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.
1.Short title; table of
contents; references
(a)This Act may be cited as the Chemical Safety Improvement
Act
.
(b)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)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)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 intentSection 2 (15 U.S.C. 2601) is amended by
striking subsections (a) through (c) and inserting the following:
(a)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)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)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.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)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 useThe 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)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)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)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)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)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)
(A)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)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 validityThe 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)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 fundingThe 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)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)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)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)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)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 sourcesIn 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)
(1)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 publicThe 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)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)
(A)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 substancesIn 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 substancesIn 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)The Administrator shall make every effort to complete the
prioritization of all active substances in a timely manner.
(ii)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)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 substancesThe 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 substancesFrom 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)
(A)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)
(i)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)The
initial list shall contain as many chemical substances as the Administrator
determines appropriate.
(iii)The
Administrator may modify the initial list on the basis of comments received on
the proposed process and criteria.
(C)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)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)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)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 informationDuring 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 substancesThe 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 substancesThe 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)The identifications made under subparagraphs (E) and (F)
shall be subject to notice and an opportunity for comment.
(H)Order of safety
assessments
(i)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)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)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)
(I)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)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)The Administrator shall publish and keep current a list
of high-priority substances and a list of low-priority substances.
(ii)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)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)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)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)The public shall be provided notice and an opportunity to
comment on the recommendation described in subparagraph (A).
(C)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)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)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)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)
(A)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)The Administrator shall explain the basis for a
decision made in subparagraph (A)(ii) in a statement made available to the
public.
(4)
(A)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)The
period described in subparagraph (A)(iv) shall not be of an unreasonable
duration.
(C)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)
(1)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)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)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)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)Subject
to subsections (b) and (c), the framework shall have 2 tiers.
(A)
(i)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 modelingScreening 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)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)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)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 methodsTo 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 requirementsOn 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)
(1)Persons
required to develop test data and information
(A)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)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)
(i)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)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)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)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)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)
(i)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
guidelinesThe Administrator may develop guidelines for
evaluating data from biomonitoring studies.
(iii)Prior
to prescribing epidemiologic studies of employees, the Administrator shall
coordinate with the Director of the National Institute for Occupational Safety
and Health.
(C)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)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)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 usesSection 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)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)
(1)
(A)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)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)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)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)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)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)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
informationIf 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)
(1)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)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)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)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 determinationsSection 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)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)
(1)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)
(A)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)
(i)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)
(I)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 extensionsThe 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 assessmentsEach 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 sourcesIn 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)
(A)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)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)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)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)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)The Administrator shall use the best available science in
conducting a safety assessment under this subsection.
(5)Additional test
informationIf 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)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)
(1)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)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)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)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)The Administrator shall use the best available science in
making a safety determination under this subsection.
(6)Subject to section 14, the Administrator shall provide
notice and an opportunity for public comment on each proposed safety
determination under this subsection.
(7)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 informationIf 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)
(A)
(i)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
promulgated under this section may apply to mixtures containing the chemical
substance, as appropriate.
(B)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)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 standardIf 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)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)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.Section 7 (15 U.S.C.
2606) is amended—
(1)by striking
subsection (a) and inserting the following:
(a)
(1)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 proceedingA 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 reportingSection 8 (15 U.S.C. 2607) is
amended—
(1)in subsection (a), by adding at the end the
following:
(4)
(A)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)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)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)
(A)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 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)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)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)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)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 substancesThe 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)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)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)
(A)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)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)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)
(A)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)Each
inactive substance shall remain on the list published under paragraph
(1).
(C)
(i)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)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)The list of inactive chemical substances shall not be
considered a category for purposes of section 26(c).
(8)
(A)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)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)Any person
;
and
(B)by adding at the
end the following:
(2)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 lawsSection 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 dataSection 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.Section 12 (15 U.S.C. 2611) is
amended—
(1)in subsection
(a), by striking paragraph (2) and inserting the following:
(2)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)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)
(1)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)
(A)The Administrator shall promulgate regulations to carry
out paragraph (1).
(B)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)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.Section 13 (15 U.S.C. 2612) is amended to
read as follows:
13.
(a)Definition of
chemical substance or mixtureIn 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)
(1)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)
(A)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)
(i)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)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)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)
(1)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)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)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.Section 14 (15
U.S.C. 2613) is amended to read as follows:
14.
(a)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)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
protectionThe 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)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)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)
(A)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)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 identitiesA
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)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 disclosureSubsection (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)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)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)
(A)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)
(i)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 modificationThe 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)If
it is not feasible for the Administrator to review each request under this
section, the Administrator shall review a representative subset.
(2)
(A)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)
(i)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)
(I)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)For information under paragraph (6) or (7) of
subsection (e), no prior notification is necessary.
(3)
(A)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)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)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)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)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)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)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.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.Section 18 (15 U.S.C. 2617) is amended by
striking subsections (a) and (b) and inserting the following:
(a)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 restrictionsExcept 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)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)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 RequestThe 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)The application of a State or political subdivision of
the State shall be subject to public notice and comment.
(5)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 waiversA 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)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)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)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.Section 19 (15 U.S.C.
2618) is amended—
(1)in subsection
(a)—
(A)by striking
paragraph (1) and inserting the following:
(1)
(A)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 appealsThe 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)In this subparagraph, the term evidence
means any matter in the rulemaking record.
(ii)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.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)
(i)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)
(I)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)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.Section 25 (15 U.S.C. 2624) is
repealed.
19.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 methodsSection 27(a) (15 U.S.C. 2626(a)) is amended
by striking Health, Education, and Welfare
and inserting
Health and Human Services
.
21.Section 28 (15 U.S.C.
2627) is amended by striking subsections (c) and (d).
22.Authorization
of appropriationsSection 29
(15 U.S.C. 2628) is repealed.
23.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);
.