that the Secretary has reason to believe is adulter-
ated, misbranded, or otherwise in violation of this 
Act, to the extent necessary to protect the safety of 
the public, the Secretary may request that any entity 
(including a supplier of an ingredient, manufacturer, 
packer, distributor, or retailer) in the supply chain 
of such cosmetic submit to the Secretary information 
that is similar to the information described under 
subparagraphs (A) and (B) of paragraph (1). 
‘‘(3) MAINTENANCE OF RECORDS.—Any entity 
in supply chain of a cosmetic (including the brand 
owner named on the label of a cosmetic) shall— 
‘‘(A) maintain records sufficient to provide 
the information described in subparagraphs (A) 
and (B) of paragraph (1); and 
‘‘(B) provide such information to the Sec-
retary upon the request of the Secretary. 
‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting the authority of the 
Secretary to issue an order to cease distribution of, or to 
recall, a cosmetic under any other provision of this Act. 
‘‘SEC. 621. PETITIONS. 
‘‘(a) IN GENERAL.—The Secretary shall complete 
and publish a review, and, if appropriate, immediately re-
vise related, relevant information, including ingredient 
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lists, ingredient restrictions or prohibitions, or ingredient 
or cosmetic safety determinations, not later than 6 months 
after the date on which the Secretary receives from any 
individual or entity a reasonable petition— 
‘‘(1) to prohibit or restrict an ingredient for use 
in cosmetics and list such ingredient on the list 
under section 616(b); 
‘‘(2) to remove an ingredient from the list of in-
gredients that are safe without limits under section 
616(c); 
‘‘(3) to add an ingredient to the priority assess-
ment list under section 616(d); or 
‘‘(4) to add an ingredient to the list of contami-
nants under section 618. 
‘‘(b) REASONABLE PETITION.—Not later than 1 year 
after the date of the enactment of this Act, the Secretary 
shall issue rules specifying the criteria which the Secretary 
will use to determine if a petition submitted under this 
section is a reasonable petition. 
‘‘SEC. 622. MANDATORY REPORTING OF SERIOUS ADVERSE 
EVENTS. 
‘‘(a) SUBMISSION OF REPORT ON SERIOUS ADVERSE 
EVENTS.—The Secretary shall require that the brand 
owner of a cosmetic whose name appears on the label of 
a cosmetic marketed in the United States submit to the 
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Secretary a report containing information received con-
cerning any serious adverse event associated with the use 
of the cosmetic. 
‘‘(b) TIMING OF REPORT.—A report under subsection 
(a) shall be submitted to the Secretary not later than 15 
business days after information concerning the serious ad-
verse event is received at the place of business of the brand 
owner. 
‘‘(c) CONTENT OF REPORT.—A report under sub-
section (a) shall include the following information, to the 
extent to which the brand owner submitting the report has 
been able to verify the information: 
‘‘(1) The identity of the individual experiencing 
the adverse health event. 
‘‘(2) An identifiable report of such effect. 
‘‘(3) The name of the cosmetic suspected of 
causing such effect. 
‘‘(4) A description of the adverse health event. 
‘‘(d) PUBLIC AVAILABILITY AND PRIVACY.— 
‘‘(1) PUBLIC AVAILABILITY.—Subject to para-
graph (2), the serious adverse event reports collected 
by the Secretary under this section shall be sub-
mitted electronically and shall be made accessible to 
the public. 
‘‘(2) PRIVACY.— 
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‘‘(A) PERSONALLY IDENTIFIABLE INFOR-
MATION.—Notwithstanding any other provision 
of law, personally identifiable information in se-
rious adverse event reports provided to the Sec-
retary under this section, shall not— 
‘‘(i) be made publicly available pursu-
ant to any State or other law requiring dis-
closure of information or records; or 
‘‘(ii) otherwise be disclosed or distrib-
uted to any party without the written con-
sent of the Secretary and the person sub-
mitting such information to the Secretary. 
‘‘(B) 
TREATMENT
OF
INFORMATION 
UNDER PRIVACY ACT AND FOIA.—A report sub-
mitted to the Secretary under this section, shall 
be considered to be a record about an individual 
under section 552a of title 5, United States 
Code (commonly referred to as the ‘‘Privacy 
Act of 1974’’) and a medical or similar file the 
disclosure of which would constitute a violation 
of section 552 of such title 5 (commonly re-
ferred to as the ‘‘Freedom of Information 
Act’’), and shall not be publicly disclosed unless 
all personally identifiable information is re-
dacted. 
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‘‘SEC. 623. NONCONFIDENTIAL INFORMATION. 
‘‘(a) INFORMATION AVAILABLE TO PUBLIC.—Subject 
to subsection (c) and section 622(d)(2), all nonconfidential 
information submitted pursuant to this subchapter shall 
be made available to the public, including the following 
types of information: 
‘‘(1) The name, identity, and structure of a 
chemical substance, contaminant, or impurity that is 
an ingredient. 
‘‘(2) All information concerning function, expo-
sure, toxicity data, health hazards, and environ-
mental hazards for a cosmetic. 
‘‘(3) The functions of ingredients in cosmetics. 
‘‘(4) Fragrance, flavor, and colorants in a cos-
metic. 
‘‘(b) CONFIDENTIAL INFORMATION.—The concentra-
tion of cosmetic ingredients used in a finished cosmetic 
shall be considered confidential business information and 
may not be made available to the public under subsection 
(a). 
‘‘(c) PETITION FOR INFORMATION TO REMAIN CON-
FIDENTIAL.— 
‘‘(1) IN GENERAL.—The Secretary shall create 
a process for an entity to petition for nonconfidential 
information described in subsection (a) to remain 
confidential if the entity shows that there would be 
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a serious negative impact to the entity’s commercial 
interests if such information were disclosed to the 
public. 
‘‘(2) LIMITATION.—The Secretary may not ap-
prove a petition under paragraph (1) to the extent 
that such petition would prevent the public disclo-
sure of— 
‘‘(A) the name, identity, and structure of 
any chemical substance, contaminant, or impu-
rity that is an ingredient; 
‘‘(B) all health and safety data related to 
that substance, contaminant, or impurity; or 
‘‘(C) any data used to substantiate the 
safety of that substance, contaminant, or impu-
rity. 
‘‘SEC. 624. ANIMAL TESTING ALTERNATIVES. 
‘‘(a) IN GENERAL.—To minimize the use of animal 
testing of ingredients and cosmetics, the Secretary shall— 
‘‘(1) require, where practicable, alternative test-
ing methods that— 
‘‘(A) do not involve the use of an animal 
to test the chemical substance; 
‘‘(B) provide information that is equivalent 
or superior in scientific quality to the animal 
testing method; and 
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‘‘(C) use fewer animals than conventional 
animal-based tests when nonanimal methods 
are impracticable, including the use of tests 
that combine multiple endpoints; and 
‘‘(2) encourage, where practicable— 
‘‘(A) estimation of toxicological properties 
of a chemical through the use of testing infor-
mation for one or more structurally similar 
chemicals where such estimates provide infor-
mation of sufficient scientific quality; 
‘‘(B) the formation of industry consortia to 
conduct testing to avoid duplication of tests; 
and 
‘‘(C) funding for research and validation of 
alternative test methods, in accordance with 
this subsection. 
‘‘(b) LIST OF ALTERNATIVE TESTING METHODS.— 
Not later than 1 year after the date of the enactment of 
this subchapter, and triennially thereafter, the Secretary 
shall publish a list of the alternative testing methods de-
scribed in subsection (a). 
‘‘SEC. 625. PRODUCT TESTING AND REVIEW AUDIT. 
‘‘The Secretary shall conduct annual audits of ran-
dom samples of cosmetics to assess or test for acute nega-
tive reactions, pathogen hazards, contaminants, leaching 
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of packaging additives, mislabeling, or other relevant 
issues of concern (as determined by the Secretary). 
‘‘SEC. 626. RESOURCES FOR SMALL BUSINESSES. 
‘‘The Secretary shall provide technical support to as-
sist small businesses in carrying out the requirements of 
this subchapter. 
‘‘SEC. 627. INTERAGENCY COOPERATION. 
‘‘(a) INTERAGENCY COUNCIL ON COSMETIC SAFE-
TY.—There is established an Interagency Council on Cos-
metic Safety for the purpose of sharing data and pro-
moting collaboration on cosmetic safety between the Food 
and Drug Administration, the National Institute of Envi-
ronmental Health Sciences, the Centers for Disease Con-
trol and Prevention, the Occupational Safety and Health 
Administration, and the Environmental Protection Agen-
cy. 
‘‘(b) USE OF DATA FROM FEDERAL SOURCES.—For 
purposes of this subchapter, the Secretary, as appropriate, 
shall request and utilize ingredient and cosmetic toxicity, 
use, and exposure data from other Federal agencies. 
‘‘SEC. 628. SAVINGS CLAUSE. 
‘‘Nothing in this Act affects the right of a State or 
a political subdivision of a State to adopt or enforce any 
regulation, requirement, or standard of performance that 
is different from, or in addition to, a regulation, require-
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ment, liability, or standard for performance established 
pursuant to this Act unless compliance with both this Act 
and the State or political subdivision of a State regulation, 
requirement, or standard of performance is impossible, in 
which case the applicable provisions of this Act shall con-
trol. 
‘‘SEC. 629. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated such sums 
as may be necessary to carry out this subchapter for each 
of the fiscal years 2014 through 2018.’’. 
(b) ADULTERATED AND MISBRANDED COSMETICS.— 
(1) ADULTERATED COSMETICS.—Section 601 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 361) is amended in paragraph (a)— 
(A) by striking ‘‘, except that this provi-
sion shall not apply to coal-tar hair dye’’ and all 
that follows through ‘‘or eyebrow dyes’’; and 
(B) by adding at the end the following: 
‘‘(f) If it is manufactured in a manner that fails 
to comply with section 617(a). 
‘‘(g) If it is imported, distributed, or marketed 
and— 
‘‘(1) it contains an ingredient on the list 
under section 616(b)(1)(A), and the manufac-
turer has not complied with section 616(b)(4) 
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with respect to such ingredient and such cos-
metic; or 
‘‘(2) it contains an ingredient on the list 
under section 616(b)(1)(B), such ingredient is 
being used in a manner that violates the limit 
on use or concentration of such ingredient 
under section 616(b)(2), and the manufacturer 
has not complied with section 616(b)(4) with 
respect to such ingredient and such cosmetic. 
‘‘(h) If it is marketed by a brand owner that, 
with respect to such cosmetic, is required to dem-
onstrate, under section 617(b)(2), that the cosmetic 
meets the safety standard and the brand owner has 
not yet submitted the required data under section 
617(b)(3).’’. 
(2) MISBRANDED COSMETICS.—Section 602 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 362) is amended— 
(A) in paragraph (a), by inserting ‘‘or fails 
to meet the requirements of section 613 or 
618(b)’’ before the period; and 
(B) by adding at the end the following: 
‘‘(g) If it— 
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‘‘(1) was brought to market by a brand 
owner that failed to register and pay the appli-
cable fee as required under section 612; 
‘‘(2) is brought to market, manufactured, 
packaged, distributed, or sold in retail by a 
brand owner, manufacturer, packager, dis-
tributor, or retailer, respectively, who fails to 
notify the Secretary as required under section 
620(a)(1); 
‘‘(3) is distributed in violation of an order 
under section 620(c); 
‘‘(4) is not recalled as required by an order 
under subsection (d) or (e) of section 620; 
‘‘(5) is manufactured in a manner that 
fails to comply with good manufacturing prac-
tices prescribed by the Secretary under section 
614(b); or 
‘‘(6) is brought to market by a brand 
owner who fails— 
‘‘(A) to submit the statement required 
under section 619; or 
‘‘(B) notify the Secretary of changes 
to information contained in such report, as 
required by such section.’’. 
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(3) ADDITIONAL PROHIBITIONS.—Section 301 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331) is amended— 
(A) in paragraph (e), by inserting ‘‘612,’’ 
after ‘‘564,’’ each place it appears; and 
(B) by adding at the end the following: 
‘‘(ccc) The failure of a brand owner, manufac-
turer, or supplier of a cosmetic or an ingredient for 
use in a cosmetic to submit and update data and in-
formation as required under section 615(a). 
‘‘(ddd) The manufacture, importation, distribu-
tion, or marketing of an ingredient for use in a cos-
metic that is on the list under section 616(b)(1)(A). 
‘‘(eee) The failure of a supplier of an ingredient 
for use in a cosmetic— 
‘‘(1) to provide data and information as re-
quired by section 615(a)(4)(B); or 
‘‘(2) comply with the testing requirements 
under section 618(c). 
‘‘(fff) The failure of a manufacturer to comply 
with the requirements of section 618(d). 
‘‘(ggg) The failure of a brand owner of a cos-
metic to comply with the requirement of reporting 
serious adverse events under section 622.’’. 
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SEC. 3. WORKER ISSUES. 
(a) IN GENERAL.—The Secretary of Labor shall pro-
mulgate an occupational safety and health standard under 
section 6 of the Occupational Safety and Health Act of 
1970 (29 U.S.C. 655) that requires the following: 
(1) MANUFACTURERS AND IMPORTERS.—Each 
manufacturer or importer selling any cosmetic for 
professional use shall— 
(A) obtain or develop a material safety 
data sheet described in subsection (b) for each 
such cosmetic or personal care product that— 
(i) the manufacturer or importer pro-
duces or imports; and 
(ii) includes a hazardous chemical, or 
a product ingredient associated with any 
chemical hazard, that is classified as a 
health hazard in accordance with the cri-
teria found in section 1910.1200(d) of title 
29 of the Code of Federal Regulations, and 
any successor regulations; and 
(B) make the material safety data sheet 
available to distributors and employers, includ-
ing salon owners, in English and, upon request, 
in other languages, including Spanish and Viet-
namese. 
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(2) DISTRIBUTORS.—Each distributor of a cos-
metic or personal care product for professional use 
shall distribute and provide material safety data 
sheets described in subsection (b) in the same man-
ner as a distributor of a chemical hazard is required 
to distribute and provide material safety data sheets 
under section 1910.1200(g) of title 29, Code of Fed-
eral Regulations, or any successor regulations. 
(3) EMPLOYERS.—Each employer, including 
any operator of a salon, shall— 
(A) have a material safety data sheet in 
the workplace for each cosmetic or personal 
care product for professional use that is used in 
the course of the employer’s business; 
(B) make such material safety data sheet 
available to all employees of the employer who 
are exposed or use the product to the same ex-
tent and in the same manner as material safety 
data sheets are required to be made available 
under section 1910.1200(g) of title 29, Code of 
Federal Regulations, or any successor regula-
tions; and 
(C) upon request, provide employees with 
translations of such material safety data sheet 
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in other languages, including Spanish and Viet-
namese. 
(b) CONTENTS
OF
MATERIAL
SAFETY
DATA 
SHEET.—A material safety data sheet for a cosmetic or 
personal care product for professional use described in this 
section shall— 
(1) contain the information required in a mate-
rial safety data sheet under section 1910.1200(g) of 
title 29, Code of Federal Regulations, or any suc-
cessor regulations, for each hazardous chemical, or 
product ingredient associated with any chemical haz-
ard, described in subsection (a)(1)(A)(ii); and 
(2) include the following statement: ‘‘This ma-
terial safety data sheet is also available in multiple 
languages by contacting the manufacturer, using the 
contact information provided on this sheet.’’. 
(c) PROFESSIONAL USE DEFINED.—In this section, 
the term ‘‘professional use’’ has the meaning given such 
term in section 611(6) of the Federal Food, Drug, and 
Cosmetic Act, except to the extent that such term applies 
to a product that is sold as a retail product in any of the 
establishments listed under such definition. 
Æ 
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