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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5786 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 5786

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

                             July 20, 2010

   Ms. Schakowsky (for herself, Mr. Markey of Massachusetts, and Ms. 
   Baldwin) 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.

    This Act may be cited as the ``Safe Cosmetics Act of 2010''.

SEC. 2. COSMETIC REGULATION.

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

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

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

                ``Subchapter B--Regulation of Cosmetics

``SEC. 611. DEFINITIONS.

    ``In this subchapter:
            ``(1) Ingredient.--The term `ingredient' means a chemical 
        in a cosmetic, including--
                    ``(A) chemicals that provide a technical or 
                functional effect;
                    ``(B) chemicals that have no technical or 
                functional effect in the cosmetic but are present by 
                reason of having been incorporated into the cosmetic as 
                an ingredient of another cosmetic ingredient;
                    ``(C) processing aids that are present by reason of 
                having been added to a cosmetic during the processing 
                of such cosmetic;
                    ``(D) substances that are present by reason of 
                having been added to a cosmetic during processing for 
                their technical or functional effect;
                    ``(E) contaminants present at levels above 
                technically feasible detection limits;
                    ``(F) contaminants that may leach from container 
                materials or form via reactions over the shelf life of 
                a cosmetic and that may be present at levels above 
                technically feasible detection limits;
                    ``(G) the components of a fragrance, flavor, or 
                preservative declared individually by their appropriate 
                label names; and
                    ``(H) any individual component of a botanical, 
                petroleum-derived, animal-derived, or other ingredient 
                that the Secretary determines be considered an 
                ingredient.
            ``(2) Professional use.--The term `professional use' means 
        the use of any cosmetic--
                    ``(A) by an employee (within the scope of the 
                employment of such employee) of; or
                    ``(B) purchased by a consumer in,
        a hair salon, nail salon, beauty salon, spa, or other 
        establishment that provides cosmetic treatment services for 
        humans.
            ``(3) Reasonable certainty.--The term `reasonable 
        certainty', when used in establishing a safety standard (as 
        defined in paragraph (5)) for an ingredient or cosmetic--
                    ``(A) means that no harm will be caused by 
                aggregate exposure for a member of a vulnerable 
                population to that ingredient or cosmetic; and
                    ``(B) corresponds to the lower dose derived from--
                            ``(i) data demonstrating that exposure to 
                        all sources of the ingredient or cosmetic 
                        present not more than a 1 in a million risk for 
                        any adverse effect in the population of 
                        concern, at the lower 95th percentile 
                        confidence bound; or
                            ``(ii) the amount of an ingredient or 
                        cosmetic shown to produce no adverse effects, 
                        incorporating an uncertainty factor of at least 
                        1,000 and considering all sources of exposure.
            ``(4) Reproductive and developmental toxicity.--With 
        respect to an ingredient or cosmetic, the term `reproductive 
        and developmental toxicity' means that the ingredient or 
        cosmetic causes biologically adverse effects on the 
        reproductive systems of female or male humans or animals, 
        including alterations to the female or male reproductive system 
        development, the related endocrine system, fertility, 
        pregnancy, pregnancy outcomes, or modifications in other 
        functions that are dependent on the integrity of the 
        reproductive system.
            ``(5) Safety standard.--
                    ``(A) In general.--The term `safety standard' 
                means--
                            ``(i) with respect to an ingredient, when 
                        the route of exposure is directly relevant to a 
                        particular cosmetic use, a standard that--
                                    ``(I) provides a reasonable 
                                certainty that no harm will result from 
                                aggregate exposure to the cosmetic or 
                                ingredient, including impacts on 
                                vulnerable populations, taking into 
                                account possible harmful effects from 
                                low dose exposures to the cosmetic or 
                                ingredient or from additive effects, 
                                where such evidence exists; and
                                    ``(II) is requisite to protect the 
                                public welfare from any known or 
                                anticipated adverse effects associated 
                                with the cosmetic or ingredient; and
                            ``(ii) with respect to a cosmetic, when the 
                        route of exposure is directly relevant to the 
                        use of the cosmetic, a standard that a cosmetic 
                        fails to meet if--
                                    ``(I) the cosmetic would fail to 
                                meet the standard under clause (i) if 
                                the cosmetic was treated in the same 
                                manner as an ingredient under such 
                                clause; or
                                    ``(II) one or more ingredients in 
                                the cosmetic fail to meet such 
                                standard.
                    ``(B) Determination of safety.--A cosmetic or 
                ingredient shall fail to meet the safety standard under 
                subparagraph (A)--
                            ``(i) unless the Secretary determines that 
                        there is a reasonable certainty that no harm 
                        will result from aggregate exposure to the 
                        ingredient or cosmetic, including impacts on 
                        highly exposed or vulnerable populations, 
                        taking into account, where evidence exists, 
                        possible harmful effects from--
                                    ``(I) low dose exposures to the 
                                cosmetic or ingredient; or
                                    ``(II) additive effects; or
                            ``(ii) if the Secretary determines 
                        necessary to protect the public welfare from 
                        any known or anticipated adverse effects 
                        associated with the cosmetic or ingredient.
            ``(6) Vulnerable populations.--The term `vulnerable 
        populations' includes pregnant women, infants, children, the 
        elderly, people with compromised immune systems, and highly 
        exposed populations, including workers employed by 
        establishments listed under paragraph (2) and cosmetic 
        manufacturing plants.

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

    ``(a) Definitions.--In this section:
            ``(1) Domestic establishment.--The term `domestic 
        establishment' means an establishment located in any State that 
        manufactures, packages, or distributes cosmetics.
            ``(2) Foreign establishment.--
                    ``(A) In general.--The term `foreign establishment' 
                means an establishment that manufactures, packages, or 
                distributes cosmetics that are exported to the United 
                States without further processing or packaging outside 
                the United States.
                    ``(B) Not considered to have undergone further 
                processing or packaging.--A cosmetic may not be 
                considered to have undergone further processing or 
                packaging for purposes of subparagraph (A) solely on 
                the basis that labeling was added or that any similar 
                activity of a de minimis nature was carried out with 
                respect to the cosmetic.
    ``(b) Registration.--The Secretary shall require that any 
establishment engaged in manufacturing, packaging, or distributing 
cosmetics for use in the United States register annually with the 
Secretary. To be registered--
            ``(1) as a domestic establishment, the owner, operator, or 
        agent in charge of the domestic establishment shall submit a 
        registration to the Secretary; or
            ``(2) as a foreign establishment, the owner, operator, or 
        agent in charge of the foreign establishment--
                    ``(A) shall submit a registration to the Secretary; 
                and
                    ``(B) shall include with the registration the name 
                of the United States agent for the foreign 
                establishment.
    ``(c) Submission of Registration.--
            ``(1) In general.--An establishment (referred to in this 
        section as the `registrant') shall submit a registration under 
        subsection (b) to the Secretary containing, with respect to any 
        cosmetics that the establishment manufactures, packages, or 
        distributes--
                    ``(A) any information necessary to notify the 
                Secretary of the name and address of each establishment 
                at which, and all trade names under which, the 
                registrant manufactures, packages, or distributes 
                cosmetics;
                    ``(B) a description of the establishment's 
                activities with respect to cosmetics;
                    ``(C) the number of workers employed at the 
                establishment;
                    ``(D) the gross receipts of sales; and
                    ``(E) the name and address of any company that 
                supplies the establishment, if the establishment 
                manufactures cosmetics, with any ingredient (including 
                preservatives, fragrances, or any other chemical 
                component of a finished cosmetic product) and the name 
                of the ingredient supplied to such establishment by 
                such supplier.
            ``(2) Notification of changes.--
                    ``(A) In general.--The registrant shall notify the 
                Secretary in a timely manner of changes to the 
                information described in paragraph (1).
                    ``(B) Deadline for certain changes.--The registrant 
                shall notify the Secretary of any change in the 
                products, function, or legal status of each 
                establishment at which the registrant manufactures, 
                packages, or distributes cosmetics (including cessation 
                of business activities) not later than 60 days after 
                the date of such change.
    ``(d) Procedure.--Upon receipt of a completed registration 
submitted under subsection (b), the Secretary shall notify the 
registrant of the receipt of such registration and assign a 
registration number to each registered establishment.
    ``(e) List of Registered Establishments.--
            ``(1) Maintenance of list.--The Secretary shall compile and 
        maintain an up-to-date list of establishments that are 
        registered under this section.
            ``(2) Removal and suspension.--The Secretary shall remove 
        from the list under paragraph (1) the name of any establishment 
        that fails to reregister in accordance with this section and 
        shall treat such removal as a suspension of the establishment's 
        registration.
            ``(3) Application of foia.--
                    ``(A) List.--The list under paragraph (1) shall be 
                subject to disclosure under section 552 of title 5, 
                United States Code.
                    ``(B) 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.
                    ``(C) 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.
    ``(f) 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 more than $1,000,000.
    ``(g) Registration Cancellation.--The Secretary may cancel the 
registration of any establishment under this section--
            ``(1) if the information submitted by the establishment for 
        such registration is incomplete, inaccurate, or out-of-date; or
            ``(2) if a registered establishment fails to update such 
        information promptly when there is a change in such 
        information.

``SEC. 613. INGREDIENTS LABELS ON COSMETICS.

    ``(a) In General.--The Secretary shall require the label on each 
package of cosmetics, including cosmetics distributed for retail sale 
and professional use, to bear a declaration of the name of each 
ingredient in such cosmetic in descending order of predominance. The 
Secretary may allow that the declaration of an ingredient present as a 
contaminant is not required if the contaminant is present at levels 
below technically feasible detection limits.
    ``(b) Labeling of Ingredients in Cosmetics Sold Through Internet 
Commerce.--Subject to subsection (d), the Secretary shall require--
            ``(1) in the case of a cosmetic sold on the Web site of an 
        Internet vendor, that the manufacturers and distributors of 
        such cosmetic provide to such Internet vendor a list of the 
        ingredients of the cosmetic; and
            ``(2) each Internet vendor to display the list of 
        ingredients of each cosmetic sold by such vendor on the Web 
        site of the vendor.
    ``(c) Trade Secrets.--Notwithstanding any other provision of law, 
an ingredient required to be listed or labeled under this section shall 
not have protection as a trade secret.
    ``(d) Deadline.--Not later than one year after the date of the 
enactment of the Safe Cosmetics Act of 2010--
            ``(1) all cosmetics that are available for retail sale 
        shall be labeled in a manner that complies with the 
        requirements under subsection (a); and
            ``(2) manufacturers, distributors, and Internet venders 
        shall comply with the applicable requirements of subsection 
        (b).

``SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFETY.

    ``(a) Publicly Available Cosmetic and Ingredient Test Data.--
            ``(1) Submission of information.--
                    ``(A) Initial submission.--Not later than 1 year 
                after the date of the enactment of the Safe Cosmetics 
                Act of 2010, manufacturers and distributors of 
                cosmetics and ingredients shall submit to the Secretary 
                (in an electronic format that the Secretary shall 
                determine) all reasonably available information in the 
                possession or control of the manufacturer or 
                distributor that has not previously been submitted to 
                the Secretary regarding the physical, chemical, and 
                toxicological properties of single or multiple 
                chemicals listed on the cosmetic labels under section 
                613, including--
                            ``(i) functions and uses;
                            ``(ii) exposure and fate information;
                            ``(iii) tests of finished cosmetics; and
                            ``(iv) any other information used to 
                        substantiate the safety of such cosmetics or 
                        ingredients.
                    ``(B) New or updated information.--Not later than 
                60 days after the date on which new or updated 
                information that is required under subparagraph (A) 
                becomes available to a manufacturer or distributer, 
                such manufacturer or distributor shall submit such 
                information to the Secretary in the same form and 
                manner as information submitted under subparagraph (A).
            ``(2) Availability of information.--The Secretary shall 
        require that any manufacturer, distributor, or marketer of a 
        cosmetic or ingredient (including a fragrance or preservative) 
        make available to any entity purchasing the cosmetic or 
        ingredient (excluding an individual who is a consumer and who 
        is purchasing the cosmetic or ingredient for personal use) all 
        available information in the possession or control of the 
        manufacturer, distributor, or marketer described in paragraph 
        (1), within 90 days of receipt of the request from such entity.
            ``(3) Database.--
                    ``(A) Initial publication.--Not later than 12 
                months after the date of the enactment of the Safe 
                Cosmetics Act of 2010, the Secretary shall publish a 
                comprehensive, publicly accessible database containing 
                all non-confidential information submitted under 
                paragraph (1).
                    ``(B) Updates.--Not later than 90 days after the 
                Secretary receives new or updated information under 
                paragraph (1)(B), the Secretary shall update the 
                database described in subparagraph (A) with such 
                information.
    ``(b) Lists of Ingredients.--
            ``(1) Prohibited and restricted ingredients.--
                    ``(A) List of ingredients that are prohibited or 
                restricted.--Not later than 2 years after the date of 
                the enactment of the Safe Cosmetics Act of 2010, the 
                Secretary shall issue, by regulation, a list of 
                ingredients that are identified by the Secretary as--
                            ``(i) prohibited ingredients; or
                            ``(ii) restricted ingredients.
                    ``(B) Updates.--The Secretary shall continually 
                update the list under subparagraph (A), including 
                when--
                            ``(i) determinations under paragraph (3)(D) 
                        are made; or
                            ``(ii) new information becomes available 
                        demonstrating that an ingredient fails to meet 
                        the safety standard.
                    ``(C) Information sources.--
                            ``(i) Use of authoritative information.--
                        The list under subparagraph (A) shall contain 
                        ingredients that are known to be carcinogenic, 
                        mutagenic, or have reproductive and 
                        developmental toxicity, based on information 
                        from the Environmental Protection Agency, the 
                        International Agency for Research on Cancer, 
                        the National Toxicity Program through the 
                        National Institutes of Health, the California 
                        Environmental Protection Agency, and other 
                        authoritative international, Federal, and State 
                        entities (as determined by the Secretary).
                            ``(ii) Use of other information sources.--
                        In identifying ingredients for purposes of the 
                        list under subparagraph (A), the Secretary 
                        shall use all reasonably available information, 
                        including new scientific information and 
                        submissions from manufacturers and distributors 
                        of cosmetics.
                    ``(D) Prohibited ingredients.--Ingredients that are 
                listed as prohibited under subparagraph (A) shall 
                include all ingredients that the Secretary determines 
                are unsafe for use in cosmetics in any amount because 
                such ingredients fail to meet the safety standard 
                defined in section 611(5).
                    ``(E) Restricted ingredients.--Ingredients that are 
                listed as restricted under subparagraph (A) shall 
                include all ingredients for which the Secretary 
                determines that limits on use or concentration are 
                necessary to satisfy the safety standard defined in 
                section 611(5).
                    ``(F) Ingredients and cosmetics found to induce 
                cancer or birth defects or have reproductive or 
                developmental toxicity.--
                            ``(i) Presumption.--The Secretary shall 
                        presume that any ingredient or cosmetic that 
                        induces cancer or birth defects or has 
                        reproductive or developmental toxicity when 
                        ingested by, inhaled by, or dermally applied to 
                        a human or an animal has failed to meet the 
                        safety standard (as defined in section 611(5)).
                            ``(ii) Rebuttal.--The presumption under 
                        clause (i) may be rebutted only if the 
                        Secretary determines that the ingredient or 
                        cosmetic meets such safety standard.
                            ``(iii) Public comment.--The Secretary 
                        shall solicit public comment before making a 
                        determination under clause (ii).
            ``(2) Safe without limits.--
                    ``(A) In general.--Not later than 2 years after the 
                date of the enactment of the Safe Cosmetics Act of 
                2010, the Secretary shall issue, by regulation, a list 
                of ingredients that the Secretary has determined are 
                safe without limits for use in cosmetics.
                    ``(B) Standard for inclusion in list.--The 
                Secretary may only include an ingredient on the list 
                under subparagraph (A) if the Secretary determines that 
                such ingredient meets the safety standard (as defined 
                in section 611(5)) regardless of--
                            ``(i) the type and form of cosmetic the 
                        ingredient is used in; or
                            ``(ii) the concentration of the ingredient 
                        that is used in a cosmetic.
                    ``(C) Update.--The Secretary shall update the list 
                under subparagraph (A) when new information becomes 
                available.
                    ``(D) Consultations.--In determining whether a 
                cosmetic or ingredient is safe, the Secretary shall 
                consult hazard listings and assessments from 
                authoritative international, Federal, and State 
                entities, including the entities listed in paragraph 
                (1)(C)(i).
                    ``(E) Redeterminations.--The Secretary may 
                redetermine whether a cosmetic or ingredient 
                distributed in commerce meets the safety standard if, 
                in the judgment of the Secretary, new information 
                raises a credible question as to whether the cosmetic 
                or ingredient continues to meet the safety standard.
            ``(3) Priority assessment list.--
                    ``(A) In general.--Not later than 18 months after 
                the date of the enactment of the Safe Cosmetics Act of 
                2010, the Secretary shall develop a priority assessment 
                list of not less than 300 ingredients--
                            ``(i) which cannot be included on the 
                        restricted and prohibited list under paragraph 
                        (1) or the safe without limits list under 
                        paragraph (2) because of a lack of 
                        authoritative information on the safety of the 
                        ingredient; and
                            ``(ii) for which safety determinations 
                        under subparagraph (D) shall be made.
                    ``(B) Additional ingredients.--The Secretary shall 
                add not less than 100 ingredients to the priority 
                assessment list under subparagraph (A) annually until 
                all ingredients that are used in the formulation or 
                manufacture of cosmetics have been added to the 
                priority assessment list, the safe without limits list, 
                or the prohibited and restricted list.
                    ``(C) Considerations.--In developing or updating 
                the priority assessment list under this paragraph, the 
                Secretary shall take into account all relevant data 
                with respect to ingredients including whether the 
                ingredients--
                            ``(i) react to form harmful byproducts;
                            ``(ii) are found to be present in the body 
                        through biomonitoring;
                            ``(iii) are found in drinking water or 
                        indoor or outdoor air;
                            ``(iv) are a known or suspected 
                        neurological or immunological toxicant, 
                        respiratory asthmagens, or endocrine disruptor, 
                        or have other toxicological concerns; or
                            ``(v) persist in the environment or 
                        bioaccumulate.
                    ``(D) Determination of whether ingredient meets 
                safety standard.--
                            ``(i) In general.--Not later than 24 months 
                        after the date on which an ingredient is placed 
                        on the priority assessment list under 
                        subparagraph (A), the Secretary shall issue, by 
                        rule, a determination of--
                                    ``(I) whether the ingredient meets 
                                the safety standard (as defined in 
                                section 611(5)) and can be placed on 
                                the safe without limits list under 
                                paragraph (2); or
                                    ``(II) whether to include the 
                                ingredient in the prohibited and 
                                restricted ingredients list under 
                                paragraph (1), to ensure that the 
                                safety standard is not violated.
                            ``(ii) Rulemaking.--Before issuing final 
                        regulations under clause (ii), the Secretary 
                        shall issue a notice of proposed rulemaking and 
                        provide a period of not less than 60 days for 
                        public comment on the proposed regulation, 
                        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) states the reasons for such 
                                finding in the notice of proposed 
                                rulemaking.
    ``(c) Manufacturer Information and Safety Testing.--
            ``(1) Provision of information.--A manufacturer of an 
        ingredient or cosmetic shall provide to the Secretary, through 
        a statement under paragraph (3), all information required to 
        determine if an ingredient or cosmetic meets the safety 
        standard.
            ``(2) Minimum data requirements and test protocols.--Not 
        later than 1 year after the date of the enactment of the Safe 
        Cosmetics Act of 2010, the Secretary shall establish minimum 
        data requirements and test protocols to be used by 
        manufacturers to assess the safety of cosmetic ingredients that 
        would ensure that statements under paragraph (3)(A) regarding 
        compliance with the safety standard are based on sufficient and 
        reliable data.
            ``(3) Statements.--
                    ``(A) In general.--Not later than 18 months after 
                the date of the enactment of the Safe Cosmetics Act of 
                2010, each manufacturer or marketer of a cosmetic shall 
                submit to the Secretary a statement signed by the chief 
                executive officer of such manufacturer or marketer, 
                based on available information after a good faith 
                inquiry, that--
                            ``(i) the cosmetic and its ingredients meet 
                        the safety standard; or
                            ``(ii) there is insufficient data to 
                        determine whether the cosmetic and its 
                        ingredients meet the safety standard.
                    ``(B) Updates.--Each manufacturer or marketer of a 
                cosmetic shall update the statement under subparagraph 
                (A) when there becomes available significant new 
                information regarding the safety, or lack thereof, of a 
                cosmetic or its ingredients.
            ``(4) Audit.--The Secretary shall perform an annual 
        comprehensive data audit on a statistically significant number 
        of the statements submitted by manufacturers or marketers under 
        paragraph (3).
    ``(d) Nanomaterials in Cosmetics.--The Secretary shall--
            ``(1) monitor developments in the scientific understanding 
        of any adverse health effects related to the use of 
        nanotechnology in the formulation of cosmetics; and
            ``(2) consider scale specific hazard properties of 
        ingredients when conducting or reviewing safety substantiation 
        of cosmetic ingredients.
    ``(e) Product Testing and Review Audit.--The Secretary shall 
conduct annual audits of random samples of cosmetic products to assess 
or test for acute negative reactions, pathogen hazards, contaminants, 
or leaching of packaging additives, mislabeling, or other relevant 
issues of concern (as determined by the Secretary).

``SEC. 615. MARKET RESTRICTIONS.

    ``(a) Failure To Provide Data or Meet Safety Standard.--No person 
shall manufacture, import, distribute, or market in commerce a cosmetic 
or an ingredient for use in a cosmetic if the Secretary determines 
that--
            ``(1) the person failed to provide information to the 
        Secretary as required under this subchapter; or
            ``(2) beginning 180 days after the date on which the 
        Secretary places an ingredient on a list under section 
        614(b)(1)--
                    ``(A) the ingredient--
                            ``(i) is on the list under section 
                        614(b)(1)(A)(i); or
                            ``(ii) is a cosmetic containing an 
                        ingredient on such list;
                    ``(B) the ingredient is on the list under section 
                614(b)(1)(A)(ii) and is being used in a cosmetic in a 
                manner that violates the limit on use or concentration 
                of such ingredient under section 614(b)(1)(E).
    ``(b) Failure of Secretary To Act.--
            ``(1) Issuance of pending notification.--If the Secretary 
        fails to act by an applicable deadline under section 614, a 
        manufacturer or marketer of an ingredient affected by the 
        failure to act shall issue to the Secretary, the public, and 
        each known customer of the ingredient a written notice that a 
        determination by the Secretary of the safety of the ingredient 
        for use in cosmetics is pending.
            ``(2) Prohibited use.--If, by the last day of the 5 year 
        period beginning on the date on which an ingredient is placed 
        on the priority assessment list under section 614(b)(3), the 
        Secretary has not made a determination under such section 
        concerning whether such ingredient meets the safety standard, 
        the ingredient may not be--
                    ``(A) used in cosmetics; or
                    ``(B) manufactured, imported, distributed, or 
                marketed for use in cosmetics.

``SEC. 616. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED COSMETICS.

    ``(a) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Cosmetics.--
            ``(1) In general.--A responsible party that has reason to 
        believe that a cosmetic, when introduced into or while in 
        interstate commerce, or while held for sale (regardless of 
        whether such sale is the first sale of such cosmetic) after 
        shipment in interstate commerce, is adulterated or misbranded 
        in a manner that presents a reasonable probability that the use 
        or exposure to the cosmetic (or an ingredient or component used 
        in any such cosmetic) will cause a threat of serious adverse 
        health consequences or death to humans shall, as soon as 
        practicable, notify the Secretary of the identity and location 
        of the cosmetic.
            ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation or guidance.
            ``(3) Responsible party defined.--For purposes of this 
        subsection, the term `responsible party' means a manufacturer, 
        packager, retailer, or distributor of the cosmetic.
    ``(b) Voluntary Recall.--The Secretary may request that any person 
who distributes a cosmetic that the Secretary has reason to believe is 
adulterated, misbranded, or otherwise in violation of this Act 
voluntarily--
            ``(1) recall such cosmetic; and
            ``(2) provide for notice, including to individuals as 
        appropriate, to persons who may be affected by the recall.
    ``(c) Order To Cease Distribution.--
            ``(1) In general.--If the Secretary has reason to believe 
        that--
                    ``(A) the use of, or exposure to, a cosmetic may 
                cause serious adverse health consequences or death to 
                humans;
                    ``(B) the cosmetic is misbranded; or
                    ``(C) the cosmetic is manufactured, packaged, or 
                distributed by an unregistered facility;
        the Secretary shall have the authority to issue an order 
        requiring any person who distributes such cosmetic to 
        immediately cease distribution of such cosmetic.
            ``(2) Action following order.--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, and may appeal such order to the 
        Secretary within 24 hours of the issuance of such order. 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). Except as provided in subsection (e), an 
        informal hearing shall be held as soon as practicable, but not 
        later than 5 calendar days, or less as determined by the 
        Secretary, after such an appeal is filed, unless the parties 
        jointly agree to an extension. After affording an opportunity 
        for an informal hearing, the Secretary shall determine whether 
        the order should be amended to require a recall of such 
        cosmetic. If, after providing an opportunity for such a 
        hearing, the Secretary determines that inadequate grounds exist 
        to support the actions required by the order, the Secretary 
        shall vacate the order.
    ``(d) Order To Recall.--
            ``(1) Amendment.--Except as provided under subsection (e), 
        if after providing an opportunity for an informal hearing under 
        subsection (c)(2), the Secretary determines that the order 
        should be amended to include a recall of the cosmetic with 
        respect to which the order was issued, the Secretary shall 
        amend the order to require a recall.
            ``(2) Contents.--An amended order under paragraph (1) 
        shall--
                    ``(A) specify a timetable in which the recall will 
                occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(C) provide for notice, including to individuals 
                as appropriate, to persons who may be affected by the 
                recall.
        In providing for such notice, the Secretary may allow for the 
        assistance of health professionals, State or local officials, 
        or other individuals designated by the Secretary.
            ``(3) Nondelegation.--An amended order under this 
        subsection shall be ordered by the Secretary or an official 
        designated by the Secretary. An official may not be so 
        designated unless the official is the director of the district 
        under this Act in which the cosmetic involved is located, or is 
        an official senior to such director.
    ``(e) Emergency Recall Order.--
            ``(1) In general.--If the Secretary has credible evidence 
        or information that a cosmetic subject to an order under 
        subsection (c) presents an imminent threat of serious adverse 
        health consequences or death to humans, the Secretary may issue 
        an order requiring any person who distributes such cosmetic--
                    ``(A) to immediately recall such cosmetic; and
                    ``(B) to provide for notice, including to 
                individuals as appropriate, to persons who may be 
                affected by the recall.
            ``(2) Action following order.--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, and may appeal within 24 hours after 
        issuance such order to the Secretary. 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. After affording an opportunity for an informal 
        hearing, the Secretary shall determine whether the order should 
        be amended pursuant to subsection (d)(1). If, after providing 
        an opportunity for such a hearing, the Secretary determines 
        that inadequate grounds exist to support the actions required 
        by the order, the Secretary shall vacate the order.
            ``(3) Nondelegation.--An order under this subsection shall 
        be issued by the Commissioner of Food and Drugs, the Principal 
        Deputy Commissioner, or the Associate Commissioner for 
        Regulatory Affairs of the Food and Drug Administration.
    ``(f) Notice to Consumers and Health Officials.--The Secretary 
shall, as the Secretary determines to be necessary, provide notice of a 
recall order under this section to consumers to whom the cosmetic was, 
or may have been, distributed and to appropriate State and local health 
officials.
    ``(g) 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. 617. 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 180 days 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 
        614(b)(1);
            ``(2) to remove an ingredient from the list of ingredients 
        that are safe without limits under section 614(b)(2); or
            ``(3) to add an ingredient to the priority assessment list 
        under section 614(b)(3).
    ``(b) Reasonable Petition.--Not later than one year after the date 
of the enactment of this Act, the Secretary shall issue rules 
specifying the criteria which the Secretary will use to determine if a 
petition submitted under this section is a reasonable petition.

``SEC. 618. COSMETIC AND INGREDIENT STATEMENTS.

    ``(a) In General.--Each establishment engaged in the manufacture of 
a cosmetic intended to be marketed in the United States shall submit 
electronically to the Secretary for each cosmetic manufactured in the 
establishment that is intended to be marketed in the United States a 
statement containing--
            ``(1) the registration number of the manufacturing 
        establishment where the cosmetic is manufactured or, if the 
        same cosmetic is manufactured in more than 1 establishment, the 
        registration number of each establishment where it is 
        manufactured;
            ``(2) the registration number of the establishment 
        responsible for distributing the cosmetic;
            ``(3) the brand name and the product name for the cosmetic;
            ``(4) the applicable use for the cosmetic;
            ``(5) the ingredient list as it appears on the cosmetic 
        label or insert, including the particle size of any nanoscale 
        cosmetic ingredients;
            ``(6) any warnings and directions for use from the cosmetic 
        label or insert; and
            ``(7) the title and full contact information for the 
        individual responsible for submitting and maintaining such 
        statement.
    ``(b) Notification of Changes.--The establishment shall notify the 
Secretary in a timely manner of any change to the information required 
under subsection (a).
    ``(c) Procedure.--Upon receipt of a completed statement described 
under subsection (a), the Secretary shall notify the establishment of 
the receipt of such statement and assign a cosmetic statement number.
    ``(d) List.--The Secretary shall compile and maintain an up-to-date 
list of cosmetics for which statements are submitted under this 
section.
    ``(e) 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 dimension is 100 nanometers or smaller for not less 
        than 1 percent of the ingredient particles in the cosmetic; 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.
    ``(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 614(a)(3).
    ``(g) Effective Dates.--
            ``(1) In general.--The provisions of this section shall 
        take effect 1 year after the date of the enactment of the Safe 
        Cosmetics Act of 2010.
            ``(2) Application to new cosmetics.--An establishment that 
        begins to manufacture a cosmetic after the date of the 
        enactment of the Safe Cosmetics Act of 2010 shall comply with 
        the requirements of subsections (a) and (b) not later than 6 
        months after beginning to manufacture such cosmetic.

``SEC. 619. MANDATORY REPORTING OF ADVERSE HEALTH EFFECTS.

    ``(a) Submission of Report on Adverse Health Effects.--The 
Secretary shall require that the manufacturer, packager, or distributer 
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 adverse event is received at the place of 
business of the manufacturer, packager, or distributer.
    ``(c) Content of Report.--A report under subsection (a) shall 
include the following information to the extent to which the 
manufacturer, packager, or distributer submitting the report has been 
able to verify the information:
            ``(1) An identifiable patient.
            ``(2) An identifiable report.
            ``(3) A suspect cosmetic.
            ``(4) A serious and unexpected adverse event.
    ``(d) Public Availability and Privacy.--
            ``(1) Public availability.--Subject to paragraph (2), the 
        adverse health effects reports collected by the Secretary under 
        this section shall be submitted electronically and shall be 
        made accessible to the public.
            ``(2) Privacy.--
                    ``(A) Personally identifiable information.--
                Notwithstanding any other provision of law, personally 
                identifiable information in adverse 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.--An adverse event 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. 620. NONCONFIDENTIAL INFORMATION.

    ``(a) In General.--Subject to subsection (b) and section 619(d)(2), 
all nonconfidential information submitted pursuant to this subchapter 
shall be made available to the public. The name, identity, and 
structure of a chemical substance, contaminant, or impurity that is an 
ingredient and all information concerning function, exposure, health 
hazards, and environmental hazards, and the functions of ingredients in 
cosmetics shall not be considered to be confidential business 
information under this subchapter. Fragrance, flavor, and colorants 
shall not be considered confidential business information under this 
subchapter. The concentration of cosmetic ingredients used in a 
finished cosmetic shall be considered confidential business information 
except as otherwise required in section 613.
    ``(b) 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 serious commercial harm to such entity if 
        such information were disclosed publicly.
            ``(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 
                substance referred to in subsection (a);
                    ``(B) all health and safety data related to that 
                substance; or
                    ``(C) any data used to substantiate the safety of 
                that substance.

``SEC. 621. SAVINGS CLAUSE.

    ``Nothing in this subchapter shall affect the right of a State, 
political subdivision of a State, or tribe to adopt or enforce any 
regulation, requirement, liability, or standard of performance that is 
more stringent than a regulation, requirement, liability, or standard 
of performance established by this subchapter, including requiring the 
provision of a warning of risk, illness, or injury.

``SEC. 622. ANIMAL TESTING ALTERNATIVES.

    ``(a) In General.--To minimize the use of animal testing of 
ingredients, the Secretary shall--
            ``(1) require, where practicable, alternative testing 
        methods that--
                    ``(A) do not involve the use of an animal to test 
                the chemical substance;
                    ``(B) provide information that is equivalent or 
                superior in scientific quality to the animal testing 
                method; and
                    ``(C) use fewer animals than conventional animal-
                based tests when non-animal methods are impracticable, 
                including the use of tests that combine multiple 
                endpoints; and
            ``(2) encourage, where practicable--
                    ``(A) estimation of toxicological properties of a 
                chemical through the use of testing information for 1 
                or more structurally similar chemicals where such 
                estimates provide information of sufficient scientific 
                quality;
                    ``(B) the formation of industry consortia to 
                conduct testing to avoid duplication of tests; and
                    ``(C) funding for research and validation of 
                alternative test methods, in accordance with this 
                subsection.
    ``(b) List of Alternative Testing Methods.--Not later than 1 year 
after the date of the enactment of the Safe Cosmetics Act of 2010, and 
triennially thereafter, the Secretary shall publish a list of the 
alternative testing methods described in subsection (a).

``SEC. 623. INTERAGENCY COOPERATION AND FUNDING.

    ``There is established an Interagency Council on Cosmetic Safety 
for the purpose of sharing data and promoting collaboration on cosmetic 
safety among and 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.

``SEC. 624. 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 
2011 through 2015.''.
    (b) Adulterated and Misbranded Cosmetics.--
            (1) Adulterated cosmetics.--Section 601 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended--
                    (A) in subsection (a), by striking ``, except that 
                this provision shall not apply to coal-tar hair dye'' 
                and all that follows through ``or eyebrow dyes''; and
                    (B) by adding at the end the following:
    ``(f) If it--
            ``(1) was manufactured, packaged, or distributed by an 
        entity that failed to register as required under section 612;
            ``(2) was sold by an Internet vendor that failed to comply 
        with the requirements of section 613(b);
            ``(3) the person who manufactures, imports, distributes, or 
        markets the cosmetic, or an ingredient in the cosmetic, fails 
        to comply with the applicable requirements of section 615 
        (including failure to issue a notice required under section 
        615(b)(1));
            ``(4) is manufactured, packaged, distributed, or sold in 
        retail by a manufacturer, packager, distributor, or retailer, 
        respectively, who fails to notify the Secretary as required 
        under section 616(a);
            ``(5) is distributed in violation of an order under section 
        616(c);
            ``(6) is not recalled as required by an order under 
        subsection (d) or (e) of section 616;
            ``(7) is manufactured in a manner that fails to comply with 
        good manufacturing practices for cosmetics, as determined (and 
        periodically updated), by the Secretary; or
            ``(8) is manufactured by a manufacturer who fails to submit 
        the statement required under section 618 or notify the 
        Secretary of changes to information contained in such statement 
        as required by such section.''.
            (2) Misbranded cosmetics.--Section 602 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 362) is amended in subsection 
        (a), by inserting ``, fails to meet the requirements of section 
        613(a), or fails to meet any requirements under section 
        618(e)'' before the period.

SEC. 3. WORKER ISSUES.

    (a) In General.--The Secretary of Labor shall promulgate an 
occupational safety and health standard under section 6 of the 
Occupational Safety and Health Act of 1970 (29 U.S.C. 655) that 
requires the following:
            (1) Manufacturers and importers.--
                    (A) In general.--Each manufacturer or importer 
                selling any cosmetic for professional use shall--
                            (i) obtain or develop an expanded 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 product ingredient associated with 
                                any chemical hazard, that has been 
                                indicated by authoritative bodies or 
                                scientific studies to be linked to 
                                health hazards including mutation, 
                                reproductive or developmental toxicity, 
                                neurotoxicity, endocrine disruption, 
                                asthma, or other immunological 
                                toxicity; and
                            (ii) make the expanded material safety data 
                        sheet available to distributors and employers, 
                        including salon owners, in English and, upon 
                        request, in other languages, including Spanish 
                        and Vietnamese.
                    (B) Professional use defined.--In this paragraph, 
                the term ``professional use'' has the meaning given 
                such term in section 611 of the Federal Food, Drug, and 
                Cosmetic Act.
            (2) Distributors.--Each distributor of a cosmetic or 
        personal care product for professional use shall distribute and 
        provide expanded material safety data sheets described in 
        subsection (b) in the same manner as a distributor of a 
        chemical hazard is required to distribute and provide material 
        safety data sheets under section 1910.1200(g) of title 29, Code 
        of Federal Regulations, or any successor regulations.
            (3) Employers.--Each employer, including any operator of a 
        salon, shall--
                    (A) have an expanded 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 expanded 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 expanded material safety data 
                sheet in other languages, including Spanish and 
                Vietnamese.
    (b) Contents of Expanded Material Safety Data Sheet.--An expanded 
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)(i)(II); and
            (2) include the following statement: ``This expanded 
        material safety data sheet is also available in multiple 
        languages by contacting the manufacturer, using the contact 
        information provided on this sheet.''.

SEC. 4. FDA SAFETY STANDARD AS IT RELATES TO OTHER ADMINISTRATIVE 
              AGENCIES.

    (a) Use of Data From Federal Sources.--The Secretary shall request 
and utilize ingredient toxicity, use, and exposure data from other 
Federal agencies as appropriate, to assist with developing the priority 
assessment list under section 614(b)(3) of the Federal Food, Drug, and 
Cosmetic Act, and for reaching safety determinations under section 
614(b)(3)(E) of such Act.
    (b) Use of Other Federal Standards.--If any Federal agency has 
promulgated a standard for an ingredient that satisfies the safety 
standard under section 611 of the Federal Food, Drug, and Cosmetic Act, 
the Secretary may adopt it for purposes of this Act or an amendment 
made by this Act.
                                 <all>
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