114 HR 2576 EAH: Frank R. Lautenberg Chemical Safety for the 21st Century Act
U.S. House of Representatives
2016-05-24
text/xml
EN
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.
114th CONGRESS2d Session
In the House of Representatives, U. S.,
May 24, 2016
HOUSE AMENDMENT TO SENATE AMENDMENT:
That the House agree to the amendment of the Senate to the bill (H.R. 2576) entitled An Act to modernize the Toxic Substances Control Act, and for other purposes.
with the following In lieu of the matter proposed to be inserted by the amendment of the Senate, insert the following:
1.Short title; table of contents (a)This Act may be cited as the Frank R. Lautenberg Chemical Safety for the 21st Century Act
.
(b)The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—CHEMICAL SAFETY Sec. 2. Findings, policy, and intent. Sec. 3. Definitions. Sec. 4. Testing of chemical substances and mixtures. Sec. 5. Manufacturing and processing notices. Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures. Sec. 7. Imminent hazards. Sec. 8. Reporting and retention of information. Sec. 9. Relationship to other Federal laws. Sec. 10. Exports of elemental mercury. Sec. 11. Confidential information. Sec. 12. Penalties. Sec. 13. State-Federal relationship. Sec. 14. Judicial review. Sec. 15. Citizens’ civil actions. Sec. 16. Studies. Sec. 17. Administration of the Act. Sec. 18. State programs. Sec. 19. Conforming amendments. Sec. 20. No retroactivity. Sec. 21. Trevor’s Law. TITLE II—RURAL HEALTHCARE CONNECTIVITY Sec. 201. Short title. Sec. 202. Telecommunications services for skilled nursing facilities. <enum>I</enum><header>Chemical Safety</header> <section id="HFB00B321F1434A25A92BE13460A52A50" commented="no"><enum>2.</enum><header>Findings, policy, and intent</header><text display-inline="no-display-inline">Section 2(c) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2601">15 U.S.C. 2601(c)</external-xref>) is amended by striking <quote>proposes to take</quote> and inserting <quote>proposes as provided</quote>. </text></section>
<section id="H53A3C6008F4D43178B89F8969EFD4AFC"><enum>3.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 3 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2602">15 U.S.C. 2602</external-xref>) is amended—</text> <paragraph id="HAD690501F92A4273B0BDA6F4AF52BCA6"><enum>(1)</enum><text>by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively;</text></paragraph>
<paragraph id="HBF2B0BBA50384008B6DFAAFB3BD0D8D3"><enum>(2)</enum><text>by inserting after paragraph (3) the following:</text> <quoted-block display-inline="no-display-inline" id="H5ED2413C1A6642748B50253CA326CFA9" style="OLC"> <paragraph id="HF4F2A14565604357830CE69FF6E357B1" indent="up1" commented="no"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>conditions of use</term> means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HF42F2A5F262348F9B254F6DD99B98638"><enum>(3)</enum><text>by inserting after paragraph (6), as so redesignated, the following:</text> <quoted-block style="OLC" id="H74848B1CA04440FBBCC87197D33DE93B" display-inline="no-display-inline"> <paragraph id="H60DB04DBB79F4A05B1B7F732D2CC8D81" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>guidance</term> means any significant written guidance of general applicability prepared by the Administrator. </text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="HDFD91A1D236D4B09AC7448587DD42632"><enum>(4)</enum><text>by inserting after paragraph (11), as so redesignated, the following:</text> <quoted-block display-inline="no-display-inline" id="H0B9BC447D5294236B0D3FC656493AFAB" style="OLC"> <paragraph id="H02139E501FEA45978040E89343A589C6" indent="up1" commented="no"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>potentially exposed or susceptible subpopulation</term> means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="HCA4CA9FF13484C51924216C4DB05147F" section-type="subsequent-section"><enum>4.</enum><header>Testing of chemical substances and mixtures</header><text display-inline="no-display-inline">Section 4 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2603">15 U.S.C. 2603</external-xref>) is amended—</text> <paragraph id="HA437F1F10CEF4FF8A37FB217C9393F79"><enum>(1)</enum><text>by striking <quote>standards</quote> each place it appears and inserting <quote>protocols and methodologies</quote>; </text></paragraph>
<paragraph id="H85B22030F0C54877B7CA35E9419B17AE"><enum>(2)</enum><text>in subsection (a)—</text> <subparagraph id="H0453C197825D4CCC859D40F07F327412"><enum>(A)</enum><text>by striking <quote>If the Administrator finds</quote> and inserting <quote>(1) If the Administrator finds</quote>;</text></subparagraph>
<subparagraph id="H7DA3D8B3CB754B5CA49EA8C94E636C8A"><enum>(B)</enum><text>in paragraph (1), as so designated—</text> <clause id="H7EF61FD0AA2943AAA4103ED05F882D9B"><enum>(i)</enum><text>by striking <quote>(1)(A)(i)</quote> and inserting <quote>(A)(i)(I)</quote>;</text></clause>
<clause id="H370DB09C31CC40E4953CC2A07FC9EB60"><enum>(ii)</enum><text>by striking <quote>(ii)</quote> each place it appears and inserting <quote>(II)</quote>; </text></clause> <clause id="H06344E83D5DD44D09BFDE34D5F24C560"><enum>(iii)</enum><text>by striking <quote>are insufficient data</quote> and inserting <quote>is insufficient information</quote> each place it appears;</text></clause>
<clause id="H7A3F3C373D1E4E819053FD1BAC9F430A"><enum>(iv)</enum><text>by striking <quote>(iii)</quote> each place it appears and inserting <quote>(III)</quote>; </text></clause> <clause id="HBFDB57F2E311480CAA32BDE9983807E4"><enum>(v)</enum><text>by striking <quote>such data</quote> and inserting <quote>such information</quote> each place it appears;</text></clause>
<clause id="H5388E8C3D84A4104BD361717DD9AEEB7"><enum>(vi)</enum><text>by striking <quote>(B)(i)</quote> and inserting <quote>(ii)(I)</quote>;</text></clause> <clause id="H9FB3B33ED7134851B8973C275E481CF4"><enum>(vii)</enum><text>by striking <quote>(I)</quote> and inserting <quote>(aa)</quote>;</text></clause>
<clause id="H0FFA34555EF94AF9BF53D8C71CE8CA7B"><enum>(viii)</enum><text>by striking <quote>(II)</quote> and inserting <quote>(bb)</quote>;</text></clause> <clause id="H64A146CDDAA24BAD9E756C9BDFC0A592"><enum>(ix)</enum><text>by striking <quote>(2)</quote> and inserting <quote>(B)</quote>; and</text></clause>
<clause id="HBC8C39EB91D24FD292736B47D6FC0049"><enum>(x)</enum><text>in the matter following subparagraph (B), as so redesignated—</text> <subclause id="HFC2B62EC3F56452EA3FED9EEC4226245"><enum>(I)</enum><text>by inserting <quote>, or, in the case of a chemical substance or mixture described in subparagraph (A)(i), by rule, order, or consent agreement,</quote> after <quote>rule</quote>;</text></subclause>
<subclause id="H1C3476C4B6B140A9AC432B64D468AB9D"><enum>(II)</enum><text>by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>; and</text></subclause> <subclause id="HB18C54CA398746E58DCB0CC722931854"><enum>(III)</enum><text>by striking <quote>and which are relevant</quote> and inserting <quote>and which is relevant</quote>; and </text></subclause></clause></subparagraph>
<subparagraph id="HD0EDFFBDE6424C9CB22424FA48D2B4EA"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="H6B2C617030864DA9939EFB4AE1B43CF7" display-inline="no-display-inline"> <paragraph id="H0F0F9513A6E045F386E193D7C7FFB6CC"><enum>(2)</enum><header>Additional testing authority</header><text display-inline="yes-display-inline">In addition to the authority provided under paragraph (1), the Administrator may, by rule, order, or consent agreement—</text>
<subparagraph id="H9716DB4BC1624CD4B5A0E2842BF0791D"><enum>(A)</enum><text>require the development of new information relating to a chemical substance or mixture if the Administrator determines that the information is necessary—</text> <clause id="HC2F74DAEE064460A8D086D1FB00D5380"><enum>(i)</enum><text>to review a notice under section 5 or to perform a risk evaluation under section 6(b);</text></clause>
<clause id="H0711C07A5BA341F8AFA641BB99B57156"><enum>(ii)</enum><text>to implement a requirement imposed in a rule, order, or consent agreement under subsection (e) or (f) of section 5 or in a rule promulgated under section 6(a);</text></clause> <clause id="HB9FA8BF1CD9B47BA9DCAC165A781B234"><enum>(iii)</enum><text display-inline="yes-display-inline">at the request of a Federal implementing authority under another Federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure; or</text></clause>
<clause id="H7754B5075C434514BC989CA67DED8458"><enum>(iv)</enum><text display-inline="yes-display-inline">pursuant to section 12(a)(2); and</text></clause></subparagraph> <subparagraph id="H5DCE45E40B904842BB294F986EE3D0B2"><enum>(B)</enum><text display-inline="yes-display-inline">require the development of new information for the purposes of prioritizing a chemical substance under section 6(b) only if the Administrator determines that such information is necessary to establish the priority of the substance, subject to the limitations that—</text>
<clause id="H8ACBD2A5659D40B8BFB57C72BD451D89"><enum>(i)</enum><text display-inline="yes-display-inline">not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, order, or consent agreement under this subparagraph, the Administrator shall designate the chemical substance as a high-priority substance or a low-priority substance; and</text></clause> <clause id="HAF3316A74AAA4F89984EA5C1D4A787D1"><enum>(ii)</enum><text display-inline="yes-display-inline">information required by the Administrator under this subparagraph shall not be required for the purposes of establishing or implementing a minimum information requirement of broader applicability.</text></clause></subparagraph></paragraph>
<paragraph id="H9C502A8A62C74097A2EB9BC52512E18E"><enum>(3)</enum><header>Statement of need</header><text display-inline="yes-display-inline">When requiring the development of new information relating to a chemical substance or mixture under paragraph (2), the Administrator shall identify the need for the new information, describe how information reasonably available to the Administrator was used to inform the decision to require new information, explain the basis for any decision that requires the use of vertebrate animals, and, as applicable, explain why issuance of an order is warranted instead of promulgating a rule or entering into a consent agreement.</text></paragraph> <paragraph id="HC745B340149E44D1B4CD33EAA22773DA"><enum>(4)</enum><header>Tiered testing</header><text display-inline="yes-display-inline">When requiring the development of new information under this subsection, the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary, unless information available to the Administrator justifies more advanced testing of potential health or environmental effects or potential exposure without first conducting screening-level testing.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HE45FCD391B29457BB320513F896C0FD6"><enum>(3)</enum><text>in subsection (b)—</text> <subparagraph id="HCCEABAFB210C4A669D0D9C7379BF52AB"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause id="H62CD39AFEF7041ABB2228D5EC05951A6"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>test data</quote> and inserting <quote>information</quote>;</text></clause> <clause id="H87F79C9018F94FEE9C2405996E0874F9"><enum>(ii)</enum><text>in subparagraph (C), by striking <quote>data</quote> and inserting <quote>information</quote>; and</text></clause>
<clause id="HB92E89EF4535416AB07BF4588242DE6F"><enum>(iii)</enum><text>in the matter following subparagraph (C), by striking <quote>data</quote> and inserting <quote>information</quote>;</text></clause></subparagraph> <subparagraph id="H6B45D2AE67AC4D6E98C2C58B85769D4A"><enum>(B)</enum><text>in paragraph (2)—</text>
<clause id="HDA53B0F409BA4F028F5E72D907F65890"><enum>(i)</enum><text>in subparagraph (A)—</text> <subclause id="H1FAC0215BE1E4C67B92F7B07979097D0"><enum>(I)</enum><text>by striking <quote>test data</quote> and inserting <quote>information</quote>;</text></subclause>
<subclause id="H02285331725C47AF80CE2ABB587374F7"><enum>(II)</enum><text>by inserting <quote>Protocols and methodologies for the development of information may also be prescribed for the assessment of exposure or exposure potential to humans or the environment.</quote> after the first sentence; and</text></subclause> <subclause id="H47AC52401F93404AA05EEA23F7CB16C2"><enum>(III)</enum><text>by striking <quote>hierarchical tests</quote> and inserting <quote>tiered testing</quote>; and</text></subclause></clause>
<clause id="H9BD580B7412E47DFBACBF2FCC65C2FE3"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>data</quote> and inserting <quote>information</quote>;</text></clause></subparagraph> <subparagraph id="HA1CFA571614740CDB9275BDDD4531F7F"><enum>(C)</enum><text>in paragraph (3)—</text>
<clause id="H368E755165DD46CC95CC7866C8092275"><enum>(i)</enum><text>by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>;</text></clause> <clause id="H1A9C9BE5BB764E9CB456799945FAE7E2"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting <quote>or (C), as applicable,</quote> after <quote>subparagraph (B)</quote>;</text></clause>
<clause id="H763D115A46E74793904440C729841216"><enum>(iii)</enum><text>by striking <quote>(a)(1)(A)(ii) or (a)(1)(B)(ii)</quote> each place it appears in subparagraph (B) and inserting <quote>(a)(1)(A)(i)(II) or (a)(1)(A)(ii)(II)</quote>;</text></clause> <clause id="HDDC70D19A38944ACBD7CE0C9536080D9"><enum>(iv)</enum><text>in subparagraph (B), in the matter before clause (i), by striking <quote>subsection (a)</quote> and inserting <quote>subsection (a)(1)</quote>; and</text></clause>
<clause id="H3594AF1458D64E2A9BE09A5FC77FB901"><enum>(v)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="H978F5AE469264486957D55415B3838E3" display-inline="no-display-inline"> <subparagraph id="H573702B86F3C4FA2A011B5BB7E27A1BE" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">A rule or order under paragraph (1) or (2) of subsection (a) may require the development of information by any person who manufactures or processes, or intends to manufacture or process, a chemical substance or mixture subject to the rule or order.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="HBF1E4FBA89884E9BA37EC10429102170"><enum>(D)</enum><text>in paragraph (4)—</text> <clause id="H3B66159A40DB4D04B9E56C843187DF7D"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>of data</quote> each place it appears and inserting <quote>of information</quote>; and</text></clause>
<clause id="HD8F4E9D5231B4CDFBF4D318E02169E07"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>test data</quote> each place it appears and inserting <quote>information</quote>; and</text></clause></subparagraph> <subparagraph id="H6A2FBFF1A58E499D8F84528640CE19E9"><enum>(E)</enum><text>by striking paragraph (5);</text></subparagraph></paragraph>
<paragraph id="HB8C31E77B2B74643B3BA75636183B1F1"><enum>(4)</enum><text>in subsection (c)—</text> <subparagraph id="H55AFA62F84BE4022B0C899488674F084"><enum>(A)</enum><text>in paragraph (1), by striking <quote>data</quote> and inserting <quote>information</quote>;</text></subparagraph>
<subparagraph id="H4510B28417DA4481A1CF0E2246DDA057"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>;</text></subparagraph> <subparagraph id="HB5BDB159ACC24D328A5FA52963923001"><enum>(C)</enum><text>in paragraph (3)—</text>
<clause id="H1DFDB8879CD04A9EB38C4A396C846982"><enum>(i)</enum><text>by striking <quote>test data</quote> each place it appears and inserting <quote>information</quote>; and</text></clause> <clause id="H728259E198494E77BEE0BB182533B171"><enum>(ii)</enum><text>by striking <quote>such data</quote> each place it appears and inserting <quote>such information</quote>; and</text></clause></subparagraph>
<subparagraph id="H021B09FDB45344009A270FBEC1D45ED2"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4) by striking <quote>test data</quote> each place it appears and inserting <quote>information</quote>;</text></subparagraph></paragraph> <paragraph id="H9C5170B251E04C3582F579F92E20DF51"><enum>(5)</enum><text>in subsection (d)—</text>
<subparagraph id="H7FD959AFD2464186A09E5553049DF1A7"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>test data</quote> each place it appears and inserting <quote>information</quote>;</text></subparagraph> <subparagraph id="H5AB96C6C44C541C9A83CB0260C1E6336"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>such data</quote> each place it appears and inserting <quote>such information</quote>; and</text></subparagraph>
<subparagraph id="HBD8BACBC1EF04ABBA8EC12C6F3E33F82"><enum>(C)</enum><text>by striking <quote>for which data have</quote> and inserting <quote>for which information has</quote>;</text></subparagraph></paragraph> <paragraph id="H8AA6E3DAE03F4BFBA0ACC25A9BEF8396"><enum>(6)</enum><text>in subsection (e)—</text>
<subparagraph id="HE0D7DF337C294DEEBEFC56E3B778B816"><enum>(A)</enum><text>in paragraph (1)—</text> <clause id="HC87B44114F7942FCBC9CBCB63CF6643B"><enum>(i)</enum><text>in subparagraph (A)—</text>
<subclause id="H1CBEF44AA5084B40B81F2BCCF7E7B8E2"><enum>(I)</enum><text>by striking <quote>promulgation of a rule</quote> and inserting <quote>development of information</quote>; and</text></subclause> <subclause id="HDCE24308A5494816B0A8FA9AB81304DE"><enum>(II)</enum><text>by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>; and</text></subclause></clause>
<clause id="HEF97AFCC50B046ECB060D14B3E8BBD0B"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>either initiate a rulemaking proceeding under subsection (a) or if such a proceeding is not initiated within such period, publish in the Federal Register the Administrator's reason for not initiating such a proceeding</quote> and insert <quote>issue an order, enter into a consent agreement, or initiate a rulemaking proceeding under subsection (a), or, if such an order or consent agreement is not issued or such a proceeding is not initiated within such period, publish in the Federal Register the Administrator’s reason for not issuing such an order, entering into such a consent agreement, or initiating such a proceeding</quote>; and</text></clause></subparagraph> <subparagraph id="HB83E9F62E0F944CCA20268AFE786BBCE" commented="no"><enum>(B)</enum><text>in paragraph (2)(A)—</text>
<clause id="H23CE2AB2E0004EA79CBB74CC11AF80CA" commented="no"><enum>(i)</enum><text>by striking <quote>eight members</quote> and inserting <quote>ten members</quote>; and </text></clause> <clause id="H29341A808F68409ABD92FFEB8A9065DB" commented="no"><enum>(ii)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" id="H787DA074E69C4600B4B9CC2C3B3969D6" display-inline="no-display-inline">
<clause id="HA5FFAC68348F47BDBBCFC7EE6AD7DC79" commented="no" indent="up2"><enum>(ix)</enum><text display-inline="yes-display-inline">One member appointed by the Chairman of the Consumer Product Safety Commission from Commissioners or employees of the Commission.</text></clause> <clause id="HCAA285B83ED04C7DBFD455896073CEA1" commented="no" indent="up2"><enum>(x)</enum><text>One member appointed by the Commissioner of Food and Drugs from employees of the Food and Drug Administration.</text></clause><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph></paragraph>
<paragraph id="H0CF065F3160F4FBF9C033794197DA980"><enum>(7)</enum><text>in subsection (f)—</text> <subparagraph id="HA200DE510F3B45A79E53A0B5143138CB"><enum>(A)</enum><text>in paragraph (1), by striking <quote>test data</quote> and inserting <quote>information</quote>; and</text></subparagraph>
<subparagraph id="H2F5DDB0BFA6C41DD898C3C447425A87B"><enum>(B)</enum><text>in the matter following paragraph (2)—</text> <clause id="H3C9DD2C387F44767A944A34F95AEBDFE"><enum>(i)</enum><text>by striking <quote>or will present</quote>; </text></clause>
<clause id="H38527410B6674AADAE3567B93278D784"><enum>(ii)</enum><text>by striking <quote>from cancer, gene mutations, or birth defects</quote>;</text></clause> <clause id="HC7F7B62B7D844CB2B7EAC7B8D6273534" commented="no"><enum>(iii)</enum><text>by striking <quote>data or</quote>;</text></clause>
<clause id="HD13BA9211FCD4FD49010DE8DA569CE80"><enum>(iv)</enum><text>by striking <quote>appropriate</quote> and inserting <quote>applicable</quote>; and</text></clause> <clause id="HE20B466D5F2645A0B5CED9D129F4331C"><enum>(v)</enum><text>by inserting <quote>, made without consideration of costs or other nonrisk factors,</quote> after <quote>publish in the Federal Register a finding</quote>;</text></clause></subparagraph></paragraph>
<paragraph id="HBD8AA491C1464007AEEA5348C44D947E"><enum>(8)</enum><text>in subsection (g)—</text> <subparagraph id="HAFDFF23F2BAE44F883BF837F3A679D0A"><enum>(A)</enum><text>by amending the subsection heading to read as follows: <quote><header-in-text level="subsection" style="OLC">Petition for protocols and methodologies for the development of information</header-in-text></quote>;</text></subparagraph>
<subparagraph id="H0AB8B39D641E43A5B1AA8A01AA749E60"><enum>(B)</enum><text>by striking <quote>test data</quote> each place it appears and inserting <quote>information</quote>; and</text></subparagraph> <subparagraph id="H2FEF08B706DC4A3984A4E89B2363183D"><enum>(C)</enum><text>by striking <quote>submit data</quote> and inserting <quote>submit information</quote>; and</text></subparagraph></paragraph>
<paragraph id="H6470632A0B6942CA88507B873C3B6A05" commented="no"><enum>(9)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="HC044C9E1348447949C31C895B9997262" display-inline="no-display-inline"> <subsection id="H71D90E6BA21E4131B30C99186496532D" commented="no"><enum>(h)</enum><header>Reduction of testing on vertebrates</header> <paragraph id="HA80207E8036940139A5CCC4EE31FAB03" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures under this title by—</text>
<subparagraph id="H991111BBAA124E75BC6E60DF4274389B" commented="no"><enum>(A)</enum><text>prior to making a request or adopting a requirement for testing using vertebrate animals, and in accordance with subsection (a)(3), taking into consideration, as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including—</text> <clause id="H02B480172B1A4402BFE75DF9BE638844" commented="no"><enum>(i)</enum><text>toxicity information;</text></clause>
<clause id="H8C263D421F364AF390065D2B24D384E4" commented="no"><enum>(ii)</enum><text>computational toxicology and bioinformatics; and </text></clause> <clause id="H28AA2E2B4B8747359A5F40BAC15E53FB" commented="no"><enum>(iii)</enum><text>high-throughput screening methods and the prediction models of those methods; and</text></clause></subparagraph>
<subparagraph id="HDA76D04FDDC44206BDDEDBCF06DF657F" commented="no"><enum>(B)</enum><text>encouraging and facilitating—</text> <clause id="HFCA6DE59D1234EB48669303512A8ED1C" commented="no"><enum>(i)</enum><text>the use of scientifically valid test methods and strategies that reduce or replace the use of vertebrate animals while providing information of equivalent or better scientific quality and relevance that will support regulatory decisions under this title;</text></clause>
<clause id="H6888C0543B914B28A5873AE0AABAE7A7" commented="no"><enum>(ii)</enum><text>the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category; and</text></clause> <clause id="H88D2608BAACB40B4A632A2690DCDBE4F" commented="no"><enum>(iii)</enum><text>the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests, provided that such consortia make all information from such testing available to the Administrator.</text></clause></subparagraph></paragraph>
<paragraph id="HD3D82691EF93499FA7FB042539FF8C87" commented="no"><enum>(2)</enum><header>Implementation of alternative testing methods</header><text>To promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals, the Administrator shall—</text> <subparagraph id="H4A65800E5E834056AF706543ABA9F97A" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">not later than 2 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures through, for example—</text>
<clause id="H0F2123DE496546539F2A2A7ABC21E64F" commented="no"><enum>(i)</enum><text>computational toxicology and bioinformatics;</text></clause> <clause id="HB9E0F5100E6140FE9A85B2486AA8E91C" commented="no"><enum>(ii)</enum><text>high-throughput screening methods; </text></clause>
<clause id="HB3AC3E15256D4FCBB1C6AE8D10BC3EC0" commented="no"><enum>(iii)</enum><text>testing of categories of chemical substances; </text></clause> <clause id="HA7DB0817E55F444CB6E71379AAA6EF0C" commented="no"><enum>(iv)</enum><text>tiered testing methods; </text></clause>
<clause id="H99936B22DFCE4E96BB4BDF41EFF99F36" commented="no"><enum>(v)</enum><text>in vitro studies; </text></clause> <clause id="H1F40C28727014D2FB5050CF77E6C8623" commented="no"><enum>(vi)</enum><text>systems biology; </text></clause>
<clause id="H67566C34565847018FFBB7CE5DF44FDE" commented="no"><enum>(vii)</enum><text>new or revised methods identified by validation bodies such as the Interagency Coordinating Committee on the Validation of Alternative Methods or the Organization for Economic Co-operation and Development; or</text></clause> <clause id="H46FD32CA9B3A4B438D50E5EAD52C06F1" commented="no"><enum>(viii)</enum><text>industry consortia that develop information submitted under this title;</text></clause></subparagraph>
<subparagraph id="H8C25836AF24248628510EB49C8F6F877" commented="no"><enum>(B)</enum><text>as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section;</text></subparagraph> <subparagraph id="HB790A843670B495E89DEB8029FA37CD1" commented="no"><enum>(C)</enum><text>include in the strategic plan developed under subparagraph (A) a list, which the Administrator shall update on a regular basis, of particular alternative test methods or strategies the Administrator has identified that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing;</text></subparagraph>
<subparagraph id="HCA59066B02A641FC815D21069CDA6BBB" commented="no"><enum>(D)</enum><text>provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific reliability and relevance of the test methods and strategies that may be identified pursuant to subparagraph (C);</text></subparagraph> <subparagraph id="HF904AC4DAD034C2A8A0E2332204F1CFD" commented="no"><enum>(E)</enum><text>beginning on the date that is 5 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing the plan developed under subparagraph (A) and goals for future alternative test methods and strategies implementation; and</text></subparagraph>
<subparagraph id="H36D520F5A2EE422B9C1A7A25C2F5AE7E" commented="no"><enum>(F)</enum><text>prioritize and, to the extent consistent with available resources and the Administrator’s other responsibilities under this title, carry out performance assessment, validation, and translational studies to accelerate the development of scientifically valid test methods and strategies that reduce, refine, or replace the use of vertebrate animals, including minimizing duplication, in any testing under this title.</text></subparagraph></paragraph> <paragraph id="H09E6C1DB2A6747998858CEC92B76279F"><enum>(3)</enum><header>Voluntary testing</header> <subparagraph id="HA7EBE4A17825405C800552C54BF76057"><enum>(A)</enum><header>In general</header><text>Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative test method or strategy identified by the Administrator pursuant to paragraph (2)(C), if the Administrator has identified such a test method or strategy for the development of such information, before conducting new vertebrate animal testing.</text></subparagraph>
<subparagraph id="HA2137A2669C6438895999F992A8B39E7"><enum>(B)</enum><header>Effect of paragraph</header><text>Nothing in this paragraph shall, under any circumstance, limit or restrict the submission of any existing information to the Administrator.</text></subparagraph> <subparagraph id="H1FEAEAB85EC04DF39C4A0D437573DA1E"><enum>(C)</enum><header>Relationship to other law</header><text>A violation of this paragraph shall not be a prohibited act under section 15.</text></subparagraph>
<subparagraph id="HFB60F26EDC0240B1995E71FB86A753CE" commented="no"><enum>(D)</enum><header>Review of means</header><text>This paragraph authorizes, but does not require, the Administrator to review the means by which a person conducted testing described in subparagraph (A).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H7FE6D6248E8D4574A03894451C3072FF" section-type="subsequent-section"><enum>5.</enum><header>Manufacturing and processing notices</header><text display-inline="no-display-inline">Section 5 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2604">15 U.S.C. 2604</external-xref>) is amended—</text>
<paragraph id="H74D45697FA8C45E693F54ADD48D3D95A"><enum>(1)</enum><text>in subsection (a)—</text> <subparagraph id="H154FA012DD8B42BCB735D0F4F426A802"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause id="HBECA9AFEE3AC48A697D913E178F6CF73"><enum>(i)</enum><text>by striking <quote>Except as provided in</quote> and inserting <quote>(A) Except as provided in subparagraph (B) of this paragraph and</quote>;</text></clause> <clause id="H71B2E688F5F84E1CA43DF8D5A6FAE6F0"><enum>(ii)</enum><text>by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively;</text></clause>
<clause id="H8F009D49AD51454BB8C0A186BD564CA0"><enum>(iii)</enum><text>by striking all that follows <quote>significant new use</quote> and inserting a period; and</text></clause> <clause id="HFD47F473BD1A4DBA95D2644CD0593195"><enum>(iv)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" id="HF8ACB49A33B740F5A3DECFD31CA18AEC" display-inline="no-display-inline">
<subparagraph id="HAA58F497079D433D89889FFC11BF4A6E" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">A person may take the actions described in subparagraph (A) if—</text> <clause id="H2036D6C0F0124BD9ABF95441B83187CC"><enum>(i)</enum><text display-inline="yes-display-inline">such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection (d), of such person’s intention to manufacture or process such substance and such person complies with any applicable requirement of, or imposed pursuant to, subsection (b), (e), or (f); and</text></clause>
<clause id="HD6F9D9A3F6DB49ADB88E5F94EBF7EEC8"><enum>(ii)</enum><text display-inline="yes-display-inline">the Administrator—</text> <subclause id="H526B80AA21F04CFB8B2D55AAD9B83CBF"><enum>(I)</enum><text>conducts a review of the notice; and</text></subclause>
<subclause id="H67EE4ABF39A345C69C96CE045430FB53"><enum>(II)</enum><text display-inline="yes-display-inline">makes a determination under subparagraph (A), (B), or (C) of paragraph (3) and takes the actions required in association with that determination under such subparagraph within the applicable review period.</text></subclause></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="HFDAD8A1D573A421DBFF8BD42993C3523"><enum>(B)</enum><text>by adding at the end the following new paragraphs:</text>
<quoted-block style="OLC" id="HF756F575C7804B9AAC5029D6ECC89AD3" display-inline="no-display-inline">
<paragraph id="H4E1E9BEA05714A6C8BD215E07672456E"><enum>(3)</enum><header>Review and determination</header><text display-inline="yes-display-inline">Within the applicable review period, subject to section 18, the Administrator shall review such notice and determine—</text> <subparagraph id="HE3FCA7F7C9CE4D158CFC8D037C959F07" display-inline="no-display-inline"><enum>(A)</enum><text display-inline="yes-display-inline">that the relevant chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the Administrator shall take the actions required under subsection (f);</text></subparagraph>
<subparagraph id="H57FA9AD9DB2448CC85814FD365A2DFE7" commented="no"><enum>(B)</enum><text>that—</text> <clause id="H2C1CDE52DD76401499875F839A7CF8D8" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the relevant chemical substance or significant new use; or</text></clause>
<clause id="H8CA6B279B7FF4B9E996F97FFEA00CE77" commented="no"><enum>(ii)</enum>
<subclause id="H00161336808E414F8A47B5A13A61141C" display-inline="yes-display-inline" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator; or</text></subclause> <subclause id="H7E5C2323EF874292BA1283B11068912A" indent="up1" commented="no"><enum>(II)</enum><text>such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance,</text></subclause><continuation-text continuation-text-level="subparagraph">in which case the Administrator shall take the actions required under subsection (e); or</continuation-text></clause></subparagraph>
<subparagraph id="H7C5BE3BBE47B4E7BAAF1884F937972B8"><enum>(C)</enum><text display-inline="yes-display-inline">that the relevant chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for a significant new use.</text></subparagraph> </paragraph> <paragraph id="H8316AE278565403CB609061239BD82A7"><enum>(4)</enum><header>Failure to render determination</header> <subparagraph id="H4DFC20DA9A974A888BB6076DE6D69606"><enum>(A)</enum><header>Failure to render determination</header><text>If the Administrator fails to make a determination on a notice under paragraph (3) by the end of the applicable review period and the notice has not been withdrawn by the submitter, the Administrator shall refund to the submitter all applicable fees charged to the submitter for review of the notice pursuant to section 26(b), and the Administrator shall not be relieved of any requirement to make such determination.</text></subparagraph>
<subparagraph id="HE1D8F6D3F7724976A074947BEA7DED2D"><enum>(B)</enum><header>Limitations</header>
<clause id="HBBCB8FFA0990462CA10693C88684A0A6" display-inline="yes-display-inline"><enum>(i)</enum><text>A refund of applicable fees under subparagraph (A) shall not be made if the Administrator certifies that the submitter has not provided information required under subsection (b) or has otherwise unduly delayed the process such that the Administrator is unable to render a determination within the applicable review period.</text></clause> <clause id="H5E819576043D4AA69B72F9FA608EA24E" indent="up1"><enum>(ii)</enum><text>A failure of the Administrator to render a decision shall not be deemed to constitute a withdrawal of the notice.</text></clause>
<clause id="H9874071B37F4454D8E893DAC33399454" indent="up1"><enum>(iii)</enum><text>Nothing in this paragraph shall be construed as relieving the Administrator or the submitter of the notice from any requirement of this section.</text></clause></subparagraph></paragraph> <paragraph id="H8A44BD2ABFB846CA8F548B753F071DA5"><enum>(5)</enum><header>Article consideration</header><text display-inline="yes-display-inline">The Administrator may require notification under this section for the import or processing of a chemical substance as part of an article or category of articles under paragraph (1)(A)(ii) if the Administrator makes an affirmative finding in a rule under paragraph (2) that the reasonable potential for exposure to the chemical substance through the article or category of articles subject to the rule justifies notification.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HBBE66E98CCF24350BD4E9FA064E2C259"><enum>(2)</enum><text>in subsection (b)—</text> <subparagraph id="HDB2FCE8D46324C9FBD8EAC71B509F6BD"><enum>(A)</enum><text>in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">Test Data</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">Information</header-in-text></quote>; </text></subparagraph>
<subparagraph id="H2AFE44ABCB0547E99F9BDC5C2DB1DE63"><enum>(B)</enum><text>in paragraph (1)—</text> <clause id="H63793ADB80F94454B485D94C9294E49E"><enum>(i)</enum><text> in subparagraph (A)—</text>
<subclause id="HDB05DB48A9FD4757ABB69F7BA6D04844"><enum>(I)</enum><text>by striking <quote>test data</quote> and inserting <quote>information</quote>; and</text></subclause> <subclause id="HCB7B9D19B20B433B99BD7D705E98F240"><enum>(II)</enum><text>by striking <quote>such data</quote> and inserting <quote>such information</quote>; and</text></subclause></clause>
<clause id="H2AF1554B95DE428BAEC706001E93310C"><enum>(ii)</enum><text>in subparagraph (B)—</text> <subclause id="H52CEDC869A064452B85F8C412DD53838"><enum>(I)</enum><text>by striking <quote>test data</quote> and inserting <quote>information</quote>;</text></subclause>
<subclause id="H583914CC413249E5A85EAD45C578A780"><enum>(II)</enum><text>by striking <quote>subsection (a)(1)(A)</quote> and inserting <quote>subsection (a)(1)(A)(i)</quote>; and</text></subclause> <subclause id="H1AC8621928624D9BA1333FEECC78C225"><enum>(III)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (a)(1)(B)</quote> and inserting <quote>subsection (a)(1)(A)(ii)</quote>;</text></subclause></clause></subparagraph>
<subparagraph id="H3C773C829D5E486FA2F7F39E6FC04A3B"><enum>(C)</enum><text>in paragraph (2)—</text> <clause id="H43DFBD0CCA1940CA9FB0B9513EDA6D32"><enum>(i)</enum><text>in subparagraph (A)—</text>
<subclause id="HB0800137FCA54EF8868BB1481AD7A8D0"><enum>(I)</enum><text>by striking <quote>test data</quote> in clause (ii) and inserting <quote>information</quote>;</text></subclause> <subclause id="H934C35F462FC446EAFB327D8B2AF4D1F"><enum>(II)</enum><text>by striking <quote>shall</quote> and inserting <quote>may</quote>; and</text></subclause>
<subclause id="HF3F63ABD0B6B4A1C9D5C09C5223FD87C"><enum>(III)</enum><text>by striking <quote>data prescribed</quote> and inserting <quote>information prescribed</quote>; and</text></subclause></clause> <clause id="H963300335CB24737BA4DB80ED5ADD23D"><enum>(ii)</enum><text>in subparagraph (B)—</text>
<subclause id="H673DD6E71C3A49C982B356D52257DEA8"><enum>(I)</enum><text>by striking <quote>Data</quote> and inserting <quote>Information</quote>;</text></subclause> <subclause id="H9192DABDE97F402E80C1DA283375BA89"><enum>(II)</enum><text>by striking <quote>data</quote> both places it appears and inserting <quote>information</quote>;</text></subclause>
<subclause id="HC722DFFBFA0B4464AB15C374D75DD976"><enum>(III)</enum><text>by striking <quote>show</quote> and inserting <quote>shows</quote>;</text></subclause> <subclause id="HBC86C54FB525409883136111A83A1DD9"><enum>(IV)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (a)(1)(A)</quote> in clause (i) and inserting <quote>subsection (a)(1)(A)(i)</quote>; and</text></subclause>
<subclause id="H64827B87B84D4EF59D94F148C0C799B4"><enum>(V)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (a)(1)(B)</quote> in clause (ii) and inserting <quote>subsection (a)(1)(A)(ii)</quote>;</text></subclause></clause></subparagraph> <subparagraph id="H528D7F36D8134F86A9F4F478F9131BE1"><enum>(D)</enum><text>in paragraph (3)—</text>
<clause id="HDA5C614F4FF84AD8A708C624B30FD290"><enum>(i)</enum><text>by striking <quote>Data</quote> and inserting <quote>Information</quote>; and</text></clause> <clause id="H42D19A5A2374454992F1AC2A9142B9E2"><enum>(ii)</enum><text>by striking <quote>paragraph (1) or (2)</quote> and inserting <quote>paragraph (1) or (2) of this subsection or under subsection (e)</quote>; and</text></clause></subparagraph>
<subparagraph id="HBE4EC47A1E7D4C149275D624CBD5E235"><enum>(E)</enum><text>in paragraph (4)—</text> <clause id="H752AB11DDB0E47238BE8894174DA2243"><enum>(i)</enum><text>in subparagraph (A)(i), by inserting <quote>, without consideration of costs or other nonrisk factors</quote> after <quote>health or the environment</quote>; and</text></clause>
<clause id="H8142F4E65CD14E6BACD6E9510D75325A"><enum>(ii)</enum><text>in subparagraph (C), by striking <quote>, except that</quote> and all that follows through <quote>subparagraph (A)</quote>;</text></clause></subparagraph></paragraph> <paragraph id="H6880C9FC12F84C39A51179241C59AC16"><enum>(3)</enum><text>in subsection (c)—</text>
<subparagraph id="HAEBE654472DF4AECA706F1C1FCDA357A"><enum>(A)</enum><text>in the subsection heading, by striking <header-in-text level="subsection" style="OLC"><quote><header-in-text level="subsection" style="OLC">Notice</header-in-text></quote></header-in-text> and inserting <quote><header-in-text level="subsection" style="OLC">Review</header-in-text></quote>; and</text></subparagraph> <subparagraph id="H489691874F0B4474808ED51132FA1293"><enum>(B)</enum><text>by striking <quote>before which</quote> and all that follows through <quote>subsection may begin</quote>;</text></subparagraph></paragraph>
<paragraph id="HE33C93A826224714BEE36C0CAB6B63AB"><enum>(4)</enum><text>in subsection (d)—</text> <subparagraph id="HEB0B0D4F1C8246F3A5EBB3F2F03B87B6"><enum>(A)</enum><text>by striking <quote>test data</quote> in paragraph (1)(B) and inserting <quote>information</quote>;</text></subparagraph>
<subparagraph id="H79C7E256BE684F4F9582ECC0164A33E5"><enum>(B)</enum><text>by striking <quote>data</quote> each place it appears in paragraph (1)(C) and paragraph (2) and inserting <quote>information</quote>;</text></subparagraph> <subparagraph id="HAF25D7B0D4704757BEDCE49950BD3CC3"><enum>(C)</enum><text>in paragraph (2)(B), by striking <quote>uses or intended uses of such substance</quote> and inserting <quote>uses of such substance identified in the notice</quote>; and</text></subparagraph>
<subparagraph id="H18B63BBB776D4E288008B224FCA9FC2A"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text> <clause id="HC0CABE81A679410D9C245873BABCA501"><enum>(i)</enum><text>by striking <quote>for which the notification period prescribed by subsection (a), (b), or (c)</quote> and inserting <quote>for which the applicable review period</quote>; and</text></clause>
<clause id="H7DB5FDA4A8B44A00A0E124F5D9D40CAD"><enum>(ii)</enum><text>by striking <quote>such notification period</quote> and inserting <quote>such period</quote>;</text></clause></subparagraph></paragraph> <paragraph id="H88EE95D4B4C04B76857DD089442B1897"><enum>(5)</enum><text>in subsection (e)—</text>
<subparagraph id="HCB1527D170004F81972F79BB6532EF97"><enum>(A)</enum><text>in paragraph (1)(A)—</text> <clause id="H2F895BA13DD644A5BD818A5DA10289B2"><enum>(i)</enum><text>in clause (i), by striking <quote>; and</quote> and inserting <quote>; or</quote>; </text></clause>
<clause id="H166F00277F344B5289B542D14A4FC1B4"><enum>(ii)</enum><text>in clause (ii)(I), by inserting <quote>without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use;</quote> after <quote>health or the environment,</quote>; and</text></clause> <clause id="H35E734B3B949406DA00591CC90A7728D"><enum>(iii)</enum><text>in the matter after clause (ii)(II)—</text>
<subclause id="H355D0A35F5AF414BAA7F765450784B11"><enum>(I)</enum><text>by striking <quote>may issue a proposed order</quote> and inserting <quote>shall issue an order</quote>;</text></subclause> <subclause id="H80EA8607B05F488CB2FE33CD9D7BD1DA"><enum>(II)</enum><text>by striking <quote>notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), (c)</quote> and inserting <quote>applicable review period</quote>; and</text></subclause>
<subclause id="HBDEBEA965A8E4196A3C17F00B2D53F07"><enum>(III)</enum><text>by inserting <quote>to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, and the submitter of the notice may commence manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, including while any required information is being developed, only in compliance with the order</quote> before the period at the end; </text></subclause></clause></subparagraph> <subparagraph id="H2F4217C0075943F880072C8CED5B6B58"><enum>(B)</enum><text>in paragraph (1)(B)—</text>
<clause id="HA411C1A0F0654293BA6CB7D92EA8C2E0"><enum>(i)</enum><text>by striking <quote>A proposed order</quote> and inserting <quote>An order</quote>;</text></clause> <clause id="H453CAEAD7347452B9450E655D28DF112"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>notification period applicable to the manufacture or processing of such substance under subsection (a), (b), (c)</quote> and inserting <quote>applicable review period</quote>; and</text></clause>
<clause id="HFF22084509B1450F9C1CAFAFAB93C4C2"><enum>(iii)</enum><text>by striking <quote>of the proposed order</quote> and inserting <quote>of the order</quote>; </text></clause></subparagraph> <subparagraph id="H9D127BB326134BD39B66ED231439209B"><enum>(C)</enum><text>by striking paragraph (1)(C); and</text></subparagraph>
<subparagraph id="H98FBCC863AFD4B83BB80CECED1CE683D"><enum>(D)</enum><text>by striking paragraph (2);</text></subparagraph></paragraph> <paragraph id="H7DE361B31EDB46E498EFC5707ABA409F"><enum>(6)</enum><text>in subsection (f)—</text>
<subparagraph id="H700AB4BC82964916830F19333B428F14"><enum>(A)</enum><text>in paragraph (1)—</text> <clause id="H5E6DE560FC5F4EBD89421F455DF532F1"><enum>(i)</enum><text>by striking <quote>finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with</quote> and inserting <quote>determines that a chemical substance or significant new use with</quote>;</text></clause>
<clause id="H8583DA70168448B3A45937EF3CF0F775"><enum>(ii)</enum><text>by striking <quote>, or that any combination of such activities,</quote>;</text></clause> <clause id="HB8E125AB49FC477B90D4FDDFDF3FD320"><enum>(iii)</enum><text>by striking <quote>or will present</quote>; </text></clause>
<clause id="H51067297E9CD4EA493433F7420143C10"><enum>(iv)</enum><text>by striking <quote>before a rule promulgated under section 6 can protect against such risk,</quote> and inserting <quote>, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use,</quote>; and</text></clause> <clause id="H4DB4202CDA644CCF9FD7FEBB763911E7"><enum>(v)</enum><text>by striking <quote>notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such substance</quote> and inserting <quote>applicable review period</quote>;</text></clause></subparagraph>
<subparagraph id="H98A28397B16B43D9B3381E7542EE421D"><enum>(B)</enum><text>in paragraph (2), the matter following subparagraph (C), by striking <quote>Section 6(d)(2)(B)</quote> and inserting <quote>Section 6(d)(3)(B)</quote>; </text></subparagraph> <subparagraph id="H9324A765A86E4344AE37F06E515E2156"><enum>(C)</enum><text>in paragraph (3)—</text>
<clause id="HE035176CF47845B38E55311E76C4A16B"><enum>(i)</enum><text>in subparagraph (A)—</text> <subclause id="H823219B563254FC4B0C634226A41C550"><enum>(I)</enum><text>by striking <quote>Administrator may</quote> and all that follows through <quote>issue a proposed order to prohibit the</quote> and inserting <quote>Administrator may issue an order to prohibit or limit the</quote>; and</text></subclause>
<subclause id="H7FAD29E0DBE943E08E7A74586B6297B7"><enum>(II)</enum><text>by striking <quote>under paragraph (1)</quote> and all that follows through <quote>processing of such substance.</quote> and inserting <quote>under paragraph (1). Such order shall take effect on the expiration of the applicable review period.</quote>;</text></subclause></clause> <clause id="HA25B9C384BAB4E84BF6AEBFCD9EDF911"><enum>(ii)</enum><text>by striking subparagraph (B) and redesignating subparagraph (C) as subparagraph (B);</text></clause>
<clause id="HB84FAFB759EE43FB8D4B5E5EE3B129D2"><enum>(iii)</enum><text>in subparagraph (B), as so redesignated—</text> <subclause id="H55E68EF721DF43ABAB9EBC43EDF4524E"><enum>(I)</enum><text>by striking <quote>subparagraphs (B) and (C)</quote> and inserting <quote>subparagraph (B)</quote>;</text></subclause>
<subclause id="H98DBD0576EAA4E589C78BD5B8F299FB3"><enum>(II)</enum><text>by striking <quote>clause (i) of</quote>; and</text></subclause> <subclause id="HA7DC187817C8491AA8D648D1DE3F9D97"><enum>(III)</enum><text>by striking <quote>; and the provisions of subparagraph (C) of subsection (e)(2) shall apply with respect to an injunction issued under subparagraph (B)</quote>; and</text></subclause></clause>
<clause id="H346D5B942E6B4E28A2732C97DC2A9757"><enum>(iv)</enum><text>by striking subparagraph (D); and</text></clause></subparagraph> <subparagraph id="H6D8728BA9F1644DE86F15C65832E95D9"><enum>(D)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" id="HBA25F4E4586E41F6954E73A658C83C31" display-inline="no-display-inline">
<paragraph id="H3D8999D8EBBB403BA0F8799C75B51C5D"><enum>(4)</enum><header>Treatment of nonconforming uses</header><text display-inline="yes-display-inline">Not later than 90 days after taking an action under paragraph (2) or (3) or issuing an order under subsection (e) relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B), the Administrator shall consider whether to promulgate a rule pursuant to subsection (a)(2) that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the action or order, and, as applicable, initiate such a rulemaking or publish a statement describing the reasons of the Administrator for not initiating such a rulemaking.</text></paragraph> <paragraph id="HD6A1D856240A42CF913D03AF11FBA993"><enum>(5)</enum><header>Workplace exposures</header><text display-inline="yes-display-inline">To the extent practicable, the Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B) to address workplace exposures.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HAE0200E84E934C04B1C49B7022856A03"><enum>(7)</enum><text>by amending subsection (g) to read as follows:</text> <quoted-block style="OLC" id="H12C188894104405882562F37EE6A2B2D" display-inline="no-display-inline"> <subsection id="H03E6850ADEF24B2E85C7F2AF4B3B0ADF"><enum>(g)</enum><header>Statement on administrator finding</header><text display-inline="yes-display-inline">If the Administrator finds in accordance with subsection (a)(3)(C) that a chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, then notwithstanding any remaining portion of the applicable review period, the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for the significant new use, and the Administrator shall make public a statement of the Administrator’s finding. Such a statement shall be submitted for publication in the Federal Register as soon as is practicable before the expiration of such period. Publication of such statement in accordance with the preceding sentence is not a prerequisite to the manufacturing or processing of the substance with respect to which the statement is to be published.</text></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HE243C00E5D9845DEB38D7B30904742E8"><enum>(8)</enum><text>in subsection (h)—</text> <subparagraph id="HEF7FBF44C9E24DDB95BE5CCCD4BD2C6D"><enum>(A)</enum><text>in paragraph (1)(A), by inserting <quote>, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator for the specific conditions of use identified in the application</quote> after <quote>health or the environment</quote>;</text></subparagraph>
<subparagraph id="H13483317BEA247F1823030F19536ECA4"><enum>(B)</enum><text>in paragraph (2), by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>; and</text></subparagraph> <subparagraph id="HA5716E382616419594FC0257845A678F"><enum>(C)</enum><text>in paragraph (4), by striking <quote>. A rule promulgated</quote> and all that follows through <quote>section 6(c)</quote> and inserting <quote>, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator under the conditions of use</quote>; and</text></subparagraph></paragraph>
<paragraph id="HA742538696464765BB4523D95B459965"><enum>(9)</enum><text>by amending subsection (i) to read as follows:</text> <quoted-block style="OLC" id="H520EEF3DFC7640A395DDD141F79379AF" display-inline="no-display-inline"> <subsection id="H5EBA7F5F33C145A7B09B1A14106FF3A4"><enum>(i)</enum><header>Definitions</header> <paragraph id="HF396ABC5D5B44DFC8AEDEDD50C19DB1A" display-inline="yes-display-inline"><enum>(1)</enum><text>For purposes of this section, the terms <term>manufacture</term> and <term>process</term> mean manufacturing or processing for commercial purposes.</text></paragraph>
<paragraph id="H249A41742595432DBF61ABFBF9BF4C36" indent="up1"><enum>(2)</enum><text>For purposes of this Act, the term <term>requirement</term> as used in this section shall not displace any statutory or common law.</text></paragraph> <paragraph id="H7F6336BF313940F29EEE2B4E6F1CEDAA" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">For purposes of this section, the term <term>applicable review period</term> means the period starting on the date the Administrator receives a notice under subsection (a)(1) and ending 90 days after that date, or on such date as is provided for in subsection (b)(1) or (c).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="HE92D953464DF4CB8AA24816BA5F34540" section-type="subsequent-section"><enum>6.</enum><header>Prioritization, risk evaluation, and regulation of chemical substances and mixtures</header><text display-inline="no-display-inline">Section 6 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2605">15 U.S.C. 2605</external-xref>) is amended—</text> <paragraph id="HA86AD8F5F14D433491617930DE930FBD"><enum>(1)</enum><text>by striking the section heading and inserting <quote><header-in-text level="section" style="OLC">Prioritization, risk evaluation, and regulation of chemical substances and mixtures</header-in-text></quote>;</text></paragraph>
<paragraph id="H1BF3976A81344D03901AC87447667130"><enum>(2)</enum><text>in subsection (a)—</text> <subparagraph id="HD359521311464F0BA9F8B491001FCA69"><enum>(A)</enum><text>by striking <quote>finds that there is a reasonable basis to conclude</quote> and inserting <quote>determines in accordance with subsection (b)(4)(A)</quote>;</text></subparagraph>
<subparagraph id="H99BC4DD07C5C462AB8EB50614795C63D"><enum>(B)</enum><text>by striking <quote>or will present</quote>; </text></subparagraph> <subparagraph id="HCDA75D57827A4D2B83C4CC17E22F8DC8"><enum>(C)</enum><text>by inserting <quote>and subject to section 18, and in accordance with subsection (c)(2),</quote> after <quote>shall by rule</quote>;</text></subparagraph>
<subparagraph id="H2895386EA4574BF5B4956D99E0AF8ED3"><enum>(D)</enum><text>by striking <quote>to protect adequately against such risk using the least burdensome requirements</quote> and inserting <quote>so that the chemical substance or mixture no longer presents such risk</quote>;</text></subparagraph> <subparagraph id="H9BBBE1B1C6AC4974AE73E8A7690ABDD3"><enum>(E)</enum><text>by inserting <quote>or otherwise restricting</quote> after <quote>prohibiting</quote> in paragraphs (1)(A) and (2)(A);</text></subparagraph>
<subparagraph id="HC62413587552432AA0E33CB7FCDABA99"><enum>(F)</enum><text>by inserting <quote>minimum</quote> before <quote>warnings</quote> both places it appears in paragraph (3);</text></subparagraph> <subparagraph id="H4CD6A7FEAA614735B14D8A5659201685"><enum>(G)</enum><text>by striking <quote>and monitor or conduct tests</quote> and inserting <quote>or monitor or conduct tests</quote> in paragraph (4); and</text></subparagraph>
<subparagraph id="HAE2A91E3829F4478A7BF270695A84AD5"><enum>(H)</enum><text>in paragraph (7)—</text> <clause id="H7C7EBF0400604037A692A32221E1FF3C"><enum>(i)</enum><text>by striking <quote>such unreasonable risk of injury</quote> and inserting <quote>such determination</quote>; and</text></clause>
<clause id="H4F5716C1D46C4A36ADE10B0E55E0882E"><enum>(ii)</enum><text>by striking <quote>such risk of injury</quote> and inserting <quote>such determination</quote>;</text></clause></subparagraph></paragraph> <paragraph id="H4E1C4104A74A41F98378C72FF3E6A583"><enum>(3)</enum><text>by amending subsection (b) to read as follows:</text>
<quoted-block style="OLC" id="H6D7E201A40354DE4928BFAE861F11A5B" display-inline="no-display-inline">
<subsection id="H0A226C1164D749869455CC2C1AB92105"><enum>(b)</enum><header>Risk evaluations</header>
<paragraph id="H691BCAFB93744F6BBC4ED59E9E2E353B"><enum>(1)</enum><header>Prioritization for risk evaluations</header>
<subparagraph id="HCCBEB9AE9E2A428FA5A8E8250E92FAF2"><enum>(A)</enum><header>Establishment of process</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall establish, by rule, a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. The process to designate the priority of chemical substances shall include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed.</text></subparagraph> <subparagraph id="HABBF83392B09454CA0D94CE873980D83"><enum>(B)</enum><header>Identification of priorities for risk evaluation</header> <clause id="HA0B2B32A2A3A4D2CA0CD01E98A43C553"><enum>(i)</enum><header>High-priority substances</header><text>The Administrator shall designate as a high-priority substance a chemical substance that the Administrator concludes, without consideration of costs or other nonrisk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator.</text></clause>
<clause id="H1FC2F4F20A794532854A890B3CD22D52"><enum>(ii)</enum><header>Low-priority substances</header><text display-inline="yes-display-inline">The Administrator shall designate a chemical substance as a low-priority substance if the Administrator concludes, based on information sufficient to establish, without consideration of costs or other nonrisk factors, that such substance does not meet the standard identified in clause (i) for designating a chemical substance a high-priority substance.</text></clause> </subparagraph> <subparagraph id="HDB38967B84724303BC9D10683DC37C40"><enum>(C)</enum><header>Information request and review and proposed and final prioritization designation</header><text display-inline="yes-display-inline">The rulemaking required in subparagraph (A) shall ensure that the time required to make a priority designation of a chemical substance be no shorter than nine months and no longer than 1 year, and that the process for such designations includes—</text>
<clause id="H8E98817EA6C94280AD7BC6E2119128E4"><enum>(i)</enum><text>a requirement that the Administrator request interested persons to submit relevant information on a chemical substance that the Administrator has initiated the prioritization process on, before proposing a priority designation for the chemical substance, and provide 90 days for such information to be provided;</text></clause> <clause id="H1556A0971D264C838A31630EB218068F"><enum>(ii)</enum><text>a requirement that the Administrator publish each proposed designation of a chemical substance as a high- or low-priority substance, along with an identification of the information, analysis, and basis used to make the proposed designations, and provide 90 days for public comment on each such proposed designation; and</text></clause>
<clause id="H7775229808504A3EAB2CF611DD79013F"><enum>(iii)</enum><text display-inline="yes-display-inline">a process by which the Administrator may extend the deadline in clause (i) for up to three months in order to receive or evaluate information required to be submitted in accordance with section 4(a)(2)(B), subject to the limitation that if the information available to the Administrator at the end of such an extension remains insufficient to enable the designation of the chemical substance as a low-priority substance, the Administrator shall designate the chemical substance as a high-priority substance.</text></clause></subparagraph></paragraph> <paragraph id="H47CD60F58441462BA28E645B752BBE4B"><enum>(2)</enum><header>Initial risk evaluations and subsequent designations of high- and low-priority substances</header> <subparagraph id="H4BC7B2B7A6D8488891BE1ACE7CA749E6"><enum>(A)</enum><header>Initial risk evaluations</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall ensure that risk evaluations are being conducted on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and shall publish the list of such chemical substances during the 180 day period.</text></subparagraph>
<subparagraph id="H8B9595C205884864899B1B0CE0E6304C"><enum>(B)</enum><header>Additional risk evaluations</header><text>Not later than three and one half years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall ensure that risk evaluations are being conducted on at least 20 high-priority substances and that at least 20 chemical substances have been designated as low-priority substances, subject to the limitation that at least 50 percent of all chemical substances on which risk evaluations are being conducted by the Administrator are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments.</text></subparagraph> <subparagraph id="HCD578811A1184C28A1011E8E24A1B16F"><enum>(C)</enum><header>Continuing designations and risk evaluations</header><text display-inline="yes-display-inline">The Administrator shall continue to designate priority substances and conduct risk evaluations in accordance with this subsection at a pace consistent with the ability of the Administrator to complete risk evaluations in accordance with the deadlines under paragraph (4)(G).</text></subparagraph>
<subparagraph id="HEED6C9513CDB4C0BB1827CFA6F081550"><enum>(D)</enum><header>Preference</header><text>In designating high-priority substances, the Administrator shall give preference to—</text> <clause id="HFAB4A29A88C24460924930F452AA3852"><enum>(i)</enum><text>chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a Persistence and Bioaccumulation Score of 3; and</text></clause>
<clause id="HF1C4914D04A447EDB0A43E32B1734300"><enum>(ii)</enum><text>chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity.</text></clause></subparagraph> <subparagraph id="HF039F69D8344449CB100C148062B2405" commented="no"><enum>(E)</enum><header>Metals and metal compounds</header><text display-inline="yes-display-inline">In identifying priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board.</text></subparagraph></paragraph>
<paragraph id="H6FCA67BAB1674F81B330294BB66CE6A5"><enum>(3)</enum><header>Initiation of risk evaluations; designations</header>
<subparagraph id="HA4B0B0B5EE4D406BB03564D633620006"><enum>(A)</enum><header>Risk evaluation initiation</header><text>Upon designating a chemical substance as a high-priority substance, the Administrator shall initiate a risk evaluation on the substance.</text></subparagraph> <subparagraph id="H8B30215C150E47398706AB9A1A43CC50"><enum>(B)</enum><header>Revision</header><text>The Administrator may revise the designation of a low-priority substance based on information made available to the Administrator.</text></subparagraph>
<subparagraph id="H3BF8E6F61D2E4D08B774DC9D1940D0CB"><enum>(C)</enum><header>Ongoing designations</header><text>The Administrator shall designate at least one high-priority substance upon the completion of each risk evaluation (other than risk evaluations for chemical substances designated under paragraph (4)(C)(ii)).</text></subparagraph></paragraph> <paragraph id="H63A2D21B3DB24846A73D587718A73923"><enum>(4)</enum><header>Risk evaluation process and deadlines</header> <subparagraph id="HBC153468345141CB8A92F31AE018BDC4"><enum>(A)</enum><header>In general</header><text>The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.</text></subparagraph>
<subparagraph id="H3E25144BD0A043DE934EE76EA4E34DA3"><enum>(B)</enum><header>Establishment of process</header><text>Not later than 1 year after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A).</text></subparagraph> <subparagraph id="HBA85803B9BFF4DF6BD96320A8A7B9726"><enum>(C)</enum><header>Requirement</header><text>The Administrator shall conduct and publish risk evaluations, in accordance with the rule promulgated under subparagraph (B), for a chemical substance—</text>
<clause id="H30BDB15EED8A4EFE9DD742BCC567DC29"><enum>(i)</enum><text>that has been identified under paragraph (2)(A) or designated under paragraph (1)(B)(i); and</text></clause> <clause id="H298550E4C11C4ECC8C6DB29142949FD2"><enum>(ii)</enum><text>subject to subparagraph (E), that a manufacturer of the chemical substance has requested, in a form and manner and using the criteria prescribed by the Administrator in the rule promulgated under subparagraph (B), be subjected to a risk evaluation.</text></clause></subparagraph>
<subparagraph id="H14603BAF9C4E4889A62251F56E31F1F6"><enum>(D)</enum><header>Scope</header><text display-inline="yes-display-inline">The Administrator shall, not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider, and, for each designation of a high-priority substance, ensure not less than 12 months between the initiation of the prioritization process for the chemical substance and the publication of the scope of the risk evaluation for the chemical substance, and for risk evaluations conducted on chemical substances that have been identified under paragraph (2)(A) or selected under subparagraph (E)(iv)(II) of this paragraph, ensure not less than 3 months before the Administrator publishes the scope of the risk evaluation.</text></subparagraph> <subparagraph id="H13D515BC76374133B98D7225D13EAAA7"><enum>(E)</enum><header>Limitation and criteria</header> <clause id="H0E262BFA9D064D058E130EF3E3297FB1"><enum>(i)</enum><header>Percentage requirements</header><text>The Administrator shall ensure that, of the number of chemical substances that undergo a risk evaluation under clause (i) of subparagraph (C), the number of chemical substances undergoing a risk evaluation under clause (ii) of subparagraph (C) is—</text>
<subclause id="HAAD7844B80614D0EB8974F55252DBEE2"><enum>(I)</enum><text>not less than 25 percent, if sufficient requests are made under clause (ii) of subparagraph (C); and</text></subclause> <subclause id="HA2629D666EEE493DB63BCD0C1515D244"><enum>(II)</enum><text>not more than 50 percent.</text></subclause></clause>
<clause id="H046894FF44E54151AEA655800DD8A362"><enum>(ii)</enum><header>Requested risk evaluations</header><text>Requests for risk evaluations under subparagraph (C)(ii) shall be subject to the payment of fees pursuant to section 26(b), and the Administrator shall not expedite or otherwise provide special treatment to such risk evaluations.</text></clause> <clause id="H88F1D8210DEF42518E81F0E4D5DE60ED"><enum>(iii)</enum><header>Preference</header><text display-inline="yes-display-inline">In deciding whether to grant requests under subparagraph (C)(ii), the Administrator shall give preference to requests for risk evaluations on chemical substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment.</text></clause>
<clause id="H8FD83E2A30714F058E51583F020CE4A5"><enum>(iv)</enum><header>Exceptions</header>
<subclause id="H4EB2534193A14566BCF6A190898ACDA4" display-inline="yes-display-inline"><enum>(I)</enum><text>Chemical substances for which requests have been granted under subparagraph (C)(ii) shall not be subject to section 18(b).</text></subclause> <subclause id="H4543DCE32C7D49958753B91C0349B4C4" indent="up1"><enum>(II)</enum><text>Requests for risk evaluations on chemical substances which are made under subparagraph (C)(ii) and that are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments shall be granted at the discretion of the Administrator and not be subject to clause (i)(II).</text></subclause></clause></subparagraph>
<subparagraph id="HC79D3038561C45FDB3D39A200BA14BF8"><enum>(F)</enum><header>Requirements</header><text>In conducting a risk evaluation under this subsection, the Administrator shall—</text> <clause id="H95A916B62CF34AD99CF83F2D46D7E916"><enum>(i)</enum><text>integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator;</text></clause>
<clause id="H1FDEDAD625BC48918B892E00512BA29A"><enum>(ii)</enum><text>describe whether aggregate or sentinel exposures to a chemical substance under the conditions of use were considered, and the basis for that consideration;</text></clause> <clause id="H5631FA2E579E4E59941526CC42139B67"><enum>(iii)</enum><text>not consider costs or other nonrisk factors;</text></clause>
<clause id="HB91B4670BD244A0F8D4368B9F030BA03"><enum>(iv)</enum><text>take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance; and</text></clause> <clause id="HA98D81ADE70B4A0EB95F8DBC1B53239B"><enum>(v)</enum><text>describe the weight of the scientific evidence for the identified hazard and exposure.</text></clause></subparagraph>
<subparagraph id="H789C4682DA85413EB71ECA2BBEC7C1A4"><enum>(G)</enum><header>Deadlines</header><text>The Administrator—</text> <clause id="H002495C227624A648C01DAABB51F5D75"><enum>(i)</enum><text>shall complete a risk evaluation for a chemical substance as soon as practicable, but not later than 3 years after the date on which the Administrator initiates the risk evaluation under subparagraph (C); and</text></clause>
<clause id="HFACF2A9FDF42414EA340A717D6FAAB53"><enum>(ii)</enum><text>may extend the deadline for a risk evaluation for not more than 6 months.</text></clause></subparagraph> <subparagraph id="H4A359AB4E6DD48F08B752B26AB0ADF43"><enum>(H)</enum><header>Notice and comment</header><text>The Administrator shall provide no less than 30 days public notice and an opportunity for comment on a draft risk evaluation prior to publishing a final risk evaluation.</text></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="H696C3E906DE94613A412052C04A8FDF1"><enum>(4)</enum><text>by amending subsection (c) to read as follows:</text> <quoted-block style="OLC" id="H8E2A9ADC3E2948EA821A2C56CC77D0F6" display-inline="no-display-inline"> <subsection id="HEECA89F3780B4712BD09DD5C5BB12FAA"><enum>(c)</enum><header>Promulgation of subsection <enum-in-header>(a)</enum-in-header> rules</header> <paragraph id="H203DF9313E5D4E93897958208591F7B8"><enum>(1)</enum><header>Deadlines</header><text>If the Administrator determines that a chemical substance presents an unreasonable risk of injury to health or the environment in accordance with subsection (b)(4)(A), the Administrator—</text>
<subparagraph id="H404D2256AEE546A9B6E4FAF31890561F"><enum>(A)</enum><text>shall propose in the Federal Register a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the final risk evaluation regarding the chemical substance is published;</text></subparagraph> <subparagraph id="H1444FF97024742DDA57C6BBB84B9B1F9"><enum>(B)</enum><text>shall publish in the Federal Register a final rule not later than 2 years after the date on which the final risk evaluation regarding the chemical substance is published; and</text></subparagraph>
<subparagraph id="H21AE60E761ED4665B942EED55B6A4E09"><enum>(C)</enum><text>may extend the deadlines under this paragraph for not more than 2 years, subject to the condition that the aggregate length of extensions under this subparagraph and subsection (b)(4)(G)(ii) does not exceed 2 years, and subject to the limitation that the Administrator may not extend a deadline for the publication of a proposed or final rule regarding a chemical substance drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments or a chemical substance that, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), without adequate public justification that demonstrates, following a review of the information reasonably available to the Administrator, that the Administrator cannot complete the proposed or final rule without additional information regarding the chemical substance.</text></subparagraph></paragraph> <paragraph id="H6A972B41C63041A2819EB856E8F061EE"><enum>(2)</enum><header>Requirements for rule</header> <subparagraph id="HBCF5E69AD8FB4ECE81E99082E19EAE50"><enum>(A)</enum><header>Statement of effects</header><text>In proposing and promulgating a rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall consider and publish a statement based on reasonably available information with respect to—</text>
<clause id="H385B0ACEEC494C9288F6CA9A5FDB417C"><enum>(i)</enum><text>the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture;</text></clause> <clause id="HBB71FE9027074E54AA7902AE04767A69"><enum>(ii)</enum><text>the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture;</text></clause>
<clause id="H80CADD0DF52B46A29F41ADB92A099BCC"><enum>(iii)</enum><text>the benefits of the chemical substance or mixture for various uses; and</text></clause> <clause id="H5237548A1C884899B87048CC14110443"><enum>(iv)</enum><text>the reasonably ascertainable economic consequences of the rule, including consideration of—</text>
<subclause id="HEC5BC10EA9E54A3EB52489E46CC2E71C"><enum>(I)</enum><text>the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health;</text></subclause> <subclause id="H6B3C935E72B740238C34A1C3E1943842"><enum>(II)</enum><text>the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator; and</text></subclause>
<subclause id="H31600CC3B906436CAE2A0A11DB1C04A2"><enum>(III)</enum><text display-inline="yes-display-inline">the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator.</text></subclause></clause></subparagraph> <subparagraph id="HE57235EC043C4C059C02B159CD198392"><enum>(B)</enum><header>Selecting requirements</header><text display-inline="yes-display-inline">In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the considerations under subparagraph (A) in accordance with subsection (a).</text></subparagraph>
<subparagraph id="HACCC163E416E48A4AB1E86AB173870BB"><enum>(C)</enum><header>Consideration of alternatives</header><text display-inline="yes-display-inline">Based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, the Administrator shall consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect.</text></subparagraph> <subparagraph id="H841E6D5802754511BE79292701B87AB7"><enum>(D)</enum><header>Replacement parts</header> <clause id="H987AF38DC8264079AEF44185DD410A7E"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The Administrator shall exempt replacement parts for complex durable goods and complex consumer goods that are designed prior to the date of publication in the Federal Register of the rule under subsection (a), unless the Administrator finds that such replacement parts contribute significantly to the risk, identified in a risk evaluation conducted under subsection (b)(4)(A), to the general population or to an identified potentially exposed or susceptible subpopulation.</text></clause>
<clause id="H43544CA5CAD34784A6AA053739F0C1A3"><enum>(ii)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this subparagraph—</text> <subclause id="HFC7E0DFD51104BD68EF809F809304FAC"><enum>(I)</enum><text display-inline="yes-display-inline">the term <term>complex consumer goods</term> means electronic or mechanical devices composed of multiple manufactured components, with an intended useful life of 3 or more years, where the product is typically not consumed, destroyed, or discarded after a single use, and the components of which would be impracticable to redesign or replace; and</text></subclause>
<subclause id="H4627DF93378144938E199EC0EF753B2B"><enum>(II)</enum><text display-inline="yes-display-inline">the term <term>complex durable goods</term> means manufactured goods composed of 100 or more manufactured components, with an intended useful life of 5 or more years, where the product is typically not consumed, destroyed, or discarded after a single use. </text></subclause></clause></subparagraph> <subparagraph id="H5F8CF897672449F0967CA54C5176A48E"><enum>(E)</enum><header>Articles</header><text display-inline="yes-display-inline">In selecting among prohibitions and other restrictions, the Administrator shall apply such prohibitions or other restrictions to an article or category of articles containing the chemical substance or mixture only to the extent necessary to address the identified risks from exposure to the chemical substance or mixture from the article or category of articles so that the substance or mixture does not present an unreasonable risk of injury to health or the environment identified in the risk evaluation conducted in accordance with subsection (b)(4)(A).</text></subparagraph></paragraph>
<paragraph id="H9192D1D6FBBD474DAC16520D6797B14E"><enum>(3)</enum><header>Procedures</header><text>When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with section 553 of title 5, United States Code (without regard to any reference in such section to sections 556 and 557 of such title), and shall also—</text> <subparagraph id="HA774A17E810C420C815C0E1962B9509E"><enum>(A)</enum><text>publish a notice of proposed rulemaking stating with particularity the reason for the proposed rule;</text></subparagraph>
<subparagraph id="H0E8BD3604C594B09958564B3BEF6378B"><enum>(B)</enum><text>allow interested persons to submit written data, views, and arguments, and make all such submissions publicly available;</text></subparagraph> <subparagraph id="H46DD81A4926D4BC6B1C5CB884AD9F067"><enum>(C)</enum><text>promulgate a final rule based on the matter in the rulemaking record; and</text></subparagraph>
<subparagraph id="HE77CE28E12144C9786BFADED2DB0EF04"><enum>(D)</enum><text>make and publish with the rule the determination described in subsection (a).</text></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="H8DA23447F71B48BA8E6FAE81342EB149"><enum>(5)</enum><text>in subsection (d)—</text>
<subparagraph id="H98A42B66639B4D729505B013EB957D9C"><enum>(A)</enum><text>by redesignating paragraph (2) as paragraph (3);</text></subparagraph> <subparagraph id="H925EE95BF4A84FEBA9526A62F95E0037"><enum>(B)</enum><text>by striking paragraph (1) and inserting the following:</text>
<quoted-block style="OLC" id="HD88766B1794E42B1A9645F8D0F4C45BF" display-inline="no-display-inline">
<paragraph id="HD3795C69E8264FF984C4A7775A121F9C"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">In any rule under subsection (a), the Administrator shall—</text> <subparagraph id="H9174620FB89341EA806BC71A3A5BD249"><enum>(A)</enum><text>specify the date on which it shall take effect, which date shall be as soon as practicable;</text></subparagraph>
<subparagraph id="HB79F9DC7A85E4469AC4FE7A6D399542D"><enum>(B)</enum><text>except as provided in subparagraphs (C) and (D), specify mandatory compliance dates for all of the requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in a case of a use exempted under subsection (g);</text></subparagraph> <subparagraph id="HB27D034C293C44A6865291D5E8BF47FD"><enum>(C)</enum><text>specify mandatory compliance dates for the start of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in the case of a use exempted under subsection (g);</text></subparagraph>
<subparagraph id="H7BC767F4F3E240E88C89AAD21F4C4D9F"><enum>(D)</enum><text>specify mandatory compliance dates for full implementation of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable; and</text></subparagraph> <subparagraph id="HB678ED82A44346D0993565E3F6A123BD"><enum>(E)</enum><text>provide for a reasonable transition period.</text></subparagraph></paragraph>
<paragraph id="H21477C5D86614522A66C50EDFD13CA52"><enum>(2)</enum><header>Variability</header><text>As determined by the Administrator, the compliance dates established under paragraph (1) may vary for different affected persons.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph> <subparagraph id="H58D3A116C2964AE18991CA1C1030CC38"><enum>(C)</enum><text>in paragraph (3), as so redesignated by subparagraph (A) of this paragraph—</text>
<clause id="H28ABCEBE1DF84587A922EFC7A1A22BF7"><enum>(i)</enum><text>in subparagraph (A)—</text> <subclause id="H47852A07E8CC4289B69D456B909D6AEE"><enum>(I)</enum><text>by striking <quote>upon its publication</quote> and all that follows through <quote>respecting such rule if</quote> and inserting <quote>, and compliance with the proposed requirements to be mandatory, upon publication in the Federal Register of the proposed rule and until the compliance dates applicable to such requirements in a final rule promulgated under section 6(a) or until the Administrator revokes such proposed rule, in accordance with subparagraph (B), if</quote>; and</text></subclause>
<subclause id="HDA1E7D18E84A4230A94DB44F6A96808D" commented="no"><enum>(II)</enum><text>in clause (i)(I), by inserting <quote>without consideration of costs or other non-risk factors</quote> after <quote>effective date</quote>; and </text></subclause></clause> <clause id="HD22CFD0FAA604EED98357957FF9927A5"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>, provide reasonable opportunity</quote> and all that follows through the period at the end and inserting <quote>in accordance with subsection (c), and either promulgate such rule (as proposed or with modifications) or revoke it.</quote>;</text></clause></subparagraph></paragraph>
<paragraph id="HE6B59C9A38D244059C67D026F19BA342"><enum>(6)</enum><text>in subsection (e)(4), by striking <quote>paragraphs (2), (3), and (4)</quote> and inserting <quote>paragraph (3)</quote>; and</text></paragraph> <paragraph id="HF11C78C4B33344D8A673C2C2D241650D"><enum>(7)</enum><text>by adding at the end the following new subsections:</text>
<quoted-block style="OLC" id="H12D2B6E86C9B4B93992B4556F5031AE8" display-inline="no-display-inline">
<subsection id="HB10DBCED236B4263B6B97E0C1835E990"><enum>(g)</enum><header>Exemptions</header>
<paragraph id="H37C9287B533D41139A381AABB0C65AED"><enum>(1)</enum><header>Criteria for exemption</header><text>The Administrator may, as part of a rule promulgated under subsection (a), or in a separate rule, grant an exemption from a requirement of a subsection (a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that—</text> <subparagraph id="HF5EE9DA19878457D98C4447E3AB0BA1C"><enum>(A)</enum><text>the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure;</text></subparagraph>
<subparagraph id="H5291C50BD5FE4624B3E899CD6503E5D7"><enum>(B)</enum><text>compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or</text></subparagraph> <subparagraph id="H337512E581FE4B93B0EBC36AE9A38474"><enum>(C)</enum><text>the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety.</text></subparagraph></paragraph>
<paragraph id="H5EC139B5D35C4770B9B77D295C62E280"><enum>(2)</enum><header>Exemption analysis and statement</header><text>In proposing an exemption under this subsection, the Administrator shall analyze the need for the exemption, and shall make public the analysis and a statement describing how the analysis was taken into account.</text></paragraph> <paragraph id="H91B6A7990D0148BC8F23B064D1B818D5"><enum>(3)</enum><header>Period of exemption</header><text>The Administrator shall establish, as part of a rule under this subsection, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis, and, by rule, may extend, modify, or eliminate an exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary.</text></paragraph>
<paragraph id="H8C941FA77BC94440839ACED68458DA5C"><enum>(4)</enum><header>Conditions</header><text>As part of a rule promulgated under this subsection, the Administrator shall include conditions, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption.</text></paragraph></subsection> <subsection id="H1F460DF4445F4745AF7A2D3D37500016"><enum>(h)</enum><header>Chemicals that are persistent, bioaccumulative, and toxic</header> <paragraph id="H36C7E7CF66A3439EABD09DE7E44D5098" commented="no"><enum>(1)</enum><header>Expedited action</header><text display-inline="yes-display-inline">Not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall propose rules under subsection (a) with respect to chemical substances identified in the 2014 update of the TSCA Work Plan for Chemical Assessments—</text>
<subparagraph id="H18445A7DF6114C6882BB80946F96E90F" commented="no"><enum>(A)</enum><text>that the Administrator has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), and are not a metal or a metal compound, and for which the Administrator has not completed a Work Plan Problem Formulation, initiated a review under section 5, or entered into a consent agreement under section 4, prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; and</text></subparagraph> <subparagraph id="H8FF363DEDD5C46D69841AB013D2BF704" commented="no"><enum>(B)</enum><text>exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator.</text></subparagraph></paragraph>
<paragraph id="H53CEA846689C4D30A5719CAC0C5E2820"><enum>(2)</enum><header>No risk evaluation required</header><text>The Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to paragraph (1).</text></paragraph> <paragraph id="HB1F84E0F705B430FA6005879130EC0EF"><enum>(3)</enum><header>Final rule</header><text>Not later than 18 months after proposing a rule pursuant to paragraph (1), the Administrator shall promulgate a final rule under subsection (a). </text></paragraph>
<paragraph id="H8B8B742309C94C8AB8DA4E7F2E00206D"><enum>(4)</enum><header>Selecting restrictions</header><text>In selecting among prohibitions and other restrictions promulgated in a rule under subsection (a) pursuant to paragraph (1), the Administrator shall address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and shall reduce exposure to the substance to the extent practicable.</text></paragraph> <paragraph id="HC9CDF9D3B7C04148BDB882B2F80EF639"><enum>(5)</enum><header>Relationship to subsection <enum-in-header>(b)</enum-in-header></header><text display-inline="yes-display-inline">If, at any time prior to the date that is 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator makes a designation under subsection (b)(1)(B)(i), or receives a request under subsection (b)(4)(C)(ii), such chemical substance shall not be subject to this subsection, except that in selecting among prohibitions and other restrictions promulgated in a rule pursuant to subsection (a), the Administrator shall both ensure that the chemical substance meets the rulemaking standard under subsection (a) and reduce exposure to the substance to the extent practicable.</text></paragraph></subsection>
<subsection id="HBA4158FDDB8447D3BCDF723102A217FF"><enum>(i)</enum><header>Final agency action</header><text>Under this section and subject to section 18—</text> <paragraph id="HF6F8DAB4427A4863B127F515B3C373FA"><enum>(1)</enum><text>a determination by the Administrator under subsection (b)(4)(A) that a chemical substance does not present an unreasonable risk of injury to health or the environment shall be issued by order and considered to be a final agency action, effective beginning on the date of issuance of the order; and</text></paragraph>
<paragraph id="HCFD85CD025BD4FAE8C8F20CE72900E6A"><enum>(2)</enum><text display-inline="yes-display-inline">a final rule promulgated under subsection (a), including the associated determination by the Administrator under subsection (b)(4)(A) that a chemical substance presents an unreasonable risk of injury to health or the environment, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule.</text></paragraph></subsection> <subsection id="HC160894A3EDC4A059801BA8C76D38433"><enum>(j)</enum><header>Definition</header><text>For the purposes of this Act, the term <term>requirement</term> as used in this section shall not displace statutory or common law.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="HE5C2A857F8CA49879903D0FF7641858A" commented="no"><enum>7.</enum><header>Imminent hazards</header><text display-inline="no-display-inline">Section 7 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2606">15 U.S.C. 2606</external-xref>) is amended—</text> <paragraph id="HD42042BF95DC46778BB18EFBBE615494" commented="no"><enum>(1)</enum><text>in subsection (b)(1), by inserting <quote>(as identified by the Administrator without consideration of costs or other nonrisk factors)</quote> after <quote>from the unreasonable risk</quote>; and</text></paragraph>
<paragraph id="H55C6FD58F2604431AD65ADCABAC0A25D" commented="no"><enum>(2)</enum><text>in subsection (f), by inserting <quote>, without consideration of costs or other nonrisk factors</quote> after <quote>widespread injury to health or the environment</quote>.</text></paragraph></section> <section id="H3E8F92E009D1472EB8AA7144108AD07E" commented="no"><enum>8.</enum><header>Reporting and retention of information</header> <subsection id="H3C136FA0FA0541F0852BFE1171AAA3C5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 8 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2607">15 U.S.C. 2607</external-xref>) is amended—</text>
<paragraph id="H80A41C6D1BAD448DA7D57B7025DB62FC" commented="no"><enum>(1)</enum><text>in subsection (a)—</text> <subparagraph id="H0F2F2EB627F344A991518CBB33C45BC1" commented="no"><enum>(A)</enum><text>in paragraph (2), by striking the matter that follows subparagraph (G);</text></subparagraph>
<subparagraph id="H3962056CCCE941EDAB3B8D543F2E624F" commented="no"><enum>(B)</enum><text>in paragraph (3), by adding at the end the following:</text> <quoted-block style="OLC" id="H485571038ECC42268069A4D364DC3CCC" display-inline="no-display-inline"> <subparagraph id="HCD2915BFE74F4AC48F8C64099D693CCA" indent="up2" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, and not less frequently than once every 10 years thereafter, the Administrator, after consultation with the Administrator of the Small Business Administration, shall—</text>
<clause id="HB45867D1EE4243679C309411A1C580C8" commented="no"><enum>(i)</enum><text>review the adequacy of the standards prescribed under subparagraph (B); and</text></clause> <clause id="H926164B4197049E7A0BD5158143A0790" commented="no"><enum>(ii)</enum><text>after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="HC6DE63EC30234E55917D93075CA8A74C" commented="no"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="H4749DE2608E74694A729785A483B9302" display-inline="no-display-inline"> <paragraph id="HDE89CA85EAFA43448D0AD5D4CB88617D" commented="no"><enum>(4)</enum><header>Contents</header><text>The rules promulgated pursuant to paragraph (1)—</text>
<subparagraph id="HA04FB69CD5D340E3A1B8FCAAA4A73727" commented="no"><enum>(A)</enum><text>may impose differing reporting and recordkeeping requirements on manufacturers and processors; and</text></subparagraph> <subparagraph id="H6829BAC0760C47999FFE04FB79F9F8C2" commented="no"><enum>(B)</enum><text>shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported.</text></subparagraph></paragraph>
<paragraph id="H6A05ADF6A7CD4EB198EDEC885BE78154" commented="no"><enum>(5)</enum><header>Administration</header><text display-inline="yes-display-inline">In carrying out this section, the Administrator shall, to the extent feasible—</text> <subparagraph id="H52A3F8EB316E4218B07C359A20549959" commented="no"><enum>(A)</enum><text>not require reporting which is unnecessary or duplicative; </text></subparagraph>
<subparagraph id="HC75A49668C834229A4B054821C535C55" commented="no"><enum>(B)</enum><text>minimize the cost of compliance with this section and the rules issued thereunder on small manufacturers and processors; and</text></subparagraph> <subparagraph id="HC07DFFCB64C5446EBD708083ACD1DAB1" commented="no"><enum>(C)</enum><text>apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title.</text></subparagraph></paragraph>
<paragraph id="H56EF13EB4C6345F69587EB1CC4EB0E60" commented="no"><enum>(6)</enum><header>Negotiated rulemaking</header>
<subparagraph id="H9D668E7933C942248A7E69DBEC5FB501" display-inline="yes-display-inline" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">The Administrator shall enter into a negotiated rulemaking pursuant to subchapter III of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter 5</external-xref> of title 5, United States Code, to develop and publish, not later than 3 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.</text></subparagraph> <subparagraph id="H06B1A0D5085E45FB9A032D366ECAA4E0" indent="up1" commented="no"><enum>(B)</enum><text>Not later than 3 and one-half years after such date of enactment, the Administrator shall publish a final rule resulting from such negotiated rulemaking.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H14C4962A3E3A4461BC51D02F07016BB9" commented="no"><enum>(2)</enum><text>in subsection (b), by adding at the end the following:</text> <quoted-block style="OLC" id="HD6FFF3B5257A49D991001AD3E00BF8BE" display-inline="no-display-inline"> <paragraph id="H8A564882BE264A1994FFB46E8A6BD86D"><enum>(3)</enum><header>Nomenclature</header> <subparagraph id="HF3F3DFF0EC744FDCA57D1388120682B7"><enum>(A)</enum><header>In general</header><text>In carrying out paragraph (1), the Administrator shall—</text>
<clause id="H71BD229CA75D40309F73B98997DF6512"><enum>(i)</enum><text>maintain the use of Class 2 nomenclature in use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act;</text></clause> <clause id="H2820F2A259604578BDAEE6B41D2606BA"><enum>(ii)</enum><text>maintain the use of the Soap and Detergent Association Nomenclature System, published in March 1978 by the Administrator in section 1 of addendum III of the document entitled <quote>Candidate List of Chemical Substances</quote>, and further described in the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and</text></clause>
<clause id="H0C08FF1E64F645489EBE054BB7839EA4"><enum>(iii)</enum><text>treat the individual members of the categories of chemical substances identified by the Administrator as statutory mixtures, as defined in Inventory descriptions established by the Administrator, as being included on the list established under paragraph (1).</text></clause></subparagraph> <subparagraph id="HA5B957DD4C50484DA3EC6D3A86B0CF24"><enum>(B)</enum><header>Multiple nomenclature listings</header><text>If a manufacturer or processor demonstrates to the Administrator that a chemical substance appears multiple times on the list published under paragraph (1) under different CAS numbers, the Administrator may recognize the multiple listings as a single chemical substance.</text></subparagraph> </paragraph>
<paragraph id="HE9035A22C4C94B56B0D407C41A2B39AA"><enum>(4)</enum><header>Chemical substances in commerce</header>
<subparagraph id="H5B5B8247EB8F4F8B90F2F814329588AA" display-inline="no-display-inline"><enum>(A)</enum><header>Rules</header>
<clause id="HC760BDAF0CB2429586D216A7E2C0191D"><enum>(i)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>.</text></clause> <clause id="HC8FFEEFFC43E4FEBB42BE53B0916CEB2"><enum>(ii)</enum><header>Active substances</header><text>The Administrator shall designate chemical substances for which notices are received under clause (i) to be active substances on the list published under paragraph (1).</text></clause>
<clause id="HEC283FD2939F4E7A957EA6C2DB8FC5AB"><enum>(iii)</enum><header>Inactive substances</header><text>The Administrator shall designate chemical substances for which no notices are received under clause (i) to be inactive substances on the list published under paragraph (1).</text></clause> <clause id="HF8731CF5356E46AEA55B126A98B4A939"><enum>(iv)</enum><header>Limitation</header><text>No chemical substance on the list published under paragraph (1) shall be removed from such list by reason of the implementation of this subparagraph, or be subject to section 5(a)(1)(A)(i) by reason of a change to active status under paragraph (5)(B).</text></clause></subparagraph>
<subparagraph id="HBCC208F5E46543EFA5C4DAD1FD60F8CF" commented="no"><enum>(B)</enum><header>Confidential chemical substances</header><text display-inline="yes-display-inline">In promulgating a rule under subparagraph (A), the Administrator shall—</text> <clause id="H7EED47F509484F48BDF4F55C7F3C67F4" commented="no"><enum>(i)</enum><text>maintain the list under paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this section and section 14;</text></clause>
<clause id="H917988E0ECB54919B5539C68F5A9B1EB" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">require any manufacturer or processor of a chemical substance on the confidential portion of the list published under paragraph (1) that seeks to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential pursuant to section 14 to submit a notice under subparagraph (A) that includes such request;</text></clause> <clause id="HCC7692EE960949198492D3000460DD38" commented="no"><enum>(iii)</enum><text>require the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph (C); and</text></clause>
<clause id="H570AD86F496148EE96938FF86D3D936C" commented="no"><enum>(iv)</enum><text display-inline="yes-display-inline">move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list.</text></clause></subparagraph> <subparagraph id="H3799A55B98AC4C15AC35C21C5EA78E6D"><enum>(C)</enum><header>Review plan</header><text>Not later than 1 year after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the list published under paragraph (1) that are asserted pursuant to subparagraph (B).</text></subparagraph>
<subparagraph id="H5956D16BFE5C4A0697DFAB3EB52458DD"><enum>(D)</enum><header>Requirements of review plan</header><text display-inline="yes-display-inline">In establishing the review plan under subparagraph (C), the Administrator shall—</text> <clause id="H9AA403CF093A42E2B8E64B2EDADEB5C2"><enum>(i)</enum><text display-inline="yes-display-inline">require, at a time specified by the Administrator, all manufacturers or processors asserting claims under subparagraph (B) to substantiate the claim, in accordance with section 14, unless the manufacturer or processor has substantiated the claim in a submission made to the Administrator during the 5-year period ending on the last day of the of the time period specified by the Administrator; and</text></clause>
<clause id="H8C85F8DF232343DF8927A82FB8A17195"><enum>(ii)</enum><text>in accordance with section 14—</text> <subclause id="HF6496B9751D74D8E912FBF7DCAC928E1"><enum>(I)</enum><text>review each substantiation—</text>
<item id="HEEB6D57211F945E8AC2A2DAF351AB3EF"><enum>(aa)</enum><text>submitted pursuant to clause (i) to determine if the claim qualifies for protection from disclosure; and</text></item> <item id="HFF1041A36C1840C2987D88ED168EA88D"><enum>(bb)</enum><text>submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause (i), if the substantiation has not been previously reviewed by the Administrator, to determine if the claim warrants protection from disclosure;</text></item></subclause>
<subclause id="H0CB0764F3B3D4F81ACD5969FF16E3EE5"><enum>(II)</enum><text display-inline="yes-display-inline">approve, approve in part and deny in part, or deny each claim; and</text></subclause> <subclause id="H3452A83B0175451B8F0DF99995398FBE"><enum>(III)</enum><text>except as provided in this section and section 14, protect from disclosure information for which the Administrator approves such a claim for a period of 10 years, unless, prior to the expiration of the period—</text>
<item id="HFCB04E36B8A84243BB826EAA18BBFD28"><enum>(aa)</enum><text>the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall not protect the information from disclosure; or</text></item> <item id="HAF12BBCCD1AA45A49C12A319E05562EA"><enum>(bb)</enum><text>the Administrator otherwise becomes aware that the information does not qualify for protection from disclosure, in which case the Administrator shall take the actions described in section 14(g)(2).</text></item></subclause></clause></subparagraph>
<subparagraph id="H1304D23EA31B43E6BEB2922F2CF33134"><enum>(E)</enum><header>Timeline for completion of reviews</header><text display-inline="yes-display-inline"></text> <clause id="H4E00FB3F10E54621A0CF6BED5BA87163"><enum>(i)</enum><header>In general</header><text>The Administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph (C) not later than 5 years after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A).</text></clause>
<clause id="H9AA7635EAF4B4FF6A9F9F19FE0317956"><enum>(ii)</enum><header>Considerations</header>
<subclause id="H4101A3FB1DBF41BCAE8CB9D8C20CE43C"><enum>(I)</enum><header>In general</header><text>The Administrator may extend the deadline for completion of the reviews for not more than 2 additional years, after an adequate public justification, if the Administrator determines that the extension is necessary based on the number of claims needing review and the available resources.</text></subclause> <subclause id="H284EA1F4D26F4733A54FD984335A08F4"><enum>(II)</enum><header>Annual review goal and results</header><text display-inline="yes-display-inline">At the beginning of each year, the Administrator shall publish an annual goal for reviews and the number of reviews completed in the prior year.</text></subclause></clause></subparagraph></paragraph>
<paragraph id="HB0B7156FA695401F85B03ABF1B67C2C4"><enum>(5)</enum><header>Active and inactive substances</header>
<subparagraph id="HF76AD3148FA740A68E67677D9C7D6E01"><enum>(A)</enum><header>In general</header><text>The Administrator shall keep designations of active substances and inactive substances on the list published under paragraph (1) current. </text></subparagraph> <subparagraph id="H9894AD7DD7404218BF9EE7F7CC82EF3E"><enum>(B)</enum><header>Change to active status</header> <clause id="HB1D83949461549E49A7DFAD2FBB84BBC"><enum>(i)</enum><header>In general</header><text>Any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. </text></clause>
<clause id="H6D9295C516A143D89215AE4F79D963EF"><enum>(ii)</enum><header>Confidential chemical identity</header><text display-inline="yes-display-inline">If a person submitting a notice under clause (i) for an inactive substance on the confidential portion of the list published under paragraph (1) seeks to maintain an existing claim for protection against disclosure of the specific chemical identity of the inactive substance as confidential, the person shall, consistent with the requirements of section 14—</text> <subclause id="HA762B392D6974AD792272D0CA3DAD68B"><enum>(I)</enum><text>in the notice submitted under clause (i), assert the claim; and</text></subclause>
<subclause id="HC4B123C4C349437499DC3D88C7EE6362" commented="no"><enum>(II)</enum><text>by not later than 30 days after providing the notice under clause (i), substantiate the claim.</text></subclause></clause> <clause id="H5D5E4D29F0C44DC79BC505E863803AF9"><enum>(iii)</enum><header>Active status</header><text>On receiving a notification under clause (i), the Administrator shall—</text>
<subclause id="HED1EA3C0ED734AA69BF2C6083178535F"><enum>(I)</enum><text>designate the applicable chemical substance as an active substance;</text></subclause> <subclause id="H20D67C0EC85947D383BBCAC3A4E1C708" commented="no"><enum>(II)</enum><text display-inline="yes-display-inline">pursuant to section 14, promptly review any claim and associated substantiation submitted pursuant to clause (ii) for protection against disclosure of the specific chemical identity of the chemical substance and approve, approve in part and deny in part, or deny the claim;</text></subclause>
<subclause id="H26FFB00096024C9990E2C040532D7885"><enum>(III)</enum><text display-inline="yes-display-inline">except as provided in this section and section 14, protect from disclosure the specific chemical identity of the chemical substance for which the Administrator approves a claim under subclause (II) for a period of 10 years, unless, prior to the expiration of the period—</text> <item id="H679F42735F824CD7A6CC318E152FBA9D"><enum>(aa)</enum><text display-inline="yes-display-inline">the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall not protect the information from disclosure; or</text></item>
<item id="HB66D7FCA3CD0475BBEA62502B1584421"><enum>(bb)</enum><text display-inline="yes-display-inline">the Administrator otherwise becomes aware that the information does not qualify for protection from disclosure, in which case the Administrator shall take the actions described in section 14(g)(2); and</text></item></subclause> <subclause id="H44C6259591D249CA979A43052EF709B4"><enum>(IV)</enum><text>pursuant to section 6(b), review the priority of the chemical substance as the Administrator determines to be necessary.</text></subclause></clause></subparagraph>
<subparagraph id="HB34A2E259EA440028505998AE63C1B35"><enum>(C)</enum><header>Category status</header><text>The list of inactive substances shall not be considered to be a category for purposes of section 26(c).</text></subparagraph></paragraph> <paragraph id="H58ADDB510FA4486DB59DD5700DB55D4D"><enum>(6)</enum><header>Interim list of active substances</header><text display-inline="yes-display-inline">Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>), during the reporting period that most closely preceded the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, as the interim list of active substances for the purposes of section 6(b).</text></paragraph>
<paragraph id="HE26859C0BC284151A60F3ED38B969176"><enum>(7)</enum><header>Public information</header><text>Subject to this subsection and section 14, the Administrator shall make available to the public—</text> <subparagraph id="H6F292E328A0049AAA4E80B11032C0D6E" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">each specific chemical identity on the nonconfidential portion of the list published under paragraph (1) along with the Administrator’s designation of the chemical substance as an active or inactive substance;</text></subparagraph>
<subparagraph id="H42D3D044D7534568897793DDE1D27392"><enum>(B)</enum><text>the unique identifier assigned under section 14, accession number, generic name, and, if applicable, premanufacture notice case number for each chemical substance on the confidential portion of the list published under paragraph (1) for which a claim of confidentiality was received; and</text></subparagraph> <subparagraph id="H46EEDB708F87498CAC1E6BE3590B475F"><enum>(C)</enum><text display-inline="yes-display-inline">the specific chemical identity of any active substance for which—</text>
<clause id="H9F5ED13BB48F4D26B50E8448544667AB"><enum>(i)</enum><text display-inline="yes-display-inline">a claim for protection against disclosure of the specific chemical identity of the active substance was not asserted, as required under this subsection or section 14;</text></clause> <clause id="HC2D20C1A89CB485CAFDF1F28C8899768" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">all claims for protection against disclosure of the specific chemical identity of the active substance have been denied by the Administrator; or</text></clause>
<clause id="H73CC52915FCC43CF892670AA33F268B2"><enum>(iii)</enum><text display-inline="yes-display-inline">the time period for protection against disclosure of the specific chemical identity of the active substance has expired.</text></clause></subparagraph></paragraph> <paragraph id="H70CD4B5A1B7B4EFBB4A2C02BFD01BCB2" commented="no"><enum>(8)</enum><header>Limitation</header><text display-inline="yes-display-inline">No person may assert a new claim under this subsection or section 14 for protection from disclosure of a specific chemical identity of any active or inactive substance for which a notice is received under paragraph (4)(A)(i) or (5)(B)(i) that is not on the confidential portion of the list published under paragraph (1).</text></paragraph>
<paragraph id="H7DBBE171FC8F4A089092C6CC112B18E0"><enum>(9)</enum><header>Certification</header><text>Under the rules promulgated under this subsection, manufacturers and processors, as applicable, shall be required—</text> <subparagraph id="HB4F1435ED3B84DC6A7BA576AB1D923B6"><enum>(A)</enum><text>to certify that each notice or substantiation the manufacturer or processor submits complies with the requirements of the rule, and that any confidentiality claims are true and correct; and</text></subparagraph>
<subparagraph id="HA67E27BF1CA544D6801FDEB6F9C1FAFB"><enum>(B)</enum><text>to retain a record documenting compliance with the rule and supporting confidentiality claims for a period of 5 years beginning on the last day of the submission period.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HCF16EFE25D2F4D6F8D435D47D570246E"><enum>(b)</enum><header>Mercury inventory</header><text>Section 8(b) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2607">15 U.S.C. 2607(b)</external-xref>) (as amended by subsection (a)) is further amended by adding at the end the following:</text>
<quoted-block id="H3A5C0A0666F5496398BFA9FD4B25146D" style="OLC">
<paragraph id="HD893C8FFB836443CB640150269961503"><enum>(10)</enum><header>Mercury</header>
<subparagraph id="HA6E4857C0B9F45F0AD714A7ECECDFFAC"><enum>(A)</enum><header>Definition of mercury</header><text>In this paragraph, notwithstanding section 3(2)(B), the term <term>mercury</term> means—</text> <clause id="H9D76883C7F5A4AF1AE379BAC58A088FB"><enum>(i)</enum><text>elemental mercury; and</text></clause>
<clause id="H4EA6F2F492844681968E099D11708B1F"><enum>(ii)</enum><text>a mercury compound.</text></clause></subparagraph> <subparagraph id="H2EDFF8C213CB4213A75AD76578856701"><enum>(B)</enum><header>Publication</header><text>Not later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish in the Federal Register an inventory of mercury supply, use, and trade in the United States.</text></subparagraph>
<subparagraph id="H624B1C277E94442A962676652E130839"><enum>(C)</enum><header>Process</header><text>In carrying out the inventory under subparagraph (B), the Administrator shall—</text> <clause id="H2D9D172EB64244E2AA39789BDF0A5541"><enum>(i)</enum><text>identify any manufacturing processes or products that intentionally add mercury; and</text></clause>
<clause id="HAF4FCC6F86974CE5AF8182E38608E89B"><enum>(ii)</enum><text>recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.</text></clause></subparagraph> <subparagraph id="H0307499D4B5A4713B54D492076BD7C2D"><enum>(D)</enum><header>Reporting</header> <clause id="H24AE2D134A43424A99A1F18C460F4A30"><enum>(i)</enum><header>In general</header><text>To assist in the preparation of the inventory under subparagraph (B), any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine by rule promulgated not later than 2 years after the date of enactment of this paragraph.</text></clause>
<clause id="HF993A914D7EA49E7BD0D1EC68D8E72D3"><enum>(ii)</enum><header>Coordination</header><text>To avoid duplication, the Administrator shall coordinate the reporting under this subparagraph with the Interstate Mercury Education and Reduction Clearinghouse.</text></clause> <clause id="H3AAEEBE17D3C43D38C9F65773674C8E8"><enum>(iii)</enum><header>Exemption</header><text>Clause (i) shall not apply to a person engaged in the generation, handling, or management of mercury-containing waste, unless that person manufactures or recovers mercury in the management of that waste.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<section commented="no" id="H05CF184FEC9D49E19379F1574B428BF7"><enum>9.</enum><header>Relationship to other Federal laws</header><text display-inline="no-display-inline">Section 9 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2608">15 U.S.C. 2608</external-xref>) is amended—</text> <paragraph id="H0842D6F56FA44DAB82C2C96FDE2D955F" commented="no"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph id="HFC5FA8DCCA3542358F4CEE52A4F4DEBA" commented="no"><enum>(A)</enum><text>in paragraph (1)—</text> <clause id="H82E5E7DCF72F4DF08336C536084B1C52" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>has reasonable basis to conclude</quote> and inserting <quote>determines</quote>;</text></clause>
<clause id="H22E5A7EAA9304733A1F41F8115DAC9B1"><enum>(ii)</enum><text>by striking <quote>or will present</quote>; and</text></clause> <clause id="H20B89C13FAAC4BC4B4B6980ED3F1BCF4" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">by inserting <quote>, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator, under the conditions of use,</quote> after <quote>or the environment</quote>;</text></clause></subparagraph>
<subparagraph id="H9A0F29AC549B49A6AF1CBEF34865B4A1" commented="no"><enum>(B)</enum><text>in paragraph (2)—</text> <clause id="HBF05C64AD2364FEBA987F0F3B292F065" commented="no"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>, within the time period specified by the Administrator in the report,</quote> after <quote>issues an order</quote>; and</text></clause>
<clause id="HC9DF443E762D4D68B25A18B8F083773D" commented="no"><enum>(ii)</enum><text>in subparagraph (B), by inserting <quote>responds within the time period specified by the Administrator in the report and</quote> before <quote>initiates, within 90</quote>;</text></clause></subparagraph> <subparagraph id="H5D27E311287E4B7CB0877079633F075C" commented="no"><enum>(C)</enum><text>by redesignating paragraph (3) as paragraph (6); and</text></subparagraph>
<subparagraph id="H6490667C25D2437FB4EC4E2B40F8A457" commented="no"><enum>(D)</enum><text>by inserting after paragraph (2) the following:</text> <quoted-block style="OLC" id="HE65EA602BC844B489603D736B1B32FE4" display-inline="no-display-inline"> <paragraph id="H02D178A431854C6EA5D9A7783B2ABDDA" indent="up1" commented="no"><enum>(3)</enum><text>The Administrator shall take the actions described in paragraph (4) if the Administrator makes a report under paragraph (1) with respect to a chemical substance or mixture and the agency to which the report was made does not—</text>
<subparagraph id="HCFE78AEFA0BD4075847665087575C409" commented="no"><enum>(A)</enum><text>issue the order described in paragraph (2)(A) within the time period specified by the Administrator in the report; or</text></subparagraph> <subparagraph id="H27E8A49A62104F63AED7B2CEB3506993" commented="no"><enum>(B)</enum> <clause id="H864E0A48698447838A5E964CE6350FA7" display-inline="yes-display-inline" commented="no"><enum>(i)</enum><text>respond under paragraph (1) within the timeframe specified by the Administrator in the report; and</text></clause>
<clause id="H8B688AD961CB43EFA877CBA07D63DF68" indent="up1" commented="no"><enum>(ii)</enum><text>initiate action within 90 days of publication in the Federal Register of the response described in clause (i).</text></clause></subparagraph></paragraph> <paragraph id="H1A387F74751447F88FF28514D67B75A4" indent="up1" commented="no"><enum>(4)</enum><text>If an agency to which a report is submitted under paragraph (1) does not take the actions described in subparagraph (A) or (B) of paragraph (3), the Administrator shall—</text>
<subparagraph id="H50AF60E42C2549098928BDC36A7E7AA9" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">initiate or complete appropriate action under section 6; or </text></subparagraph> <subparagraph id="HD775B32D3B6F4889A863AB8E7B5A6195" commented="no"><enum>(B)</enum><text>take any action authorized or required under section 7, as applicable.</text></subparagraph></paragraph>
<paragraph id="HCD7CC90B2B7349D783EB94C25C8850B0" indent="up1" commented="no"><enum>(5)</enum><text>This subsection shall not relieve the Administrator of any obligation to take any appropriate action under section 6(a) or 7 to address risks from the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of those activities, that are not identified in a report issued by the Administrator under paragraph (1).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H94E68D170BD44C998CB9EF445B5DB51A" commented="no"><enum>(2)</enum><text>in subsection (b)—</text>
<subparagraph id="HE8B1169968F14BB38F753B24D272477E" commented="no"><enum>(A)</enum><text>by striking <quote>The Administrator shall coordinate</quote> and inserting <quote>(1) The Administrator shall coordinate</quote>; and</text></subparagraph> <subparagraph id="H249D31CD2BCF4144970204168838FE65" commented="no"><enum>(B)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H911C5232A23C4936AF41E7554129691A" style="OLC">
<paragraph commented="no" id="H88A178C481BD4A8D9DBD56EC9607B21F" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of the risk described in paragraph (1) and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H85ED68C608354C609B2DDAA18D45614F" commented="no"><enum>(3)</enum><text>by adding at the end the following: </text>
<quoted-block style="OLC" id="HF00F89D8ECB54C329919721AE001C916" display-inline="no-display-inline">
<subsection id="H50C95B83D00843FE8C87C856EE6C5F0F" commented="no"><enum>(e)</enum><header>Exposure information</header><text display-inline="yes-display-inline">In addition to the requirements of subsection (a), if the Administrator obtains information related to exposures or releases of a chemical substance or mixture that may be prevented or reduced under another Federal law, including a law not administered by the Administrator, the Administrator shall make such information available to the relevant Federal agency or office of the Environmental Protection Agency.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="HF12518B176DF4974BB57B422A27FBC18"><enum>10.</enum><header>Exports</header> <subsection id="HBF582E7E7349424CA158D02494FEF41A" display-inline="no-display-inline"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 12(a)(2) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2611">15 U.S.C. 2611(a)(2)</external-xref>) is amended by striking <quote>will present</quote> and inserting <quote>presents</quote>.</text></subsection>
<subsection id="HF48480F3C4F64F4D9B6441BFF48A2A38"><enum>(b)</enum><header>Prohibition on export of certain mercury compounds</header><text display-inline="yes-display-inline">Section 12(c) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2611">15 U.S.C. 2611(c)</external-xref>) is amended—</text> <paragraph id="H240E799DAD5747F1AA561353C0F0DC47"><enum>(1)</enum><text>in the subsection heading, by inserting <quote><header-in-text level="subsection" style="OLC">and Mercury Compounds</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Mercury</header-in-text></quote>; and</text></paragraph>
<paragraph id="H38CEAE224436443E812C5A47F0C142B0"><enum>(2)</enum><text>by adding at the end the following:</text> <quoted-block id="H33B582586258481F9C534A92E0E86DE1" style="OLC"> <paragraph id="H233CFC161CB34A59A96A7BDFFE663C08"><enum>(7)</enum><header>Prohibition on export of certain mercury compounds</header> <subparagraph id="HD7F8F389B0F4445D8D1F2F69EDD054FC"><enum>(A)</enum><header>In general</header><text>Effective January 1, 2020, the export of the following mercury compounds is prohibited:</text>
<clause id="H633F0144A0544DC8A844BCE4C8660CC0"><enum>(i)</enum><text>Mercury (I) chloride or calomel.</text></clause> <clause id="HAA2C83E4A65E4D6D82B37BC89B7FC897"><enum>(ii)</enum><text>Mercury (II) oxide.</text></clause>
<clause id="HB4CD23F8C2EE493CAF42D130FD7781FB"><enum>(iii)</enum><text>Mercury (II) sulfate.</text></clause> <clause id="HF56E6AEE493E413BA6D15764C78E7258"><enum>(iv)</enum><text>Mercury (II) nitrate.</text></clause>
<clause id="HDF4E697012EE45BBB13B70A31C23DAE4"><enum>(v)</enum><text>Cinnabar or mercury sulphide.</text></clause> <clause id="H08EAD63BEEB2412AA4CFD35432A50332"><enum>(vi)</enum><text>Any mercury compound that the Administrator adds to the list published under subparagraph (B) by rule, on determining that exporting that mercury compound for the purpose of regenerating elemental mercury is technically feasible.</text></clause></subparagraph>
<subparagraph id="H95E0BFBD136F43DFAD949657AE0695E0"><enum>(B)</enum><header>Publication</header><text>Not later than 90 days after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, and as appropriate thereafter, the Administrator shall publish in the Federal Register a list of the mercury compounds that are prohibited from export under this paragraph.</text></subparagraph> <subparagraph id="H946214D86CC84C2B9485D2B30A69986E"><enum>(C)</enum><header>Petition</header><text display-inline="yes-display-inline">Any person may petition the Administrator to add a mercury compound to the list published under subparagraph (B).</text></subparagraph>
<subparagraph id="H2E284A5D740641449036D019EDADB3A4"><enum>(D)</enum><header>Environmentally sound disposal</header><text>This paragraph does not prohibit the export of mercury compounds on the list published under subparagraph (B) to member countries of the Organization for Economic Co-operation and Development for environmentally sound disposal, on the condition that no mercury or mercury compounds so exported are to be recovered, recycled, or reclaimed for use, or directly reused, after such export.</text></subparagraph> <subparagraph id="HACE352733A324C6E889A3EFD5D187976"><enum>(E)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 5 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall evaluate any exports of mercury compounds on the list published under subparagraph (B) for disposal that occurred after such date of enactment and shall submit to Congress a report that—</text>
<clause id="HB65350E7CDD8414388C3ECD170289E47"><enum>(i)</enum><text display-inline="yes-display-inline">describes volumes and sources of mercury compounds on the list published under subparagraph (B) exported for disposal;</text></clause> <clause id="H1C32C00584704EE58BB036081764AD69"><enum>(ii)</enum><text display-inline="yes-display-inline">identifies receiving countries of such exports;</text></clause>
<clause id="H8952877710984946ADE689713AE9E9AE"><enum>(iii)</enum><text display-inline="yes-display-inline">describes methods of disposal used after such export;</text></clause> <clause id="H2F5AEA317F654748A798CA7B04DA2AEB"><enum>(iv)</enum><text display-inline="yes-display-inline">identifies issues, if any, presented by the export of mercury compounds on the list published under subparagraph (B);</text></clause>
<clause id="H28564D256CB743A39AB7F4D553376DF5"><enum>(v)</enum><text display-inline="yes-display-inline">includes an evaluation of management options in the United States for mercury compounds on the list published under subparagraph (B), if any, that are commercially available and comparable in cost and efficacy to methods being utilized in such receiving countries; and</text></clause> <clause id="H0BCB3D75FCC441779369C167BC778182"><enum>(vi)</enum><text display-inline="yes-display-inline">makes a recommendation regarding whether Congress should further limit or prohibit the export of mercury compounds on the list published under subparagraph (B) for disposal.</text></clause></subparagraph>
<subparagraph id="HCCCEABA4BB194EB1B4BB6DCA9B3E51EE"><enum>(F)</enum><header>Effect on other law</header><text>Nothing in this paragraph shall be construed to affect the authority of the Administrator under the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6901">42 U.S.C. 6901 et seq.</external-xref>).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H2D363ED7AF53426EAFED376E1302769A"><enum>(c)</enum><header>Temporary generator accumulation</header><text>Section 5 of the Mercury Export Ban Act of 2008 (<external-xref legal-doc="usc" parsable-cite="usc/42/6939f">42 U.S.C. 6939f</external-xref>) is amended—</text>
<paragraph id="H7D6691903E3643C08C389DAFB7A41545"><enum>(1)</enum><text>in subsection (a)(2), by striking <quote>2013</quote> and inserting <quote>2019</quote>;</text></paragraph> <paragraph id="H11550337821C4E0D9421A76790A9EA59"><enum>(2)</enum><text>in subsection (b)—</text>
<subparagraph id="HB12269BA8AEB417B92AF5C95220A72E7"><enum>(A)</enum><text>in paragraph (1)—</text> <clause id="H14290CD88D5C4D2184304775AC1BB0BC"><enum>(i)</enum><text>by redesignating subparagraphs (A), (B), and (C), as clauses (i), (ii), and (iii), respectively and indenting appropriately;</text></clause>
<clause id="H4616B716E89E43AFB12CF5413F09C927"><enum>(ii)</enum><text>in the first sentence, by striking <quote>After consultation</quote> and inserting the following:</text> <quoted-block id="H2572E1793DB8460798851AC50788AFCE" style="OLC"> <subparagraph id="H5C6D4DEE0B6144B497AF15C96C74C01F"><enum>(A)</enum><header>Assessment and collection</header><text>After consultation</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause>
<clause id="H561479A343A947C3AD5B629EB1504226"><enum>(iii)</enum><text>in the second sentence, by striking <quote>The amount of such fees</quote> and inserting the following:</text> <quoted-block id="HBC7FDD451D1548A6A2FE693A5EF2E561" style="OLC"> <subparagraph id="H9F4788933C90419091CD1EBFA9225BF1"><enum>(B)</enum><header>Amount</header><text>The amount of the fees described in subparagraph (A)</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause>
<clause id="H8E30013C32C44A2C860DCE3337E77B7B"><enum>(iv)</enum><text>in subparagraph (B) (as so designated)—</text> <subclause id="H70E80E585F4D4C49A5E1FDE335DE2292"><enum>(I)</enum><text>in clause (i) (as so redesignated), by striking <quote>publically available not later than October 1, 2012</quote> and inserting <quote>publicly available not later than October 1, 2018</quote>;</text></subclause>
<subclause id="HF6FA97E92B6C4D45A0C918E3502F27BC"><enum>(II)</enum><text>in clause (ii) (as so redesignated), by striking <quote>and</quote>;</text></subclause> <subclause id="H62AB0280D0BC476A8A4B957F9D928EC5"><enum>(III)</enum><text>in clause (iii) (as so redesignated), by striking the period at the end and inserting <quote>, subject to clause (iv); and</quote>; and</text></subclause>
<subclause id="H68757CD787AD434DA2CFE788D38509B7"><enum>(IV)</enum><text>by adding at the end the following:</text> <quoted-block id="H63A2F34E24FE4766AA7339A41DF5D5F1" style="OLC"> <clause id="HAEECF320BADD4D4CA6DD7092C5F68370"><enum>(iv)</enum><text>for generators temporarily accumulating elemental mercury in a facility subject to subparagraphs (B) and (D)(iv) of subsection (g)(2) if the facility designated in subsection (a) is not operational by January 1, 2019, shall be adjusted to subtract the cost of the temporary accumulation during the period in which the facility designated under subsection (a) is not operational.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause>
<clause id="H96567BD63F78470781B52FF266D8F136"><enum>(v)</enum><text>by adding at the end the following:</text> <quoted-block id="HFC1EC57766D4426FA198F21250B94F55" style="OLC"> <subparagraph id="H0ECDA60056184A5EB3075AE4950E9FFF"><enum>(C)</enum><header>Conveyance of title and permitting</header><text>If the facility designated in subsection (a) is not operational by January 1, 2020, the Secretary—</text>
<clause id="H23DBAC6C0A704D4F88C9E83FC0873E60"><enum>(i)</enum><text>shall immediately accept the conveyance of title to all elemental mercury that has accumulated in facilities in accordance with subsection (g)(2)(D), before January 1, 2020, and deliver the accumulated mercury to the facility designated under subsection (a) on the date on which the facility becomes operational;</text></clause> <clause id="HE635B7617EEE48EDA01D676B7383BFA1"><enum>(ii)</enum><text>shall pay any applicable Federal permitting costs, including the costs for permits issued under section 3005(c) of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6925">42 U.S.C. 6925(c)</external-xref>); and</text></clause>
<clause id="HD4167CEBA9AB44FDA8CBA6A368F79268"><enum>(iii)</enum><text>shall store, or pay the cost of storage of, until the time at which a facility designated in subsection (a) is operational, accumulated mercury to which the Secretary has title under this subparagraph in a facility that has been issued a permit under section 3005(c) of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6925">42 U.S.C. 6925(c)</external-xref>).</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="HC678AFAF61EA4FDFA76AA45F333555AA"><enum>(B)</enum><text>in paragraph (2), in the first sentence, by striking <quote>paragraph (1)(C)</quote> and inserting <quote>paragraph (1)(B)(iii)</quote>; and</text></subparagraph></paragraph>
<paragraph id="H3ADABF739FD346C7916525D0604105C4"><enum>(3)</enum><text>in subsection (g)(2)—</text> <subparagraph id="HE83ECF108B594066997606AABCA1F5D2"><enum>(A)</enum><text>in the undesignated material at the end, by striking <quote>This subparagraph</quote> and inserting the following:</text>
<quoted-block id="H872588C79C3B47F79009E2F028224057" style="OLC">
<subparagraph id="H136074089F3940D1A774572EE9E9314F"><enum>(C)</enum><text>Subparagraph (B)</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph> <subparagraph id="H948D7E4C015B48B5A7ABF56B16F9B35B"><enum>(B)</enum><text>in subparagraph (C) (as designated by subparagraph (A)), by inserting <quote>of that subparagraph</quote> before the period at the end; and</text></subparagraph>
<subparagraph id="H0ACEC9288B98449F86FEA6ACAD0EAED4"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block id="HD56F5E6EB4A54DAEBE29019B1EF9F24B" style="OLC"> <subparagraph id="H93FA38D0620B40F2AB26225982626B77"><enum>(D)</enum><text>A generator producing elemental mercury incidentally from the beneficiation or processing of ore or related pollution control activities may accumulate the mercury produced onsite that is destined for a facility designated by the Secretary under subsection (a) for more than 90 days without a permit issued under section 3005(c) of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6925">42 U.S.C. 6925(c)</external-xref>), and shall not be subject to the storage prohibition of section 3004(j) of that Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6924">42 U.S.C. 6924(j)</external-xref>), if—</text>
<clause id="HC5F790C4691E45B385B938E4662DC129"><enum>(i)</enum><text>the Secretary is unable to accept the mercury at a facility designated by the Secretary under subsection (a) for reasons beyond the control of the generator;</text></clause> <clause id="HEF68392EFA454B9D9C4725AB57018567"><enum>(ii)</enum><text>the generator certifies in writing to the Secretary that the generator will ship the mercury to a designated facility when the Secretary is able to accept the mercury;</text></clause>
<clause id="H631E16EE4534479EADEBB8C13341CFA7"><enum>(iii)</enum><text>the generator certifies in writing to the Secretary that the generator is storing only mercury the generator has produced or recovered onsite and will not sell, or otherwise place into commerce, the mercury; and</text></clause> <clause id="HB79916F916734A44973AE7E64AD50DAE"><enum>(iv)</enum><text>the generator has obtained an identification number under section 262.12 of title 40, Code of Federal Regulations, and complies with the requirements described in paragraphs (1) through (4) of section 262.34(a) of title 40, Code of Federal Regulations (as in effect on the date of enactment of this subparagraph).</text></clause></subparagraph>
<subparagraph id="H77C45885D0AF437FB7AF3834C2B91BE0" commented="no"><enum>(E)</enum><header>Management standards for temporary storage</header><text>Not later than January 1, 2017, the Secretary, after consultation with the Administrator of the Environmental Protection Agency and State agencies in affected States, shall develop and make available guidance that establishes procedures and standards for the management and short-term storage of elemental mercury at a generator covered under subparagraph (D), including requirements to ensure appropriate use of flasks or other suitable containers. Such procedures and standards shall be protective of health and the environment and shall ensure that the elemental mercury is stored in a safe, secure, and effective manner. A generator may accumulate mercury in accordance with subparagraph (D) immediately upon enactment of this subparagraph, and notwithstanding that guidance called for by this paragraph has not been developed or made available.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> <subsection id="H1688C269A90E417AB031832637E46DF2"><enum>(d)</enum><header>Interim status</header><text>Section 5(d)(1) of the Mercury Export Ban Act of 2008 (<external-xref legal-doc="usc" parsable-cite="usc/42/6939f">42 U.S.C. 6939f(d)(1)</external-xref>) is amended—</text>
<paragraph id="H3AF35BC9BCC641BFBC464FCB6C5BD694"><enum>(1)</enum><text>in the fourth sentence, by striking <quote>in existence on or before January 1, 2013,</quote>; and</text></paragraph> <paragraph id="HB4EA74C3DECC41AB917BAE2B14F48D06"><enum>(2)</enum><text>in the last sentence, by striking <quote>January 1, 2015</quote> and inserting <quote>January 1, 2020</quote>.</text></paragraph></subsection></section>
<section id="HE5EB9C64ACBB4E4E918295BF40146603"><enum>11.</enum><header>Confidential information</header><text display-inline="no-display-inline">Section 14 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2613">15 U.S.C. 2613</external-xref>) is amended to read as follows:</text> <quoted-block style="OLC" id="H948DCC2C9D144AEBB1C5B4C3A981D0EC" display-inline="no-display-inline"> <section id="H225690C726594281A96AA438B465C72C"><enum>14.</enum><header>Confidential information</header> <subsection id="HCB5A286C2ACB48609C0D31FC4203A68F" commented="no"><enum>(a)</enum><header>In general</header><text>Except as provided in this section, the Administrator shall not disclose information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of that section—</text>
<paragraph id="H994256AFC3BD46C69BDA4AFAE424EC73" commented="no"><enum>(1)</enum><text>that is reported to, or otherwise obtained by, the Administrator under this Act; and</text></paragraph> <paragraph id="H373687CABEEA4EEB8635FB13C1EA4545" commented="no"><enum>(2)</enum><text>for which the requirements of subsection (c) are met.</text></paragraph><continuation-text continuation-text-level="subsection" commented="no">In any proceeding under section 552(a) of title 5, United States Code, to obtain information the disclosure of which has been denied because of the provisions of this subsection, the Administrator may not rely on section 552(b)(3) of such title to sustain the Administrator's action. </continuation-text></subsection>
<subsection id="HA23562CC06F0420E97F166C7B8ADF245"><enum>(b)</enum><header>Information not protected from disclosure</header>
<paragraph id="H0E5F66F750E4423CA8060F2C14D51A02" commented="no"><enum>(1)</enum><header>Mixed confidential and nonconfidential information</header><text display-inline="yes-display-inline">Information that is protected from disclosure under this section, and which is mixed with information that is not protected from disclosure under this section, does not lose its protection from disclosure notwithstanding that it is mixed with information that is not protected from disclosure.</text></paragraph> <paragraph id="HD904A9AE0F204CB0A329F395DBA38BAE" commented="no"><enum>(2)</enum><header>Information from health and safety studies</header><text>Subsection (a) does not prohibit the disclosure of—</text>
<subparagraph id="HD9D4B37D4BA94AFAAFAC89674A0281C6" commented="no"><enum>(A)</enum><text>any health and safety study which is submitted under this Act with respect to—</text> <clause id="HFFB94FDA02974B5DB15F2605A94EE017" commented="no"><enum>(i)</enum><text>any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for commercial distribution; or</text></clause>
<clause id="HEE08DCAF79F2489CAD2CA3D46ADA285A" commented="no"><enum>(ii)</enum><text>any chemical substance or mixture for which testing is required under section 4 or for which notification is required under section 5; and</text></clause></subparagraph> <subparagraph id="H5292F47BBA1B4F0DA0649A5E316C9247" commented="no"><enum>(B)</enum><text>any information reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A).</text></subparagraph><continuation-text continuation-text-level="paragraph" commented="no">This paragraph does not authorize the disclosure of any information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture.</continuation-text></paragraph>
<paragraph id="H7EE068E5BEDE480B82F2A3AD5843A722"><enum>(3)</enum><header>Other information not protected from disclosure</header><text display-inline="yes-display-inline">Subsection (a) does not prohibit the disclosure of—</text> <subparagraph id="H6EF65DDDD81A47768CDFB2F43AB30980"><enum>(A)</enum><text>any general information describing the manufacturing volumes, expressed as specific aggregated volumes or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges; or</text></subparagraph>
<subparagraph id="HF1BD1ACDA067479DB2516B2AF3F40D91"><enum>(B)</enum><text>a general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector.</text></subparagraph></paragraph> <paragraph id="H89BF7AD01C844FA9ABE332B633E4DA80"><enum>(4)</enum><header>Bans and phase-outs</header> <subparagraph id="HBC2B6DBE1899412999F232E7338103F7"><enum>(A)</enum><header>In general</header><text>If the Administrator promulgates a rule pursuant to section 6(a) that establishes a ban or phase-out of a chemical substance or mixture, the protection from disclosure of any information under this section with respect to the chemical substance or mixture shall be presumed to no longer apply, subject to subsection (g)(1)(E) and subparagraphs (B) and (C) of this paragraph.</text></subparagraph>
<subparagraph id="HBFB6919AB41D44DD8214400FBC477168"><enum>(B)</enum><header>Limitations</header>
<clause id="H1631A3F53A1D43BE8E41F96443111D30"><enum>(i)</enum><header>Critical use</header><text display-inline="yes-display-inline">In the case of a chemical substance or mixture for which a specific condition of use is subject to an exemption pursuant to section 6(g), if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to any conditions of use of the chemical substance or mixture to which the exemption does not apply.</text></clause> <clause id="HF904FFC101B54C269DDE9AF936BE604E"><enum>(ii)</enum><header>Export</header><text display-inline="yes-display-inline">In the case of a chemical substance or mixture for which there is manufacture, processing, or distribution in commerce that meets the conditions of section 12(a)(1), if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to any other manufacture, processing, or distribution in commerce of the chemical substance or mixture for the conditions of use subject to the ban or phase-out, unless the Administrator makes the determination in section 12(a)(2).</text></clause>
<clause id="H35338FF6183B48BA84F09CFEECB87B91"><enum>(iii)</enum><header>Specific conditions of use</header><text display-inline="yes-display-inline">In the case of a chemical substance or mixture for which the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to a specific condition of use of the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to the condition of use of the chemical substance or mixture for which the ban or phase-out is established.</text></clause></subparagraph> <subparagraph id="HC9AA3500D9F142578DB5FF4B3FA3FC82"><enum>(C)</enum><header>Request for nondisclosure</header> <clause id="HC651B7A2508A4F4599727F92295A3F91"><enum>(i)</enum><header>In general</header><text>A manufacturer or processor of a chemical substance or mixture subject to a ban or phase-out described in this paragraph may submit to the Administrator, within 30 days of receiving a notification under subsection (g)(2)(A), a request, including documentation supporting such request, that some or all of the information to which the notice applies should not be disclosed or that its disclosure should be delayed, and the Administrator shall review the request under subsection (g)(1)(E).</text></clause>
<clause id="HB4422F097EA84404843558E6B8D7C577"><enum>(ii)</enum><header>Effect of no request or denial</header><text display-inline="yes-display-inline">If no request for nondisclosure or delay is submitted to the Administrator under this subparagraph, or the Administrator denies such a request under subsection (g)(1)(A), the information shall not be protected from disclosure under this section.</text></clause></subparagraph></paragraph> <paragraph id="HD1FA9961A86142E3A36842BD7A7E9287"><enum>(5)</enum><header>Certain requests</header><text>If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information reported to or otherwise obtained by the Administrator under this Act that is not protected from disclosure under this subsection, the Administrator may not deny the request on the basis of section 552(b)(4) of title 5, United States Code.</text></paragraph></subsection>
<subsection id="HCD2C17B8331F4C8DBD15512B4E58071C"><enum>(c)</enum><header>Requirements for confidentiality claims</header>
<paragraph id="H8272CB0619C348DFB5A6C7CA09C20011" display-inline="no-display-inline"><enum>(1)</enum><header>Assertion of claims</header>
<subparagraph id="HED63525B196943E58B7768FD8C39848B"><enum>(A)</enum><header>In general</header><text>A person seeking to protect from disclosure any information that person submits under this Act (including information described in paragraph (2)) shall assert to the Administrator a claim for protection from disclosure concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant to this title.</text></subparagraph> <subparagraph id="H4629A21DED654155B8EB7E9C68A95B4C"><enum>(B)</enum><header>Inclusion</header><text>An assertion of a claim under subparagraph (A) shall include a statement that the person has—</text>
<clause id="HA5AE0F91B11A4B0788D23F250ED31EAD"><enum>(i)</enum><text>taken reasonable measures to protect the confidentiality of the information;</text></clause> <clause id="H6E2572F3B046416B8B9675CB8AE4A158"><enum>(ii)</enum><text>determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;</text></clause>
<clause id="HB6B29B89D65349D18FF8AD9CA2F22054"><enum>(iii)</enum><text>a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and</text></clause> <clause id="H73284D2CF53D4F369739DDE7C2F0707C"><enum>(iv)</enum><text>a reasonable basis to believe that the information is not readily discoverable through reverse engineering.</text></clause></subparagraph>
<subparagraph id="HEFED7364AC5C4EABA65D57F2B38487FE"><enum>(C)</enum><header>Additional requirements for claims regarding chemical identity information</header><text>In the case of a claim under subparagraph (A) for protection from disclosure of a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that such generic name shall—</text> <clause id="HAEEA45713E32406EBA5BE95E95169C91"><enum>(i)</enum><text>be consistent with guidance developed by the Administrator under paragraph (4)(A); and</text></clause>
<clause id="H643C5C1C13174EDA96446BAA6794E74D"><enum>(ii)</enum><text>describe the chemical structure of the chemical substance as specifically as practicable while protecting those features of the chemical structure—</text> <subclause id="HC7BFC53AFCA049A88BF8F2A90DE855A1"><enum>(I)</enum><text>that are claimed as confidential; and</text></subclause>
<subclause id="H1D0AA2D3A95E4A2B84C83EA2334D0616"><enum>(II)</enum><text>the disclosure of which would be likely to cause substantial harm to the competitive position of the person.</text></subclause></clause></subparagraph></paragraph> <paragraph id="HB241AB70FFD74C8DAE7D64EAAC7B8AB2"><enum>(2)</enum><header>Information generally not subject to substantiation requirements</header><text display-inline="yes-display-inline">Subject to subsection (f), the following information shall not be subject to substantiation requirements under paragraph (3):</text>
<subparagraph id="HE52F8322A5C84F2493DE74F21A6549AE"><enum>(A)</enum><text>Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article.</text></subparagraph> <subparagraph id="H14A5F264BA804A12B01C12C93374AAE2"><enum>(B)</enum><text>Marketing and sales information.</text></subparagraph>
<subparagraph id="H367BECE1C53646048AD9EB069FB0EEEA"><enum>(C)</enum><text>Information identifying a supplier or customer.</text></subparagraph> <subparagraph id="HAA525123A1134348A8DFC8D3402F91E1"><enum>(D)</enum><text>In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents.</text></subparagraph>
<subparagraph id="HC55B0224599A4F94B8D560C06A1E60D6"><enum>(E)</enum><text>Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article.</text></subparagraph> <subparagraph id="H94352881BF494C239BA4557FCFE84E96"><enum>(F)</enum><text>Specific production or import volumes of the manufacturer or processor.</text></subparagraph>
<subparagraph id="HE30F070A99624DF799054BB9F9426184"><enum>(G)</enum><text display-inline="yes-display-inline">Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under section 5.</text></subparagraph></paragraph> <paragraph id="H6113857AB6D94B3C923D05AC5EB7C43D"><enum>(3)</enum><header>Substantiation requirements</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), a person asserting a claim to protect information from disclosure under this section shall substantiate the claim, in accordance with such rules as the Administrator has promulgated or may promulgate pursuant to this section.</text></paragraph>
<paragraph id="HB700E01ED818417CAEB523426EE91033"><enum>(4)</enum><header>Guidance</header><text>The Administrator shall develop guidance regarding—</text> <subparagraph id="HC78DF77B0111412BB2A743EC7032C5BA"><enum>(A)</enum><text>the determination of structurally descriptive generic names, in the case of claims for the protection from disclosure of specific chemical identity; and</text></subparagraph>
<subparagraph id="H6DDA953D1B294279AC129569CEEBAF6E"><enum>(B)</enum><text>the content and form of the statements of need and agreements required under paragraphs (4), (5), and (6) of subsection (d).</text></subparagraph></paragraph> <paragraph id="H2179A37EB60F44B98463A0BC38C71939"><enum>(5)</enum><header>Certification</header><text>An authorized official of a person described in paragraph (1)(A) shall certify that the statement required to assert a claim submitted pursuant to paragraph (1)(B), and any information required to substantiate a claim submitted pursuant to paragraph (3), are true and correct.</text></paragraph></subsection>
<subsection id="H89554D798F30462FB3F18CC28F7AE9B1"><enum>(d)</enum><header>Exceptions to protection from disclosure</header><text>Information described in subsection (a)—</text> <paragraph id="HE010A0780E3C43599FEB46074567A533"><enum>(1)</enum><text>shall be disclosed to an officer or employee of the United States—</text>
<subparagraph id="HDD795D14D44849DEAA72DB00C8BF423E"><enum>(A)</enum><text>in connection with the official duties of that person under any Federal law for the protection of health or the environment; or</text></subparagraph> <subparagraph id="HFA3CA6D1AE5943F0A13AD2F42D9DDA77"><enum>(B)</enum><text>for a specific Federal law enforcement purpose;</text></subparagraph></paragraph>
<paragraph id="H1848D52143F94409AF38A4BF8B6FA7C5"><enum>(2)</enum><text>shall be disclosed to a contractor of the United States and employees of that contractor—</text> <subparagraph id="H8F30BC02D9304D61A355450023C363A7"><enum>(A)</enum><text>if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act; and</text></subparagraph>
<subparagraph id="HB114668979DB42848BA35E1B3254E8E2"><enum>(B)</enum><text>subject to such conditions as the Administrator may specify;</text></subparagraph></paragraph> <paragraph id="HA799349BEB4C44A79B095CC3905EB706"><enum>(3)</enum><text>shall be disclosed if the Administrator determines that disclosure is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use;</text></paragraph>
<paragraph id="HC1C0396B10AA40A594A4E194D0DFD791"><enum>(4)</enum><text>shall be disclosed to a State, political subdivision of a State, or tribal government, on written request, for the purpose of administration or enforcement of a law, if such entity has 1 or more applicable agreements with the Administrator that are consistent with the guidance developed under subsection (c)(4)(B) and ensure that the entity will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information;</text></paragraph> <paragraph id="H7031AFD94B884E638E38F797D0FEDBD0"><enum>(5)</enum><text>shall be disclosed to a health or environmental professional employed by a Federal or State agency or tribal government or a treating physician or nurse in a nonemergency situation if such person provides a written statement of need and agrees to sign a written confidentiality agreement with the Administrator, subject to the conditions that—</text>
<subparagraph id="HC5A37BAAF1384AE28722A4330243560C"><enum>(A)</enum><text>the statement of need and confidentiality agreement are consistent with the guidance developed under subsection (c)(4)(B);</text></subparagraph> <subparagraph id="H99CB02567FCD4DF19EBC668EE6A31BEF"><enum>(B)</enum><text>the statement of need shall be a statement that the person has a reasonable basis to suspect that—</text>
<clause id="HD4F888CACAAD4E66BE982597BFDF4525"><enum>(i)</enum><text>the information is necessary for, or will assist in—</text> <subclause id="H1AE33A3E750740DCB917E5BF1DACA695"><enum>(I)</enum><text>the diagnosis or treatment of 1 or more individuals; or</text></subclause>
<subclause id="H3065793ADF4949BA8391224D57FC4671"><enum>(II)</enum><text>responding to an environmental release or exposure; and</text></subclause></clause> <clause id="H94CA62BF3AB44B678031C6F982540AEB"><enum>(ii)</enum><text>1 or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned, or an environmental release of or exposure to the chemical substance or mixture concerned has occurred; and</text></clause></subparagraph>
<subparagraph id="H7F634A46AA124ACF822E59B3708239C7"><enum>(C)</enum><text display-inline="yes-display-inline">the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need, except as otherwise may be authorized by the terms of the agreement or by the person who has a claim under this section with respect to the information;</text></subparagraph></paragraph> <paragraph id="H46B9B927E142411FBBF0D95A79479D56"><enum>(6)</enum><text display-inline="yes-display-inline">shall be disclosed in the event of an emergency to a treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a State, political subdivision of a State, or tribal government, or first responder (including any individual duly authorized by a Federal agency, State, political subdivision of a State, or tribal government who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) if such person requests the information, subject to the conditions that such person shall—</text>
<subparagraph id="HDA967D56E8024E1999424466884153B0"><enum>(A)</enum><text>have a reasonable basis to suspect that—</text> <clause id="HBFD4B907556B42E59B201E14769373F4"><enum>(i)</enum><text>a medical, public health, or environmental emergency exists;</text></clause>
<clause id="H57F9776F017E4E36AAD5FE62FA8B9549"><enum>(ii)</enum><text>the information is necessary for, or will assist in, emergency or first-aid diagnosis or treatment; or</text></clause> <clause id="H9CA61C3B5C684819BDC1468A81DF8600"><enum>(iii)</enum><text display-inline="yes-display-inline">1 or more individuals being diagnosed or treated have likely been exposed to the chemical substance or mixture concerned, or a serious environmental release of or exposure to the chemical substance or mixture concerned has occurred; and</text></clause></subparagraph>
<subparagraph id="H89EBDDB35F2E4FC18E3BAE7AF6F46DF0"><enum>(B)</enum><text display-inline="yes-display-inline">if requested by a person who has a claim with respect to the information under this section—</text> <clause id="H0D236C1EB0B64B16A53665A6ED0E42AA"><enum>(i)</enum><text>provide a written statement of need and agree to sign a confidentiality agreement, as described in paragraph (5); and </text></clause>
<clause id="HFBD21492F6154A15862C55393240DF0A"><enum>(ii)</enum><text>submit to the Administrator such statement of need and confidentiality agreement as soon as practicable, but not necessarily before the information is disclosed;</text></clause></subparagraph></paragraph> <paragraph id="H2B6F0792203841BDBC403EB7E35D108D"><enum>(7)</enum><text>may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure is made in such a manner as to preserve confidentiality to the extent practicable without impairing the proceeding; </text></paragraph>
<paragraph id="HFBF7D674A3644403A99C707CEA70B8E4"><enum>(8)</enum><text display-inline="yes-display-inline">shall be disclosed if the information is required to be made public under any other provision of Federal law; and</text></paragraph> <paragraph id="H01CF89D50C2741AC9D306F59A7BDC749"><enum>(9)</enum><text>shall be disclosed as required pursuant to discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law. </text></paragraph></subsection>
<subsection id="HEBC535D8AA3B4910BCCBD01FE29DD518"><enum>(e)</enum><header>Duration of protection from disclosure</header>
<paragraph id="HE413E8B9411648EAA6ED140DEA5F027F" commented="no"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), subsection (f)(3), and section 8(b), the Administrator shall protect from disclosure information described in subsection (a)—</text> <subparagraph id="HB527E5CF7CCF474EAD0978F15E99AD97" commented="no"><enum>(A)</enum><text>in the case of information described in subsection (c)(2), until such time as—</text>
<clause id="H63134C832B4F4D64846CFD444CFE55E1" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or</text></clause> <clause id="H4A790A5EE0764F2293AB3CB731AEA587" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g); and</text></clause></subparagraph>
<subparagraph id="HA42297AC3BE749A8BF093397C055F7BF" commented="no"><enum>(B)</enum><text>in the case of information other than information described in subsection (c)(2)—</text> <clause id="HAD2BDDF8BF824DA6914C4D50E007C634" commented="no"><enum>(i)</enum><text>for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to the Administrator; or</text></clause>
<clause id="H762B55F846404C868BA1F12B89B8EDB5" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">if applicable before the expiration of such 10-year period, until such time as—</text> <subclause id="HB14DE2C12C78480AA57A2F8D658F2EF5" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or</text></subclause>
<subclause id="H56C7F1EE9FA64B4BA9769A21BB7C54ED" commented="no"><enum>(II)</enum><text display-inline="yes-display-inline">the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g).</text></subclause></clause></subparagraph></paragraph> <paragraph id="H2826B951995842A385753251977BEB72"><enum>(2)</enum><header>Extensions</header> <subparagraph id="H0EF5DD32128B4883A9045A6663AD5F96"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of information other than information described in subsection (c)(2), not later than the date that is 60 days before the expiration of the period described in paragraph (1)(B)(i), the Administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period.</text></subparagraph>
<subparagraph id="HEDEB69751D114F5AA0052DB8103A8B5D"><enum>(B)</enum><header>Request</header>
<clause id="HAEB95F9723D04B2097F5CA74C4C21ED2"><enum>(i)</enum><header>In general</header><text>Not later than the date that is 30 days before the expiration of the period described in paragraph (1)(B)(i), a person reasserting the relevant claim shall submit to the Administrator a request for extension substantiating, in accordance with subsection (c)(3), the need to extend the period.</text></clause> <clause id="HCDA7AB6621D94B8E831133D465066F19"><enum>(ii)</enum><header>Action by Administrator</header><text>Not later than the date of expiration of the period described in paragraph (1)(B)(i), the Administrator shall, in accordance with subsection (g)(1)—</text>
<subclause id="HE26B204A02094A73A3A4F875D68B6AF0"><enum>(I)</enum><text>review the request submitted under clause (i);</text></subclause> <subclause id="HD77EA66AF6DD40F7AA64594D59219228"><enum>(II)</enum><text>make a determination regarding whether the claim for which the request was submitted continues to meet the relevant requirements of this section; and</text></subclause>
<subclause id="H12426B3F67EA4070B1BABF434113DCF9"><enum>(III)</enum>
<item id="HE1B1C804A00C4D86B2054AFB0FA0189C" display-inline="yes-display-inline"><enum>(aa)</enum><text>grant an extension of 10 years; or</text></item> <item id="H471ABD4D8AA642AB97B5F6EE54DA6658" indent="up1"><enum>(bb)</enum><text>deny the request.</text></item></subclause></clause></subparagraph>
<subparagraph id="H9118E6E24D394DBB93B19543870FD26D"><enum>(C)</enum><header>No limit on number of extensions</header><text>There shall be no limit on the number of extensions granted under this paragraph, if the Administrator determines that the relevant request under subparagraph (B)(i)—</text> <clause id="H319A528551874FF8B1CB258A68AAB289"><enum>(i)</enum><text>establishes the need to extend the period; and</text></clause>
<clause id="H6875B147FD2D450790D219205D8AF594"><enum>(ii)</enum><text>meets the requirements established by the Administrator.</text></clause></subparagraph></paragraph></subsection> <subsection id="HE2AD0F27EA8C414DAF9F918830C807F9"><enum>(f)</enum><header>Review and resubstantiation</header> <paragraph id="H5937F32EABFB4277BA0CDDED1077EBD1"><enum>(1)</enum><header>Discretion of Administrator</header><text display-inline="yes-display-inline">The Administrator may require any person that has claimed protection for information from disclosure under this section, whether before, on, or after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, to reassert and substantiate or resubstantiate the claim in accordance with this section—</text>
<subparagraph id="H48F75A52772043ED977F8813EA79A919"><enum>(A)</enum><text>after the chemical substance is designated as a high-priority substance under section 6(b);</text></subparagraph> <subparagraph id="H85AC7D795F394EBE84DF127EAE89A72B"><enum>(B)</enum><text display-inline="yes-display-inline">for any chemical substance designated as an active substance under section 8(b)(5)(B)(iii); or</text></subparagraph>
<subparagraph id="H9202EEEC923440C1880B8EFD9A8310A5"><enum>(C)</enum><text>if the Administrator determines that disclosure of certain information currently protected from disclosure would be important to assist the Administrator in conducting risk evaluations or promulgating rules under section 6.</text></subparagraph></paragraph> <paragraph id="H4D8FD17CB5234D468D054929F54DE42C"><enum>(2)</enum><header>Review required</header><text>The Administrator shall review a claim for protection of information from disclosure under this section and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, to reassert and substantiate or resubstantiate the claim in accordance with this section—</text>
<subparagraph id="H563499E9238844CF90478D28F587D3A5"><enum>(A)</enum><text>as necessary to determine whether the information qualifies for an exemption from disclosure in connection with a request for information received by the Administrator under section 552 of title 5, United States Code;</text></subparagraph> <subparagraph id="HEED8F74B2D9246CCBAA51A1086398A16"><enum>(B)</enum><text>if the Administrator has a reasonable basis to believe that the information does not qualify for protection from disclosure under this section; or</text></subparagraph>
<subparagraph id="H0A5E6D348BB740F3B295BE59B55FEBA5"><enum>(C)</enum><text>for any chemical substance the Administrator determines under section 6(b)(4)(A) presents an unreasonable risk of injury to health or the environment.</text></subparagraph></paragraph> <paragraph id="H3A97778EAF1E48569D469DF3B9C1D3F7" commented="no"><enum>(3)</enum><header>Period of protection</header><text display-inline="yes-display-inline">If the Administrator requires a person to reassert and substantiate or resubstantiate a claim under this subsection, and determines that the claim continues to meet the relevant requirements of this section, the Administrator shall protect the information subject to the claim from disclosure for a period of 10 years from the date of such determination, subject to any subsequent requirement by the Administrator under this subsection.</text></paragraph></subsection>
<subsection id="H05855AEDE5294748B52FF996C0F0A65B"><enum>(g)</enum><header>Duties of Administrator</header>
<paragraph id="H850E1B8E80774538BC5D472FF03012C6" display-inline="no-display-inline"><enum>(1)</enum><header>Determination</header>
<subparagraph id="HE7EBCE978BAF4708BA2BECBDF55A0532"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Except for claims regarding information described in subsection (c)(2), the Administrator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (c), and not later than 30 days after the receipt of a request for extension of a claim under subsection (e) or a request under subsection (b)(4)(C), review and approve, approve in part and deny in part, or deny the claim or request.</text></subparagraph> <subparagraph id="H15CFEC6D6BEC4F7BBD1F5225F495A80A"><enum>(B)</enum><header>Reasons for denial</header><text display-inline="yes-display-inline">If the Administrator denies or denies in part a claim or request under subparagraph (A) the Administrator shall provide to the person that asserted the claim or submitted the request a written statement of the reasons for the denial or denial in part of the claim or request.</text></subparagraph>
<subparagraph id="H6092C7CB38D348A2B87B1EBF5CD61B51"><enum>(C)</enum><header>Subsets</header><text>The Administrator shall—</text> <clause id="HDA057D6B5E844CDF95CB5D1C005A4966"><enum>(i)</enum><text display-inline="yes-display-inline">except with respect to information described in subsection (c)(2)(G), review all claims or requests under this section for the protection from disclosure of the specific chemical identity of a chemical substance; and</text></clause>
<clause id="H85ADACF838AD4081BEA608569EE5A9FF"><enum>(ii)</enum><text>review a representative subset, comprising at least 25 percent, of all other claims or requests for protection from disclosure under this section.</text></clause></subparagraph> <subparagraph id="H1614C4106A0A4993A656A3F60096A067"><enum>(D)</enum><header>Effect of failure to act</header><text>The failure of the Administrator to make a decision regarding a claim or request for protection from disclosure or extension under this section shall not have the effect of denying or eliminating a claim or request for protection from disclosure.</text></subparagraph>
<subparagraph id="H3C91013ADF9847BDA4637B03CB370738"><enum>(E)</enum><header>Determination of requests under subsection (<enum-in-header>b</enum-in-header>)(<enum-in-header>4</enum-in-header>)(<enum-in-header>C</enum-in-header>)</header><text display-inline="yes-display-inline">With respect to a request submitted under subsection (b)(4)(C), the Administrator shall, with the objective of ensuring that information relevant to the protection of health and the environment is disclosed to the extent practicable, determine whether the documentation provided by the person rebuts what shall be the presumption of the Administrator that the public interest in the disclosure of the information outweighs the public or proprietary interest in maintaining the protection for all or a portion of the information that the person has requested not be disclosed or for which disclosure be delayed.</text></subparagraph></paragraph> <paragraph id="H10DDC789EB6A4BD1B62987C909A0D089"><enum>(2)</enum><header>Notification</header> <subparagraph id="HFD325413A0AA40829EB0D73B26C26DE2"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B) and subsections (b), (d), and (e), if the Administrator denies or denies in part a claim or request under paragraph (1), concludes, in accordance with this section, that the information does not qualify for protection from disclosure, intends to disclose information pursuant to subsection (d), or promulgates a rule under section 6(a) establishing a ban or phase-out with respect to a chemical substance or mixture, the Administrator shall notify, in writing, the person that asserted the claim or submitted the request of the intent of the Administrator to disclose the information or not protect the information from disclosure under this section. The notice shall be furnished by certified mail (return receipt requested), by personal delivery, or by other means that allows verification of the fact and date of receipt.</text></subparagraph>
<subparagraph id="H7445282BC718413AB8B7A9F8A7FA2C0D"><enum>(B)</enum><header>Disclosure of information</header><text>Except as provided in subparagraph (C), the Administrator shall not disclose information under this subsection until the date that is 30 days after the date on which the person that asserted the claim or submitted the request receives notification under subparagraph (A).</text></subparagraph> <subparagraph id="H4D48AEFCA04244458823208984B0A58A"><enum>(C)</enum><header>Exceptions</header> <clause id="HD7F71FD8D36F40ECAF4B4AF3944A4CDD"><enum>(i)</enum><header>Fifteen day notification</header><text display-inline="yes-display-inline">For information the Administrator intends to disclose under subsections (d)(3), (d)(4), (d)(5), and (j), the Administrator shall not disclose the information until the date that is 15 days after the date on which the person that asserted the claim or submitted the request receives notification under subparagraph (A), except that, with respect to information to be disclosed under subsection (d)(3), if the Administrator determines that disclosure of the information is necessary to protect against an imminent and substantial harm to health or the environment, no prior notification shall be necessary.</text></clause>
<clause id="H66C14FF6E1274CF8A26D5FEC769F1FD6"><enum>(ii)</enum><header>Notification as soon as practicable</header><text display-inline="yes-display-inline">For information the Administrator intends to disclose under paragraph (6) of subsection (d), the Administrator shall notify the person that submitted the information that the information has been disclosed as soon as practicable after disclosure of the information.</text></clause> <clause id="HA9CE643CDF274A9AA29D11145BCA2F7C"><enum>(iii)</enum><header>No notification required</header><text>Notification shall not be required—</text>
<subclause id="HC3904C47AE8C46239D8E5E087109EBCC"><enum>(I)</enum><text>for the disclosure of information under paragraphs (1), (2), (7), or (8) of subsection (d); or</text></subclause> <subclause id="H91BBAD8FCCBA4385A24CA8F80831C0A4"><enum>(II)</enum><text>for the disclosure of information for which—</text>
<item id="HDC278289F841477EA84AE6FE41178A13"><enum>(aa)</enum><text>the Administrator has provided to the person that asserted the claim a notice under subsection (e)(2)(A); and</text></item> <item id="HEA19FF71A41D4A52A0335368CE58DF09"><enum>(bb)</enum><text>such person does not submit to the Administrator a request under subsection (e)(2)(B) on or before the deadline established in subsection (e)(2)(B)(i).</text></item></subclause></clause></subparagraph>
<subparagraph id="HBF272BADD4B64B52A8F70D3ACA1A9473"><enum>(D)</enum><header>Appeals</header>
<clause id="H7FD42E0FD5584F33BD9AEFDE863BFC54"><enum>(i)</enum><header>Action to restrain disclosure</header><text>If a person receives a notification under this paragraph and believes the information is protected from disclosure under this section, before the date on which the information is to be disclosed pursuant to subparagraph (B) or (C) the person may bring an action to restrain disclosure of the information in—</text> <subclause id="H24196048B7A1406DA2D944D5ECB4C883"><enum>(I)</enum><text>the United States district court of the district in which the complainant resides or has the principal place of business; or</text></subclause>
<subclause id="HB1186387DFFF4BDA8F8293B7240751BF"><enum>(II)</enum><text>the United States District Court for the District of Columbia.</text></subclause></clause> <clause id="H4040735C631B499B801D67C645768CE9"><enum>(ii)</enum><header>No disclosure</header> <subclause id="H7C39A14FFEC64E518A4A379094E76F24"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to subsection (d), the Administrator shall not disclose information that is the subject of an appeal under this paragraph before the date on which the applicable court rules on an action under clause (i).</text></subclause>
<subclause id="H7BDD7658DC124FF2BFE87C88DE3B9244"><enum>(II)</enum><header>Exception</header><text display-inline="yes-display-inline">Subclause (I) shall not apply to disclosure of information described under subsections (d)(4) and (j). </text></subclause></clause></subparagraph></paragraph> <paragraph id="HE9485565DB4A44CE85C89B2CB912B866"><enum>(3)</enum><header>Request and notification system</header><text display-inline="yes-display-inline">The Administrator, in consultation with the Director of the Centers for Disease Control and Prevention, shall develop a request and notification system that, in a format and language that is readily accessible and understandable, allows for expedient and swift access to information disclosed pursuant to paragraphs (5) and (6) of subsection (d).</text></paragraph>
<paragraph id="HFE24AD1EE4DB43BE855BB9F2BC320103"><enum>(4)</enum><header>Unique identifier</header><text>The Administrator shall—</text> <subparagraph id="HA540902B03BD441C9EF47454DCEBE46A"><enum>(A)</enum> <clause id="H6E918A498BFB46318AEAEED622F8FCBE" display-inline="yes-display-inline"><enum>(i)</enum><text>develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, which shall not be either the specific chemical identity or a structurally descriptive generic term; and</text></clause>
<clause id="H52D3F5D810534E5F9F7D249D02279A3D" indent="up1"><enum>(ii)</enum><text>apply that identifier consistently to all information relevant to the applicable chemical substance;</text></clause></subparagraph> <subparagraph id="H491DA2C6D992489BAF78B1DA2F2330E0"><enum>(B)</enum><text>annually publish and update a list of chemical substances, referred to by their unique identifiers, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim;</text></subparagraph>
<subparagraph id="H8B2408ADAFB8436ABB0586B83B3F578B" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">ensure that any nonconfidential information received by the Administrator with respect to a chemical substance included on the list published under subparagraph (B) while the specific chemical identity of the chemical substance is protected from disclosure under this section identifies the chemical substance using the unique identifier; and</text></subparagraph> <subparagraph id="H18BBBEB94E794D13BC608768C09E56EC"><enum>(D)</enum><text>for each claim for protection of a specific chemical identity that has been denied by the Administrator or expired, or that has been withdrawn by the person who asserted the claim, and for which the Administrator has used a unique identifier assigned under this paragraph to protect the specific chemical identity in information that the Administrator has made public, clearly link the specific chemical identity to the unique identifier in such information to the extent practicable.</text></subparagraph></paragraph></subsection>
<subsection id="H8767FEF8F8944ACC9622BDBF929935C9"><enum>(h)</enum><header>Criminal penalty for wrongful disclosure</header>
<paragraph id="H70E5CCDA40864DA59C0E85229F754D2C" commented="no"><enum>(1)</enum><header>Individuals subject to penalty</header>
<subparagraph id="HD35E420AA09E4401B0648C6E8809BC31" commented="no"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (C) and paragraph (2), an individual described in subparagraph (B) shall be fined under title 18, United States Code, or imprisoned for not more than 1 year, or both.</text></subparagraph> <subparagraph id="H32B7650FDCA748A09B09B6FA80CF0E33" commented="no"><enum>(B)</enum><header>Description</header><text>An individual referred to in subparagraph (A) is an individual who—</text>
<clause id="HA642138FB806401498FAD275B6903CB1" commented="no"><enum>(i)</enum><text>pursuant to this section, obtained possession of, or has access to, information protected from disclosure under this section; and</text></clause> <clause id="H780C51541ACC426AB9529BEA3128E464" commented="no"><enum>(ii)</enum><text>knowing that the information is protected from disclosure under this section, willfully discloses the information in any manner to any person not entitled to receive that information.</text></clause></subparagraph>
<subparagraph id="HA77A6A63C4574D53904DD95A22B2153A"><enum>(C)</enum><header>Exception</header><text>This paragraph shall not apply to any medical professional (including an emergency medical technician or other first responder) who discloses any information obtained under paragraph (5) or (6) of subsection (d) to a patient treated by the medical professional, or to a person authorized to make medical or health care decisions on behalf of such a patient, as needed for the diagnosis or treatment of the patient.</text></subparagraph></paragraph> <paragraph id="HAC782A9C7EB84415AE993EB09A9AD527"><enum>(2)</enum><header>Other laws</header><text display-inline="yes-display-inline">Section 1905 of title 18, United States Code, shall not apply with respect to the publishing, divulging, disclosure, or making known of, or making available, information reported to or otherwise obtained by the Administrator under this Act.</text></paragraph></subsection>
<subsection id="H617FCD3C89C147609E1454AA3FB48D65"><enum>(i)</enum><header>Applicability</header>
<paragraph id="H180B79E1FB74419189F6135D1E8382D9"><enum>(1)</enum><header>In general</header><text>Except as otherwise provided in this section, section 8, or any other applicable Federal law, the Administrator shall have no authority—</text> <subparagraph id="H603E12AD0F044DD697756154B96773FE"><enum>(A)</enum><text>to require the substantiation or resubstantiation of a claim for the protection from disclosure of information reported to or otherwise obtained by the Administrator under this Act prior to the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>; or</text></subparagraph>
<subparagraph id="HFAE13EB077C04BCFBE80643DFF5BA49A"><enum>(B)</enum><text>to impose substantiation or resubstantiation requirements, with respect to the protection of information described in subsection (a), under this Act that are more extensive than those required under this section.</text></subparagraph></paragraph> <paragraph id="HFC7F7E50DB7246469B99207B3BAC2F93"><enum>(2)</enum><header>Actions prior to promulgation of rules</header><text display-inline="yes-display-inline">Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation of, or approving, approving in part, or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the Administrator may promulgate after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>.</text></paragraph></subsection>
<subsection id="H82C3D5B14F6F4E4E9F894F253054318F" commented="no"><enum>(j)</enum><header>Access by Congress</header><text>Notwithstanding any limitation contained in this section or any other provision of law, all information reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made available, upon written request of any duly authorized committee of the Congress, to such committee.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H6DC082292A924B77BCF47E7722C49B0C" section-type="subsequent-section"><enum>12.</enum><header>Penalties</header><text display-inline="no-display-inline">Section 16 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2615">15 U.S.C. 2615</external-xref>) is amended—</text>
<paragraph id="HF160EC91443E4033A50E0443611C8423"><enum>(1)</enum><text>in subsection (a)(1), by striking <quote>$25,000</quote> and inserting <quote>$37,500</quote>; and</text></paragraph> <paragraph id="H26AD144C003D474294C072C0F57BF9EF"><enum>(2)</enum><text>in subsection (b)—</text>
<subparagraph id="H76F29E8F40694DE1BA45EF7D0EF1C919"><enum>(A)</enum><text>by striking <quote>Any person</quote> and inserting the following: </text> <quoted-block style="OLC" id="HCD0D5A64E2E040B7862B92BE1FEEF8D4" display-inline="no-display-inline"> <paragraph id="H8D844CD65B864CFAAF3DFBA4F8289078"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Any person</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="HBE09A5D4259849D49E84AF93CF001A61"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>$25,000</quote> and inserting <quote>$50,000</quote>; and</text></subparagraph> <subparagraph id="HC1CAC2ED0B15413EBA2FB2A492D4EEC7"><enum>(C)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" id="H1DEDC27790974F5EA851141D2BC35804" display-inline="no-display-inline">
<paragraph id="H57EFF8660EA54D0B9F39C54B5B125008"><enum>(2)</enum><header>Imminent danger of death or serious bodily injury</header>
<subparagraph id="H97640090D51849608D8D87BABEE94B99"><enum>(A)</enum><header>In general</header><text>Any person who knowingly and willfully violates any provision of section 15 or 409, and who knows at the time of the violation that the violation places an individual in imminent danger of death or serious bodily injury, shall be subject on conviction to a fine of not more than $250,000, or imprisonment for not more than 15 years, or both.</text></subparagraph> <subparagraph id="HA9B467696A46425EB008C3F19ED5D457"><enum>(B)</enum><header>Organizations</header><text>Notwithstanding the penalties described in subparagraph (A), an organization that commits a knowing violation described in subparagraph (A) shall be subject on conviction to a fine of not more than $1,000,000 for each violation.</text></subparagraph>
<subparagraph id="H610DDEA52BBE4768950261759C9D6E3D"><enum>(C)</enum><header>Incorporation of corresponding provisions</header><text>Subparagraphs (B) through (F) of section 113(c)(5) of the Clean Air Act (<external-xref legal-doc="usc" parsable-cite="usc/42/7413">42 U.S.C. 7413(c)(5)(B)</external-xref>–(F)) shall apply to the prosecution of a violation under this paragraph.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></section> <section id="HF65E8B56330D425BB2CD7C5C50D34A2C"><enum>13.</enum><header>State-Federal relationship</header><text display-inline="no-display-inline">Section 18 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2617">15 U.S.C. 2617</external-xref>) is amended—</text>
<paragraph id="HE4710471A6714D4BA52FCEA212409EFA"><enum>(1)</enum><text>by amending subsection (a) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H131562E63ED34C7CB6FEBF3D47C5BBED" style="OLC"> <subsection id="HCDBC9B62F1CB4922BE39C564BA396193"><enum>(a)</enum><header>In general</header> <paragraph id="H32F2276C84A741CB94D6D3D20CB193AC"><enum>(1)</enum><header>Establishment or enforcement</header><text display-inline="yes-display-inline">Except as otherwise provided in subsections (c), (d), (e), (f), and (g), and subject to paragraph (2), no State or political subdivision of a State may establish or continue to enforce any of the following:</text>
<subparagraph id="H74DB9A82972047809161898114DE4DC5"><enum>(A)</enum><header>Development of information</header><text display-inline="yes-display-inline">A statute or administrative action to require the development of information about a chemical substance or category of chemical substances that is reasonably likely to produce the same information required under section 4, 5, or 6 in—</text> <clause id="H6C5B738B249C487CBAE276F426941720"><enum>(i)</enum><text>a rule promulgated by the Administrator;</text></clause>
<clause id="H204A5F95C0514DF9B664FF8C374D5D97"><enum>(ii)</enum><text>a consent agreement entered into by the Administrator; or</text></clause> <clause id="H9097A5BD27744831B7FD75B362DC6DD6"><enum>(iii)</enum><text>an order issued by the Administrator.</text></clause></subparagraph>
<subparagraph id="H8BC007BBD9A345CF9FBB6289655F2A5C"><enum>(B)</enum><header>Chemical substances found not to present an unreasonable risk or restricted</header><text display-inline="yes-display-inline">A statute, criminal penalty, or administrative action to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical substance—</text> <clause id="HA8F318C546EF4A76B85C02E440A975F9"><enum>(i)</enum><text display-inline="yes-display-inline">for which the determination described in section 6(i)(1) is made, consistent with the scope of the risk evaluation under section (6)(b)(4)(D); or</text></clause>
<clause id="HD89B27B0389943B69B4C358B99384447"><enum>(ii)</enum><text display-inline="yes-display-inline">for which a final rule is promulgated under section 6(a), after the effective date of the rule issued under section 6(a) for the chemical substance, consistent with the scope of the risk evaluation under section (6)(b)(4)(D).</text></clause></subparagraph> <subparagraph id="HD2BF1168FF914C52A2409C0D05E61FB3"><enum>(C)</enum><header>Significant new use</header><text>A statute or administrative action requiring the notification of a use of a chemical substance that the Administrator has specified as a significant new use and for which the Administrator has required notification pursuant to a rule promulgated under section 5.</text></subparagraph></paragraph>
<paragraph id="H55706E4E9D194404BD45F862F01EF5F0"><enum>(2)</enum><header>Effective date of preemption</header><text display-inline="yes-display-inline">Under this subsection, Federal preemption of statutes and administrative actions applicable to specific chemical substances shall not occur until the effective date of the applicable action described in paragraph (1) taken by the Administrator.</text></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="H39CD3F8728764108B083D7D9FB0F5111"><enum>(2)</enum><text>by amending subsection (b) to read as follows:</text>
<quoted-block style="OLC" id="HCF6161F23D3348928DA17112600A275E" display-inline="no-display-inline">
<subsection id="HE941D61407934E4BB5FC67F81DA354EF" commented="no"><enum>(b)</enum><header>New statutes, criminal penalties, or administrative actions creating prohibitions or other restrictions</header>
<paragraph id="H7EDD6BF6610845D9AA8ABF436596A393"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in subsections (c), (d), (e), (f), and (g), beginning on the date on which the Administrator defines the scope of a risk evaluation for a chemical substance under section 6(b)(4)(D) and ending on the date on which the deadline established pursuant to section 6(b)(4)(G) for completion of the risk evaluation expires, or on the date on which the Administrator publishes the risk evaluation under section 6(b)(4)(C), whichever is earlier, no State or political subdivision of a State may establish a statute, criminal penalty, or administrative action prohibiting or otherwise restricting the manufacture, processing, distribution in commerce, or use of such chemical substance that is a high-priority substance designated under section 6(b)(1)(B)(i).</text></paragraph> <paragraph id="HF9E4B3887177469FAAD0D402A18D0409"><enum>(2)</enum><header>Effect of subsection</header><text display-inline="yes-display-inline">This subsection does not restrict the authority of a State or political subdivision of a State to continue to enforce any statute enacted, criminal penalty assessed, or administrative action taken, prior to the date on which the Administrator defines and publishes the scope of a risk evaluation under section 6(b)(4)(D).</text></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="HDC1C42904050420493011E08E1188DE3"><enum>(3)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="H449169B7024849B9AD28E7B54299EFC4" display-inline="no-display-inline"> <subsection id="H1C7FC92383034EB1A81064D8E5FE0A19"><enum>(c)</enum><header>Scope of preemption</header><text display-inline="yes-display-inline">Federal preemption under subsections (a) and (b) of statutes, criminal penalties, and administrative actions applicable to specific chemical substances shall apply only to—</text>
<paragraph id="H9EE425AF831C45BE96EF3F855FC66585"><enum>(1)</enum><text display-inline="yes-display-inline">with respect to subsection (a)(1)(A), the chemical substances or category of chemical substances subject to a rule, order, or consent agreement under section 4, 5, or 6;</text></paragraph> <paragraph id="H3094383FD78B4CCFB957E96E5FFD6EE6" display-inline="no-display-inline"><enum>(2)</enum><text display-inline="yes-display-inline">with respect to subsection (b), the hazards, exposures, risks, and uses or conditions of use of such chemical substances included in the scope of the risk evaluation pursuant to section 6(b)(4)(D);</text></paragraph>
<paragraph id="H1DA6B12ACD1A4B0DAD242398013299E1"><enum>(3)</enum><text>with respect to subsection (a)(1)(B), the hazards, exposures, risks, and uses or conditions of use of such chemical substances included in any final action the Administrator takes pursuant to section 6(a) or 6(i)(1); or</text></paragraph> <paragraph id="HF16A5B5AF8D04E009B704EF7DD7F5859"><enum>(4)</enum><text display-inline="yes-display-inline">with respect to subsection (a)(1)(C), the uses of such chemical substances that the Administrator has specified as significant new uses and for which the Administrator has required notification pursuant to a rule promulgated under section 5.</text></paragraph></subsection>
<subsection id="H5EB3AECAE7C24DB88BCE4C57B0D72ACE"><enum>(d)</enum><header>Exceptions</header>
<paragraph id="HDFC73C1061D742D080F3DF69C01219C6"><enum>(1)</enum><header>No preemption of statutes and administrative actions</header>
<subparagraph id="H855953170B0D409C8FD7147C1F0AB976"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Nothing in this Act, nor any amendment made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, nor any rule, standard of performance, risk evaluation, or scientific assessment implemented pursuant to this Act, shall affect the right of a State or a political subdivision of a State to adopt or enforce any rule, standard of performance, risk evaluation, scientific assessment, or any other protection for public health or the environment that—</text> <clause id="H9EE25C93D0284E5FB56B92836E751834"><enum>(i)</enum><text>is adopted or authorized under the authority of any other Federal law or adopted to satisfy or obtain authorization or approval under any other Federal law;</text></clause>
<clause id="HC2725CC6901E454DBF5C3D6E619C143C"><enum>(ii)</enum><text>implements a reporting, monitoring, or other information obligation for the chemical substance not otherwise required by the Administrator under this Act or required under any other Federal law;</text></clause> <clause id="HCFF3B7DFF6F64EBD8888487BEBFE5B25"><enum>(iii)</enum><text>is adopted pursuant to authority under a law of the State or political subdivision of the State related to water quality, air quality, or waste treatment or disposal, except to the extent that the action—</text>
<subclause id="HF3A188E80F194C3ABC61B72E4BFD2E78"><enum>(I)</enum><text>imposes a restriction on the manufacture, processing, distribution in commerce, or use of a chemical substance; and</text></subclause> <subclause id="HBB40C31044B4426DBEA8AFE468E7BADE"><enum>(II)</enum> <item commented="no" display-inline="yes-display-inline" id="HD7A1FBB2238C47B48D95C1A6ED5BC4C3"><enum>(aa)</enum><text display-inline="yes-display-inline">addresses the same hazards and exposures, with respect to the same conditions of use as are included in the scope of the risk evaluation published pursuant to section 6(b)(4)(D), but is inconsistent with the action of the Administrator; or</text></item>
<item id="HECEB94219569442C8D26638D8C369923" indent="up1"><enum>(bb)</enum><text>would cause a violation of the applicable action by the Administrator under section 5 or 6; or</text></item></subclause></clause> <clause id="H18B70347EC1C416490B2F71ECCFD21F5"><enum>(iv)</enum><text>subject to subparagraph (B), is identical to a requirement prescribed by the Administrator.</text></clause></subparagraph>
<subparagraph id="H6A4443CE7EDB4F889B3C9C5F1166AE01"><enum>(B)</enum><header>Identical requirements</header>
<clause id="HA47017FDEB2B43AA8E27BDB895337572"><enum>(i)</enum><header>In general</header><text>The penalties and other sanctions applicable under a law of a State or political subdivision of a State in the event of noncompliance with the identical requirement shall be no more stringent than the penalties and other sanctions available to the Administrator under section 16 of this Act.</text></clause> <clause id="H0A07A9F763824720B74DD5BE6183FBB0"><enum>(ii)</enum><header>Penalties</header><text>In the case of an identical requirement—</text>
<subclause id="H5710D63F6B554329810861471D94A23B"><enum>(I)</enum><text>a State or political subdivision of a State may not assess a penalty for a specific violation for which the Administrator has assessed an adequate penalty under section 16; and</text></subclause> <subclause id="HF35F4093239C411DBD38F79468E8112A"><enum>(II)</enum><text>if a State or political subdivision of a State has assessed a penalty for a specific violation, the Administrator may not assess a penalty for that violation in an amount that would cause the total of the penalties assessed for the violation by the State or political subdivision of a State and the Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16.</text></subclause></clause></subparagraph></paragraph>
<paragraph id="HDDE987D8B43146E485C7396CC202BE1B"><enum>(2)</enum><header>Applicability to certain rules or orders</header>
<subparagraph id="HE1AD82E901934BD28BDD6CE1C1CD7194"><enum>(A)</enum><header>Prior rules and orders</header><text>Nothing in this section shall be construed as modifying the preemptive effect under this section, as in effect on the day before the effective date of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, of any rule or order promulgated or issued under this Act prior to that effective date.</text></subparagraph> <subparagraph id="H7258978FECD14FECB0E36BCEDFA2C096"><enum>(B)</enum><header>Certain chemical substances and mixtures</header><text>With respect to a chemical substance or mixture for which any rule or order was promulgated or issued under section 6 prior to the effective date of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title> with respect to manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance or mixture, nothing in this section shall be construed as modifying the preemptive effect of this section as in effect prior to the enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title> of any rule or order that is promulgated or issued with respect to such chemical substance or mixture under section 6 after that effective date, unless the latter rule or order is with respect to a chemical substance or mixture containing a chemical substance and follows a designation of that chemical substance as a high-priority substance under section 6(b)(1)(B)(i), the identification of that chemical substance under section 6(b)(2)(A), or the selection of that chemical substance for risk evaluation under section 6(b)(4)(E)(iv)(II).</text></subparagraph></paragraph></subsection>
<subsection id="HBBDFDEBBCD7747E5BB16D44D2B391834"><enum>(e)</enum><header>Preservation of certain laws</header>
<paragraph id="H8D64BD344FB8486FA4167F09754A98D0"><enum>(1)</enum><header>In general</header><text>Nothing in this Act, subject to subsection (g) of this section, shall—</text> <subparagraph id="H1ACCEEF11F384C60A198CA586CFE533E"><enum>(A)</enum><text display-inline="yes-display-inline">be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken or requirement imposed or requirement enacted relating to a specific chemical substance before April 22, 2016, under the authority of a law of the State or political subdivision of the State that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or</text></subparagraph>
<subparagraph id="H6F1AD3A2D63B446D9A884B17AE9AC02A"><enum>(B)</enum><text>be construed to preempt or otherwise affect any action taken pursuant to a State law that was in effect on August 31, 2003.</text></subparagraph></paragraph> <paragraph id="HC99B4A8C0F104CE8B0C32ADE69FA4DF9"><enum>(2)</enum><header>Effect of subsection</header><text>This subsection does not affect, modify, or alter the relationship between Federal law and laws of a State or political subdivision of a State pursuant to any other Federal law.</text></paragraph></subsection>
<subsection id="H595F2E79EAD141A7A2AD375888B4B3BE"><enum>(f)</enum><header>Waivers</header>
<paragraph id="H013778F1D2244A2F8CF7FE3B85680753"><enum>(1)</enum><header>Discretionary exemptions</header><text display-inline="yes-display-inline">Upon application of a State or political subdivision of a State, the Administrator may, by rule, exempt from subsection (a), under such conditions as may be prescribed in the rule, a statute, criminal penalty, or administrative action of that State or political subdivision of the State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that—</text> <subparagraph id="H3717ED7204BE473EBFD2223377DDE645"><enum>(A)</enum><text>compelling conditions warrant granting the waiver to protect health or the environment;</text></subparagraph>
<subparagraph id="H2CDDF2988F2C44D5A2381566486572EA"><enum>(B)</enum><text>compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance;</text></subparagraph> <subparagraph id="H2FEDC36702FA4E679335B6BDF97B3177"><enum>(C)</enum><text>compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and</text></subparagraph>
<subparagraph id="H79745299BB6E4B1B8441EF1CA10E991D"><enum>(D)</enum><text>in the judgment of the Administrator, the proposed requirement of the State or political subdivision of the State is designed to address a risk of a chemical substance, under the conditions of use, that was identified—</text> <clause id="H4C87593651F94AB7ACDFD7C98A889088"><enum>(i)</enum><text>consistent with the best available science;</text></clause>
<clause id="HBF15033B337D40C9A06C2E989514B7B5"><enum>(ii)</enum><text>using supporting studies conducted in accordance with sound and objective scientific practices; and</text></clause> <clause id="H2731AB3612FE406F9DE3B90E7F3CD594"><enum>(iii)</enum><text>based on the weight of the scientific evidence.</text></clause></subparagraph></paragraph>
<paragraph id="HDB3C3075EC074FFC8F7F125E62C3C1AF"><enum>(2)</enum><header>Required exemptions</header><text display-inline="yes-display-inline">Upon application of a State or political subdivision of a State, the Administrator shall exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that—</text> <subparagraph id="HA2B7720F401B48D7ACEEF59325949717"><enum>(A)</enum> <clause id="H20E256AEC2654223AFF74E9823971088" display-inline="yes-display-inline"><enum>(i)</enum><text>compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance;</text></clause>
<clause id="HBB34620AB0BC49719F449DB256D42976" indent="up1"><enum>(ii)</enum><text>compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and</text></clause> <clause id="H321E81D6B5DA4C68BCF284A68AEBC7E9" indent="up1"><enum>(iii)</enum><text>the State or political subdivision of the State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science; or</text></clause></subparagraph>
<subparagraph id="HE63F3672DDDF461385F0ACA5D6B24DCD"><enum>(B)</enum><text display-inline="yes-display-inline">no later than the date that is 18 months after the date on which the Administrator has initiated the prioritization process for a chemical substance under the rule promulgated pursuant to section 6(b)(1)(A), or the date on which the Administrator publishes the scope of the risk evaluation for a chemical substance under section 6(b)(4)(D), whichever is sooner, the State or political subdivision of the State has enacted a statute or proposed or finalized an administrative action intended to prohibit or otherwise restrict the manufacture, processing, distribution in commerce, or use of the chemical substance.</text></subparagraph></paragraph> <paragraph id="H5A8D8F4E41C0471B9FA39D1025EFE9F3"><enum>(3)</enum><header>Determination of a waiver request</header><text display-inline="yes-display-inline">The duty of the Administrator to grant or deny a waiver application shall be nondelegable and shall be exercised—</text>
<subparagraph id="H528FFEB940754D4DA8FE87C27E2C830F"><enum>(A)</enum><text>not later than 180 days after the date on which an application under paragraph (1) is submitted; and</text></subparagraph> <subparagraph id="H1F0981B106334433B29B4156F783BF85"><enum>(B)</enum><text>not later than 110 days after the date on which an application under paragraph (2) is submitted.</text></subparagraph></paragraph>
<paragraph id="H287790AF26B5471481C4171E6D4B133B"><enum>(4)</enum><header>Failure to make a determination</header><text display-inline="yes-display-inline">If the Administrator fails to make a determination under paragraph (3)(B) during the 110-day period beginning on the date on which an application under paragraph (2) is submitted, the statute or administrative action of the State or political subdivision of the State that was the subject of the application shall not be considered to be an existing statute or administrative action for purposes of subsection (b) by reason of the failure of the Administrator to make a determination.</text></paragraph> <paragraph id="H167488036E474F59A4295071A3A77C42"><enum>(5)</enum><header>Notice and comment</header><text display-inline="yes-display-inline">Except in the case of an application approved under paragraph (9), the application of a State or political subdivision of a State under this subsection shall be subject to public notice and comment.</text></paragraph>
<paragraph id="HADCB1DC6BDE444149CA4C1D7671FA310"><enum>(6)</enum><header>Final agency action</header><text>The decision of the Administrator on the application of a State or political subdivision of a State shall be—</text> <subparagraph id="H7A59DC2C1AD94D8E804AA5705F5585F4"><enum>(A)</enum><text>considered to be a final agency action; and</text></subparagraph>
<subparagraph id="H378A0E36C24A4F94B0E46584A4E370DE"><enum>(B)</enum><text>subject to judicial review. </text></subparagraph></paragraph> <paragraph id="HFC89CAF3E3C245508827F876BE3F59BE"><enum>(7)</enum><header>Duration of waivers</header><text display-inline="yes-display-inline">A waiver granted under paragraph (2) or approved under paragraph (9) shall remain in effect until such time as the Administrator publishes the risk evaluation under section 6(b).</text></paragraph>
<paragraph id="HD6A25B13BDDE4924AB03BD9C79E72752"><enum>(8)</enum><header>Judicial review of waivers</header><text>Not later than 60 days after the date on which the Administrator makes a determination on an application of a State or political subdivision of a State under paragraph (1) or (2), any person may file a petition for judicial review in the United States Court of Appeals for the District of Columbia Circuit, which shall have exclusive jurisdiction over the determination.</text></paragraph> <paragraph id="HB438AD8412484B56B51742BC173936D5"><enum>(9)</enum><header>Approval</header> <subparagraph id="H2F55FA1DDF334E888732A877A6B4BA0C"><enum>(A)</enum><header>Automatic approval</header><text>If the Administrator fails to meet the deadline established under paragraph (3)(B), the application of a State or political subdivision of a State under paragraph (2) shall be automatically approved, effective on the date that is 10 days after the deadline.</text></subparagraph>
<subparagraph id="H02E2B0530F4941F89974FDF502CD3D9A"><enum>(B)</enum><header>Requirements</header><text>Notwithstanding paragraph (6), approval of a waiver application under subparagraph (A) for failure to meet the deadline under paragraph (3)(B) shall not be considered final agency action or be subject to judicial review or public notice and comment.</text></subparagraph></paragraph></subsection> <subsection id="H431ACF6D4364465CB60074BCD07119E9"><enum>(g)</enum><header>Savings</header> <paragraph id="HA21BBA043DC84C15B747D3884475409F"><enum>(1)</enum><header>No preemption of common law or statutory causes of action for civil relief or criminal conduct</header> <subparagraph id="HE345EA8B36724C35956942D37203660F"><enum>(A)</enum><header>In general</header><text>Nothing in this Act, nor any amendment made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, nor any standard, rule, requirement, standard of performance, risk evaluation, or scientific assessment implemented pursuant to this Act, shall be construed to preempt, displace, or supplant any State or Federal common law rights or any State or Federal statute creating a remedy for civil relief, including those for civil damage, or a penalty for a criminal conduct.</text></subparagraph>
<subparagraph commented="no" id="H7B055D8ABB324DABBC5F11B5B2EB6432"><enum>(B)</enum><header>Clarification of no preemption</header><text>Notwithstanding any other provision of this Act, nothing in this Act, nor any amendments made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, shall preempt or preclude any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory of liability under any State law, maritime law, or Federal common law or statutory theory.</text></subparagraph></paragraph> <paragraph id="H036002239EC548DD8E53CAE47D64235E"><enum>(2)</enum><header>No effect on private remedies</header> <subparagraph id="HA35DED10B53A4E1094B1A2087439359C"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Nothing in this Act, nor any amendments made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, nor any rules, regulations, requirements, risk evaluations, scientific assessments, or orders issued pursuant to this Act shall be interpreted as, in either the plaintiff’s or defendant’s favor, dispositive in any civil action.</text></subparagraph>
<subparagraph id="HBF9A1492EFD04FF585484D5EB72666D6"><enum>(B)</enum><header>Authority of courts</header><text display-inline="yes-display-inline">This Act does not affect the authority of any court to make a determination in an adjudicatory proceeding under applicable State or Federal law with respect to the admission into evidence or any other use of this Act or rules, regulations, requirements, standards of performance, risk evaluations, scientific assessments, or orders issued pursuant to this Act.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H286DBE7F67A54CB3B6975954DD07D370" section-type="subsequent-section" commented="no"><enum>14.</enum><header>Judicial review</header><text display-inline="no-display-inline">Section 19(a) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2618">15 U.S.C. 2618(a)</external-xref>) is amended—</text>
<paragraph id="H81E57E105DA3438781F36C5CAA969106"><enum>(1)</enum><text>in paragraph (1), by adding at the end the following:</text> <quoted-block style="OLC" id="H0EC2419330E848CAA7BA1B47EEDF94EC" display-inline="no-display-inline"> <subparagraph id="HBAFD039C9B65496AB809FB2D59CF7C8B" commented="no" indent="up1"><enum>(C)</enum> <clause id="HB0B0087C659748C589534F2C728EA44A" commented="no" display-inline="yes-display-inline" indent="up1"><enum>(i)</enum><text>Not later than 60 days after the publication of a designation under section 6(b)(1)(B)(ii), any person may commence a civil action to challenge the designation.</text></clause>
<clause id="HE788A03BD16C49A1B7A3D1DF8282D731" commented="no" indent="up1"><enum>(ii)</enum><text>The United States Court of Appeals for the District of Columbia Circuit shall have exclusive jurisdiction over a civil action filed under this subparagraph.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="HC9B8E64D74A64500A2DBC0B05AAB8BB7"><enum>(2)</enum><text>by striking paragraph (3).</text></paragraph></section>
<section id="HB5A8FA6BCCB1451BA112632D66134133" commented="no"><enum>15.</enum><header>Citizens’ civil actions</header><text display-inline="no-display-inline">Section 20(b) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2619">15 U.S.C. 2619(b)</external-xref>) is amended—</text> <paragraph id="H93044BA9305C4C65AC189EA18478C38F" commented="no"><enum>(1)</enum><text>in paragraph (1)(B), by striking <quote>or</quote> at the end; and</text></paragraph>
<paragraph id="H165ABEC952664F6B85017CF918F95BA4" commented="no"><enum>(2)</enum><text>in paragraph (2), by striking the period at the end and inserting the following: </text> <quoted-block id="HA73177DEA6AC43A7959EB529D8CCF4D8" style="OLC" display-inline="yes-display-inline"><text display-inline="yes-display-inline">, except that no prior notification shall be required in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B); or</text>
<paragraph id="H3D7A9D9E6FC449B894BB1BC7D5F81AB5" commented="no"><enum>(3)</enum><text>in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B), after the date that is 60 days after the deadline specified in section 18(f)(3)(B).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="HE856CD74E55246B7B9443522070A377D" commented="no"><enum>16.</enum><header>Studies</header><text display-inline="no-display-inline">Section 25 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2624">15 U.S.C. 2624</external-xref>) is repealed.</text></section>
<section id="H22A3FCDF97DC4A379227F6F935964052"><enum>17.</enum><header>Administration of the Act</header><text display-inline="no-display-inline">Section 26 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2625">15 U.S.C. 2625</external-xref>) is amended—</text> <paragraph id="H4F058D40982E4E00916FE3A02506D3A9"><enum>(1)</enum><text>in subsection (b)(1)—</text>
<subparagraph id="HA854F359480A461D87F1E605294560F7"><enum>(A)</enum><text>by striking <quote>of a reasonable fee</quote>;</text></subparagraph> <subparagraph id="H140532CFB3894C4E9DDA21CAA2AE9847" commented="no"><enum>(B)</enum><text>by striking <quote>data under section 4 or 5 to defray the cost of administering this Act</quote> and inserting <quote>information under section 4 or a notice or other information to be reviewed by the Administrator under section 5, or who manufactures or processes a chemical substance that is the subject of a risk evaluation under section 6(b), of a fee that is sufficient and not more than reasonably necessary to defray the cost related to such chemical substance of administering sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, including contractor costs incurred by the Administrator</quote>;</text></subparagraph>
<subparagraph id="HA6319E77D7F349649AD90EA01A822888"><enum>(C)</enum><text>by striking <quote>Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100.</quote>; and</text></subparagraph> <subparagraph id="H9781B8DE43A24061BA1F8BAF3018796B" commented="no"><enum>(D)</enum><text>by striking <quote>submit the data and the cost to the Administrator of reviewing such data</quote> and inserting <quote>pay such fee and the cost to the Administrator of carrying out the activities described in this paragraph</quote>;</text></subparagraph></paragraph>
<paragraph id="H25DA881A42EE4B0F814028B9CFC5BECA"><enum>(2)</enum><text>in subsection (b)—</text> <subparagraph id="HB3D4E4284804489B99D3D21D768AE8B1"><enum>(A)</enum><text>in paragraph (2), by striking <quote>paragraph (1)</quote> and inserting <quote>paragraph (4)</quote>; and</text></subparagraph>
<subparagraph id="H2981B64F429A47F9AB31C11E6FDF563C"><enum>(B)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H4C5A209E79CB49E4AF1E2BB1C0F9493F" style="OLC"> <paragraph commented="no" id="H51DA89F1BC7646AD8BA050FEAF30CB0D" indent="up1"><enum>(3)</enum><header>Fund</header> <subparagraph commented="no" id="H430B0A7D14084BD88DF9A2B5D40E29C2"><enum>(A)</enum><header>Establishment</header><text display-inline="yes-display-inline">There is established in the Treasury of the United States a fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the <quote>Fund</quote>), consisting of such amounts as are deposited in the Fund under this paragraph.</text></subparagraph>
<subparagraph commented="no" id="H830D2469CF4C4C9F9A8C8B38FA993C28"><enum>(B)</enum><header>Collection and deposit of fees</header><text display-inline="yes-display-inline">Subject to the conditions of subparagraph (C), the Administrator shall collect the fees described in this subsection and deposit those fees in the Fund.</text></subparagraph> <subparagraph commented="no" id="H8B6FF7DF543C4852BF432F19EAA3636D"><enum>(C)</enum><header>Use of funds by Administrator</header><text display-inline="yes-display-inline">Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use in defraying the costs of the activities described in paragraph (1).</text></subparagraph>
<subparagraph commented="no" id="H0F1D0CAF0D3346CC805C80C08352AD1B"><enum>(D)</enum><header>Accounting and auditing</header>
<clause commented="no" id="H52CBAFAD73D84EE0B29E25DA68A8F667"><enum>(i)</enum><header>Accounting</header><text display-inline="yes-display-inline">The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code.</text></clause> <clause commented="no" id="H4094BEF2B9FF44F6A29AD6B6E90C3A63"><enum>(ii)</enum><header>Auditing</header> <subclause commented="no" id="HF74BE4CE2CDD4827BCF1C3961E2DE13B"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency.</text></subclause>
<subclause commented="no" id="HC892D0226E6E41F9BF2EB91D730B3C6A"><enum>(II)</enum><header>Components of audit</header><text display-inline="yes-display-inline">The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of—</text> <item commented="no" id="HE729F60A489A4C64915CB53564967634"><enum>(aa)</enum><text>the fees collected and amounts disbursed under this subsection;</text></item>
<item commented="no" id="H0E7F9E99BC554D56B8AE496224E79FAB"><enum>(bb)</enum><text>the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of this title for which the fees may be used; and</text></item> <item commented="no" id="H91183D3B32EE47F0BF562379B8BE3825"><enum>(cc)</enum><text>the number of requests for a risk evaluation made by manufacturers under section 6(b)(4)(C)(ii).</text></item></subclause>
<subclause commented="no" id="H53383CE1C5CC4A7F85889B3D05E3DDEF"><enum>(III)</enum><header>Federal responsibility</header><text display-inline="yes-display-inline">The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit.</text></subclause></clause></subparagraph></paragraph> <paragraph id="H946D300615A145A0AD4042CA04FBD558" indent="up1" commented="no"><enum>(4)</enum><header>Amount and adjustment of fees; refunds</header><text display-inline="yes-display-inline">In setting fees under this section, the Administrator shall—</text>
<subparagraph id="HB89B5797759E4000A81B8E7C921C179A" commented="no"><enum>(A)</enum><text>prescribe lower fees for small business concerns, after consultation with the Administrator of the Small Business Administration;</text></subparagraph> <subparagraph id="HC8767D41DDCC461EA96996604A009A99" commented="no"><enum>(B)</enum><text>set the fees established under paragraph (1) at levels such that the fees will, in aggregate, provide a sustainable source of funds to annually defray—</text>
<clause id="HF9CE5A6B9152425D90DDD1990C835973" commented="no"><enum>(i)</enum><text>the lower of—</text> <subclause id="H95E7560DC7434779BCD0ACCC43A6838A" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations under section 6(b); or </text></subclause>
<subclause id="H0DC4FFB14CD742D6AF62A832C2F622BD" commented="no"><enum>(II)</enum><text>$25,000,000 (subject to adjustment pursuant to subparagraph (F)); and</text></subclause></clause> <clause id="H300841199A564EC797516680010F6862" commented="no"><enum>(ii)</enum><text>the costs of risk evaluations specified in subparagraph (D); </text></clause></subparagraph>
<subparagraph id="HB892AE205150459EA867BB071961F8FF" commented="no"><enum>(C)</enum><text>reflect an appropriate balance in the assessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; </text></subparagraph> <subparagraph id="H687B7F7A7A9C41C0B3EB74ABC5162372" commented="no"><enum>(D)</enum><text>notwithstanding subparagraph (B)—</text>
<clause id="HC967D57B994247739BC79A54B9EFCE38" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">except as provided in clause (ii), for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), establish the fee at a level sufficient to defray the full costs to the Administrator of conducting the risk evaluation under section 6(b);</text></clause> <clause id="HD418A31224294662B31F365577E9B04F" commented="no"><enum>(ii)</enum><text>for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), and which are included in the 2014 update of the TSCA Work Plan for Chemical Assessments, establish the fee at a level sufficient to defray 50 percent of the costs to the Administrator of conducting the risk evaluation under section 6(b); and</text></clause>
<clause id="H9F062A52A63D46C191142BF0BBCDBD5A" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">apply fees collected pursuant to clauses (i) and (ii) only to defray the costs described in those clauses;</text></clause></subparagraph> <subparagraph id="H91174DF6FC364DCA915D9245ED3E40E6" commented="no"><enum>(E)</enum><text display-inline="yes-display-inline">prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee Act (5 U.S.C. App.) or 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, is applicable with respect to such meetings;</text></subparagraph>
<subparagraph id="H610B111896C7401AA1D859BB986059D7" commented="no"><enum>(F)</enum><text>beginning with the fiscal year that is 3 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives pursuant to subparagraph (E), increase or decrease the fees established under paragraph (1) as necessary to adjust for inflation and to ensure that funds deposited in the Fund are sufficient to defray—</text> <clause id="H99C38B7A53A94044AC1FA2EF3634DB10" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">approximately but not more than 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations requested under section 6(b)(4)(C)(ii); and</text></clause>
<clause id="HC422B4377AAF43388AF178B090B94E5E" commented="no"><enum>(ii)</enum><text>the costs of risk evaluations specified in subparagraph (D); and</text></clause></subparagraph> <subparagraph id="H6E5973BD94D549B897F3B6D558D4A86D" commented="no"><enum>(G)</enum><text display-inline="yes-display-inline">if a notice submitted under section 5 is not reviewed or such a notice is withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice.</text></subparagraph></paragraph>
<paragraph id="H786F54B72E2D4F97B7A70E2854AC554E" indent="up1" commented="no"><enum>(5)</enum><header>Minimum amount of appropriations</header><text display-inline="yes-display-inline">Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for the Chemical Risk Review and Reduction program project of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014.</text></paragraph> <paragraph id="HA13E226C601F4AC288E6BF59E3DA7244" indent="up1" commented="no"><enum>(6)</enum><header>Termination</header><text display-inline="yes-display-inline">The authority provided by this subsection shall terminate at the conclusion of the fiscal year that is 10 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title> unless otherwise reauthorized or modified by Congress.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H9A1355878D594107AEF75A702F1176BF"><enum>(3)</enum><text>by adding at the end the following:</text> <quoted-block id="HF7A9181D1ACD4583AB18BA22E311BB3F" style="OLC"> <subsection id="HA10FD145898C4DD5BA956054CFA5440A"><enum>(h)</enum><header>Scientific standards</header><text display-inline="yes-display-inline">In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and shall consider as applicable—</text>
<paragraph id="H6C197678880E40388415A754D4CA4FE4"><enum>(1)</enum><text display-inline="yes-display-inline">the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;</text></paragraph> <paragraph id="H74969AAA20D44F5E991443ADFF14C353"><enum>(2)</enum><text>the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture;</text></paragraph>
<paragraph id="HD7A5C72DD8D642BD82A636BF13353E8A"><enum>(3)</enum><text>the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;</text></paragraph> <paragraph id="HAEA69F0383024B2FAC633882BA0FCB3B"><enum>(4)</enum><text>the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and</text></paragraph>
<paragraph id="HA856E4F85F884DF280EBCD75971A9D29"><enum>(5)</enum><text display-inline="yes-display-inline">the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models.</text></paragraph></subsection> <subsection commented="no" id="HE27E22E1946B43EEBAB367B439542716"><enum>(i)</enum><header>Weight of scientific evidence</header><text>The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence.</text></subsection>
<subsection id="H314CD7F6F9EC458EB4E78BE38E4F3742"><enum>(j)</enum><header>Availability of information</header><text>Subject to section 14, the Administrator shall make available to the public—</text> <paragraph id="HABC495C6E16F429D8E296FDD327974FC"><enum>(1)</enum><text>all notices, determinations, findings, rules, consent agreements, and orders of the Administrator under this title;</text></paragraph>
<paragraph id="H44E7309C4A754B0E9817B3F68BAE9226"><enum>(2)</enum><text display-inline="yes-display-inline">any information required to be provided to the Administrator under section 4;</text></paragraph> <paragraph id="H9B42CE8B01A34633967A2A131EE927CB"><enum>(3)</enum><text>a nontechnical summary of each risk evaluation conducted under section 6(b);</text></paragraph>
<paragraph id="H0EE98DFCCEB54616A4D5B05380AC0EDB"><enum>(4)</enum><text>a list of the studies considered by the Administrator in carrying out each such risk evaluation, along with the results of those studies; and</text></paragraph> <paragraph id="H8894ABBC26C34D79BA32C6B36C6E5DCD"><enum>(5)</enum><text display-inline="yes-display-inline">each designation of a chemical substance under section 6(b), along with an identification of the information, analysis, and basis used to make the designations.</text></paragraph></subsection>
<subsection id="H88744C75308D40EABB9E0C28A3DB89B3" commented="no"><enum>(k)</enum><header>Reasonably available information</header><text>In carrying out sections 4, 5, and 6, the Administrator shall take into consideration information relating to a chemical substance or mixture, including hazard and exposure information, under the conditions of use, that is reasonably available to the Administrator. </text></subsection> <subsection id="HADEB94DA6A9747628E0864652EEDC655"><enum>(l)</enum><header>Policies, procedures, and guidance</header> <paragraph id="H7A7695193ABF4E43AAD84BE6D5ADD4BA"><enum>(1)</enum><header>Development</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>.</text></paragraph>
<paragraph id="H1E54D8240544484997F8326C0B160ECD"><enum>(2)</enum><header>Review</header><text>Not later than 5 years after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, and not less frequently than once every 5 years thereafter, the Administrator shall—</text> <subparagraph id="HF9AFF7E72321437E89A6E31E46C0FB91"><enum>(A)</enum><text>review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and</text></subparagraph>
<subparagraph id="H5CC6C5503B78456E8B6D72854EDB861B"><enum>(B)</enum><text>revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings.</text></subparagraph></paragraph> <paragraph id="HC1AB166CEFB74A19A5CE1F1F6EE836A7"><enum>(3)</enum><header>Testing of Chemical Substances and Mixtures</header><text display-inline="yes-display-inline">The policies, procedures, and guidance developed under paragraph (1) applicable to testing chemical substances and mixtures shall—</text>
<subparagraph id="HAD0D18514AF6470AA03B5CB28AE6F6EC"><enum>(A)</enum><text>address how and when the exposure level or exposure potential of a chemical substance or mixture would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; and</text></subparagraph> <subparagraph id="HA1E1F4663A4846A6B5B745116B2860AE"><enum>(B)</enum><text>describe the manner in which the Administrator will determine that additional information is necessary to carry out this title, including information relating to potentially exposed or susceptible populations. </text></subparagraph></paragraph>
<paragraph id="H564EF35B41DE479EA9EE9BC83EB12B67" commented="no"><enum>(4)</enum><header>Chemical substances with completed risk assessments</header><text display-inline="yes-display-inline">With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which the Administrator has published a completed risk assessment prior to the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator may publish proposed and final rules under section 6(a) that are consistent with the scope of the completed risk assessment for the chemical substance and consistent with other applicable requirements of section 6.</text></paragraph> <paragraph id="H9A7B148612C24560A5D88E0A525C21DF"><enum>(5)</enum><header>Guidance</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator. The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing draft risk evaluations for consideration by the Administrator.</text></paragraph></subsection>
<subsection id="H3AEF31E683DA4300A94E05DB842EBFD0" commented="no"><enum>(m)</enum><header>Report to Congress</header>
<paragraph id="H0EF669090AAF4187AA82A8C35332E546" commented="no"><enum>(1)</enum><header>Initial report</header><text display-inline="yes-display-inline">Not later than 6 months after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of—</text> <subparagraph id="HFF25556837E9415B9E0666F3727CF2AC" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(i), and the resources necessary to conduct the minimum number of risk evaluations required under section 6(b)(2);</text></subparagraph>
<subparagraph id="H92CF2AC0707048DCBF206C6023103525" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand;</text></subparagraph> <subparagraph id="H6BA7059092F748A6AC6B77CF42580517" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and</text></subparagraph>
<subparagraph id="H871D388A01F94620AE141F33DDA8E536" commented="no"><enum>(D)</enum><text display-inline="yes-display-inline">the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b).</text></subparagraph></paragraph> <paragraph id="H5933DC13FB924ABA9E6AF491960FA599" commented="no"><enum>(2)</enum><header>Subsequent reports</header><text display-inline="yes-display-inline">The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years.</text></paragraph></subsection>
<subsection id="H3FBD22E8AF064FB2B21D4C8FD565EB65" commented="no"><enum>(n)</enum><header>Annual plan</header>
<paragraph id="H1AA54480BA214E21B2870A1CF9F59A8F" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Administrator shall inform the public regarding the schedule and the resources necessary for the completion of each risk evaluation as soon as practicable after initiating the risk evaluation.</text></paragraph> <paragraph id="H49F8D978926145B38699AAE8633035C9"><enum>(2)</enum><header>Publication of plan</header><text>At the beginning of each calendar year, the Administrator shall publish an annual plan that—</text>
<subparagraph id="HC8740B78C24C4773843CE5D69B60A37C" commented="no"><enum>(A)</enum><text>identifies the chemical substances for which risk evaluations are expected to be initiated or completed that year and the resources necessary for their completion;</text></subparagraph> <subparagraph id="HC03A2D4BCF04433A9EEC329A47533804" commented="no"><enum>(B)</enum><text>describes the status of each risk evaluation that has been initiated but not yet completed; and</text></subparagraph>
<subparagraph id="HB8CA81C5AA8748A896D701949D5421FD" commented="no"><enum>(C)</enum><text>if the schedule for completion of a risk evaluation has changed, includes an updated schedule for that risk evaluation.</text></subparagraph></paragraph></subsection> <subsection id="H9209A72EC0B547FFB89D4C35D18552AC"><enum>(o)</enum><header>Consultation with science advisory committee on chemicals</header> <paragraph id="H3A8CBA44513449D6A54D7AAD2A36ADAA"><enum>(1)</enum><header>Establishment</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>, the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the <quote>Committee</quote>).</text></paragraph>
<paragraph id="H1A0A876C403242E285EBE7BD3423739F"><enum>(2)</enum><header>Purpose</header><text>The purpose of the Committee shall be to provide independent advice and expert consultation, at the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title.</text></paragraph> <paragraph id="H928F2873EEB94F4DAC8C5F6549E3CCDE"><enum>(3)</enum><header>Composition</header><text>The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.</text></paragraph>
<paragraph id="H9D2FC66CAF33403F9DBA2DBBC95D09E5"><enum>(4)</enum><header>Schedule</header><text>The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years.</text></paragraph></subsection> <subsection id="H4EF5EB8B1D0A489285D3958ACB4A9DA9"><enum>(p)</enum><header>Prior actions</header> <paragraph id="H1E069525820C4CC080186AF25F633EE0"><enum>(1)</enum><header>Rules, orders, and exemptions</header><text display-inline="yes-display-inline">Nothing in the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title> eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>. </text></paragraph>
<paragraph id="H0909C881F624418C8DD28DBF0FF8892E" commented="no"><enum>(2)</enum><header>Prior-initiated evaluations</header><text display-inline="yes-display-inline">Nothing in this Act prevents the Administrator from initiating a risk evaluation regarding a chemical substance, or from continuing or completing such risk evaluation, prior to the effective date of the policies, procedures, and guidance required to be developed by the Administrator pursuant to the amendments made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>.</text></paragraph> <paragraph id="HAB0784A9F24B49CE92E9ABA0316B2104" commented="no"><enum>(3)</enum><header>Actions completed prior to completion of policies, procedures, and guidance</header><text display-inline="yes-display-inline">Nothing in this Act requires the Administrator to revise or withdraw a completed risk evaluation, determination, or rule under this Act solely because the action was completed prior to the development of a policy, procedure, or guidance pursuant to the amendments made by the <short-title>Frank R. Lautenberg Chemical Safety for the 21st Century Act</short-title>.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="H6BAF862855424ADA9551FB863CE01915" commented="no"><enum>18.</enum><header>State programs</header><text display-inline="no-display-inline">Section 28 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2627">15 U.S.C. 2627</external-xref>) is amended by striking subsections (c) and (d).</text></section> <section id="H3916B7F40EAF47CB8C21F89E1ABF00F7"><enum>19.</enum><header>Conforming amendments</header> <subsection id="HFA79CFC080EF416E82240640CEBB4316"><enum>(a)</enum><header>Table of contents</header><text display-inline="yes-display-inline">The table of contents in section 1 of the Toxic Substances Control Act is amended—</text>
<paragraph id="H18E4550AF6814F3D8C9FB2BEFFBB4223"><enum>(1)</enum><text>by striking the item relating to section 6 and inserting the following:</text> <quoted-block style="OLC" id="H0ACC1B0DA8DD4E0E9314D9DB733D0208" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures.</toc-entry></toc><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="H610CD7B1A0CA4D609B9556A00313EEFD"><enum>(2)</enum><text>by striking the item relating to section 10 and inserting the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H0BD52BF22EE846F083D10D0643E40289">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 10. Research, development, collection, dissemination, and utilization of information.</toc-entry></toc><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HA86CCE0308414808964C0143CE810115"><enum>(3)</enum><text>by striking the item relating to section 14 and inserting the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HA943091A376D402098D55666851FC247"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 14. Confidential information.</toc-entry></toc><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="HC3349B52EED24133B841D37DD4461285"><enum>(4)</enum><text>by striking the item relating to section 25.</text></paragraph></subsection>
<subsection id="HE798BDCD9BAB4FC597CC91ACBBC6FA29"><enum>(b)</enum><header>Section 2</header><text display-inline="yes-display-inline">Section 2(b)(1) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2601">15 U.S.C. 2601(b)(1)</external-xref>) is amended by striking <quote>data</quote> both places it appears and inserting <quote>information</quote>.</text></subsection> <subsection id="HC16497005C424B5B98A9EDBA85AA9CF9"><enum>(c)</enum><header>Section 3</header><text display-inline="yes-display-inline">Section 3 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2602">15 U.S.C. 2602</external-xref>) is amended—</text>
<paragraph id="H586ED2AE1F5E4E80A5F47D3F00180660"><enum>(1)</enum><text>in paragraph (8) (as redesignated by section 3 of this Act), by striking <quote>data</quote> and inserting <quote>information</quote>; and</text></paragraph> <paragraph id="H9344A8638EB348EAB4B569CB76256443"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (15) (as redesignated by section 3 of this Act)—</text>
<subparagraph id="H13D86D7BB31D470CA8379457324ACC64"><enum>(A)</enum><text>by striking <quote>standards</quote> and inserting <quote>protocols and methodologies</quote>; </text></subparagraph> <subparagraph id="HA6261CA4BEF3400FB7FFD413357CE4AA"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>test data</quote> both places it appears and inserting <quote>information</quote>; and</text></subparagraph>
<subparagraph id="H39856D979F9B4DFC80346298FD25C8D7"><enum>(C)</enum><text>by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>.</text></subparagraph></paragraph></subsection> <subsection commented="no" id="HD2888875B68447B5B9E50399EA9D65DA"><enum>(d)</enum><header>Section 4</header><text display-inline="yes-display-inline">Section 4 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2603">15 U.S.C. 2603</external-xref>) is amended—</text>
<paragraph commented="no" id="H57CCE1629E2B478B803EB88C7894C598"><enum>(1)</enum><text>in subsection (b)—</text> <subparagraph commented="no" id="H36631ECFFA9D4B6EACF702619099661E"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause id="H20AE476DFFFF43A1B941A8C48A677779" commented="no"><enum>(i)</enum><text>in the paragraph heading, by adding <quote><header-in-text level="paragraph" style="OLC">, order, or consent agreement</header-in-text></quote> at the end; and</text></clause> <clause id="HFE0A2A790DF94C179C798AFB3E797FAB" commented="no"><enum>(ii)</enum><text>by striking <quote>rule</quote> each place it appears and inserting <quote>rule, order, or consent agreement</quote>;</text></clause></subparagraph>
<subparagraph commented="no" id="HB8416C23667042C6ABA34D99C1B93CE5"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)(B), by striking <quote>rules</quote> and inserting <quote>rules, orders, and consent agreements</quote>;</text></subparagraph> <subparagraph id="H6CBA300D24D9412F93AB4055A16AE470"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3)(A), by striking <quote>rule</quote> and inserting <quote>rule or order</quote>; and</text></subparagraph>
<subparagraph commented="no" id="HD0554C8F03EF4C6EBE2D157ED3547CF0"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text> <clause commented="no" id="H5853634BD491459C87D8B7F3743D067E"><enum>(i)</enum><text>by striking <quote>rule under subsection (a)</quote> each place it appears and inserting <quote>rule, order, or consent agreement under subsection (a)</quote>;</text></clause>
<clause commented="no" id="H77E3141FF1054856860E08521EF13CA5"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>repeals the rule</quote> each place it appears and inserting <quote>repeals the rule or order or modifies the consent agreement to terminate the requirement</quote>; and</text></clause> <clause commented="no" id="H3421B224DB6A48A4A162B67A58A22ED0"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>repeals the application of the rule</quote> and inserting <quote>repeals or modifies the application of the rule, order, or consent agreement</quote>;</text></clause></subparagraph></paragraph>
<paragraph commented="no" id="H9BAF8B36BAEF4AA4BCCE01BCD6622A9E"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (c)—</text> <subparagraph commented="no" id="H474AEFA5FD914B85A3104441DD60B681"><enum>(A)</enum><text>in paragraph (1), by striking <quote>rule</quote> and inserting <quote>rule or order</quote>;</text></subparagraph>
<subparagraph commented="no" id="H7B8C68EBCA344B9C97517B4745C70345"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <clause commented="no" id="HF2636188A7C54E86AD0C7BB07EB55ACF"><enum>(i)</enum><text>in subparagraph (A), by striking <quote>a rule under subsection (a) or for which data is being developed pursuant to such a rule</quote> and inserting <quote>a rule, order, or consent agreement under subsection (a) or for which information is being developed pursuant to such a rule, order, or consent agreement</quote>;</text></clause>
<clause commented="no" id="H642D77EB6C9C41AD9FC926EDB90AC779"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>such rule or which is being developed pursuant to such rule</quote> and inserting <quote>such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement</quote>; and</text></clause> <clause commented="no" id="HCBD8F22FA9F348C5B769279A5C3AF7A6"><enum>(iii)</enum><text>in the matter following subparagraph (B), by striking <quote>the rule</quote> and inserting <quote>the rule or order</quote>;</text></clause></subparagraph>
<subparagraph commented="no" id="H07D451E7A60A4A3BB6F7B91F524D21AA"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3)(B)(i), by striking <quote>rule promulgated</quote> and inserting <quote>rule, order, or consent agreement</quote>; and</text></subparagraph> <subparagraph commented="no" id="H1D786BF5BEF04044B02880C646C0DBD0"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause commented="no" id="H8F726DA4C57D4AB7B35FDD54ED306CE9"><enum>(i)</enum><text>by striking <quote>rule promulgated</quote> each place it appears and inserting <quote>rule, order, or consent agreement</quote>;</text></clause> <clause commented="no" id="H7F1C1E326902451B9882AA1C06072CE0"><enum>(ii)</enum><text>by striking <quote>such rule</quote> each place it appears and inserting <quote>such rule, order, or consent agreement</quote>; and</text></clause>
<clause commented="no" id="H5E2D8A09EED2400480318953EBFD95E9"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>the rule</quote> and inserting <quote>the rule or order</quote>;</text></clause></subparagraph></paragraph> <paragraph commented="no" id="H9A15F8776A2549A2B590BF560D46B868"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d), by striking <quote>rule</quote> and inserting <quote>rule, order, or consent agreement</quote>; and</text></paragraph>
<paragraph commented="no" id="H81F2044697334A8DA32FA6844D2BF063"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (g), by striking <quote>rule</quote> and inserting <quote>rule, order, or consent agreement</quote>.</text></paragraph></subsection> <subsection id="H64F2704D090C4D0F8674132023592C6C"><enum>(e)</enum><header>Section 5</header><text display-inline="yes-display-inline">Section 5 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2604">15 U.S.C. 2604</external-xref>) is amended—</text>
<paragraph id="H1C096AF5228C4B55AC2F33757AE03C98"><enum>(1)</enum><text>in subsection (b)—</text> <subparagraph id="H6718A8FF8F1B44F1AC0D16E3EF63ADC0"><enum>(A)</enum><text>in paragraph (1)(A)—</text>
<clause commented="no" id="H6BE14B17CA3A4757B570E88FAD31E6E3"><enum>(i)</enum><text>by striking <quote>rule promulgated</quote> and inserting <quote>rule, order, or consent agreement</quote>; and</text></clause> <clause id="H0A88900F70D9495D96CD9F81E824BB99"><enum>(ii)</enum><text>by striking <quote>such rule</quote> and inserting <quote>such rule, order, or consent agreement</quote>;</text></clause></subparagraph>
<subparagraph id="HC28CF88A50E34212A2003DA90462949B"><enum>(B)</enum><text>in paragraph (1)(B), by striking <quote>rule promulgated</quote> and inserting <quote>rule or order</quote>; and</text></subparagraph> <subparagraph commented="no" id="HF8C3DD3251A145CB8B050A73AF4A6932"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2)(A)(ii), by striking <quote>rule promulgated</quote> and inserting <quote>rule, order, or consent agreement</quote>; and</text></subparagraph></paragraph>
<paragraph id="HAA6E8BC6074743E981569A54D026EA47"><enum>(2)</enum><text>in subsection (d)(2)(C), by striking <quote>rule</quote> and inserting <quote>rule, order, or consent agreement</quote>.</text></paragraph></subsection> <subsection commented="no" id="H0A987AA7A90144D8975EA3CA9E4DC8DB"><enum>(f)</enum><header>Section 7</header><text display-inline="yes-display-inline">Section 7(a) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2606">15 U.S.C. 2606(a)</external-xref>) is amended—</text>
<paragraph id="H530BE1E791BB491C8AC1CA21AFF304EA"><enum>(1)</enum><text>in paragraph (1), in the matter following subparagraph (C), by striking <quote>a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV</quote> and inserting <quote>a determination under section 5 or 6, a rule under section 4, 5, or 6 or title IV, an order under section 4, 5, or 6 or title IV, or a consent agreement under section 4</quote>; and</text></paragraph> <paragraph id="H49F6802859BF41859B5DCDB0C5A73241"><enum>(2)</enum><text>in paragraph (2), by striking <quote>subsection 6(d)(2)(A)(i)</quote> and inserting <quote>section 6(d)(3)(A)(i)</quote>.</text></paragraph></subsection>
<subsection commented="no" id="HF842452D76BA43E7BF37BC670D5E359A"><enum>(g)</enum><header>Section 8</header><text display-inline="yes-display-inline">Section 8(a) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2607">15 U.S.C. 2607(a)</external-xref>) is amended—</text> <paragraph id="H1862F4C45E4F45AEB7E1C7B0EC2B75C2"><enum>(1)</enum><text>in paragraph (2)(E), by striking <quote>data</quote> and inserting <quote>information</quote>; and </text></paragraph>
<paragraph id="H3B665F7303B24C178FDF41748A3A4099"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (3)(A)(ii)(I), by striking <quote>or an order in effect under section 5(e)</quote> and inserting <quote>, an order in effect under section 4 or 5(e), or a consent agreement under section 4</quote>.</text></paragraph></subsection> <subsection id="HFF28B488BED940D2A37052B858263067"><enum>(h)</enum><header>Section 9</header><text display-inline="yes-display-inline">Section 9 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2608">15 U.S.C. 2608</external-xref>) is amended—</text>
<paragraph id="H519FC68C1F174B77B42141987DC810AD" commented="no"><enum>(1)</enum><text>in subsection (a), by striking <quote>section 6</quote> each place it appears and inserting <quote>section 6(a)</quote>; and</text></paragraph> <paragraph id="H1DCAE5C9069A442C9E7B3167C26C5DCC" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (d), by striking <quote>Health, Education, and Welfare</quote> and inserting <quote>Health and Human Services</quote>.</text></paragraph></subsection>
<subsection id="H30F628E74B0F434BAA3989FDE8BE4BDD" commented="no"><enum>(i)</enum><header>Section 10</header><text>Section 10 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2609">15 U.S.C. 2609</external-xref>) is amended—</text> <paragraph id="HCA1A99DD1EB2423C98E3326913063B99" commented="no"><enum>(1)</enum><text>in the section heading, by striking <quote><header-in-text level="section" style="OLC">data</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">information</header-in-text></quote>;</text></paragraph>
<paragraph id="H535A839464834EB0B772D0ADC4FB810F" commented="no"><enum>(2)</enum><text>by striking <quote>Health, Education, and Welfare</quote> each place it appears and inserting <quote>Health and Human Services</quote>;</text></paragraph> <paragraph id="HB0F87C14DF7D49C38CA0278C9CA52B5F" commented="no"><enum>(3)</enum><text>in subsection (b)—</text>
<subparagraph id="HA63476A6D44448719B1D84EFD254A148" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">Data</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">Information</header-in-text></quote>;</text></subparagraph> <subparagraph id="H13AA2A8D70194014917502A2BDB6F16B" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>data</quote> and inserting <quote>information</quote> in paragraph (1);</text></subparagraph>
<subparagraph id="HF1C803840B5A4AFA8CDBBE3C43FCBE42" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>data</quote> and inserting <quote>information</quote> in paragraph (2)(A); and</text></subparagraph> <subparagraph id="H0307BDAA3E4247AEA4D9777F1DB25DD7" commented="no"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>a data</quote> and inserting <quote>an information</quote> in paragraph (2)(B); and</text></subparagraph></paragraph>
<paragraph id="HB918EB2CAD984F5F881703C085BF2C4E" commented="no"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (g), by striking <quote>data</quote> and inserting <quote>information</quote>.</text></paragraph></subsection> <subsection id="HE607733325F2435F9D37E07A45583626"><enum>(j)</enum><header>Section 11</header><text display-inline="yes-display-inline">Section 11(b)(2) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2610">15 U.S.C. 2610(b)(2)</external-xref>) is amended—</text>
<paragraph id="HE94E24ACB5904236A25BA683ADCAC79A"><enum>(1)</enum><text>by striking <quote>data</quote> each place it appears and inserting <quote>information</quote>; and</text></paragraph> <paragraph id="HDF3F38D670C446228ED2C67D75575DEA"><enum>(2)</enum><text>in subparagraph (E), by striking <quote>rule promulgated</quote> and inserting <quote>rule promulgated, order issued, or consent agreement entered into</quote>.</text></paragraph></subsection>
<subsection id="HD1DF9950026F439AB24AAD5E2004D7E1"><enum>(k)</enum><header>Section 12</header><text display-inline="yes-display-inline">Section 12(b)(1) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2611">15 U.S.C. 2611(b)(1)</external-xref>) is amended by striking <quote>data</quote> both places it appears and inserting <quote>information</quote>.</text></subsection> <subsection commented="no" id="HD2695AA6A19343B58F6291B7CDC572EF"><enum>(l)</enum><header>Section 15</header><text display-inline="yes-display-inline">Section 15(1) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2614">15 U.S.C. 2614(1)</external-xref>) is amended by striking <quote>(A) any rule</quote> and all that follows through <quote>or (D)</quote> and inserting <quote>any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or</quote>. </text></subsection>
<subsection commented="no" id="HF924B57F1A894147A1C6AA91B4569C77" display-inline="no-display-inline"><enum>(m)</enum><header>Section 19</header><text display-inline="yes-display-inline">Section 19 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2618">15 U.S.C. 2618</external-xref>) is amended—</text> <paragraph commented="no" id="HD4459FA4BDAF48BDAA10778B870BC172"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph commented="no" id="H601695D7EDD94D8FAE317B4743346471"><enum>(A)</enum><text>in paragraph (1)(A)—</text> <clause id="H4EBD4E543F894323B102BC22CDD92CE3"><enum>(i)</enum><text>by striking <quote>Not later than 60 days after the date of the promulgation of a rule under section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV</quote> and inserting <quote>Except as otherwise provided in this title, not later than 60 days after the date on which a rule is promulgated under this title, title II, or title IV, or the date on which an order is issued under section 4, 5(e), 5(f), or 6(i)(1),</quote>;</text></clause>
<clause id="HD16C8BE287224DBBA38BACFBD5883C03"><enum>(ii)</enum><text>by striking <quote>such rule</quote> and inserting <quote>such rule or order</quote>; and</text></clause> <clause id="HA572802385714FD1928EDF4F650AF485"><enum>(iii)</enum><text>by striking <quote>such a rule</quote> and inserting <quote>such a rule or order</quote>;</text></clause></subparagraph>
<subparagraph commented="no" id="H795798624CE9458A8AA03FE81B362967"><enum>(B)</enum><text>in paragraph (1)(B)—</text> <clause id="H99CAF82F308347258FE4EC2BEEB4E5C8" commented="no"><enum>(i)</enum><text>by striking <quote>Courts</quote> and inserting <quote>Except as otherwise provided in this title, courts</quote>; and</text></clause>
<clause id="H493BB4B27F814B119A08E9ADEC3D11F5" commented="no"><enum>(ii)</enum><text>by striking <quote>subparagraph (A) or (B) of section 6(b)(1)</quote> and inserting <quote>this title, other than an order under section 4, 5(e), 5(f), or 6(i)(1),</quote>; and</text></clause></subparagraph> <subparagraph commented="no" id="H94AC90D2ECB04D0BACEC93FAF1AACA27"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause id="H27C63DE416114BA7AAA4C25D3E830BBC"><enum>(i)</enum><text>by striking <quote>rulemaking record</quote> and inserting <quote>record</quote>; and</text></clause> <clause id="H05710736AF534FAD9CAD31A6E728D994"><enum>(ii)</enum><text>by striking <quote>based the rule</quote> and inserting <quote>based the rule or order</quote>;</text></clause></subparagraph></paragraph>
<paragraph commented="no" id="HDC2A9236C3194724B6E58E112FD35EBC"><enum>(2)</enum><text>in subsection (b)—</text> <subparagraph commented="no" id="H5FCEF92225064CB18D4C851BA58364AE"><enum>(A)</enum><text>by striking <quote>review a rule</quote> and inserting <quote>review a rule, or an order under section 4, 5(e), 5(f), or 6(i)(1),</quote>;</text></subparagraph>
<subparagraph commented="no" id="HB1A36369825D4E168E9918102BC4F8C9"><enum>(B)</enum><text>by striking <quote>such rule</quote> and inserting <quote>such rule or order</quote>;</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HD5D16C872B2545F6BF99BA16CFFDF793"><enum>(C)</enum><text>by striking <quote>the rule</quote> and inserting <quote>the rule or order</quote>;</text></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="H0EFA0C27488C43C0AA9341923508D8DD"><enum>(D)</enum><text>by striking <quote>new rule</quote> each place it appears and inserting <quote>new rule or order</quote>; and</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H61F84AB641984EF290980688ED20DAE4"><enum>(E)</enum><text>by striking <quote>modified rule</quote> and inserting <quote>modified rule or order</quote>; and</text></subparagraph></paragraph>
<paragraph commented="no" id="H8C4E62C63B8D46FF9FB2137ED618F088"><enum>(3)</enum><text>in subsection (c)—</text> <subparagraph commented="no" id="HAA6062B97A3D474A8A5C160F392B03B9"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause commented="no" id="H508D6E71C5BE485395022235D441C9D7"><enum>(i)</enum><text>in subparagraph (A)—</text> <subclause id="H12D005B9ED8547C9B41AA98BAC34BA93"><enum>(I)</enum><text>by striking <quote>a rule</quote> and inserting <quote>a rule or order</quote>; and</text></subclause>
<subclause id="H03FFEDE724D3461A8A0439A64CE22799"><enum>(II)</enum><text>by striking <quote>such rule</quote> and inserting <quote>such rule or order</quote>; </text></subclause></clause> <clause commented="no" id="HA71BA31C75D0488993941613E237CB91"><enum>(ii)</enum><text>in subparagraph (B)—</text>
<subclause commented="no" id="H13994CC639B44B949AFE42366C666225"><enum>(I)</enum><text>in the matter preceding clause (i), by striking <quote>a rule</quote> and inserting <quote>a rule or order</quote>;</text></subclause> <subclause id="H0E020F4D711E47D3BA76317D5009E3CF" commented="no"><enum>(II)</enum><text>by amending clause (i) to read as follows:</text>
<quoted-block style="OLC" id="HA73BAA30375443488C578209AA60C9BB" display-inline="no-display-inline">
<clause id="H0790EE1185C140008278E2FEA13D4A16" commented="no" indent="up2"><enum>(i)</enum><text>in the case of review of—</text> <subclause id="HFCC9209E97FF447EA313ED3759F989F6" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">a rule under section 4(a), 5(b)(4), 6(a) (including review of the associated determination under section 6(b)(4)(A)), or 6(e), the standard for review prescribed by paragraph (2)(E) of such section 706 shall not apply and the court shall hold unlawful and set aside such rule if the court finds that the rule is not supported by substantial evidence in the rulemaking record taken as a whole; and</text></subclause>
<subclause id="HF6D7E97D716A423F9EF20985830F74F9" commented="no"><enum>(II)</enum><text display-inline="yes-display-inline">an order under section 4, 5(e), 5(f), or 6(i)(1), the standard for review prescribed by paragraph (2)(E) of such section 706 shall not apply and the court shall hold unlawful and set aside such order if the court finds that the order is not supported by substantial evidence in the record taken as a whole; and</text></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause> <subclause id="HA788CF95BDF4470B8B8B2B852AF6A452"><enum>(III)</enum><text>by striking clauses (ii) and (iii) and the matter after clause (iii) and inserting the following:</text>
<quoted-block style="OLC" id="H7ED77500B5B340B1AE907C7F5554E503" display-inline="no-display-inline">
<clause id="H2F016EC5230247FFBA6D0BF0AFD18FBD" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">the court may not review the contents and adequacy of any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule or order, except as part of the record, taken as a whole.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause> <clause id="H142A4A875D084BDBA60C719E0F9899C0" commented="no"><enum>(iii)</enum><text>by striking subparagraph (C); and</text></clause></subparagraph>
<subparagraph commented="no" id="H81435679634E4DE8A3824A9DDE4D7E12"><enum>(B)</enum><text>in paragraph (2), by striking <quote>any rule</quote> and inserting <quote>any rule or order</quote>.</text></subparagraph></paragraph></subsection> <subsection commented="no" id="H6E835981A6D14A6383B9F3933A85E78C"><enum>(n)</enum><header>Section 20</header><text display-inline="yes-display-inline">Section 20(a)(1) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2619">15 U.S.C. 2619(a)(1)</external-xref>) is amended by striking <quote>order issued under section 5</quote> and inserting <quote>order issued under section 4 or 5</quote>.</text></subsection>
<subsection commented="no" id="HF4422EC0A17B44BB8962677197BEE277"><enum>(o)</enum><header>Section 21</header><text display-inline="yes-display-inline">Section 21 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2620">15 U.S.C. 2620</external-xref>) is amended—</text> <paragraph commented="no" id="HC73E40BA61C941598E7ED8B0E344500E"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a), by striking <quote>order under section 5(e) or (6)(b)(2)</quote> and inserting <quote>order under section 4 or 5(e) or (f)</quote>; and</text></paragraph>
<paragraph commented="no" id="H7C50BCE4E28545BCAAFEA2A0DFE23AEB"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text> <subparagraph commented="no" id="H71980906F5924DA4B617CCE76F8D76B5"><enum>(A)</enum><text>in paragraph (1), by striking <quote>order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)</quote> and inserting <quote>order under section 4 or 5(e) or (f)</quote>; and</text></subparagraph>
<subparagraph commented="no" id="H56D0ED3E4ADA446D916DE33603C24E37"><enum>(B)</enum><text>in paragraph (4)(B)—</text> <clause commented="no" id="H22083D40B3864503A3E0FF4008CFE6B9"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i), by striking <quote>order under section 5(e) or 6(b)(2)</quote> and inserting <quote>order under section 4 or 5(e) or (f)</quote>;</text></clause>
<clause commented="no" id="H311C6DBB47894755BB533162C589AB0C"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (i), by striking <quote>order under section 5(e)</quote> and inserting <quote>order under section 4 or 5(e)</quote>; and</text></clause> <clause id="H09D5AF48D1C94A3DA389D3579E3169D7"><enum>(iii)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>section 6 or 8 or an order under section 6(b)(2), there is a reasonable basis to conclude that the issuance of such a rule or order is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment</quote> and inserting <quote>section 6(a) or 8 or an order under section 5(f), the chemical substance or mixture to be subject to such rule or order presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use</quote>. </text></clause> </subparagraph></paragraph></subsection>
<subsection id="HE4BB55CA46324030854CAE7EC0083C12"><enum>(p)</enum><header>Section 24</header><text display-inline="yes-display-inline">Section 24(b)(2)(B) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2623">15 U.S.C. 2623(b)(2)(B)</external-xref>) is amended—</text> <paragraph id="HE32BE033C90741B4BDAFC1ACD5673665"><enum>(1)</enum><text>by inserting <quote>and</quote> at the end of clause (i);</text></paragraph>
<paragraph id="HCA69F79C8AA340DB9FA2EE1DC2288C34"><enum>(2)</enum><text>by striking clause (ii); and</text></paragraph> <paragraph id="H9DF1FF48F3B24FCDA05158CDA3A5A38E"><enum>(3)</enum><text>by redesignating clause (iii) as clause (ii).</text></paragraph></subsection>
<subsection id="HFB14ED0BC62E451FA015EB43F4A2D578" commented="no"><enum>(q)</enum><header>Section 26</header><text>Section 26 of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2625">15 U.S.C. 2625</external-xref>) is amended—</text> <paragraph id="H6686C61CF95A4040A4834DE46EFDA802" commented="no"><enum>(1)</enum><text>in subsection (e), by striking <quote>Health, Education, and Welfare</quote> each place it appears and inserting <quote>Health and Human Services</quote>; and</text></paragraph>
<paragraph id="H9E70547899664AC3B6B8A5FE8A097BD9" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (g)(1), by striking <quote>data</quote> and inserting <quote>information</quote>.</text></paragraph></subsection> <subsection commented="no" id="HC791AB09B131469C8E65E0DED9730C91"><enum>(r)</enum><header>Section 27</header><text display-inline="yes-display-inline">Section 27(a) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2626">15 U.S.C. 2626(a)</external-xref>) is amended—</text>
<paragraph id="H1D40212FEB314102BE59DE6CC72E2176" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>Health, Education, and Welfare</quote> and inserting <quote>Health and Human Services</quote>;</text></paragraph> <paragraph id="H391C9B87F3F940E9BCAA87F9D15E200A"><enum>(2)</enum><text>by striking <quote>test data</quote> both places it appears and inserting <quote>information</quote>; </text></paragraph>
<paragraph id="H7527D54C705542B0B7F4886B1016D1B2"><enum>(3)</enum><text>by striking <quote>rules promulgated</quote> and inserting <quote>rules, orders, or consent agreements</quote>; and</text></paragraph> <paragraph id="H57AFC2768E98465DBAAC21EF4913D759" commented="no"><enum>(4)</enum><text>by striking <quote>standards</quote> and inserting <quote>protocols and methodologies</quote>.</text></paragraph></subsection>
<subsection commented="no" id="H58EE48F088374BBA853F35722F38B6DD"><enum>(s)</enum><header>Section 30</header><text display-inline="yes-display-inline">Section 30(2) of the Toxic Substances Control Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2629">15 U.S.C. 2629(2)</external-xref>) is amended by striking <quote>rule</quote> and inserting <quote>rule, order, or consent agreement</quote>.</text></subsection></section> <section id="H0D5B5C5036714FDFA00C719D57644F32" section-type="subsequent-section" commented="no"><enum>20.</enum><header>No retroactivity</header><text display-inline="no-display-inline">Nothing in sections 1 through 19, or the amendments made by sections 1 through 19, shall be interpreted to apply retroactively to any State, Federal, or maritime legal action filed before the date of enactment of this Act.</text></section>
<section id="H4270F4541C5F4E8FBC1DEA2FE75B94C2" section-type="subsequent-section"><enum>21.</enum><header>Trevor’s Law</header>
<subsection id="H7C31764095B940A7928AC94360120626" commented="no"><enum>(a)</enum><header>Purposes</header><text>The purposes of this section are—</text> <paragraph id="HF4FD94A075F744A89C7F7D624AE79002" commented="no"><enum>(1)</enum><text>to provide the appropriate Federal agencies with the authority to help conduct investigations into potential cancer clusters;</text></paragraph>
<paragraph id="HCEF5565CAF30463E8AB81DA2FF78B4AD" commented="no"><enum>(2)</enum><text>to ensure that Federal agencies have the authority to undertake actions to help address cancer clusters and factors that may contribute to the creation of potential cancer clusters; and</text></paragraph> <paragraph id="H1DD8C11B00064C75B90F802C2A991F27" commented="no"><enum>(3)</enum><text>to enable Federal agencies to coordinate with other Federal, State, and local agencies, institutes of higher education, and the public in investigating and addressing cancer clusters.</text></paragraph></subsection>
<subsection id="H1A0E779C9E67435F9D5358E192FEFED5"><enum>(b)</enum><header>Designation and investigation of potential cancer clusters</header><text>Part P of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g">42 U.S.C. 280g et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block id="H3BFDE60DE9114645A5ECAD16006B3549" style="OLC"> <section id="HB7A4CC2ED61945A9BEC557B515276EE9"><enum>399V–6.</enum><header>Designation and investigation of potential cancer clusters</header> <subsection id="H0C3D8EE7F7E141DE9E7BA67E32F13729"><enum>(a)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H6B47F67664734B23BAB1E9C34783324D"><enum>(1)</enum><header>Cancer cluster</header><text>The term <term>cancer cluster</term> means the incidence of a particular cancer within a population group, a geographical area, and a period of time that is greater than expected for such group, area, and period.</text></paragraph> <paragraph id="H463DA743885A42579FD8D9DABD3B968B"><enum>(2)</enum><header>Particular cancer</header><text>The term <term>particular cancer</term> means one specific type of cancer or a type of cancers scientifically proven to have the same cause.</text></paragraph>
<paragraph id="H56A90E842DE6458B80FCED02308E8EFF"><enum>(3)</enum><header>Population group</header><text>The term <term>population group</term> means a group, for purposes of calculating cancer rates, defined by factors such as race, ethnicity, age, or gender.</text></paragraph></subsection> <subsection id="HAC7C5889C6CD4991AF696543ECA23636"><enum>(b)</enum><header>Criteria for designation of potential cancer clusters</header> <paragraph id="HB0EA065BF0DD4255910177C66ABC228C"><enum>(1)</enum><header>Development of criteria</header><text>The Secretary shall develop criteria for the designation of potential cancer clusters.</text></paragraph>
<paragraph id="H1194EBB9AC7D4585A1F39E8E3DEA4E3C"><enum>(2)</enum><header>Requirements</header><text>The criteria developed under paragraph (1) shall consider, as appropriate—</text> <subparagraph id="H8E4DA6D5BA544FEF945474F61264EBFB"><enum>(A)</enum><text>a standard for cancer cluster identification and reporting protocols used to determine when cancer incidence is greater than would be typically observed;</text></subparagraph>
<subparagraph id="H01D3C89CB9064FE4AEE939E79D2E0B30"><enum>(B)</enum><text>scientific screening standards that ensure that a cluster of a particular cancer involves the same type of cancer, or types of cancers;</text></subparagraph> <subparagraph id="H128A1A553ADC408EA072B2069E9F9460"><enum>(C)</enum><text>the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age, and gender, for purposes of calculating cancer rates;</text></subparagraph>
<subparagraph id="H884004E6E3834D878F50BA53FDBD3D7E"><enum>(D)</enum><text>the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create or obscure a potential cluster by selection of a specific area; and</text></subparagraph> <subparagraph id="HBDA4A5FF76BB4E7DA3ED476310B80A02"><enum>(E)</enum><text>the time period over which the number of cases of a particular cancer, or the calculation of an expected number of cases, occurs.</text></subparagraph></paragraph></subsection>
<subsection id="HF44B739BAD3446D1A8746BA9CE6C314A"><enum>(c)</enum><header>Guidelines for investigation of potential cancer clusters</header><text>The Secretary, in consultation with the Council of State and Territorial Epidemiologists and representatives of State and local health departments, shall develop, publish, and periodically update guidelines for investigating potential cancer clusters. The guidelines shall—</text> <paragraph id="H4D4DABB33984430F8620357C450BD792"><enum>(1)</enum><text>recommend that investigations of cancer clusters—</text>
<subparagraph id="HE3BD297846404BC3B6DD2B7C0435E124"><enum>(A)</enum><text>use the criteria developed under subsection (b);</text></subparagraph> <subparagraph id="H8AB5C9C63395476F9E521E4EF0821BC0"><enum>(B)</enum><text>use the best available science; and</text></subparagraph>
<subparagraph id="H760A018471B7422081BEC5C65B972B68"><enum>(C)</enum><text>rely on a weight of the scientific evidence;</text></subparagraph></paragraph> <paragraph id="H68E3871852AF4A4591937F86B5D2C3B1"><enum>(2)</enum><text>provide standardized methods of reviewing and categorizing data, including from health surveillance systems and reports of potential cancer clusters; and</text></paragraph>
<paragraph id="HA24CB2E67D2B45009AF884183F0B204A"><enum>(3)</enum><text>provide guidance for using appropriate epidemiological and other approaches for investigations.</text></paragraph></subsection> <subsection id="H15567F83FB794661A99CC06365E0E280"><enum>(d)</enum><header>Investigation of cancer clusters</header> <paragraph id="HE28A02EC7C5C4B72AACD72397AC84D33"><enum>(1)</enum><header>Secretary discretion</header><text>The Secretary—</text>
<subparagraph id="H028628E223364615AB5142CA077DFC49"><enum>(A)</enum><text>in consultation with representatives of the relevant State and local health departments, shall consider whether it is appropriate to conduct an investigation of a potential cancer cluster; and</text></subparagraph> <subparagraph id="H17B057FCE66E4E2E91CE4134EC6DD842"><enum>(B)</enum><text>in conducting investigations shall have the discretion to prioritize certain potential cancer clusters, based on the availability of resources.</text></subparagraph></paragraph>
<paragraph id="HC6FAB2AD319B468DA852C105C4BF1FAA"><enum>(2)</enum><header>Coordination</header><text>In investigating potential cancer clusters, the Secretary shall coordinate with agencies within the Department of Health and Human Services and other Federal agencies, such as the Environmental Protection Agency.</text></paragraph> <paragraph id="H6250A5E04AF7495E9AF381CABD7BB61E"><enum>(3)</enum><header>Biomonitoring</header><text>In investigating potential cancer clusters, the Secretary shall rely on all appropriate biomonitoring information collected under other Federal programs, such as the National Health and Nutrition Examination Survey. The Secretary may provide technical assistance for relevant biomonitoring studies of other Federal agencies.</text></paragraph></subsection>
<subsection id="HD7CAD9CBDA4F42FA95E1711604AF6D31"><enum>(e)</enum><header>Duties</header><text>The Secretary shall—</text> <paragraph id="HAE3E8362B8CB4F8080BA402D29CC7C03"><enum>(1)</enum><text>ensure that appropriate staff of agencies within the Department of Health and Human Services are prepared to provide timely assistance, to the extent practicable, upon receiving a request to investigate a potential cancer cluster from a State or local health authority;</text></paragraph>
<paragraph id="H9B9415753F8146A1B48A1FC5A3775D36"><enum>(2)</enum><text>maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer surveillance, exposure assessment, pediatric health, pollution control, community outreach, health education, laboratory sampling and analysis, spatial mapping, and informatics;</text></paragraph> <paragraph id="H7D71E33AA0594793BE5F61F8EFB295B2"><enum>(3)</enum><text>consult with community members as investigations into potential cancer clusters are conducted, as the Secretary determines appropriate;</text></paragraph>
<paragraph id="H01DAD136E78F43228596F26A25C401F7"><enum>(4)</enum><text>collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes of such clusters, and the actions taken to address such clusters; and</text></paragraph> <paragraph id="HF2CDF231D77444C9BA19C4DE5B385431"><enum>(5)</enum><text>provide technical assistance for investigating cancer clusters to State and local health departments through existing programs, such as the Epi-Aids program of the Centers for Disease Control and Prevention and the Assessments of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<enum>II</enum><header>Rural Healthcare Connectivity</header>
<section id="HF3F80C7E23AF4AC4B5229F2EEA038A5F"><enum>201.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Rural Healthcare Connectivity Act of 2016</quote>. </text></section> <section id="HBACF64738BCE43F78E39AFA3D2A24EDC" section-type="subsequent-section"><enum>202.</enum><header>Telecommunications services for skilled nursing facilities</header> <subsection id="HB91995C0B9EE47BBABA7F813B109952B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 254(h)(7)(B) of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/254">47 U.S.C. 254(h)(7)(B)</external-xref>) is amended—</text>
<paragraph id="HDCE87C8D18B144C3B6C6BB3354E86568"><enum>(1)</enum><text>in clause (vi), by striking <quote>and</quote> at the end;</text></paragraph> <paragraph id="H28C35AD790664C4381000FAC0C963160"><enum>(2)</enum><text>by redesignating clause (vii) as clause (viii);</text></paragraph>
<paragraph id="H10F21169B6BD4512A35D6FA5BEDF6209"><enum>(3)</enum><text>by inserting after clause (vi) the following:</text> <quoted-block display-inline="no-display-inline" id="H95D230584162475DB94AEB60B5F107D9" style="OLC"> <clause id="H2D90D55C21964A00B80C8593746ABDBB"><enum>(vii)</enum><text display-inline="yes-display-inline">skilled nursing facilities (as defined in section 1819(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395i-3">42 U.S.C. 1395i–3(a)</external-xref>)); and</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="H5305622E810843D881F10CAEE6C28BC9"><enum>(4)</enum><text>in clause (viii), as redesignated, by striking <quote>clauses (i) through (vi)</quote> and inserting <quote>clauses (i) through (vii)</quote>.</text></paragraph></subsection> <subsection id="HF58418025FAC46F5B84EB7D20ECD0A46"><enum>(b)</enum><header>Savings clause</header><text>Nothing in subsection (a) shall be construed to affect the aggregate annual cap on Federal universal service support for health care providers under section 54.675 of title 47, Code of Federal Regulations, or any successor regulation.</text></subsection>
<subsection id="HA6DC7D4300C947129CA47F9ECB4DB6E4"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by subsection (a) shall apply beginning on the date that is 180 days after the date of the enactment of this Act.</text></subsection></section> Karen L. HaasClerk.