Short title

This Act may be cited as the

Frank R. Lautenberg Chemical Safety for the 21st Century Act

Findings, policy, and intent

Section 2(c) of the Toxic Substances Control Act (15 U.S.C. 2601(c)) is amended— (1)by striking It is the intent and inserting the following:

(1)

Administration

It is the intent

;

(2)in paragraph (1) (as so redesignated), by inserting , as provided under this Act before the period at the end; and (3)by adding at the following:

(2)

Reform

It is the intent of Congress that reform of this Act in accordance with the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act— (A)shall be administered in a manner that— (i)protects the health of children, pregnant women, the elderly, workers, consumers, the general public, and the environment from the risks of harmful exposures to chemical substances and mixtures; and (ii)ensures that appropriate information on chemical substances and mixtures is available to public health officials and first responders in the event of an emergency; and (B)shall not displace or supplant common law rights of action or remedies for civil relief.

Definitions

Section 3 of the Toxic Substances Control Act (15 U.S.C. 2602) is amended— (1)by redesignating paragraphs (4), (5), (6), (7), (8), (9), (10), (11), (12), (13), and (14) as paragraphs (5), (6), (7), (8), (9), (10), (12), (13), (17), (18), and (19), respectively; (2)by inserting after paragraph (3) the following:

(4)

Conditions of use

The term conditions of use means the intended, known, or reasonably foreseeable circumstances the Administrator determines a chemical substance is manufactured, processed, distributed in commerce, used, or disposed of.

;

(3)by inserting after paragraph (10) (as so redesignated) the following:

(11)

Potentially exposed or susceptible population

The term potentially exposed or susceptible population means 1 or more groups— (A)of individuals within the general population who may be— (i)differentially exposed to chemical substances under the conditions of use; or (ii)susceptible to greater adverse health consequences from chemical exposures than the general population; and (B)that when identified by the Administrator may include such groups as infants, children, pregnant women, workers, and the elderly.

; and

(4)by inserting after paragraph (13) (as so redesignated) the following:

(14)

Safety assessment

The term safety assessment means an assessment of the risk posed by a chemical substance under the conditions of use, integrating hazard, use, and exposure information regarding the chemical substance. (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 conditions of use. (16)

Safety standard

The term safety standard means a standard that ensures, without taking into consideration cost or other nonrisk factors, that no unreasonable risk of harm to health or the environment will result from exposure to a chemical substance under the conditions of use, including no unreasonable risk of harm to— (A)the general population; or (B)any potentially exposed or susceptible population that the Administrator has identified as relevant to the safety assessment and safety determination for a chemical substance.

Policies, procedures, and guidance

The Toxic Substances Control Act is amended by inserting after section 3 (15 U.S.C. 2602) the following:

3A.

Policies, procedures, and guidance

(a)

Definition of guidance

In this section, the term guidance includes any significant written guidance of general applicability prepared by the Administrator. (b)

Deadline

Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall develop, after providing public notice and an opportunity for comment, any policies, procedures, and guidance the Administrator determines to be necessary to carry out sections 4, 4A, 5, and 6, including the policies, procedures, and guidance required by this section. (c)

Use of science

(1)

In general

The Administrator shall establish policies, procedures, and guidance on the use of science in making decisions under sections 4, 4A, 5, and 6. (2)

Goal

A goal of the policies and procedures described in paragraph (1) shall be to make the basis of decisions clear to the public. (3)

Requirements

The policies, procedures, and guidance issued under this section shall describe the manner in which the Administrator shall ensure that— (A)decisions made by the Administrator— (i)are based on information, procedures, measures, methods, and models employed in a manner consistent with the best available science; (ii)take into account the extent to which— (I)assumptions and methods are clearly and completely described and documented; (II)variability and uncertainty are evaluated and characterized; and (III)the information has been subject to independent verification and peer review; and (iii)are based on the weight of the scientific evidence, by which the Administrator considers all information in a systematic and integrative framework to consider the relevance of different information; (B)to the extent practicable and if appropriate, the use of peer review, standardized test design and methods, consistent data evaluation procedures, and good laboratory practices will be encouraged; (C)a clear description of each individual and entity that funded the generation or assessment of information, and the degree of control those individuals and entities had over the generation, assessment, and dissemination of information (including control over the design of the work and the publication of information) is made available; and (D)if appropriate, the recommendations in reports of the National Academy of Sciences that provide advice regarding assessing the hazards, exposures, and risks of chemical substances are considered. (d)

Existing EPA policies, procedures, and guidance

The policies, procedures, and guidance described in subsection (b) shall incorporate, as appropriate, existing relevant hazard, exposure, and risk assessment guidelines and methodologies, data evaluation and quality criteria, testing methodologies, and other relevant guidelines and policies of the Environmental Protection Agency. (e)

Review

Not later than 5 years after the date of enactment of this section, and not less frequently than once every 5 years thereafter, the Administrator shall— (1)review the adequacy of any policies, procedures, and guidance developed under this section, including animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this Act; and (2)after providing public notice and an opportunity for comment, revise the policies, procedures, and guidance if necessary to reflect new scientific developments or understandings. (f)

Sources of information

In making any decision with respect to a chemical substance under section 4, 4A, 5, or 6, the Administrator shall take into consideration information relating to the hazards and exposures of a chemical substance under the conditions of use that is reasonably available to the Administrator, including information that is— (1)submitted to the Administrator pursuant to any rule, consent agreement, order, or other requirement of this Act, or on a voluntary basis, including pursuant to any request made under this Act, by— (A)manufacturers or processors of a substance; (B)the public; (C)other Federal departments or agencies; or (D)the Governor of a State or a State agency with responsibility for protecting health or the environment; (2)submitted to a governmental entity in any jurisdiction pursuant to a governmental requirement relating to the protection of health or the environment; or (3)identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible by the Administrator. (g)

Testing of chemical substances and mixtures

(1)

In general

The Administrator shall establish policies and procedures for the testing of chemical substances or mixtures under section 4. (2)

Goal

A goal of the policies and procedures established under paragraph (1) shall be to make the basis of decisions clear to the public. (3)

Contents

The policies and procedures established under paragraph (1) shall— (A)address how and when the exposure level or exposure potential of a chemical substance would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; (B)describe the manner in which the Administrator will determine that additional information is necessary to carry out this Act, including information relating to potentially exposed or susceptible populations; (C)require the Administrator to consult with the Director of the National Institute for Occupational Safety and Health prior to prescribing epidemiologic studies of employees; and (D)prior to adopting a requirement for testing using vertebrate animals, require the Administrator to take into consideration, as appropriate and to the extent practicable, reasonably available— (i)toxicity information; (ii)computational toxicology and bioinformatics; (iii)high-throughput screening methods and the prediction models of those methods; and (iv)scientifically reliable and relevant alternatives to tests on animals that would provide equivalent information. (4)

Tiered testing

(A)

In general

Except as provided in subparagraph (D), the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary. (B)

Screening-level tests

(i)

In general

The screening-level tests required for a chemical substance or mixture may include tests for hazard (which may include in silico, in vitro, and in vivo tests), environmental and biological fate and transport, and measurements or modeling of exposure or exposure potential, as appropriate. (ii)

Use

Screening-level tests shall be used— (I)to screen chemical substances or mixtures for potential adverse effects; and (II)to inform a decision of the Administrator regarding whether more complex or targeted additional testing is necessary. (C)

Additional testing

If the Administrator determines under subparagraph (B) that additional testing is necessary to provide more definitive information for safety assessments or safety determinations, the Administrator may require more advanced tests for potential health or environmental effects or exposure potential. (D)

Advanced testing without screening

The Administrator may require more advanced testing without conducting screening-level testing when other information available to the Administrator justifies the advanced testing, pursuant to guidance developed by the Administrator under this section. (h)

Safety assessments and safety determinations

(1)

Schedule

(A)

In general

The Administrator shall inform the public regarding the schedule for the completion of each safety assessment and safety determination as soon as practicable after designation as a high-priority substance pursuant to section 4A. (B)

Differing times

The Administrator may allot different times for different chemical substances in the schedules under this paragraph, subject to the condition that all schedules shall comply with the deadlines established under section 6. (C)

Annual plan

At the beginning of each calendar year, the Administrator shall identify the substances subject to safety assessments and safety determinations to be completed that year. (2)

Policies and procedures for safety assessments and safety determinations

(A)

In general

The Administrator shall establish, by rule, policies and procedures regarding the manner in which the Administrator shall carry out section 6. (B)

Goal

A goal of the policies and procedures under this paragraph shall be to make the basis of decisions of the Administrator clear to the public. (C)

Minimum requirements

At a minimum, the policies and procedures under this paragraph shall— (i)describe— (I)the manner in which the Administrator will identify informational needs and seek that information from the public; (II)the information (including draft safety assessments) that may be submitted by interested individuals or entities, including States; and (III)the criteria by which that information will be evaluated; (ii)require the Administrator— (I)(aa)to define the scope of the safety assessment and safety determination to be conducted under section 6, including the hazards, exposures, conditions of use, and potentially exposed and susceptible populations that the Administrator expects to consider in a safety assessment; (bb)to explain the basis for the scope of the safety assessment and safety determination; and (cc)to accept comments regarding the scope of the safety assessment and safety determination; and (II)(aa)to identify the items described in subclause (I) that the Administrator has considered in the final safety assessment; and (bb)to explain the basis for the consideration of those items; (iii)describe the manner in which aggregate exposures, or significant subsets of exposures, to a chemical substance under the conditions of use will be considered, and explain the basis for that consideration in the final safety assessment; (iv)require that each safety assessment and safety determination shall include— (I)a description of the weight of the scientific evidence of risk; and (II)a summary of the information regarding the impact on health and the environment of the chemical substance that was used to make the assessment or determination, including, as available, mechanistic, animal toxicity, and epidemiology studies; (v)establish a timely and transparent process for evaluating whether new information submitted or obtained after the date of a final safety assessment or safety determination warrants reconsideration of the safety assessment or safety determination; and (vi)when relevant information is provided or otherwise made available to the Administrator, shall consider the extent of Federal regulation under other Federal laws. (D)

Guidance

(i)

In general

Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall develop guidance to assist interested persons in developing draft safety assessments and other information for submission to the Administrator, which may be considered at the discretion of the Administrator. (ii)

Requirement

The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing a draft assessment for consideration by the Administrator. (3)

Articles

If the Administrator intends to prohibit or otherwise restrict an article on the basis of a chemical substance contained in that article, the Administrator shall have evidence of significant exposure to the chemical substance from such article. (i)

Publicly available information

Subject to section 14, the Administrator shall— (1)make publicly available a nontechnical summary, and the final version, of each safety assessment and safety determination; (2)provide public notice and an opportunity for comment on each proposed safety assessment and safety determination; and (3)make public in a final safety assessment and safety determination— (A)the list of studies considered by the Administrator in carrying out the safety assessment or safety determination; and (B)the list of policies, procedures, and guidance that were followed in carrying out the safety assessment or safety determination. (j)

Consultation with Science Advisory Committee on Chemicals

(1)

Establishment

Not later than 1 year after the date of enactment of this section, the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the Committee). (2)

Purpose

The purpose of the Committee shall be to provide independent advice and expert consultation, on the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title. (3)

Composition

The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including, at a minimum, representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible populations. (4)

Schedule

The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years. (5)

Relationship to other law

All proceedings and meetings of the Committee shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.).

Testing of chemical substances or mixtures

(a)

In general

Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is amended— (1)by striking subsections (a), (b), (c), (d), and (g); (2)by redesignating subsections (e) and (f) as subsections (f) and (g), respectively; (3)in subsection (f) (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), in the last sentence, by striking rulemaking; (4)in subsection (g) (as so redesignated)— (A)in the first sentence, by striking from cancer, gene mutations, or birth defects; and (B)by striking the last sentence; and (5)by inserting before subsection (f) (as so redesignated) the following:

(a)

Development of new information on chemical substances and mixtures

(1)

In general

The Administrator may require the development of new information relating to a chemical substance or mixture in accordance with this section if the Administrator determines that the information is necessary— (A)to review a notice under section 5(d) or to perform a safety assessment or safety determination under section 6; (B)to implement a requirement imposed in a consent agreement or order issued under section 5(d)(4) or under a rule promulgated under section 6(d)(3); (C)pursuant to section 12(a)(4); or (D)at the request of the implementing authority under another Federal law, to meet the regulatory testing needs of that authority. (2)

Limited testing for prioritization purposes

(A)

In general

Except as provided in subparagraph (B), the Administrator may require the development of new information for the purposes of section 4A. (B)

Prohibition

Testing required under subparagraph (A) shall not be required for the purpose of establishing or implementing a minimum information requirement. (C)

Limitation

The Administrator may require the development of new information pursuant to subparagraph (A) only if the Administrator determines that additional information is necessary to establish the priority of a chemical substance. (3)

Form

Subject to section 3A(h), the Administrator may require the development of information described in paragraph (1) or (2) by— (A)promulgating a rule; (B)entering into a testing consent agreement; or (C)issuing an order. (4)

Contents

(A)

In general

A rule, testing consent agreement, or order issued under this subsection 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)test protocols and methodologies 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 individuals and entities required to conduct the testing shall submit to the Administrator the information developed in accordance with the procedures described in clause (iii). (B)

Considerations

In determining the procedures and period to be required under subparagraph (A), the Administrator shall take into consideration— (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 required to perform the testing. (b)

Statement of need

(1)

In general

In promulgating a rule, entering into a testing consent agreement, or issuing an order for the development of additional information (including information on exposure or exposure potential) pursuant to this section, the Administrator shall— (A)identify the need intended to be met by the rule, agreement, or order; (B)explain why information reasonably available to the Administrator at that time is inadequate to meet that need, including a reference, as appropriate, to the information identified in paragraph (2)(B); and (C)explain the basis for any decision that requires the use of vertebrate animals. (2)

Explanation in case of order

(A)

In general

If the Administrator issues an order under this section, the Administrator shall issue a statement providing a justification for why issuance of an order is warranted instead of promulgating a rule or entering into a testing consent agreement. (B)

Contents

A statement described in subparagraph (A) shall contain a description of— (i)information that is readily accessible to the Administrator, including information submitted under any other provision of law; (ii)the extent to which the Administrator has obtained or attempted to obtain the information through voluntary submissions; and (iii)any information relied on in safety assessments for other chemical substances relevant to the chemical substances that would be the subject of the order. (c)

Reduction of testing on vertebrates

(1)

In general

The Administrator shall minimize, to the extent practicable, the use of vertebrate animals in testing of chemical substances or mixtures, by— (A)encouraging and facilitating— (i)the use of integrated and tiered testing and assessment strategies; (ii)the use of best available science 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 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 information on other chemical substances in the category; (v)the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; and (vi)the submission of information from— (I)animal-based studies; and (II)emerging methods and models; 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 based on vertebrate animals, 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 under this title that can reduce, refine, or replace the use of vertebrate animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening; (B)as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section; (C)beginning on the date that is 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing this subsection and goals for future alternative test methods implementation; and (D)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 vertebrate animals in any testing under this title. (3)

Criteria for adapting or waiving animal testing requirements

On request from a manufacturer or processor that is required to conduct testing of a chemical substance or mixture on vertebrate animals under this section, the Administrator may adapt or waive the 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)as a result of 1 or more physical or chemical properties of the chemical substance or mixture or other toxicokinetic considerations— (i)the substance 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 vertebrate 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. (d)

Testing requirements

(1)

In general

The Administrator may require the development of information by— (A)manufacturers and processors of the chemical substance or mixture; and (B)persons that begin to manufacture or process the chemical substance or mixture— (i)after the effective date of the rule, testing consent agreement, or order; but (ii)subject to paragraph (3), before the period ending on the date that is 180 days after the end of the period described in this section. (2)

Designation

The Administrator may permit 2 or more persons identified in subparagraph (A) or (B) of paragraph (1) to designate 1 of the persons or a qualified third party— (A)to develop the information; and (B)to submit the information on behalf of the persons making the designation. (3)

Exemptions

(A)

In general

A person otherwise subject to a rule, testing consent agreement, or order under this section may submit to the Administrator an application for an exemption on the basis that the information is being developed by a person designated under paragraph (2). (B)

Fair and equitable reimbursement to designee

(i)

In general

If the Administrator accepts an application submitted under subparagraph (A), the Administrator shall direct the applicant to provide to the person designated under paragraph (2) fair and equitable reimbursement, as agreed to between the applicant and the designee. (ii)

Arbitration

If the applicant and a person designated under paragraph (2) cannot reach agreement on the amount of fair and equitable reimbursement, the amount shall be determined by arbitration. (C)

Termination

If, after granting an exemption under this paragraph, the Administrator determines that a person covered by the exemption has failed to comply with the rule, testing consent agreement, or order, the Administrator shall— (i)by order, terminate the exemption; and (ii)notify in writing each person that received an exemption of the requirements with respect to which the exemption was granted. (e)

Transparency

Subject to section 14, the Administrator shall make available to the public all testing consent agreements and orders and all information submitted under this section.

(b)

Conforming amendment

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 in the third sentence by striking section 4(e) and inserting section 4(f).

Prioritization screening

The Toxic Substances Control Act is amended by inserting after section 4 (15 U.S.C. 2603) the following:

4A.

Prioritization screening

(a)

Establishment and list of substances

(1)

In general

Not later than 1 year after the date of enactment of this section, the Administrator shall establish, by rule, a risk-based screening process and explicit criteria for identifying existing chemical substances that are— (A)a high priority for a safety assessment and safety determination under section 6 (referred to in this Act as high-priority substances); and (B)a low priority for a safety assessment and safety determination (referred to in this Act as low-priority substances). (2)

Initial list of high- and low-priority substances

(A)

In general

Before the date of promulgation of the rule under paragraph (1) and not later than 180 days after the date of enactment of this section, the Administrator— (i)shall take into consideration and publish an initial list of high-priority substances and low-priority substances; and (ii)pursuant to section 6(b), may initiate or continue safety assessments and safety determinations for those high-priority substances. (B)

Requirements

(i)

In general

The initial list of chemical substances shall contain at least 10 high-priority substances, at least 5 of which are drawn from the list of chemical substances identified by the Administrator in the October, 2014 TSCA Work Plan and subsequent updates, and at least 10 low-priority substances. (ii)

Subsequently identified substances

Insofar as possible, at least 50 percent of all substances subsequently identified by the Administrator as high-priority substances shall be drawn from the list of chemical substances identified by the Administrator in the October, 2014 TSCA Work Plan and subsequent updates, until all Work Plan chemicals have been designated under this subsection. (C)

Additional chemical reviews

The Administrator shall— (i)3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, add additional high-priority substances sufficient to ensure that at least a total of 20 high-priority substances have undergone or are undergoing the process established in section 6(a), and additional low-priority substances sufficient to ensure that at least a total of 20 low-priority substances have been designated; and (ii)as soon as practicable and not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, add additional high-priority substances sufficient to ensure that at least a total of 25 high-priority substances have undergone or are undergoing the process established in section 6(a), and additional low-priority substances sufficient to ensure that at least a total of 25 low-priority substances have been designated. (3)

Implementation

(A)

Consideration of active and inactive substances

(i)

Active substances

In carrying out paragraph (1), the Administrator shall take into consideration active substances, as determined under section 8, which may include chemical substances on the interim list of active substances established under that section. (ii)

Inactive substances

In carrying out paragraph (1), the Administrator may take into consideration inactive substances, as determined under section 8, that the Administrator determines— (I)(aa)have not been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and (bb)have the potential for high hazard and widespread exposure; or (II)(aa)have been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and (bb)with respect to which there exists the potential for residual high hazards or widespread exposures not otherwise addressed by the regulatory or other action. (iii)

Repopulation

(I)

In general

On the completion of a safety determination under section 6 for a chemical substance, the Administrator shall remove the chemical substance from the list of high-priority substances established under this subsection. (II)

Additions

The Administrator shall add at least 1 chemical substance to the list of high-priority substances for each chemical substance removed from the list of high-priority substances established under this subsection, until a safety assessment and safety determination is completed for all high-priority substances. (III)

Low-priority substances

If a low-priority substance is subsequently designated as a high-priority substance, the Administrator shall remove that substance from the list of low-priority substances. (B)

Timely completion of prioritization screening process

(i)

In general

The Administrator shall— (I)not later than 180 days after the effective date of the final rule under paragraph (1), begin the prioritization screening process; and (II)make every effort to complete the designation of all active substances as high-priority substances or low-priority substances in a timely manner. (ii)

Decisions on substances subject to testing for prioritization purposes

Not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, testing consent agreement, or order issued under section 4(a)(2), the Administrator shall designate the chemical substance as a high-priority substance or low-priority substance. (iii)

Consideration

(I)

In general

The Administrator shall screen substances and designate high-priority substances taking into consideration the ability of the Administrator to schedule and complete safety assessments and safety determinations under section 6 in a timely manner. (II)

Annual goal

The Administrator shall publish an annual goal for the number of chemical substances to be subject to the prioritization screening process. (C)

Screening of categories of substances

The Administrator may screen categories of chemical substances to ensure an efficient prioritization screening process to allow for timely and adequate designations of high-priority substances and low-priority substances and safety assessments and safety determinations for high-priority substances. (D)

Publication of list of chemical substances

Not less frequently than once each year, the Administrator shall publish a list of chemical substances that— (i)are being considered in the prioritization screening process and the status of the chemical substances in the prioritization process, including those chemical substances for which prioritization decisions have been deferred; and (ii)are designated as high-priority substances or low-priority substances, including the bases for such designations. (4)

Criteria

The criteria described in paragraph (1) shall account for— (A)the recommendation of the Governor of a State or a State agency with responsibility for protecting health or the environment from chemical substances appropriate for prioritization screening; (B)the hazard and exposure potential of the chemical substance (or category of substances), including specific scientific classifications and designations by authoritative governmental entities; (C)the conditions of use or significant changes in the conditions of use of the chemical substance; (D)evidence and indicators of exposure potential to humans or the environment from the chemical substance, including potentially exposed or susceptible populations; (E)the volume of a chemical substance manufactured or processed; (F)whether the volume of a chemical substance as reported under a rule promulgated pursuant to section 8(a) has significantly increased or decreased during the period beginning on the date of a previous report or the date on which a notice has been submitted under section 5(b) for that chemical substance; (G)the availability of information regarding potential hazards and exposures required for conducting a safety assessment or safety determination, with limited availability of relevant information to be a sufficient basis for designating a chemical substance as a high-priority substance, subject to the condition that limited availability shall not require designation as a high-priority substance; and (H)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 substance. (b)

Prioritization screening process and decisions

(1)

In general

The prioritization screening process developed under subsection (a) shall include a requirement that the Administrator shall— (A)identify the chemical substances being considered for prioritization; (B)request interested persons to supply information regarding the chemical substances being considered; (C)apply the criteria identified in subsection (a)(4); and (D)subject to paragraph (5) and using the information available to the Administrator at the time of the decision, identify a chemical substance as a high-priority substance or a low-priority substance. (2)

Integration of information

The prioritization screening decision regarding a chemical substance shall integrate any hazard and exposure information relating to the chemical substance that is available to the Administrator. (3)

Identification of high-priority substances

The Administrator— (A)shall identify as a high-priority substance a chemical substance that, relative to other chemical substances, the Administrator determines has the potential for high hazard and widespread exposure; (B)may identify as a high-priority substance a chemical substance that, relative to other chemical substances, the Administrator determines has the potential for high hazard or widespread exposure; and (C)may identify as a high-priority substance an inactive substance, as determined under subsection (a)(3)(A)(ii) and section 8(b), that the Administrator determines warrants a safety assessment and safety determination under section 6. (4)

Identification of low-priority substances

The Administrator shall identify as a low-priority substance a chemical substance that the Administrator concludes has information sufficient to establish that the chemical substance is likely to meet the applicable safety standard. (5)

Deferring a decision

If the Administrator determines that additional information is required to establish the priority of a chemical substance under this section, the Administrator may defer the prioritization screening decision for a reasonable period— (A)to allow for the submission of additional information by an interested person and for the Administrator to evaluate the additional information; or (B)to require the development of information pursuant to a rule, testing consent agreement, or order issued under section 4(a)(2). (6)

Deadlines for submission of information

If the Administrator requests the development or submission of information under this section, the Administrator shall establish a deadline for submission of the information. (7)

Notice and comment

The Administrator shall— (A)publish the proposed decisions made under paragraphs (3), (4), and (5) and the basis for the decisions; and (B)provide an opportunity for public comment. (8)

Revisions of prior designations

(A)

In general

At any time, and at the discretion of the Administrator, the Administrator may revise the designation of a chemical substance as a high-priority substance or a low-priority substance based on information available to the Administrator after the date of the determination under paragraph (3) or (4). (B)

Limited availability

If limited availability of relevant information was a basis in the designation of a chemical substance as a high-priority substance, the Administrator shall reevaluate the prioritization screening of the chemical substance on receiving the relevant information. (9)

Other information relevant to prioritization

(A)

In general

If, after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, a State proposes an administrative action or enacts a statute or takes an administrative action to prohibit or otherwise restrict the manufacturing, processing, distribution in commerce, or use of a chemical substance that the Administrator has not as designated a high-priority substance, the Governor or State agency with responsibility for implementing the statute or administrative action shall notify the Administrator. (B)

Requests for information

Following receipt of a notification provided under subparagraph (A), the Administrator may request any available information from the Governor or the State agency with respect to— (i)scientific evidence related to the hazards, exposures and risks of the chemical substance under the conditions of use which the statute or administrative action is intended to address; (ii)any State or local conditions which warranted the statute or administrative action; (iii)the statutory or administrative authority on which the action is based; and (iv)any other available information relevant to the prohibition or other restriction, including information on any alternatives considered and their hazards, exposures, and risks. (C)

Prioritization screening

The Administrator shall conduct a prioritization screening under this subsection for all substances that— (i)are the subject of notifications received under subparagraph (A); and (ii)the Administrator determines— (I)are likely to have significant health or environmental impacts; (II)are likely to have significant impact on interstate commerce; or (III)have been subject to a prohibition or other restriction under a statute or administrative action in 2 or more States. (D)

Availability to public

Subject to section 14 and any applicable State law regarding the protection of confidential information provided to the State or to the Administrator, the Administrator shall make information received from a Governor or State agency under subparagraph (A) publicly available. (E)

Effect of paragraph

Nothing in this paragraph shall preempt a State statute or administrative action, require approval of a State statute or administrative action, or apply section 15 to a State. (10)

Review

Not less frequently than once every 5 years after the date on which the process under this subsection is established, the Administrator shall— (A)review the process on the basis of experience and taking into consideration resources available to efficiently and effectively screen and prioritize chemical substances; and (B)if necessary, modify the prioritization screening process. (11)

Effect

Subject to section 18, a designation by the Administrator under this section with respect to a chemical substance shall not affect— (A)the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance; or (B)the regulation of those activities. (c)

Additional priorities for safety assessments and determinations

(1)

In general

The prioritization screening process developed under subsection (a) shall— (A)include a process by which a manufacturer or processor of an active chemical substance that has not been designated a high-priority substance, or that has not been subject to or is not in the process of a prioritization screening by the Administrator, may request that the Administrator designate the substance for a safety assessment and safety determination, subject to the payment of fees pursuant to section 26(b)(3)(E); and (B)provide guidance to submitters on the information to be provided in such requests, and specify the criteria the Administrator shall use to determine whether or not to grant such a request, which shall include whether the substance is subject to restrictions imposed by statutes enacted or administrative actions taken by 1 or more States on the manufacture, processing, distribution in commerce, or use of the substance. (2)

Preference

Subject to paragraph (3), in deciding whether to grant requests under this subsection the Administrator shall give a preference to requests concerning substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment. (3)

Limitations

In considering whether to grant a request submitted under paragraph (1), the Administrator shall ensure that— (A)not more than 15 percent of the total number of substances designated to undergo safety assessments and safety determinations under this section are substances designated under the process and criteria pursuant to paragraph (1); and (B)the resources allocated to conducting safety assessments and safety determinations for additional priorities designated under this subsection are proportionate to the number of such substances relative to the total number of substances designated to undergo safety assessments and safety determinations under this section. (4)

Requirements

(A)

In general

The public shall be provided notice and an opportunity to comment on requests submitted under this subsection. (B)

Decision by Administrator

Not later than 180 days after the date on which the Administrator receives a request under this subsection, the Administrator shall decide whether or not to grant the request. (C)

Assessment and determination

If the Administrator grants a request under this subsection, the safety assessment and safety determination— (i)shall be conducted in accordance with the deadlines and other requirements of sections 3A(i) and 6; and (ii)shall not be expedited or otherwise subject to special treatment relative to high-priority substances designated pursuant to subsection (b)(3) that are undergoing safety assessments and safety determinations. (5)

Exceptions

Requests granted under this subsection shall not be subject to subsection (a)(3)(A)(iii) or section 18(b).

New chemicals and significant new uses

Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is amended— (1)by striking the section designation and heading and inserting the following:

New chemicals and significant new uses

;

(2)by striking subsection (b); (3)by redesignating subsection (a) as subsection (b); (4)by redesignating subsection (i) as subsection (a) and moving the subsection so as to appear at the beginning of the section; (5)in subsection (b) (as so redesignated)— (A)in the subsection heading, by striking

In general

and inserting

Notices

; and (B)in paragraph (1), in the matter following subparagraph (B)— (i)by striking subsection (d) and inserting subsection (b); and (ii)by striking and such person complies with any applicable requirement of subsection (b); (6)by redesignating subsections (c) and (d) as subsection (d) and (c), respectively, and moving subsection (c) (as so redesigned) so as appear after subsection (b) (as redesignated by paragraph (3)); (7)in subsection (c) (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 conditions of use and reasonably anticipated exposures.

;

(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 subsection (a) and for which the notification period prescribed by subsection (a), (b), or (c) and inserting subsection (b) and for which the notification period prescribed by subsection (b) or (d); (8)by striking subsection (d) (as redesignated by paragraph (6)) and inserting the following:

(d)

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 (b), 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 (3). (B)

Extension

Except as provided in paragraph (5), the Administrator may extend the period described in subparagraph (A) for good cause for 1 or more periods, the total of which shall be not more than 90 days. (2)

Information sources

In evaluating a notice under paragraph (1), the Administrator shall take into consideration— (A)any relevant information identified in subsection (c)(1); and (B)any other relevant additional information available to the Administrator. (3)

Determinations

Before the end of the applicable period for review under paragraph (1), based on the information described in paragraph (2), and subject to section 18(g), the Administrator shall determine that— (A)the relevant chemical substance or significant new use is not likely to meet the safety standard, in which case the Administrator shall take appropriate action under paragraph (4); (B)the relevant chemical substance or significant new use is likely to meet the safety standard, 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 (5). (4)

Restrictions

(A)

Determination by Administrator

(i)

In general

If the Administrator makes a determination under subparagraph (A) or (C) of paragraph (3) with respect to a notice submitted under subsection (b)— (I)the Administrator, before the end of the applicable period for review under paragraph (1) and by consent agreement or order, as appropriate, shall prohibit or otherwise restrict the manufacture, processing, use, distribution in commerce, or disposal (as applicable) of the chemical substance, or of the chemical substance for a significant new use, without compliance with the restrictions specified in the consent agreement or order that the Administrator determines are sufficient to ensure that the chemical substance or significant new use is likely to meet the safety standard; and (II)no person may commence manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, except in compliance with the restrictions specified in the consent agreement or order. (ii)

Likely to meet standard

If the Administrator makes a determination under subparagraph (B) of paragraph (3) with respect to a chemical substance or significant new use for which a notice was submitted under subsection (b), at the end of the applicable period for review under paragraph (1), the submitter of the notice may commence manufacture for commercial purposes of the chemical substance or manufacture or processing of the chemical substance for a significant new use. (B)

Requirements

Not later than 90 days after issuing a consent agreement or order under subparagraph (A), the Administrator shall— (i)take into consideration whether to promulgate a rule pursuant to subsection (b)(2) that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance, or of the chemical substance for a new use, that is not in compliance with the restrictions imposed by the consent agreement or order; and (ii)(I)initiate a rulemaking described in clause (i); or (II)publish a statement describing the reasons of the Administrator for not initiating a rulemaking. (C)

Inclusions

A prohibition or other restriction under subparagraph (A) may include, as appropriate— (i)subject to section 18(g), a requirement that a chemical substance shall be marked with, or accompanied by, clear and adequate minimum 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 minimum warnings and instructions to be prescribed by the Administrator; (ii)a requirement that manufacturers or processors of the chemical substance shall— (I)make and retain records of the processes used to manufacture or process, as applicable, the chemical substance; or (II)monitor or conduct such additional tests as are reasonably necessary to address potential risks from the manufacture, processing, distribution in commerce, use, or disposal, as applicable, of the chemical substance, subject to section 4; (iii)a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce— (I)in general; or (II)for a particular use; (iv)a prohibition or other restriction of— (I)the manufacture, processing, or distribution in commerce of the chemical substance for a significant new use; (II)any method of commercial use of the chemical substance; or (III)any method of disposal of the chemical substance; or (v)a prohibition or other restriction on the manufacture, processing, or distribution in commerce of the chemical substance— (I)in general; or (II)for a particular use. (D)

Workplace exposures

The Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction under this subsection to address workplace exposures. (E)

Definition of requirement

For purposes of this Act, the term requirement as used in this section does not displace common law. (5)

Additional information

If the Administrator determines under paragraph (3)(C) that additional information is necessary to conduct a review under this subsection, the Administrator— (A)shall provide an opportunity for the submitter of the notice to submit the 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)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 (D)on receipt of information the Administrator finds supports the determination under paragraph (3), shall promptly make the determination.

;

(9)by striking subsections (e) through (g) and inserting the following:

(e)

Notice of commencement

(1)

In general

Not later than 30 days after the date on which a manufacturer that has submitted a notice under subsection (b) commences nonexempt commercial manufacture of a chemical substance, the manufacturer shall submit to the Administrator a notice of commencement that identifies— (A)the name of the manufacturer; and (B)the initial date of nonexempt commercial manufacture. (2)

Withdrawal

A manufacturer or processor that has submitted a notice under subsection (b), but that has not commenced nonexempt commercial manufacture or processing of the chemical substance, may withdraw the notice. (f)

Further evaluation

The Administrator may review a chemical substance under section 4A at any time after the Administrator receives— (1)a notice of commencement for a chemical substance under subsection (c); or (2)new information regarding the chemical substance. (g)

Transparency

Subject to section 14, the Administrator shall make available to the public— (1)all notices, determinations, consent agreements, rules, and orders of the Administrator; and (2)all information submitted or issued under this section.

; and

(10)in subsection (h)— (A)in paragraph (1), in the matter preceding subparagraph (A), by striking (a) or; (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), in the matter preceding subparagraph (A), by striking subsections (a) and (b) and inserting subsection (b); (E)in paragraph (3) (as so redesignated)— (i)in the first sentence, by striking will not present an unreasonable risk of injury to health or the environment and inserting will meet the safety standard; and (ii)by striking the second sentence; (F)in paragraph (4) (as so redesignated), by striking subsections (a) and (b) and inserting subsection (b); and (G)in paragraph (5) (as so redesignated), in the first sentence, by striking paragraph (1) or (5) and inserting paragraph (1) or (4).

Safety assessments and safety determinations

Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) is amended— (1)by striking the section designation and heading and inserting the following:

Safety assessments and safety determinations

;

(2)by redesignating subsections (e) and (f) as subsections (g) and (h), respectively; (3)by striking subsections (a) through (d) and inserting the following:

(a)

In general

The Administrator— (1)shall conduct a safety assessment and make a safety determination of each high-priority substance in accordance with subsections (b) and (c); (2)shall, as soon as practicable and not later than 6 months after the date on which a chemical substance is designated as a high-priority substance, define the scope of the safety assessment and safety determination to be conducted pursuant to this section, including the hazards, exposures, conditions of use, and potentially exposed or susceptible populations that the Administrator expects to consider; (3)as appropriate based on the results of a safety determination, shall establish restrictions pursuant to subsection (d); (4)shall complete a safety assessment and safety determination not later than 3 years after the date on which a chemical substance is designated as a high-priority substance; (5)shall promulgate a final rule pursuant to subsection (d) by not later than 2 years after the date on which the safety determination is completed; and (6)may extend any deadline under this subsection for a reasonable period of time after an adequate public justification, subject to the condition that the aggregate length of all extensions of deadlines under paragraphs (4) and (5) and any deferral under subsection (c)(2) does not exceed 2 years. (b)

Prior actions

(1)

Prior-initiated assessments

(A)

In general

Nothing in this Act prevents the Administrator from initiating a safety assessment or safety determination regarding a chemical substance, or from continuing or completing such a safety assessment or safety determination that was initiated before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, prior to the effective date of the policies and procedures required to be established by the Administrator under section 3A or 4A. (B)

Integration of prior policies and procedures

As policies and procedures under section 3A and 4A are established, to the maximum extent practicable, the Administrator shall integrate the policies and procedures into ongoing safety assessments and safety determinations. (2)

Actions completed prior to completion of policies and procedures

Nothing in this Act requires the Administrator to revise or withdraw a completed safety assessment, safety determination, or rule solely because the action was completed prior to the completion of a policy or procedure established under section 3A or 4A, and the validity of a completed assessment, determination, or rule shall not be determined based on the content of such a policy or procedure. (c)

Safety determinations

(1)

In general

Based on a review of the information available to the Administrator, including draft safety assessments submitted by interested persons, and subject to section 18, the Administrator shall determine that— (A)the relevant chemical substance meets the safety standard; (B)the relevant chemical substance does not meet the safety standard, in which case the Administrator shall, by rule under subsection (d)— (i)impose restrictions necessary to ensure that the chemical substance meets the safety standard under the conditions of use; or (ii)if the safety standard cannot be met with the application of restrictions, ban or phase out the chemical substance, as appropriate; 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 (2). (2)

Additional information

If the Administrator determines that additional information is necessary to make a safety assessment or safety determination 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; (C)may defer, for a reasonable period consistent with the deadlines described in subsection (a), a safety assessment and safety determination until after receipt of the information; and (D)consistent with the deadlines described in subsection (a), on receipt of information the Administrator finds supports the safety assessment and safety determination, shall make a determination under paragraph (1). (3)

Establishment of deadline

In requesting the development or submission of information under this section, the Administrator shall establish a deadline for the submission of the information. (d)

Rule

(1)

Implementation

If the Administrator makes a determination under subsection (c)(1)(B) with respect to a chemical substance, the Administrator shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard. (2)

Scope

The rule promulgated pursuant to this subsection— (A)may— (i)apply to mixtures containing the chemical substance, as appropriate; and (ii)exempt replacement parts for articles manufactured prior to the applicable compliance deadline; and (B)shall include dates by which compliance is mandatory, which— (i)shall be as soon as practicable; and (ii)as determined by the Administrator, may vary for different affected persons. (C)

Workplace exposures

The Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health before adopting any prohibition or other restriction under this subsection to address workplace exposures. (D)

Definition of requirement

For the purposes of this Act, the term requirement as used in this section does not displace common law. (3)

Restrictions

A restriction under paragraph (1) may include, as appropriate— (A)subject to section 18, a requirement that a chemical substance shall be marked with, or accompanied by, clear and adequate minimum 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 minimum warnings and instructions to be prescribed by the Administrator; (B)a requirement that manufacturers or processors of the chemical substance shall— (i)make and retain records of the processes used to manufacture or process the chemical substance; (ii)describe and apply the relevant quality control procedures followed in the manufacturing or processing of the substance; or (iii)monitor or conduct tests that are reasonably necessary to ensure compliance with the requirements of any rule under this subsection; (C)a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce; (D)a requirement to ban or phase out, or any other rule regarding, the manufacture, processing, or distribution in commerce of the chemical substance for— (i)a particular use; (ii)a particular use at a concentration in excess of a level specified by the Administrator; or (iii)all uses; (E)a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce for— (i)a particular use; or (ii)a particular use at a concentration in excess of a level specified by the Administrator; (F)a requirement to ban, phase out, or otherwise restrict any method of commercial use of the chemical substance; (G)a requirement to ban, phase out, or otherwise restrict any method of disposal of the chemical substance or any article containing the chemical substance; and (H)a requirement directing manufacturers or processors of the chemical substance to give notice of the Administrator’s determination under subsection (c)(1)(B) 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. (4)

Analysis for rulemaking

(A)

Considerations

In deciding which restrictions to impose under paragraph (3) as part of developing a rule under paragraph (1), the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator. (B)

Alternatives

As part of the analysis, the Administrator shall review any 1 or more technically and economically feasible alternatives to the chemical substance that the Administrator determines are relevant to the rulemaking. (C)

Public availability

In proposing a rule under paragraph (1), the Administrator shall make publicly available any analysis conducted under this paragraph. (D)

Statement required

In making final a rule under paragraph (1), the Administrator shall include a statement describing how the analysis considered under subparagraph (A) was taken into account. (5)

Exemptions

(A)

In general

The Administrator may exempt 1 or more uses of a chemical substance from any restriction in a rule promulgated under paragraph (1) if the Administrator determines that— (i)the rule cannot be complied with, without— (I)harming national security; (II)causing significant disruption in the national economy due to the lack of availability of a chemical substance; or (III)interfering with a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; or (ii)the use of the chemical substance, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. (B)

Exemption analysis

In proposing a rule under paragraph (1) that includes an exemption under this paragraph, the Administrator shall make publicly available any analysis conducted under this paragraph to assess the need for the exemption. (C)

Statement required

In making final a rule under paragraph (1) that includes an exemption under this paragraph, the Administrator shall include a statement describing how the analysis considered under subparagraph (B) was taken into account. (D)

Analysis in case of ban or phase-out

In determining whether an exemption should be granted under this paragraph for a chemical substance for which a ban or phase-out is proposed, the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the 1 or more technically and economically feasible alternatives to the chemical substance most likely to be used in place of the chemical substance under the conditions of use if the rule is promulgated. (E)

Conditions

As part of a rule promulgated under paragraph (1), the Administrator shall include conditions in any exemption established under this paragraph, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. (F)

Duration

(i)

In general

The Administrator shall establish, as part of a rule under paragraph (1) that contains an exemption under this paragraph, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis. (ii)

Authority of Administrator

The Administrator, by rule, may extend, modify, or eliminate the exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or is no longer necessary. (iii)

Considerations

(I)

In general

Subject to subclause (II), the Administrator shall issue exemptions and establish time periods by considering factors determined by the Administrator to be relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard. (II)

Limitation

Any renewal of an exemption in the case of a rule requiring the ban or phase-out of a chemical substance shall not exceed 5 years. (e)

Immediate effect

The Administrator may declare a proposed rule under subsection (d) to be effective on publication of the rule in the Federal Register and until the effective date of final action taken respecting the rule, if— (1)the Administrator determines that— (A)the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture subject to the proposed rule or any combination of those activities is likely to result in an unreasonable risk of serious or widespread harm to health or the environment before the effective date; and (B)making the proposed rule so effective is necessary to protect the public interest; and (2)in the case of a proposed rule to prohibit the manufacture, processing, or distribution of a chemical substance or mixture because of the risk determined under paragraph (1)(A), a court has granted relief in an action under section 7 with respect to that risk associated with the chemical substance or mixture. (f)

Final agency action

Under this section and subject to section 18— (1)a safety determination, and the associated safety assessment, for a chemical substance that the Administrator determines under subsection (c) meets the safety standard, shall be considered to be a final agency action, effective beginning on the date of issuance of the final safety determination; and (2)a final rule promulgated under subsection (d), and the associated safety assessment and safety determination that a chemical substance does not meet the safety standard, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule.

; and

(4)in subsection (g) (as redesignated by paragraph (2))— (A)by striking paragraph (4); and (B)by redesignating paragraph (5) as paragraph (4).

Imminent hazards

Section 7 of the Toxic Substances Control Act (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 United States district court for— (A)seizure of an imminently hazardous chemical substance or mixture or any article containing the chemical substance or mixture; (B)relief (as authorized by subsection (b)) against any person that manufactures, processes, distributes in commerce, uses, or disposes of, an imminently hazardous chemical substance or mixture or any article containing the chemical 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 4A, 5(d)(3), or 6(c)(1); or (ii)a rule, testing consent agreement, or order under section 4, 5(d)(4), 6(d), or 6(h); 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.

10.

Information collection and reporting

Section 8 of the Toxic Substances Control Act (15 U.S.C. 2607) is amended— (1)in subsection (a)— (A)in paragraph (3)(A)(ii)(I)— (i)by striking 5(b)(4) and inserting 5; (ii)by inserting section 4 or after in effect under; and (iii)by striking 5(e), and inserting 5(d)(4);; and (B)by adding at the end the following:

(4)

Rules

(A)

Deadline

(i)

In general

Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall promulgate rules requiring the maintenance of records and the reporting of information known 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. (ii)

Modification of prior rules

In carrying out this subparagraph, the Administrator may modify, as appropriate, rules promulgated before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. (B)

Contents

The rules promulgated pursuant to subparagraph (A)— (i)may impose different reporting and recordkeeping requirements on manufacturers and processors; and (ii)shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. (C)

Administration

In implementing the reporting and recordkeeping requirements under this paragraph, the Administrator shall take measures— (i)to limit the potential for duplication in reporting requirements; (ii)to minimize the impact of the rules on small manufacturers and processors; and (iii)to apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title. (5)

Guidance

The Administrator shall develop guidance relating to the information required to be reported under the rules promulgated under this subsection.

;

(2)in subsection (b), by adding at the end the following:

(3)

Nomenclature

(A)

In general

In carrying out paragraph (1), the Administrator shall— (i)maintain the use of Class 2 nomenclature in use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; (ii)maintain the use of the Soap and Detergent Association Nomenclature System, published in March 1978 by the Administrator in section 1 of addendum III of the document entitled Candidate List of Chemical Substances, and further described in the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and (iii)treat 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

If an 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 the 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)

Chemical substances in commerce

(A)

Rules

(i)

In general

Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers and processors to notify the Administrator, by not later than 180 days after the date of promulgation of the rule, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. (ii)

Active substances

The Administrator shall, pursuant to paragraph (5)(A), designate chemical substances for which notices are received under clause (i) to be active substances on the list published under paragraph (1). (B)

Confidential chemical substances

The rule promulgated by the Administrator pursuant to subparagraph (A) shall require— (i)the Administrator to maintain the list under paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this section and section 14; (ii)a manufacturer or processor that is submitting a notice pursuant to subparagraph (A) for a chemical substance on the confidential portion of the list published under paragraph (1) to indicate in the notice whether the manufacturer or processor seeks to maintain any existing claim for protection against disclosure of the specific identity of the substance as confidential pursuant to section 14; and (iii)the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph (C). (C)

Review plan

Not later than 1 year after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific identities of chemical substances on the confidential portion of the list published under paragraph (1) that are notified pursuant to subparagraph (A) or identified as active substances under subsection (f)(1). (D)

Requirements of review plan

The review plan under subparagraph (C) shall— (i)require, at the time requested by the Administrator, all manufacturers or processors asserting claims under subparagraph (B) to substantiate the claim unless the manufacturer or processor has substantiated the claim in a submission made to the Administrator during the 5-year period ending on the date of the request by the Administrator; (ii)require the Administrator, in accordance with section 14— (I)to review each substantiation— (aa)submitted pursuant to clause (i) to determine if the claim warrants protection from disclosure; and (bb)submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause (i), if the substantiation has not been previously reviewed by the Administrator, to determine if the claim warrants protection from disclosure; (II)approve, modify, or deny each claim; and (III)except as provided in this section and section 14, protect from disclosure information for which the Administrator approves such a claim for a period of 10 years, unless, prior to the expiration of the period— (aa)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 (bb)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 section 14(g)(2); and (iii)encourage manufacturers or processors that have previously made claims to protect the specific identities of chemical substances identified as inactive pursuant to subsection (f)(2) to review and either withdraw or substantiate the claims. (E)

Timeline for completion of reviews

(i)

In general

The Administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph (C) not later than 5 years after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A). (ii)

Considerations

(I)

In general

The Administrator may extend the deadline for completion of the reviews for not more than 2 additional years, after an adequate public justification, if the Administrator determines that the extension is necessary based on the number of applicable claims needing review and the available resources. (II)

Annual goal

The Administrator shall publish an annual goal for the number of reviews to be completed over the course of implementation of the plan. (5)

Active and inactive substances

(A)

In general

The Administrator shall maintain and keep current designations of active substances and inactive substances on the list published under paragraph (1). (B)

Update

The Administrator shall update the list of chemical substances designated as active substances as soon as practicable after the date of publication of the most recent data reported under— (i)part 711 of title 40, Code of Federal Regulations (or successor regulations); and (ii)the rules promulgated pursuant to subsection (a)(4). (C)

Change to active status

(i)

In general

Any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. (ii)

Confidential chemical identity claims

If a person submitting a notice under clause (i) for an inactive substance on the confidential portion of the list published under paragraph (1) seeks to maintain an existing claim for protection against disclosure of the specific identity of the inactive substance as confidential, the person shall— (I)in the notice submitted under clause (i), assert the claim; and (II)by not later than 30 days after providing the notice under clause (i), substantiate the claim. (iii)

Active status

On receiving a notification under clause (i), the Administrator shall— (I)designate the applicable chemical substance as an active substance; (II)pursuant to section 14, promptly review any claim and associated substantiation submitted pursuant to clause (ii) for protection against disclosure of the specific identity of the chemical substance and approve, modify, or deny the claim; (III)except as provided in this section and section 14, protect from disclosure the specific identity of the chemical substance for which the Administrator approves a claim under subclause (II) for a period of not less than 10 years, unless, prior to the expiration of the period— (aa)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 (bb)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 section 14(g)(2); and (IV)pursuant to section 4A, review the priority of the chemical substance as the Administrator determines to be necessary. (D)

Category status

The list of inactive substances shall not be considered to be a category for purposes of section 26(c). (6)

Interim list of active substances

Prior to the promulgation of the rule required under this subsection, the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (or successor regulations), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, as the interim list of active substances for the purposes of section 4A. (7)

Public participation

Subject to this subsection, the Administrator shall make available to the public— (A)the specific identity of each chemical substance on the nonconfidential portion of the list published under paragraph (1) that the Administrator has designated as— (i)an active substance; or (ii)an inactive substance; (B)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 approved by the Administrator pursuant to section 14; and (C)subject to section 14(g), the specific identity of any active substance for which— (i)no claim of protection against disclosure of the specific identity of the active substance pursuant to this subsection was received; (ii)a claim for protection against disclosure of the specific identity of the active substance has been denied by the Administrator; or (iii)the time period for protection against disclosure of the specific identity of the active substance has expired. (8)

Limitation

No person may assert a new claim under this subsection for protection from disclosure of a specific identity of any active or inactive chemical substance for which a notice is received under paragraph (4)(A)(i) or (5)(C)(i) that is not on the confidential portion of the list published under paragraph (1). (9)

Certification

Under the rule promulgated under this subsection, manufacturers and processors shall be required— (A)to certify that each report the manufacturer or processor submits complies with the requirements of the rule, and that any confidentiality claims are true and correct; and (B)to retain a record supporting the certification for a period of 5 years beginning on the last day of the submission period.

;

(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 information reasonably supporting the conclusion that a chemical substance or mixture presents, will present, or does not present a substantial risk of harm to health and the environment.

; and

(4)in subsection (f), by striking For purposes of this section, the and inserting the following:

In this section:(1)

Active substance

The term active substance means a chemical substance— (A)that has been manufactured or processed for a nonexempt commercial purpose at any point during the 10-year period ending on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; (B)that is added to the list published under subsection (b)(1) after that date of enactment; or (C)for which a notice is received under subsection (b)(5)(C). (2)

Inactive substance

The term inactive substance means a chemical substance on the list published under subsection (b)(1) that does not meet any of the criteria described in paragraph (1). (3)

Manufacture; process

The

11.

Relationship to other Federal laws

Section 9 of the Toxic Substances Control Act (15 U.S.C. 2608) is amended— (1)in subsection (a)— (A)in paragraph (1), in the first sentence— (i)by striking presents or will present an unreasonable risk to health or the environment and inserting does not meet the safety standard; 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 section 6(d) or section 7; and (C)in paragraph (3), by striking section 6 or 7 and inserting section 6(d) or 7; (2)in subsection (d), in the first sentence, by striking Health, Education, and Welfare and inserting Health and Human Services; and (3)by adding at the end the following:

(e)

Exposure information

If the Administrator obtains information related to exposures or releases of a chemical substance that may be prevented or reduced under another Federal law, including laws not administered by the Administrator, the Administrator shall make such information available to the relevant Federal agency or office of the Environmental Protection Agency.

12.

Research, development, collection, dissemination, and utilization of data

Section 10 of the Toxic Substances Control Act (15 U.S.C. 2609) is amended by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services.

13.

Exports

Section 12 of the Toxic Substances Control Act (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; or (B)under section 6 does not meet the safety standard. (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 the mixture or article; or (B)establish a threshold concentration in a mixture or article at which paragraph (1) shall not apply. (4)

Testing

The Administrator may require testing under section 4 of any chemical substance or mixture exempted from this Act under paragraph (1) for the purpose of determining whether the chemical substance or mixture meets the safety standard within the United States.

;

(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 and for which a prohibition or other restriction has been proposed or established under that section; (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 and for which a prohibition or other restriction has been proposed or established under that section; (C)a chemical substance for which the United States is obligated by treaty to provide export notification; (D)a chemical substance or mixture subject to a prohibition or other restriction pursuant to a rule, order, or consent agreement in effect under this Act; or (E)a chemical substance or mixture for which the submission of information is required under section 4. (2)

Rules

(A)

In general

The Administrator shall promulgate rules to carry out paragraph (1). (B)

Contents

The rules promulgated pursuant to subparagraph (A) shall— (i)include such exemptions as the Administrator determines to be appropriate, which may include exemptions identified under section 5(h); and (ii)indicate whether, or to what extent, the rules 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), (B), or (D) of paragraph (1), a notice of the determination, rule, order, consent agreement, requirement, or designation; (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 (C)for a chemical substance or mixture described in paragraph (1)(E), a notice of availability of the information on the chemical substance or mixture submitted to the Administrator.

; and

(3)in subsection (c)— (A)by striking paragraph (3); and (B)by redesignating paragraphs (4) through (6) as paragraphs (3) through (5), respectively.

14.

Imports

Section 13 of the Toxic Substances Control Act (15 U.S.C. 2612) is amended to read as follows:

13.

Imports

(a)

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, mixture, or article containing a chemical substance or mixture offered for such entry, if— (A)the Administrator— (i)has determined under section 6(c) that the chemical substance or mixture does not meet the safety standard; and (ii)has promulgated a rule pursuant to section 6(d) banning the chemical substance or mixture, as of the effective date of the rule; (B)the chemical substance— (i)is not included on the list under section 8(b)(1); and (ii)is not exempt from any requirement to be included on that list by this title or a rule promulgated by the Administrator pursuant to this title; or (C)the chemical substance, mixture, or any article containing the chemical substance or mixture is offered for entry in violation of— (i)a rule, consent agreement, or order in effect under this Act; or (ii)an order issued in a civil action brought under section 7 or title IV. (2)

Procedure

(A)

In general

Subject to subparagraph (B), if a chemical substance, mixture, or article containing 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 during 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, pending a review by the Administrator, may 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 on demand, the consignee shall be liable to the United States for liquidated damages equal to the full amount of the bond executed under clause (i)(I). (C)

Storage

All charges for storage, cartage, and labor on or 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. (b)

Certification

(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 certify to the Secretary of Homeland Security that— (A)after reasonable inquiry and to the best knowledge and belief of the person, the chemical substance or mixture is in compliance with any applicable rule, consent agreement, or order under section 5 or 6; and (B)the chemical substance— (i)is included on the list under section 8(b)(1); or (ii)is exempt from any requirement to be included on that list by this title or a rule promulgated by the Administrator pursuant to this title. (2)

Articles

(A)

In general

The Administrator, by rule, may require certification under paragraph (1) for an article containing a chemical substance or mixture that is subject to rule under section 5 or 6. (B)

Requirement

The rule under subparagraph (A) shall identify, with reasonable specificity, the types of articles, including parts or components of articles, that will be subject to the certification requirement. (C)

Factors for consideration

In determining the need for and content of a certification rule under this paragraph, the Administrator shall take into consideration— (i)the utility of the certification to enforcement of the applicable rule, consent agreement, or order under section 5 or 6; (ii)the contribution of imported articles to the potential risk presented by exposure to the chemical substance or mixture subject to rule under section 5 or 6; (iii)the impact on commerce and potential for the certification to impede or disrupt import of articles; (iv)the frequency or duration of the certification requirement; and (v)specification of the concentration of a chemical substance in an article that would subject the article to the certification requirement. (3)

Reasonable inquiry

(A)

In general

For purposes of a certification under paragraph (1), reasonable inquiry shall include good faith reliance by an importer on— (i)a safety data sheet or similar declaration provided by a supplier that documents the specific identity of the chemical substance or the specific identities of all chemical substances in a mixture; or (ii)for chemical substances or mixtures claimed by the supplier as confidential, or not otherwise disclosed by the supplier, a certification by the supplier that the imported chemical substance or mixture satisfies the applicable certification requirements under paragraph (1). (B)

Articles

For purposes of a certification under paragraph (2), reasonable inquiry shall include good faith reliance by an importer on a certification by the supplier that the imported article satisfies the applicable certification requirements in a rule promulgated pursuant to paragraph (2). (4)

Information regarding identity

For purposes of this subsection, the Administrator shall provide publicly accessible information regarding the identity of a chemical substance or mixture subject to rule under this Act that would be readily understood in import transactions. (c)

Notice

A person offering a chemical substance for entry into the customs territory of the United States shall notify the Secretary of Homeland Security if— (1)the chemical substance or chemical substance in a mixture is a high-priority substance; (2)the chemical substance or chemical substance in a mixture is 1 for which the United States is obligated to provide export notification by treaty; or (3)the chemical substance or chemical substance in a mixture— (A)is the subject of a safety assessment and safety determination conducted pursuant to section 6; and (B)has been found not to meet the safety standard. (d)

Rules

(1)

In general

The Secretary of Homeland Security, after consultation with the Administrator, shall promulgate rules to carry out this section. (2)

Application

The rules under paragraph (1) may modify the application of any requirement of this section, as appropriate for the efficient and effective implementation of this Act.

15.

Confidential information

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

14.

Confidential information

(a)

In general

Except as otherwise provided in this section, the Administrator shall not disclose information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, under subsection (b)(4) of that section— (1)that is reported to, or otherwise obtained by, the Administrator under this Act; and (2)for which the requirements of subsection (d) are met. (b)

Information generally protected from disclosure

The following information specific to, and submitted by, a manufacturer, processor, or distributor that meets the requirements of subsections (a) and (d) shall be presumed to be protected from disclosure, subject to the condition that nothing in this Act prohibits the disclosure of any such information through discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law: (1)Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. (2)Marketing and sales information. (3)Information identifying a supplier or customer. (4)Details of the full composition of a mixture and the respective percentages of constituents. (5)Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or product. (6)Specific production or import volumes of the manufacturer and specific aggregated volumes across manufacturers, if the Administrator determines that disclosure of the specific aggregated volumes would reveal confidential information. (7)Except as otherwise provided in this section, the specific identity of a chemical substance prior to the date on which the chemical substance is first offered for commercial distribution, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify a specific chemical substance, if— (A)the specific identity was claimed as confidential information at the time it was submitted in a notice under section 5; and (B)the claim— (i)is not subject to an exception under subsection (e); or (ii)has not subsequently been withdrawn or found by the Administrator not to warrant protection as confidential information under subsection (f)(2) or (g). (c)

Information not protected from disclosure

Notwithstanding subsections (a) and (b), the following information shall not be protected from disclosure: (1)

Information from health and safety studies

(A)

In general

Subject to subparagraph (B), subsection (a) does not prohibit the disclosure of— (i)any health and safety study that is submitted under this Act with respect to— (I)any chemical substance or mixture that, on the date on which the study is to be disclosed, has been offered for commercial distribution; or (II)any chemical substance or mixture for which— (aa)testing is required under section 4; or (bb)a notification is required under section 5; or (ii)any information reported to, or otherwise obtained by, the Administrator from a health and safety study relating to a chemical substance or mixture described in subclause (I) or (II) of clause (i). (B)

Effect of paragraph

Nothing in this paragraph authorizes the release of any information that discloses— (i)a process used in the manufacturing or processing of a chemical substance or mixture; or (ii)in the case of a mixture, the portion of the mixture comprised by any chemical substance in the mixture. (2)

Certain requests

If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information that is described in paragraph (1) that is not described in paragraph (1)(B), the Administrator may not deny the request on the basis of section 552(b)(4) of title 5, United States Code. (3)

Other information not protected from disclosure

The following information is not protected from disclosure under this section: (A)For information submitted after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the specific identity of a chemical substance as of the date on which the chemical substance is first offered for commercial distribution, 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)Any general information describing the manufacturing volumes, expressed as specific aggregated volumes or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges. (D)A general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector. (4)

Mixed confidential and nonconfidential information

Any information that is otherwise eligible for protection under this section and contained in a submission of information described in this subsection shall be protected from disclosure, if the submitter complies with subsection (d), subject to the condition that information in the submission that is not eligible for protection against disclosure shall be disclosed. (5)

Ban or phase-out

If the Administrator promulgates a rule pursuant to section 6(d) that establishes a ban or phase-out of the manufacture, processing, or distribution in commerce of a chemical substance— (A)any protection from disclosure provided under this section with respect to information relating to the chemical substance shall no longer apply; and (B)the Administrator promptly shall make the information public. (d)

Requirements for confidentiality claims

(1)

Assertion of claims

(A)

In general

A person seeking to protect any information submitted under this Act from disclosure (including information described in subsection (b)) shall assert to the Administrator a claim for protection concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant to this title. (B)

Inclusion

An assertion of a claim under subparagraph (A) shall include a statement that the person has— (i)taken reasonable measures to protect the confidentiality of the information; (ii)determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (iii)a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (iv)a reasonable basis to believe that the information is not readily discoverable through reverse engineering. (C)

Specific chemical identity

In the case of a claim under subparagraph (A) for protection against disclosure of a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that the generic name shall— (i)conform with guidance prescribed by the Administrator under paragraph (3)(A); and (ii)describe the chemical structure of the substance as specifically as practicable while protecting those features of the chemical structure— (I)that are considered to be confidential; and (II)the disclosure of which would be likely to harm the competitive position of the person. (D)

Public information

No person may assert a claim under this section for protection from disclosure of information that is already publicly available. (2)

Additional requirements for confidentiality claims

Except for information described in paragraphs (1) through (7) of subsection (b), a person asserting a claim to protect information from disclosure under this Act shall substantiate the claim, in accordance with the rules promulgated and guidance issued by the Administrator. (3)

Guidance

The Administrator shall develop guidance regarding— (A)the determination of structurally descriptive generic names, in the case of claims for the protection against disclosure of specific chemical identity; and (B)the content and form of the statements of need and agreements required under paragraphs (4), (5), and (6) of subsection (e). (4)

Certification

An authorized official of a person described in paragraph (1)(A) shall certify that the information that has been submitted is true and correct. (e)

Exceptions to protection from disclosure

Information described in subsection (a) shall be disclosed if— (1)the information is to be disclosed to an officer or employee of the United States in connection with the official duties of the officer or employee— (A)under any law for the protection of health or the environment; or (B)for a specific law enforcement purpose; (2)the information is to be disclosed to a contractor of the United States and employees of that contractor— (A)if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act; and (B)subject to such conditions as the Administrator may specify; (3)the Administrator determines that disclosure is necessary to protect 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)1 or more applicable agreements with the Administrator that conform with the guidance issued under subsection (d)(3)(B) ensure that the recipient will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information; and (B)the Administrator notifies the person that submitted the information that the information has been disclosed to the State or political subdivision of a State; (5)a health or environmental 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 agrees to sign a written confidentiality agreement with the Administrator, subject to the conditions that— (A)the statement of need and confidentiality agreement shall conform with the guidance issued under subsection (d)(3)(B); (B)the written statement of need shall be a statement that the person has a reasonable basis to suspect that— (i)the information is necessary for, or will assist in— (I)the diagnosis or treatment of 1 or more individuals; or (II)responding to an environmental release or exposure; and (ii)1 or more individuals being diagnosed or treated have been exposed to the chemical substance concerned, or an environmental release or exposure has occurred; and (C)the confidentiality agreement shall provide that the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need, except as otherwise may be authorized by the terms of the agreement or by the person submitting the information to the Administrator, except that nothing in this Act prohibits the disclosure of any such information through discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law; (6)in the event of an emergency, a treating physician, nurse, agent of a poison control center, public health or environmental official of a State or political subdivision of a State, or first responder (including any individual duly authorized by a Federal agency, State, or political subdivision of a State who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) requests the information, subject to the conditions that— (A)the treating physician, nurse, agent, public health or environmental official of a State or a political subdivision of a State, or first responder shall have a reasonable basis to suspect that— (i)a medical or public health or environmental emergency exists; (ii)the information is necessary for, or will assist in, emergency or first-aid diagnosis or treatment; or (iii)1 or more individuals being diagnosed or treated have likely been exposed to the chemical substance concerned, or a serious environmental release of or exposure to the chemical substance concerned has occurred; (B)if requested by the person submitting the information to the Administrator, the treating physician, nurse, agent, public health or environmental official of a State or a political subdivision of a State, or first responder shall, as described in paragraph (5)— (i)provide a written statement of need; and (ii)agree to sign a confidentiality agreement; and (C)the written confidentiality agreement or statement of need shall be submitted as soon as practicable, but not necessarily before the information is disclosed; (7)the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure shall be made in such a manner as to preserve confidentiality to the maximum extent practicable without impairing the proceeding; (8)the information is to be disclosed, on written request of any duly authorized congressional committee, to that committee; or (9)the information is required to be disclosed or otherwise made public under any other provision of Federal law. (f)

Duration of protection from disclosure

(1)

In general

(A)

Information protected from disclosure

Subject to paragraph (2), the Administrator shall protect from disclosure information that meets the requirements of subsection (d) for a period of 10 years, unless, prior to the expiration of the period— (i)an affected 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 (ii)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). (B)

Extensions

(i)

In general

Not later than the date that is 60 days before the expiration of the period described in subparagraph (A), the Administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period. (ii)

Statement

(I)

In general

Not later than the date that is 30 days before the expiration of the period described in subparagraph (A), a person reasserting the relevant claim shall submit to the Administrator a statement substantiating, in accordance with subsection (d)(2), the need to extend the period. (II)

Action by Administrator

Not later than the date that is 30 days after the date of receipt of a statement under subclause (I), the Administrator shall— (aa)review the request; (bb)make a determination regarding whether the information for which the request is made continues to meet the relevant criteria established under this section; and (cc)(AA)grant an extension of not more than 10 years; or (BB)deny the claim. (C)

No limit on number of extensions

There shall be no limit on the number of extensions granted under subparagraph (B), if the Administrator determines that the relevant statement under subparagraph (B)(ii)(I)— (i)establishes the need to extend the period; and (ii)meets the requirements established by the Administrator. (2)

Review and resubstantiation

(A)

Discretion of Administrator

The Administrator may review, at any time, a claim for protection against disclosure under subsection (a) for information submitted to the Administrator regarding a chemical substance and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section— (i)after the chemical substance is identified as a high-priority substance under section 4A; (ii)for any chemical substance for which the Administrator has made a determination under section 6(c)(1)(C); (iii)for any inactive chemical substance identified under section 8(b)(5); or (iv)in limited circumstances, if the Administrator determines that disclosure of certain information currently protected from disclosure would assist the Administrator in conducting safety assessments and safety determinations under subsections (b) and (c) of section 6 or promulgating rules pursuant to section 6(d), subject to the condition that the information shall not be disclosed unless the claimant withdraws the claim or the Administrator determines that the information does not meet the requirements of subsection (d). (B)

Review required

The Administrator shall review a claim for protection from disclosure under subsection (a) for information submitted to the Administrator regarding a chemical substance and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section— (i)as necessary to comply with a request for information received by the Administrator under section 552 of title 5, United States Code; (ii)if information available to the Administrator provides a basis that the requirements of section 552(b)(4) of title 5, United States Code, are no longer met; or (iii)for any substance for which the Administrator has made a determination under section 6(c)(1)(B). (C)

Action by recipient

If the Administrator makes a request under subparagraph (A) or (B), the recipient of the request shall— (i)reassert and substantiate or resubstantiate the claim; or (ii)withdraw the claim. (D)

Period of protection

Protection from disclosure of information subject to a claim that is reviewed and approved by the Administrator under this paragraph shall be extended for a period of 10 years from the date of approval, subject to any subsequent request by the Administrator under this paragraph. (3)

Unique identifier

The Administrator shall— (A)(i)develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, other than a specific chemical identity or structurally descriptive generic term; and (ii)apply that identifier consistently to all information relevant to the applicable chemical substance; (B)annually publish and update a list of chemical substances, referred to by unique identifier, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim; (C)ensure that any nonconfidential information received by the Administrator with respect to such a chemical substance during the period of protection from disclosure— (i)is made public; and (ii)identifies the chemical substance using the unique identifier; and (D)for each claim for protection of specific chemical identity that has been denied by the Administrator on expiration of the period for appeal under subsection (g)(3), that has expired, or that has been withdrawn by the submitter, provide public access to the specific chemical identity clearly linked to all nonconfidential information received by the Administrator with respect to the chemical substance. (g)

Duties of Administrator

(1)

Determination

(A)

In general

Except as provided in subsection (b), the Administrator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (d), and not later than 30 days after the receipt of a request for extension of a claim under subsection (f), review and approve, modify, or deny the claim or request. (B)

Denial or modification

(i)

In general

Except as provided in subsections (c) and (f), the Administrator shall deny a claim to protect a chemical identity from disclosure only if the person that has submitted the claim fails to meet the requirements of subsections (a) and (d). (ii)

Reasons for denial or modification

The Administrator shall provide to a person that has submitted a claim described in clause (i) a written statement of the reasons for the denial or modification of the claim. (C)

Subsets

The Administrator shall— (i)except for claims described in subsection (b)(7), review all claims under this section for the protection against disclosure of the specific identity of a chemical substance; and (ii)review a representative subset, comprising at least 25 percent, of all other claims for protection against disclosure. (D)

Effect of failure to act

The failure of the Administrator to make a decision regarding a claim for protection against disclosure or extension under this section shall not be the basis for denial or elimination of a claim for protection against disclosure. (2)

Notification

(A)

In general

Except as provided in subparagraph (B) and subsections (c), (e), and (f), if the Administrator denies or modifies a claim under paragraph (1), the Administrator shall notify, in writing and by certified mail, the person that submitted the claim 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 shall not release information under this subsection until the date that is 30 days after the date on which the person that 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 shall not release that information until the date that is 15 days after the date on which the person that submitted the claim receives a notification, unless the Administrator determines that release of the information is necessary to protect against an imminent and substantial harm to health or the environment, in which case no prior notification shall be necessary. (II)

No notification

For information under paragraph (1), (2), (6), (7), or (9) of subsection (e), no prior notification shall be necessary. (3)

Appeals

(A)

In general

If a person receives a notification under paragraph (2) and believes disclosure of the information is prohibited under subsection (a), before the date on which the information is to be released, the person may bring an action to restrain disclosure of the information in— (i)the United States district court of the district in which the complainant resides or has the principal place of business; or (ii)the United States District Court for the District of Columbia. (B)

No disclosure

The Administrator shall not disclose any information that is the subject of an appeal under this section before the date on which the applicable court rules on an action under subparagraph (A). (4)

Administration

In carrying out this subsection, the Administrator shall use the procedures described in part 2 of title 40, Code of Federal Regulations (or successor regulations). (h)

Criminal penalty for wrongful disclosure

(1)

Officers and employees of United States

(A)

In general

Subject to paragraph (2), a current or former officer or employee of the United States described in subparagraph (B) shall be guilty of a misdemeanor and fined under title 18, United States Code, or imprisoned for not more than 1 year, or both. (B)

Description

A current or former officer or employee of the United States referred to in subparagraph (A) is a current or former officer or employee of the United States who— (i)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 (ii)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. (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 purposes of this subsection, any contractor of the United States that is provided 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

(1)

In general

Except as otherwise provided in this section, section 8, or any other applicable Federal law, the Administrator shall have no authority— (A)to require the substantiation or resubstantiation of a claim for the protection from disclosure of information submitted to the Administrator under this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; or (B)to impose substantiation or resubstantiation requirements under this Act that are more extensive than those required under this section. (2)

Prior actions

Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation for, or approving, modifying or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the Administrator may promulgate after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

16.

Prohibited acts

Section 15 of the Toxic Substances Control Act (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 under section 5 or 6; (C)any rule promulgated, consent agreement entered into, or order issued under section 5 or 6; or (D)any requirement of, or any rule promulgated or order issued pursuant to title II;

17.

Penalties

Section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) is amended— (1)in subsection (a)(1)— (A)in the first sentence— (i)by inserting this Act or a rule or order promulgated or issued pursuant to this Act, including after a provision of; and (ii)by striking $25,000 and inserting $37,500; and (B)in the second sentence, by striking violation of section 15 or 409 and inserting violation of this Act; and (2)in subsection (b)— (A)by striking Any person who and inserting the following:

(1)

In general

Any person that

;

(B)by striking section 15 or 409 and inserting this Act; (C)by striking $25,000 and inserting $50,000; and (D)by adding at the end the following:

(2)

Imminent danger of death or serious bodily injury

(A)

In general

Any person that knowingly or willfully violates any provision of this Act, and that knows at the time of the violation that the violation places an individual in imminent danger of death or serious bodily injury, shall be subject on conviction to a fine of not more than $250,000, or imprisonment for not more than 15 years, or both. (B)

Organizations

An organization that commits a violation described in subparagraph (A) shall be subject on conviction to a fine of not more than $1,000,000 for each violation. (3)

Knowledge of imminent danger or injury

For purposes of determining whether a defendant knew that the violation placed another individual in imminent danger of death or serious bodily injury— (A)the defendant shall be responsible only for actual awareness or actual belief possessed; and (B)knowledge possessed by an individual may not be attributed to the defendant.

18.

State-Federal relationship

Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is amended by striking subsections (a) and (b) and inserting the following:

(a)

In general

(1)

Establishment or enforcement

Except as provided in subsections (c), (d), (e), (f), and (g), and subject to paragraph (2), no State or political subdivision of a State may establish or continue to enforce any of the following: (A)

Testing and information collection

A statute or administrative action to require the development of information on a chemical substance or category of substances that is reasonably likely to produce the same information required under section 4, 5, or 6 in— (i)a rule promulgated by the Administrator; (ii)a testing consent agreement entered into by the Administrator; or (iii)an order issued by the Administrator. (B)

Chemical substances found to meet the safety standard or restricted

A statute or administrative action to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical substance— (i)found to meet the safety standard and consistent with the scope of the determination made under section 6; or (ii)found not to meet the safety standard, after the effective date of the rule issued under section 6(d) for the substance, consistent with the scope of the determination made by the Administrator. (C)

Significant new use

A statute or administrative action requiring the notification of a use of a chemical substance that the Administrator has specified as a significant new use and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (2)

Effective date of preemption

Under this subsection, Federal preemption of State statutes and administrative actions applicable to specific substances shall not occur until the effective date of the applicable action described in paragraph (1) taken by the Administrator. (b)

New statutes or administrative actions creating prohibitions or other restrictions

Except as provided in subsections (c), (d), and (e), no State or political subdivision of a State may establish (after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act) a statute or administrative action prohibiting or restricting the manufacture, processing, distribution in commerce or use of a chemical substance that is a high-priority substance designated under section 4A, as of the date on which the Administrator commences a safety assessment under section 6. (c)

Scope of preemption

Federal preemption under subsections (a) and (b) of State statutes and administrative actions applicable to specific substances shall apply only to— (1)the chemical substances or category of substances subject to a rule, order, or consent agreement under section 4; (2)the uses or conditions of use of such substances that are identified by the Administrator as subject to review in a safety assessment and included in the scope of the safety determination made by the Administrator for the substance, or of any rule the Administrator promulgates pursuant to section 6(d); or (3)the uses of such substances that the Administrator has specified as significant new uses and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (d)

Exceptions

(1)

In general

Subsections (a) and (b) shall not apply to a statute or administrative action of a State or a political subdivision of a State applicable to a specific chemical substance that— (A)is adopted under the authority of, or authorized to comply with, any other Federal law; (B)implements a reporting, monitoring, or other information collection obligation for the chemical substance not otherwise required by the Administrator under this Act or required under any other Federal law; or (C)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, unless the action taken by the State or political subdivision of a State— (i)imposes a restriction on the manufacture, processing, distribution in commerce, or use of a chemical substance; and (ii)(I)is already required by a decision by the Administrator under section 5 or 6; (II)is taken to address a health or environmental concern that applies to the uses or conditions of use that are included in the scope of a safety determination pursuant to section 6 or the scope of a significant new use rule promulgated pursuant to section 5, but is inconsistent with the action of the Administrator; or (III)would cause a violation of the applicable action by the Administrator under section 5 or 6. (2)

No preemption of State statutes and administrative actions

Nothing in this Act, nor any amendment made by this Act, nor any rule, standard of performance, safety determination, or scientific assessment implemented pursuant to this Act, shall affect the right of a State or a political subdivision of a State to adopt or enforce any rule, standard of performance, safety determination, scientific assessment, or any protection for public health or the environment that— (A)is adopted under the authority of, or authorized to comply with, any other Federal law; (B)implements a reporting, monitoring, or other information collection obligation for the chemical substance not otherwise required by the Administrator under this Act or required under any other Federal law; or (C)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, unless the action taken by the State or political subdivision of a State— (i)imposes a restriction on the manufacture, processing, distribution in commerce, or use of a chemical substance; and (ii)(I)is already required by a decision by the Administrator under section 5 or 6; (II)is taken to address a health or environmental concern that applies to the uses or conditions of use that are included in the scope of a safety determination pursuant to section 6 or the scope of a significant new use rule promulgated pursuant to section 5, but is inconsistent with the action of the Administrator; or (III)would cause a violation of the applicable action by the Administrator under section 5 or 6. (3)

Applicability to certain rules or orders

Notwithstanding subsection (e)— (A)nothing in this section shall be construed as modifying the effect under this section, as in effect on the day before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, of any rule or order promulgated or issued under this Act prior to that effective date; and (B)with respect to a chemical substance or mixture for which any rule or order was promulgated or issued under section 6 prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with regards to manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, this section (as in effect on the day before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act) shall govern the preemptive effect of any rule or order that is promulgated or issued respecting such chemical substance or mixture under section 6 of this Act after that effective date, unless the latter rule or order is with respect to a chemical substance or mixture containing a chemical substance and follows a designation of that chemical substance as a high-priority substance under subsection (b) or (c) of section 4A or as an additional priority for safety assessment and safety determination under section 4A(d). (e)

Preservation of certain State law

(1)

In general

Nothing in this Act, subject to subsection (g) of this section, shall— (A)be construed to preempt or otherwise affect any action taken before January 1, 2015, under the authority of a State law that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B)be construed to preempt or otherwise affect any action taken pursuant to a State law that was in effect on August 31, 2003. (2)

Effect of subsection

This subsection does not affect, modify, or alter the relationship between State and Federal law pursuant to any other Federal law. (f)

State waivers

(1)

In general

Upon application of a State or political subdivision of a State, the Administrator may— (A)by rule, exempt from subsection (a), under such conditions as may be prescribed in the rule, a statute or administrative action of that State or political subdivision of the State that relates to the effects of, or exposure to, a chemical substance under the conditions of use if the Administrator determines that— (i)compelling State or local conditions warrant granting the waiver to protect health or the environment; (ii)compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (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)based on the judgment of the Administrator, the proposed requirement of the State or political subdivision of the State is consistent with sound objective scientific practices, the weight of the evidence, and the best available science; or (B)exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— (i)the State has a compelling local interest that warrants granting the waiver to protect health or the environment; (ii)compliance with the proposed requirement of the State will not unduly burden interstate 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. (2)

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)(A) is submitted; and (B)not later than 90 days after the date on which an application under paragraph (1)(B) is submitted. (3)

Notice and comment

The application of a State or political subdivision of the State shall be subject to public notice and comment. (4)

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. (5)

Duration of waivers

A waiver granted under paragraph (1)(B) shall remain in effect until the later of— (A)such time as the safety assessment and safety determination is completed; and (B)the date on which compliance with an applicable rule issued under section 6(d) is required. (6)

Judicial review of waivers

Not later than 60 days after the date on which the Administrator makes a determination on an application of a State or political subdivision of the State under subparagraph (A) or (B) of 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. (7)

Judicial review of prioritization screening decision

Not later than 60 days after the date on which the Administrator makes a decision on a recommendation made under section 4A(b)(4) to designate a chemical substance as a low priority, the Governor of a State or a State agency with responsibility for protecting health and the environment that submitted the recommendation under section 4A(a)(4)(A), as applicable, 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. (g)

Savings

(1)

No preemption of common law or statutory causes of action for civil relief or criminal conduct

(A)

In general

Nothing in this Act, nor any amendment made by this Act, nor any safety standard, rule, requirement, standard of performance, safety determination, or scientific assessment implemented pursuant to this Act, shall be construed to preempt, displace, or supplant any state or Federal common law rights or any state or Federal statute creating a remedy for civil relief, including those for civil damage, or a penalty for a criminal conduct. (B)

Clarification of no preemption

Notwithstanding any other provision of this Act, nothing in this Act, nor any amendments made by this Act, shall preempt or preclude any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory of liability under any State law, maritime law, or Federal common law or statutory theory. (2)

No effect on private remedies

(A)Nothing in this Act, nor any amendments made by this Act, nor any rules, regulations, requirements, safety assessments, safety determinations, scientific assessments, or orders issued pursuant to this Act shall be interpreted as, in either the plaintiff’s or defendant’s favor, dispositive in any civil action. (B)This Act does not affect the authority of any court to make a determination in an adjudicatory proceeding under applicable State or Federal law with respect to the admission into evidence or any other use of this Act or rules, regulations, requirements, standards of performance, safety assessments, scientific assessments, or orders issued pursuant to this Act.

19.

Judicial review

Section 19 of the Toxic Substances Control Act (15 U.S.C. 2618) is amended— (1)in subsection (a)— (A)in paragraph (1)— (i)in subparagraph (A), by striking section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV and inserting section 4(a), 5(d), 6(c), 6(d), 6(g), or 8, or title II or IV; and (ii)in subparagraph (B), by striking an order issued under subparagraph (A) or (B) of section 6(b)(1) and inserting an order issued under this title; and (B)in paragraph (2), in the first sentence, by striking paragraph (1)(A) and inserting paragraph (1); and (C)by striking paragraph (3); and (2)in subsection (c)(1)(B)— (A)in clause (i)— (i)by striking section 4(a), 5(b)(4), 6(a), or 6(e) and inserting section 4(a), 5(d), 6(d), or 6(g); and (ii)by striking evidence in the rulemaking record (as defined in subsection (a)(3)) taken as a whole; and inserting evidence (including any matter) in the rulemaking record, taken as a whole; and; and (B)by striking clauses (ii) and (iii) and the matter following clause (iii) and inserting the following:

(ii)the court may not review the contents and adequacy of any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule, except as part of the rulemaking record, taken as a whole.

20.

Citizens' petitions

Section 21 of the Toxic Substances Control Act (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 or 5(d); 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 or 5(d); and (B)in paragraph (4), by striking subparagraph (B) and inserting the following:

(B)

De novo proceeding

(i)

In general

In an action under subparagraph (A) to initiate a proceeding to promulgate a rule pursuant to section 4, 5, 6, or 8 or an order issued under section 4 or 5, 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 in a de novo proceeding under this subparagraph 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, the information available to the Administrator is insufficient for the Administrator to perform an action described in section 4, 4A, 5, or 6(d); (bb)in the case of a petition to issue an order under section 5(d), there is a reasonable basis to conclude that the chemical substance is not likely to meet the safety standard; (cc)in the case of a petition to initiate a proceeding for the issuance of a rule under section 6(d), there is a reasonable basis to conclude that the chemical substance will not meet the safety standard; or (dd)in the case of a petition to initiate a proceeding for the issuance of a rule under section 8, there is a reasonable basis to conclude that the rule is necessary to protect health or the environment or ensure that the chemical substance meets the safety standard. (II)

Deferment

The court in a de novo proceeding under this subparagraph 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 health or the environment alleged by the petitioner is less than the extent of risks to 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.

21.

Employment effects

Section 24(b)(2)(B)(ii) of the Toxic Substances Control Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by striking section 6(c)(3), and inserting the applicable requirements of this Act;.

22.

Studies

Section 25 of the Toxic Substances Control Act (15 U.S.C. 2624) is repealed.

23.

Administration

Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is amended— (1)by striking subsection (b) and inserting the following:

(b)

Fees

(1)

In general

The Administrator shall establish, not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, by rule— (A)the payment of 1 or more reasonable fees as a condition of submitting a notice or requesting an exemption under section 5; and (B)the payment of 1 or more reasonable fees by a manufacturer or processor that— (i)is required to submit a notice pursuant to the rule promulgated under section 8(b)(4)(A)(i) identifying a chemical substance as active; (ii)is required to submit a notice pursuant to section 8(b)(5)(B)(i) changing the status of a chemical substance from inactive to active; (iii)is required to report information pursuant to the rules promulgated under section 8(a)(4); and (iv)manufactures or processes a chemical substance subject to a safety assessment and safety determination pursuant to section 6. (2)

Utilization and collection of fees

The Administrator shall— (A)utilize the fees collected under paragraph (1) only to defray costs associated with the actions of the Administrator— (i)to collect, process, review, provide access to, and protect from disclosure (where appropriate) information on chemical substances under this Act; (ii)to review notices and make determinations for chemical substances under paragraphs (1) and (3) of section 5(d) and impose any necessary restrictions under section 5(d)(4); (iii)to make prioritization decisions under section 4A; (iv)to conduct and complete safety assessments and determinations under section 6; and (v)to conduct any necessary rulemaking pursuant to section 6(d); (B)insofar as possible, collect the fees described in paragraph (1) in advance of conducting any fee-supported activity; (C)deposit the fees in the Fund established by paragraph (4)(A); and (D)not collect excess fees or retain a significant amount of unused fees. (3)

Amount and adjustment of fees; refunds

In setting fees under this section, the Administrator shall— (A)take into account the cost to the Administrator of conducting the activities described in paragraph (2); (B)prescribe lower fees for small business concerns, after consultation with the Administrator of the Small Business Administration; (C)set the fees established under paragraph (1) at levels such that the fees will, in aggregate, provide a sustainable source of funds to defray approximately 25 percent of the costs of conducting the activities identified in paragraph (2)(A), not to exceed $18,000,000, not including fees under subparagraph (E) of this paragraph; (D)reflect an appropriate balance in the assessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; (E)for substances designated as additional priorities pursuant to section 4A(c), establish the fee at a level sufficient to defray the full costs to the Administrator of conducting the safety assessment and safety determination under section 6; (F)prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee Act (5 U.S.C. App.) or subchapter III of chapter 5 of title 5, United States Code, is applicable with respect to such meetings; (G)beginning with the fiscal year that is 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives, increase or decrease the fees established under paragraph (1) as necessary— (i)to ensure that funds deposited in the Fund are sufficient to conduct the activities identified in paragraph (2)(A) and the full costs of safety assessments and safety determinations pursuant to subparagraph (E); and (ii)to account for inflation; (H)adjust fees established under paragraph (1) as necessary to vary on account of differing circumstances, including reduced fees or waivers in appropriate circumstances, to reduce the burden on manufacturing or processing, remove barriers to innovation, or where the costs to the Administrator of collecting the fees exceed the fee revenue anticipated to be collected; and (I)if a notice submitted under section 5 is refused or subsequently withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice. (4)

TSCA Implementation Fund

(A)

Establishment

There is established in the Treasury of the United States a fund, to be known as the TSCA Implementation Fund (referred to in this subsection as the Fund), consisting of— (i)such amounts as are deposited in the Fund under paragraph (2)(C); and (ii)any interest earned on the investment of amounts in the Fund; and (iii)any proceeds from the sale or redemption of investments held in the Fund. (B)

Crediting and availability of fees

(i)

In general

Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation. (ii)

Requirements

Fees collected under this section shall not— (I)be made available or obligated for any purpose other than to defray the costs of conducting the activities identified in paragraph (2)(A); (II)otherwise be available for any purpose other than implementation of this Act; and (III)so long as amounts in the Fund remain available, be subject to restrictions on expenditures applicable to the Federal government as a whole. (C)

Unused funds

Amounts in the Fund not currently needed to carry out this subsection shall be— (i)maintained readily available or on deposit; (ii)invested in obligations of the United States or guaranteed by the United States; or (iii)invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds. (D)

Minimum amount of appropriations

Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for salaries, contracts, and expenses for the functions (as in existence in fiscal year 2015) of the Office of Pollution Prevention and Toxics of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for covered functions for fiscal year 2015 (excluding the amount of any fees appropriated for the fiscal year). (5)

Auditing

(A)

Financial statements of agencies

For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of an executive agency. (B)

Components

The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this subsection shall include an analysis of— (i)the fees collected under paragraph (1) and disbursed; (ii)compliance with the deadlines established in section 6 of this Act; (iii)the amounts budgeted, appropriated, collected from fees, and disbursed to meet the requirements of sections 4, 4A, 5, 6, 8, and 14, including the allocation of full time equivalent employees to each such section or activity; and (iv)the reasonableness of the allocation of the overhead associated with the conduct of the activities described in paragraph (2)(A). (C)

Inspector General

The Inspector General of the Environmental Protection Agency shall— (i)conduct the annual audit required under this subsection; and (ii)report the findings and recommendations of the audit to the Administrator and to the appropriate committees of Congress. (6)

Termination

The authority provided by this section shall terminate at the conclusion of the fiscal year that is 10 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, unless otherwise reauthorized or modified by Congress.

;

(2)in subsection (e), by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services; and (3)adding at the end the following:

(h)

Prior actions

Nothing in this Act eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

24.

Development and evaluation of test methods and sustainable chemistry

Section 27 of the Toxic Substances Control Act (15 U.S.C. 2626) is amended— (1)in subsection (a), in the first sentence by striking Health, Education, and Welfare and inserting Health and Human Services; and (2)by adding at the end the following:

(c)

Sustainable Chemistry Program

The President shall establish an interagency Sustainable Chemistry Program to promote and coordinate Federal sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training activities. (d)

Program activities

The activities of the Program shall be designed to— (1)provide sustained support for sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training through— (A)coordination of sustainable chemistry research, development, demonstration, and technology transfer conducted at Federal laboratories and agencies; and (B)to the extent practicable, encouragement of consideration of sustainable chemistry in, as appropriate— (i)the conduct of Federal and State science and engineering research and development; and (ii)the solicitation and evaluation of applicable proposals for science and engineering research and development; (2)examine methods by which the Federal Government can create incentives for consideration and use of sustainable chemistry processes and products, including innovative financing mechanisms; (3)expand the education and training of undergraduate and graduate students and professional scientists and engineers, including through partnerships with industry, in sustainable chemistry science and engineering; (4)collect and disseminate information on sustainable chemistry research, development, and technology transfer including information on— (A)incentives and impediments to development, manufacturing, and commercialization; (B)accomplishments; (C)best practices; and (D)costs and benefits; and (5)support (including through technical assistance, participation, financial support, or other forms of support) economic, legal, and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry. (e)

Interagency working group

(1)

Establishment

Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the President, in consultation with the Office of Science and Technology Policy, shall establish an Interagency Working Group that shall include representatives from the National Science Foundation, the National Institute of Standards and Technology, the Department of Energy, the Environmental Protection Agency, the Department of Agriculture, the Department of Defense, the National Institutes of Health, and any other agency that the President may designate to oversee the planning, management, and coordination of the Program. (2)

Governance

The Director of the National Science Foundation and the Assistant Administrator for Research and Development of the Environmental Protection Agency, or their designees, shall serve as co-chairs of the Interagency Working Group. (3)

Responsibilities

In overseeing the planning, management, and coordination of the Program, the Interagency Working Group shall— (A)establish goals and priorities for the Program, in consultation with the Advisory Council; (B)provide for interagency coordination, including budget coordination, of activities under the Program; (C)meet not later than 90 days from its establishment and periodically thereafter; and (D)establish and consult with an Advisory Council on a regular basis. (4)

Membership

The Advisory Council members shall not be employees of the Federal Government and shall include a diverse representation of knowledgeable individuals from the private sector (including small- and medium-sized enterprises from across the value chain), academia, State and tribal governments, and nongovernmental organizations and others who are in a position to provide expertise. (f)

Agency budget requests

(1)

In general

Each Federal agency and department participating in the Program shall, as part of its annual request for appropriations to the Office of Management and Budget, submit a report to the Office of Management and Budget that— (A)identifies the activities of the agency or department that contribute directly to the Program; and (B)states the portion of the agency or department’s request for appropriations that is allocated to those activities. (2)

Annual budget request to congress

The President shall include in the annual budget request to Congress a statement of the portion of the annual budget request for each agency or department that will be allocated to activities undertaken pursuant to the Program. (g)

Report to congress

(1)

In general

Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Interagency Working Group shall submit a report to the Committee on Science, Space, and Technology and Committee on Energy and Commerce of the House of Representatives and the Committee on Environment and Public Works and the Committee on Commerce, Science, and Transportation of the Senate that shall include— (A)a summary of federally funded sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training activities; (B)a summary of the financial resources allocated to sustainable chemistry initiatives; (C)an analysis of the progress made toward achieving the goals and priorities of this Act, and recommendations for future program activities; (D)an assessment of the benefits of expanding existing, federally supported regional innovation and manufacturing hubs to include sustainable chemistry and the value of directing the creation of 1 or more dedicated sustainable chemistry centers of excellence or hubs; and (E)an evaluation of steps taken and future strategies to avoid duplication of efforts, streamline interagency coordination, facilitate information sharing, and spread best practices between participating agencies in the Program. (2)

Submission to GAO

The Interagency Working Group shall also submit the report described in paragraph (1) to the Government Accountability Office for consideration in future Congressional inquiries.

25.

State programs

Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is amended— (1)in subsection (b)(1)— (A)in subparagraphs (A) through (D), by striking the comma at the end of each subparagraph and inserting a semicolon; and (B)in subparagraph (E), by striking , and and inserting ; and; and (2)by striking subsections (c) and (d).

26.

Authorization of appropriations

Section 29 of the Toxic Substances Control Act (15 U.S.C. 2628) is repealed.

27.

Annual report

Section 30 of the Toxic Substances Control Act (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;

28.

Effective date

Section 31 of the Toxic Substances Control Act (15 U.S.C. 2601 note; Public Law 94–469) is amended— (1)by striking Except as provided in section 4(f), this and inserting the following:

(a)

In general

This

; and

(2)by adding at the end the following:

(b)

Retroactive applicability

Nothing in this Act shall be interpreted to apply retroactively to any State, Federal, or maritime legal action commenced prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.