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[114th Congress Public Law 182]
[From the U.S. Government Publishing Office]

[[Page 447]]

      FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 21ST CENTURY ACT

[[Page 130 STAT. 448]]

Public Law 114-182
114th Congress

                                 An Act

 
      To modernize the Toxic Substances Control Act, and for other 
            purposes. <<NOTE: June 22, 2016 -  [H.R. 2576]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Frank R. 
Lautenberg Chemical Safety for the 21st Century Act. 15 USC 2601 
note.>> 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Frank R. Lautenberg 
Chemical Safety for the 21st Century Act''.
    (b) Table of Contents.--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.

                        TITLE I--CHEMICAL SAFETY

SEC. 2. FINDINGS, POLICY, AND INTENT.

    Section 2(c) of the Toxic Substances Control Act (15 U.S.C. 2601(c)) 
is amended by striking ``proposes to take'' and inserting ``proposes as 
provided''.
SEC. 3. DEFINITIONS.

    Section 3 of the Toxic Substances Control Act (15 U.S.C. 2602) is 
amended--

[[Page 130 STAT. 449]]

            (1) by redesignating paragraphs (4) through (14) as 
        paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), 
        (16), and (17), respectively;
            (2) by inserting after paragraph (3) the following:

    ``(4) The term `conditions of use' 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.'';
            (3) by inserting after paragraph (6), as so redesignated, 
        the following:

    ``(7) The term `guidance' means any significant written guidance of 
general applicability prepared by the Administrator.''; and
            (4) by inserting after paragraph (11), as so redesignated, 
        the following:

    ``(12) The term `potentially exposed or susceptible subpopulation' 
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.''.
SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.

    Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is 
amended--
            (1) by striking ``standards'' each place it appears and 
        inserting ``protocols and methodologies'';
            (2) in subsection (a)--
                    (A) by striking ``If the Administrator finds'' and 
                inserting ``(1) If the Administrator finds'';
                    (B) in paragraph (1), as so designated--
                          (i) by striking ``(1)(A)(i)'' and inserting 
                      ``(A)(i)(I)'';
                          (ii) by striking ``(ii)'' each place it 
                      appears and inserting ``(II)'';
                          (iii) by striking ``are insufficient data'' 
                      and inserting ``is insufficient information'' each 
                      place it appears;
                          (iv) by striking ``(iii)'' each place it 
                      appears and inserting ``(III)'';
                          (v) by striking ``such data'' and inserting 
                      ``such information'' each place it appears;
                          (vi) by striking ``(B)(i)'' and inserting 
                      ``(ii)(I)'';
                          (vii) by striking ``(I)'' and inserting 
                      ``(aa)'';
                          (viii) by striking ``(II)'' and inserting 
                      ``(bb)'';
                          (ix) by striking ``(2)'' and inserting 
                      ``(B)''; and
                          (x) in the matter following subparagraph (B), 
                      as so redesignated--
                                    (I) by inserting ``, or, in the case 
                                of a chemical substance or mixture 
                                described in subparagraph (A)(i), by 
                                rule, order, or consent agreement,'' 
                                after ``rule'';
                                    (II) by striking ``data'' each place 
                                it appears and inserting 
                                ``information''; and
                                    (III) by striking ``and which are 
                                relevant'' and inserting ``and which is 
                                relevant''; and
                    (C) by adding at the end the following:

[[Page 130 STAT. 450]]

            ``(2) <<NOTE: Determination.>>  Additional testing 
        authority.--In addition to the authority provided under 
        paragraph (1), the Administrator may, by rule, order, or consent 
        agreement--
                    ``(A) require the development of new information 
                relating to a chemical substance or mixture if the 
                Administrator determines that the information is 
                necessary--
                          ``(i) <<NOTE: Review. Notice. Evaluation.>>  
                      to review a notice under section 5 or to perform a 
                      risk evaluation under section 6(b);
                          ``(ii) 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);
                          ``(iii) 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
                          ``(iv) pursuant to section 12(a)(2); and
                    ``(B) 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--
                          ``(i) <<NOTE: Deadline.>>  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
                          ``(ii) 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.
            ``(3) Statement of need.--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.
            ``(4) Tiered testing.--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.'';
            (3) in subsection (b)--
                    (A) in paragraph (1)--
                          (i) in subparagraph (B), by striking ``test 
                      data'' and inserting ``information'';
                          (ii) in subparagraph (C), by striking ``data'' 
                      and inserting ``information''; and

[[Page 130 STAT. 451]]

                          (iii) in the matter following subparagraph 
                      (C), by striking ``data'' and inserting 
                      ``information'';
                    (B) in paragraph (2)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``test data'' and 
                                inserting ``information'';
                                    (II) by inserting ``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.'' after the first sentence; 
                                and
                                    (III) by striking ``hierarchical 
                                tests'' and inserting ``tiered 
                                testing''; and
                          (ii) in subparagraph (B), by striking ``data'' 
                      and inserting ``information'';
                    (C) in paragraph (3)--
                          (i) by striking ``data'' each place it appears 
                      and inserting ``information'';
                          (ii) in subparagraph (A), by inserting ``or 
                      (C), as applicable,'' after ``subparagraph (B)'';
                          (iii) by striking ``(a)(1)(A)(ii) or 
                      (a)(1)(B)(ii)'' each place it appears in 
                      subparagraph (B) and inserting ``(a)(1)(A)(i)(II) 
                      or (a)(1)(A)(ii)(II)'';
                          (iv) in subparagraph (B), in the matter before 
                      clause (i), by striking ``subsection (a)'' and 
                      inserting ``subsection (a)(1)''; and
                          (v) by adding at the end the following:

    ``(C) 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.'';
                    (D) in paragraph (4)--
                          (i) by striking ``of data'' each place it 
                      appears and inserting ``of information''; and
                          (ii) by striking ``test data'' each place it 
                      appears and inserting ``information''; and
                    (E) by striking paragraph (5);
            (4) in subsection (c)--
                    (A) in paragraph (1), by striking ``data'' and 
                inserting ``information'';
                    (B) in paragraph (2), by striking ``data'' each 
                place it appears and inserting ``information'';
                    (C) in paragraph (3)--
                          (i) by striking ``test data'' each place it 
                      appears and inserting ``information''; and
                          (ii) by striking ``such data'' each place it 
                      appears and inserting ``such information''; and
                    (D) in paragraph (4) by striking ``test data'' each 
                place it appears and inserting ``information'';
            (5) in subsection (d)--
                    (A) by striking ``test data'' each place it appears 
                and inserting ``information'';
                    (B) by striking ``such data'' each place it appears 
                and inserting ``such information''; and
                    (C) by striking ``for which data have'' and 
                inserting ``for which information has'';

[[Page 130 STAT. 452]]

            (6) in subsection (e)--
                    (A) in paragraph (1)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``promulgation of a 
                                rule'' and inserting ``development of 
                                information''; and
                                    (II) by striking ``data'' each place 
                                it appears and inserting 
                                ``information''; and
                          (ii) <<NOTE: Federal Register, publication.>>  
                      in subparagraph (B), by striking ``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'' and insert ``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''; and
                    (B) in paragraph (2)(A)--
                          (i) by striking ``eight members'' and 
                      inserting ``ten members''; and
                          (ii) by adding at the end the following:
            ``(ix) One member appointed by the Chairman of the Consumer 
        Product Safety Commission from Commissioners or employees of the 
        Commission.
            ``(x) One member appointed by the Commissioner of Food and 
        Drugs from employees of the Food and Drug Administration.'';
            (7) in subsection (f)--
                    (A) in paragraph (1), by striking ``test data'' and 
                inserting ``information''; and
                    (B) in the matter following paragraph (2)--
                          (i) by striking ``or will present'';
                          (ii) by striking ``from cancer, gene 
                      mutations, or birth defects'';
                          (iii) by striking ``data or'';
                          (iv) by striking ``appropriate'' and inserting 
                      ``applicable''; and
                          (v) by inserting ``, made without 
                      consideration of costs or other nonrisk factors,'' 
                      after ``publish in the Federal Register a 
                      finding'';
            (8) in subsection (g)--
                    (A) by amending the subsection heading to read as 
                follows: ``Petition for Protocols and Methodologies for 
                the Development of Information'';
                    (B) by striking ``test data'' each place it appears 
                and inserting ``information''; and
                    (C) by striking ``submit data'' and inserting 
                ``submit information''; and
            (9) by adding at the end the following:

    ``(h) Reduction of Testing on Vertebrates.--
            ``(1) In general.--The Administrator shall reduce and 
        replace, to the extent practicable, scientifically justified, 
        and consistent with the policies of this title, the use of 
        vertebrate

[[Page 130 STAT. 453]]

        animals in the testing of chemical substances or mixtures under 
        this title by--
                    ``(A) 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--
                          ``(i) toxicity information;
                          ``(ii) computational toxicology and 
                      bioinformatics; and
                          ``(iii) high-throughput screening methods and 
                      the prediction models of those methods; and
                    ``(B) encouraging and facilitating--
                          ``(i) 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;
                          ``(ii) 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
                          ``(iii) 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.
            ``(2) Implementation of alternative testing methods.--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--
                    ``(A) <<NOTE: Deadline. Strategic plan.>>  not later 
                than 2 years after the date of enactment of the Frank R. 
                Lautenberg Chemical Safety for the 21st Century Act, 
                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--
                          ``(i) computational toxicology and 
                      bioinformatics;
                          ``(ii) high-throughput screening methods;
                          ``(iii) testing of categories of chemical 
                      substances;
                          ``(iv) tiered testing methods;
                          ``(v) in vitro studies;
                          ``(vi) systems biology;
                          ``(vii) 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
                          ``(viii) industry consortia that develop 
                      information submitted under this title;
                    ``(B) as practicable, ensure that the strategic plan 
                developed under subparagraph (A) is reflected in the 
                development of requirements for testing under this 
                section;

[[Page 130 STAT. 454]]

                    ``(C) <<NOTE: List.>>  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;
                    ``(D) <<NOTE: Public information.>>  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);
                    ``(E) <<NOTE: Effective date. Deadlines. Reports.>>  
                beginning on the date that is 5 years after the date of 
                enactment of the Frank R. Lautenberg Chemical Safety for 
                the 21st Century Act, 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
                    ``(F) <<NOTE: Assessment.>>  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.
            ``(3) Voluntary testing.--
                    ``(A) In general.--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.
                    ``(B) Effect of paragraph.--Nothing in this 
                paragraph shall, under any circumstance, limit or 
                restrict the submission of any existing information to 
                the Administrator.
                    ``(C) Relationship to other law.--A violation of 
                this paragraph shall not be a prohibited act under 
                section 15.
                    ``(D) Review of means.--This paragraph authorizes, 
                but does not require, the Administrator to review the 
                means by which a person conducted testing described in 
                subparagraph (A).''.
SEC. 5. MANUFACTURING AND PROCESSING NOTICES.

    Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is 
amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--

[[Page 130 STAT. 455]]

                          (i) by striking ``Except as provided in'' and 
                      inserting ``(A) Except as provided in subparagraph 
                      (B) of this paragraph and'';
                          (ii) by redesignating subparagraphs (A) and 
                      (B) as clauses (i) and (ii), respectively;
                          (iii) by striking all that follows 
                      ``significant new use'' and inserting a period; 
                      and
                          (iv) by adding at the end the following:
            ``(B) A person may take the actions described in 
        subparagraph (A) if--
                    ``(i) <<NOTE: Deadline.>>  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
                    ``(ii) the Administrator--
                          ``(I) <<NOTE: Review.>>  conducts a review of 
                      the notice; and
                          ``(II) <<NOTE: Determination.>>  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.''; and
                    (B) by adding at the end the following new 
                paragraphs:
            ``(3) Review and determination.--Within the applicable 
        review period, subject to section 18, the Administrator shall 
        review such notice and determine--
                    ``(A) 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);
                    ``(B) that--
                          ``(i) 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
                          ``(ii)(I) 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
                          ``(II) 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,

[[Page 130 STAT. 456]]

                in which case the Administrator shall take the actions 
                required under subsection (e); or
                    ``(C) 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.
            ``(4) Failure to render determination.--
                    ``(A) <<NOTE: Refund.>>  Failure to render 
                determination.--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.
                    ``(B) Limitations.--(i) 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.
                    ``(ii) A failure of the Administrator to render a 
                decision shall not be deemed to constitute a withdrawal 
                of the notice.
                    ``(iii) Nothing in this paragraph shall be construed 
                as relieving the Administrator or the submitter of the 
                notice from any requirement of this section.
            ``(5) Article consideration.--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.'';
            (2) in subsection (b)--
                    (A) in the subsection heading, by striking ``Test 
                Data'' and inserting ``Information'';
                    (B) in paragraph (1)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``test data'' and 
                                inserting ``information''; and
                                    (II) by striking ``such data'' and 
                                inserting ``such information''; and
                          (ii) in subparagraph (B)--
                                    (I) by striking ``test data'' and 
                                inserting ``information'';
                                    (II) by striking ``subsection 
                                (a)(1)(A)'' and inserting ``subsection 
                                (a)(1)(A)(i)''; and

[[Page 130 STAT. 457]]

                                    (III) by striking ``subsection 
                                (a)(1)(B)'' and inserting ``subsection 
                                (a)(1)(A)(ii)'';
                    (C) in paragraph (2)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``test data'' in 
                                clause (ii) and inserting 
                                ``information'';
                                    (II) by striking ``shall'' and 
                                inserting ``may''; and
                                    (III) by striking ``data 
                                prescribed'' and inserting ``information 
                                prescribed''; and
                          (ii) in subparagraph (B)--
                                    (I) by striking ``Data'' and 
                                inserting ``Information'';
                                    (II) by striking ``data'' both 
                                places it appears and inserting 
                                ``information'';
                                    (III) by striking ``show'' and 
                                inserting ``shows'';
                                    (IV) by striking ``subsection 
                                (a)(1)(A)'' in clause (i) and inserting 
                                ``subsection (a)(1)(A)(i)''; and
                                    (V) by striking ``subsection 
                                (a)(1)(B)'' in clause (ii) and inserting 
                                ``subsection (a)(1)(A)(ii)'';
                    (D) in paragraph (3)--
                          (i) by striking ``Data'' and inserting 
                      ``Information''; and
                          (ii) by striking ``paragraph (1) or (2)'' and 
                      inserting ``paragraph (1) or (2) of this 
                      subsection or under subsection (e)''; and
                    (E) in paragraph (4)--
                          (i) in subparagraph (A)(i), by inserting ``, 
                      without consideration of costs or other nonrisk 
                      factors'' after ``health or the environment''; and
                          (ii) in subparagraph (C), by striking ``, 
                      except that'' and all that follows through 
                      ``subparagraph (A)'';
            (3) in subsection (c)--
                    (A) in the subsection heading, by striking 
                ``Notice'' and inserting ``Review''; and
                    (B) by striking ``before which'' and all that 
                follows through ``subsection may begin'';
            (4) in subsection (d)--
                    (A) by striking ``test data'' in paragraph (1)(B) 
                and inserting ``information'';
                    (B) by striking ``data'' each place it appears in 
                paragraph (1)(C) and paragraph (2) and inserting 
                ``information'';
                    (C) in paragraph (2)(B), by striking ``uses or 
                intended uses of such substance'' and inserting ``uses 
                of such substance identified in the notice''; and
                    (D) in paragraph (3)--
                          (i) by striking ``for which the notification 
                      period prescribed by subsection (a), (b), or (c)'' 
                      and inserting ``for which the applicable review 
                      period''; and
                          (ii) by striking ``such notification period'' 
                      and inserting ``such period'';
            (5) in subsection (e)--
                    (A) in paragraph (1)(A)--
                          (i) in clause (i), by striking ``; and'' and 
                      inserting ``; or'';
                          (ii) in clause (ii)(I), by inserting ``without 
                      consideration of costs or other nonrisk factors, 
                      including an

[[Page 130 STAT. 458]]

                      unreasonable risk to a potentially exposed 
                      subpopulation identified as relevant by the 
                      Administrator under the conditions of use;'' after 
                      ``health or the environment,''; and
                          (iii) in the matter after clause (ii)(II)--
                                    (I) by striking ``may issue a 
                                proposed order'' and inserting ``shall 
                                issue an order'';
                                    (II) by striking ``notification 
                                period applicable to the manufacturing 
                                or processing of such substance under 
                                subsection (a), (b), (c)'' and inserting 
                                ``applicable review period''; and
                                    (III) by inserting ``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'' 
                                before the period at the end;
                    (B) in paragraph (1)(B)--
                          (i) by striking ``A proposed order'' and 
                      inserting ``An order'';
                          (ii) by striking ``notification period 
                      applicable to the manufacture or processing of 
                      such substance under subsection (a), (b), (c)'' 
                      and inserting ``applicable review period''; and
                          (iii) by striking ``of the proposed order'' 
                      and inserting ``of the order'';
                    (C) by striking paragraph (1)(C); and
                    (D) by striking paragraph (2);
            (6) in subsection (f)--
                    (A) in paragraph (1)--
                          (i) by striking ``finds that there is a 
                      reasonable basis to conclude that the manufacture, 
                      processing, distribution in commerce, use, or 
                      disposal of a chemical substance with'' and 
                      inserting ``determines that a chemical substance 
                      or significant new use with'';
                          (ii) by striking ``, or that any combination 
                      of such activities,'';
                          (iii) by striking ``or will present'';
                          (iv) by striking ``before a rule promulgated 
                      under section 6 can protect against such risk,'' 
                      and inserting ``, 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,''; and
                          (v) by striking ``notification period 
                      applicable under subsection (a), (b), or (c) to 
                      the manufacturing or processing of such 
                      substance'' and inserting ``applicable review 
                      period'';

[[Page 130 STAT. 459]]

                    (B) in paragraph (2), the matter following 
                subparagraph (C), by striking ``Section 6(d)(2)(B)'' and 
                inserting ``Section 6(d)(3)(B)'';
                    (C) in paragraph (3)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``Administrator 
                                may'' and all that follows through 
                                ``issue a proposed order to prohibit 
                                the'' and inserting ``Administrator may 
                                issue an order to prohibit or limit 
                                the''; and
                                    (II) by striking ``under paragraph 
                                (1)'' and all that follows through 
                                ``processing of such substance.'' and 
                                inserting ``under paragraph (1). Such 
                                order shall take effect on the 
                                expiration of the applicable review 
                                period.'';
                          (ii) by striking subparagraph (B) and 
                      redesignating subparagraph (C) as subparagraph 
                      (B);
                          (iii) in subparagraph (B), as so 
                      redesignated--
                                    (I) by striking ``subparagraphs (B) 
                                and (C)'' and inserting ``subparagraph 
                                (B)'';
                                    (II) by striking ``clause (i) of''; 
                                and
                                    (III) by striking ``; and the 
                                provisions of subparagraph (C) of 
                                subsection (e)(2) shall apply with 
                                respect to an injunction issued under 
                                subparagraph (B)''; and
                          (iv) by striking subparagraph (D); and
                    (D) by adding at the end the following:
            ``(4) <<NOTE: Deadline. Regulations. Publication.>>  
        Treatment of nonconforming uses.--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.
            ``(5) <<NOTE: Consultation.>>  Workplace exposures.--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.'';
            (7) by amending subsection (g) to read as follows:

    ``(g) <<NOTE: Public information.>>  Statement on Administrator 
Finding.--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. <<NOTE: Federal Register, publication.>> Such a 
statement shall be submitted for publication in the Federal Register as 
soon as

[[Page 130 STAT. 460]]

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.'';
            (8) in subsection (h)--
                    (A) in paragraph (1)(A), by inserting ``, 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'' after ``health or the 
                environment'';
                    (B) in paragraph (2), by striking ``data'' each 
                place it appears and inserting ``information''; and
                    (C) in paragraph (4), by striking ``. A rule 
                promulgated'' and all that follows through ``section 
                6(c)'' and inserting ``, including an unreasonable risk 
                to a potentially exposed or susceptible subpopulation 
                identified by the Administrator under the conditions of 
                use''; and
            (9) by amending subsection (i) to read as follows:

    ``(i) Definitions.--(1) For purposes of this section, the terms 
`manufacture' and `process' mean manufacturing or processing for 
commercial purposes.
    ``(2) For purposes of this Act, the term `requirement' as used in 
this section shall not displace any statutory or common law.
    ``(3) For purposes of this section, the term `applicable review 
period' 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).''.
SEC. 6. PRIORITIZATION, RISK EVALUATION, AND REGULATION OF 
                    CHEMICAL SUBSTANCES AND MIXTURES.

    Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) is 
amended--
            (1) by striking the section heading and inserting 
        ``prioritization, risk evaluation, and regulation of chemical 
        substances and mixtures'';
            (2) in subsection (a)--
                    (A) by striking ``finds that there is a reasonable 
                basis to conclude'' and inserting ``determines in 
                accordance with subsection (b)(4)(A)'';
                    (B) by striking ``or will present'';
                    (C) by inserting ``and subject to section 18, and in 
                accordance with subsection (c)(2),'' after ``shall by 
                rule'';
                    (D) by striking ``to protect adequately against such 
                risk using the least burdensome requirements'' and 
                inserting ``so that the chemical substance or mixture no 
                longer presents such risk'';
                    (E) by inserting ``or otherwise restricting'' after 
                ``prohibiting'' in paragraphs (1)(A) and (2)(A);
                    (F) by inserting ``minimum'' before ``warnings'' 
                both places it appears in paragraph (3);
                    (G) by striking ``and monitor or conduct tests'' and 
                inserting ``or monitor or conduct tests'' in paragraph 
                (4); and
                    (H) in paragraph (7)--
                          (i) by striking ``such unreasonable risk of 
                      injury'' and inserting ``such determination''; and

[[Page 130 STAT. 461]]

                          (ii) by striking ``such risk of injury'' and 
                      inserting ``such determination'';
            (3) by amending subsection (b) to read as follows:

    ``(b) Risk Evaluations.--
            ``(1) Prioritization for risk evaluations.--
                    ``(A) <<NOTE: Deadline. Criteria.>>  Establishment 
                of process.--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 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.
                    ``(B) Identification of priorities for risk 
                evaluation.--
                          ``(i) High-priority substances.--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.
                          ``(ii) Low-priority substances.--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.
                    ``(C) <<NOTE: Time periods.>>  Information request 
                and review and proposed and final prioritization 
                designation.--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--
                          ``(i) 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;

[[Page 130 STAT. 462]]

                          ``(ii) <<NOTE: Publication. Public 
                      information.>>  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
                          ``(iii) 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.
            ``(2) Initial risk evaluations and subsequent designations 
        of high- and low-priority substances.--
                    ``(A) <<NOTE: Deadline. Publication. Lists. Time 
                period.>>  Initial risk evaluations.--Not later than 180 
                days after the date of enactment of the Frank R. 
                Lautenberg Chemical Safety for the 21st Century Act, 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.
                    ``(B) <<NOTE: Deadline.>>  Additional risk 
                evaluations.--Not later than three and one half years 
                after the date of enactment of the Frank R. Lautenberg 
                Chemical Safety for the 21st Century Act, 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.
                    ``(C) Continuing designations and risk 
                evaluations.--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).
                    ``(D) Preference.--In designating high-priority 
                substances, the Administrator shall give preference to--
                          ``(i) 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
                          ``(ii) 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.
                    ``(E) Metals and metal compounds.--In identifying 
                priorities for risk evaluation and conducting risk 
                evaluations of metals and metal compounds, the 
                Administrator

[[Page 130 STAT. 463]]

                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.
            ``(3) Initiation of risk evaluations; designations.--
                    ``(A) Risk evaluation initiation.--Upon designating 
                a chemical substance as a high-priority substance, the 
                Administrator shall initiate a risk evaluation on the 
                substance.
                    ``(B) Revision.--The Administrator may revise the 
                designation of a low-priority substance based on 
                information made available to the Administrator.
                    ``(C) Ongoing designations.--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)).
            ``(4) Risk evaluation process and deadlines.--
                    ``(A) <<NOTE: Determination.>>  In general.--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.
                    ``(B) <<NOTE: Deadline.>>  Establishment of 
                process.--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 establish, 
                by rule, a process to conduct risk evaluations in 
                accordance with subparagraph (A).
                    ``(C) <<NOTE: Publication.>>  Requirement.--The 
                Administrator shall conduct and publish risk 
                evaluations, in accordance with the rule promulgated 
                under subparagraph (B), for a chemical substance--
                          ``(i) that has been identified under paragraph 
                      (2)(A) or designated under paragraph (1)(B)(i); 
                      and
                          ``(ii) 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.
                    ``(D) <<NOTE: Deadlines. Publications.>>  Scope.--
                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

[[Page 130 STAT. 464]]

                not less than 3 months before the Administrator 
                publishes the scope of the risk evaluation.
                    ``(E) Limitation and criteria.--
                          ``(i) Percentage requirements.--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--
                                    ``(I) not less than 25 percent, if 
                                sufficient requests are made under 
                                clause (ii) of subparagraph (C); and
                                    ``(II) not more than 50 percent.
                          ``(ii) Requested risk evaluations.--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.
                          ``(iii) Preference.--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.
                          ``(iv) Exceptions.--(I) Chemical substances 
                      for which requests have been granted under 
                      subparagraph (C)(ii) shall not be subject to 
                      section 18(b).
                          ``(II) 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).
                    ``(F) Requirements.--In conducting a risk evaluation 
                under this subsection, the Administrator shall--
                          ``(i) <<NOTE: Assessment.>>  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;
                          ``(ii) describe whether aggregate or sentinel 
                      exposures to a chemical substance under the 
                      conditions of use were considered, and the basis 
                      for that consideration;
                          ``(iii) not consider costs or other nonrisk 
                      factors;
                          ``(iv) take into account, where relevant, the 
                      likely duration, intensity, frequency, and number 
                      of exposures under the conditions of use of the 
                      chemical substance; and
                          ``(v) describe the weight of the scientific 
                      evidence for the identified hazard and exposure.
                    ``(G) Deadlines.--The Administrator--

[[Page 130 STAT. 465]]

                          ``(i) 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
                          ``(ii) may extend the deadline for a risk 
                      evaluation for not more than 6 months.
                    ``(H) <<NOTE: Time period.>>  Notice and comment.--
                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.'';
            (4) by amending subsection (c) to read as follows:

    ``(c) Promulgation of Subsection (a) Rules.--
            ``(1) <<NOTE: Determination. Federal Register, 
        publication.>>  Deadlines.--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--
                    ``(A) 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;
                    ``(B) 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
                    ``(C) 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.
            ``(2) Requirements for rule.--
                    ``(A) <<NOTE: Publication.>>  Statement of 
                effects.--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--
                          ``(i) 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;
                          ``(ii) 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;

[[Page 130 STAT. 466]]

                          ``(iii) the benefits of the chemical substance 
                      or mixture for various uses; and
                          ``(iv) the reasonably ascertainable economic 
                      consequences of the rule, including consideration 
                      of--
                                    ``(I) the likely effect of the rule 
                                on the national economy, small business, 
                                technological innovation, the 
                                environment, and public health;
                                    ``(II) 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
                                    ``(III) the cost effectiveness of 
                                the proposed regulatory action and of 
                                the 1 or more primary alternative 
                                regulatory actions considered by the 
                                Administrator.
                    ``(B) Selecting requirements.--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).
                    ``(C) Consideration of alternatives.--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.
                    ``(D) Replacement parts.--
                          ``(i) <<NOTE: Exemption.>>  In general.--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.
                          ``(ii) Definitions.--In this subparagraph--
                                    ``(I) the term `complex consumer 
                                goods' 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
                                    ``(II) the term `complex durable 
                                goods' 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.

[[Page 130 STAT. 467]]

                    ``(E) <<NOTE: Applicability.>>  Articles.--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).
            ``(3) Procedures.--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--
                    ``(A) <<NOTE: Publication. Notice.>>  publish a 
                notice of proposed rulemaking stating with particularity 
                the reason for the proposed rule;
                    ``(B) <<NOTE: Public information.>>  allow 
                interested persons to submit written data, views, and 
                arguments, and make all such submissions publicly 
                available;
                    ``(C) promulgate a final rule based on the matter in 
                the rulemaking record; and
                    ``(D) <<NOTE: Publication.>>  make and publish with 
                the rule the determination described in subsection 
                (a).'';
            (5) in subsection (d)--
                    (A) by redesignating paragraph (2) as paragraph (3);
                    (B) by striking paragraph (1) and inserting the 
                following:
            ``(1) <<NOTE: Compliance dates. Deadline. Effective date.>>  
        In general.--In any rule under subsection (a), the Administrator 
        shall--
                    ``(A) specify the date on which it shall take 
                effect, which date shall be as soon as practicable;
                    ``(B) 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);
                    ``(C) 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);
                    ``(D) 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
                    ``(E) provide for a reasonable transition period.
            ``(2) <<NOTE: Determination.>>  Variability.--As determined 
        by the Administrator, the compliance dates established under 
        paragraph (1) may vary for different affected persons.''; and
                    (C) in paragraph (3), as so redesignated by 
                subparagraph (A) of this paragraph--
                          (i) in subparagraph (A)--
                                    (I) by striking ``upon its 
                                publication'' and all that follows 
                                through ``respecting such rule if'' and

[[Page 130 STAT. 468]]

                                inserting ``, 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''; and
                                    (II) in clause (i)(I), by inserting 
                                ``without consideration of costs or 
                                other non-risk factors'' after 
                                ``effective date''; and
                          (ii) in subparagraph (B), by striking ``, 
                      provide reasonable opportunity'' and all that 
                      follows through the period at the end and 
                      inserting ``in accordance with subsection (c), and 
                      either promulgate such rule (as proposed or with 
                      modifications) or revoke it.'';
            (6) in subsection (e)(4), by striking ``paragraphs (2), (3), 
        and (4)'' and inserting ``paragraph (3)''; and
            (7) by adding at the end the following new subsections:

    ``(g) Exemptions.--
            ``(1) Criteria for exemption.--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--
                    ``(A) 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;
                    ``(B) 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
                    ``(C) 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.
            ``(2) <<NOTE: Public information.>>  Exemption analysis and 
        statement.--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.
            ``(3) <<NOTE: Determination.>>  Period of exemption.--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.
            ``(4) <<NOTE: Records. Reports. Determination.>>  
        Conditions.--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.

[[Page 130 STAT. 469]]

    ``(h) Chemicals That Are Persistent, Bioaccumulative, and Toxic.--
            ``(1) <<NOTE: Deadline.>>  Expedited action.--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--
                    ``(A) 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
                    ``(B) 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.
            ``(2) No risk evaluation required.--The Administrator shall 
        not be required to conduct risk evaluations on chemical 
        substances that are subject to paragraph (1).
            ``(3) <<NOTE: Deadline.>>  Final rule.--Not later than 18 
        months after proposing a rule pursuant to paragraph (1), the 
        Administrator shall promulgate a final rule under subsection 
        (a).
            ``(4) Selecting restrictions.--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.
            ``(5) <<NOTE: Time period.>>  Relationship to subsection 
        (b).--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.

    ``(i) Final Agency Action.--Under this section and subject to 
section 18--
            ``(1) <<NOTE: Determination. Effective date.>>  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

[[Page 130 STAT. 470]]

            ``(2) 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.

    ``(j) Definition.--For the purposes of this Act, the term 
`requirement' as used in this section shall not displace statutory or 
common law.''.
SEC. 7. IMMINENT HAZARDS.

    Section 7 of the Toxic Substances Control Act (15 U.S.C. 2606) is 
amended--
            (1) in subsection (b)(1), by inserting ``(as identified by 
        the Administrator without consideration of costs or other 
        nonrisk factors)'' after ``from the unreasonable risk''; and
            (2) in subsection (f), by inserting ``, without 
        consideration of costs or other nonrisk factors'' after 
        ``widespread injury to health or the environment''.
SEC. 8. REPORTING AND RETENTION OF INFORMATION.

    (a) In General.--Section 8 of the Toxic Substances Control Act (15 
U.S.C. 2607) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2), by striking the matter that 
                follows subparagraph (G);
                    (B) in paragraph (3), by adding at the end the 
                following:

    ``(C) <<NOTE: Time period. Consultation.>>  Not later than 180 days 
after the date of enactment of the Frank R. Lautenberg Chemical Safety 
for the 21st Century Act, and not less frequently than once every 10 
years thereafter, the Administrator, after consultation with the 
Administrator of the Small Business Administration, shall--
            ``(i) <<NOTE: Review.>>  review the adequacy of the 
        standards prescribed under subparagraph (B); and
            ``(ii) <<NOTE: Public information. Determination.>>  after 
        providing public notice and an opportunity for comment, make a 
        determination as to whether revision of the standards is 
        warranted.''; and
                    (C) by adding at the end the following:
            ``(4) Contents.--The rules promulgated pursuant to paragraph 
        (1)--
                    ``(A) may impose differing reporting and 
                recordkeeping requirements on manufacturers and 
                processors; and
                    ``(B) shall include the level of detail necessary to 
                be reported, including the manner by which use and 
                exposure information may be reported.
            ``(5) Administration.--In carrying out this section, the 
        Administrator shall, to the extent feasible--
                    ``(A) not require reporting which is unnecessary or 
                duplicative;
                    ``(B) minimize the cost of compliance with this 
                section and the rules issued thereunder on small 
                manufacturers and processors; and
                    ``(C) <<NOTE: Applicability.>>  apply any reporting 
                obligations to those persons likely to have information 
                relevant to the effective implementation of this title.
            ``(6) <<NOTE: Publications.>>  Negotiated rulemaking.--(A) 
        The Administrator shall enter into a negotiated rulemaking 
        pursuant to subchapter III of chapter 5 of title 5, United 
        States Code, to develop

[[Page 130 STAT. 471]]

        and publish, not later than 3 years after the date of enactment 
        of the Frank R. Lautenberg Chemical Safety for the 21st Century 
        Act, 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.
            ``(B) 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.''; and
            (2) in subsection (b), by adding at the end the following:
            ``(3) Nomenclature.--
                    ``(A) In general.--In carrying out paragraph (1), 
                the Administrator shall--
                          ``(i) 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;
                          ``(ii) 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 
                      `Candidate List of Chemical Substances', 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
                          ``(iii) 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).
                    ``(B) Multiple nomenclature listings.--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.
            ``(4) Chemical substances in commerce.--
                    ``(A) Rules.--
                          ``(i) <<NOTE: Notification. Federal Register, 
                      publication. Time period.>>  In general.--Not 
                      later than 1 year after the date of enactment of 
                      the Frank R. Lautenberg Chemical Safety for the 
                      21st Century Act, 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 Frank R. Lautenberg Chemical Safety for the 
                      21st Century Act.
                          ``(ii) Active substances.--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).

[[Page 130 STAT. 472]]

                          ``(iii) Inactive substances.--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).
                          ``(iv) Limitation.--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).
                    ``(B) <<NOTE: Claims.>>  Confidential chemical 
                substances.--In promulgating a rule under subparagraph 
                (A), the Administrator shall--
                          ``(i) <<NOTE: List.>>  maintain the list under 
                      paragraph (1), which shall include a confidential 
                      portion and a nonconfidential portion consistent 
                      with this section and section 14;
                          ``(ii) <<NOTE: Notice.>>  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;
                          ``(iii) require the substantiation of those 
                      claims pursuant to section 14 and in accordance 
                      with the review plan described in subparagraph 
                      (C); and
                          ``(iv) 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.
                    ``(C) <<NOTE: Regulations.>>  Review plan.--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).
                    ``(D) <<NOTE: Claims.>>  Requirements of review 
                plan.--In establishing the review plan under 
                subparagraph (C), the Administrator shall--
                          ``(i) <<NOTE: Time period.>>  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
                          ``(ii) in accordance with section 14--
                                    ``(I) review each substantiation--

[[Page 130 STAT. 473]]

                                            ``(aa) submitted pursuant to 
                                        clause (i) to determine if the 
                                        claim qualifies for protection 
                                        from disclosure; and
                                            
                                        ``(bb) <<NOTE: Determination.>>  
                                        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;
                                    ``(II) approve, approve in part and 
                                deny in part, or deny each claim; and
                                    ``(III) <<NOTE: Time period.>>  
                                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--
                                            
                                        ``(aa) <<NOTE: Notification.>>  
                                        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
                                            ``(bb) 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).
                    ``(E) <<NOTE: Claims.>>  Timeline for completion of 
                reviews.--
                          ``(i) In general.--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).
                          ``(ii) Considerations.--
                                    ``(I) <<NOTE: Determination.>>  In 
                                general.--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.
                                    ``(II) <<NOTE: Publication.>>  
                                Annual review goal and results.--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.
            ``(5) Active and inactive substances.--
                    ``(A) In general.--The Administrator shall keep 
                designations of active substances and inactive 
                substances on the list published under paragraph (1) 
                current.
                    ``(B) Change to active status.--
                          ``(i) <<NOTE: Notification.>>  In general.--
                      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.

[[Page 130 STAT. 474]]

                          ``(ii) <<NOTE: Claims.>>  Confidential 
                      chemical identity.--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--
                                    ``(I) in the notice submitted under 
                                clause (i), assert the claim; and
                                    ``(II) by not later than 30 days 
                                after providing the notice under clause 
                                (i), substantiate the claim.
                          ``(iii) Active status.--On receiving a 
                      notification under clause (i), the Administrator 
                      shall--
                                    ``(I) designate the applicable 
                                chemical substance as an active 
                                substance;
                                    ``(II) <<NOTE: Review.>>  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;
                                    ``(III) <<NOTE: Time period.>>  
                                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--
                                            
                                        ``(aa) <<NOTE: Notification.>>  
                                        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
                                            ``(bb) 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
                                    ``(IV) <<NOTE: Review.>>  pursuant 
                                to section 6(b), review the priority of 
                                the chemical substance as the 
                                Administrator determines to be 
                                necessary.
                    ``(C) Category status.--The list of inactive 
                substances shall not be considered to be a category for 
                purposes of section 26(c).
            ``(6) Interim list of active substances.--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 Frank R. Lautenberg 
        Chemical Safety for the 21st Century Act), during the reporting 
        period that most closely preceded the date of enactment of the 
        Frank R. Lautenberg Chemical Safety for the 21st Century Act, as 
        the interim list of active substances for the purposes of 
        section 6(b).
            ``(7) Public information.--Subject to this subsection and 
        section 14, the Administrator shall make available to the 
        public--

[[Page 130 STAT. 475]]

                    ``(A) 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;
                    ``(B) 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
                    ``(C) the specific chemical identity of any active 
                substance for which--
                          ``(i) 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;
                          ``(ii) all claims for protection against 
                      disclosure of the specific chemical identity of 
                      the active substance have been denied by the 
                      Administrator; or
                          ``(iii) the time period for protection against 
                      disclosure of the specific chemical identity of 
                      the active substance has expired.
            ``(8) Limitation.--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).
            ``(9) Certification.--Under the rules promulgated under this 
        subsection, manufacturers and processors, as applicable, shall 
        be required--
                    ``(A) 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
                    ``(B) <<NOTE: Records. Time period. Effective 
                date.>>  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.''.

    (b) Mercury Inventory.--Section 8(b) of the Toxic Substances Control 
Act (15 U.S.C. 2607(b)) (as amended by subsection (a)) is further 
amended by adding at the end the following:
            ``(10) Mercury.--
                    ``(A) Definition of mercury.--In this paragraph, 
                notwithstanding section 3(2)(B), the term `mercury' 
                means--
                          ``(i) elemental mercury; and
                          ``(ii) a mercury compound.
                    ``(B) <<NOTE: Federal Register, publication.>>  
                Publication.--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.
                    ``(C) Process.--In carrying out the inventory under 
                subparagraph (B), the Administrator shall--
                          ``(i) identify any manufacturing processes or 
                      products that intentionally add mercury; and

[[Page 130 STAT. 476]]

                          ``(ii) recommend actions, including proposed 
                      revisions of Federal law or regulations, to 
                      achieve further reductions in mercury use.
                    ``(D) Reporting.--
                          ``(i) <<NOTE: Determination. Regulations.>>  
                      In general.--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.
                          ``(ii) Coordination.--To avoid duplication, 
                      the Administrator shall coordinate the reporting 
                      under this subparagraph with the Interstate 
                      Mercury Education and Reduction Clearinghouse.
                          ``(iii) Exemption.--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.''.
SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.

    Section 9 of the Toxic Substances Control Act (15 U.S.C. 2608) is 
amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                          (i) by striking ``has reasonable basis to 
                      conclude'' and inserting ``determines'';
                          (ii) by striking ``or will present''; and
                          (iii) by inserting ``, 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,'' after ``or the environment'';
                    (B) in paragraph (2)--
                          (i) in subparagraph (A), by inserting ``, 
                      within the time period specified by the 
                      Administrator in the report,'' after ``issues an 
                      order''; and
                          (ii) in subparagraph (B), by inserting 
                      ``responds within the time period specified by the 
                      Administrator in the report and'' before 
                      ``initiates, within 90'';
                    (C) by redesignating paragraph (3) as paragraph (6); 
                and
                    (D) by inserting after paragraph (2) the following:

    ``(3) <<NOTE: Reports. Time period. Deadline.>>  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--
            ``(A) issue the order described in paragraph (2)(A) within 
        the time period specified by the Administrator in the report; or
            ``(B)(i) respond under paragraph (1) within the timeframe 
        specified by the Administrator in the report; and
            ``(ii) initiate action within 90 days of publication in the 
        Federal Register of the response described in clause (i).

[[Page 130 STAT. 477]]

    ``(4) 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--
            ``(A) initiate or complete appropriate action under section 
        6; or
            ``(B) take any action authorized or required under section 
        7, as applicable.

    ``(5) 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).'';
            (2) in subsection (b)--
                    (A) by striking ``The Administrator shall 
                coordinate'' and inserting ``(1) The Administrator shall 
                coordinate''; and
                    (B) by adding at the end the following:

    ``(2) <<NOTE: Determination.>>  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.''; and
            (3) by adding at the end the following:

    ``(e) Exposure Information.--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.''.
SEC. 10. EXPORTS.

    (a) In General.--Section 12(a)(2) of the Toxic Substances Control 
Act (15 U.S.C. 2611(a)(2)) is amended by striking ``will present'' and 
inserting ``presents''.
    (b) Prohibition on Export of Certain Mercury Compounds.--Section 
12(c) of the Toxic Substances Control Act (15 U.S.C. 2611(c)) is 
amended--
            (1) in the subsection heading, by inserting ``and Mercury 
        Compounds'' after ``Mercury''; and
            (2) by adding at the end the following:
            ``(7) Prohibition on export of certain mercury compounds.--
                    ``(A) <<NOTE: Effective date.>>  In general.--
                Effective January 1, 2020, the export of the following 
                mercury compounds is prohibited:
                          ``(i) Mercury (I) chloride or calomel.
                          ``(ii) Mercury (II) oxide.
                          ``(iii) Mercury (II) sulfate.
                          ``(iv) Mercury (II) nitrate.
                          ``(v) Cinnabar or mercury sulphide.
                          ``(vi) Any mercury compound that the 
                      Administrator adds to the list published under 
                      subparagraph

[[Page 130 STAT. 478]]

                      (B) by rule, on determining that exporting that 
                      mercury compound for the purpose of regenerating 
                      elemental mercury is technically feasible.
                    ``(B) <<NOTE: Deadline. Federal Register, 
                publication. List.>>  Publication.--Not later than 90 
                days after the date of enactment of the Frank R. 
                Lautenberg Chemical Safety for the 21st Century Act, 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.
                    ``(C) Petition.--Any person may petition the 
                Administrator to add a mercury compound to the list 
                published under subparagraph (B).
                    ``(D) Environmentally sound disposal.--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.
                    ``(E) <<NOTE: Evaluation.>>  Report.--Not later than 
                5 years after the date of enactment of the Frank R. 
                Lautenberg Chemical Safety for the 21st Century Act, 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--
                          ``(i) describes volumes and sources of mercury 
                      compounds on the list published under subparagraph 
                      (B) exported for disposal;
                          ``(ii) identifies receiving countries of such 
                      exports;
                          ``(iii) describes methods of disposal used 
                      after such export;
                          ``(iv) identifies issues, if any, presented by 
                      the export of mercury compounds on the list 
                      published under subparagraph (B);
                          ``(v) 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
                          ``(vi) <<NOTE: Recommenda- tion.>>  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.
                    ``(F) Effect on other law.--Nothing in this 
                paragraph shall be construed to affect the authority of 
                the Administrator under the Solid Waste Disposal Act (42 
                U.S.C. 6901 et seq.).''.

    (c) Temporary Generator Accumulation.--Section 5 of the Mercury 
Export Ban Act of 2008 (42 U.S.C. 6939f) is amended--
            (1) in subsection (a)(2), by striking ``2013'' and inserting 
        ``2019'';
            (2) in subsection (b)--
                    (A) in paragraph (1)--

[[Page 130 STAT. 479]]

                          (i) by redesignating subparagraphs (A), (B), 
                      and (C), as clauses (i), (ii), and (iii), 
                      respectively and indenting appropriately;
                          (ii) in the first sentence, by striking 
                      ``After consultation'' and inserting the 
                      following:
                    ``(A) Assessment and collection.--After 
                consultation'';
                          (iii) in the second sentence, by striking 
                      ``The amount of such fees'' and inserting the 
                      following:
                    ``(B) Amount.--The amount of the fees described in 
                subparagraph (A)'';
                          (iv) in subparagraph (B) (as so designated)--
                                    (I) in clause (i) (as so 
                                redesignated), by striking ``publically 
                                available not later than October 1, 
                                2012'' and inserting ``publicly 
                                available not later than October 1, 
                                2018'';
                                    (II) in clause (ii) (as so 
                                redesignated), by striking ``and'';
                                    (III) in clause (iii) (as so 
                                redesignated), by striking the period at 
                                the end and inserting ``, subject to 
                                clause (iv); and''; and
                                    (IV) by adding at the end the 
                                following:
                          ``(iv) 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.''; and
                          (v) by adding at the end the following:
                    ``(C) <<NOTE: Deadline.>>  Conveyance of title and 
                permitting.--If the facility designated in subsection 
                (a) is not operational by January 1, 2020, the 
                Secretary--
                          ``(i) 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;
                          ``(ii) shall pay any applicable Federal 
                      permitting costs, including the costs for permits 
                      issued under section 3005(c) of the Solid Waste 
                      Disposal Act (42 U.S.C. 6925(c)); and
                          ``(iii) 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 (42 U.S.C. 
                      6925(c)).''; and
                    (B) in paragraph (2), in the first sentence, by 
                striking ``paragraph (1)(C)'' and inserting ``paragraph 
                (1)(B)(iii)''; and
            (3) in subsection (g)(2)--
                    (A) in the undesignated material at the end, by 
                striking ``This subparagraph'' and inserting the 
                following:

[[Page 130 STAT. 480]]

                    ``(C) Subparagraph (B)'';
                    (B) in subparagraph (C) (as designated by 
                subparagraph (A)), by inserting ``of that subparagraph'' 
                before the period at the end; and
                    (C) by adding at the end the following:
                    ``(D) <<NOTE: Time period. Certification.>>  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 (42 U.S.C. 
                6925(c)), and shall not be subject to the storage 
                prohibition of section 3004(j) of that Act (42 U.S.C. 
                6924(j)), if--
                          ``(i) 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;
                          ``(ii) 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;
                          ``(iii) 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
                          ``(iv) <<NOTE: Compliance.>>  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).
                    
                ``(E) <<NOTE: Deadline. Consultation. Guidance. Procedure
                s.>>  Management standards for temporary storage.--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.''.

    (d) Interim Status.--Section 5(d)(1) of the Mercury Export Ban Act 
of 2008 (42 U.S.C. 6939f(d)(1)) is amended--
            (1) in the fourth sentence, by striking ``in existence on or 
        before January 1, 2013,''; and
            (2) in the last sentence, by striking ``January 1, 2015'' 
        and inserting ``January 1, 2020''.

[[Page 130 STAT. 481]]

SEC. 11. CONFIDENTIAL INFORMATION.

    Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is 
amended to read as follows:
``SEC. 14. CONFIDENTIAL INFORMATION.

    ``(a) In General.--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--
            ``(1) that is reported to, or otherwise obtained by, the 
        Administrator under this Act; and
            ``(2) for which the requirements of subsection (c) are met.

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.
    ``(b) Information Not Protected From Disclosure.--
            ``(1) Mixed confidential and nonconfidential information.--
        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.
            ``(2) Information from health and safety studies.--
        Subsection (a) does not prohibit the disclosure of--
                    ``(A) any health and safety study which is submitted 
                under this Act with respect to--
                          ``(i) any chemical substance or mixture which, 
                      on the date on which such study is to be disclosed 
                      has been offered for commercial distribution; or
                          ``(ii) any chemical substance or mixture for 
                      which testing is required under section 4 or for 
                      which notification is required under section 5; 
                      and
                    ``(B) 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).
        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.
            ``(3) Other information not protected from disclosure.--
        Subsection (a) does not prohibit the disclosure of--
                    ``(A) <<NOTE: Determination.>>  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
                    ``(B) 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

[[Page 130 STAT. 482]]

                sector that customarily would be shared with the general 
                public or within an industry or industry sector.
            ``(4) Bans and phase-outs.--
                    ``(A) <<NOTE: Regulation. Applicability.>>  In 
                general.--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.
                    ``(B) Limitations.--
                          ``(i) <<NOTE: Applicability.>>  Critical 
                      use.--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.
                          ``(ii) Export.--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).
                          ``(iii) <<NOTE: Applicability.>>  Specific 
                      conditions of use.--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.
                    ``(C) Request for nondisclosure.--
                          ``(i) <<NOTE: Deadline. Records. Review.>>  In 
                      general.--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).
                          ``(ii) Effect of no request or denial.--If no 
                      request for nondisclosure or delay is submitted to 
                      the Administrator under this subparagraph, or the

[[Page 130 STAT. 483]]

                      Administrator denies such a request under 
                      subsection (g)(1)(A), the information shall not be 
                      protected from disclosure under this section.
            ``(5) Certain requests.--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.

    ``(c) Requirements for Confidentiality Claims.--
            ``(1) Assertion of claims.--
                    ``(A) In general.--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.
                    ``(B) Inclusion.--An assertion of a claim under 
                subparagraph (A) shall include a statement that the 
                person has--
                          ``(i) taken reasonable measures to protect the 
                      confidentiality of the information;
                          ``(ii) determined that the information is not 
                      required to be disclosed or otherwise made 
                      available to the public under any other Federal 
                      law;
                          ``(iii) a reasonable basis to conclude that 
                      disclosure of the information is likely to cause 
                      substantial harm to the competitive position of 
                      the person; and
                          ``(iv) a reasonable basis to believe that the 
                      information is not readily discoverable through 
                      reverse engineering.
                    ``(C) Additional requirements for claims regarding 
                chemical identity information.--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--
                          ``(i) be consistent with guidance developed by 
                      the Administrator under paragraph (4)(A); and
                          ``(ii) describe the chemical structure of the 
                      chemical substance as specifically as practicable 
                      while protecting those features of the chemical 
                      structure--
                                    ``(I) that are claimed as 
                                confidential; and
                                    ``(II) the disclosure of which would 
                                be likely to cause substantial harm to 
                                the competitive position of the person.
            ``(2) Information generally not subject to substantiation 
        requirements.--Subject to subsection (f), the following 
        information shall not be subject to substantiation requirements 
        under paragraph (3):

[[Page 130 STAT. 484]]

                    ``(A) Specific information describing the processes 
                used in manufacture or processing of a chemical 
                substance, mixture, or article.
                    ``(B) Marketing and sales information.
                    ``(C) Information identifying a supplier or 
                customer.
                    ``(D) In the case of a mixture, details of the full 
                composition of the mixture and the respective 
                percentages of constituents.
                    ``(E) Specific information regarding the use, 
                function, or application of a chemical substance or 
                mixture in a process, mixture, or article.
                    ``(F) Specific production or import volumes of the 
                manufacturer or processor.
                    ``(G) 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.
            ``(3) Substantiation requirements.--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.
            ``(4) Guidance.--The Administrator shall develop guidance 
        regarding--
                    ``(A) the determination of structurally descriptive 
                generic names, in the case of claims for the protection 
                from disclosure of specific chemical identity; and
                    ``(B) the content and form of the statements of need 
                and agreements required under paragraphs (4), (5), and 
                (6) of subsection (d).
            ``(5) Certification.--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.

    ``(d) <<NOTE: Contracts.>>  Exceptions to Protection From 
Disclosure.--Information described in subsection (a)--
            ``(1) shall be disclosed to an officer or employee of the 
        United States--
                    ``(A) in connection with the official duties of that 
                person under any Federal law for the protection of 
                health or the environment; or
                    ``(B) for a specific Federal law enforcement 
                purpose;
            ``(2) shall be disclosed to a contractor of the United 
        States and employees of that contractor--
                    ``(A) 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
                    ``(B) subject to such conditions as the 
                Administrator may specify;
            ``(3) <<NOTE: Determination.>>  shall be disclosed if the 
        Administrator determines that disclosure is necessary to protect 
        health or the environment

[[Page 130 STAT. 485]]

        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;
            ``(4) 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;
            ``(5) 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--
                    ``(A) the statement of need and confidentiality 
                agreement are consistent with the guidance developed 
                under subsection (c)(4)(B);
                    ``(B) the statement of need shall be a statement 
                that the person has a reasonable basis to suspect that--
                          ``(i) the information is necessary for, or 
                      will assist in--
                                    ``(I) the diagnosis or treatment of 
                                1 or more individuals; or
                                    ``(II) responding to an 
                                environmental release or exposure; and
                          ``(ii) 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
                    ``(C) 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;
            ``(6) 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--
                    ``(A) have a reasonable basis to suspect that--
                          ``(i) a medical, public health, or 
                      environmental emergency exists;

[[Page 130 STAT. 486]]

                          ``(ii) the information is necessary for, or 
                      will assist in, emergency or first-aid diagnosis 
                      or treatment; or
                          ``(iii) 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
                    ``(B) if requested by a person who has a claim with 
                respect to the information under this section--
                          ``(i) provide a written statement of need and 
                      agree to sign a confidentiality agreement, as 
                      described in paragraph (5); and
                          ``(ii) submit to the Administrator such 
                      statement of need and confidentiality agreement as 
                      soon as practicable, but not necessarily before 
                      the information is disclosed;
            ``(7) <<NOTE: Determination.>>  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;
            ``(8) shall be disclosed if the information is required to 
        be made public under any other provision of Federal law; and
            ``(9) 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.

    ``(e) Duration of Protection From Disclosure.--
            ``(1) In general.--Subject to paragraph (2), subsection 
        (f)(3), and section 8(b), the Administrator shall protect from 
        disclosure information described in subsection (a)--
                    ``(A) in the case of information described in 
                subsection (c)(2), until such time as--
                          ``(i) <<NOTE: Notification.>>  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
                          ``(ii) 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
                    ``(B) in the case of information other than 
                information described in subsection (c)(2)--
                          ``(i) <<NOTE: Time period.>>  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
                          ``(ii) if applicable before the expiration of 
                      such 10-year period, until such time as--
                                    ``(I) <<NOTE: Notification.>>  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
                                    ``(II) the Administrator becomes 
                                aware that the information does not 
                                qualify for protection from disclosure 
                                under this section, in which case the

[[Page 130 STAT. 487]]

                                Administrator shall take any actions 
                                required under subsections (f) and (g).
            ``(2) <<NOTE: Deadlines.>>  Extensions.--
                    ``(A) <<NOTE: Notice.>>  In general.--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.
                    ``(B) Request.--
                          ``(i) In general.--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.
                          ``(ii) Action by administrator.--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)--
                                    ``(I) <<NOTE: Review.>>  review the 
                                request submitted under clause (i);
                                    ``(II) <<NOTE: Determination.>>  
                                make a determination regarding whether 
                                the claim for which the request was 
                                submitted continues to meet the relevant 
                                requirements of this section; and
                                    ``(III)(aa) grant an extension of 10 
                                years; or
                                    ``(bb) deny the request.
                    ``(C) <<NOTE: Determination.>>  No limit on number 
                of extensions.--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)--
                          ``(i) establishes the need to extend the 
                      period; and
                          ``(ii) meets the requirements established by 
                      the Administrator.

    ``(f) Review and Resubstantiation.--
            ``(1) Discretion of administrator.--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 Frank R. Lautenberg Chemical Safety 
        for the 21st Century Act, to reassert and substantiate or 
        resubstantiate the claim in accordance with this section--
                    ``(A) after the chemical substance is designated as 
                a high-priority substance under section 6(b);
                    ``(B) for any chemical substance designated as an 
                active substance under section 8(b)(5)(B)(iii); or
                    ``(C) <<NOTE: Determination.>>  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.
            ``(2) Review required.--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 Frank R. Lautenberg Chemical Safety

[[Page 130 STAT. 488]]

        for the 21st Century Act, to reassert and substantiate or 
        resubstantiate the claim in accordance with this section--
                    ``(A) 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;
                    ``(B) if the Administrator has a reasonable basis to 
                believe that the information does not qualify for 
                protection from disclosure under this section; or
                    ``(C) for any chemical substance the Administrator 
                determines under section 6(b)(4)(A) presents an 
                unreasonable risk of injury to health or the 
                environment.
            ``(3) <<NOTE: Claims. Determination.>>  Period of 
        protection.--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.

    ``(g) Duties of Administrator.--
            ``(1) Determination.--
                    ``(A) <<NOTE: Claims. Deadlines.>>  In general.--
                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.
                    ``(B) Reasons for denial.--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.
                    ``(C) Subsets.--The Administrator shall--
                          ``(i) 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
                          ``(ii) review a representative subset, 
                      comprising at least 25 percent, of all other 
                      claims or requests for protection from disclosure 
                      under this section.
                    ``(D) Effect of failure to act.--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.
                    ``(E) Determination of requests under subsection 
                (b)(4)(C).--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

[[Page 130 STAT. 489]]

                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.
            ``(2) <<NOTE: Claims.>>  Notification.--
                    ``(A) In general.--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.
                    ``(B) <<NOTE: Deadline.>>  Disclosure of 
                information.--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).
                    ``(C) Exceptions.--
                          ``(i) <<NOTE: Determination.>>  Fifteen day 
                      notification.--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.
                          ``(ii) Notification as soon as practicable.--
                      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.
                          ``(iii) No notification required.--
                      Notification shall not be required--
                                    ``(I) for the disclosure of 
                                information under paragraphs (1), (2), 
                                (7), or (8) of subsection (d); or
                                    ``(II) for the disclosure of 
                                information for which--

[[Page 130 STAT. 490]]

                                            ``(aa) the Administrator has 
                                        provided to the person that 
                                        asserted the claim a notice 
                                        under subsection (e)(2)(A); and
                                            ``(bb) 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).
                    ``(D) Appeals.--
                          ``(i) Action to restrain disclosure.--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--
                                    ``(I) the United States district 
                                court of the district in which the 
                                complainant resides or has the principal 
                                place of business; or
                                    ``(II) the United States District 
                                Court for the District of Columbia.
                          ``(ii) No disclosure.--
                                    ``(I) In general.--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).
                                    ``(II) Exception.--Subclause (I) 
                                shall not apply to disclosure of 
                                information described under subsections 
                                (d)(4) and (j).
            ``(3) <<NOTE: Consultation.>>  Request and notification 
        system.--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).
            ``(4) Unique identifier.--The Administrator shall--
                    ``(A)(i) 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
                    ``(ii) <<NOTE: Applicability.>>  apply that 
                identifier consistently to all information relevant to 
                the applicable chemical substance;
                    ``(B) <<NOTE: Deadline. Publication. List.>>  
                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;
                    ``(C) 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

[[Page 130 STAT. 491]]

                    ``(D) 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.

    ``(h) Criminal Penalty for Wrongful Disclosure.--
            ``(1) Individuals subject to penalty.--
                    ``(A) In general.--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.
                    ``(B) Description.--An individual referred to in 
                subparagraph (A) is an individual who--
                          ``(i) pursuant to this section, obtained 
                      possession of, or has access to, information 
                      protected from disclosure under this section; and
                          ``(ii) 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.
                    ``(C) Exception.--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.
            ``(2) Other laws.--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.

    ``(i) Applicability.--
            ``(1) In general.--Except as otherwise provided in this 
        section, section 8, or any other applicable Federal law, the 
        Administrator shall have no authority--
                    ``(A) 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 Frank R. Lautenberg 
                Chemical Safety for the 21st Century Act; or
                    ``(B) 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.
            ``(2) Actions prior to promulgation of rules.--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

[[Page 130 STAT. 492]]

        promulgate after the date of enactment of the Frank R. 
        Lautenberg Chemical Safety for the 21st Century Act.

    ``(j) Access by Congress.--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.''.
SEC. 12. PENALTIES.

    Section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) is 
amended--
            (1) in subsection (a)(1), by striking ``$25,000'' and 
        inserting ``$37,500''; and
            (2) in subsection (b)--
                    (A) by striking ``Any person'' and inserting the 
                following:
            ``(1) In general.--Any person'';
                    (B) by striking ``$25,000'' and inserting 
                ``$50,000''; and
                    (C) by adding at the end the following:
            ``(2) Imminent danger of death or serious bodily injury.--
                    ``(A) In general.--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.
                    ``(B) Organizations.--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.
                    ``(C) <<NOTE: Applicability.>>  Incorporation of 
                corresponding provisions.--Subparagraphs (B) through (F) 
                of section 113(c)(5) of the Clean Air Act (42 U.S.C. 
                7413(c)(5)(B)-(F)) shall apply to the prosecution of a 
                violation under this paragraph.''.
SEC. 13. STATE-FEDERAL RELATIONSHIP.

    Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is 
amended--
            (1) by amending subsection (a) to read as follows:

    ``(a) In General.--
            ``(1) Establishment or enforcement.--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:
                    ``(A) Development of information.--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--
                          ``(i) a rule promulgated by the Administrator;
                          ``(ii) a consent agreement entered into by the 
                      Administrator; or
                          ``(iii) an order issued by the Administrator.

[[Page 130 STAT. 493]]

                    ``(B) Chemical substances found not to present an 
                unreasonable risk or restricted.--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--
                          ``(i) 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
                          ``(ii) 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).
                    ``(C) Significant new use.--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.
            ``(2) Effective date of preemption.--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.'';
            (2) by amending subsection (b) to read as follows:

    ``(b) New Statutes, Criminal Penalties, or Administrative Actions 
Creating Prohibitions or Other Restrictions.--
            ``(1) <<NOTE: Time period.>>  In general.--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).
            ``(2) Effect of subsection.--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).''; and
            (3) by adding at the end the following:

    ``(c) <<NOTE: Applicability.>>  Scope of Preemption.--Federal 
preemption under subsections (a) and (b) of statutes, criminal 
penalties, and administrative actions applicable to specific chemical 
substances shall apply only to--
            ``(1) 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;
            ``(2) with respect to subsection (b), the hazards, 
        exposures, risks, and uses or conditions of use of such chemical 
        substances

[[Page 130 STAT. 494]]

        included in the scope of the risk evaluation pursuant to section 
        6(b)(4)(D);
            ``(3) 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
            ``(4) 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.

    ``(d) Exceptions.--
            ``(1) No preemption of statutes and administrative 
        actions.--
                    ``(A) In general.--Nothing in this Act, nor any 
                amendment made by the Frank R. Lautenberg Chemical 
                Safety for the 21st Century Act, 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--
                          ``(i) 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;
                          ``(ii) 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;
                          ``(iii) 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--
                                    ``(I) imposes a restriction on the 
                                manufacture, processing, distribution in 
                                commerce, or use of a chemical 
                                substance; and
                                    ``(II)(aa) 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
                                    ``(bb) would cause a violation of 
                                the applicable action by the 
                                Administrator under section 5 or 6; or
                          ``(iv) subject to subparagraph (B), is 
                      identical to a requirement prescribed by the 
                      Administrator.
                    ``(B) Identical requirements.--
                          ``(i) In general.--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.
                          ``(ii) Penalties.--In the case of an identical 
                      requirement--

[[Page 130 STAT. 495]]

                                    ``(I) 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
                                    ``(II) 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.
            ``(2) Applicability to certain rules or orders.--
                    ``(A) Prior rules and orders.--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 Frank R. Lautenberg 
                Chemical Safety for the 21st Century Act, of any rule or 
                order promulgated or issued under this Act prior to that 
                effective date.
                    ``(B) Certain chemical substances and mixtures.--
                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 Frank R. 
                Lautenberg Chemical Safety for the 21st Century Act 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 Frank R. Lautenberg 
                Chemical Safety for the 21st Century Act 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).

    ``(e) Preservation of Certain Laws.--
            ``(1) In general.--Nothing in this Act, subject to 
        subsection (g) of this section, shall--
                    ``(A) 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
                    ``(B) be construed to preempt or otherwise affect 
                any action taken pursuant to a State law that was in 
                effect on August 31, 2003.
            ``(2) Effect of subsection.--This subsection does not 
        affect, modify, or alter the relationship between Federal law

[[Page 130 STAT. 496]]

        and laws of a State or political subdivision of a State pursuant 
        to any other Federal law.

    ``(f) Waivers.--
            ``(1) <<NOTE: Determination.>>  Discretionary exemptions.--
        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--
                    ``(A) compelling conditions warrant granting the 
                waiver to protect health or the environment;
                    ``(B) 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;
                    ``(C) 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
                    ``(D) 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--
                          ``(i) consistent with the best available 
                      science;
                          ``(ii) using supporting studies conducted in 
                      accordance with sound and objective scientific 
                      practices; and
                          ``(iii) based on the weight of the scientific 
                      evidence.
            ``(2) <<NOTE: Determination.>>  Required exemptions.--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--
                    ``(A)(i) 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;
                    ``(ii) 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
                    ``(iii) 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
                    ``(B) <<NOTE: Deadline.>>  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

[[Page 130 STAT. 497]]

                or otherwise restrict the manufacture, processing, 
                distribution in commerce, or use of the chemical 
                substance.
            ``(3) <<NOTE: Deadlines.>>  Determination of a waiver 
        request.--The duty of the Administrator to grant or deny a 
        waiver application shall be nondelegable and shall be 
        exercised--
                    ``(A) not later than 180 days after the date on 
                which an application under paragraph (1) is submitted; 
                and
                    ``(B) not later than 110 days after the date on 
                which an application under paragraph (2) is submitted.
            ``(4) <<NOTE: Time period.>>  Failure to make a 
        determination.--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.
            ``(5) Notice and comment.--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.
            ``(6) Final agency action.--The decision of the 
        Administrator on the application of a State or political 
        subdivision of a State shall be--
                    ``(A) considered to be a final agency action; and
                    ``(B) subject to judicial review.
            ``(7) Duration of waivers.--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).
            ``(8) <<NOTE: Deadline.>>  Judicial review of waivers.--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.
            ``(9) Approval.--
                    ``(A) <<NOTE: Effective date.>>  Automatic 
                approval.--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.
                    ``(B) Requirements.--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.

    ``(g) Savings.--
            ``(1) No preemption of common law or statutory causes of 
        action for civil relief or criminal conduct.--
                    ``(A) In general.--Nothing in this Act, nor any 
                amendment made by the Frank R. Lautenberg Chemical 
                Safety for the 21st Century Act, nor any standard, rule, 
                requirement, standard of performance, risk evaluation, 
                or scientific assessment implemented pursuant to this 
                Act, shall be

[[Page 130 STAT. 498]]

                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.
                    ``(B) Clarification of no preemption.--
                Notwithstanding any other provision of this Act, nothing 
                in this Act, nor any amendments made by the Frank R. 
                Lautenberg Chemical Safety for the 21st Century Act, 
                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.
            ``(2) No effect on private remedies.--
                    ``(A) In general.--Nothing in this Act, nor any 
                amendments made by the Frank R. Lautenberg Chemical 
                Safety for the 21st Century Act, 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.
                    ``(B) Authority of courts.--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.''.
SEC. 14. JUDICIAL REVIEW.

    Section 19(a) of the Toxic Substances Control Act (15 U.S.C. 
2618(a)) is amended--
            (1) in paragraph (1), by adding at the end the following:
            ``(C)(i) <<NOTE: Deadline.>>  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.
            ``(ii) The United States Court of Appeals for the District 
        of Columbia Circuit shall have exclusive jurisdiction over a 
        civil action filed under this subparagraph.''; and
            (2) by striking paragraph (3).
SEC. 15. CITIZENS' CIVIL ACTIONS.

    Section 20(b) of the Toxic Substances Control Act (15 U.S.C. 
2619(b)) is amended--
            (1) in paragraph (1)(B), by striking ``or'' at the end; and
            (2) in paragraph (2), by striking the period at the end and 
        inserting the following: ``, 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
            ``(3) <<NOTE: Time period.>>  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).''.

[[Page 130 STAT. 499]]

SEC. 16. STUDIES.

    Section 25 of the Toxic Substances Control Act (15 U.S.C. 2624) is 
repealed. <<NOTE: Repeal.>> 
SEC. 17. ADMINISTRATION OF THE ACT.

    Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is 
amended--
            (1) in subsection (b)(1)--
                    (A) by striking ``of a reasonable fee'';
                    (B) by striking ``data under section 4 or 5 to 
                defray the cost of administering this Act'' and 
                inserting ``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'';
                    (C) by striking ``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.''; and
                    (D) by striking ``submit the data and the cost to 
                the Administrator of reviewing such data'' and inserting 
                ``pay such fee and the cost to the Administrator of 
                carrying out the activities described in this 
                paragraph'';
            (2) in subsection (b)--
                    (A) in paragraph (2), by striking ``paragraph (1)'' 
                and inserting ``paragraph (4)''; and
                    (B) by adding at the end the following:

    ``(3) Fund.--
            ``(A) Establishment.--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 `Fund'), consisting 
        of such amounts as are deposited in the Fund under this 
        paragraph.
            ``(B) Collection and deposit of fees.--Subject to the 
        conditions of subparagraph (C), the Administrator shall collect 
        the fees described in this subsection and deposit those fees in 
        the Fund.
            ``(C) Use of funds by administrator.--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).
            ``(D) Accounting and auditing.--
                    ``(i) <<NOTE: Deadline. Reports.>>  Accounting.--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,

[[Page 130 STAT. 500]]

                as reflected by financial statements provided in 
                accordance with sections 3515 and 3521 of title 31, 
                United States Code.
                    ``(ii) Auditing.--
                          ``(I) In general.--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.
                          ``(II) <<NOTE: Analysis.>>  Components of 
                      audit.--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--
                                    ``(aa) the fees collected and 
                                amounts disbursed under this subsection;
                                    ``(bb) 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
                                    ``(cc) the number of requests for a 
                                risk evaluation made by manufacturers 
                                under section 6(b)(4)(C)(ii).
                          ``(III) <<NOTE: Reports.>>  Federal 
                      responsibility.--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.

    ``(4) Amount and Adjustment of Fees; Refunds.--In setting fees under 
this section, the Administrator shall--
            ``(A) <<NOTE: Consultation.>>  prescribe lower fees for 
        small business concerns, after consultation with the 
        Administrator of the Small Business Administration;
            ``(B) 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--
                    ``(i) the lower of--
                          ``(I) 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
                          ``(II) $25,000,000 (subject to adjustment 
                      pursuant to subparagraph (F)); and
                    ``(ii) the costs of risk evaluations specified in 
                subparagraph (D);
            ``(C) 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;
            ``(D) notwithstanding subparagraph (B)--
                    ``(i) 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

[[Page 130 STAT. 501]]

                costs to the Administrator of conducting the risk 
                evaluation under section 6(b);
                    ``(ii) 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
                    ``(iii) <<NOTE: Applicability.>>  apply fees 
                collected pursuant to clauses (i) and (ii) only to 
                defray the costs described in those clauses;
            ``(E) <<NOTE: Consultation.>>  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 chapter 5 of title 5, United States Code, is 
        applicable with respect to such meetings;
            ``(F) <<NOTE: Effective date. Deadline. Consultation.>>  
        beginning with the fiscal year that is 3 years after the date of 
        enactment of the Frank R. Lautenberg Chemical Safety for the 
        21st Century Act, 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--
                    ``(i) 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
                    ``(ii) the costs of risk evaluations specified in 
                subparagraph (D); and
            ``(G) <<NOTE: Notice.>>  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.

    ``(5) Minimum Amount of Appropriations.--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.
    ``(6) Termination.--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 Frank R. Lautenberg Chemical Safety for the 
21st Century Act unless otherwise reauthorized or modified by 
Congress.''; and
            (3) by adding at the end the following:

    ``(h) <<NOTE: Applicability.>>  Scientific Standards.--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--

[[Page 130 STAT. 502]]

            ``(1) 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;
            ``(2) the extent to which the information is relevant for 
        the Administrator's use in making a decision about a chemical 
        substance or mixture;
            ``(3) the degree of clarity and completeness with which the 
        data, assumptions, methods, quality assurance, and analyses 
        employed to generate the information are documented;
            ``(4) 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
            ``(5) the extent of independent verification or peer review 
        of the information or of the procedures, measures, methods, 
        protocols, methodologies, or models.

    ``(i) Weight of Scientific Evidence.--The Administrator shall make 
decisions under sections 4, 5, and 6 based on the weight of the 
scientific evidence.
    ``(j) <<NOTE: Public information.>>  Availability of Information.--
Subject to section 14, the Administrator shall make available to the 
public--
            ``(1) all notices, determinations, findings, rules, consent 
        agreements, and orders of the Administrator under this title;
            ``(2) any information required to be provided to the 
        Administrator under section 4;
            ``(3) a nontechnical summary of each risk evaluation 
        conducted under section 6(b);
            ``(4) <<NOTE: List.>>  a list of the studies considered by 
        the Administrator in carrying out each such risk evaluation, 
        along with the results of those studies; and
            ``(5) 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.

    ``(k) Reasonably Available Information.--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.
    ``(l) <<NOTE: Deadlines.>>  Policies, Procedures, and Guidance.--
            ``(1) Development.--Not later than 2 years after the date of 
        enactment of the Frank R. Lautenberg Chemical Safety for the 
        21st Century Act, 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 
        Frank R. Lautenberg Chemical Safety for the 21st Century Act.
            ``(2) Review.--Not later than 5 years after the date of 
        enactment of the Frank R. Lautenberg Chemical Safety for the 
        21st Century Act, and not less frequently than once every 5 
        years thereafter, the Administrator shall--
                    ``(A) 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

[[Page 130 STAT. 503]]

                    ``(B) revise such policies, procedures, and guidance 
                as the Administrator determines necessary to reflect new 
                scientific developments or understandings.
            ``(3) <<NOTE: Applicability.>>  Testing of chemical 
        substances and mixtures.--The policies, procedures, and guidance 
        developed under paragraph (1) applicable to testing chemical 
        substances and mixtures shall--
                    ``(A) 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
                    ``(B) 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.
            ``(4) Chemical substances with completed risk assessments.--
        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 Frank R. Lautenberg Chemical Safety 
        for the 21st Century Act, 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.
            ``(5) <<NOTE: Deadline.>>  Guidance.--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.

    ``(m) Report to Congress.--
            ``(1) <<NOTE: Estimate.>>  Initial report.--Not later than 6 
        months after the date of enactment of the Frank R. Lautenberg 
        Chemical Safety for the 21st Century Act, 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--
                    ``(A) 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);
                    ``(B) 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;
                    ``(C) the capacity of the Environmental Protection 
                Agency to promulgate rules under section 6(a) as 
                required

[[Page 130 STAT. 504]]

                based on risk evaluations conducted and published under 
                section 6(b); and
                    ``(D) 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).
            ``(2) Subsequent reports.--The Administrator shall update 
        and resubmit the report described in paragraph (1) not less 
        frequently than once every 5 years.

    ``(n) Annual Plan.--
            ``(1) In general.--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.
            ``(2) Publication of plan.--At the beginning of each 
        calendar year, the Administrator shall publish an annual plan 
        that--
                    ``(A) identifies the chemical substances for which 
                risk evaluations are expected to be initiated or 
                completed that year and the resources necessary for 
                their completion;
                    ``(B) describes the status of each risk evaluation 
                that has been initiated but not yet completed; and
                    ``(C) if the schedule for completion of a risk 
                evaluation has changed, includes an updated schedule for 
                that risk evaluation.

    ``(o) Consultation With Science Advisory Committee on Chemicals.--
            ``(1) <<NOTE: Deadline.>>  Establishment.--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 establish an advisory committee, to be known as the 
        Science Advisory Committee on Chemicals (referred to in this 
        subsection as the `Committee').
            ``(2) Purpose.--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.
            ``(3) Composition.--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.
            ``(4) Schedule.--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.

    ``(p) Prior Actions.--
            ``(1) Rules, orders, and exemptions.--Nothing in the Frank 
        R. Lautenberg Chemical Safety for the 21st Century Act 
        eliminates, modifies, or withdraws any rule promulgated, order 
        issued, or exemption established pursuant to this Act before the 
        date of enactment of the Frank R. Lautenberg Chemical Safety for 
        the 21st Century Act.
            ``(2) Prior-initiated evaluations.--Nothing in this Act 
        prevents the Administrator from initiating a risk evaluation

[[Page 130 STAT. 505]]

        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 Frank 
        R. Lautenberg Chemical Safety for the 21st Century Act.
            ``(3) Actions completed prior to completion of policies, 
        procedures, and guidance.--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 Frank R. 
        Lautenberg Chemical Safety for the 21st Century Act.''.
SEC. 18. STATE PROGRAMS.

    Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is 
amended by striking subsections (c) and (d).
SEC. 19. CONFORMING AMENDMENTS.

    (a) Table of Contents.--The table of contents in section 1 of the 
Toxic Substances Control Act is amended--
            (1) by striking the item relating to section 6 and inserting 
        the following:

``Sec. 6. Prioritization, risk evaluation, and regulation of chemical 
           substances and mixtures.'';

            (2) by striking the item relating to section 10 and 
        inserting the following:

``Sec. 10. Research, development, collection, dissemination, and 
           utilization of information.'';

            (3) by striking the item relating to section 14 and 
        inserting the following:

``Sec. 14. Confidential information.''; and

            (4) by striking the item relating to section 25.

    (b) Section 2.--Section 2(b)(1) of the Toxic Substances Control Act 
(15 U.S.C. 2601(b)(1)) is amended by striking ``data'' both places it 
appears and inserting ``information''.
    (c) Section 3.--Section 3 of the Toxic Substances Control Act (15 
U.S.C. 2602) is amended--
            (1) in paragraph (8) (as redesignated by section 3 of this 
        Act), by striking ``data'' and inserting ``information''; and
            (2) in paragraph (15) (as redesignated by section 3 of this 
        Act)--
                    (A) by striking ``standards'' and inserting 
                ``protocols and methodologies'';
                    (B) by striking ``test data'' both places it appears 
                and inserting ``information''; and
                    (C) by striking ``data'' each place it appears and 
                inserting ``information''.

    (d) Section 4.--Section 4 of the Toxic Substances Control Act (15 
U.S.C. 2603) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)--

[[Page 130 STAT. 506]]

                          (i) in the paragraph heading, by adding ``, 
                      order, or consent agreement'' at the end; and
                          (ii) by striking ``rule'' each place it 
                      appears and inserting ``rule, order, or consent 
                      agreement'';
                    (B) in paragraph (2)(B), by striking ``rules'' and 
                inserting ``rules, orders, and consent agreements'';
                    (C) in paragraph (3)(A), by striking ``rule'' and 
                inserting ``rule or order''; and
                    (D) in paragraph (4)--
                          (i) by striking ``rule under subsection (a)'' 
                      each place it appears and inserting ``rule, order, 
                      or consent agreement under subsection (a)'';
                          (ii) by striking ``repeals the rule'' each 
                      place it appears and inserting ``repeals the rule 
                      or order or modifies the consent agreement to 
                      terminate the requirement''; and
                          (iii) by striking ``repeals the application of 
                      the rule'' and inserting ``repeals or modifies the 
                      application of the rule, order, or consent 
                      agreement'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by striking ``rule'' and 
                inserting ``rule or order'';
                    (B) in paragraph (2)--
                          (i) in subparagraph (A), by striking ``a rule 
                      under subsection (a) or for which data is being 
                      developed pursuant to such a rule'' and inserting 
                      ``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'';
                          (ii) in subparagraph (B), by striking ``such 
                      rule or which is being developed pursuant to such 
                      rule'' and inserting ``such rule, order, or 
                      consent agreement or which is being developed 
                      pursuant to such rule, order, or consent 
                      agreement''; and
                          (iii) in the matter following subparagraph 
                      (B), by striking ``the rule'' and inserting ``the 
                      rule or order'';
                    (C) in paragraph (3)(B)(i), by striking ``rule 
                promulgated'' and inserting ``rule, order, or consent 
                agreement''; and
                    (D) in paragraph (4)--
                          (i) by striking ``rule promulgated'' each 
                      place it appears and inserting ``rule, order, or 
                      consent agreement'';
                          (ii) by striking ``such rule'' each place it 
                      appears and inserting ``such rule, order, or 
                      consent agreement''; and
                          (iii) in subparagraph (B), by striking ``the 
                      rule'' and inserting ``the rule or order'';
            (3) in subsection (d), by striking ``rule'' and inserting 
        ``rule, order, or consent agreement''; and
            (4) in subsection (g), by striking ``rule'' and inserting 
        ``rule, order, or consent agreement''.

    (e) Section 5.--Section 5 of the Toxic Substances Control Act (15 
U.S.C. 2604) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)(A)--

[[Page 130 STAT. 507]]

                          (i) by striking ``rule promulgated'' and 
                      inserting ``rule, order, or consent agreement''; 
                      and
                          (ii) by striking ``such rule'' and inserting 
                      ``such rule, order, or consent agreement'';
                    (B) in paragraph (1)(B), by striking ``rule 
                promulgated'' and inserting ``rule or order''; and
                    (C) in paragraph (2)(A)(ii), by striking ``rule 
                promulgated'' and inserting ``rule, order, or consent 
                agreement''; and
            (2) in subsection (d)(2)(C), by striking ``rule'' and 
        inserting ``rule, order, or consent agreement''.

    (f) Section 7.--Section 7(a) of the Toxic Substances Control Act (15 
U.S.C. 2606(a)) is amended--
            (1) in paragraph (1), in the matter following subparagraph 
        (C), by striking ``a rule under section 4, 5, 6, or title IV or 
        an order under section 5 or title IV'' and inserting ``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''; and
            (2) in paragraph (2), by striking ``subsection 
        6(d)(2)(A)(i)'' and inserting ``section 6(d)(3)(A)(i)''.

    (g) Section 8.--Section 8(a) of the Toxic Substances Control Act (15 
U.S.C. 2607(a)) is amended--
            (1) in paragraph (2)(E), by striking ``data'' and inserting 
        ``information''; and
            (2) in paragraph (3)(A)(ii)(I), by striking ``or an order in 
        effect under section 5(e)'' and inserting ``, an order in effect 
        under section 4 or 5(e), or a consent agreement under section 
        4''.

    (h) Section 9.--Section 9 of the Toxic Substances Control Act (15 
U.S.C. 2608) is amended--
            (1) in subsection (a), by striking ``section 6'' each place 
        it appears and inserting ``section 6(a)''; and
            (2) in subsection (d), by striking ``Health, Education, and 
        Welfare'' and inserting ``Health and Human Services''.

    (i) Section 10.--Section 10 of the Toxic Substances Control Act (15 
U.S.C. 2609) is amended--
            (1) in the section heading, by striking ``data'' and 
        inserting ``information'';
            (2) by striking ``Health, Education, and Welfare'' each 
        place it appears and inserting ``Health and Human Services'';
            (3) in subsection (b)--
                    (A) in the subsection heading, by striking ``Data'' 
                and inserting ``Information'';
                    (B) by striking ``data'' and inserting 
                ``information'' in paragraph (1);
                    (C) by striking ``data'' and inserting 
                ``information'' in paragraph (2)(A); and
                    (D) by striking ``a data'' and inserting ``an 
                information'' in paragraph (2)(B); and
            (4) in subsection (g), by striking ``data'' and inserting 
        ``information''.

    (j) Section 11.--Section 11(b)(2) of the Toxic Substances Control 
Act (15 U.S.C. 2610(b)(2)) is amended--
            (1) by striking ``data'' each place it appears and inserting 
        ``information''; and

[[Page 130 STAT. 508]]

            (2) in subparagraph (E), by striking ``rule promulgated'' 
        and inserting ``rule promulgated, order issued, or consent 
        agreement entered into''.

    (k) Section 12.--Section 12(b)(1) of the Toxic Substances Control 
Act (15 U.S.C. 2611(b)(1)) is amended by striking ``data'' both places 
it appears and inserting ``information''.
    (l) Section 15.--Section 15(1) of the Toxic Substances Control Act 
(15 U.S.C. 2614(1)) is amended by striking ``(A) any rule'' and all that 
follows through ``or (D)'' and inserting ``any requirement of this title 
or any rule promulgated, order issued, or consent agreement entered into 
under this title, or''.
    (m) Section 19.--Section 19 of the Toxic Substances Control Act (15 
U.S.C. 2618) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)(A)--
                          (i) by striking ``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'' and inserting ``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),'';
                          (ii) by striking ``such rule'' and inserting 
                      ``such rule or order''; and
                          (iii) by striking ``such a rule'' and 
                      inserting ``such a rule or order'';
                    (B) in paragraph (1)(B)--
                          (i) by striking ``Courts'' and inserting 
                      ``Except as otherwise provided in this title, 
                      courts''; and
                          (ii) by striking ``subparagraph (A) or (B) of 
                      section 6(b)(1)'' and inserting ``this title, 
                      other than an order under section 4, 5(e), 5(f), 
                      or 6(i)(1),''; and
                    (C) in paragraph (2)--
                          (i) by striking ``rulemaking record'' and 
                      inserting ``record''; and
                          (ii) by striking ``based the rule'' and 
                      inserting ``based the rule or order'';
            (2) in subsection (b)--
                    (A) by striking ``review a rule'' and inserting 
                ``review a rule, or an order under section 4, 5(e), 
                5(f), or 6(i)(1),'';
                    (B) by striking ``such rule'' and inserting ``such 
                rule or order'';
                    (C) by striking ``the rule'' and inserting ``the 
                rule or order'';
                    (D) by striking ``new rule'' each place it appears 
                and inserting ``new rule or order''; and
                    (E) by striking ``modified rule'' and inserting 
                ``modified rule or order''; and
            (3) in subsection (c)--
                    (A) in paragraph (1)--
                          (i) in subparagraph (A)--
                                    (I) by striking ``a rule'' and 
                                inserting ``a rule or order''; and
                                    (II) by striking ``such rule'' and 
                                inserting ``such rule or order'';
                          (ii) in subparagraph (B)--

[[Page 130 STAT. 509]]

                                    (I) in the matter preceding clause 
                                (i), by striking ``a rule'' and 
                                inserting ``a rule or order'';
                                    (II) by amending clause (i) to read 
                                as follows:
            ``(i) in the case of review of--
                    ``(I) 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
                    ``(II) 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''; and
                                    (III) by striking clauses (ii) and 
                                (iii) and the matter after clause (iii) 
                                and inserting the following:
            ``(ii) 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.''; and
                          (iii) by striking subparagraph (C); and
                    (B) in paragraph (2), by striking ``any rule'' and 
                inserting ``any rule or order''.

    (n) Section 20.--Section 20(a)(1) of the Toxic Substances Control 
Act (15 U.S.C. 2619(a)(1)) is amended by striking ``order issued under 
section 5'' and inserting ``order issued under section 4 or 5''.
    (o) Section 21.--Section 21 of the Toxic Substances Control Act (15 
U.S.C. 2620) is amended--
            (1) in subsection (a), by striking ``order under section 
        5(e) or (6)(b)(2)'' and inserting ``order under section 4 or 
        5(e) or (f)''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by striking ``order under 
                section 5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting 
                ``order under section 4 or 5(e) or (f)''; and
                    (B) in paragraph (4)(B)--
                          (i) in the matter preceding clause (i), by 
                      striking ``order under section 5(e) or 6(b)(2)'' 
                      and inserting ``order under section 4 or 5(e) or 
                      (f)'';
                          (ii) in clause (i), by striking ``order under 
                      section 5(e)'' and inserting ``order under section 
                      4 or 5(e)''; and
                          (iii) in clause (ii), by striking ``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'' and 
                      inserting ``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

[[Page 130 STAT. 510]]

                      factors, including an unreasonable risk to a 
                      potentially exposed or susceptible subpopulation, 
                      under the conditions of use''.

    (p) Section 24.--Section 24(b)(2)(B) of the Toxic Substances Control 
Act (15 U.S.C. 2623(b)(2)(B)) is amended--
            (1) by inserting ``and'' at the end of clause (i);
            (2) by striking clause (ii); and
            (3) by redesignating clause (iii) as clause (ii).

    (q) Section 26.--Section 26 of the Toxic Substances Control Act (15 
U.S.C. 2625) is amended--
            (1) in subsection (e), by striking ``Health, Education, and 
        Welfare'' each place it appears and inserting ``Health and Human 
        Services''; and
            (2) in subsection (g)(1), by striking ``data'' and inserting 
        ``information''.

    (r) Section 27.--Section 27(a) of the Toxic Substances Control Act 
(15 U.S.C. 2626(a)) is amended--
            (1) by striking ``Health, Education, and Welfare'' and 
        inserting ``Health and Human Services'';
            (2) by striking ``test data'' both places it appears and 
        inserting ``information'';
            (3) by striking ``rules promulgated'' and inserting ``rules, 
        orders, or consent agreements''; and
            (4) by striking ``standards'' and inserting ``protocols and 
        methodologies''.

    (s) Section 30.--Section 30(2) of the Toxic Substances Control Act 
(15 U.S.C. 2629(2)) is amended by striking ``rule'' and inserting 
``rule, order, or consent agreement''.
SEC. 20. <<NOTE: 15 USC 2601 note.>>  NO RETROACTIVITY.

    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.
SEC. 21. <<NOTE: 42 USC 280g-17 note.>>  TREVOR'S LAW.

    (a) Purposes.--The purposes of this section are--
            (1) to provide the appropriate Federal agencies with the 
        authority to help conduct investigations into potential cancer 
        clusters;
            (2) 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
            (3) 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.

    (b) Designation and Investigation of Potential Cancer Clusters.--
Part P of title III of the Public Health Service Act (42 U.S.C. 280g et 
seq.) is amended by adding at the end the following:
``SEC. 399V-6. <<NOTE: 42 USC 280g-17.>>  DESIGNATION AND 
                              INVESTIGATION OF POTENTIAL CANCER 
                              CLUSTERS.

    ``(a) Definitions.--In this section:
            ``(1) Cancer cluster.--The term `cancer cluster' means the 
        incidence of a particular cancer within a population group,

[[Page 130 STAT. 511]]

        a geographical area, and a period of time that is greater than 
        expected for such group, area, and period.
            ``(2) Particular cancer.--The term `particular cancer' means 
        one specific type of cancer or a type of cancers scientifically 
        proven to have the same cause.
            ``(3) Population group.--The term `population group' means a 
        group, for purposes of calculating cancer rates, defined by 
        factors such as race, ethnicity, age, or gender.

    ``(b) Criteria for Designation of Potential Cancer Clusters.--
            ``(1) Development of criteria.--The Secretary shall develop 
        criteria for the designation of potential cancer clusters.
            ``(2) Requirements.--The criteria developed under paragraph 
        (1) shall consider, as appropriate--
                    ``(A) a standard for cancer cluster identification 
                and reporting protocols used to determine when cancer 
                incidence is greater than would be typically observed;
                    ``(B) scientific screening standards that ensure 
                that a cluster of a particular cancer involves the same 
                type of cancer, or types of cancers;
                    ``(C) 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;
                    ``(D) 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
                    ``(E) the time period over which the number of cases 
                of a particular cancer, or the calculation of an 
                expected number of cases, occurs.

    ``(c) Guidelines for Investigation of Potential Cancer Clusters.--
The Secretary, <<NOTE: Consultation. Publication.>>  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--
            ``(1) <<NOTE: Recommenda- tion.>>  recommend that 
        investigations of cancer clusters--
                    ``(A) use the criteria developed under subsection 
                (b);
                    ``(B) use the best available science; and
                    ``(C) rely on a weight of the scientific evidence;
            ``(2) provide standardized methods of reviewing and 
        categorizing data, including from health surveillance systems 
        and reports of potential cancer clusters; and
            ``(3) provide guidance for using appropriate epidemiological 
        and other approaches for investigations.

    ``(d) Investigation of Cancer Clusters.--
            ``(1) Secretary discretion.--The Secretary--
                    ``(A) <<NOTE: Consultation.>>  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
                    ``(B) in conducting investigations shall have the 
                discretion to prioritize certain potential cancer 
                clusters, based on the availability of resources.
            ``(2) Coordination.--In investigating potential cancer 
        clusters, the Secretary shall coordinate with agencies within 
        the

[[Page 130 STAT. 512]]

        Department of Health and Human Services and other Federal 
        agencies, such as the Environmental Protection Agency.
            ``(3) Biomonitoring.--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.

    ``(e) Duties.--The Secretary shall--
            ``(1) 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;
            ``(2) 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;
            ``(3) consult with community members as investigations into 
        potential cancer clusters are conducted, as the Secretary 
        determines appropriate;
            ``(4) 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
            ``(5) 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.''.

 TITLE <<NOTE: Rural Healthcare Connectivity Act of 2016.>>  II--RURAL 
HEALTHCARE CONNECTIVITY
SEC. 201. <<NOTE: 47 USC 609 note.>>  SHORT TITLE.

    This title may be cited as the ``Rural Healthcare Connectivity Act 
of 2016''.
SEC. 202. TELECOMMUNICATIONS SERVICES FOR SKILLED NURSING 
                        FACILITIES.

    (a) In General.--Section 254(h)(7)(B) of the Communications Act of 
1934 (47 U.S.C. 254(h)(7)(B)) is amended--
            (1) in clause (vi), by striking ``and'' at the end;
            (2) by redesignating clause (vii) as clause (viii);
            (3) by inserting after clause (vi) the following:
                          ``(vii) skilled nursing facilities (as defined 
                      in section 1819(a) of the Social Security Act (42 
                      U.S.C. 1395i-3(a))); and''; and
            (4) in clause (viii), as redesignated, by striking ``clauses 
        (i) through (vi)'' and inserting ``clauses (i) through (vii)''.

    (b) <<NOTE: 47 USC 254 note.>>  Savings Clause.--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.

[[Page 130 STAT. 513]]

    (c) <<NOTE: 47 USC 254 note.>>  Effective Date.--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.

    Approved June 22, 2016.

LEGISLATIVE HISTORY--H.R. 2576:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 114-176 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD:
                                                        Vol. 161 (2015):
                                    June 23, considered and passed 
                                        House.
                                    Dec. 17, considered and passed 
                                        Senate, amended.
                                                        Vol. 162 (2016):
                                    May 24, House concurred in Senate 
                                        amendment with an amendment.
                                    June 7, Senate concurred in House 
                                        amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016):
            June 22, Presidential remarks.

                                  <all>
```