BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Sheila J. Kuehl, Chair
BILL NO: SB 1712
S
AUTHOR: Migden & Romero
B
AMENDED: As introduced
HEARING DATE: April 9, 2008
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FISCAL: Appropriations
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CONSULTANT:
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Moreno/
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SUBJECT
Adulterated cosmetics
SUMMARY
Includes lipstick that bears or contains lead or lead
compounds as an adulterated cosmetic for purposes of the
Sherman Food, Drug, and Cosmetic Act, and requires
manufacturers, packagers, and sellers of lipstick to report
specified information to the Department of Public Health
(DPH).
CHANGES TO EXISTING LAW
Existing law:
The Sherman Food, Drug, and Cosmetic Act contains various
provisions regarding the contents, packaging, labeling, and
advertising of food, drugs, and cosmetics. The act makes it
unlawful for any person to manufacture, sell, deliver,
hold, or offer for sale any cosmetic that is adulterated.
The act deems a cosmetic to be adulterated if, among
other things, it bears or contains any poisonous or
deleterious substance that may render it injurious to users
under customary or usual conditions.
Existing law also gives the DPH authority to access a range
Continued---
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of information from cosmetic manufacturers, but only if a
product is deemed adulterated or dangerous.
This bill:
SB 1712 would include lipstick that bears or contains lead
or lead compounds as an "adulterated cosmetic" under the
Sherman Food, Drug, and Cosmetic Act. The bill would
require any person who manufactures, packages, or sells
lipstick in California to report this fact to the DPH and
provide evidence that the lipstick was tested and found not
to contain lead.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
According to the author, in October 2007, the Campaign for Safe
Cosmetics (CSC) released findings of a random study of more than
30 lipsticks that found that 61 percent contained detectable
levels of lead, with levels ranging from 0.03 to 0.65 parts per
million (ppm). Of those, one-third exceeded the U.S. Food and
Drug Administration's (FDA) limit for lead in candy -- a
standard established to protect children from directly ingesting
lead. The author states that lipstick, like candy, can be
directly ingested, and is classified as an "ingestible cosmetic"
by the FDA. The author states that the FDA has not set a limit
for lead in lipstick, nor does the agency test finished cosmetic
products for lead, while the European Union has banned lead in
cosmetics since 1976 and lead compounds since 2004. The author
further states that lead is usually a by-product contaminant of
either a color additive or raw material used in lipstick. The
CSC study showed that nearly 40 percent of the lipsticks tested
were lead free, indicating that products can be reformulated to
remove lead, as is the practice in the European Union.
Background
Lead is a highly toxic substance that accumulates in the
body, over time, as a person is exposed. There are many
ways in which humans are exposed to lead, including through
deteriorating paint, household dust, bare soil, air,
drinking water, food, ceramics, home remedies, hair dyes,
and other cosmetics. Young children under the age of six
are especially vulnerable to lead's harmful health effects,
STAFF ANALYSIS OF SENATE BILL 1712 (Migden and Romero)Page
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because their brains and central nervous systems are still
being formed. Even very low levels of exposure can result
in reduced IQ, learning disabilities, attention deficit
disorders, behavioral problems, stunted growth, impaired
hearing, and kidney damage in children. According to the
Centers for Disease Control and Prevention (CDC), there is
no level of lead in a child's blood that can be specified
as safe, and the CDC has emphasized the need to make
primary prevention of lead poisoning, through interventions
that control or eliminate lead hazards before children are
exposed, a high priority for health, housing, and
environmental agencies. It takes a significantly greater
level of exposure to lead for adults than for children to
sustain adverse health effects. However, in adults, lead
can increase blood pressure and cause fertility problems,
nerve disorders, muscle and joint pain, irritability, and
memory or concentration problems.
European Union ban
Effective September 2004, the European Union prohibited the
use in cosmetics of certain chemicals that cause cancer,
reproductive harm, or mutagenicity. The ban is absolute for
chemicals that fall in categories 1 and 2 of these
substances. For category 3, it is conditional, meaning a
manufacturer may use the chemicals only if the proposed use
is determined to be safe. The categories denote the level
of certainty that the chemical harms human health. Category
1 substances are those that are known to cause the
specified health problems in humans. Category 2 substances
are known to cause the effects in animals and the
scientific literature is strong enough that the European
Union has determined to treat the chemicals as though they
cause the effects in humans. Category 3 substances have
also shown health effects in animals, but the scientific
literature is less robust than for category 2. Lead is
considered a Category 1 substance.
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Proposition 65
The Safe Drinking Water and Toxic Enforcement Act of 1986
(commonly known as Proposition 65), requires the public
listing of chemicals that are known to cause cancer or
reproductive toxicity. A chemical may be listed under
Proposition 65 when a body considered to be authoritative
by the state's qualified experts has formally identified
the chemical as causing cancer or reproductive toxicity.
The entities identified as "authoritative bodies" for
purposes of Proposition 65 include the EPA, the
International Agency for Research on Cancer, the FDA, the
National Institute for Occupational Safety and Health, and
the National Toxicology Program. Lead was added to the
Proposition 65 list as a developmental toxic in 1987, and
as a carcinogen in 1992.
Attorney General's letter
In response to the 2007 CSC report, two individuals served
Notices of Violation under Proposition 65 alleging that
certain lipstick manufacturers had violated the law by
failing to warn of the presence of lead in their products.
The Attorney General declined to pursue enforcement in
these two cases. In a March 3, 2008 letter to the
attorneys representing the plaintiffs in these cases, the
Attorney General's office set forth the reasons why they
had concluded that lead in lipstick at the levels
identified in the CSC report does not raise a reasonable
claim of a Proposition 65 violation. The Attorney
General's decision was primarily based on the fact that the
amount of exposure to lead through the use of lipstick has
not been fully determined, but stated that existing data
suggests that the lipstick identified in the CSC report did
not contain sufficient levels of lead to require a
Proposition 65 warning.
Related legislation
SB 1713 (Migden and Perata) would prohibit the manufacture,
sale, or distribution of any toy or child care article for
children under three years of age containing bisphenol A or
lead in detectable levels. The bill would also require
manufacturers to use the least toxic alternative when
replacing bisphenol A or lead in their products and would
prohibit manufacturers from replacing those chemicals with
certain carcinogens and reproductive toxicants. This bill
is scheduled to be heard in the Senate Environmental
STAFF ANALYSIS OF SENATE BILL 1712 (Migden and Romero)Page
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Quality Committee on April 7, 2008.
AB 2115 (Mullin) would require, after July 1, 2010,
children 6 years of age or younger, before being admitted
to a school, child care center, day nursery, nursery
school, family day care home or developmental center, to
obtain a certificate from a physician showing that they
have been evaluated for lead poisoning. This bill passed
by a vote of 7-3 when it was heard in the Assembly
Education Committee on April 2, 2008.
AB 2694 (Ma) 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. This bill is pending hearing in the Assembly
Environmental Safety and Toxic Materials Committee.
AB 2957 (Swanson) would require the DPH to post on its web
site the name and a short description of any toy that is
contaminated with any toxic substance or that is coated
with paints and lacquers that contain compounds of lead in
any amount. This bill is pending hearing in the Assembly
Health Committee.
Prior legislation
SB 484 (Migden) Chapter 729, Statutes of 2006), requires
cosmetic manufacturers to provide DPH with a complete and
accurate list of its cosmetic products that, as of the date
of submission, are sold in the state and contain any
ingredient that is a chemical identified as causing cancer
or reproductive toxicity, as specified.
AB 595 (Dymally) of 2007 would have authorized the DPH to
require cosmetic manufacturers that chose not to
voluntarily report their product ingredients to the FDA to
provide all product ingredients to DPH. AB 595 was held in
the Senate Appropriations Committee.
AB 121 (Vargas) Chapter 707, Statutes of 2005, prohibits
the sale of candy with lead in excess of the naturally
occurring level and requires the DPH to conduct a number of
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activities related to the regulation of lead content in
candy, including testing for candy lead content.
Arguments in support
According to the American Association of University Women,
the sponsor of this bill, lead accumulates in the body over
time so that even a small amount consumed daily, beginning
in early teen years, can be hazardous to a woman's health.
According to a number of supporters, lead is a potent
neurotoxin which is linked to a variety of health and
reproductive problems, including learning, language, and
behavioral problems. Supporters state that pregnant women
and young children are particularly vulnerable to exposure
because lead easily crosses the placenta and enters the
fetal brain, where it interferes with normal development.
Supporters also contend that lead has been eliminated from
paint and gasoline and many other products for good reason,
and should be eliminated in one of the most commonly used
cosmetics for women.
Arguments in opposition
The Personal Care Products Council (Council) writes that
this bill appears to be based on assertions by the CSC,
that the reported levels of lead in lipsticks are unsafe,
but the Council asserts the levels identified in lipstick
by that report are far below all known standards
established by regulatory authorities. According to the
Council, the amount of lead that a consumer is exposed to
from lipstick is almost 2,000 times below the limit
established by the EPA for drinking water and approximately
30 times below the safe limit set under Proposition 65.
COMMENTS
1. Clarification needed. This bill requires DPH to be
provided with evidence that lipstick is tested and found to
be lead free. The bill should also identify the level at
which the product is considered to be lead free for these
purposes. Additionally, the bill should be amended to
clarify that only lipstick manufacturers are subject to the
reporting requirements.
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On page 3, line 12
111671.1. On and after January 1, 2009, any person who
manufactures, packages, or sells lipstick in this state
the manufacturer of any lipstick subject to regulation
by the federal Food and Drug Administration that is
sold in this state shall report this fact to the
department and provide evidence to the department that
the lipstick was tested and found not to contain no
detectable level of lead.
POSITIONS
Support: American Association of University Women (sponsor)
Teens for Safe Cosmetics (sponsor)
ACCESS/Women's Health Rights Coalition
American College of Obstetricians and Gynecologists,
District IX (CA)
Breast Cancer Fund
California Commission on the Status of Women
California National Organization for Women
California Nurses Association/National Nurses
Organizing Committee
Center on Race, Poverty & the Environment
Coastal Classic Creations
Consumer Federation of California
Environment California
FamiliesFirst
MomsRising.org!
Older Women's League
Physicians for Reproductive Choice and Health
Planned Parenthood Affiliates of California
Planned Parenthood: Shasta-Diablo Action Fund
Planning and Conservation League
SF Bay Area Physicians for Social Responsibility
Sierra Club California
Women's Cancer Resource Center
Women's Foundation of California
Oppose: California Grocers Association
Personal Care Products Council
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