BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1319
A
AUTHOR: Butler
B
AMENDED: May 10, 2011
HEARING DATE: June 15, 2011
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REFERRAL: Environmental Quality
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CONSULTANT:
1
Orr
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SUBJECT
Product safety: bisphenol A
SUMMARY
Enacts the Toxin-Free Infants and Toddlers Act, prohibiting
the sale, manufacture, or distribution of any infant
formula, liquid, baby food, or beverage that contains
bisphenol A (BPA) on or after July 1, 2013, as specified.
CHANGES TO EXISTING LAW
Existing law:
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 percent. Defines a "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.
Continued---
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Prohibits the manufacture, sale, and distribution of toys
that are contaminated with any toxic substance.
Requires the Department of Toxic Substances Control (DTSC),
to adopt regulations by January 1, 2011, to identify and
prioritize chemicals of concern, evaluate alternatives, and
specify regulatory responses to limit exposure or to reduce
the level of hazard posed by a chemical of concern found in
consumer products.
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.
Under the Safe Drinking Water and Toxic Enforcement Act of
1986 (commonly known as Proposition 65), requires the
Governor to publish and annually revise a list of chemicals
that have been scientifically proven to cause cancer or
reproductive toxicity each year. 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.
Under the Toxic Substances Control Act of 1976, authorizes
the United States Environmental Protection Agency (US EPA)
to track industrial chemicals produced or imported into the
United States.
Prohibits the sale of children's jewelry containing lead or
cadmium.
This bill:
Enacts the Toxin-Free Infants and Toddlers Act, prohibiting
the sale, manufacture, or distribution in commerce of any
bottle or cup that contains BPA at a level above 0.1 parts
per billion (ppb), if its primary intent is to be filled
with liquids, foods, or beverages for infants or children
three years of age or younger, on and after July 1, 2013.
Prohibits the sale, manufacture, or distribution of any
infant formula, liquid, baby food, or beverage containing
BPA at a level above 0.1 ppb if its primary intent is to be
consumed by infants or children three years of age or
younger, on and after July 1, 2013.
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Exempts medical devices, as defined, and food and beverage
containers designed or intended primarily to contain
liquid, food, or beverages for consumption by the general
population.
Requires that the maximum amount of BPA allowable be based
on the infant formula, liquid, baby food, or beverage as it
is intended or directed to be consumed.
Requires that the above provisions no longer be implemented
if the Department of Toxic Substances Control (DTSC) adopts
regulations regarding the use of BPA in an abovementioned
item and DTSC posts a notice on its web site regarding the
regulations.
Specifies that these provisions are not intended to
prohibit or restrict DTSC from adopting regulations to
limit exposure to or reduce the level of hazard posed by
BPA.
Requires manufacturers to use the least toxic alternative
when replacing BPA in items specified by this bill.
Prohibits manufacturers from replacing BPA with carcinogens
or reproductive toxicants as identified by the US EPA or
listed in the Safe Drinking Water and Toxic Enforcement Act
of 1986, as specified.
Makes a number of findings and declarations related to BPA,
its pervasiveness in humans and the environment, and its
health effects.
FISCAL IMPACT
This bill is keyed non-fiscal.
BACKGROUND AND DISCUSSION
According to the author, AB 1319 is a child safety measure
that seeks to protect infants and toddlers from a harmful
toxin that leaches into babies' milk and food. The author
asserts that while most consumers believe that everyday
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products are tested for dangerous chemicals and determined
to be safe by government authorities, the reality is that
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. Because children's bodies are
growing and developing, the author claims 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, which indicate
that BPA leaches into food and beverage products and is
toxic at even extremely low doses.
The author believes it is in the best interest of
California to reduce infants' and toddlers' exposure to BPA
as soon as possible. The author argues that California's
Green Chemistry program will not come to fruition soon
enough to protect the 550,000 babies born in California
each year from the health risks of BPA. Furthermore, the
author claims that infant formula and baby food is exempted
by law from the Green Chemistry program.
BPA
According to the federal Centers for Disease Control and
Prevention (CDC), BPA is used to manufacture polycarbonate
plastics. This type of plastic is used to make a wide
variety of consumer products, including some types of
beverage and food containers, compact disks, plastic
dinnerware, impact-resistant safety equipment, including
shatter-resistant baby bottles, automobile parts,
sunglasses and toys. BPA epoxy resins are often used in the
protective linings of food cans, in dental sealants, and in
other products.
BPA has been used for more than 40 years in the manufacture
of many hard plastic food containers such as baby bottles
and reusable cups as well as the lining of metal food and
beverage cans, including canned liquid infant formula.
Trace amounts of BPA can be found in some foods packaged in
these containers.
BPA exposure
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General exposure to BPA at low levels comes from eating
food or drinking water stored in containers that have BPA.
Small children may be exposed by hand-to-mouth and direct
oral contact with materials containing BPA. Dental
treatment with BPA-containing sealants also results in
short-term exposure. In addition, workers who manufacture
products that contain BPA can be exposed.
According to a National Toxicology Program (NTP) Draft
Brief on BPA issued in April of 2008, 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, and higher temperatures cause more migration.
Short-term exposure can occur following application of
certain dental sealants or composites made with BPA-derived
material.
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 CDC found
detectable levels of BPA in 93 percent 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 twelve
months had much higher intake levels of BPA than breast-fed
infants less than six months of age, and higher than adults
in the general population, due to polycarbonate formula
bottles, epoxy formula can linings, canned foods, and
polycarbonate tableware. 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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Health impacts 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 or lack of adjustment for
potential confounders. However, a group of scientists
convened by the National Institutes of Health have
concluded that animal studies of BPA should be considered a
valid indicator of potential harm to humans.
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 early
onset of 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, decreased
sperm production and motility, and abnormal sperm formation
associated with infertility.
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. In
laboratory animals, developmental exposure to BPA at doses
comparable to human exposures appear to cause changes that
may increase the 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.
Reduced use of BPA
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
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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 has 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 2009
that it will require its customers to guarantee that they
will not use BPA in food and water containers for children
under three years.
California's Green Chemistry Initiative
For the last century, environmental protection has
concentrated on storing and disposing hazardous waste.
Green chemistry is a fundamentally new approach to
environmental protection, transitioning away from managing
toxic chemicals at the end of the lifecycle, to reducing or
eliminating the toxicity of chemicals from the start. Green
chemistry is the design of chemical products and processes
that reduce or eliminate the use or generation of hazardous
substances. Green chemistry applies across the life cycle
of a chemical product, including its design, manufacture,
and use. It intends to address chemicals before they
become hazards, with the goal of making chemicals and
products "benign by design."
The California Green Chemistry Initiative (Initiative) was
launched in April 2007 as a collaborative arrangement with
the California Environmental Protection Agency (Cal/EPA)
boards, departments and offices, as well as other state
agencies. The initiative seeks to identify options to
significantly reduce the impacts of toxic chemicals on
public health and the environment, and its purpose is to
develop policy options for implementing green chemistry
principles and promote better coordination of laws intended
to manage single chemicals. As the lead agency for the
Initiative, DTSC has conducted a broad public process to
generate ideas and develop overall policy goals, and has
made recommendations for a comprehensive green chemistry
policy framework for the state. In December 2008, the
Initiative released six policy recommendations for
establishing a comprehensive Green Chemistry program in
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California, of which Governor Schwarzenegger signed two
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 a draft regulation in June 2010.
DTSC submitted a proposed regulation to the Office of
Administrative Law (OAL) in September 2010 that included
changes made as a result of the stakeholder and public
input process. The Green Chemistry Proposed Regulation for
Safer Consumer Products was submitted to the state OAL to
begin the official rulemaking process. In December 2010,
the California Office of Environmental Health Hazard
Assessment (OEHHA) released 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.
Status of the Green Chemistry Initiative
AB 1879 (Feuer), Chapter 559, Statutes of 2008, required
DTSC to adopt regulations by January 1, 2011, to: (1)
establish a process by which chemicals or chemical
ingredients in products may be identified and prioritized
for consideration as being chemicals of concern, and (2)
adopt regulations to establish a process by which chemicals
of concern in products, and their potential alternatives,
are evaluated to determine how best to limit exposure or to
reduce the level of hazard posed by a chemical of concern.
In a letter to Assemblymember Mike Feuer in December 2010,
CalEPA Secretary Linda Adams claims that the most recent
draft of green chemistry regulations raised substantive and
valid concerns from the chemicals industry, environmental
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groups, scientists and legislative leaders. As a result,
Secretary Adams requested that DTSC take additional time to
be responsive to the concerns raised, and that DTSC
reconvene the Green Ribbon Science Panel early in 2011 to
further vet the programmatic issues that were brought to
DTSC's attention via the public comment process. In March
2011, Secretary Adams hosted stakeholder meetings to hear
concerns and to discuss next steps. The Green Ribbon
Science Panel has essentially been asked to start over and
has now organized itself into three subcommittees to
address a issues pertaining to the earlier aspects of the
process in the regulations:
Product Identification and
Prioritization,
Chemical identification and
prioritization , and
De Minimis and Unintentionally-Added
Chemicals.
Each subcommittee met twice in April this year, and the
issues discussed in the subcommittees were further
discussed at the full Green Ribbon Science Panel meeting
this past May. DTSC now hopes to issue new draft
regulations by August of this year.
Legislative hearings on toxics
In January 2006, the Assembly Environmental Safety and
Toxic Materials Committee and the 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 the levels at which people
are exposed to these chemicals pose no risk. A leading
researcher on the effects of BPA testified on 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
testified 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.
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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.
Other actions on BPA
In 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 NTP at the National Institutes of Health and the
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
carry out in-depth studies to answer key questions and
clarify uncertainties about the risks of BPA in cooperation
with the NTP and FDA's National Center for Toxicological
Research. In March 2010 the EPA declared BPA a "chemical
of concern." It later announced it would initiate an
assessment under its Design for the Environment (DfE)
program, to encourage reductions in BPA releases and
exposures. The DfE environmental and health assessment is
expected to be completed in the latter half of 2011.
There have also 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.
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 has 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. In August 2010, the Maine Board
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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.
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.
Prior legislation
SB 797 (Pavley) of the 2009-10 Session was substantially
similar to this bill. SB 797 failed passage on the Assembly
Floor.
SB 509 (Simitian), Chapter 560, Statutes of 2008, requires
DTSC to establish a Toxics Information Clearinghouse, as
specified, and defines terms relating to a Green Chemistry
program to be administered by DTSC.
SB 1713 (Migden) of 2008 contained provisions similar to
this bill and would have prohibited the sale, manufacture
or distribution in commerce of food containers for children
that contain BPA above a specified level. SB 1713 failed
passage on the Assembly Floor.
AB 1879 (Feuer), 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.
AB 1108 (Ma), Chapter 672, Statues of 2007, prohibits the
use of phthalates in toys and childcare products designed
for babies and children under three years of age.
AB 2694 (Ma) of the 2007-2008 Session would prohibit a
person, firm, or corporation from manufacturing, selling,
or exchanging, having in his or her possession with intent
to sell or exchange, or expose, or offer for sale or
exchange to any retailer, any toy or child care article or
any other product intended for use by, or for the care of,
a child 12 years of age or younger, that contains a
lead-bearing substance, as defined. AB 2694 was set to be
heard in the Senate Health Committee, but was cancelled at
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the request of the author.
Arguments in support
Several supporters, including Environment California, Great
Beginnings for Black Babies, the US Autism and Asperger
Association, and the Silicon Valley Toxics Coalition, all
claim that there are many alternatives for the products
that are the subjects of AB 1319, and some major
manufacturers have already taken the responsible path
toward eliminating these hazards from their products. They
believe that AB 1319 will help ensure that products laden
with BPA are not channeled towards poorer communities.
The American Academy of Pediatrics, California (AAP-CA)
believes that while it is difficult to establish a causal
link, existing and emerging data are sufficient to warrant
banning BPA in products that are used for food consumption
by infants and children including infant formula and baby
food. The California WIC (Women, Infants and Children
program) Association believes that while breastfeeding is
best for infants, proper nutrition for infants should
strive to be BPA-free. To enforce that belief, CA WIC
provides BPA-free powdered infant formula to WIC clients.
CA WIC notes that WIC recipients often shop in discount
stores, which are least likely to sell BPA-free products.
Arguments in opposition
Several opponents, including the California Chamber of
Commerce, the Consumer Specialty Products Association and
the American Chemistry Council, all believe AB 1319 runs
contrary to the consensus of the scientific community and
of international regulatory agencies that have concluded
that BPA is safe as used. Opponents assert that the FDA has
not recommended that families change the use of infant
formulas or foods, because the benefit of a stable source
of good nutrition outweighs the potential risk of BPA
exposure. Opponents also claim that BPA does not
accumulate in the body and is rapidly eliminated in urine.
Opponents dispute the notion that alternatives are readily
available, and claim that any alternative coating is merely
a candidate material until safety and performance are
thoroughly evaluated.
PRIOR ACTIONS
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Assembly Environmental Safety and Toxic Materials:6- 2
Assembly Health: 12- 7
Assembly Floor: 42- 29
COMMENTS
1. Double Referral. This bill has also been referred to
the Senate Environmental Quality Committee.
POSITIONS
Support: Black Women for Wellness (co-sponsor)
Consumers Union (co-sponsor)
Environmental Working Group (co-sponsor)
Physicians for Social Responsibility-Los Angeles
(co-sponsor)
Alliance of California Autism Organizations
American Academy of Pediatrics, California
The American Congress of Obstetricians and
Gynecologists
Asian Communities for Reproductive Justice
Autism One
Autism Research Institute
Breast Cancer Fund
California League of Conservation Voters
California Medical Association
California Nurses Association
California WIC Association
Californians for a Healthy & Green Economy
Center For Environmental Health
Children Now
Clean Water Action
Commonweal
Consumer Federation of California
County of Los Angeles Board of Supervisors
County of Santa Clara Board of Supervisors
EcoMom Alliance
Environment California
First 5 Fresno County
First 5 LA
Food & Water Watch Green to Grow
Great Beginnings for Black Babies
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Healthy Child Healthy World
Los Angeles County Board of Supervisors
Making Our Milk Safe (MOMS)
Moms Advocating Sustainability
Natural Resource Defense Council
Planned Parenthood Advocacy Project Los Angeles
County
Planned Parenthood Affiliates of California
Planning and Conservation League
Reproductive Justice Association of Los Angeles
SF Environment
Sierra Club of California
Silicon Valley Toxics Coalition
St. John's Well Child and Family Center
Teens Turning Green
U.S. Autism & Asperger Association
United States Senator Dianne Feinstein
One individual
Oppose: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.
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