BILL ANALYSIS Ó
AB 1319
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Date of Hearing: May 3, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 1319 (Butler) - As Amended: April 28, 2011
SUBJECT : Product safety: bisphenol A.
SUMMARY : Enacts the Toxin-Free Infants and Toddlers Act and
prohibits the sale, manufacture, or distribution of a bottle,
cup, liquid, baby food, formula, or beverage that contains
bisphenol A (BPA), as specified, if it is primarily intended for
children three years of age or younger. Specifically, this
bill :
1)Prohibits, effective July 1, 2013, the sale, manufacture, or
distribution of any bottle or cup that contains BPA, at a
level above 0.1 parts per billion (ppb), if it is designed
for, or intended to be filled with a liquid, food, or beverage
intended primarily for consumption by, children three years of
age or younger.
2)Prohibits, effective July 1, 2013, the manufacture, sale, or
distribution of a liquid, baby food, formula, or beverage
containing BPA, at a level above 0.1 ppb, if it is intended
primarily for consumption children three years of age or
younger. Requires that the maximum amount of BPA permitted be
based on the likely concentration of the infant formula,
liquid, baby food, or beverage that will be consumed.
3)Defines "baby food" to mean a prepared solid food consisting
of a soft paste that is intended primarily for consumption by
children three years of age or younger and that is
commercially available.
4)Exempts from the above prohibitions medical devices and food
and beverage containers designed or intended primarily to
contain liquid, food, or beverages for consumption by the
general population.
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5)Requires the provisions of this bill, if the Department of
Toxic Substances Control (DTSC) takes regulatory action
regarding the use of BPA under its Green Chemistry Initiative
for an item in 1) or 2) above, to cease to be implemented with
respect to that item upon the date that DTSC posts a notice on
its Internet Website that it has adopted the response.
Prohibits this bill from being construed to prohibit or
restrict the authority of DTSC to adopt regulations to limit
exposure to or reduce the level of hazard posed by BPA.
6)Requires manufacturers to use the least toxic alternative when
replacing BPA in containers in accordance with this bill.
Prohibits manufacturers from replacing BPA, pursuant to this
bill, with carcinogens or reproductive toxins identified by
the United States Environmental Protection Agency (EPA) or the
Safe Drinking Water and Toxic Enforcement Act of 1986
(Proposition 65) list of chemicals known to cause cancer or
reproductive toxicity.
7)Makes a number of findings and declarations related to BPA,
its pervasiveness in humans and the environment, and its
health effects.
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%. 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. Requires manufacturers to use the
least toxic alternative when replacing phthalates in products.
2)Prohibits the manufacture, sale, and distribution of toys that
are contaminated with any toxic substance.
3)Requires DTSC, to adopt regulations by January 1, 2011, to
identify and prioritize chemicals of concern, to evaluate
alternatives, and to specify regulatory responses to limit
exposure or to reduce the level of hazard posed by a chemical
of concern found in consumer products.
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4)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.
5)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.
6)Under the Toxic Substances Control Act of 1976, authorizes EPA
to track industrial chemicals produced or imported into the
United States.
7)Add lead and cadmium in children's jewelry prohibitions.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is a
child safety measure that seeks to protect infants and
toddlers from a harmful toxin that leaches into babies' milk
and food. While most consumers believe that everyday products
are tested for dangerous chemicals and determined to be safe
by government authorities, the reality is many children's
products contain toxic chemicals, such as BPA, that have been
shown to cause harm to children's health and the environment.
BPA has been linked to a number of long-term health impacts
such as birth defects, reproductive harm, impaired learning,
hyperactivity, and breast and prostate cancer. The author
states that regulation of BPA in children's products is
woefully inadequate and has not kept pace with the explosion
of government funded peer-reviewed studies in the last few
years, which indicate that BPA leaches into food and beverage
products and is toxic at even extremely low doses. The author
states that while she fully supports the Green Chemistry
Initiative, she believes BPA poses a clear and present danger
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and it may be several years before the Initiative is
implemented and regulatory reform will not occur fast enough
to protect children against a health risk that is well known
and where alternative products are available.
2)EXPOSURE TO BPA . According to the National Toxicology Program
(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 (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
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range to cause harm in animals and is therefore a health
concern for infants.
3)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 Ýdiscussed 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.
4)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
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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.
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.
5)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
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first place, rather than merely manage their toxic waste after
use and disposal.
In 2007, DTSC launched the California Green Chemistry
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. DTSC completed a two-year process of
stakeholder and public involvement and issued the draft
regulation on June 23, 2010. The Proposed Regulation was
submitted to state Office of Administrative Law (OAL)
September of 2010 and includes changes made as a result of
that consultation. The Green Chemistry Proposed Regulation
for Safer Consumer Products were submitted to the state OAL to
begin the official rulemaking process. In December 2010, the
California Office of Environmental Health Hazard Assessment
(OEHHA) released its proposed regulations that seek to
implement the mandate of SB 509 and identify four general
categories of hazard traits: Toxicological Hazard Traits;
Environmental Hazard Traits; Exposure Potential Hazard Traits;
and, Physical Hazard Traits.
6)INFORMATIONAL HEARINGS . In January 2006, the Assembly
Environmental Safety and Toxic Materials 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
hyperactivity. The researcher also showed that
industry-funded studies show no health effects of BPA
exposure, while government-funded studies generally show
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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, August 2010, and February 2011, the Assembly
Committees on Environmental Safety and Toxic Materials,
Health, and Natural Resources held oversight hearings on the
Green Chemistry Initiative. Representatives from DTSC and
OEHHA reported on their progress in implementing Green
Chemistry.
7)FEDERAL ACTIONS CONCERNING BPA . January 2010, the federal
Food and Drug Administration (FDA) announced that on the basis
of results from recent studies using novel approaches to test
for subtle effects, both the National Toxicology Program at
the National Institutes of Health and FDA have some concern
about the potential effects of BPA on the brain, behavior, and
prostate gland in fetuses, infants, and young children. The
FDA stated that it would be carrying out in-depth studies to
answer key questions and clarify uncertainties about the risks
of BPA in cooperation with the National Toxicology Program,
FDA's National Center for Toxicological Research. In March
2010 the EPA declared BPA a "chemical of concern" and later
announced it would initiate collaborative alternatives
assessment activities under its Design for the Environment
(DfE) program to encourage reductions in BPA releases and
exposures. This DfE environmental and health assessment is
expected to be completed in the latter half of 2011.
Additionally, EPA intends to initiate alternatives analyses
for BPA used in foundry castings since foundries are
accountable for large releases of BPA as reported under the
Toxic Release Inventory, and for BPA-based materials lining
water and waste water pipes since this application may have a
potential for human and environmental exposure. Prior to
this, there had been attempts in Congress to ban BPA. In
2009, 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. Congressman John Dingell also introduced
the federal Food Safety Enhancement Act, H.R. 2749, which
would have required the Secretary of the U.S. Department of
Health and Human Services to examine the evidence concerning
BPA.
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8)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. In August 2010, the Maine Board of Environmental
Protection voted unanimously to ban the sale of baby bottles
and other reusable food and beverage containers made with BPA
as of January 2012.
9)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.
10)PREVIOUS LEGISLATION . SB 797 (Pavley) of 2009 and SB 1713
(Migden) of 2008 were substantially similar to this bill and
contained a ban on the use of BPA in baby bottles and baby
food containers. AB 797 failed passage on the Senate Floor
and SB 1713 failed passage on the Assembly Floor.
11)DOUBLE REFERRAL . This bill was heard by the Assembly
Environmental Safety and Toxic Materials Committee on April
26, 2011 and passed by a vote of 6-2.
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12)TECHNICAL AMENDMENT . On page 4, beginning on line 28:
(c) The maximum amount of bisphenol A allowed pursuant to
subdivision (b) shall be based on the likely concentration of
the infant formula, liquid, baby food, or beverage that will
as it is intended or directed to be consumed.
REGISTERED SUPPORT / OPPOSITION :
Support
Alliance of California Autism Organizations
American Academy of Pediatrics
American Congress of Obstetricians and Gynecologist (California)
Asian Communities for Reproductive Justice
Autism One
Autism Research Institute
Black Women for Wellness
Breast Cancer Fund
California League of Conservation Voters
California Medical Association
California Nurses Association
California WIC Association
Californians for a Healthy and Green Economy
Center for Environmental Health
Children Now
Clean Water Action
Commonweal
Consumers Union
County of Santa Clara
East Yard Communities for Environmental Justice
EcoMom Alliance
Environment California
Environmental Working Group
First 5 LA
Food & Water Watch
Great Beginnings for Black Babies, Inc.
Green to Grow
Healthy Child Healthy World
Making Our Milk Safe
Moms Advocating Sustainability
Natural Resources Defense Council
Physicians for Social Responsibility
Reproductive Justice Coalition of Los Angeles
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San Francisco Department of Environment
Senator Dianne Feinstein
Sierra Club California
Silicon Valley Toxics Coalition
Solano County Board of Supervisors
St. John's Well Child & Family Center (Los Angeles)
Teens Turning Green
US Autism & Asperger Association
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Opposition
AdvaMed - Advanced Medical Technology Association
American Chemistry Council
California Chamber of Commerce
California Citizens Against Lawsuit Abuse
California Grocers Association
California Healthcare Institute
California League of Food Processors
California Manufacturers and Technology Association
Can Manufacturers Institute
Civil Justice Association of California
Consumer Specialty Products Association
Grocery Manufacturers Association
Industrial Environmental Association
International Formula Council
Juvenile Products Manufacturers Association
National Federation of Independent Business
North American Metal Packaging Alliance, Inc.
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097