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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2359 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2359

To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure 
           the safe use of cosmetics, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             June 24, 2011

 Ms. Schakowsky (for herself, Mr. Markey, Ms. Baldwin, Mr. Moran, Ms. 
Woolsey, Mr. Blumenauer, Ms. Chu, Mr. Gutierrez, Ms. Lee of California, 
 Mr. Frank of Massachusetts, and Ms. Wasserman Schultz) introduced the 
   following bill; which was referred to the Committee on Energy and 
    Commerce, and in addition to the Committee on Education and the 
 Workforce, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

 
To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure 
           the safe use of cosmetics, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Safe Cosmetics Act 
of 2011''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Cosmetic regulation.
          ``subchapter a--adulterated and misbranded cosmetics

                ``subchapter b--regulation of cosmetics

        ``Sec. 611. Definitions.
        ``Sec. 612. Registration of establishments and registration 
                            fees.
        ``Sec. 613. Ingredients labels on cosmetics.
        ``Sec. 614. Safety standard and good manufacturing practices.
        ``Sec. 615. Cosmetic and ingredient safety information.
        ``Sec. 616. Lists of ingredients and required responses.
        ``Sec. 617. Treatment of cosmetics based on ingredient lists.
        ``Sec. 618. Treatment of contaminants.
        ``Sec. 619. Cosmetic and ingredient statements.
        ``Sec. 620. Notification, nondistribution, and recall of 
                            adulterated or misbranded cosmetics.
        ``Sec. 621. Petitions.
        ``Sec. 622. Mandatory reporting of adverse health effects.
        ``Sec. 623. Nonconfidential information.
        ``Sec. 624. Animal testing alternatives.
        ``Sec. 625. Product Testing and Review Audit.
        ``Sec. 626. Resources for small businesses.
        ``Sec. 627. Interagency cooperation.
        ``Sec. 628. Savings clause.
        ``Sec. 629. Authorization of appropriations.
Sec. 3. Worker issues.

SEC. 2. COSMETIC REGULATION.

    (a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.) is amended--
            (1) by inserting before section 601 the following:

        ``Subchapter A--Adulterated and Misbranded Cosmetics'';

        and
            (2) by adding at the end the following:

                ``Subchapter B--Regulation of Cosmetics

``SEC. 611. DEFINITIONS.

    ``In this subchapter:
            ``(1) Domestic establishment.--The term `domestic 
        establishment' means an establishment located in any State that 
        manufactures or packages cosmetics.
            ``(2) Foreign establishment.--The term `foreign 
        establishment' means an establishment that manufactures or 
        packages cosmetics that are exported to the United States.
            ``(3) Manufacturer.--The term `manufacturer' only includes 
        manufacturers that determine the final formulation of a 
        cosmetic.
            ``(4) Ingredient.--
                    ``(A) In general.--The term `ingredient' means a 
                chemical in a cosmetic, including--
                            ``(i) chemicals that provide a technical or 
                        functional effect;
                            ``(ii) chemicals that have no technical or 
                        functional effect in the cosmetic but are 
                        present by reason of having been incorporated 
                        into the cosmetic as an ingredient of another 
                        cosmetic ingredient;
                            ``(iii) processing aids that are present by 
                        reason of having been added to a cosmetic 
                        during the processing of such cosmetic;
                            ``(iv) substances that are present by 
                        reason of having been added to a cosmetic 
                        during processing for their technical or 
                        functional effect;
                            ``(v) the components of a fragrance, 
                        flavor, or preservative; and
                            ``(vi) any individual component of a 
                        petroleum-derived, animal-derived, or other 
                        ingredient that the Secretary deems an 
                        ingredient for purposes of this chapter.
                    ``(B) Treatment of contaminants.--For purposes of 
                sections 614 through 617, the term `ingredient' also 
                includes--
                            ``(i) contaminants present at levels above 
                        technically feasible detection limits; and
                            ``(ii) contaminants that may leach from 
                        container materials or form via reactions over 
                        the shelf life of a cosmetic and that may be 
                        present at levels above technically feasible 
                        detection limits.
            ``(5) Microbusiness.--The term `microbusiness' means a 
        business--
                    ``(A) that is engaged in the manufacturing or 
                packaging of cosmetics; and
                    ``(B) that has annual sales receipts for cosmetic 
                products that do not exceed $2,000,000.
            ``(6) Professional use.--The term `professional use' means 
        the use of any cosmetic--
                    ``(A) by an employee (within the scope of the 
                employment of such employee) of; or
                    ``(B) purchased by a consumer in,
        a hair salon, nail salon, beauty salon, spa, or other 
        establishment that provides cosmetic treatment services for 
        humans.
            ``(7) Reasonable certainty of no harm.--With respect to an 
        ingredient or cosmetic, the term `reasonable certainty of no 
        harm' means that no harm will be caused to members of the 
        general population or any vulnerable population by aggregate 
        exposure to the cosmetic or ingredient, taking into account 
        possible harmful effects from--
                    ``(A) low-dose exposures to the cosmetic or 
                ingredient; or
                    ``(B) additive effects resulting from repeated 
                exposure to the cosmetic or ingredient over time; or
                    ``(C) cumulative exposure resulting from all 
                sources, including both the cosmetic or ingredient and 
                environmental sources.
            ``(8) Reproductive or developmental toxicity.--With respect 
        to an ingredient or cosmetic, the term `reproductive or 
        developmental toxicity' means that the ingredient or cosmetic 
        can contribute to biologically adverse effects on the 
        development of humans or animals, including effects on the 
        female or male reproductive system, the endocrine system, 
        fertility, pregnancy, pregnancy outcomes, or modifications in 
        other functions of the body that are dependent on the integrity 
        of the reproductive system as well normal fetal development.
            ``(9) Vulnerable populations.--The term `vulnerable 
        populations' includes pregnant women, infants, children, the 
        elderly, people with compromised immune systems, and highly 
        exposed populations, including workers employed by hair salons, 
        nail salons, beauty salons, spas, other establishments that 
        provide cosmetic treatment services for humans, and cosmetic 
        manufacturing plants.

``SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REGISTRATION FEES.

    ``(a) Registration.--
            ``(1) In general.--Beginning 1 year after the date of the 
        enactment of this subchapter, and annually thereafter, any 
        establishment (except for microbusinesses) engaged in 
        manufacturing or packaging cosmetics for use in the United 
        States shall register with the Secretary and pay to the 
        Secretary the applicable fee, as established under the fee 
        schedule in subsection (e).
            ``(2) Rules for domestic and foreign establishments.--To be 
        registered under paragraph (1)--
                    ``(A) as a domestic establishment, the owner, 
                operator, or agent in charge of the domestic 
                establishment shall submit a registration to the 
                Secretary; or
                    ``(B) as a foreign establishment, the owner, 
                operator, or agent in charge of the foreign 
                establishment shall--
                            ``(i) submit a registration to the 
                        Secretary; and
                            ``(ii) include with the registration the 
                        name of the United States agent for the foreign 
                        establishment.
            ``(3) New establishments.--Any establishment that begins to 
        manufacture or package a cosmetic after the date on which the 
        requirements of paragraph (1) apply shall, not later than 60 
        days after the date on which the establishment began to 
        manufacture or package such cosmetic, register with the 
        Secretary and pay the applicable fee, as required under 
        paragraph (1).
    ``(b) Submission of Registration.--
            ``(1) In general.--In order to register under subsection 
        (a), an establishment (referred to in this section as the 
        `registrant') shall submit to the Secretary, with respect to 
        any cosmetics that the establishment manufactures or package, 
        all of the following:
                    ``(A) Any information necessary to notify the 
                Secretary of the name, address, and legal status of 
                each establishment at which, and all trade names under 
                which, the registrant manufactures or package 
                cosmetics.
                    ``(B) A description of the establishment's 
                activities with respect to cosmetics, including a list 
                of all cosmetic products manufactured or packaged by 
                the establishment and the functions of such cosmetics.
                    ``(C) The gross receipts or sales for the 
                establishment from cosmetics.
                    ``(D) The name and address of any company that 
                supplies the establishment, if the establishment 
                manufactures cosmetics, with any ingredient and the 
                name of the ingredient supplied to such establishment 
                by such supplier.
            ``(2) Notification of changes.--When submitting the annual 
        registration, the registrant shall notify the Secretary of 
        changes to the information described in paragraph (1).
    ``(c) Procedure.--Upon receipt of a completed registration 
submitted under subsection (a), the Secretary shall notify the 
registrant of the receipt of such registration and assign a 
registration number to each registered establishment.
    ``(d) List of Registered Establishments.--
            ``(1) Maintenance of list.--The Secretary shall--
                    ``(A) compile, maintain, and update as appropriate, 
                a list of establishments that are registered under this 
                section;
                    ``(B) make such list publically available; and
                    ``(C) remove from such list the name of any 
                establishment that fails to register in accordance with 
                this section.
            ``(2) Application of foia.--
                    ``(A) Registration documents.--Any registration 
                documents submitted pursuant to this section shall not 
                be subject to disclosure under section 552 of title 5, 
                United States Code.
                    ``(B) Other information.--Information derived 
                from--
                            ``(i) the list under paragraph (1); or
                            ``(ii) registration documents submitted 
                        pursuant to this section,
                shall not be subject to disclosure under section 552 of 
                title 5, United States Code, except to the extent that 
                such information discloses the identity or location of 
                a specific registrant.
    ``(e) Fee Schedule.--A schedule of fees shall be developed by the 
Secretary to provide for oversight and enforcement of this subchapter. 
The fee structure shall--
            ``(1) be prorated based on the establishment's gross 
        receipts or sales; and
            ``(2) only be assessed on companies with annual gross 
        receipts or sales of cosmetics that exceed $10,000,000.
    ``(f) Suspension and Cancellation of Registration.--
            ``(1) Criteria for suspension.--Registration under this 
        section is subject to suspension if the Secretary finds--
                    ``(A) the information submitted by the 
                establishment for registration under subsection (a) is 
                incomplete, inaccurate, or out of date;
                    ``(B) the establishment fails to notify the 
                Secretary of changes required under subsection (b)(2);
                    ``(C) the establishment fails to pay registration 
                fees, as required under subsection (a), in a timely 
                manner; or
                    ``(D) the establishment violates any portion of 
                this chapter.
            ``(2) Suspension of registration.--If the Secretary 
        determines that an establishment is subject to suspension under 
        subsection (f) and that it is appropriate to suspend the 
        registration of such establishment, the Secretary shall--
                    ``(A) suspend the registration of such 
                establishment; and
                    ``(B) provide a notice of suspension to such 
                establishment.
            ``(3) Cancellation.--If the establishment fails to correct 
        the issue that resulted in the suspension under paragraph (2) 
        before the last day of the 30-day period beginning on the date 
        that the establishment receives notice under such paragraph, 
        the Secretary may cancel the registration of such 
        establishment.

``SEC. 613. INGREDIENTS LABELS ON COSMETICS.

    ``(a) In General.--Subject to subsections (b) and (c), the 
Secretary shall require that the label on each package of cosmetics 
(including cosmetics distributed for retail sale and professional use) 
bears a declaration of the name of each ingredient in such cosmetic in 
descending order of predominance.
    ``(b) Adjustments for Label Size.--
            ``(1) Rules for small products.--Not later than 6 months 
        after the date of the enactment of this subchapter, the 
        Secretary shall issue regulations that apply to any cosmetic 
        for which the product packaging is not of sufficient size to 
        bear or contain a label that meets the requirements of 
        subsection (a).
            ``(2) Requirements for public disclosure.--Such regulations 
        shall establish requirements for listing ingredients on the 
        label of such cosmetics and additional requirements for public 
        disclosure of the ingredients in such cosmetics.
    ``(c) Special Rule for Contaminants.--The Secretary shall require, 
in the case of a contaminant, that a contaminant be declared on the 
label of a cosmetic, in the same manner as an ingredient under 
subsection (a), if the contaminant is present at the lower of the 
following levels:
            ``(1) A level that is greater than one part-per-billion by 
        weight of product formation.
            ``(2) A level that is greater than one percent of the 
        restriction on the concentration for such contaminant for such 
        use, as determined by the Secretary under section 616(a)(2).
    ``(d) Labeling of Nanomaterials in Cosmetics.--The Secretary may 
require that--
            ``(1) minerals and other particulate ingredients be labeled 
        as `nano-scale' on a cosmetic ingredient label or list if not 
        less than 1 percent of the ingredient particles in the cosmetic 
        are 100 nanometers or smaller in not less than 1 dimension; and
            ``(2) other ingredients in a cosmetic be designated with 
        scale-specific information on a cosmetic ingredient label or 
        list if such ingredients possess scale-specific hazard 
        properties.
    ``(e) Labeling of Ingredients in Cosmetics Sold Through Internet 
Commerce.--The Secretary shall require--
            ``(1) in the case of a cosmetic sold on the Web site of an 
        Internet vendor, that the manufacturers and distributors of 
        such cosmetic provide to such Internet vendor a list of the 
        ingredients of the cosmetic; and
            ``(2) that each Internet vendor display the list of 
        ingredients of a cosmetic sold by such vendor on the Web page 
        that is the primary Web page providing information relating to 
        the sale of such cosmetic on the Web site of the vendor.
    ``(f) Trade Secrets.--Notwithstanding any other provision of law, 
an ingredient required to be listed on a label under this section shall 
not be treated as a trade secret.
    ``(g) Application.--Beginning 18 months after the date of the 
enactment of this subchapter, the requirements of this section shall 
apply to--
            ``(1) all cosmetics that are available for retail sale; and
            ``(2) manufacturers, distributors, and Internet vendors of 
        such cosmetics.

``SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING PRACTICES.

    ``(a) Safety Standard.--
            ``(1) In general.--Taking into account the expected use of 
        a cosmetic, the Secretary shall establish a safety standard 
        that, with respect to a cosmetic or an ingredient in a cosmetic 
        provides a reasonable certainty of no harm (as such term is 
        defined in section 611(7)) from exposure to the cosmetic or 
        ingredient and protects the public from any known or 
        anticipated adverse health effects associated with the cosmetic 
        or ingredient.
            ``(2) Standards for establishing safety standard.--In 
        establishing the safety standard under paragraph (1), the 
        Secretary shall ensure that--
                    ``(A) the likely level of exposure to all sources 
                of the ingredient or cosmetic (including environmental 
                sources) that will result under the safety standard 
                presents not more than a 1 in a million risk for any 
                adverse health effect in any vulnerable population at 
                the lower 95th percentile confidence interval; or
                    ``(B) the safety standard results in exposure to 
                the amount or concentration of an ingredient or 
                cosmetic that is shown to produce no adverse health 
                effects, incorporating an margin of safety of at least 
                1,000 and considering the impact of cumulative exposure 
                from all sources (including environmental sources).
            ``(3) Use of other federal standards.--If any Federal 
        agency has promulgated a standard for an ingredient that 
        satisfies the requirements under paragraph (1), the Secretary 
        may treat such standard as the safety standard under paragraph 
        (1) for purposes of such ingredient.
            ``(4) Application of safety standard.--The Secretary may 
        only determine that an ingredient or a cosmetic meets the 
        safety standard under paragraph (1) if there is a reasonable 
        certainty of no harm from exposure to the ingredient or 
        cosmetic.
    ``(b) Good Manufacturing Practices.--
            ``(1) In general.--The Secretary shall issue guidance 
        prescribing good manufacturing practices for cosmetics and 
        ingredients, including quality control procedures that the 
        Secretary determines are necessary, and shall update such 
        regulations as necessary.
            ``(2) Consideration of small business.--In developing the 
        guidance under paragraph (1), the Secretary shall consider how 
        such practices will impact small businesses.

``SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMATION.

    ``(a) Required Submission of All Safety Information.--
            ``(1) In general.--Manufacturers of cosmetics and 
        ingredients shall submit to the Secretary (in an electronic 
        format that the Secretary shall determine) all data and 
        information that the manufacturer can access regarding the 
        safety of the--
                    ``(A) ingredients listed on the cosmetic label 
                under section 613 for a cosmetic; and
                    ``(B) cosmetic itself.
            ``(2) Required information.--The required data and 
        information under paragraph (1) shall include, for each 
        ingredient in a cosmetic and for the cosmetic, the following:
                    ``(A) Functions and uses.
                    ``(B) Data and information on the physical, 
                chemical, and toxicological properties of each such 
                ingredient or cosmetic.
                    ``(C) Exposure and fate information.
                    ``(D) Results of all safety tests that the 
                manufacturer can access or has conducted.
                    ``(E) Any other information used to substantiate 
                the safety of such ingredient and cosmetic.
            ``(3) Deadlines.--
                    ``(A) Initial submission.--A manufacturer shall 
                submit the data and information required under 
                paragraph (1)--
                            ``(i) in the case of an ingredient or 
                        cosmetic which is marketed for sale in 
                        interstate commerce on or before the date of 
                        the enactment of this subchapter, not later 
                        than 1 year after such date; and
                            ``(ii) in the case of an ingredient or 
                        cosmetic which is not marketed for sale on or 
                        before such date--
                                    ``(I) not later than the end of the 
                                14-month period beginning on the date 
                                of the enactment of this subchapter; or
                                    ``(II) if the ingredient or 
                                cosmetic is first marketed for sale in 
                                interstate commerce after the end of 
                                the period described in subclause (I), 
                                not later than 60 days after the date 
                                on which such ingredient or cosmetic is 
                                first marketed for sale.
                    ``(B) Updates.--
                            ``(i) In general.--Subject to clause (ii), 
                        a manufacturer shall update the data and 
                        information submitted under subparagraph (A) 
                        annually.
                            ``(ii) Adverse health effects.--In the case 
                        of information related to an adverse health 
                        effect that is suspected to be caused by an 
                        ingredient or a cosmetic, a manufacturer shall 
                        update the information not later than 60 days 
                        after receiving such information.
            ``(4) Supplier information.--
                    ``(A) Use of supplier information.--In order to 
                meet the requirements of paragraph (1) with respect to 
                an ingredient, a manufacturer may submit safety data 
                and information provided by the supplier of the 
                ingredient.
                    ``(B) Supplier provision of information.--If a 
                manufacturer requests that a supplier of an ingredient 
                provide to such manufacturer any of the data and 
                information described under paragraph (2), such 
                supplier shall provide such data and information to 
                such manufacturer not later than 90 days after 
                receiving such request.
    ``(b) Database.--
            ``(1) Initial publication.--Not later than 1 year after the 
        date of the enactment of this subchapter, the Secretary shall 
        publish a comprehensive, publicly accessible database 
        containing all nonconfidential information (as such term is 
        used under section 623) submitted under subsection (a)(1).
            ``(2) Updates.--Not later than 90 days after the Secretary 
        receives new or updated information under subsection (a)(3)(B), 
        the Secretary shall update the database under paragraph (1) 
        with such information.
    ``(c) Review and Evaluation of Information.--
            ``(1) In general.--Based on the data and information 
        submitted under subsection (a)(1), available from an 
        authoritative source (as such term is defined in paragraph (3), 
        including data described under section 627(b)), and such other 
        information as the Secretary may have available, the Secretary 
        shall review and evaluate the safety of cosmetics and 
        ingredients of cosmetics that are marketed in interstate 
        commerce.
            ``(2) Consideration of nanomaterials.--The Secretary 
        shall--
                    ``(A) monitor developments in the scientific 
                understanding from any adverse health effects related 
                to the use of nanotechnology in the formulation of 
                cosmetic (including progress in the standardization of 
                testing methods and specific size definitions for 
                nanomaterials); and
                    ``(B) consider scale specific hazard properties of 
                ingredients when reviewing and evaluating the safety of 
                cosmetics and ingredients under paragraph (1).
            ``(3) Authoritative source defined.--For purposes of this 
        paragraph, the term `authoritative source' means--
                    ``(A) the Environmental Protection Agency;
                    ``(B) the International Agency for Research on 
                Cancer;
                    ``(C) the National Toxicity Program through the 
                National Institutes of Health;
                    ``(D) the California Environmental Protection 
                Agency; and
                    ``(E) any other authoritative international, 
                Federal, and State entity, as determined by the 
                Secretary.

``SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RESPONSES.

    ``(a) Placement on List.--
            ``(1) In general.--Based on an initial review and 
        evaluation of an ingredient under subsection (c), the Secretary 
        shall place the ingredient on one of the following lists:
                    ``(A) The prohibited and restricted list under 
                subsection (b).
                    ``(B) The safe without limits list under subsection 
                (c).
                    ``(C) The priority assessment list under subsection 
                (d).
            ``(2) Considerations.--In determining the placement of an 
        ingredient on a list under subsection (a), the Secretary shall 
        consider whether the ingredient--
                    ``(A) reacts with other substances to form harmful 
                contaminants;
                    ``(B) is found to be present in the body through 
                biomonitoring;
                    ``(C) is found in drinking water or air;
                    ``(D) is a known or suspected neurological or 
                immunological toxicant, respiratory asthmagen, 
                carcinogen, teratogen, or endocrine disruptor, or have 
                other toxicological concerns (including reproductive or 
                developmental toxicity); or
                    ``(E) is known to persist in the environment or 
                bioaccumulate.
            ``(3) Prioritiziation of ingredients that are food.--In 
        placing ingredients on the lists under paragraph (1), the 
        Secretary shall prioritize the placement of ingredients that 
        are food (as such term is defined under section 201(f)) on such 
        lists.
    ``(b) Prohibited and Restricted List.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of this subchapter, the Secretary shall issue, by 
        regulation, a list of ingredients that are identified by the 
        Secretary--
                    ``(A) as prohibited for use because the Secretary 
                determines that such ingredients are unsafe for use in 
                cosmetics in any amount because such ingredients fail 
                to meet the safety standard under section 614(a); or
                    ``(B) as being subject to necessary restrictions in 
                use or concentration to allow the use of the ingredient 
                in a cosmetic to satisfy the safety standard.
            ``(2) Specification of restrictions.--In the case of any 
        ingredient listed under paragraph (1)(B), the Secretary shall 
        specify the restrictions on use or concentration that are 
        necessary to satisfy the safety standard for such ingredient.
            ``(3) Updates.--The Secretary shall, at a minimum, annually 
        update the list under paragraph (1), including any--
                    ``(A) determinations under subsection (d)(3); or
                    ``(B) new information that demonstrates that an 
                ingredient fails to meet the safety standard, or 
                requires restrictions on use to meet such standard.
            ``(4) Manufacturer requirements.--Not later than 1 year 
        after the date that an ingredient is placed on a list under 
        subsection (b), any manufacturer using such ingredient in a 
        cosmetic shall reformulate such cosmetic to--
                    ``(A) eliminate the use of the ingredient, if it is 
                listed under paragraph (1)(A); or
                    ``(B) modify the use of the ingredient if it is 
                listed under paragraph (1)(B), to meet the restrictions 
                specified under paragraph (2).
    ``(c) Safe Without Limits List.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of this subchapter, the Secretary shall issue, by 
        regulation, a list of ingredients that the Secretary has 
        determined are safe for use in cosmetics, without limits or 
        restrictions.
            ``(2) Standard for inclusion in list.--The Secretary may 
        only include an ingredient on the list under paragraph (1) if 
        the Secretary determines that the ingredient meets the safety 
        standard under section 614(a), regardless of--
                    ``(A) the type and form of cosmetic the ingredient 
                is used in; and
                    ``(B) the concentration of the ingredient that is 
                used in a cosmetic.
            ``(3) Updates and redeterminations.--The Secretary shall 
        annually update the list under paragraph (1) and may 
        redetermine whether an ingredient distributed in commerce meets 
        the safety standard if, in the judgment of the Secretary, new 
        information raises a credible question as to whether the 
        ingredient continues to meet the safety standard.
    ``(d) Priority Assessment List and Related Safety Determinations.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of this subchapter, the Secretary shall develop 
        and publish a priority assessment list of not less than 300 
        ingredients--
                    ``(A) which, because of a lack of authoritative 
                information on the safety of the ingredient, cannot be 
                included on--
                            ``(i) the list under subsection (b) 
                        (relating to prohibited and restricted 
                        ingredients); or
                            ``(ii) the list under subsection (c) 
                        (relating to ingredients that are safe without 
                        limits); and
                    ``(B) for which the Secretary has determined it is 
                a priority to conduct a safety determination under 
                paragraph (3).
            ``(2) Annual addition of ingredients.--After the list is 
        developed under paragraph (1), the Secretary shall annually add 
        at least 100 additional ingredients to such list until all 
        ingredients that are used in the formulation or manufacture of 
        cosmetics have been added--
                    ``(A) to such list;
                    ``(B) to the list under subsection (b); or
                    ``(C) to the list under subsection (c).
            ``(3) Determination of whether ingredient meets safety 
        standard.--
                    ``(A) Review of priority ingredients.--During the 
                2-year period following the date on which an ingredient 
                is placed on the list under paragraph (1), the 
                Secretary shall--
                            ``(i) collect data and information on such 
                        ingredient; and
                            ``(ii) review and evaluate the safety of 
                        such ingredient.
                    ``(B) Determination of list placement.--Not later 
                than the end of the period under subparagraph (A), the 
                Secretary shall issue a determination, based on the 
                review and evaluation under such clause, that--
                            ``(i) the ingredient meets the requirements 
                        for inclusion on a list under subsection (b) 
                        (relating to prohibited and restricted 
                        ingredients) or subsection (c) (relating to 
                        ingredients that are safe without limits); or
                            ``(ii) insufficient information exists to 
                        place the ingredient on either such list.
                    ``(C) Guidance in the case of insufficient 
                information.--If the Secretary determines under 
                subparagraph (B) that, with respect to an ingredient, 
                insufficient information exists to place such 
                ingredient on either of the lists under subsection (b) 
                or subsection (c), the Secretary shall provide guidance 
                to manufacturers on the data and information (including 
                minimum data requirements and safety testing protocols) 
                that the Secretary requires to evaluate whether the 
                ingredient meets the safety standard under section 
                614(a) for purposes of placing such ingredient on such 
                a list.
                    ``(D) Comment period.--Upon issuing the 
                determination under subparagraph (B), and, if 
                applicable, the guidance under subparagraph (C), the 
                Secretary shall provide a period of not less than 60 
                days for public comment on the determination before 
                applying such determination to an ingredient, except 
                that a shorter period for comment may be provided if 
                the Secretary--
                            ``(i) finds that it would be in the public 
                        interest to have a shorter period; and
                            ``(ii) publically declares the reasons for 
                        such finding.
            ``(4) Manufacturer response to inadequate information.--Not 
        later than 18 months after the date that the Secretary issues 
        guidance under paragraph (3)(C) with respect to an ingredient 
        subject to a determination under paragraph (3)(B), a 
        manufacturer using such ingredient in a cosmetic shall--
                    ``(A) reformulate such cosmetic to eliminate the 
                use of the ingredient; or
                    ``(B) provide the Secretary with the data and 
                information specified in such guidance.
            ``(5) Evaluation of additional data and information.--With 
        respect to an ingredient, not later than 6 months after a 
        manufacturer provides the Secretary with the data and 
        information under paragraph (4)(B) the Secretary shall review 
        such data and information and shall make a redetermination 
        under paragraph (3)(B) for such ingredient, subject to the 
        comment period under paragraph (3)(D).
            ``(6) Limitation.--If the Secretary has not placed an 
        ingredient on either of the lists under subsection (b) and 
        subsection (c) by the end of the 5-year period beginning on the 
        date that such ingredient is first placed on the list under 
        subsection (d), beginning on the first day after such period 
        such ingredient may not be--
                    ``(A) used in a cosmetic; and
                    ``(B) manufactured, imported, distributed, or 
                marketed for use in cosmetics.

``SEC. 617. TREATMENT OF COSMETICS BASED ON INGREDIENT LISTS.

    ``(a) In General.--Subject to subsections (b)(4) and (d)(4) of 
section 616, a manufacturer may only manufacture a cosmetic for 
distribution in interstate commerce if such cosmetic meets the safety 
standard under section 614(a).
    ``(b) Presumption Related to the Safety of Cosmetics.--
            ``(1) In general.--Subject to paragraph (2), for purposes 
        of subsection (a), the Secretary shall presume that the 
        following cosmetics meet the safety standard under section 
        614(a):
                    ``(A) A cosmetic that is made solely of ingredients 
                on the list under section 616(c)(1) (relating to 
                ingredients that are safe without limits).
                    ``(B) A cosmetic that is made solely of ingredients 
                on the list under section 616(b)(1)(B) (relating to 
                ingredients subject to restrictions) and the use of 
                each of such ingredients in such cosmetic is in 
                compliance with the restrictions on the use of such 
                ingredients specified under section 616(b)(2).
                    ``(C) A cosmetic that is made solely of ingredients 
                described under subparagraph (A) and subparagraph (B).
            ``(2) Exceptions.--The Secretary may require that a 
        manufacturer demonstrate that a cosmetic meets the safety 
        standard under section 614(a) (including by requiring that the 
        manufacturer conduct safety testing of a cosmetic described 
        under paragraph (1)) if the cosmetic--
                    ``(A) contains penetration enhancers, sensitizers, 
                estrogenic chemicals, or other similar ingredients;
                    ``(B) contains ingredients that react with each 
                other or with other substances to form harmful 
                byproducts; or
                    ``(C) the Secretary has any additional reason to 
                believe that such cosmetic does not meet the safety 
                standard under section 614(a).
            ``(3) Guidance.--If, under paragraph (2), the Secretary 
        requires that a manufacturer demonstrate that a cosmetic meets 
        the safety standard under section 614(a), the Secretary shall 
        provide the manufacturer with guidance on the data and 
        information that the Secretary requires to evaluate whether the 
        cosmetic meets the safety standard under such section.
    ``(c) Notification of Failure of Secretary To Act.--If the 
Secretary fails to act by an applicable deadline under section 616 or 
this section, a manufacturer of an ingredient or a cosmetic affected by 
such failure of the Secretary to act shall issue to the Secretary, the 
public, and each known customer of the ingredient or cosmetic, a 
written notice that a determination by the Secretary of the safety of 
the ingredient for use in cosmetics is pending.

``SEC. 618. TREATMENT OF CONTAMINANTS.

    ``(a) Publication of List.--Not later than 1 year after the date of 
the enactment of this subchapter, and annually thereafter, the 
Secretary shall publish a list of--
            ``(1) ingredients used in cosmetics that may contain 
        contaminants;
            ``(2) combinations of ingredients that may create 
        contaminants when such ingredients interact;
            ``(3) contaminants that may leech from product packaging 
        into a cosmetic; and
            ``(4) any other contaminant of cosmetics identified by the 
        Secretary.
    ``(b) Requirements for Testing.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this subchapter, the Secretary shall establish, by 
        rule, requirements for testing ingredients and cosmetics for 
        contaminants listed under subsection (a).
            ``(2) Contents.--The requirements under paragraph (1) shall 
        include--
                    ``(A) testing methods and applicable protocols; and
                    ``(B) maximum allowable detection limits for each 
                contaminant in an ingredient.
            ``(3) Update.--The Secretary shall annually update the 
        requirements under paragraph (1).
    ``(c) Supplier Requirements.--Not later than 1 year after the 
promulgation of the rule under subsection (b)(1), a supplier of an 
ingredient that is used in a cosmetic shall, with respect to such 
ingredient--
            ``(1) comply with the requirements under subsection (b)(1) 
        for any ingredient listed under subsection (a);
            ``(2) conduct similar testing on any ingredient that--
                    ``(A) the supplier expects may be used in a 
                cosmetic;
                    ``(B) the supplier suspects may contain a 
                contaminant; and
                    ``(C) is not listed under subsection (a); and
            ``(3) upon the sale of an ingredient to the manufacturer, 
        provide to the manufacturer specifications for the ingredient 
        that--
                    ``(A) include the levels of contaminants present in 
                such ingredient; and
                    ``(B) are based on the results of the tests under 
                paragraph (1) and paragraph (2).
    ``(d) Manufacturer Requirements.--Not later than 1 year after the 
promulgation of the rule under subsection (b)(1), a manufacturer of a 
cosmetic shall, with respect to each ingredient that the manufacturer 
uses in a cosmetic--
            ``(1) obtain, from each supplier of the ingredient, 
        specifications for the ingredient that include--
                    ``(A) the level of each contaminant present in the 
                ingredient; and
                    ``(B) the detection limits of the analytical test 
                used to detect the contaminant; or
            ``(2) comply with the requirements under paragraphs (1) and 
        (2) of subsection (c) for the ingredient, in the same manner as 
        if the manufacturer were a supplier.

``SEC. 619. COSMETIC AND INGREDIENT STATEMENTS.

    ``(a) In General.--Beginning 1 year after the date of the enactment 
of this subchapter, each establishment engaged in the manufacture of a 
cosmetic intended to be marketed in the United States shall submit 
electronically to the Secretary, for each cosmetic manufactured in the 
establishment that is intended to be marketed in the United States, a 
statement containing--
            ``(1) the registration number of the manufacturing 
        establishment where the cosmetic is manufactured or, if the 
        same cosmetic is manufactured in more than 1 establishment, the 
        registration number of each establishment where it is 
        manufactured;
            ``(2) the registration number of the establishment 
        responsible for distributing the cosmetic;
            ``(3) the brand name and the product name for the cosmetic;
            ``(4) the applicable use for the cosmetic;
            ``(5) the ingredient list as it appears on the cosmetic 
        label or insert, including the particle size range of any 
        nanoscale cosmetic ingredients;
            ``(6) any warnings and directions for use from the cosmetic 
        label or insert; and
            ``(7) the title and full contact information for the 
        individual responsible for submitting and maintaining such 
        statement.
    ``(b) New Cosmetics.--Any establishment that begins to manufacture 
a cosmetic after the date of the enactment of this subchapter shall 
comply with the requirements of subsection (a) beginning on the later 
of the following:
            ``(1) The end of the 18-month period beginning on the date 
        of the enactment of this subchapter.
            ``(2) The 6-month period after the date on which the 
        establishment begins to manufacture such cosmetic.
    ``(c) Notification of Changes.--The establishment shall notify the 
Secretary annually of any change to the information required under 
subsection (a).
    ``(d) Procedure.--Upon receipt of a completed statement described 
under subsection (a), the Secretary shall notify the establishment of 
the receipt of such statement and assign a cosmetic statement number.
    ``(e) List.--The Secretary shall compile, maintain, and update as 
appropriate, a list of cosmetics for which statements are submitted 
under this section.
    ``(f) Access to Safety Information.--The cosmetic and ingredient 
statements collected under this section shall be added to the publicly 
accessible database created by the Secretary under section 615(b).

``SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED COSMETICS.

    ``(a) Notification of Adulterated or Misbranded Cosmetics.--
            ``(1) In general.--A responsible party that has reason to 
        believe that a cosmetic, when introduced into or while in 
        interstate commerce, or while held for sale (regardless of 
        whether such sale is the first sale of such cosmetic) after 
        shipment in interstate commerce, is adulterated or misbranded 
        in a manner that presents a reasonable probability that the use 
        or exposure to the cosmetic (or an ingredient or component used 
        in any such cosmetic) will cause a threat of serious adverse 
        health effects or death to humans shall notify the Secretary of 
        the identity and location of the cosmetic.
            ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation or guidance.
            ``(3) Responsible party defined.--For purposes of this 
        subsection, the term `responsible party' means a manufacturer, 
        packager, retailer, or distributor of the cosmetic.
    ``(b) Voluntary Recall.--The Secretary may request that any person 
who distributes a cosmetic that the Secretary has reason to believe is 
adulterated, misbranded, or otherwise in violation of this Act 
voluntarily--
            ``(1) recall such cosmetic; and
            ``(2) provide for notice, including to individuals as 
        appropriate, to persons who may be affected by the recall.
    ``(c) Order To Cease Distribution.--
            ``(1) In general.--If the Secretary has reason to believe 
        that--
                    ``(A) the use of, or exposure to, a cosmetic may 
                cause serious adverse health effects or death to 
                humans;
                    ``(B) the cosmetic is misbranded; or
                    ``(C) the cosmetic is manufactured, packaged, or 
                distributed by an unregistered facility;
        the Secretary shall have the authority to issue an order 
        requiring any person who distributes such cosmetic to 
        immediately cease distribution of such cosmetic.
            ``(2) Cease distribution and notice.--Any person who is 
        subject to an order under paragraph (1) shall immediately cease 
        distribution of such cosmetic and provide notification as 
        required by such order.
            ``(3) Appeal.--
                    ``(A) 24 hours.--A person subject to an order under 
                paragraph (1) may appeal such order to the Secretary 
                within 24 hours of the issuance of such order.
                    ``(B) Contents of appeal.--Such appeal may include 
                a request for an informal hearing and a description of 
                any efforts to recall such cosmetic undertaken 
                voluntarily by the person, including after a request 
                under subsection (b).
                    ``(C) Informal hearing.--Except as provided in 
                subsection (e), an informal hearing shall be held as 
                soon as practicable, but not later than 5 calendar days 
                (or less as determined by the Secretary) after such an 
                appeal is filed, unless the parties jointly agree to an 
                extension.
                    ``(D) Impact on recall.--If an appeal is filed 
                under subparagraph (A), the Secretary may not amend the 
                order to require a recall under subsection (d) until 
                after the conclusion of the hearing under subparagraph 
                (C).
            ``(4) Vacation of order.--If the Secretary determines that 
        inadequate grounds exist to support the actions required by the 
        order under paragraph (1), the Secretary shall vacate the 
        order.
    ``(d) Order To Recall.--
            ``(1) Amendment.--Except as provided under subsection (e) 
        and subject to subsection (c)(3)(D), if the Secretary 
        determines that a recall of a cosmetic subject to an order 
        under subsection (c) is appropriate, the Secretary shall amend 
        the order to require a recall.
            ``(2) Contents.--An amended order under paragraph (1) 
        shall--
                    ``(A) specify a timetable in which the recall will 
                occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(C) provide for notice, including to individuals 
                as appropriate, to persons who may be affected by the 
                recall.
        In providing for such notice, the Secretary may allow for the 
        assistance of health professionals, State or local officials, 
        or other individuals designated by the Secretary.
            ``(3) Nondelegation.--An amended order under this 
        subsection may only be issued by the Secretary or an official 
        designated by the Secretary, and may not be delegated to 
        another official or employee.
            ``(4) Determination.--If the Secretary determines that 
        inadequate grounds exist to support the amendment made to the 
        order under paragraph (1), the Secretary shall remove such 
        amendment from such order.
    ``(e) Emergency Recall Order.--
            ``(1) In general.--If the Secretary has credible evidence 
        or information that a cosmetic subject to an order under 
        subsection (c) presents an imminent threat of serious adverse 
        health effects or death to humans, the Secretary may issue an 
        order requiring any person who distributes such cosmetic--
                    ``(A) to immediately recall such cosmetic; and
                    ``(B) to provide for notice, including to 
                individuals as appropriate, to persons who may be 
                affected by the recall.
            ``(2) Recall and notice.--Any person who is subject to an 
        emergency recall order under this subsection shall immediately 
        recall such cosmetic and provide notification as required by 
        such order.
            ``(3) Appeal.--
                    ``(A) 24 hours.--Any person subject to such an 
                order may appeal such order to the Secretary within 24 
                hours of the issuance of such order.
                    ``(B) Contents of appeal.--Such appeal may include 
                a request for an informal hearing and a description of 
                any efforts to recall such cosmetic undertaken 
                voluntarily by the person, including after a request 
                under subsection (b).
                    ``(C) Informal hearing.--An informal hearing shall 
                be held as soon as practicable after the appeal is 
                filed under subparagraph (A), but not later than 5 
                calendar days after such an appeal is filed, or fewer 
                days (as determined by the Secretary), unless the 
                parties jointly agree to an extension.
            ``(4) Vacation of order.--If the Secretary determines that 
        inadequate grounds exist to support the actions required by the 
        order under paragraph (1), the Secretary shall vacate the 
        order.
            ``(5) Nondelegation.--An order under this subsection may 
        only be issued by the Secretary or an official designated by 
        the Secretary, and may not be delegated to another official or 
        employee.
    ``(f) Notice to Consumers and Health Officials.--The Secretary 
shall, as the Secretary determines to be necessary, provide notice of a 
recall order under this section to consumers to whom the cosmetic was, 
or may have been, distributed and to appropriate State and local health 
officials.
    ``(g) Supply Chain Information.--
            ``(1) In general.--In the case of a cosmetic that the 
        Secretary has reason to believe is adulterated, misbranded, or 
        otherwise in violation of this Act, the Secretary shall request 
        that the entity named on the label of such cosmetic (as 
        required under section 602(b)(1)) submit all of the following 
        information:
                    ``(A) The name and place of business of the 
                manufacturer, packer, or distributor from which such 
                entity received the cosmetic or ingredients for 
                manufacturing such cosmetic.
                    ``(B) The name and place of business of any entity 
                (including any retailer) that was provided with such 
                cosmetic by the entity named on the label.
            ``(2) Collection of additional supply chain information.--
        In the case of a cosmetic that the Secretary has reason to 
        believe is adulterated, 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 entity 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 Secretary 
                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 revise related, relevant 
information, including ingredient 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 ingredients 
        that are safe without limits under section 616(c);
            ``(3) to add an ingredient to the priority assessment list 
        under section 616(d); or
            ``(4) to add an ingredient to the list of contaminants 
        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 ADVERSE HEALTH EFFECTS.

    ``(a) Submission of Report on Adverse Health Effects.--The 
Secretary shall require that the manufacturer, packager, or distributor 
of a cosmetic whose name appears on the label of a cosmetic marketed in 
the United States submit to the Secretary a report containing 
information received concerning any adverse health effect 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 adverse health effect is received at the 
place of business of the manufacturer, packager, or distributor.
    ``(c) Content of Report.--A report under subsection (a) shall 
include the following information, to the extent to which the 
manufacturer, packager, or distributor submitting the report has been 
able to verify the information:
            ``(1) The identity of the individual experiencing the 
        adverse health effect.
            ``(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 effect.
    ``(d) Public Availability and Privacy.--
            ``(1) Public availability.--Subject to paragraph (2), the 
        adverse health effect reports collected by the Secretary under 
        this section shall be submitted electronically and shall be 
        made accessible to the public.
            ``(2) Privacy.--
                    ``(A) Personally identifiable information.--
                Notwithstanding any other provision of law, personally 
                identifiable information in adverse health effect 
                reports provided to the Secretary under this section, 
                shall not--
                            ``(i) be made publicly available pursuant 
                        to any State or other law requiring disclosure 
                        of information or records; or
                            ``(ii) otherwise be disclosed or 
                        distributed to any party without the written 
                        consent of the Secretary and the person 
                        submitting such information to the Secretary.
                    ``(B) Treatment of information under privacy act 
                and foia.--An adverse health effect report submitted 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 
                referred to as the ``Freedom of Information Act''), and 
                shall not be publicly disclosed unless all personally 
                identifiable information is redacted.

``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, exposure, health 
        hazards, and environmental hazards for a cosmetic., and
            ``(3) The functions of ingredients in cosmetics.
            ``(4) Fragrance, flavor, and colorants in a cosmetic
    ``(b) Confidential Information.--The concentration 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 Confidential.--
            ``(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 a serious negative impact to the entity's 
        commercial interests if such information were disclosed to the 
        public.
            ``(2) Limitation.--The Secretary may not approve a petition 
        under paragraph (1) to the extent that such petition would 
        prevent the public disclosure of--
                    ``(A) the name, identity, and structure of any 
                chemical substance, contaminant, or impurity 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 impurity.

``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 testing 
        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
                    ``(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 information for 1 
                or more structurally similar chemicals where such 
                estimates provide information 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 described in subsection (a).

``SEC. 625. PRODUCT TESTING AND REVIEW AUDIT.

    ``The Secretary shall conduct annual audits of random samples of 
cosmetics to assess or test for acute negative reactions, pathogen 
hazards, contaminants, leaching 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 assist small 
businesses in carrying out the requirements of this subchapter.

``SEC. 627. INTERAGENCY COOPERATION.

    ``(a) Interagency Council on Cosmetic Safety.--There is established 
an Interagency Council on Cosmetic Safety for the purpose of sharing 
data and promoting collaboration on cosmetic safety between the Food 
and Drug Administration, the National Institute of Environmental Health 
Sciences, the Centers for Disease Control and Prevention, the 
Occupational Safety and Health Administration, and the Environmental 
Protection Agency.
    ``(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 subchapter shall affect the right of a State, 
political subdivision of a State, or tribe to adopt or enforce any 
regulation, requirement, liability, or standard of performance that is 
more stringent than a regulation, requirement, liability, or standard 
of performance established by this subchapter, including requiring the 
provision of a warning of risk, illness, or injury.

``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 
2012 through 2016.''.
    (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 provision 
                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 manufacturer has not 
                complied with section 616(b)(4) with respect to such 
                ingredient and such cosmetic; 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 manufactured by a manufacturer that, with 
        respect to such cosmetic, is required to demonstrate, under 
        section 617(b)(2), that the cosmetic meets the safety standard 
        and the manufacturer 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'' before the 
                period; and
                    (B) by adding at the end the following:
            ``(g) If it--
                    ``(1) was manufactured, packaged, or distributed by 
                an entity that failed to register and pay the 
                applicable fee as required under section 612;
                    ``(2) is manufactured, packaged, distributed, or 
                sold in retail by a manufacturer, packager, 
                distributor, 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 practices prescribed by 
                the Secretary under section 614(b); or
                    ``(6) is manufactured by a manufacturer 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.''.
            (3) Additional prohibitions.--Section 301 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by 
        adding at the end the following:
            ``(aaa) The failure of a manufacturer of a cosmetic or an 
        ingredient for use in a cosmetic to submit and update data and 
        information as required under section 615(a).
            ``(bbb) The manufacture, importation, distribution, or 
        marketing of an ingredient for use in a cosmetic that is on the 
        list under section 616(b)(1)(A).
            ``(ccc) The failure of a supplier of an ingredient for use 
        in a cosmetic--
                    ``(1) to provide data and information as required 
                by section 615(a)(4)(B); or
                    ``(2) comply with the testing requirements under 
                section 618(c).
            ``(ddd) The failure of a manufacturer to comply with the 
        requirements of section 618(d).
            ``(eee) The failure of a manufacturer, packager, or 
        distributor of a cosmetic to comply with the requirement of 
        reporting adverse health effects under section 622.''.

SEC. 3. WORKER ISSUES.

    (a) In General.--The Secretary of Labor shall promulgate 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 produces 
                        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 criteria 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, including salon owners, 
                in English and, upon request, in other languages, 
                including Spanish and Vietnamese.
            (2) Distributors.--Each distributor of a cosmetic or 
        personal care product for professional use shall distribute and 
        provide material safety data sheets described in subsection (b) 
        in the same manner 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 Federal 
        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 extent 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 regulations; 
                and
                    (C) upon request, provide employees with 
                translations of such material safety data sheet in 
                other languages, including Spanish and Vietnamese.
    (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 material safety 
        data sheet under section 1910.1200(g) of title 29, Code of 
        Federal Regulations, or any successor regulations, for each 
        hazardous chemical, or product ingredient associated with any 
        chemical hazard, described in subsection (a)(1)(A)(ii); and
            (2) include the following statement: ``This material 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.
                                 <all>
```