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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 1009 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                S. 1009

To reauthorize and modernize the Toxic Substances Control Act, and for 
                            other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 22, 2013

 Mr. Lautenberg (for himself, Mr. Vitter, Mrs. Gillibrand, Mr. Crapo, 
 Mr. Durbin, Mr. Alexander, Mr. Schumer, Mr. Inhofe, Mr. Udall of New 
Mexico, Ms. Collins, Ms. Landrieu, Mr. Rubio, Mr. Manchin, Mr. Boozman, 
  Mr. Menendez, Mr. Hoeven, and Mr. Begich) introduced the following 
bill; which was read twice and referred to the Committee on Environment 
                            and Public Works

_______________________________________________________________________

                                 A BILL

 
To reauthorize and modernize the Toxic Substances Control Act, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS; REFERENCES.

    (a) Short Title.--This Act may be cited as the ``Chemical Safety 
Improvement Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents; references.
Sec. 2. Findings, policy, and intent.
Sec. 3. Definitions.
Sec. 4. Chemical assessment framework; prioritization screening; 
                            testing.
Sec. 5. New chemicals and significant new uses.
Sec. 6. Safety assessments and determinations.
Sec. 7. Imminent hazards.
Sec. 8. Information collection and reporting.
Sec. 9. Relationship to other Federal laws.
Sec. 10. Research, development, collection, dissemination, and 
                            utilization of data.
Sec. 11. Exports.
Sec. 12. Imports.
Sec. 13. Confidential information.
Sec. 14. Prohibited acts.
Sec. 15. Preemption.
Sec. 16. Judicial review.
Sec. 17. Citizens' petitions.
Sec. 18. Studies.
Sec. 19. Administration.
Sec. 20. Development and evaluation of test methods.
Sec. 21. State programs.
Sec. 22. Authorization of appropriations.
Sec. 23. Annual report.
    (c) References.--Except as otherwise expressly provided, wherever 
in this Act an amendment or repeal is expressed in terms of an 
amendment to, or repeal of, a section or other provision, the reference 
shall be considered to be made to a section or other provision of the 
Toxic Substances Control Act (15 U.S.C. 2601 et seq.).

SEC. 2. FINDINGS, POLICY, AND INTENT.

    (a) Purposes.--The purposes of this Act are--
            (1) to improve the safety of consumers in the United 
        States; and
            (2) to ensure that risks from chemical substances are 
        adequately understood and managed by modernizing title I of the 
        Toxic Substances Control Act (15 U.S.C. 2601 et seq.).
    (b) Findings, Policy, and Intent.--Section 2 (15 U.S.C. 2601) is 
amended by striking subsections (a) through (c) and inserting the 
following:
    ``(a) Findings.--Congress finds that--
            ``(1) chemicals should be safe for the intended use of the 
        chemicals;
            ``(2) the unmanaged risks of chemical substances may pose a 
        danger to human health and the environment;
            ``(3) public confidence in the Federal chemical regulatory 
        program has diminished over time;
            ``(4) scientific understanding of chemicals and the 
        possible risks of the chemicals has evolved greatly since 1976, 
        requiring that Congress update the law to ensure that chemical 
        regulation in the United States reflects modern science, 
        technology and knowledge;
            ``(5) this Act should be modernized to create a robust 
        Federal system for assessing and managing chemical risks;
            ``(6) chemicals are used in diverse manufacturing 
        industries and other valuable commercial, institutional, and 
        consumer applications that have benefitted society;
            ``(7) for the purposes of promoting uniform protections 
        through regulation of chemical substances in commerce, to 
        minimize undue burdens on commerce, and to minimize burdens on 
        States, specified actions by the Administrator should preempt 
        requirements by States and political subdivisions of States 
        that relate to the effects of or exposure to a chemical 
        substance under the intended conditions of use; and
            ``(8) innovation in the development of new chemical 
        substances, especially safer chemical substances, should be 
        encouraged to reduce risk, provide improved products, stimulate 
        the economy, create jobs, and protect interstate commerce.
    ``(b) Policy.--It is the policy of the United States that--
            ``(1) this Act--
                    ``(A) should protect the health of people and the 
                environment from the unmanaged risks of chemical 
                substances; and
                    ``(B) should be modernized to build public 
                confidence in the ability of the Federal regulatory 
                system to protect health and the environment, promote 
                innovation, and sustain a globally competitive chemical 
                industry in the United States;
            ``(2) the Administrator--
                    ``(A) should have the appropriate hazard, use, and 
                exposure information necessary to make safety 
                determinations;
                    ``(B) should minimize the use of animal testing 
                through the use of scientifically reliable and relevant 
                test methods, where appropriate;
                    ``(C) should encourage the use of best laboratory 
                practices to ensure high quality, relevant, and 
                reliable results from test methods and studies;
                    ``(D) should have the authority to share 
                confidential business information with States and 
                political subdivisions of the States, subject to 
                appropriate safeguards against inappropriate 
                disclosure;
                    ``(E) should have the resources and tools necessary 
                to implement this Act; and
                    ``(F) should implement this Act in a manner that 
                promotes transparency of information and 
                decisionmaking, protects substantiated confidential 
                business information, and promotes innovation, 
                including innovation in chemical substances that have 
                reduced hazard, exposure, and risk patterns;
            ``(3) adequate data and information should be available 
        with respect to the effect of and exposure to chemical 
        substances and mixtures on health and the environment, to the 
        extent necessary for safety assessments and determinations, and 
        that, where necessary, the development of such test data and 
        information should be the primary responsibility of those who 
        manufacture or process such chemical substances and mixtures; 
        and
            ``(4) States have an important role in protecting health 
        and the environment from the unmanaged risks of chemical 
        substances in commerce, particularly in recommending priorities 
        for Federal assessment and regulation, providing safety 
        assessment information, and fostering programs to protect 
        consumers.
    ``(c) Intent of Congress.--It is the intent of Congress that the 
Administrator shall--
            ``(1) rely on robust scientific evidence to implement this 
        Act in a way that balances the mutual goals of promoting the 
        safety of American consumers and preventing harm to American 
        innovation, manufacturing, and the economy; and
            ``(2) implement this Act to protect the health of the 
        people of the United States and the environment in such a 
        manner as not to unduly impede commerce or create unnecessary 
        economic barriers to technological innovation, including safer 
        chemistry.''.

SEC. 3. DEFINITIONS.

    Section 3 (15 U.S.C. 2602) is amended--
            (1) by redesignating paragraphs (2) through (6), (7) 
        through (11), and (12) through (14) as paragraphs (3) through 
        (7), (9) through (13), and (17) through (19), respectively;
            (2) by inserting after paragraph (1) the following:
            ``(2) Best available science.--The term `best available 
        science' means science that--
                    ``(A) maximizes the quality, objectivity, and 
                integrity of information, including statistical 
                information;
                    ``(B) uses peer-reviewed and publically available 
                data; and
                    ``(C) clearly documents and communicates risks and 
                uncertainties in the scientific basis for decisions.'';
            (3) by inserting after paragraph (7) (as so redesignated) 
        the following:
            ``(8) Intended conditions of use.--The term `intended 
        conditions of use' means the circumstances under which a 
        chemical substance is intended or reasonably anticipated to be 
        manufactured, processed, distributed in commerce, used, and 
        disposed of.''; and
            (4) by inserting after paragraph (13) (as so redesignated) 
        the following:
            ``(14) Safety assessment.--The term `safety assessment' 
        means a risk-based assessment of the safety of a chemical 
        substance that--
                    ``(A) integrates hazard; use; and exposure 
                information about a chemical substance; and
                    ``(B) includes--
                            ``(i) an assessment of exposure under the 
                        intended conditions of use; and
                            ``(ii) reference parameters that may be 
                        appropriate with regard to a specific chemical 
                        substance (such as a margin of exposure).
            ``(15) Safety determination.--The term `safety 
        determination' means a determination by the Administrator as to 
        whether a chemical substance meets the safety standard under 
        the intended conditions of use.
            ``(16) Safety standard.--The term `safety standard' means a 
        standard that ensures that no unreasonable risk of harm to 
        human health or the environment will result from exposure to a 
        chemical substance.''.

SEC. 4. CHEMICAL ASSESSMENT FRAMEWORK; PRIORITIZATION SCREENING; 
              TESTING.

    (a) In General.--Section 4 (15 U.S.C. 2603) is amended--
            (1) in the heading, by striking ``testing of chemical 
        substances and mixtures'' and inserting ``chemical assessment 
        framework; prioritization screening; testing''.
            (2) by redesignating subsection (e) as subsection (l);
            (3) in subsection (l) (as so redesignated)--
                    (A) by striking ``rule'' each place it appears and 
                inserting ``rule, testing consent agreement, or 
                order'';
                    (B) by striking ``under subsection (a)'' each place 
                it appears and inserting ``under this subsection''; and
                    (C) in paragraph (1)(B), by striking 
                ``rulemaking''; and
            (4) by striking subsections (a) through (d), (f), and (g) 
        and inserting the following:
    ``(a) Chemical Assessment Framework.--
            ``(1) In general.--The Administrator shall develop a 
        framework in accordance with subsection (e) and sections 5 and 
        6 for evaluating the safety of chemical substances in commerce 
        that shall employ the best available science and risk 
        assessment principles in existence at the time the 
        Administrator is developing the framework.
            ``(2) Policies and procedures.--
                    ``(A) In general.--After the date of enactment of 
                the Chemical Safety Improvement Act, the Administrator 
                shall promptly develop appropriate policies and 
                procedures for implementing the framework, including 
                procedures on the collection, evaluation, and 
                development of data and information.
                    ``(B) Contents.--The policies and procedures shall 
                require--
                            ``(i) the collection of existing data and 
                        information from manufacturers and processors 
                        of chemical substances and other sources, 
                        including the use of voluntary agreements to 
                        provide the data and information;
                            ``(ii) an evaluation of the quality of 
                        existing data and information;
                            ``(iii) an analysis of data and 
                        information;
                            ``(iv) a determination of the need for 
                        additional data and information, including 
                        information related to the exposures of 
                        different subpopulations; and
                            ``(v) subject to section 14, transparency 
                        of data and information considered by the 
                        Administrator, including both positive and 
                        negative findings.
            ``(3) Transparency and validity.--The Administrator shall 
        ensure that the evaluation framework described in subsection 
        (a)(1)--
                    ``(A) is transparent;
                    ``(B) assures that data and information are valid;
                    ``(C) addresses the strengths and limitations of--
                            ``(i) the design of the framework,
                            ``(ii) the reliability of the test methods; 
                        and
                            ``(iii) the quality of the data and 
                        information; and
                    ``(D) pursues the goal of maximizing the quality, 
                objectivity, utility, and integrity of the data and 
                information.
    ``(b) Data and Information Quality.--
            ``(1) In general.--The Administrator shall establish and 
        publish scientifically sound criteria for evaluating all of the 
        data and information, including the results of animal and 
        nonanimal testing, regardless of affiliation or funding source, 
        on which the Administrator relies in making a decision under 
        this Act.
            ``(2) Disclosure of sources of funding.--The Administrator 
        shall require that the submitter of any health and safety study 
        disclose to the Administrator and to the public the sources of 
        any funding used for the study or publication of the study 
        received by the researcher who conducted the study, to the 
        extent reasonably ascertainable.
            ``(3) Test data.--For test data developed under this Act, 
        the Administrator shall encourage the use of good laboratory 
        practices, peer review, scientifically reliable and relevant 
        test methods, standardized protocols, and other methods to 
        ensure scientific quality for all data and information 
        submitted under this Act.
            ``(4) Data and information that do not meet criteria.--
                    ``(A) In general.--Nothing in this subsection shall 
                preclude the Administrator from considering data and 
                information which do not meet the quality criteria 
                established under paragraph (1).
                    ``(B) Identification.--The Administrator shall--
                            ``(i) identify any data and information 
                        described in subparagraph (A) on which the 
                        Administrator relies;
                            ``(ii) describe the quality of the data and 
                        information described in subparagraph (A) and 
                        the extent to which the data and information 
                        depart from those criteria;
                            ``(iii) indicate any limitations on the 
                        usefulness of the data and information 
                        described in subparagraph (A); and
                            ``(iv) explain how the data and information 
                        described in subparagraph (A) was used and the 
                        basis for reliance on the data and information.
            ``(5) Evaluative framework for decisionmaking.--
                    ``(A) In general.--The Administrator shall develop 
                and use a structured evaluative framework consisting of 
                science-based criteria, consistent with the protection 
                of human health and the environment, for making any 
                decision under this Act, and for determining the 
                relevance, quality, and reliability of data and 
                information.
                    ``(B) Contents.--The framework described in 
                subparagraph (A) shall, at a minimum--
                            ``(i) use sound and objective scientific 
                        practices in assessing risks;
                            ``(ii) consider the current best available 
                        science (including peer-reviewed studies);
                            ``(iii) when consistent with the underlying 
                        data, consider, for both cancer and noncancer 
                        endpoints, whether available data support or do 
                        not support the identification of threshold 
                        doses of a chemical substance below which no 
                        adverse effects can be expected to occur; and
                            ``(iv) include a description of the weight 
                        of the scientific evidence concerning risks, 
                        including mechanistic information (such as 
                        appropriate modes of action).
    ``(c) Data and Information Sources.--In making any decision with 
respect to a chemical substance under subsection (e) and sections 5 and 
6, the Administrator shall consider data and information relevant to 
the substance that are reasonably available to the Administrator at 
that time, including data and information that are--
            ``(1) submitted to the Administrator by--
                    ``(A) manufacturers and processors of the 
                substance;
                    ``(B) the public; or
                    ``(C) a Governor of a State or a State agency with 
                responsibility for protecting health or the 
                environment;
            ``(2) submitted to a governmental body in another 
        jurisdiction under a governmental requirement relating to the 
        protection of human health and the environment, if the 
        information is accessible to the Administrator;
            ``(3) derived through the application of scientifically 
        reliable and relevant structure-activity relationship, or other 
        methods or models to estimate the environmental and human 
        health effects, environmental and biological fate and behavior, 
        and exposure potential for the substance;
            ``(4) inferred based on the degree of structural similarity 
        or properties of the substance, or categories of substances, to 
        those of 1 or more other chemical substances for which reliable 
        information exists that is relevant to predicting the potential 
        environmental or human health effects, environmental or 
        biological fate and behavior, or exposure potential for the 
        chemical substance; and
            ``(5) identified through an active search by the 
        Administrator of information sources that are publicly 
        available or otherwise accessible to the Administrator.
    ``(d) Transparency.--
            ``(1) In general.--Subject to section 14, the data and 
        information considered by the Administrator in taking action 
        under this Act shall be available to the public.
            ``(2) Types of information available to the public.--The 
        Administrator shall make available to the public the guidance, 
        procedures, and tools used in evaluating data and information 
        under this section, including models, studies, and, as 
        appropriate, the data underlying any study.
            ``(3) Guidance.--Any written guidance of general 
        applicability prepared by the Administrator under this Act 
        shall be subject to public notice and an opportunity for 
        comment.
    ``(e) Prioritization Screening Process.--
            ``(1) In general.--
                    ``(A) Process.--Not later than 1 year after the 
                date of enactment of the Chemical Safety Improvement 
                Act, the Administrator shall establish a risk-based 
                screening process for identifying existing chemical 
                substances that are--
                            ``(i) a high priority for a safety 
                        assessment and determination under section 6, 
                        to be known as `high-priority substances'; and
                            ``(ii) a low priority for a safety 
                        assessment and determination, to be known as 
                        `low-priority substances'.
                    ``(B) Consideration of active and inactive 
                substances.--
                            ``(i) Consideration of active substances.--
                        In implementing the process described in 
                        subparagraph (A), the Administrator shall only 
                        consider active substances, as determined under 
                        section 8(b)(6), as either high-priority 
                        substances or low-priority substances.
                            ``(ii) Consideration of inactive 
                        substances.--In implementing the process 
                        described in subparagraph (A), the 
                        Administrator shall only consider inactive 
                        substances, as determined under section 
                        8(b)(7), that the Administrator determines, on 
                        the basis of credible scientific evidence 
                        that--
                                    ``(I) have not been subject to a 
                                regulatory or other enforceable action 
                                by the Administrator to ban or phase 
                                out the substances; and
                                    ``(II) demonstrate high hazard and 
                                high exposure.
                    ``(C) Timely completion of prioritization 
                process.--
                            ``(i) In general.--The Administrator shall 
                        make every effort to complete the 
                        prioritization of all active substances in a 
                        timely manner.
                            ``(ii) Consideration.--The Administrator 
                        shall prioritize substances taking into 
                        consideration the ability of the Administrator 
                        to schedule and complete safety assessments and 
                        determinations under section 6 in a timely 
                        manner.
                    ``(D) Use of data.--In making a decision under the 
                prioritization screening process, the Administrator 
                shall use reasonably available data and information 
                concerning the hazard, exposure, and use 
                characteristics of chemical substances on the list 
                developed by the Administrator under section 8(b)(1) at 
                the time the decision is made.
                    ``(E) Screening of categories or classes of 
                substances.--The Administrator may screen categories or 
                classes of chemical substances to ensure an efficient 
                prioritization screening process to allow for timely 
                and adequate safety assessments and determinations.
                    ``(F) Publication of list of chemical substances.--
                From time to time the Administrator shall--
                            ``(i) publish a list of chemical substances 
                        being considered in the prioritization 
                        screening process; and
                            ``(ii) request the submission of data and 
                        information on the chemical substances.
            ``(2) Proposed process.--
                    ``(A) In general.--The Administrator shall--
                            ``(i) publish for public comment a proposed 
                        prioritization screening process; and
                            ``(ii) establish criteria for determining 
                        whether a substance is a high or low priority 
                        for a safety assessment and determination.
                    ``(B) Initial list.--
                            ``(i) In general.--The proposal shall 
                        include an initial list of chemical substances 
                        that includes, at a minimum, those substances 
                        prioritized by the Administrator before the 
                        date of enactment of the Chemical Safety 
                        Improvement Act and for which assessments or 
                        safety determinations have not been completed, 
                        and proposed prioritization outcomes based on 
                        the proposed criteria.
                            ``(ii) Contents.--The initial list shall 
                        contain as many chemical substances as the 
                        Administrator determines appropriate.
                            ``(iii) Modification.--The Administrator 
                        may modify the initial list on the basis of 
                        comments received on the proposed process and 
                        criteria.
                    ``(C) Criteria.--The criteria described in 
                subparagraph (A) shall consider--
                            ``(i) the recommendation of a Governor of a 
                        State or a State agency with responsibility for 
                        protecting health or the environment from 
                        chemical substances appropriate for 
                        prioritization screening;
                            ``(ii) the hazard and exposure potential of 
                        the chemical substance (or category or class of 
                        substances), including specific scientific 
                        classifications and designations by 
                        authoritative governmental entities;
                            ``(iii) the intended conditions of use or 
                        significant changes in the conditions of use of 
                        the chemical substance;
                            ``(iv) evidence and indicators of exposure 
                        potential to humans or the environment from the 
                        chemical substance;
                            ``(v) the volume of a chemical substance 
                        manufactured or processed;
                            ``(vi) whether the volume of a chemical 
                        substance as reported under a regulation issued 
                        under section 8(a) (as in effect on the date on 
                        which the criteria are proposed) has 
                        significantly increased or decreased since a 
                        previous report or since the date on which a 
                        notice has been submitted under section 5(a);
                            ``(vii) the availability of information 
                        about potential hazards and exposures needed 
                        for conducting a safety assessment or 
                        determination, with limited availability of 
                        relevant data and information to be a factor in 
                        designating a substance as a high priority; and
                            ``(viii) the extent of Federal or State 
                        regulation of the chemical substance or the 
                        extent of the impact of State regulation of the 
                        chemical substance on the United States, with 
                        existing Federal or State regulation of any 
                        uses evaluated in the prioritization screening 
                        process as a factor in designating a chemical 
                        substance to be a low priority.
            ``(3) Prioritization screening decisions.--
                    ``(A) In general.--For the chemical substances 
                considered for prioritization screening, the 
                Administrator shall apply the criteria identified in 
                paragraph (2), using the information identified in 
                subsection (c), to identify a chemical substance as a 
                high-priority substance or a low-priority substance.
                    ``(B) Additional test data.--If the Administrator 
                determines that additional test data and information 
                are needed to establish the priority of a chemical 
                substance, the Administrator shall provide an 
                opportunity for interested persons to submit data and 
                information to the extent that it is reasonably 
                ascertainable.
                    ``(C) Deferring a decision.--If the Administrator 
                determines that it is appropriate, the Administrator 
                may defer a prioritization screening decision for a 
                chemical substance under subparagraph (A) for a 
                reasonable period to allow for the submission and 
                evaluation of additional data and information.
                    ``(D) Integration of data and information.--During 
                the prioritization screening of a chemical substance, 
                the Administrator shall integrate any hazard and 
                exposure data and information related to a chemical 
                substance available to the Administrator.
                    ``(E) Identification of high-priority substances.--
                The Administrator--
                            ``(i) shall identify as a high-priority 
                        substance a chemical substance that, relative 
                        to other substances, has the potential for high 
                        hazard and high exposure;
                            ``(ii) may identify as a high-priority 
                        substance a chemical substance that, relative 
                        to other substances, has the potential for high 
                        hazard or high exposure; and
                            ``(iii) may identify as a high-priority 
                        substance an inactive substance, as determined 
                        under section 8(b)(7), that the Administrator 
                        determines, on the basis of credible scientific 
                        evidence that--
                                    ``(I) has not been subject to a 
                                regulatory action by the Administrator 
                                to ban or phase out the substance; and
                                    ``(II) demonstrates high hazard and 
                                high exposure.
                    ``(F) Identification of low-priority substances.--
                The Administrator shall identify as a low-priority 
                substance a chemical substance that the Administrator 
                on the basis of the available information determines is 
                likely to meet the safety standard under the intended 
                conditions of use.
                    ``(G) Notice and comment.--The identifications made 
                under subparagraphs (E) and (F) shall be subject to 
                notice and an opportunity for comment.
                    ``(H) Order of safety assessments.--
                            ``(i) High-priority substances.--The 
                        Administrator--
                                    ``(I) shall determine the order for 
                                performing safety assessments on high-
                                priority substances under section 6; 
                                and
                                    ``(II) may revise the order as the 
                                Administrator determines appropriate.
                            ``(ii) Low-priority substance.--The 
                        Administrator shall not perform safety 
                        assessments on low-priority substances, unless 
                        a low-priority substance is redesignated under 
                        subparagraph (I).
                    ``(I) Revision based on new data.--
                            ``(i) In general.--Subject to subparagraph 
                        (D), at any time the Administrator may revise 
                        the identification of a chemical substance as a 
                        high-priority substance or a low-priority 
                        substance based on consideration of data or 
                        information made available to the Administrator 
                        after the date on which the Administrator makes 
                        the identification under subparagraphs (E) and 
                        (F).
                            ``(ii) Reevaluation.--
                                    ``(I) In general.--The 
                                Administrator shall evaluate the data 
                                or information described in clause (i) 
                                on a high-priority substance or a low-
                                priority substance for possible 
                                reevaluation of the priority of the 
                                substance.
                                    ``(II) Limited availability.--If 
                                limited availability of relevant data 
                                and information was a factor in the 
                                original identification of a chemical 
                                substance as a high-priority substance, 
                                the Administrator shall reevaluate the 
                                prioritization screening of the 
                                substance on receiving the relevant 
                                data and information.
                    ``(J) Publication of a list of high-priority and 
                low-priority substances.--
                            ``(i) In general.--The Administrator shall 
                        publish and keep current a list of high-
                        priority substances and a list of low-priority 
                        substances.
                            ``(ii) Justification.--Whenever the 
                        Administrator places a chemical substance on 
                        one of the lists described in clause (i) or 
                        changes the priority of the chemical substance, 
                        the Administrator shall include a justification 
                        for the decision in accordance with paragraph 
                        (2)(C).
                    ``(K) Removal.--The Administrator shall remove a 
                chemical substance from the list of high-priority 
                substances on the date on which a safety determination 
                for the chemical substance is published.
                    ``(L) Effect.--Subject to section 18, a decision by 
                the Administrator under this paragraph with respect to 
                a chemical substance shall not affect the manufacture, 
                processing, distribution, use, or disposal of the 
                chemical substance, or regulation of those activities.
            ``(4) Expedited prioritization screening.--
                    ``(A) In general.--Not later than 180 days after 
                the date on which the Administrator receives a 
                recommendation and relevant data and information from a 
                Governor of a State or a State agency with 
                responsibility for protecting health and the 
                environment that an active chemical substance be 
                identified as a high-priority or low-priority 
                substance, the Administrator shall make a 
                prioritization screening decision for the substance.
                    ``(B) Notice and comment.--The public shall be 
                provided notice and an opportunity to comment on the 
                recommendation described in subparagraph (A).
                    ``(C) Explanation of reasons.--The Administrator 
                shall--
                            ``(i) make available to the Governor or the 
                        appropriate State agency, as applicable, and to 
                        the public a brief explanation of reasons for 
                        identifying a chemical substance recommended by 
                        the Governor or the agency for prioritization 
                        screening as either a high-priority substance 
                        or a low-priority substance; and
                            ``(ii) identify the information relied upon 
                        in making that identification.
            ``(5) Final agency action.--Any action by the Administrator 
        under this subsection shall not be--
                    ``(A) considered to be a final agency action; or
                    ``(B) subject to judicial review.
    ``(f) Development of New Test Data and Information.--
            ``(1) In general.--The Administrator may require the 
        development of new test data and information related to a 
        chemical substance or mixture in accordance with this section 
        if the Administration determines that the data and information 
        are needed--
                    ``(A) to perform a safety assessment;
                    ``(B) to make a safety determination; or
                    ``(C) to meet the testing needs of the implementing 
                authority under another Federal statute.
            ``(2) Form.--The Administrator may require the development 
        of test data and information described in paragraph (1) by--
                    ``(A) promulgating a rule;
                    ``(B) entering into a testing consent agreement; or
                    ``(C) issuing an order.
            ``(3) Requirements.--
                    ``(A) In general.--In promulgating a rule, adopting 
                a testing consent agreement, or issuing an order 
                described in paragraph (2), the Administrator shall 
                require the use of--
                            ``(i) an evaluation framework that, prior 
                        to requiring additional testing of vertebrate 
                        animals, integrates relevant information from 
                        multiple sources, including, to the extent 
                        reliable--
                                    ``(I) toxicity information;
                                    ``(II) computational toxicology;
                                    ``(III) bioinformatics;
                                    ``(IV) high-throughput screening 
                                methods; and
                                    ``(V) scientifically reliable and 
                                relevant alternatives to vertebrate 
                                animal tests; and
                            ``(ii) tiered testing in accordance with 
                        subsection (h), wherein the results of a 
                        screening level tier of tests relating to a 
                        toxicity pathway or target organ or target 
                        system inform the decision of the Administrator 
                        as to whether tests from a higher tier related 
                        to that pathway or organ or system are 
                        necessary.
                    ``(B) Statement to the public.--The Administrator 
                shall explain the basis for a decision made in 
                subparagraph (A)(ii) in a statement made available to 
                the public.
            ``(4) Contents.--
                    ``(A) In general.--A rule, testing consent 
                agreement, or order issued under paragraph (2) shall 
                include--
                            ``(i) identification of the chemical 
                        substance or mixture for which testing is 
                        required;
                            ``(ii) identification of the persons 
                        required to conduct the testing;
                            ``(iii) procedures for the development of 
                        test data and information for the chemical 
                        substance or mixture, including specific 
                        reference to reliable nonanimal test 
                        procedures; and
                            ``(iv) specification of the period within 
                        which persons required to conduct the testing 
                        shall submit to the Administrator test data and 
                        information developed in accordance with the 
                        procedures described in clause (iii).
                    ``(B) Duration.--The period described in 
                subparagraph (A)(iv) shall not be of an unreasonable 
                duration.
                    ``(C) Considerations.--In determining the 
                procedures and period to be required under subparagraph 
                (A), the Administrator shall consider--
                            ``(i) the relative costs of the various 
                        test protocols and methodologies that may be 
                        required; and
                            ``(ii) the reasonably foreseeable 
                        availability of facilities and personnel needed 
                        to perform the testing.
    ``(g) Statement of Need.--
            ``(1) In general.--In promulgating a rule, entering into a 
        testing consent agreement, or issuing an order for development 
        of additional data and information (including information on 
        exposure or exposure potential) under subsection (f)(2), the 
        Administrator shall issue a statement--
                    ``(A) identifying the need intended to be met by 
                the rule, agreement, or order;
                    ``(B) explaining why existing data and information 
                reasonably available to the Administrator at that time 
                are inadequate to meet that need; and
                    ``(C) encouraging, to the extent possible, the use 
                of nonanimal test methods to develop additional data 
                and information.
            ``(2) Contents of statement in case of order.--
                    ``(A) In general.--If the Administrator issues an 
                order, the statement described in paragraph (1) shall 
                explain why good cause exists for issuance of an order 
                instead of promulgating a rule or entering into a 
                testing consent agreement.
                    ``(B) Contents.--A statement described in 
                subparagraph (A) shall contain a discussion of--
                            ``(i) data and information that are readily 
                        accessible to the Administrator, including data 
                        and information submitted under any other 
                        provision of law;
                            ``(ii) the extent to which the 
                        Administrator has obtained or attempted to 
                        obtain the data and information through 
                        voluntary submissions;
                            ``(iii) the extent to which the 
                        Administrator may use available data and 
                        information for structurally related substances 
                        (grouping or read-across), or use valid 
                        structure-activity relationship models or 
                        nonanimal test alternatives; and
                            ``(iv) safety assessments, and the data and 
                        information relied on in the assessments, on 
                        other chemical substances to the extent 
                        relevant to the chemical substances that would 
                        be the subject of the rule or order.
    ``(h) Tiered Toxicity Testing and Evaluation.--
            ``(1) In general.--The Administrator shall develop an 
        evidence-based review system for conducting consistent 
        evaluations of the relevance and reliability of studies of 
        chemical substances and their exposure (including exposure 
        pathways), and a structured evaluative framework to provide a 
        systematic and transparent approach for assessing the overall 
        weight of the evidence for observed biological or other 
        effects, mechanistic information, and exposure.
            ``(2) Tiers.--Subject to subsections (b) and (c), the 
        framework shall have 2 tiers.
                    ``(A) Tier 1.--
                            ``(i) In general.--Tier 1 shall include 
                        both a screening level exposure assessment, 
                        including modeling if appropriate, and 
                        screening tests for hazard.
                            ``(ii) Uses of screening tests and 
                        modeling.--Screening tests for hazard (which 
                        may include, as appropriate, scientifically 
                        reliable and relevant in silico, in vitro, and 
                        focused in vivo tests) and exposure information 
                        and modeling shall be used--
                                    ``(I) to screen chemical substances 
                                or mixtures for major toxic effects 
                                (including acute toxicity, subchronic 
                                toxicity, chronic toxicity, 
                                carcinogenicity, genotoxicity, 
                                developmental toxicity, and 
                                neurotoxicity); and
                                    ``(II) to direct planning for more 
                                complex and targeted testing in tier 2, 
                                if necessary.
                    ``(B) Tier 2.--If the Administrator determines that 
                additional testing is necessary, based on the results 
                of tier 1 testing and modeling and any other available 
                relevant information, tier 2 shall include--
                            ``(i) an exposure assessment and tests for 
                        specific endpoints triggered on the basis of 
                        biologically based decisions; and
                            ``(ii) an assessment of potential exposure 
                        using scientifically valid approaches.
            ``(3) Guidance.--The Administrator shall prepare guidance 
        for implementing this subsection and review that guidance not 
        less than once every 5 years thereafter.
    ``(i) Reduction of Animal-Based Testing.--
            ``(1) In general.--The Administrator shall minimize the use 
        of animals in testing of chemical substances or mixtures, 
        including by--
                    ``(A) encouraging and facilitating, to the maximum 
                extent practicable--
                            ``(i) the use of integrated and tiered 
                        testing and assessment strategies;
                            ``(ii) the use of data and information of 
                        sufficient scientific quality in existence on 
                        the date on which the test is conducted;
                            ``(iii) the use of test methods that 
                        eliminate or reduce the use of animals while 
                        providing test data and information of high 
                        scientific quality;
                            ``(iv) the grouping of 2 or more chemical 
                        substances into scientifically appropriate 
                        categories in cases in which testing of a 
                        chemical substance would provide reliable and 
                        useful test data and information on others in 
                        the category;
                            ``(v) the formation of industry consortia 
                        to jointly conduct testing to avoid unnecessary 
                        duplication of tests;
                            ``(vi) the submission of test data and 
                        information from animal-based studies and from 
                        emerging methods and models; and
                            ``(vii) the use of exposure potential as a 
                        factor in decisions to require new testing; and
                    ``(B) funding research and validation studies to 
                reduce, refine, and replace the use of animal tests in 
                accordance with this subsection.
            ``(2) Implementation of alternative testing methods.--To 
        promote the development and timely incorporation of new testing 
        methods that are not laboratory animal-based, the Administrator 
        shall--
                    ``(A) after providing an opportunity for public 
                comment, develop a strategic plan to promote the 
                development and implementation of alternative test 
                methods and testing strategies to generate information 
                used for any safety-standard determination made that 
                reduce, refine, or replace the use of laboratory 
                animals, including toxicity pathway-based risk 
                assessment, in vitro studies, systems biology, 
                computational toxicology, bioinformatics, and high-
                throughput screening;
                    ``(B) beginning on the date that is 5 years after 
                the date of enactment of the Chemical Safety 
                Improvement Act and every 5 years thereafter, submit to 
                Congress a report that describes the progress made in 
                implementing this section; and
                    ``(C) fund and carry out research, development, 
                performance assessment, and translational studies to 
                accelerate the development of test methods and testing 
                strategies that reduce, refine, or replace the use of 
                laboratory animals in any safety-standard determination 
                made under this section.
            ``(3) Criteria for adapting or waiving animal testing 
        requirements.--On request from a manufacturer or processor that 
        is required to conduct animal-based testing of a chemical 
        substance or mixture under this title, the Administrator may 
        adapt or waive the animal-testing requirement if the 
        Administrator determines that--
                    ``(A) there is sufficient evidence from several 
                independent sources of information to support a 
                conclusion that a chemical substance or mixture has, or 
                does not have, a particular property if the information 
                from each individual source alone is insufficient to 
                support the conclusion;
                    ``(B) because of one or more physical or chemical 
                properties of the chemical substance or mixture or 
                other toxicokinetic considerations--
                            ``(i) the material cannot be absorbed; or
                            ``(ii) testing for a specific endpoint is 
                        technically not practicable to conduct; or
                    ``(C) a chemical substance or mixture cannot be 
                tested in animals at concentrations that do not result 
                in significant pain or distress, because of physical or 
                chemical properties of the chemical substance or 
                mixture, such as a potential to cause severe corrosion 
                or severe irritation to the tissues of the animal.
    ``(j) Testing Requirements.--
            ``(1) Persons required to develop test data and 
        information.--
                    ``(A) In general.--The Administrator may require 
                the following persons to develop test data and 
                information:
                            ``(i) Manufacturers and processors of the 
                        chemical substance or mixture identified in 
                        subsection (f)(4)(A)(i).
                            ``(ii) Persons who begin to manufacture or 
                        process such chemical substance or mixture--
                                    ``(I) after the effective date of 
                                the rule, testing consent agreement, or 
                                order; but
                                    ``(II) subject to subparagraph (C), 
                                before the period ending 180 days after 
                                the end of the period identified in 
                                subsection (f)(4)(A)(iv).
                    ``(B) Designation.--The Administrator may permit 2 
                or more of the persons identified in subparagraph (A) 
                to designate a person or a qualified third party--
                            ``(i) to develop the data and information; 
                        and
                            ``(ii) to submit the data and information 
                        on behalf of the persons making the 
                        designation.
                    ``(C) Exemptions.--
                            ``(i) In general.--A person otherwise 
                        subject to a rule, testing consent agreement, 
                        or order under subsection (f) may submit to the 
                        Administrator an application for an exemption 
                        on the basis that the data and information are 
                        being developed by a person designated under 
                        subparagraph (B).
                            ``(ii) Fair and equitable reimbursement to 
                        designee.--
                                    ``(I) In general.--If the 
                                Administrator accepts an application 
                                submitted under clause (i), the 
                                Administrator shall direct the 
                                applicant to provide to the person 
                                designated under subparagraph (B) fair 
                                and equitable reimbursement, as agreed 
                                to between the applicant and the person 
                                designated.
                                    ``(II) Arbitration.--If the 
                                applicant and a person designated under 
                                subparagraph (B) cannot reach agreement 
                                on the amount of fair and equitable 
                                reimbursement, the amount shall be 
                                determined by arbitration.
                            ``(iii) Termination.--If, after granting an 
                        exemption under this subparagraph, the 
                        Administrator determines that no person has 
                        complied with the rule, testing consent 
                        agreement, or order, the Administrator shall--
                                    ``(I) by order terminate the 
                                exemption; and
                                    ``(II) notify in writing each 
                                person who received an exemption of the 
                                requirements with respect to which the 
                                exemption was granted.
            ``(2) Types of health and environmental data and 
        information.--
                    ``(A) In general.--The Administrator may prescribe 
                guidelines for the development of test data and 
                information under subsection (f) for health and 
                environmental information, including--
                            ``(i) test data pertaining to acute 
                        toxicity, subchronic toxicity, chronic 
                        toxicity, carcinogenicity, genotoxicity, 
                        developmental toxicity, and neurotoxicity that 
                        may be indicative of an adverse effect;
                            ``(ii) test data and information pertaining 
                        to exposure to the chemical substance or 
                        mixture, including information regarding 
                        bioaccumulation, persistence, and the presence 
                        of the chemical substance or mixture in human 
                        blood, fluids, or tissue; and
                            ``(iii) information pertaining to aggregate 
                        exposure, or other effects that may be 
                        considered in a safety assessment.
                    ``(B) Methodologies.--
                            ``(i) In general.--The Administrator--
                                    ``(I) may prescribe methodologies 
                                in guidelines for the development of 
                                data and information; and
                                    ``(II) shall encourage the use of 
                                nonanimal methodologies.
                            ``(ii) Development of guidelines.--The 
                        Administrator may develop guidelines for 
                        evaluating data from biomonitoring studies.
                            ``(iii) Requirement.--Prior to prescribing 
                        epidemiologic studies of employees, the 
                        Administrator shall coordinate with the 
                        Director of the National Institute for 
                        Occupational Safety and Health.
                    ``(C) Review.--Periodically, but not less 
                frequently than once every 5 years, the Administrator 
                shall--
                            ``(i) review the adequacy of the guidelines 
                        for development of data and information 
                        prescribed under subparagraph (B);
                            ``(ii) if necessary, institute proceedings 
                        to make appropriate revisions of the 
                        guidelines; and
                            ``(iii) revise the guidelines as 
                        appropriate, particularly to--
                                    ``(I) reflect the availability of 
                                scientifically reliable and relevant 
                                nonanimal test methods; and
                                    ``(II) eliminate obsolete 
                                methodologies that do not produce 
                                reliable and relevant results.
    ``(k) Transparency.--Subject to section 14, the Administrator shall 
make available to the public all testing consent agreements and orders 
and all data and information submitted under this section.''.
    (b) Conforming Amendments.--Section 104(i)(5)(A) of the 
Comprehensive Environmental Response, Compensation, and Liability Act 
of 1980 (42 U.S.C. 9604(i)(5)(A)) is amended by striking ``section 
4(e)'' and inserting ``section 4(l)''.

SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.

    Section 5 (15 U.S.C. 2604) is amended--
            (1) by striking the section designation and heading and 
        inserting the following:

``SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.'';

            (2) in subsection (a)(1), in the matter following 
        subparagraph (B)--
                    (A) by striking ``subsection (d)'' and inserting 
                ``subsection (b)''; and
                    (B) by striking ``and such person complies with any 
                applicable requirement of subsection (b)'';
            (3) by striking subsection (b);
            (4) by redesignating subsection (d) as subsection (b) and 
        moving the subsection so as to appear after subsection (a);
            (5) in subsection (b) (as so redesignated)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) In general.--The notice required by subsection (a) 
        shall include, with respect to a chemical substance--
                    ``(A) the information required by sections 720.45 
                and 720.50 of title 40, Code of Federal Regulations (or 
                successor regulations); and
                    ``(B) information regarding intended conditions of 
                use and reasonably anticipated exposure.'';
                    (B) in paragraph (2)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``or of data under subsection 
                        (b)'';
                            (ii) in subparagraph (A), by adding ``and'' 
                        after the semicolon at the end;
                            (iii) in subparagraph (B), by striking ``; 
                        and'' and inserting a period; and
                            (iv) by striking subparagraph (C); and
                    (C) in paragraph (3), by striking ``, (b),'';
            (6) by striking subsection (c) and inserting the following:
    ``(c) Review of Notice.--
            ``(1) Initial review.--
                    ``(A) In general.--Subject to subparagraph (B), not 
                later than 90 days after the date of receipt of a 
                notice submitted under subsection (a), the 
                Administrator shall--
                            ``(i) conduct an initial review of the 
                        notice;
                            ``(ii) as needed, develop a profile of the 
                        relevant chemical substance and the potential 
                        for exposure to humans and the environment; and
                            ``(iii) make any necessary determination 
                        under paragraph (4).
                    ``(B) Extension.--Except as provided in paragraph 
                (6), the Administrator may extend the period described 
                in subparagraph (A) for good cause for one or more 
                periods, the total of which shall be not more than 90 
                days.
            ``(2) Notice of commencement.--Unless the Administrator 
        determines under paragraph (4)(A) that a chemical substance is 
        not likely to meet the safety standard, at the end of the 
        applicable period for review under paragraph (1), a chemical 
        substance may be the subject of a notice of commencement under 
        subsection (d).
            ``(3) Information sources.--In evaluating a notice under 
        paragraph (1), the Administrator shall take into 
        consideration--
                    ``(A) the information identified in section 4(c); 
                and
                    ``(B) any additional information provided by the 
                submitter.
            ``(4) Determinations.--Before the end of the applicable 
        period for review under paragraph (1), based on the information 
        described in paragraph (3), the Administrator shall determine 
        that--
                    ``(A) the relevant chemical substance is not likely 
                to meet the safety standard under the intended 
                conditions of use, in which case the Administrator 
                shall take appropriate action under paragraph (5);
                    ``(B) the relevant chemical substance is likely to 
                meet the safety standard under the intended conditions 
                of use, in which case the Administrator shall allow the 
                review period to expire without additional 
                restrictions; or
                    ``(C) additional information is necessary in order 
                to make a determination under subparagraph (A) or (B), 
                in which case the Administrator shall take appropriate 
                action under paragraph (6).
            ``(5) Prohibitions and limitations.--
                    ``(A) In general.--If the Administrator makes a 
                determination under paragraph (4)(A) with respect to a 
                notice, before the end of the applicable period for 
                review under paragraph (1), the Administrator shall, by 
                consent agreement or order, as appropriate--
                            ``(i) prohibit manufacture of the chemical 
                        substance, or prohibit such manufacture without 
                        compliance with restrictions specified in a 
                        relevant consent agreement or order; or
                            ``(ii) prohibit manufacture or processing 
                        of the chemical substance for a significant new 
                        use, or prohibit such manufacture or processing 
                        without compliance with restrictions specified 
                        in a relevant consent agreement or order.
                    ``(B) Inclusions.--A prohibition or limitation 
                under subparagraph (A) may include, as appropriate--
                            ``(i) a requirement that a chemical 
                        substance be marked with, or accompanied by, 
                        clear and adequate warnings and instructions 
                        with respect to use, distribution in commerce, 
                        or disposal, or any combination of those 
                        activities, with the form and content of the 
                        warnings and instructions to be prescribed by 
                        the Administrator;
                            ``(ii) a requirement that manufacturers or 
                        processors, as applicable, of the chemical 
                        substance make and retain records of the 
                        processes used to manufacture or process the 
                        chemical substance;
                            ``(iii) a requirement that manufacturers or 
                        processors, as applicable, monitor or conduct 
                        such additional tests as are reasonably 
                        necessary to ensure compliance with this Act, 
                        subject to section 4(g);
                            ``(iv) a limitation on the quantity of the 
                        chemical substance that may be manufactured, 
                        processed, or distributed in commerce;
                            ``(v) a limitation on the quantity of the 
                        chemical substance that may be manufactured, 
                        processed, or distributed in commerce for a 
                        particular use;
                            ``(vi) a prohibition or other regulation of 
                        the manufacture, processing, or distribution in 
                        commerce of the chemical substance for a 
                        significant new use;
                            ``(vii) a prohibition or other regulation 
                        of any method of commercial use of the chemical 
                        substance;
                            ``(viii) a prohibition or other regulation 
                        of any method of disposal of the chemical 
                        substance;
                            ``(ix) a prohibition on the manufacture, 
                        processing, or distribution in commerce of the 
                        chemical substance;
                            ``(x) a prohibition on the manufacture, 
                        processing, or distribution in commerce of the 
                        chemical substance for a particular use; or
                            ``(xi) such other requirements as the 
                        Administrator determines to be necessary.
            ``(6) Additional data and information.--If the 
        Administrator determines under paragraph (4)(C) that additional 
        data and information (including, for example, information on 
        exposure or exposure potential) are needed in order to conduct 
        a review under this subsection, the Administrator--
                    ``(A) shall provide an opportunity for the 
                submitter of the notice to submit such additional 
                information;
                    ``(B) may, by agreement with the submitter, extend 
                the review period for a reasonable time to allow the 
                development and submission of the additional 
                information;
                    ``(C) on receipt of the information, shall promptly 
                make a determination under paragraph (4); and
                    ``(D) may take action under paragraph (5) pending 
                receipt of the additional data and information, which 
                may, as appropriate, permit the submitter of the notice 
                to file a notice of commencement under subsection 
                (d).'';
            (7) by striking subsections (e) through (g) and inserting 
        the following:
    ``(d) Notice of Commencement.--
            ``(1) In general.--Not later than 30 days after the date on 
        which a manufacturer or processor that has submitted a notice 
        under subsection (a) commences nonexempt commercial manufacture 
        of a chemical substance or nonexempt commercial manufacture or 
        processing of a chemical substance for a significant new use, 
        as applicable, the manufacturer or processor shall submit to 
        the Administrator a notice of commencement that identifies--
                    ``(A) the name of the manufacturer or processor; 
                and
                    ``(B) the initial date of nonexempt commercial 
                manufacture or nonexempt commercial manufacture or 
                processing for a significant new use.
            ``(2) Withdrawal.--A manufacturer or processor that has 
        submitted a notice under subsection (a), but that has not 
        commenced nonexempt commercial manufacture or processing of the 
        chemical substance, may withdraw the notice.
    ``(e) Further Evaluation.--The Administrator may review a chemical 
substance under section 4(e) at any time after the Administrator 
receives--
            ``(1) a notice of commencement for a chemical substance 
        under subsection (d); or
            ``(2) significant new information regarding the chemical 
        substance.
    ``(f) Transparency.--Subject to section 14, the Administrator shall 
make available to the public all notices, rules and orders of the 
Administrator, and all data and information submitted or issued under 
this section.'';
            (8) by redesignating subsections (h) and (i) as subsections 
        (g) and (h), respectively; and
            (9) in subsection (g) (as so redesignated)--
                    (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by striking ``or (b)'';
                    (B) by striking paragraph (2);
                    (C) by redesignating paragraphs (3) through (6) as 
                paragraphs (2) through (5), respectively;
                    (D) in paragraph (2) (as so redesignated), by 
                striking ``subsections (a) and (b)'' and inserting 
                ``subsection (a)'';
                    (E) in paragraph (3) (as so redesignated), in the 
                first sentence, by striking ``will not present an 
                unreasonable risk of injury to health or the 
                environment'' and inserting ``is expected to meet the 
                safety standard under the intended conditions of use'';
                    (F) in paragraph (4) (as so redesignated), by 
                striking ``subsections (a) and (b)'' and inserting 
                ``subsection (a)''; and
                    (G) in paragraph (5) (as so redesignated), in the 
                first sentence, by striking ``paragraph (1) or (5)'' 
                and inserting ``paragraph (1) or (4),''.

SEC. 6. SAFETY ASSESSMENTS AND DETERMINATIONS.

    Section 6 (15 U.S.C. 2605) is amended--
            (1) by striking the section designation and heading and 
        inserting the following:

``SEC. 6. SAFETY ASSESSMENTS AND DETERMINATIONS.'';

            (2) by striking subsections (a) through (d) and inserting 
        the following:
    ``(a) In General.--The Administrator shall--
            ``(1) conduct a safety assessment of each high-priority 
        substance in accordance with subsection (b);
            ``(2) make a safety determination for each high-priority 
        substance; and
            ``(3) as appropriate based on the results of a safety 
        determination, establish requirements for risk management of a 
        high-priority substance.
    ``(b) Safety Assessments.--
            ``(1) In general.--The Administrator shall conduct a risk-
        based safety assessment of each high-priority substance, in 
        accordance with such schedule as the Administrator establishes, 
        to be based solely on considerations of risk to human health 
        and the environment.
            ``(2) Procedural rules.--
                    ``(A) In general.--The Administrator shall 
                establish procedural rules for safety assessments and 
                determinations under this subsection, including 
                schedules for the submission of relevant data and 
                information and the initiation and completion of safety 
                assessments and safety determinations.
                    ``(B) Requirements.--
                            ``(i) In general.--The rules under 
                        subparagraph (A) shall--
                                    ``(I) identify the basis on which 
                                the Administrator shall decide which 
                                high-priority substances take 
                                precedence in the safety assessment and 
                                determination process;
                                    ``(II) require the Administrator to 
                                inform the public regarding--
                                            ``(aa) the approximate 
                                        order in which safety 
                                        assessments and determinations 
                                        will be performed;
                                            ``(bb) the informational 
                                        needs of the Administrator 
                                        relating to the safety 
                                        assessment and determination 
                                        process;
                                            ``(cc) the importance of 
                                        expeditiously completing safety 
                                        assessments and determinations 
                                        and the need for rigorous 
                                        evaluation of the data and 
                                        information;
                                            ``(dd) the schedule by 
                                        which each assessment and 
                                        determination will be 
                                        conducted; and
                                            ``(ee) subject to clause 
                                        (ii), the deadline for the 
                                        completion of each assessment 
                                        and determination;
                                    ``(III) allow interested persons, 
                                including States, to submit 
                                information, including safety 
                                assessments, regarding high-priority 
                                substances that may facilitate the 
                                safety assessment and determination 
                                process; and
                                    ``(IV) subject to section 14, 
                                require the Administrator--
                                            ``(aa) to make available to 
                                        the public the information 
                                        taken into consideration in 
                                        preparing each safety 
                                        assessment and determination;
                                            ``(bb) to publish and 
                                        provide an opportunity for 
                                        comment on proposed safety 
                                        assessments and determinations; 
                                        and
                                            ``(cc) to publish final 
                                        safety assessments and 
                                        determinations.
                            ``(ii) Deadlines.--
                                    ``(I) In general.--The rules 
                                described in subparagraph (A) shall 
                                also include--
                                            ``(aa) a schedule by which 
                                        each safety assessment and 
                                        determination is expected to be 
                                        conducted; and
                                            ``(bb) a deadline for the 
                                        completion of each assessment 
                                        and determination.
                                    ``(II) Flexibility and reasonable 
                                extensions.--The deadlines described in 
                                subclause (I)(bb)--
                                            ``(aa) may vary among 
                                        chemical substances to grant 
                                        the Administrator flexibility; 
                                        and
                                            ``(bb) shall allow for 
                                        reasonable extensions after an 
                                        adequate public justification.
                    ``(C) Inclusions in final assessments.--Each safety 
                assessment under this subsection shall include--
                            ``(i) a weight-of-the evidence summary; and
                            ``(ii) a nontechnical summary explaining 
                        what the relevant information demonstrates in 
                        the context of the intended conditions of use 
                        and exposure patterns of the chemical 
                        substance.
            ``(3) Data and information sources.--In conducting a safety 
        assessment under this subsection, the Administrator shall, at a 
        minimum, take into consideration--
                    ``(A) the information described in section 4(c); 
                and
                    ``(B) any additional information submitted under 
                paragraph (5).
            ``(4) Methodology.--
                    ``(A) In general.--The Administrator shall--
                            ``(i) develop an appropriate science-based 
                        methodology for conducting safety assessments 
                        under this subsection, which shall include 
                        consideration of the weight of the evidence for 
                        observed effects, mechanistic information, and 
                        exposure evaluations; and
                            ``(ii) make the proposed methodology 
                        available for public comment and scientific 
                        peer review.
                    ``(B) Review and revisions.--Not later than 5 years 
                after the date of enactment of the Chemical Safety 
                Improvement Act, and not less frequently than once 
                every 5 years thereafter, the Administrator--
                            ``(i) shall review the methodology 
                        developed under subparagraph (A); and
                            ``(ii) may revise the methodology to 
                        reflect new scientific developments or 
                        understandings, in accordance with subparagraph 
                        (A).
                    ``(C) Requirements.--The methodology shall apply 
                scientifically recognized factors to address the 
                following topics:
                            ``(i) Strengths and limitations of study 
                        design.
                            ``(ii) Reliability and relevance of test 
                        methods to human health and the environment.
                            ``(iii) Quality of data.
                            ``(iv) Use of good laboratory practices.
                            ``(v) Peer review and peer review 
                        processes.
                            ``(vi) Use of standardized protocols.
                            ``(vii) Structured evaluative frameworks to 
                        determine the overall weight of the evidence, 
                        based on a review of positive and negative 
                        findings.
                    ``(D) Hazard, use, and exposure information.--
                            ``(i) In general.--A safety assessment 
                        under this subsection shall evaluate existing 
                        hazard, use, and exposure information for the 
                        chemical substance under the intended 
                        conditions of use of the chemical substance, 
                        including information submitted by interested 
                        persons.
                            ``(ii) Exposure.--For purposes of 
                        evaluating exposure under clause (i), a safety 
                        assessment shall take into consideration--
                                    ``(I) exposures or significant 
                                subsets of exposures;
                                    ``(II) exposure duration, 
                                intensity, frequency, and number; and
                                    ``(III) the vulnerability of 
                                exposed subpopulations.
                    ``(E) Best available science.--The Administrator 
                shall use the best available science in conducting a 
                safety assessment under this subsection.
            ``(5) Additional test information.--If the Administrator 
        determines that additional test information is needed in order 
        to make a safety assessment for a high-priority substance, the 
        Administrator--
                    ``(A) shall provide an opportunity for interested 
                persons to submit the additional information;
                    ``(B) may promulgate a rule, enter into a testing 
                consent agreement, or issue an order under section 4 to 
                require the development of the information; and
                    ``(C) may defer, for a reasonable period, a safety 
                assessment until after receipt of the information.
            ``(6) Treatment.--A safety assessment under this 
        subsection--
                    ``(A) shall not be considered to be a final agency 
                action; and
                    ``(B) shall not be subject to judicial review.
    ``(c) Safety Determination.--
            ``(1) In general.--As soon as possible after the date on 
        which the safety assessment is completed for a high-priority 
        substance under subsection (b), the Administrator shall 
        determine whether the chemical substance meets the safety 
        standard under the intended conditions of use of the chemical 
        substance.
            ``(2) Determinations.--Based on a review of the information 
        described in paragraph (3), the Administrator shall determine, 
        based solely on considerations of risk to human health and the 
        environment, that--
                    ``(A) the relevant chemical substance meets the 
                safety standard under intended conditions of use;
                    ``(B) the relevant chemical substance does not meet 
                the safety standard under intended conditions of use, 
                in which case the Administrator shall impose additional 
                restrictions, as appropriate, under paragraph (9); or
                    ``(C) additional information is necessary in order 
                to make a determination under subparagraph (A) or (B), 
                in which case the Administrator shall take appropriate 
                action under paragraph (8).
            ``(3) Considerations.--In making a safety determination 
        under this subsection, the Administrator shall take into 
        consideration and publish a statement that includes, at a 
        minimum--
                    ``(A) the safety assessment for the chemical 
                substance, including the uses considered in the 
                assessment and any uses that are considered critical or 
                essential;
                    ``(B) the range of exposure to the chemical 
                substance under the intended conditions of use of the 
                chemical substance and appropriate reference 
                parameters;
                    ``(C) the weight of the evidence of risk posed by 
                the chemical substance under the intended conditions of 
                use of the chemical substance; and
                    ``(D) the magnitude of the risk posed by the 
                chemical substance under the intended conditions of use 
                of the chemical substance.
            ``(4) Information sources.--In making a safety 
        determination under this subsection, the Administrator shall 
        take into consideration, at a minimum--
                    ``(A) the information described in section 4(c); 
                and
                    ``(B) the safety assessment conducted with respect 
                to the chemical substance under subsection (b).
            ``(5) Best available science.--The Administrator shall use 
        the best available science in making a safety determination 
        under this subsection.
            ``(6) Notice and comment.--Subject to section 14, the 
        Administrator shall provide notice and an opportunity for 
        public comment on each proposed safety determination under this 
        subsection.
            ``(7) Transparency.--Subject to section 14, the 
        Administrator shall publish--
                    ``(A) each safety determination under this 
                subsection, together with a summary of the information 
                considered in the determination;
                    ``(B) a summary of the evaluation by the 
                Administrator of the information; and
                    ``(C) an explanation of the reasons for the 
                determination.
            ``(8) Additional test data and information.--If the 
        Administrator determines that additional test data and 
        information is needed in order to make a safety determination 
        for a high-priority substance, the Administrator--
                    ``(A) shall provide an opportunity for interested 
                persons to submit the additional data and information;
                    ``(B) may promulgate a rule, enter into a testing 
                consent agreement, or issue an order under section 4 to 
                require the development of the data and information;
                    ``(C) may defer, for a reasonable period, a safety 
                determination until after receipt of the data and 
                information; and
                    ``(D) on receipt of the data and information, shall 
                make a determination under paragraph (2).
            ``(9) Additional restrictions.--
                    ``(A) In general.--
                            ``(i) Determination.--If the Administrator 
                        makes a determination under paragraph (2)(B) 
                        with respect to a chemical substance, the 
                        Administrator shall promulgate a rule 
                        establishing necessary restrictions (based on 
                        the weight of the evidence of risk and the 
                        magnitude of risk), including if appropriate, a 
                        ban or phase out of the manufacture, 
                        processing, or use of the chemical substance in 
                        accordance with subparagraph (C).
                            ``(ii) Rules.--Rules promulgated under this 
                        section may apply to mixtures containing the 
                        chemical substance, as appropriate.
                    ``(B) Inclusions.--A restriction under subparagraph 
                (A) may include, as appropriate--
                            ``(i) a requirement that a chemical 
                        substance be marked with, or accompanied by, 
                        clear and adequate warnings and instructions 
                        with respect to use, distribution in commerce, 
                        or disposal, or any combination of those 
                        activities, with the form and content of the 
                        warnings and instructions to be prescribed by 
                        the Administrator;
                            ``(ii) a requirement that manufacturers and 
                        processors of the chemical substance--
                                    ``(I) make and retain records of 
                                the processes used to manufacture or 
                                process the chemical substance; and
                                    ``(II) subject to section 4(f), 
                                develop test information that is 
                                reasonably necessary to ensure 
                                compliance with this Act;
                            ``(iii) a limitation on the quantity of the 
                        chemical substance that may be manufactured, 
                        processed, or distributed in commerce;
                            ``(iv) a requirement to ban or phase out or 
                        other regulation on the manufacture, 
                        processing, or distribution in commerce of the 
                        chemical substance--
                                    ``(I) for a particular use; or
                                    ``(II) for a particular use at a 
                                concentration in excess of a level 
                                specified by the Administrator;
                            ``(v) a limitation on the quantity of the 
                        chemical substance that may be manufactured, 
                        processed, or distributed in commerce--
                                    ``(I) for a particular use; or
                                    ``(II) for a particular use at a 
                                concentration in excess of a level 
                                specified by the Administrator;
                            ``(vi) a requirement to ban or phase out or 
                        other regulation of any method of commercial 
                        use of the chemical substance;
                            ``(vii) a requirement to ban or phase out 
                        or other regulation of any method of disposal 
                        of the chemical substance or any article 
                        containing the chemical substance;
                            ``(viii) a requirement directing 
                        manufacturers or processors of the chemical 
                        substance to give notice of unreasonable risks 
                        of harm to distributors in commerce of the 
                        chemical substance and, to the extent 
                        reasonably ascertainable, to other persons in 
                        the chain of commerce in possession of the 
                        chemical substance; and
                            ``(ix) such other requirements as the 
                        Administrator determines to be necessary.
                    ``(C) Bans and phase outs.--The Administrator shall 
                base a determination under subparagraph (A) that a ban 
                or phase out of the manufacture, processing, or use of 
                a chemical substance is necessary on the considerations 
                described in subparagraph (D).
                    ``(D) Determination that chemical substance does 
                not meet safety standard.--If the Administrator 
                determines that the chemical substance does not meet 
                the safety standard under the intended conditions of 
                use, the Administrator shall consider and publish a 
                statement on--
                            ``(i) the availability of technically and 
                        economically feasible alternatives for the 
                        chemical substance under the intended 
                        conditions of use;
                            ``(ii) the risks posed by those 
                        alternatives as compared to those of the 
                        chemical substance;
                            ``(iii) the economic and social costs and 
                        benefits of the proposed regulatory action and 
                        options considered, and of potential 
                        alternatives; and
                            ``(iv) the economic and social benefits and 
                        costs of--
                                    ``(I) the chemical substance;
                                    ``(II) alternatives to the chemical 
                                substance; and
                                    ``(III) any necessary restrictions 
                                on the chemical substance or 
                                alternatives.
            ``(10) Exemptions.--The Administrator may exempt the use of 
        a chemical substance from any additional restriction 
        established under paragraph (9) if the Administrator determines 
        that--
                    ``(A) the exemption is in the interest of national 
                security;
                    ``(B) the lack of availability of the chemical 
                substance would cause significant disruption in the 
                national economy;
                    ``(C) the use for which the exemption is sought is 
                a critical or essential use for which--
                            ``(i) no feasible alternative for the use 
                        would materially reduce risk to health or the 
                        environment; or
                            ``(ii) no feasible alternative for the use 
                        is economically, technically, or efficiently 
                        available; or
                    ``(D) the use, as compared to reasonably available 
                alternatives, provides a net benefit to human health, 
                the environment, or public safety.
            ``(11) Final agency action.--A safety determination under 
        this subsection shall be--
                    ``(A) considered to be a final agency action; and
                    ``(B) subject to judicial review, including review 
                of the associated safety assessment under this 
                subsection.'';
            (3) by redesignating subsections (e) and (f) as subsections 
        (d) and (e), respectively; and
            (4) in subsection (d) (as so redesignated)--
                    (A) by striking paragraph (4); and
                    (B) by redesignating paragraph (5) as paragraph 
                (4).

SEC. 7. IMMINENT HAZARDS.

    Section 7 (15 U.S.C. 2606) is amended--
            (1) by striking subsection (a) and inserting the following:
    ``(a) Civil Actions.--
            ``(1) In general.--The Administrator may commence a civil 
        action in an appropriate district court of the United States 
        for--
                    ``(A) seizure of an imminently hazardous chemical 
                substance or mixture or any article containing the 
                substance or mixture;
                    ``(B) relief (as authorized by subsection (b)) 
                against any person who manufactures, processes, 
                distributes in commerce, uses, or disposes of, an 
                imminently hazardous chemical substance or mixture or 
                any article containing the substance or mixture; or
                    ``(C) both seizure described in subparagraph (A) 
                and relief described in subparagraph (B).
            ``(2) Rule, order, or other proceeding.--A civil action may 
        be commenced under this paragraph notwithstanding--
                    ``(A) the existence of--
                            ``(i) a decision by the Administrator under 
                        section 4(c)(3), 5(c)(4), or 6(c)(2); or
                            ``(ii) a rule, testing consent agreement, 
                        or order under section 4(f), 5(g), 6(b)(5), 
                        6(c)(8), 6(c)(9), or 6(d); or
                    ``(B) the pendency of any administrative or 
                judicial proceeding under any provision of this Act.'';
            (2) in subsection (d), by striking ``section 6(a)'' and 
        inserting ``section 6(c)''; and
            (3) in subsection (f), in the first sentence, by striking 
        ``and unreasonable''.

SEC. 8. INFORMATION COLLECTION AND REPORTING.

    Section 8 (15 U.S.C. 2607) is amended--
            (1) in subsection (a), by adding at the end the following:
            ``(4) Regulations.--
                    ``(A) In general.--The Administrator shall 
                promulgate rules requiring the reporting of information 
                known by, or reasonably ascertainable by, the person 
                making the report, including rules requiring processors 
                to report information, so that the Administrator has 
                the information necessary to carry out sections 4 and 
                6.
                    ``(B) Contents.--The rules promulgated under 
                subparagraph (A)--
                            ``(i) may impose different reporting 
                        requirements on manufacturers and processors;
                            ``(ii) shall be limited to active 
                        substances or mixtures containing active 
                        substances as designated under subsection (b); 
                        and
                            ``(iii) shall apply only to the extent the 
                        Administrator determines the submission of 
                        reports is necessary for the effective 
                        enforcement of this Act.
            ``(5) Guidance.--The Administrator shall develop guidance 
        relating to the information required to be reported under the 
        rules promulgated under this subsection that--
                    ``(A) include the level of detail necessary to be 
                reported; and
                    ``(B) describes the manner by which manufacturers 
                and processors may report use and exposure information 
                on a voluntary basis.'';
            (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 date of enactment of the 
                        Chemical Safety Improvement 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 all components of categories 
                        that are considered to be statutory mixtures 
                        under this Act as being included on the list 
                        published under paragraph (1) under the 
                        Chemical Abstracts Service numbers for the 
                        respective categories, including, without 
                        limitation--
                                    ``(I) cement, Portland, chemicals, 
                                CAS No. 65997-15-1;
                                    ``(II) cement, alumina, chemicals, 
                                CAS No. 65997-16-2;
                                    ``(III) glass, oxide, chemicals, 
                                CAS No. 65997-17-3;
                                    ``(IV) frits, chemicals, CAS No. 
                                65997-18-4;
                                    ``(V) steel manufacture, chemicals, 
                                CAS No. 65997-19-5; and
                                    ``(VI) ceramic materials and wares, 
                                chemicals, CAS No. 66402-68-4.
                    ``(B) Multiple nomenclature conventions.--
                            ``(i) In general.--In the event that 
                        existing guidance allows for multiple 
                        nomenclature conventions, the Administrator 
                        shall--
                                    ``(I) maintain the nomenclature 
                                conventions for substances; and
                                    ``(II) develop new guidance that--
                                            ``(aa) establishes 
                                        equivalency between the 
                                        nomenclature conventions for 
                                        chemical substances on the list 
                                        published under paragraph (1); 
                                        and
                                            ``(bb) permits persons to 
                                        rely on that new guidance for 
                                        purposes of determining whether 
                                        a chemical substance is on the 
                                        list published under paragraph 
                                        (1).
                            ``(ii) Multiple cas numbers.--For any 
                        chemical substance appearing multiple times on 
                        the list under different Chemical Abstracts 
                        Service numbers, the Administrator shall 
                        develop guidance recognizing the multiple 
                        listings as a single chemical substance.
            ``(4) Candidate list of active substances in commerce.--
                    ``(A) In general.--Subject to section 14, the 
                Administrator shall make publicly available a candidate 
                list of active chemical substances, which shall 
                include--
                            ``(i) any chemical substance reported under 
                        part 711 of title 40, Code of Federal 
                        Regulations, as in effect on the date of 
                        enactment of the Chemical Safety Improvement 
                        Act, during the period beginning on the date 
                        that is 10 years before the date of enactment 
                        of the Chemical Safety Improvement Act and 
                        ending on the date of enactment of the Chemical 
                        Safety Improvement Act;
                            ``(ii) any chemical substance for which a 
                        notice of commencement of manufacture has been 
                        submitted;
                            ``(iii) any chemical substance for which a 
                        significant new use notice has been submitted;
                            ``(iv) any chemical substance for which an 
                        export notification has been submitted during 
                        the period beginning on the date that is 10 
                        years before the date of enactment of the 
                        Chemical Safety Improvement Act and ending on 
                        the date of enactment of the Chemical Safety 
                        Improvement Act; and
                            ``(v) any other chemical substance 
                        identified by the Administrator as likely to 
                        qualify as active.
                    ``(B) Rule.--The Administrator shall, by rule, 
                require manufacturers and processors to notify the 
                Administrator that the manufacturer or processor, as 
                applicable, has manufactured or processed a chemical 
                substance on the list described in subparagraph (A), or 
                the list published under paragraph (1) for a nonexempt 
                commercial purpose during the 5-year period prior to 
                the date of enactment of the Chemical Safety 
                Improvement Act.
                    ``(C) Guidance.--Before issuing a final rule under 
                subparagraph (A), the Administrator shall make publicly 
                available guidance relating to the rule for chemical 
                substances on the confidential portion of the candidate 
                list of active substances and of the list published 
                under paragraph (1), including --
                            ``(i) accession numbers;
                            ``(ii) premanufacture notice case numbers, 
                        if applicable; and
                            ``(iii) generic names.
                    ``(D) Confidential chemical substances.--The rule 
                under subparagraph (B) shall require a manufacturer or 
                processor that is reporting information relating to a 
                chemical substance on the confidential portion of the 
                list published under paragraph (1) to indicate whether 
                the manufacturer or processor claims the specific 
                identity of the substance as confidential pursuant to 
                section 14.
                    ``(E) Certification.--The rule under subparagraph 
                (B) shall require a manufacturer or processor--
                            ``(i) to certify the accuracy of each 
                        report of the manufacturer or processor carried 
                        out under the rule; and
                            ``(ii) to retain a record supporting that 
                        certification for a period of 5 years beginning 
                        on the last day of the submission period.
                    ``(F) Applicability.--Nothing in this paragraph 
                requires the resubstantiation of a claim for protection 
                against disclosure for information submitted to the 
                Administrator prior to the date of enactment of the 
                Chemical Safety Improvement Act.
            ``(5) List.--
                    ``(A) In general.--Based on the notifications 
                received in response to the rule under paragraph (4), 
                the Administrator shall designate each chemical 
                substance that is on the list published under paragraph 
                (1) on the date of enactment of the Chemical Safety 
                Improvement Act as active or inactive.
                    ``(B) Update.--The Administrator shall update the 
                list of chemicals designated as active or inactive as 
                soon as practicable following the publication of the 
                most recent data reported under part 711 of title 40, 
                Code of Federal Regulations.
            ``(6) Active substances.--The Administrator shall designate 
        as an active substance--
                    ``(A) a chemical substance that has been 
                manufactured or processed for a nonexempt commercial 
                purposes at any point during the 5-year period prior to 
                the date of enactment of the Chemical Safety 
                Improvement Act;
                    ``(B) a chemical substance that is added to the 
                list published under paragraph (1) after the date of 
                enactment of the Chemical Safety Improvement Act;
                    ``(C) a chemical substance for which a notice is 
                received under paragraph (7)(C); and
                    ``(D) a chemical substance reported under part 711 
                of title 40, Code of Federal Regulations, after the 
                date of enactment of the Chemical Safety Improvement 
                Act.
            ``(7) Inactive substances.--
                    ``(A) In general.--The Administrator shall 
                designate as an inactive substance each chemical 
                substance on the list published under paragraph (1) 
                that has not been manufactured or processed for a 
                nonexempt commercial purpose in the 5-year period 
                ending on the date of enactment of the Chemical Safety 
                Improvement Act.
                    ``(B) Treatment.--Each inactive substance shall 
                remain on the list published under paragraph (1).
                    ``(C) Change to active status.--
                            ``(i) In general.--Any person who 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 substance is manufactured or 
                        processed.
                            ``(ii) Active status.--On receiving 
                        notification under clause (i), the 
                        Administrator--
                                    ``(I) shall designate the chemical 
                                substance as an active substance; and
                                    ``(II) shall, pursuant to section 
                                4(e), review the priority of the 
                                chemical substance as the Administrator 
                                determines necessary.
                    ``(D) Category status.--The list of inactive 
                chemical substances shall not be considered a category 
                for purposes of section 26(c).
            ``(8) Public participation.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Administrator shall make available to the public--
                            ``(i) the specific identity of each 
                        chemical substance on the nonconfidential 
                        portion of the list published under paragraph 
                        (5) that the Administrator has designated as an 
                        active substance;
                            ``(ii) the specific identity of each 
                        chemical substance on the nonconfidential 
                        portion of the list published under paragraph 
                        (1) that the Administrator has designated as an 
                        inactive substance;
                            ``(iii) the 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
                            ``(iv) the specific identity of any active 
                        or inactive substance on the confidential 
                        portion of the list published under paragraph 
                        (1) for which no claim of confidentiality was 
                        received, subject to the condition that, before 
                        revealing the specific identity of the 
                        substance, the Administrator shall--
                                    ``(I) publish a notice in the 
                                Federal Register identifying the 
                                accession number, generic name, and, if 
                                applicable, premanufacture notice case 
                                number for that substance; and
                                    ``(II) provide an opportunity for 
                                any person--
                                            ``(aa) to certify to the 
                                        Administrator that the person 
                                        intends to manufacture or 
                                        process the substance at any 
                                        point in the subsequent 4-year 
                                        period; and
                                            ``(bb) to claim 
                                        confidentiality for the 
                                        specific identity of the 
                                        substance.
                    ``(B) Confidentiality.--Subject section 14, the 
                Administrator shall not make available to the public 
                the specific chemical identity of any substance for 
                which the Administrator receives a notice under 
                subparagraph (A)(iv).''; and
            (3) in subsection (e)--
                    (A) by striking ``Any person'' and inserting the 
                following:
            ``(1) In general.--Any person''; and
                    (B) by adding at the end the following:
            ``(2) Applicability.--Any person may submit to the 
        Administrator data and information reasonably supporting the 
        conclusion that a chemical substance or mixture does not 
        present a substantial risk of injury to health and the 
        environment.''.

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.

    Section 9 (15 U.S.C. 2608) is amended--
            (1) in subsection (a)--
                    (A) in the first sentence of paragraph (1)--
                            (i) by striking ``presents or will present 
                        an unreasonable risk to health or the 
                        environment'' and inserting ``does not meet the 
                        safety standard under the intended conditions 
                        of use''; and
                            (ii) by striking ``such risk'' the first 
                        place it appears and inserting ``the risk posed 
                        by the substance or mixture'';
                    (B) in paragraph (2), in the matter following 
                subparagraph (B), by striking ``section 6 or 7'' and 
                inserting ``paragraph (8) or (9) of subsection (c) of 
                section 6 or section 7''; and
                    (C) in paragraph (3), by striking ``section 6 or 
                7'' and inserting ``paragraph (8) or (9) of subsection 
                (c) of section 6 or section 7''; and
            (2) in subsection (d), in the first sentence, by striking 
        ``Health, Education, and Welfare'' and inserting ``Health and 
        Human Services''.

SEC. 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION, AND 
              UTILIZATION OF DATA.

    Section 10 (15 U.S.C. 2609) is amended by striking ``Health, 
Education, and Welfare'' each place it appears and inserting ``Health 
and Human Services''.

SEC. 11. EXPORTS.

    Section 12 (15 U.S.C. 2611) is amended--
            (1) in subsection (a), by striking paragraph (2) and 
        inserting the following:
            ``(2) Exception.--Paragraph (1) shall not apply to any 
        chemical substance that the Administrator determines--
                    ``(A) under section 5 is not likely to meet the 
                safety standard under the intended conditions of use of 
                the chemical substance; or
                    ``(B) under section 6 does not meet the safety 
                standard under the intended conditions of use of the 
                chemical substance.
            ``(3) Waivers.--For a mixture or article containing a 
        chemical substance described in paragraph (2), the 
        Administrator may--
                    ``(A) determine that paragraph (1) shall not apply 
                to that mixture or article; and
                    ``(B) establish a threshold concentration in a 
                mixture or article at which paragraph (1) shall not 
                apply.'';
            (2) by striking subsection (b) and inserting the following:
    ``(b) Notice.--
            ``(1) In general.--A person shall notify the Administrator 
        that the person is exporting or intends to export to a foreign 
        country--
                    ``(A) a chemical substance or a mixture containing 
                a chemical substance that the Administrator has 
                determined under section 5 is not likely to meet the 
                safety standard under the intended conditions of use of 
                the chemical substance;
                    ``(B) a chemical substance or a mixture containing 
                a chemical substance that the Administrator has 
                determined under section 6 does not meet the safety 
                standard under the intended conditions of use of the 
                chemical substance; or
                    ``(C) a chemical substance for which the United 
                States is obligated by treaty to provide export 
                notification.
            ``(2) Regulations.--
                    ``(A) In general.--The Administrator shall 
                promulgate regulations to carry out paragraph (1).
                    ``(B) Contents.--The regulations promulgated under 
                subparagraph (A) shall--
                            ``(i) include any exemptions the 
                        Administrator determines to be appropriate, 
                        which may include exemptions identified under 
                        section 5(g); and
                            ``(ii) indicate whether or to what extent 
                        the regulations apply to articles containing a 
                        chemical substance or mixture described in 
                        paragraph (1).
            ``(3) Notification.--The Administrator shall submit to the 
        government of each country to which a chemical substance or 
        mixture is exported--
                    ``(A) for a chemical substance or mixture described 
                in subparagraph (A) or (B) of paragraph (1), a notice 
                that information on the chemical substance or mixture 
                can be obtained from the Administrator, unless the 
                Administrator determines that good cause exists not to 
                provide the notice; and
                    ``(B) for a chemical substance described in 
                paragraph (1)(C), a notice that satisfies the 
                obligation of the United States under the applicable 
                treaty.''; and
            (3) in subsection (c)--
                    (A) by striking paragraph (3); and
                    (B) by redesignating paragraphs (4) through (6) as 
                paragraphs (3) through (5), respectively.

SEC. 12. IMPORTS.

    Section 13 (15 U.S.C. 2612) is amended to read as follows:

``SEC. 13. IMPORTS.

    ``(a) Definition of Chemical Substance or Mixture.--In this 
section, the term `chemical substance or mixture' includes--
            ``(1) a mixture containing a chemical substance or mixture; 
        and
            ``(2) an article containing a chemical substance or 
        mixture.
    ``(b) Refusal of Entry.--
            ``(1) In general.--The Secretary of Homeland Security shall 
        refuse entry into the customs territory of the United States 
        (as defined in general note 2 to the Harmonized Tariff Schedule 
        of the United States) any chemical substance or mixture offered 
        for such entry if--
                    ``(A) the Administrator has determined under 
                section 6(c) that the chemical substance or mixture 
                does not meet the safety standard under the intended 
                conditions of use of the chemical substance; or
                    ``(B) the chemical substance or mixture is offered 
                for entry in violation of a rule or order in effect 
                under this Act.
            ``(2) Procedure.--
                    ``(A) In general.--Subject to subparagraph (B), if 
                a chemical substance or mixture is refused entry under 
                paragraph (1), the Secretary of Homeland Security--
                            ``(i) shall notify the consignee of the 
                        entry of the refusal;
                            ``(ii) shall not release the chemical 
                        substance or mixture to the consignee; and
                            ``(iii) shall cause the disposal or storage 
                        of the chemical substance or mixture under such 
                        rules as the Secretary may prescribe, if the 
                        chemical substance or mixture has not been 
                        exported by the consignee in the 90-day period 
                        beginning on the date of receipt of the notice 
                        of the refused entry.
                    ``(B) Exception.--
                            ``(i) In general.--The Secretary of 
                        Homeland Security may, pending a review by the 
                        Administrator, release to the consignee the 
                        chemical substance or mixture if the 
                        consignee--
                                    ``(I) executes a bond for the 
                                amount of the full invoice of the 
                                chemical substance or mixture (as set 
                                forth in the customs entry); and
                                    ``(II) pays a duty on the chemical 
                                substance or mixture.
                            ``(ii) Administration.--If a consignee 
                        fails to return a chemical substance or mixture 
                        released to that consignee under clause (i) for 
                        any cause to the custody of the Secretary of 
                        Homeland Security when demanded, the consignee 
                        shall be liable to the United States for 
                        liquidated damages equal to the full amount of 
                        the bond.
                    ``(C) Storage.--All charges for storage, cartage, 
                and labor on and for the disposal of a chemical 
                substance or mixture that is refused entry or released 
                under this subsection shall be paid by the owner or 
                consignee, and a default on that payment shall 
                constitute a lien against any future entry made by the 
                owner or consignee.
    ``(c) Notice.--
            ``(1) In general.--A person offering a chemical substance 
        or mixture subject to this Act for entry into the customs 
        territory of the United States shall--
                    ``(A) certify to the Secretary of Homeland Security 
                that, after reasonable inquiry and to the best 
                knowledge and belief of the person, the chemical 
                substance or mixture is--
                            ``(i) in compliance with any applicable 
                        rule, consent agreement, or order under section 
                        5 or 6; and
                            ``(ii)(I) included on the list under 
                        section 8(b); or
                            ``(II) exempt from any requirement to be 
                        included on that list; and
                    ``(B) provide to the Secretary of Homeland Security 
                any notice required under paragraph (2).
            ``(2) Notice.--A person offering a chemical substance or 
        mixture for entry into the customs territory of the United 
        States shall notify the Secretary of Homeland Security if--
                    ``(A) the chemical substance is a high-priority 
                substance;
                    ``(B) the chemical substance is a chemical for 
                which the United States is obligated to provide export 
                notification by treaty; or
                    ``(C) the chemical substance or mixture or any 
                article containing the substance or mixture--
                            ``(i) is the subject of a safety assessment 
                        and safety determination conducted pursuant to 
                        section 6 and has been found not to meet the 
                        safety standard; and
                            ``(ii) is identified in a rule promulgated 
                        by the Secretary of Homeland Security pursuant 
                        to subsection (c) as meriting notification due 
                        to the potential impact of the chemical 
                        substance or mixture or any article containing 
                        the substance or mixture on human health or the 
                        environment.
    ``(d) Rules.--The Secretary of Homeland Security, after 
consultation with the Administrator, shall issue rules for the 
administration of subsection (c), including whether, or to what extent, 
the provisions of subsections (b) and (c) apply.''.

SEC. 13. CONFIDENTIAL INFORMATION.

    Section 14 (15 U.S.C. 2613) is amended to read as follows:

``SEC. 14. CONFIDENTIAL INFORMATION.

    ``(a) In General.--Except as provided in subsections (c) and (e), 
the Administrator shall not disclose information described in 
subsection (b)--
            ``(1) that is reported to, or otherwise obtained by, the 
        Administrator under this Act; and
            ``(2) for which the requirements of subsection (d) are met.
    ``(b) Information Generally Protected From Disclosure.--
            ``(1) In general.--Information referred to in subsection 
        (a) includes confidential information that is exempt from 
        disclosure pursuant to subsection (a) of section 552 of title 
        5, United States Code, under subsection (b)(4) of that section.
            ``(2) Presumption of protection.--The following information 
        submitted by a manufacturer, processor, or distributor is 
        presumed to be protected from disclosure:
                    ``(A) Specific information describing the 
                manufacture, processing, or distribution in commerce of 
                a chemical substance, mixture, or article.
                    ``(B) Marketing and sales information.
                    ``(C) Information identifying suppliers or 
                customers.
                    ``(D) The identity of constituents in a mixture and 
                the respective percentages of those constituents.
                    ``(E) Specific information about the use, function, 
                or application of a chemical substance or mixture in a 
                process, mixture, or product.
                    ``(F) Specific production or import volumes of a 
                manufacturer and specific volumes aggregated across 
                manufacturers if the Administrator determines that 
                disclosure of the aggregated data could reveal 
                confidential information.
                    ``(G) The specific identity of a chemical 
                substance, including the chemical name, molecular 
                formula, Chemical Abstracts Service number, and other 
                information that would identify a specific chemical 
                substance, if--
                            ``(i) the specific identity was claimed as 
                        confidential information at the time it was 
                        submitted; and
                            ``(ii) the claim has not subsequently been 
                        withdrawn or found by the Administrator not to 
                        warrant protection as confidential information 
                        under subsection (g).
    ``(c) Information Not Protected From Disclosure.--
            ``(1) In general.--Notwithstanding subsections (a) and (b), 
        and except as provided in paragraph (2), the following 
        information shall not be protected from disclosure:
                    ``(A) For information submitted after the date of 
                enactment of the Chemical Safety Improvement Act, the 
                identity of a chemical substance if the person 
                submitting the information does not meet the 
                requirements of subsection (d).
                    ``(B) A safety assessment developed or a safety 
                determination made under section 6.
                    ``(C) Health and safety data that are submitted 
                under this Act with respect to a chemical substance or 
                mixture that has been offered for commercial 
                distribution as of the date on which the study is to be 
                disclosed or for which testing is required under 
                section 4.
                    ``(D) Health and safety data in notices of 
                substantial risk submitted under section 8(e) and in 
                the underlying studies.
                    ``(E) General information describing the 
                manufacturing volumes, expressed in ranges would not 
                reveal confidential information.
                    ``(F) General descriptions of industrial, 
                commercial, or consumer functions and uses of a 
                chemical substance or mixture.
            ``(2) Exception.--Information elements contained in 
        submissions described in paragraph (1) that are otherwise 
        eligible for protection under this section shall be protected 
        from disclosure if the submitter complies with subsection (d).
    ``(d) Requirements for Confidentiality Claims.--
            ``(1) Claims.--
                    ``(A) In general.--For information to be protected 
                from disclosure under this section, a person who 
                submits information to the Administrator under this Act 
                shall--
                            ``(i) indicate the information that the 
                        person believes is entitled to protection from 
                        disclosure under this section in a submission 
                        to the Administrator in such manner and at such 
                        time as the Administrator shall prescribe; and
                            ``(ii) except in the case of information 
                        described in subparagraphs (A) through (F) of 
                        subsection (b)(2), submit written documentation 
                        justifying why the information qualifies for 
                        protection from disclosure.
                    ``(B) Certification.--An authorized official of the 
                person described in subparagraph (A) shall certify that 
                the information that has been submitted is true and 
                correct.
            ``(2) Additional requirements for confidentiality claims 
        for chemical identities.--A person submitting information under 
        this Act related to a chemical identity and who claims 
        protection from disclosure for that identity shall provide the 
        Administrator with--
                    ``(A) information establishing that--
                            ``(i) the person takes reasonable measures 
                        to protect the confidentiality of the chemical 
                        identity;
                            ``(ii) the chemical identity is not 
                        required to be disclosed, or otherwise made 
                        available, to the public under any other 
                        Federal law in connection with one or more uses 
                        subject to this Act;
                            ``(iii) disclosure of the chemical identity 
                        is likely to cause substantial harm to the 
                        competitive position of the person; and
                            ``(iv) the chemical identity is not 
                        reasonably believed to be readily discoverable 
                        through reverse engineering;
                    ``(B) the time period for which protection of the 
                chemical identity from disclosure is necessary;
                    ``(C) a generic name for the chemical substance 
                that the Administrator may disclose to the public, 
                subject to the condition that the generic name 
                discloses a maximum amount of information on the 
                chemical structure of the substance while protecting 
                those features of the chemical structure that are 
                considered confidential and the disclosure of which 
                would potentially harm the competitive position of the 
                person; and
                    ``(D) in the event the Administrator makes a 
                request under subsection (f)--
                            ``(i) redocumentation and recertification 
                        of the information submitted under subsection 
                        (a); or
                            ``(ii) withdrawal of the claim for 
                        protection of the chemical identity from 
                        disclosure.
            ``(3) Guidance.--The Administrator shall develop guidance, 
        after notice and opportunity to comment, on the determination 
        of generic names for confidential chemical identities.
    ``(e) Exceptions to Protection From Disclosure.--Subsection (a) 
shall not apply if--
            ``(1) the information is to be disclosed to an officer or 
        employee of the United States in connection with the official 
        duties of that person under any law for the protection of human 
        health or the environment or for specific law enforcement 
        purposes;
            ``(2) the information is to be disclosed to a contractor 
        with the United States and employees of that contractor 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 under such conditions as the 
        Administrator shall specify;
            ``(3) the Administrator determines that disclosure is 
        necessary to protect human health or the environment;
            ``(4) the information is to be disclosed to a State or 
        political subdivision of a State, on written request, for the 
        purpose of development, administration, or enforcement of a 
        law, if--
                    ``(A) one or more applicable agreements with the 
                Administrator ensure that the recipient government will 
                take appropriate steps, and has adequate authority, to 
                maintain the confidentiality of the information in 
                accordance with procedures as stringent as those which 
                the Administrator uses to safeguard the information; 
                and
                    ``(B) the Administrator notifies the person who 
                submitted the information that the information has been 
                disclosed to a State or political subdivision of a 
                State;
            ``(5) a health professional employed by a Federal or State 
        agency or a treating physician or nurse in a nonemergency 
        situation provides a written statement of need and a written 
        confidentiality agreement, subject to the conditions that--
                    ``(A) the written statement of need is a statement 
                that the person has a reasonable basis to suspect 
                that--
                            ``(i) the information is needed for 
                        purposes of diagnosis or treatment of one or 
                        more individuals;
                            ``(ii) one or more individuals being 
                        diagnosed or treated have been exposed to the 
                        chemical substance concerned; and
                            ``(iii) knowledge of the specific chemical 
                        identity of the chemical substance will assist 
                        in diagnosis or treatment; and
                    ``(B) the confidentiality agreement provides that 
                the person will not use the specific chemical identity 
                for any purpose other than the health needs asserted in 
                the statement of need, except as may otherwise be 
                authorized by the terms of the agreement or by the 
                person submitting the specific chemical identity to the 
                Administrator;
            ``(6) a treating physician or nurse requests the 
        information, subject to the conditions that--
                    ``(A) the treating physician or nurse determines 
                that--
                            ``(i) a medical emergency exists;
                            ``(ii) the specific chemical identity of 
                        the chemical substance concerned is necessary 
                        for or will assist in emergency or first-aid 
                        diagnosis or treatment; and
                            ``(iii) the one or more individuals being 
                        diagnosed or treated have likely been exposed 
                        to the chemical substance concerned;
                    ``(B) if requested by the person submitting the 
                specific chemical identity to the Administrator, the 
                treating physician or nurse provides a written 
                statement of need and a confidentiality agreement as 
                described in paragraph (5); and
                    ``(C) the written confidentiality agreement or 
                statement of need is submitted as soon as practicable, 
                but not necessarily before the information is 
                disclosed;
            ``(7) the Administrator determines that disclosure is 
        necessary 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 maximum extent practicable 
        without impairing the proceeding; or
            ``(8) the information is to be disclosed, on written 
        request of any duly authorized committee of the Congress, to 
        that committee.
    ``(f) Duration of Protection From Disclosure.--
            ``(1) In general.--The Administrator shall protect from 
        disclosure information described in subsection (b) that meets 
        the requirements of subsection (d)(2) for the period of time 
        requested by the person submitting the claim or for such period 
        of time as the Administrator, after reviewing the request for 
        confidential treatment and the documentation, otherwise 
        determines to be reasonable, unless--
                    ``(A) prior to the expiration of the period, the 
                person notifies the Administrator that the person is 
                withdrawing the confidentiality claim, in which case, 
                the Administrator shall promptly make the information 
                available to the public; or
                    ``(B) prior to the expiration of the period, the 
                Administrator otherwise becomes aware that the need for 
                protection from disclosure can no longer be 
                substantiated, in which case the Administrator shall 
                take the actions described in subsection (g)(2).
            ``(2) Redocumentation.--The Administrator may request--
                    ``(A) at any time, a person who has requested 
                protection from disclosure for the identity of a 
                substance under subsection (d) to redocument the 
                confidentiality claim of the person; and
                    ``(B) any person who has requested that 
                confidential information be protected from disclosure 
                under section 8(b) to reassert the confidentiality 
                claim of the person after the chemical substance is 
                identified as a high-priority substance under section 
                4(e).
    ``(g) Duties of the Administrator.--
            ``(1) Determination.--
                    ``(A) In general.--Except as provided in subsection 
                (b)(2), the Administrator shall--
                            ``(i) review a request received under this 
                        section to maintain the confidentiality of 
                        information submitted under this Act; and
                            ``(ii) determine whether to approve, 
                        modify, or deny that request.
                    ``(B) Denial or modification.--
                            ``(i) In general.--The Administrator shall 
                        deny a claim to protect a chemical identity 
                        from disclosure only if the person who has 
                        submitted the request fails to meet the 
                        requirements of subsection (d).
                            ``(ii) Reasons for denial or 
                        modification.--The Administrator shall provide 
                        to the person who has submitted the request a 
                        written statement of the reasons for the denial 
                        or modification of the claim.
                    ``(C) Subsets.--If it is not feasible for the 
                Administrator to review each request under this 
                section, the Administrator shall review a 
                representative subset.
            ``(2) Notification.--
                    ``(A) In general.--Except as provided in 
                subsections (c) and (e), if the Administrator denies a 
                request under paragraph (1), the Administrator shall 
                notify, in writing and by certified mail, the person 
                who submitted the request of the intent of the 
                Administrator to release the information.
                    ``(B) Release of information.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), the Administrator may not release 
                        information under this subsection until the 
                        date that is 30 days after the date on which 
                        the person who submitted the request receives 
                        notification under subparagraph (A).
                            ``(ii) Exceptions.--
                                    ``(I) In general.--For information 
                                under paragraph (3) or (8) of 
                                subsection (e), the Administrator may 
                                not release that information until the 
                                date that is 15 days after the date on 
                                which the person who submitted the 
                                request receives a notification, unless 
                                the Administrator determines that 
                                release of the information is necessary 
                                to protect against an imminent and 
                                substantial harm to human health or the 
                                environment, in which case, no prior 
                                notification is necessary.
                                    ``(II) No notification.--For 
                                information under paragraph (6) or (7) 
                                of subsection (e), no prior 
                                notification is necessary.
            ``(3) Appeals.--
                    ``(A) In general.--A person who receives 
                notification under this subsection may, if the person 
                believes disclosure of the information is prohibited 
                under subsection (a), before the date on which the 
                information is to be released, bring an action to 
                restrain disclosure of the information in--
                            ``(i) the district court of the United 
                        States in the district in which--
                                    ``(I) the complainant resides or 
                                has the principal place of business; or
                                    ``(II) the information is located; 
                                or
                            ``(ii) the United States District Court for 
                        the District of Columbia.
                    ``(B) No disclosure.--The Administrator shall not 
                disclose any information under this section prior to 
                the date on which the applicable court rules on an 
                action under subparagraph (A).
            ``(4) Administration.--In carrying out this subsection, the 
        Administrator shall employ the procedures in part 2 of title 
        40, Code of Federal Regulations (or successor regulations).
    ``(h) Criminal Penalty for Wrongful Disclosure.--
            ``(1) In general.--Subject to paragraph (2), any officer or 
        employee of the United States or former officer or employee of 
        the United States, who--
                    ``(A) by virtue of that employment or official 
                position has obtained possession of, or has access to, 
                material the disclosure of which is prohibited by 
                subsection (a); and
                    ``(B) knowing that disclosure of that material is 
                prohibited by subsection (a), willfully discloses the 
                material in any manner to any person not entitled to 
                receive that material, shall be--
                            ``(i) guilty of a misdemeanor and fined 
                        under title 18, United States Code, imprisoned 
                        for not more than 1 year, or both; and
                            ``(ii) removed from office or employment.
            ``(2) Other laws.--Section 1905 of title 18, United States 
        Code, shall not apply with respect to the publishing, 
        divulging, disclosure, making known of, or making available, 
        information reported or otherwise obtained under this Act.
            ``(3) Contractors.--For the purposes of this subsection, 
        any contractor of the United States who is furnished 
        information in accordance with subsection (e)(2), including any 
        employee of that contractor, shall be considered to be an 
        employee of the United States.
    ``(i) Applicability.--Except as otherwise provided in this section, 
the Administrator shall have no authority--
            ``(1) to require the documentation or redocumentation of a 
        claim for the protection from disclosure of information 
        submitted to the Administrator under this Act prior to the date 
        of enactment of the Chemical Safety Improvement Act; or
            ``(2) to impose redocumentation requirements under this Act 
        that are more extensive than those required under this 
        section.''.

SEC. 14. PROHIBITED ACTS.

    Section 15 (15 U.S.C. 2614) is amended by striking paragraph (1) 
and inserting the following:
            ``(1) fail or refuse to comply with--
                    ``(A) any rule promulgated, consent agreement 
                entered into, or order issued under section 4;
                    ``(B) any requirement prescribed by section 5 or 6;
                    ``(C) any rule promulgated, consent agreement 
                entered into, or order issued under section 5 or 6;
                    ``(D) any requirement of title II or any rule 
                promulgated or order issued under title II; or
                    ``(E) any requirement of title VII or any rule 
                promulgated or order issued under title VII;''.

SEC. 15. PREEMPTION.

    Section 18 (15 U.S.C. 2617) is amended by striking subsections (a) 
and (b) and inserting the following:
    ``(a) In General.--Except as provided in subsections (c) and (d), 
no State or political subdivision of a State may establish or continue 
to enforce--
            ``(1) a requirement for the development of test data or 
        information on a chemical substance or category of substances 
        that is reasonably likely to produce the same data and 
        information required under section 4, 5, or 6 by--
                    ``(A) a rule promulgated by the Administrator;
                    ``(B) a consent agreement entered into by the 
                Administrator; or
                    ``(C) an order issued by the Administrator;
            ``(2) a prohibition or restriction on the manufacture, 
        processing, or distribution in commerce or use of a chemical 
        substance after issuance of a completed safety determination 
        for a chemical substance under section 6, consistent with the 
        scope of the review and decisions addressed by the 
        Administrator; or
            ``(3) a requirement for 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.
    ``(b) New Prohibitions or Restrictions.--Except as provided in 
subsections (c) and (d), no State or political subdivision of a State 
may establish (after the date of enactment of the Chemical Safety 
Improvement Act)--
            ``(1) a prohibition or restriction on the manufacture, 
        processing, distribution in commerce or use of a chemical 
        substance that is a high-priority substance identified under 
        section 4(e)(3) (as of the date on which the Administrator 
        publishes a schedule under section 6(b)); or
            ``(2) a prohibition or restriction on the manufacture, 
        processing, distribution in commerce or use of a chemical 
        substance that is a low-priority substance identified under 
        section 4(e)(3).
    ``(c) Exceptions.--Subsections (a) and (b) shall not apply to a 
requirement, prohibition, or restriction of a State or a political 
subdivision of a State that--
            ``(1) is adopted under the authority of any other Federal 
        law;
            ``(2) implements a reporting or information collection 
        requirement not otherwise required by the Administrator under 
        this Act or required under any other Federal law; or
            ``(3) 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 that--
                    ``(A) does not impose a restriction on the 
                manufacture, processing, distribution in commerce, or 
                use of a chemical substance; and
                    ``(B) is not otherwise required by or inconsistent 
                with an action by the Administrator under section 5 or 
                6.
    ``(d) State Waivers.--Upon application of a State or political 
subdivision of a State, the Administrator may provide a waiver from 
subsection (a) and subsection (b)(1), regarding a requirement of that 
State or political subdivision of the State that relates to the effects 
or exposure to any chemical substance under the intended conditions of 
use if--
            ``(1)(A) the State or political subdivision of the State 
        determines it cannot wait until the end of the period specified 
        in the established schedule and deadline for the completion of 
        a full safety assessment and determination established under 
        section 6(b)(2)(B)(ii); and
            ``(B) the Administrator determines that--
                    ``(i) compelling State or local conditions warrant 
                granting the waiver to protect human health or the 
                environment;
                    ``(ii) compliance with the proposed requirement of 
                the State or political subdivision of the State does 
                not unduly burden interstate and foreign commerce in 
                the manufacture, processing, distribution in commerce, 
                or use of a chemical substance;
                    ``(iii) 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
                    ``(iv) the proposed requirement of the State or 
                political subdivision of the State is based on the best 
                available science and is supported by the weight of the 
                evidence; or
            ``(2)(A) the Administrator finds a safety assessment or 
        determination has been unreasonably delayed; and
            ``(B) the State certifies that--
                    ``(i) the State has a compelling local interest to 
                protect human health or the environment;
                    ``(ii) compliance with the proposed requirement of 
                the State does not unduly burden interstate and foreign 
                commerce in the manufacture, processing, distribution 
                in commerce, or use of a chemical substance;
                    ``(iii) compliance with the proposed requirement 
                would not cause a violation of any applicable Federal 
                law, rule, or order; and
                    ``(iv) the proposed requirement is grounded in 
                reasonable scientific concern.
            ``(3) Approval of a state waiver request.--The 
        Administrator shall grant or deny a waiver application--
                    ``(A) not later than 180 days after the date on 
                which an application under paragraph (1) is submitted; 
                and
                    ``(B) not later than 90 days after the date on 
                which an application under paragraph (2) is submitted.
            ``(4) Notice and comment.--The application of a State or 
        political subdivision of the State shall be subject to public 
        notice and comment.
            ``(5) Final agency action.--The decision of the 
        Administrator on the application of a State or political 
        subdivision of the State shall be--
                    ``(A) considered to be a final agency action; and
                    ``(B) subject to judicial review.
            ``(6) Duration of state waivers.--A State waiver--
                    ``(A) granted under paragraph (1) shall remain in 
                effect unless the waiver is found to be in conflict 
                with a completed safety assessment and determination; 
                and
                    ``(B) granted under paragraph (2) shall remain in 
                effect until such time as the safety assessment and 
                determination is completed.
            ``(7) Judicial review.--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 the State 
        under paragraph (1), 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.
    ``(e) Effect on Private Remedies.--
            ``(1) In general.--If the Administrator completes a safety 
        determination for a high-priority substance under section 6, 
        the determination shall be admissible as evidence in any public 
        or private action in any court of the United States or State 
        court for recovery of damages or for equitable relief relating 
        to injury to human health or the environment from exposure to a 
        chemical substance.
            ``(2) Safety standard.--The safety determination shall be 
        determinative of whether the substance meets the safety 
        standard under the conditions of use addressed in the safety 
        determination.''.

SEC. 16. JUDICIAL REVIEW.

    Section 19 (15 U.S.C. 2618) is amended--
            (1) in subsection (a)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) Filing of petition.--
                    ``(A) In general.--Not later than 60 days after the 
                date of the promulgation of a rule under section 4(f), 
                6(c), 6(e), or 8, any person may file a petition for 
                judicial review of the rule in--
                            ``(i) the United States Court of Appeals 
                        for the District of Columbia Circuit;
                            ``(ii) the circuit in which the person 
                        resides; or
                            ``(iii) the circuit in which the principal 
                        place of business of the person is located.
                    ``(B) Exclusive jurisdiction of courts of 
                appeals.--The courts of appeals of the United States 
                shall have exclusive jurisdiction of any action to 
                obtain judicial review (other than in an enforcement 
                proceeding) under subparagraph (A) if any district 
                court of the United States would have had jurisdiction 
                of the action but for this paragraph.'';
                    (B) in paragraph (2), by striking ``paragraph 
                (1)(A)'' and inserting ``paragraph (1)''; and
                    (C) by striking paragraph (3); and
            (2) in subsection (c)(1), by striking subparagraph (B) and 
        inserting the following:
                    ``(B) Applicability of section 706 of title 5, 
                united states code.--
                            ``(i) Definition of evidence.--In this 
                        subparagraph, the term `evidence' means any 
                        matter in the rulemaking record.
                            ``(ii) Applicability.--Section 706 of title 
                        5, United States Code, shall apply to review of 
                        a rule under this section, except that--
                                    ``(I) in the case of a rule under 
                                section 4(f), 6(c), or 6(e)--
                                            ``(aa) the standard of 
                                        review prescribed in section 
                                        706(2)(E) of title 5, United 
                                        States Code, shall not apply; 
                                        and
                                            ``(bb) the court shall hold 
                                        as unlawful and set aside the 
                                        rule if the court finds that 
                                        the rule is not supported by 
                                        substantial evidence in the 
                                        rulemaking record; and
                                    ``(II) the court shall not review 
                                the contents and adequacy of the 
                                statement of basis and purpose required 
                                by section 553(c) of title 5, United 
                                States Code, to be incorporated in the 
                                rule except as part of a review of the 
                                rulemaking record taken as a whole.''.

SEC. 17. CITIZENS' PETITIONS.

    Section 21 (15 U.S.C. 2620) is amended--
            (1) in subsection (a), by striking ``an order under section 
        5(e) or 6(b)(2)'' and inserting ``an order under section 4(f) 
        or 5(c)''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by striking ``an order under 
                section 5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting 
                ``an order under section 4(f) or 5(c)''; and
                    (B) by striking subparagraph (B) of paragraph (4) 
                and inserting the following:
                    ``(B) De novo proceeding.--
                            ``(i) In general.--In an action under 
                        subparagraph (A) to initiate a proceeding to 
                        issue a rule under section 4(f), 6(b), 6(c), 
                        6(d), or 8 or an order issued under section 
                        4(f) or 5(c), the petitioner shall be provided 
                        an opportunity to have the petition considered 
                        by the court in a de novo proceeding.
                            ``(ii) Demonstration.--
                                    ``(I) In general.--The court shall 
                                order the Administrator to initiate the 
                                action requested by the petitioner if 
                                the petitioner demonstrates to the 
                                satisfaction of the court by a 
                                preponderance of the evidence that--
                                            ``(aa) in the case of a 
                                        petition to initiate a 
                                        proceeding for the issuance of 
                                        a rule or order under section 
                                        4(f), the information available 
                                        to the Administrator is 
                                        insufficient for the 
                                        Administrator to perform an 
                                        action described in section 
                                        4(f), 6(b)(5), or 6(c)(8);
                                            ``(bb) in the case of a 
                                        petition to issue an order 
                                        under section 5(c), there is a 
                                        reasonable basis to conclude 
                                        that the substance is not 
                                        likely to meet the safety 
                                        standard under the intended 
                                        conditions of use;
                                            ``(cc) in the case of a 
                                        petition to initiate a 
                                        proceeding for the issuance of 
                                        a rule under section 6(c)(9), 
                                        there is a reasonable basis to 
                                        conclude that the substance 
                                        will not meet the safety 
                                        standard under the intended 
                                        conditions of use; or
                                            ``(dd) in the case of a 
                                        petition to initiate a 
                                        proceeding for the issuance of 
                                        a rule under section 6(b)(2), 
                                        6(d) or 8, there is a 
                                        reasonable basis to conclude 
                                        that the rule is necessary to 
                                        protect human health or the 
                                        environment from an 
                                        unreasonable risk of harm to 
                                        human health or the 
                                        environment.
                                    ``(II) Deferment.--The court may 
                                permit the Administrator to defer 
                                initiating the action requested by the 
                                petitioner until such time as the court 
                                prescribes if the court finds that--
                                            ``(aa) the extent of the 
                                        risk to human health or the 
                                        environment alleged by the 
                                        petitioner is less than the 
                                        extent of risks to human health 
                                        or the environment with respect 
                                        to which the Administrator is 
                                        taking action under this Act; 
                                        and
                                            ``(bb) there are 
                                        insufficient resources 
                                        available to the Administrator 
                                        to take the action requested by 
                                        the petitioner.''.

SEC. 18. STUDIES.

    Section 25 (15 U.S.C. 2624) is repealed.

SEC. 19. ADMINISTRATION.

    Section 26(e) (15 U.S.C. 2625(e)) is amended by striking ``Health, 
Education, and Welfare'' each place it appears and inserting ``Health 
and Human Services''.

SEC. 20. DEVELOPMENT AND EVALUATION OF TEST METHODS.

    Section 27(a) (15 U.S.C. 2626(a)) is amended by striking ``Health, 
Education, and Welfare'' and inserting ``Health and Human Services''.

SEC. 21. STATE PROGRAMS.

    Section 28 (15 U.S.C. 2627) is amended by striking subsections (c) 
and (d).

SEC. 22. AUTHORIZATION OF APPROPRIATIONS.

    Section 29 (15 U.S.C. 2628) is repealed.

SEC. 23. ANNUAL REPORT.

    Section 30 (15 U.S.C. 2629) is amended by striking paragraph (2) 
and inserting the following:
            ``(2)(A) the number of notices received during each year 
        under section 5; and
            ``(B) the number of the notices described in subparagraph 
        (A) for chemical substances subject to a rule, testing consent 
        agreement, or order under section 4(f);''.
                                 <all>
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