BILL ANALYSIS
SB 797
Page 1
Date of Hearing: July 7, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 797 (Pavley) - As Amended: June 25, 2009
SENATE VOTE : 21-16
SUBJECT : Product safety: bisphenol A.
SUMMARY : Prohibits the manufacture, sale, or distribution of
any bottle or cup, and any liquid, food, or beverage in a
container containing bisphenol A (BPA) at a level above 0.1
parts per billion (ppb), if the product is intended for children
three years of age or younger. Specifically, this bill :
1)Prohibits the manufacture, sale, or distribution in commerce
of any bottle or cup that contains BPA at a level above 0.1
ppb, if the bottle or cup is designed to be filled with any
liquid, food, or beverage intended primarily for consumption
by infants or children three years of age or younger.
2)Prohibits the manufacture, sale, or distribution of a liquid,
food, or beverage in a can, jar, or plastic bottle containing
BPA, or lined with a material containing BPA, at a level above
0.1 ppb, if the liquid, food, or beverage is intended
primarily for consumption by infants or children three years
of age or younger.
3)Specifies that the prohibitions in 1) and 2) above do not
apply to food and beverage containers designed or intended
primarily to contain liquid, food, or beverages for
consumption by the general population.
4)Requires manufacturers to use the least toxic alternative when
replacing BPA in containers.
5)Prohibits manufacturers from replacing BPA with carcinogens or
reproductive toxicants that cause birth defects, reproductive
harm, or developmental harm, as identified by the United
States (U.S.) Environmental Protection Agency (EPA) or the
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Safe Drinking Water and Toxic Enforcement Act of 1986
(Proposition 65) list of chemicals known to cause cancer or
reproductive toxicity.
6)Makes legislative findings and declarations.
EXISTING LAW :
1)Prohibits the sale, manufacture, or distribution in commerce
of toys, child care articles, or products that can be placed
in a child's mouth that contain phthalates in concentrations
exceeding 0.1%. Requires manufacturers to use the least toxic
alternative when replacing phthalates in products.
2)Defines "child care article" as all products designed or
intended by the manufacturer to facilitate sleep, relaxation,
or the feeding of children, or to help children with sucking
or teething.
3)Prohibits the manufacture, sale, and distribution of toys that
are contaminated with any toxic substance.
4)Under Proposition 65:
a) Requires the Governor to publish a list of chemicals
known to cause cancer or reproductive toxicity, and to
annually revise the list; and,
b) Prohibits any person in the course of doing business in
California from knowingly exposing any individual to a
chemical known to the state to cause cancer or reproductive
toxicity.
5)Requires, by January 1, 2011, the Department of Toxic
Substances Control (DTSC), to adopt regulations to identify
and prioritize chemicals of concern, evaluate alternatives,
and promulgate regulations to limit exposure to, or reduce the
level of hazard posed by, a chemical of concern found in
consumer products.
6)Requires DTSC to establish an online, public Toxics
Information Clearinghouse that includes science-based
information on the toxicity and hazard traits of chemicals
used in daily life.
7)Under the federal Toxic Substances Control Act of 1976,
authorizes EPA to track industrial chemicals produced or
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imported into the U.S.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, most consumers
believe that everyday products are tested for dangerous
chemicals and determined to be safe by government authorities,
but in reality, many children's products contain toxic
chemicals, such as BPA, which have been shown to cause harm to
children's health and the environment. According to the
author, BPA has been linked to a number of long-term health
impacts such as birth defects, reproductive harm, impaired
learning, liver toxicity, and cancer. Because children's
bodies are growing and developing, they are especially
vulnerable to the effects of BPA. The author states that
current federal Food and Drug Administration (FDA) regulations
have failed to keep pace with a multitude of independent,
peer-reviewed studies that link low doses of BPA with harm to
developing systems. The author argues that EPA regulates BPA,
but considers 50 micrograms of BPA per kilogram of body
weight, per day, to be safe, while animal studies have shown
adverse effects at lower doses. The author contends this bill
is needed because regulation of BPA in children's products is
woefully inadequate and has not kept pace with recent
government-funded, peer reviewed studies indicating a problem
with BPA in food and beverage products.
2)BACKGROUND . BPA was produced for use as a synthetic estrogen
in 1936 and is now referred to as an environmental estrogen
because it mimics estrogenic action. BPA is now one of the
most commonly used industrial chemicals. According to an
April 2008 Draft Brief from the National Center for
Environmental Health Science, National Toxicology Program
(NTP), BPA is a chemical produced in large quantities
primarily for use in the manufacture of polycarbonate plastics
and epoxy resins. Polycarbonate plastics are typically clear
and hard and have many applications, including use in certain
food and drink packaging, such as water and infant bottles,
compact discs, impact-resistant safety equipment, and medical
devices. Epoxy resins are used as lacquers to coat metal
products such as food cans, bottle tops, and water supply
pipes. In addition, some polymers used in dental sealants or
composites contain BPA-derived materials. The estimated
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production of BPA in the U.S. in 2004 was approximately 2.3
billion pounds.
3)EXPOSURE TO BPA . According to the NTP Draft Brief, diet is
the primary source of exposure to BPA for most people,
although air, dust, and water (including skin contact) are
also possible sources of exposure. According to the NTP, BPA
can migrate into food from containers with internal epoxy
resin coatings and from polycarbonate plastic products such as
baby bottles, tableware, food containers, and water bottles.
The degree to which BPA migrates from polycarbonate containers
into liquid appears to depend more on the temperature of the
liquid than the age of the container; higher temperatures
cause more migration. Short-term exposure can occur following
application of certain dental sealants or composites made with
BPA-derived material. Workers may also be exposed during the
manufacture of BPA and BPA-containing products. The
Environmental Working Group (EWG), a nonprofit research
organization and sponsor of this bill, found that almost all
infant formula cans are lined with an epoxy that contains BPA.
BPA is also found in breast milk.
According to the NTP Draft Brief, the highest estimated daily
intakes of BPA in the general population occur in infants and
children because, relative to their size, they eat, drink, and
breathe more than adults. The U.S. Centers for Disease
Control and Prevention (CDC) found detectable levels of BPA in
93% of a large, representative sample of people six years and
older. People with the lowest household incomes had higher
levels of BPA than people in the highest income bracket. The
NTP Draft Brief cited estimates that formula-fed infants
younger than six months and infants six to 12 months had much
higher intake levels of BPA than breast-fed infants less than
six months of age and adults in the general population, due to
polycarbonate formula bottles, epoxy formula can linings,
canned foods, and polycarbonate tableware. EWG estimates that
one in 16 infants fed liquid, ready-to-eat formula would be
exposed to the chemicals at doses exceeding those that caused
harm in laboratory studies. Baby's Toxic Bottle, a February
2008 report released by a coalition of U.S. and Canadian
public health and environment groups, concluded that the
amount of leaching from heated baby bottles is within the
range to cause harm in animals and is therefore a health
concern for infants.
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4)HEALTH EFFECTS OF BPA . NTP states that it is difficult to
draw conclusions about developmental or reproductive effects
of BPA from human studies due to factors such as lack of
variation in exposure, small sample size, cross-sectional
design, or lack of adjustment for potential confounders.
However, a group of scientists convened by the National
Institutes of Health (discussed in 5) below) concluded that
animal studies of BPA should be considered a valid indicator
of potential harm to humans.
Developmental Effects . NTP finds that there is some concern for
neural and behavioral effects in fetuses, infants, and
children at current human exposures to BPA. NTP also has some
concern for effects in the prostate gland, mammary gland, and
an earlier age for puberty in females associated with BPA
exposure to fetuses, infants, and children. Also, NTP did not
find sufficient evidence to rule out the possibility that BPA
exposure is associated with obesity and diabetes, earlier
puberty in females, decreased sperm production and motility,
and abnormal sperm formation associated with infertility.
Reproductive Effects . NTP concluded that several human studies,
including one in occupationally exposed male workers,
collectively suggest hormonal effects of BPA exposure in
adults. Examples of hormonal effects of BPA include increased
testosterone in men and women, polycystic ovary syndrome,
recurrent miscarriages, and chromosomal defects in fetuses.
Also, in laboratory animals, developmental exposure to BPA at
doses comparable to human exposures appear to cause changes
that may increase risk of breast cancer later in life. NTP
expressed negligible concern that exposure of pregnant women
to BPA will result in fetal or neonatal mortality, birth
defects or reduced birth weight and growth in their offspring.
NTP has negligible concern that nonoccupational exposure to
BPA has reproductive effects and minimal concern that
occupational exposures to BPA cause reproductive harm.
5)CHAPEL HILL CONSENSUS STATEMENT . In November 2006, the
National Institutes of Health convened in Chapel Hill, North
Carolina, an international group of scientists with expertise
in BPA to critically examine the relevance of the large body
of ecological, in vitro, and laboratory animal studies for
assessing risks to human health. The group issued the Chapel
Hill Consensus Statement, which included only findings with
which all members of the topic-specific workgroups concurred.
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According to the Consensus Statement, the group was confident
of the following:
a) BPA exposure induces similar effects in reproductive
systems in wildlife as in laboratory experiments;
b) Responses in a variety of species are qualitatively
consistent with controlled laboratory studies of BPA, and
are predictive of similar effects in humans;
c) Metabolic studies in rats suggest that current human
exposures are comparable to those in laboratory animal
studies;
d) Exposure to BPA in concentrations within range of those
observed in human fetal blood
produced multiple adverse outcomes in fetal mice;
e) Sensitivity to endocrine disruptors varies extensively
with life stage;
f) BPA in low doses alters genes and results in persistent
effects that are expressed later in life; and,
g) Low doses of BPA in adulthood can have neurobehavioral
and reproductive effects.
The Chapel Hill Group concluded that the wide range of adverse
effects of low doses of BPA in laboratory animals exposed
during development and adulthood gives great cause for concern
with regard to the potential for similar adverse effects in
humans. They further argued that the effects seen in
experimental animals exposed to BPA relate to recent trends in
human diseases, such as increases in prostate and breast
cancer, uro-genital defects in male babies, decline in semen
quality, early onset of puberty in girls, and metabolic
disorders such as type 2 diabetes and obesity, and
neurobehavioral problems. The group also stated that there is
extensive evidence that outcomes may not become apparent until
long after BPA exposure occurs.
6)GREEN CHEMISTRY INITIATIVE . According to the final report of
the California Green Chemistry Initiative, green chemistry
focuses on environmental protection at the design and
manufacturing stages of product production. It intends to
address chemicals before they become hazards, with the goal of
making chemicals and products "benign by design." Green
chemistry seeks to reduce the toxicity of chemicals in the
first place, rather than merely manage their toxic waste after
use and disposal.
In 2007, DTSC launched the California Green Chemistry
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Initiative, and in December 2008, released six policy
recommendations for establishing a comprehensive Green
Chemistry program in California. Governor Schwarzenegger
signed two of the six recommendations into law: AB 1879
(Feuer and Huffman) Chapter 559, Statutes of 2008, requires
DTSC to adopt regulations by January 1, 2011 to identify and
prioritize chemicals of concern, to evaluate alternatives, and
to specify regulatory responses where chemicals of concern are
found in consumer products. SB 509 (Simitian) Chapter 560,
Statutes of 2008, requires DTSC to establish an online, public
Toxics Information Clearinghouse that includes science-based
information on the toxicity and hazard traits of chemicals
used in daily life.
The Green Chemistry Initiative is still in development and is
not yet considering specific chemicals. However, DTSC has
issued an "Industry Challenge" to manufacturers and retailers
of baby products and plastic bottles, to obtain information to
help DTSC in developing decision-making tools and guidelines
for alternative assessment.
7)PROPOSITION 65 REVIEW . The California Office of Environmental
Health Hazard Assessment (OEHHA) has prepared a Hazard
Identification Materials document on BPA that the Proposition
65 Developmental and Reproductive Toxicant Identification
Committee is reviewing as it decides whether to list BPA as a
reproductive toxicant or carcinogen when it meets on July 15,
2009. The document provides a comprehensive review of studies
of BPA, and reports that while studies reporting adverse
reproductive effects and studies reporting no such effects are
both numerous, overall, studies that used sensitive
methodologies to assess appropriate endpoints consistently
reported developmental and female- and male-reproductive
effects.
8)INFORMATIONAL HEARINGS . In January 2006, the Assembly
Environmental Safety and Toxic Materials (ES&TM) Committee and
Assembly Health Committee held a joint informational hearing
on the health effects of phthalates and BPA on children.
During the hearing, the manufacturers and industries that use
phthalates and BPA in children's products claimed that levels
at which people are exposed pose no risk. A leading
researcher on the effects of BPA showed the similarities
between effects of low doses of BPA on laboratory animals and
human health trends, such as prostate disease, obesity,
decreased sperm counts, early puberty in females, and
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hyperactivity. The researcher also showed that
industry-funded studies show no health effects of BPA
exposure, while government-funded studies generally show
effects. The researcher showed that low doses, not high
doses, of BPA stimulate proliferation of human prostate cancer
cells, and that elevated levels of BPA in the blood are
associated with recurrent miscarriages, obesity, and
polycystic ovarian disease.
In February 2009, the Assembly ES&TM and Health Committees held
a joint informational hearing on the Green Chemistry
Initiative. Representatives from DTSC and OEHHA reported on
their progress in implementing Green Chemistry.
9)FEDERAL ACTIONS CONCERNING BPA . FDA issued a draft
assessment, dated August 2008, finding that BPA remains safe
in food contact materials. On October 31, 2008, the FDA
Science Board Subcommittee on BPA raised concerns over the
whether the draft assessment had adequately considered the
most recent scientific information available. FDA states it
is again reviewing the science of BPA and intends to explain
the results of this review in late summer or early fall. In
March of this year, U.S. Senators Dianne Feinstein and Chuck
Schumer introduced S. 593 and Congressman Edward Markey
introduced H.R. 1523 to establish a federal ban on BPA in all
food and beverage containers. In June 2009, Congressman John
Dingell introduced the federal Food Safety Enhancement Act,
H.R. 2749, which requires the Secretary of the U.S. Department
of Health and Human Services to examine the evidence
concerning BPA.
10)OTHER GOVERNMENT ACTIONS RELATED TO BPA . In October 2008,
the Canadian government announced that it would ban the use of
BPA in baby bottles, and take measures to limit the release of
BPA in the environment. In March 2009, Suffolk County, New
York became the first place in the nation to enact a BPA ban.
Minnesota also banned BPA in baby bottles and cups, and in
June 2009, Connecticut acted to ban BPA in all children's
feeding products, including formula cans, and the full range
of reusable food and beverage containers. The European Food
Safety Authority, however, and the United Kingdom Food
Standards Agency recently reaffirmed their position that BPA
is safe at a daily intake below 0.05 milligrams/kilogram of
body weight.
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11)BPA IN THE MARKETPLACE . Numerous manufacturers and retailers
have decreased or halted sales of children's products
containing BPA, and quickly increased the availability of
BPA-free products. Wal-Mart announced in April 2008 that it
would immediately halt sales of baby bottles, "sippy cups,"
pacifiers, food containers, and water bottles made with BPA in
its Canadian stores, and that it would stop selling baby
bottles made with BPA in its U.S. stores in early 2009. Toys
"R" Us also announced it would stop selling baby bottles and
other baby feeding products containing BPA by the end of 2008.
Whole Foods stopped selling polycarbonate baby bottles and
child drinking cups. Eden Foods has eliminated BPA in cans
for some foods. According to the Milwaukee Journal Sentinel,
gas and chemical maker Sunoco, citing uncertainty over the
safety of BPA, announced in March that it will require its
customers to guarantee that they will not use BPA in food and
water containers for children under three years.
12)AMENDMENTS TO BE TAKEN IN COMMITTEE . On June 30, 2009, the
Assembly ES&TM Committee approved the following amendments to
Section 3 of this bill, to be adopted in Assembly Health
Committee:
"(e) In lieu of the provisions of subdivision (a) and (b), the
Department of Toxic Substances Control may take a regulatory
response pursuant to sections 25253 to limit exposure or
reduce the level of hazard posed by bisphenol A.
(f) Notwithstanding subdivision (b), the provisions of this
bill relating to bottles and cans that contain liquid infant
formula shall go into effect on July 1, 2011 unless the
Department of Toxic Substances Control takes a regulatory
response pursuant to section 25253 to limit exposure or reduce
the level of hazard posed by bisphenol A for the products
specified in this subdivision.
(g) Notwithstanding 25257.1(b) and (c), nothing in this section
shall prohibit or restrict the authority of the Department of
Toxic Substances Control to adopt regulations to limit
exposure or reduce the level of hazard posed by bisphenol A."
13)PRIOR LEGISLATION .
a) SB 1713 (Migden) of 2008 was nearly identical to this
bill. SB 1713 failed passage on the Assembly Floor.
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b) SB 509 (Simitian), Chapter 560, Statutes of 2008
requires DTSC to establish a Toxics Information
Clearinghouse, as specified, and defines terms relating to
the Green Chemistry program to be administered by DTSC.
c) AB 1879 (Feuer and Huffman), Chapter 559, Statutes of
2008 requires DTSC, by January 1, 2011, to adopt
regulations to establish a process to identify and
prioritize chemicals or chemical ingredients in products
that may be considered a "chemical of concern," in
accordance with a review process, as specified.
d) AB 2694 (Ma) of 2008 would have prohibited the use of
lead above a specified level in children's products, as
defined. AB 2694 was not heard in the Senate Health
Committee at the request of the author.
e) AB 1108 (Ma), Chapter 672, Statutes of 2007 prohibits
the use of phthalates in toys and childcare products
designed for babies and children under three years of age.
f) AB 319 (Chan) of 2006 would have prohibited the use of
phthalates and BPA in toys and childcare products designed
for babies and children under three years of age. AB 319
failed passage in the Assembly Appropriations Committee.
14)SUPPORT . EWG, sponsor of this bill, writes in support that
infant formula is an important source of children's exposure
to BPA, and according to a 2003 Environmental Health
Perspectives study, BPA contamination of canned beverages and
foods became a matter of concern in Japan, and in 1997 most
major manufacturing companies changed the interior can
coatings to eliminate or reduce the use of BPA. EWG and
Natural Resources Defense Council argue that California cannot
afford to wait for the Green Chemistry process because we know
now that BPA is harmful. Consumers Union (CU) writes in
support that the safety standard for BPS is more than 20 years
old, and based on a few animal studies that lacked proper
controls. CU states it would like to see BPA banned in all
products that come into contact with foods and beverages, but
applaud this bill, which they assert will protect infants and
small children, who are most vulnerable to developmental
problems from exposure. Clean Water Action states that while
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some companies are acting to phase BPA out of their products,
many are not.
U.S. Senator Dianne Feinstein writes in support that while
members of Congress are increasingly concerned about BPA and
working on chemical policy reform, California should continue
to lead by reducing children's exposure to dangerous
substances like BPA whenever possible. The County of Santa
Clara Board of Supervisors states it supports this bill
because preventing illness and toxic exposure saves time,
money and lives. The County of Alameda, County of Marin, and
County of Los Angeles Boards of Supervisors also write they
support this bill to protect the health of children and
toddlers.
Commonweal states that federal regulations continue to rely on
long-outdated assessments of BPA, which makes action at the
state level critical to drive needed policy change. Planned
Parenthood Affiliates of California argues in support that
current regulation of chemicals in children's products is
woefully inadequate. The California WIC Association writes
that this bill is consistent with its mission of keeping
children and families healthy. A number of supporters,
including the Breast Cancer Fund, California Nurses
Association / National Nurses Organizing Committee, Asian
Health Services, Making Our Milk Safe (M.O.M.S.), Service
Employees International Union (SEIU), Physicians for Social
Responsibility: Los Angeles, San Diego Coastkeeper,
Environment California, Consumer Federation of California,
California Teamsters Public Affairs Council, Breastfeeding
Task Force of Greater Los Angeles, Healthy Child Healthy
World, and Asian Law Caucus, write that BPA is known to
disrupt the endocrine system, and there are over 200 studies
that document the adverse impacts of this dangerous chemical
on human development. These supporters write that safe
alternatives to BPA are already on the market, as some major
manufacturers have already taken the responsible path toward
eliminating these hazards from their products. Zero Breast
Cancer writes that many studies show that BPA alters genes and
may be associated with numerous health problems, including
breast cancer. California Association of Sanitation Agencies
writes in support that there is currently no means to
eradicate BPA from the waste stream. The California League of
Conservation Voters contends that the strategy of opponents of
this bill is to raise doubts and confusion about the dangers
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of BPA, and argues in support of this bill that no entity in
the state other than the Legislature is in a position to act.
15)OPPOSITION . Trade associations, including the American
Chemistry Council, California Grocers Association, California
League of Food Processors, California Manufacturers and
Technology Association, Can Manufacturers Institute, Chemical
Industry Council of California, Juvenile Products
Manufacturers Association, Industrial Environmental
Association, Santa Barbara Technology and Industry
Association, and the California Chamber of Commerce write in
opposition that safety assessments of BPA have been
comprehensively examined by many government and scientific
bodies worldwide, which have all reached conclusions that
consistently support the continued safe use of BPA in its
current applications. These organizations further argue that
DTSC is moving expeditiously to implement the Green Chemistry
Initiative, which represents a balanced, science-based, and
more expansive approach to addressing potentially harmful
chemicals, and puts an end to chemical-by-chemical bans.
North American Metal Packaging Alliance, Inc. contends that
BPA is needed to protect the integrity of food products and
that FDA will be issuing a decision on BPA in the near future.
The International Formula Council (IFC) states that switching to
alternative packaging is not a simple process and could take
years as the industry must go through a number of steps to
ensure that any new packaging materials provide at least the
same level of quality and safety provided by their current
packaging. IFC asserts that because few viable alternatives
currently exist, this bill would drastically reduce the
availability of infant formula for the hundreds of thousands
of California families who safely feed their babies infant
formula. The Grocery Manufacturers Association writes that
the CDC recently published data from a large-scale study which
shows that typical human daily intake of BPA is one million
times less than the levels that showed no adverse effects in
multi-generational animal studies, and 1,000 times less than
the very conservative regulatory limits set by the U.S. and
European governments. The Civil Justice Association of
California and California Citizens Against Lawsuit Abuse argue
that this bill will lead to more lawsuits against
manufacturers and users of BPA.
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16)SECOND COMMITTEE OF REFERENCE . This bill was previously
heard in Assembly ES&TM Committee, and was approved on a 5-2
vote with amendments to be adopted in Assembly Health
Committee, as discussed under 12) above.
17)TECHNICAL AMENDMENT . On page 4, line 4, insert "list of
chemicals known to cause cancer or reproductive toxicity."
REGISTERED SUPPORT / OPPOSITION :
Support
Environmental Working Group (sponsor)
United States Senator Dianne Feinstein
Alliance of California Autism Organizations
Asian Health Services
Asian Law Caucus
Breast Cancer Fund
Breastfeeding Task Force of Greater Los Angeles
California Association of Sanitation Agencies
California League of Conservation Voters
California Nurses Association / National Nurses Organizing
Committee
California Public Interest Research Group (CALPIRG)
California State PTA
California Teamsters Public Affairs Council
California WIC Association
City and County of San Francisco
Clean Water Action
Commonweal
Consumer Federation of California
Consumers Union
Consumers Union
County of Alameda Board of Supervisors
County of Los Angeles Board of Supervisors
County of Marin Board of Supervisors
County of Santa Clara Board of Supervisors
Environment California
Environmental Working Group
Healthy Child Healthy World
Making Our Milk Safe (M.O.M.S.)
Mothers of Marin Against the Spray
National WIC Association
Natural Resources Defense Council
Physicians for Social Responsibility: Los Angeles
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Planned Parenthood Affiliates of California
San Diego Coastkeeper
Service Employees International Union
Sierra Club California
Women's Foundation of California
Zero Breast Cancer
Opposition
American Chemistry Council
California Chamber of Commerce
California Citizens Against Lawsuit Abuse
California Grocers Association
California League of Food Processors
California Manufacturers and Technology Association
Can Manufacturers Institute
Chemical Industry Council of California
Civil Justice Association of California
Consumer Specialty Products Association
Grocery Manufacturers Association
Industrial Environmental Association
International Formula Council
Juvenile Products Manufacturers Association
North American Metal Packaging Alliance, Inc. (NAMPA)
Santa Barbara Technology and Industry Association
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097