Title: Safe Cosmetics and Personal Care Products Act of 2018
Policy area: Commerce

Summary:
Safe Cosmetics and Personal Care Products Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing the regulation of cosmetics by the Food and Drug Administration (FDA), including requiring the FDA to establish safety standards and good manufacturing practices for cosmetics.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6903 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 6903

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

                           September 26, 2018

Ms. Schakowsky 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 and 
Personal Care Products Act of 2018''.
    (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 serious adverse events.
        ``Sec. 623. Nonconfidential information.
        ``Sec. 624. Ban on use of animal testing.
        ``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) Brand owner.--The term `brand owner' means the entity 
        responsible for bringing a cosmetic to market.
            ``(2) Contaminant.--The term `contaminant' means unintended 
        substances, such as those that can originate from sources 
        outside the chemical pathway, chemical processes, storage of 
        primary substances, instability of the packaging or harmful 
        byproducts of the manufacturing process.
            ``(3) Domestic establishment.--The term `domestic 
        establishment' means an establishment located in any State that 
        brings a cosmetic to market.
            ``(4) Foreign establishment.--The term `foreign 
        establishment' means an establishment that brings a cosmetic to 
        market and exports those cosmetics to the United States.
            ``(5) Ingredient.--The term `ingredient' means a chemical 
        in a cosmetic, including--
                    ``(A) chemicals that provide a technical or 
                functional effect;
                    ``(B) chemicals that have a technical or functional 
                effect in the cosmetic, including the components of 
                intentionally added fragrance ingredients and colorants 
                and intentional breakdown products of an added chemical 
                that also have a functional or technical effect in the 
                cosmetic;
                    ``(C) processing aids that are present by reason of 
                having been added to a cosmetic during the processing 
                of such cosmetic;
                    ``(D) substances that are present by reason of 
                having been added to a cosmetic during processing for 
                their technical or functional effect;
                    ``(E) the components of a fragrance, flavor, or 
                preservative; and
                    ``(F) any individual component that the Secretary 
                deems an ingredient for purposes of this chapter.
            ``(6) Manufacturer.--The term `manufacturer' means the 
        entity that produces ingredients or combines one or more 
        ingredients to produce a cosmetic product.
            ``(7) Microbusiness.--The term `microbusiness' means a 
        business--
                    ``(A) that is a brand owner as defined in this 
                subchapter; and
                    ``(B) that has annual sales receipts for cosmetic 
                products that do not exceed $2,000,000.
            ``(8) 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.
            ``(9) 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;
                    ``(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.
            ``(10) 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.
            ``(11) Serious adverse event.--The term `serious adverse 
        event' means--
                    ``(A) an acute or chronic response that results in 
                death, a life-threatening experience, short- or long-
                term hospitalization, a persistent or significant 
                disability or incapacity, a congenital anomaly or birth 
                defect, serious and persistent rashes or infections, 
                significant hair loss, permanent or significant 
                alteration of appearance, or impacts to maternal 
                health, including placentia previa, gestational 
                diabetes, and miscarriage;
                    ``(B) an event that requires, based on a reasonable 
                medical judgment, a medical or surgical intervention; 
                or
                    ``(C) any other serious adverse health-related 
                event associated with the use of the product.
            ``(12) Supplier.--The term `supplier' means the entity that 
        supplies ingredients, raw materials, or specific components of 
        a cosmetic product, including packaging.
            ``(13) Vulnerable populations.--The term `vulnerable 
        populations' includes pregnant women, infants, children, the 
        elderly, individuals with a compromised immune system, and 
        highly exposed populations, including workers employed by a 
        hair salon, nail salon, beauty salon, spa, or cosmetic 
        manufacturing plant.

``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 
        brand owner (except for microbusinesses) engaged in bringing a 
        cosmetic to market 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 brand owner that initially 
        brings a cosmetic to market after the date on which the 
        requirements of paragraph (1) apply shall, not later than 60 
        days after the date on which the establishment brings a 
        cosmetic to market, 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 brings to market, 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 brings cosmetics to market.
                    ``(B) A description of the establishment's 
                activities with respect to cosmetics, including a list 
                of all cosmetic products brought to market by the 
                establishment and the functions of such cosmetics.
                    ``(C) The gross receipts or sales for the 
                establishment from cosmetics.
            ``(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 publicly available, including 
                by posting such list on the public Web site of the Food 
                and Drug Administration;
                    ``(C) remove from such list the name of any 
                establishment that fails to register in accordance with 
                this section; and
                    ``(D) indicate on such list any establishment which 
                has had its registration suspended or cancelled by the 
                Secretary under 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 
        this subsection 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.
    ``(g) Recordkeeping.--All establishments that are required to 
register under this section shall maintain records that include a 
current list of suppliers and manufacturers, if the registrant does not 
manufacture or package its own product. Those records shall be 
accessible by the Secretary upon request for review or audit.

``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 for retail sale and including cosmetics for 
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 brand owner 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 
        (including such cosmetics for professional use); and
            ``(2) brand owners 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(9)) 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 one 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.--Brand owners of cosmetics shall submit 
        to the Secretary (in an electronic format that the Secretary 
        shall determine) all data and information that the brand owner 
        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 toxicity of each such ingredient or 
                cosmetic.
                    ``(C) Exposure and fate information.
                    ``(D) Results of all safety tests that the brand 
                owner 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 brand owner 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 brand owner 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 brand owner shall 
                        update the information not later than 60 days 
                        after receiving such information.
            ``(4) Supplier and manufacturer information.--
                    ``(A) Use of supplier or manufacturer 
                information.--In order to meet the requirements of 
                paragraph (1) with respect to an ingredient, a brand 
                owner may submit safety data and information provided 
                by the supplier or manufacturer of the ingredient or 
                cosmetic.
                    ``(B) Supplier or manufacturer provision of 
                information.--If a brand owner requests that a supplier 
                or manufacturer of an ingredient provide to such brand 
                owner any of the data and information described under 
                paragraph (2) or under section 617, such supplier or 
                manufacturer shall provide such data and information to 
                such brand owner 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 database that--
                    ``(A) is publicly accessible, including on the 
                public Web site of the Food and Drug Administration; 
                and
                    ``(B) contains 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 
                cosmetics (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 toxicity concerns (including reproductive or 
                developmental toxicity); or
                    ``(E) is known to persist in the environment or 
                bioaccumulate.
            ``(3) Prioritization 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.--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) Initial list.--
                    ``(A) Deemed prohibited ingredients.--Effective as 
                of the date of enactment of this subchapter, the 
                following ingredients are deemed to be listed pursuant 
                to paragraph (1)(A) as prohibited for use:
                            ``(i) Benzophenones (benzophenone, 
                        benzophenone-1, benzophenone-3 aka oxybenzone).
                            ``(ii) Octinoxate.
                            ``(iii) Butylated Hydroxyanisole and 
                        Butylated Hydroxyoluen.
                            ``(iv) Coal tar dyes (P-phenylenediamine).
                            ``(v) Cocamide Diethanolamine.
                            ``(vi) Dibutyalated Phthalate (Phthalates 
                        DBP), Bis(2-ethylhexyl) Phthalate (DEHP).
                            ``(vii) Toluene.
                            ``(viii) Styrene or Styrene acrylates.
                            ``(ix) Formaldehydes (Methylene glycol/
                        methanediol/formaldehyde) and Formaldehyde-
                        releasing preservatives (DMDM hydantoin, 
                        diazolidinyl urea, imidazolidinyl urea, 
                        methenamine, quaternium-15, and sodium 
                        hydroxymethylglycinate).
                            ``(x) Triclosan.
                            ``(xi) Lead acetate or other lead 
                        compounds.
                            ``(xii) Parabens (isoproylparaben, 
                        isobutylparaben, pheylparaben, benzylparaben, 
                        pentylparaben, propylparaben and butylparaben).
                    ``(B) First ingredients listed by regulation.--Not 
                later than 2 years after the date of enactment of this 
                subchapter, the Secretary shall promulgate by final 
                regulation the list required by subparagraphs (A) and 
                (B) of paragraph (1), to supplement the ingredients 
                deemed by subparagraph (A) of this paragraph to be 
                listed pursuant to paragraph (1)(A).
            ``(3) 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.
            ``(4) Updates.--After promulgating the initial list 
        pursuant to paragraph (2)(B), 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.
            ``(5) Manufacturer requirements.--Not later than 1 year 
        after the date that an ingredient is placed on a list under 
        this subsection, 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 (3).
    ``(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 
                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) publicly declares the reasons for 
                        such finding.
            ``(4) 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 brand owner 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 the 
        Secretary receives 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)(5) and (d)(4) of 
section 616, a brand owner may only distribute in interstate commerce a 
cosmetic that 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)(3).
                    ``(C) A cosmetic that is made solely of ingredients 
                described under subparagraph (A) and subparagraph (B).
            ``(2) Exceptions.--The Secretary may require that a brand 
        owner demonstrate that a cosmetic meets the safety standard 
        under section 614(a) (including by requiring that the brand 
        owner conduct safety testing, or request such safety testing 
        from relevant suppliers and manufacturers, 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 brand owner demonstrate that a cosmetic meets 
        the safety standard under section 614(a), the Secretary shall 
        provide the brand owner 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, brand owners and manufacturers 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 contaminants of concern linked to 
severe acute reactions or long-term adverse health effects, including--
            ``(1) ingredients used in cosmetics that may contain 
        contaminants of concern;
            ``(2) combinations of ingredients that may create 
        contaminants of concern when such ingredients interact;
            ``(3) contaminants of concern that may leech from product 
        packaging into a cosmetic; and
            ``(4) any other contaminant of concern identified by the 
        Secretary that are present in cosmetics.
    ``(b) Evaluation; Labeling.--The Secretary shall use the process 
described in sections 615 and 616 to evaluate contaminants of concern 
for possible elimination or restriction in cosmetics. The Secretary 
shall require that a contaminant on the list under subsection (a) be 
declared on the label of a cosmetic, in the same manner as an 
ingredient under section 613.
    ``(c) 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 or cosmetic.
            ``(3) Update.--The Secretary shall annually update the 
        requirements under paragraph (1).
    ``(d) 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 of concern; 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).
    ``(e) Brand Owner Requirements.--Not later than 1 year after the 
promulgation of the rule under subsection (b)(1), a brand owner of a 
cosmetic shall, with respect to each ingredient that the brand owner 
uses in a cosmetic--
            ``(1) obtain, from each supplier or manufacturer 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 brand owner 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 brand owner of a cosmetic intended to be 
marketed in the United States shall submit electronically to the 
Secretary, for each cosmetic that is intended to be marketed in the 
United States, a statement containing--
            ``(1) the registration number of the brand owner;
            ``(2) the brand name and the product name for the cosmetic;
            ``(3) the applicable use for the cosmetic;
            ``(4) the ingredient list as it appears on the cosmetic 
        label or insert, including the particle size range of any 
        nanoscale cosmetic ingredients;
            ``(5) any warnings and directions for use from the cosmetic 
        label or insert; and
            ``(6) the title and full contact information for the 
        individual responsible for submitting and maintaining such 
        statement.
    ``(b) New Cosmetics.--Any brand owner that begins to market 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 brand owner 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 brand owner 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 
        event 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 brand owner, 
        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 event;
                    ``(B) the cosmetic is misbranded; or
                    ``(C) the cosmetic is marketed, manufactured, 
                packaged, or distributed by an unregistered brand 
                owner;
        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 
        event, 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 brand owner 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, packager, supplier, 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 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 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 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 Secretary a report containing information received concerning 
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 adverse event is received at the 
place of business of the brand owner.
    ``(c) Content of Report.--A report under subsection (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 paragraph (2), the 
        serious adverse event 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 serious adverse event 
                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.--A 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, 
        toxicity data, health hazards, and environmental hazards for a 
        cosmetic.
            ``(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. BAN ON USE OF ANIMAL TESTING.

    ``(a) Ban.--Beginning on the date of enactment of this subchapter, 
it shall be unlawful for any entity to conduct, directly or pursuant to 
contract, animal testing for the purpose of developing a cosmetic for 
sale in or affecting interstate commerce.
    ``(b) Limitation on Consideration of Data.--The Secretary shall not 
take into consideration any animal testing on a finished cosmetic 
product or an ingredient that occurs on or after the date of enactment 
of this subchapter with respect to any determination as to whether a 
cosmetic or ingredient meets the safety standard under section 614(a).
    ``(c) Exception.--Subsections (a) and (b) shall not apply with 
respect to animal testing if--
            ``(1) the animal testing is for the purpose of determining 
        whether an ingredient, or the relevant category of ingredients, 
        meets the safety standard under section 614(a); and
            ``(2) the Secretary determines that the safety of the 
        ingredient, or the relevant category of ingredients, cannot be 
        established using a non-animal testing method that is validated 
        by the Interagency Coordinating Committee on the Validation of 
        Alternative Methods.
    ``(d) Validated, Eligible Non-Animal Testing Methods.--
            ``(1) List.--The Secretary shall develop, maintain, and 
        make publicly available a list of non-animal testing methods 
        that--
                    ``(A) are validated by the Interagency Coordinating 
                Committee on the Validation of Alternative Methods; and
                    ``(B) are eligible for use pursuant to the 
                exception described in subsection (c).
            ``(2) Initial list; updates.--The Secretary shall--
                    ``(A) not later than 1 year after the date of 
                enactment of this subchapter, publish the initial list 
                under paragraph (1); and
                    ``(B) annually thereafter, update such list.
    ``(e) Grants.--The Secretary shall award grants for the development 
of testing methods that may be used to replace animal testing pursuant 
to the exception described in subsection (c).

``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 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, requirement, 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 control.

``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 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)(5) 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)(3), and the manufacturer has not complied with 
                section 616(b)(5) 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 demonstrate, 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--
                    ``(1) was brought to market by a brand owner that 
                failed to register and pay the applicable fee as 
                required under section 612;
                    ``(2) is brought to market, manufactured, packaged, 
                distributed, or sold in retail by a brand owner, 
                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 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.''.
            (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, manufacturer, or 
        supplier of a cosmetic or an ingredient for use in a cosmetic 
        to submit and update data and information as required under 
        section 615(a).
            ``(ddd) 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).
            ``(eee) 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).
            ``(fff) The failure of a manufacturer to comply with the 
        requirements of section 618(d).
            ``(ggg) The failure of a brand owner of a cosmetic to 
        comply with the requirement of reporting serious adverse events 
        under section 622.
            ``(hhh) The conduct of animal testing in violation of 
        section 624.''.

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 
                on the manufacturer or importer's Web site (in addition 
                to any other required manner of making such sheet 
                available) to distributors and employers, including 
                salon owners, in English, Spanish, Vietnamese, and, 
                upon request, other languages.
            (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(8) 
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>