diff --git "a/RawData/Bills/BILLS-113-1-s/BILLS-113s1009is.xml" "b/RawData/Bills/BILLS-113-1-s/BILLS-113s1009is.xml" new file mode 100644--- /dev/null +++ "b/RawData/Bills/BILLS-113-1-s/BILLS-113s1009is.xml" @@ -0,0 +1,2812 @@ + + + + + + +113 S1009 IS: Chemical Safety Improvement Act +U.S. Senate +2013-05-22 +text/xml +EN +Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. + + +
+ II + 113th CONGRESS + 1st Session + S. 1009 + IN THE SENATE OF THE UNITED STATES + + May 22, 2013 + Mr. Lautenberg (for + himself, Mr. Vitter, + Mrs. Gillibrand, + Mr. Crapo, Mr. + Durbin, Mr. Alexander, + Mr. Schumer, Mr. Inhofe, Mr. Udall of + New Mexico, Ms. Collins, + Ms. Landrieu, Mr. Rubio, Mr. + Manchin, Mr. Boozman, + Mr. Menendez, Mr. Hoeven, and Mr. + Begich) introduced the following bill; which was read twice and + referred to the Committee on Environment + and Public Works + + A BILL + To reauthorize and modernize the Toxic Substances Control + Act, and for other purposes. +
+ +
1.
Short title; table of + contents; references
+ (a)
Short + title
This Act may be cited as the Chemical Safety Improvement + Act. + (b)
Table of + contents
The table of contents for this Act is as follows: + + Sec. 1. Short title; table of contents; references. + Sec. 2. Findings, policy, and intent. + Sec. 3. Definitions. + Sec. 4. Chemical assessment framework; prioritization + screening; testing. + Sec. 5. New chemicals and significant new uses. + Sec. 6. Safety assessments and determinations. + Sec. 7. Imminent hazards. + Sec. 8. Information collection and reporting. + Sec. 9. Relationship to other Federal laws. + Sec. 10. Research, development, collection, dissemination, and + utilization of data. + Sec. 11. Exports. + Sec. 12. Imports. + Sec. 13. Confidential information. + Sec. 14. Prohibited acts. + Sec. 15. Preemption. + Sec. 16. Judicial review. + Sec. 17. Citizens' petitions. + Sec. 18. Studies. + Sec. 19. Administration. + Sec. 20. Development and evaluation of test + methods. + Sec. 21. State programs. + Sec. 22. Authorization of appropriations. + Sec. 23. Annual report. + + (c)
References
Except + as otherwise expressly provided, wherever in this Act an amendment or repeal is + expressed in terms of an amendment to, or repeal of, a section or other + provision, the reference shall be considered to be made to a section or other + provision of the Toxic Substances Control Act (15 U.S.C. 2601 et seq.). +
2.
Findings, + policy, and intent
+ (a)
Purposes
The + purposes of this Act are— + (1)to improve the + safety of consumers in the United States; and + (2)to ensure that + risks from chemical substances are adequately understood and managed by + modernizing title I of the Toxic Substances Control Act (15 U.S.C. 2601 et + seq.). + (b)
Findings, + policy, and intent
Section 2 (15 U.S.C. 2601) is amended by + striking subsections (a) through (c) and inserting the following: + + (a)
Findings
Congress + finds that— + (1)chemicals should + be safe for the intended use of the chemicals; + (2)the unmanaged + risks of chemical substances may pose a danger to human health and the + environment; + (3)public confidence + in the Federal chemical regulatory program has diminished over time; + (4)scientific + understanding of chemicals and the possible risks of the chemicals has evolved + greatly since 1976, requiring that Congress update the law to ensure that + chemical regulation in the United States reflects modern science, technology + and knowledge; + (5)this Act should + be modernized to create a robust Federal system for assessing and managing + chemical risks; + (6)chemicals are + used in diverse manufacturing industries and other valuable commercial, + institutional, and consumer applications that have benefitted society; + (7)for the purposes + of promoting uniform protections through regulation of chemical substances in + commerce, to minimize undue burdens on commerce, and to minimize burdens on + States, specified actions by the Administrator should preempt requirements by + States and political subdivisions of States that relate to the effects of or + exposure to a chemical substance under the intended conditions of use; + and + (8)innovation in the + development of new chemical substances, especially safer chemical substances, + should be encouraged to reduce risk, provide improved products, stimulate the + economy, create jobs, and protect interstate commerce. + (b)
Policy
It + is the policy of the United States that— + (1)this Act— + (A)should protect + the health of people and the environment from the unmanaged risks of chemical + substances; and + (B)should be + modernized to build public confidence in the ability of the Federal regulatory + system to protect health and the environment, promote innovation, and sustain a + globally competitive chemical industry in the United States; + (2)the + Administrator— + (A)should have the + appropriate hazard, use, and exposure information necessary to make safety + determinations; + (B)should minimize + the use of animal testing through the use of scientifically reliable and + relevant test methods, where appropriate; + (C)should encourage + the use of best laboratory practices to ensure high quality, relevant, and + reliable results from test methods and studies; + (D)should have the + authority to share confidential business information with States and political + subdivisions of the States, subject to appropriate safeguards against + inappropriate disclosure; + (E)should have the + resources and tools necessary to implement this Act; and + (F)should implement + this Act in a manner that promotes transparency of information and + decisionmaking, protects substantiated confidential business information, and + promotes innovation, including innovation in chemical substances that have + reduced hazard, exposure, and risk patterns; + (3)adequate data and + information should be available with respect to the effect of and exposure to + chemical substances and mixtures on health and the environment, to the extent + necessary for safety assessments and determinations, and that, where necessary, + the development of such test data and information should be the primary + responsibility of those who manufacture or process such chemical substances and + mixtures; and + (4)States have an + important role in protecting health and the environment from the unmanaged + risks of chemical substances in commerce, particularly in recommending + priorities for Federal assessment and regulation, providing safety assessment + information, and fostering programs to protect consumers. + (c)
Intent of + Congress
It is the intent of Congress that the Administrator + shall— + (1)rely on robust + scientific evidence to implement this Act in a way that balances the mutual + goals of promoting the safety of American consumers and preventing harm to + American innovation, manufacturing, and the economy; and + (2)implement this + Act to protect the health of the people of the United States and the + environment in such a manner as not to unduly impede commerce or create + unnecessary economic barriers to technological innovation, including safer + chemistry. + . +
3.
Definitions
Section 3 (15 U.S.C. 2602) is + amended— + (1)by redesignating paragraphs (2) through + (6), (7) through (11), and (12) through (14) as paragraphs (3) through (7), (9) + through (13), and (17) through (19), respectively; + (2)by inserting after paragraph (1) the + following: + + (2)
Best available + science
The term best + available science means science that— + (A)maximizes the quality, objectivity, and + integrity of information, including statistical information; + (B)uses peer-reviewed and publically available + data; and + (C)clearly documents and communicates risks + and uncertainties in the scientific basis for + decisions. + ; + (3)by inserting + after paragraph (7) (as so redesignated) the following: + + (8)
Intended + conditions of use
The term intended conditions of + use means the circumstances under which a chemical substance is intended + or reasonably anticipated to be manufactured, processed, distributed in + commerce, used, and disposed of. + ; + and + (4)by inserting + after paragraph (13) (as so redesignated) the following: + + (14)
Safety + assessment
The term safety assessment means a + risk-based assessment of the safety of a chemical substance that— + (A)integrates + hazard; use; and exposure information about a chemical substance; and + (B)includes— + (i)an assessment of + exposure under the intended conditions of use; and + (ii)reference + parameters that may be appropriate with regard to a specific chemical substance + (such as a margin of exposure). + (15)
Safety + determination
The term safety determination means a + determination by the Administrator as to whether a chemical substance meets the + safety standard under the intended conditions of use. + (16)
Safety + standard
The term safety standard means a standard + that ensures that no unreasonable risk of harm to human health or the + environment will result from exposure to a chemical + substance. + . +
4.
Chemical + assessment framework; prioritization screening; testing
+ (a)
In + general
Section 4 (15 U.S.C. + 2603) is amended— + (1)in the heading, by striking + Testing of chemical + substances and mixtures and inserting + Chemical assessment + framework; prioritization screening; testing. + (2)by redesignating + subsection (e) as subsection (l); + (3)in subsection (l) + (as so redesignated)— + (A)by striking + rule each place it appears and inserting rule, testing + consent agreement, or order; + (B)by striking + under subsection (a) each place it appears and inserting + under this subsection; and + (C)in paragraph + (1)(B), by striking rulemaking; and + (4)by striking + subsections (a) through (d), (f), and (g) and inserting the following: + + (a)
Chemical + assessment framework
+ (1)
In + general
The Administrator shall develop a framework in accordance + with subsection (e) and sections 5 and 6 for evaluating the safety of chemical + substances in commerce that shall employ the best available science and risk + assessment principles in existence at the time the Administrator is developing + the framework. + (2)
Policies and + procedures
+ (A)
In + general
After the date of enactment of the + Chemical Safety Improvement + Act, the Administrator shall promptly develop appropriate + policies and procedures for implementing the framework, including procedures on + the collection, evaluation, and development of data and information. + (B)
Contents
The + policies and procedures shall require— + (i)the collection of + existing data and information from manufacturers and processors of chemical + substances and other sources, including the use of voluntary agreements to + provide the data and information; + (ii)an evaluation of + the quality of existing data and information; + (iii)an analysis of + data and information; + (iv)a determination + of the need for additional data and information, including information related + to the exposures of different subpopulations; and + (v)subject to + section 14, transparency of data and information considered by the + Administrator, including both positive and negative findings. + (3)
Transparency + and validity
The Administrator shall ensure that the evaluation + framework described in subsection (a)(1)— + (A)is + transparent; + (B)assures that data + and information are valid; + (C)addresses the + strengths and limitations of— + (i)the design of the + framework, + (ii)the reliability + of the test methods; and + (iii)the quality of + the data and information; and + (D)pursues the goal + of maximizing the quality, objectivity, utility, and integrity of the data and + information. + (b)
Data and + information quality
+ (1)
In + general
The Administrator shall establish and publish + scientifically sound criteria for evaluating all of the data and information, + including the results of animal and nonanimal testing, regardless of + affiliation or funding source, on which the Administrator relies in making a + decision under this Act. + (2)
Disclosure of + sources of funding
The Administrator shall require that the + submitter of any health and safety study disclose to the Administrator and to + the public the sources of any funding used for the study or publication of the + study received by the researcher who conducted the study, to the extent + reasonably ascertainable. + (3)
Test + data
For test data developed under this Act, the Administrator + shall encourage the use of good laboratory practices, peer review, + scientifically reliable and relevant test methods, standardized protocols, and + other methods to ensure scientific quality for all data and information + submitted under this Act. + (4)
Data and + information that do not meet criteria
+ (A)
In + general
Nothing in this subsection shall preclude the + Administrator from considering data and information which do not meet the + quality criteria established under paragraph (1). + (B)
Identification
The + Administrator shall— + (i)identify any data + and information described in subparagraph (A) on which the Administrator + relies; + (ii)describe the + quality of the data and information described in subparagraph (A) and the + extent to which the data and information depart from those criteria; + (iii)indicate any + limitations on the usefulness of the data and information described in + subparagraph (A); and + (iv)explain how the + data and information described in subparagraph (A) was used and the basis for + reliance on the data and information. + (5)
Evaluative + framework for decisionmaking
+ (A)
In + general
The Administrator shall develop and use a structured + evaluative framework consisting of science-based criteria, consistent with the + protection of human health and the environment, for making any decision under + this Act, and for determining the relevance, quality, and reliability of data + and information. + (B)
Contents
The + framework described in subparagraph (A) shall, at a minimum— + (i)use sound and + objective scientific practices in assessing risks; + (ii)consider the + current best available science (including peer-reviewed studies); + (iii)when consistent + with the underlying data, consider, for both cancer and noncancer endpoints, + whether available data support or do not support the identification of + threshold doses of a chemical substance below which no adverse effects can be + expected to occur; and + (iv)include a + description of the weight of the scientific evidence concerning risks, + including mechanistic information (such as appropriate modes of action). + (c)
Data and + information sources
In making any decision with respect to a + chemical substance under subsection (e) and sections 5 and 6, the Administrator + shall consider data and information relevant to the substance that are + reasonably available to the Administrator at that time, including data and + information that are— + (1)submitted to the + Administrator by— + (A)manufacturers and + processors of the substance; + (B)the public; + or + (C)a Governor of a + State or a State agency with responsibility for protecting health or the + environment; + (2)submitted to a + governmental body in another jurisdiction under a governmental requirement + relating to the protection of human health and the environment, if the + information is accessible to the Administrator; + (3)derived through + the application of scientifically reliable and relevant structure-activity + relationship, or other methods or models to estimate the environmental and + human health effects, environmental and biological fate and behavior, and + exposure potential for the substance; + (4)inferred based on + the degree of structural similarity or properties of the substance, or + categories of substances, to those of 1 or more other chemical substances for + which reliable information exists that is relevant to predicting the potential + environmental or human health effects, environmental or biological fate and + behavior, or exposure potential for the chemical substance; and + (5)identified + through an active search by the Administrator of information sources that are + publicly available or otherwise accessible to the Administrator. + (d)
Transparency
+ (1)
In + general
Subject to section 14, the data and information + considered by the Administrator in taking action under this Act shall be + available to the public. + (2)
Types of + information available to the public
The Administrator shall make + available to the public the guidance, procedures, and tools used in evaluating + data and information under this section, including models, studies, and, as + appropriate, the data underlying any study. + (3)
Guidance
Any + written guidance of general applicability prepared by the Administrator under + this Act shall be subject to public notice and an opportunity for + comment. + (e)
Prioritization + screening process
+ (1)
In + general
+ (A)
Process
Not + later than 1 year after the date of enactment of the + Chemical Safety Improvement + Act, the Administrator shall establish a risk-based screening + process for identifying existing chemical substances that are— + (i)a + high priority for a safety assessment and determination under section 6, to be + known as high-priority substances; and + (ii)a low priority + for a safety assessment and determination, to be known as low-priority + substances. + (B)
Consideration + of active and inactive substances
+ (i)
Consideration + of active substances
In implementing the process described in + subparagraph (A), the Administrator shall only consider active substances, as + determined under section 8(b)(6), as either high-priority substances or + low-priority substances. + (ii)
Consideration + of inactive substances
In implementing the process described in + subparagraph (A), the Administrator shall only consider inactive substances, as + determined under section 8(b)(7), that the Administrator determines, on the + basis of credible scientific evidence that— + (I)have not been + subject to a regulatory or other enforceable action by the Administrator to ban + or phase out the substances; and + (II)demonstrate high + hazard and high exposure. + (C)
Timely + completion of prioritization process
+ (i)
In + general
The Administrator shall make every effort to complete the + prioritization of all active substances in a timely manner. + (ii)
Consideration
The + Administrator shall prioritize substances taking into consideration the ability + of the Administrator to schedule and complete safety assessments and + determinations under section 6 in a timely manner. + (D)
Use of + data
In making a decision under the prioritization screening + process, the Administrator shall use reasonably available data and information + concerning the hazard, exposure, and use characteristics of chemical substances + on the list developed by the Administrator under section 8(b)(1) at the time + the decision is made. + (E)
Screening of + categories or classes of substances
The Administrator may screen + categories or classes of chemical substances to ensure an efficient + prioritization screening process to allow for timely and adequate safety + assessments and determinations. + (F)
Publication of + list of chemical substances
From time to time the Administrator + shall— + (i)publish a list of + chemical substances being considered in the prioritization screening process; + and + (ii)request the + submission of data and information on the chemical substances. + (2)
Proposed + process
+ (A)
In + general
The Administrator shall— + (i)publish for + public comment a proposed prioritization screening process; and + (ii)establish + criteria for determining whether a substance is a high or low priority for a + safety assessment and determination. + (B)
Initial + list
+ (i)
In + general
The proposal shall include an initial list of chemical + substances that includes, at a minimum, those substances prioritized by the + Administrator before the date of enactment of the + Chemical Safety Improvement Act + and for which assessments or safety determinations have not been completed, and + proposed prioritization outcomes based on the proposed criteria. + (ii)
Contents
The + initial list shall contain as many chemical substances as the Administrator + determines appropriate. + (iii)
Modification
The + Administrator may modify the initial list on the basis of comments received on + the proposed process and criteria. + (C)
Criteria
The + criteria described in subparagraph (A) shall consider— + (i)the + recommendation of a Governor of a State or a State agency with responsibility + for protecting health or the environment from chemical substances appropriate + for prioritization screening; + (ii)the hazard and + exposure potential of the chemical substance (or category or class of + substances), including specific scientific classifications and designations by + authoritative governmental entities; + (iii)the intended + conditions of use or significant changes in the conditions of use of the + chemical substance; + (iv)evidence and + indicators of exposure potential to humans or the environment from the chemical + substance; + (v)the volume of a + chemical substance manufactured or processed; + (vi)whether the + volume of a chemical substance as reported under a regulation issued under + section 8(a) (as in effect on the date on which the criteria are proposed) has + significantly increased or decreased since a previous report or since the date + on which a notice has been submitted under section 5(a); + (vii)the + availability of information about potential hazards and exposures needed for + conducting a safety assessment or determination, with limited availability of + relevant data and information to be a factor in designating a substance as a + high priority; and + (viii)the extent of + Federal or State regulation of the chemical substance or the extent of the + impact of State regulation of the chemical substance on the United States, with + existing Federal or State regulation of any uses evaluated in the + prioritization screening process as a factor in designating a chemical + substance to be a low priority. + (3)
Prioritization + screening decisions
+ (A)
In + general
For the chemical substances considered for prioritization + screening, the Administrator shall apply the criteria identified in paragraph + (2), using the information identified in subsection (c), to identify a chemical + substance as a high-priority substance or a low-priority substance. + (B)
Additional test + data
If the Administrator determines that additional test data + and information are needed to establish the priority of a chemical substance, + the Administrator shall provide an opportunity for interested persons to submit + data and information to the extent that it is reasonably ascertainable. + (C)
Deferring a + decision
If the Administrator determines that it is appropriate, + the Administrator may defer a prioritization screening decision for a chemical + substance under subparagraph (A) for a reasonable period to allow for the + submission and evaluation of additional data and information. + (D)
Integration of + data and information
During the prioritization screening of a + chemical substance, the Administrator shall integrate any hazard and exposure + data and information related to a chemical substance available to the + Administrator. + (E)
Identification + of high-priority substances
The Administrator— + (i)shall identify as + a high-priority substance a chemical substance that, relative to other + substances, has the potential for high hazard and high exposure; + (ii)may identify as + a high-priority substance a chemical substance that, relative to other + substances, has the potential for high hazard or high exposure; and + (iii)may identify as + a high-priority substance an inactive substance, as determined under section + 8(b)(7), that the Administrator determines, on the basis of credible scientific + evidence that— + (I)has not been + subject to a regulatory action by the Administrator to ban or phase out the + substance; and + (II)demonstrates + high hazard and high exposure. + (F)
Identification + of low-priority substances
The Administrator shall identify as a + low-priority substance a chemical substance that the Administrator on the basis + of the available information determines is likely to meet the safety standard + under the intended conditions of use. + (G)
Notice and + comment
The identifications made under subparagraphs (E) and (F) + shall be subject to notice and an opportunity for comment. + (H)
Order of safety + assessments
+ (i)
High-priority + substances
The Administrator— + (I)shall determine + the order for performing safety assessments on high-priority substances under + section 6; and + (II)may revise the + order as the Administrator determines appropriate. + (ii)
Low-priority + substance
The Administrator shall not perform safety assessments + on low-priority substances, unless a low-priority substance is redesignated + under subparagraph (I). + (I)
Revision based + on new data
+ (i)
In + general
Subject to subparagraph (D), at any time the + Administrator may revise the identification of a chemical substance as a + high-priority substance or a low-priority substance based on consideration of + data or information made available to the Administrator after the date on which + the Administrator makes the identification under subparagraphs (E) and + (F). + (ii)
Reevaluation
+ (I)
In + general
The Administrator shall evaluate the data or information + described in clause (i) on a high-priority substance or a low-priority + substance for possible reevaluation of the priority of the substance. + (II)
Limited + availability
If limited availability of relevant data and + information was a factor in the original identification of a chemical substance + as a high-priority substance, the Administrator shall reevaluate the + prioritization screening of the substance on receiving the relevant data and + information. + (J)
Publication of + a list of high-priority and low-priority substances
+ (i)
In + general
The Administrator shall publish and keep current a list + of high-priority substances and a list of low-priority substances. + (ii)
Justification
Whenever + the Administrator places a chemical substance on one of the lists described in + clause (i) or changes the priority of the chemical substance, the Administrator + shall include a justification for the decision in accordance with paragraph + (2)(C). + (K)
Removal
The + Administrator shall remove a chemical substance from the list of high-priority + substances on the date on which a safety determination for the chemical + substance is published. + (L)
Effect
Subject + to section 18, a decision by the Administrator under this paragraph with + respect to a chemical substance shall not affect the manufacture, processing, + distribution, use, or disposal of the chemical substance, or regulation of + those activities. + (4)
Expedited + prioritization screening
+ (A)
In + general
Not later than 180 days after the date on which the + Administrator receives a recommendation and relevant data and information from + a Governor of a State or a State agency with responsibility for protecting + health and the environment that an active chemical substance be identified as a + high-priority or low-priority substance, the Administrator shall make a + prioritization screening decision for the substance. + (B)
Notice and + comment
The public shall be provided notice and an opportunity to + comment on the recommendation described in subparagraph (A). + (C)
Explanation of + reasons
The Administrator shall— + (i)make available to + the Governor or the appropriate State agency, as applicable, and to the public + a brief explanation of reasons for identifying a chemical substance recommended + by the Governor or the agency for prioritization screening as either a + high-priority substance or a low-priority substance; and + (ii)identify the + information relied upon in making that identification. + (5)
Final agency + action
Any action by the Administrator under this subsection + shall not be— + (A)considered to be + a final agency action; or + (B)subject to + judicial review. + (f)
Development of + new test data and information
+ (1)
In + general
The Administrator may require the development of new test + data and information related to a chemical substance or mixture in accordance + with this section if the Administration determines that the data and + information are needed— + (A)to perform a + safety assessment; + (B)to make a safety + determination; or + (C)to meet the + testing needs of the implementing authority under another Federal + statute. + (2)
Form
The + Administrator may require the development of test data and information + described in paragraph (1) by— + (A)promulgating a + rule; + (B)entering into a + testing consent agreement; or + (C)issuing an + order. + (3)
Requirements
+ (A)
In + general
In promulgating a rule, adopting a testing consent + agreement, or issuing an order described in paragraph (2), the Administrator + shall require the use of— + (i)an evaluation + framework that, prior to requiring additional testing of vertebrate animals, + integrates relevant information from multiple sources, including, to the extent + reliable— + (I)toxicity + information; + (II)computational + toxicology; + (III)bioinformatics; + (IV)high-throughput + screening methods; and + (V)scientifically + reliable and relevant alternatives to vertebrate animal tests; and + (ii)tiered testing + in accordance with subsection (h), wherein the results of a screening level + tier of tests relating to a toxicity pathway or target organ or target system + inform the decision of the Administrator as to whether tests from a higher tier + related to that pathway or organ or system are necessary. + (B)
Statement to + the public
The Administrator shall explain the basis for a + decision made in subparagraph (A)(ii) in a statement made available to the + public. + (4)
Contents
+ (A)
In + general
A rule, testing consent agreement, or order issued under + paragraph (2) shall include— + (i)identification of + the chemical substance or mixture for which testing is required; + (ii)identification + of the persons required to conduct the testing; + (iii)procedures for + the development of test data and information for the chemical substance or + mixture, including specific reference to reliable nonanimal test procedures; + and + (iv)specification of + the period within which persons required to conduct the testing shall submit to + the Administrator test data and information developed in accordance with the + procedures described in clause (iii). + (B)
Duration
The + period described in subparagraph (A)(iv) shall not be of an unreasonable + duration. + (C)
Considerations
In + determining the procedures and period to be required under subparagraph (A), + the Administrator shall consider— + (i)the relative + costs of the various test protocols and methodologies that may be required; + and + (ii)the reasonably + foreseeable availability of facilities and personnel needed to perform the + testing. + (g)
Statement of + need
+ (1)
In + general
In promulgating a rule, entering into a testing consent + agreement, or issuing an order for development of additional data and + information (including information on exposure or exposure potential) under + subsection (f)(2), the Administrator shall issue a statement— + (A)identifying the + need intended to be met by the rule, agreement, or order; + (B)explaining why + existing data and information reasonably available to the Administrator at that + time are inadequate to meet that need; and + (C)encouraging, to + the extent possible, the use of nonanimal test methods to develop additional + data and information. + (2)
Contents of + statement in case of order
+ (A)
In + general
If the Administrator issues an order, the statement + described in paragraph (1) shall explain why good cause exists for issuance of + an order instead of promulgating a rule or entering into a testing consent + agreement. + (B)
Contents
A + statement described in subparagraph (A) shall contain a discussion of— + (i)data and + information that are readily accessible to the Administrator, including data + and information submitted under any other provision of law; + (ii)the extent to + which the Administrator has obtained or attempted to obtain the data and + information through voluntary submissions; + (iii)the extent to + which the Administrator may use available data and information for structurally + related substances (grouping or read-across), or use valid structure-activity + relationship models or nonanimal test alternatives; and + (iv)safety + assessments, and the data and information relied on in the assessments, on + other chemical substances to the extent relevant to the chemical substances + that would be the subject of the rule or order. + (h)
Tiered toxicity + testing and evaluation
+ (1)
In + general
The Administrator shall develop an evidence-based review + system for conducting consistent evaluations of the relevance and reliability + of studies of chemical substances and their exposure (including exposure + pathways), and a structured evaluative framework to provide a systematic and + transparent approach for assessing the overall weight of the evidence for + observed biological or other effects, mechanistic information, and + exposure. + (2)
Tiers
Subject + to subsections (b) and (c), the framework shall have 2 tiers. + (A)
Tier 1
+ (i)
In + general
Tier 1 shall include both a screening level exposure + assessment, including modeling if appropriate, and screening tests for + hazard. + (ii)
Uses of + screening tests and modeling
Screening tests for hazard (which + may include, as appropriate, scientifically reliable and relevant in silico, in + vitro, and focused in vivo tests) and exposure information and modeling shall + be used— + (I)to screen + chemical substances or mixtures for major toxic effects (including acute + toxicity, subchronic toxicity, chronic toxicity, carcinogenicity, genotoxicity, + developmental toxicity, and neurotoxicity); and + (II)to direct + planning for more complex and targeted testing in tier 2, if necessary. + (B)
Tier + 2
If the Administrator determines that additional testing is + necessary, based on the results of tier 1 testing and modeling and any other + available relevant information, tier 2 shall include— + (i)an exposure + assessment and tests for specific endpoints triggered on the basis of + biologically based decisions; and + (ii)an assessment of + potential exposure using scientifically valid approaches. + (3)
Guidance
The + Administrator shall prepare guidance for implementing this subsection and + review that guidance not less than once every 5 years thereafter. + (i)
Reduction of + animal-Based testing
+ (1)
In + general
The Administrator shall minimize the use of animals in + testing of chemical substances or mixtures, including by— + (A)encouraging and + facilitating, to the maximum extent practicable— + (i)the use of + integrated and tiered testing and assessment strategies; + (ii)the use of data + and information of sufficient scientific quality in existence on the date on + which the test is conducted; + (iii)the use of test + methods that eliminate or reduce the use of animals while providing test data + and information of high scientific quality; + (iv)the grouping of + 2 or more chemical substances into scientifically appropriate categories in + cases in which testing of a chemical substance would provide reliable and + useful test data and information on others in the category; + (v)the formation of + industry consortia to jointly conduct testing to avoid unnecessary duplication + of tests; + (vi)the submission + of test data and information from animal-based studies and from emerging + methods and models; and + (vii)the use of + exposure potential as a factor in decisions to require new testing; and + (B)funding research + and validation studies to reduce, refine, and replace the use of animal tests + in accordance with this subsection. + (2)
Implementation + of alternative testing methods
To promote the development and + timely incorporation of new testing methods that are not laboratory + animal-based, the Administrator shall— + (A)after providing + an opportunity for public comment, develop a strategic plan to promote the + development and implementation of alternative test methods and testing + strategies to generate information used for any safety-standard determination + made that reduce, refine, or replace the use of laboratory animals, including + toxicity pathway-based risk assessment, in vitro studies, systems biology, + computational toxicology, bioinformatics, and high-throughput screening; + (B)beginning on the + date that is 5 years after the date of enactment of the + Chemical Safety Improvement Act + and every 5 years thereafter, submit to Congress a report that describes the + progress made in implementing this section; and + (C)fund and carry + out research, development, performance assessment, and trans­la­tion­al studies + to accelerate the development of test methods and testing strategies that + reduce, refine, or replace the use of laboratory animals in any safety-standard + determination made under this section. + (3)
Criteria for + adapting or waiving animal testing requirements
On request from a + manufacturer or processor that is required to conduct animal-based testing of a + chemical substance or mixture under this title, the Administrator may adapt or + waive the animal-testing requirement if the Administrator determines + that— + (A)there is + sufficient evidence from several independent sources of information to support + a conclusion that a chemical substance or mixture has, or does not have, a + particular property if the information from each individual source alone is + insufficient to support the conclusion; + (B)because of one or + more physical or chemical properties of the chemical substance or mixture or + other toxicokinetic considerations— + (i)the material + cannot be absorbed; or + (ii)testing for a + specific endpoint is technically not practicable to conduct; or + (C)a chemical + substance or mixture cannot be tested in animals at concentrations that do not + result in significant pain or distress, because of physical or chemical + properties of the chemical substance or mixture, such as a potential to cause + severe corrosion or severe irritation to the tissues of the animal. + (j)
Testing + requirements
+ (1)
Persons + required to develop test data and information
+ (A)
In + general
The Administrator may require the following persons to + develop test data and information: + (i)Manufacturers and + processors of the chemical substance or mixture identified in subsection + (f)(4)(A)(i). + (ii)Persons who + begin to manufacture or process such chemical substance or mixture— + (I)after the + effective date of the rule, testing consent agreement, or order; but + (II)subject to + subparagraph (C), before the period ending 180 days after the end of the period + identified in subsection (f)(4)(A)(iv). + (B)
Designation
The + Administrator may permit 2 or more of the persons identified in subparagraph + (A) to designate a person or a qualified third party— + (i)to develop the + data and information; and + (ii)to submit the + data and information on behalf of the persons making the designation. + (C)
Exemptions
+ (i)
In + general
A person otherwise subject to a rule, testing consent + agreement, or order under subsection (f) may submit to the Administrator an + application for an exemption on the basis that the data and information are + being developed by a person designated under subparagraph (B). + (ii)
Fair and + equitable reimbursement to designee
+ (I)
In + general
If the Administrator accepts an application submitted + under clause (i), the Administrator shall direct the applicant to provide to + the person designated under subparagraph (B) fair and equitable reimbursement, + as agreed to between the applicant and the person designated. + (II)
Arbitration
If + the applicant and a person designated under subparagraph (B) cannot reach + agreement on the amount of fair and equitable reimbursement, the amount shall + be determined by arbitration. + (iii)
Termination
If, + after granting an exemption under this subparagraph, the Administrator + determines that no person has complied with the rule, testing consent + agreement, or order, the Administrator shall— + (I)by order + terminate the exemption; and + (II)notify in + writing each person who received an exemption of the requirements with respect + to which the exemption was granted. + (2)
Types of health + and environmental data and information
+ (A)
In + general
The Administrator may prescribe guidelines for the + development of test data and information under subsection (f) for health and + environmental information, including— + (i)test data + pertaining to acute toxicity, subchronic toxicity, chronic toxicity, + carcinogenicity, genotoxicity, developmental toxicity, and neurotoxicity that + may be indicative of an adverse effect; + (ii)test data and + information pertaining to exposure to the chemical substance or mixture, + including information regarding bioaccumulation, persistence, and the presence + of the chemical substance or mixture in human blood, fluids, or tissue; + and + (iii)information + pertaining to aggregate exposure, or other effects that may be considered in a + safety assessment. + (B)
Methodologies
+ (i)
In + general
The Administrator— + (I)may prescribe + methodologies in guidelines for the development of data and information; + and + (II)shall encourage + the use of nonanimal methodologies. + (ii)
Development of + guidelines
The Administrator may develop guidelines for + evaluating data from biomonitoring studies. + (iii)
Requirement
Prior + to prescribing epidemiologic studies of employees, the Administrator shall + coordinate with the Director of the National Institute for Occupational Safety + and Health. + (C)
Review
Periodically, + but not less frequently than once every 5 years, the Administrator + shall— + (i)review the + adequacy of the guidelines for development of data and information prescribed + under subparagraph (B); + (ii)if necessary, + institute proceedings to make appropriate revisions of the guidelines; + and + (iii)revise the + guidelines as appropriate, particularly to— + (I)reflect the + availability of scientifically reliable and relevant nonanimal test methods; + and + (II)eliminate + obsolete methodologies that do not produce reliable and relevant + results. + (k)
Transparency
Subject + to section 14, the Administrator shall make available to the public all testing + consent agreements and orders and all data and information submitted under this + section. + . + (b)
Conforming + amendments
Section 104(i)(5)(A) of the Comprehensive + Environmental Response, Compensation, and Liability Act of 1980 (42 U.S.C. + 9604(i)(5)(A)) is amended by striking section 4(e) and inserting + section 4(l). +
5.
New chemicals + and significant new uses
Section 5 (15 U.S.C. 2604) is + amended— + (1)by striking the + section designation and heading and inserting the following: + +
5.
New chemicals + and significant new + uses
+
; + (2)in subsection + (a)(1), in the matter following subparagraph (B)— + (A)by striking + subsection (d) and inserting subsection (b); + and + (B)by striking + and such person complies with any applicable requirement of subsection + (b); + (3)by striking + subsection (b); + (4)by redesignating + subsection (d) as subsection (b) and moving the subsection so as to appear + after subsection (a); + (5)in subsection (b) + (as so redesignated)— + (A)by striking + paragraph (1) and inserting the following: + + (1)
In + general
The notice required by subsection (a) shall include, with + respect to a chemical substance— + (A)the information + required by sections 720.45 and 720.50 of title 40, Code of Federal Regulations + (or successor regulations); and + (B)information + regarding intended conditions of use and reasonably anticipated + exposure. + ; + (B)in paragraph + (2)— + (i)in + the matter preceding subparagraph (A), by striking or of data under + subsection (b); + (ii)in + subparagraph (A), by adding and after the semicolon at the + end; + (iii)in subparagraph + (B), by striking ; and and inserting a period; and + (iv)by + striking subparagraph (C); and + (C)in paragraph (3), + by striking , (b),; + (6)by striking + subsection (c) and inserting the following: + + (c)
Review of + notice
+ (1)
Initial + review
+ (A)
In + general
Subject to subparagraph (B), not later than 90 days after + the date of receipt of a notice submitted under subsection (a), the + Administrator shall— + (i)conduct an + initial review of the notice; + (ii)as needed, + develop a profile of the relevant chemical substance and the potential for + exposure to humans and the environment; and + (iii)make any + necessary determination under paragraph (4). + (B)
Extension
Except + as provided in paragraph (6), the Administrator may extend the period described + in subparagraph (A) for good cause for one or more periods, the total of which + shall be not more than 90 days. + (2)
Notice of + commencement
Unless the Administrator determines under paragraph + (4)(A) that a chemical substance is not likely to meet the safety standard, at + the end of the applicable period for review under paragraph (1), a chemical + substance may be the subject of a notice of commencement under subsection + (d). + (3)
Information + sources
In evaluating a notice under paragraph (1), the + Administrator shall take into consideration— + (A)the information + identified in section 4(c); and + (B)any additional + information provided by the submitter. + (4)
Determinations
Before + the end of the applicable period for review under paragraph (1), based on the + information described in paragraph (3), the Administrator shall determine + that— + (A)the relevant + chemical substance is not likely to meet the safety standard under the intended + conditions of use, in which case the Administrator shall take appropriate + action under paragraph (5); + (B)the relevant + chemical substance is likely to meet the safety standard under the intended + conditions of use, in which case the Administrator shall allow the review + period to expire without additional restrictions; or + (C)additional + information is necessary in order to make a determination under subparagraph + (A) or (B), in which case the Administrator shall take appropriate action under + paragraph (6). + (5)
Prohibitions + and limitations
+ (A)
In + general
If the Administrator makes a determination under + paragraph (4)(A) with respect to a notice, before the end of the applicable + period for review under paragraph (1), the Administrator shall, by consent + agreement or order, as appropriate— + (i)prohibit + manufacture of the chemical substance, or prohibit such manufacture without + compliance with restrictions specified in a relevant consent agreement or + order; or + (ii)prohibit + manufacture or processing of the chemical substance for a significant new use, + or prohibit such manufacture or processing without compliance with restrictions + specified in a relevant consent agreement or order. + (B)
Inclusions
A + prohibition or limitation under subparagraph (A) may include, as + appropriate— + (i)a + requirement that a chemical substance be marked with, or accompanied by, clear + and adequate warnings and instructions with respect to use, distribution in + commerce, or disposal, or any combination of those activities, with the form + and content of the warnings and instructions to be prescribed by the + Administrator; + (ii)a requirement + that manufacturers or processors, as applicable, of the chemical substance make + and retain records of the processes used to manufacture or process the chemical + substance; + (iii)a requirement + that manufacturers or processors, as applicable, monitor or conduct such + additional tests as are reasonably necessary to ensure compliance with this + Act, subject to section 4(g); + (iv)a limitation on + the quantity of the chemical substance that may be manufactured, processed, or + distributed in commerce; + (v)a + limitation on the quantity of the chemical substance that may be manufactured, + processed, or distributed in commerce for a particular use; + (vi)a prohibition or + other regulation of the manufacture, processing, or distribution in commerce of + the chemical substance for a significant new use; + (vii)a prohibition + or other regulation of any method of commercial use of the chemical + substance; + (viii)a prohibition + or other regulation of any method of disposal of the chemical substance; + (ix)a prohibition on + the manufacture, processing, or distribution in commerce of the chemical + substance; + (x)a + prohibition on the manufacture, processing, or distribution in commerce of the + chemical substance for a particular use; or + (xi)such other + requirements as the Administrator determines to be necessary. + (6)
Additional data and + information
If the + Administrator determines under paragraph (4)(C) that additional data and + information (including, for example, information on exposure or exposure + potential) are needed in order to conduct a review under this subsection, the + Administrator— + (A)shall provide an opportunity for the + submitter of the notice to submit such additional information; + (B)may, by agreement with the submitter, + extend the review period for a reasonable time to allow the development and + submission of the additional information; + (C)on receipt of the information, shall + promptly make a determination under paragraph (4); and + (D)may take action under paragraph (5) pending + receipt of the additional data and information, which may, as appropriate, + permit the submitter of the notice to file a notice of commencement under + subsection + (d). + ; + (7)by striking + subsections (e) through (g) and inserting the following: + + (d)
Notice of + commencement
+ (1)
In + general
Not later than 30 days after the date on which a + manufacturer or processor that has submitted a notice under subsection (a) + commences nonexempt commercial manufacture of a chemical substance or nonexempt + commercial manufacture or processing of a chemical substance for a significant + new use, as applicable, the manufacturer or processor shall submit to the + Administrator a notice of commencement that identifies— + (A)the name of the + manufacturer or processor; and + (B)the initial date + of nonexempt commercial manufacture or nonexempt commercial manufacture or + processing for a significant new use. + (2)
Withdrawal
A + manufacturer or processor that has submitted a notice under subsection (a), but + that has not commenced nonexempt commercial manufacture or processing of the + chemical substance, may withdraw the notice. + (e)
Further + evaluation
The Administrator may review a chemical substance + under section 4(e) at any time after the Administrator receives— + (1)a notice of + commencement for a chemical substance under subsection (d); or + (2)significant new + information regarding the chemical substance. + (f)
Transparency
Subject + to section 14, the Administrator shall make available to the public all + notices, rules and orders of the Administrator, and all data and information + submitted or issued under this + section. + ; + (8)by redesignating + subsections (h) and (i) as subsections (g) and (h), respectively; and + (9)in subsection (g) + (as so redesignated)— + (A)in paragraph (1), + in the matter preceding subparagraph (A), by striking or + (b); + (B)by striking + paragraph (2); + (C)by redesignating + paragraphs (3) through (6) as paragraphs (2) through (5), respectively; + (D)in paragraph (2) + (as so redesignated), by striking subsections (a) and (b) and + inserting subsection (a); + (E)in paragraph (3) + (as so redesignated), in the first sentence, by striking will not + present an unreasonable risk of injury to health or the environment and + inserting is expected to meet the safety standard under the intended + conditions of use; + (F)in paragraph (4) + (as so redesignated), by striking subsections (a) and (b) and + inserting subsection (a); and + (G)in paragraph (5) + (as so redesignated), in the first sentence, by striking paragraph (1) + or (5) and inserting paragraph (1) or (4),. +
6.
Safety + assessments and determinations
Section 6 (15 U.S.C. 2605) is + amended— + (1)by striking the + section designation and heading and inserting the following: + +
6.
Safety + assessments and + determinations
+
; + (2)by striking + subsections (a) through (d) and inserting the following: + + (a)
In + general
The Administrator shall— + (1)conduct a safety + assessment of each high-priority substance in accordance with subsection + (b); + (2)make a safety + determination for each high-priority substance; and + (3)as appropriate + based on the results of a safety determination, establish requirements for risk + management of a high-priority substance. + (b)
Safety + assessments
+ (1)
In + general
The Administrator shall conduct a risk-based safety + assessment of each high-priority substance, in accordance with such schedule as + the Administrator establishes, to be based solely on considerations of risk to + human health and the environment. + (2)
Procedural + rules
+ (A)
In + general
The Administrator shall establish procedural rules for + safety assessments and determinations under this subsection, including + schedules for the submission of relevant data and information and the + initiation and completion of safety assessments and safety + determinations. + (B)
Requirements
+ (i)
In + general
The rules under subparagraph (A) shall— + (I)identify the + basis on which the Administrator shall decide which high-priority substances + take precedence in the safety assessment and determination process; + (II)require the + Administrator to inform the public regarding— + (aa)the approximate + order in which safety assessments and determinations will be performed; + (bb)the + informational needs of the Administrator relating to the safety assessment and + determination process; + (cc)the importance + of expeditiously completing safety assessments and determinations and the need + for rigorous evaluation of the data and information; + (dd)the schedule by + which each assessment and determination will be conducted; and + (ee)subject to + clause (ii), the deadline for the completion of each assessment and + determination; + (III)allow + interested persons, including States, to submit information, including safety + assessments, regarding high-priority substances that may facilitate the safety + assessment and determination process; and + (IV)subject to + section 14, require the Administrator— + (aa)to + make available to the public the information taken into consideration in + preparing each safety assessment and determination; + (bb)to + publish and provide an opportunity for comment on proposed safety assessments + and determinations; and + (cc)to + publish final safety assessments and determinations. + (ii)
Deadlines
+ (I)
In + general
The rules described in subparagraph (A) shall also + include— + (aa)a + schedule by which each safety assessment and determination is expected to be + conducted; and + (bb)a + deadline for the completion of each assessment and determination. + (II)
Flexibility + and reasonable extensions
The deadlines described in subclause + (I)(bb)— + (aa)may vary among + chemical substances to grant the Administrator flexibility; and + (bb)shall allow for + reasonable extensions after an adequate public justification. + (C)
Inclusions in + final assessments
Each safety assessment under this subsection + shall include— + (i)a + weight-of-the evidence summary; and + (ii)a nontechnical + summary explaining what the relevant information demonstrates in the context of + the intended conditions of use and exposure patterns of the chemical + substance. + (3)
Data and + information sources
In conducting a safety assessment under this + subsection, the Administrator shall, at a minimum, take into + consideration— + (A)the information + described in section 4(c); and + (B)any additional + information submitted under paragraph (5). + (4)
Methodology
+ (A)
In + general
The Administrator shall— + (i)develop an + appropriate science-based methodology for conducting safety assessments under + this subsection, which shall include consideration of the weight of the + evidence for observed effects, mechanistic information, and exposure + evaluations; and + (ii)make the + proposed methodology available for public comment and scientific peer + review. + (B)
Review and + revisions
Not later than 5 years after the date of enactment of + the Chemical Safety Improvement + Act, and not less frequently than once every 5 years thereafter, + the Administrator— + (i)shall review the + methodology developed under subparagraph (A); and + (ii)may revise the + methodology to reflect new scientific developments or understandings, in + accordance with subparagraph (A). + (C)
Requirements
The + methodology shall apply scientifically recognized factors to address the + following topics: + (i)Strengths and + limitations of study design. + (ii)Reliability and + relevance of test methods to human health and the environment. + (iii)Quality of + data. + (iv)Use of good + laboratory practices. + (v)Peer review and + peer review processes. + (vi)Use of + standardized protocols. + (vii)Structured + evaluative frameworks to determine the overall weight of the evidence, based on + a review of positive and negative findings. + (D)
Hazard, use, + and exposure information
+ (i)
In + general
A safety assessment under this subsection shall evaluate + existing hazard, use, and exposure information for the chemical substance under + the intended conditions of use of the chemical substance, including information + submitted by interested persons. + (ii)
Exposure
For + purposes of evaluating exposure under clause (i), a safety assessment shall + take into consideration— + (I)exposures or + significant subsets of exposures; + (II)exposure + duration, intensity, frequency, and number; and + (III)the + vulnerability of exposed subpopulations. + (E)
Best available + science
The Administrator shall use the best available science in + conducting a safety assessment under this subsection. + (5)
Additional test + information
If the Administrator determines that additional test + information is needed in order to make a safety assessment for a high-priority + substance, the Administrator— + (A)shall provide an + opportunity for interested persons to submit the additional information; + (B)may promulgate a + rule, enter into a testing consent agreement, or issue an order under section 4 + to require the development of the information; and + (C)may defer, for a + reasonable period, a safety assessment until after receipt of the + information. + (6)
Treatment
A + safety assessment under this subsection— + (A)shall not be + considered to be a final agency action; and + (B)shall not be + subject to judicial review. + (c)
Safety + determination
+ (1)
In + general
As soon as possible after the date on which the safety + assessment is completed for a high-priority substance under subsection (b), the + Administrator shall determine whether the chemical substance meets the safety + standard under the intended conditions of use of the chemical substance. + (2)
Determinations
Based + on a review of the information described in paragraph (3), the Administrator + shall determine, based solely on considerations of risk to human health and the + environment, that— + (A)the relevant + chemical substance meets the safety standard under intended conditions of + use; + (B)the relevant + chemical substance does not meet the safety standard under intended conditions + of use, in which case the Administrator shall impose additional restrictions, + as appropriate, under paragraph (9); or + (C)additional + information is necessary in order to make a determination under subparagraph + (A) or (B), in which case the Administrator shall take appropriate action under + paragraph (8). + (3)
Considerations
In + making a safety determination under this subsection, the Administrator shall + take into consideration and publish a statement that includes, at a + minimum— + (A)the safety + assessment for the chemical substance, including the uses considered in the + assessment and any uses that are considered critical or essential; + (B)the range of + exposure to the chemical substance under the intended conditions of use of the + chemical substance and appropriate reference parameters; + (C)the weight of the + evidence of risk posed by the chemical substance under the intended conditions + of use of the chemical substance; and + (D)the magnitude of + the risk posed by the chemical substance under the intended conditions of use + of the chemical substance. + (4)
Information + sources
In making a safety determination under this subsection, + the Administrator shall take into consideration, at a minimum— + (A)the information + described in section 4(c); and + (B)the safety + assessment conducted with respect to the chemical substance under subsection + (b). + (5)
Best available + science
The Administrator shall use the best available science in + making a safety determination under this subsection. + (6)
Notice and + comment
Subject to section 14, the Administrator shall provide + notice and an opportunity for public comment on each proposed safety + determination under this subsection. + (7)
Transparency
Subject + to section 14, the Administrator shall publish— + (A)each safety + determination under this subsection, together with a summary of the information + considered in the determination; + (B)a summary of the + evaluation by the Administrator of the information; and + (C)an explanation of + the reasons for the determination. + (8)
Additional test + data and information
If the Administrator determines that + additional test data and information is needed in order to make a safety + determination for a high-priority substance, the Administrator— + (A)shall provide an + opportunity for interested persons to submit the additional data and + information; + (B)may promulgate a + rule, enter into a testing consent agreement, or issue an order under section 4 + to require the development of the data and information; + (C)may defer, for a + reasonable period, a safety determination until after receipt of the data and + information; and + (D)on receipt of the + data and information, shall make a determination under paragraph (2). + (9)
Additional + restrictions
+ (A)
In + general
+ (i)
Determination
If + the Administrator makes a determination under paragraph (2)(B) with respect to + a chemical substance, the Administrator shall promulgate a rule establishing + necessary restrictions (based on the weight of the evidence of risk and the + magnitude of risk), including if appropriate, a ban or phase out of the + manufacture, processing, or use of the chemical substance in accordance with + subparagraph (C). + (ii)
Rules
Rules + promulgated under this section may apply to mixtures containing the chemical + substance, as appropriate. + (B)
Inclusions
A + restriction under subparagraph (A) may include, as appropriate— + (i)a + requirement that a chemical substance be marked with, or accompanied by, clear + and adequate warnings and instructions with respect to use, distribution in + commerce, or disposal, or any combination of those activities, with the form + and content of the warnings and instructions to be prescribed by the + Administrator; + (ii)a requirement + that manufacturers and processors of the chemical substance— + (I)make and retain + records of the processes used to manufacture or process the chemical substance; + and + (II)subject to + section 4(f), develop test information that is reasonably necessary to ensure + compliance with this Act; + (iii)a limitation on + the quantity of the chemical substance that may be manufactured, processed, or + distributed in commerce; + (iv)a requirement to + ban or phase out or other regulation on the manufacture, processing, or + distribution in commerce of the chemical substance— + (I)for a particular + use; or + (II)for a particular + use at a concentration in excess of a level specified by the + Administrator; + (v)a + limitation on the quantity of the chemical substance that may be manufactured, + processed, or distributed in commerce— + (I)for a particular + use; or + (II)for a particular + use at a concentration in excess of a level specified by the + Administrator; + (vi)a requirement to + ban or phase out or other regulation of any method of commercial use of the + chemical substance; + (vii)a requirement + to ban or phase out or other regulation of any method of disposal of the + chemical substance or any article containing the chemical substance; + (viii)a requirement + directing manufacturers or processors of the chemical substance to give notice + of unreasonable risks of harm to distributors in commerce of the chemical + substance and, to the extent reasonably ascertainable, to other persons in the + chain of commerce in possession of the chemical substance; and + (ix)such other + requirements as the Administrator determines to be necessary. + (C)
Bans and phase + outs
The Administrator shall base a determination under + subparagraph (A) that a ban or phase out of the manufacture, processing, or use + of a chemical substance is necessary on the considerations described in + subparagraph (D). + (D)
Determination + that chemical substance does not meet safety standard
If the + Administrator determines that the chemical substance does not meet the safety + standard under the intended conditions of use, the Administrator shall consider + and publish a statement on— + (i)the availability + of technically and economically feasible alternatives for the chemical + substance under the intended conditions of use; + (ii)the risks posed + by those alternatives as compared to those of the chemical substance; + (iii)the economic + and social costs and benefits of the proposed regulatory action and options + considered, and of potential alternatives; and + (iv)the economic and + social benefits and costs of— + (I)the chemical + substance; + (II)alternatives to + the chemical substance; and + (III)any necessary + restrictions on the chemical substance or alternatives. + (10)
Exemptions
The + Administrator may exempt the use of a chemical substance from any additional + restriction established under paragraph (9) if the Administrator determines + that— + (A)the exemption is + in the interest of national security; + (B)the lack of + availability of the chemical substance would cause significant disruption in + the national economy; + (C)the use for which + the exemption is sought is a critical or essential use for which— + (i)no feasible + alternative for the use would materially reduce risk to health or the + environment; or + (ii)no feasible + alternative for the use is economically, technically, or efficiently available; + or + (D)the use, as + compared to reasonably available alternatives, provides a net benefit to human + health, the environment, or public safety. + (11)
Final agency + action
A safety determination under this subsection shall + be— + (A)considered to be + a final agency action; and + (B)subject to + judicial review, including review of the associated safety assessment under + this + subsection. + ; + (3)by redesignating + subsections (e) and (f) as subsections (d) and (e), respectively; and + (4)in subsection (d) + (as so redesignated)— + (A)by striking + paragraph (4); and + (B)by redesignating + paragraph (5) as paragraph (4). +
7.
Imminent + hazards
Section 7 (15 U.S.C. + 2606) is amended— + (1)by striking + subsection (a) and inserting the following: + + (a)
Civil + actions
+ (1)
In + general
The Administrator may commence a civil action in an + appropriate district court of the United States for— + (A)seizure of an + imminently hazardous chemical substance or mixture or any article containing + the substance or mixture; + (B)relief (as + authorized by subsection (b)) against any person who manufactures, processes, + distributes in commerce, uses, or disposes of, an imminently hazardous chemical + substance or mixture or any article containing the substance or mixture; + or + (C)both seizure + described in subparagraph (A) and relief described in subparagraph (B). + (2)
Rule, order, or + other proceeding
A civil action may be commenced under this + paragraph notwithstanding— + (A)the existence + of— + (i)a + decision by the Administrator under section 4(c)(3), 5(c)(4), or 6(c)(2); + or + (ii)a rule, testing + consent agreement, or order under section 4(f), 5(g), 6(b)(5), 6(c)(8), + 6(c)(9), or 6(d); or + (B)the pendency of + any administrative or judicial proceeding under any provision of this + Act. + ; + (2)in subsection + (d), by striking section 6(a) and inserting section + 6(c); and + (3)in subsection + (f), in the first sentence, by striking and unreasonable. +
8.
Information + collection and reporting
Section 8 (15 U.S.C. 2607) is + amended— + (1)in subsection (a), by adding at the end the + following: + + (4)
Regulations
+ (A)
In + general
The Administrator shall promulgate rules requiring the + reporting of information known by, or reasonably ascertainable by, the person + making the report, including rules requiring processors to report information, + so that the Administrator has the information necessary to carry out sections 4 + and 6. + (B)
Contents
The + rules promulgated under subparagraph (A)— + (i)may impose + different reporting requirements on manufacturers and processors; + (ii)shall be limited + to active substances or mixtures containing active substances as designated + under subsection (b); and + (iii)shall apply + only to the extent the Administrator determines the submission of reports is + necessary for the effective enforcement of this Act. + (5)
Guidance
The + Administrator shall develop guidance relating to the information required to be + reported under the rules promulgated under this subsection that— + (A)include the level + of detail necessary to be reported; and + (B)describes the + manner by which manufacturers and processors may report use and exposure + information on a voluntary + basis. + ; + (2)in subsection + (b), by adding at the end the following: + + (3)
Nomenclature
+ (A)
In + general
In carrying out paragraph (1), the Administrator + shall— + (i)maintain the use + of Class 2 nomenclature in use on date of enactment of the + Chemical Safety Improvement + Act; + (ii)maintain the use + of the Soap and Detergent Association Nomenclature System, published in March + 1978 by the Administrator in section 1 of addendum III of the document entitled + Candidate List of Chemical Substances, and further described in + the appendix A of volume I of the 1985 edition of the Toxic Substances Control + Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and + (iii)treat all + components of categories that are considered to be statutory mixtures under + this Act as being included on the list published under paragraph (1) under the + Chemical Abstracts Service numbers for the respective categories, including, + without limitation— + (I)cement, Portland, + chemicals, CAS No. 65997–15–1; + (II)cement, alumina, + chemicals, CAS No. 65997–16–2; + (III)glass, oxide, + chemicals, CAS No. 65997–17–3; + (IV)frits, + chemicals, CAS No. 65997–18–4; + (V)steel + manufacture, chemicals, CAS No. 65997–19–5; and + (VI)ceramic + materials and wares, chemicals, CAS No. 66402–68–4. + (B)
Multiple + nomenclature conventions
+ (i)
In + general
In the event that existing guidance allows for multiple + nomenclature conventions, the Administrator shall— + (I)maintain the + nomenclature conventions for substances; and + (II)develop new + guidance that— + (aa)establishes + equivalency between the nomenclature conventions for chemical substances on the + list published under paragraph (1); and + (bb)permits persons + to rely on that new guidance for purposes of determining whether a chemical + substance is on the list published under paragraph (1). + (ii)
Multiple CAS + numbers
For any chemical substance appearing multiple times on + the list under different Chemical Abstracts Service numbers, the Administrator + shall develop guidance recognizing the multiple listings as a single chemical + substance. + (4)
Candidate list + of active substances in commerce
+ (A)
In + general
Subject to section 14, the Administrator shall make + publicly available a candidate list of active chemical substances, which shall + include— + (i)any chemical + substance reported under part 711 of title 40, Code of Federal Regulations, as + in effect on the date of enactment of the Chemical Safety Improvement Act, during the + period beginning on the date that is 10 years before the date of enactment of + the Chemical Safety Improvement + Act and ending on the date of enactment of the + Chemical Safety Improvement + Act; + (ii)any chemical + substance for which a notice of commencement of manufacture has been + submitted; + (iii)any chemical + substance for which a significant new use notice has been submitted; + (iv)any chemical + substance for which an export notification has been submitted during the period + beginning on the date that is 10 years before the date of enactment of the + Chemical Safety Improvement Act + and ending on the date of enactment of the Chemical Safety Improvement Act; and + (v)any other + chemical substance identified by the Administrator as likely to qualify as + active. + (B)
Rule
The + Administrator shall, by rule, require manufacturers and processors to notify + the Administrator that the manufacturer or processor, as applicable, has + manufactured or processed a chemical substance on the list described in + subparagraph (A), or the list published under paragraph (1) for a nonexempt + commercial purpose during the 5-year period prior to the date of enactment of + the Chemical Safety Improvement + Act. + (C)
Guidance
Before + issuing a final rule under subparagraph (A), the Administrator shall make + publicly available guidance relating to the rule for chemical substances on the + confidential portion of the candidate list of active substances and of the list + published under paragraph (1), including — + (i)accession + numbers; + (ii)premanufacture + notice case numbers, if applicable; and + (iii)generic + names. + (D)
Confidential + chemical substances
The rule under subparagraph (B) shall require + a manufacturer or processor that is reporting information relating to a + chemical substance on the confidential portion of the list published under + paragraph (1) to indicate whether the manufacturer or processor claims the + specific identity of the substance as confidential pursuant to section + 14. + (E)
Certification
The + rule under subparagraph (B) shall require a manufacturer or processor— + (i)to certify the + accuracy of each report of the manufacturer or processor carried out under the + rule; and + (ii)to retain a + record supporting that certification for a period of 5 years beginning on the + last day of the submission period. + (F)
Applicability
Nothing + in this paragraph requires the resubstantiation of a claim for protection + against disclosure for information submitted to the Administrator prior to the + date of enactment of the Chemical Safety + Improvement Act. + (5)
List
+ (A)
In + general
Based on the notifications received in response to the + rule under paragraph (4), the Administrator shall designate each chemical + substance that is on the list published under paragraph (1) on the date of + enactment of the Chemical Safety Improvement + Act as active or inactive. + (B)
Update
The + Administrator shall update the list of chemicals designated as active or + inactive as soon as practicable following the publication of the most recent + data reported under part 711 of title 40, Code of Federal Regulations. + (6)
Active + substances
The Administrator shall designate as an active + substance— + (A)a chemical + substance that has been manufactured or processed for a nonexempt commercial + purposes at any point during the 5-year period prior to the date of enactment + of the Chemical Safety Improvement + Act; + (B)a chemical + substance that is added to the list published under paragraph (1) after the + date of enactment of the Chemical Safety + Improvement Act; + (C)a chemical + substance for which a notice is received under paragraph (7)(C); and + (D)a chemical + substance reported under part 711 of title 40, Code of Federal Regulations, + after the date of enactment of the Chemical + Safety Improvement Act. + (7)
Inactive + substances
+ (A)
In + general
The Administrator shall designate as an inactive + substance each chemical substance on the list published under paragraph (1) + that has not been manufactured or processed for a nonexempt commercial purpose + in the 5-year period ending on the date of enactment of the + Chemical Safety Improvement + Act. + (B)
Treatment
Each + inactive substance shall remain on the list published under paragraph + (1). + (C)
Change to + active status
+ (i)
In + general
Any person who intends to manufacture or process for a + nonexempt commercial purpose a chemical substance that is designated as an + inactive substance shall notify the Administrator before the date on which the + substance is manufactured or processed. + (ii)
Active + status
On receiving notification under clause (i), the + Administrator— + (I)shall designate + the chemical substance as an active substance; and + (II)shall, pursuant + to section 4(e), review the priority of the chemical substance as the + Administrator determines necessary. + (D)
Category + status
The list of inactive chemical substances shall not be + considered a category for purposes of section 26(c). + (8)
Public + participation
+ (A)
In + general
Subject to subparagraph (B), the Administrator shall make + available to the public— + (i)the specific + identity of each chemical substance on the nonconfidential portion of the list + published under paragraph (5) that the Administrator has designated as an + active substance; + (ii)the specific + identity of each chemical substance on the nonconfidential portion of the list + published under paragraph (1) that the Administrator has designated as an + inactive substance; + (iii)the accession + number, generic name, and, if applicable, premanufacture notice case number for + each chemical substance on the confidential portion of the list published under + paragraph (1) for which a claim of confidentiality was received; and + (iv)the specific + identity of any active or inactive substance on the confidential portion of the + list published under paragraph (1) for which no claim of confidentiality was + received, subject to the condition that, before revealing the specific identity + of the substance, the Administrator shall— + (I)publish a notice + in the Federal Register identifying the accession number, generic name, and, if + applicable, premanufacture notice case number for that substance; and + (II)provide an + opportunity for any person— + (aa)to + certify to the Administrator that the person intends to manufacture or process + the substance at any point in the subsequent 4-year period; and + (bb)to + claim confidentiality for the specific identity of the substance. + (B)
Confidentiality
Subject + section 14, the Administrator shall not make available to the public the + specific chemical identity of any substance for which the Administrator + receives a notice under subparagraph + (A)(iv). + ; + and + (3)in subsection + (e)— + (A)by striking + Any person and inserting the following: + + (1)
In + general
Any person + ; + and + (B)by adding at the + end the following: + + (2)
Applicability
Any + person may submit to the Administrator data and information reasonably + supporting the conclusion that a chemical substance or mixture does not present + a substantial risk of injury to health and the + environment. + . +
9.
Relationship to + other Federal laws
Section 9 + (15 U.S.C. 2608) is amended— + (1)in subsection + (a)— + (A)in the first + sentence of paragraph (1)— + (i)by + striking presents or will present an unreasonable risk to health or the + environment and inserting does not meet the safety standard + under the intended conditions of use; and + (ii)by + striking such risk the first place it appears and inserting + the risk posed by the substance or mixture; + (B)in paragraph (2), + in the matter following subparagraph (B), by striking section 6 or + 7 and inserting paragraph (8) or (9) of subsection (c) of + section 6 or section 7; and + (C)in paragraph (3), + by striking section 6 or 7 and inserting paragraph (8) or + (9) of subsection (c) of section 6 or section 7; and + (2)in subsection + (d), in the first sentence, by striking Health, Education, and + Welfare and inserting Health and Human Services. +
10.
Research, + development, collection, dissemination, and utilization of data
Section 10 (15 U.S.C. 2609) is amended by + striking Health, Education, and Welfare each place it appears + and inserting Health and Human Services. +
11.
Exports
Section 12 (15 U.S.C. 2611) is + amended— + (1)in subsection + (a), by striking paragraph (2) and inserting the following: + + (2)
Exception
Paragraph + (1) shall not apply to any chemical substance that the Administrator + determines— + (A)under section 5 + is not likely to meet the safety standard under the intended conditions of use + of the chemical substance; or + (B)under section 6 + does not meet the safety standard under the intended conditions of use of the + chemical substance. + (3)
Waivers
For + a mixture or article containing a chemical substance described in paragraph + (2), the Administrator may— + (A)determine that + paragraph (1) shall not apply to that mixture or article; and + (B)establish a + threshold concentration in a mixture or article at which paragraph (1) shall + not + apply. + ; + (2)by striking + subsection (b) and inserting the following: + + (b)
Notice
+ (1)
In + general
A person shall notify the Administrator that the person + is exporting or intends to export to a foreign country— + (A)a chemical + substance or a mixture containing a chemical substance that the Administrator + has determined under section 5 is not likely to meet the safety standard under + the intended conditions of use of the chemical substance; + (B)a chemical + substance or a mixture containing a chemical substance that the Administrator + has determined under section 6 does not meet the safety standard under the + intended conditions of use of the chemical substance; or + (C)a chemical + substance for which the United States is obligated by treaty to provide export + notification. + (2)
Regulations
+ (A)
In + general
The Administrator shall promulgate regulations to carry + out paragraph (1). + (B)
Contents
The + regulations promulgated under subparagraph (A) shall— + (i)include any + exemptions the Administrator determines to be appropriate, which may include + exemptions identified under section 5(g); and + (ii)indicate whether + or to what extent the regulations apply to articles containing a chemical + substance or mixture described in paragraph (1). + (3)
Notification
The + Administrator shall submit to the government of each country to which a + chemical substance or mixture is exported— + (A)for a chemical + substance or mixture described in subparagraph (A) or (B) of paragraph (1), a + notice that information on the chemical substance or mixture can be obtained + from the Administrator, unless the Administrator determines that good cause + exists not to provide the notice; and + (B)for a chemical + substance described in paragraph (1)(C), a notice that satisfies the obligation + of the United States under the applicable + treaty. + ; + and + (3)in subsection + (c)— + (A)by striking + paragraph (3); and + (B)by redesignating + paragraphs (4) through (6) as paragraphs (3) through (5), respectively. +
12.
Imports
Section 13 (15 U.S.C. 2612) is amended to + read as follows: + +
13.
Imports
+ (a)
Definition of + chemical substance or mixture
In this section, the term + chemical substance or mixture includes— + (1)a mixture + containing a chemical substance or mixture; and + (2)an article + containing a chemical substance or mixture. + (b)
Refusal of + entry
+ (1)
In + general
The Secretary of Homeland Security shall refuse entry + into the customs territory of the United States (as defined in general note 2 + to the Harmonized Tariff Schedule of the United States) any chemical substance + or mixture offered for such entry if— + (A)the Administrator + has determined under section 6(c) that the chemical substance or mixture does + not meet the safety standard under the intended conditions of use of the + chemical substance; or + (B)the chemical + substance or mixture is offered for entry in violation of a rule or order in + effect under this Act. + (2)
Procedure
+ (A)
In + general
Subject to subparagraph (B), if a chemical substance or + mixture is refused entry under paragraph (1), the Secretary of Homeland + Security— + (i)shall notify the + consignee of the entry of the refusal; + (ii)shall not + release the chemical substance or mixture to the consignee; and + (iii)shall cause the + disposal or storage of the chemical substance or mixture under such rules as + the Secretary may prescribe, if the chemical substance or mixture has not been + exported by the consignee in the 90-day period beginning on the date of receipt + of the notice of the refused entry. + (B)
Exception
+ (i)
In + general
The Secretary of Homeland Security may, pending a review + by the Administrator, release to the consignee the chemical substance or + mixture if the consignee— + (I)executes a bond + for the amount of the full invoice of the chemical substance or mixture (as set + forth in the customs entry); and + (II)pays a duty on + the chemical substance or mixture. + (ii)
Administration
If + a consignee fails to return a chemical substance or mixture released to that + consignee under clause (i) for any cause to the custody of the Secretary of + Homeland Security when demanded, the consignee shall be liable to the United + States for liquidated damages equal to the full amount of the bond. + (C)
Storage
All + charges for storage, cartage, and labor on and for the disposal of a chemical + substance or mixture that is refused entry or released under this subsection + shall be paid by the owner or consignee, and a default on that payment shall + constitute a lien against any future entry made by the owner or + consignee. + (c)
Notice
+ (1)
In + general
A person offering a chemical substance or mixture subject + to this Act for entry into the customs territory of the United States + shall— + (A)certify to the + Secretary of Homeland Security that, after reasonable inquiry and to the best + knowledge and belief of the person, the chemical substance or mixture + is— + (i)in compliance + with any applicable rule, consent agreement, or order under section 5 or 6; + and + (ii)(I)included on the list + under section 8(b); or + (II)exempt from any requirement to be + included on that list; and + (B)provide to the + Secretary of Homeland Security any notice required under paragraph (2). + (2)
Notice
A + person offering a chemical substance or mixture for entry into the customs + territory of the United States shall notify the Secretary of Homeland Security + if— + (A)the chemical + substance is a high-priority substance; + (B)the chemical + substance is a chemical for which the United States is obligated to provide + export notification by treaty; or + (C)the chemical + substance or mixture or any article containing the substance or mixture— + (i)is the subject of + a safety assessment and safety determination conducted pursuant to section 6 + and has been found not to meet the safety standard; and + (ii)is identified in + a rule promulgated by the Secretary of Homeland Security pursuant to subsection + (c) as meriting notification due to the potential impact of the chemical + substance or mixture or any article containing the substance or mixture on + human health or the environment. + (d)
Rules
The + Secretary of Homeland Security, after consultation with the Administrator, + shall issue rules for the administration of subsection (c), including whether, + or to what extent, the provisions of subsections (b) and (c) + apply. +
. +
13.
Confidential + information
Section 14 (15 + U.S.C. 2613) is amended to read as follows: + +
14.
Confidential + information
+ (a)
In + general
Except as provided in subsections (c) and (e), the + Administrator shall not disclose information described in subsection + (b)— + (1)that is reported + to, or otherwise obtained by, the Administrator under this Act; and + (2)for which the + requirements of subsection (d) are met. + (b)
Information + generally protected from disclosure
+ (1)
In + general
Information referred to in subsection (a) includes + confidential information that is exempt from disclosure pursuant to subsection + (a) of section 552 of title 5, United States Code, under subsection (b)(4) of + that section. + (2)
Presumption of + protection
The following information submitted by a manufacturer, + processor, or distributor is presumed to be protected from disclosure: + (A)Specific + information describing the manufacture, processing, or distribution in commerce + of a chemical substance, mixture, or article. + (B)Marketing and + sales information. + (C)Information + identifying suppliers or customers. + (D)The identity of + constituents in a mixture and the respective percentages of those + constituents. + (E)Specific + information about the use, function, or application of a chemical substance or + mixture in a process, mixture, or product. + (F)Specific + production or import volumes of a manufacturer and specific volumes aggregated + across manufacturers if the Administrator determines that disclosure of the + aggregated data could reveal confidential information. + (G)The specific + identity of a chemical substance, including the chemical name, molecular + formula, Chemical Abstracts Service number, and other information that would + identify a specific chemical substance, if— + (i)the specific + identity was claimed as confidential information at the time it was submitted; + and + (ii)the claim has + not subsequently been withdrawn or found by the Administrator not to warrant + protection as confidential information under subsection (g). + (c)
Information not + protected from disclosure
+ (1)
In + general
Notwithstanding subsections (a) and (b), and except as + provided in paragraph (2), the following information shall not be protected + from disclosure: + (A)For information + submitted after the date of enactment of the Chemical Safety Improvement Act, the + identity of a chemical substance if the person submitting the information does + not meet the requirements of subsection (d). + (B)A safety + assessment developed or a safety determination made under section 6. + (C)Health and safety + data that are submitted under this Act with respect to a chemical substance or + mixture that has been offered for commercial distribution as of the date on + which the study is to be disclosed or for which testing is required under + section 4. + (D)Health and safety + data in notices of substantial risk submitted under section 8(e) and in the + underlying studies. + (E)General + information describing the manufacturing volumes, expressed in ranges would not + reveal confidential information. + (F)General + descriptions of industrial, commercial, or consumer functions and uses of a + chemical substance or mixture. + (2)
Exception
Information + elements contained in submissions described in paragraph (1) that are otherwise + eligible for protection under this section shall be protected from disclosure + if the submitter complies with subsection (d). + (d)
Requirements + for confidentiality claims
+ (1)
Claims
+ (A)
In + general
For information to be protected from disclosure under + this section, a person who submits information to the Administrator under this + Act shall— + (i)indicate the + information that the person believes is entitled to protection from disclosure + under this section in a submission to the Administrator in such manner and at + such time as the Administrator shall prescribe; and + (ii)except in the + case of information described in subparagraphs (A) through (F) of subsection + (b)(2), submit written documentation justifying why the information qualifies + for protection from disclosure. + (B)
Certification
An + authorized official of the person described in subparagraph (A) shall certify + that the information that has been submitted is true and correct. + (2)
Additional + requirements for confidentiality claims for chemical identities
A + person submitting information under this Act related to a chemical identity and + who claims protection from disclosure for that identity shall provide the + Administrator with— + (A)information + establishing that— + (i)the person takes + reasonable measures to protect the confidentiality of the chemical + identity; + (ii)the chemical + identity is not required to be disclosed, or otherwise made available, to the + public under any other Federal law in connection with one or more uses subject + to this Act; + (iii)disclosure of + the chemical identity is likely to cause substantial harm to the competitive + position of the person; and + (iv)the chemical + identity is not reasonably believed to be readily discoverable through reverse + engineering; + (B)the time period + for which protection of the chemical identity from disclosure is + necessary; + (C)a generic name + for the chemical substance that the Administrator may disclose to the public, + subject to the condition that the generic name discloses a maximum amount of + information on the chemical structure of the substance while protecting those + features of the chemical structure that are considered confidential and the + disclosure of which would potentially harm the competitive position of the + person; and + (D)in the event the + Administrator makes a request under subsection (f)— + (i)redocumentation + and recertification of the information submitted under subsection (a); + or + (ii)withdrawal of + the claim for protection of the chemical identity from disclosure. + (3)
Guidance
The + Administrator shall develop guidance, after notice and opportunity to comment, + on the determination of generic names for confidential chemical + identities. + (e)
Exceptions to + protection from disclosure
Subsection (a) shall not apply + if— + (1)the information + is to be disclosed to an officer or employee of the United States in connection + with the official duties of that person under any law for the protection of + human health or the environment or for specific law enforcement + purposes; + (2)the information + is to be disclosed to a contractor with the United States and employees of that + contractor if, in the opinion of the Administrator, the disclosure is necessary + for the satisfactory performance by the contractor of a contract with the + United States for the performance of work in connection with this Act and under + such conditions as the Administrator shall specify; + (3)the Administrator + determines that disclosure is necessary to protect human health or the + environment; + (4)the information + is to be disclosed to a State or political subdivision of a State, on written + request, for the purpose of development, administration, or enforcement of a + law, if— + (A)one or more + applicable agreements with the Administrator ensure that the recipient + government will take appropriate steps, and has adequate authority, to maintain + the confidentiality of the information in accordance with procedures as + stringent as those which the Administrator uses to safeguard the information; + and + (B)the Administrator + notifies the person who submitted the information that the information has been + disclosed to a State or political subdivision of a State; + (5)a health + professional employed by a Federal or State agency or a treating physician or + nurse in a nonemergency situation provides a written statement of need and a + written confidentiality agreement, subject to the conditions that— + (A)the written + statement of need is a statement that the person has a reasonable basis to + suspect that— + (i)the information + is needed for purposes of diagnosis or treatment of one or more + individuals; + (ii)one or more + individuals being diagnosed or treated have been exposed to the chemical + substance concerned; and + (iii)knowledge of + the specific chemical identity of the chemical substance will assist in + diagnosis or treatment; and + (B)the + confidentiality agreement provides that the person will not use the specific + chemical identity for any purpose other than the health needs asserted in the + statement of need, except as may otherwise be authorized by the terms of the + agreement or by the person submitting the specific chemical identity to the + Administrator; + (6)a treating + physician or nurse requests the information, subject to the conditions + that— + (A)the treating + physician or nurse determines that— + (i)a + medical emergency exists; + (ii)the specific + chemical identity of the chemical substance concerned is necessary for or will + assist in emergency or first-aid diagnosis or treatment; and + (iii)the one or more + individuals being diagnosed or treated have likely been exposed to the chemical + substance concerned; + (B)if requested by + the person submitting the specific chemical identity to the Administrator, the + treating physician or nurse provides a written statement of need and a + confidentiality agreement as described in paragraph (5); and + (C)the written + confidentiality agreement or statement of need is submitted as soon as + practicable, but not necessarily before the information is disclosed; + (7)the Administrator + determines that disclosure is necessary in a proceeding under this Act, subject + to the condition that the disclosure is made in such a manner as to preserve + confidentiality to the maximum extent practicable without impairing the + proceeding; or + (8)the information + is to be disclosed, on written request of any duly authorized committee of the + Congress, to that committee. + (f)
Duration of + protection from disclosure
+ (1)
In + general
The Administrator shall protect from disclosure + information described in subsection (b) that meets the requirements of + subsection (d)(2) for the period of time requested by the person submitting the + claim or for such period of time as the Administrator, after reviewing the + request for confidential treatment and the documentation, otherwise determines + to be reasonable, unless— + (A)prior to the + expiration of the period, the person notifies the Administrator that the person + is withdrawing the confidentiality claim, in which case, the Administrator + shall promptly make the information available to the public; or + (B)prior to the + expiration of the period, the Administrator otherwise becomes aware that the + need for protection from disclosure can no longer be substantiated, in which + case the Administrator shall take the actions described in subsection + (g)(2). + (2)
Redocumentation
The + Administrator may request— + (A)at any time, a + person who has requested protection from disclosure for the identity of a + substance under subsection (d) to redocument the confidentiality claim of the + person; and + (B)any person who + has requested that confidential information be protected from disclosure under + section 8(b) to reassert the confidentiality claim of the person after the + chemical substance is identified as a high-priority substance under section + 4(e). + (g)
Duties of the + administrator
+ (1)
Determination
+ (A)
In + general
Except as provided in subsection (b)(2), the + Administrator shall— + (i)review a request + received under this section to maintain the confidentiality of information + submitted under this Act; and + (ii)determine + whether to approve, modify, or deny that request. + (B)
Denial or + modification
+ (i)
In + general
The Administrator shall deny a claim to protect a + chemical identity from disclosure only if the person who has submitted the + request fails to meet the requirements of subsection (d). + (ii)
Reasons for + denial or modification
The Administrator shall provide to the + person who has submitted the request a written statement of the reasons for the + denial or modification of the claim. + (C)
Subsets
If + it is not feasible for the Administrator to review each request under this + section, the Administrator shall review a representative subset. + (2)
Notification
+ (A)
In + general
Except as provided in subsections (c) and (e), if the + Administrator denies a request under paragraph (1), the Administrator shall + notify, in writing and by certified mail, the person who submitted the request + of the intent of the Administrator to release the information. + (B)
Release of + information
+ (i)
In + general
Except as provided in clause (ii), the Administrator may + not release information under this subsection until the date that is 30 days + after the date on which the person who submitted the request receives + notification under subparagraph (A). + (ii)
Exceptions
+ (I)
In + general
For information under paragraph (3) or (8) of subsection + (e), the Administrator may not release that information until the date that is + 15 days after the date on which the person who submitted the request receives a + notification, unless the Administrator determines that release of the + information is necessary to protect against an imminent and substantial harm to + human health or the environment, in which case, no prior notification is + necessary. + (II)
No + notification
For information under paragraph (6) or (7) of + subsection (e), no prior notification is necessary. + (3)
Appeals
+ (A)
In + general
A person who receives notification under this subsection + may, if the person believes disclosure of the information is prohibited under + subsection (a), before the date on which the information is to be released, + bring an action to restrain disclosure of the information in— + (i)the district + court of the United States in the district in which— + (I)the complainant + resides or has the principal place of business; or + (II)the information + is located; or + (ii)the United + States District Court for the District of Columbia. + (B)
No + disclosure
The Administrator shall not disclose any information + under this section prior to the date on which the applicable court rules on an + action under subparagraph (A). + (4)
Administration
In + carrying out this subsection, the Administrator shall employ the procedures in + part 2 of title 40, Code of Federal Regulations (or successor + regulations). + (h)
Criminal + penalty for wrongful disclosure
+ (1)
In + general
Subject to paragraph (2), any officer or employee of the + United States or former officer or employee of the United States, who— + (A)by virtue of that + employment or official position has obtained possession of, or has access to, + material the disclosure of which is prohibited by subsection (a); and + (B)knowing that + disclosure of that material is prohibited by subsection (a), willfully + discloses the material in any manner to any person not entitled to receive that + material, shall be— + (i)guilty of a + misdemeanor and fined under title 18, United States Code, imprisoned for not + more than 1 year, or both; and + (ii)removed from + office or employment. + (2)
Other + laws
Section 1905 of title 18, United States Code, shall not + apply with respect to the publishing, divulging, disclosure, making known of, + or making available, information reported or otherwise obtained under this + Act. + (3)
Contractors
For + the purposes of this subsection, any contractor of the United States who is + furnished information in accordance with subsection (e)(2), including any + employee of that contractor, shall be considered to be an employee of the + United States. + (i)
Applicability
Except + as otherwise provided in this section, the Administrator shall have no + authority— + (1)to require the + documentation or redocumentation of a claim for the protection from disclosure + of information submitted to the Administrator under this Act prior to the date + of enactment of the Chemical Safety + Improvement Act; or + (2)to impose + redocumentation requirements under this Act that are more extensive than those + required under this + section. +
. +
14.
Prohibited + acts
Section 15 (15 U.S.C. + 2614) is amended by striking paragraph (1) and inserting the following: + + (1)fail or refuse to comply with— + (A)any rule promulgated, consent agreement + entered into, or order issued under section 4; + (B)any requirement prescribed by section 5 or + 6; + (C)any rule promulgated, consent agreement + entered into, or order issued under section 5 or 6; + (D)any requirement of title II or any rule + promulgated or order issued under title II; or + (E)any requirement of title VII or any rule + promulgated or order issued under title + VII; + . +
15.
Preemption
Section 18 (15 U.S.C. 2617) is amended by + striking subsections (a) and (b) and inserting the following: + + (a)
In + general
Except as provided in subsections (c) and (d), no State + or political subdivision of a State may establish or continue to + enforce— + (1)a requirement for + the development of test data or information on a chemical substance or category + of substances that is reasonably likely to produce the same data and + information required under section 4, 5, or 6 by— + (A)a rule + promulgated by the Administrator; + (B)a consent + agreement entered into by the Administrator; or + (C)an order issued + by the Administrator; + (2)a prohibition or + restriction on the manufacture, processing, or distribution in commerce or use + of a chemical substance after issuance of a completed safety determination for + a chemical substance under section 6, consistent with the scope of the review + and decisions addressed by the Administrator; or + (3)a requirement for + the notification of a use of a chemical substance that the Administrator has + specified as a significant new use and for which the Administrator has required + notification pursuant to a rule promulgated under section 5. + (b)
New + prohibitions or restrictions
Except as provided in subsections + (c) and (d), no State or political subdivision of a State may establish (after + the date of enactment of the Chemical Safety + Improvement Act)— + (1)a prohibition or + restriction on the manufacture, processing, distribution in commerce or use of + a chemical substance that is a high-priority substance identified under section + 4(e)(3) (as of the date on which the Administrator publishes a schedule under + section 6(b)); or + (2)a prohibition or + restriction on the manufacture, processing, distribution in commerce or use of + a chemical substance that is a low-priority substance identified under section + 4(e)(3). + (c)
Exceptions
Subsections + (a) and (b) shall not apply to a requirement, prohibition, or restriction of a + State or a political subdivision of a State that— + (1)is adopted under + the authority of any other Federal law; + (2)implements a + reporting or information collection requirement not otherwise required by the + Administrator under this Act or required under any other Federal law; or + (3)is adopted + pursuant to authority under a law of the State or political subdivision of the + State related to water quality, air quality, or waste treatment or disposal + that— + (A)does not impose a + restriction on the manufacture, processing, distribution in commerce, or use of + a chemical substance; and + (B)is not otherwise + required by or inconsistent with an action by the Administrator under section 5 + or 6. + (d)
State + waivers
Upon application of a State or political subdivision of a + State, the Administrator may provide a waiver from subsection (a) and + subsection (b)(1), regarding a requirement of that State or political + subdivision of the State that relates to the effects or exposure to any + chemical substance under the intended conditions of use if— + (1)(A)the State or political + subdivision of the State determines it cannot wait until the end of the period + specified in the established schedule and deadline for the completion of a full + safety assessment and determination established under section 6(b)(2)(B)(ii); + and + (B)the Administrator determines + that— + (i)compelling State or local + conditions warrant granting the waiver to protect human health or the + environment; + (ii)compliance with the proposed + requirement of the State or political subdivision of the State does not unduly + burden interstate and foreign commerce in the manufacture, processing, + distribution in commerce, or use of a chemical substance; + (iii)compliance with the proposed + requirement of the State or political subdivision of the State would not cause + a violation of any applicable Federal law, rule, or order; and + (iv)the proposed requirement of the + State or political subdivision of the State is based on the best available + science and is supported by the weight of the evidence; or + (2)(A)the Administrator finds + a safety assessment or determination has been unreasonably delayed; and + (B)the State certifies that— + (i)the State has a compelling local + interest to protect human health or the environment; + (ii)compliance with the proposed + requirement of the State does not unduly burden interstate and foreign commerce + in the manufacture, processing, distribution in commerce, or use of a chemical + substance; + (iii)compliance with the proposed + requirement would not cause a violation of any applicable Federal law, rule, or + order; and + (iv)the proposed requirement is + grounded in reasonable scientific concern. + (3)
Approval of a + State Waiver Request
The Administrator shall grant or deny a + waiver application— + (A)not later than + 180 days after the date on which an application under paragraph (1) is + submitted; and + (B)not later than 90 + days after the date on which an application under paragraph (2) is + submitted. + (4)
Notice and + comment
The application of a State or political subdivision of + the State shall be subject to public notice and comment. + (5)
Final agency + action
The decision of the Administrator on the application of a + State or political subdivision of the State shall be— + (A)considered to be + a final agency action; and + (B)subject to + judicial review. + (6)
Duration of + State waivers
A State waiver— + (A)granted under + paragraph (1) shall remain in effect unless the waiver is found to be in + conflict with a completed safety assessment and determination; and + (B)granted under + paragraph (2) shall remain in effect until such time as the safety assessment + and determination is completed. + (7)
Judicial + review
Not later than 60 days after the date on which the + Administrator makes a determination on an application of a State or political + subdivision of the State under paragraph (1), any person may file a petition + for judicial review in the United States Court of Appeals for the District of + Columbia Circuit, which shall have exclusive jurisdiction over the + determination. + (e)
Effect on + private remedies
+ (1)
In + general
If the Administrator completes a safety determination for + a high-priority substance under section 6, the determination shall be + admissible as evidence in any public or private action in any court of the + United States or State court for recovery of damages or for equitable relief + relating to injury to human health or the environment from exposure to a + chemical substance. + (2)
Safety + standard
The safety determination shall be determinative of + whether the substance meets the safety standard under the conditions of use + addressed in the safety + determination. + . +
16.
Judicial + review
Section 19 (15 U.S.C. + 2618) is amended— + (1)in subsection + (a)— + (A)by striking + paragraph (1) and inserting the following: + + (1)
Filing of + petition
+ (A)
In + general
Not later than 60 days after the date of the promulgation + of a rule under section 4(f), 6(c), 6(e), or 8, any person may file a petition + for judicial review of the rule in— + (i)the United States + Court of Appeals for the District of Columbia Circuit; + (ii)the circuit in + which the person resides; or + (iii)the circuit in + which the principal place of business of the person is located. + (B)
Exclusive + jurisdiction of courts of appeals
The courts of appeals of the + United States shall have exclusive jurisdiction of any action to obtain + judicial review (other than in an enforcement proceeding) under subparagraph + (A) if any district court of the United States would have had jurisdiction of + the action but for this + paragraph. + ; + (B)in paragraph (2), + by striking paragraph (1)(A) and inserting paragraph + (1); and + (C)by striking + paragraph (3); and + (2)in subsection + (c)(1), by striking subparagraph (B) and inserting the following: + + (B)
Applicability + of section 706 of title 5, United States Code
+ (i)
Definition of + evidence
In this subparagraph, the term evidence + means any matter in the rulemaking record. + (ii)
Applicability
Section + 706 of title 5, United States Code, shall apply to review of a rule under this + section, except that— + (I)in the case of a + rule under section 4(f), 6(c), or 6(e)— + (aa)the standard of + review prescribed in section 706(2)(E) of title 5, United States Code, shall + not apply; and + (bb)the court shall + hold as unlawful and set aside the rule if the court finds that the rule is not + supported by substantial evidence in the rulemaking record; and + (II)the court shall + not review the contents and adequacy of the statement of basis and purpose + required by section 553(c) of title 5, United States Code, to be incorporated + in the rule except as part of a review of the rulemaking record taken as a + whole. + . +
17.
Citizens' + petitions
Section 21 (15 + U.S.C. 2620) is amended— + (1)in subsection + (a), by striking an order under section 5(e) or 6(b)(2) and + inserting an order under section 4(f) or 5(c); and + (2)in subsection + (b)— + (A)in paragraph (1), + by striking an order under section 5(e), 6(b)(1)(A), or + 6(b)(1)(B) and inserting an order under section 4(f) or + 5(c); and + (B)by striking + subparagraph (B) of paragraph (4) and inserting the following: + + (B)
De novo + proceeding
+ (i)
In + general
In an action under subparagraph (A) to initiate a + proceeding to issue a rule under section 4(f), 6(b), 6(c), 6(d), or 8 or an + order issued under section 4(f) or 5(c), the petitioner shall be provided an + opportunity to have the petition considered by the court in a de novo + proceeding. + (ii)
Demonstration
+ (I)
In + general
The court shall order the Administrator to initiate the + action requested by the petitioner if the petitioner demonstrates to the + satisfaction of the court by a preponderance of the evidence that— + (aa)in + the case of a petition to initiate a proceeding for the issuance of a rule or + order under section 4(f), the information available to the Administrator is + insufficient for the Administrator to perform an action described in section + 4(f), 6(b)(5), or 6(c)(8); + (bb)in + the case of a petition to issue an order under section 5(c), there is a + reasonable basis to conclude that the substance is not likely to meet the + safety standard under the intended conditions of use; + (cc)in + the case of a petition to initiate a proceeding for the issuance of a rule + under section 6(c)(9), there is a reasonable basis to conclude that the + substance will not meet the safety standard under the intended conditions of + use; or + (dd)in + the case of a petition to initiate a proceeding for the issuance of a rule + under section 6(b)(2), 6(d) or 8, there is a reasonable basis to conclude that + the rule is necessary to protect human health or the environment from an + unreasonable risk of harm to human health or the environment. + (II)
Deferment
The + court may permit the Administrator to defer initiating the action requested by + the petitioner until such time as the court prescribes if the court finds + that— + (aa)the extent of + the risk to human health or the environment alleged by the petitioner is less + than the extent of risks to human health or the environment with respect to + which the Administrator is taking action under this Act; and + (bb)there are + insufficient resources available to the Administrator to take the action + requested by the + petitioner. + . +
18.
Studies
Section 25 (15 U.S.C. 2624) is + repealed. +
19.
Administration
Section 26(e) (15 U.S.C. 2625(e)) is amended + by striking Health, Education, and Welfare each place it appears + and inserting Health and Human Services. +
20.
Development and + evaluation of test methods
Section 27(a) (15 U.S.C. 2626(a)) is amended + by striking Health, Education, and Welfare and inserting + Health and Human Services. +
21.
State + programs
Section 28 (15 U.S.C. + 2627) is amended by striking subsections (c) and (d). +
22.
Authorization + of appropriations
Section 29 + (15 U.S.C. 2628) is repealed. +
23.
Annual + report
Section 30 (15 U.S.C. + 2629) is amended by striking paragraph (2) and inserting the following: + + (2)(A)the number of notices received during each + year under section 5; and + (B)the number of the notices described in + subparagraph (A) for chemical substances subject to a rule, testing consent + agreement, or order under section + 4(f); + . +
+ + +