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	<dublinCore>
	<dc:title>114 S1014 IS: Personal Care Products Safety Act</dc:title>
	<dc:publisher>U.S. Senate</dc:publisher>
	<dc:date>2015-04-20</dc:date>
	<dc:format>text/xml</dc:format>
	<dc:language>EN</dc:language>
	<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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	<distribution-code display="yes">II</distribution-code><congress>114th CONGRESS</congress><session>1st Session</session><legis-num>S. 1014</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20150420">April 20, 2015</action-date><action-desc><sponsor name-id="S221">Mrs. Feinstein</sponsor> (for herself and <cosponsor name-id="S252">Ms. Collins</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. </official-title></form>
	<legis-body>
	<section id="S1" section-type="section-one"><enum>1.</enum><header>Short title; table of contents</header>
	<subsection id="id49C2EAC0769D4EED99EE4AD89B157F5B"><enum>(a)</enum><header>Short title</header><text display-inline="yes-display-inline">This Act may be cited as the <quote><short-title>Personal Care Products Safety Act</short-title></quote>.</text>
	</subsection><subsection id="id96f1a607f69a40c6b59ecca76753c75e"><enum>(b)</enum><header>Table of contents</header><text>The table of contents for this Act is as follows:</text><toc><toc-entry idref="S1" level="section">Sec. 1. Short title; table of contents.</toc-entry> <toc-entry idref="id1de71f67a9f64c0bbd09462a1b28f305" level="title">TITLE I—Cosmetic safety</toc-entry> <toc-entry idref="idd3d0d60be8544672a21dab956559f74c" level="section">Sec. 101. Registration of cosmetics facilities and cosmetic ingredient statements.</toc-entry> <toc-entry idref="id4F0351E334E74236982370132C0E0BC7" level="section">Sec. 102. Review of ingredients and non-functional constituents; safety of finished products.</toc-entry> <toc-entry idref="idcdfea0dbebed4f69aea543849ee865d3" level="section">Sec. 103. Good manufacturing practices for cosmetics.</toc-entry> <toc-entry idref="ida991f07e8ba34f39a09c2fedaa1d3a22" level="section">Sec. 104. Adverse event reports.</toc-entry> <toc-entry idref="idc861ae78948045b295993db51b8d99d2" level="section">Sec. 105. Records inspection; mandatory recall authority.</toc-entry> <toc-entry idref="id6D216B48FCFE4B5999FDD8ADDD54F21A" level="section">Sec. 106. Labeling.</toc-entry> <toc-entry idref="idA0A4DBCA4EF043C683C090CBDC4473F1" level="section">Sec. 107. Coal tar chemicals.</toc-entry> <toc-entry idref="id3a9c48ae3daf4161bef6df60a3230a7d" level="section">Sec. 108. Animal testing alternatives.</toc-entry> <toc-entry idref="id294582e684c540a2b2cc88ce74421420" level="section">Sec. 109. Preemption.</toc-entry> <toc-entry idref="id4fbc7624221342abba2ec2337840b774" level="section">Sec. 110. Reporting.</toc-entry> <toc-entry idref="id7DDB42D0690B45809BCBB632B3985CA3" level="section">Sec. 111. Small businesses.</toc-entry> <toc-entry idref="idBF1649BD1EFC4FB684B2BAC9D3F0FE81" level="section">Sec. 112. Applicability with respect to certain cosmetics.</toc-entry> <toc-entry idref="id1BF1739F573C401BAA4A7D09D45D234A" level="section">Sec. 113. Enforcement.</toc-entry> <toc-entry idref="id7941A0883C994AE78AD0F997B7EAF5D5" level="section">Sec. 114. Consumer information.</toc-entry> <toc-entry idref="id533c4e31958547f48d1e6734b0bcc81a" level="title">TITLE II—Fees related to cosmetic safety</toc-entry> <toc-entry idref="id0a038e43906348fbb72125329bb9d6ec" level="section">Sec. 201. Findings.</toc-entry> <toc-entry idref="idF8582C833DB94670B36E5EFFC0E021AA" level="section">Sec. 202. Authority to assess and use cosmetic safety fees.</toc-entry> <toc-entry idref="id863e1f88ac854a119ffe28408fcac753" level="section">Sec. 203. Direct hiring authority to support activities related to cosmetics.</toc-entry> </toc> </subsection></section><title id="id1de71f67a9f64c0bbd09462a1b28f305"><enum>I</enum><header>Cosmetic safety</header> <section id="idd3d0d60be8544672a21dab956559f74c"><enum>101.</enum><header>Registration of cosmetics facilities and cosmetic ingredient statements</header> <subsection id="id0F404B80D63F41B0BAD7DE04B1CFD968"><enum>(a)</enum><header>Amendments</header><text display-inline="yes-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>) is amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id138cde7a998344669d93373db45f67df" style="OLC">
	<section id="idE3AB574C8E0245669B699C49CDA11780"><enum>604.</enum><header>Definitions</header><text display-inline="no-display-inline">In this chapter:</text> <paragraph id="id778ae10b248045dd81e663f008b3ac5e"><enum>(1)</enum><header>Cosmetic formulation</header><text>The term <term>cosmetic formulation</term> means a preparation of cosmetic raw materials with a qualitatively and quantitatively set composition.</text>
	</paragraph><paragraph id="idd8bc4b18c5fb47cea56206731ca91d98"><enum>(2)</enum><header>Cosmetic product</header><text>The term <term>cosmetic product</term> 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.</text>
	</paragraph><paragraph id="id67222ba12eac4d88bd5171634355492e"><enum>(3)</enum><header>Facility</header><text>The term <term>facility</term> 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—</text>
	<subparagraph id="id3c43330baba842d787e0f7f66291f9a6"><enum>(A)</enum><text>beauty shops and salons that do not otherwise manufacture, process, or package cosmetics at that location;</text>
	</subparagraph><subparagraph id="idb3433f89a6b64447bd5b1e398ace3ab2"><enum>(B)</enum><text>cosmetic product retailers, including individual sales representatives, retail distribution facilities, and pharmacies, that do not otherwise manufacture, process, or package cosmetics at that location;</text>
	</subparagraph><subparagraph id="ide374ef07b8fa448faaa8c6c4a1e61971"><enum>(C)</enum><text>hospitals, physicians’ offices, and health care clinics;</text> </subparagraph><subparagraph id="id5440cda9d4ce41a297c77bf8a9d03efa"><enum>(D)</enum><text>public health agencies and other nonprofit entities that provide cosmetics directly to the consumer;</text>
	</subparagraph><subparagraph id="id197a308adf744f8ab644a01a62573c22"><enum>(E)</enum><text>hotels and other entities that provide complimentary cosmetics to guests;</text> </subparagraph><subparagraph id="id8e8a861e37c5473b990f72a147f3c330"><enum>(F)</enum><text>trade shows and other venues where cosmetic product samples are provided free of charge;</text>
	</subparagraph><subparagraph id="id02c543a2c679443080d3bce0f1a2bea3"><enum>(G)</enum><text>domestic manufacturers with less than $100,000 in gross annual sales of cosmetic products; or</text> </subparagraph><subparagraph id="id7C537FF001B24D288C4DA62F036BE779"><enum>(H)</enum><text>entities that manufacture or compound cosmetic products solely for use in research, teaching, or pilot plant production and not for sale.</text>
	</subparagraph></paragraph><paragraph id="id2983ad72d5754a43932112d62d09d29a"><enum>(4)</enum><header>Foreign facility</header><text>The term <term>foreign facility</term> 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.</text>
	</paragraph><paragraph id="idfef71304b7b24fef92571ce049966572"><enum>(5)</enum><header>Non-functional constituent</header><text>The term <term>non-functional constituent</term> 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.</text>
	</paragraph><paragraph commented="no" id="id16C99514A2194A228F7B59F9A4C1E0E5"><enum>(6)</enum><header>Responsible person</header><text>The term <term>responsible person</term> means—</text> <subparagraph commented="no" id="id6C238DD93B52400DB6695075EB36E1BB"><enum>(A)</enum><text>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</text>
	</subparagraph><subparagraph id="idf6b0e21839164dd690aa9a858434d44e"><enum>(B)</enum><text>a contract manufacturer who provides cosmetic products to the entities described in subparagraphs (A) through (H) of paragraph (3).</text></subparagraph></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block>
	<quoted-block display-inline="no-display-inline" id="idB4EA3D5C3EB1491098A9352592AFA26A" style="OLC">
	<section id="idf67675c7aa8e421aa0e1e19f8686d303"><enum>605.</enum><header>Registration of cosmetic facilities</header>
	<subsection id="id89a5fda184a14efcb3874e305fef1790"><enum>(a)</enum><header>Registration and fees for existing manufacturing or processing of cosmetics</header>
	<paragraph id="idF1ADAFE9BF2547FEA960A24B7928EC79"><enum>(1)</enum><header>Registration, in general</header><text>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.</text>
	</paragraph><paragraph id="id70A1901000B641238964603D2194B8C4"><enum>(2)</enum><header>Fees</header><text>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.</text>
	</paragraph></subsection><subsection id="iddc3a7a3fb41945479df823b603662247"><enum>(b)</enum><header>Registration for existing packing or holding of cosmetics</header><text>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.</text>
	</subsection><subsection id="id098e9038c2734bab901c6037363b389c"><enum>(c)</enum><header>Registration by new facilities</header><text>Any facility first engaging after the date of enactment of the <short-title>Personal Care Products Safety Act</short-title> 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).</text>
	</subsection><subsection id="id1A65DDDBD4084C8F890EA37B8B50429F"><enum>(d)</enum><header>Changes to information</header><text>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.</text>
	</subsection><subsection id="idd8816606334e4a2f810f3d95cb8557ca"><enum>(e)</enum><header>Format; contents</header>
	<paragraph id="id7DCE78EDD76A49768E3665414391D953"><enum>(1)</enum><header>Electronic format</header><text>Each registration shall be submitted using an electronic format, as specified in a registration form provided by the Food and Drug Administration.</text>
	</paragraph><paragraph id="idABA9354313A94ABB9A6AC0E1DDB99D2B"><enum>(2)</enum><header>Contents</header><text>The registration shall contain the following information:</text>
	<subparagraph id="id6aff3192774447b886a3fd17a29e322b"><enum>(A)</enum><text>Each facility’s name and full address, identifying the precise physical location of the facility.</text>
	</subparagraph><subparagraph id="id757e10c1258a4310b689070c4bdfde6b"><enum>(B)</enum><text>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).</text>
	</subparagraph><subparagraph id="id5c1ad05d79f34d80bc0c75a43fdef5c0"><enum>(C)</enum><text>All business trading names used by the facility.</text> </subparagraph><subparagraph id="id80dfc9b74ee443079bd042006ad87f6d"><enum>(D)</enum><text>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.</text>
	</subparagraph><subparagraph id="id2864a1a84f9e4d27851c36e58960b56a"><enum>(E)</enum><text>The type of activity conducted at the facility (such as manufacturing, processing, packing, or holding).</text>
	</subparagraph><subparagraph id="ideb8db1d2de664d418f952a6a3d869887"><enum>(F)</enum><text>The name, title, street address, telephone number, and electronic contact information of the emergency contact for the facility.</text>
	</subparagraph><subparagraph id="id6463dc6e427f4f75a301dae4cb9966ae"><enum>(G)</enum><text>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.</text>
	</subparagraph><subparagraph id="ide3b300331c6946e7874a0477e8fae57f"><enum>(H)</enum><text>The name, title, street address, telephone number, and electronic contact information of the individual submitting the registration.</text>
	</subparagraph><subparagraph id="id3CB6DF3B28AB486D87BD6AEEC5D4F371"><enum>(I)</enum><text>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.</text>
	</subparagraph><subparagraph id="id111D623E9B9B4EE1B54F0155C4D537BE"><enum>(J)</enum><text>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.</text>
	</subparagraph></paragraph><paragraph id="id37EEECD60DB54F0992B31B3DCFD4FC6F"><enum>(3)</enum><header>Abbreviated registration</header><text>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.</text>
	</paragraph></subsection><subsection id="idaa7d0b99e25245bcae0ce8f58f264be8"><enum>(f)</enum><header>Incomplete or inaccurate registration</header>
	<paragraph id="id645a96c2e40147b688211f6f1f9ceb26"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="idbcee329ecf5944a5a4f929076eba92d0"><enum>(2)</enum><header>Timely update or correction</header><text>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.</text>
	</paragraph></subsection><subsection id="id477da769545644f0b767d9107866207e"><enum>(g)</enum><header>Unique identifier</header><text>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.</text>
	</subsection><subsection id="id0b079513cc4f43099f08f6f5ed217f6b"><enum>(h)</enum><header>Registry of facilities</header>
	<paragraph id="id58761640764D4FC68AB640B71F1A284A"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="id09e21fc3ef394e27a55d7349a767afb9"><enum>(2)</enum><header>Public availability exceptions</header><text>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.</text>
	</paragraph></subsection></section><section id="idCDAEDD3D3E3F4F9AB139C04B63FD5FCA"><enum>606.</enum><header>Cosmetic ingredient statements</header>
	<subsection id="id68F5EB2441074EF2BFF9EC831C7B1C34"><enum>(a)</enum><header>In general</header><text>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.</text>
	</subsection><subsection id="id2a225c5407d545169cd30372d1231cd9"><enum>(b)</enum><header>Submission of a cosmetic ingredient statement</header>
	<paragraph id="idb04a69f24f8c498aac002bf6fc189aa0"><enum>(1)</enum><header>Existing cosmetic products</header><text>In the case of a cosmetic product that is marketed on the date of enactment of the <short-title>Personal Care Products Safety Act</short-title>, 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.</text>
	</paragraph><paragraph commented="no" id="id34a636426b994f45b37f453a797fd4f6"><enum>(2)</enum><header>Cosmetic ingredient statement for new cosmetic products</header>
	<subparagraph commented="no" id="idD0A00CDCFF6044B8BFAA964145421A25"><enum>(A)</enum><header>In general</header><text>Except as provided under subparagraph (B), in the case of a cosmetic product that is first marketed after the date of enactment of the <short-title>Personal Care Products Safety Act</short-title> 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.</text>
	</subparagraph><subparagraph commented="no" id="id95CFA052BA354DA38494BB498811F1C4"><enum>(B)</enum><header>Small businesses</header><text>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.</text>
	</subparagraph><subparagraph commented="no" id="idCAAAD849DBC243BE8CBE1C7F42F15B11"><enum>(C)</enum><header>Definition</header><text>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—</text>
	<clause commented="no" id="idc8e0610ee8d840349ed97233ead19eb1"><enum>(i)</enum><text>the amount of an existing ingredient if it is within the range previously reported under subsection (c)(2)(E); or</text>
	</clause><clause commented="no" id="idaaa9e9de4c564c39a40a8b8fe5d994a8"><enum>(ii)</enum><text>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.</text>
	</clause></subparagraph></paragraph></subsection><subsection id="id231ed9c388dd4667b6fe56a36848897f"><enum>(c)</enum><header>Format; contents</header>
	<paragraph id="id756B78EBA8F94057A7059DE87AB8269B"><enum>(1)</enum><header>Form</header><text>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.</text>
	</paragraph><paragraph id="idFC3D68CA72E24BD2BD0EA11B665A4244"><enum>(2)</enum><header>Contents</header><text>The cosmetic ingredient statement shall include the following information:</text>
	<subparagraph id="idefbe221ebd204db18bf51658cc98292b"><enum>(A)</enum><text>The unique identifier, assigned under section 605(g), as applicable, of—</text> <clause id="id5b603707b7a64ec5a83d032cb600b24a"><enum>(i)</enum><text>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</text>
	</clause><clause id="id1415aefe712845768a95c7fb63ec1df2"><enum>(ii)</enum><text>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).</text>
	</clause></subparagraph><subparagraph id="id28a3702c122346fa8098212ea24a6aea"><enum>(B)</enum><text>The brand name and the full name for the cosmetic product as it appears on the label.</text>
	</subparagraph><subparagraph id="id1e338f6f81244d9180914b8ac08c34c9"><enum>(C)</enum><text>The cosmetic product listing number, if any, previously assigned by the Food and Drug Administration under subsection (f) to the cosmetic product.</text>
	</subparagraph><subparagraph id="id93d83f17ce1c421894524185a34a0b5d"><enum>(D)</enum><text>The applicable cosmetic category for the cosmetic product.</text> </subparagraph><subparagraph id="id0c1bbdd76923464ea35a76a4f8a60b7c"><enum>(E)</enum><text>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—</text>
	<clause id="idceeca3a8f4b24164ab2227f80506052d"><enum>(i)</enum><text>a list of fragrances, flavors, and colors that may be included in the product, interchangeably, with ranges of possible amounts, which shall include—</text>
	<subclause id="ide101427699c34d6ea81e17740c9f0476"><enum>(I)</enum><text>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;</text>
	</subclause><subclause id="id772b62be3a5b4e978b00deb5153018a1"><enum>(II)</enum><text>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</text>
	</subclause><subclause id="ide9015bad7d04491cbf7ad5a26bb2415c"><enum>(III)</enum><text>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</text>
	</subclause></clause><clause id="iddf8b4d5e11e541d9b67f013530f90acb"><enum>(ii)</enum><text>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.</text>
	</clause></subparagraph><subparagraph id="id0a18783f06c34c8891287502fb879516"><enum>(F)</enum><text>The title and full contact information of each individual submitting the statement.</text> </subparagraph><subparagraph id="idC4F4CAF623EA409A8D2267A80353EF92"><enum>(G)</enum><text>If applicable, information on the labeling required under section 614.</text>
	</subparagraph><subparagraph id="id8e3cd4cf52d2453abdeb2ece19eee42a"><enum>(H)</enum><text>Such additional information pertaining to the cosmetic product as the Food and Drug Administration may require.</text>
	</subparagraph></paragraph><paragraph commented="no" id="id4854864A8861458D8EED11CB80CE4743"><enum>(3)</enum><header>Cosmetic ingredient statement for certain small businesses</header>
	<subparagraph commented="no" id="idD48953CA20134621A45D9195C845EA78"><enum>(A)</enum><header>In General</header><text>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—</text>
	<clause commented="no" id="id918E596236A04574819AD597BAE13B22"><enum>(i)</enum><text>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</text>
	</clause><clause commented="no" id="id6300D587FFC540C38CF0863D63C97A9A"><enum>(ii)</enum><text>has had an average of less than $500,000 in annual domestic cosmetic sales over the previous 3 years.</text>
	</clause></subparagraph><subparagraph commented="no" id="idCCF6020BAF9B4D21B74F7DDE9EB73C07"><enum>(B)</enum><header>Contents</header><text>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.</text>
	</subparagraph></paragraph></subsection><subsection id="id9b192ec980f24a839c3f650b061f093e"><enum>(d)</enum><header>Incomplete or inaccurate cosmetic ingredient statement</header>
	<paragraph id="id22f374e1333c43118424f85300ef8700"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="id996b87ec88684a0e9d18377c87272ff0"><enum>(2)</enum><header>Notice of nullification</header><text>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.</text>
	</paragraph><paragraph id="id164fa426d4754e77af6df46638f59107"><enum>(3)</enum><header>Timely update or correction</header><text>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.</text>
	</paragraph></subsection><subsection id="ide6d0d7f5ca1648b3b87f667058de15cf"><enum>(e)</enum><header>Additional requirements</header>
	<paragraph id="id7160b598009047b9bbd4a709bd06d128"><enum>(1)</enum><header>Safety requirements</header><text>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.</text>
	</paragraph><paragraph id="idF4AAC5E681704C209F582B78FFD8EB55"><enum>(2)</enum><header>Abbreviated filing</header><text>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.</text>
	</paragraph><paragraph commented="no" id="id9A149DC290114DCFA461BAF3B922F1BC"><enum>(3)</enum><header>Changes to information</header>
	<subparagraph commented="no" id="id8B6B6854E5FA4177B94AAD4FEE274827"><enum>(A)</enum><header>In General</header><text>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—</text>
	<clause commented="no" id="id9c34c2c42f654db0a4ea8739dc14b8bc"><enum>(i)</enum><text>the amount of an existing ingredient if it is within the range previously reported under subsection (c)(2)(E); or</text>
	</clause><clause commented="no" id="id9de89dbb53ab44eea53742b5c11c60ad"><enum>(ii)</enum><text>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.</text>
	</clause></subparagraph><subparagraph commented="no" id="idAD383C78D2674D559EE394EA581CF805"><enum>(B)</enum><header>Small business</header><text>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).</text>
	</subparagraph></paragraph></subsection><subsection id="idbc05efadffd74a6da196957395cc8e45"><enum>(f)</enum><header>Cosmetic products list</header><text>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.</text>
	</subsection></section><section id="id8ef0a31ca95d4428b908997a38b42fa7"><enum>607.</enum><header>Suspension of registration or cosmetic ingredient statement</header>
	<subsection id="id0788ea0afb1f46a6ab83ae371a3f594e"><enum>(a)</enum><header>Suspension of registration of a facility</header><text>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.</text>
	</subsection><subsection id="id97049bcba31641e29b4f7990d5e1d83f"><enum>(b)</enum><header>Suspension of cosmetic ingredient statement</header><text>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.</text>
	</subsection><subsection id="id7479a076412d4963ae748550484df59f"><enum>(c)</enum><header>Notice of suspension</header><text>Before suspending a facility registration or a cosmetic ingredient statement under this section, the Food and Drug Administration shall provide—</text>
	<paragraph id="idf95ec4a8e25e4d588bc5b6e5f4746c66"><enum>(1)</enum><text>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</text>
	</paragraph><paragraph id="id852976ffff6446ceaa744e360fd25635"><enum>(2)</enum><text>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.</text>
	</paragraph></subsection><subsection id="id1708508581084600970553d179f0441d"><enum>(d)</enum><header>Reinstatement</header><text>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.</text>
	</subsection><subsection id="id7cf40472e91a4538803ce57db1f4dae0"><enum>(e)</enum><header>Effect of suspension</header>
	<paragraph id="id0513d4fc61644b0ba7498296f0a013fb"><enum>(1)</enum><header>Registration</header><text>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.</text>
	</paragraph><paragraph id="id065ef01583514ae19e1fbf2877cd50c2"><enum>(2)</enum><header>Cosmetic ingredient statement</header><text>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.</text>
	</paragraph></subsection><subsection id="id460766988eb54bfa80ef89b7f7e2b278"><enum>(f)</enum><header>No delegation</header><text>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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</subsection></section><section id="id4F0351E334E74236982370132C0E0BC7"><enum>102.</enum><header>Review of ingredients and non-functional constituents; safety of finished products</header>
	<subsection id="idC08F73AAC0EF465789F1F3105479D052"><enum>(a)</enum><header>Amendments</header><text display-inline="yes-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 101, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="idBD4CADF2D20E4D2780BA0614B54B9B92" style="OLC">
	<section id="id3DA305D12F9B43EE98EDADB5D55F345C"><enum>608.</enum><header>Review of ingredients and non-functional constituents</header>
	<subsection id="idc6565fbded6241839c4e2a913813d011"><enum>(a)</enum><header>Ingredients and non-Functional constituents subject to review</header>
	<paragraph id="id193886d0fe634af986a9520156a7e27f"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="idADFF809E20A545C3B95DC94BFE30AD07"><enum>(2)</enum><header>Public notice and comment</header><text>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.</text>
	</paragraph><paragraph id="idE60B58AB39554326B7E777AB1C4A3F37"><enum>(3)</enum><header>Cosmetic ingredients</header>
	<subparagraph id="idE945F5BAD0DF46F3B1D431466CBFA4EA"><enum>(A)</enum><header>Ingredients to be considered in first year</header><text>During fiscal year 2016, the Food and Drug Administration shall initiate the review for safety of the following cosmetic ingredients:</text>
	<clause id="idE7764105AD704F368DEA7288FA2BC74E"><enum>(i)</enum><text>Diazolidinyl urea.</text> </clause><clause id="idC8A72FB6AA1240E19BFC9CEEFA358B33"><enum>(ii)</enum><text>Lead acetate.</text>
	</clause><clause id="id57BC9DC2AC4047F2AD2678D4459397B3"><enum>(iii)</enum><text>Methylene glycol/methanediol/formaldehyde.</text> </clause><clause id="id76D1427F207544609B7026A5C9A0FBEA"><enum>(iv)</enum><text>Propyl paraben.</text>
	</clause><clause id="id1EE5E58A22564C1FBC11F8E39995E8F6"><enum>(v)</enum><text>Quaternium-15.</text> </clause></subparagraph><subparagraph id="idBE925E0D39554B94AF5B660A33B5786F"><enum>(B)</enum><header>Ingredients to be considered in subsequent years</header> <clause id="id85CA1B33F0334937A6F5A8E4D5849187"><enum>(i)</enum><header>In general</header><text>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).</text>
	</clause><clause id="idC67B68FACF534E1282705D1D00116DD8"><enum>(ii)</enum><header>Considerations</header><text>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).</text>
	</clause><clause id="id2D3CEF340B26489BA59EFBE517B134F1"><enum>(iii)</enum><header>Consultation</header><text>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.</text>
	</clause></subparagraph></paragraph><paragraph id="id652C88198DF0408D8AB0BC5E13A2863B"><enum>(4)</enum><header>Comment period</header><text>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.</text>
	</paragraph></subsection><subsection id="idef4795f1fd3948a986fa33a996ad6147"><enum>(b)</enum><header>List</header><text>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).</text>
	</subsection><subsection id="id49cab7781a6e42788e0be0a8db9c1eb7"><enum>(c)</enum><header>Initiative of the FDA</header><text>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).</text>
	</subsection><subsection id="idf34dbe85da844f949bbb82ceeaded118"><enum>(d)</enum><header>Determination on safety</header>
	<paragraph id="idCC3B7FEF588A4F7DBC5645C91BF9F143"><enum>(1)</enum><header>Initial proposed administrative order</header><text>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 <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter 5</external-xref> of title 5, United States Code.</text>
	</paragraph><paragraph id="id440589EE2B6946E6AD5EA7D4CEE0F394"><enum>(2)</enum><header>Public comment</header><text>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.</text>
	</paragraph><paragraph id="id11103688A1B04479BEF95E01A3992DE4"><enum>(3)</enum><header>Final administrative order</header><text>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 <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter 5</external-xref> of title 5, United States Code.</text>
	</paragraph><paragraph id="id06DF16AEDBE441618FEBF5E6C4E5730E"><enum>(4)</enum><header>Determinations</header><text>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—</text>
	<subparagraph id="id6053d3896b34431a8d93120840035f6f"><enum>(A)</enum><text>safe in cosmetic products under specified conditions of use or tolerances;</text> </subparagraph><subparagraph id="id28f07c9bd1784f68a6979096f4acf8a5"><enum>(B)</enum><text>safe in cosmetic products without the need for specified conditions of use or tolerances; or</text>
	</subparagraph><subparagraph id="id0676f8bdfcc844f59bd179a0972fb14b"><enum>(C)</enum><text>not safe in cosmetic products.</text> </subparagraph></paragraph><paragraph id="iddf64d1ec8c01435a8b23e35fce413b39"><enum>(5)</enum><header>Conditions of use and tolerances</header><text>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—</text>
	<subparagraph id="ida623cc2c80c14f1db7801ca01f3e170a"><enum>(A)</enum><text>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;</text>
	</subparagraph><subparagraph id="id0a468965c4524db8a0bbc3875b9ec405"><enum>(B)</enum><text>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</text>
	</subparagraph><subparagraph id="id25566f729bc54f54a10fc1bb7abf04e8"><enum>(C)</enum><text>such other conditions as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent.</text>
	</subparagraph></paragraph><paragraph id="idb4f98725ff414ecda820d63a4506ca06"><enum>(6)</enum><header>Public notice</header><text>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.</text>
	</paragraph></subsection><subsection id="id571c912a1bd6407d87c6eec90bfa14f0"><enum>(e)</enum><header>Order</header><text>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.</text>
	</subsection><subsection id="id2fcce617f88c485fb130d25d5f6777f0"><enum>(f)</enum><header>Modification of an order</header><text>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.</text>
	</subsection><subsection id="id3d0c25fdad5e41258b99acab3c35aec5"><enum>(g)</enum><header>Inadequate evidence</header>
	<paragraph id="idb04181d8144840b2ad708ab39560d48d"><enum>(1)</enum><header>Notice; Extension</header><text>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—</text>
	<subparagraph id="ide1f0508611b3414e8144c12ae60d632a"><enum>(A)</enum><text>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</text>
	</subparagraph><subparagraph id="id46D92CD9AD5048FB93DD41F7D698E221"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id93E98437EB5E48E98F82958B09831398"><enum>(i)</enum><text>include a notice providing interested persons an additional 30 days from the notice date to provide additional data and information; and</text>
	</clause><clause id="id90D5105C56164543AD0065E8BA4B883C" indent="up1"><enum>(ii)</enum><text>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.</text>
	</clause></subparagraph></paragraph><paragraph id="idd179f2e89ac94d17bf5e59d022dee151"><enum>(2)</enum><header>Determination; Order</header>
	<subparagraph id="id503264C69E2A4C32A70EEA6CCE719B8E"><enum>(A)</enum><header>Inadequate data and information</header><text>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—</text>
	<clause id="id8780568597C74CBAB93B728A16C537E2"><enum>(i)</enum><text>making a determination that the ingredient or non-functional constituent has not been shown to be safe in cosmetic products; and</text>
	</clause><clause id="id34B58C9C433D4B298A16DAF867DB3172"><enum>(ii)</enum><text>explaining why the available data and information are not adequate to assess the safety of the ingredient or non-functional constituent.</text>
	</clause></subparagraph><subparagraph id="id1657550EE75841D6A6B18970095FC387"><enum>(B)</enum><header>Adequate data and information</header><text>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.</text>
	</subparagraph></paragraph></subsection><subsection id="iddcc13979bc81476ea375196a5b34b184"><enum>(h)</enum><header>Safety assessment</header>
	<paragraph id="idfbeca889556f4d0a9ec1a132d6e2b099"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="id8c7bbaa6b1444a24ae405643523fa7e6"><enum>(2)</enum><header>Factors</header><text>In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider, among other relevant factors, the following:</text>
	<subparagraph id="ideef171da2b5a4e0ba33aabf403e300f8"><enum>(A)</enum><text>The probable human exposure to the ingredient or non-functional constituent from expected use in cosmetics.</text>
	</subparagraph><subparagraph id="id8e3847e013a347c5b73af6a173bd2042"><enum>(B)</enum><text>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.</text>
	</subparagraph><subparagraph id="id1d1a8f69cb504cf89d3a09f72d7851ef"><enum>(C)</enum><text>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.</text>
	</subparagraph></paragraph><paragraph id="idfbc0fb196080421e8ef04b03ea6db3e4"><enum>(3)</enum><header>Data and information</header>
	<subparagraph id="id40d0df0f51494e709b8f328185fe1ef7"><enum>(A)</enum><header>Required information</header><text>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.</text>
	</subparagraph><subparagraph id="id51dc8d400c76435e9c590468df9cfd17"><enum>(B)</enum><header>Additional relevant information</header><text>The Food and Drug Administration shall consider any other relevant information related to the safety of the ingredient or non-functional constituent, including—</text>
	<clause id="idb056bee0be454134a00387305bd12fbb"><enum>(i)</enum><text>adverse event reports;</text> </clause><clause id="id17ee6cd0d0ff4f1a89b2afc0e385558e"><enum>(ii)</enum><text>findings and information from State, Federal, national, and international entities and other bodies composed of scientific and medical experts;</text>
	</clause><clause id="id3ad126ed1a814525bbe33967c04983b2"><enum>(iii)</enum><text>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</text>
	</clause><clause id="id75847a7028e647c59fc6dff9aa905d67"><enum>(iv)</enum><text>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.</text>
	</clause></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	<quoted-block display-inline="no-display-inline" id="id9CC958BA0FFA46A4B9CBF092D546E5CF" style="OLC">
	<section id="id956e1e2509ac45f8bd14d351f751750d"><enum>609.</enum><header>Safety of finished cosmetic products</header>
	<subsection id="idbd3f44bc64ba4c1181aca42e84ea8cef"><enum>(a)</enum><header>Determination</header>
	<paragraph id="id9694af42e6944b41a21e245dc1d6659f"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="id076f28584a734a0aa17ce9a2abaa09ac"><enum>(2)</enum><header>New information</header><text>If new information relevant to the determination becomes available, the responsible person shall promptly update the determination to address that information.</text>
	</paragraph><paragraph id="id45B0ECB6CD454C9CB3E5C8B7FE1AB725"><enum>(3)</enum><header>Safety with respect to ranges of possible amounts</header><text>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.</text>
	</paragraph></subsection><subsection id="idf45fca8cc9c34d20813859105f8f4519"><enum>(b)</enum><header>Presumption of adequate evidence</header>
	<paragraph id="idfbf0b75f5a5140ae8f69b4ffe47282c3"><enum>(1)</enum><header>In general</header><text>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—</text>
	<subparagraph id="idb6360fa09d9b4ab99da096806bfb8a67"><enum>(A)</enum><text>with respect to each ingredient in the finished product—</text> <clause id="id64c7d58b32a249fea76efc3a35400354"><enum>(i)</enum><text>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</text>
	</clause><clause id="ide0c93276787e4d9db8dff9888080c913"><enum>(ii)</enum><text>appropriate safety testing of the ingredient; and</text> </clause></subparagraph><subparagraph id="idf7945013304e4e609f52479a44c2c16e"><enum>(B)</enum><text>appropriate safety substantiation of the finished product beyond the safety substantiation of individual ingredients and consideration of the combination of ingredients.</text>
	</subparagraph></paragraph><paragraph id="id2af9c50b6531449fa5cc2706157560c2"><enum>(2)</enum><header>Statement of an expert medical or scientific body</header><text>For purposes of this section, a statement of an expert medical or scientific body is an official statement of that body, if—</text>
	<subparagraph id="ideb2ed469ad694164bf0617677b6adeea"><enum>(A)</enum><text>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;</text>
	</subparagraph><subparagraph id="ida9d419a9ebf24334b735abdd21fa2ee0"><enum>(B)</enum><text>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</text>
	</subparagraph><subparagraph id="idfb53ff3061e44afdb9f2a3a0a30e81a7"><enum>(C)</enum><text>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.</text>
	</subparagraph></paragraph></subsection><subsection id="id9aef749a61214e7fb5f1a1065605120b"><enum>(c)</enum><header>Rebuttal of presumption</header><text>Notwithstanding subsection (b), a determination under subsection (a) will not be presumed to be based on adequate evidence if—</text>
	<paragraph id="idb5493570074548ef8cbb31610927bfc6"><enum>(1)</enum><text>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</text>
	</paragraph><paragraph id="id371c1fd0025740b1a03ed0fcc8a05aa5"><enum>(2)</enum><text>the Food and Drug Administration has provided the manufacturer with notice that—</text> <subparagraph id="idcecd3054fc8d40e8a1bcb79d25e0efff"><enum>(A)</enum><text>the manufacturer has not met the criteria under subsection (b); or</text>
	</subparagraph><subparagraph id="id85e4b49e6e014d2ea5cab9b5a904b4a2"><enum>(B)</enum><text>the Food and Drug Administration has information that raises significant questions about the safety of the product or any of its ingredients.</text>
	</subparagraph></paragraph></subsection><subsection id="id8ce618daaba8473894ebdddf8e68de83"><enum>(d)</enum><header>Timely update</header><text>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.</text>
	</subsection><subsection id="idaa1fd1842b75442188cbd7448387b9ee"><enum>(e)</enum><header>Records maintenance</header><text>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.</text>
	</subsection><subsection id="id62cf10cb4c6447af8a297ffc367f9508"><enum>(f)</enum><header>Submission of records</header>
	<paragraph id="id19D5E2962FB04D60991B8565FFAACEA9"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="idEA097374ACC94103AD9BDDE46EB54547"><enum>(2)</enum><header>Criteria</header><text>The Food and Drug Administration may require records under paragraph (1) if—</text> <subparagraph id="id229B6110E6AF47A0BCFDD0AFFD3E756D"><enum>(A)</enum><text>the Food and Drug Administration has a reasonable belief, described in written notice, that—</text>
	<clause id="id19101B7E28084A64B9927AC401B1897F"><enum>(i)</enum><text>the finished product may be harmful based on adverse event reports or other scientific information;</text> </clause><clause id="id32D179D9700F478F8272034D2CCD5DA4"><enum>(ii)</enum><text>scientific information raises credible and relevant questions about the safety of the product or any of its ingredients;</text>
	</clause><clause id="idC6EA46A516364A9E8068DC79790C9963"><enum>(iii)</enum><text>the responsible person has not made the determination required under subsection (a), or such determination is not supported by adequate evidence; or</text>
	</clause><clause id="id13EA265E83E543FEBDFAD6D86168AF52"><enum>(iv)</enum><text>one or more of the criteria to establish a presumption of adequate evidence of safety in subsection (b) has not been satisfied;</text>
	</clause></subparagraph><subparagraph id="idE2582E16F85540CC9639112947266077"><enum>(B)</enum><text>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</text>
	</subparagraph><subparagraph id="id985857E104F1492586EC5BEE6F366548"><enum>(C)</enum><text>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.</text>
	</subparagraph></paragraph></subsection><subsection id="idecff9e1396494cc99dee4ebe3c998b85"><enum>(g)</enum><header>Guidance and regulations</header>
	<paragraph id="id3E6EBC5D3DC949DC8BF16C7D015BE8FC"><enum>(1)</enum><header>In General</header><text>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.</text>
	</paragraph><paragraph id="id243CB7AD59004B29A15606735A56D171"><enum>(2)</enum><header>Small businesses</header><text>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.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</subsection><subsection id="idB0D56E4C7AF245E2B02524049BE1ED17"><enum>(b)</enum><header>Effective date</header><text>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.</text>
	</subsection></section><section commented="no" id="idcdfea0dbebed4f69aea543849ee865d3"><enum>103.</enum><header>Good manufacturing practices for cosmetics</header>
	<subsection commented="no" id="idC54F7C5A95DA427AA32FD698095BB515"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 102, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id8180F00DF85247CA88809F19CFD682CE" style="OLC">
	<section id="idB2F8FF147DF44612B6D0911103E06AF5"><enum>610.</enum><header>Good manufacturing practices for cosmetics</header>
	<subsection id="idE45E9CEC2C5C477A88E808F127E0DC2C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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 <short-title>Personal Care Products Safety Act</short-title> 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.</text>
	</subsection><subsection id="id76E3970130C849D98C3E6A52AF205372"><enum>(b)</enum><header>Timeframe</header><text display-inline="yes-display-inline">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 <short-title>Personal Care Products Safety Act</short-title> and shall publish a final such rule not later than 3 years after such date of enactment.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</subsection><subsection id="idb2e6b2e0dd244d83a19ae78655a5dd9b"><enum>(b)</enum><header>Effective date for cosmetic manufacturers</header>
	<paragraph id="idd811fe391f9d43508087ec55f14c2716"><enum>(1)</enum><header>Large businesses</header><text>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.</text>
	</paragraph><paragraph id="id50cf008961ab47b0b7a2d7879b11d8f5"><enum>(2)</enum><header>Small businesses</header><text>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.</text>
	</paragraph></subsection><subsection commented="no" id="id817CF4D1AC6C44B28FDAC1691C8815C7"><enum>(c)</enum><header>Enforcement</header><text display-inline="yes-display-inline">Section 601 of Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361</external-xref>) is amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="iddefa14c526684aa5abe999e774f4c0c4" style="OLC">
	<subsection commented="no" id="iddbdd5ddb06d24cfd8f1c6fd62b9ecda2"><enum>(f)</enum><text>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.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
	</subsection></section><section id="ida991f07e8ba34f39a09c2fedaa1d3a22"><enum>104.</enum><header>Adverse event reports</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 103(a), is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="idea95976843024439a02b4a0a44f23657" style="OLC">
	<section id="id95eefa66e84f41fa9f4c16b711031540"><enum>611.</enum><header>Adverse event reporting for cosmetics</header>
	<subsection id="id2bf5a164a2d94edfa8a35c40fd192c05"><enum>(a)</enum><header>In general</header><text>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.</text>
	</subsection><subsection id="ide8a7d9402c7d4ae083734cc12a1248e7"><enum>(b)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="idb03193dcb3e74e088585d47438e0f684"><enum>(1)</enum><text>An <term>adverse event</term> for a cosmetic product is a health-related event associated with the use of this product that is adverse.</text>
	</paragraph><paragraph id="idbd046fa5712547d08f91420ed604e7dc"><enum>(2)</enum><text>A <term>serious adverse event</term> for a cosmetic product is an adverse event that—</text> <subparagraph id="ideae9e0b5d3f34835b4c80545d07b585b"><enum>(A)</enum><text>results in—</text>
	<clause id="id1cc404225d2645479372bc9c90bf2e0a"><enum>(i)</enum><text>death;</text> </clause><clause id="id1441d72d56924913b2a499683da28ca7"><enum>(ii)</enum><text>a life-threatening experience;</text>
	</clause><clause id="ide34187a7613d478d949f83599444470f"><enum>(iii)</enum><text>inpatient hospitalization;</text> </clause><clause id="id882861bab82746ca9b7852a9247296ec"><enum>(iv)</enum><text>a persistent or significant disability or incapacity;</text>
	</clause><clause id="ida6151271b859407d9ccbf55b3f4fde63"><enum>(v)</enum><text>congenital anomaly or birth defect; or</text> </clause><clause id="idea45eb6454d54b4bbe7ac58d5fe4e826"><enum>(vi)</enum><text>significant disfigurement, including serious and persistent rashes and infections; or</text>
	</clause></subparagraph><subparagraph id="id79f77df1aae345299d7707df317f19d1"><enum>(B)</enum><text>requires, based on appropriate medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).</text>
	</subparagraph></paragraph></subsection><subsection id="id0302500e87394a02adb32557fd47c9ed"><enum>(c)</enum><header>Submission of reports</header>
	<paragraph id="id61a2b864d01148368d7167f62dd6ffeb"><enum>(1)</enum><header>Serious adverse event reports</header><text>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.</text>
	</paragraph><paragraph id="idbc949e5f22654b40ba0008029c7f9d47"><enum>(2)</enum><header>New medical information</header><text>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.</text>
	</paragraph><paragraph id="idc29579525b45486b9bcc1b16951624f3"><enum>(3)</enum><header>Annual report</header>
	<subparagraph id="id37F180D24B854A398C8365863AD849CC"><enum>(A)</enum><header>In general</header><text>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.</text>
	</subparagraph><subparagraph id="id3E3A22608415486C842B4E4C6784AE17"><enum>(B)</enum><header>Contents</header><text>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.</text>
	</subparagraph></paragraph><paragraph id="idb570f0b551c94959abfe77d64e47e62f"><enum>(4)</enum><header>Exemption</header><text>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.</text>
	</paragraph></subsection><subsection id="idd66b5b4e4ee3440b9e170a5d86238a1f"><enum>(d)</enum><header>Requirements</header>
	<paragraph id="id89A3EDF8BC794C36B9001AC7B052975D"><enum>(1)</enum><header>In general</header><text>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 <short-title>Personal Care Products Safety Act</short-title>.</text>
	</paragraph><paragraph id="idD7CD7D3C3C9D4AAFAE97C5053FE36A15"><enum>(2)</enum><header>Modification</header><text>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.</text>
	</paragraph><paragraph id="id56131cd37eba4793b1bc405318ffa070"><enum>(3)</enum><header>Scope of serious adverse event report</header><text>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—</text>
	<subparagraph id="id69f518393eb046698e7e5e20088a9bce"><enum>(A)</enum><text>a report under section 756 with respect to safety and related to a specific cosmetic product;</text> </subparagraph><subparagraph id="idE683B1F4ED9948EBB599FA4B8A591EDE"><enum>(B)</enum><text>a record about an individual who suffered the serious adverse event under section 552a of title 5, United States Code;</text>
	</subparagraph><subparagraph id="idD345C11766A24E8FA6F7BC84A8738FF2"><enum>(C)</enum><text>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</text>
	</subparagraph><subparagraph id="idA5B282FC58A34870A79455053263210B"><enum>(D)</enum><text>contact information for the individual reporting the serious adverse event.</text> </subparagraph></paragraph><paragraph id="id94fe9237f0b146249e03612cd9a635e4"><enum>(4)</enum><header>Responsibility to gather information</header><text>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.</text>
	</paragraph><paragraph id="id682638B3A3C94D6A9EC4A4B3B992FB00"><enum>(5)</enum><header>No adverse events to report</header><text>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.</text>
	</paragraph></subsection><subsection id="id37748D3CAEFD40BEBC61AB25CB5B3AAA"><enum>(e)</enum><header>Limitation with respect to adverse event reports</header><text>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.</text>
	</subsection><subsection id="id182255b27c0d40f8a8ba96c3e3147802"><enum>(f)</enum><header>Contact information</header><text>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.</text>
	</subsection><subsection id="idA89298A800634E7C8625C5884F530EDD"><enum>(g)</enum><header>Maintenance of records</header><text>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.</text>
	</subsection><subsection id="idA22D9B5C510B4BA0A56D0E46F0B219AB"><enum>(h)</enum><header>Availability to States</header><text>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.</text>
	</subsection><subsection id="id914B60747C2042A8B286E0E50E302350"><enum>(i)</enum><header>Effective date of requirement with respect to serious adverse events</header><text>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).</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="idc861ae78948045b295993db51b8d99d2"><enum>105.</enum><header>Records inspection; mandatory recall authority</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 104, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id9c2837fde5534dc6b28dbb1f23a2f690" style="OLC">
	<section id="idf1af633b27b746a3be04b045921fe174"><enum>612.</enum><header>Inspection of cosmetic records</header>
	<subsection id="id38932748b4914a9c8a0588ef218b4c94"><enum>(a)</enum><header>Inspection of records</header><text>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—</text>
	<paragraph id="idf844c3e0894b4472a1d5f67b52a45ee5"><enum>(1)</enum><text>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</text>
	</paragraph><paragraph id="idfb76ba794c274583a134e9419134829f"><enum>(2)</enum><text>except as provided in subsection (b), all other records, if the Food and Drug Administration—</text> <subparagraph id="id824B00FE0AB94D9F932C0FEB19DB40E5"><enum>(A)</enum><text>has a reasonable belief that the cosmetic—</text>
	<clause id="id64d238d0a76344d9bfedaa92e0fa28b6"><enum>(i)</enum><text>is adulterated;</text> </clause><clause id="id921c121cdace4c2fbd094f6dada94980"><enum>(ii)</enum><text>has caused a reportable serious adverse event; or</text>
	</clause><clause id="id3cb3d7348a194b7a933d1959010a4a93"><enum>(iii)</enum><text>contains an ingredient that substantial new scientific information shows may be unsafe when present in a cosmetic; and</text>
	</clause></subparagraph><subparagraph id="id5A6F74BAFC8C455786E14985ED1ACEB3"><enum>(B)</enum><text>provides written notice of the basis for the Food and Drug Administration’s reasonable belief described in subparagraph (A).</text>
	</subparagraph></paragraph></subsection><subsection id="id3da5e71d218b45eeb6bb5b525fa6fc7e"><enum>(b)</enum><header>Exclusions</header><text>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.</text>
	</subsection><subsection id="id9c0b8f30ebe141f5bf7cf1eb6dfae7d9"><enum>(c)</enum><header>Scope</header><text>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.</text>
	</subsection><subsection id="id7e86dbb993d940a5a7b3475838ae5ebf"><enum>(d)</enum><header>Protection of sensitive information</header><text>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.</text>
	</subsection><subsection id="ida7b4525bc2a94429bee119c0cb1fb974"><enum>(e)</enum><header>Limitations</header><text>This section shall not be construed—</text> <paragraph id="id0c94698089bb4b6b872ca1da6f9a4f5f"><enum>(1)</enum><text>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</text>
	</paragraph><paragraph id="idc70f88035a8e44e79e6524d7ac6bdbf3"><enum>(2)</enum><text>to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	<quoted-block display-inline="no-display-inline" id="idD18EB43F1B5C4134BEC11D3275675EE2" style="OLC">
	<section id="id19056b7ab9b84cf8828634429be786d9"><enum>613.</enum><header>Mandatory recall authority</header>
	<subsection id="id59e5f1f1b493473c973a4d1bbee4cbcf"><enum>(a)</enum><header>Voluntary procedures</header><text>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.</text>
	</subsection><subsection id="id56da150c386e45d394aac07c0f6b4344"><enum>(b)</enum><header>Prehearing order To mandatorily cease distribution and give notice</header>
	<paragraph id="id735b9d6e95d346a682187ca6b6150153"><enum>(1)</enum><header>In general</header><text>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—</text>
	<subparagraph id="ide191392593744a57a16e32a8fe556b6f"><enum>(A)</enum><text>immediately cease distribution of such cosmetic; and</text> </subparagraph><subparagraph id="idb64949ad64aa46e49488420adfcc8a40"><enum>(B)</enum><text>as applicable, immediately notify all persons—</text>
	<clause id="idba9c000da6524b298cd0d5f0d16ad6a5"><enum>(i)</enum><text>manufacturing, processing, packing, transporting, holding, receiving, distributing, or importing and selling such cosmetic; and</text>
	</clause><clause id="id2ec983f4ef214d3f99d5ed7450fde61e"><enum>(ii)</enum><text>to which such cosmetic has been distributed, transported, or sold,</text> </clause><continuation-text continuation-text-level="subparagraph">to immediately cease distribution of such cosmetic.</continuation-text></subparagraph></paragraph><paragraph id="idff37c61afa0e4d70bb3a30404b77ad38"><enum>(2)</enum><header>Required additional information</header> <subparagraph id="idc2f5c63aaca443778bab8276868fa8dc"><enum>(A)</enum><header>In general</header><text>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.</text>
	</subparagraph><subparagraph id="ida828c41407f64e34b2c6ee81a2809a94"><enum>(B)</enum><header>Rules of construction</header><text>Nothing in this paragraph shall be construed—</text> <clause id="id82f7c1232688413c901ad3fc3e43423b"><enum>(i)</enum><text>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</text>
	</clause><clause id="id6792e4c82cbb424aad01376aec3427d6"><enum>(ii)</enum><text>to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order.</text>
	</clause></subparagraph></paragraph><paragraph id="id2dc00491feef48d2a0e99f05435fba7a"><enum>(3)</enum><header>Determination to limit areas affected</header><text>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.</text>
	</paragraph></subsection><subsection id="id1e6080eb9b6a442ab123d494f7d1326e"><enum>(c)</enum><header>Hearing on order</header><text>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.</text>
	</subsection><subsection id="id168e183138914035b372710e726b4ba3"><enum>(d)</enum><header>Post-Hearing recall order and modification of order</header>
	<paragraph id="id81e46fdc151446cfb3793351c57b6e7d"><enum>(1)</enum><header>Amendment of order</header><text>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—</text>
	<subparagraph id="idb5605bb7a0d149439c65ec2a2b20ab2a"><enum>(A)</enum><text>amend the order to require recall of such cosmetic or other appropriate action;</text> </subparagraph><subparagraph id="id25c86ee60f0d4e28855f3042fa625034"><enum>(B)</enum><text>specify a timetable in which the recall shall occur;</text>
	</subparagraph><subparagraph id="idb85ecabcde394b838a55d9696bd3943e"><enum>(C)</enum><text>require periodic reports to the Food and Drug Administration describing the progress of the recall; and</text>
	</subparagraph><subparagraph id="ideb001a458b354e6a8afb64a90eb61dfc"><enum>(D)</enum><text>provide notice to consumers to whom such cosmetic was, or may have been, distributed.</text> </subparagraph></paragraph><paragraph id="idc859cb489cae4cd2ba7e3f17c380e19d"><enum>(2)</enum><header>Vacating of order</header><text>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.</text>
	</paragraph></subsection><subsection id="ideac775acae0b424293a191e8483570d4"><enum>(e)</enum><header>Cooperation and consultation</header><text>The Food and Drug Administration shall work with State and local public health officials in carrying out this section, as appropriate.</text>
	</subsection><subsection id="id536aadfe4a184bbaa0ddb74268da22b5"><enum>(f)</enum><header>Public notification</header><text>In conducting a recall under this section, the Food and Drug Administration shall—</text> <paragraph id="id541f9aaf1ec3486680bcbc1fee7b81db"><enum>(1)</enum><text>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—</text>
	<subparagraph id="idb814112358a34ce4abca98c70b18274a"><enum>(A)</enum><text>of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and</text>
	</subparagraph><subparagraph id="id842bb7f72f924ae682bf0e2dd18511db"><enum>(B)</enum><text>that includes, at a minimum—</text> <clause id="id95a4dccaac6e40c69b9d69e2d56cd4d1"><enum>(i)</enum><text>the name of the cosmetic subject to the recall;</text>
	</clause><clause id="id80be0989e5674c96899c0f9382c51e36"><enum>(ii)</enum><text>a description of the risk associated with such article; and</text> </clause><clause id="id736e50216049440891af1adb560ff3b3"><enum>(iii)</enum><text>to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and</text>
	</clause></subparagraph></paragraph><paragraph id="id4adc653a98de4b1a989593ab5cdc9e80"><enum>(2)</enum><text>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.</text>
	</paragraph></subsection><subsection id="id1ada4c185a8d466bbb15a07187c1be68"><enum>(g)</enum><header>No delegation</header><text>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.</text>
	</subsection><subsection id="idc9d7efd813ee4569afd15c3a865da065"><enum>(h)</enum><header>Effect</header><text>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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="id6D216B48FCFE4B5999FDD8ADDD54F21A"><enum>106.</enum><header>Labeling</header>
	<subsection id="id771E54FD4FD7473E8F397C3195CDA964"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 105, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id9a7e5ea45f7c495aa26dfd19ed4fc9f9" style="OLC">
	<section id="ide0ec90334c464676ad2da03b9f3a907c"><enum>614.</enum><header>Labeling</header>
	<subsection id="idFEA826B67EC748119880A5660F235CAA"><enum>(a)</enum><header>Safety review and labeling</header><text>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.</text>
	</subsection><subsection commented="no" id="id44BAA39AE1DE45509A6B0E620C518686"><enum>(b)</enum><header>Cosmetic products for professional use</header>
	<paragraph commented="no" id="id8C135BF2504E41E586D142DB9E35A048"><enum>(1)</enum><header>Definition of professional</header><text>With respect to cosmetics, the term <term>professional</term> means an individual who—</text> <subparagraph commented="no" id="id309C3E34D34441139BDFEEBA57790F58"><enum>(A)</enum><text>is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, and or esthetics;</text>
	</subparagraph><subparagraph commented="no" id="idEB24EBC069A448B8BD925AF37BC308C9"><enum>(B)</enum><text>has complied with all requirements set forth by the State for such licensing; and</text> </subparagraph><subparagraph commented="no" id="id5D08EB26D8DC451A9D5DF379FC502620"><enum>(C)</enum><text>has been granted a license by a State board or legal agency or legal authority.</text>
	</subparagraph></paragraph><paragraph commented="no" id="id9F7CCE27188E46B59A90D0BB72B13259"><enum>(2)</enum><header>Listing of ingredients</header><text>Cosmetic products used and sold by professionals shall list all ingredients, as required for other cosmetic products under this chapter.</text>
	</paragraph><paragraph commented="no" id="id3C4A8E214DA44590B5D4395F5215F360"><enum>(3)</enum><header>Professional use labeling</header><text>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: <quote>To be Administered Only by Licensed Professionals</quote>.</text>
	</paragraph></subsection><subsection id="idf386fe4d3ed74ad8907c5a48fc8d5116"><enum>(c)</enum><header>Display</header><text>The warning required under subsection (a) and the statement required under subsection (b)(3) shall be prominently displayed—</text>
	<paragraph id="id90662edb998442e884eb3d81034c433c"><enum>(1)</enum><text>in the primary language used on the label; and</text> </paragraph><paragraph id="id0f04bed0f6a94fe2b8d5a2e83a103c32"><enum>(2)</enum><text>in conspicuous and legible type in contrast by typography, layout, or color with other material printed or displayed on the label.</text>
	</paragraph></subsection><subsection id="id53C24011505347CEAA320CB057CBCE7D"><enum>(d)</enum><header>Internet sales</header><text>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.</text>
	</subsection><subsection id="id33EB0911750C44ECA7CE050299867EF7"><enum>(e)</enum><header>Contact information</header><text>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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</subsection><subsection id="id3840C868CE3E47A4A08F52F7AFCBFCB4"><enum>(b)</enum><header>Effective date</header><text>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.</text>
	</subsection></section><section id="idA0A4DBCA4EF043C683C090CBDC4473F1"><enum>107.</enum><header>Coal tar chemicals</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 106, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="idF8325882BE7A4FD29B60D92828E7D676" style="OLC">
	<section id="id90685F24B0964356B161FACF9FFE41E8"><enum>615.</enum><header>Coal tar chemicals</header>
	<subsection commented="no" id="id7FEFBF0D604F4D42A8B77B6B889844CE"><enum>(a)</enum><header>In general</header><text>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.</text>
	</subsection><subsection id="id56C4BF29AB704582A73F846F7D8D740D"><enum>(b)</enum><header>Coal tar hair dyes</header><text>Specific chemicals in coal tar hair dyes may be selected and reviewed under section 608(a)(3).</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section><section id="id3a9c48ae3daf4161bef6df60a3230a7d"><enum>108.</enum><header>Animal testing alternatives</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 107, is further amended by adding the following:</text>
	<quoted-block display-inline="no-display-inline" id="idEF98BF36F5CB4051862B4D055DEE49DB" style="OLC">
	<section id="id719b1c973d394a2689a9e13383ecba65"><enum>616.</enum><header>Animal testing alternatives</header>
	<subsection id="idC94885B238694E319795112032A70413"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text>
	<paragraph id="idfe9cdf5a3cab40459a8aeb41d28b9dad"><enum>(1)</enum><text>encourage the use of alternative testing methods that provide information that is equivalent or superior in scientific quality to the animal testing method to—</text>
	<subparagraph id="id51d05f701f2745c48b92795d6027da0d"><enum>(A)</enum><text>not involve the use of an animal to test a chemical substance for safe use in cosmetics; or</text> </subparagraph><subparagraph id="idb239d85c08a94fbe99d4545ef091d72a"><enum>(B)</enum><text>use fewer animals than conventional animal-based tests for safe use in cosmetics when nonanimal methods are impracticable; and</text>
	</subparagraph></paragraph><paragraph id="idb43f4580e68b42e3a8b659af22cc1615"><enum>(2)</enum><text>encourage—</text> <subparagraph id="id731213252b494f43ac0fedb400e47605"><enum>(A)</enum><text>the sharing of data across companies and organizations that are testing for safety in cosmetics, so as to avoid duplication of animal tests; and</text>
	</subparagraph><subparagraph id="id73dc5a7984994a9da876ed2d759b0701"><enum>(B)</enum><text>funding for research and validation of alternative testing methods.</text> </subparagraph></paragraph></subsection><subsection id="id3B7EE1A03F604F16AD48F987F5A600DA"><enum>(b)</enum><header>Guidance</header><text>Not later than 3 years after the date of enactment of the <short-title>Personal Care Products Safety Act</short-title>, 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.</text>
	</subsection><subsection id="id0631A39795454DD29BE9E94C3552E58F"><enum>(c)</enum><header>Resources regarding animal testing alternatives</header><text>Not later than 180 days after the date of enactment of the <short-title>Personal Care Products Safety Act</short-title>, 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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="id294582e684c540a2b2cc88ce74421420"><enum>109.</enum><header>Preemption</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 108, is further amended by adding the following:</text>
	<quoted-block display-inline="no-display-inline" id="id10089AA46E9847C1817211B0C7B23B30" style="OLC">
	<section id="id6a5e695f17774bc1908dbad8178890f1"><enum>617.</enum><header>Preemption</header>
	<subsection id="idc646bab94384421083ebeea7ef79bcc9"><enum>(a)</enum><header>Registration, good manufacturing practices, recalls, adverse event
	reporting</header><text>Except for a State requirement that is in full effect and implemented on the date of enactment of the <short-title>Personal Care Products Safety Act</short-title>, 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.</text>
	</subsection><subsection id="id2FF92369967142F3987FE64D16599032"><enum>(b)</enum><header>Safety of cosmetic ingredients and non-Functional constituents</header>
	<paragraph id="id75F96CEFE52A4026B9F0C561A2B142AF"><enum>(1)</enum><header>In general</header><text>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 <short-title>Personal Care Products Safety Act</short-title>, 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).</text>
	</paragraph><paragraph id="idE4A756E8FAFA4FFBA526307E93EE94E0"><enum>(2)</enum><header>Delayed effect of new State requirements</header><text>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.</text>
	</paragraph><paragraph id="id457783AD11864708BCB235A3662FD3E5"><enum>(3)</enum><header>Scope</header><text>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.</text>
	</paragraph><paragraph id="idE944869D290E4461B29EB72B04E50520"><enum>(4)</enum><header>Sense of Congress</header><text>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).</text>
	</paragraph></subsection><subsection commented="no" id="id331872f9610b424eb9d036e0f57570c3"><enum>(c)</enum><header>State requirement that is in full effect and implemented</header><text>For purposes of this section:</text> <paragraph commented="no" id="id7263E29E8C084BC8811BCAFB45017C49"><enum>(1)</enum><header>State requirement</header><text>A State requirement includes a State requirement that is adopted by a State public initiative or referendum.</text>
	</paragraph><paragraph commented="no" id="idE3F00585A101454B92AE8D0F9DDA91AC"><enum>(2)</enum><header>Full effect and implemented</header><text>The term <quote>full effect and implemented</quote> includes requirements of States that are implemented after the date of enactment of the <short-title>Personal Care Products Safety Act</short-title>, 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 <short-title>Personal Care Products Safety Act</short-title>.</text>
	</paragraph></subsection><subsection id="idC458BC32D07F47F885CFFFBD6C8F9813"><enum>(d)</enum><header>Rule of construction regarding product liability</header><text>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.</text>
	</subsection><subsection id="idDB625E06B5AB412D90388EE3F88B0D8D"><enum>(e)</enum><header>Limitation</header><text>The <short-title>Personal Care Products Safety Act</short-title>, 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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="id4fbc7624221342abba2ec2337840b774"><enum>110.</enum><header>Reporting</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 109, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id4CBACDC14C834A879DEC1A11D5EAE166" style="OLC">
	<section commented="no" id="idF5D008C3767943DF946C2B0B0881B698"><enum>618.</enum><header>Reporting</header>
	<subsection commented="no" id="id8E76CE947EC44C4F802A18328B97D732"><enum>(a)</enum><header>Performance report</header><text>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 <short-title>Personal Care Products Safety Act</short-title> 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—</text>
	<paragraph id="id401ca8e693f249908412b12cf27f6b96"><enum>(1)</enum><text>the number of registered facilities and cosmetic ingredient statements on file with the Food and Drug Administration;</text>
	</paragraph><paragraph id="idf1f822ca33cf49b8897cb83a5a70305d"><enum>(2)</enum><text>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;</text>
	</paragraph><paragraph id="ida4e8042f4fcd44c485d93c8610469545"><enum>(3)</enum><text>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;</text>
	</paragraph><paragraph id="id7342765e4cf34bd3851b3941362036b8"><enum>(4)</enum><text>the number of facilities inspected and mandatory recalls that transpired during that fiscal year;</text> </paragraph><paragraph id="id0e10615de1cd4f3db4b44834f2385bb2"><enum>(5)</enum><text>the number of serious adverse event reports received by the Food and Drug Administration during that fiscal year;</text>
	</paragraph><paragraph id="idfdbb1c6d3a6542d1ae79ad4e3e114f49"><enum>(6)</enum><text>any trends identified by the Food and Drug Administration about adverse event reports related to specific cosmetic ingredients or non-functional constituents; and</text>
	</paragraph><paragraph id="idb53c92e79f724e8a94b972b2da39f90a"><enum>(7)</enum><text>efforts of the Food and Drug Administration to reduce animal testing for safety of cosmetic ingredients, non-functional constituents, and cosmetic products.</text>
	</paragraph></subsection><subsection id="idABD0FA12BAC3427CB446DA837982C387"><enum>(b)</enum><header>Public availability</header><text>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.</text>
	</subsection><subsection id="idEEBBBCBB7022428B94E9C17279330E7A"><enum>(c)</enum><header>Public input on safety review</header><text>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—</text>
	<paragraph id="idD4E13C0A989040558504CE284B4DB08C"><enum>(1)</enum><text>providing an electronic portal, upon release of the report, enabling the public to—</text> <subparagraph id="id04F3844AD5D441FF8D5C8AA8FE5389C5"><enum>(A)</enum><text>recommend additional cosmetic ingredients and non-functional constituents to be considered for review for safety in future years; and</text>
	</subparagraph><subparagraph id="id7EE98EE62FB048DC8535ACA12D7355CF"><enum>(B)</enum><text>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;</text>
	</subparagraph></paragraph><paragraph id="id402168AEDF884487BABC1CE12EB63438"><enum>(2)</enum><text>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</text>
	</paragraph><paragraph id="id7C9500D17DF44B8B95A1AE33D3FA5057"><enum>(3)</enum><text>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).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="id7DDB42D0690B45809BCBB632B3985CA3"><enum>111.</enum><header>Small businesses</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 110, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id6CFFB38C574F49398DDC46C02831F9A8" style="OLC">
	<section id="idFE867FA54F274F8FB8A7C251C2EFE48F"><enum>619.</enum><header>Small businesses</header><text display-inline="no-display-inline">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 <short-title>Personal Care Products Safety Act</short-title>, including the amendments made by such Act.</text></section><after-quoted-block>. </after-quoted-block></quoted-block>
	</section><section id="idBF1649BD1EFC4FB684B2BAC9D3F0FE81"><enum>112.</enum><header>Applicability with respect to certain cosmetics</header><text display-inline="no-display-inline">Chapter VI of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361 et seq.</external-xref>), as amended by section 111, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="idD77076E723524819AF5F414666996562" style="OLC">
	<section id="id2D62352A1CEA450894A545A58E5728A3"><enum>620.</enum><header>Applicability with respect to certain cosmetics</header><text display-inline="no-display-inline">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.</text></section><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="id1BF1739F573C401BAA4A7D09D45D234A"><enum>113.</enum><header>Enforcement</header>
	<subsection id="id7513B821BB5B48D982F2F7FAD37893FE"><enum>(a)</enum><header>Prohibited acts</header><text display-inline="yes-display-inline">Section 301 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended—</text> <paragraph id="id03b4479f7c40458f8c49d2321ac1bf8f"><enum>(1)</enum><text>in subsection (e)—</text>
	<subparagraph id="idd1621942d78d49ecadbc557226451821"><enum>(A)</enum><text>by striking <quote>504, 564</quote> and inserting <quote>504, 564, 611, or 612</quote>; and</text> </subparagraph><subparagraph id="idf5cf205c73854200acdb507b6aa091c9"><enum>(B)</enum><text>by striking <quote>519, 564</quote> and inserting <quote>519, 564, 611,</quote>;</text>
	</subparagraph></paragraph><paragraph id="id8696d5c93454498f8c77714f049e3065"><enum>(2)</enum><text>in subsection (j) by inserting <quote>607, 608, 610,</quote> before <quote>704</quote>;</text> </paragraph><paragraph id="id7a70428570bd4d8fa2de49ec6b21e11d"><enum>(3)</enum><text>in subsection (ii)—</text>
	<subparagraph id="id6cfd8773d98f45dcbe79c9573415bcbf"><enum>(A)</enum><text>by striking <quote>760 or 761)</quote> and inserting <quote>604, 760, or 761)</quote>; and</text> </subparagraph><subparagraph id="id453d14d078154428b9d7fb2ee766d403"><enum>(B)</enum><text>by striking <quote>760 or 761) submitted</quote> and inserting <quote>611, 760, or 761) submitted</quote>;</text>
	</subparagraph></paragraph><paragraph id="id89dca78f20c149c693c2255cd3957301"><enum>(4)</enum><text>in subsection (xx) by inserting <quote>or 613</quote> after <quote>423</quote>; and</text>
	</paragraph><paragraph id="id5a4a3519a46f4bcbbb5e77c34ad7493c"><enum>(5)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id03B8D774EF2C4A03B55B4421A9CDEFF6" style="OLC"> <subsection id="idF190FAECD6E547E99934F80661C5513E"><enum>(ddd)</enum><text>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.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
	</paragraph></subsection><subsection id="idc970aa17bbcd46f49ae7db4f77e7643d"><enum>(b)</enum><header>Adulteration</header><text>Section 601 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/361">21 U.S.C. 361</external-xref>), as amended by section 103, is further amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id68D1887535954E5CBCE56F72A9B58990" style="OLC">
	<subsection id="id350102c4508642a6bb6c4e51aa2e570c"><enum>(g)</enum><text>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.</text>
	</subsection><subsection id="id31d3dd7c28c34ec1b69bb7e7ba78f930"><enum>(h)</enum><text>If it is a cosmetic product for which any requirement of section 609 (relating to safety substantiation) is not met.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
	</subsection><subsection id="id4707bd2298d14113ac3a21f59d8f56bb"><enum>(c)</enum><header>Misbranding</header><text>Section 602 is amended—</text> <paragraph id="id63A46A5FE74144629D4BA17A0478E1FB"><enum>(1)</enum><text>in subsection (b)—</text>
	<subparagraph id="id2B0C64A1889C49AA829BB4ADE8A05F80"><enum>(A)</enum><text>by striking <quote>and (2)</quote> and inserting <quote>(2)</quote>; and</text> </subparagraph><subparagraph id="idB9FAC69AE2D84181BFF5032D50E3644C"><enum>(B)</enum><text>by inserting <quote>; 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</quote> after <quote>numerical count</quote>; and</text>
	</subparagraph></paragraph><paragraph id="id77343DB724F8414585636ADF9419F3B2"><enum>(2)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idfb4ca125ae5d4a22b8fe2994328380e1" style="OLC"> <subsection id="idF838A02E04AF4B57B37C35CE99749606"><enum>(g)</enum><text>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.</text>
	</subsection><subsection commented="no" id="id7406994C20B84E2FA01A6F3D0B818F88"><enum>(h)</enum><text>If its labeling does not conform with a requirement under section 614.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection id="id0B948A8BA99F48F898A2F7EA9BB53272"><enum>(d)</enum><header>Guidance</header><text>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).</text>
	</subsection><subsection id="idfa270ab949db4d34bfb33a5dd2b84177"><enum>(e)</enum><header>Imports</header><text>Section 801(a) is amended—</text> <paragraph commented="no" id="id3513086B686B4F67B25F649EA7C6F721"><enum>(1)</enum><text>by striking <quote>section 760 or 761</quote> the first, third, and fourth place such term appears and inserting <quote>section 611, 760, or 761</quote>; and</text>
	</paragraph><paragraph commented="no" id="id18584D554080403AB6E8CE019E1A6E69"><enum>(2)</enum><text>by striking <quote>760 or 761)</quote> and inserting <quote>604, 760, or 761)</quote>.</text> </paragraph></subsection><subsection id="id3c78d4ff64b34c3bb1ec7bf9d87a4ef8"><enum>(f)</enum><header>Factory inspection</header><text>Section 704(a)(1) is amended by inserting after the third sentence the following: <quote>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.</quote>.</text>
	</subsection></section><section id="id7941A0883C994AE78AD0F997B7EAF5D5"><enum>114.</enum><header>Consumer information</header><text display-inline="no-display-inline">The Food and Drug Administration shall post on its Internet website information for consumers regarding—</text>
	<paragraph id="id760DB4F3E19243C585B878DDA81DDD16"><enum>(1)</enum><text display-inline="yes-display-inline">final orders regarding the safety of a cosmetic ingredient or non-functional constituent under section 608(d)(3);</text>
	</paragraph><paragraph id="id05DBB9E0D38144639BEBFEC9E6643F50"><enum>(2)</enum><text>cosmetic product recalls (including voluntary and mandatory recalls); and</text> </paragraph><paragraph id="id0BC765A6B9004BBC9EF51C36F2C210F1"><enum>(3)</enum><text>identified counterfeit cosmetic products.</text>
	</paragraph></section></title><title id="id533c4e31958547f48d1e6734b0bcc81a"><enum>II</enum><header>Fees related to cosmetic safety</header>
	<section id="id0a038e43906348fbb72125329bb9d6ec"><enum>201.</enum><header>Findings</header><text display-inline="no-display-inline">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.</text>
	</section><section id="idF8582C833DB94670B36E5EFFC0E021AA"><enum>202.</enum><header>Authority to assess and use cosmetic safety fees</header><text display-inline="no-display-inline">Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379f">21 U.S.C. 379f et seq.</external-xref>) is amended by adding at the end the following:</text>
	<quoted-block display-inline="no-display-inline" id="id3FE495028D584877A5A2CA23685E6E2D" style="OLC">
	<part id="idF5EA4904D2BE4CAAB4E97E8D7469C8FD" style="OLC"><enum>10</enum><header>Fees relating to cosmetics</header>
	<section id="idA138630F983B43468FD88F5395DBA9AC"><enum>744L.</enum><header>Registration fee</header>
	<subsection id="id0b8f4711f5e44c6ea003f24bc817e550"><enum>(a)</enum><header>Assessment and collection</header>
	<paragraph id="idd51c300007bb494381a0cb313cb490ff"><enum>(1)</enum><header>In general</header><text>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 <quote>registrant</quote>) 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).</text>
	</paragraph><paragraph id="idb59af10ed17f417cb1964d9a88b63e8d"><enum>(2)</enum><header>Payable date</header><text>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).</text>
	</paragraph></subsection><subsection id="id57b4393bde1143daa7fcc769c8c9ef88"><enum>(b)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="id2a7aba2be93944559dd7c78fa5ae22bd"><enum>(1)</enum><header>Adjustment factor</header><text>The term <term>adjustment factor</term> 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.</text>
	</paragraph><paragraph id="idfd6a611c479744eba174b8149c996049"><enum>(2)</enum><header>Affiliate</header><text>The term <term>affiliate</term> means any business entity that has a relationship with a second business entity if, directly or indirectly—</text>
	<subparagraph id="id5C43DA2551A746D58BC7C25BC1359157"><enum>(A)</enum><text>one business entity controls, or has power to control, the other business entity; or</text>
	</subparagraph><subparagraph id="idDDD931ADF00743D5BFE57BEBAB1AF9DD"><enum>(B)</enum><text>a third-party controls, or has the power to control, both of the business entities.</text>
	</subparagraph></paragraph><paragraph id="idbc6d4ab7d54f429395f89439d0a72a89"><enum>(3)</enum><header>Cosmetic safety activities</header><text>The term <term>cosmetic safety activities</term>—</text> <subparagraph id="idA7BD5CC20314436BA0A114DA7D41F21B"><enum>(A)</enum><text>means activities related to compliance by registrants under section 605 with the requirements of this Act with respect to cosmetics, including—</text>
	<clause id="id1312713AE7E549DCBBC145CA97A89F51"><enum>(i)</enum><text>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</text>
	</clause><clause id="id4DE9EEE145F34FF39E4859F0C3EBD0F0"><enum>(ii)</enum><text>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</text>
	</clause></subparagraph><subparagraph id="id50A96227DFA844D68D71C322E8D5EFFA"><enum>(B)</enum><text>includes activities related to implementation of section 608, regarding the review of cosmetic ingredients and non-functional constituents.</text>
	</subparagraph></paragraph><paragraph id="id4fb695e01beb4f97a72118c8c8f85272"><enum>(4)</enum><header>Gross annual sales</header><text>The term <term>gross annual sales</term> 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.</text>
	</paragraph></subsection><subsection id="idc83afec3f5474bbf87d5dc95d1371bae"><enum>(c)</enum><header>Fee setting and amounts</header>
	<paragraph id="id3b446e01772e42d6985f3b2bcc72043b"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="id62a94381e4c24745bca85098f4bfac7c"><enum>(2)</enum><header>Fee exemption</header><text>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.</text>
	</paragraph><paragraph id="ida654c3042edb47c291571d38347d465a"><enum>(3)</enum><header>Annual fee setting</header>
	<subparagraph id="id7e4e9aa9fe3f446ead3a0dd6415ad72d"><enum>(A)</enum><header>Fiscal year 2016</header><text>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:</text>
	<clause id="iddec853943b864f03bdea793ec7087de2"><enum>(i)</enum><header>Tier I–A</header><text>For a registrant that has gross annual sales of $5,000,000,000 or more in 2015, $1,100,000.</text>
	</clause><clause id="idde1b33b571f2492cbf707f7b07f6b712"><enum>(ii)</enum><header>Tier I–B</header><text>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.</text>
	</clause><clause id="idB6A20E87FCBB47FEBB3E73DC92B2E72C"><enum>(iii)</enum><header>Tier II–A</header><text>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.</text>
	</clause><clause id="id9479666F466E4DB6B38731EC01078583"><enum>(iv)</enum><header>Tier II–B</header><text>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.</text>
	</clause><clause id="idB81E070FDDC64C2BBF55B0A26F024DE9"><enum>(v)</enum><header>Tier III–A</header><text>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.</text>
	</clause><clause id="idAF273F8740A7488A85E9B792563F4E9A"><enum>(vi)</enum><header>Tier III–B</header><text>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.</text>
	</clause><clause id="idA064305FBD6446A7A3F3F6ED9962928A"><enum>(vii)</enum><header>Tier IV–A</header><text>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.</text>
	</clause><clause id="idbb9784fe92e04478be71df616b241db9"><enum>(viii)</enum><header>Tier IV–B</header><text>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.</text>
	</clause><clause id="id7baf04f3837041b59ba8eefc6db020ea"><enum>(ix)</enum><header>Tier V–A</header><text>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.</text>
	</clause><clause id="id4dbd4c08174c49929a17c745cdda81e1"><enum>(x)</enum><header>Tier V–B</header><text>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.</text>
	</clause><clause id="idbb627fe1df1d4d6eaa018d357b30c115"><enum>(xi)</enum><header>Tier VI–A</header><text>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.</text>
	</clause><clause id="idcdf955b37c9747c3835cea3523e47885"><enum>(xii)</enum><header>Tier IV–B</header><text>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.</text>
	</clause><clause id="id39b7408e9d664892b00a9c020972b9d1"><enum>(xiii)</enum><header>Tier VII–A</header><text>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.</text>
	</clause><clause id="idce51948e12b343bb8f69893f1e3374f3"><enum>(xiv)</enum><header>Tier VII–B</header><text>For a registrant that has gross annual sales of at least $500,000 per annum but less than $2,500,000 in 2015, $250.</text>
	</clause></subparagraph><subparagraph id="idde81cb533c12451eb301ce35ad70896e"><enum>(B)</enum><header>Fiscal years 2017–2022</header><text>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:</text>
	<clause id="ida46a668b67454bc3ae443fef1a2454e5"><enum>(i)</enum><header>Tier I–A</header><text>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.</text>
	</clause><clause id="id456F656DF3174968A34D50C99FB253B8"><enum>(ii)</enum><header>Tier I–B</header><text>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.</text>
	</clause><clause id="idE3121357C1F143AFBA5BA967E151055A"><enum>(iii)</enum><header>Tier II–A</header><text>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.</text>
	</clause><clause id="idA0454FFCC41F4D419D15DF173270369B"><enum>(iv)</enum><header>Tier II–B</header><text>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.</text>
	</clause><clause id="id7ECEF3E14B10477BA358181CEC874DD5"><enum>(v)</enum><header>Tier III–A</header><text>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.</text>
	</clause><clause id="idB3002947F04646F4B1923A269F86B378"><enum>(vi)</enum><header>Tier III–B</header><text>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.</text>
	</clause><clause id="id950C96ECBEA84509A45A857948CADC9F"><enum>(vii)</enum><header>Tier IV–A</header><text>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.</text>
	</clause><clause id="idf2f78edf6ce842bd9abc25c43b4eff13"><enum>(viii)</enum><header>Tier IV–B</header><text>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.</text>
	</clause><clause id="id9c19d0630b6a412cbb72cd0966a91e64"><enum>(ix)</enum><header>Tier V–A</header><text>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.</text>
	</clause><clause id="id025B82A1867F4064A7F36A92779997D6"><enum>(x)</enum><header>Tier V–B</header><text>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.</text>
	</clause><clause id="idEE98E4360A154E24AC068108A65B12B8"><enum>(xi)</enum><header>Tier VI–A</header><text>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.</text>
	</clause><clause id="id3d1657d40ff84c74a78c470a2c50f8a1"><enum>(xii)</enum><header>Tier VI–B</header><text>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.</text>
	</clause><clause id="id86EF76F5A5164A79B2BF1F61C789B84C"><enum>(xiii)</enum><header>Tier VII–A</header><text>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.</text>
	</clause><clause id="id9ADEE8F4037946B5B156ED84004E5632"><enum>(xiv)</enum><header>Tier VII–B</header><text>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.</text>
	</clause></subparagraph></paragraph></subsection><subsection id="ide0c8720d001449aa9aada28550b1a5b7"><enum>(d)</enum><header>Adjustments</header>
	<paragraph id="id0784f4938a9745dbad71134a90b2788c"><enum>(1)</enum><header>Inflation adjustment</header>
	<subparagraph id="idEF32D033D8B64A9893F410056704AC47"><enum>(A)</enum><header>In general</header><text>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—</text>
	<clause id="id5cb908db83534c369fbeb703d5ce47ba"><enum>(i)</enum><text>one;</text> </clause><clause id="id01c51e9ed0f94eeca9d5d928ef272531"><enum>(ii)</enum><text>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</text>
	</clause><clause id="id9561629e25044073adc778a07c7a45ed"><enum>(iii)</enum><text>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.</text>
	</clause></subparagraph><subparagraph id="id5727F2A1D50D48779FE64F2B0CBAA918"><enum>(B)</enum><header>Compounded basis</header><text>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.</text>
	</subparagraph></paragraph><paragraph id="idadd5347fca5f4237bec46f463c7f7dfa"><enum>(2)</enum><header>Final year adjustment</header><text>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.</text>
	</paragraph><paragraph id="id184282afc38f4615800ff82ffd96eac4"><enum>(3)</enum><header>Workload adjustment</header>
	<subparagraph id="id745d98284be54edea830290984ebc9a9"><enum>(A)</enum><header>In general</header><text>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).</text>
	</subparagraph><subparagraph id="iddc8e9fe49d044a52a08f7be57040c098"><enum>(B)</enum><header>Determination of adjustment</header><text>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.</text>
	</subparagraph><subparagraph id="id25064b2342a0462b96abec4e7ed0b08a"><enum>(C)</enum><header>Minimum revenues</header><text>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).</text>
	</subparagraph></paragraph></subsection><subsection id="id56ba01ce179247c0921230a491a65494"><enum>(e)</enum><header>Limitations</header>
	<paragraph id="id2414efcd51cc4966b9c24bd638448723"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="id463de6e3c6784829878aa79383e04702"><enum>(2)</enum><header>Authority</header><text>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.</text>
	</paragraph></subsection><subsection id="idad23d6001925479cabdf0c2818023747"><enum>(f)</enum><header>Crediting and availability of fees</header>
	<paragraph id="id4ccfc89532d24e40bfa89291091b93ba"><enum>(1)</enum><header>In general</header><text>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.</text>
	</paragraph><paragraph id="idfa9d251cdbd54224aa244648e8464d88"><enum>(2)</enum><header>Collections and appropriations acts</header><text>The fees authorized by this section—</text> <subparagraph id="id1fb041310f0447c38a9ea3ea408ee01b"><enum>(A)</enum><header>In general</header><text>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.</text>
	</subparagraph><subparagraph id="id76d4f7ea55264fe7bd761430076ae3ad"><enum>(B)</enum><header>Use of fees and limitation</header><text>The fees authorized by this section shall be collected and available only to defray the costs of cosmetic safety activities.</text>
	</subparagraph><subparagraph id="id72dbacabfecd46a192bf16bca9b11bb3"><enum>(C)</enum><header>Fee collections during first program year</header><text>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.</text>
	</subparagraph><subparagraph id="id0e54edfd20e44332b6bcda33d6386eb3"><enum>(D)</enum><header>Reimbursement of start-up amounts</header><text>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.</text>
	</subparagraph></paragraph><paragraph id="id2a84ca25739e4bcea0ae92918fe6db3a"><enum>(3)</enum><header>Authorization of appropriations</header><text>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).</text>
	</paragraph><paragraph id="id6ff0e2e7049348ad8327ce7b7b7b46c7"><enum>(4)</enum><header>Offset of overcollections; recovery of collection shortfalls</header>
	<subparagraph id="id54e9c8d99f4f4fda966ba30056dd2b68"><enum>(A)</enum><header>Offset of overcollections</header><text>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.</text>
	</subparagraph><subparagraph id="id93ab1ce4c349435fbe331c1a47040aaa"><enum>(B)</enum><header>Recovery of collection shortfalls</header>
	<clause id="id8c52255616824448b022ff38266757ef"><enum>(i)</enum><header>2018</header><text>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).</text>
	</clause><clause id="idf3e3324b33f845eabbcef36514a06465"><enum>(ii)</enum><header>2019</header><text>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).</text>
	</clause><clause id="id1f0794f876c742d8a57eb842a87c405a"><enum>(iii)</enum><header>2020</header><text>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).</text>
	</clause><clause id="id2963248de1284079836dcd382586501a"><enum>(iv)</enum><header>2021</header><text>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).</text>
	</clause><clause id="ida3c0663acb8445c8991eda9b7bb9b624"><enum>(v)</enum><header>2022</header><text>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).</text>
	</clause></subparagraph></paragraph></subsection><subsection id="id236149bd07214284a607f86f05916788"><enum>(g)</enum><header>Effect of failure To pay fees</header><text>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.</text>
	</subsection><subsection id="id93d231150f29420da806f790949ee576"><enum>(h)</enum><header>False statements</header><text>Any statement or representation made to the Food and Drug Administration shall be subject to section 1001 of title 18, United States Code.</text>
	</subsection><subsection id="id145a22d8609f439ea5fd522a79bc9569"><enum>(i)</enum><header>Collection of unpaid fees</header><text>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 <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
	</subsection><subsection id="id0c52c00413c243f891054177515c556d"><enum>(j)</enum><header>Construction</header><text>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.</text>
	</subsection><subsection id="idffb0d3ccbf574f10a92afb3a6adbb57c"><enum>(k)</enum><header>Records</header><text>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.</text></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
	</section><section id="id863e1f88ac854a119ffe28408fcac753"><enum>203.</enum><header>Direct hiring authority to support activities related to cosmetics</header><text display-inline="no-display-inline">Part 10 of subchapter C of chapter VII, as added by section 202, is amended by inserting after section 744L the following:</text>
	<quoted-block display-inline="no-display-inline" id="id004D931BF8414D9795D96A75E114391B" style="OLC">
	<section id="id52fb2130c67e46228f3f9e7270dc6776"><enum>744M.</enum><header>Direct hiring authority to support activities related to cosmetics</header>
	<subsection commented="no" display-inline="no-display-inline" id="idC3B3892BB07B4A26B889A36CCE2C7CFF"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text>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 <short-title>Personal Care Products Safety Act</short-title>.</text>
	</subsection><subsection commented="no" display-inline="no-display-inline" id="id3C64DBA94A2948ECBCEBC4198FEC6B6E"><enum>(b)</enum><header>Sunset</header><text>The authority under subsection (a) shall terminate on the date that is 3 years after the date of enactment of such title.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></title></legis-body></bill>