BILL ANALYSIS �
AB 1319
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator S. Joseph Simitian, Chairman
2011-2012 Regular Session
BILL NO: AB 1319
AUTHOR: Butler
AMENDED: June 28, 2011
FISCAL: No HEARING DATE: July 6, 2011
URGENCY: No CONSULTANT:
Rachel Machi Wagoner
SUBJECT : PRODUCT SAFETY: BISPHENOL A
SUMMARY :
Existing law :
1)Under the Safe Drinking Water and Toxic Enforcement Act of
1986 (commonly known as Proposition 65), requires the
Governor to revise and publish a list of chemicals that have
been scientifically proven to cause cancer or reproductive
toxicity each year.
2)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 without first giving clear and reasonable warning,
nor can such chemicals be discharged into the drinking
water.
3)Prohibits the sale of toys that are contaminated with toxic
substances.
4)Prohibits the manufacture, processing, and distribution of
products containing certain chemicals found to raise health
risks, including polybrominated diphenyl ethers and
phthalates.
5)Requires the Department of Toxic Substances Control (DTSC),
by January 1, 2011, to adopt regulations to establish a
process to identify and prioritize chemicals or chemical
ingredients in consumer products that may be considered a
"chemical of concern," in accordance with a review process,
as specified.
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6)Requires DTSC, on or before January 1, 2011, to adopt
regulations to establish a process to evaluate chemicals of
concern, and their potential alternatives, in consumer
products in order to determine how best to limit exposure or
to reduce the level of hazard posed by a chemical of
concern, as specified.
This bill enacts the Toxin-Free Infants and Toddlers Act that:
1) Prohibits the manufacture, sale or distribution in commerce
of any bottle or cup, intended to be used to consume foods,
beverages or liquids by children under the age of three,
and contains more than 0.1 parts per billion (ppb) of
bisphenol-A (BPA) on or after July 1, 2013.
2) Requires manufacturers to use the least toxic alternative
when replacing BPA.
3) Prohibits manufacturers from replacing BPA with
cancer-causing chemicals and reproductive toxicants, as
specified.
4) Requires that the above provisions no longer be implemented
if DTSC adopts regulations regarding the use of BPA in an
above-mentioned item and DTSC posts a notice on its
Internet Web site regarding the regulations.
5) 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.
6) Makes findings and declarations regarding BPA.
COMMENTS :
1) Purpose of Bill . 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 products are tested for
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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.
2) What is BPA ? BPA was first synthesized in 1891, as a
synthetic estrogen by Dianin. Its estrogen properties were
not as strong as other estrogens, so it essentially took a
backseat. In 1930, the properties of BPA were investigated
and it made its return in the 1950s as polycarbonate and
epoxy resin; most commonly found in plastic bottles and the
inside lining of cans. BPA is used as a primary monomer
in polycarbonate plastic and epoxy resins. It is also used
as an antioxidant in plasticizers and as a polymerization
inhibitor in PVC.
Polycarbonates are widely used in many consumer products,
from sunglasses and compact discs to water and food
containers and shatter-resistant baby bottles. Some
polymers epoxy resins containing BPA are popular coatings
for the inside of cans used for food. Although disputed,
BPA has been shown to have hormone disrupting effects, and
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some mice studies have shown that it can produce
hyperactivity, faster growth in females and earlier onset
of puberty.
3) Exposure Pathways . 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
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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.
4) University of California, San Francisco (UCSF) Program on
Reproductive Health and the Environment (PRHE) Study on
Pregnant Women: "Environmental Chemicals in Pregnant Women
in the US: NHANES 2003-2004." A new PRHE study published
in Environmental Health Perspectives (EHP) in January,
2011, analyzed biomonitoring data from the National Health
and Nutritional Examination Survey (NHANES) to characterize
both individual and multiple chemical exposures in U.S.
pregnant women. The study analyzed data for 163 chemicals
in 286 pregnant women. The authors found that 43 banned and
contemporary use chemicals, including PCBs, organochlorine
pesticides, PFCs, phenols, PBDE flame retardants,
phthalates, polycyclic 14 aromatic hydrocarbons (PAHs) and
perchlorate, were detected in 99-100% of pregnant women.
The study states biomonitoring studies report nearly
ubiquitous exposure to many chemicals in the U.S.
population - for example, bisphenol A (BPA), perchlorate,
and certain phthalates and polybrominated diphenyl ethers
(PBDEs) � Centers for Disease Control and Prevention (CDC)
2009a ].
5) Health impacts of BPA - NTP reports . In the late 1970s,
due to the increasing popularity surrounding BPA-containing
products, a carcinogenesis study was done. NTP tested the
safety of BPA. The report stated that the evidence around
carcinogenicity effects were not convincing. However, the
NTP reported reproductive toxicity.
NTP in recent years has stated 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
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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.
6) Health Effects of BPA - Other Research . There has been
extensive, and often controversial, research on the health
effects of BPA. There has been great debate over scope,
content, funding and other factors of the studies that are
cited by stakeholders on both sides of the debate. Even
the federal Food and Drug Administration (FDA) has faced
issues regarding the science on the issue. The FDA has
maintained that BPA is safe, relying largely on two studies
that were funded by the chemical industry. In October, the
agency was faulted by its own panel of independent science
advisers, who said the FDA's position on BPA was
scientifically flawed. As a result, FDA is revisiting its
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position on the chemical. For example, in October 2008 the
FDA's Advisory Science Board found that the FDA safety
assessment "overlooks a wide range of potentially serious
findings" and demanded that FDA more carefully assess risks
to children.
However, what is surfacing is the trend toward caution
regarding BPA, especially exposure to infants and children.
One of the more recent efforts was done by NTP and
finalized in September 2008. The NTP declared that it is
concerned about the impact of BPA on the brain development,
behavior, and the male reproductive system for infants and
children. The NTP states that there is scientific evidence
to support the following conclusions, including:
Some concern for neural and behavioral effects in
fetuses, infants, and children at current human
exposures.
Some concern for BPA exposure in these same
populations based on effects in the prostate gland,
mammary gland, and an earlier age for puberty in females.
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.
Negligible concern that exposure to BPA causes
reproductive effects in nonoccupationally exposed adults.
Minimal concern for workers exposed to higher levels
in occupational settings.
1) 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 containers, and water bottles made
with BPA in its Canadian stores, and that it would stop
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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.
2) Other actions on BPA . In January 2010, the 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
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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
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.
3) Arguments in Support . Supporters state that there are many
alternatives for products that are the subject 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.
4) Arguments in Opposition . Opponents believe AB 1319 runs
contrary to the consensus of the scientific community and
of international regulatory agencies that have concluded
BPA is safe as used. Opponents state that the Legislature
established a process by which state scientists would be
empowered to evaluate chemicals in consumer products and
implement a variety of regulatory actions if necessary.
The opponents assert that the bill requires manufacturers
to use the "least toxic alternative" but provides no clear
indication of what that is or what regulatory body will
make such a determination. The opponents believe that any
assessment of chemicals and potential replacement products
is best handled in the scientific arena, not a political
setting.
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5) Prior Legislation .
SB 797 (Pavley) of the 2009-10 Regular Session was
substantially similar to AB 1319, and the Senate did not
concur in Assembly amendments.
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.
SB 509 (Simitian) Chapter 560, Statutes of 2008,
establishes a Toxics Information Clearinghouse, as
specified, and defines terms relating to a Green Chemistry
program to be administered by DTSC.
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 specified review process,
as specified.
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.
AB 2694 (Ma) of the 2007-08 Regular 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. AB 2694 was set to be heard in the
Senate Health Committee, but was cancelled at the request
of the author.
Amendment Needed . This bill specifies a 0.1 ppb allowable
limit of BPA in any bottle or cup, intended to be used to
consume foods, beverages or liquids by children because
that is currently the lowest detectable level
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technologically feasible. The bill should explicitly state
that it is a detectable level of 0.1 ppb BPA and give DTSC
the ability to adjust that level in the future as
technology improves.
SOURCE : Environmental Working Group
SUPPORT : Alliance of California Autism Organizations
American Academy of Pediatrics
American Congress of Obstetricians and
Gynecologists, District IX
American Federation of State, County and
Municipal Employees
Asian Communities for Reproductive Justice
Autism One
Autism Research Institute
Black Women for Wellness
Breast Cancer Fund
California League for 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
Consumer Federation of California
Consumer's Union
County of Los Angeles Board of Supervisors
County of Santa Clara Board of Supervisors
County of Santa Clara Office of the County
Executive
EconMom Alliance
Environment California
Environmental Working Group
First 5 Association of California
Food and Water Watch
Fresno Metro Ministry
Great Beginnings for Black Babies, Inc.
Green to Grow
Having Our Say Coalition
Healthy Child Healthy World
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Latino Coalition for a Healthy California
Latinos United for Clean Air
Mothers of Marin Against the Spray
Making Our Milk Safe
Natural Resource Defense Council
Physicians for Social Responsibility, Los
Angeles
Planned Parenthood Advocacy Project Los Angeles
County
Planned Parenthood of California
Reproductive Justice Coalition of Los Angeles
San Diego Coastkeeper
San Francisco Department of Environment
Sierra Club California
Silicon Valley Toxics Coalition
Solano County Board of Supervisors
St. John's Well Child and Family Center
Teens Turning Green
US Autism and Asperger Association
U.S. Senator, the Honorable Diane Feinstein
OPPOSITION : California Chamber of Commerce
Advanced Medical Technology Association
California League of Food Processors
International Formula Council
California Manufacturers and Technology
Association
California Citizens Against Lawsuit Abuse
Grocery Manufacturers Association
California Grocers Association
American Chemistry Council
Can Manufacturers Institute
Civil Justice Association of California
Consumer Specialty Products Association
Juvenile Products Manufacturers Association
North American Metal Packaging Alliance, Inc.
California Healthcare Institute