BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 173
S
AUTHOR: Florez
B
AMENDED: April 20, 2009
HEARING DATE: April 29, 2009
1
CONSULTANT:
7
Tadeo/
3
SUBJECT
Food safety: testing and recalls
SUMMARY
Requires the State Public Health Officer to recall food
believed to carry a food-borne illness, infection,
pathogen, contagion, toxin, or cause death or illness in
humans. Requires all growers, food processors, and
facilities that test for food-borne illness to maintain
records and results of those tests for at least two years,
have them available for inspection by the Department of
Public Health (DPH), and report positive test results to
DPH within one hour. Creates new penalties, follow-up
inspection requirements, and suspensions with exceptions,
for those growers, food processors and facilities
responsible for a food-borne illness or outbreak, as
specified.
CHANGES TO EXISTING LAW
Existing law:
Gives DPH general authority to take actions necessary to
protect public health and to direct actions to be taken by
local public health agencies to protect public health;
gives DPH specific authority to embargo any food, drug,
device, or cosmetic that is, or is suspected of being,
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STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 2
adulterated, misbranded, or falsely advertised; and allows
DPH or its authorized agent to condemn or destroy unsound
or unsafe foods.
Requires meat or poultry suppliers, distributors, brokers
or processors that sell products meeting certain classes of
recall, according to the United States Department of
Agriculture (USDA) guidelines, to notify DPH and to provide
information, as specified.
Provides that the Secretary of Food and Agriculture shall
establish, by regulation, uniform standards for field crop
producers, and also establish inspection districts within
the state and provide sampling, inspection, and
certification services for field crop products within the
state, as specified.
This bill:
Requires the State Public Health Officer to recall food
believed to carry a food-borne illness, infection,
pathogen, contagion, toxin, or cause death or illness in
humans, as specified.
Requires all growers, food processors and facilities that
test for food-borne illness to maintain records and results
of those tests for at least two years and have them
available for inspection by DPH. Requires growers or food
processors that receive a positive test result for
food-borne illness to report to the DPH within one hour of
the test result.
Requires those growers, food processors and facilities
responsible for a food-borne illness or outbreak, if found
liable, to pay triple damages to any food-borne illness
victim, have onsite inspection by an agent of DPH at least
eight times per month for at least one year at the expense
of the grower or food processor, and suspend operation as
determined by DPH, but not for more than six months.
Specifies that in the event of a food-borne illness or
outbreak those growers, food processors, or facilities that
have a written Hazard Analysis Critical Control Point Plan
(HACCP) that delineates procedures for following principles
developed by the National Advisory Committee on
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 3
Microbiological Criteria for Foods (NACMCF), and routinely
test their food product for a microbe, pathogen, poisonous
chemical, or other harmful substance that may cause
food-borne disease, are exempt from the provisions stated
above.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
According to the author, current law does not provide DPH
the ability to issue mandatory recalls and this power is
also absent in federal law. The Food and Drug
Administration (FDA) asked for this authority in testimony
before Congress, after the recent peanut butter recall.
The author states that current law does not require firms
that have a positive test result for food-borne illness to
report that to DPH, and that this information would be
helpful in helping DPH decide what firms may need to be
inspected. The author further states that SB 173 also
gives firms incentive to act responsibly by implementing
appropriate food safety programs and testing programs.
The author contends that SB 173 establishes much needed
provisions to improve the safety of the food supply, and
will empower public health officials to act quickly and
independently to protect public health, deploy their
inspectors to the places where they are needed most, create
significant penalties for firms that choose not to perform
their due diligence, and provide protections for firms that
do choose to perform their due diligence.
Outbreaks of food-borne illness
According to the Centers for Disease Control, it is
estimated that each year 76 million Americans get sick,
300,000 are hospitalized and 5,000 die from food-borne
illnesses. Since 1995, there have been more than 20
documented instances of contaminated leafy green produce
originating on farms in California. On September 14, 2006,
federal and state public health officials issued a
nationwide health alert, warning consumers that E. coli
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 4
O157:H7 was detected in packages of fresh uncooked spinach.
Escherichia coli O157:H7 is a leading cause of food-borne
illness, causing bloody diarrhea, and, occasionally,
hemolytic uremic syndrome (HUS), a cause of acute kidney
failure, in vulnerable populations, such as the elderly and
children under five years of age.
According to the Centers for Disease Control and Prevention
(CDC), cattle are generally the principal source of E. coli
O157:H7 infections. The E. coli in their intestines can
contaminate other parts during slaughter. Cattle manure
containing E. coli O157:H7 can contaminate streams that
flow through produce fields and are used for irrigation,
pesticide application, or washing. The CDC indicates that
contamination of fresh produce may result from exposure to
poor water quality, manure used for fertilizer, workers
with poor hygiene, and animals, both domesticated and wild.
According to the FDA, the 2006 spinach outbreak was one of
the largest and deadliest outbreaks of food-borne illness
in recent years, affecting 26 states and resulting in 204
cases of illness, 104 hospitalizations, 31 cases of HUS,
and three deaths. During the course of the investigation,
the source of the E. coli tainted spinach was traced back
to four fields in the Monterey and San Benito County areas.
California's Salinas Valley has been identified as the
source of at least seven confirmed outbreaks of E. coli in
leafy greens.
About two million pounds of pistachios processed by Setton
Pistachio in California have been recalled amid fears the
nuts might carry salmonella, a common and life-threatening
form of food poisoning. Earlier this year, an outbreak of
salmonella in peanut butter and other peanut foods was
blamed for hundreds of illnesses and one of the largest
food recalls in U.S. history.
Leafy Green Handler Marketing Agreement
Following the 2006 E. coli outbreak, the agriculture
industry requested that the Department of Food and
Agriculture (DFA) approve the formation of a voluntary
California Leafy Green Handlers Marketing Agreement (LGMA),
which requires participating handlers to ensure that all of
their growers are farming their leafy greens under a
standard of Good Agricultural Practices (GAP) developed by
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 5
an industry panel of food safety specialists.
The most recent revision of the guidelines, dated June 13,
2008, (which focuses solely on production and harvest
practices) was prepared to provide more specific and
quantitative measures of identified best practices. A key
focus of this revision was to identify, where possible and
practical, metrics and measures that could be used to
assist the industry with compliance with the guidelines. In
preparing the document, metrics were researched for three
primary areas: water quality, soil amendments, and
environmental assessments/conditions.
According to the LGMA website, nearly 120 farmers,
shippers, and processors, representing over 99 percent of
the volume of California leafy greens, have demonstrated
their willingness to follow these practices by voluntarily
signing on to the Marketing Agreement. Once the Marketing
Agreement is signed, it becomes mandatory for those
shippers and processors to purchase product solely from
farmers who comply with the food safety practices accepted
by the LGMA Board.
Federal guidance for produce safety
The United States Department of Agriculture administers a
voluntary Good Agriculture Practices (GAP) program. This
program is available for all commodities. Under this
program, Federal-State Inspection Service personnel review
a participating company's facility and agronomic practices,
along with its documented procedures, to help determine if
"Good Agricultural Practices" and/or "Good Handling
Practices" are maintained. According to the Senate
Agriculture Committee analysis of SB 201 in 2008, only two
vegetable growers are participating in the program in
California, and the majority of participants are in the
fruit industry.
The National Advisory Committee on Microbiological Criteria
for Foods (NACMCF) NACMCF was established on March 18,
1988, in response to recommendations of the National
Academy of Sciences for an interagency approach to
microbiological criteria for foods. NACMCF provides
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 6
impartial, scientific advice to federal food safety
agencies for use in the development of an integrated
national food safety system approach from farm to final
consumption to assure the safety of domestic, imported, and
exported foods. NACMCF subcommittees have developed
microbiological criteria for specific foods such as raw
shellfish, cooked ready-to-eat shrimp, and crabmeat.
NACMCF reports provide current information and scientific
advice to participating federal food safety agencies and
serve as a foundation for regulations and programs aimed at
reducing foodborne disease and enhancing public health.
Hazard Analysis Critical Control Point (HACCP) Plan
According to the FDA, an HACCP plan is a systematic
approach to identifying, evaluating, and controlling food
safety hazards. HACCP involves seven principles to ensure
food safety at a food production site as follows:
Analyze potential hazards associated with a food.
Identify critical control points in a food's
production--from its raw state through processing and
shipping to consumption by the consumer--at which the
potential hazard can be controlled or eliminated.
Establish preventive measures for each control point.
Establish procedures to monitor the critical control
points.
Establish corrective actions to be taken when monitoring
shows that a critical limit has not been met.
Establish procedures to verify that the system is working
properly.
Establish effective recordkeeping to document the HACCP
system.
Recalls, quarantines, embargoes
The FDA is currently seeking the power to issue mandatory
recalls of suspect food products. The USDA is seeking
stronger food recall powers to help minimize future disease
outbreaks as well.
Despite DHS' broad authority to protect public health, the
department maintains it does not currently have the
authority to force businesses to recall their products. It
does, however, have specific statutory authority to embargo
a variety of products, including food. While embargo can
prevent movement of a product by allowing DHS or its
authorized agents to tag, take possession of, or destroy a
product, recall authority would provide greater efficiency
in any large-scale effort to remove a large number or class
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 7
of products from commerce. Quarantine is a term the
department uses in relation to people and animals, but not
to products.
Related legislation
AB 1372 (Feuer) would require a food processing
establishment to adopt and implement an HACCP plan, impose
reporting and recordkeeping requirements on food processing
establishments, as specified, commencing January 1, 2012,
or January 1, 2013, depending upon the gross annual revenue
of the food processing establishment. Would require DPH to
establish minimum standards and requirements for the HACCP
plans, review adopted plans for compliance and conduct
inspections, as prescribed. The bill would also require a
food processing establishment to test its food and
ingredients, as prescribed. Set for hearing in the Assembly
Health Committee on April 28, 2009.
AB 1021 (Emmerson) would permit authorized agents of DPH,
who identify conditions likely to result in illness or
injury at a food processing establishment, to immediately
suspend the license or registration of the food processing
establishment and order the food processing establishment
to close immediately pending an administrative hearing.
Would also require the department to provide a licensee or
registrant with a written notice that contains prescribed
information about the suspension and administrative
hearing. Set for hearing in the Assembly Health Committee
on April 28, 2009.
Prior legislation
SB 611 (Speier), Chapter 592, Statutes of 2006, requires a
meat or poultry supplier, distributor, broker or processor
to immediately notify the Department of Health Services, as
specified, when meat or poultry products they sell are
subject to a Class I or Class II recall by the U.S.
Department of Agriculture, and take other specified
actions.
SB 162 (Ortiz), Chapter 241, Statutes of 2006 transfers
public health programs from the Department of Health
Services (DHS) to a new DPH. The State Public Health
Officer, serving as the executive officer of DPH, is a
governor-appointed physician and surgeon who has
substantial scientific, medical, public health, leadership,
and management experience.
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 8
SB 200 (Florez) 2008 would have authorized the State
Public Health Officer to adopt recall, quarantine, and
sanitary regulations necessary to prevent or eliminate
conditions where produce or food processed from produce may
carry an illness, infection, pathogen, contagion, toxin or
condition that could kill or seriously affect the health of
humans. Would have also required all leafy green vegetable
growers to be licensed by DPH, and would have established
an inspection program for leafy green vegetables under the
State Public Health Officer to conduct field inspections
for compliance with food safety requirements and conduct
field, water, soil, and produce tests. Failed in the
Assembly Agriculture Committee.
SB 201 (Florez) 2008 would have established a
state-mandated standard for Good Agriculture Practices and
Hazardous Analysis and Critical Control Point program
through DPH. However, the bill was gutted and amended in
the Assembly to establish the Fresh Raw Milk Act of 2008,
to require raw milk dairy farms that choose to comply with
the requirements, to develop and maintain an individualized
Hazard Analysis Critical Control Point (HACCP) plan.
Vetoed by the Governor.
SB 202 (Florez) 2008 would have required growers, handlers,
and processors of leafy green vegetables to use a coded lot
numbering system or other scientifically validated system
for the purposes of tracing a product throughout the
production, distribution, and marketing chain; to conduct
periodic mock recalls; and to identify a recall
coordination team within its operation to rapidly identify
and remove products. Failed in the Assembly Agriculture
Committee.
PRIOR VOTES
Senate Food and Agriculture Committee: 3 - 1
COMMENTS
1.Test results for food-borne illness. The bill requires
growers, food processors and facilities that receive a
positive test result for food-borne illness to report to
DPH within one hour of the test result.
a) Is it feasible for growers, food processors and
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 9
facilities to report results within one hour?
b) Does DPH have the ability to receive test results
within one hour?
2.False positive tests results. Food processors that
currently test for food-borne illness may use quick
initial tests that have a high rate of false positive
results. If a positive result is discovered, there is a
next level of testing that can take up to five days to
complete to verify the positive result or render a
different outcome.
The author may wish to consider amending the bill in
order to allow time for retesting in the event of a
positive test result to rule out a false positive result,
as well as specify how retests would be reported to DPH
as well.
3.Is an HACCP plan appropriate across the board? The bill
requires those growers, food processors, and facilities
responsible for a food-borne illness or outbreak, if
found liable, to pay triple damages to any food-borne
illness victim, have onsite inspections by an agent of
DPH at least eight times per month for at least one year
at the expense of the grower, food processor, or
facility, and suspend operation as determined by DPH, up
to six months. The bill would exempt from these
provisions growers, food processor and facilities that
have a written HACCP plan.
HACCP plans are standard and required for the retail food
industry, seafood processors, juice, low acid canning,
and meat products; a voluntary Dairy Grade A HACCP plan
program is also in place at this time.
a) How would the new provisions relate to current food
safety requirements?
b.) Since the bill addresses three different industries
in growers, food processors and facilities, each with
varying control points, are there good practices or other
standards that are more appropriate in different
industries and at different levels?
4.Small business and the ability to comply. The ability to
STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 10
test and otherwise comply with the provisions in SB 173
may vary for growers, food processors and facilities,
depending on their size. The author may wish to consider
a plan that would help smaller businesses comply, for
instance in the case of small farms.
5.Definition of food facility needs clarification. The bill
uses the definitions of an HACCP plan as it is defined in
the Health and Safety California Retail Food Code
(CalCode), but does not define food facility.
The author may wish to clarify if it is the author's
intention that the provisions in the bill that apply to
food facilities be food facilities as defined in CalCode,
which would include food facilities that prepare food for
consumption, such as restaurants and temporary food
facilities. If not, the author may wish to provide a
specific definition of food facilities in the bill.
Support: None received
Oppose: None received
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