Personal Care Products Safety Act
This bill amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities.
If the FDA determines that a cosmetic has a reasonable probability of causing serious adverse health consequences, it may prohibit the cosmetic's distribution by suspending the cosmetic ingredient statement. If other cosmetics from the same facility may be affected, the FDA may prohibit distribution from the facility by suspending the facility's registration.
The FDA must review the safety of at least five cosmetic ingredients each year, and it may establish conditions for safe use of an ingredient, including a limit on the amount of the ingredient or a requirement for a warning label. A cosmetic cannot be sold if it contains an ingredient that is not safe, not safe under the recommended conditions of use, or not safe in the amount present in the cosmetic.
Cosmetics companies are required to report to the FDA any serious adverse health event associated with their cosmetics.
The FDA must:
[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1014 Introduced in Senate (IS)]
114th CONGRESS
1st Session
S. 1014
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety
of cosmetics.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 20, 2015
Mrs. Feinstein (for herself and Ms. Collins) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety
of cosmetics.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Personal Care
Products Safety Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--COSMETIC SAFETY
Sec. 101. Registration of cosmetics facilities and cosmetic ingredient
statements.
Sec. 102. Review of ingredients and non-functional constituents; safety
of finished products.
Sec. 103. Good manufacturing practices for cosmetics.
Sec. 104. Adverse event reports.
Sec. 105. Records inspection; mandatory recall authority.
Sec. 106. Labeling.
Sec. 107. Coal tar chemicals.
Sec. 108. Animal testing alternatives.
Sec. 109. Preemption.
Sec. 110. Reporting.
Sec. 111. Small businesses.
Sec. 112. Applicability with respect to certain cosmetics.
Sec. 113. Enforcement.
Sec. 114. Consumer information.
TITLE II--FEES RELATED TO COSMETIC SAFETY
Sec. 201. Findings.
Sec. 202. Authority to assess and use cosmetic safety fees.
Sec. 203. Direct hiring authority to support activities related to
cosmetics.
TITLE I--COSMETIC SAFETY
SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND COSMETIC INGREDIENT
STATEMENTS.
(a) Amendments.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.) is amended by adding at the end the
following:
``SEC. 604. DEFINITIONS.
``In this chapter:
``(1) Cosmetic formulation.--The term `cosmetic
formulation' means a preparation of cosmetic raw materials with
a qualitatively and quantitatively set composition.
``(2) Cosmetic product.--The term `cosmetic product' means
a cosmetic comprised of a specified set of ingredients, which
may come in a range of possible amounts for each ingredient and
which may include a variety of fragrances, flavors, and colors.
``(3) Facility.--The term `facility' includes any factory,
warehouse, or establishment (including a factory, warehouse, or
establishment of an importer) that manufactures, processes,
packs, or holds cosmetic products or cosmetic formulations, or
any other entity whose name and address appear on the label of
a cosmetic product. Such term does not include--
``(A) beauty shops and salons that do not otherwise
manufacture, process, or package cosmetics at that
location;
``(B) cosmetic product retailers, including
individual sales representatives, retail distribution
facilities, and pharmacies, that do not otherwise
manufacture, process, or package cosmetics at that
location;
``(C) hospitals, physicians' offices, and health
care clinics;
``(D) public health agencies and other nonprofit
entities that provide cosmetics directly to the
consumer;
``(E) hotels and other entities that provide
complimentary cosmetics to guests;
``(F) trade shows and other venues where cosmetic
product samples are provided free of charge;
``(G) domestic manufacturers with less than
$100,000 in gross annual sales of cosmetic products; or
``(H) entities that manufacture or compound
cosmetic products solely for use in research, teaching,
or pilot plant production and not for sale.
``(4) Foreign facility.--The term `foreign facility' means
a facility that manufactures, processes, packs, or holds, a
cosmetic formulation or cosmetic product that is exported to
the United States without further processing or packaging
inside the United States. A cosmetic is not considered to have
undergone further processing or packaging for purposes of this
definition 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.
``(5) Non-functional constituent.--The term `non-functional
constituent' means any substance that is an incidental
component of an ingredient, a breakdown product of an
ingredient or a byproduct of the manufacturing process that has
not been intentionally added as a separate substance and serves
no technical function in the cosmetic.
``(6) Responsible person.--The term `responsible person'
means--
``(A) the brand owner who is the domestic or
foreign manufacturer, packer, or entity whose name
appears on a cosmetic product label of a cosmetic
product distributed in the United States, except for
entities described in subparagraphs (A) through (H) of
paragraph (3); or
``(B) a contract manufacturer who provides cosmetic
products to the entities described in subparagraphs (A)
through (H) of paragraph (3).''.
``SEC. 605. REGISTRATION OF COSMETIC FACILITIES.
``(a) Registration and Fees for Existing Manufacturing or
Processing of Cosmetics.--
``(1) Registration, in general.--Not later than December 1,
2015, and at a similar time in each subsequent year, as
determined by the Food and Drug Administration, each
responsible person engaged in manufacturing or processing a
cosmetic product or a cosmetic formulation distributed in the
United States shall register all of the responsible person's
facilities with the Food and Drug Administration.
``(2) Fees.--If the average gross annual sales in the
United States of cosmetic products of all of the responsible
person's facilities registered under paragraph (1) for the
previous 3-year period is greater than $500,000, a registration
shall not be complete under this subsection until the
responsible person has paid any registration fee required under
section 744L.
``(b) Registration for Existing Packing or Holding of Cosmetics.--
Not later than December 1, 2015, and at a similar time once every 3
years thereafter, as determined by the Food and Drug Administration,
each person who owns or operates a cosmetic facility or facilities
engaged in packing or holding a cosmetic product distributed in the
United States shall register each such facility with the Food and Drug
Administration.
``(c) Registration by New Facilities.--Any facility first engaging
after the date of enactment of the Personal Care Products Safety Act in
an activity that would require it to register under subsection (a) or
(b) shall register with the Food and Drug Administration within 60 days
of first engaging in such activity, and thereafter in accordance with
subsection (a) or (b).
``(d) Changes to Information.--A registrant who has submitted a
registration under this section shall notify the Food and Drug
Administration of any change to the information required under
subsection (a) or (b) not later than 60 days after the date of such
change, unless otherwise specified by the Food and Drug Administration.
``(e) Format; Contents.--
``(1) Electronic format.--Each registration shall be
submitted using an electronic format, as specified in a
registration form provided by the Food and Drug Administration.
``(2) Contents.--The registration shall contain the
following information:
``(A) Each facility's name and full address,
identifying the precise physical location of the
facility.
``(B) The identity of the facility, including the
unique facility identifier, if any, previously assigned
by the Food and Drug Administration to the facility
under subsection (g).
``(C) All business trading names used by the
facility.
``(D) The product category or categories of each
cosmetic product or cosmetic formulation manufactured,
processed, packed, or held at the facility or on whose
label the facility's name and address appear.
``(E) The type of activity conducted at the
facility (such as manufacturing, processing, packing,
or holding).
``(F) The name, title, street address, telephone
number, and electronic contact information of the
emergency contact for the facility.
``(G) In the case of a foreign facility, the name,
street address, telephone number, emergency contact
information for the facility, the name of the United
States agent for the facility, and, if available, the
electronic contact information of the United States
agent.
``(H) The name, title, street address, telephone
number, and electronic contact information of the
individual submitting the registration.
``(I) An assurance that the Food and Drug
Administration will be permitted to inspect such
facility at the times and in the manner permitted by
this Act.
``(J) Additional information pertaining to the
facility or to the cosmetic products or cosmetic
formulations manufactured, processed, packed, or held
at the facility, or on whose label the facility's name
and address appear, including all brand names known to
consumers, as the Food and Drug Administration may
require by regulation.
``(3) Abbreviated registration.--The Food and Drug
Administration shall provide for an abbreviated registration
renewal process for any registrant that has not had any changes
to such information with respect to the facility or facilities
involved since the registrant submitted the preceding
registration.
``(f) Incomplete or Inaccurate Registration.--
``(1) In general.--Not earlier than 10 days after providing
notice of the intent to cancel a registration and the basis for
such cancellation, the Food and Drug Administration may cancel
a registration under this section if the Food and Drug
Administration has reasonable grounds to believe that the
registration was not properly completed or updated in
accordance with this section or otherwise contains false,
incomplete, or inaccurate information.
``(2) Timely update or correction.--If, not later than 7
days after receipt of a notice of intent to cancel, the sponsor
corrects the registration in accordance with the basis for the
cancellation, and the required registration fee, if any, is
paid, the Food and Drug Administration shall not cancel such
registration.
``(g) Unique Identifier.--At the time of the initial registration
of any cosmetic facility under this section, the Food and Drug
Administration shall assign a unique identifier to the facility.
``(h) Registry of Facilities.--
``(1) In general.--The Food and Drug Administration shall
compile, maintain, and update a registry of facilities that are
registered under this section, and shall remove from such
registry the name of any facility whose registration under this
section is cancelled. The registry shall be publicly available.
``(2) Public availability exceptions.--Information derived
from the registry or registration documents that discloses the
residential address of a registrant or that discloses specific
facilities where specific cosmetic products are manufactured or
processed shall not be subject to disclosure under section 552
of title 5, United States Code.
``SEC. 606. COSMETIC INGREDIENT STATEMENTS.
``(a) In General.--For each cosmetic product, the responsible
person shall submit to the Food and Drug Administration a cosmetic
ingredient statement, at such time and in such manner as the Food and
Drug Administration may prescribe. The cosmetic ingredient statement
shall not become effective until the responsible person pays any
applicable fee required under section 744L.
``(b) Submission of a Cosmetic Ingredient Statement.--
``(1) Existing cosmetic products.--In the case of a
cosmetic product that is marketed on the date of enactment of
the Personal Care Products Safety Act, the responsible person
shall submit a cosmetic ingredient statement not later than
December 1, 2015. The responsible person shall submit to the
Food and Drug Administration a renewal of such statement on a
yearly basis.
``(2) Cosmetic ingredient statement for new cosmetic
products.--
``(A) In general.--Except as provided under
subparagraph (B), in the case of a cosmetic product
that is first marketed after the date of enactment of
the Personal Care Products Safety Act or a cosmetic
product that is reformulated after such date of
enactment, the responsible person shall submit a
cosmetic ingredient statement to the Food and Drug
Administration within 60 days of first marketing the
new cosmetic product or the reformulated cosmetic
product, and annually thereafter.
``(B) Small businesses.--The Food and Drug
Administration shall allow a responsible person that is
a business that meets the applicable industry-based
small business size standard established by the
Administrator of the Small Business Administration
under section 3 of the Small Business Act to have a
period longer than 60 days to submit an initial new
cosmetic ingredient statement under subparagraph (A).
Such responsible person shall submit a cosmetic
ingredient statement annually thereafter.
``(C) Definition.--A cosmetic product shall not be
considered first marketed or reformulated after the
date of enactment under subparagraph (A) if the only
change in such product is in--
``(i) the amount of an existing ingredient
if it is within the range previously reported
under subsection (c)(2)(E); or
``(ii) the addition or subtraction of a
fragrance, flavor, or color, or such other
interchangeable ingredients specified by the
Food and Drug Administration in regulations or
guidance, previously reported as a potential
ingredient under subsection (c)(2)(E), if, in
the case of such an addition, the amount is
within the range previously reported.
``(c) Format; Contents.--
``(1) Form.--For each cosmetic product, the cosmetic
ingredient statement shall be submitted using an electronic
format, as specified in a cosmetic and ingredient form provided
by the Food and Drug Administration.
``(2) Contents.--The cosmetic ingredient statement shall
include the following information:
``(A) The unique identifier, assigned under section
605(g), as applicable, of--
``(i) the facility or facilities where the
cosmetic product is manufactured, processed,
packed, or held or, if the same cosmetic
product is manufactured, processed, packed, or
held in more than one facility, the unique
facility identifier of each facility where it
is manufactured, processed, packed, or held;
and
``(ii) the facility whose name and address
appear on the label, unless the statement is
filed by a contract manufacturer, described in
section 604(6)(B).
``(B) The brand name and the full name for the
cosmetic product as it appears on the label.
``(C) The cosmetic product listing number, if any,
previously assigned by the Food and Drug Administration
under subsection (f) to the cosmetic product.
``(D) The applicable cosmetic category for the
cosmetic product.
``(E) A list of ingredients in the cosmetic
product, including a range of possible amounts of each
ingredient, and with each ingredient identified by the
name adopted in regulations promulgated by the Food and
Drug Administration, if any, or by the common or usual
name of the ingredient. The cosmetic ingredient
statement shall contain--
``(i) a list of fragrances, flavors, and
colors that may be included in the product,
interchangeably, with ranges of possible
amounts, which shall include--
``(I) in the case of fragrances
that are purchased from a fragrance
supplier, the fragrances shall be
identified by the name or code provided
by the supplier, and include the name
and contact information for the
fragrance supplier;
``(II) in the case of flavors that
are purchased from a flavor supplier,
the flavors shall be identified by the
name or code provided by the supplier,
and include the name and contact
information for the flavor supplier;
and
``(III) in the case of a
notification provided by the Food and
Drug Administration to the responsible
person for the cosmetic manufacturer,
the Food and Drug Administration may
request, from the fragrance or flavor
supplier, the complete list of
ingredients in specific fragrances or
flavors and the supplier shall have 30
days to provide such list to the Food
and Drug Administration; and
``(ii) other appropriate interchangeable
ingredients as the Food and Drug Administration
may specify in regulations or guidance that may
be included in the product, with ranges of
possible amounts.
``(F) The title and full contact information of
each individual submitting the statement.
``(G) If applicable, information on the labeling
required under section 614.
``(H) Such additional information pertaining to the
cosmetic product as the Food and Drug Administration
may require.
``(3) Cosmetic ingredient statement for certain small
businesses.--
``(A) In general.--Notwithstanding any other
provision of this subsection, the Food and Drug
Administration may permit a simplified cosmetic
ingredient statement under this section for a
responsible person that--
``(i) is a business that meets the
applicable industry-based small business size
standard established by the Administrator of
the Small Business Administration under section
3 of the Small Business Act; and
``(ii) has had an average of less than
$500,000 in annual domestic cosmetic sales over
the previous 3 years.
``(B) Contents.--A responsible person described in
subparagraph (A) shall include in each cosmetic
ingredient statement under this section, at a minimum,
a list of ingredients in the cosmetic product and the
applicable cosmetic category for the cosmetic product.
``(d) Incomplete or Inaccurate Cosmetic Ingredient Statement.--
``(1) In general.--Not earlier than 10 days after providing
notice under paragraph (2), the Food and Drug Administration
may nullify a cosmetic ingredient statement filed under this
section if the Food and Drug Administration has reasonable
grounds to believe that the cosmetic ingredient statement was
not completed or updated in accordance with this section or
otherwise contains false, incomplete, or inaccurate
information.
``(2) Notice of nullification.--A nullification under
paragraph (1) shall be preceded by notice to the responsible
person of the intent to cancel the cosmetic ingredient
statement and the basis for such cancellation.
``(3) Timely update or correction.--If the cosmetic
ingredient statement is appropriately updated or corrected not
later than 7 days after notice is provided under paragraph (1),
the Food and Drug Administration shall not nullify such
cosmetic ingredient statement.
``(e) Additional Requirements.--
``(1) Safety requirements.--In filing each cosmetic
ingredient statement cosmetic product, the responsible person
shall include an attestation that the safety of the product,
including the individual ingredients of such product and the
product as a whole, has been substantiated in accordance with
section 609. In the case of a cosmetic ingredient statement
that includes a range of possible amounts (as described in
subsection (c)(2)(E)), the responsible person shall include an
attestation that the safety of the full range in the finished
product has been substantiated, in accordance with section 609.
``(2) Abbreviated filing.--The Food and Drug Administration
shall provide for an abbreviated renewal process for any such
filing with respect to which there has been no change since the
responsible person submitted the previous filing.
``(3) Changes to information.--
``(A) In general.--Except as provided in
subparagraph (B), the responsible person shall notify
the Food and Drug Administration within 60 days of any
change to the information required to be in a cosmetic
ingredient statement, including discontinuation of the
manufacture of a cosmetic product, except that
notification under this paragraph is not required for a
change in--
``(i) the amount of an existing ingredient
if it is within the range previously reported
under subsection (c)(2)(E); or
``(ii) the addition or subtraction of a
fragrance, flavor, or color, or such other
interchangeable ingredients specified by the
Food and Drug Administration in regulations or
guidance, previously reported as a potential
ingredient under subsection (c)(2)(E), if, in
the case of an addition of such an ingredient,
the amount is within the range previously
reported.
``(B) Small business.--The Food and Drug
Administration shall allow a responsible person that is
a business that meets the applicable industry-based
small business size standard established by the
Administrator of the Small Business Administration
under section 3 of the Small Business Act to have a
period longer than 60 days, but not longer than the
next annual registration deadline under section
605(a)(1), to submit any change to the information
required to be in a cosmetic ingredient statement as
described in subparagraph (A).
``(f) Cosmetic Products List.--At the time of the initial
submission of any cosmetic ingredient statement under this section, the
Food and Drug Administration shall assign a unique cosmetic product
listing number to the cosmetic ingredient statement. Based on such
cosmetic ingredient statements, the Food and Drug Administration shall
compile and maintain a list of cosmetic products distributed in the
United States, including the ingredients of each such product, and
shall make available such list to any State, upon request. Information
disclosed to a State that is exempt from disclosure under section
552(b)(4) of title 5, United States Code, shall be treated as a trade
secret and confidential information by the State.
``SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC INGREDIENT
STATEMENT.
``(a) Suspension of Registration of a Facility.--If the Food and
Drug Administration determines that a cosmetic formulation or cosmetic
product manufactured, processed, packed, or held by a registered
facility has a reasonable probability of causing serious adverse health
consequences or death to humans, and there is reason to believe that
other formulations or products manufactured, processed, packed, or held
by the facility may be similarly affected because of a failure
affecting multiple products in that facility, the Food and Drug
Administration may suspend the registration of a facility.
``(b) Suspension of Cosmetic Ingredient Statement.--If the Food and
Drug Administration determines that a cosmetic product manufactured in
a registered facility has a reasonable probability of causing serious
adverse health consequences or death to humans, the Food and Drug
Administration may suspend the cosmetic ingredient statement of that
product.
``(c) Notice of Suspension.--Before suspending a facility
registration or a cosmetic ingredient statement under this section, the
Food and Drug Administration shall provide--
``(1) notice to the facility registrant of the cosmetic
product or formulation or other responsible person, as
appropriate, of the intent to suspend the facility registration
or the cosmetic ingredient statement, which shall specify the
basis of the determination by the Food and Drug Administration
that the facility or the cosmetic ingredient should be
suspended and recommendations for specific actions to avoid
suspension; and
``(2) an opportunity, within 2 business days of the notice
provided under paragraph (1), for the responsible person to
address the reasons for possible suspension of the facility
registration or cosmetic ingredient statement.
``(d) Reinstatement.--Upon a determination by the Food and Drug
Administration that adequate grounds do not exist to continue the
suspension actions, the Food and Drug Administration shall promptly
vacate the suspension and reinstate the registration of the facility or
the cosmetic ingredient statement.
``(e) Effect of Suspension.--
``(1) Registration.--If the registration of a facility is
suspended under this section, no person shall import or export
cosmetics or otherwise distribute cosmetics from such facility.
``(2) Cosmetic ingredient statement.--If the cosmetic
ingredient statement for a cosmetic product is suspended under
this section, no person shall import or export such cosmetic
product or otherwise distribute in the United States such
cosmetic product that is the subject of such statement.
``(f) No Delegation.--The authority conferred by this section to
issue an order to suspend a registration or vacate an order of
suspension shall not be delegated to any officer or employee other than
the Commissioner.''.
SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS; SAFETY
OF FINISHED PRODUCTS.
(a) Amendments.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 101, is further
amended by adding at the end the following:
``SEC. 608. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL CONSTITUENTS.
``(a) Ingredients and Non-Functional Constituents Subject to
Review.--
``(1) In general.--Beginning in fiscal year 2016, the Food
and Drug Administration shall review the safety of the cosmetic
ingredients and non-functional constituents under paragraph
(3), as modified under subsection (c), if applicable, and issue
an order under subsection (d) with respect to the use of each
such ingredient and presence of each such non-functional
constituent.
``(2) Public notice and comment.--At the initiation of the
review of each cosmetic ingredient or non-functional
constituent, the Food and Drug Administration shall open a
docket for the submission of public comment and additional data
relevant to the safety of the ingredient or non-functional
constituent. The Food and Drug Administration shall provide 60
days for public comment.
``(3) Cosmetic ingredients.--
``(A) Ingredients to be considered in first year.--
During fiscal year 2016, the Food and Drug
Administration shall initiate the review for safety of
the following cosmetic ingredients:
``(i) Diazolidinyl urea.
``(ii) Lead acetate.
``(iii) Methylene glycol/methanediol/
formaldehyde.
``(iv) Propyl paraben.
``(v) Quaternium-15.
``(B) Ingredients to be considered in subsequent
years.--
``(i) In general.--Beginning in fiscal year
2017, the Food and Drug Administration shall
annually select and complete a review of at
least 5 cosmetic ingredients or non-functional
constituents that were not reviewed in the
prior 3 years from a list determined in
consultation with industry and consumer groups
for review of safety. The Food and Drug
Administration may modify such list under
subsection (c).
``(ii) Considerations.--The determination
of which ingredients or functional ingredients
will be reviewed in a given year shall be
publicized in annual reports to Congress and
the public, in accordance with section 618, and
subject to consultation as provided for in
clause (iii). The review of any cosmetic
ingredient or non-functional constituent shall
commence with a public announcement by the Food
and Drug Administration and the opening of a
docket as required under paragraph (2).
``(iii) Consultation.--The Food and Drug
Administration shall establish a Cosmetics
Safety Advisory Committee, which shall include
equal numbers of individuals from the cosmetics
industry and consumer groups, and other
individuals, as the Food and Drug
Administration determines appropriate,
including medical practitioners. Such advisory
committee shall advise the Food and Drug
Administration on cosmetic ingredients and non-
functional constituents to be considered for
review, summarize public comments received
pursuant to paragraph (4), and recommend 5
cosmetic ingredients or non-functional
constituents to be reviewed for safety each
year, as described in clause (i). The Food and
Drug Administration may consult with the
Cosmetics Safety Advisory Committee on other
matters pertaining to cosmetic safety.
``(4) Comment period.--As part of the annual reporting to
Congress and the public under section 618, the Food and Drug
Administration shall solicit public comment on which cosmetic
ingredients or non-functional constituents on the list are of
greatest interest to be reviewed next for early review and
which additional cosmetic ingredients or non-functional
constituents should be added to the list. The public may submit
comments to the Food and Drug Administration at any time during
the year regarding which cosmetic ingredients or non-functional
constituents of interest that the Food and Drug Administration
may consider during that year or subsequent years.
``(b) List.--The Food and Drug Administration shall maintain a
list, posted on the Internet website of the Food and Drug
Administration, of the cosmetic ingredients and non-functional
constituents for which final orders have been issued under subsection
(d)(3), the finding made for each such ingredient or non-functional
constituent under subsection (d)(4), as modified by any order under
subsection (f), and, if applicable, compliance dates that are the
subject of a final order under subsection (e).
``(c) Initiative of the FDA.--The Food and Drug Administration may
at any time, after consultation with the Cosmetics Safety Advisory
Committee, propose the issuance of an order on the safety of a cosmetic
ingredient or non-functional constituent that was not previously listed
in subsection (a) or under section 618(a)(3).
``(d) Determination on Safety.--
``(1) Initial proposed administrative order.--Following
consideration of data and comments to the public docket and any
other information before the Food and Drug Administration, the
Food and Drug Administration shall determine whether there is
adequate evidence to make an initial finding on the safety of
the ingredient or non-functional constituent. If the Food and
Drug Administration determines that there is adequate evidence,
the Food and Drug Administration shall issue a proposed
administrative order and shall post such order on the Internet
website of the Food and Drug Administration, notwithstanding
subchapter II of chapter 5 of title 5, United States Code.
``(2) Public comment.--Upon publication of the proposed
administrative order described in paragraph (1), the Food and
Drug Administration shall open a docket for the submission of
public comment. The Food and Drug Administration shall provide
30 days for public comment following publication of the
proposed administrative order.
``(3) Final administrative order.--Following the public
comment period described in paragraph (2) and consideration of
comments to the public docket and any other information before
the Food and Drug Administration, the Food and Drug
Administration shall determine whether there is adequate
evidence to make a final finding on the safety of the
ingredient or non-functional constituent. If the Food and Drug
Administration determines that there is adequate evidence, the
Food and Drug Administration shall issue a final administrative
order and shall post such order on the Internet website of the
Food and Drug Administration, notwithstanding subchapter II of
chapter 5 of title 5, United States Code.
``(4) Determinations.--In the proposed administrative order
or the final administrative order, as applicable, the Food and
Drug Administration shall make a determination that the
ingredient or non-functional constituent is--
``(A) safe in cosmetic products under specified
conditions of use or tolerances;
``(B) safe in cosmetic products without the need
for specified conditions of use or tolerances; or
``(C) not safe in cosmetic products.
``(5) Conditions of use and tolerances.--An order under
paragraph (4)(A) shall include such conditions on the use of an
ingredient or such tolerances on the presence of a non-
functional constituent as are necessary for the safety of
cosmetic products containing such ingredient or non-functional
constituent, including--
``(A) limits on the amount or concentration of the
ingredient or non-functional constituent that may be
present in a cosmetic product, including limits in
products intended for children and other vulnerable
populations, and limits on use near the eye or mucosal
membranes;
``(B) warnings that are necessary or appropriate
under section 614, including warnings related to use by
children, pregnant women, populations with high
exposure to the ingredient (such as workers who are
exposed through production practices or handling of
final products), or other vulnerable populations, to
help ensure safe use of cosmetic products containing
the ingredient or non-functional constituent; and
``(C) such other conditions as are necessary for
the safety of cosmetic products containing such
ingredient or non-functional constituent.
``(6) Public notice.--A final order under this subsection
shall set forth the determination of the Food and Drug
Administration on safety, any conditions of use or tolerances
under subparagraph (A) or (B) of paragraph (4) and a summary of
the valid scientific evidence supporting the finding. The order
shall be effective upon its publication on the Internet website
of the Food and Drug Administration and shall be considered
final agency action.
``(e) Order.--If the Food and Drug Administration issues a final
administrative order under subparagraph (A) or (C) of subsection
(d)(4), the Food and Drug Administration shall, at the same time as
publication of the notice under subsection (d)(6), publish a proposed
order identifying dates by which use of the ingredient or non-
functional constituent in cosmetic products shall comply with the final
administrative order, and provide 60 days for public comment, including
comment on whether compliance is feasible within the proposed dates.
After considering comments on the proposed order, the Food and Drug
Administration shall publish in the Federal Register a final order.
``(f) Modification of an Order.--An order issued under subsection
(d) or (e) may be modified or revoked by the Food and Drug
Administration on the initiative of the Food and Drug Administration or
in response to a petition.
``(g) Inadequate Evidence.--
``(1) Notice; extension.--If the Food and Drug
Administration determines that the available data and
information are not adequate to make a proposed or final
determination regarding safety under subsection (d)(4), with
respect to a cosmetic ingredient or non-functional constituent,
the Food and Drug Administration shall--
``(A) publish such finding on the Internet website
of the Food and Drug Administration not later than 90
days after the close of the relevant comment period for
the ingredient or non-functional constituent under
subsection (a)(2), in the case of a proposed order, or
subsection (d)(2), in the case of a final order; and
``(B)(i) include a notice providing interested
persons an additional 30 days from the notice date to
provide additional data and information; and
``(ii) if, after the 30-day period under clause
(i), the Food and Drug Administration determines that
additional safety substantiation with respect to such
ingredient or non-functional constituent is necessary
to make a safety determination, include a notice
specifying an additional time period, not to exceed 18
months from the notice date, and plan to obtain such
data and information.
``(2) Determination; order.--
``(A) Inadequate data and information.--If the Food
and Drug Administration determines, after considering
any additional data and information submitted under
paragraph (1)(B), that the available data and
information still are not adequate to make a
determination regarding safety under subsection (d)(4),
the Food and Drug Administration shall, within 90 days
of the close of the additional time period provided
under paragraph (1)(B), issue a proposed order or a
final administrative order--
``(i) making a determination that the
ingredient or non-functional constituent has
not been shown to be safe in cosmetic products;
and
``(ii) explaining why the available data
and information are not adequate to assess the
safety of the ingredient or non-functional
constituent.
``(B) Adequate data and information.--If the Food
and Drug Administration determines, after considering
any additional data and information submitted under
paragraph (1)(B), that the available data and
information are adequate to make a determination
regarding safety under subsection (d)(4), the Food and
Drug Administration shall, within 180 days of the close
of the comment period, issue a proposed order, followed
by a final order, on such cosmetic ingredient or non-
functional constituent, in accordance with such
subsection.
``(h) Safety Assessment.--
``(1) In general.--In assessing the safety of an ingredient
or non-functional constituent, the Food and Drug Administration
shall consider whether there is adequate evidence to support a
reasonable certainty among competent scientists that the
ingredient is not harmful under the recommended or suggested
conditions of use or customary or usual use, or that a non-
functional constituent is not harmful under the recommended or
suggested tolerance levels or the level at which it is
customarily or usually present. The Food and Drug
Administration may not consider an ingredient or non-functional
constituent harmful solely because it can cause minor adverse
health reactions, such as minor transient allergic reactions or
minor transient skin irritations, in some users.
``(2) Factors.--In assessing the safety of an ingredient or
non-functional constituent, the Food and Drug Administration
shall consider, among other relevant factors, the following:
``(A) The probable human exposure to the ingredient
or non-functional constituent from expected use in
cosmetics.
``(B) The probable cumulative and aggregate effect
in humans of relevant exposure to the ingredient or
non-functional constituent or to any chemically or
pharmacologically related substances from use in
cosmetics or other products with similar routes of
exposure under recommended or suggested conditions of
use or their customary use, to the extent adequate data
is available for analysis. In appropriate cases, the
Food and Drug Administration may consider available
information on the total exposure to an ingredient or
non-functional constituent from all sources.
``(C) Whether warnings or recommendations in a
product label, as part of any conditions of use or
tolerances imposed by the Food and Drug Administration,
would be necessary and appropriate to help ensure the
safety of the ingredient or non-functional constituent.
``(3) Data and information.--
``(A) Required information.--A determination that
an ingredient or non-functional constituent is safe in
cosmetics shall be based upon adequate evidence
submitted or otherwise known to the Food and Drug
Administration, which shall include full reports of all
available studies, published or unpublished, that are
adequately designed to show whether the ingredient or
non-functional constituent is safe. Such studies may
include in vitro and in silico studies and
epidemiological studies, biomonitoring studies, and
studies focused on various points during the lifespan
of the subject, that use scientifically valid
methodology.
``(B) Additional relevant information.--The Food
and Drug Administration shall consider any other
relevant information related to the safety of the
ingredient or non-functional constituent, including--
``(i) adverse event reports;
``(ii) findings and information from State,
Federal, national, and international entities
and other bodies composed of scientific and
medical experts;
``(iii) if the ingredient or non-functional
constituent is lawfully used or present in
other products regulated by the Food and Drug
Administration, the scientific basis for such
use; and
``(iv) experience with the ingredient or
non-functional constituent in products that are
distributed in the United States or in other
countries, if such experience is well-
documented and has resulted in substantial
human exposure to the ingredient or non-
functional constituent over time.''.
``SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS.
``(a) Determination.--
``(1) In general.--Each responsible person for a finished
cosmetic product shall, before first distributing the product
for sale, make a written determination that the product is safe
under the conditions of use recommended in the labeling of the
product. Such determination shall be based on adequate evidence
that each ingredient in the finished product is safe for the
use recommended or suggested in the labeling of the product and
that the finished product is safe.
``(2) New information.--If new information relevant to the
determination becomes available, the responsible person shall
promptly update the determination to address that information.
``(3) Safety with respect to ranges of possible amounts.--
In the case of a cosmetic product for which there is a range of
possible amounts of cosmetic ingredients included in the
cosmetic ingredient statement, as described in section
606(c)(2)(E), the safety determination under paragraph (1)
shall include substantiation of the safety of the full range in
the finished product.
``(b) Presumption of Adequate Evidence.--
``(1) In general.--Except as provided in subsection (c), a
determination made under subsection (a) shall be presumed to be
based on adequate evidence if it is supported by--
``(A) with respect to each ingredient in the
finished product--
``(i) references to an official statement
by one or more expert medical or scientific
bodies that the ingredient is safe under the
conditions of use recommended or suggested in
the product's labeling; or
``(ii) appropriate safety testing of the
ingredient; and
``(B) appropriate safety substantiation of the
finished product beyond the safety substantiation of
individual ingredients and consideration of the
combination of ingredients.
``(2) Statement of an expert medical or scientific body.--
For purposes of this section, a statement of an expert medical
or scientific body is an official statement of that body, if--
``(A) the medical or scientific body is a Federal,
State, national, or international entity with
recognized expertise in chemical or cosmetic safety, or
other similarly recognized body composed of scientific
and medical experts;
``(B) the statement is based upon adequate data to
support the finding of safety, and such data are
available to the Food and Drug Administration; and
``(C) the statement is published and endorsed by
the medical or scientific body and is not a statement
of an employee of such body made in the individual
capacity of the employee.
``(c) Rebuttal of Presumption.--Notwithstanding subsection (b), a
determination under subsection (a) will not be presumed to be based on
adequate evidence if--
``(1) the Food and Drug Administration issues an order
under section 608 that an ingredient or non-functional
constituent in the finished product is not safe under the
product's conditions of use or customary or usual use; or
``(2) the Food and Drug Administration has provided the
manufacturer with notice that--
``(A) the manufacturer has not met the criteria
under subsection (b); or
``(B) the Food and Drug Administration has
information that raises significant questions about the
safety of the product or any of its ingredients.
``(d) Timely Update.--Upon notice of inadequate evidence under
subsection (c), the responsible person shall have 10 days to submit
additional evidence to the Food and Drug Administration regarding the
safety of an ingredient, non-functional constituent, or the entire
cosmetic product, and the Food and Drug Administration shall have 30
days from the date of receipt of such additional evidence to provide
the responsible person with notice that the criteria under subsection
(b) have been met or not met.
``(e) Records Maintenance.--The responsible person shall maintain
records documenting the determination required under this section and
the information on which it is based until 5 years after the finished
product is no longer marketed.
``(f) Submission of Records.--
``(1) In general.--The records required under subsection
(e) shall, upon the written request of the Food and Drug
Administration to the responsible person, be provided to the
Food and Drug Administration within a reasonable timeframe not
to exceed 60 days, in either electronic or paper form.
``(2) Criteria.--The Food and Drug Administration may
require records under paragraph (1) if--
``(A) the Food and Drug Administration has a
reasonable belief, described in written notice, that--
``(i) the finished product may be harmful
based on adverse event reports or other
scientific information;
``(ii) scientific information raises
credible and relevant questions about the
safety of the product or any of its
ingredients;
``(iii) the responsible person has not made
the determination required under subsection
(a), or such determination is not supported by
adequate evidence; or
``(iv) one or more of the criteria to
establish a presumption of adequate evidence of
safety in subsection (b) has not been
satisfied;
``(B) the Food and Drug Administration, an expert
regulatory body, or an expert body composed of
scientific and medical experts finds an ingredient in
the product to be unsafe under the conditions of use of
the product; or
``(C) the Food and Drug Administration concludes
that submission of the records will serve the public
health or otherwise enable the Food and Drug
Administration to fulfill the cosmetic safety purposes
of this section.
``(g) Guidance and Regulations.--
``(1) In general.--The Food and Drug Administration shall
issue guidance describing the evidence necessary to support a
determination under subsection (a), and may, by regulation,
establish exemptions to the requirements of this section, if
the Food and Drug Administration determines that such
exemptions are supported by adequate evidence and would have no
adverse effect on public health.
``(2) Small businesses.--The Food and Drug Administration
shall, after consultation with the Small Business
Administration and small businesses that manufacture cosmetics,
provide additional guidance for small businesses on compliance
with the requirements of this section. Such guidance shall
include specific examples of options for compliance that do not
place an undue burden on small businesses.''.
(b) Effective Date.--Section 609 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall take effect 180 days
after the date of enactment of this Act.
SEC. 103. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
(a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 102, is further
amended by adding at the end the following:
``SEC. 610. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
``(a) In General.--The Food and Drug Administration shall review
national and international standards for cosmetic good manufacturing
practices that are in existence on the date of enactment of the
Personal Care Products Safety Act and shall develop and implement,
through regulations, United States standards consistent, to the extent
the Food and Drug Administration determines practicable and
appropriate, with such national and international standards for
cosmetic good manufacturing practices to ensure that requirements of
this chapter with respect to the manufacture of cosmetic products are
in harmony.
``(b) Timeframe.--The Food and Drug Administration shall publish a
proposed rule described in subsection (a) not later than 18 months
after the date of enactment of the Personal Care Products Safety Act
and shall publish a final such rule not later than 3 years after such
date of enactment.''.
(b) Effective Date for Cosmetic Manufacturers.--
(1) Large businesses.--For businesses of a size greater
than the Small Business Administration's standard for a small
business, section 610 of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)) shall take effect beginning
180 days after the date on which the Food and Drug
Administration makes effective cosmetic good manufacturing
practices.
(2) Small businesses.--For businesses of a size that meets
the Small Business Administration's standard for a small
business, section 610 of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)) shall take effect beginning 2
years after the date the Food and Drug Administration makes
effective cosmetic good manufacturing practices.
(c) Enforcement.--Section 601 of Chapter VI of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 361) is amended by adding at the end
the following:
``(f) If the methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or holding do not conform to
current good manufacturing practice, as prescribed by the Food and Drug
Administration.''.
SEC. 104. ADVERSE EVENT REPORTS.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 103(a), is further amended by
adding at the end the following:
``SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS.
``(a) In General.--With respect to any cosmetic product distributed
in the United States, the responsible person shall submit to the Food
and Drug Administration a report of any serious adverse event
associated with such cosmetic product, when used in the United States,
accompanied by a copy of the label on or with the retail packaging of
the cosmetic, any new medical information, related to a submitted
serious adverse event report that is received by the responsible
person, and an annual report for all adverse events received by the
responsible person.
``(b) Definitions.--In this section:
``(1) An `adverse event' for a cosmetic product is a
health-related event associated with the use of this product
that is adverse.
``(2) A `serious adverse event' for a cosmetic product is
an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant
disability or incapacity;
``(v) congenital anomaly or birth defect;
or
``(vi) significant disfigurement, including
serious and persistent rashes and infections;
or
``(B) requires, based on appropriate medical
judgment, a medical or surgical intervention to prevent
an outcome described in subparagraph (A).
``(c) Submission of Reports.--
``(1) Serious adverse event reports.--Except as provided in
paragraph (2), the responsible person shall submit a serious
adverse event report to the Food and Drug Administration not
later than 15 business days after information concerning the
adverse event is received. If a serious adverse event report
for a cosmetic with drug properties is filed using Form FDA
3500A (or any successor form developed for such purpose) or its
electronic equivalent for over-the-counter drugs, the
responsible person shall not have to submit a duplicative
serious adverse event report under this section.
``(2) New medical information.--The responsible person
shall submit to the Food and Drug Administration any new
medical information, related to a submitted serious adverse
event report that is received by the responsible person within
1 year of the initial report, and shall submit such information
not later than 15 business days after the new information is
received by the responsible person.
``(3) Annual report.--
``(A) In general.--Not later than March 1 of each
year, the responsible person shall submit an electronic
report for the prior calendar year for each cosmetic
product marketed during that year.
``(B) Contents.--Each report under this paragraph
shall contain a summary of all adverse events received
during the reporting period, a complete list of
individual reports, and an estimate of the total number
of product units estimated to have been distributed to
consumers during such period. The report shall not
include consumer complaints that are solely regarding
efficacy and do not contain any information about an
adverse event. The Food and Drug Administration shall
further specify the contents of the annual electronic
report by regulation or guidance.
``(4) Exemption.--The Food and Drug Administration may
establish by regulation an exemption to any of the requirements
under this subsection if the Food and Drug Administration
determines that such exemption is supported by adequate
evidence and would have no adverse effect on public health.
``(d) Requirements.--
``(1) In general.--Each serious adverse event report under
this section shall be submitted to the Food and Drug
Administration using an electronic system of the Food and Drug
Administration. The Food and Drug Administration shall make
such electronic system available not later than 1 year after
the date of enactment of the Personal Care Products Safety Act.
``(2) Modification.--The format of the reporting system may
be modified by the Food and Drug Administration and the reports
may include additional information. The Food and Drug
Administration may, in guidance, further specify the format and
contents of required reports.
``(3) Scope of serious adverse event report.--A serious
adverse event report (including all information submitted in
the initial report or added later) submitted to the Food and
Drug Administration under subsection (a) includes--
``(A) a report under section 756 with respect to
safety and related to a specific cosmetic product;
``(B) a record about an individual who suffered the
serious adverse event under section 552a of title 5,
United States Code;
``(C) a medical or similar file documenting the
serious adverse event, the disclosure of which would
constitute a violation of section 552(b)(6) of such
title 5, and shall not be publicly disclosed unless all
personally identifiable information is redacted; and
``(D) contact information for the individual
reporting the serious adverse event.
``(4) Responsibility to gather information.--After an
individual initiates the reporting of a serious adverse event,
the responsible person for the cosmetic product shall actively
gather all of the information to complete and file the report
with the Food and Drug Administration.
``(5) No adverse events to report.--The Food and Drug
Administration shall provide an option as part of the
electronic registration process for the responsible person to
indicate if such responsible person had no adverse events to
report over the previous year. With respect to a responsible
person who received no adverse event reports for a year, the
annual adverse event report requirement may be met by
indicating no such events on the annual registration form.
``(e) Limitation With Respect to Adverse Event Reports.--The
submission of an 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) Contact Information.--The label of a cosmetic shall bear the
domestic telephone number or electronic contact information, and it is
encouraged that the label include both the telephone number and
electronic contact information, through which the responsible person
may receive a report of an adverse event.
``(g) Maintenance of Records.--The responsible person shall
maintain records related to each report of an adverse event received by
the responsible person for a period of 6 years.
``(h) Availability to States.--The Food and Drug Administration
shall make available records submitted under this section to any State,
upon request. Information disclosed to a State that is exempt from
disclosure under section 552(b)(4) of title 5, United States Code,
shall be treated as a trade secret and confidential information by the
State.
``(i) Effective Date of Requirement With Respect to Serious Adverse
Events.--The requirement under this section to report serious adverse
events shall become effective on the date that the Food and Drug
Administration publicizes the availability of the electronic system
described in subsection (d)(1).''.
SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AUTHORITY.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 104, is further amended by adding
at the end the following:
``SEC. 612. INSPECTION OF COSMETIC RECORDS.
``(a) Inspection of Records.--Each manufacturer, processor, packer,
or holder of a cosmetic shall, at the request of an officer or employee
duly designated by the Food and Drug Administration, permit such
officer or employee, upon presentation of appropriate credentials and
written notice to such person, at reasonable times and within
reasonable limits and in a reasonable manner, to have access to and
copy--
``(1) all records maintained under section 611 and in
accordance with the rules promulgated by the Food and Drug
Administration under section 610, as applicable; and
``(2) except as provided in subsection (b), all other
records, if the Food and Drug Administration--
``(A) has a reasonable belief that the cosmetic--
``(i) is adulterated;
``(ii) has caused a reportable serious
adverse event; or
``(iii) contains an ingredient that
substantial new scientific information shows
may be unsafe when present in a cosmetic; and
``(B) provides written notice of the basis for the
Food and Drug Administration's reasonable belief
described in subparagraph (A).
``(b) Exclusions.--No inspection authorized by this section shall
extend to financial data, pricing data, personnel data (other than data
as to qualification of technical and professional personnel performing
functions subject to this Act), research data (other than safety data)
or sales data other than shipment data.
``(c) Scope.--The requirements under subsection (a) apply to
records maintained by or on behalf of such person in any format
(including paper and electronic formats) and at any location.
``(d) Protection of Sensitive Information.--The Food and Drug
Administration shall take appropriate measures to ensure that there are
effective procedures to prevent the unauthorized disclosure of any
trade secret or confidential information that is obtained by the Food
and Drug Administration pursuant to this section. Information disclosed
to a State that is exempt from disclosure under section 552(b)(4) of
title 5, United States Code, shall be treated as a trade secret and
confidential information by the State.
``(e) Limitations.--This section shall not be construed--
``(1) to limit the authority of the Food and Drug
Administration to inspect records or to require establishment
and maintenance of records under any other provision of this
Act; or
``(2) to have any legal effect on section 552 of title 5,
United States Code, or section 1905 of title 18, United States
Code.''.
``SEC. 613. MANDATORY RECALL AUTHORITY.
``(a) Voluntary Procedures.--If the Food and Drug Administration
determines that there is a reasonable probability that a cosmetic is
adulterated under section 601 or misbranded under section 602 and the
use of or exposure to such cosmetic is likely to cause serious adverse
health consequences or death, the Food and Drug Administration shall
provide the responsible person with an opportunity to voluntarily cease
distribution and recall such article.
``(b) Prehearing Order To Mandatorily Cease Distribution and Give
Notice.--
``(1) In general.--If the responsible person refuses to or
does not voluntarily cease distribution or recall such cosmetic
within the time and in the manner prescribed by the Food and
Drug Administration, the Food and Drug Administration may order
such person to--
``(A) immediately cease distribution of such
cosmetic; and
``(B) as applicable, immediately notify all
persons--
``(i) manufacturing, processing, packing,
transporting, holding, receiving, distributing,
or importing and selling such cosmetic; and
``(ii) to which such cosmetic has been
distributed, transported, or sold,
to immediately cease distribution of such cosmetic.
``(2) Required additional information.--
``(A) In general.--If a cosmetic covered by a
recall order issued under paragraph (1)(B) has been
distributed to a warehouse-based third party logistics
provider without providing such provider sufficient
information to know or reasonably determine the precise
identity of such cosmetic covered by a recall order
that is in its possession, the notice provided by the
responsible person subject to the order issued under
paragraph (1)(B) shall include such information as is
necessary for the warehouse-based third party logistics
provider to identify the cosmetic.
``(B) Rules of construction.--Nothing in this
paragraph shall be construed--
``(i) to exempt a warehouse-based third
party logistics provider from the requirements
of this chapter, including the requirements of
this section and section 612; or
``(ii) to exempt a warehouse-based third
party logistics provider from being the subject
of a mandatory recall order.
``(3) Determination to limit areas affected.--If the Food
and Drug Administration requires a responsible person to cease
distribution under paragraph (1)(A) of a cosmetic, the Food and
Drug Administration may limit the size of the geographic area
and the markets affected by such cessation if such limitation
would not compromise the public health.
``(c) Hearing on Order.--The Food and Drug Administration shall
provide the responsible party subject to an order under subsection (b)
with an opportunity for an informal hearing, to be held as soon as
possible, but not later than 2 days after the issuance of the order, on
the actions required by the order and on why the cosmetic that is the
subject of the order should not be recalled.
``(d) Post-Hearing Recall Order and Modification of Order.--
``(1) Amendment of order.--If, after providing opportunity
for an informal hearing under subsection (c), the Food and Drug
Administration determines that removal of the cosmetic from
commerce is necessary, the Food and Drug Administration shall,
as appropriate--
``(A) amend the order to require recall of such
cosmetic or other appropriate action;
``(B) specify a timetable in which the recall shall
occur;
``(C) require periodic reports to the Food and Drug
Administration describing the progress of the recall;
and
``(D) provide notice to consumers to whom such
cosmetic was, or may have been, distributed.
``(2) Vacating of order.--If, after such hearing, the Food
and Drug Administration determines that adequate grounds do not
exist to continue the actions required by the order, or that
such actions should be modified, the Food and Drug
Administration shall vacate the order or modify the order.
``(e) Cooperation and Consultation.--The Food and Drug
Administration shall work with State and local public health officials
in carrying out this section, as appropriate.
``(f) Public Notification.--In conducting a recall under this
section, the Food and Drug Administration shall--
``(1) ensure that a press release is published regarding
the recall, and that alerts and public notices are issued, as
appropriate, in order to provide notification--
``(A) of the recall to consumers and retailers to
whom such cosmetic was, or may have been, distributed;
and
``(B) that includes, at a minimum--
``(i) the name of the cosmetic subject to
the recall;
``(ii) a description of the risk associated
with such article; and
``(iii) to the extent practicable,
information for consumers about similar
cosmetics that are not affected by the recall;
and
``(2) ensure publication on the Internet website of the
Food and Drug Administration an image of the cosmetic that is
the subject of the press release described in paragraph (1), if
available.
``(g) No Delegation.--The authority conferred by this section to
order a recall or vacate a recall order shall not be delegated to any
officer or employee other than the Commissioner.
``(h) Effect.--Nothing in this section shall affect the authority
of the Food and Drug Administration to request or participate in a
voluntary recall, or to issue an order to cease distribution or to
recall under any other provision of this chapter or under the Public
Health Service Act.''.
SEC. 106. LABELING.
(a) In General.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.), as amended by section 105, is further
amended by adding at the end the following:
``SEC. 614. LABELING.
``(a) Safety Review and Labeling.--Following a review of cosmetic
ingredients that determines that warnings are required to help ensure
safe use of cosmetic products under section 608(d)(5), the Food and
Drug Administration shall require labeling of cosmetics that are not
appropriate for use in the entire population, including warnings that
vulnerable populations, such as children or pregnant women, should
limit or avoid using the product.
``(b) Cosmetic Products for Professional Use.--
``(1) Definition of professional.--With respect to
cosmetics, the term `professional' means an individual who--
``(A) is licensed by an official State authority to
practice in the field of cosmetology, nail care,
barbering, and or esthetics;
``(B) has complied with all requirements set forth
by the State for such licensing; and
``(C) has been granted a license by a State board
or legal agency or legal authority.
``(2) Listing of ingredients.--Cosmetic products used and
sold by professionals shall list all ingredients, as required
for other cosmetic products under this chapter.
``(3) Professional use labeling.--In the case of a cosmetic
product intended to be used only by a professional on account
of a specific ingredient or increased concentration of an
ingredient that requires safe handling by trained
professionals, the product shall bear a statement as follows:
`To be Administered Only by Licensed Professionals'.
``(c) Display.--The warning required under subsection (a) and the
statement required under subsection (b)(3) shall be prominently
displayed--
``(1) in the primary language used on the label; and
``(2) in conspicuous and legible type in contrast by
typography, layout, or color with other material printed or
displayed on the label.
``(d) Internet Sales.--In the case of Internet sales of cosmetics,
each Internet website offering cosmetic products for sale to consumers
shall provide the same information that is included on the packaging of
the cosmetic products as regularly available, and the warnings and
statements described in subsection (c) shall be prominently and
conspicuously displayed on the website.
``(e) Contact Information.--The label on each cosmetic shall bear
the domestic telephone number or electronic contact information, and it
is encouraged that the label include both the telephone number and
electronic contact information, that consumers may use to contact the
responsible person with respect to adverse events. The contact number
shall provide a means for consumers to obtain additional information
about ingredients in a cosmetic, including the ability to ask if a
specific ingredient may be present that is not listed on the label,
including whether a specific ingredient may be contained in the
fragrance or flavor used in the cosmetic. The manufacturer of the
cosmetic is responsible for providing such information, including
obtaining the information from suppliers if it is not readily
available. Suppliers are required to release such information upon
request of the cosmetic manufacturer.''.
(b) Effective Date.--Section 614 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall take effect on the date
that is 1 year after the date of enactment of this Act.
SEC. 107. COAL TAR CHEMICALS.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 106, is further amended by adding
at the end the following:
``SEC. 615. COAL TAR CHEMICALS.
``(a) In General.--Under section 608, the Food and Drug
Administration may review any cosmetic ingredient in order to determine
if it is safe in cosmetic products without the need for specified
conditions of use or tolerances, safe in cosmetic products under
specified conditions of use or tolerances, or not safe in cosmetic
products.
``(b) Coal Tar Hair Dyes.--Specific chemicals in coal tar hair dyes
may be selected and reviewed under section 608(a)(3).''.
SEC. 108. ANIMAL TESTING ALTERNATIVES.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 107, is further amended by adding
the following:
``SEC. 616. ANIMAL TESTING ALTERNATIVES.
``(a) In General.--To minimize the use of animal testing for safety
of cosmetic ingredients, non-functional constituents, and finished
cosmetic products, the Food and Drug Administration shall--
``(1) encourage the use of alternative testing methods that
provide information that is equivalent or superior in
scientific quality to the animal testing method to--
``(A) not involve the use of an animal to test a
chemical substance for safe use in cosmetics; or
``(B) use fewer animals than conventional animal-
based tests for safe use in cosmetics when nonanimal
methods are impracticable; and
``(2) encourage--
``(A) the sharing of data across companies and
organizations that are testing for safety in cosmetics,
so as to avoid duplication of animal tests; and
``(B) funding for research and validation of
alternative testing methods.
``(b) Guidance.--Not later than 3 years after the date of enactment
of the Personal Care Products Safety Act, the Food and Drug
Administration shall issue guidance on the acceptability of
scientifically reliable and relevant alternatives to animal testing for
the safety of cosmetic ingredients, non-functional constituents, and
finished cosmetic products, and encouraging the use of such methods.
The Food and Drug Administration shall update such guidance on an
annual basis.
``(c) Resources Regarding Animal Testing Alternatives.--Not later
than 180 days after the date of enactment of the Personal Care Products
Safety Act, the Food and Drug Administration shall provide information
on the Internet website of the Food and Drug Administration regarding
resources available for information about non-animal methods, and
methods that reduce animal usage, in testing for the safety of cosmetic
ingredients, non-functional constituents, and finished cosmetic
products.''.
SEC. 109. PREEMPTION.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 108, is further amended by adding
the following:
``SEC. 617. PREEMPTION.
``(a) Registration, Good Manufacturing Practices, Recalls, Adverse
Event Reporting.--Except for a State requirement that is in full effect
and implemented on the date of enactment of the Personal Care Products
Safety Act, no State or political subdivision of a State may establish
or continue in effect any requirement for cosmetics with respect to
registration, good manufacturing practices, mandatory recalls, or
adverse event reporting.
``(b) Safety of Cosmetic Ingredients and Non-Functional
Constituents.--
``(1) In general.--Except for a State requirement that is
more restrictive than a final order issued under section
608(d)(3) and that is in full effect and implemented on the
date of enactment of the Personal Care Products Safety Act, no
State or political subdivision of a State may establish or
continue in effect any requirement with respect to the safety
of a cosmetic ingredient or non-functional constituent that is
the subject of a final order under section 608(d)(3) that is
different from, or in addition to, a final order issued under
section 608(d)(3).
``(2) Delayed effect of new state requirements.--From the
date that the Food and Drug Administration has made public the
final selection of a cosmetic ingredient or non-functional
constituent to be reviewed in the coming year under section
608(a)(3)(B), and opened the public comment period under
section 608(a)(2), until the date that is one year after the
Food and Drug Administration has made public such selection, no
State or political subdivision of a State may establish any new
requirement related to such cosmetic ingredient or non-
functional constituent.
``(3) Scope.--This subsection shall not be construed to
modify or affect the authority of a State or political
subdivision of a State with respect to such safety requirements
unrelated to the scope of the safety assessment under section
608.
``(4) Sense of congress.--It is the sense of Congress that
a State or political subdivision that regulates the safety of
cosmetics with respect to the health of humans beyond the scope
of section 608 should utilize the safety assessment criteria
described in section 608(h).
``(c) State Requirement That Is in Full Effect and Implemented.--
For purposes of this section:
``(1) State requirement.--A State requirement includes a
State requirement that is adopted by a State public initiative
or referendum.
``(2) Full effect and implemented.--The term `full effect
and implemented' includes requirements of States that are
implemented after the date of enactment of the Personal Care
Products Safety Act, if such requirements are under a law that
was in effect, or a lawful program that was established and
functioning, prior to the date of enactment of the Personal
Care Products Safety Act.
``(d) Rule of Construction Regarding Product Liability.--
Notwithstanding any other provision of this Act, no provision of this
chapter relating to a cosmetic shall be construed to modify or
otherwise affect any action or the liability of any person under State
or Federal common law.
``(e) Limitation.--The Personal Care Products Safety Act, including
the amendments made by such Act, shall not be construed to preempt any
State statute, public initiative, referendum, or common law, except as
expressly provided in this section.''.
SEC. 110. REPORTING.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 109, is further amended by adding
at the end the following:
``SEC. 618. REPORTING.
``(a) Performance Report.--Beginning with fiscal year 2016, and not
later than 60 days prior to the end of each fiscal year for which fees
are collected under section 744L, the Food and Drug Administration
shall prepare and submit to Congress a report concerning the progress
of the Food and Drug Administration in achieving the objectives of the
Personal Care Products Safety Act during such fiscal year and the
future plans of the Food and Drug Administration for meeting the
objectives. The annual report for a fiscal year shall include--
``(1) the number of registered facilities and cosmetic
ingredient statements on file with the Food and Drug
Administration;
``(2) identification of the cosmetic ingredients and non-
functional constituents that have been fully reviewed for
safety by the Food and Drug Administration in the prior fiscal
year and for which a final administrative order has been
released;
``(3) identification of at least 5 specific cosmetic
ingredients and non-functional constituents that will be
reviewed by the Food and Drug Administration in the next fiscal
year;
``(4) the number of facilities inspected and mandatory
recalls that transpired during that fiscal year;
``(5) the number of serious adverse event reports received
by the Food and Drug Administration during that fiscal year;
``(6) any trends identified by the Food and Drug
Administration about adverse event reports related to specific
cosmetic ingredients or non-functional constituents; and
``(7) efforts of the Food and Drug Administration to reduce
animal testing for safety of cosmetic ingredients, non-
functional constituents, and cosmetic products.
``(b) Public Availability.--The Food and Drug Administration shall
make the reports required under subsections (a) available to the public
on the Internet website of the Food and Drug Administration on the date
of submission of such reports to Congress.
``(c) Public Input on Safety Review.--Upon release of the report
described in subsection (a), the Food and Drug Administration shall
provide the public with an opportunity to provide feedback on
subsection (a)(3) by--
``(1) providing an electronic portal, upon release of the
report, enabling the public to--
``(A) recommend additional cosmetic ingredients and
non-functional constituents to be considered for review
for safety in future years; and
``(B) comment on the priorities for the specific
cosmetic ingredients and non-functional constituents
that the Food and Drug Administration anticipates will
be reviewed in the next fiscal year;
``(2) announcing on the Internet website of the Food and
Drug Administration, within the first 30 days of the new fiscal
year, any amendments to subsection (a)(3) based on public
input, pursuant to paragraph (1); and
``(3) together with the final announcement of 5 specific
cosmetic ingredients and non-functional constituents that will
be reviewed in the coming year under subsection (a)(3),
providing a comment period for further public input, pursuant
to section 608(a)(2).''.
SEC. 111. SMALL BUSINESSES.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 110, is further amended by adding
at the end the following:
``SEC. 619. SMALL BUSINESSES.
``The Commissioner, in coordination with the Administrator of the
Small Business Administration, shall provide technical assistance, such
as guidance and expertise, to small businesses regarding compliance
with the Personal Care Products Safety Act, including the amendments
made by such Act.''.
SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 111, is further amended by adding
at the end the following:
``SEC. 620. APPLICABILITY WITH RESPECT TO CERTAIN COSMETICS.
``In the case of a cosmetic product or a facility that is subject
to the requirements under this chapter and chapter V, if any
requirement under chapter V with respect to such cosmetic or facility
is substantially similar to a requirement under this chapter, the
cosmetic product or facility shall be deemed to be in compliance with
the applicable requirement under this chapter if such product or
facility is in compliance with such substantially similar requirement
under chapter V, provided that the product or facility has not obtained
a waiver from the requirement under chapter V.''.
SEC. 113. ENFORCEMENT.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in subsection (e)--
(A) by striking ``504, 564'' and inserting ``504,
564, 611, or 612''; and
(B) by striking ``519, 564'' and inserting ``519,
564, 611,'';
(2) in subsection (j) by inserting ``607, 608, 610,''
before ``704'';
(3) in subsection (ii)--
(A) by striking ``760 or 761)'' and inserting
``604, 760, or 761)''; and
(B) by striking ``760 or 761) submitted'' and
inserting ``611, 760, or 761) submitted'';
(4) in subsection (xx) by inserting ``or 613'' after
``423''; and
(5) by adding at the end the following:
``(ddd) The failure to register in accordance with section 605, the
failure to submit a cosmetic ingredient statement under section 606,
the failure to provide any information required by section 605 or 606,
or the failure to update the information required by section 605 or
606, as required.''.
(b) Adulteration.--Section 601 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 361), as amended by section 103, is further
amended by adding at the end the following:
``(g) If it contains, after the date prescribed under section
608(e), an ingredient that the Food and Drug Administration has
determined under section 608(d)(4) to be not safe, or not safe under
the conditions of use recommended or suggested in the label or a non-
functional constituent that the Food and Drug Administration has
determined under section 608(d)(4) to be not safe or not safe in the
amount present in the cosmetic.
``(h) If it is a cosmetic product for which any requirement of
section 609 (relating to safety substantiation) is not met.''.
(c) Misbranding.--Section 602 is amended--
(1) in subsection (b)--
(A) by striking ``and (2)'' and inserting ``(2)'';
and
(B) by inserting ``; and (3) a domestic address or
a domestic telephone number, and it is encouraged that
the label include both a domestic address and a
domestic telephone number, through which the
responsible person may receive a report of an adverse
event associated with the use of such cosmetic
product'' after ``numerical count''; and
(2) by adding at the end the following:
``(g) If it has been manufactured, processed, packed, or held in
any factory, warehouse, or establishment and the responsible person,
operator, or agent of such factory, warehouse, or establishment delays,
denies, or limits an inspection, or refuses to permit entry or
inspection.
``(h) If its labeling does not conform with a requirement under
section 614.''.
(d) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Food and Drug Administration shall issue guidance that
defines the circumstances that would constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection, for
purposes of section 602(g) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (c)(2).
(e) Imports.--Section 801(a) is amended--
(1) by striking ``section 760 or 761'' the first, third,
and fourth place such term appears and inserting ``section 611,
760, or 761''; and
(2) by striking ``760 or 761)'' and inserting ``604, 760,
or 761)''.
(f) Factory Inspection.--Section 704(a)(1) is amended by inserting
after the third sentence the following: ``In the case of any person who
manufactures, processes, packs, holds, distributes, or imports a
cosmetic product, or distributes a cosmetic product and affixes its
name on the cosmetic label, the inspection shall extend to all records
and other information described in section 612 (regarding inspection of
cosmetic records), when the standard for records inspections under
paragraph (1) or (2) of subsection (a) of such section applies, subject
to the limitations under subsection (d) of such section.''.
SEC. 114. CONSUMER INFORMATION.
The Food and Drug Administration shall post on its Internet website
information for consumers regarding--
(1) final orders regarding the safety of a cosmetic
ingredient or non-functional constituent under section
608(d)(3);
(2) cosmetic product recalls (including voluntary and
mandatory recalls); and
(3) identified counterfeit cosmetic products.
TITLE II--FEES RELATED TO COSMETIC SAFETY
SEC. 201. FINDINGS.
Congress finds that the fees authorized by the amendments made by
this title will be dedicated to cosmetic safety activities, as set
forth in the goals identified for purposes of part 10 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the Chairman
of the Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record.
SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFETY FEES.
Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379f et seq.) is amended by adding at the end the
following:
``PART 10--FEES RELATING TO COSMETICS
``SEC. 744L. REGISTRATION FEE.
``(a) Assessment and Collection.--
``(1) In general.--Beginning in fiscal year 2016, the Food
and Drug Administration shall assess and collect an annual fee
from every responsible person (referred to in this section as a
`registrant') who owns or operates any cosmetic facility
engaged in manufacturing or processing, or whose name and
address appear on the label of a cosmetic product distributed
in the United States, except that this subsection shall not
apply to entities described in subparagraphs (A) through (H) of
section 604(3).
``(2) Payable date.--A fee under this section shall be
payable during the period of initial registration and on the
date of registration each year thereafter as prescribed in
section 605(a)(1).
``(b) Definitions.--In this section:
``(1) Adjustment factor.--The term `adjustment factor'
applicable to a fiscal year means the Consumer Price Index for
all urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by such index for
October 2015.
``(2) Affiliate.--The term `affiliate' means any business
entity that has a relationship with a second business entity
if, directly or indirectly--
``(A) one business entity controls, or has power to
control, the other business entity; or
``(B) a third-party controls, or has the power to
control, both of the business entities.
``(3) Cosmetic safety activities.--The term `cosmetic
safety activities'--
``(A) means activities related to compliance by
registrants under section 605 with the requirements of
this Act with respect to cosmetics, including--
``(i) administrative activities, such as
information technology support, human
resources, financial management, the
administration and maintenance of the cosmetic
registration system and the cosmetic ingredient
statement system under sections 605 and 606,
and fee assessment and collection under this
section; and
``(ii) implementation and enforcement
activities, such as the establishment of good
manufacturing practices, the review of adverse
event reports, inspection planning and
inspections, and use of enforcement tools; and
``(B) includes activities related to implementation
of section 608, regarding the review of cosmetic
ingredients and non-functional constituents.
``(4) Gross annual sales.--The term `gross annual sales'
means the average United States gross annual sales for the
previous 3-year period of cosmetics for a registrant, including
the sales of all of its affiliates, as reported in the
registration under section 605.
``(c) Fee Setting and Amounts.--
``(1) In general.--Subject to subsection (d), the Food and
Drug Administration shall establish the fees to be collected
under this section for each fiscal year after fiscal year 2016,
based on the methodology described in paragraph (3)(B), and
shall publish such fees in a Federal Register notice not later
than 60 days before the beginning of each such fiscal year.
``(2) Fee exemption.--Any registrant whose average gross
annual sales of cosmetic products in the 3-year period
immediately preceding the fiscal year for which the annual fee
will be paid was not more than $500,000, shall be exempt from
registration fees under this section for that fiscal year.
``(3) Annual fee setting.--
``(A) Fiscal year 2016.--For fiscal year 2016, to
generate a total estimated revenue amount of
$20,600,000, the amount of the registration fee under
subsection (a) shall be as follows:
``(i) Tier i-a.--For a registrant that has
gross annual sales of $5,000,000,000 or more in
2015, $1,100,000.
``(ii) Tier i-b.--For a registrant that has
gross annual sales of at least $4,000,000,000
per annum but less than $5,000,000,000 in 2015,
$840,000.
``(iii) Tier ii-a.--For a registrant that
has gross annual sales of at least
$3,000,000,000 per annum but less than
$4,000,000,000 in 2015, $720,000.
``(iv) Tier ii-b.--For a registrant that
has gross annual sales of at least
$2,000,000,000 per annum but less than
$3,000,000,000 in 2015, $600,000.
``(v) Tier iii-a.--For a registrant that
has gross annual sales of at least
$1,000,000,000 per annum but less than
$2,000,000,000 in 2015, $500,000.
``(vi) Tier iii-b.--For a registrant that
has gross annual sales of at least $500,000,000
per annum but less than $1,000,000,000 in 2015,
$395,000.
``(vii) Tier iv-a.--For a registrant that
has gross annual sales of at least $200,000,000
per annum but less than $500,000,000 in 2015,
$325,000.
``(viii) Tier iv-b.--For a registrant that
has gross annual sales of at least $100,000,000
per annum but less than $200,000,000 in 2015,
$275,000.
``(ix) Tier v-a.--For a registrant that has
gross annual sales of at least $80,000,000 per
annum but less than $100,000,000 in 2015,
$185,000.
``(x) Tier v-b.--For a registrant that has
gross annual sales of at least $60,000,000 per
annum but less than $80,000,000 in 2015,
$95,000.
``(xi) Tier vi-a.--For a registrant that
has gross annual sales of at least $40,000,000
per annum but less than $60,000,000 in 2015,
$15,000.
``(xii) Tier iv-b.--For a registrant that
has gross annual sales of at least $20,000,000
per annum but less than $40,000,000 in 2015,
$12,000.
``(xiii) Tier vii-a.--For a registrant that
has gross annual sales of at least $2,500,000
per annum but less than $20,000,000 in 2015,
$500.
``(xiv) Tier vii-b.--For a registrant that
has gross annual sales of at least $500,000 per
annum but less than $2,500,000 in 2015, $250.
``(B) Fiscal years 2017-2022.--For fiscal years
2017-2022, fees under subsection (a) shall be
established to generate a total estimated revenue
amount of $20,600,000, as adjusted by subsection (d).
Of that amount:
``(i) Tier i-a.--Registrants that have
gross annual sales of $5,000,000,000 or more in
the fiscal year immediately preceding the
fiscal year in which the annual fee will be
paid, shall be responsible, collectively, for
10.7 percent.
``(ii) Tier i-b.--Registrants that have
gross annual sales of at least $4,000,000,000
per annum but less than $5,000,000,000 in the
fiscal year immediately preceding the fiscal
year in which the annual fee will be paid,
shall be responsible, collectively, for 4.1
percent.
``(iii) Tier ii-a.--Registrants that have
gross annual sales of at least $3,000,000,000
per annum but less than $4,000,000,000 in the
fiscal year immediately preceding the fiscal
year in which the annual fee will be paid,
shall be responsible, collectively, for 3.5
percent.
``(iv) Tier ii-b.--Registrants that have
gross annual sales of at least $2,000,000,000
per annum but less than $3,000,000,000 in the
fiscal year immediately preceding the fiscal
year in which the annual fee will be paid,
shall be responsible, collectively, for 2.9
percent.
``(v) Tier iii-a.--Registrants that have
gross annual sales of at least $1,000,000,000
per annum but less than $2,000,000,000 in the
fiscal year immediately preceding the fiscal
year in which the annual fee will be paid,
shall be responsible, collectively, for 7.3
percent.
``(vi) Tier iii-b.--Registrants that have
gross annual sales of at least $500,000,000 per
annum but less than $1,000,000,000 in the
fiscal year immediately preceding the fiscal
year in which the annual fee will be paid,
shall be responsible, collectively, for 13.4
percent.
``(vii) Tier iv-a.--Registrants that have
gross annual sales of at least $200,000,000 per
annum but less than $500,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 15.8 percent.
``(viii) Tier iv-b.--Registrants that have
gross annual sales of at least $100,000,000 per
annum but less than $200,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 13.3 percent.
``(ix) Tier v-a.--Registrants that have
gross annual sales of at least $80,000,000 per
annum but less than $100,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 9 percent.
``(x) Tier v-b.--Registrants that have
gross annual sales of at least $60,000,000 per
annum but less than $80,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 6.9 percent.
``(xi) Tier vi-a.--Registrants that have
gross annual sales of at least $40,000,000 per
annum but less than $60,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 5.1 percent.
``(xii) Tier vi-b.--Registrants that have
gross annual sales of at least $20,000,000 per
annum but less than $40,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 4.4 percent.
``(xiii) Tier vii-a.--Registrants that have
gross annual sales of at least $2,500,000 per
annum but less than $20,000,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 1.2 percent.
``(xiv) Tier vii-b.--Registrants that have
gross annual sales of at least $500,000 per
annum but less than $2,500,000 in the fiscal
year immediately preceding the fiscal year in
which the annual fee will be paid, shall be
responsible, collectively, for 2.4 percent,
except that no such registrant shall be
responsible for more than $250 per fiscal year.
``(d) Adjustments.--
``(1) Inflation adjustment.--
``(A) In general.--For fiscal year 2017 and each
subsequent fiscal year, the revenues and fee amounts
under subsection (c)(3)(B) shall be adjusted by the
Food and Drug Administration in the annual Federal
Register notice establishing fees in subsection (c)(1),
by an amount equal to the sum of--
``(i) one;
``(ii) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 of
the preceding 4 fiscal years for which data are
available, multiplied by the average proportion
of personnel compensation and benefits costs to
total Food and Drug Administration costs for
the first 3 years of the preceding 4 fiscal
years for which data are available; and
``(iii) the average annual percent change
that occurred in the Consumer Price Index for
urban consumers (Washington-Baltimore, DC6 MD-
VA-WV; not seasonally adjusted; all items less
food and energy; annual index) for the first 3
years of the preceding 4 years for which data
are available multiplied by the average
proportion of all costs other than personnel
compensation and benefits costs to total Food
and Drug Administration costs for the first 3
years of the preceding 4 fiscal years for which
data are available.
``(B) Compounded basis.--The adjustment made each
fiscal year under this subsection shall be added on a
compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2016 under this
subsection.
``(2) Final year adjustment.--For fiscal year 2022, the
Food and Drug Administration may, in addition to adjustments
under paragraph (1), further increase the fee revenues and fees
established in subsection (c) if such an adjustment is
necessary to provide for not more than 3 months of operating
reserves of carryover fees for cosmetic safety activities for
the first 3 months of fiscal year 2023. If such an adjustment
is necessary, the rationale for the increase, shall be
contained in the annual Federal Register notice establishing
fees, in subsection (c)(1), for fiscal year 2022. If the Food
and Drug Administration has carryover balances for such
activities in excess of 3 months of such operating reserves,
the adjustment under this subparagraph shall not be made.
``(3) Workload adjustment.--
``(A) In general.--For fiscal year 2017 and each
subsequent fiscal year, after fee revenues established
in subsection (c)(3)(B) are adjusted for a fiscal year
for inflation in accordance with paragraph (1), the fee
revenues shall be adjusted further for each fiscal year
to reflect changes in the workload of the Food and Drug
Administration for actual changes in workload volume
due to the process of reviewing cosmetic ingredients or
non-functional constituents not listed under section
608(b).
``(B) Determination of adjustment.--The adjustment
shall be determined by the Food and Drug Administration
based on the workload in the most recent 1-year period
for which workload data is available. The Food and Drug
Administration shall publish in the Federal Register
the fee revenues and fees resulting from the adjustment
and the supporting methodologies.
``(C) Minimum revenues.--The adjustment shall not
result in fee revenues for a fiscal year that are less
than the sum of the amount under subsection (c)(3)(B),
as adjusted for inflation under subparagraph (1).
``(e) Limitations.--
``(1) In general.--With respect to the amount that, under
the salaries and expenses account of the Food and Drug
Administration, is appropriated for a fiscal year for the
cosmetics program in the Center for Food Safety and Applied
Nutrition and related field activities, fees may not be
assessed under subsection (a) for the fiscal year unless the
amount so appropriated for the fiscal year (excluding the
amount of fees appropriated for the fiscal year), is equal to
or greater than that assessed for fiscal year 2015, multiplied
by the adjustment factor applicable to the fiscal year
involved.
``(2) Authority.--If the Food and Drug Administration does
not assess fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later date in
such fiscal year the Food and Drug Administration may assess
such fees, the Food and Drug Administration may assess and
collect such fees, without any modification in the rate, for
registration under section 605 at any time in such fiscal year.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for cosmetic safety activities.
``(2) Collections and appropriations acts.--The fees
authorized by this section--
``(A) In general.--Subject to subparagraphs (C) and
(D), the fees authorized by this section shall be
collected and available in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation for such fiscal year.
``(B) Use of fees and limitation.--The fees
authorized by this section shall be collected and
available only to defray the costs of cosmetic safety
activities.
``(C) Fee collections during first program year.--
Until the date of enactment of an Act making
appropriations through September 30, 2015, for the
salaries and expenses account of the Food and Drug
Administration, fees authorized by this section for
fiscal year 2016 may be collected and shall be credited
to such account to remain available until expended.
Fees collected under this subparagraph shall be
considered discretionary for purposes of the Balanced
Budget and Emergency Deficit Control Act of 1985.
``(D) Reimbursement of start-up amounts.--Any
amounts allocated to establish programs under sections
605 and 606, prior to collection of fees, may be
reimbursed through any appropriated fees collected
under this section, in such manner as the Food and Drug
Administration determines appropriate. Any amounts
reimbursed under this subparagraph shall be available
for the programs and activities for which funds
allocated to establish the programs were available,
prior to such allocation, until the end of the fiscal
year in which the reimbursement occurs, notwithstanding
any otherwise applicable limits on amounts for such
program or activities for a fiscal year.
``(3) Authorization of appropriations.--For each of fiscal
years 2016-2022, there are authorized to be appropriated for
fees under this section $20,600,000, as adjusted by subsection
(d).
``(4) Offset of overcollections; recovery of collection
shortfalls.--
``(A) Offset of overcollections.--If the sum of the
cumulative amount of fees collected under this section
for the fiscal years 2016 through 2020 exceeds the
cumulative amount appropriated pursuant to paragraph
(3) for fiscal years 2016-2021, the excess amount shall
be credited to the appropriation account of the Food
and Drug Administration as provided in paragraph (1),
and shall be subtracted from the amount of fees that
would otherwise be authorized to be collected under
this section pursuant to appropriation Acts for fiscal
year 2022.
``(B) Recovery of collection shortfalls.--
``(i) 2018.--For fiscal year 2018, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2016 falls below the amount of
fees authorized for fiscal year 2016 under
paragraph (3).
``(ii) 2019.--For fiscal year 2019, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2017 falls below the amount of
fees authorized for fiscal year 2017 under
paragraph (3).
``(iii) 2020.--For fiscal year 2020, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2018 falls below the amount of
fees authorized for fiscal year 2018 under
paragraph (3).
``(iv) 2021.--For fiscal year 2021, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2019 falls below the amount of
fees authorized for fiscal year 2019 under
paragraph (3).
``(v) 2022.--For fiscal year 2022, the
amount of fees otherwise authorized to be
collected under this section shall be increased
by the amount, if any, by which the amount
collected under this section and appropriated
for fiscal year 2020 falls below the amount of
fees authorized for fiscal year 2020 under
paragraph (3).
``(g) Effect of Failure To Pay Fees.--The Food and Drug
Administration shall not consider a registration submitted to be
complete until such fee under subsection (a) is paid. Until the fee is
paid, the registration is incomplete and the registrant is deemed to
have failed to register in accordance with section 605.
``(h) False Statements.--Any statement or representation made to
the Food and Drug Administration shall be subject to section 1001 of
title 18, United States Code.
``(i) Collection of Unpaid Fees.--In any case where the Food and
Drug Administration does not receive payment of a fee assessed under
subsection (a), such fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37 of title 31,
United States Code.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in cosmetic activities, be reduced to offset the
number of officers, employees, and advisory committees so engaged.
``(k) Records.--Each facility shall retain all records necessary to
demonstrate the facility's gross annual sales for at least 2 fiscal
years after such information is reported in the facility's
registration. Such records shall be made available to the Food and Drug
Administration for review and duplication upon request of the Food and
Drug Administration.''.
SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO
COSMETICS.
Part 10 of subchapter C of chapter VII, as added by section 202, is
amended by inserting after section 744L the following:
``SEC. 744M. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO
COSMETICS.
``(a) In General.--The Food and Drug Administration shall have
direct hiring authority with respect to the appointment of employees
into the competitive service or the excepted service to administer the
amendments made by title I of the Personal Care Products Safety Act.
``(b) Sunset.--The authority under subsection (a) shall terminate
on the date that is 3 years after the date of enactment of such
title.''.
<all>
Introduced in Senate
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2274-2275)
Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 114-804.
Committee on Health, Education, Labor, and Pensions. Hearings held.
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