BILL NUMBER: SB 484	CHAPTERED
	BILL TEXT

	CHAPTER  729
	FILED WITH SECRETARY OF STATE  OCTOBER 7, 2005
	APPROVED BY GOVERNOR  OCTOBER 7, 2005
	PASSED THE SENATE  SEPTEMBER 7, 2005
	PASSED THE ASSEMBLY  AUGUST 31, 2005
	AMENDED IN ASSEMBLY  AUGUST 25, 2005
	AMENDED IN ASSEMBLY  JULY 6, 2005
	AMENDED IN ASSEMBLY  JUNE 15, 2005
	AMENDED IN SENATE  APRIL 26, 2005
	AMENDED IN SENATE  MARCH 29, 2005

INTRODUCED BY   Senator Migden
   (Coauthors: Senators Alquist, Kuehl, Ortiz, and Torlakson)
   (Coauthors: Assembly Members Berg, Chan, Evans, Goldberg,
Karnette, Lieber, Montanez, and Nation)

                        FEBRUARY 18, 2005

   An act to add Article 3.5 (commencing with Section 111791) to
Chapter 7 of Part 5 of Division 104 of the Health and Safety Code,
relating to cosmetics.



	LEGISLATIVE COUNSEL'S DIGEST


   SB 484, Migden  Cosmetics: chronic health effects.
   The existing Sherman Food, Drug, and Cosmetic Law requires the
State Department of Health Services to regulate the packaging,
labeling, and advertising of food, drugs, and cosmetics. The 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.
The law also prohibits a person from manufacturing or selling any
cosmetic that is misbranded. A violation of these provisions is a
crime.
   This bill would establish the California Safe Cosmetics Act of
2005. The bill, commencing January 1, 2007, would require the
manufacturer of any cosmetic product subject to regulation by the
federal Food and Drug Administration that is sold in the state, with
certain exceptions, on a schedule and in electronic or other format,
as determined by the Division of Environmental and Occupational
Disease Control within the department, to provide the division with a
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. Since a
violation of the provisions applicable to the packaging, labeling,
and advertising of food, drugs, and cosmetics is a crime, this bill
would impose a state-mandated local program.
   The bill would authorize the division to conduct an investigation
of cosmetic products that contain chemicals identified as causing
cancer or reproductive toxicity or other ingredients of concern to
the division. The bill would authorize the division to require
manufacturers of products subject to investigation to submit relevant
health effects data and studies and other information as requested
by the division. The bill would require the division to establish
reasonable deadlines for the submittal of that information and would
make failure by a manufacturer to submit the information a crime,
thereby imposing a state-mandated local program. If the division
determines that an ingredient in a cosmetic product is potentially
toxic, the bill would require the division to immediately refer the
results of its investigation to the Division of Occupational Safety
and Health in the Department of Industrial Relations and would
require the Division of Occupational Safety and Health, within 180
days after it receives the results, to develop and present one or
more proposed occupational health standards to the Occupational
Safety and Health Standards Board in the Department of Industrial
Relations, unless the Division of Occupational Safety and Health
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.
   The bill would authorize the division, as early as feasible within
existing resources, to determine whether certain cosmetics have been
adequately substantiated for safety, and if the cosmetic has, to
determine if the cosmetic contains any ingredient that is not safe
for the specific use indicated on the product's label. If the
division finds that a product has been adequately substantiated for
safety despite containing an unsafe ingredient, the bill would
require the division to refer its findings to the Attorney General
and the federal Food and Drug Administration for possible enforcement
action.
  The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  The Legislature finds and declares all of the
following:
   (a) Independent testing in the United States and the European
Union has determined that some cosmetic products contain substances
known or suspected to cause cancer and reproductive toxicity that can
harm the mother, fetus, and nursing children.
   (b) Neither the federal Food and Drug Administration (FDA) nor the
State Department of Health Services (DHS) require premarket safety
testing, review, or approval of cosmetic products. According to the
FDA, the regulatory requirements governing the sale of cosmetics are
not as stringent as those that apply to other FDA-regulated products.

   (c) Under the federal Food, Drug and Cosmetic Act (21 U.S.C. Sec.
301), cosmetics and their ingredients are not required to be approved
before they are sold to the public and the FDA does not have the
authority to require manufacturers to file health and safety data on
cosmetic ingredients or to order a recall of a dangerous cosmetic
product.
   (d) Under the state Sherman Food, Drug, and Cosmetic Act, DHS has
no authority to identify, review, or regulate ingredients in cosmetic
products that may cause chronic health effects, such as cancer and
reproductive toxicity.
   (e) Cosmetic products are most heavily used by women of
childbearing age, increasing the likelihood of exposing mothers,
fetuses, and nursing children to substances that can cause cancer and
reproductive toxicity.
   (f) Beauty care workers, including cosmetologists and manicurists,
are most exposed to the potentially harmful effects of carcinogens
and reproductive toxins in cosmetics. Cosmetologists and manicurists
are dominated by women and minorities, particularly from Southeast
Asia. In California, an estimated 80 percent of nail salons are
operated by Vietnamese women.
   (g) Federal law exempts chemicals used as fragrances or flavoring
from being identified as ingredients on the labels of cosmetic
products. Laboratory analyses of cosmetic products sold in California
have found products that contain substances known to or likely to
cause cancer or reproductive toxicity and not identified as an
ingredient on the product's label. The law also does not require any
ingredient labeling on cosmetic products sold for commercial use,
thereby denying any information on ingredients to beauty care
workers.
   (h) The Division of Environmental and Occupational Disease Control
in DHS conducts investigations of toxic materials in the workplace
and analyzes data on workplace exposures to toxic materials. The
Division of Occupational Safety and Health in the Department of
Industrial Relations enforces occupational safety and health
standards adopted by the Occupational Safety and Health Standards
Board.
   (i) Alternatives to substances that cause cancer or reproductive
toxicity are readily available for use in cosmetic products. A number
of manufacturers, including both small domestic producers and large
multinational corporations, have eliminated substances that cause
cancer or reproductive toxicity from their products.
   (j) Given the presence of substances in cosmetic products that
cause cancer and reproductive toxicity, the heavy use of these
products by women of childbearing age, the significant exposure to
these products in occupational settings such as nail and beauty
salons, the adverse impacts of these substances on human health, the
inadequate information about the presence of these substances in
products or the extent of their impacts, and the availability of
alternatives to the use of these substances, it is in the interest of
the people of the State of California to take steps to ensure that
cosmetic products sold and used in the state can be used safely.
  SEC. 2.  Article 3.5 (commencing with Section 111791) is added to
Chapter 7 of Part 5 of Division 104 of the Health and Safety Code, to
read:

      Article 3.5.  Chronic Health Effects of Cosmetics

   111791.  This article shall be known, and may be cited, as the
California Safe Cosmetics Act of 2005.
   111791.5.  For purposes of this article, the following terms have
the following meanings:
   (a) "Authoritative body" means any agency or formally organized
program or group recognized pursuant to Section 12306 of Title 22 of
the California Code of Regulations as being authoritative for the
purpose of identifying chemicals that cause cancer or reproductive
toxicity.
   (b) "Chemical identified as causing cancer or reproductive
toxicity" means a chemical identified pursuant to Section 25249.8 or
identified by an authoritative body as any of the following:
   (1) A substance listed as known or reasonably anticipated to be a
human carcinogen in a National Toxicology Report on carcinogens.
   (2) A substance given an overall carcinogenicity evaluation of
Group 1, Group 2A, or Group 2B by the International Agency for
Research on Cancer.
   (3) A substance 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.
   (4) A substance 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.
   (c) "Division" means the Division of Environmental and
Occupational Disease Control within the State Department of Health
Services.
   (d) "Ingredient" has the same meaning as that term is defined in
subdivision (e) of Section 700.3 of Part 700 of Chapter 1 of Title 21
of the Code of Federal Regulations and does not include any
incidental ingredient as defined in subdivision (l) of Section 701.3
of Part 701 of Chapter 1 of Title 21 of the Code of Federal
Regulations.
   (e) "Manufacturer" means any person whose name appears on the
label of a cosmetic product pursuant to the requirements of Section
701.12 of Title 21 of the Code of Federal Regulations.
   111792.  (a) Commencing January 1, 2007, the manufacturer of any
cosmetic product subject to regulation by the federal Food and Drug
Administration that is sold in this state shall, on a schedule and in
electronic or other format, as determined by the division, provide
the division with a complete and accurate list of its cosmetic
products that, as of the date of submission, are sold in the state
and that contain any ingredient that is a chemical identified as
causing cancer or reproductive toxicity, including any chemical that
meets either of the following conditions:
   (1) A chemical contained in the product for purposes of fragrance
or flavoring.
   (2) A chemical identified by the phrase "and other ingredients"
and determined to be a trade secret pursuant to the procedure
established in Part 20 and Section 720.8 of Part 720 of Title 21 of
the Code of Federal Regulations. Any ingredient identified pursuant
to this paragraph shall be considered to be a trade secret and shall
be treated by the division in a manner consistent with the
requirements of Part 20 and Part 720 of Title 21 of the Code of
Federal Regulations. Any ingredients considered to be a trade secret
shall not be subject to the California Public Records Act (Chapter
3.5 (commencing with Section 6250) of Division 7 of Title 1 of the
Government Code) for the purposes of this section.
   (b) Any information submitted pursuant to subdivision (a) shall
identify each chemical both by name and Chemical Abstract Service
number and shall specify the product or products in which the
chemical is contained.
   (c) If an ingredient identified pursuant to this section
subsequently is removed from the product in which it was contained,
is removed from the list of chemicals known to cause cancer or
reproductive toxicity published under Section 25249.8, or is no
longer a chemical identified as causing cancer or reproductive
toxicity by an authoritative body, the manufacturer of the product
containing the ingredient shall submit the new information to the
division. Upon receipt of new information, the division, after
verifying the accuracy of that information, shall revise the
manufacturer's information on record with the division to reflect the
new information. The manufacturer shall not be under obligation to
submit subsequent information on the presence of the ingredient in
the product unless subsequent changes require submittal of the
information.
   (d) This section shall not apply to any manufacturer of cosmetic
products with annual aggregate sales of cosmetic products, both
within and outside of California, of less than one million dollars
($1,000,000), based on the manufacturer's most recent tax year
filing.
   111792.5.  (a) In order to determine potential health effects of
exposure to ingredients in cosmetics sold in the state, the division
may 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 the division.
   (b) An investigation conducted pursuant to subdivision (a) may
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.
   (c) If an investigation is conducted pursuant to subdivision (a),
the manufacturer of any product subject to the investigation may
submit relevant health effects data and studies to the division.
   (d) In order to further the purposes of an investigation, the
division may require manufacturers of products subject to the
investigation to submit to the division relevant health effects data
and studies available to the manufacturer and other available
information as requested by the division, 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.
   (e) The division shall establish reasonable deadlines for the
submittal of information required pursuant to subdivision (d).
Failure by a manufacturer to submit the information in compliance
with the requirements of the division shall constitute a violation of
this part.
   111793.  (a) If the division 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, the division shall immediately refer the results of
its investigation to the Division of Occupational Safety and Health
in the Department of Industrial Relations and the Office of
Environmental Health Hazard Assessment.
   (b) Within 180 days after it receives the results of an
investigation pursuant to subdivision (b), the Division of
Occupational Safety and Health shall, pursuant to Section 147.1 of
the Labor Code, develop and present one or more proposed occupational
health standards to the Occupational Safety and Health Standards
Board in the Department of Industrial Relations, unless the Division
of Occupational Safety and Health 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. The written finding
shall identify the reasons for determining the standard is not
necessary and the factual basis for the finding.
   111793.5.  (a) The Legislature finds and declares the following:
   (1) The Cosmetic Ingredient Review (CIR) panel is a
nongovernmental body established and funded by the cosmetics industry
to review the safety of cosmetic ingredients.
   (2) According to a 2004 analysis of the 2003 CIR Compendium by the
Environmental Working Group, 54 cosmetic products violate the CIR's
own safe use recommendations to manufacturers by containing an
ingredient that the CIR has found is not safe for the specific use
indicated on the product's label.
   (3) Federal regulations (21 C.F.R. 740.10) require every
ingredient in a cosmetic product and every finished cosmetic product
to be adequately substantiated for safety prior to marketing, and
state that any ingredient or product whose safety has not been
adequately substantiated prior to marketing is misbranded unless it
displays a warning statement declaring, "The safety of this product
has not been determined."
   (b) The division may, as early as feasible within existing
resources, determine whether the products identified in paragraph (2)
of subdivision (a) have been adequately substantiated for safety
pursuant to Section 740.10 of Title 21 of the Code of Federal
Regulations. For any product adequately substantiated for safety, the
division shall 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.
   (c) If the division 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, the division shall refer its findings to the
Attorney General and the federal Food and Drug Administration for
possible enforcement action pursuant to this part and the federal
Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
  SEC. 3.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.