BILL ANALYSIS
SB 484
Page 1
Date of Hearing: June 28, 2005
ASSEMBLY COMMITTEE ON HEALTH
Wilma Chan, Chair
SB 484 (Migden) - As Amended: June 15, 2005
SENATE VOTE : 23-15
SUBJECT : Cosmetics: chronic health effects.
SUMMARY : Establishes the California Safe Cosmetics Act of
2005. Specifically, this bill :
1)Makes a number of findings and declarations, including that
testing has determined that some cosmetic products contain
substances known or suspected to cause cancer and reproductive
toxicity, there is a lack of ingredient labeling on certain
products, there is a heavy use of cosmetics by women of
childbearing age, and there is an availability to alternative
substances for use in cosmetics.
2)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 (EPA); and,
d) Identified as having some or clear evidence of adverse
developmental, male reproductive, or female reproductive
toxicity effects in a report by an expert panel of the
National Toxicology Program's Center for the Evaluation of
Risks to Human Reproduction.
3)Requires the manufacturer of any cosmetic product subject to
regulation by the Food and Drug Administration (FDA) that is
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sold in this state, commencing January 1, 2007, to, on a
schedule 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 are
sold in the state as of the date of submission and identify by
product 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.
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
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
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toxicity or other ingredients of concern to DEODC. Permits
such 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
(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.
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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.
EXISTING LAW :
1)Regulates the packaging, labeling, and advertising of food,
drugs, and cosmetics under the Sherman Food, Drug, and
Cosmetic Law. Prohibits a person from manufacturing, selling,
delivering, holding, offering for sale, or receiving in
commerce any cosmetic that is adulterated, and prohibits a
person from adulterating any cosmetic. Prohibits a person
from manufacturing or selling any cosmetic that is misbranded,
as prescribed.
2)Under Prop 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. 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.
3)Pursuant to federal law, requires the FDA to request the
manufacturer, packer, or distributor of a cosmetic product to
submit, among other information, a list of ingredients in each
of its products, and to provide ingredient information to a
licensed physician who requests assistance in determining
whether an ingredient in the product is the cause of a problem
for which the patient is being treated. Requires any change
in information to be filed within 60 days after the product
enters into commercial distribution. Makes specific labeling
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requirements, including mandating that all ingredients be
listed on the label. Permits manufacturers to submit a
request of confidentiality of identity of an ingredient by
presenting factual and legal grounds for that request.
Requires a product to bear a warning statement, prominently
and conspicuously displayed on the label, whenever necessary
or appropriate to prevent a health hazard that may be
associated with the product. Requires each ingredient used in
a cosmetic product to be adequately substantiated for safety
prior to marketing and requires any product whose safety is
not substantiated to contain a conspicuous statement so
stating. Permits the FDA to collect samples for examination
of products and to take action through the U. S. Department of
Justice to remove adulterated and misbranded cosmetics from
the market.
FISCAL EFFECT : According to the Senate Appropriations
Committee analysis, $100,000 general fund (GF) for the receipt
of disclosures by DHS in fiscal year (FY) 2005-06; GF costs of
$863,000 in FY 2006-07 and $1.2 million GF in FY 2007-08 for the
receipt of disclosures, 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. Costs to DIR are
unknown and depend upon the number of submittals by DHS
following an investigation.
COMMENTS :
1)PURPOSE OF THIS BILL 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 the FDA has
any statutory 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.
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2)PROPOSITION 65 . 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 the
EPA, the International Agency for Research on Cancer, the 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.
3)COSMETIC LABELING . According to the 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.
The FDA states that consumers can use the ingredient
declaration to identify ingredients they wish to avoid.
Cosmetic products and ingredients are not subject to FDA
testing or approval, with the exception of color additives.
According to the FDA, cosmetic manufacturers are responsible
for substantiating the safety of their products and
ingredients before marketing. The 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.
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4)COSMETIC INGREDIENT REVIEW . According to the CIR website, it
was established in 1976 by the Cosmetic, Toiletry & Fragrance
Association (CTFA) with support of the FDA and the Consumer
Federation of America (CFA). Although funded by CTFA, CIR and
the review process are independent from CTFA and the cosmetics
industry. According to the CIR, it reviews and assesses the
safety of ingredients used in cosmetics in an open, unbiased,
and expert manner, and publishes the results in the open,
peer-reviewed scientific literature. The seven CIR Expert
Panel voting members include physicians and scientists who
have been publicly nominated by consumer, scientific and
medical groups, government agencies and industry. Three
liaison members serve as non-voting members representing the
FDA, CFA, and CTFA. Working on the "high priority"
ingredients, the CIR conducts literature searches, compile
data, and prepare draft reports. If the scientific literature
contains insufficient information, CIR requests the industry
or other interested parties to undertake specific studies or
to provide previously unpublished data. After completion of a
development process that includes multiple opportunities for
public comment and open, public discussion of the report, a
final report is issued. These final reports are available
from CIR and published in the International Journal of
Toxicology.
A May 1992 article in the FDA's consumer magazine said the CIR
was the "most well-known of industry-sponsored self-regulation
. . . sponsored by the CTFA." The CIR is accomplished by a
panel of scientific and medical experts who evaluate cosmetic
ingredients for safety and publish detailed reviews of
available safety data. The article went on to say that "A
finding of safety by the CIR provides a degree of confidence
that the ingredient can safely be used in cosmetics," and
that in the absence of CIR, there would be no systematic
examination of the safety of individual cosmetic ingredients.
5)EUROPEAN UNION BAN . 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,
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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.
6)RELATED LEGISLATION . AB 908 (Chu) prohibits a person or
entity, on or after January 1, 2007, from manufacturing,
selling, or distributing in commerce any cosmetic that
contains dibutyl phthalate (DBP) or di-(2-ethylhexyl)
phthalate (DEHP) and provides that any cosmetic is misbranded
if it is sold by an Internet Web site where the list of
ingredients in the cosmetic is not easily and readily
available to be viewed by the prospective purchaser before the
purchase is completed. AB 908 failed passage in the Assembly
Committee on Health when it was heard on April 19, 2005 by a
vote of 5-5.
7)PREVIOUS LEGISLATION . Last year, AB 2025 (Chu) would have
required the manufacturer of any cosmetic or personal care
product sold in California to submit to OEHHA a list of
ingredients contained in the product, including the name of
each ingredient for purposes of fragrance or flavoring and the
name of each ingredient identified by the phrase "and other
ingredients." AB 2025 would also have required the
manufacturer to identify any ingredient that is a chemical
identified as causing cancer or reproductive toxicity or to
declare in writing to OEHHA that its products do not contain
any chemical identified as causing cancer or reproductive
toxicity. Finally, the bill would have prohibited any person
from manufacturing, processing, or distributing in a cosmetic
or personal care product that contains a chemical identified
as causing cancer or reproductive toxicity. AB 2025 was set
to be heard in the Assembly Committee on Health, but the
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hearing of this bill was cancelled at the request of the
author.
Also last year, AB 2012 (Chu) was amended in the Senate to
require, by January 1, 2006, the manufacturer of any cosmetic
or personal care product subject to regulation by the FDA and
manufactured, processed, or distributed in commerce in the
state to notify OEHHA of any ingredient in its product that is
a chemical identified as causing cancer or reproductive
toxicity, as specified. This bill failed passage in the
Assembly Committee on Health by a vote of 4-5.
8)SUPPORT . The National Environmental Trust (NET) states that
men use multiple cosmetic and personal care products and women
use an estimated 25 such products a day. NET states that a
class of chemicals called phthalates, known to cause cancer
and reproductive toxicity are used in cosmetic products and
that a national laboratory found phthalates in 52 of 72
products tested even though the chemical was not listed on the
product label. NET writes that in 1978 the U.S. Governmental
Accounting Office told Congress that certain cosmetics
marketed in the United States contain ingredients that may
cause cancer, cause birth defects, or have other health
consequences. Numerous supporters claim that those most at
risk to exposure to carcinogens and reproductive toxins are
nail and beauty salon workers and that these women are
generally of child-bearing age. Breast Cancer Action states
that not only do women of child-bearing age frequently use
personal care products, they also transfer many of the
chemicals they contain across the placental cord to the
developing fetus. Asian Americans for Civil Rights and
Equity, the California Nurses Association, Asian Health
Services, the Asian Pacific Environmental Network, and
California Women Lawyers claim the FDA does not review
cosmetic ingredients for their health and safety before they
come to market nor have the authority to recall hazardous
products and relies instead on the industry's self-policing
committee, the CIR, for information on product safety. Garden
of Eve writes they take responsibility for the safety of their
products and believe it is necessary in their industry's best
interest to provide U.S. consumers the same protection
provided to European consumers. The California League of
Conservation Voters state that this bill is a responsible
proposal that recognizes fiscal constraints and reduces
mandated costs to a minimum.
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9)OPPOSE . Raffaello Research Laboratories, Inc states that this
bill would require all manufacturers of personal care products
and cosmetics who sell products in California to report every
ingredient, including trace amounts of any chemical, in their
products to DHS. Raffaello argues that Prop 65 allows trace
levels of chemicals known to cause cancer or reproductive
toxicity and that trace levels of these chemicals are found in
water and food. A number of companies, including GAR
Laboratories, Alberto Culver Company, TCR Industries,
Universal Packaging Systems, Inc., Kimberly-Clark, Creative
Nail Design, American International Industries, and SMAP
Manufacturing, Inc. write that every cosmetic manufacturer who
sells products in California is already subject to a long list
of federal and state laws and rules governing everything from
product formulation to air quality. Estee Lauder writes that
this bill references chemical lists prepared by three
different institutions without providing exceptions for
unintended or unavoidable trace amounts of ingredients, an
exception recognized under federal regulations, EU law, and
other existing California law. Numerous individuals write
that that this bill is not based on sound scientific evidence
or standard safety practice. The California Chamber of
Commerce contends that this bill places an unnecessary burden
on the hundreds of cosmetic and personal care product
manufacturers in this state and provides no benefit to public
health and will only serve to charge the state government and
manufacturers with new and significant costs. The Grocery
Manufacturers of America states that this bill requires the
reporting of chemicals even though they are present in forms
or at levels that pose no health risk.
10) SUGGESTED AMENDMENTS .
a) On page 6, line 24, "division" should replace the word
"office."
b) In order to conform with other language related to DEODC
duties, the author may wish to delete the word "shall" on
page 9, line 11 and insert "may."
REGISTERED SUPPORT / OPPOSITION :
Support
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National Environmental Trust (sponsor)
Breast Cancer Fund (co-sponsor)
Breast Cancer Action (co-sponsor)
AMURIE toxic free products
Asian Americans for Civil Rights and Equality (AACRE)
Asian Communities for Reproductive Justice (ACRJ)
Asian Health Services
Asian Immigrant Women Advocates
Asian Pacific Environmental Network (APEN)
Association of Asian Pacific Community Health Organizations
(AAPCHO)
California Black Women's Health Project
California Church IMPACT/California Council of Churches
California Commission on the Status of Women
California Interfaith Partnership for Children's Health and the
Environment
California League of Conservation Voters
California Nurses Association
California Women Lawyers
Center for Environmental Health
Center for Ethics and Toxics (CETOS)
Chinese for Affirmative Action/Center for Asian American
Advocacy (CAA)
Commonweal Biomonitoring Center
Dropwise Essentials
East Bay Asian Consortium
Ecology Action of Santa Cruz
Environment California
Environmental Justice Coalition for Water
Filipino American Coalition for Environmental Solutions (FACES)
Filipinos for Affirmative Action (FAA)
Friends Committee on Legislation
Friends of the Earth
Garden of Eve
J.P. Durga, LLC
Learning Disabilities Association of California
Marie Veronique Skin Therapy
Mariun Cancer Project
National Brain Tumor Foundation
National Resources Defense Council
Orange County Interfaith Coalition for the Environment
Physicians for Social Responsibility San Francisco-Bay Area
Chapter
Presbyterians for Restoring Creation
Sierra Club California
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Silicon Valley Toxics Coalition
The Women's Foundation of California
United Food and Commercial Workers
VietUnity
153 individuals
Opposition
2-2-0 Laboratories
Alberto Culver
American Chemistry Council
American Health and Beauty Aids Institute
American International Industries
Anna Nails
BioOrganic Concepts
California Botana International, Inc.
California Chamber of Commerce
California Grocers Association
California Retailers Association
Chicago Aerosol
Clinical Industry Council
Color Techniques
Cosmetic, Toiletry, and Fragrance Association
Cosmoceutical Research Center
Creative Nail Design
Derma e
DERMdoctor
Dermix
Dial Corporation
Doctors' Dermatologic Corporation
Elizabeth Arden
Environ Skin Care
Estee Lauder Companies, Inc.
Flavor and Extract Manufacturers Association
Floratech
Formulation Research Laboratories, LLC
Fragrance Materials Association
GAR Labs
Gillette Company
Grocery Manufacturers of America
Herbalife
Innovative Body Science
International Cosmetics
Johnson & Johnson
Kao Brands Company
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Kimberly Clark Corporation
Laboratoire Dr. Renaud
Laclede, Inc.
Levlad, Inc.
Maleface Skin Care
MDPar International Corporation
Murad
Nailtiques
Neostrata Company
Nitrilife
NuSkin
Nyakio Bath and Body
OPI Products, Inc.
Pacific World
Procter & Gamble
Raffaello Research Laboratories
Randall International, LLC
Sacramento Asian Pacific Chamber of Commerce
Sacramento Hispanic Chamber of Commerce
Schroeder & Tremayne, Inc.
Schwarzkopf Professional
SEPPIC
Shaklee Corporation
SMAP Manufacturing
Spatz Laboratories
TCR Industries
Unilever
Universal Packaging Systems
USANA
Victoria Consulting
Wella Corporation
156 individuals
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097