BILL ANALYSIS
SB 173
Page 1
Date of Hearing: June 23, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 173 (Florez) - As Amended: June 1, 2009
SENATE VOTE : 26-12
SUBJECT : Food safety: testing and recalls.
SUMMARY : Authorizes the State Public Health Officer (PHO) to
adopt regulations for the voluntary recall of food suspected of
carrying an illness, infection, pathogen, contagion, toxin, or
condition that, without intervention, could kill or seriously
affect the health of humans.
EXISTING LAW :
1)Establishes the PHO to serve as the Director of the Department
of Public Health (DPH). Requires the PHO to be a licensed
physician and surgeon who has demonstrated medical, public
health, and management experience.
2)Confers upon DPH duties required by law for the detection and
prevention of the adulteration of articles used for food and
drink, and for the punishment of persons guilty of violating
any law protecting against adulteration.
3)Authorizes the State Veterinarian to quarantine or destroy, if
he or she believes that, based upon scientific evidence, a
population of domestic animals, or food product from animals,
has contracted, or may carry, an illness, infection, pathogen,
contagion, toxin, or condition that, without intervention,
could kill or seriously damage other animals or humans, as
specified.
4)Establishes the Food and Drug Branch within DPH to regulate
the manufacture, processing, storage, and distribution of food
products in California.
5)Requires DPH, or its authorized agent, to detain or embargo
any food, drug, device, or cosmetic, in the event that DPH or
its authorized agent finds, or has probable cause to believe,
that the item is adulterated, misbranded, or falsely
advertised. Authorizes DPH, or its authorized agent, to
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condemn or destroy detained or embargoed items, as specified.
6)Imposes specified fines and/or imprisonment for failure to
comply with an order by DPH to remove from sale any product
linked to an outbreak of illness, injury, or product
tampering.
7)Requires a facility that manufactures, processes, or stores
food products in California to register with DPH and meet
prescribed sanitation requirements for food safety.
8)Requires a meat or poultry supplier, distributor, broker, or
processor that sells a meat- or poultry-related product in
California that meets the criteria for a federal Class I or
Class II recall to immediately notify DPH and provide to DPH a
list of all customers that have received or will receive any
product subject to recall that the supplier, distributor,
broker, or processor has handled or anticipates handling, as
specified.
9)Permits DPH to notify appropriate local health officers and
environmental health directors, and inform the public, as
specified, that a supplier, distributor, broker, processor, or
retailer in the local jurisdiction has handled or received, or
anticipates handling or receiving, a meat- or poultry-related
product that is subject to a voluntary federal recall.
FISCAL EFFECT : The current provisions of this bill have not
yet been analyzed by a fiscal committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is
intended to provide the PHO with the necessary authority to
effectively manage and protect public health in the event of a
food-borne illness outbreak. The author notes that,
presently, DPH lacks the statutory authority to issue
mandatory recalls and does not have any regulations to guide
such actions. This bill allows DPH to adopt regulations
governing the appropriate actions to take during a food-borne
illness recall and empowers public health officials to act
quickly to improve the safety of the state's food supply.
2)BACKGROUND . The federal Centers for Disease Control estimates
that 76 million Americans get sick, 300,000 are hospitalized,
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and 5,000 die from food-borne illnesses each year. In 2006,
spinach from California tainted with E.coli bacteria was
identified as the source of food-borne contamination,
resulting in 204 cases of illness, 104 hospitalizations, and
three deaths across 26 impacted states. Over the course of
the investigation, the source of the bacteria was traced to
four fields in Monterey and San Benito counties. In addition,
the Salinas Valley area of California has also been the source
of at least seven confirmed cases of E.coli bacteria found in
leafy greens.
Most recently, Setton Farms in Terra Bella, California,
initiated a voluntary nationwide recall in March 2009 of its
pistachios because they were found to be contaminated with
salmonella.
The federal Food and Drug Administration (FDA) has since
completed its inspection of salmonella contamination in
pistachios and pistachio products at Setton and the FDA
indicates that most of the products associated with the recall
appear to have been identified. The FDA reports that, to
date, there is no conclusive evidence that links the recalled
pistachio products to cases of human illness, although a
connection cannot be completely ruled out. The number of new
recalls has dropped dramatically, and very few additions are
being made to the FDA's recall database at this time.
According to the FDA, actions have been taken to remove the
recalled products from the food supply, and it is advising
consumers and retailers to continue to safely dispose of any
recalled products they have in their pantries or stockrooms.
As an additional consumer protection, the FDA has also advised
wholesalers, retailers, and operators of restaurants and
food-service establishments not to sell or serve pistachios or
pistachio-containing products unless it can be determined that
they do not contain the recalled Setton products.
3)FEDERAL RECALL ACTION . FDA regulations define a recall as a
firm's removal or correction of a marketed product that the
FDA considers to be in violation of the laws it administers
and against which the agency would initiate legal action.
Currently, FDA's statutory authority to issue mandatory
recalls is limited to infant formula, medical devices, and
certain biological products. It does not have authority to
order a recall of a food or dietary supplement. FDA's
regulations provide general guidance for the voluntary recall
of products, including those recalls initiated by a firm on
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its own and those initiated at FDA's request. FDA's recall
guidance describes actions that FDA and the industry can take
to carry out their respective recall responsibilities.
FDA assigns recalls to one of three categories according to the
level of hazard associated with the violative product that is
being recalled. Class I recalls are those where there is a
reasonable probability that the use of, or exposure to, a
violative product, such as food found to contain botulinum
toxin (botulism) or salmonella, will cause serious adverse
health consequences or death. Class II recalls are those in
which use of, or exposure to, a violative product may cause
temporary or medically reversible adverse health consequences
or where the probability of serious adverse health
consequences is remote. Class III recalls are those in which
use of, or exposure to, a violative product is not likely to
cause adverse health consequences, such as a food product sold
at retail with a label that does not contain the required
information in English.
The FDA reserves a formal "request" for a recall, although still
voluntary, for urgent situations in which violative
distributed products pose a hazard to the consumer. In most
instances, companies are willing either to conduct voluntary
recalls of their own accord or after a formal request from
FDA. If a firm refuses to recall a violative product, the FDA
is authorized to pursue a legal remedy, such as a seizure or
court injunction. FDA may also choose to issue press releases
to warn the public about violative products that are in the
marketplace. The FDA maintains that, throughout the course of
a recall, it is the recalling firm's responsibility to
determine whether the recall is progressing satisfactorily by
performing effectiveness checks. These checks help to verify
that all known, affected merchandise shippers have received
notification about a recall and have taken appropriate action.
At the same time, FDA conducts audit checks to assess the
effectiveness of a firm's recall efforts. The FDA also has
field recall coordinators located throughout the country to
act as the point of contact for a recalling firm and to assist
firms with a recall.
4)RECENT FEDERAL HEARING . At a March 2009 hearing of the House
Subcommittee on Regulations and Healthcare, the FDA testified
to its limited recall authority and highlighted a need for
enhancing its statutory authority to protect consumers from
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food-borne outbreaks. The FDA stated that it is currently
reviewing with the U.S. Department of Health and Human
Services prior legislative requests it has made to strengthen
its authority to require recalls. According to the FDA's
testimony, one of the areas under discussion is mandatory
recall authority, which it argues, would be a useful tool
that, in some circumstances, could result in faster removal of
implicated products from commerce. The FDA also testified
that it is currently discussing the need for new or enhanced
authority with regard to requiring preventive controls;
enhancing access to food records during routine inspections;
and, requiring food facilities to renew their registrations
more frequently.
5)STATE RECALL AUTHORITY . DPH reports that it does not
currently have specific authority to recall food, nor does it
have statutory authority to develop mandatory recall
regulations. While DPH indicates that it does not have
authority to recall food that is believed to be contaminated
with a microbial pathogen or harmful chemical, it can initiate
an embargo of adulterated food and issue press releases
advising consumers not to purchase the suspect food. Current
law provides authority to an authorized agent of DPH to enter
and inspect any factory, warehouse, or establishment in which
food is manufactured, packed, or held. An authorized agent of
DPH can also review and collect documents related to the
production, testing, and distribution of food products and
collect samples.
While DPH states that voluntary recalls are initiated by the
responsible business, it notes that, through its existing
authorities, DPH helps mitigate risks associated with recalled
products. For example, according to DPH, it works to provide
information to the public through press releases and
collaborates with local, state, and federal agencies to
minimize public harm by coordinating contaminated product
distribution information, performing laboratory analysis, and
conducting recall effectiveness audits when feasible. DPH
also assists the responsible firm in notifying their
merchandise shippers and the public about the recall.
6)RELATED LEGISLATION .
a) AB 1021 (Emmerson) would permit authorized agents of
DPH, upon identifying conditions likely to result in
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illness or injury at a food processing establishment (FPE),
to immediately suspend the license or registration of the
FPE and order the FPE to close immediately pending an
administrative hearing. AB 1021 is pending in the Assembly
Health Committee.
b) AB 1372 (Feuer) would have required specified FPEs to
adopt and implement a Hazard Analysis and Critical Control
Point 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
DPH within 24 hours, as specified. AB 1372 was held on the
Assembly Appropriations Committee suspense file.
7)PRIOR LEGISLATION .
a) SB 200 (Florez) of 2008 would have authorized the State
PHO 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.
However, this bill was gutted and amended to, among other
things, prohibit the serving of food from downed cattle, as
defined, to students as part of a school meal program and
revise notification requirements for meat- or
poultry-related recalls. SB 200 failed passage in the
Assembly Agriculture Committee.
b) 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 (DHS now DPH), as specified, when meat or poultry
products they sell are subject to a federal Class I or
Class II recall, as specified.
c) SB 162 (Ortiz), Chapter 241, Statutes of 2006, transfers
public health programs from DHS to a new DPH. The State
PHO serves as the Executive Officer of DPH and is a
Governor-appointed physician and surgeon with substantial
scientific, medical, public health, leadership, and
management experience.
8)DOUBLE-REFERRAL . This bill has been double-referred. Should
this bill pass out of this committee, it will be referred to
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the Assembly Committee on Agriculture.
9)POLICY COMMENT . A prior version of this bill provided DPH
with mandatory recall authority. Since a voluntary recall by
its nature requires the recalling firm to be responsible for
the protection of public health, a more effective state
enforcement mechanism may be to provide DPH with the authority
to issue a mandatory recall.
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097