each
critical process in the production and processing of raw milk
on the dairy farm.
2)Defines a "dairy farm that produces and processes raw milk" as
a vertically integrated operation that includes a dairy farm
and processing plant owned and operated by the same entity
that produces guaranteed raw milk, or Grade A raw milk, to be
sold to the consumer.
3)Requires the HACCP plan to be approved or rejected by the
California Department of Food and Agriculture (CDFA) and the
State Department of Public Health (DPH) within 60 days of
receipt.
4)Requires, if the plan is not accepted, CDFA, in consultation
with DPH, to provide a written statement of the reasons for
not approving the plan.
5)Specifies that a raw milk dairy farm that complies with this
bill must comply with the plan as approved by CDFA and DPH.
6)Requires any material change to an approved plan to be
approved by CDFA and DPH prior to implementation pursuant to
#3) and #4) above.
7)Allows a third party specializing in the auditing of HACCP
plans that has been approved by CDFA to conduct audits of a
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raw milk dairy farm pursuant to this bill to ensure compliance
with the plan, and requires the results of the audits to be
transmitted electronically as specified.
8)Requires a raw milk dairy farm that has implemented a HACCP
plan to provide HACCP plan training for employees working in
the production and processing of raw milk and requires the
training provided to be documented as specified.
9)Requires a laboratory approved by CDFA to verify a HACCP plan
prior to its implementation and requires the laboratory
verification to be maintained with the HACCP plan for the
duration of its implementation.
10)Directs the entity operating the raw milk dairy farm pursuant
to a HACCP plan to designate at least one person to be
responsible for verification of the plan and provide specified
HACCP plan training to that designated person.
11)Specifies that HACCP plan training records for the designated
person must be retained for the duration of employment or a
minimum of two years, whichever is greater.
12)Requires the raw milk dairy farm to maintain all calibration
records relating to specified monitoring equipment for a
minimum of two years.
13)Permits CDFA, in consultation with DPH, to suspend or revoke
its approval of a HACCP plan without prior notice for
specified reasons.
14)Specifies due process procedures available to a raw milk
dairy farm that has been notified in writing that its HACCP
plan has been suspended or revoked.
15)Prohibits a raw milk dairy farm from receiving any raw milk
from a non-raw milk dairy farm.
16)Requires a raw milk dairy farm to have its raw milk tested
twice per week by a state accredited laboratory for specified
bacteria and a standard plate count from a location deemed
appropriate by CDFA and requires the results to be transmitted
electronically as specified.
17)Requires, with certain exceptions, the data and results from
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the tests conducted pursuant to #16) above to be used for
informational, not enforcement, purposes only.
18)Requires a raw milk dairy farm to have its raw milk sampled
and tested at least once per month by the CDFA for specified
bacteria that cause illness in humans and requires CDFA to
deem raw milk containing an amount of any such bacteria
sufficient to cause illness in humans as nonconforming.
19)Specifies that CDFA may take raw milk samples from a location
it deems appropriate.
20)Prohibits a raw milk dairy farm that complies with the
requirements of this bill from being required to comply with
bacteria standards established in existing law.
21)Requires a raw milk dairy farm to notify CDFA in writing of
its intent to comply with the requirements of this bill at
least 30 days prior to submitting any information required by
this bill.
22)Requires a raw milk dairy farm that does not choose to opt in
to the requirements of this bill to comply with bacteria
standards established in existing law.
EXISTING FEDERAL LAW prohibits the introduction into interstate
commerce of any unpasteurized milk product in final package form
that is intended for human consumption.
EXISTING STATE LAW :
1)Establishes the Milk and Dairy Food Branch within CDFA to
inspect dairy farms and milk processing plants, and collect
samples of milk and milk products for safety and compliance
with microbial and compositional requirements.
2)Establishes the Infectious Disease Branch within DPH to
conduct investigation, surveillance, prevention, and control
of general communicable diseases of public health importance,
including food-borne, water-borne, and vector-borne diseases.
3)Authorizes DPH to quarantine, isolate, test specimens,
inspect, and disinfect persons, animals, homes, and other
property when DPH determines that these actions are necessary
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to protect or preserve health.
4)Requires raw milk that is sold to the public to meet a
microbial standard of 10 coliform bacteria or less per
milliliter.
5)Requires the health of the cows of raw milk dairy farms to be
determined at least once per month by an official
representative of a milk inspection service approved by CDFA.
6)Requires raw milk to be sold to the consumer within 30 hours
after production and labeled to indicate the date of the sale
to the consumer.
7)Requires, in regulations, raw milk and raw milk products to
bear the following warning: "Raw and raw milk products may
contain disease-causing micro-organisms. Persons at highest
risk of disease from these organisms include newborns and
infants; the elderly; pregnant women; those taking
corticosteroids, antibiotics, or antacids; and those with
chronic illnesses or other conditions that weaken their
immunity."
FISCAL EFFECT : Unknown. The Senate Appropriations Committee
analysis is not relevant to the current version of this bill.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, current law
requiring raw milk to test at or below the limit of 10
coliform bacteria per milliliter is too restrictive and will
result in driving California's two raw milk dairies out of
business and removing the availability of raw milk on store
shelves. The author asserts that the 10 coliform count is
impossible for these particular dairies to meet consistently
because coliform bacteria are regularly present in the
environment and in cows and the nature of their business
requires the milk to be in an unpasteurized state.
Furthermore, the author contends that the 10 coliform standard
is largely a measure of sanitation and less a measurement of
the presence of harmful bacteria. Consequently, the author
states that this bill proposes a more effective but less
restrictive approach to sanitation and microbial standards by
requiring raw milk dairies that choose to opt in to develop
and maintain a HACCP plan to address every critical process on
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the dairy. The author adds that this bill also subjects raw
milk dairies to rigorous testing absent in current law by
requiring them to submit samples to independent and
state-approved laboratories at least twice per week.
2)COLIFORM . According to CDFA, coliforms are a group of
bacteria commonly found in the environment, including soil,
surface water, vegetation, and the intestinal tracts of
warm-blooded animals. Most coliforms do not cause disease,
but a small percentage, including E. coli, salmonella,
listeria, and campylobacter, can cause illness in people,
especially young children, the elderly, and those with
weakened immune systems. Since most coliform bacteria are not
harmful, the finding of coliforms in milk does not necessarily
mean that a disease causing, or pathogenic, form of the
bacteria is present. However, elevated coliform counts in
milk and dairy products suggest unsanitary conditions exist
during production, processing or packaging. In the dairy farm
setting, a coliform count is a useful indicator of the extent
of fecal bacteria in the milk, and is a recognized index of
the level of sanitation at a facility.
CDFA states that the process of pasteurization easily kills
coliform bacteria in dairy products. Therefore, according to
CDFA, the finding of coliforms in pasteurized products
indicates some level of contamination has occurred after
pasteurization during product manufacturing or packaging. For
milk sold raw, where no intervening pasteurization step is
utilized, CDFA indicates that coliform counts reflect
sanitation practices throughout milk handling, from the cow to
final bottling. In addition to food safety and public health
concerns, coliforms, along with other bacteria, may produce
off flavors in milk and reduce shelf life of dairy products.
CDFA advises that strict sanitary practices be followed to
minimize the risk to people consuming raw milk products,
including thorough cleansing and sanitization of all the
milking system equipment, proper herd health maintenance,
proper hygiene control for employees, sufficient refrigeration
for proper cooling and storage, and cross-contamination
prevention.
3)BACKGROUND LITIGATION . AB 1735 (Committee on Agriculture),
Chapter 339, Statutes of 2007, establishes a limit of 10
coliform bacteria per milliliter of raw milk that is sold to
consumers. After the bill became law, opposition, including
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the state's two raw milk producers and raw milk consumers,
came forward and raised concerns that this standard could not
be met and consumers may not have access to raw milk. In
March 2008, the Hollister Superior Court in San Benito County
granted the state's two raw milk dairy operators, Claravale
Dairy, Inc., and Organic Pastures Dairy Company, LLC., a
temporary restraining order (TRO) enjoining and barring CDFA
from using the 10 coliform count as a measure in raw milk
production based on arguments from the dairy operators that
the new standard is unnecessary and raw milk naturally
contains helpful bacteria that neutralize harmful bacteria.
However, in May 2008, the court denied a request by the dairy
operators for a preliminary injunction to continue prohibiting
the state from enforcing the 10 coliform standard for raw milk
and ordered the earlier TRO dissolved after the state argued
that it had a rational basis for establishing the standard in
AB 1735 in order to protect the public from food-related
illness.
4)RECENT RECALLS . In September 2006, CDFA announced a
statewide recall and quarantine order of raw milk produced by
Organic Pastures in Fresno County. Under the recall, all
Organic Pastures whole and skim raw milk was pulled
immediately from retail shelves. The quarantine order came
following a report that raw milk caused bacterial illness,
identified as E. coli, in a 10-year old girl and a subsequent
investigation by DPH (formerly the Department of Health
Services) detected two additional bacterial illnesses in
children consuming raw milk. Epidemiologic data collected by
DPH at the time pointed to a link in all three cases with
Organic Pastures raw milk but, according to CDFA, laboratory
samples of raw milk from the dairy did not detect E. coli
contamination. In September 2007, CDFA issued an order to
withdraw Organic Pastures raw cream from retail distribution
when listeria bacteria was detected as a result of product
testing conducted as part of routine inspection and sample
collection at the facility. According to Organic Pastures,
the cream was purchased from a non-raw milk dairy.
5)RECENT INFORMATIONAL HEARING . In April 2008, the Senate
Agriculture Committee and Senate Select Committee on
Food-Borne Illness convened a joint informational hearing
related to farm fresh milk. Panels of interested
stakeholders, representing scientists, public health
officials, raw milk dairies, raw milk retailers, and raw milk
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consumers provided testimony regarding public health concerns,
product safety, potential benefits of unprocessed milk, and
consumer choice. During the hearing, participants noted that
raw milk processing lacks a single critical control point, or
kill-step, such as pasteurization, that is designed to
eliminate pathogens in the milk. Some scientists suggested a
HACCP plan as an alternative to the current single 10 coliform
count test performed once a month because it focuses on the
end result as an indicator of sanitation while a HACCP plan
focuses on sanitation throughout the entire milking process by
requiring monitoring, employee training, record-keeping, and
verification. While other experts pointed to the risks for
illness associated with the consumption of raw milk and cited
the federal Food and Drug Administration's (FDA) warning that
it is inherently dangerous, several raw milk consumers
insisted that milk in its natural state is full of beneficial
enzymes, vitamins, proteins, and good bacteria that help to
counter conditions as diverse as lactose intolerance, asthma,
allergies, ear infections, and autism.
6)DAIRY HACCP PLANS . According to the FDA, a HACCP plan is a
systematic approach to identifying, evaluating, and
controlling food safety hazards. A dairy HACCP plan covers
the entire dairy foods manufacturing process starting with the
cow and finishing with the consumption of the final product.
The HACCP plan identifies chemical, physical, or microbial
hazards associated with the production and distribution of
milk and minimizes these hazards by monitoring and controlling
the process at carefully selected points known as critical
control points (CCPs) to ensure safe dairy products. In
instituting a HACCP plan, microbial and operational expertise
is needed to systematically and scientifically evaluate a
product's process from raw materials through distribution.
The dairy HACCP plan includes a process to verify that the
CCPs have been met, a corrective action plan to address
instances in which the CCPs are not met, and a record keeping
system to document compliance with the HACCP plan. The plan
is reviewed as part of a facility's routine permitting
inspection.
7)FEDERAL RAW MILK POLICY . Federal law requires milk that is
shipped across state lines to be pasteurized. The FDA
maintains on its Website that raw milk should not be consumed
by anyone at any time for any purpose and may contain harmful
pathogens, including but not limited to, E. coli, salmonella,
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listeria, and campylobacter. The FDA's Website also cites
statistics from the federal Centers for Disease Control and
Prevention (CDC) indicating that from 1998 to 2005, there were
45 outbreaks of food-borne illness in which unpasteurized milk
or cheese likely made from unpasteurized milk were implicated.
Lastly, the FDA asserts that pasteurization protects
consumers because it kills the pathogenic bacteria through the
heating process while raw milk potentially harbors a wide
range of dangerous pathogens that can cause illness.
8)OTHER STATES . Raw milk policy varies greatly across the
nation, with some states banning the sale of raw milk.
California, Arizona, Nevada, Oregon, Utah and Washington have
specific coliform standards for milk sold raw to consumers.
9)SUPPORT . The California Real Milk Association (CREMA) writes
in support that this strikes the appropriate balance between
protecting the safety of raw milk products and ensuring that
these products are available on retail shelves for the 40,000
raw milk consumers in California. CREMA asserts that this
bill proposes more stringent standards for farm fresh milk
than what is provided under current law and ensures that
thousands of consumers and their children have access to this
whole and unprocessed food to maintain health. Organic
Pastures points out in support that pasteurized milk, like raw
milk, is not without its own set of risks and it has also been
linked to food-borne illness. Organic Pastures asserts that,
regardless of the risks associated with farm fresh milk,
consumers should be entitled to choose whether or not they
want to drink it. The National Association of Nutrition
Professionals notes that this bill allows consumers to
continue to purchase raw milk but makes certain that it is
safe by, among other things, prohibiting raw milk dairies from
receiving milk from non-raw milk dairies. Lastly, dairy trade
organizations state that this bill keeps the existing coliform
bacteria standard in place, and in addition, provides an
alternative safety program that a raw milk producer/processor
can use to meet sanitation standards that dairy product
consumers insist upon.
10)OPPOSITION . The Health Officers Association of California
(HOAC) contends in opposition that this bill is an attempt to
circumvent the existing 10 coliform standard by allowing raw
milk dairies to establish internal HACCP plans at various
points in the production process. HOAC asserts that the
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current coliform standard is not an unreasonable burden for
raw milk producers to meet as long as they maintain proper
cleaning and care of the animals and appropriate sanitary
practices for workers and equipment.
11)RELATED LEGISLATION . AB 2284 (Galgiani) makes changes to the
cooling requirements for storage and transportation of
pasteurized and market, including raw, milk. AB 2284 is
pending in the Senate Appropriations Committee.
12)PRIOR LEGISLATION .
a) AB 1735 (Committee on Agriculture), Chapter 339,
Statutes of 2007, establishes a limit of 10 coliform
bacteria per milliliter of raw milk that is sold to
consumers.
b) AB 1604 (Parra) would have repealed the current standard
of 10 coliform bacteria or less per milliliter for raw milk
that is sold to the public and required enforcement of the
coliform bacteria standard to be suspended until June 30,
2008. AB 1604 was referred to the Assembly Appropriations
Committee but never received a hearing.
13)SUGGESTED TECHNICAL AMENDMENT . On page 4, line 15, insert a
period after "milk".
14)DOUBLE REFERRAL . This bill has been double-referred. Should
this bill pass out of this committee, it will be referred to
the Assembly Committee on Agriculture.
REGISTERED SUPPORT / OPPOSITION :
Support
Alliance of Western Milk Producers
California Dairy Institute
California Real Milk Association
Organic Pastures Dairy Company LLC
National Association of Nutrition Professionals
Western United Dairymen
Several individuals
Opposition
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Health Officers Association of California
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097