BILL ANALYSIS
SB 797
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Date of Hearing: June 30, 2009
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Wesley Chesbro, Chair
SB 797 (Pavley) - As Amended: June 25, 2009
SENATE VOTE : 21-16
SUBJECT : Product safety: bisphenol A.
SUMMARY : Prohibits the sale, manufacture or distribution of a
bottle or cup or a liquid, food or beverage in a can, jar or
plastic bottle that contains bisphenol A if the item is
primarily intended for children three years of age or younger.
Specifically, this bill :
1)Enacts the Toxin-Free Infants and Toddlers Act.
2)Prohibits the sale, manufacture or distribution of any bottle
or cup that contains bisphenol A, at a level above 0.1 parts
per billion (ppb), if the bottle or cup is designed or
intended to be filled with a liquid, food, or beverage
intended primarily for consumption by children three years of
age or younger.
3)Prohibits the manufacture, sale, or distribution of a liquid,
food, or beverage in a can, jar, or plastic bottle containing
bisphenol A, or lined with a material containing bisphenol A,
at a level above 0.1 ppb, if the liquid, food, or beverage is
intended primarily for consumption children three years of age
or younger.
4)Exempts from the above prohibitions food and beverage
containers designed or intended primarily to contain liquid,
food, or beverages for consumption by the general population.
5)Requires manufacturers to use the least toxic alternative when
replacing bisphenol A in containers.
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6)Prohibits manufacturers from replacing bisphenol A with
carcinogens or reproductive toxicants as identified by the
United States Environmental Protection Agency (US EPA) or as
listed in the Safe Drinking Water and Toxic Enforcement Act of
1986 (Proposition 65).
7)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, as defined.
2)Prohibits the manufacture, sale and distribution of toys that
are contaminated with any toxic substance.
3)Under the Safe Drinking Water and Toxic Enforcement Act of
1986 (Proposition 65):
a) Requires the office of Environmental Health Hazard
Assessment (OEHHA) to publish a list of chemicals known to
cause cancer or reproductive toxicity and to annually
revise the list.
b) Prohibits the discharge or release of a chemical known
to the state to cause cancer or reproductive toxicity into
water, or onto or into land from which the chemical may
pass into drinking water.
c) Prohibits the knowing and intentional exposure of people
to a chemical known to the state to cause cancer or
reproductive toxicity without first giving clear and
reasonable warning.
4)Requires the Department of Toxic Substances Control (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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5)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.
6)Under the Toxic Substances Control Act of 1976 (TSCA),
authorizes US EPA to track industrial chemicals produced or
imported into the United States.
FISCAL EFFECT : Unknown.
COMMENTS :
Purpose : According to the author's office, "SB 797 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 bisphenol A, 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. Because
children's bodies are growing and developing, they are
especially vulnerable to the effects of BPA. 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 indicating a problem with BPA in
food and beverage products. While the author fully supports the
Green Chemistry Initiative, the author believes BPA poses a
clear and present danger 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 alternative products are available."
What is bisphenol A ? According to the National Toxicology
Program (NTP) at the US Department of Health and Human Services,
bisphenol A, also known as BPA, is a chemical produced in large
quantities for use primarily in the production of polycarbonate
plastics and epoxy resins. Polycarbonate plastics have many
applications including use in certain food and drink packaging,
water and infant bottles, compact discs, impact-resistant safety
equipment, and medical devices. Polycarbonate plastics are
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typically clear and hard and marked with the recycle symbol "7"
or may contain the letters "PC" near the recycle symbol. Epoxy
resins are used as lacquers to coat metal products such as food
cans, bottle tops, and water supply pipes. Some polymers used
in dental sealants or composites contain bisphenol A-derived
materials. In 2004, the estimated production of bisphenol A in
the United States was approximately 2.3 billion pounds, most of
which was used in polycarbonate plastics and resins.
Pathways of exposure: The NTP maintains that the primary source
of exposure to bisphenol A for most people is through diet.
While air, dust, and water are other possible sources of
exposure, bisphenol A in food and beverages accounts for the
majority of daily human exposure. Bisphenol A can migrate into
food from food and beverage containers with internal epoxy resin
coatings and from consumer products made of polycarbonate
plastic such as baby bottles, tableware, food containers, and
water bottles. Bisphenol A can also be found in breast milk and
dental sealants or composites. Workers may be exposed during
the manufacture of bisphenol A and bisphenol A-containing
products.
Biomonitoring studies show that human exposure to bisphenol A is
widespread. In 2004, the Centers for Disease Control and
Prevention (CDC) found detectable levels of bisphenol A in 93%
of 2517 urine samples from people 6 years and older (the study
did not include children younger than six). The NTP study shows
that the highest estimated daily intakes of bisphenol A in the
general population occur in infants and children.
Health concerns related to bisphenol A : The scientific
literature on bisphenol A is complex, rapidly expanding and
seemingly pointing toward negative human health effects due to
bisphenol A exposure. The NTP-CERHR Monograph on the Potential
Human Reproductive and Developmental Effects of Bisphenol A is
the most thorough scientific literature review completed by a
governmental agency to date. Released in September 2008, the
monograph was prepared following a formal review and evaluation
process that included public comment and peer review. Regarding
bisphenol A exposure, the NTP found:
Some concern for effects on the brain, behavior, and
prostate gland in fetuses, infants, and children at current
human exposures to bisphenol A.
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Minimal concern for effects on the mammary gland and an
earlier age for puberty for females in fetuses, infants,
and children at current human exposures to bisphenol A.
Negligible concern that exposure of pregnant women to
bisphenol A will result in fetal or neonatal mortality,
birth defects, or reduced birth weight and growth in their
offspring.
Negligible concern that exposure to bisphenol A will
cause reproductive effects in non-occupationally exposed
adults.
Minimal concern for workers exposed to higher levels in
occupational settings.
(Note that the possible levels of concern, from lowest to
highest, are negligible concern, minimal concern, some concern,
concern, and serious concern.)
Since a similar bill was heard in the Assembly last year, dozens
of additional studies chronicling potential adverse effects of
bisphenol A exposure have been published in scientific journals,
including studies with findings beyond potential reproductive
and developmental toxicity. For example, a study published in
the September 17, 2008 issue of the Journal of the American
Medical Association found that higher levels of urinary
bisphenol A in humans is associated with cardiovascular disease,
diabetes and liver-enzyme abnormalities.
California's Green Chemistry Initiative : In 2007, DTSC
commenced developing the California Green Chemistry Initiative,
and in December, 2008, it released six policy recommendations
for establishing a comprehensive Green Chemistry program in
California. Last year, the Governor signed AB 1879 and SB 509
into law, which enacted two of the six recommendations. 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.
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The Green Chemistry program should yield a comprehensive process
to identify and manage chemicals of concern and their
alternatives. However, the program is in the developmental
stage and there are not yet chemicals being considered at this
time. AB 1879 and SB 509 did not specifically preclude the
Legislature from acting on chemicals that pose threats to public
health and the environment.
Bisphenol A and Proposition 65 : OEHHA is the lead agency for
the implementation of Proposition 65. The Developmental and
Reproductive Toxicant Identification Committee (DARTIC) of
OEHHA's Science Advisory Board advises and assists OEHHA in
compiling the list of chemicals known to the state to cause
reproductive toxicity. DARTIC, which is compiled of qualified
scientific experts, will consider the listing of bisphenol A at
its next meeting on Wednesday, July 15, 2009.
Trends in bisphenol A management: As anxiety about the health
effects of bisphenol A exposure rises and more studies on the
chemical are published, the trend is to restrict bisphenol A in
products intended for use by children, especially. Last year,
Canada became the first country in the world to ban the import
and sale polycarbonate baby bottles containing bisphenol A. The
government also pledged to spend $1.7 million over three years
to study the chemical. This year, Minnesota and Connecticut
passed similar bans, as did the city of Chicago and counties in
California and New York. A ban is under consideration in New
York. A nationwide ban has also been proposed by Congress.
In March, six baby bottle manufacturers confirmed their
intention to stop using bisphenol A in their bottles sold in the
US but will continue to sell the bottles in the UK. Major
retailers and manufacturers, such as Wal-Mart and Toys R Us,
have publically promised to phase out the use of bisphenol A in
children's products.
Setting standards in statute: The sponsors of the bill indicate
that bisphenol A has been shown to adversely affect human health
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with exposure in the parts per trillion range, down to 25 parts
per trillion and lower. To be adequately protective of public
health, sponsors indicate that independent scientists point to a
detectable level of 0.01 ppb bisphenol A. However, the sponsors
note that 0.1 ppb, the standard in the bill, is the lowest level
of bisphenol A that is reliably detectable at this time. Is it
appropriate to set standards in statute, where they cannot be
readily adjusted after consideration of new scientific evidence
or advances in technology, or is it more effective to set
standards through the regulatory process, which is more dynamic?
State authority and oversight: Just like California's current
prohibition on the use of phthalates in children's products,
this bill does not extend express enforcement authority to any
state agency. Enforcement of the provisions of this bill would
most likely occur under Unfair Competition Law. Additionally,
since Health and Safety Code 25257.1 (c) prohibits DTSC from
duplicating or adopting conflicting regulations for product
categories already regulated or subject to pending regulation,
it is unclear if, in the future, DTSC could take any action on
the products covered by this bill, even under the Green
Chemistry program. Should a state agency, such as DTSC, be
expressly authorized to enforce the provisions of this bill?
Regrettable alternatives : When a specific substance is banned,
the alternative may result in even more severe public health and
environmental consequences than were brought about by the
original substance. To avoid this problem, alternatives to
bisphenol A should be analyzed to limit exposure and to reduce
the level of hazard they may pose. Additionally, hazard traits
beyond carcinogenicity and reproductive toxicity (such as
endocrine disruption, neurological damage, etc.) should be
considered when determining allowable alternatives. Such a
process is delineated in the Green Chemistry Initiative.
Arguments in support : According to the Consumers Union,
"Consumers Union was one of the first organizations to test and
report on bisphenol A in consumer products, warning consumers
about the potential risks almost a decade ago. Since Consumers
Union's first study, more than a hundred studies have been
published showing a wide range of adverse effects in animals at
low doses of bisphenol A, doses that approximate current levels
circulating in the human population. In just this past year,
studies have linked BPA exposure to human health problems like
infertility, diabetes, and cardiovascular risk." Environmental
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Working Group contends, "When the federal government will not
act or drags its feet, it can become necessary for a state to
lead the way when it comes to protecting children from the most
toxic chemicals in consumer products? California cannot afford
to wait to see how the recently enacted Green Chemistry process
will work for a chemical like BPA because it is clear that we
might wait years for that process to be worked out. We know
right now that BPA is harmful and action is needed now." Breast
Cancer Fund writes, "BPA is known to disrupt the endocrine
system... There are over 200 studies that document the adverse
impacts of this dangerous chemical on human development? Safe
alternatives for BPA are already on the market."
Arguments in opposition: The Civil Justice Coalition of
California opposes the bill because they contend that the
science behind the proposed ban is weak; banning bisphenol A
will lead to more lawsuits; scientists, not legislators, should
decide chemical safety; and this bill already died (in the form
of SB 1713, 2009). A coalition of other opponents, including
the American Chemistry Council and the California Chamber of
Commerce, contend that, "The scientific evidence supporting the
safety of BPA has been comprehensively examined by many
government and scientific bodies worldwide in recent years?
These bodies have all reached conclusions that consistently
support the continued safe use of bisphenol A in its current
applications? Assessing chemical and product safety is a
complex undertaking, requiring extensive scientific expertise
and rigorous analysis. It is for this reason that the
California Legislature last year adopted in a bi-partisan manner
arguably the world's most comprehensive chemical management
regulatory program for consumer products? The Green Chemistry
program is the most appropriate venue for assessing consumer
product and chemical safety. SB 797 would circumvent the
science-based Green Chemistry program?"
Proposed committee amendments : The committee may wish to
consider the following amendments, which, due to time
constraints, the author will need to take in the Assembly Health
Committee.
1)Integrate the proposed bisphenol A ban, as specified by this
bill, with the Green Chemistry process as specified in Health
and Safety Code Sections 25252 and 25253, as established by AB
1879 (2008).
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2)Add: Notwithstanding 25257.1 (b) and (c), nothing in this
section shall prohibit or restrict the authority of the
department to take actions on a chemical or chemical
ingredient pursuant to Sections 25252 and 25253.
Prior legislation : In 2008, Senators Migden and Perata authored
SB 1713, an almost identical bill to SB 797. SB 1713 failed
passage on the Assembly floor.
Double referral : This bill was double-referred by the Assembly
Rules Committee to the Assembly Health Committee.
REGISTERED SUPPORT / OPPOSITION :
SUPPORT
Environmental Working Group (sponsor)
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 (CASA)
California League of Conservation Voters (CLCV)
California Nurses Association
California Nurses Foundation
California State PTA
California Teamsters Public Affairs Council
California Public Interest Research Group (CALPIRG)
California WIC Association
Clean Water Action
Commonweal
Consumer Federation of California
Consumers Union
County of Los Angeles
County of Marin Board of Supervisors
County of Santa Clara Board of Supervisors
County and City of San Francisco
Diane Feinstein, United State Senator
Environment California
Environmental Working Group
Heal the Bay
Healthy Child Healthy World
Making Our Milk Safe (M.O.M.S.)
Mothers of Marin Against the Spray
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Natural Resource Defense Council
Physicians for Social Responsibility: Los Angeles
Planned Parenthood Affiliates of California
Planning and Conservation League
San Diego Coast Keeper
Service Employees International Union (SEIU)
Sierra Club, California
The Women's Foundation of California
Zero Breast Cancer
OPPOSITION
American Chemistry Council
California Chamber of Commerce
California Citizens Against Lawsuits Abuse
California Council for Environmental and Economic Balance
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)
Pharmaceutical Research and Manufacturers of American (PhRMA)
Santa Barbara Technology and Industry Association
Analysis Prepared by : Shannon McKinney / E.S. & T.M. / (916)
319-3965