BILL ANALYSIS
SB 484
Page 1
SENATE THIRD READING
SB 484 (Migden)
As Amended August 25, 2005
Majority vote
SENATE VOTE :23-15
HEALTH 9-5 APPROPRIATIONS 13-4
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|Ayes:|Chan, Berg, Mullin, |Ayes:|Chu, Bass, Berg, |
| |Goldberg, Jones, Hancock, | |Calderon, Karnette, |
| |Laird, Ridley-Thomas, | |Klehs, Leno, Nation, |
| |De La Torre | |Oropeza, Laird, Saldana, |
| | | |Yee, Mullin |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Aghazarian, Dymally, |Nays:|Sharon Runner, Emmerson, |
| |Nakanishi, Richman, | |Nakanishi, Walters |
| |Strickland | | |
| | | | |
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SUMMARY : Establishes the California Safe Cosmetics Act of
2005. Specifically, this bill :
1)Defines a "chemical identified as causing cancer or
reproductive toxicity" as a chemical identified pursuant to
Proposition 65 (Prop. 65) or identified by an authoritative
body, as defined, as a substance:
a) Listed as known or reasonably anticipated to be a human
carcinogen in a National Toxicology Report on carcinogens;
b) Given an overall carcinogenicity evaluation of Group 1,
Group 2A, or Group 2B by the International Agency for
Research on Cancer (IARC);
c) Identified as a Group A, Group B1, or Group B2
carcinogen, or as a known or likely carcinogen by the
United States Environmental Protection Agency (USEPA); and,
d) Identified as having some or clear evidence of adverse
developmental, male reproductive, or female reproductive
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toxicity effects in a report by an expert panel of the
National Toxicology Program's Center for the Evaluation of
Risks to Human Reproduction.
2)Requires the manufacturer, as defined, of any cosmetic product
subject to regulation by the Food and Drug Administration
(FDA) that is sold in this state, commencing January 1, 2007,
to, on a schedule, and in electronic or other format, as
determined by the Division of Environmental and Occupational
Disease Control (DEODC) of the Department of Health Services
(DHS), provide DEODC with a complete and accurate list of its
cosmetic products, as specified, that, as of the date of
submission, that are sold in the state that contain any
ingredient, as defined, that is a chemical identified as
causing cancer or reproductive toxicity, including any
chemical that is:
a) Contained in the product for purposes of fragrance or
flavoring; or,
b) Identified by the phrase "and other ingredients" and
determined to be a trade secret, as specified. Requires
any ingredient identified pursuant to this bill to be
considered to be a trade secret and be treated by the
office in a manner consistent with current federal law.
Prohibits any ingredients considered to be a trade secret
from being subject to the California Public Records Act for
the purposes of this bill.
3)Requires information submitted pursuant to #2 above to
identify each chemical by name and Chemical Abstract Service
number and the product in which the chemical is contained.
4)Requires the manufacturer, if an ingredient identified
pursuant to this bill is removed from a product and removed
from the list of chemicals known to cause cancer or
reproductive toxicity under Prop. 65 or is no longer a
chemical identified as causing cancer or reproductive toxicity
by an authoritative body, to submit that information to the
DEODC. Requires DEODC, upon receipt of new information and
after verifying its accuracy, to revise the manufacturer's
information on record. Prohibits the manufacturer from being
under obligation to submit subsequent information on the
presence of the ingredient in the product unless subsequent
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changes require submittal of the information.
5)Exempts any cosmetics manufacturer with annual aggregate sales
of cosmetic products, both within and outside of California,
of less than $1 million, based on the manufacturer's most
recent tax year filing from the provisions contained in #3)
and #4) above.
6)Permits DEODC, in order to determine potential health effects
of exposure to ingredients in cosmetics sold in the state, to
conduct an investigation of one or more cosmetic products that
contain chemicals identified as causing cancer or reproductive
toxicity or other ingredients of concern to DEODC. Permits an
investigation to include, but not be limited to, a review of
available health effects data and studies, worksite health
hazard evaluations, epidemiological studies to determine the
health effects of exposures to chemicals in various
subpopulations, and exposure assessments to determine total
exposures to individuals in various settings.
7)Permits the manufacturer of any product subject to the
investigation to submit relevant health effects data and
studies to DEODC. Permits DEODC, in order to further the
purposes of an investigation, to require manufacturers to
submit relevant health effects data and studies available to
the manufacturer and other available information as requested,
including, but not limited to, the concentration of the
chemical in the product, the amount by volume or weight of the
product that comprises the average daily application or use,
and sales and use data necessary to determine where the
product is used in the occupational setting.
8)Requires DEODC to establish reasonable deadlines for the
submittal of information. Specifies that failure by a
manufacturer to submit the information in compliance with the
requirements of DEODC constitutes a violation of this bill.
9)Requires DEODC, if it determines pursuant to an investigation
that an ingredient in a cosmetic product is potentially toxic
at the concentrations present in the product or under the
conditions used, to immediately refer the results of its
investigation to the Division of Occupational Safety and
Health (DOSH) in the Department of Industrial Relations (DIR)
and the Office of Environmental Health Hazard Assessment
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(OEHHA).
10)Requires DOSH, within 180 days after it receives the results
of an investigation, to develop and present one or more
proposed occupational health standards to the DIR Occupational
Safety and Health Standards Board (OSHSB), unless DOSH
affirmatively determines, in a written finding within 90 days,
that a standard is not necessary to protect the health of an
employee who has regular exposure to the hazard for the period
of his or her working life. Requires the written finding to
identify the reasons for the determination and the factual
basis for the finding.
11)Requires DEODC, as early as feasible within existing
resources, to determine whether the products identified as in
violation of the Cosmetic Ingredient Review's (CIR) safe use
recommendations have been adequately substantiated for safety
pursuant to federal law. Requires DEODC, for any product
adequately substantiated for safety, to determine if the
product contains any ingredient that the CIR has found is not
safe for the specific use indicated on the product's label.
12)Requires DEODC, if it finds that a product has been
adequately substantiated for safety despite containing an
ingredient that the CIR has found is not safe for the specific
use indicated on the product's label, to refer its findings to
the Attorney General and the FDA for possible enforcement
action pursuant to this bill and the federal Food, Drug and
Cosmetic Act.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, DHS estimates on-going GF costs of approximately $1
million annually for the receipt of disclosures by cosmetic
manufacturers, testing, and environmental investigation. The
testing and investigation costs are discretionary on the part of
DHS, and would be subject to the availability of funding in
future budgets. On-going costs (GF and federal funds) of
approximately $500,000 annually for testing, investigations and
regulation development.
COMMENTS : According to the author, chemicals that cause cancer
and birth defects should not be in products that are used
regularly by women of child-bearing age, especially when there
are safe alternatives. Neither DHS nor FDA has any statutory
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authority to analyze cosmetic products for their possible
long-term health impacts, such as cancer and birth defects. The
law also shields cosmetic manufacturers from informing the
public about toxic chemicals used in their products for
fragrance and flavoring. Recent studies suggest these
ingredients can include chemicals that cause cancer and birth
defect. This bill requires cosmetic manufacturers to tell DHS
what chemicals in their products cause cancer or reproductive
toxicity and gives the state the authority to protect the public
from dangerous exposures to those chemicals.
The Safe Drinking Water and Toxic Enforcement Act of 1986
(commonly known as Prop. 65), provides two primary mechanisms
for administratively listing chemicals that are known to the
state to cause cancer or reproductive toxicity. A chemical may
be listed under Prop. 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 Prop. 65 include EPA, the International Agency for
Research on Cancer, FDA, the National Institute for Occupational
Safety and Health, and the National Toxicology Program (NTP).
As the lead agency for the implementation of Prop. 65, OEHHA
lists chemicals as known to the state to cause reproductive
toxicity.
According to FDA, all cosmetics, whether they are sold on a
retail basis to consumers or marketed for salon or workplace
use, are subject to the Food, Drug and Cosmetics Act. This law
and subsequent regulations require the cosmetic label to state
the name and place of business of the manufacturer, packer or
distributor; an accurate statement of the quantity of contents;
and any appropriate directions for safe use and/or warning
statements. This information must comply with additional
regulatory requirements and be prominent and appear in the
proper location on the label. Regulations enacted under the
Fair Packaging and Labeling Act require ingredients to be listed
on the labels of cosmetics sold on a retail basis to consumers.
Ingredients are listed in descending order of predominance. FDA
states that consumers can use the ingredient declaration to
identify ingredients they wish to avoid. Cosmetic products and
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ingredients are not subject to FDA testing or approval, with the
exception of color additives. According to FDA, cosmetic
manufacturers are responsible for substantiating the safety of
their products and ingredients before marketing. FDA is not
authorized to require recalls of "hazardous" cosmetics, but does
monitor companies that conduct product recall and may request a
recall if the manufacturer is not willing to remove dangerous
products from the market.
According to the sponsors of this bill, National Environmental
Trust, Breast Cancer Action, and Breast Cancer Fund, in January
2003, the European Parliament prohibited the use in cosmetics of
certain chemicals that cause cancer, reproductive harm, or
mutagenicity. The ban, which took effect in September of 2004,
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. These terms correspond to the terms "known," "probable," and
"possible" used by the EPA to describe health effects of
chemicals.
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097
FN: 0012551