[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4296 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 4296

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 12, 2019

Ms. Schakowsky (for herself, Mr. Sean Patrick Maloney of New York, Ms. 
   Lee of California, Mr. Ted Lieu of California, Mr. Grijalva, Ms. 
 DeLauro, Mr. Huffman, Ms. Pressley, Mr. Hastings, Mr. Lowenthal, Ms. 
   Judy Chu of California, Ms. Speier, Ms. Jayapal, Ms. DeGette, Ms. 
    Pingree, Ms. Matsui, 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 Labor, 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 2019''.
    (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 and website disclosure for 
                            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. Adulterated and misbranded cosmetics.
Sec. 4. Support for creating safer alternatives.
Sec. 5. Support by National Institute of Environmental Health Sciences 
                            for research on health disparities 
                            impacting communities of color.
        ``Sec. 463C. Research on health disparities related to 
                            cosmetics impacting communities of color.
Sec. 6. Worker issues.

SEC. 2. COSMETIC REGULATION.

    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 have a technical or functional 
                effect in the cosmetic, including the breakdown 
                products of an intentionally added chemical that also 
                have a functional or technical effect in the cosmetic;
                    ``(B) substances that are present by reason of 
                having been added to a cosmetic during processing for 
                their technical or functional effect;
                    ``(C) the components of a fragrance, flavor, 
                preservative, or colorant; and
                    ``(D) 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 $1,000,000.
            ``(8) Professional use.--The term `professional use' 
        means--
                    ``(A) the application of a cosmetic to a human 
                customer or client by an employee or contractor of a 
                hair salon, nail salon, beauty salon, spa, or other 
                establishment within the scope of the work conducted by 
                such employee or contractor; or
                    ``(B) the use by or application to a human of a 
                cosmetic purchased from 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 as 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 or cosmetic 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 in 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 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) Exception for microbusinesses.--The requirements of 
        this section do not apply with respect to microbusinesses.
            ``(3) 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.
            ``(4) 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 website 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 $5,000,000.
    ``(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 AND WEBSITE DISCLOSURE FOR 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 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, as 
        appropriate, for public disclosure of the ingredients in such 
        cosmetics.
    ``(c) Special Rule for Contaminants.--The Secretary shall require, 
in the case of a contaminant (as defined by section 618), 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 in 
a personal care product in any quantity exceeding one half of one 
percent of the content of the product by weight.
    ``(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) Website Disclosure of Cosmetic Ingredients.--The Secretary 
shall require that the website of a brand owner of a cosmetic include a 
declaration of the ingredients in the cosmetic in descending order of 
predominance, including the function of each ingredient.
    ``(f) Labeling of Ingredients in Cosmetics Sold Through Internet 
Commerce.--The Secretary shall require--
            ``(1) in the case of a cosmetic sold on the website of an 
        internet vendor, that the brand owner of such cosmetic provide 
        to such internet vendor a list of the ingredients in the 
        cosmetic; and
            ``(2) that each internet vendor display the list of 
        ingredients in 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 website of the vendor.
    ``(g) Product Labeling of Fragrance and Flavor Ingredients.--
            ``(1) Requirements.--The Secretary shall require that all 
        fragrance and flavor ingredients in a cosmetic that are deemed 
        hazardous to human health or the environment by paragraph (2) 
        appear on the label of the cosmetic.
            ``(2) List of ingredients deemed hazardous.--The following 
        ingredients (including chemicals added by the relevant 
        government agency or authoritative body subsequent to the date 
        of enactment of this subchapter) are deemed hazardous to human 
        health or the environment for purposes of paragraph (1)(A):
                    ``(A) Chemicals known to cause cancer or 
                reproductive toxicity that are listed pursuant to 
                California Health & Safety Code Section 25249.5 et seq.
                    ``(B) Chemicals classified by the European Union as 
                carcinogens, mutagens, or reproductive toxicants 
                pursuant to Category 1A or 1B in Annex VI to Regulation 
                (EC) No. 1272/2008.
                    ``(C) Chemicals included in the European Union 
                Candidate List of Substances of Very High Concern in 
                accordance with Article 59 of Regulation (EC) No. 1907/
                2006 on the basis of Article 57(f) for endocrine 
                disrupting properties.
                    ``(D) Chemicals for which a reference dose or 
                reference concentration has been developed based on 
                neurotoxicity in the Environmental Protection Agency's 
                Integrated Risk Information System.
                    ``(E) Chemicals that are identified as carcinogenic 
                to humans, likely to be carcinogenic to humans, or as 
                Group A, B1, or B2 carcinogens, in the Environmental 
                Protection Agency's Integrated Risk Information System.
                    ``(F) Chemicals included in the European Chemicals 
                Agency Candidate List of Substances of Very High 
                Concern in accordance with Article 59 of Regulation 
                (EC) No. 1907/2006 on the basis of Article 57(d), 
                Article 57(e), or Article 57(f) of Regulation (EC) No. 
                1907/2006 for persistent, bioaccumulative and toxic, or 
                very persistent and very bioaccumulative, properties.
                    ``(G) Chemicals that are identified as persistent, 
                bioaccumulative, and inherently toxic to the 
                environment by the Canadian Environmental Protection 
                Act Environmental Registry Domestic Substances List 
                pursuant to subsection 66(1) of the Canadian 
                Environmental Protection Act, 1999.
                    ``(H) Chemicals classified by the European Union in 
                Annex VI to Regulation (EC) No. 1272/2008 as 
                respiratory sensitizer category 1.
                    ``(I) Group 1, 2A, or 2B carcinogens identified by 
                the International Agency for Research on Cancer.
                    ``(J) Neurotoxicants that are identified in the 
                Agency for Toxic Substances and Disease Registry's 
                Toxic Substances Portal.
                    ``(K) Persistent bioaccumulative and toxic priority 
                chemicals that are identified by the Environmental 
                Protection Agency's National Waste Minimization Program 
                as of February 22, 2016.
                    ``(L) Reproductive and developmental toxicants 
                identified by National Toxicology Program Center for 
                the Evaluation of Risks monographs.
                    ``(M) Chemicals identified as `Persistent 
                Bioaccumulative Toxic' by the Environmental Protection 
                Agency on the Toxics Release Inventory under section 
                313 of the Emergency Planning and Community Right-to-
                Know Act of 1986 (42 U.S.C. 11023).
                    ``(N) The State of Washington Department of 
                Ecology's Persistent, Bioaccumulative, Toxic (PBT) 
                Chemicals identified in Chapter 173-333 of Title 173 of 
                the Washington Administrative Code.
                    ``(O) Chemicals that are identified as known to be, 
                or reasonably anticipated to be, human carcinogens by 
                the most recent Report on Carcinogens prepared by the 
                Federal National Toxicology Program.
                    ``(P) Chemicals for which primary maximum 
                contaminant levels have been established for drinking 
                water by the Environmental Protection Agency.
                    ``(Q) Chemicals identified as hazardous air 
                pollutants by the Environmental Protection Agency 
                pursuant to section 112 of the Clean Air Act (42 U.S.C. 
                7412).
                    ``(R) Toxic pollutants listed under section 
                307(a)(1) of the Federal Water Pollution Control Act 
                (33 U.S.C. 1317) and priority pollutants identified in 
                appendix A to part 423 of title 40, Code of Federal 
                Regulations.
                    ``(S) Chemicals that are identified on the Centers 
                for Disease Control and Prevention's most recent Report 
                on Human Exposure to Environmental Chemicals and 
                Updated Tables Volume 1 and Volume 2.
                    ``(T) Chemicals that are identified on Part A of 
                the list of Chemicals for Priority Action prepared by 
                the Oslo and Paris Conventions for the Protection of 
                the Marine Environment of the North-East Atlantic.
                    ``(U) Chemicals identified as hazardous under 
                section 101(14) or 102 of the Comprehensive 
                Environmental Response, Compensation, and Liability Act 
                of 1980 (42 U.S.C. 9601(14), 9602).
    ``(h) Fragrance Allergens.--The Secretary shall require that any 
fragrance allergen in a cosmetic be included on the label of the 
cosmetic and identified as a fragrance allergen if the fragrance 
allergen is--
            ``(1) included in Annex III of European Union Cosmetics 
        Regulation No. 1223/2009, as required to be disclosed pursuant 
        to European Union Detergents Regulation No. 21648/2004, and 
        subsequent updates to those regulations; and
            ``(2) is present in--
                    ``(A) a rinse-off cosmetic at a concentration at or 
                above 0.01 percent; or
                    ``(B) a leave-on cosmetic product at a 
                concentration at or above 0.001 percent.
    ``(i) Trade Secrets.--Notwithstanding any other provision of law, 
an ingredient required to be listed on a product label or on a brand 
owner or internet commerce website under this section shall not be 
treated as a trade secret.
    ``(j) 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 or 
        reasonably foreseeable 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 a 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 of paragraph (1), the Secretary may 
        treat such standard as the safety standard under paragraph (1) 
        for purposes of such ingredient.
    ``(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 
        guidance 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 
        electronically to the Secretary all data and information that 
        the brand owner can access regarding the safety of--
                    ``(A) the ingredients listed on the cosmetic label 
                and the brand owner's website under section 613 for a 
                cosmetic; and
                    ``(B) the 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 properties 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 website of the Food and Drug Administration; and
                    ``(B) contains all nonconfidential information (as 
                such term is used in 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 in 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 
        subsection, the term `authoritative source' means--
                    ``(A) the Environmental Protection Agency;
                    ``(B) the International Agency for Research on 
                Cancer;
                    ``(C) the National Institutes of Health;
                    ``(D) the California Environmental Protection 
                Agency; and
                    ``(E) any other authoritative international, 
                Federal, or 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 the chronic health impacts associated with an 
        ingredient that is used in one or more cosmetics, the Secretary 
        shall create and periodically update a list of ingredients for 
        safety review. From such list, the Secretary shall place 
        ingredients on a priority assessment list and, after 
        comprehensive safety review, place each ingredient on the 
        priority assessment list on one of the following lists:
                    ``(A) The prohibited and restricted lists under 
                subsection (b).
                    ``(B) The safe without limits list under subsection 
                (c).
                    ``(C) The insufficient data list under subsection 
                (d).
            ``(2) Initial list.--The Secretary shall add 20 ingredients 
        to the initial priority assessment list created under paragraph 
        (1) immediately after the enactment of this subchapter.
            ``(3) Considerations.--In determining the placement of an 
        ingredient on the priority assessment list under paragraph (1), 
        the Secretary shall consider the scientific evidence linking 
        that ingredient to harm and conduct further prioritization 
        based on whether the ingredient--
                    ``(A) is found to be present in the body through 
                biomonitoring;
                    ``(B) is found in drinking water or air;
                    ``(C) 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);
                    ``(D) is known to persist in the environment or 
                bioaccumulate; or
                    ``(E) is of particular concern to a community 
                disproportionately impacted by cosmetic chemicals in 
                products marketed to them because of their particular 
                race, ethnicity, or occupation.
            ``(4) 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 Lists.--
            ``(1) In general.--The Secretary shall issue, by 
        regulation, two lists of ingredients that are identified by the 
        Secretary--
                    ``(A) in the first list, as prohibited for use in 
                cosmetics 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) in the second list, 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 prohibited list.--
                    ``(A) Immediately 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, including 
                        benzophenone-1, benzophenone-3 (also known as 
                        ozybenzone), benzophenone-4, and benzophenone-
                        5.
                            ``(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 lists 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.--
                    ``(A) In general.--After promulgating the initial 
                list pursuant to paragraph (2)(B), the Secretary shall 
                update the lists under paragraph (1) at a minimum 
                annually, including--
                            ``(i) updates to determinations under 
                        subsection (d)(3); or
                            ``(ii) any updates prompted by new 
                        information that demonstrates that an 
                        ingredient fails to meet the safety standard, 
                        or requires restrictions on use to meet such 
                        standard.
                    ``(B) Chemicals identified pursuant to nih-funded 
                research.--The Secretary shall--
                            ``(i) consult with the Director of the 
                        National Institute of Environmental Health 
                        Sciences to identify any chemicals that are 
                        determined to be of concern pursuant to 
                        investigations funded under section 463C of the 
                        Public Health Service Act; and
                            ``(ii) review any such chemicals in 
                        accordance with this section to determine 
                        whether such chemicals should be prohibited or 
                        subject to restrictions under this section.
            ``(5) Manufacturer requirements.--Not later than 1 year 
        after the date on which 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.--After promulgating the 
        initial list pursuant to paragraph (1), the Secretary--
                    ``(A) shall annually update the list under 
                paragraph (1); and
                    ``(B) may redetermine whether an ingredient 
                distributed in commerce meets the safety standard under 
                section 614(a) 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 1 year after the creation 
        of the initial priority assessment list of ingredients for 
        review under subsection (a)(1), the Secretary shall evaluate 
        the safety of not less than 10 ingredients 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 initial 
        evaluation of 10 ingredients pursuant to paragraph (1), the 
        Secretary shall annually add at least 10 additional ingredients 
        to such list until all ingredients that are used in the 
        formulation or manufacture of cosmetics have been evaluated for 
        safety and added to--
                    ``(A) the prohibited and restricted lists under 
                subsection (b);
                    ``(B) the safe without limits list under subsection 
                (c); or
                    ``(C) the insufficient data list under this 
                subsection.
            ``(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 listed pursuant to paragraph (1) or (2), 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 subparagraph, that the 
                ingredient meets the requirements for inclusion on a 
                list specified in subparagraph (A), (B), or (C) of 
                paragraph (2).
                    ``(C) Guidance in the case of insufficient or no 
                data.--If the Secretary determines under subparagraph 
                (B) that, with respect to an ingredient, insufficient 
                or no data exists to place such ingredient on either 
                the prohibited and restricted list under subsection (b) 
                or the safe without limits list under 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 either such 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--
                    ``(A) review such data and information; and
                    ``(B) make a redetermination under paragraph (3)(B) 
                for such ingredient, subject to the comment period 
                under paragraph (3)(D).

``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 in 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--
                    ``(A) the cosmetic contains--
                            ``(i) penetration enhancers, sensitizers, 
                        endocrine-disrupting compounds, or other 
                        similar ingredients; or
                            ``(ii) ingredients that react with each 
                        other or with other substances to form harmful 
                        byproducts; or
                    ``(B) 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 and electronic notice that a determination by 
the Secretary of the safety of the ingredient or cosmetic 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 chronic 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.--Beginning not later than 1 year after 
the promulgation of the rule under subsection (c)(1) with respect to an 
ingredient that is used in a cosmetic, a supplier of the ingredient 
shall, with respect to such ingredient--
            ``(1) comply with the requirements under subsection (c)(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 of 
        a cosmetic, 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 (c)(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 (d) 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) a list of the ingredients in the product, including 
        fragrance, flavorants, and 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 name, 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 end of 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 a 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 a 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 may 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 (d)(2), 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) Mandatory Recall Orders.--
            ``(1) In conjunction with order to cease distribution.--
                    ``(A) Amendment.--Except as provided under 
                paragraph (2) 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.
                    ``(B) Contents.--An amended order under 
                subparagraph (A) shall--
                            ``(i) specify a timetable in which the 
                        recall will occur;
                            ``(ii) require periodic reports to the 
                        Secretary describing the progress of the 
                        recall; and
                            ``(iii) provide for notice, including to 
                        individuals as appropriate, to persons who may 
                        be affected by the recall.
                    ``(C) Assistance in providing notice.--In providing 
                for notice under subparagraph (B), the Secretary may 
                allow for the assistance of health professionals, State 
                or local officials, or other individuals designated by 
                the Secretary.
                    ``(D) Determination.--If the Secretary determines 
                that inadequate grounds exist to support the amendment 
                made to the order under subparagraph (A), the Secretary 
                shall remove such amendment from such order.
            ``(2) For imminent threat of a serious adverse event.--
                    ``(A) 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 a serious adverse event, the Secretary shall issue 
                an order requiring any person who distributes such 
                cosmetic--
                            ``(i) to immediately recall such cosmetic; 
                        and
                            ``(ii) to provide for notice, including to 
                        individuals as appropriate, to persons who may 
                        be affected by the recall.
                    ``(B) 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 (including an amended order) under paragraph (1) 
                or (2) 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.
                    ``(D) Vacation of order.--If the Secretary 
                determines that inadequate grounds exist to support the 
                actions required by the order under paragraph (1) or 
                (2), the Secretary shall vacate the order.
            ``(4) Nondelegation.--An order (including an amended order) 
        under paragraph (1) or (2) may only be issued by the Secretary 
        or an official designated by the Secretary, and may not be 
        delegated to another official or employee.
    ``(e) Notice to Consumers and Health Officials.--The Secretary 
shall post on the Food and Drug Administration's website and 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.
    ``(f) 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 in subparagraphs (A) and (B) of paragraph 
        (1).
            ``(3) Maintenance of records.--Any entity in the 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.
    ``(g) 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);
            ``(4) to add an ingredient to the list of ingredients with 
        insufficient data under section 616(d); or
            ``(5) to add an ingredient to the list of contaminants 
        under section 618.
    ``(b) Reasonable Petition.--Not later than 1 year after the date of 
enactment of this subchapter, 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 in a summary fashion on the Food 
        and Drug Administration's website.
            ``(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 authorized by section 3 of the ICCVAM 
        Authorization Act of 2000 (42 U.S.C. 285l-3) .
    ``(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's regulation, 
requirement, liability, 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 
2020 through 2024.''.

SEC. 3. ADULTERATED AND MISBRANDED COSMETICS.

    (a) Adulterated Cosmetics.--Section 601 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 361) is amended--
            (1) in paragraph (a), by striking ``, except that this 
        provision shall not apply to coal-tar hair dye'' and all that 
        follows through ``or eyebrow dyes''; and
            (2) 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).''.
    (b) Misbranded Cosmetics.--Section 602 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 362) is amended--
            (1) in paragraph (a), by inserting ``or fails to meet the 
        requirements of section 613 or 618(b)'' before the period; and
            (2) 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 section 
        620(d);
            ``(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.''.
    (c) Additional Prohibitions.--Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in paragraph (e), by inserting ``612,'' after ``564,'' 
        each place it appears; and
            (2) by adding at the end the following:
    ``(fff) 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).
    ``(ggg) 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).
    ``(hhh) 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) to comply with the testing requirements under section 
        618(d).
    ``(iii) The failure of a manufacturer to comply with the 
requirements of section 618(e).
    ``(jjj) The failure of a brand owner of a cosmetic to comply with 
the requirement of reporting serious adverse events under section 622.
    ``(kkk) The conduct of animal testing in violation of section 
624.''.

SEC. 4. SUPPORT FOR CREATING SAFER ALTERNATIVES.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, in consultation with the Administrator 
of the Environmental Protection Agency, shall award grants to eligible 
entities to support research focused on the design of safer 
alternatives to chemicals in cosmetics with inherent toxicity or 
associated with chronic adverse health effects.
    (b) Eligible Entities.--To be eligible to receive a grant under 
subsection (a), an entity shall--
            (1) be a public institution such as a university, a not-
        for-profit research institution, or a small business; and
            (2) not benefit from a financial relationship with a 
        cosmetics manufacturer, supplier, or trade association.
    (c) Priority.--In awarding grants under subsection (a), the 
Secretary shall give priority to applicants proposing to focus on--
            (1) replacing chemicals in professional cosmetic products 
        used by nail and hair and beauty salon workers with safer 
        alternatives; or
            (2) replacing chemicals in cosmetic products marketed to 
        women and girls of color, including any such beauty, personal 
        hygiene, and intimate care products, with safer alternatives.
    (d) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be necessary 
for fiscal years 2020 through 2025.

SEC. 5. SUPPORT BY NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES 
              FOR RESEARCH ON HEALTH DISPARITIES IMPACTING COMMUNITIES 
              OF COLOR.

    Subpart 12 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285l et seq.) is amended by adding at the end the following 
new section:

``SEC. 463C. RESEARCH ON HEALTH DISPARITIES RELATED TO COSMETICS 
              IMPACTING COMMUNITIES OF COLOR.

    ``(a) In General.--The Director of the Institute shall award grants 
to eligible entities--
            ``(1) to expand support for basic, epidemiological, and 
        social scientific investigations into--
                    ``(A) the chemicals linked to adverse health 
                effects most commonly found in cosmetics marketed to 
                women and girls of color, including beauty, personal 
                hygiene, and intimate care products;
                    ``(B) the marketing and sale of such cosmetics 
                containing chemicals linked to adverse health effects 
                to women and girls of color across their lifespans; or
                    ``(C) the use of such cosmetics by women and girls 
                of color across their lifespans; and
            ``(2) to disseminate the results of any such research 
        described in subparagraph (A) or (B) of paragraph (1) 
        (conducted by the grantee pursuant to this section or 
        otherwise) to help communities identify and address potentially 
        unsafe chemical exposures in the use of cosmetics.
    ``(b) Eligible Entities.--To be eligible to receive a grant under 
subsection (a), an entity shall--
            ``(1) be a public institution such as a university, a not-
        for-profit research institution, or a small business; and
            ``(2) not benefit from a financial relationship with a 
        cosmetics manufacturer, supplier, or trade association.
    ``(c) Report.--Not later than the end 1 year after awarding grants 
under this section, the Director of the Institute shall issue for the 
public and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the results of the investigations 
funded under subsection (a), including--
            ``(1) summary findings on--
                    ``(A) marketing strategies, product categories, and 
                specific cosmetics containing ingredients linked to 
                adverse health effects; and
                    ``(B) the demographics of the populations marketed 
                to and using these cosmetics; and
            ``(2) recommended public health information strategies to 
        reduce potentially unsafe exposures to cosmetics.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be necessary 
for fiscal years 2020 through 2025.''.

SEC. 6. 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 website (in addition 
                to any other required manner of making such sheet 
                available) to distributors and employers, including 
                owners of hair, nail, and beauty salons or spas or 
                other establishments that provide cosmetic services for 
                humans, in English, Spanish, Vietnamese, Chinese, 
                Korean, 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 or other establishment described in paragraph (1)(B), 
        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, Vietnamese, 
                Chinese, Korean, and upon request other languages.
    (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 of 
the Federal Food, Drug, and Cosmetic Act, as added by this 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>