BILL ANALYSIS
AB 1372
Page 1
-Date of Hearing: April 28, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 1372 (Feuer) - As Amended: April 22, 2009
SUBJECT : Food processing establishments: Hazard Analysis and
Critical Control Point plans.
SUMMARY : Requires specified food processing establishments
(FPEs) to adopt and implement a Hazard Analysis and Critical
Control Points (HACCP) plan, conduct regular testing of
ingredient and product samples or specimens, and report any test
result that is positive for poisonous or deleterious substances
to the Department of Public Health (DPH) within 24 hours, as
specified. Specifically, this bill :
1)Requires a FPE that generates more than an unspecified amount
of gross annual revenue to adopt and implement a HACCP plan by
January 1, 2012. Requires DPH to prescribe the minimum
contents of the HACCP plan.
2)Requires a FPE that generates less than an unspecified amount
of gross annual revenue to adopt and implement a HACCP plan by
January 1, 2012. Requires DPH to prescribe the minimum
contents of the HACCP plan.
3)Directs DPH to establish, by regulation, the minimum
requirements of a general HACCP plan by February 1, 2010, and
requires the regulation to at least adhere to the HACCP
principles and application guidelines adopted by the National
Advisory Committee on Microbiological Criteria for Foods.
4)Specifies that the regulation must provide both of the
following:
a) Describe the procedures, as specified, used at the FPE
to prevent the presence of hazards, such as poisonous or
deleterious substances or other contaminants that may
render finished foods or ingredients manufactured at the
establishment injurious to health; and,
b) Provide for the regular testing of samples or specimens
of ingredients and final product at the FPE for the
presence of poisonous or deleterious substances or other
contaminants that may render the food and ingredients
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injurious to health.
5)Directs a FPE, in complying with 4) above, to conduct testing
in a manner consistent with certain specified standards.
6)Requires a FPE to report to DPH any test result this is
positive for poisonous or deleterious substances or other
contaminants within 24 hours.
7)Requires a FPE to maintain a record of all testing that is
done pursuant to this bill for a minimum period of unspecified
years. Directs the FPE to make these records available to DPH
for inspection upon request.
8)Authorizes DPH to do any or all of the following in
implementing this bill:
a) Adopt rules and regulations that establish minimum
standards and requirements for a product-specific HACCP
plan; and/or,
b) Review all HACCP plans, as adopted by the FPE, to
determine that the HACCP plan meets the requirements of
this bill and any applicable rules and regulations.
9)Directs DPH to conduct inspections to ensure that a FPE
complies with its HACCP plan.
10)Requires the inspections pursuant to 9) above to be conducted
as part of DPH's existing authority to inspect FPEs and
requires the existing fee for inspections to be increased by
an additional unspecified amount to cover, but not exceed, the
cost of the inspections required by this bill.
11)Allows DPH, upon reasonable grounds to suspect that food or
ingredients, or both, at a FPE may be injurious to health, to
order the FPE to test samples or specimens of its food or
ingredients, or both, for the presence of any poisonous or
deleterious substances or other contaminants.
EXISTING LAW :
1)Establishes the Food and Drug Branch (FDB) within DPH to
regulate the manufacture, processing, storage, and
distribution of food products in California.
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2)Requires a facility that manufactures, processes, or stores
food products in California to register with FDB.
3)Establishes the California Food Sanitation Act to require FPEs
to meet prescribed sanitation requirements for food safety.
4)Defines a FPE as any room, building or place or portion
thereof, maintained, used or operated for the purpose of
commercially storing, packaging, making, cooking, mixing,
processing, bottling, canning, packing, slaughtering, or
otherwise preparing or handling food except restaurants.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . The author states that current recalls
of products both in California and around the nation have
illustrated the need for more robust state oversight. Last
summer, a salmonella outbreak made 1,400 people sick in 43
states, and initially tomatoes were identified as the source.
However, the author notes that the outbreak was later traced
to jalape?os and serrano peppers, but the author points out
that the tomato industry still has not fully recovered as a
result. According to the author, estimates suggest that
tomato growers lost $100 million in sales.
Most recently, the author cites a nationwide recall of
salmonella-contaminated pistachios issued by a California
pistachio processor. The author states that the contaminated
product was initially identified on March 26, 2009, by a Kraft
Foods food-borne illness test, and then traced back to Setton
Farms of Terra Bella in California. The author asserts that
the entire domestic pistachio industry, 96% of which is in
California, is currently in turmoil because consumers do not
know which companies' pistachio products are safe to eat. The
author indicates that over 2 million pounds of pistachios have
been recalled and the state's entire $540 million pistachio
industry is facing the consequences.
Furthermore, the author notes that the state does not currently
require the adoption of plans that detail which procedures
will be used to prevent the presence of hazards that may
render finished food products or ingredients manufactured at
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the establishment injurious to health. The author maintains
that DPH is not informed if testing samples of food are found
to contain poisonous substances and lacks the ability to order
testing if it believes there are reasonable grounds to do so.
The author contends that establishing HACCP plans at
individual processing plants will make California's food
safety system more preventative.
2)PISTACHIO RECALL . According to information from the federal
Food and Drug Administration (FDA) and DPH, the joint
investigation of salmonella contamination in pistachios and
pistachio products at Setton Farms is ongoing. Setton is
recalling all lots of roasted in-shell pistachios and roasted
shelled pistachios that were produced from nuts harvested in
2008 and some pistachios from the 2007 crop that were
processed on the same equipment as the 2008 crop. Setton is
also recalling those raw shelled pistachios from the 2008 crop
and some from the 2007 crop that were also processed on the
same equipment as the 2008 crop.
Initially, Setton's recall was limited to certain lots of
roasted pistachios. After FDA shared information with Setton
from the joint FDA and DPH inspection, which indicated the
presence of salmonella in critical areas of Setton's facility
and the potential for cross-contamination between raw and
roasted products, Setton expanded its recall on April 6, 2009.
The FDA states that, because the pistachios were used as
ingredients in a variety of foods, this recall affects many
products and is expected to result in additional recalls. The
FDA has created a searchable database of recalled products at
http://www.fda.gov/pistachios/ and will continue to update the
public as the investigation progresses. In the meantime, the
FDA is advising consumers to avoid eating pistachios or food
products containing them, such as pistachio bakery goods and
pistachio ice cream, until they can determine that the
products do not contain pistachios recalled by Setton.
3)HACCP PLANS . According to DPH, HACCP is a system that helps
ensure the safety of foods. HACCP was developed in the 1960s
for the space program. HACCP is used to identify potential
problems with food products and implement corrections before
the products reach consumers. HACCP is mandatory for seafood
and juice products regulated by FDB and for meat products
under jurisdiction of the U.S. Department of Agriculture. DPH
indicates that although HACCP is optional in most foods, many
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processors have voluntarily implemented HACCP programs within
their manufacturing and distribution facilities.
A HACCP plan involves seven principles to ensure food safety at
the production site: analyze hazards, identify critical
control points, establish preventive measures with critical
limits 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, and establish effective recordkeeping to
document the HACCP system. The general guidelines for HACCP
plans mandated at the federal level are developed by the
National Advisory Committee on Microbiological Criteria for
Foods.
4)PROCESSED FOOD REGISTRATION . Processors of general food
commodities must obtain a Processed Food Registration (PFR)
from FDB. General foods such as bakery products, noodles,
seafood (except molluscan shellfish), fruit juices, snacks,
nuts, oils, processed or packaged vegetables, and candy are
regulated by the PFR program. The PFR is a basic license
issued to FPEs that allows them to legally manufacture,
package, label, or warehouse food in California. The PFR
provides evidence to a FPE's customers and to regulatory
agencies that the FPE is licensed and inspected by FDB. The
registration fee is determined by the size of the FPE, the
number of employees, and the FPE's activities (i.e.
manufacturing or warehousing). Funds from registration fees
are used to support the FDB's Food Safety Inspection Program.
A FPE's PFR registration is valid for one year.
5)FACILITY INSPECTIONS . DPH reports that FDB conducts
regulatory inspections to assure the safety of food products
manufactured, processed, stored or distributed in California.
The frequency of inspections may be determined by requirements
in law, risks associated with the food, and a FPE's history of
compliance, complaints and/or reports of illness. The four
most common inspections are readiness inspections, routine
inspections, reinspections, and complaint, recall, or illness
inspections. Readiness inspections are conducted to verify a
FPE's compliance with applicable health and safety
requirements prior to beginning processing operations. A
readiness inspection usually occurs after FDB receives a FPE's
initial PFR application.
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FDB routinely inspects FPEs based on the risk associated with
the operation. Most facilities are inspected annually;
however, some low risk facilities may be inspected less
frequently, and some very high risk facilities may be
inspected more frequently. Reinspections are recommended if
significant deficiencies are identified during the routine or
readiness inspection. Reinspections are conducted to assure a
FPE's compliance and verify that corrective actions have
occurred. A FPE is charged a fee of $100 per hour to conduct
a reinspection. Complaint, recall, or illness inspections are
usually assigned because a food is known to be adulterated or
misbranded, or FDB has received a complaint or illness report.
These inspections may be conducted at times other than normal
business hours when there is a potential for significant,
adverse impact to the public. They are generally urgent in
nature and frequently involve extensive facility inspections
and record reviews.
6)RELATED LEGISLATION .
a) SB 173 (Florez), among other things, provides DPH with
mandatory recall authority of food reasonably or
scientifically believed to carry a food-borne illness,
infection, pathogen, contagion, toxin, or cause illness in
humans; requires all growers or food processors that test
for food-borne illness to maintain records and results of
those tests for at least two years; and requires growers or
food processors that receive a positive test result for
food-borne illness to report to DPH within one hour of the
test result. SB 173 is pending in the Senate Health
Committee.
b) AB 1021 (Emmerson) authorizes DPH to immediately suspend
the license or order the closure of a FPE if imminent
health hazards are observed. AB 1021 is pending in the
Assembly Health Committee.
7)SUPPORT . Consumers Union (CU) writes in support that this
bill will make up for major lapses by the FDA in protecting
the food supply. CU points out that the FDA inspects FPEs on
average only once every ten years, inspects just 1% of the
foods coming in from other countries, and has no authority to
require companies to recall their potentially contaminated
products, to test their products for pathogens, or to disclose
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to FDA when contaminants are found. CU maintains that the
requirements in this bill to establish and implement safety
standards and HACCP plans at California's FPEs, provide for
inspections and regular testing of products for pathogens, and
mandate the disclosure of positive test results to DPH will do
much to safeguard the state's food supply and ensure that
California is a leader on the food safety front.
8)AUTHOR'S AMENDMENTS . The author intends to offer amendments
in committee to replace "establishment" with "facility" and
correct other drafting errors, and to clarify that the sample
or specimen testing that a FPE is required to do, will be
based on the most current versions of the standards specified
in this bill.
9)POLICY COMMENT . This bill does not specify the amount of
gross annual revenue that an FPE must generate in order to be
subject to the requirements of this bill and does not specify
the number of years that a FPE is required to maintain a
record of all testing that is done pursuant to this bill. The
author may wish to clarify how these amounts will be
determined in a manner consistent with this bill.
REGISTERED SUPPORT / OPPOSITION :
Support
Consumers Union
Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097