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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4395 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 4395

  To amend the Federal Food, Drug, and Cosmetic Act to establish new 
 procedures and requirements for the registration of cosmetic product 
 manufacturing establishments, the submission of cosmetic product and 
  ingredient statements, and the reporting of serious and unexpected 
        cosmetic product adverse events, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 18, 2012

  Mr. Lance introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
  To amend the Federal Food, Drug, and Cosmetic Act to establish new 
 procedures and requirements for the registration of cosmetic product 
 manufacturing establishments, the submission of cosmetic product and 
  ingredient statements, and the reporting of serious and unexpected 
        cosmetic product adverse events, 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 AND REFERENCES.

    (a) Short Title.--This Act may be cited as the ``Cosmetic Safety 
Amendments Act of 2012''.
    (b) References to the Federal Food, Drug, and Cosmetic Act.--Except 
as otherwise specified, whenever in this Act an amendment is expressed 
in terms of an amendment to a section or other provision, the reference 
shall be considered to be made to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short title and references.
Sec. 2. Table of contents.
Sec. 3. Registration of cosmetic manufacturing establishments.
Sec. 4. Cosmetic and ingredient statement.
Sec. 5. Serious and unexpected adverse event reporting for cosmetics.
Sec. 6. Good manufacturing practice for cosmetics.
Sec. 7. Tolerances for nonfunctional constituents in cosmetics.
Sec. 8. Cosmetic ingredient review.
Sec. 9. Cosmetic ingredient safety.
Sec. 10. National cosmetic regulatory databank.
Sec. 11. Cosmetic records inspection.
Sec. 12. Rules of construction.
Sec. 13. Conforming amendments.
Sec. 14. National uniformity for cosmetics.
Sec. 15. Importation.
Sec. 16. Authorization of appropriations.
Sec. 17. Effective dates.

SEC. 3. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.

    Chapter VI is amended by adding at the end the following:

``SEC. 604. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.

    ``(a) In General.--
            ``(1) The Secretary shall by regulation require that every 
        domestic and foreign establishment engaged in the manufacture 
        of a cosmetic intended to be marketed in the United States be 
        registered with the Secretary within 60 days after beginning 
        such manufacture. If a cosmetic is processed in more than one 
        establishment, registration shall be required only for the 
        establishment that performs the final portion of the 
        manufacturing operation. The registration shall state the name 
        of the company or other organization, the city, street address, 
        State, and country of the establishment, and the title, email 
        address, and telephone number for the office within the 
        establishment that is responsible for submitting and 
        maintaining the registration.
            ``(2) The Secretary shall establish and provide to the 
        registrant a unique cosmetic establishment registration number 
        within 15 business days after receiving the registration. Where 
        more than one person registers the same manufacturing 
        establishment, the Secretary shall provide only one unique 
        establishment registration number for the establishment.
    ``(b) Maintenance.--The information required in a registration 
under subsection (a) or in an existing registration under subsection 
(e) shall be maintained as current and accurate by the registrant by 
withdrawing or amending the registration within 60 days after the 
information becomes no longer current and accurate.
    ``(c) List.--The Secretary shall compile and maintain an up-to-date 
and publicly available electronic list of establishments that are 
registered under this section.
    ``(d) Definitions.--For purposes of this chapter the following 
definitions apply:
            ``(1) The term `establishment' is a place of business where 
        a cosmetic is manufactured, without further processing outside 
        or within the United States.
            ``(2)(A) The term `domestic establishment' means an 
        establishment location in any State.
            ``(B) The term `foreign establishment' means an 
        establishment location outside the States from which a cosmetic 
        is exported to the United States.
            ``(3) A cosmetic shall not be considered to have undergone 
        further processing for purposes of paragraph (1) solely on the 
        basis that packaging or other labeling was added or that any 
        similar activity of a de minimis nature was carried out with 
        respect to the cosmetic.
    ``(e) Exemptions.--Registration under subsection (a) shall not be 
required for any establishment that as of the date of enactment of this 
section is registered as a cosmetic establishment under part 710 of 
title 21, Code of Federal Regulations.
    ``(f) Suspension of Registration.--
            ``(1) In general.--The Secretary may suspend the 
        registration of any facility under this section for a violation 
        of this Act that presents a significant risk of serious adverse 
        health consequences or death to humans.
            ``(2) Notice of suspension.--Suspension of a registration 
        under this section shall be preceded by--
                    ``(A) notice to the establishment of the intent to 
                suspend the registration; and
                    ``(B) an opportunity for an informal hearing 
                concerning the suspension.
            ``(3) Reinstatement.--A registration that is suspended 
        under this section may be reinstated by the Secretary.
            ``(4) Procedures.--The Secretary shall by regulations 
        establish procedures for the implementation of this subsection.
    ``(g) Cancellation of Registration.--
            ``(1) In general.--Not earlier than 10 days after providing 
        notice under paragraph (2), the Secretary may cancel a 
        registration under this section if the Secretary determines 
        that the registration was not updated in accordance with this 
        section or otherwise is not current and accurate.
            ``(2) Notice of cancellation.--Cancellation shall be 
        preceded by notice to the establishment of the intent to cancel 
        the registration and the basis for such cancellation.
            ``(3) Timely update or correction.--If the registration for 
        the establishment is updated or corrected no later than 7 days 
        after notice is provided under paragraph (2), the Secretary 
        shall not cancel the registration.''.

SEC. 4. COSMETIC AND INGREDIENT STATEMENT.

    Chapter VI, as amended by section 3, is amended by adding at the 
end the following:

``SEC. 605. COSMETIC AND INGREDIENT STATEMENT.

    ``(a) In General.--The Secretary shall by regulation require that 
every domestic and foreign establishment engaged in the manufacture of 
a cosmetic intended to be marketed in the United States submit to the 
Secretary, for each cosmetic manufactured in the establishment, within 
60 days after beginning manufacture of the product, a cosmetic and 
ingredient statement containing--
            ``(1) the unique establishment registration number of the 
        manufacturing establishment where the cosmetic is manufactured 
        or, if the same cosmetic product is manufactured in more than 
        one establishment, the unique establishment registration number 
        of each establishment where it is manufactured;
            ``(2) the brand name or names for the cosmetic;
            ``(3) the applicable cosmetic category or categories for 
        the cosmetic;
            ``(4) the ingredients in the cosmetic (in accordance with 
        section 701.3 of title 21, Code of Federal Regulations, and 
        using the name of each ingredient established under subsection 
        (b), if any), in descending order of predominance by weight, 
        except that--
                    ``(A) flavors and fragrances may be designated as 
                such; and
                    ``(B) all variations in color, flavor, or fragrance 
                may be included in one statement; and
            ``(5) the title, email address, and telephone number for 
        the office within the establishment that is responsible for 
        filing and maintaining the statement.
The Secretary shall establish and provide to the person submitting the 
statement a unique cosmetic and ingredient statement number within 15 
business days after receiving the statement.
    ``(b) Name of Ingredient.--For purposes of this section and 
cosmetic ingredient labeling under section 701.3 of title 21, Code of 
Federal Regulations, the name of a cosmetic ingredient shall be the 
name, if any, in the most recent edition of the International Cosmetic 
Ingredient Dictionary, unless the Secretary, after public notice and an 
opportunity for public comment, by regulation or guidance establishes a 
different name for the ingredient.
    ``(c) Maintenance.--The information required in a statement 
submitted to the Secretary under subsection (a) or in an existing 
statement under subsection (e)(1) shall be maintained as current and 
accurate by the person who filed the statement by withdrawing or 
amending the statement within 60 days after the information becomes no 
longer current and accurate, except that no amendment shall be required 
for a change in the order of predominance of the ingredients or for any 
other type or category of change for which the Secretary determines 
that the costs of amending the statement exceed the benefits.
    ``(d) List.--The Secretary shall compile and maintain an up-to-date 
and publicly available electronic list of cosmetics and ingredients for 
which statements are submitted under this section. A statement 
submitted pursuant to this section shall not be subject to disclosure 
under section 552 of title 5, United States Code. The Secretary may 
make publicly available information derived from such statements that 
discloses the names of ingredients used in cosmetic products and the 
number of cosmetic products in which a specific ingredient is used but 
may not make publicly available any information that relates to any 
ingredient that is exempt from public disclosure under section 720.8 of 
title 21, Code of Federal Regulations, or that discloses at what 
establishment a cosmetic is manufactured. At the request of the 
director of a State agency responsible for regulating the safety of 
cosmetics, the Secretary may disclose to such official confidential 
business and trade secret information contained in a statement and such 
official and other State employees who have access to such information 
shall then be subject to the provisions of section 301(j), subsection 
552(b) of title 5, United States Code, and section 1905 of title 18, 
United States Code, with respect to such information.
    ``(e) Exemptions.--Submission of a statement under subsection (a) 
shall not be required for--
            ``(1) a cosmetic for which as of the date of enactment of 
        this section a cosmetic ingredient statement has been submitted 
        to the Secretary under part 710 of title 21, Code of Federal 
        Regulations; or
            ``(2) a cosmetic ingredient exempt from public disclosure 
        under section 720.8 of title 21, Code of Federal 
        Regulations.''.

SEC. 5. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.

    Chapter VI, as amended by sections 3 and 4, is amended by adding at 
the end the following:

``SEC. 606. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR 
              COSMETICS.

    ``(a) In General.--The Secretary shall by regulation require that a 
domestic or foreign manufacturer, packer, or distributor whose name 
appears on the label pursuant to section 602(b)(1) of a cosmetic 
marketed in the United States submit to the Secretary under subsection 
(b) a report containing information received concerning a serious and 
unexpected adverse event in the United States allegedly associated with 
the use of the product.
    ``(b) Submission of Reports.--A serious and unexpected adverse 
event report shall be submitted to the Secretary no later than 15 
business days after information concerning the adverse event is 
received at the place of business labeled on the product under section 
602(b)(1).
    ``(c) Contents.--No such report shall be submitted unless the 
person submitting the report has been able to verify--
            ``(1) an identifiable patient;
            ``(2) an identifiable reporter;
            ``(3) a suspect cosmetic product; and
            ``(4) a serious and unexpected adverse event.
The person submitting the report may include in the submission any 
additional pertinent information and may supplement the report with 
additional information at a later time.
    ``(d) Definitions.--
            ``(1) A `serious' adverse event is one that--
                    ``(A) results in--
                            ``(i) death;
                            ``(ii) a life-threatening experience;
                            ``(iii) inpatient hospitalization;
                            ``(iv) a persistent and significant 
                        disability or incapacity; or
                            ``(v) congenital anomaly or birth defect; 
                        or
                    ``(B) requires, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described under subparagraph (A).
            ``(2) An `unexpected' adverse event is one that is not 
        identified in the current labeling for the cosmetic.
    ``(e) Rules of Construction.--
            ``(1) A serious and unexpected adverse event report 
        (including all information submitted in the initial report or 
        added later) submitted to the Secretary under subsection (a) 
        is--
                    ``(A) a safety report under section 756 that is 
                subject to the provisions of that section;
                    ``(B)(i) a record about an individual under section 
                552a of title 5, United States Code; and
                    ``(ii) a medical or similar file the disclosure of 
                which would constitute a violation of section 552(b)(6) 
                of such title 5, and shall not be publicly disclosed.
            ``(2) The submission of a serious and unexpected adverse 
        event report in compliance with subsection (a) shall not 
        constitute an admission that the cosmetic involved caused or 
        contributed to the adverse event.
    ``(f) The label of a cosmetic shall bear the domestic telephone 
number through which the person whose name and place of business appear 
on the label may receive a report of a serious and unexpected adverse 
event.''.

SEC. 6. GOOD MANUFACTURING PRACTICE FOR COSMETICS.

    Chapter VI, as amended by sections 3, 4, and 5, is amended by 
adding at the end the following:

``SEC. 607. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

    ``The Secretary shall, after public notice and an opportunity for 
public comment, by regulation establish good manufacturing practices 
for the methods used in, or the facilities or controls used for, the 
manufacture, processing, filling, or packaging of cosmetics. In issuing 
such regulations or guidance, the Secretary shall review international 
standards for cosmetic good manufacturing practices to ensure that such 
regulations or guidance are consistent, to the extent the Secretary 
determines practicable and appropriate, with such standards.''.

SEC. 7. TOLERANCES FOR NONFUNCTIONAL CONSTITUENTS IN COSMETICS.

    Chapter VI, as amended by sections 3, 4, 5, and 6, is amended by 
adding at the end the following:

``SEC. 608. TOLERANCES FOR NONFUNCTIONAL CONSTITUENTS IN COSMETICS.

    ``(a) In General.--The Secretary may on the Secretary's own 
initiative, and shall in response to a petition submitted by an 
interested person, including a State, under subsection (b) or in 
accordance with the provisions under subsection (c), after public 
notice and an opportunity for public comment, establish by regulation 
or guidance a tolerance level for a nonfunctional constituent in 
cosmetics. For purposes of this section, a `nonfunctional constituent' 
in a cosmetic is any substance that is an ancillary part of an 
ingredient or the manufacturing process, has not been added as a 
separate substance, and serves no cosmetic function in the cosmetic. 
The Secretary shall establish such a tolerance at a level that is 
necessary for the protection of the public health using generally 
recognized principles of scientific risk assessment. In issuing such a 
regulation or guidance, the Secretary shall take into consideration the 
level that is reasonably achievable through good manufacturing 
practices and shall review tolerance levels for such nonfunctional 
constituent established by authoritative scientific or regulatory 
organizations to ensure that such regulation or guidance is consistent, 
to the extent the Secretary determines practicable and appropriate, 
with such other tolerance levels.
    ``(b) Procedure.--
            ``(1)(A)(i) If the review of a nonfunctional constituent is 
        being conducted on the Secretary's own initiative or under 
        subsection (c), the Secretary shall initiate the proceeding by 
        publishing in the Federal Register a proposed regulation or 
        guidance. The Secretary shall provide 180 days for public 
        comment.
            ``(ii) Not later than 180 days after the end of the period 
        for public comment, the Secretary shall publish in the Federal 
        Register a final regulation or guidance.
            ``(B)(i) If the review of a nonfunctional constituent is 
        being conducted in response to a petition submitted by an 
        interested person, the Secretary shall publish the petition in 
        the Federal Register for public comment not later than 60 days 
        after receipt of the petition. All appendices to the petition 
        shall be made available on the Secretary's website. The 
        Secretary shall provide 180 days for public comment.
            ``(ii) Any such petition shall specify the nonfunctional 
        constituent, the proposed tolerance level, and the scientific 
        data and information on which the proposed tolerance level is 
        based.
            ``(iii) Not later than 180 days after the end of the period 
        for public comment, the Secretary shall publish in the Federal 
        Register a proposed regulation or guidance for public comment. 
        The Secretary shall provide 90 days for public comment.
            ``(iv) Not later than 90 days after the end of the period 
        for public comment, the Secretary shall publish in the Federal 
        Register a final regulation or guidance.
            ``(C) The Secretary may on the Secretary's own initiative, 
        and shall in response to a petition submitted by an interested 
        person, reconsider any tolerance level established under 
        subparagraph (A) or (B), using the same procedure established 
        in this paragraph (1).
            ``(D) Any regulation or guidance, including any revised 
        regulation or guidance, shall apply to cosmetics first shipped 
        in interstate commerce beginning two years after the date of 
        issue of the regulation or guidance, unless the Secretary 
        determines, after public notice and an opportunity for public 
        comment, that an earlier effective date is required to prevent 
        serious adverse health consequences or death.
            ``(2) The failure of the Secretary to comply with any 
        applicable time period requirement under paragraph (1) shall 
        constitute final agency action for purposes of judicial review. 
        If the court conducting such review determines that the 
        Secretary has failed to comply with the requirement, the court 
        shall order the Secretary to comply within a time period 
        determined by the court to be appropriate, but in no event 
        later than 90 days following the court's order.
    ``(c) Priority List.--Within 180 days after the date of enactment, 
the Secretary shall establish a publicly available electronic priority 
list of nonfunctional constituents in cosmetics for review under this 
section. The Secretary shall begin and complete a review of at least 
one such priority nonfunctional constituent every 365 days.
    ``(d) Application.--A tolerance level established by the Secretary 
under this section shall apply in every State.''.

SEC. 8. COSMETIC INGREDIENT REVIEW.

    Chapter VI, as amended by sections 3, 4, 5, 6, and 7, is amended by 
adding at the end the following:

``SEC. 609. COSMETIC INGREDIENT REVIEW.

    ``(a) Panel's Recommendation.--The Cosmetic Ingredient Review 
Expert Panel determination in an approved final report that a cosmetic 
ingredient--
            ``(1) is safe for use in cosmetic products without the need 
        for specified conditions of use;
            ``(2) is safe for use in cosmetic products under specified 
        conditions for use;
            ``(3) is not safe for use in a cosmetic product under any 
        conditions of use;
            ``(4) requires more information in order to make a 
        determination whether the ingredient is safe for use in a 
        cosmetic product under any conditions of use; or
            ``(5) is the subject of any other type of determination by 
        the Cosmetic Ingredient Review Expert Panel, shall be deemed to 
        constitute a recommendation that the Secretary accept that 
        determination for purposes of implementing and enforcing this 
        chapter in accordance with the effective dates established 
        under subsection (d).
    ``(b) Secretary's Determination.--The Secretary shall be deemed to 
accept that determination and recommendation unless the Secretary at 
any time determines, by regulation or guidance, after public notice and 
an opportunity for public comment, to make a different determination. A 
determination and recommendation described in subsection (a) that is 
deemed to be accepted by the Secretary shall be implemented and 
enforced by the Secretary by banning any use of any ingredient that 
does not conform to the specified safe conditions of use under 
subsection (a)(2) and any ingredient described under subsection (a)(3) 
or (4).
    ``(c) Proprietary Data.--The determination described in subsection 
(a)(4) shall not apply to a person using the ingredient who has 
adequate safety substantiation and provides that substantiation to the 
Secretary as confidential business or trade secret information that 
shall not be publicly disclosed under section 301(j) of this Act or 
sections 552(b)(4) of title 5 or 1905 of title 18, United States Code.
    ``(d) Effective Dates.--Subsection (b) shall be effective--
            ``(1) three years after the date of enactment for 
        ingredients that are the subject of an approved final report as 
        of the date of enactment of this subsection; and
            ``(2) two years after the date of approval of the final 
        report for ingredients that are the subject of an approved 
        final report after the date of enactment of this subsection.
    ``(e) Secretary's Representative.--The Secretary shall appoint a 
representative who shall be a member of and shall participate in the 
deliberations of the Cosmetic Ingredient Review Expert Panel.
    ``(f) Application.--A safety determination accepted or made by the 
Secretary under this section shall apply in every State.''.

SEC. 9. COSMETIC INGREDIENT SAFETY.

    Chapter VI, as amended by sections 3, 4, 5, 6, 7, and 8, is amended 
by adding at the end the following:

``SEC. 610. COSMETIC INGREDIENT SAFETY.

    ``(a) In General.--
            ``(1) The Secretary may on the Secretary's own initiative, 
        and shall in response to a petition submitted by an interested 
        person, including a State, under subsection (b) or in 
        accordance with the provisions under subsection (c), evaluate 
        the safety of any ingredient intended for use as or in a 
        cosmetic product and, after public notice and an opportunity 
        for public comment, establish by regulation or guidance the 
        conditions, if any, under which the ingredient is safe for 
        human use.
            ``(2) In evaluating the safety of any such ingredient, the 
        Secretary shall apply generally recognized principles of 
        scientific risk assessment and shall take into account--
                    ``(A) the conditions of use recommended or 
                suggested in the labeling;
                    ``(B) any relevant safety evaluation conducted by 
                the Cosmetic Ingredient Review Expert Panel; and
                    ``(C) all relevant unpublished and published safety 
                data and information, including human exposure during 
                marketing.
        The Secretary shall determine the conditions for the use of the 
        ingredient that are necessary for safe use, or that the 
        ingredient is safe for use without the need for specified 
        conditions of use, or that there are no conditions under which 
        the ingredient can be safely used.
    ``(b) Procedure.--
            ``(1)(A)(i) If the review of an ingredient is being 
        conducted on the Secretary's own initiative or under subsection 
        (c), the Secretary shall initiate the proceeding by publishing 
        in the Federal Register a proposed regulation or guidance. The 
        Secretary shall provide 180 days for public comment.
            ``(ii) Not later than 180 days after the end of the period 
        for public comment, the Secretary shall publish in the Federal 
        Register a final regulation or guidance.
            ``(B)(i) If the review of an ingredient is being conducted 
        in response to a petition submitted by an interested person, 
        the Secretary shall publish the petition in the Federal 
        Register for public comment not later than 60 days after 
        receipt of the petition. All appendices to the petition shall 
        be made available on the Secretary's website. The Secretary 
        shall provide 180 days for public comment.
            ``(ii) Any such petition shall specify the ingredient, the 
        uses for which the ingredient is intended, any proposed 
        conditions of safe use, and the scientific data and 
        information, including human exposure during marketing, on 
        which the proposed conditions are based.
            ``(iii) Not later than 180 days after the end of the period 
        for public comment, the Secretary shall publish in the Federal 
        Register a proposed regulation or guidance for public comment. 
        The Secretary shall provide 90 days for public comment.
            ``(iv) Not later than 90 days after the end of the period 
        for public comment, the Secretary shall publish in the Federal 
        Register a final regulation or guidance.
            ``(C) The Secretary may on the Secretary's own initiative, 
        and shall in response to a petition submitted by an interested 
        person, reconsider any conditions for safe use established 
        under subparagraph (A) or (B), using the same procedure 
        established in this paragraph (1).
            ``(D) Any regulation or guidance, including any revised 
        regulation or guidance, shall apply to cosmetics first shipped 
        in interstate commerce beginning two years after the date of 
        issuance of the regulation or guidance, unless the Secretary 
        determines, after public notice and an opportunity for public 
        comment, that an earlier effective date is required to prevent 
        serious adverse health consequences or death.
            ``(2) The failure of the Secretary to comply with any 
        applicable time period requirement under paragraph (1) shall 
        constitute final agency action for purposes of judicial review. 
        If the court conducting such review determines that the 
        Secretary has failed to comply with the requirement, the court 
        shall order the Secretary to comply within a time period 
        determined by the court to be appropriate, but in no event 
        later than 90 days following the court's order.
    ``(c) Priority List.--Within 180 days after the date of enactment, 
the Secretary shall establish a publicly available electronic priority 
list of cosmetic ingredients. The Secretary shall begin and complete a 
review of at least one such priority cosmetic ingredient every 365 
days.
    ``(d) Application.--A safety determination accepted or made by the 
Secretary under this section shall apply in every State.''.

SEC. 10. NATIONAL COSMETIC REGULATORY DATABANK.

    Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, and 9, is 
amended by adding at the end the following:

``SEC. 613. NATIONAL COSMETIC REGULATORY DATABANK.

    ``In order to consolidate all information pertaining to regulation 
of the safety of cosmetics in one place for use by State officials 
responsible for the regulation of cosmetics and by the general public, 
the Secretary shall establish and maintain in the Center for Food 
Safety and Applied Nutrition (or any successor organization of such 
Center) of the Food and Drug Administration an electronic National 
Cosmetic Regulatory Databank that shall contain the information 
submitted to the Secretary under sections 604, 605, and 606, and such 
other information pertaining to the regulation of cosmetics as the 
Secretary shall deem appropriate. Information in the National Cosmetic 
Regulatory Databank that is not subject to public disclosure under 
section 552 of title 5, United States Code, may be disclosed on request 
to the director of a State agency responsible for regulating the safety 
of cosmetics, and such official and other State employees who have 
access to such information shall then be subject to the provisions of 
section 301(j), subsection 552(b) of title 5, United States Code, and 
section 1905 of title 18, United States Code, with respect to such 
information. Information available in the National Cosmetic Regulatory 
Databank shall not be subject to State laws on submission of that 
information, whether in the same or a different format.''.

SEC. 11. COSMETIC RECORDS INSPECTION.

    Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, and 10, is 
amended by adding at the end the following:

``SEC. 614. COSMETIC RECORDS INSPECTION.

    ``If the Secretary has a reasonable belief that a cosmetic product, 
and any other related cosmetic product that the Secretary reasonably 
believes is affected in the same manner, is adulterated and presents a 
threat of serious adverse health consequences or death to humans, each 
person who manufactures, processes, packs, distributes, receives, 
holds, or imports such article shall, at the request of an officer or 
employee duly designated by the Secretary, permit such officer or 
employee, upon presentation of appropriate credentials and a written 
notice to such person setting forth the basis for the Secretary's 
belief, at reasonable times and within reasonable limits and in a 
reasonable manner, to have access to and copy records that are needed 
to assist the Secretary in determining whether the cosmetic product is 
adulterated and presents a threat of serious adverse health 
consequences or death to humans. The Secretary shall prevent the 
disclosure of trade secret or confidential information obtained by the 
Secretary pursuant to this section. This section does not extend to 
cosmetic product formulas, financial data, pricing data, personnel 
data, research data, or sales data other than shipment data.''.

SEC. 12. RULES OF CONSTRUCTION.

    Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, 10, and 11, 
is amended by adding at the end the following:

``SEC. 615. RULES OF CONSTRUCTION.

    ``(a) Cosmetic Products.--Whenever the term cosmetic or cosmetics 
is used in sections 604, 605, 606, or 607, it shall be deemed to refer 
only to a cosmetic product or cosmetic products. A cosmetic product 
that is subject to the caution legend in section 601(a) shall not be 
subject to the provisions of sections 608, 609, or 610.
    ``(b) Contractors.--A requirement for registration of a cosmetic 
establishment under section 604, submission of a cosmetic and 
ingredient statement under section 605, or submission of a serious and 
unexpected adverse event report for a cosmetic under section 606, may 
be satisfied by a person who contracts to perform that function for the 
person who is required to register or make the submission.
    ``(c) Exemptions.--The Secretary may, in the Secretary's 
discretion, establish exemptions from the requirements in this title 
for the efficient and cost-effective implementation of these 
provisions.
    ``(d) Safety.--For purposes of chapter VI, a cosmetic shall be 
deemed to be safe if it does not present a risk of significant illness 
or injury to humans under the conditions of use recommended or 
suggested in the labeling.''.

SEC. 13. CONFORMING AMENDMENTS.

    (a) Section 301 is amended by adding at the end the following:
                                            ``(aaa) The failure to 
                                        register a cosmetic 
                                        establishment required to be 
                                        registered under section 604 or 
                                        to maintain the registration 
                                        current and accurate.
                                            ``(bbb) The failure to 
                                        submit a cosmetic and 
                                        ingredient statement required 
                                        under section 605 or to 
                                        maintain the statement current 
                                        and accurate.
                                            ``(ccc) The failure to 
                                        submit a serious and unexpected 
                                        adverse event report or to 
                                        include on a label the domestic 
                                        telephone number through which 
                                        a report of a serious and 
                                        unexpected adverse event may be 
                                        received, as required under 
                                        section 606.
                                            ``(ddd) The failure to 
                                        comply with cosmetic good 
                                        manufacturing practices 
                                        established under section 607.
                                            ``(eee) The failure to 
                                        comply with a tolerance for a 
                                        nonfunctional constituent in 
                                        cosmetics established under 
                                        section 608.
                                            ``(fff) The failure to 
                                        comply with a determination 
                                        with respect to the safety of a 
                                        cosmetic ingredient under 
                                        section 609 or section 610.
                                            ``(ggg) For a cosmetic 
                                        product that is being imported 
                                        or offered for import, the 
                                        failure of the importer to 
                                        present both the unique 
                                        cosmetic establishment 
                                        registration number established 
                                        by the Secretary under section 
                                        604(a) and the unique cosmetic 
                                        and ingredient statement number 
                                        established by the Secretary 
                                        under section 605(a).''.
    (b) Section 301(j) is amended by inserting ``605, 609, 613,'' after 
``573,''.

SEC. 14. NATIONAL UNIFORMITY FOR COSMETICS.

    Section 752 is amended--
            (1) by amending the section heading to read as follows: 
        ``national uniformity for cosmetics'';
            (2) in subsection (b), by inserting ``or (f)'' after 
        ``subsection (a)''; and
            (3) by adding at the end the following:
    ``(f) Cosmetic Safety.--
            ``(1) In general.--Subject to paragraphs (2) and (3), no 
        State or political subdivision of a State may establish or 
        continue in effect any law, regulation, order, or other 
        requirement relating to cosmetic constituents, cosmetic 
        ingredients, or cosmetic products--
                    ``(A) that is different from, in addition to, or 
                otherwise not identical to, the provisions of chapter 
                VI and the requirements and determinations established 
                or accepted by the Secretary thereunder; or
                    ``(B) relating to registration, listing, or fees 
                for establishments, products, ingredients, or 
                constituents, or to submission of reports.
            ``(2) State petitions.--Not later than 180 days after the 
        date of the enactment of this subsection, a State may petition 
        the Secretary under section 609 or 610 to establish as a 
        national standard a tolerance for a nonfunctional constituent 
        or a safety requirement for a cosmetic ingredient that exists 
        in a State law or a duly promulgated State regulation that is 
        effective on the date of enactment of this subsection. Pending 
        completion of the process established under section 608 or 610, 
        the State requirement shall remain in effect for that State. 
        Upon completion of the process established under section 608 or 
        610, the final regulation or guidance published by the 
        Secretary in the Federal Register shall be the national safety 
        standard for the constituent or ingredient.
            ``(3) Requirements adopted by state public initiative or 
        referendum.--This subsection shall not apply to a State 
        requirement adopted by a State public initiative or referendum 
        enacted prior to the enactment of this subsection.''.

SEC. 15. IMPORTATION.

    Section 801(a) is amended by adding at the end the following:
    ``If a cosmetic product is being imported or offered for import 
into the United States and the importer does not present both the 
unique cosmetic establishment registration number established under 
section 604 and the unique cosmetic and ingredient statement number 
established under section 605, or the registration number or statement 
number is not correct and accurate, the cosmetic product shall be 
denied entry.''.

SEC. 16. AUTHORIZATION OF APPROPRIATIONS.

    Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, 10, 11, and 
12, is amended by adding at the end the following:

``SEC. 616. AUTHORIZATION OF APPROPRIATIONS.

    ``To carry out this chapter and section 752, there is authorized to 
be appropriated $11,700,000 for each of fiscal years 2014 through 2018. 
The Secretary shall annually allocate for personnel and functions for 
the regulation of cosmetics during the period of such fiscal years at 
least $11,700,000 out of the total funds appropriated for the Food and 
Drug Administration, 10 full-time equivalent personnel in the Office of 
Regulatory Affairs, and 1 full-time equivalent lawyer in the Office of 
Chief Counsel.''.

SEC. 17. EFFECTIVE DATES.

    (a) Sections 3, 4, 5, 6, and 15 of this Act shall be effective on 
the later date of--
            (1) one year after the Secretary of Health and Human 
        Services promulgates final regulations or guidance implementing 
        these sections; or
            (2) one year after the Secretary of Health and Human 
        Services publishes a notice in the Federal Register determining 
        that an effective electronic system has been established and is 
        operational for the submission of cosmetic manufacturing 
        establishment registrations, cosmetic and ingredient filings, 
        reports of serious and unexpected cosmetic adverse events, good 
        manufacturing practices for cosmetics, and the National 
        Cosmetic Regulatory Databank.
    (b) The remaining sections of this Act shall be effective on the 
date of the enactment of this Act.
                                 <all>
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