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