[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 697 Reported in Senate (RS)]
Calendar No. 121
114th CONGRESS
1st Session
S. 697
To amend the Toxic Substances Control Act to reauthorize and modernize
that Act, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 10, 2015
Mr. Udall (for himself, Mr. Vitter, Mr. Manchin, Mr. Inhofe, Mr.
Carper, Mr. Blunt, Mr. Coons, Mr. Boozman, Mr. Donnelly, Mrs. Capito,
Mr. Heinrich, Mr. Cassidy, Ms. Heitkamp, Mr. Crapo, Ms. Stabenow, Mr.
Hoeven, Mr. Portman, Mr. Warner, Mr. Peters, Mr. Rounds, Mr. Brown, Mr.
Thune, Mr. Barrasso, Mr. Booker, Mr. Cornyn, Mr. Cotton, Mr. Isakson,
Mr. Kaine, Mrs. McCaskill, Mr. Merkley, Ms. Murkowski, Mr. Murphy, Mr.
Rubio, Mr. Scott, Mrs. Shaheen, Mr. Whitehouse, Mr. Casey, Mr. Perdue,
Ms. Klobuchar, Mr. Coats, and Mr. Toomey) introduced the following
bill; which was read twice and referred to the Committee on Environment
and Public Works
June 17, 2015
Reported by Mr. Inhofe, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Toxic Substances Control Act to reauthorize and modernize
that Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Frank R. Lautenberg
Chemical Safety for the 21st Century Act''.</DELETED>
<DELETED>SEC. 2. FINDINGS, POLICY, AND INTENT.</DELETED>
<DELETED> Section 2(c) of the Toxic Substances Control Act (15
U.S.C. 2601(c)) is amended--</DELETED>
<DELETED> (1) by striking ``It is the intent'' and inserting
the following:</DELETED>
<DELETED> ``(1) Administration.--It is the
intent'';</DELETED>
<DELETED> (2) in paragraph (1) (as so redesignated), by
inserting ``, as provided under this Act'' before the period at
the end; and</DELETED>
<DELETED> (3) by adding at the following:</DELETED>
<DELETED> ``(2) Reform.--It is the intent of Congress that
reform of this Act in accordance with the amendments made by
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act--</DELETED>
<DELETED> ``(A) shall be administered in a manner
that--</DELETED>
<DELETED> ``(i) protects the health of
children, pregnant women, the elderly, workers,
consumers, the general public, and the
environment from the risks of harmful exposures
to chemical substances and mixtures;
and</DELETED>
<DELETED> ``(ii) ensures that appropriate
information on chemical substances and mixtures
is available to public health officials and
first responders in the event of an emergency;
and</DELETED>
<DELETED> ``(B) shall not displace or supplant
common law rights of action or remedies for civil
relief.''.</DELETED>
<DELETED>SEC. 3. DEFINITIONS.</DELETED>
<DELETED> Section 3 of the Toxic Substances Control Act (15 U.S.C.
2602) is amended--</DELETED>
<DELETED> (1) by redesignating paragraphs (4), (5), (6),
(7), (8), (9), (10), (11), (12), (13), and (14) as paragraphs
(5), (6), (7), (8), (9), (10), (12), (13), (17), (18), and
(19), respectively;</DELETED>
<DELETED> (2) by inserting after paragraph (3) the
following:</DELETED>
<DELETED> ``(4) Conditions of use.--The term `conditions of
use' means the intended, known, or reasonably foreseeable
circumstances the Administrator determines a chemical substance
is manufactured, processed, distributed in commerce, used, or
disposed of.'';</DELETED>
<DELETED> (3) by inserting after paragraph (10) (as so
redesignated) the following:</DELETED>
<DELETED> ``(11) Potentially exposed or susceptible
population.--The term `potentially exposed or susceptible
population' means 1 or more groups--</DELETED>
<DELETED> ``(A) of individuals within the general
population who may be--</DELETED>
<DELETED> ``(i) differentially exposed to
chemical substances under the conditions of
use; or</DELETED>
<DELETED> ``(ii) susceptible to greater
adverse health consequences from chemical
exposures than the general population;
and</DELETED>
<DELETED> ``(B) that when identified by the
Administrator may include such groups as infants,
children, pregnant women, workers, and the elderly.'';
and</DELETED>
<DELETED> (4) by inserting after paragraph (13) (as so
redesignated) the following:</DELETED>
<DELETED> ``(14) Safety assessment.--The term `safety
assessment' means an assessment of the risk posed by a chemical
substance under the conditions of use, integrating hazard, use,
and exposure information regarding the chemical
substance.</DELETED>
<DELETED> ``(15) Safety determination.--The term `safety
determination' means a determination by the Administrator as to
whether a chemical substance meets the safety standard under
the conditions of use.</DELETED>
<DELETED> ``(16) Safety standard.--The term `safety
standard' means a standard that ensures, without taking into
consideration cost or other nonrisk factors, that no
unreasonable risk of harm to health or the environment will
result from exposure to a chemical substance under the
conditions of use, including no unreasonable risk of harm to--
</DELETED>
<DELETED> ``(A) the general population; or</DELETED>
<DELETED> ``(B) any potentially exposed or
susceptible population that the Administrator has
identified as relevant to the safety assessment and
safety determination for a chemical
substance.''.</DELETED>
<DELETED>SEC. 4. POLICIES, PROCEDURES, AND GUIDANCE.</DELETED>
<DELETED> The Toxic Substances Control Act is amended by inserting
after section 3 (15 U.S.C. 2602) the following:</DELETED>
<DELETED>``SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE.</DELETED>
<DELETED> ``(a) Definition of Guidance.--In this section, the term
`guidance' includes any significant written guidance of general
applicability prepared by the Administrator.</DELETED>
<DELETED> ``(b) Deadline.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, the Administrator shall develop, after providing public
notice and an opportunity for comment, any policies, procedures, and
guidance the Administrator determines to be necessary to carry out
sections 4, 4A, 5, and 6, including the policies, procedures, and
guidance required by this section.</DELETED>
<DELETED> ``(c) Use of Science.--</DELETED>
<DELETED> ``(1) In general.--The Administrator shall
establish policies, procedures, and guidance on the use of
science in making decisions under sections 4, 4A, 5, and
6.</DELETED>
<DELETED> ``(2) Goal.--A goal of the policies and procedures
described in paragraph (1) shall be to make the basis of
decisions clear to the public.</DELETED>
<DELETED> ``(3) Requirements.--The policies, procedures, and
guidance issued under this section shall describe the manner in
which the Administrator shall ensure that--</DELETED>
<DELETED> ``(A) decisions made by the
Administrator--</DELETED>
<DELETED> ``(i) are based on information,
procedures, measures, methods, and models
employed in a manner consistent with the best
available science;</DELETED>
<DELETED> ``(ii) take into account the
extent to which--</DELETED>
<DELETED> ``(I) assumptions and
methods are clearly and completely
described and documented;</DELETED>
<DELETED> ``(II) variability and
uncertainty are evaluated and
characterized; and</DELETED>
<DELETED> ``(III) the information
has been subject to independent
verification and peer review;
and</DELETED>
<DELETED> ``(iii) are based on the weight of
the scientific evidence, by which the
Administrator considers all information in a
systematic and integrative framework to
consider the relevance of different
information;</DELETED>
<DELETED> ``(B) to the extent practicable and if
appropriate, the use of peer review, standardized test
design and methods, consistent data evaluation
procedures, and good laboratory practices will be
encouraged;</DELETED>
<DELETED> ``(C) a clear description of each
individual and entity that funded the generation or
assessment of information, and the degree of control
those individuals and entities had over the generation,
assessment, and dissemination of information (including
control over the design of the work and the publication
of information) is made available; and</DELETED>
<DELETED> ``(D) if appropriate, the recommendations
in reports of the National Academy of Sciences that
provide advice regarding assessing the hazards,
exposures, and risks of chemical substances are
considered.</DELETED>
<DELETED> ``(d) Existing EPA Policies, Procedures, and Guidance.--
The policies, procedures, and guidance described in subsection (b)
shall incorporate, as appropriate, existing relevant hazard, exposure,
and risk assessment guidelines and methodologies, data evaluation and
quality criteria, testing methodologies, and other relevant guidelines
and policies of the Environmental Protection Agency.</DELETED>
<DELETED> ``(e) Review.--Not later than 5 years after the date of
enactment of this section, and not less frequently than once every 5
years thereafter, the Administrator shall--</DELETED>
<DELETED> ``(1) review the adequacy of any policies,
procedures, and guidance developed under this section,
including animal, nonanimal, and epidemiological test methods
and procedures for assessing and determining risk under this
Act; and</DELETED>
<DELETED> ``(2) after providing public notice and an
opportunity for comment, revise the policies, procedures, and
guidance if necessary to reflect new scientific developments or
understandings.</DELETED>
<DELETED> ``(f) Sources of Information.--In making any decision with
respect to a chemical substance under section 4, 4A, 5, or 6, the
Administrator shall take into consideration information relating to the
hazards and exposures of a chemical substance under the conditions of
use that is reasonably available to the Administrator, including
information that is--</DELETED>
<DELETED> ``(1) submitted to the Administrator pursuant to
any rule, consent agreement, order, or other requirement of
this Act, or on a voluntary basis, including pursuant to any
request made under this Act, by--</DELETED>
<DELETED> ``(A) manufacturers or processors of a
substance;</DELETED>
<DELETED> ``(B) the public;</DELETED>
<DELETED> ``(C) other Federal departments or
agencies; or</DELETED>
<DELETED> ``(D) the Governor of a State or a State
agency with responsibility for protecting health or the
environment;</DELETED>
<DELETED> ``(2) submitted to a governmental entity in any
jurisdiction pursuant to a governmental requirement relating to
the protection of health or the environment; or</DELETED>
<DELETED> ``(3) identified through an active search by the
Administrator of information sources that are publicly
available or otherwise accessible by the
Administrator.</DELETED>
<DELETED> ``(g) Testing of Chemical Substances and Mixtures.--
</DELETED>
<DELETED> ``(1) In general.--The Administrator shall
establish policies and procedures for the testing of chemical
substances or mixtures under section 4.</DELETED>
<DELETED> ``(2) Goal.--A goal of the policies and procedures
established under paragraph (1) shall be to make the basis of
decisions clear to the public.</DELETED>
<DELETED> ``(3) Contents.--The policies and procedures
established under paragraph (1) shall--</DELETED>
<DELETED> ``(A) address how and when the exposure
level or exposure potential of a chemical substance
would factor into decisions to require new testing,
subject to the condition that the Administrator shall
not interpret the lack of exposure information as a
lack of exposure or exposure potential;</DELETED>
<DELETED> ``(B) describe the manner in which the
Administrator will determine that additional
information is necessary to carry out this Act,
including information relating to potentially exposed
or susceptible populations;</DELETED>
<DELETED> ``(C) require the Administrator to consult
with the Director of the National Institute for
Occupational Safety and Health prior to prescribing
epidemiologic studies of employees; and</DELETED>
<DELETED> ``(D) prior to adopting a requirement for
testing using vertebrate animals, require the
Administrator to take into consideration, as
appropriate and to the extent practicable, reasonably
available--</DELETED>
<DELETED> ``(i) toxicity
information;</DELETED>
<DELETED> ``(ii) computational toxicology
and bioinformatics;</DELETED>
<DELETED> ``(iii) high-throughput screening
methods and the prediction models of those
methods; and</DELETED>
<DELETED> ``(iv) scientifically reliable and
relevant alternatives to tests on animals that
would provide equivalent information.</DELETED>
<DELETED> ``(4) Tiered testing.--</DELETED>
<DELETED> ``(A) In general.--Except as provided in
subparagraph (D), the Administrator shall employ a
tiered screening and testing process, under which the
results of screening-level tests or assessments of
available information inform the decision as to whether
1 or more additional tests are necessary.</DELETED>
<DELETED> ``(B) Screening-level tests.--</DELETED>
<DELETED> ``(i) In general.--The screening-
level tests required for a chemical substance
or mixture may include tests for hazard (which
may include in silico, in vitro, and in vivo
tests), environmental and biological fate and
transport, and measurements or modeling of
exposure or exposure potential, as
appropriate.</DELETED>
<DELETED> ``(ii) Use.--Screening-level tests
shall be used--</DELETED>
<DELETED> ``(I) to screen chemical
substances or mixtures for potential
adverse effects; and</DELETED>
<DELETED> ``(II) to inform a
decision of the Administrator regarding
whether more complex or targeted
additional testing is
necessary.</DELETED>
<DELETED> ``(C) Additional testing.--If the
Administrator determines under subparagraph (B) that
additional testing is necessary to provide more
definitive information for safety assessments or safety
determinations, the Administrator may require more
advanced tests for potential health or environmental
effects or exposure potential.</DELETED>
<DELETED> ``(D) Advanced testing without
screening.--The Administrator may require more advanced
testing without conducting screening-level testing when
other information available to the Administrator
justifies the advanced testing, pursuant to guidance
developed by the Administrator under this
section.</DELETED>
<DELETED> ``(h) Safety Assessments and Safety Determinations.--
</DELETED>
<DELETED> ``(1) Schedule.--</DELETED>
<DELETED> ``(A) In general.--The Administrator shall
inform the public regarding the schedule for the
completion of each safety assessment and safety
determination as soon as practicable after designation
as a high-priority substance pursuant to section
4A.</DELETED>
<DELETED> ``(B) Differing times.--The Administrator
may allot different times for different chemical
substances in the schedules under this paragraph,
subject to the condition that all schedules shall
comply with the deadlines established under section
6.</DELETED>
<DELETED> ``(C) Annual plan.--At the beginning of
each calendar year, the Administrator shall identify
the substances subject to safety assessments and safety
determinations to be completed that year.</DELETED>
<DELETED> ``(2) Policies and procedures for safety
assessments and safety determinations.--</DELETED>
<DELETED> ``(A) In general.--The Administrator shall
establish, by rule, policies and procedures regarding
the manner in which the Administrator shall carry out
section 6.</DELETED>
<DELETED> ``(B) Goal.--A goal of the policies and
procedures under this paragraph shall be to make the
basis of decisions of the Administrator clear to the
public.</DELETED>
<DELETED> ``(C) Minimum requirements.--At a minimum,
the policies and procedures under this paragraph
shall--</DELETED>
<DELETED> ``(i) describe--</DELETED>
<DELETED> ``(I) the manner in which
the Administrator will identify
informational needs and seek that
information from the public;</DELETED>
<DELETED> ``(II) the information
(including draft safety assessments)
that may be submitted by interested
individuals or entities, including
States; and</DELETED>
<DELETED> ``(III) the criteria by
which that information will be
evaluated;</DELETED>
<DELETED> ``(ii) require the Administrator--
</DELETED>
<DELETED> ``(I)(aa) to define the
scope of the safety assessment and
safety determination to be conducted
under section 6, including the hazards,
exposures, conditions of use, and
potentially exposed and susceptible
populations that the Administrator
expects to consider in a safety
assessment;</DELETED>
<DELETED> ``(bb) to explain the
basis for the scope of the safety
assessment and safety determination;
and</DELETED>
<DELETED> ``(cc) to accept comments
regarding the scope of the safety
assessment and safety determination;
and</DELETED>
<DELETED> ``(II)(aa) to identify the
items described in subclause (I) that
the Administrator has considered in the
final safety assessment; and</DELETED>
<DELETED> ``(bb) to explain the
basis for the consideration of those
items;</DELETED>
<DELETED> ``(iii) describe the manner in
which aggregate exposures, or significant
subsets of exposures, to a chemical substance
under the conditions of use will be considered,
and explain the basis for that consideration in
the final safety assessment;</DELETED>
<DELETED> ``(iv) require that each safety
assessment and safety determination shall
include--</DELETED>
<DELETED> ``(I) a description of the
weight of the scientific evidence of
risk; and</DELETED>
<DELETED> ``(II) a summary of the
information regarding the impact on
health and the environment of the
chemical substance that was used to
make the assessment or determination,
including, as available, mechanistic,
animal toxicity, and epidemiology
studies;</DELETED>
<DELETED> ``(v) establish a timely and
transparent process for evaluating whether new
information submitted or obtained after the
date of a final safety assessment or safety
determination warrants reconsideration of the
safety assessment or safety determination;
and</DELETED>
<DELETED> ``(vi) when relevant information
is provided or otherwise made available to the
Administrator, shall consider the extent of
Federal regulation under other Federal
laws.</DELETED>
<DELETED> ``(D) Guidance.--</DELETED>
<DELETED> ``(i) In general.--Not later than
1 year after the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st
Century Act, the Administrator shall develop
guidance to assist interested persons in
developing draft safety assessments and other
information for submission to the
Administrator, which may be considered at the
discretion of the Administrator.</DELETED>
<DELETED> ``(ii) Requirement.--The guidance
shall, at a minimum, address the quality of the
information submitted and the process to be
followed in developing a draft assessment for
consideration by the Administrator.</DELETED>
<DELETED> ``(3) Articles.--If the Administrator intends to
prohibit or otherwise restrict an article on the basis of a
chemical substance contained in that article, the Administrator
shall have evidence of significant exposure to the chemical
substance from such article.</DELETED>
<DELETED> ``(i) Publicly Available Information.--Subject to section
14, the Administrator shall--</DELETED>
<DELETED> ``(1) make publicly available a nontechnical
summary, and the final version, of each safety assessment and
safety determination;</DELETED>
<DELETED> ``(2) provide public notice and an opportunity for
comment on each proposed safety assessment and safety
determination; and</DELETED>
<DELETED> ``(3) make public in a final safety assessment and
safety determination--</DELETED>
<DELETED> ``(A) the list of studies considered by
the Administrator in carrying out the safety assessment
or safety determination; and</DELETED>
<DELETED> ``(B) the list of policies, procedures,
and guidance that were followed in carrying out the
safety assessment or safety determination.</DELETED>
<DELETED> ``(j) Consultation With Science Advisory Committee on
Chemicals.--</DELETED>
<DELETED> ``(1) Establishment.--Not later than 1 year after
the date of enactment of this section, the Administrator shall
establish an advisory committee, to be known as the `Science
Advisory Committee on Chemicals' (referred to in this
subsection as the `Committee').</DELETED>
<DELETED> ``(2) Purpose.--The purpose of the Committee shall
be to provide independent advice and expert consultation, on
the request of the Administrator, with respect to the
scientific and technical aspects of issues relating to the
implementation of this title.</DELETED>
<DELETED> ``(3) Composition.--The Committee shall be
composed of representatives of such science, government, labor,
public health, public interest, animal protection, industry,
and other groups as the Administrator determines to be
advisable, including, at a minimum, representatives that have
specific scientific expertise in the relationship of chemical
exposures to women, children, and other potentially exposed or
susceptible populations.</DELETED>
<DELETED> ``(4) Schedule.--The Administrator shall convene
the Committee in accordance with such schedule as the
Administrator determines to be appropriate, but not less
frequently than once every 2 years.</DELETED>
<DELETED> ``(5) Relationship to other law.--All proceedings
and meetings of the Committee shall be subject to the Federal
Advisory Committee Act (5 U.S.C. App.).''.</DELETED>
<DELETED>SEC. 5. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES.</DELETED>
<DELETED> (a) In General.--Section 4 of the Toxic Substances Control
Act (15 U.S.C. 2603) is amended--</DELETED>
<DELETED> (1) by striking subsections (a), (b), (c), (d),
and (g);</DELETED>
<DELETED> (2) by redesignating subsections (e) and (f) as
subsections (f) and (g), respectively;</DELETED>
<DELETED> (3) in subsection (f) (as so redesignated)--
</DELETED>
<DELETED> (A) by striking ``rule'' each place it
appears and inserting ``rule, testing consent
agreement, or order'';</DELETED>
<DELETED> (B) by striking ``under subsection (a)''
each place it appears and inserting ``under this
subsection''; and</DELETED>
<DELETED> (C) in paragraph (1)(B), in the last
sentence, by striking ``rulemaking'';</DELETED>
<DELETED> (4) in subsection (g) (as so redesignated)--
</DELETED>
<DELETED> (A) in the first sentence, by striking
``from cancer, gene mutations, or birth defects'';
and</DELETED>
<DELETED> (B) by striking the last sentence;
and</DELETED>
<DELETED> (5) by inserting before subsection (f) (as so
redesignated) the following:</DELETED>
<DELETED> ``(a) Development of New Information on Chemical
Substances and Mixtures.--</DELETED>
<DELETED> ``(1) In general.--The Administrator may require
the development of new information relating to a chemical
substance or mixture in accordance with this section if the
Administrator determines that the information is necessary--
</DELETED>
<DELETED> ``(A) to review a notice under section
5(d) or to perform a safety assessment or safety
determination under section 6;</DELETED>
<DELETED> ``(B) to implement a requirement imposed
in a consent agreement or order issued under section
5(d)(4) or under a rule promulgated under section
6(d)(3);</DELETED>
<DELETED> ``(C) pursuant to section 12(a)(4);
or</DELETED>
<DELETED> ``(D) at the request of the implementing
authority under another Federal law, to meet the
regulatory testing needs of that authority.</DELETED>
<DELETED> ``(2) Limited testing for prioritization
purposes.--</DELETED>
<DELETED> ``(A) In general.--Except as provided in
subparagraph (B), the Administrator may require the
development of new information for the purposes of
section 4A.</DELETED>
<DELETED> ``(B) Prohibition.--Testing required under
subparagraph (A) shall not be required for the purpose
of establishing or implementing a minimum information
requirement.</DELETED>
<DELETED> ``(C) Limitation.--The Administrator may
require the development of new information pursuant to
subparagraph (A) only if the Administrator determines
that additional information is necessary to establish
the priority of a chemical substance.</DELETED>
<DELETED> ``(3) Form.--Subject to section 3A(h), the
Administrator may require the development of information
described in paragraph (1) or (2) by--</DELETED>
<DELETED> ``(A) promulgating a rule;</DELETED>
<DELETED> ``(B) entering into a testing consent
agreement; or</DELETED>
<DELETED> ``(C) issuing an order.</DELETED>
<DELETED> ``(4) Contents.--</DELETED>
<DELETED> ``(A) In general.--A rule, testing consent
agreement, or order issued under this subsection shall
include--</DELETED>
<DELETED> ``(i) identification of the
chemical substance or mixture for which testing
is required;</DELETED>
<DELETED> ``(ii) identification of the
persons required to conduct the
testing;</DELETED>
<DELETED> ``(iii) test protocols and
methodologies for the development of test data
and information for the chemical substance or
mixture, including specific reference to
reliable nonanimal test procedures;
and</DELETED>
<DELETED> ``(iv) specification of the period
within which individuals and entities required
to conduct the testing shall submit to the
Administrator the information developed in
accordance with the procedures described in
clause (iii).</DELETED>
<DELETED> ``(B) Considerations.--In determining the
procedures and period to be required under subparagraph
(A), the Administrator shall take into consideration--
</DELETED>
<DELETED> ``(i) the relative costs of the
various test protocols and methodologies that
may be required; and</DELETED>
<DELETED> ``(ii) the reasonably foreseeable
availability of facilities and personnel
required to perform the testing.</DELETED>
<DELETED> ``(b) Statement of Need.--</DELETED>
<DELETED> ``(1) In general.--In promulgating a rule,
entering into a testing consent agreement, or issuing an order
for the development of additional information (including
information on exposure or exposure potential) pursuant to this
section, the Administrator shall--</DELETED>
<DELETED> ``(A) identify the need intended to be met
by the rule, agreement, or order;</DELETED>
<DELETED> ``(B) explain why information reasonably
available to the Administrator at that time is
inadequate to meet that need, including a reference, as
appropriate, to the information identified in paragraph
(2)(B); and</DELETED>
<DELETED> ``(C) explain the basis for any decision
that requires the use of vertebrate animals.</DELETED>
<DELETED> ``(2) Explanation in case of order.--</DELETED>
<DELETED> ``(A) In general.--If the Administrator
issues an order under this section, the Administrator
shall issue a statement providing a justification for
why issuance of an order is warranted instead of
promulgating a rule or entering into a testing consent
agreement.</DELETED>
<DELETED> ``(B) Contents.--A statement described in
subparagraph (A) shall contain a description of--
</DELETED>
<DELETED> ``(i) information that is readily
accessible to the Administrator, including
information submitted under any other provision
of law;</DELETED>
<DELETED> ``(ii) the extent to which the
Administrator has obtained or attempted to
obtain the information through voluntary
submissions; and</DELETED>
<DELETED> ``(iii) any information relied on
in safety assessments for other chemical
substances relevant to the chemical substances
that would be the subject of the
order.</DELETED>
<DELETED> ``(c) Reduction of Testing on Vertebrates.--</DELETED>
<DELETED> ``(1) In general.--The Administrator shall
minimize, to the extent practicable, the use of vertebrate
animals in testing of chemical substances or mixtures, by--
</DELETED>
<DELETED> ``(A) encouraging and facilitating--
</DELETED>
<DELETED> ``(i) the use of integrated and
tiered testing and assessment
strategies;</DELETED>
<DELETED> ``(ii) the use of best available
science in existence on the date on which the
test is conducted;</DELETED>
<DELETED> ``(iii) the use of test methods
that eliminate or reduce the use of animals
while providing information of high scientific
quality;</DELETED>
<DELETED> ``(iv) the grouping of 2 or more
chemical substances into scientifically
appropriate categories in cases in which
testing of a chemical substance would provide
reliable and useful information on other
chemical substances in the category;</DELETED>
<DELETED> ``(v) the formation of industry
consortia to jointly conduct testing to avoid
unnecessary duplication of tests; and</DELETED>
<DELETED> ``(vi) the submission of
information from--</DELETED>
<DELETED> ``(I) animal-based
studies; and</DELETED>
<DELETED> ``(II) emerging methods
and models; and</DELETED>
<DELETED> ``(B) funding research and validation
studies to reduce, refine, and replace the use of
animal tests in accordance with this
subsection.</DELETED>
<DELETED> ``(2) Implementation of alternative testing
methods.--To promote the development and timely incorporation
of new testing methods that are not based on vertebrate
animals, the Administrator shall--</DELETED>
<DELETED> ``(A) after providing an opportunity for
public comment, develop a strategic plan to promote the
development and implementation of alternative test
methods and testing strategies to generate information
under this title that can reduce, refine, or replace
the use of vertebrate animals, including toxicity
pathway-based risk assessment, in vitro studies,
systems biology, computational toxicology,
bioinformatics, and high-throughput
screening;</DELETED>
<DELETED> ``(B) as practicable, ensure that the
strategic plan developed under subparagraph (A) is
reflected in the development of requirements for
testing under this section;</DELETED>
<DELETED> ``(C) beginning on the date that is 5
years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act and
every 5 years thereafter, submit to Congress a report
that describes the progress made in implementing this
subsection and goals for future alternative test
methods implementation; and</DELETED>
<DELETED> ``(D) fund and carry out research,
development, performance assessment, and translational
studies to accelerate the development of test methods
and testing strategies that reduce, refine, or replace
the use of vertebrate animals in any testing under this
title.</DELETED>
<DELETED> ``(3) Criteria for adapting or waiving animal
testing requirements.--On request from a manufacturer or
processor that is required to conduct testing of a chemical
substance or mixture on vertebrate animals under this section,
the Administrator may adapt or waive the requirement, if the
Administrator determines that--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(B) as a result of 1 or more physical or
chemical properties of the chemical substance or
mixture or other toxicokinetic considerations--
</DELETED>
<DELETED> ``(i) the substance cannot be
absorbed; or</DELETED>
<DELETED> ``(ii) testing for a specific
endpoint is technically not practicable to
conduct; or</DELETED>
<DELETED> ``(C) a chemical substance or mixture
cannot be tested in vertebrate animals at
concentrations that do not result in significant pain
or distress, because of physical or chemical properties
of the chemical substance or mixture, such as a
potential to cause severe corrosion or severe
irritation to the tissues of the animal.</DELETED>
<DELETED> ``(d) Testing Requirements.--</DELETED>
<DELETED> ``(1) In general.--The Administrator may require
the development of information by--</DELETED>
<DELETED> ``(A) manufacturers and processors of the
chemical substance or mixture; and</DELETED>
<DELETED> ``(B) persons that begin to manufacture or
process the chemical substance or mixture--</DELETED>
<DELETED> ``(i) after the effective date of
the rule, testing consent agreement, or order;
but</DELETED>
<DELETED> ``(ii) subject to paragraph (3),
before the period ending on the date that is
180 days after the end of the period described
in this section.</DELETED>
<DELETED> ``(2) Designation.--The Administrator may permit 2
or more persons identified in subparagraph (A) or (B) of
paragraph (1) to designate 1 of the persons or a qualified
third party--</DELETED>
<DELETED> ``(A) to develop the information;
and</DELETED>
<DELETED> ``(B) to submit the information on behalf
of the persons making the designation.</DELETED>
<DELETED> ``(3) Exemptions.--</DELETED>
<DELETED> ``(A) In general.--A person otherwise
subject to a rule, testing consent agreement, or order
under this section may submit to the Administrator an
application for an exemption on the basis that the
information is being developed by a person designated
under paragraph (2).</DELETED>
<DELETED> ``(B) Fair and equitable reimbursement to
designee.--</DELETED>
<DELETED> ``(i) In general.--If the
Administrator accepts an application submitted
under subparagraph (A), the Administrator shall
direct the applicant to provide to the person
designated under paragraph (2) fair and
equitable reimbursement, as agreed to between
the applicant and the designee.</DELETED>
<DELETED> ``(ii) Arbitration.--If the
applicant and a person designated under
paragraph (2) cannot reach agreement on the
amount of fair and equitable reimbursement, the
amount shall be determined by
arbitration.</DELETED>
<DELETED> ``(C) Termination.--If, after granting an
exemption under this paragraph, the Administrator
determines that a person covered by the exemption has
failed to comply with the rule, testing consent
agreement, or order, the Administrator shall--
</DELETED>
<DELETED> ``(i) by order, terminate the
exemption; and</DELETED>
<DELETED> ``(ii) notify in writing each
person that received an exemption of the
requirements with respect to which the
exemption was granted.</DELETED>
<DELETED> ``(e) Transparency.--Subject to section 14, the
Administrator shall make available to the public all testing consent
agreements and orders and all information submitted under this
section.''.</DELETED>
<DELETED> (b) Conforming Amendment.--Section 104(i)(5)(A) of the
Comprehensive Environmental Response, Compensation, and Liability Act
of 1980 (42 U.S.C. 9604(i)(5)(A)) is amended in the third sentence by
striking ``section 4(e)'' and inserting ``section 4(f)''.</DELETED>
<DELETED>SEC. 6. PRIORITIZATION SCREENING.</DELETED>
<DELETED> The Toxic Substances Control Act is amended by inserting
after section 4 (15 U.S.C. 2603) the following:</DELETED>
<DELETED>``SEC. 4A. PRIORITIZATION SCREENING.</DELETED>
<DELETED> ``(a) Establishment and List of Substances.--</DELETED>
<DELETED> ``(1) In general.--Not later than 1 year after the
date of enactment of this section, the Administrator shall
establish, by rule, a risk-based screening process and explicit
criteria for identifying existing chemical substances that
are--</DELETED>
<DELETED> ``(A) a high priority for a safety
assessment and safety determination under section 6
(referred to in this Act as `high-priority
substances'); and</DELETED>
<DELETED> ``(B) a low priority for a safety
assessment and safety determination (referred to in
this Act as `low-priority substances').</DELETED>
<DELETED> ``(2) Initial list of high- and low-priority
substances.--</DELETED>
<DELETED> ``(A) In general.--Before the date of
promulgation of the rule under paragraph (1) and not
later than 180 days after the date of enactment of this
section, the Administrator--</DELETED>
<DELETED> ``(i) shall take into
consideration and publish an initial list of
high-priority substances and low-priority
substances; and</DELETED>
<DELETED> ``(ii) pursuant to section 6(b),
may initiate or continue safety assessments and
safety determinations for those high-priority
substances.</DELETED>
<DELETED> ``(B) Requirements.--</DELETED>
<DELETED> ``(i) In general.--The initial
list of chemical substances shall contain at
least 10 high-priority substances, at least 5
of which are drawn from the list of chemical
substances identified by the Administrator in
the October, 2014 TSCA Work Plan and subsequent
updates, and at least 10 low-priority
substances.</DELETED>
<DELETED> ``(ii) Subsequently identified
substances.--Insofar as possible, at least 50
percent of all substances subsequently
identified by the Administrator as high-
priority substances shall be drawn from the
list of chemical substances identified by the
Administrator in the October, 2014 TSCA Work
Plan and subsequent updates, until all Work
Plan chemicals have been designated under this
subsection.</DELETED>
<DELETED> ``(C) Additional chemical reviews.--The
Administrator shall--</DELETED>
<DELETED> ``(i) 3 years after the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, add additional
high-priority substances sufficient to ensure
that at least a total of 20 high-priority
substances have undergone or are undergoing the
process established in section 6(a), and
additional low-priority substances sufficient
to ensure that at least a total of 20 low-
priority substances have been designated;
and</DELETED>
<DELETED> ``(ii) as soon as practicable and
not later than 5 years after the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, add additional
high-priority substances sufficient to ensure
that at least a total of 25 high-priority
substances have undergone or are undergoing the
process established in section 6(a), and
additional low-priority substances sufficient
to ensure that at least a total of 25 low-
priority substances have been
designated.</DELETED>
<DELETED> ``(3) Implementation.--</DELETED>
<DELETED> ``(A) Consideration of active and inactive
substances.--</DELETED>
<DELETED> ``(i) Active substances.--In
carrying out paragraph (1), the Administrator
shall take into consideration active
substances, as determined under section 8,
which may include chemical substances on the
interim list of active substances established
under that section.</DELETED>
<DELETED> ``(ii) Inactive substances.--In
carrying out paragraph (1), the Administrator
may take into consideration inactive
substances, as determined under section 8, that
the Administrator determines--</DELETED>
<DELETED> ``(I)(aa) have not been
subject to a regulatory or other
enforceable action by the Administrator
to ban or phase out the substances;
and</DELETED>
<DELETED> ``(bb) have the potential
for high hazard and widespread
exposure; or</DELETED>
<DELETED> ``(II)(aa) have been
subject to a regulatory or other
enforceable action by the Administrator
to ban or phase out the substances;
and</DELETED>
<DELETED> ``(bb) with respect to
which there exists the potential for
residual high hazards or widespread
exposures not otherwise addressed by
the regulatory or other
action.</DELETED>
<DELETED> ``(iii) Repopulation.--</DELETED>
<DELETED> ``(I) In general.--On the
completion of a safety determination
under section 6 for a chemical
substance, the Administrator shall
remove the chemical substance from the
list of high-priority substances
established under this
subsection.</DELETED>
<DELETED> ``(II) Additions.--The
Administrator shall add at least 1
chemical substance to the list of high-
priority substances for each chemical
substance removed from the list of
high-priority substances established
under this subsection, until a safety
assessment and safety determination is
completed for all high-priority
substances.</DELETED>
<DELETED> ``(III) Low-priority
substances.--If a low-priority
substance is subsequently designated as
a high-priority substance, the
Administrator shall remove that
substance from the list of low-priority
substances.</DELETED>
<DELETED> ``(B) Timely completion of prioritization
screening process.--</DELETED>
<DELETED> ``(i) In general.--The
Administrator shall--</DELETED>
<DELETED> ``(I) not later than 180
days after the effective date of the
final rule under paragraph (1), begin
the prioritization screening process;
and</DELETED>
<DELETED> ``(II) make every effort
to complete the designation of all
active substances as high-priority
substances or low-priority substances
in a timely manner.</DELETED>
<DELETED> ``(ii) Decisions on substances
subject to testing for prioritization
purposes.--Not later than 90 days after the
date of receipt of information regarding a
chemical substance complying with a rule,
testing consent agreement, or order issued
under section 4(a)(2), the Administrator shall
designate the chemical substance as a high-
priority substance or low-priority
substance.</DELETED>
<DELETED> ``(iii) Consideration.--</DELETED>
<DELETED> ``(I) In general.--The
Administrator shall screen substances
and designate high-priority substances
taking into consideration the ability
of the Administrator to schedule and
complete safety assessments and safety
determinations under section 6 in a
timely manner.</DELETED>
<DELETED> ``(II) Annual goal.--The
Administrator shall publish an annual
goal for the number of chemical
substances to be subject to the
prioritization screening
process.</DELETED>
<DELETED> ``(C) Screening of categories of
substances.--The Administrator may screen categories of
chemical substances to ensure an efficient
prioritization screening process to allow for timely
and adequate designations of high-priority substances
and low-priority substances and safety assessments and
safety determinations for high-priority
substances.</DELETED>
<DELETED> ``(D) Publication of list of chemical
substances.--Not less frequently than once each year,
the Administrator shall publish a list of chemical
substances that--</DELETED>
<DELETED> ``(i) are being considered in the
prioritization screening process and the status
of the chemical substances in the
prioritization process, including those
chemical substances for which prioritization
decisions have been deferred; and</DELETED>
<DELETED> ``(ii) are designated as high-
priority substances or low-priority substances,
including the bases for such
designations.</DELETED>
<DELETED> ``(4) Criteria.--The criteria described in
paragraph (1) shall account for--</DELETED>
<DELETED> ``(A) the recommendation of the Governor
of a State or a State agency with responsibility for
protecting health or the environment from chemical
substances appropriate for prioritization
screening;</DELETED>
<DELETED> ``(B) the hazard and exposure potential of
the chemical substance (or category of substances),
including specific scientific classifications and
designations by authoritative governmental
entities;</DELETED>
<DELETED> ``(C) the conditions of use or significant
changes in the conditions of use of the chemical
substance;</DELETED>
<DELETED> ``(D) evidence and indicators of exposure
potential to humans or the environment from the
chemical substance, including potentially exposed or
susceptible populations;</DELETED>
<DELETED> ``(E) the volume of a chemical substance
manufactured or processed;</DELETED>
<DELETED> ``(F) whether the volume of a chemical
substance as reported under a rule promulgated pursuant
to section 8(a) has significantly increased or
decreased during the period beginning on the date of a
previous report or the date on which a notice has been
submitted under section 5(b) for that chemical
substance;</DELETED>
<DELETED> ``(G) the availability of information
regarding potential hazards and exposures required for
conducting a safety assessment or safety determination,
with limited availability of relevant information to be
a sufficient basis for designating a chemical substance
as a high-priority substance, subject to the condition
that limited availability shall not require designation
as a high-priority substance; and</DELETED>
<DELETED> ``(H) the extent of Federal or State
regulation of the chemical substance or the extent of
the impact of State regulation of the chemical
substance on the United States, with existing Federal
or State regulation of any uses evaluated in the
prioritization screening process as a factor in
designating a chemical substance to be a low-priority
substance.</DELETED>
<DELETED> ``(b) Prioritization Screening Process and Decisions.--
</DELETED>
<DELETED> ``(1) In general.--The prioritization screening
process developed under subsection (a) shall include a
requirement that the Administrator shall--</DELETED>
<DELETED> ``(A) identify the chemical substances
being considered for prioritization;</DELETED>
<DELETED> ``(B) request interested persons to supply
information regarding the chemical substances being
considered;</DELETED>
<DELETED> ``(C) apply the criteria identified in
subsection (a)(4); and</DELETED>
<DELETED> ``(D) subject to paragraph (5) and using
the information available to the Administrator at the
time of the decision, identify a chemical substance as
a high-priority substance or a low-priority
substance.</DELETED>
<DELETED> ``(2) Integration of information.--The
prioritization screening decision regarding a chemical
substance shall integrate any hazard and exposure information
relating to the chemical substance that is available to the
Administrator.</DELETED>
<DELETED> ``(3) Identification of high-priority
substances.--The Administrator--</DELETED>
<DELETED> ``(A) shall identify as a high-priority
substance a chemical substance that, relative to other
chemical substances, the Administrator determines has
the potential for high hazard and widespread
exposure;</DELETED>
<DELETED> ``(B) may identify as a high-priority
substance a chemical substance that, relative to other
chemical substances, the Administrator determines has
the potential for high hazard or widespread exposure;
and</DELETED>
<DELETED> ``(C) may identify as a high-priority
substance an inactive substance, as determined under
subsection (a)(3)(A)(ii) and section 8(b), that the
Administrator determines warrants a safety assessment
and safety determination under section 6.</DELETED>
<DELETED> ``(4) Identification of low-priority substances.--
The Administrator shall identify as a low-priority substance a
chemical substance that the Administrator concludes has
information sufficient to establish that the chemical substance
is likely to meet the applicable safety standard.</DELETED>
<DELETED> ``(5) Deferring a decision.--If the Administrator
determines that additional information is required to establish
the priority of a chemical substance under this section, the
Administrator may defer the prioritization screening decision
for a reasonable period--</DELETED>
<DELETED> ``(A) to allow for the submission of
additional information by an interested person and for
the Administrator to evaluate the additional
information; or</DELETED>
<DELETED> ``(B) to require the development of
information pursuant to a rule, testing consent
agreement, or order issued under section
4(a)(2).</DELETED>
<DELETED> ``(6) Deadlines for submission of information.--If
the Administrator requests the development or submission of
information under this section, the Administrator shall
establish a deadline for submission of the
information.</DELETED>
<DELETED> ``(7) Notice and comment.--The Administrator
shall--</DELETED>
<DELETED> ``(A) publish the proposed decisions made
under paragraphs (3), (4), and (5) and the basis for
the decisions; and</DELETED>
<DELETED> ``(B) provide an opportunity for public
comment.</DELETED>
<DELETED> ``(8) Revisions of prior designations.--</DELETED>
<DELETED> ``(A) In general.--At any time, and at the
discretion of the Administrator, the Administrator may
revise the designation of a chemical substance as a
high-priority substance or a low-priority substance
based on information available to the Administrator
after the date of the determination under paragraph (3)
or (4).</DELETED>
<DELETED> ``(B) Limited availability.--If limited
availability of relevant information was a basis in the
designation of a chemical substance as a high-priority
substance, the Administrator shall reevaluate the
prioritization screening of the chemical substance on
receiving the relevant information.</DELETED>
<DELETED> ``(9) Other information relevant to
prioritization.--</DELETED>
<DELETED> ``(A) In general.--If, after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, a State proposes an
administrative action or enacts a statute or takes an
administrative action to prohibit or otherwise restrict
the manufacturing, processing, distribution in
commerce, or use of a chemical substance that the
Administrator has not as designated a high-priority
substance, the Governor or State agency with
responsibility for implementing the statute or
administrative action shall notify the
Administrator.</DELETED>
<DELETED> ``(B) Requests for information.--Following
receipt of a notification provided under subparagraph
(A), the Administrator may request any available
information from the Governor or the State agency with
respect to--</DELETED>
<DELETED> ``(i) scientific evidence related
to the hazards, exposures and risks of the
chemical substance under the conditions of use
which the statute or administrative action is
intended to address;</DELETED>
<DELETED> ``(ii) any State or local
conditions which warranted the statute or
administrative action;</DELETED>
<DELETED> ``(iii) the statutory or
administrative authority on which the action is
based; and</DELETED>
<DELETED> ``(iv) any other available
information relevant to the prohibition or
other restriction, including information on any
alternatives considered and their hazards,
exposures, and risks.</DELETED>
<DELETED> ``(C) Prioritization screening.--The
Administrator shall conduct a prioritization screening
under this subsection for all substances that--
</DELETED>
<DELETED> ``(i) are the subject of
notifications received under subparagraph (A);
and</DELETED>
<DELETED> ``(ii) the Administrator
determines--</DELETED>
<DELETED> ``(I) are likely to have
significant health or environmental
impacts;</DELETED>
<DELETED> ``(II) are likely to have
significant impact on interstate
commerce; or</DELETED>
<DELETED> ``(III) have been subject
to a prohibition or other restriction
under a statute or administrative
action in 2 or more States.</DELETED>
<DELETED> ``(D) Availability to public.--Subject to
section 14 and any applicable State law regarding the
protection of confidential information provided to the
State or to the Administrator, the Administrator shall
make information received from a Governor or State
agency under subparagraph (A) publicly
available.</DELETED>
<DELETED> ``(E) Effect of paragraph.--Nothing in
this paragraph shall preempt a State statute or
administrative action, require approval of a State
statute or administrative action, or apply section 15
to a State.</DELETED>
<DELETED> ``(10) Review.--Not less frequently than once
every 5 years after the date on which the process under this
subsection is established, the Administrator shall--</DELETED>
<DELETED> ``(A) review the process on the basis of
experience and taking into consideration resources
available to efficiently and effectively screen and
prioritize chemical substances; and</DELETED>
<DELETED> ``(B) if necessary, modify the
prioritization screening process.</DELETED>
<DELETED> ``(11) Effect.--Subject to section 18, a
designation by the Administrator under this section with
respect to a chemical substance shall not affect--</DELETED>
<DELETED> ``(A) the manufacture, processing,
distribution in commerce, use, or disposal of the
chemical substance; or</DELETED>
<DELETED> ``(B) the regulation of those
activities.</DELETED>
<DELETED> ``(c) Additional Priorities for Safety Assessments and
Determinations.--</DELETED>
<DELETED> ``(1) In general.--The prioritization screening
process developed under subsection (a) shall--</DELETED>
<DELETED> ``(A) include a process by which a
manufacturer or processor of an active chemical
substance that has not been designated a high-priority
substance, or that has not been subject to or is not in
the process of a prioritization screening by the
Administrator, may request that the Administrator
designate the substance for a safety assessment and
safety determination, subject to the payment of fees
pursuant to section 26(b)(3)(E); and</DELETED>
<DELETED> ``(B) provide guidance to submitters on
the information to be provided in such requests, and
specify the criteria the Administrator shall use to
determine whether or not to grant such a request, which
shall include whether the substance is subject to
restrictions imposed by statutes enacted or
administrative actions taken by 1 or more States on the
manufacture, processing, distribution in commerce, or
use of the substance.</DELETED>
<DELETED> ``(2) Preference.--Subject to paragraph (3), in
deciding whether to grant requests under this subsection the
Administrator shall give a preference to requests concerning
substances for which the Administrator determines that
restrictions imposed by 1 or more States have the potential to
have a significant impact on interstate commerce or health or
the environment.</DELETED>
<DELETED> ``(3) Limitations.--In considering whether to
grant a request submitted under paragraph (1), the
Administrator shall ensure that--</DELETED>
<DELETED> ``(A) not more than 15 percent of the
total number of substances designated to undergo safety
assessments and safety determinations under this
section are substances designated under the process and
criteria pursuant to paragraph (1); and</DELETED>
<DELETED> ``(B) the resources allocated to
conducting safety assessments and safety determinations
for additional priorities designated under this
subsection are proportionate to the number of such
substances relative to the total number of substances
designated to undergo safety assessments and safety
determinations under this section.</DELETED>
<DELETED> ``(4) Requirements.--</DELETED>
<DELETED> ``(A) In general.--The public shall be
provided notice and an opportunity to comment on
requests submitted under this subsection.</DELETED>
<DELETED> ``(B) Decision by administrator.--Not
later than 180 days after the date on which the
Administrator receives a request under this subsection,
the Administrator shall decide whether or not to grant
the request.</DELETED>
<DELETED> ``(C) Assessment and determination.--If
the Administrator grants a request under this
subsection, the safety assessment and safety
determination--</DELETED>
<DELETED> ``(i) shall be conducted in
accordance with the deadlines and other
requirements of sections 3A(i) and 6;
and</DELETED>
<DELETED> ``(ii) shall not be expedited or
otherwise subject to special treatment relative
to high-priority substances designated pursuant
to subsection (b)(3) that are undergoing safety
assessments and safety
determinations.</DELETED>
<DELETED> ``(5) Exceptions.--Requests granted under this
subsection shall not be subject to subsection (a)(3)(A)(iii) or
section 18(b).''.</DELETED>
<DELETED>SEC. 7. NEW CHEMICALS AND SIGNIFICANT NEW USES.</DELETED>
<DELETED> Section 5 of the Toxic Substances Control Act (15 U.S.C.
2604) is amended--</DELETED>
<DELETED> (1) by striking the section designation and
heading and inserting the following:</DELETED>
<DELETED>``SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.'';</DELETED>
<DELETED> (2) by striking subsection (b);</DELETED>
<DELETED> (3) by redesignating subsection (a) as subsection
(b);</DELETED>
<DELETED> (4) by redesignating subsection (i) as subsection
(a) and moving the subsection so as to appear at the beginning
of the section;</DELETED>
<DELETED> (5) in subsection (b) (as so redesignated)--
</DELETED>
<DELETED> (A) in the subsection heading, by striking
``In General'' and inserting ``Notices''; and</DELETED>
<DELETED> (B) in paragraph (1), in the matter
following subparagraph (B)--</DELETED>
<DELETED> (i) by striking ``subsection (d)''
and inserting ``subsection (b)''; and</DELETED>
<DELETED> (ii) by striking ``and such person
complies with any applicable requirement of
subsection (b)'';</DELETED>
<DELETED> (6) by redesignating subsections (c) and (d) as
subsection (d) and (c), respectively, and moving subsection (c)
(as so redesigned) so as appear after subsection (b) (as
redesignated by paragraph (3));</DELETED>
<DELETED> (7) in subsection (c) (as so redesignated)--
</DELETED>
<DELETED> (A) by striking paragraph (1) and
inserting the following:</DELETED>
<DELETED> ``(1) In general.--The notice required by
subsection (a) shall include, with respect to a chemical
substance--</DELETED>
<DELETED> ``(A) the information required by sections
720.45 and 720.50 of title 40, Code of Federal
Regulations (or successor regulations); and</DELETED>
<DELETED> ``(B) information regarding conditions of
use and reasonably anticipated exposures.'';</DELETED>
<DELETED> (B) in paragraph (2)--</DELETED>
<DELETED> (i) in the matter preceding
subparagraph (A), by striking ``or of data
under subsection (b)'';</DELETED>
<DELETED> (ii) in subparagraph (A), by
adding ``and'' after the semicolon at the
end;</DELETED>
<DELETED> (iii) in subparagraph (B), by
striking ``; and'' and inserting a period;
and</DELETED>
<DELETED> (iv) by striking subparagraph (C);
and</DELETED>
<DELETED> (C) in paragraph (3), by striking
``subsection (a) and for which the notification period
prescribed by subsection (a), (b), or (c)'' and
inserting ``subsection (b) and for which the
notification period prescribed by subsection (b) or
(d)'';</DELETED>
<DELETED> (8) by striking subsection (d) (as redesignated by
paragraph (6)) and inserting the following:</DELETED>
<DELETED> ``(d) Review of Notice.--</DELETED>
<DELETED> ``(1) Initial review.--</DELETED>
<DELETED> ``(A) In general.--Subject to subparagraph
(B), not later than 90 days after the date of receipt
of a notice submitted under subsection (b), the
Administrator shall--</DELETED>
<DELETED> ``(i) conduct an initial review of
the notice;</DELETED>
<DELETED> ``(ii) as needed, develop a
profile of the relevant chemical substance and
the potential for exposure to humans and the
environment; and</DELETED>
<DELETED> ``(iii) make any necessary
determination under paragraph (3).</DELETED>
<DELETED> ``(B) Extension.--Except as provided in
paragraph (5), the Administrator may extend the period
described in subparagraph (A) for good cause for 1 or
more periods, the total of which shall be not more than
90 days.</DELETED>
<DELETED> ``(2) Information sources.--In evaluating a notice
under paragraph (1), the Administrator shall take into
consideration--</DELETED>
<DELETED> ``(A) any relevant information identified
in subsection (c)(1); and</DELETED>
<DELETED> ``(B) any other relevant additional
information available to the Administrator.</DELETED>
<DELETED> ``(3) Determinations.--Before the end of the
applicable period for review under paragraph (1), based on the
information described in paragraph (2), and subject to section
18(g), the Administrator shall determine that--</DELETED>
<DELETED> ``(A) the relevant chemical substance or
significant new use is not likely to meet the safety
standard, in which case the Administrator shall take
appropriate action under paragraph (4);</DELETED>
<DELETED> ``(B) the relevant chemical substance or
significant new use is likely to meet the safety
standard, in which case the Administrator shall allow
the review period to expire without additional
restrictions; or</DELETED>
<DELETED> ``(C) additional information is necessary
in order to make a determination under subparagraph (A)
or (B), in which case the Administrator shall take
appropriate action under paragraph (5).</DELETED>
<DELETED> ``(4) Restrictions.--</DELETED>
<DELETED> ``(A) Determination by administrator.--
</DELETED>
<DELETED> ``(i) In general.--If the
Administrator makes a determination under
subparagraph (A) or (C) of paragraph (3) with
respect to a notice submitted under subsection
(b)--</DELETED>
<DELETED> ``(I) the Administrator,
before the end of the applicable period
for review under paragraph (1) and by
consent agreement or order, as
appropriate, shall prohibit or
otherwise restrict the manufacture,
processing, use, distribution in
commerce, or disposal (as applicable)
of the chemical substance, or of the
chemical substance for a significant
new use, without compliance with the
restrictions specified in the consent
agreement or order that the
Administrator determines are sufficient
to ensure that the chemical substance
or significant new use is likely to
meet the safety standard; and</DELETED>
<DELETED> ``(II) no person may
commence manufacture of the chemical
substance, or manufacture or processing
of the chemical substance for a
significant new use, except in
compliance with the restrictions
specified in the consent agreement or
order.</DELETED>
<DELETED> ``(ii) Likely to meet standard.--
If the Administrator makes a determination
under subparagraph (B) of paragraph (3) with
respect to a chemical substance or significant
new use for which a notice was submitted under
subsection (b), at the end of the applicable
period for review under paragraph (1), the
submitter of the notice may commence
manufacture for commercial purposes of the
chemical substance or manufacture or processing
of the chemical substance for a significant new
use.</DELETED>
<DELETED> ``(B) Requirements.--Not later than 90
days after issuing a consent agreement or order under
subparagraph (A), the Administrator shall--</DELETED>
<DELETED> ``(i) take into consideration
whether to promulgate a rule pursuant to
subsection (b)(2) that identifies as a
significant new use any manufacturing,
processing, use, distribution in commerce, or
disposal of the chemical substance, or of the
chemical substance for a new use, that is not
in compliance with the restrictions imposed by
the consent agreement or order; and</DELETED>
<DELETED> ``(ii)(I) initiate a rulemaking
described in clause (i); or</DELETED>
<DELETED> ``(II) publish a statement
describing the reasons of the Administrator for
not initiating a rulemaking.</DELETED>
<DELETED> ``(C) Inclusions.--A prohibition or other
restriction under subparagraph (A) may include, as
appropriate--</DELETED>
<DELETED> ``(i) subject to section 18(g), a
requirement that a chemical substance shall be
marked with, or accompanied by, clear and
adequate minimum warnings and instructions with
respect to use, distribution in commerce, or
disposal, or any combination of those
activities, with the form and content of the
minimum warnings and instructions to be
prescribed by the Administrator;</DELETED>
<DELETED> ``(ii) a requirement that
manufacturers or processors of the chemical
substance shall--</DELETED>
<DELETED> ``(I) make and retain
records of the processes used to
manufacture or process, as applicable,
the chemical substance; or</DELETED>
<DELETED> ``(II) monitor or conduct
such additional tests as are reasonably
necessary to address potential risks
from the manufacture, processing,
distribution in commerce, use, or
disposal, as applicable, of the
chemical substance, subject to section
4;</DELETED>
<DELETED> ``(iii) a restriction on the
quantity of the chemical substance that may be
manufactured, processed, or distributed in
commerce--</DELETED>
<DELETED> ``(I) in general;
or</DELETED>
<DELETED> ``(II) for a particular
use;</DELETED>
<DELETED> ``(iv) a prohibition or other
restriction of--</DELETED>
<DELETED> ``(I) the manufacture,
processing, or distribution in commerce
of the chemical substance for a
significant new use;</DELETED>
<DELETED> ``(II) any method of
commercial use of the chemical
substance; or</DELETED>
<DELETED> ``(III) any method of
disposal of the chemical substance;
or</DELETED>
<DELETED> ``(v) a prohibition or other
restriction on the manufacture, processing, or
distribution in commerce of the chemical
substance--</DELETED>
<DELETED> ``(I) in general;
or</DELETED>
<DELETED> ``(II) for a particular
use.</DELETED>
<DELETED> ``(D) Workplace exposures.--The
Administrator shall consult with the Assistant
Secretary of Labor for Occupational Safety and Health
prior to adopting any prohibition or other restriction
under this subsection to address workplace
exposures.</DELETED>
<DELETED> ``(E) Definition of requirement.--For
purposes of this Act, the term `requirement' as used in
this section does not displace common law.</DELETED>
<DELETED> ``(5) Additional information.--If the
Administrator determines under paragraph (3)(C) that additional
information is necessary to conduct a review under this
subsection, the Administrator--</DELETED>
<DELETED> ``(A) shall provide an opportunity for the
submitter of the notice to submit the additional
information;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(C) may promulgate a rule, enter into a
testing consent agreement, or issue an order under
section 4 to require the development of the
information; and</DELETED>
<DELETED> ``(D) on receipt of information the
Administrator finds supports the determination under
paragraph (3), shall promptly make the
determination.'';</DELETED>
<DELETED> (9) by striking subsections (e) through (g) and
inserting the following:</DELETED>
<DELETED> ``(e) Notice of Commencement.--</DELETED>
<DELETED> ``(1) In general.--Not later than 30 days after
the date on which a manufacturer that has submitted a notice
under subsection (b) commences nonexempt commercial manufacture
of a chemical substance, the manufacturer shall submit to the
Administrator a notice of commencement that identifies--
</DELETED>
<DELETED> ``(A) the name of the manufacturer;
and</DELETED>
<DELETED> ``(B) the initial date of nonexempt
commercial manufacture.</DELETED>
<DELETED> ``(2) Withdrawal.--A manufacturer or processor
that has submitted a notice under subsection (b), but that has
not commenced nonexempt commercial manufacture or processing of
the chemical substance, may withdraw the notice.</DELETED>
<DELETED> ``(f) Further Evaluation.--The Administrator may review a
chemical substance under section 4A at any time after the Administrator
receives--</DELETED>
<DELETED> ``(1) a notice of commencement for a chemical
substance under subsection (c); or</DELETED>
<DELETED> ``(2) new information regarding the chemical
substance.</DELETED>
<DELETED> ``(g) Transparency.--Subject to section 14, the
Administrator shall make available to the public--</DELETED>
<DELETED> ``(1) all notices, determinations, consent
agreements, rules, and orders of the Administrator;
and</DELETED>
<DELETED> ``(2) all information submitted or issued under
this section.''; and</DELETED>
<DELETED> (10) in subsection (h)--</DELETED>
<DELETED> (A) in paragraph (1), in the matter
preceding subparagraph (A), by striking ``(a)
or'';</DELETED>
<DELETED> (B) by striking paragraph (2);</DELETED>
<DELETED> (C) by redesignating paragraphs (3)
through (6) as paragraphs (2) through (5),
respectively;</DELETED>
<DELETED> (D) in paragraph (2) (as so redesignated),
in the matter preceding subparagraph (A), by striking
``subsections (a) and (b)'' and inserting ``subsection
(b)'';</DELETED>
<DELETED> (E) in paragraph (3) (as so
redesignated)--</DELETED>
<DELETED> (i) in the first sentence, by
striking ``will not present an unreasonable
risk of injury to health or the environment''
and inserting ``will meet the safety
standard''; and</DELETED>
<DELETED> (ii) by striking the second
sentence;</DELETED>
<DELETED> (F) in paragraph (4) (as so redesignated),
by striking ``subsections (a) and (b)'' and inserting
``subsection (b)''; and</DELETED>
<DELETED> (G) in paragraph (5) (as so redesignated),
in the first sentence, by striking ``paragraph (1) or
(5)'' and inserting ``paragraph (1) or (4)''.</DELETED>
<DELETED>SEC. 8. SAFETY ASSESSMENTS AND SAFETY
DETERMINATIONS.</DELETED>
<DELETED> Section 6 of the Toxic Substances Control Act (15 U.S.C.
2605) is amended--</DELETED>
<DELETED> (1) by striking the section designation and
heading and inserting the following:</DELETED>
<DELETED>``SEC. 6. SAFETY ASSESSMENTS AND SAFETY
DETERMINATIONS.'';</DELETED>
<DELETED> (2) by redesignating subsections (e) and (f) as
subsections (g) and (h), respectively;</DELETED>
<DELETED> (3) by striking subsections (a) through (d) and
inserting the following:</DELETED>
<DELETED> ``(a) In General.--The Administrator--</DELETED>
<DELETED> ``(1) shall conduct a safety assessment and make a
safety determination of each high-priority substance in
accordance with subsections (b) and (c);</DELETED>
<DELETED> ``(2) shall, as soon as practicable and not later
than 6 months after the date on which a chemical substance is
designated as a high-priority substance, define the scope of
the safety assessment and safety determination to be conducted
pursuant to this section, including the hazards, exposures,
conditions of use, and potentially exposed or susceptible
populations that the Administrator expects to
consider;</DELETED>
<DELETED> ``(3) as appropriate based on the results of a
safety determination, shall establish restrictions pursuant to
subsection (d);</DELETED>
<DELETED> ``(4) shall complete a safety assessment and
safety determination not later than 3 years after the date on
which a chemical substance is designated as a high-priority
substance;</DELETED>
<DELETED> ``(5) shall promulgate a final rule pursuant to
subsection (d) by not later than 2 years after the date on
which the safety determination is completed; and</DELETED>
<DELETED> ``(6) may extend any deadline under this
subsection for a reasonable period of time after an adequate
public justification, subject to the condition that the
aggregate length of all extensions of deadlines under
paragraphs (4) and (5) and any deferral under subsection (c)(2)
does not exceed 2 years.</DELETED>
<DELETED> ``(b) Prior Actions.--</DELETED>
<DELETED> ``(1) Prior-initiated assessments.--</DELETED>
<DELETED> ``(A) In general.--Nothing in this Act
prevents the Administrator from initiating a safety
assessment or safety determination regarding a chemical
substance, or from continuing or completing such a
safety assessment or safety determination that was
initiated before the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act,
prior to the effective date of the policies and
procedures required to be established by the
Administrator under section 3A or 4A.</DELETED>
<DELETED> ``(B) Integration of prior policies and
procedures.--As policies and procedures under section
3A and 4A are established, to the maximum extent
practicable, the Administrator shall integrate the
policies and procedures into ongoing safety assessments
and safety determinations.</DELETED>
<DELETED> ``(2) Actions completed prior to completion of
policies and procedures.--Nothing in this Act requires the
Administrator to revise or withdraw a completed safety
assessment, safety determination, or rule solely because the
action was completed prior to the completion of a policy or
procedure established under section 3A or 4A, and the validity
of a completed assessment, determination, or rule shall not be
determined based on the content of such a policy or
procedure.</DELETED>
<DELETED> ``(c) Safety Determinations.--</DELETED>
<DELETED> ``(1) In general.--Based on a review of the
information available to the Administrator, including draft
safety assessments submitted by interested persons, and subject
to section 18, the Administrator shall determine that--
</DELETED>
<DELETED> ``(A) the relevant chemical substance
meets the safety standard;</DELETED>
<DELETED> ``(B) the relevant chemical substance does
not meet the safety standard, in which case the
Administrator shall, by rule under subsection (d)--
</DELETED>
<DELETED> ``(i) impose restrictions
necessary to ensure that the chemical substance
meets the safety standard under the conditions
of use; or</DELETED>
<DELETED> ``(ii) if the safety standard
cannot be met with the application of
restrictions, ban or phase out the chemical
substance, as appropriate; or</DELETED>
<DELETED> ``(C) additional information is necessary
in order to make a determination under subparagraph (A)
or (B), in which case the Administrator shall take
appropriate action under paragraph (2).</DELETED>
<DELETED> ``(2) Additional information.--If the
Administrator determines that additional information is
necessary to make a safety assessment or safety determination
for a high-priority substance, the Administrator--</DELETED>
<DELETED> ``(A) shall provide an opportunity for
interested persons to submit the additional
information;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(C) may defer, for a reasonable period
consistent with the deadlines described in subsection
(a), a safety assessment and safety determination until
after receipt of the information; and</DELETED>
<DELETED> ``(D) consistent with the deadlines
described in subsection (a), on receipt of information
the Administrator finds supports the safety assessment
and safety determination, shall make a determination
under paragraph (1).</DELETED>
<DELETED> ``(3) Establishment of deadline.--In requesting
the development or submission of information under this
section, the Administrator shall establish a deadline for the
submission of the information.</DELETED>
<DELETED> ``(d) Rule.--</DELETED>
<DELETED> ``(1) Implementation.--If the Administrator makes
a determination under subsection (c)(1)(B) with respect to a
chemical substance, the Administrator shall promulgate a rule
establishing restrictions necessary to ensure that the chemical
substance meets the safety standard.</DELETED>
<DELETED> ``(2) Scope.--The rule promulgated pursuant to
this subsection--</DELETED>
<DELETED> ``(A) may--</DELETED>
<DELETED> ``(i) apply to mixtures containing
the chemical substance, as appropriate;
and</DELETED>
<DELETED> ``(ii) exempt replacement parts
for articles manufactured prior to the
applicable compliance deadline; and</DELETED>
<DELETED> ``(B) shall include dates by which
compliance is mandatory, which--</DELETED>
<DELETED> ``(i) shall be as soon as
practicable; and</DELETED>
<DELETED> ``(ii) as determined by the
Administrator, may vary for different affected
persons.</DELETED>
<DELETED> ``(C) Workplace exposures.--The
Administrator shall consult with the Assistant
Secretary of Labor for Occupational Safety and Health
before adopting any prohibition or other restriction
under this subsection to address workplace
exposures.</DELETED>
<DELETED> ``(D) Definition of requirement.--For the
purposes of this Act, the term `requirement' as used in
this section does not displace common law.</DELETED>
<DELETED> ``(3) Restrictions.--A restriction under paragraph
(1) may include, as appropriate--</DELETED>
<DELETED> ``(A) subject to section 18, a requirement
that a chemical substance shall be marked with, or
accompanied by, clear and adequate minimum warnings and
instructions with respect to use, distribution in
commerce, or disposal, or any combination of those
activities, with the form and content of the minimum
warnings and instructions to be prescribed by the
Administrator;</DELETED>
<DELETED> ``(B) a requirement that manufacturers or
processors of the chemical substance shall--</DELETED>
<DELETED> ``(i) make and retain records of
the processes used to manufacture or process
the chemical substance;</DELETED>
<DELETED> ``(ii) describe and apply the
relevant quality control procedures followed in
the manufacturing or processing of the
substance; or</DELETED>
<DELETED> ``(iii) monitor or conduct tests
that are reasonably necessary to ensure
compliance with the requirements of any rule
under this subsection;</DELETED>
<DELETED> ``(C) a restriction on the quantity of the
chemical substance that may be manufactured, processed,
or distributed in commerce;</DELETED>
<DELETED> ``(D) a requirement to ban or phase out,
or any other rule regarding, the manufacture,
processing, or distribution in commerce of the chemical
substance for--</DELETED>
<DELETED> ``(i) a particular use;</DELETED>
<DELETED> ``(ii) a particular use at a
concentration in excess of a level specified by
the Administrator; or</DELETED>
<DELETED> ``(iii) all uses;</DELETED>
<DELETED> ``(E) a restriction on the quantity of the
chemical substance that may be manufactured, processed,
or distributed in commerce for--</DELETED>
<DELETED> ``(i) a particular use;
or</DELETED>
<DELETED> ``(ii) a particular use at a
concentration in excess of a level specified by
the Administrator;</DELETED>
<DELETED> ``(F) a requirement to ban, phase out, or
otherwise restrict any method of commercial use of the
chemical substance;</DELETED>
<DELETED> ``(G) a requirement to ban, phase out, or
otherwise restrict any method of disposal of the
chemical substance or any article containing the
chemical substance; and</DELETED>
<DELETED> ``(H) a requirement directing
manufacturers or processors of the chemical substance
to give notice of the Administrator's determination
under subsection (c)(1)(B) to distributors in commerce
of the chemical substance and, to the extent reasonably
ascertainable, to other persons in the chain of
commerce in possession of the chemical
substance.</DELETED>
<DELETED> ``(4) Analysis for rulemaking.--</DELETED>
<DELETED> ``(A) Considerations.--In deciding which
restrictions to impose under paragraph (3) as part of
developing a rule under paragraph (1), the
Administrator shall take into consideration, to the
extent practicable based on reasonably available
information, the quantifiable and nonquantifiable costs
and benefits of the proposed regulatory action and of
the 1 or more primary alternative regulatory actions
considered by the Administrator.</DELETED>
<DELETED> ``(B) Alternatives.--As part of the
analysis, the Administrator shall review any 1 or more
technically and economically feasible alternatives to
the chemical substance that the Administrator
determines are relevant to the rulemaking.</DELETED>
<DELETED> ``(C) Public availability.--In proposing a
rule under paragraph (1), the Administrator shall make
publicly available any analysis conducted under this
paragraph.</DELETED>
<DELETED> ``(D) Statement required.--In making final
a rule under paragraph (1), the Administrator shall
include a statement describing how the analysis
considered under subparagraph (A) was taken into
account.</DELETED>
<DELETED> ``(5) Exemptions.--</DELETED>
<DELETED> ``(A) In general.--The Administrator may
exempt 1 or more uses of a chemical substance from any
restriction in a rule promulgated under paragraph (1)
if the Administrator determines that--</DELETED>
<DELETED> ``(i) the rule cannot be complied
with, without--</DELETED>
<DELETED> ``(I) harming national
security;</DELETED>
<DELETED> ``(II) causing significant
disruption in the national economy due
to the lack of availability of a
chemical substance; or</DELETED>
<DELETED> ``(III) interfering with a
critical or essential use for which no
technically and economically feasible
safer alternative is available, taking
into consideration hazard and exposure;
or</DELETED>
<DELETED> ``(ii) the use of the chemical
substance, as compared to reasonably available
alternatives, provides a substantial benefit to
health, the environment, or public
safety.</DELETED>
<DELETED> ``(B) Exemption analysis.--In proposing a
rule under paragraph (1) that includes an exemption
under this paragraph, the Administrator shall make
publicly available any analysis conducted under this
paragraph to assess the need for the
exemption.</DELETED>
<DELETED> ``(C) Statement required.--In making final
a rule under paragraph (1) that includes an exemption
under this paragraph, the Administrator shall include a
statement describing how the analysis considered under
subparagraph (B) was taken into account.</DELETED>
<DELETED> ``(D) Analysis in case of ban or phase-
out.--In determining whether an exemption should be
granted under this paragraph for a chemical substance
for which a ban or phase-out is proposed, the
Administrator shall take into consideration, to the
extent practicable based on reasonably available
information, the quantifiable and nonquantifiable costs
and benefits of the 1 or more technically and
economically feasible alternatives to the chemical
substance most likely to be used in place of the
chemical substance under the conditions of use if the
rule is promulgated.</DELETED>
<DELETED> ``(E) Conditions.--As part of a rule
promulgated under paragraph (1), the Administrator
shall include conditions in any exemption established
under this paragraph, including reasonable
recordkeeping, monitoring, and reporting requirements,
to the extent that the Administrator determines the
conditions are necessary to protect health and the
environment while achieving the purposes of the
exemption.</DELETED>
<DELETED> ``(F) Duration.--</DELETED>
<DELETED> ``(i) In general.--The
Administrator shall establish, as part of a
rule under paragraph (1) that contains an
exemption under this paragraph, a time limit on
any exemption for a time to be determined by
the Administrator as reasonable on a case-by-
case basis.</DELETED>
<DELETED> ``(ii) Authority of
administrator.--The Administrator, by rule, may
extend, modify, or eliminate the exemption if
the Administrator determines, on the basis of
reasonably available information and after
adequate public justification, the exemption
warrants extension or is no longer
necessary.</DELETED>
<DELETED> ``(iii) Considerations.--
</DELETED>
<DELETED> ``(I) In general.--Subject
to subclause (II), the Administrator
shall issue exemptions and establish
time periods by considering factors
determined by the Administrator to be
relevant to the goals of fostering
innovation and the development of
alternatives that meet the safety
standard.</DELETED>
<DELETED> ``(II) Limitation.--Any
renewal of an exemption in the case of
a rule requiring the ban or phase-out
of a chemical substance shall not
exceed 5 years.</DELETED>
<DELETED> ``(e) Immediate Effect.--The Administrator may declare a
proposed rule under subsection (d) to be effective on publication of
the rule in the Federal Register and until the effective date of final
action taken respecting the rule, if--</DELETED>
<DELETED> ``(1) the Administrator determines that--
</DELETED>
<DELETED> ``(A) the manufacture, processing,
distribution in commerce, use, or disposal of the
chemical substance or mixture subject to the proposed
rule or any combination of those activities is likely
to result in an unreasonable risk of serious or
widespread harm to health or the environment before the
effective date; and</DELETED>
<DELETED> ``(B) making the proposed rule so
effective is necessary to protect the public interest;
and</DELETED>
<DELETED> ``(2) in the case of a proposed rule to prohibit
the manufacture, processing, or distribution of a chemical
substance or mixture because of the risk determined under
paragraph (1)(A), a court has granted relief in an action under
section 7 with respect to that risk associated with the
chemical substance or mixture.</DELETED>
<DELETED> ``(f) Final Agency Action.--Under this section and subject
to section 18--</DELETED>
<DELETED> ``(1) a safety determination, and the associated
safety assessment, for a chemical substance that the
Administrator determines under subsection (c) meets the safety
standard, shall be considered to be a final agency action,
effective beginning on the date of issuance of the final safety
determination; and</DELETED>
<DELETED> ``(2) a final rule promulgated under subsection
(d), and the associated safety assessment and safety
determination that a chemical substance does not meet the
safety standard, shall be considered to be a final agency
action, effective beginning on the date of promulgation of the
final rule.''; and</DELETED>
<DELETED> (4) in subsection (g) (as redesignated by
paragraph (2))--</DELETED>
<DELETED> (A) by striking paragraph (4);
and</DELETED>
<DELETED> (B) by redesignating paragraph (5) as
paragraph (4).</DELETED>
<DELETED>SEC. 9. IMMINENT HAZARDS.</DELETED>
<DELETED> Section 7 of the Toxic Substances Control Act (15 U.S.C.
2606) is amended--</DELETED>
<DELETED> (1) by striking subsection (a) and inserting the
following:</DELETED>
<DELETED> ``(a) Civil Actions.--</DELETED>
<DELETED> ``(1) In general.--The Administrator may commence
a civil action in an appropriate United States district court
for--</DELETED>
<DELETED> ``(A) seizure of an imminently hazardous
chemical substance or mixture or any article containing
the chemical substance or mixture;</DELETED>
<DELETED> ``(B) relief (as authorized by subsection
(b)) against any person that manufactures, processes,
distributes in commerce, uses, or disposes of, an
imminently hazardous chemical substance or mixture or
any article containing the chemical substance or
mixture; or</DELETED>
<DELETED> ``(C) both seizure described in
subparagraph (A) and relief described in subparagraph
(B).</DELETED>
<DELETED> ``(2) Rule, order, or other proceeding.--A civil
action may be commenced under this paragraph, notwithstanding--
</DELETED>
<DELETED> ``(A) the existence of--</DELETED>
<DELETED> ``(i) a decision by the
Administrator under section 4A, 5(d)(3), or
6(c)(1); or</DELETED>
<DELETED> ``(ii) a rule, testing consent
agreement, or order under section 4, 5(d)(4),
6(d), or 6(h); or</DELETED>
<DELETED> ``(B) the pendency of any administrative
or judicial proceeding under any provision of this
Act.'';</DELETED>
<DELETED> (2) in subsection (d), by striking ``section
6(a)'' and inserting ``section 6(c)''; and</DELETED>
<DELETED> (3) in subsection (f), in the first sentence, by
striking ``and unreasonable''.</DELETED>
<DELETED>SEC. 10. INFORMATION COLLECTION AND REPORTING.</DELETED>
<DELETED> Section 8 of the Toxic Substances Control Act (15 U.S.C.
2607) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) in paragraph (3)(A)(ii)(I)--</DELETED>
<DELETED> (i) by striking ``5(b)(4)'' and
inserting ``5'';</DELETED>
<DELETED> (ii) by inserting ``section 4 or''
after ``in effect under''; and</DELETED>
<DELETED> (iii) by striking ``5(e),'' and
inserting ``5(d)(4);''; and</DELETED>
<DELETED> (B) by adding at the end the
following:</DELETED>
<DELETED> ``(4) Rules.--</DELETED>
<DELETED> ``(A) Deadline.--</DELETED>
<DELETED> ``(i) In general.--Not later than
2 years after the date of enactment of the
Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall
promulgate rules requiring the maintenance of
records and the reporting of information known
or reasonably ascertainable by the person
making the report, including rules requiring
processors to report information, so that the
Administrator has the information necessary to
carry out sections 4 and 6.</DELETED>
<DELETED> ``(ii) Modification of prior
rules.--In carrying out this subparagraph, the
Administrator may modify, as appropriate, rules
promulgated before the date of enactment of the
Frank R. Lautenberg Chemical Safety for the
21st Century Act.</DELETED>
<DELETED> ``(B) Contents.--The rules promulgated
pursuant to subparagraph (A)--</DELETED>
<DELETED> ``(i) may impose different
reporting and recordkeeping requirements on
manufacturers and processors; and</DELETED>
<DELETED> ``(ii) shall include the level of
detail necessary to be reported, including the
manner by which use and exposure information
may be reported.</DELETED>
<DELETED> ``(C) Administration.--In implementing the
reporting and recordkeeping requirements under this
paragraph, the Administrator shall take measures--
</DELETED>
<DELETED> ``(i) to limit the potential for
duplication in reporting
requirements;</DELETED>
<DELETED> ``(ii) to minimize the impact of
the rules on small manufacturers and
processors; and</DELETED>
<DELETED> ``(iii) to apply any reporting
obligations to those persons likely to have
information relevant to the effective
implementation of this title.</DELETED>
<DELETED> ``(5) Guidance.--The Administrator shall develop
guidance relating to the information required to be reported
under the rules promulgated under this subsection.'';</DELETED>
<DELETED> (2) in subsection (b), by adding at the end the
following:</DELETED>
<DELETED> ``(3) Nomenclature.--</DELETED>
<DELETED> ``(A) In general.--In carrying out
paragraph (1), the Administrator shall--</DELETED>
<DELETED> ``(i) maintain the use of Class 2
nomenclature in use on the date of enactment of
the Frank R. Lautenberg Chemical Safety for the
21st Century Act;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(I) cement, Portland,
chemicals, CAS No. 65997-15-
1;</DELETED>
<DELETED> ``(II) cement, alumina,
chemicals, CAS No. 65997-16-
2;</DELETED>
<DELETED> ``(III) glass, oxide,
chemicals, CAS No. 65997-17-
3;</DELETED>
<DELETED> ``(IV) frits, chemicals,
CAS No. 65997-18-4;</DELETED>
<DELETED> ``(V) steel manufacture,
chemicals, CAS No. 65997-19-5;
and</DELETED>
<DELETED> ``(VI) ceramic materials
and wares, chemicals, CAS No. 66402-68-
4.</DELETED>
<DELETED> ``(B) Multiple nomenclature conventions.--
</DELETED>
<DELETED> ``(i) In general.--If an existing
guidance allows for multiple nomenclature
conventions, the Administrator shall--
</DELETED>
<DELETED> ``(I) maintain the
nomenclature conventions for
substances; and</DELETED>
<DELETED> ``(II) develop new
guidance that--</DELETED>
<DELETED> ``(aa) establishes
equivalency between the
nomenclature conventions for
chemical substances on the list
published under paragraph (1);
and</DELETED>
<DELETED> ``(bb) permits
persons to rely on the new
guidance for purposes of
determining whether a chemical
substance is on the list
published under paragraph
(1).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Chemical substances in commerce.--</DELETED>
<DELETED> ``(A) Rules.--</DELETED>
<DELETED> ``(i) In general.--Not later than
1 year after the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st
Century Act, the Administrator, by rule, shall
require manufacturers and processors to notify
the Administrator, by not later than 180 days
after the date of promulgation of the rule, of
each chemical substance on the list published
under paragraph (1) that the manufacturer or
processor, as applicable, has manufactured or
processed for a nonexempt commercial purpose
during the 10-year period ending on the day
before the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act.</DELETED>
<DELETED> ``(ii) Active substances.--The
Administrator shall, pursuant to paragraph
(5)(A), designate chemical substances for which
notices are received under clause (i) to be
active substances on the list published under
paragraph (1).</DELETED>
<DELETED> ``(B) Confidential chemical substances.--
The rule promulgated by the Administrator pursuant to
subparagraph (A) shall require--</DELETED>
<DELETED> ``(i) the Administrator to
maintain the list under paragraph (1), which
shall include a confidential portion and a
nonconfidential portion consistent with this
section and section 14;</DELETED>
<DELETED> ``(ii) a manufacturer or processor
that is submitting a notice pursuant to
subparagraph (A) for a chemical substance on
the confidential portion of the list published
under paragraph (1) to indicate in the notice
whether the manufacturer or processor seeks to
maintain any existing claim for protection
against disclosure of the specific identity of
the substance as confidential pursuant to
section 14; and</DELETED>
<DELETED> ``(iii) the substantiation of
those claims pursuant to section 14 and in
accordance with the review plan described in
subparagraph (C).</DELETED>
<DELETED> ``(C) Review plan.--Not later than 1 year
after the date on which the Administrator compiles the
initial list of active substances pursuant to
subparagraph (A), the Administrator shall promulgate a
rule that establishes a plan to review all claims to
protect the specific identities of chemical substances
on the confidential portion of the list published under
paragraph (1) that are notified pursuant to
subparagraph (A) or identified as active substances
under subsection (f)(1).</DELETED>
<DELETED> ``(D) Requirements of review plan.--The
review plan under subparagraph (C) shall--</DELETED>
<DELETED> ``(i) require, at the time
requested by the Administrator, all
manufacturers or processors asserting claims
under subparagraph (B) to substantiate the
claim unless the manufacturer or processor has
substantiated the claim in a submission made to
the Administrator during the 5-year period
ending on the date of the request by the
Administrator;</DELETED>
<DELETED> ``(ii) require the Administrator,
in accordance with section 14--</DELETED>
<DELETED> ``(I) to review each
substantiation--</DELETED>
<DELETED> ``(aa) submitted
pursuant to clause (i) to
determine if the claim warrants
protection from disclosure;
and</DELETED>
<DELETED> ``(bb) submitted
previously by a manufacturer or
processor and relied on in lieu
of the substantiation required
pursuant to clause (i), if the
substantiation has not been
previously reviewed by the
Administrator, to determine if
the claim warrants protection
from disclosure;</DELETED>
<DELETED> ``(II) approve, modify, or
deny each claim; and</DELETED>
<DELETED> ``(III) except as provided
in this section and section 14, protect
from disclosure information for which
the Administrator approves such a claim
for a period of 10 years, unless, prior
to the expiration of the period--
</DELETED>
<DELETED> ``(aa) the person
notifies the Administrator that
the person is withdrawing the
confidentiality claim, in which
case the Administrator shall
promptly make the information
available to the public;
or</DELETED>
<DELETED> ``(bb) the
Administrator otherwise becomes
aware that the need for
protection from disclosure can
no longer be substantiated, in
which case the Administrator
shall take the actions
described in section 14(g)(2);
and</DELETED>
<DELETED> ``(iii) encourage manufacturers or
processors that have previously made claims to
protect the specific identities of chemical
substances identified as inactive pursuant to
subsection (f)(2) to review and either withdraw
or substantiate the claims.</DELETED>
<DELETED> ``(E) Timeline for completion of
reviews.--</DELETED>
<DELETED> ``(i) In general.--The
Administrator shall implement the review plan
so as to complete reviews of all claims
specified in subparagraph (C) not later than 5
years after the date on which the Administrator
compiles the initial list of active substances
pursuant to subparagraph (A).</DELETED>
<DELETED> ``(ii) Considerations.--</DELETED>
<DELETED> ``(I) In general.--The
Administrator may extend the deadline
for completion of the reviews for not
more than 2 additional years, after an
adequate public justification, if the
Administrator determines that the
extension is necessary based on the
number of applicable claims needing
review and the available
resources.</DELETED>
<DELETED> ``(II) Annual goal.--The
Administrator shall publish an annual
goal for the number of reviews to be
completed over the course of
implementation of the plan.</DELETED>
<DELETED> ``(5) Active and inactive substances.--</DELETED>
<DELETED> ``(A) In general.--The Administrator shall
maintain and keep current designations of active
substances and inactive substances on the list
published under paragraph (1).</DELETED>
<DELETED> ``(B) Update.--The Administrator shall
update the list of chemical substances designated as
active substances as soon as practicable after the date
of publication of the most recent data reported under--
</DELETED>
<DELETED> ``(i) part 711 of title 40, Code
of Federal Regulations (or successor
regulations); and</DELETED>
<DELETED> ``(ii) the rules promulgated
pursuant to subsection (a)(4).</DELETED>
<DELETED> ``(C) Change to active status.--</DELETED>
<DELETED> ``(i) In general.--Any person that
intends to manufacture or process for a
nonexempt commercial purpose a chemical
substance that is designated as an inactive
substance shall notify the Administrator before
the date on which the inactive substance is
manufactured or processed.</DELETED>
<DELETED> ``(ii) Confidential chemical
identity claims.--If a person submitting a
notice under clause (i) for an inactive
substance on the confidential portion of the
list published under paragraph (1) seeks to
maintain an existing claim for protection
against disclosure of the specific identity of
the inactive substance as confidential, the
person shall--</DELETED>
<DELETED> ``(I) in the notice
submitted under clause (i), assert the
claim; and</DELETED>
<DELETED> ``(II) by not later than
30 days after providing the notice
under clause (i), substantiate the
claim.</DELETED>
<DELETED> ``(iii) Active status.--On
receiving a notification under clause (i), the
Administrator shall--</DELETED>
<DELETED> ``(I) designate the
applicable chemical substance as an
active substance;</DELETED>
<DELETED> ``(II) pursuant to section
14, promptly review any claim and
associated substantiation submitted
pursuant to clause (ii) for protection
against disclosure of the specific
identity of the chemical substance and
approve, modify, or deny the
claim;</DELETED>
<DELETED> ``(III) except as provided
in this section and section 14, protect
from disclosure the specific identity
of the chemical substance for which the
Administrator approves a claim under
subclause (II) for a period of not less
than 10 years, unless, prior to the
expiration of the period--</DELETED>
<DELETED> ``(aa) the person
notifies the Administrator that
the person is withdrawing the
confidentiality claim, in which
case the Administrator shall
promptly make the information
available to the public;
or</DELETED>
<DELETED> ``(bb) the
Administrator otherwise becomes
aware that the need for
protection from disclosure can
no longer be substantiated, in
which case the Administrator
shall take the actions
described in section 14(g)(2);
and</DELETED>
<DELETED> ``(IV) pursuant to section
4A, review the priority of the chemical
substance as the Administrator
determines to be necessary.</DELETED>
<DELETED> ``(D) Category status.--The list of
inactive substances shall not be considered to be a
category for purposes of section 26(c).</DELETED>
<DELETED> ``(6) Interim list of active substances.--Prior to
the promulgation of the rule required under this subsection,
the Administrator shall designate the chemical substances
reported under part 711 of title 40, Code of Federal
Regulations (or successor regulations), during the reporting
period that most closely preceded the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st Century Act,
as the interim list of active substances for the purposes of
section 4A.</DELETED>
<DELETED> ``(7) Public participation.--Subject to this
subsection, the Administrator shall make available to the
public--</DELETED>
<DELETED> ``(A) the specific identity of each
chemical substance on the nonconfidential portion of
the list published under paragraph (1) that the
Administrator has designated as--</DELETED>
<DELETED> ``(i) an active substance;
or</DELETED>
<DELETED> ``(ii) an inactive
substance;</DELETED>
<DELETED> ``(B) the accession number, generic name,
and, if applicable, premanufacture notice case number
for each chemical substance on the confidential portion
of the list published under paragraph (1) for which a
claim of confidentiality was received and approved by
the Administrator pursuant to section 14; and</DELETED>
<DELETED> ``(C) subject to section 14(g), the
specific identity of any active substance for which--
</DELETED>
<DELETED> ``(i) no claim of protection
against disclosure of the specific identity of
the active substance pursuant to this
subsection was received;</DELETED>
<DELETED> ``(ii) a claim for protection
against disclosure of the specific identity of
the active substance has been denied by the
Administrator; or</DELETED>
<DELETED> ``(iii) the time period for
protection against disclosure of the specific
identity of the active substance has
expired.</DELETED>
<DELETED> ``(8) Limitation.--No person may assert a new
claim under this subsection for protection from disclosure of a
specific identity of any active or inactive chemical substance
for which a notice is received under paragraph (4)(A)(i) or
(5)(C)(i) that is not on the confidential portion of the list
published under paragraph (1).</DELETED>
<DELETED> ``(9) Certification.--Under the rule promulgated
under this subsection, manufacturers and processors shall be
required--</DELETED>
<DELETED> ``(A) to certify that each report the
manufacturer or processor submits complies with the
requirements of the rule, and that any confidentiality
claims are true and correct; and</DELETED>
<DELETED> ``(B) to retain a record supporting the
certification for a period of 5 years beginning on the
last day of the submission period.'';</DELETED>
<DELETED> (3) in subsection (e)--</DELETED>
<DELETED> (A) by striking ``Any person'' and
inserting the following:</DELETED>
<DELETED> ``(1) In general.--Any person''; and</DELETED>
<DELETED> (B) by adding at the end the
following:</DELETED>
<DELETED> ``(2) Applicability.--Any person may submit to the
Administrator information reasonably supporting the conclusion
that a chemical substance or mixture presents, will present, or
does not present a substantial risk of harm to health and the
environment.''; and</DELETED>
<DELETED> (4) in subsection (f), by striking ``For purposes
of this section, the'' and inserting the following: ``In this
section:</DELETED>
<DELETED> ``(1) Active substance.--The term `active
substance' means a chemical substance--</DELETED>
<DELETED> ``(A) that has been manufactured or
processed for a nonexempt commercial purpose at any
point during the 10-year period ending on the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act;</DELETED>
<DELETED> ``(B) that is added to the list published
under subsection (b)(1) after that date of enactment;
or</DELETED>
<DELETED> ``(C) for which a notice is received under
subsection (b)(5)(C).</DELETED>
<DELETED> ``(2) Inactive substance.--The term `inactive
substance' means a chemical substance on the list published
under subsection (b)(1) that does not meet any of the criteria
described in paragraph (1).</DELETED>
<DELETED> ``(3) Manufacture; process.--The''.</DELETED>
<DELETED>SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS.</DELETED>
<DELETED> Section 9 of the Toxic Substances Control Act (15 U.S.C.
2608) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) in paragraph (1), in the first
sentence--</DELETED>
<DELETED> (i) by striking ``presents or will
present an unreasonable risk to health or the
environment'' and inserting ``does not meet the
safety standard''; and</DELETED>
<DELETED> (ii) by striking ``such risk'' the
first place it appears and inserting ``the risk
posed by the substance or mixture'';</DELETED>
<DELETED> (B) in paragraph (2), in the matter
following subparagraph (B), by striking ``section 6 or
7'' and inserting ``section 6(d) or section 7'';
and</DELETED>
<DELETED> (C) in paragraph (3), by striking
``section 6 or 7'' and inserting ``section 6(d) or
7'';</DELETED>
<DELETED> (2) in subsection (d), in the first sentence, by
striking ``Health, Education, and Welfare'' and inserting
``Health and Human Services''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(e) Exposure Information.--If the Administrator obtains
information related to exposures or releases of a chemical substance
that may be prevented or reduced under another Federal law, including
laws not administered by the Administrator, the Administrator shall
make such information available to the relevant Federal agency or
office of the Environmental Protection Agency.''.</DELETED>
<DELETED>SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION, AND
UTILIZATION OF DATA.</DELETED>
<DELETED> Section 10 of the Toxic Substances Control Act (15 U.S.C.
2609) is amended by striking ``Health, Education, and Welfare'' each
place it appears and inserting ``Health and Human Services''.</DELETED>
<DELETED>SEC. 13. EXPORTS.</DELETED>
<DELETED> Section 12 of the Toxic Substances Control Act (15 U.S.C.
2611) is amended--</DELETED>
<DELETED> (1) in subsection (a), by striking paragraph (2)
and inserting the following:</DELETED>
<DELETED> ``(2) Exception.--Paragraph (1) shall not apply to
any chemical substance that the Administrator determines--
</DELETED>
<DELETED> ``(A) under section 5 is not likely to
meet the safety standard; or</DELETED>
<DELETED> ``(B) under section 6 does not meet the
safety standard.</DELETED>
<DELETED> ``(3) Waivers.--For a mixture or article
containing a chemical substance described in paragraph (2), the
Administrator may--</DELETED>
<DELETED> ``(A) determine that paragraph (1) shall
not apply to the mixture or article; or</DELETED>
<DELETED> ``(B) establish a threshold concentration
in a mixture or article at which paragraph (1) shall
not apply.</DELETED>
<DELETED> ``(4) Testing.--The Administrator may require
testing under section 4 of any chemical substance or mixture
exempted from this Act under paragraph (1) for the purpose of
determining whether the chemical substance or mixture meets the
safety standard within the United States.'';</DELETED>
<DELETED> (2) by striking subsection (b) and inserting the
following:</DELETED>
<DELETED> ``(b) Notice.--</DELETED>
<DELETED> ``(1) In general.--A person shall notify the
Administrator that the person is exporting or intends to export
to a foreign country--</DELETED>
<DELETED> ``(A) a chemical substance or a mixture
containing a chemical substance that the Administrator
has determined under section 5 is not likely to meet
the safety standard and for which a prohibition or
other restriction has been proposed or established
under that section;</DELETED>
<DELETED> ``(B) a chemical substance or a mixture
containing a chemical substance that the Administrator
has determined under section 6 does not meet the safety
standard and for which a prohibition or other
restriction has been proposed or established under that
section;</DELETED>
<DELETED> ``(C) a chemical substance for which the
United States is obligated by treaty to provide export
notification;</DELETED>
<DELETED> ``(D) a chemical substance or mixture
subject to a prohibition or other restriction pursuant
to a rule, order, or consent agreement in effect under
this Act; or</DELETED>
<DELETED> ``(E) a chemical substance or mixture for
which the submission of information is required under
section 4.</DELETED>
<DELETED> ``(2) Rules.--</DELETED>
<DELETED> ``(A) In general.--The Administrator shall
promulgate rules to carry out paragraph (1).</DELETED>
<DELETED> ``(B) Contents.--The rules promulgated
pursuant to subparagraph (A) shall--</DELETED>
<DELETED> ``(i) include such exemptions as
the Administrator determines to be appropriate,
which may include exemptions identified under
section 5(h); and</DELETED>
<DELETED> ``(ii) indicate whether, or to
what extent, the rules apply to articles
containing a chemical substance or mixture
described in paragraph (1).</DELETED>
<DELETED> ``(3) Notification.--The Administrator shall
submit to the government of each country to which a chemical
substance or mixture is exported--</DELETED>
<DELETED> ``(A) for a chemical substance or mixture
described in subparagraph (A), (B), or (D) of paragraph
(1), a notice of the determination, rule, order,
consent agreement, requirement, or
designation;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(C) for a chemical substance or mixture
described in paragraph (1)(E), a notice of availability
of the information on the chemical substance or mixture
submitted to the Administrator.''; and</DELETED>
<DELETED> (3) in subsection (c)--</DELETED>
<DELETED> (A) by striking paragraph (3);
and</DELETED>
<DELETED> (B) by redesignating paragraphs (4)
through (6) as paragraphs (3) through (5),
respectively.</DELETED>
<DELETED>SEC. 14. IMPORTS.</DELETED>
<DELETED> Section 13 of the Toxic Substances Control Act (15 U.S.C.
2612) is amended to read as follows:</DELETED>
<DELETED>``SEC. 13. IMPORTS.</DELETED>
<DELETED> ``(a) Refusal of Entry.--</DELETED>
<DELETED> ``(1) In general.--The Secretary of Homeland
Security shall refuse entry into the customs territory of the
United States (as defined in general note 2 to the Harmonized
Tariff Schedule of the United States) any chemical substance,
mixture, or article containing a chemical substance or mixture
offered for such entry, if--</DELETED>
<DELETED> ``(A) the Administrator--</DELETED>
<DELETED> ``(i) has determined under section
6(c) that the chemical substance or mixture
does not meet the safety standard;
and</DELETED>
<DELETED> ``(ii) has promulgated a rule
pursuant to section 6(d) banning the chemical
substance or mixture, as of the effective date
of the rule;</DELETED>
<DELETED> ``(B) the chemical substance--</DELETED>
<DELETED> ``(i) is not included on the list
under section 8(b)(1); and</DELETED>
<DELETED> ``(ii) is not exempt from any
requirement to be included on that list by this
title or a rule promulgated by the
Administrator pursuant to this title;
or</DELETED>
<DELETED> ``(C) the chemical substance, mixture, or
any article containing the chemical substance or
mixture is offered for entry in violation of--
</DELETED>
<DELETED> ``(i) a rule, consent agreement,
or order in effect under this Act; or</DELETED>
<DELETED> ``(ii) an order issued in a civil
action brought under section 7 or title
IV.</DELETED>
<DELETED> ``(2) Procedure.--</DELETED>
<DELETED> ``(A) In general.--Subject to subparagraph
(B), if a chemical substance, mixture, or article
containing a chemical substance or mixture is refused
entry under paragraph (1), the Secretary of Homeland
Security--</DELETED>
<DELETED> ``(i) shall notify the consignee
of the entry of the refusal;</DELETED>
<DELETED> ``(ii) shall not release the
chemical substance or mixture to the consignee;
and</DELETED>
<DELETED> ``(iii) shall cause the disposal
or storage of the chemical substance or mixture
under such rules as the Secretary may
prescribe, if the chemical substance or mixture
has not been exported by the consignee during
the 90-day period beginning on the date of
receipt of the notice of the refused
entry.</DELETED>
<DELETED> ``(B) Exception.--</DELETED>
<DELETED> ``(i) In general.--The Secretary
of Homeland Security, pending a review by the
Administrator, may release to the consignee the
chemical substance or mixture if the
consignee--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(II) pays a duty on the
chemical substance or
mixture.</DELETED>
<DELETED> ``(ii) Administration.--If a
consignee fails to return a chemical substance
or mixture released to that consignee under
clause (i) for any cause to the custody of the
Secretary of Homeland Security on demand, the
consignee shall be liable to the United States
for liquidated damages equal to the full amount
of the bond executed under clause
(i)(I).</DELETED>
<DELETED> ``(C) Storage.--All charges for storage,
cartage, and labor on or for the disposal of a chemical
substance or mixture that is refused entry or released
under this subsection shall be paid by the owner or
consignee, and a default on that payment shall
constitute a lien against any future entry made by the
owner or consignee.</DELETED>
<DELETED> ``(b) Certification.--</DELETED>
<DELETED> ``(1) In general.--A person offering a chemical
substance or mixture subject to this Act for entry into the
customs territory of the United States shall certify to the
Secretary of Homeland Security that--</DELETED>
<DELETED> ``(A) after reasonable inquiry and to the
best knowledge and belief of the person, the chemical
substance or mixture is in compliance with any
applicable rule, consent agreement, or order under
section 5 or 6; and</DELETED>
<DELETED> ``(B) the chemical substance--</DELETED>
<DELETED> ``(i) is included on the list
under section 8(b)(1); or</DELETED>
<DELETED> ``(ii) is exempt from any
requirement to be included on that list by this
title or a rule promulgated by the
Administrator pursuant to this title.</DELETED>
<DELETED> ``(2) Articles.--</DELETED>
<DELETED> ``(A) In general.--The Administrator, by
rule, may require certification under paragraph (1) for
an article containing a chemical substance or mixture
that is subject to rule under section 5 or 6.</DELETED>
<DELETED> ``(B) Requirement.--The rule under
subparagraph (A) shall identify, with reasonable
specificity, the types of articles, including parts or
components of articles, that will be subject to the
certification requirement.</DELETED>
<DELETED> ``(C) Factors for consideration.--In
determining the need for and content of a certification
rule under this paragraph, the Administrator shall take
into consideration--</DELETED>
<DELETED> ``(i) the utility of the
certification to enforcement of the applicable
rule, consent agreement, or order under section
5 or 6;</DELETED>
<DELETED> ``(ii) the contribution of
imported articles to the potential risk
presented by exposure to the chemical substance
or mixture subject to rule under section 5 or
6;</DELETED>
<DELETED> ``(iii) the impact on commerce and
potential for the certification to impede or
disrupt import of articles;</DELETED>
<DELETED> ``(iv) the frequency or duration
of the certification requirement; and</DELETED>
<DELETED> ``(v) specification of the
concentration of a chemical substance in an
article that would subject the article to the
certification requirement.</DELETED>
<DELETED> ``(3) Reasonable inquiry.--</DELETED>
<DELETED> ``(A) In general.--For purposes of a
certification under paragraph (1), reasonable inquiry
shall include good faith reliance by an importer on--
</DELETED>
<DELETED> ``(i) a safety data sheet or
similar declaration provided by a supplier that
documents the specific identity of the chemical
substance or the specific identities of all
chemical substances in a mixture; or</DELETED>
<DELETED> ``(ii) for chemical substances or
mixtures claimed by the supplier as
confidential, or not otherwise disclosed by the
supplier, a certification by the supplier that
the imported chemical substance or mixture
satisfies the applicable certification
requirements under paragraph (1).</DELETED>
<DELETED> ``(B) Articles.--For purposes of a
certification under paragraph (2), reasonable inquiry
shall include good faith reliance by an importer on a
certification by the supplier that the imported article
satisfies the applicable certification requirements in
a rule promulgated pursuant to paragraph (2).</DELETED>
<DELETED> ``(4) Information regarding identity.--For
purposes of this subsection, the Administrator shall provide
publicly accessible information regarding the identity of a
chemical substance or mixture subject to rule under this Act
that would be readily understood in import
transactions.</DELETED>
<DELETED> ``(c) Notice.--A person offering a chemical substance for
entry into the customs territory of the United States shall notify the
Secretary of Homeland Security if--</DELETED>
<DELETED> ``(1) the chemical substance or chemical substance
in a mixture is a high-priority substance;</DELETED>
<DELETED> ``(2) the chemical substance or chemical substance
in a mixture is 1 for which the United States is obligated to
provide export notification by treaty; or</DELETED>
<DELETED> ``(3) the chemical substance or chemical substance
in a mixture--</DELETED>
<DELETED> ``(A) is the subject of a safety
assessment and safety determination conducted pursuant
to section 6; and</DELETED>
<DELETED> ``(B) has been found not to meet the
safety standard.</DELETED>
<DELETED> ``(d) Rules.--</DELETED>
<DELETED> ``(1) In general.--The Secretary of Homeland
Security, after consultation with the Administrator, shall
promulgate rules to carry out this section.</DELETED>
<DELETED> ``(2) Application.--The rules under paragraph (1)
may modify the application of any requirement of this section,
as appropriate for the efficient and effective implementation
of this Act.''.</DELETED>
<DELETED>SEC. 15. CONFIDENTIAL INFORMATION.</DELETED>
<DELETED> Section 14 of the Toxic Substances Control Act (15 U.S.C.
2613) is amended to read as follows:</DELETED>
<DELETED>``SEC. 14. CONFIDENTIAL INFORMATION.</DELETED>
<DELETED> ``(a) In General.--Except as otherwise provided in this
section, the Administrator shall not disclose information that is
exempt from disclosure pursuant to subsection (a) of section 552 of
title 5, United States Code, under subsection (b)(4) of that section--
</DELETED>
<DELETED> ``(1) that is reported to, or otherwise obtained
by, the Administrator under this Act; and</DELETED>
<DELETED> ``(2) for which the requirements of subsection (d)
are met.</DELETED>
<DELETED> ``(b) Information Generally Protected From Disclosure.--
The following information specific to, and submitted by, a
manufacturer, processor, or distributor that meets the requirements of
subsections (a) and (d) shall be presumed to be protected from
disclosure, subject to the condition that nothing in this Act prohibits
the disclosure of any such information through discovery, subpoena,
other court order, or any other judicial process otherwise allowed
under applicable Federal or State law:</DELETED>
<DELETED> ``(1) Specific information describing the
processes used in manufacture or processing of a chemical
substance, mixture, or article.</DELETED>
<DELETED> ``(2) Marketing and sales information.</DELETED>
<DELETED> ``(3) Information identifying a supplier or
customer.</DELETED>
<DELETED> ``(4) Details of the full composition of a mixture
and the respective percentages of constituents.</DELETED>
<DELETED> ``(5) Specific information regarding the use,
function, or application of a chemical substance or mixture in
a process, mixture, or product.</DELETED>
<DELETED> ``(6) Specific production or import volumes of the
manufacturer and specific aggregated volumes across
manufacturers, if the Administrator determines that disclosure
of the specific aggregated volumes would reveal confidential
information.</DELETED>
<DELETED> ``(7) Except as otherwise provided in this
section, the specific identity of a chemical substance prior to
the date on which the chemical substance is first offered for
commercial distribution, including the chemical name, molecular
formula, Chemical Abstracts Service number, and other
information that would identify a specific chemical substance,
if--</DELETED>
<DELETED> ``(A) the specific identity was claimed as
confidential information at the time it was submitted
in a notice under section 5; and</DELETED>
<DELETED> ``(B) the claim--</DELETED>
<DELETED> ``(i) is not subject to an
exception under subsection (e); or</DELETED>
<DELETED> ``(ii) has not subsequently been
withdrawn or found by the Administrator not to
warrant protection as confidential information
under subsection (f)(2) or (g).</DELETED>
<DELETED> ``(c) Information Not Protected From Disclosure.--
Notwithstanding subsections (a) and (b), the following information
shall not be protected from disclosure:</DELETED>
<DELETED> ``(1) Information from health and safety
studies.--</DELETED>
<DELETED> ``(A) In general.--Subject to subparagraph
(B), subsection (a) does not prohibit the disclosure
of--</DELETED>
<DELETED> ``(i) any health and safety study
that is submitted under this Act with respect
to--</DELETED>
<DELETED> ``(I) any chemical
substance or mixture that, on the date
on which the study is to be disclosed,
has been offered for commercial
distribution; or</DELETED>
<DELETED> ``(II) any chemical
substance or mixture for which--
</DELETED>
<DELETED> ``(aa) testing is
required under section 4;
or</DELETED>
<DELETED> ``(bb) a
notification is required under
section 5; or</DELETED>
<DELETED> ``(ii) any information reported
to, or otherwise obtained by, the Administrator
from a health and safety study relating to a
chemical substance or mixture described in
subclause (I) or (II) of clause (i).</DELETED>
<DELETED> ``(B) Effect of paragraph.--Nothing in
this paragraph authorizes the release of any
information that discloses--</DELETED>
<DELETED> ``(i) a process used in the
manufacturing or processing of a chemical
substance or mixture; or</DELETED>
<DELETED> ``(ii) in the case of a mixture,
the portion of the mixture comprised by any
chemical substance in the mixture.</DELETED>
<DELETED> ``(2) Certain requests.--If a request is made to
the Administrator under section 552(a) of title 5, United
States Code, for information that is described in paragraph (1)
that is not described in paragraph (1)(B), the Administrator
may not deny the request on the basis of section 552(b)(4) of
title 5, United States Code.</DELETED>
<DELETED> ``(3) Other information not protected from
disclosure.--The following information is not protected from
disclosure under this section:</DELETED>
<DELETED> ``(A) For information submitted after the
date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the specific identity
of a chemical substance as of the date on which the
chemical substance is first offered for commercial
distribution, if the person submitting the information
does not meet the requirements of subsection
(d).</DELETED>
<DELETED> ``(B) A safety assessment developed, or a
safety determination made, under section 6.</DELETED>
<DELETED> ``(C) Any general information describing
the manufacturing volumes, expressed as specific
aggregated volumes or, if the Administrator determines
that disclosure of specific aggregated volumes would
reveal confidential information, expressed in
ranges.</DELETED>
<DELETED> ``(D) A general description of a process
used in the manufacture or processing and industrial,
commercial, or consumer functions and uses of a
chemical substance, mixture, or article containing a
chemical substance or mixture, including information
specific to an industry or industry sector that
customarily would be shared with the general public or
within an industry or industry sector.</DELETED>
<DELETED> ``(4) Mixed confidential and nonconfidential
information.--Any information that is otherwise eligible for
protection under this section and contained in a submission of
information described in this subsection shall be protected
from disclosure, if the submitter complies with subsection (d),
subject to the condition that information in the submission
that is not eligible for protection against disclosure shall be
disclosed.</DELETED>
<DELETED> ``(5) Ban or phase-out.--If the Administrator
promulgates a rule pursuant to section 6(d) that establishes a
ban or phase-out of the manufacture, processing, or
distribution in commerce of a chemical substance--</DELETED>
<DELETED> ``(A) any protection from disclosure
provided under this section with respect to information
relating to the chemical substance shall no longer
apply; and</DELETED>
<DELETED> ``(B) the Administrator promptly shall
make the information public.</DELETED>
<DELETED> ``(d) Requirements for Confidentiality Claims.--</DELETED>
<DELETED> ``(1) Assertion of claims.--</DELETED>
<DELETED> ``(A) In general.--A person seeking to
protect any information submitted under this Act from
disclosure (including information described in
subsection (b)) shall assert to the Administrator a
claim for protection concurrent with submission of the
information, in accordance with such rules regarding a
claim for protection from disclosure as the
Administrator has promulgated or may promulgate
pursuant to this title.</DELETED>
<DELETED> ``(B) Inclusion.--An assertion of a claim
under subparagraph (A) shall include a statement that
the person has--</DELETED>
<DELETED> ``(i) taken reasonable measures to
protect the confidentiality of the
information;</DELETED>
<DELETED> ``(ii) determined that the
information is not required to be disclosed or
otherwise made available to the public under
any other Federal law;</DELETED>
<DELETED> ``(iii) a reasonable basis to
conclude that disclosure of the information is
likely to cause substantial harm to the
competitive position of the person;
and</DELETED>
<DELETED> ``(iv) a reasonable basis to
believe that the information is not readily
discoverable through reverse
engineering.</DELETED>
<DELETED> ``(C) Specific chemical identity.--In the
case of a claim under subparagraph (A) for protection
against disclosure of a specific chemical identity, the
claim shall include a structurally descriptive generic
name for the chemical substance that the Administrator
may disclose to the public, subject to the condition
that the generic name shall--</DELETED>
<DELETED> ``(i) conform with guidance
prescribed by the Administrator under paragraph
(3)(A); and</DELETED>
<DELETED> ``(ii) describe the chemical
structure of the substance as specifically as
practicable while protecting those features of
the chemical structure--</DELETED>
<DELETED> ``(I) that are considered
to be confidential; and</DELETED>
<DELETED> ``(II) the disclosure of
which would be likely to harm the
competitive position of the
person.</DELETED>
<DELETED> ``(D) Public information.--No person may
assert a claim under this section for protection from
disclosure of information that is already publicly
available.</DELETED>
<DELETED> ``(2) Additional requirements for confidentiality
claims.--Except for information described in paragraphs (1)
through (7) of subsection (b), a person asserting a claim to
protect information from disclosure under this Act shall
substantiate the claim, in accordance with the rules
promulgated and guidance issued by the Administrator.</DELETED>
<DELETED> ``(3) Guidance.--The Administrator shall develop
guidance regarding--</DELETED>
<DELETED> ``(A) the determination of structurally
descriptive generic names, in the case of claims for
the protection against disclosure of specific chemical
identity; and</DELETED>
<DELETED> ``(B) the content and form of the
statements of need and agreements required under
paragraphs (4), (5), and (6) of subsection
(e).</DELETED>
<DELETED> ``(4) Certification.--An authorized official of a
person described in paragraph (1)(A) shall certify that the
information that has been submitted is true and
correct.</DELETED>
<DELETED> ``(e) Exceptions to Protection From Disclosure.--
Information described in subsection (a) shall be disclosed if--
</DELETED>
<DELETED> ``(1) the information is to be disclosed to an
officer or employee of the United States in connection with the
official duties of the officer or employee--</DELETED>
<DELETED> ``(A) under any law for the protection of
health or the environment; or</DELETED>
<DELETED> ``(B) for a specific law enforcement
purpose;</DELETED>
<DELETED> ``(2) the information is to be disclosed to a
contractor of the United States and employees of that
contractor--</DELETED>
<DELETED> ``(A) if, in the opinion of the
Administrator, the disclosure is necessary for the
satisfactory performance by the contractor of a
contract with the United States for the performance of
work in connection with this Act; and</DELETED>
<DELETED> ``(B) subject to such conditions as the
Administrator may specify;</DELETED>
<DELETED> ``(3) the Administrator determines that disclosure
is necessary to protect health or the environment;</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) 1 or more applicable agreements with
the Administrator that conform with the guidance issued
under subsection (d)(3)(B) ensure that the recipient
will take appropriate measures, and has adequate
authority, to maintain the confidentiality of the
information in accordance with procedures comparable to
the procedures used by the Administrator to safeguard
the information; and</DELETED>
<DELETED> ``(B) the Administrator notifies the
person that submitted the information that the
information has been disclosed to the State or
political subdivision of a State;</DELETED>
<DELETED> ``(5) a health or environmental professional
employed by a Federal or State agency or a treating physician
or nurse in a nonemergency situation provides a written
statement of need and agrees to sign a written confidentiality
agreement with the Administrator, subject to the conditions
that--</DELETED>
<DELETED> ``(A) the statement of need and
confidentiality agreement shall conform with the
guidance issued under subsection (d)(3)(B);</DELETED>
<DELETED> ``(B) the written statement of need shall
be a statement that the person has a reasonable basis
to suspect that--</DELETED>
<DELETED> ``(i) the information is necessary
for, or will assist in--</DELETED>
<DELETED> ``(I) the diagnosis or
treatment of 1 or more individuals;
or</DELETED>
<DELETED> ``(II) responding to an
environmental release or exposure;
and</DELETED>
<DELETED> ``(ii) 1 or more individuals being
diagnosed or treated have been exposed to the
chemical substance concerned, or an
environmental release or exposure has occurred;
and</DELETED>
<DELETED> ``(C) the confidentiality agreement shall
provide that the person will not use the information
for any purpose other than the health or environmental
needs asserted in the statement of need, except as
otherwise may be authorized by the terms of the
agreement or by the person submitting the information
to the Administrator, except that nothing in this Act
prohibits the disclosure of any such information
through discovery, subpoena, other court order, or any
other judicial process otherwise allowed under
applicable Federal or State law;</DELETED>
<DELETED> ``(6) in the event of an emergency, a treating
physician, nurse, agent of a poison control center, public
health or environmental official of a State or political
subdivision of a State, or first responder (including any
individual duly authorized by a Federal agency, State, or
political subdivision of a State who is trained in urgent
medical care or other emergency procedures, including a police
officer, firefighter, or emergency medical technician) requests
the information, subject to the conditions that--</DELETED>
<DELETED> ``(A) the treating physician, nurse,
agent, public health or environmental official of a
State or a political subdivision of a State, or first
responder shall have a reasonable basis to suspect
that--</DELETED>
<DELETED> ``(i) a medical or public health
or environmental emergency exists;</DELETED>
<DELETED> ``(ii) the information is
necessary for, or will assist in, emergency or
first-aid diagnosis or treatment; or</DELETED>
<DELETED> ``(iii) 1 or more individuals
being diagnosed or treated have likely been
exposed to the chemical substance concerned, or
a serious environmental release of or exposure
to the chemical substance concerned has
occurred;</DELETED>
<DELETED> ``(B) if requested by the person
submitting the information to the Administrator, the
treating physician, nurse, agent, public health or
environmental official of a State or a political
subdivision of a State, or first responder shall, as
described in paragraph (5)--</DELETED>
<DELETED> ``(i) provide a written statement
of need; and</DELETED>
<DELETED> ``(ii) agree to sign a
confidentiality agreement; and</DELETED>
<DELETED> ``(C) the written confidentiality
agreement or statement of need shall be submitted as
soon as practicable, but not necessarily before the
information is disclosed;</DELETED>
<DELETED> ``(7) the Administrator determines that disclosure
is relevant in a proceeding under this Act, subject to the
condition that the disclosure shall be made in such a manner as
to preserve confidentiality to the maximum extent practicable
without impairing the proceeding;</DELETED>
<DELETED> ``(8) the information is to be disclosed, on
written request of any duly authorized congressional committee,
to that committee; or</DELETED>
<DELETED> ``(9) the information is required to be disclosed
or otherwise made public under any other provision of Federal
law.</DELETED>
<DELETED> ``(f) Duration of Protection From Disclosure.--</DELETED>
<DELETED> ``(1) In general.--</DELETED>
<DELETED> ``(A) Information protected from
disclosure.--Subject to paragraph (2), the
Administrator shall protect from disclosure information
that meets the requirements of subsection (d) for a
period of 10 years, unless, prior to the expiration of
the period--</DELETED>
<DELETED> ``(i) an affected person notifies
the Administrator that the person is
withdrawing the confidentiality claim, in which
case the Administrator shall promptly make the
information available to the public;
or</DELETED>
<DELETED> ``(ii) the Administrator otherwise
becomes aware that the need for protection from
disclosure can no longer be substantiated, in
which case the Administrator shall take the
actions described in subsection
(g)(2).</DELETED>
<DELETED> ``(B) Extensions.--</DELETED>
<DELETED> ``(i) In general.--Not later than
the date that is 60 days before the expiration
of the period described in subparagraph (A),
the Administrator shall provide to the person
that asserted the claim a notice of the
impending expiration of the period.</DELETED>
<DELETED> ``(ii) Statement.--</DELETED>
<DELETED> ``(I) In general.--Not
later than the date that is 30 days
before the expiration of the period
described in subparagraph (A), a person
reasserting the relevant claim shall
submit to the Administrator a statement
substantiating, in accordance with
subsection (d)(2), the need to extend
the period.</DELETED>
<DELETED> ``(II) Action by
administrator.--Not later than the date
that is 30 days after the date of
receipt of a statement under subclause
(I), the Administrator shall--
</DELETED>
<DELETED> ``(aa) review the
request;</DELETED>
<DELETED> ``(bb) make a
determination regarding whether
the information for which the
request is made continues to
meet the relevant criteria
established under this section;
and</DELETED>
<DELETED> ``(cc)(AA) grant
an extension of not more than
10 years; or</DELETED>
<DELETED> ``(BB) deny the
claim.</DELETED>
<DELETED> ``(C) No limit on number of extensions.--
There shall be no limit on the number of extensions
granted under subparagraph (B), if the Administrator
determines that the relevant statement under
subparagraph (B)(ii)(I)--</DELETED>
<DELETED> ``(i) establishes the need to
extend the period; and</DELETED>
<DELETED> ``(ii) meets the requirements
established by the Administrator.</DELETED>
<DELETED> ``(2) Review and resubstantiation.--</DELETED>
<DELETED> ``(A) Discretion of administrator.--The
Administrator may review, at any time, a claim for
protection against disclosure under subsection (a) for
information submitted to the Administrator regarding a
chemical substance and require any person that has
claimed protection for that information, whether
before, on, or after the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st Century Act,
to withdraw or reassert and substantiate or
resubstantiate the claim in accordance with this
section--</DELETED>
<DELETED> ``(i) after the chemical substance
is identified as a high-priority substance
under section 4A;</DELETED>
<DELETED> ``(ii) for any chemical substance
for which the Administrator has made a
determination under section
6(c)(1)(C);</DELETED>
<DELETED> ``(iii) for any inactive chemical
substance identified under section 8(b)(5);
or</DELETED>
<DELETED> ``(iv) in limited circumstances,
if the Administrator determines that disclosure
of certain information currently protected from
disclosure would assist the Administrator in
conducting safety assessments and safety
determinations under subsections (b) and (c) of
section 6 or promulgating rules pursuant to
section 6(d), subject to the condition that the
information shall not be disclosed unless the
claimant withdraws the claim or the
Administrator determines that the information
does not meet the requirements of subsection
(d).</DELETED>
<DELETED> ``(B) Review required.--The Administrator
shall review a claim for protection from disclosure
under subsection (a) for information submitted to the
Administrator regarding a chemical substance and
require any person that has claimed protection for that
information, whether before, on, or after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, to withdraw or reassert and
substantiate or resubstantiate the claim in accordance
with this section--</DELETED>
<DELETED> ``(i) as necessary to comply with
a request for information received by the
Administrator under section 552 of title 5,
United States Code;</DELETED>
<DELETED> ``(ii) if information available to
the Administrator provides a basis that the
requirements of section 552(b)(4) of title 5,
United States Code, are no longer met;
or</DELETED>
<DELETED> ``(iii) for any substance for
which the Administrator has made a
determination under section
6(c)(1)(B).</DELETED>
<DELETED> ``(C) Action by recipient.--If the
Administrator makes a request under subparagraph (A) or
(B), the recipient of the request shall--</DELETED>
<DELETED> ``(i) reassert and substantiate or
resubstantiate the claim; or</DELETED>
<DELETED> ``(ii) withdraw the
claim.</DELETED>
<DELETED> ``(D) Period of protection.--Protection
from disclosure of information subject to a claim that
is reviewed and approved by the Administrator under
this paragraph shall be extended for a period of 10
years from the date of approval, subject to any
subsequent request by the Administrator under this
paragraph.</DELETED>
<DELETED> ``(3) Unique identifier.--The Administrator
shall--</DELETED>
<DELETED> ``(A)(i) develop a system to assign a
unique identifier to each specific chemical identity
for which the Administrator approves a request for
protection from disclosure, other than a specific
chemical identity or structurally descriptive generic
term; and</DELETED>
<DELETED> ``(ii) apply that identifier consistently
to all information relevant to the applicable chemical
substance;</DELETED>
<DELETED> ``(B) annually publish and update a list
of chemical substances, referred to by unique
identifier, for which claims to protect the specific
chemical identity from disclosure have been approved,
including the expiration date for each such
claim;</DELETED>
<DELETED> ``(C) ensure that any nonconfidential
information received by the Administrator with respect
to such a chemical substance during the period of
protection from disclosure--</DELETED>
<DELETED> ``(i) is made public;
and</DELETED>
<DELETED> ``(ii) identifies the chemical
substance using the unique identifier;
and</DELETED>
<DELETED> ``(D) for each claim for protection of
specific chemical identity that has been denied by the
Administrator on expiration of the period for appeal
under subsection (g)(3), that has expired, or that has
been withdrawn by the submitter, provide public access
to the specific chemical identity clearly linked to all
nonconfidential information received by the
Administrator with respect to the chemical
substance.</DELETED>
<DELETED> ``(g) Duties of Administrator.--</DELETED>
<DELETED> ``(1) Determination.--</DELETED>
<DELETED> ``(A) In general.--Except as provided in
subsection (b), the Administrator shall, subject to
subparagraph (C), not later than 90 days after the
receipt of a claim under subsection (d), and not later
than 30 days after the receipt of a request for
extension of a claim under subsection (f), review and
approve, modify, or deny the claim or
request.</DELETED>
<DELETED> ``(B) Denial or modification.--</DELETED>
<DELETED> ``(i) In general.--Except as
provided in subsections (c) and (f), the
Administrator shall deny a claim to protect a
chemical identity from disclosure only if the
person that has submitted the claim fails to
meet the requirements of subsections (a) and
(d).</DELETED>
<DELETED> ``(ii) Reasons for denial or
modification.--The Administrator shall provide
to a person that has submitted a claim
described in clause (i) a written statement of
the reasons for the denial or modification of
the claim.</DELETED>
<DELETED> ``(C) Subsets.--The Administrator shall--
</DELETED>
<DELETED> ``(i) except for claims described
in subsection (b)(7), review all claims under
this section for the protection against
disclosure of the specific identity of a
chemical substance; and</DELETED>
<DELETED> ``(ii) review a representative
subset, comprising at least 25 percent, of all
other claims for protection against
disclosure.</DELETED>
<DELETED> ``(D) Effect of failure to act.--The
failure of the Administrator to make a decision
regarding a claim for protection against disclosure or
extension under this section shall not be the basis for
denial or elimination of a claim for protection against
disclosure.</DELETED>
<DELETED> ``(2) Notification.--</DELETED>
<DELETED> ``(A) In general.--Except as provided in
subparagraph (B) and subsections (c), (e), and (f), if
the Administrator denies or modifies a claim under
paragraph (1), the Administrator shall notify, in
writing and by certified mail, the person that
submitted the claim of the intent of the Administrator
to release the information.</DELETED>
<DELETED> ``(B) Release of information.--</DELETED>
<DELETED> ``(i) In general.--Except as
provided in clause (ii), the Administrator
shall not release information under this
subsection until the date that is 30 days after
the date on which the person that submitted the
request receives notification under
subparagraph (A).</DELETED>
<DELETED> ``(ii) Exceptions.--</DELETED>
<DELETED> ``(I) In general.--For
information under paragraph (3) or (8)
of subsection (e), the Administrator
shall not release that information
until the date that is 15 days after
the date on which the person that
submitted the claim receives a
notification, unless the Administrator
determines that release of the
information is necessary to protect
against an imminent and substantial
harm to health or the environment, in
which case no prior notification shall
be necessary.</DELETED>
<DELETED> ``(II) No notification.--
For information under paragraph (1),
(2), (6), (7), or (9) of subsection
(e), no prior notification shall be
necessary.</DELETED>
<DELETED> ``(3) Appeals.--</DELETED>
<DELETED> ``(A) In general.--If a person receives a
notification under paragraph (2) and believes
disclosure of the information is prohibited under
subsection (a), before the date on which the
information is to be released, the person may bring an
action to restrain disclosure of the information in--
</DELETED>
<DELETED> ``(i) the United States district
court of the district in which the complainant
resides or has the principal place of business;
or</DELETED>
<DELETED> ``(ii) the United States District
Court for the District of Columbia.</DELETED>
<DELETED> ``(B) No disclosure.--The Administrator
shall not disclose any information that is the subject
of an appeal under this section before the date on
which the applicable court rules on an action under
subparagraph (A).</DELETED>
<DELETED> ``(4) Administration.--In carrying out this
subsection, the Administrator shall use the procedures
described in part 2 of title 40, Code of Federal Regulations
(or successor regulations).</DELETED>
<DELETED> ``(h) Criminal Penalty for Wrongful Disclosure.--
</DELETED>
<DELETED> ``(1) Officers and employees of united states.--
</DELETED>
<DELETED> ``(A) In general.--Subject to paragraph
(2), a current or former officer or employee of the
United States described in subparagraph (B) shall be
guilty of a misdemeanor and fined under title 18,
United States Code, or imprisoned for not more than 1
year, or both.</DELETED>
<DELETED> ``(B) Description.--A current or former
officer or employee of the United States referred to in
subparagraph (A) is a current or former officer or
employee of the United States who--</DELETED>
<DELETED> ``(i) by virtue of that employment
or official position has obtained possession
of, or has access to, material the disclosure
of which is prohibited by subsection (a);
and</DELETED>
<DELETED> ``(ii) knowing that disclosure of
that material is prohibited by subsection (a),
willfully discloses the material in any manner
to any person not entitled to receive that
material.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Contractors.--For purposes of this
subsection, any contractor of the United States that is
provided information in accordance with subsection (e)(2),
including any employee of that contractor, shall be considered
to be an employee of the United States.</DELETED>
<DELETED> ``(i) Applicability.--</DELETED>
<DELETED> ``(1) In general.--Except as otherwise provided in
this section, section 8, or any other applicable Federal law,
the Administrator shall have no authority--</DELETED>
<DELETED> ``(A) to require the substantiation or
resubstantiation of a claim for the protection from
disclosure of information submitted to the
Administrator under this Act before the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act; or</DELETED>
<DELETED> ``(B) to impose substantiation or
resubstantiation requirements under this Act that are
more extensive than those required under this
section.</DELETED>
<DELETED> ``(2) Prior actions.--Nothing in this Act prevents
the Administrator from reviewing, requiring substantiation or
resubstantiation for, or approving, modifying or denying any
claim for the protection from disclosure of information before
the effective date of such rules applicable to those claims as
the Administrator may promulgate after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act.''.</DELETED>
<DELETED>SEC. 16. PROHIBITED ACTS.</DELETED>
<DELETED> Section 15 of the Toxic Substances Control Act (15 U.S.C.
2614) is amended by striking paragraph (1) and inserting the
following:</DELETED>
<DELETED> ``(1) fail or refuse to comply with--</DELETED>
<DELETED> ``(A) any rule promulgated, consent
agreement entered into, or order issued under section
4;</DELETED>
<DELETED> ``(B) any requirement under section 5 or
6;</DELETED>
<DELETED> ``(C) any rule promulgated, consent
agreement entered into, or order issued under section 5
or 6; or</DELETED>
<DELETED> ``(D) any requirement of, or any rule
promulgated or order issued pursuant to title
II;''.</DELETED>
<DELETED>SEC. 17. PENALTIES.</DELETED>
<DELETED> Section 16 of the Toxic Substances Control Act (15 U.S.C.
2615) is amended--</DELETED>
<DELETED> (1) in subsection (a)(1)--</DELETED>
<DELETED> (A) in the first sentence--</DELETED>
<DELETED> (i) by inserting ``this Act or a
rule or order promulgated or issued pursuant to
this Act, including'' after ``a provision of'';
and</DELETED>
<DELETED> (ii) by striking ``$25,000'' and
inserting ``$37,500''; and</DELETED>
<DELETED> (B) in the second sentence, by striking``
violation of section 15 or 409'' and inserting
``violation of this Act''; and</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) by striking ``Any person who'' and
inserting the following:</DELETED>
<DELETED> ``(1) In general.--Any person that'';</DELETED>
<DELETED> (B) by striking ``section 15 or 409'' and
inserting ``this Act'';</DELETED>
<DELETED> (C) by striking ``$25,000'' and inserting
``$50,000''; and</DELETED>
<DELETED> (D) by adding at the end the
following:</DELETED>
<DELETED> ``(2) Imminent danger of death or serious bodily
injury.--</DELETED>
<DELETED> ``(A) In general.--Any person that
knowingly or willfully violates any provision of this
Act, and that knows at the time of the violation that
the violation places an individual in imminent danger
of death or serious bodily injury, shall be subject on
conviction to a fine of not more than $250,000, or
imprisonment for not more than 15 years, or
both.</DELETED>
<DELETED> ``(B) Organizations.--An organization that
commits a violation described in subparagraph (A) shall
be subject on conviction to a fine of not more than
$1,000,000 for each violation.</DELETED>
<DELETED> ``(3) Knowledge of imminent danger or injury.--For
purposes of determining whether a defendant knew that the
violation placed another individual in imminent danger of death
or serious bodily injury--</DELETED>
<DELETED> ``(A) the defendant shall be responsible
only for actual awareness or actual belief possessed;
and</DELETED>
<DELETED> ``(B) knowledge possessed by an individual
may not be attributed to the defendant.''.</DELETED>
<DELETED>SEC. 18. STATE-FEDERAL RELATIONSHIP.</DELETED>
<DELETED> Section 18 of the Toxic Substances Control Act (15 U.S.C.
2617) is amended by striking subsections (a) and (b) and inserting the
following:</DELETED>
<DELETED> ``(a) In General.--</DELETED>
<DELETED> ``(1) Establishment or enforcement.--Except as
provided in subsections (c), (d), (e), (f), and (g), and
subject to paragraph (2), no State or political subdivision of
a State may establish or continue to enforce any of the
following:</DELETED>
<DELETED> ``(A) Testing and information
collection.--A statute or administrative action to
require the development of information on a chemical
substance or category of substances that is reasonably
likely to produce the same information required under
section 4, 5, or 6 in--</DELETED>
<DELETED> ``(i) a rule promulgated by the
Administrator;</DELETED>
<DELETED> ``(ii) a testing consent agreement
entered into by the Administrator; or</DELETED>
<DELETED> ``(iii) an order issued by the
Administrator.</DELETED>
<DELETED> ``(B) Chemical substances found to meet
the safety standard or restricted.--A statute or
administrative action to prohibit or otherwise restrict
the manufacture, processing, or distribution in
commerce or use of a chemical substance--</DELETED>
<DELETED> ``(i) found to meet the safety
standard and consistent with the scope of the
determination made under section 6;
or</DELETED>
<DELETED> ``(ii) found not to meet the
safety standard, after the effective date of
the rule issued under section 6(d) for the
substance, consistent with the scope of the
determination made by the
Administrator.</DELETED>
<DELETED> ``(C) Significant new use.--A statute or
administrative action requiring the notification of a
use of a chemical substance that the Administrator has
specified as a significant new use and for which the
Administrator has required notification pursuant to a
rule promulgated under section 5.</DELETED>
<DELETED> ``(2) Effective date of preemption.--Under this
subsection, Federal preemption of State statutes and
administrative actions applicable to specific substances shall
not occur until the effective date of the applicable action
described in paragraph (1) taken by the
Administrator.</DELETED>
<DELETED> ``(b) New Statutes or Administrative Actions Creating
Prohibitions or Other Restrictions.--Except as provided in subsections
(c), (d), and (e), no State or political subdivision of a State may
establish (after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act) a statute or administrative
action prohibiting or restricting the manufacture, processing,
distribution in commerce or use of a chemical substance that is a high-
priority substance designated under section 4A, as of the date on which
the Administrator commences a safety assessment under section
6.</DELETED>
<DELETED> ``(c) Scope of Preemption.--Federal preemption under
subsections (a) and (b) of State statutes and administrative actions
applicable to specific substances shall apply only to--</DELETED>
<DELETED> ``(1) the chemical substances or category of
substances subject to a rule, order, or consent agreement under
section 4;</DELETED>
<DELETED> ``(2) the uses or conditions of use of such
substances that are identified by the Administrator as subject
to review in a safety assessment and included in the scope of
the safety determination made by the Administrator for the
substance, or of any rule the Administrator promulgates
pursuant to section 6(d); or</DELETED>
<DELETED> ``(3) the uses of such substances that the
Administrator has specified as significant new uses and for
which the Administrator has required notification pursuant to a
rule promulgated under section 5.</DELETED>
<DELETED> ``(d) Exceptions.--</DELETED>
<DELETED> ``(1) In general.--Subsections (a) and (b) shall
not apply to a statute or administrative action of a State or a
political subdivision of a State applicable to a specific
chemical substance that--</DELETED>
<DELETED> ``(A) is adopted under the authority of,
or authorized to comply with, any other Federal
law;</DELETED>
<DELETED> ``(B) implements a reporting, monitoring,
or other information collection obligation for the
chemical substance not otherwise required by the
Administrator under this Act or required under any
other Federal law; or</DELETED>
<DELETED> ``(C) is adopted pursuant to authority
under a law of the State or political subdivision of
the State related to water quality, air quality, or
waste treatment or disposal, unless the action taken by
the State or political subdivision of a State--
</DELETED>
<DELETED> ``(i) imposes a restriction on the
manufacture, processing, distribution in
commerce, or use of a chemical substance;
and</DELETED>
<DELETED> ``(ii)(I) is already required by a
decision by the Administrator under section 5
or 6;</DELETED>
<DELETED> ``(II) is taken to address a
health or environmental concern that applies to
the uses or conditions of use that are included
in the scope of a safety determination pursuant
to section 6 or the scope of a significant new
use rule promulgated pursuant to section 5, but
is inconsistent with the action of the
Administrator; or</DELETED>
<DELETED> ``(III) would cause a violation of
the applicable action by the Administrator
under section 5 or 6.</DELETED>
<DELETED> ``(2) No preemption of state statutes and
administrative actions.--Nothing in this Act, nor any amendment
made by this Act, nor any rule, standard of performance, safety
determination, or scientific assessment implemented pursuant to
this Act, shall affect the right of a State or a political
subdivision of a State to adopt or enforce any rule, standard
of performance, safety determination, scientific assessment, or
any protection for public health or the environment that--
</DELETED>
<DELETED> ``(A) is adopted under the authority of,
or authorized to comply with, any other Federal
law;</DELETED>
<DELETED> ``(B) implements a reporting, monitoring,
or other information collection obligation for the
chemical substance not otherwise required by the
Administrator under this Act or required under any
other Federal law; or</DELETED>
<DELETED> ``(C) is adopted pursuant to authority
under a law of the State or political subdivision of
the State related to water quality, air quality, or
waste treatment or disposal, unless the action taken by
the State or political subdivision of a State--
</DELETED>
<DELETED> ``(i) imposes a restriction on the
manufacture, processing, distribution in
commerce, or use of a chemical substance;
and</DELETED>
<DELETED> ``(ii)(I) is already required by a
decision by the Administrator under section 5
or 6;</DELETED>
<DELETED> ``(II) is taken to address a
health or environmental concern that applies to
the uses or conditions of use that are included
in the scope of a safety determination pursuant
to section 6 or the scope of a significant new
use rule promulgated pursuant to section 5, but
is inconsistent with the action of the
Administrator; or</DELETED>
<DELETED> ``(III) would cause a violation of
the applicable action by the Administrator
under section 5 or 6.</DELETED>
<DELETED> ``(3) Applicability to certain rules or orders.--
Notwithstanding subsection (e)--</DELETED>
<DELETED> ``(A) nothing in this section shall be
construed as modifying the effect under this section,
as in effect on the day before the effective date of
the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, of any rule or order promulgated or issued
under this Act prior to that effective date;
and</DELETED>
<DELETED> ``(B) with respect to a chemical substance
or mixture for which any rule or order was promulgated
or issued under section 6 prior to the effective date
of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act with regards to manufacturing, processing,
distribution in commerce, use, or disposal of a
chemical substance, this section (as in effect on the
day before the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act)
shall govern the preemptive effect of any rule or order
that is promulgated or issued respecting such chemical
substance or mixture under section 6 of this Act after
that effective date, unless the latter rule or order is
with respect to a chemical substance or mixture
containing a chemical substance and follows a
designation of that chemical substance as a high-
priority substance under subsection (b) or (c) of
section 4A or as an additional priority for safety
assessment and safety determination under section
4A(d).</DELETED>
<DELETED> ``(e) Preservation of Certain State Law.--</DELETED>
<DELETED> ``(1) In general.--Nothing in this Act, subject to
subsection (g) of this section, shall--</DELETED>
<DELETED> ``(A) be construed to preempt or otherwise
affect any action taken before January 1, 2015, under
the authority of a State law that prohibits or
otherwise restricts manufacturing, processing,
distribution in commerce, use, or disposal of a
chemical substance; or</DELETED>
<DELETED> ``(B) be construed to preempt or otherwise
affect any action taken pursuant to a State law that
was in effect on August 31, 2003.</DELETED>
<DELETED> ``(2) Effect of subsection.--This subsection does
not affect, modify, or alter the relationship between State and
Federal law pursuant to any other Federal law.</DELETED>
<DELETED> ``(f) State Waivers.--</DELETED>
<DELETED> ``(1) In general.--Upon application of a State or
political subdivision of a State, the Administrator may--
</DELETED>
<DELETED> ``(A) by rule, exempt from subsection (a),
under such conditions as may be prescribed in the rule,
a statute or administrative action of that State or
political subdivision of the State that relates to the
effects of, or exposure to, a chemical substance under
the conditions of use if the Administrator determines
that--</DELETED>
<DELETED> ``(i) compelling State or local
conditions warrant granting the waiver to
protect health or the environment;</DELETED>
<DELETED> ``(ii) compliance with the
proposed requirement of the State or political
subdivision of the State would not unduly
burden interstate commerce in the manufacture,
processing, distribution in commerce, or use of
a chemical substance;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(iv) based on the judgment of
the Administrator, the proposed requirement of
the State or political subdivision of the State
is consistent with sound objective scientific
practices, the weight of the evidence, and the
best available science; or</DELETED>
<DELETED> ``(B) exempt from subsection (b) a statute
or administrative action of a State or political
subdivision of a State that relates to the effects of
exposure to a chemical substance under the conditions
of use if the Administrator determines that--</DELETED>
<DELETED> ``(i) the State has a compelling
local interest that warrants granting the
waiver to protect health or the
environment;</DELETED>
<DELETED> ``(ii) compliance with the
proposed requirement of the State will not
unduly burden interstate commerce in the
manufacture, processing, distribution in
commerce, or use of a chemical
substance;</DELETED>
<DELETED> ``(iii) compliance with the
proposed requirement would not cause a
violation of any applicable Federal law, rule,
or order; and</DELETED>
<DELETED> ``(iv) the proposed requirement is
grounded in reasonable scientific
concern.</DELETED>
<DELETED> ``(2) Approval of a state waiver request.--The
Administrator shall grant or deny a waiver application--
</DELETED>
<DELETED> ``(A) not later than 180 days after the
date on which an application under paragraph (1)(A) is
submitted; and</DELETED>
<DELETED> ``(B) not later than 90 days after the
date on which an application under paragraph (1)(B) is
submitted.</DELETED>
<DELETED> ``(3) Notice and comment.--The application of a
State or political subdivision of the State shall be subject to
public notice and comment.</DELETED>
<DELETED> ``(4) Final agency action.--The decision of the
Administrator on the application of a State or political
subdivision of the State shall be--</DELETED>
<DELETED> ``(A) considered to be a final agency
action; and</DELETED>
<DELETED> ``(B) subject to judicial
review.</DELETED>
<DELETED> ``(5) Duration of waivers.--A waiver granted under
paragraph (1)(B) shall remain in effect until the later of--
</DELETED>
<DELETED> ``(A) such time as the safety assessment
and safety determination is completed; and</DELETED>
<DELETED> ``(B) the date on which compliance with an
applicable rule issued under section 6(d) is
required.</DELETED>
<DELETED> ``(6) Judicial review of waivers.--Not later than
60 days after the date on which the Administrator makes a
determination on an application of a State or political
subdivision of the State under subparagraph (A) or (B) of
paragraph (1), any person may file a petition for judicial
review in the United States Court of Appeals for the District
of Columbia Circuit, which shall have exclusive jurisdiction
over the determination.</DELETED>
<DELETED> ``(7) Judicial review of prioritization screening
decision.--Not later than 60 days after the date on which the
Administrator makes a decision on a recommendation made under
section 4A(b)(4) to designate a chemical substance as a low
priority, the Governor of a State or a State agency with
responsibility for protecting health and the environment that
submitted the recommendation under section 4A(a)(4)(A), as
applicable, may file a petition for judicial review in the
United States Court of Appeals for the District of Columbia
Circuit, which shall have exclusive jurisdiction over the
determination.</DELETED>
<DELETED> ``(g) Savings.--</DELETED>
<DELETED> ``(1) No preemption of common law or statutory
causes of action for civil relief or criminal conduct.--
</DELETED>
<DELETED> ``(A) In general.--Nothing in this Act,
nor any amendment made by this Act, nor any safety
standard, rule, requirement, standard of performance,
safety determination, or scientific assessment
implemented pursuant to this Act, shall be construed to
preempt, displace, or supplant any state or Federal
common law rights or any state or Federal statute
creating a remedy for civil relief, including those for
civil damage, or a penalty for a criminal
conduct.</DELETED>
<DELETED> ``(B) Clarification of no preemption.--
Notwithstanding any other provision of this Act,
nothing in this Act, nor any amendments made by this
Act, shall preempt or preclude any cause of action for
personal injury, wrongful death, property damage, or
other injury based on negligence, strict liability,
products liability, failure to warn, or any other legal
theory of liability under any State law, maritime law,
or Federal common law or statutory theory.</DELETED>
<DELETED> ``(2) No effect on private remedies.--</DELETED>
<DELETED> ``(A) Nothing in this Act, nor any
amendments made by this Act, nor any rules,
regulations, requirements, safety assessments, safety
determinations, scientific assessments, or orders
issued pursuant to this Act shall be interpreted as, in
either the plaintiff's or defendant's favor,
dispositive in any civil action.</DELETED>
<DELETED> ``(B) This Act does not affect the
authority of any court to make a determination in an
adjudicatory proceeding under applicable State or
Federal law with respect to the admission into evidence
or any other use of this Act or rules, regulations,
requirements, standards of performance, safety
assessments, scientific assessments, or orders issued
pursuant to this Act.''.</DELETED>
<DELETED>SEC. 19. JUDICIAL REVIEW.</DELETED>
<DELETED> Section 19 of the Toxic Substances Control Act (15 U.S.C.
2618) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) in paragraph (1)--</DELETED>
<DELETED> (i) in subparagraph (A), by
striking ``section 4(a), 5(a)(2), 5(b)(4),
6(a), 6(e), or 8, or under title II or IV'' and
inserting ``section 4(a), 5(d), 6(c), 6(d),
6(g), or 8, or title II or IV''; and</DELETED>
<DELETED> (ii) in subparagraph (B), by
striking ``an order issued under subparagraph
(A) or (B) of section 6(b)(1)'' and inserting
``an order issued under this title'';
and</DELETED>
<DELETED> (B) in paragraph (2), in the first
sentence, by striking ``paragraph (1)(A)'' and
inserting ``paragraph (1)''; and</DELETED>
<DELETED> (C) by striking paragraph (3);
and</DELETED>
<DELETED> (2) in subsection (c)(1)(B)--</DELETED>
<DELETED> (A) in clause (i)--</DELETED>
<DELETED> (i) by striking ``section 4(a),
5(b)(4), 6(a), or 6(e)'' and inserting
``section 4(a), 5(d), 6(d), or 6(g)'';
and</DELETED>
<DELETED> (ii) by striking ``evidence in the
rulemaking record (as defined in subsection
(a)(3)) taken as a whole;'' and inserting
``evidence (including any matter) in the
rulemaking record, taken as a whole; and'';
and</DELETED>
<DELETED> (B) by striking clauses (ii) and (iii) and
the matter following clause (iii) and inserting the
following:</DELETED>
<DELETED> ``(ii) the court may not review
the contents and adequacy of any statement of
basis and purpose required by section 553(c) of
title 5, United States Code, to be incorporated
in the rule, except as part of the rulemaking
record, taken as a whole.''.</DELETED>
<DELETED>SEC. 20. CITIZENS' PETITIONS.</DELETED>
<DELETED> Section 21 of the Toxic Substances Control Act (15 U.S.C.
2620) is amended--</DELETED>
<DELETED> (1) in subsection (a), by striking ``an order
under section 5(e) or 6(b)(2)'' and inserting ``an order under
section 4 or 5(d)''; and</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) in paragraph (1), by striking ``an
order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)''
and inserting ``an order under section 4 or 5(d)'';
and</DELETED>
<DELETED> (B) in paragraph (4), by striking
subparagraph (B) and inserting the following:</DELETED>
<DELETED> ``(B) De novo proceeding.--</DELETED>
<DELETED> ``(i) In general.--In an action
under subparagraph (A) to initiate a proceeding
to promulgate a rule pursuant to section 4, 5,
6, or 8 or an order issued under section 4 or
5, the petitioner shall be provided an
opportunity to have the petition considered by
the court in a de novo proceeding.</DELETED>
<DELETED> ``(ii) Demonstration.--</DELETED>
<DELETED> ``(I) In general.--The
court in a de novo proceeding under
this subparagraph shall order the
Administrator to initiate the action
requested by the petitioner if the
petitioner demonstrates to the
satisfaction of the court by a
preponderance of the evidence that--
</DELETED>
<DELETED> ``(aa) in the case
of a petition to initiate a
proceeding for the issuance of
a rule or order under section
4, the information available to
the Administrator is
insufficient for the
Administrator to perform an
action described in section 4,
4A, 5, or 6(d);</DELETED>
<DELETED> ``(bb) in the case
of a petition to issue an order
under section 5(d), there is a
reasonable basis to conclude
that the chemical substance is
not likely to meet the safety
standard;</DELETED>
<DELETED> ``(cc) in the case
of a petition to initiate a
proceeding for the issuance of
a rule under section 6(d),
there is a reasonable basis to
conclude that the chemical
substance will not meet the
safety standard; or</DELETED>
<DELETED> ``(dd) in the case
of a petition to initiate a
proceeding for the issuance of
a rule under section 8, there
is a reasonable basis to
conclude that the rule is
necessary to protect health or
the environment or ensure that
the chemical substance meets
the safety standard.</DELETED>
<DELETED> ``(II) Deferment.--The
court in a de novo proceeding under
this subparagraph may permit the
Administrator to defer initiating the
action requested by the petitioner
until such time as the court
prescribes, if the court finds that--
</DELETED>
<DELETED> ``(aa) the extent
of the risk to health or the
environment alleged by the
petitioner is less than the
extent of risks to health or
the environment with respect to
which the Administrator is
taking action under this Act;
and</DELETED>
<DELETED> ``(bb) there are
insufficient resources
available to the Administrator
to take the action requested by
the petitioner.''.</DELETED>
<DELETED>SEC. 21. EMPLOYMENT EFFECTS.</DELETED>
<DELETED> Section 24(b)(2)(B)(ii) of the Toxic Substances Control
Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by striking ``section
6(c)(3),'' and inserting ``the applicable requirements of this
Act;''.</DELETED>
<DELETED>SEC. 22. STUDIES.</DELETED>
<DELETED> Section 25 of the Toxic Substances Control Act (15 U.S.C.
2624) is repealed.</DELETED>
<DELETED>SEC. 23. ADMINISTRATION.</DELETED>
<DELETED> Section 26 of the Toxic Substances Control Act (15 U.S.C.
2625) is amended--</DELETED>
<DELETED> (1) by striking subsection (b) and inserting the
following:</DELETED>
<DELETED> ``(b) Fees.--</DELETED>
<DELETED> ``(1) In general.--The Administrator shall
establish, not later than 1 year after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act, by rule--</DELETED>
<DELETED> ``(A) the payment of 1 or more reasonable
fees as a condition of submitting a notice or
requesting an exemption under section 5; and</DELETED>
<DELETED> ``(B) the payment of 1 or more reasonable
fees by a manufacturer or processor that--</DELETED>
<DELETED> ``(i) is required to submit a
notice pursuant to the rule promulgated under
section 8(b)(4)(A)(i) identifying a chemical
substance as active;</DELETED>
<DELETED> ``(ii) is required to submit a
notice pursuant to section 8(b)(5)(B)(i)
changing the status of a chemical substance
from inactive to active;</DELETED>
<DELETED> ``(iii) is required to report
information pursuant to the rules promulgated
under section 8(a)(4); and</DELETED>
<DELETED> ``(iv) manufactures or processes a
chemical substance subject to a safety
assessment and safety determination pursuant to
section 6.</DELETED>
<DELETED> ``(2) Utilization and collection of fees.--The
Administrator shall--</DELETED>
<DELETED> ``(A) utilize the fees collected under
paragraph (1) only to defray costs associated with the
actions of the Administrator--</DELETED>
<DELETED> ``(i) to collect, process, review,
provide access to, and protect from disclosure
(where appropriate) information on chemical
substances under this Act;</DELETED>
<DELETED> ``(ii) to review notices and make
determinations for chemical substances under
paragraphs (1) and (3) of section 5(d) and
impose any necessary restrictions under section
5(d)(4);</DELETED>
<DELETED> ``(iii) to make prioritization
decisions under section 4A;</DELETED>
<DELETED> ``(iv) to conduct and complete
safety assessments and determinations under
section 6; and</DELETED>
<DELETED> ``(v) to conduct any necessary
rulemaking pursuant to section 6(d);</DELETED>
<DELETED> ``(B) insofar as possible, collect the
fees described in paragraph (1) in advance of
conducting any fee-supported activity;</DELETED>
<DELETED> ``(C) deposit the fees in the Fund
established by paragraph (4)(A); and</DELETED>
<DELETED> ``(D) not collect excess fees or retain a
significant amount of unused fees.</DELETED>
<DELETED> ``(3) Amount and adjustment of fees; refunds.--In
setting fees under this section, the Administrator shall--
</DELETED>
<DELETED> ``(A) take into account the cost to the
Administrator of conducting the activities described in
paragraph (2);</DELETED>
<DELETED> ``(B) prescribe lower fees for small
business concerns, after consultation with the
Administrator of the Small Business
Administration;</DELETED>
<DELETED> ``(C) set the fees established under
paragraph (1) at levels such that the fees will, in
aggregate, provide a sustainable source of funds to
defray approximately 25 percent of the costs of
conducting the activities identified in paragraph
(2)(A), not to exceed $18,000,000, not including fees
under subparagraph (E) of this paragraph;</DELETED>
<DELETED> ``(D) reflect an appropriate balance in
the assessment of fees between manufacturers and
processors, and allow the payment of fees by consortia
of manufacturers or processors;</DELETED>
<DELETED> ``(E) for substances designated as
additional priorities pursuant to section 4A(c),
establish the fee at a level sufficient to defray the
full costs to the Administrator of conducting the
safety assessment and safety determination under
section 6;</DELETED>
<DELETED> ``(F) prior to the establishment or
amendment of any fees under paragraph (1), consult and
meet with parties potentially subject to the fees or
their representatives, subject to the condition that no
obligation under the Federal Advisory Committee Act (5
U.S.C. App.) or subchapter III of chapter 5 of title 5,
United States Code, is applicable with respect to such
meetings;</DELETED>
<DELETED> ``(G) beginning with the fiscal year that
is 3 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act,
and every 3 years thereafter, after consultation with
parties potentially subject to the fees and their
representatives, increase or decrease the fees
established under paragraph (1) as necessary--
</DELETED>
<DELETED> ``(i) to ensure that funds
deposited in the Fund are sufficient to conduct
the activities identified in paragraph (2)(A)
and the full costs of safety assessments and
safety determinations pursuant to subparagraph
(E); and</DELETED>
<DELETED> ``(ii) to account for
inflation;</DELETED>
<DELETED> ``(H) adjust fees established under
paragraph (1) as necessary to vary on account of
differing circumstances, including reduced fees or
waivers in appropriate circumstances, to reduce the
burden on manufacturing or processing, remove barriers
to innovation, or where the costs to the Administrator
of collecting the fees exceed the fee revenue
anticipated to be collected; and</DELETED>
<DELETED> ``(I) if a notice submitted under section
5 is refused or subsequently withdrawn, refund the fee
or a portion of the fee if no substantial work was
performed on the notice.</DELETED>
<DELETED> ``(4) TSCA implementation fund.--</DELETED>
<DELETED> ``(A) Establishment.--There is established
in the Treasury of the United States a fund, to be
known as the `TSCA Implementation Fund' (referred to in
this subsection as the `Fund'), consisting of--
</DELETED>
<DELETED> ``(i) such amounts as are
deposited in the Fund under paragraph (2)(C);
and</DELETED>
<DELETED> ``(ii) any interest earned on the
investment of amounts in the Fund;
and</DELETED>
<DELETED> ``(iii) any proceeds from the sale
or redemption of investments held in the
Fund.</DELETED>
<DELETED> ``(B) Crediting and availability of
fees.--</DELETED>
<DELETED> ``(i) In general.--Fees authorized
under this section shall be collected and
available for obligation only to the extent and
in the amount provided in advance in
appropriations Acts, and shall be available
without fiscal year limitation.</DELETED>
<DELETED> ``(ii) Requirements.--Fees
collected under this section shall not--
</DELETED>
<DELETED> ``(I) be made available or
obligated for any purpose other than to
defray the costs of conducting the
activities identified in paragraph
(2)(A);</DELETED>
<DELETED> ``(II) otherwise be
available for any purpose other than
implementation of this Act;
and</DELETED>
<DELETED> ``(III) so long as amounts
in the Fund remain available, be
subject to restrictions on expenditures
applicable to the Federal government as
a whole.</DELETED>
<DELETED> ``(C) Unused funds.--Amounts in the Fund
not currently needed to carry out this subsection shall
be--</DELETED>
<DELETED> ``(i) maintained readily available
or on deposit;</DELETED>
<DELETED> ``(ii) invested in obligations of
the United States or guaranteed by the United
States; or</DELETED>
<DELETED> ``(iii) invested in obligations,
participations, or other instruments that are
lawful investments for fiduciary, trust, or
public funds.</DELETED>
<DELETED> ``(D) Minimum amount of appropriations.--
Fees may not be assessed for a fiscal year under this
section unless the amount of appropriations for
salaries, contracts, and expenses for the functions (as
in existence in fiscal year 2015) of the Office of
Pollution Prevention and Toxics of the Environmental
Protection Agency for the fiscal year (excluding the
amount of any fees appropriated for the fiscal year)
are equal to or greater than the amount of
appropriations for covered functions for fiscal year
2015 (excluding the amount of any fees appropriated for
the fiscal year).</DELETED>
<DELETED> ``(5) Auditing.--</DELETED>
<DELETED> ``(A) Financial statements of agencies.--
For the purpose of section 3515(c) of title 31, United
States Code, the Fund shall be considered a component
of an executive agency.</DELETED>
<DELETED> ``(B) Components.--The annual audit
required under sections 3515(b) and 3521 of that title
of the financial statements of activities under this
subsection shall include an analysis of--</DELETED>
<DELETED> ``(i) the fees collected under
paragraph (1) and disbursed;</DELETED>
<DELETED> ``(ii) compliance with the
deadlines established in section 6 of this
Act;</DELETED>
<DELETED> ``(iii) the amounts budgeted,
appropriated, collected from fees, and
disbursed to meet the requirements of sections
4, 4A, 5, 6, 8, and 14, including the
allocation of full time equivalent employees to
each such section or activity; and</DELETED>
<DELETED> ``(iv) the reasonableness of the
allocation of the overhead associated with the
conduct of the activities described in
paragraph (2)(A).</DELETED>
<DELETED> ``(C) Inspector general.--The Inspector
General of the Environmental Protection Agency shall--
</DELETED>
<DELETED> ``(i) conduct the annual audit
required under this subsection; and</DELETED>
<DELETED> ``(ii) report the findings and
recommendations of the audit to the
Administrator and to the appropriate committees
of Congress.</DELETED>
<DELETED> ``(6) Termination.--The authority provided by this
section shall terminate at the conclusion of the fiscal year
that is 10 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, unless
otherwise reauthorized or modified by Congress.'';</DELETED>
<DELETED> (2) in subsection (e), by striking ``Health,
Education, and Welfare'' each place it appears and inserting
``Health and Human Services''; and</DELETED>
<DELETED> (3) adding at the end the following:</DELETED>
<DELETED> ``(h) Prior Actions.--Nothing in this Act eliminates,
modifies, or withdraws any rule promulgated, order issued, or exemption
established pursuant to this Act before the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st Century
Act.''.</DELETED>
<DELETED>SEC. 24. DEVELOPMENT AND EVALUATION OF TEST METHODS AND
SUSTAINABLE CHEMISTRY.</DELETED>
<DELETED> Section 27 of the Toxic Substances Control Act (15 U.S.C.
2626) is amended--</DELETED>
<DELETED> (1) in subsection (a), in the first sentence by
striking ``Health, Education, and Welfare'' and inserting
``Health and Human Services''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(c) Sustainable Chemistry Program.--The President shall
establish an interagency Sustainable Chemistry Program to promote and
coordinate Federal sustainable chemistry research, development,
demonstration, technology transfer, commercialization, education, and
training activities.</DELETED>
<DELETED> ``(d) Program Activities.--The activities of the Program
shall be designed to--</DELETED>
<DELETED> ``(1) provide sustained support for sustainable
chemistry research, development, demonstration, technology
transfer, commercialization, education, and training through--
</DELETED>
<DELETED> ``(A) coordination of sustainable
chemistry research, development, demonstration, and
technology transfer conducted at Federal laboratories
and agencies; and</DELETED>
<DELETED> ``(B) to the extent practicable,
encouragement of consideration of sustainable chemistry
in, as appropriate--</DELETED>
<DELETED> ``(i) the conduct of Federal and
State science and engineering research and
development; and</DELETED>
<DELETED> ``(ii) the solicitation and
evaluation of applicable proposals for science
and engineering research and
development;</DELETED>
<DELETED> ``(2) examine methods by which the Federal
Government can create incentives for consideration and use of
sustainable chemistry processes and products, including
innovative financing mechanisms;</DELETED>
<DELETED> ``(3) expand the education and training of
undergraduate and graduate students and professional scientists
and engineers, including through partnerships with industry, in
sustainable chemistry science and engineering;</DELETED>
<DELETED> ``(4) collect and disseminate information on
sustainable chemistry research, development, and technology
transfer including information on--</DELETED>
<DELETED> ``(A) incentives and impediments to
development, manufacturing, and
commercialization;</DELETED>
<DELETED> ``(B) accomplishments;</DELETED>
<DELETED> ``(C) best practices; and</DELETED>
<DELETED> ``(D) costs and benefits; and</DELETED>
<DELETED> ``(5) support (including through technical
assistance, participation, financial support, or other forms of
support) economic, legal, and other appropriate social science
research to identify barriers to commercialization and methods
to advance commercialization of sustainable
chemistry.</DELETED>
<DELETED> ``(e) Interagency Working Group.--</DELETED>
<DELETED> ``(1) Establishment.--Not later than 180 days
after the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the President, in consultation
with the Office of Science and Technology Policy, shall
establish an Interagency Working Group that shall include
representatives from the National Science Foundation, the
National Institute of Standards and Technology, the Department
of Energy, the Environmental Protection Agency, the Department
of Agriculture, the Department of Defense, the National
Institutes of Health, and any other agency that the President
may designate to oversee the planning, management, and
coordination of the Program.</DELETED>
<DELETED> ``(2) Governance.--The Director of the National
Science Foundation and the Assistant Administrator for Research
and Development of the Environmental Protection Agency, or
their designees, shall serve as co-chairs of the Interagency
Working Group.</DELETED>
<DELETED> ``(3) Responsibilities.--In overseeing the
planning, management, and coordination of the Program, the
Interagency Working Group shall--</DELETED>
<DELETED> ``(A) establish goals and priorities for
the Program, in consultation with the Advisory
Council;</DELETED>
<DELETED> ``(B) provide for interagency
coordination, including budget coordination, of
activities under the Program;</DELETED>
<DELETED> ``(C) meet not later than 90 days from its
establishment and periodically thereafter;
and</DELETED>
<DELETED> ``(D) establish and consult with an
Advisory Council on a regular basis.</DELETED>
<DELETED> ``(4) Membership.--The Advisory Council members
shall not be employees of the Federal Government and shall
include a diverse representation of knowledgeable individuals
from the private sector (including small- and medium-sized
enterprises from across the value chain), academia, State and
tribal governments, and nongovernmental organizations and
others who are in a position to provide expertise.</DELETED>
<DELETED> ``(f) Agency Budget Requests.--</DELETED>
<DELETED> ``(1) In general.--Each Federal agency and
department participating in the Program shall, as part of its
annual request for appropriations to the Office of Management
and Budget, submit a report to the Office of Management and
Budget that--</DELETED>
<DELETED> ``(A) identifies the activities of the
agency or department that contribute directly to the
Program; and</DELETED>
<DELETED> ``(B) states the portion of the agency or
department's request for appropriations that is
allocated to those activities.</DELETED>
<DELETED> ``(2) Annual budget request to congress.--The
President shall include in the annual budget request to
Congress a statement of the portion of the annual budget
request for each agency or department that will be allocated to
activities undertaken pursuant to the Program.</DELETED>
<DELETED> ``(g) Report to Congress.--</DELETED>
<DELETED> ``(1) In general.--Not later than 2 years after
the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the Interagency Working Group
shall submit a report to the Committee on Science, Space, and
Technology and Committee on Energy and Commerce of the House of
Representatives and the Committee on Environment and Public
Works and the Committee on Commerce, Science, and
Transportation of the Senate that shall include--</DELETED>
<DELETED> ``(A) a summary of federally funded
sustainable chemistry research, development,
demonstration, technology transfer, commercialization,
education, and training activities;</DELETED>
<DELETED> ``(B) a summary of the financial resources
allocated to sustainable chemistry
initiatives;</DELETED>
<DELETED> ``(C) an analysis of the progress made
toward achieving the goals and priorities of this Act,
and recommendations for future program
activities;</DELETED>
<DELETED> ``(D) an assessment of the benefits of
expanding existing, federally supported regional
innovation and manufacturing hubs to include
sustainable chemistry and the value of directing the
creation of 1 or more dedicated sustainable chemistry
centers of excellence or hubs; and</DELETED>
<DELETED> ``(E) an evaluation of steps taken and
future strategies to avoid duplication of efforts,
streamline interagency coordination, facilitate
information sharing, and spread best practices between
participating agencies in the Program.</DELETED>
<DELETED> ``(2) Submission to gao.--The Interagency Working
Group shall also submit the report described in paragraph (1)
to the Government Accountability Office for consideration in
future Congressional inquiries.''.</DELETED>
<DELETED>SEC. 25. STATE PROGRAMS.</DELETED>
<DELETED> Section 28 of the Toxic Substances Control Act (15 U.S.C.
2627) is amended--</DELETED>
<DELETED> (1) in subsection (b)(1)--</DELETED>
<DELETED> (A) in subparagraphs (A) through (D), by
striking the comma at the end of each subparagraph and
inserting a semicolon; and</DELETED>
<DELETED> (B) in subparagraph (E), by striking ``,
and'' and inserting ``; and''; and</DELETED>
<DELETED> (2) by striking subsections (c) and (d).</DELETED>
<DELETED>SEC. 26. AUTHORIZATION OF APPROPRIATIONS.</DELETED>
<DELETED> Section 29 of the Toxic Substances Control Act (15 U.S.C.
2628) is repealed.</DELETED>
<DELETED>SEC. 27. ANNUAL REPORT.</DELETED>
<DELETED> Section 30 of the Toxic Substances Control Act (15 U.S.C.
2629) is amended by striking paragraph (2) and inserting the
following:</DELETED>
<DELETED> ``(2)(A) the number of notices received during
each year under section 5; and</DELETED>
<DELETED> ``(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;''.</DELETED>
<DELETED>SEC. 28. EFFECTIVE DATE.</DELETED>
<DELETED> Section 31 of the Toxic Substances Control Act (15 U.S.C.
2601 note; Public Law 94-469) is amended--</DELETED>
<DELETED> (1) by striking ``Except as provided in section
4(f), this'' and inserting the following:</DELETED>
<DELETED> ``(a) In General.--This''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(b) Retroactive Applicability.--Nothing in this Act
shall be interpreted to apply retroactively to any State, Federal, or
maritime legal action commenced prior to the effective date of the
Frank R. Lautenberg Chemical Safety for the 21st Century
Act.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Frank R. Lautenberg Chemical Safety
for the 21st Century Act''.
SEC. 2. FINDINGS, POLICY, AND INTENT.
Section 2(c) of the Toxic Substances Control Act (15 U.S.C.
2601(c)) is amended--
(1) by striking ``It is the intent'' and inserting the
following:
``(1) Administration.--It is the intent'';
(2) in paragraph (1) (as so redesignated), by inserting ``,
as provided under this Act'' before the period at the end; and
(3) by adding at the end the following:
``(2) Reform.--This Act, including reforms in accordance
with the amendments made by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act--
``(A) shall be administered in a manner that--
``(i) protects the health of children,
pregnant women, the elderly, workers,
consumers, the general public, and the
environment from the risks of harmful exposures
to chemical substances and mixtures; and
``(ii) ensures that appropriate information
on chemical substances and mixtures is
available to public health officials and first
responders in the event of an emergency; and
``(B) shall not displace or supplant common law
rights of action or remedies for civil relief.''.
SEC. 3. DEFINITIONS.
Section 3 of the Toxic Substances Control Act (15 U.S.C. 2602) is
amended--
(1) by redesignating paragraphs (4), (5), (6), (7), (8),
(9), (10), (11), (12), (13), and (14) as paragraphs (5), (6),
(7), (8), (9), (10), (12), (13), (17), (18), and (19),
respectively;
(2) by inserting after paragraph (3) the following:
``(4) Conditions of use.--The term `conditions of use'
means the intended, known, or reasonably foreseeable
circumstances the Administrator determines a chemical substance
is manufactured, processed, distributed in commerce, used, or
disposed of.'';
(3) by inserting after paragraph (10) (as so redesignated)
the following:
``(11) Potentially exposed or susceptible population.--The
term `potentially exposed or susceptible population' means 1 or
more groups--
``(A) of individuals within the general population
who may be--
``(i) differentially exposed to chemical
substances under the conditions of use; or
``(ii) susceptible to greater adverse
health consequences from chemical exposures
than the general population; and
``(B) that when identified by the Administrator may
include such groups as infants, children, pregnant
women, workers, and the elderly.''; and
(4) by inserting after paragraph (13) (as so redesignated)
the following:
``(14) Safety assessment.--The term `safety assessment'
means an assessment of the risk posed by a chemical substance
under the conditions of use, integrating hazard, use, and
exposure information regarding the chemical substance.
``(15) Safety determination.--The term `safety
determination' means a determination by the Administrator as to
whether a chemical substance meets the safety standard under
the conditions of use.
``(16) Safety standard.--The term `safety standard' means a
standard that ensures, without taking into consideration cost
or other nonrisk factors, that no unreasonable risk of injury
to health or the environment will result from exposure to a
chemical substance under the conditions of use, including no
unreasonable risk of injury to--
``(A) the general population; or
``(B) any potentially exposed or susceptible
population that the Administrator has identified as
relevant to the safety assessment and safety
determination for a chemical substance.''.
SEC. 4. POLICIES, PROCEDURES, AND GUIDANCE.
The Toxic Substances Control Act is amended by inserting after
section 3 (15 U.S.C. 2602) the following:
``SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE.
``(a) Definition of Guidance.--In this section, the term `guidance'
includes any significant written guidance of general applicability
prepared by the Administrator.
``(b) Deadline.--Not later than 2 years after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st Century Act,
the Administrator shall develop, after providing public notice and an
opportunity for comment, any policies, procedures, and guidance the
Administrator determines to be necessary to carry out sections 4, 4A,
5, and 6, including the policies, procedures, and guidance required by
this section.
``(c) Use of Science.--
``(1) In general.--The Administrator shall establish
policies, procedures, and guidance on the use of science in
making decisions under sections 4, 4A, 5, and 6.
``(2) Goal.--A goal of the policies, procedures, and
guidance described in paragraph (1) shall be to make the basis
of decisions clear to the public.
``(3) Requirements.--The policies, procedures, and guidance
issued under this section shall describe the manner in which
the Administrator shall ensure that --
``(A) decisions made by the Administrator--
``(i) are based on information, procedures,
measures, methods, and models employed in a
manner consistent with the best available
science;
``(ii) take into account the extent to
which--
``(I) assumptions and methods are
clearly and completely described and
documented;
``(II) variability and uncertainty
are evaluated and characterized; and
``(III) the information has been
subject to independent verification and
peer review; and
``(iii) are based on the weight of the
scientific evidence, by which the Administrator
considers all information in a systematic and
integrative framework to consider the relevance
of different information;
``(B) to the extent practicable and if appropriate,
the use of peer review, standardized test design and
methods, consistent data evaluation procedures, and
good laboratory practices will be encouraged;
``(C) a clear description of each individual and
entity that funded the generation or assessment of
information, and the degree of control those
individuals and entities had over the generation,
assessment, and dissemination of information (including
control over the design of the work and the publication
of information) is made available; and
``(D) if appropriate, the recommendations in
reports of the National Academy of Sciences that
provide advice regarding assessing the hazards,
exposures, and risks of chemical substances are
considered.
``(d) Existing EPA Policies, Procedures, and Guidance.--The
policies, procedures, and guidance described in subsection (b) shall
incorporate, as appropriate, existing relevant hazard, exposure, and
risk assessment guidelines and methodologies, data evaluation and
quality criteria, testing methodologies, and other relevant guidelines
and policies of the Environmental Protection Agency.
``(e) Review.--Not later than 5 years after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st Century Act,
and not less frequently than once every 5 years thereafter, the
Administrator shall--
``(1) review the adequacy of any policies, procedures, and
guidance developed under this section, including animal,
nonanimal, and epidemiological test methods and procedures for
assessing and determining risk under this Act; and
``(2) after providing public notice and an opportunity for
comment, revise the policies, procedures, and guidance if
necessary to reflect new scientific developments or
understandings.
``(f) Sources of Information.--In carrying out sections 4, 4A, 5,
and 6, the Administrator shall take into consideration information
relating to a chemical substance, including hazard and exposure
information, under the conditions of use that is reasonably available
to the Administrator, including information that is--
``(1) submitted to the Administrator pursuant to any rule,
consent agreement, order, or other requirement of this Act, or
on a voluntary basis, including pursuant to any request made
under this Act, by--
``(A) manufacturers or processors of a substance;
``(B) the public;
``(C) other Federal departments or agencies; or
``(D) the Governor of a State or a State agency
with responsibility for protecting health or the
environment;
``(2) submitted to a governmental entity in any
jurisdiction pursuant to a governmental requirement relating to
the protection of health or the environment; or
``(3) identified through an active search by the
Administrator of information sources that are publicly
available or otherwise accessible by the Administrator.
``(g) Testing of Chemical Substances and Mixtures.--
``(1) In general.--The Administrator shall establish
policies and procedures for the testing of chemical substances
or mixtures under section 4.
``(2) Goal.--A goal of the policies and procedures
established under paragraph (1) shall be to make the basis of
decisions clear to the public.
``(3) Contents.--The policies and procedures established
under paragraph (1) shall--
``(A) address how and when the exposure level or
exposure potential of a chemical substance would factor
into decisions to require new testing, subject to the
condition that the Administrator shall not interpret
the lack of exposure information as a lack of exposure
or exposure potential;
``(B) describe the manner in which the
Administrator will determine that additional
information is necessary to carry out this Act,
including information relating to potentially exposed
or susceptible populations;
``(C) require the Administrator to consult with the
Director of the National Institute for Occupational
Safety and Health prior to prescribing epidemiologic
studies of employees; and
``(D) require that prior to making a request or
adopting a requirement for testing using vertebrate
animals, the Administrator shall take into
consideration, as appropriate and to the extent
practicable, reasonably available--
``(i) toxicity information;
``(ii) computational toxicology and
bioinformatics;
``(iii) high-throughput screening methods
and the prediction models of those methods; and
``(iv) scientifically reliable and relevant
alternatives to tests on animals that would
provide equivalent information.
``(h) Safety Assessments and Safety Determinations.--
``(1) Schedule.--
``(A) In general.--The Administrator shall inform
the public regarding the schedule for the completion of
each safety assessment and safety determination as soon
as practicable after designation as a high-priority
substance pursuant to section 4A.
``(B) Differing times.--The Administrator may allot
different times for different chemical substances in
the schedules under this paragraph, subject to the
condition that all schedules shall comply with the
deadlines established under section 6.
``(C) Annual plan.--At the beginning of each
calendar year, the Administrator shall identify the
substances subject to safety assessments and safety
determinations to be completed that year.
``(2) Policies and procedures for safety assessments and
safety determinations.--
``(A) In general.--The Administrator shall
establish, by rule, policies and procedures regarding
the manner in which the Administrator shall carry out
section 6.
``(B) Goal.--A goal of the policies and procedures
under this paragraph shall be to make the basis of
decisions of the Administrator clear to the public.
``(C) Minimum requirements.--At a minimum, the
policies and procedures under this paragraph shall--
``(i) describe--
``(I) the manner in which the
Administrator will identify
informational needs and seek that
information from the public;
``(II) the information (including
draft safety assessments) that may be
submitted by interested individuals or
entities, including States; and
``(III) the criteria by which that
information will be evaluated;
``(ii) require the Administrator--
``(I)(aa) to define the scope of
the safety assessment and safety
determination to be conducted under
section 6, including the hazards,
exposures, conditions of use, and
potentially exposed and susceptible
populations that the Administrator
expects to consider in a safety
assessment;
``(bb) to explain the basis for the
scope of the safety assessment and
safety determination; and
``(cc) to accept comments regarding
the scope of the safety assessment and
safety determination; and
``(II)(aa) to identify the items
described in subclause (I) that the
Administrator has considered in the
final safety assessment; and
``(bb) to explain the basis for the
consideration of those items;
``(iii) describe the manner in which
aggregate exposures, or significant subsets of
exposures, to a chemical substance under the
conditions of use will be considered, and
explain the basis for that consideration in the
final safety assessment;
``(iv) require that each safety assessment
and safety determination shall include--
``(I) a description of the weight
of the scientific evidence of risk; and
``(II) a summary of the information
regarding the impact on health and the
environment of the chemical substance
that was used to make the assessment or
determination, including, as available,
mechanistic, animal toxicity, and
epidemiology studies;
``(v) establish a timely and transparent
process for evaluating whether new information
submitted or obtained after the date of a final
safety assessment or safety determination
warrants reconsideration of the safety
assessment or safety determination; and
``(vi) when relevant information is
provided or otherwise made available to the
Administrator, shall consider the extent of
Federal regulation under other Federal laws.
``(D) Guidance.--
``(i) In general.--Not later than 1 year
after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act, the Administrator shall develop guidance
to assist interested persons in developing
their own draft safety assessments and other
information for submission to the
Administrator, which may be considered at the
discretion of the Administrator.
``(ii) Requirement.--The guidance shall, at
a minimum, address the quality of the
information submitted and the process to be
followed in developing a draft safety
assessment for consideration by the
Administrator.
``(i) Publicly Available Information.--Subject to section 14, the
Administrator shall--
``(1) make publicly available a nontechnical summary, and
the final version, of each safety assessment and safety
determination;
``(2) provide public notice and an opportunity for comment
on each proposed safety assessment and safety determination;
and
``(3) make public in a final safety assessment and safety
determination--
``(A) the list of studies considered by the
Administrator in carrying out the safety assessment or
safety determination; and
``(B) the list of policies, procedures, and
guidance that were followed in carrying out the safety
assessment or safety determination.
``(j) Consultation With Science Advisory Committee on Chemicals.--
``(1) Establishment.--Not later than 1 year after the date
of enactment of this section, the Administrator shall establish
an advisory committee, to be known as the `Science Advisory
Committee on Chemicals' (referred to in this subsection as the
`Committee').
``(2) Purpose.--The purpose of the Committee shall be to
provide independent advice and expert consultation, on the
request of the Administrator, with respect to the scientific
and technical aspects of issues relating to the implementation
of this title.
``(3) Composition.--The Committee shall be composed of
representatives of such science, government, labor, public
health, public interest, animal protection, industry, and other
groups as the Administrator determines to be advisable,
including, at a minimum, representatives that have specific
scientific expertise in the relationship of chemical exposures
to women, children, and other potentially exposed or
susceptible populations.
``(4) Schedule.--The Administrator shall convene the
Committee in accordance with such schedule as the Administrator
determines to be appropriate, but not less frequently than once
every 2 years.
``(5) Relationship to other law.--All proceedings and
meetings of the Committee shall be subject to the Federal
Advisory Committee Act (5 U.S.C. App.).''.
SEC. 5. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES.
(a) In General.--Section 4 of the Toxic Substances Control Act (15
U.S.C. 2603) is amended--
(1) by striking subsections (a), (b), (c), (d), and (g);
(2) by redesignating subsections (e) and (f) as subsections
(f) and (g), respectively;
(3) in subsection (f) (as so redesignated)--
(A) by striking ``rule'' each place it appears and
inserting ``rule, testing consent agreement, or
order'';
(B) by striking ``under subsection (a)'' each place
it appears and inserting ``under this subsection''; and
(C) in paragraph (1)--
(i) in subparagraph (A)(v), by inserting
``, without taking into account cost or other
nonrisk factors'' after ``the environment'';
and
(ii) in subparagraph (B), in the last
sentence, by striking ``rulemaking'';
(4) in subsection (g) (as so redesignated)--
(A) in the first sentence--
(i) by striking ``from cancer, gene
mutations, or birth defects''; and
(ii) by inserting ``, without taking into
account cost or other nonrisk factors'' before
the period at the end; and
(B) by striking the last sentence; and
(5) by inserting before subsection (f) (as so redesignated)
the following:
``(a) Development of New Information on Chemical Substances and
Mixtures.--
``(1) In general.--The Administrator may require the
development of new information relating to a chemical substance
or mixture in accordance with this section if the Administrator
determines that the information is necessary--
``(A) to review a notice under section 5(d) or to
perform a safety assessment or safety determination
under section 6;
``(B) to implement a requirement imposed in a
consent agreement or order issued under section 5(d)(4)
or under a rule promulgated under section 6(d)(3);
``(C) pursuant to section 12(a)(4); or
``(D) at the request of the implementing authority
under another Federal law, to meet the regulatory
testing needs of that authority.
``(2) Limited testing for prioritization purposes.--
``(A) In general.--Except as provided in
subparagraph (B), the Administrator may require the
development of new information for the purposes of
section 4A.
``(B) Prohibition.--Testing required under
subparagraph (A) shall not be required for the purpose
of establishing or implementing a minimum information
requirement.
``(C) Limitation.--The Administrator may require
the development of new information pursuant to
subparagraph (A) only if the Administrator determines
that additional information is necessary to establish
the priority of a chemical substance.
``(3) Form.--The Administrator may require the development
of information described in paragraph (1) or (2) by--
``(A) promulgating a rule;
``(B) entering into a testing consent agreement; or
``(C) issuing an order.
``(4) Contents.--
``(A) In general.--A rule, testing consent
agreement, or order issued under this subsection shall
include--
``(i) identification of the chemical
substance or mixture for which testing is
required;
``(ii) identification of the persons
required to conduct the testing;
``(iii) test protocols and methodologies
for the development of information for the
chemical substance or mixture, including
specific reference to any reliable nonanimal
test procedures; and
``(iv) specification of the period within
which individuals and entities required to
conduct the testing shall submit to the
Administrator the information developed in
accordance with the procedures described in
clause (iii).
``(B) Considerations.--In determining the
procedures and period to be required under subparagraph
(A), the Administrator shall take into consideration--
``(i) the relative costs of the various
test protocols and methodologies that may be
required; and
``(ii) the reasonably foreseeable
availability of facilities and personnel
required to perform the testing.
``(b) Statement of Need.--
``(1) In general.--In promulgating a rule, entering into a
testing consent agreement, or issuing an order for the
development of additional information (including information on
exposure or exposure potential) pursuant to this section, the
Administrator shall--
``(A) identify the need intended to be met by the
rule, agreement, or order;
``(B) explain why information reasonably available
to the Administrator at that time is inadequate to meet
that need, including a reference, as appropriate, to
the information identified in paragraph (2)(B); and
``(C) explain the basis for any decision that
requires the use of vertebrate animals.
``(2) Explanation in case of order.--
``(A) In general.--If the Administrator issues an
order under this section, the Administrator shall issue
a statement providing a justification for why issuance
of an order is warranted instead of promulgating a rule
or entering into a testing consent agreement.
``(B) Contents.--A statement described in
subparagraph (A) shall contain a description of--
``(i) information that is readily
accessible to the Administrator, including
information submitted under any other provision
of law;
``(ii) the extent to which the
Administrator has obtained or attempted to
obtain the information through voluntary
submissions; and
``(iii) any information relied on in safety
assessments for other chemical substances
relevant to the chemical substances that would
be the subject of the order.
``(c) Reduction of Testing on Vertebrates.--
``(1) In general.--The Administrator shall minimize, to the
extent practicable, the use of vertebrate animals in testing of
chemical substances or mixtures, by--
``(A) encouraging and facilitating--
``(i) the use of integrated and tiered
testing and assessment strategies;
``(ii) the use of best available science in
existence on the date on which the test is
conducted;
``(iii) the use of test methods that
eliminate or reduce the use of animals while
providing information of high scientific
quality;
``(iv) the grouping of 2 or more chemical
substances into scientifically appropriate
categories in cases in which testing of a
chemical substance would provide reliable and
useful information on other chemical substances
in the category;
``(v) the formation of industry consortia
to jointly conduct testing to avoid unnecessary
duplication of tests; and
``(vi) the submission of information from--
``(I) animal-based studies; and
``(II) emerging methods and models;
and
``(B) funding research and validation studies to
reduce, refine, and replace the use of animal tests in
accordance with this subsection.
``(2) Implementation of alternative testing methods.--To
promote the development and timely incorporation of new testing
methods that are not based on vertebrate animals, the
Administrator shall--
``(A) not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, develop a strategic plan to
promote the development and implementation of
alternative test methods and testing strategies to
generate information under this title that can reduce,
refine, or replace the use of vertebrate animals,
including toxicity pathway-based risk assessment, in
vitro studies, systems biology, computational
toxicology, bioinformatics, and high-throughput
screening;
``(B) as practicable, ensure that the strategic
plan developed under subparagraph (A) is reflected in
the development of requirements for testing under this
section;
``(C) identify in the strategic plan developed
under subparagraph (A) particular alternative test
methods or testing strategies that do not require new
vertebrate animal testing and are scientifically
reliable, relevant, and capable of providing
information of equivalent scientific reliability and
quality to that which would be obtained from vertebrate
animal testing;
``(D) provide an opportunity for public notice and
comment on the contents of the plan developed under
subparagraph (A), including the criteria for
considering scientific reliability, relevance, and
equivalent information and the test methods and
strategies identified in subparagraph (C);
``(E) beginning on the date that is 5 years after
the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act and every 5
years thereafter, submit to Congress a report that
describes the progress made in implementing this
subsection and goals for future alternative test
methods implementation;
``(F) fund and carry out research, development,
performance assessment, and translational studies to
accelerate the development of test methods and testing
strategies that reduce, refine, or replace the use of
vertebrate animals in any testing under this title; and
``(G) identify synergies with the related
information requirements of other jurisdictions to
minimize the potential for additional or duplicative
testing.
``(3) Criteria for adapting or waiving animal testing
requirements.--On request from a manufacturer or processor that
is required to conduct testing of a chemical substance or
mixture on vertebrate animals under this section, the
Administrator may adapt or waive the requirement, if the
Administrator determines that--
``(A) there is sufficient evidence from several
independent sources of information to support a
conclusion that a chemical substance or mixture has, or
does not have, a particular property if the information
from each individual source alone is insufficient to
support the conclusion;
``(B) as a result of 1 or more physical or chemical
properties of the chemical substance or mixture or
other toxicokinetic considerations--
``(i) the substance cannot be absorbed; or
``(ii) testing for a specific endpoint is
technically not practicable to conduct; or
``(C) a chemical substance or mixture cannot be
tested in vertebrate animals at concentrations that do
not result in significant pain or distress, because of
physical or chemical properties of the chemical
substance or mixture, such as a potential to cause
severe corrosion or severe irritation to the tissues of
the animal.
``(4) Voluntary testing.--
``(A) In general.--Any person developing
information for submission under this title on a
voluntary basis and not pursuant to any request or
requirement by the Administrator shall first attempt to
develop the information by means of an alternative or
nonanimal test method or testing strategy that the
Administrator has determined under paragraph (2)(C) to
be scientifically reliable, relevant, and capable of
providing equivalent information, before conducting new
animal testing.
``(B) Effect of paragraph.--Nothing in this
paragraph--
``(i) requires the Administrator to review
the basis on which the person is conducting
testing described in subparagraph (A);
``(ii) prohibits the use of other test
methods or testing strategies by any person for
purposes other than developing information for
submission under this title on a voluntary
basis; or
``(iii) prohibits the use of other test
methods or testing strategies by any person,
subsequent to the attempt to develop
information using the test methods and testing
strategies identified by the Administrator
under paragraph (2)(C).
``(d) Testing Requirements.--
``(1) In general.--The Administrator may require the
development of information by--
``(A) manufacturers and processors of the chemical
substance or mixture; and
``(B) subject to paragraph (3), persons that begin
to manufacture or process the chemical substance or
mixture--
``(i) after the effective date of the rule,
testing consent agreement, or order; but
``(ii) before the period ending on the
later of--
``(I) 5 years after the date
referred to in clause (i); or
``(II) the last day of the period
that begins on the date referred to in
clause (i) and that is equal to the
period that the Administrator
determines was necessary to develop the
information.
``(2) Designation.--The Administrator may permit 2 or more
persons identified in subparagraph (A) or (B) of paragraph (1)
to designate 1 of the persons or a qualified third party--
``(A) to develop the information; and
``(B) to submit the information on behalf of the
persons making the designation.
``(3) Exemptions.--
``(A) In general.--A person otherwise subject to a
rule, testing consent agreement, or order under this
section may submit to the Administrator an application
for an exemption on the basis that the information is
being developed by a person designated under paragraph
(2).
``(B) Fair and equitable reimbursement to
designee.--
``(i) In general.--If the Administrator
accepts an application submitted under
subparagraph (A), the Administrator shall
direct the applicant to provide to the person
designated under paragraph (2) fair and
equitable reimbursement, as agreed to between
the applicant and the designee.
``(ii) Arbitration.--If the applicant and a
person designated under paragraph (2) cannot
reach agreement on the amount of fair and
equitable reimbursement, the amount shall be
determined by arbitration.
``(C) Termination.--If, after granting an exemption
under this paragraph, the Administrator determines that
no person designated under paragraph (2) 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 that
received an exemption of the requirements with
respect to which the exemption was granted.
``(4) Tiered testing.--
``(A) In general.--Except as provided in
subparagraph (D), the Administrator shall employ a
tiered screening and testing process, under which the
results of screening-level tests or assessments of
available information inform the decision as to whether
1 or more additional tests are necessary.
``(B) Screening-level tests.--
``(i) In general.--The screening-level
tests required for a chemical substance or
mixture may include tests for hazard (which may
include in silico, in vitro, and in vivo
tests), environmental and biological fate and
transport, and measurements or modeling of
exposure or exposure potential, as appropriate.
``(ii) Use.--Screening-level tests shall be
used--
``(I) to screen chemical substances
or mixtures for potential adverse
effects; and
``(II) to inform a decision of the
Administrator regarding whether more
complex or targeted additional testing
is necessary.
``(C) Additional testing.--If the Administrator
determines under subparagraph (B) that additional
testing is necessary to provide more definitive
information for safety assessments or safety
determinations, the Administrator may require more
advanced tests for potential health or environmental
effects or exposure potential.
``(D) Advanced testing without screening.--The
Administrator may require more advanced testing without
conducting screening-level testing when other
information available to the Administrator justifies
the advanced testing, pursuant to guidance developed by
the Administrator under this section.
``(e) Transparency.--Subject to section 14, the Administrator shall
make available to the public all testing consent agreements and orders
and all information submitted under this section.''.
(b) Conforming Amendment.--Section 104(i)(5)(A) of the
Comprehensive Environmental Response, Compensation, and Liability Act
of 1980 (42 U.S.C. 9604(i)(5)(A)) is amended in the third sentence by
striking ``section 4(e)'' and inserting ``section 4(f)''.
SEC. 6. PRIORITIZATION SCREENING.
The Toxic Substances Control Act is amended by inserting after
section 4 (15 U.S.C. 2603) the following:
``SEC. 4A. PRIORITIZATION SCREENING.
``(a) Prioritization Screening Process and List of Substances.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Administrator shall establish,
by rule, a risk-based screening process and explicit criteria
for identifying existing chemical substances that are--
``(A) a high priority for a safety assessment and
safety determination under section 6 (referred to in
this Act as `high-priority substances'); and
``(B) a low priority for a safety assessment and
safety determination (referred to in this Act as `low-
priority substances').
``(2) Initial list of high- and low-priority substances.--
``(A) In general.--Before the date of promulgation
of the rule under paragraph (1) and not later than 180
days after the date of enactment of this section, the
Administrator--
``(i) shall take into consideration and
publish an initial list of high-priority
substances and low-priority substances; and
``(ii) pursuant to section 6(b), may
initiate or continue safety assessments and
safety determinations for those high-priority
substances.
``(B) Requirements.--
``(i) In general.--The initial list of
chemical substances shall contain at least 10
high-priority substances, at least 5 of which
are drawn from the list of chemical substances
identified by the Administrator in the October
2014 TSCA Work Plan and subsequent updates, and
at least 10 low-priority substances.
``(ii) Subsequently identified
substances.--Insofar as possible, at least 50
percent of all substances subsequently
identified by the Administrator as high-
priority substances shall be drawn from the
list of chemical substances identified by the
Administrator in the October 2014 TSCA Work
Plan and subsequent updates, until all Work
Plan chemicals have been designated under this
subsection.
``(iii) Persistence and bioaccumulation.--
In developing the initial list and in
identifying additional high-priority
substances, the Administrator shall give
preference to chemical substances scored as
high for persistence and bioaccumulation in the
October 2014 TSCA Work Plan and subsequent
updates.
``(C) Additional chemical reviews.--The
Administrator shall, as soon as practicable and not
later than--
``(i) 3 years after the date of enactment
of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, add additional high-
priority substances sufficient to ensure that
at least a total of 20 high-priority substances
have undergone or are undergoing the process
established in section 6(a), and additional
low-priority substances sufficient to ensure
that at least a total of 20 low-priority
substances have been designated; and
``(ii) 5 years after the date of enactment
of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, add additional high-
priority substances sufficient to ensure that
at least a total of 25 high-priority substances
have undergone or are undergoing the process
established in section 6(a), and additional
low-priority substances sufficient to ensure
that at least a total of 25 low-priority
substances have been designated.
``(3) Implementation.--
``(A) Consideration of active and inactive
substances.--
``(i) Active substances.--In carrying out
paragraph (1), the Administrator shall take
into consideration active substances, as
determined under section 8, which may include
chemical substances on the interim list of
active substances established under that
section.
``(ii) Inactive substances.--In carrying
out paragraph (1), the Administrator may take
into consideration inactive substances, as
determined under section 8, that the
Administrator determines--
``(I)(aa) have not been subject to
a regulatory or other enforceable
action by the Administrator to ban or
phase out the substances; and
``(bb) have the potential for high
hazard and widespread exposure; or
``(II)(aa) have been subject to a
regulatory or other enforceable action
by the Administrator to ban or phase
out the substances; and
``(bb) with respect to which there
exists the potential for residual high
hazards or widespread exposures not
otherwise addressed by the regulatory
or other action.
``(iii) Repopulation.--
``(I) In general.--On the
completion of a safety determination
under section 6 for a chemical
substance, the Administrator shall
remove the chemical substance from the
list of high-priority substances
established under this subsection.
``(II) Additions.--The
Administrator shall add at least 1
chemical substance to the list of high-
priority substances for each chemical
substance removed from the list of
high-priority substances established
under this subsection, until a safety
assessment and safety determination is
completed for all high-priority
substances.
``(III) Low-priority substances.--
If a low-priority substance is
subsequently designated as a high-
priority substance, the Administrator
shall remove that substance from the
list of low-priority substances.
``(B) Timely completion of prioritization screening
process.--
``(i) In general.--The Administrator
shall--
``(I) except as provided under
paragraph (2), not later than 180 days
after the effective date of the final
rule under paragraph (1), begin the
prioritization screening process; and
``(II) make every effort to
complete the designation of all active
substances as high-priority substances
or low-priority substances in a timely
manner.
``(ii) Decisions on substances subject to
testing for prioritization purposes.--Not later
than 90 days after the date of receipt of
information regarding a chemical substance
complying with a rule, testing consent
agreement, or order issued under section
4(a)(2), the Administrator shall designate the
chemical substance as a high-priority substance
or low-priority substance.
``(iii) Consideration.--
``(I) In general.--The
Administrator shall screen substances
and designate high-priority substances
taking into consideration the ability
of the Administrator to schedule and
complete safety assessments and safety
determinations under section 6 in a
timely manner.
``(II) Annual goal.--The
Administrator shall publish an annual
goal for the number of chemical
substances to be subject to the
prioritization screening process.
``(C) Screening of categories of substances.--The
Administrator may screen categories of chemical
substances to ensure an efficient prioritization
screening process to allow for timely and adequate
designations of high-priority substances and low-
priority substances and safety assessments and safety
determinations for high-priority substances.
``(D) Publication of list of chemical substances.--
The Administrator shall keep current and publish a list
of chemical substances that--
``(i) are being considered in the
prioritization screening process and the status
of the chemical substances in the
prioritization process, including those
chemical substances for which prioritization
decisions have been deferred; and
``(ii) are designated as high-priority
substances or low-priority substances,
including the bases for such designations.
``(4) Criteria.--The criteria described in paragraph (1)
shall account for--
``(A) the recommendation of the Governor of a State
or a State agency with responsibility for protecting
health or the environment from chemical substances
appropriate for prioritization screening;
``(B) the hazard and exposure potential of the
chemical substance (or category of substances),
including persistence, bioaccumulation, and specific
scientific classifications and designations by
authoritative governmental entities;
``(C) the conditions of use or significant changes
in the conditions of use of the chemical substance;
``(D) evidence and indicators of exposure potential
to humans or the environment from the chemical
substance, including potentially exposed or susceptible
populations;
``(E) the volume of a chemical substance
manufactured or processed;
``(F) whether the volume of a chemical substance as
reported under a rule promulgated pursuant to section
8(a) has significantly increased or decreased during
the period beginning on the date of a previous report
or the date on which a notice has been submitted under
section 5(b) for that chemical substance;
``(G) the availability of information regarding
potential hazards and exposures required for conducting
a safety assessment or safety determination, with
limited availability of relevant information to be a
sufficient basis for designating a chemical substance
as a high-priority substance, subject to the condition
that limited availability shall not require designation
as a high-priority substance; and
``(H) the extent of Federal or State regulation of
the chemical substance or the extent of the impact of
State regulation of the chemical substance on the
United States, with existing Federal or State
regulation of any uses evaluated in the prioritization
screening process as a factor in designating a chemical
substance to be a high-priority or a low-priority
substance.
``(b) Prioritization Screening Process and Decisions.--
``(1) In general.--The prioritization screening process
developed under subsection (a) shall include a requirement that
the Administrator shall--
``(A) identify the chemical substances being
considered for prioritization;
``(B) request interested persons to supply
information regarding the chemical substances being
considered;
``(C) apply the criteria identified in subsection
(a)(4); and
``(D) subject to paragraph (5) and using the
information available to the Administrator at the time
of the decision, identify a chemical substance as a
high-priority substance or a low-priority substance.
``(2) Integration of information.--The prioritization
screening decision regarding a chemical substance shall
integrate any hazard and exposure information relating to the
chemical substance that is available to the Administrator.
``(3) Identification of high-priority substances.--The
Administrator--
``(A) shall identify as a high-priority substance a
chemical substance that, relative to other active
chemical substances, the Administrator determines has
the potential for significant hazard and significant
exposure;
``(B) may identify as a high-priority substance a
chemical substance that, relative to other active
chemical substances, the Administrator determines has
the potential for significant hazard or significant
exposure; and
``(C) may identify as a high-priority substance an
inactive substance, as determined under subsection
(a)(3)(A)(ii) and section 8(b), that the Administrator
determines warrants a safety assessment and safety
determination under section 6.
``(4) Identification of low-priority substances.--The
Administrator shall identify as a low-priority substance a
chemical substance that the Administrator concludes has
information sufficient to establish that the chemical substance
is likely to meet the safety standard.
``(5) Deferring a decision.--If the Administrator
determines that additional information is required to establish
the priority of a chemical substance under this section, the
Administrator may defer the prioritization screening decision
for a reasonable period--
``(A) to allow for the submission of additional
information by an interested person and for the
Administrator to evaluate the additional information;
or
``(B) to require the development of information
pursuant to a rule, testing consent agreement, or order
issued under section 4(a)(2).
``(6) Deadlines for submission of information.--If the
Administrator requests the development or submission of
information under this section, the Administrator shall
establish a deadline for submission of the information.
``(7) Notice and comment.--The Administrator shall--
``(A) publish, including in the Federal Register,
the proposed decisions made under paragraphs (3), (4),
and (5) and the basis for the decisions; and
``(B) provide 90 days for public comment.
``(8) Revisions of prior designations.--
``(A) In general.--At any time, and at the
discretion of the Administrator, the Administrator may
revise the designation of a chemical substance as a
high-priority substance or a low-priority substance
based on information available to the Administrator
after the date of the determination under paragraph (3)
or (4).
``(B) Limited availability.--If limited
availability of relevant information was a basis in the
designation of a chemical substance as a high-priority
substance, the Administrator shall reevaluate the
prioritization screening of the chemical substance on
receiving the relevant information.
``(9) Other information relevant to prioritization.--
``(A) In general.--If, after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, a State proposes an administrative action
or enacts a statute or takes an administrative action
to prohibit or otherwise restrict the manufacturing,
processing, distribution in commerce, or use of a
chemical substance that the Administrator has not
designated as a high-priority substance, the Governor
or State agency with responsibility for implementing
the statute or administrative action shall notify the
Administrator.
``(B) Requests for information.--Following receipt
of a notification provided under subparagraph (A), the
Administrator may request any available information
from the Governor or the State agency with respect to--
``(i) scientific evidence related to the
hazards, exposures and risks of the chemical
substance under the conditions of use which the
statute or administrative action is intended to
address;
``(ii) any State or local conditions which
warranted the statute or administrative action;
``(iii) the statutory or administrative
authority on which the action is based; and
``(iv) any other available information
relevant to the prohibition or other
restriction, including information on any
alternatives considered and their hazards,
exposures, and risks.
``(C) Prioritization screening.--The Administrator
shall conduct a prioritization screening under this
subsection for all substances that--
``(i) are the subject of notifications
received under subparagraph (A); and
``(ii) the Administrator determines--
``(I) are likely to have
significant health or environmental
impacts;
``(II) are likely to have
significant impact on interstate
commerce; or
``(III) have been subject to a
prohibition or other restriction under
a statute or administrative action in 2
or more States.
``(D) Availability to public.--Subject to section
14 and any applicable State law regarding the
protection of confidential information provided to the
State or to the Administrator, the Administrator shall
make information received from a Governor or State
agency under subparagraph (A) publicly available.
``(E) Effect of paragraph.--Nothing in this
paragraph shall preempt a State statute or
administrative action, require approval of a State
statute or administrative action, or apply section 15
to a State.
``(10) Review.--Not less frequently than once every 5 years
after the date on which the process under this subsection is
established, the Administrator shall--
``(A) review the process on the basis of experience
and taking into consideration resources available to
efficiently and effectively screen and prioritize
chemical substances; and
``(B) if necessary, modify the prioritization
screening process.
``(11) Effect.--Subject to section 18, a designation by the
Administrator under this section with respect to a chemical
substance shall not affect--
``(A) the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance;
or
``(B) the regulation of those activities.
``(c) Additional Priorities for Safety Assessments and
Determinations.--
``(1) Requirements.--
``(A) In general.--The prioritization screening
process developed under subsection (a) shall--
``(i) include a process by which a
manufacturer or processor of an active chemical
substance that has not been designated a high-
priority substance or is not in the process of
a prioritization screening by the
Administrator, may request that the
Administrator designate the substance as an
additional priority for a safety assessment and
safety determination, subject to the payment of
fees pursuant to section 26(b)(3)(E);
``(ii) specify the information to be
provided in such requests; and
``(iii) specify the criteria the
Administrator shall use to determine whether or
not to grant such a request, which shall
include whether the substance is subject to
restrictions imposed by statutes enacted or
administrative actions taken by 1 or more
States on the manufacture, processing,
distribution in commerce, or use of the
substance.
``(B) Preference.--Subject to paragraph (2), in
deciding whether to grant requests under this
subsection the Administrator shall give a preference to
requests concerning substances for which the
Administrator determines that restrictions imposed by 1
or more States have the potential to have a significant
impact on interstate commerce or health or the
environment.
``(C) Exceptions.--Chemical substances for which
requests have been granted under this subsection shall
not be subject to subsection (a)(3)(A)(iii) or section
18(b).
``(2) Limitations.--In considering whether to grant a
request submitted under paragraph (1), the Administrator shall
ensure that--
``(A) if a sufficient number of additional priority
requests meet the requirements of paragraph (1), not
less than 25 percent, or more than 30 percent, of the
cumulative number of substances designated to undergo
safety assessments and safety determinations under
subsections (a)(2) and (b)(3) are substances designated
under the process and criteria pursuant to paragraph
(1);
``(B) the resources allocated to conducting safety
assessments and safety determinations for additional
priorities designated under this subsection are
proportionate to the number of such substances relative
to the total number of substances designated to undergo
safety assessments and safety determinations under this
section; and
``(C) the number of additional priority requests
stipulated under subparagraph (A) is in addition to the
total number of high-priority substances identified
under subsections (a)(2) and (b)(3).
``(3) Additional review of work plan chemicals for safety
assessment and safety determination.--In the case of a request
under paragraph (1) with respect to a chemical substance
identified by the Administrator in the October 2014 Work Plan--
``(A) the 30-percent cap specified in paragraph
(2)(A) shall not apply and the addition of Work Plan
chemicals shall be at the discretion of the
Administrator; and
``(B) notwithstanding paragraph (1)(C), requests
for additional Work Plan chemicals under this
subsection shall be considered high-priority chemicals
subject to section 18(b) but not subsection
(a)(3)(A)(iii).
``(4) Requirements.--
``(A) In general.--The public shall be provided
notice and an opportunity to comment on requests
submitted under this subsection.
``(B) Decision by administrator.--Not later than
180 days after the date on which the Administrator
receives a request under this subsection, the
Administrator shall decide whether or not to grant the
request.
``(C) Assessment and determination.--If the
Administrator grants a request under this subsection,
the safety assessment and safety determination--
``(i) shall be conducted in accordance with
the deadlines and other requirements of
sections 3A(i) and 6; and
``(ii) shall not be expedited or otherwise
subject to special treatment relative to high-
priority substances designated pursuant to
subsection (b)(3) that are undergoing safety
assessments and safety determinations.''.
SEC. 7. NEW CHEMICALS AND SIGNIFICANT NEW USES.
Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is
amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.'';
(2) by striking subsection (b);
(3) by redesignating subsection (a) as subsection (b);
(4) by redesignating subsection (i) as subsection (a) and
moving the subsection so as to appear at the beginning of the
section;
(5) in subsection (b) (as so redesignated)--
(A) in the subsection heading, by striking ``In
General'' and inserting ``Notices'';
(B) in paragraph (1)--
(i) in the matter preceding subparagraph
(A), by striking ``subsection (h)'' and
inserting ``paragraph (3) and subsection (h)'';
and
(ii) in the matter following subparagraph
(B)--
(I) by striking ``subsection (d)''
and inserting ``subsection (c)''; and
(II) by striking ``and such person
complies with any applicable
requirement of subsection (b)''; and
(C) by adding at the end the following:
``(3) Article consideration.--The Administrator may require
the notification for the import or processing of a chemical
substance as part of an article or category of articles under
paragraph (1)(B) if the Administrator makes an affirmative
finding in a rule under paragraph (2) that the reasonable
potential for exposure to the chemical substance through the
article or category of articles subject to the rule warrants
notification.'';
(6) by redesignating subsections (c) and (d) as subsections
(d) and (c), respectively, and moving subsection (c) (as so
redesigned) so as appear after subsection (b) (as redesignated
by paragraph (3));
(7) in subsection (c) (as so redesignated)--
(A) by striking paragraph (1) and inserting the
following:
``(1) In general.--The notice required by subsection (b)
shall include, with respect to a chemical substance--
``(A) the information required by sections 720.45
and 720.50 of title 40, Code of Federal Regulations (or
successor regulations); and
``(B) information regarding conditions of use and
reasonably anticipated exposures.'';
(B) in paragraph (2)--
(i) in the matter preceding subparagraph
(A)--
(I) by striking ``subsection (a)''
and inserting ``subsection (b)''; and
(II) by striking ``or of data under
subsection (b)'';
(ii) in subparagraph (A), by adding ``and''
after the semicolon at the end;
(iii) in subparagraph (B), by striking ``;
and'' and inserting a period; and
(iv) by striking subparagraph (C); and
(C) in paragraph (3), by striking ``subsection (a)
and for which the notification period prescribed by
subsection (a), (b), or (c)'' and inserting
``subsection (b) and for which the notification period
prescribed by subsection (b) or (d)'';
(8) by striking subsection (d) (as redesignated by
paragraph (6)) and inserting the following:
``(d) Review of Notice.--
``(1) Initial review.--
``(A) In general.--Subject to subparagraph (B), not
later than 90 days after the date of receipt of a
notice submitted under subsection (b), the
Administrator shall--
``(i) conduct an initial review of the
notice;
``(ii) as needed, develop a profile of the
relevant chemical substance and the potential
for exposure to humans and the environment; and
``(iii) make any necessary determination
under paragraph (3).
``(B) Extension.--Except as provided in paragraph
(5), the Administrator may extend the period described
in subparagraph (A) for good cause for 1 or more
periods, the total of which shall be not more than 90
days.
``(2) Information sources.--In evaluating a notice under
paragraph (1), the Administrator shall take into
consideration--
``(A) any relevant information identified in
subsection (c)(1); and
``(B) any other relevant additional information
available to the Administrator.
``(3) Determinations.--Before the end of the applicable
period for review under paragraph (1), based on the information
described in paragraph (2), and subject to section 18(g), the
Administrator shall determine that--
``(A) the relevant chemical substance or
significant new use is not likely to meet the safety
standard, in which case the Administrator shall take
appropriate action under paragraph (4);
``(B) the relevant chemical substance or
significant new use is likely to meet the safety
standard, in which case the Administrator shall allow
the review period to expire without additional
restrictions; or
``(C) additional information is necessary in order
to make a determination under subparagraph (A) or (B),
in which case the Administrator shall take appropriate
action under paragraphs (4) and (5).
``(4) Restrictions.--
``(A) Determination by administrator.--
``(i) In general.--If the Administrator
makes a determination under subparagraph (A) or
(C) of paragraph (3) with respect to a notice
submitted under subsection (b)--
``(I) the Administrator, before the
end of the applicable period for review
under paragraph (1) and by consent
agreement or order, as appropriate,
shall prohibit or otherwise restrict
the manufacture, processing, use,
distribution in commerce, or disposal
(as applicable) of the chemical
substance, or of the chemical substance
for a significant new use, without
compliance with the restrictions
specified in the consent agreement or
order that the Administrator determines
are sufficient to ensure that the
chemical substance or significant new
use is likely to meet the safety
standard; and
``(II) no person may commence
manufacture of the chemical substance,
or manufacture or processing of the
chemical substance for a significant
new use, except in compliance with the
restrictions specified in the consent
agreement or order.
``(ii) Likely to meet standard.--If the
Administrator makes a determination under
subparagraph (B) of paragraph (3) with respect
to a chemical substance or significant new use
for which a notice was submitted under
subsection (b), at the end of the applicable
period for review under paragraph (1), the
submitter of the notice may commence
manufacture for commercial purposes of the
chemical substance or manufacture or processing
of the chemical substance for a significant new
use.
``(B) Requirements.--Not later than 90 days after
issuing a consent agreement or order under subparagraph
(A), the Administrator shall--
``(i) take into consideration whether to
promulgate a rule pursuant to subsection (b)(2)
that identifies as a significant new use any
manufacturing, processing, use, distribution in
commerce, or disposal of the chemical
substance, or of the chemical substance for a
new use, that is not in compliance with the
restrictions imposed by the consent agreement
or order; and
``(ii)(I) initiate a rulemaking described
in clause (i); or
``(II) publish a statement describing the
reasons of the Administrator for not initiating
a rulemaking.
``(C) Inclusions.--A prohibition or other
restriction under subparagraph (A) may include, as
appropriate--
``(i) subject to section 18(g), a
requirement that a chemical substance shall be
marked with, or accompanied by, clear and
adequate minimum warnings and instructions with
respect to use, distribution in commerce, or
disposal, or any combination of those
activities, with the form and content of the
minimum warnings and instructions to be
prescribed by the Administrator
``(ii) a requirement that manufacturers or
processors of the chemical substance shall--
``(I) make and retain records of
the processes used to manufacture or
process, as applicable, the chemical
substance; or
``(II) monitor or conduct such
additional tests as are reasonably
necessary to address potential risks
from the manufacture, processing,
distribution in commerce, use, or
disposal, as applicable, of the
chemical substance, subject to section
4;
``(iii) a restriction on the quantity of
the chemical substance that may be
manufactured, processed, or distributed in
commerce--
``(I) in general; or
``(II) for a particular use;
``(iv) a prohibition or other restriction
of--
``(I) the manufacture, processing,
or distribution in commerce of the
chemical substance for a significant
new use;
``(II) any method of commercial use
of the chemical substance; or
``(III) any method of disposal of
the chemical substance; or
``(v) a prohibition or other restriction on
the manufacture, processing, or distribution in
commerce of the chemical substance--
``(I) in general; or
``(II) for a particular use.
``(D) Persistent and bioaccumulative substances.--
For a chemical substance the Administrator determines
ranks high for persistence and bioaccumulation, the
Administrator shall, in selecting among prohibitions
and other restrictions that the Administrator
determines are sufficient to ensure that the chemical
substance is likely to meet the safety standard, reduce
potential exposure to the substance to the maximum
extent practicable.
``(E) Workplace exposures.--The Administrator shall
consult with the Assistant Secretary of Labor for
Occupational Safety and Health prior to adopting any
prohibition or other restriction under this subsection
to address workplace exposures.
``(F) Definition of requirement.--For purposes of
this Act, the term `requirement' as used in this
section does not displace common law.
``(5) Additional information.--If the Administrator
determines under paragraph (3)(C) that additional information
is necessary to conduct a review under this subsection, the
Administrator--
``(A) shall provide an opportunity for the
submitter of the notice to submit the additional
information;
``(B) may, by agreement with the submitter, extend
the review period for a reasonable time to allow the
development and submission of the additional
information;
``(C) may promulgate a rule, enter into a testing
consent agreement, or issue an order under section 4 to
require the development of the information; and
``(D) on receipt of information the Administrator
finds supports the determination under paragraph (3),
shall promptly make the determination.'';
(9) by striking subsections (e) through (g) and inserting
the following:
``(e) Notice of Commencement.--
``(1) In general.--Not later than 30 days after the date on
which a manufacturer that has submitted a notice under
subsection (b) commences nonexempt commercial manufacture of a
chemical substance, the manufacturer shall submit to the
Administrator a notice of commencement that identifies--
``(A) the name of the manufacturer; and
``(B) the initial date of nonexempt commercial
manufacture.
``(2) Withdrawal.--A manufacturer or processor that has
submitted a notice under subsection (b), but that has not
commenced nonexempt commercial manufacture or processing of the
chemical substance, may withdraw the notice.
``(f) Further Evaluation.--The Administrator may review a chemical
substance under section 4A at any time after the Administrator
receives--
``(1) a notice of commencement for a chemical substance
under subsection (e); or
``(2) new information regarding the chemical substance.
``(g) Transparency.--Subject to section 14, the Administrator shall
make available to the public--
``(1) all notices, determinations, consent agreements,
rules, and orders of the Administrator; and
``(2) all information submitted or issued under this
section.''; and
(10) in subsection (h)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph
(A), by striking ``(a) or''; and
(ii) in subparagraph (A), by inserting ``,
without taking into account cost or other
nonrisk factors'' after ``the environment'';
(B) by striking paragraph (2);
(C) by redesignating paragraphs (3) through (6) as
paragraphs (2) through (5), respectively;
(D) in paragraph (2) (as so redesignated), in the
matter preceding subparagraph (A), by striking
``subsections (a) and (b)'' and inserting ``subsection
(b)'';
(E) in paragraph (3) (as so redesignated)--
(i) in the first sentence, by striking
``will not present an unreasonable risk of
injury to health or the environment'' and
inserting ``will meet the safety standard'';
and
(ii) by striking the second sentence;
(F) in paragraph (4) (as so redesignated), by
striking ``subsections (a) and (b)'' and inserting
``subsection (b)''; and
(G) in paragraph (5) (as so redesignated), in the
first sentence, by striking ``paragraph (1) or (5)''
and inserting ``paragraph (1) or (4)''.
SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.
Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) is
amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.'';
(2) by redesignating subsections (e) and (f) as subsections
(g) and (h), respectively;
(3) by striking subsections (a) through (d) and inserting
the following:
``(a) In General.--The Administrator--
``(1) shall conduct a safety assessment and make a safety
determination of each high-priority substance in accordance
with subsections (b) and (c);
``(2) shall, as soon as practicable and not later than 6
months after the date on which a chemical substance is
designated as a high-priority substance, define and publish the
scope of the safety assessment and safety determination to be
conducted pursuant to this section, including the hazards,
exposures, conditions of use, and potentially exposed or
susceptible populations that the Administrator expects to
consider;
``(3) as appropriate based on the results of a safety
determination, shall establish restrictions pursuant to
subsection (d);
``(4) shall complete a safety assessment and safety
determination not later than 3 years after the date on which a
chemical substance is designated as a high-priority substance;
``(5) shall promulgate a final rule pursuant to subsection
(d) by not later than 2 years after the date on which the
safety determination is completed; and
``(6) may extend any deadline under paragraph (4) or (5)
for a reasonable period of time after an adequate public
justification, subject to the condition that the aggregate
length of all extensions of deadlines under this subsection,
plus any deferral under subsection (c)(2), does not exceed 2
years.
``(b) Prior Actions and Notice of Existing Information.--
``(1) Prior-initiated assessments.--
``(A) In general.--Nothing in this Act prevents the
Administrator from initiating a safety assessment or
safety determination regarding a chemical substance, or
from continuing or completing such a safety assessment
or safety determination that was initiated before the
date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, prior to the effective
date of the policies and procedures required to be
established by the Administrator under section 3A or
4A.
``(B) Integration of prior policies and
procedures.--As policies and procedures under section
3A and 4A are established, to the maximum extent
practicable, the Administrator shall integrate the
policies and procedures into ongoing safety assessments
and safety determinations.
``(2) Actions completed prior to completion of policies and
procedures.--Nothing in this Act requires the Administrator to
revise or withdraw a completed safety assessment, safety
determination, or rule solely because the action was completed
prior to the completion of a policy or procedure established
under section 3A or 4A, and the validity of a completed
assessment, determination, or rule shall not be determined
based on the content of such a policy or procedure.
``(3) Notice of existing information.--
``(A) In general.--The Administrator shall, where
such information is available, take notice of existing
information regarding hazard and exposure published by
other Federal agencies and the National Academies and
incorporate the information in safety assessments and
safety determinations with the objective of increasing
the efficiency of the safety assessments and safety
determinations.
``(B) Inclusion of information.--Existing
information described in subparagraph (A) should be
included to the extent practicable and where the
Administrator determines the information is relevant
and scientifically reliable.
``(c) Safety Determinations.--
``(1) In general.--Based on a review of the information
available to the Administrator, including draft safety
assessments submitted by interested persons, and subject to
section 18, the Administrator shall determine that--
``(A) the relevant chemical substance meets the
safety standard;
``(B) the relevant chemical substance does not meet
the safety standard, in which case the Administrator
shall, by rule under subsection (d)--
``(i) impose restrictions necessary to
ensure that the chemical substance meets the
safety standard under the conditions of use; or
``(ii) if the safety standard cannot be met
with the application of restrictions, ban or
phase out the chemical substance, as
appropriate; or
``(C) additional information is necessary in order
to make a determination under subparagraph (A) or (B),
in which case the Administrator shall take appropriate
action under paragraph (2).
``(2) Additional information.--If the Administrator
determines that additional information is necessary to make a
safety assessment or safety determination for a high-priority
substance, the Administrator--
``(A) shall provide an opportunity for interested
persons to submit the additional information;
``(B) may promulgate a rule, enter into a testing
consent agreement, or issue an order under section 4 to
require the development of the information;
``(C) may defer, for a reasonable period consistent
with the deadlines described in subsection (a), a
safety assessment and safety determination until after
receipt of the information; and
``(D) consistent with the deadlines described in
subsection (a), on receipt of information the
Administrator finds supports the safety assessment and
safety determination, shall make a determination under
paragraph (1).
``(3) Establishment of deadline.--In requesting the
development or submission of information under this section,
the Administrator shall establish a deadline for the submission
of the information.
``(d) Rule.--
``(1) Implementation.--If the Administrator makes a
determination under subsection (c)(1)(B) with respect to a
chemical substance, the Administrator shall promulgate a rule
establishing restrictions necessary to ensure that the chemical
substance meets the safety standard.
``(2) Scope.--
``(A) In general.--The rule promulgated pursuant to
this subsection--
``(i) may apply to mixtures containing the
chemical substance, as appropriate;
``(ii) shall include dates by which
compliance is mandatory, which--
``(I) shall be as soon as
practicable;
``(II) in the case of a ban or
phase-out of the chemical substance,
shall implement the ban or phase-out in
as short a period as practicable; and
``(III) as determined by the
Administrator, may vary for different
affected persons; and
``(iii) shall exempt replacement parts that
are manufactured prior to the effective date of
the rule for articles that are first
manufactured prior to the effective date of the
rule unless the Administrator finds the
replacement parts contribute significantly to
the identified risk; and
``(iv) shall, in selecting among
prohibitions and other restrictions, apply such
prohibitions or other restrictions to articles
containing the chemical substance only to the
extent necessary to address the identified
risks in order to determine that the chemical
substance meets the safety standard.
``(B) Persistent and bioaccumulative substances.--
For a chemical substance the Administrator determines
ranks high for persistence and bioaccumulation, the
Administrator shall, in selecting among prohibitions
and other restrictions that the Administrator
determines are sufficient to ensure that the chemical
substance meets the safety standard, reduce exposure to
the substance to the maximum extent practicable.
``(C) Workplace exposures.--The Administrator shall
consult with the Assistant Secretary of Labor for
Occupational Safety and Health before adopting any
prohibition or other restriction under this subsection
to address workplace exposures.
``(D) Definition of requirement.--For the purposes
of this Act, the term `requirement' as used in this
section does not displace common law.
``(3) Restrictions.--A restriction under paragraph (1) may
include, as appropriate--
``(A) subject to section 18, a requirement that a
chemical substance shall be marked with, or accompanied
by, clear and adequate minimum warnings and
instructions with respect to use, distribution in
commerce, or disposal, or any combination of those
activities, with the form and content of the minimum
warnings and instructions to be prescribed by the
Administrator;
``(B) a requirement that manufacturers or
processors of the chemical substance shall--
``(i) make and retain records of the
processes used to manufacture or process the
chemical substance;
``(ii) describe and apply the relevant
quality control procedures followed in the
manufacturing or processing of the substance;
or
``(iii) monitor or conduct tests that are
reasonably necessary to ensure compliance with
the requirements of any rule under this
subsection;
``(C) a restriction on the quantity of the chemical
substance that may be manufactured, processed, or
distributed in commerce;
``(D) a requirement to ban or phase out, or any
other rule regarding, the manufacture, processing, or
distribution in commerce of the chemical substance
for--
``(i) a particular use;
``(ii) a particular use at a concentration
in excess of a level specified by the
Administrator; or
``(iii) all uses;
``(E) a restriction on the quantity of the chemical
substance that may be manufactured, processed, or
distributed in commerce for--
``(i) a particular use; or
``(ii) a particular use at a concentration
in excess of a level specified by the
Administrator;
``(F) a requirement to ban, phase out, or otherwise
restrict any method of commercial use of the chemical
substance;
``(G) a requirement to ban, phase out, or otherwise
restrict any method of disposal of the chemical
substance or any article containing the chemical
substance; and
``(H) a requirement directing manufacturers or
processors of the chemical substance to give notice of
the Administrator's determination under subsection
(c)(1)(B) to distributors in commerce of the chemical
substance and, to the extent reasonably ascertainable,
to other persons in the chain of commerce in possession
of the chemical substance.
``(4) Analysis for rulemaking.--
``(A) Considerations.--In deciding which
restrictions to impose under paragraph (3) as part of
developing a rule under paragraph (1), the
Administrator shall take into consideration, to the
extent practicable based on reasonably available
information, the quantifiable and nonquantifiable costs
and benefits of the proposed regulatory action and of
the 1 or more primary alternative regulatory actions
considered by the Administrator.
``(B) Alternatives.--As part of the analysis, the
Administrator shall review any 1 or more technically
and economically feasible alternatives to the chemical
substance that the Administrator determines are
relevant to the rulemaking.
``(C) Public availability.--In proposing a rule
under paragraph (1), the Administrator shall make
publicly available any analysis conducted under this
paragraph.
``(D) Statement required.--In making final a rule
under paragraph (1), the Administrator shall include a
statement describing how the analysis considered under
subparagraph (A) was taken into account.
``(5) Exemptions.--
``(A) In general.--The Administrator may exempt 1
or more uses of a chemical substance from any
restriction in a rule promulgated under paragraph (1)
if the Administrator determines that--
``(i) the rule cannot be complied with,
without--
``(I) harming national security;
``(II) causing significant
disruption in the national economy due
to the lack of availability of a
chemical substance; or
``(III) interfering with a critical
or essential use for which no
technically and economically feasible
safer alternative is available, taking
into consideration hazard and exposure;
or
``(ii) the use of the chemical substance,
as compared to reasonably available
alternatives, provides a substantial benefit to
health, the environment, or public safety.
``(B) Exemption analysis.--In proposing a rule
under paragraph (1) that includes an exemption under
this paragraph, the Administrator shall make publicly
available any analysis conducted under this paragraph
to assess the need for the exemption.
``(C) Statement required.--In making final a rule
under paragraph (1) that includes an exemption under
this paragraph, the Administrator shall include a
statement describing how the analysis considered under
subparagraph (B) was taken into account.
``(D) Analysis in case of ban or phase-out.--In
determining whether an exemption should be granted
under this paragraph for a chemical substance for which
a ban or phase-out is proposed, the Administrator shall
take into consideration, to the extent practicable
based on reasonably available information, the
quantifiable and nonquantifiable costs and benefits of
the 1 or more technically and economically feasible
alternatives to the chemical substance most likely to
be used in place of the chemical substance under the
conditions of use if the rule is promulgated.
``(E) Conditions.--As part of a rule promulgated
under paragraph (1), the Administrator shall include
conditions in any exemption established under this
paragraph, including reasonable recordkeeping,
monitoring, and reporting requirements, to the extent
that the Administrator determines the conditions are
necessary to protect health and the environment while
achieving the purposes of the exemption.
``(F) Duration.--
``(i) In general.--The Administrator shall
establish, as part of a rule under paragraph
(1) that contains an exemption under this
paragraph, a time limit on any exemption for a
time to be determined by the Administrator as
reasonable on a case-by-case basis.
``(ii) Authority of administrator.--The
Administrator, by rule, may extend, modify, or
eliminate the exemption if the Administrator
determines, on the basis of reasonably
available information and after adequate public
justification, the exemption warrants extension
or is no longer necessary.
``(iii) Considerations.--
``(I) In general.--Subject to
subclause (II), the Administrator shall
issue exemptions and establish time
periods by considering factors
determined by the Administrator to be
relevant to the goals of fostering
innovation and the development of
alternatives that meet the safety
standard.
``(II) Limitation.--Any renewal of
an exemption in the case of a rule
requiring the ban or phase-out of a
chemical substance shall not exceed 5
years.
``(e) Immediate Effect.--The Administrator may declare a proposed
rule under subsection (d)(1) to be effective on publication of the rule
in the Federal Register and until the effective date of final action
taken respecting the rule, if--
``(1) the Administrator determines that--
``(A) the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance or
mixture subject to the proposed rule or any combination
of those activities is likely to result in a risk of
serious or widespread injury to health or the
environment before the effective date; and
``(B) making the proposed rule so effective is
necessary to protect the public interest; and
``(2) in the case of a proposed rule to prohibit the
manufacture, processing, or distribution in commerce of a
chemical substance or mixture because of the risk determined
under paragraph (1)(A), a court has granted relief in an action
under section 7 with respect to that risk associated with the
chemical substance or mixture.
``(f) Final Agency Action.--Under this section and subject to
section 18--
``(1) a safety determination, and the associated safety
assessment, for a chemical substance that the Administrator
determines under subsection (c) meets the safety standard,
shall be considered to be a final agency action, effective
beginning on the date of issuance of the final safety
determination; and
``(2) a final rule promulgated under subsection (d)(1), and
the associated safety assessment and safety determination that
a chemical substance does not meet the safety standard, shall
be considered to be a final agency action, effective beginning
on the date of promulgation of the final rule.''; and
(4) in subsection (g) (as redesignated by paragraph (2))--
(A) by striking paragraph (4); and
(B) by redesignating paragraph (5) as paragraph
(4).
SEC. 9. IMMINENT HAZARDS.
Section 7 of the Toxic Substances Control Act (15 U.S.C. 2606) is
amended--
(1) by striking subsection (a) and inserting the following:
``(a) Civil Actions.--
``(1) In general.--The Administrator may commence a civil
action in an appropriate United States district court for--
``(A) seizure of an imminently hazardous chemical
substance or mixture or any article containing the
chemical substance or mixture;
``(B) relief (as authorized by subsection (b))
against any person that manufactures, processes,
distributes in commerce, uses, or disposes of, an
imminently hazardous chemical substance or mixture or
any article containing the chemical substance or
mixture; or
``(C) both seizure described in subparagraph (A)
and relief described in subparagraph (B).
``(2) Rule, order, or other proceeding.--A civil action may
be commenced under this paragraph, notwithstanding--
``(A) the existence of a decision, rule, consent
agreement, or order by the Administrator under section
4, 4A, 5, or 6 or title IV or VI; or
``(B) the pendency of any administrative or
judicial proceeding under any provision of this Act.'';
(2) in subsection (b)(1), by striking ``unreasonable'';
(3) in subsection (d), by striking ``section 6(a)'' and
inserting ``section 6(d)''; and
(4) in subsection (f), in the first sentence, by striking
``and unreasonable''.
SEC. 10. INFORMATION COLLECTION AND REPORTING.
Section 8 of the Toxic Substances Control Act (15 U.S.C. 2607) is
amended--
(1) in subsection (a)--
(A) in paragraph (3)(A)(ii)(I)--
(i) by striking ``5(b)(4)'' and inserting
``5'';
(ii) by inserting ``section 4 or'' after
``in effect under''; and
(iii) by striking ``5(e),'' and inserting
``5(d)(4);''; and
(B) by adding at the end the following:
``(4) Rules.--
``(A) Deadline.--
``(i) In general.--Not later than 2 years
after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act, the Administrator shall promulgate rules
requiring the maintenance of records and the
reporting of information known or reasonably
ascertainable by the person making the report,
including rules requiring processors to report
information, so that the Administrator has the
information necessary to carry out sections 4
and 6.
``(ii) Modification of prior rules.--In
carrying out this subparagraph, the
Administrator may modify, as appropriate, rules
promulgated before the date of enactment of the
Frank R. Lautenberg Chemical Safety for the
21st Century Act.
``(B) Contents.--The rules promulgated pursuant to
subparagraph (A)--
``(i) may impose different reporting and
recordkeeping requirements on manufacturers and
processors; and
``(ii) shall include the level of detail
necessary to be reported, including the manner
by which use and exposure information may be
reported.
``(C) Administration.--In implementing the
reporting and recordkeeping requirements under this
paragraph, the Administrator shall take measures--
``(i) to limit the potential for
duplication in reporting requirements;
``(ii) to minimize the impact of the rules
on small manufacturers and processors; and
``(iii) to apply any reporting obligations
to those persons likely to have information
relevant to the effective implementation of
this title.
``(5) Guidance.--The Administrator shall develop guidance
relating to the information required to be reported under the
rules promulgated under this subsection.'';
(2) in subsection (b), by adding at the end the following:
``(3) Nomenclature.--
``(A) In general.--In carrying out paragraph (1),
the Administrator shall--
``(i) maintain the use of Class 2
nomenclature in use on the date of enactment of
the Frank R. Lautenberg Chemical Safety for the
21st Century Act;
``(ii) maintain the use of the Soap and
Detergent Association Nomenclature System,
published in March 1978 by the Administrator in
section 1 of addendum III of the document
entitled `Candidate List of Chemical
Substances', and further described in the
appendix A of volume I of the 1985 edition of
the Toxic Substances Control Act Substances
Inventory (EPA Document No. EPA-560/7-85-002a);
and
``(iii) treat all components of categories
that are considered to be statutory mixtures
under this Act as being included on the list
published under paragraph (1) under the
Chemical Abstracts Service numbers for the
respective categories, including, without
limitation--
``(I) cement, Portland, chemicals,
CAS No. 65997-15-1;
``(II) cement, alumina, chemicals,
CAS No. 65997-16-2;
``(III) glass, oxide, chemicals,
CAS No. 65997-17-3;
``(IV) frits, chemicals, CAS No.
65997-18-4;
``(V) steel manufacture, chemicals,
CAS No. 65997-19-5; and
``(VI) ceramic materials and wares,
chemicals, CAS No. 66402-68-4.
``(B) Multiple nomenclature conventions.--
``(i) In general.--If an existing guidance
allows for multiple nomenclature conventions,
the Administrator shall--
``(I) maintain the nomenclature
conventions for substances; and
``(II) develop new guidance that--
``(aa) establishes
equivalency between the
nomenclature conventions for
chemical substances on the list
published under paragraph (1);
and
``(bb) permits persons to
rely on the new guidance for
purposes of determining whether
a chemical substance is on the
list published under paragraph
(1).
``(ii) Multiple cas numbers.--For any
chemical substance appearing multiple times on
the list under different Chemical Abstracts
Service numbers, the Administrator shall
develop guidance recognizing the multiple
listings as a single chemical substance.
``(4) Chemical substances in commerce.--
``(A) Rules.--
``(i) In general.--Not later than 1 year
after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act, the Administrator, by rule, shall require
manufacturers and processors to notify the
Administrator, by not later than 180 days after
the date of promulgation of the rule, of each
chemical substance on the list published under
paragraph (1) that the manufacturer or
processor, as applicable, has manufactured or
processed for a nonexempt commercial purpose
during the 10-year period ending on the day
before the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act.
``(ii) Active substances.--The
Administrator shall, pursuant to paragraph
(5)(A), designate chemical substances for which
notices are received under clause (i) to be
active substances on the list published under
paragraph (1).
``(B) Confidential chemical substances.--The rule
promulgated by the Administrator pursuant to
subparagraph (A) shall require--
``(i) the Administrator to maintain the
list under paragraph (1), which shall include a
confidential portion and a nonconfidential
portion consistent with this section and
section 14;
``(ii) a manufacturer or processor that is
submitting a notice pursuant to subparagraph
(A) for a chemical substance on the
confidential portion of the list published
under paragraph (1) to indicate in the notice
whether the manufacturer or processor seeks to
maintain any existing claim for protection
against disclosure of the specific identity of
the substance as confidential pursuant to
section 14; and
``(iii) the substantiation of those claims
pursuant to section 14 and in accordance with
the review plan described in subparagraph (C).
``(C) Review plan.--Not later than 1 year after the
date on which the Administrator compiles the initial
list of active substances pursuant to subparagraph (A),
the Administrator shall promulgate a rule that
establishes a plan to review all claims to protect the
specific identities of chemical substances on the
confidential portion of the list published under
paragraph (1) that are notified pursuant to
subparagraph (A) or identified as active substances
under subsection (f)(1).
``(D) Requirements of review plan.--The review plan
under subparagraph (C) shall--
``(i) require, at the time requested by the
Administrator, all manufacturers or processors
asserting claims under subparagraph (B) to
substantiate the claim unless the manufacturer
or processor has substantiated the claim in a
submission made to the Administrator during the
5-year period ending on the date of the request
by the Administrator;
``(ii) require the Administrator, in
accordance with section 14--
``(I) to review each
substantiation--
``(aa) submitted pursuant
to clause (i) to determine if
the claim warrants protection
from disclosure; and
``(bb) submitted previously
by a manufacturer or processor
and relied on in lieu of the
substantiation required
pursuant to clause (i), if the
substantiation has not been
previously reviewed by the
Administrator, to determine if
the claim warrants protection
from disclosure;
``(II) approve, modify, or deny
each claim; and
``(III) except as provided in this
section and section 14, protect from
disclosure information for which the
Administrator approves such a claim for
a period of 10 years, unless, prior to
the expiration of the period--
``(aa) the person notifies
the Administrator that the
person is withdrawing the
confidentiality claim, in which
case the Administrator shall
promptly make the information
available to the public; or
``(bb) the Administrator
otherwise becomes aware that
the need for protection from
disclosure can no longer be
substantiated, in which case
the Administrator shall take
the actions described in
section 14(g)(2); and
``(iii) encourage manufacturers or
processors that have previously made claims to
protect the specific identities of chemical
substances identified as inactive pursuant to
subsection (f)(2) to review and either withdraw
or substantiate the claims.
``(E) Timeline for completion of reviews.--
``(i) In general.--The Administrator shall
implement the review plan so as to complete
reviews of all claims specified in subparagraph
(C) not later than 5 years after the date on
which the Administrator compiles the initial
list of active substances pursuant to
subparagraph (A).
``(ii) Considerations.--
``(I) In general.--The
Administrator may extend the deadline
for completion of the reviews for not
more than 2 additional years, after an
adequate public justification, if the
Administrator determines that the
extension is necessary based on the
number of applicable claims needing
review and the available resources.
``(II) Annual goal.--The
Administrator shall publish an annual
goal for the number of reviews to be
completed over the course of
implementation of the plan.
``(5) Active and inactive substances.--
``(A) In general.--The Administrator shall maintain
and keep current designations of active substances and
inactive substances on the list published under
paragraph (1).
``(B) Update.--The Administrator shall update the
list of chemical substances designated as active
substances as soon as practicable after the date of
publication of the most recent data reported under--
``(i) part 711 of title 40, Code of Federal
Regulations (or successor regulations); and
``(ii) the rules promulgated pursuant to
subsection (a)(4).
``(C) Change to active status.--
``(i) In general.--Any person that intends
to manufacture or process for a nonexempt
commercial purpose a chemical substance that is
designated as an inactive substance shall
notify the Administrator before the date on
which the inactive substance is manufactured or
processed.
``(ii) Confidential chemical identity
claims.--If a person submitting a notice under
clause (i) for an inactive substance on the
confidential portion of the list published
under paragraph (1) seeks to maintain an
existing claim for protection against
disclosure of the specific identity of the
inactive substance as confidential, the person
shall--
``(I) in the notice submitted under
clause (i), assert the claim; and
``(II) by not later than 30 days
after providing the notice under clause
(i), substantiate the claim.
``(iii) Active status.--On receiving a
notification under clause (i), the
Administrator shall--
``(I) designate the applicable
chemical substance as an active
substance;
``(II) pursuant to section 14,
promptly review any claim and
associated substantiation submitted
pursuant to clause (ii) for protection
against disclosure of the specific
identity of the chemical substance and
approve, modify, or deny the claim;
``(III) except as provided in this
section and section 14, protect from
disclosure the specific identity of the
chemical substance for which the
Administrator approves a claim under
subclause (II) for a period of not less
than 10 years, unless, prior to the
expiration of the period--
``(aa) the person notifies
the Administrator that the
person is withdrawing the
confidentiality claim, in which
case the Administrator shall
promptly make the information
available to the public; or
``(bb) the Administrator
otherwise becomes aware that
the need for protection from
disclosure can no longer be
substantiated, in which case
the Administrator shall take
the actions described in
section 14(g)(2); and
``(IV) pursuant to section 4A,
review the priority of the chemical
substance as the Administrator
determines to be necessary.
``(D) Category status.--The list of inactive
substances shall not be considered to be a category for
purposes of section 26(c).
``(6) Interim list of active substances.--Prior to the
promulgation of the rule required under paragraph (4)(A), the
Administrator shall designate the chemical substances reported
under part 711 of title 40, Code of Federal Regulations (or
successor regulations), during the reporting period that most
closely preceded the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, as the
interim list of active substances for the purposes of section
4A.
``(7) Public participation.--Subject to this subsection,
the Administrator shall make available to the public--
``(A) the specific identity of each chemical
substance on the nonconfidential portion of the list
published under paragraph (1) that the Administrator
has designated as--
``(i) an active substance; or
``(ii) an inactive substance;
``(B) the accession number, generic name, and, if
applicable, premanufacture notice case number for each
chemical substance on the confidential portion of the
list published under paragraph (1) for which a claim of
confidentiality was received and approved by the
Administrator pursuant to section 14; and
``(C) subject to section 14(g), the specific
identity of any active substance for which--
``(i) no claim of protection against
disclosure of the specific identity of the
active substance pursuant to this subsection
was received;
``(ii) a claim for protection against
disclosure of the specific identity of the
active substance has been denied by the
Administrator; or
``(iii) the time period for protection
against disclosure of the specific identity of
the active substance has expired.
``(8) Limitation.--No person may assert a new claim under
this subsection for protection from disclosure of a specific
identity of any active or inactive chemical substance for which
a notice is received under paragraph (4)(A)(i) or (5)(C)(i)
that is not on the confidential portion of the list published
under paragraph (1).
``(9) Certification.--Under the rules promulgated under
this subsection, manufacturers and processors shall be
required--
``(A) to certify that each report the manufacturer
or processor submits complies with the requirements of
the rule, and that any confidentiality claims are true
and correct; and
``(B) to retain a record supporting the
certification for a period of 5 years beginning on the
last day of the submission period.'';
(3) in subsection (e)--
(A) by striking ``Any person'' and inserting the
following:
``(1) In general.--Any person''; and
(B) by adding at the end the following:
``(2) Applicability.--Any person may submit to the
Administrator information reasonably supporting the conclusion
that a chemical substance or mixture presents, will present, or
does not present a substantial risk of injury to health and the
environment.''; and
(4) in subsection (f), by striking ``For purposes of this
section, the'' and inserting the following: ``In this section:
``(1) Active substance.--The term `active substance' means
a chemical substance--
``(A) that has been manufactured or processed for a
nonexempt commercial purpose at any point during the
10-year period ending on the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st
Century Act;
``(B) that is added to the list published under
subsection (b)(1) after that date of enactment; or
``(C) for which a notice is received under
subsection (b)(5)(C).
``(2) Inactive substance.--The term `inactive substance'
means a chemical substance on the list published under
subsection (b)(1) that does not meet any of the criteria
described in paragraph (1).
``(3) Manufacture; process.--The''.
SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS.
Section 9 of the Toxic Substances Control Act (15 U.S.C. 2608) is
amended--
(1) in subsection (a)--
(A) in paragraph (1), in the first sentence--
(i) by striking ``presents or will present
an unreasonable risk to health or the
environment'' and inserting ``does not meet the
safety standard''; and
(ii) by striking ``such risk'' the first
place it appears and inserting ``the risk posed
by the substance or mixture'';
(B) in paragraph (2), in the matter following
subparagraph (B), by striking ``section 6 or 7'' and
inserting ``section 6(d) or section 7''; and
(C) in paragraph (3), by striking ``section 6 or
7'' and inserting ``section 6(d) or 7'';
(2) in subsection (d), in the first sentence, by striking
``Health, Education, and Welfare'' and inserting ``Health and
Human Services''; and
(3) by adding at the end the following:
``(e) Exposure Information.--If the Administrator obtains
information related to exposures or releases of a chemical substance
that may be prevented or reduced under another Federal law, including
laws not administered by the Administrator, the Administrator shall
make such information available to the relevant Federal agency or
office of the Environmental Protection Agency.''.
SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION, AND
UTILIZATION OF DATA.
Section 10 of the Toxic Substances Control Act (15 U.S.C. 2609) is
amended by striking ``Health, Education, and Welfare'' each place it
appears and inserting ``Health and Human Services''.
SEC. 13. EXPORTS.
Section 12 of the Toxic Substances Control Act (15 U.S.C. 2611) is
amended--
(1) in subsection (a), by striking paragraph (2) and
inserting the following:
``(2) Exception.--Paragraph (1) shall not apply to any
chemical substance that the Administrator determines--
``(A) under section 5 is not likely to meet the
safety standard; or
``(B) under section 6 does not meet the safety
standard.
``(3) Waivers.--For a mixture or article containing a
chemical substance described in paragraph (2), the
Administrator may--
``(A) determine that paragraph (1) shall not apply
to the mixture or article; or
``(B) establish a threshold concentration in a
mixture or article at which paragraph (1) shall not
apply.
``(4) Testing.--The Administrator may require testing under
section 4 of any chemical substance or mixture exempted from
this Act under paragraph (1) for the purpose of determining
whether the chemical substance or mixture meets the safety
standard within the United States.'';
(2) by striking subsection (b) and inserting the following:
``(b) Notice.--
``(1) In general.--A person shall notify the Administrator
that the person is exporting or intends to export to a foreign
country--
``(A) a chemical substance or a mixture containing
a chemical substance that the Administrator has
determined under section 5 is not likely to meet the
safety standard and for which a prohibition or other
restriction has been proposed or established under that
section;
``(B) a chemical substance or a mixture containing
a chemical substance that the Administrator has
determined under section 6 does not meet the safety
standard and for which a prohibition or other
restriction has been proposed or established under that
section;
``(C) a chemical substance for which the United
States is obligated by treaty to provide export
notification;
``(D) a chemical substance or mixture subject to a
significant new use rule, or a prohibition or other
restriction pursuant to a rule, order, or consent
agreement in effect under this Act; or
``(E) a chemical substance or mixture for which the
submission of information is required under section 4.
``(2) Rules.--
``(A) In general.--The Administrator shall
promulgate rules to carry out paragraph (1).
``(B) Contents.--The rules promulgated pursuant to
subparagraph (A) shall--
``(i) include such exemptions as the
Administrator determines to be appropriate,
which may include exemptions identified under
section 5(h); and
``(ii) indicate whether, or to what extent,
the rules apply to articles containing a
chemical substance or mixture described in
paragraph (1).
``(3) Notification.--The Administrator shall submit to the
government of each country to which a chemical substance or
mixture is exported--
``(A) for a chemical substance or mixture described
in subparagraph (A), (B), or (D) of paragraph (1), a
notice of the determination, rule, order, consent
agreement, requirement, or designation;
``(B) for a chemical substance described in
paragraph (1)(C), a notice that satisfies the
obligation of the United States under the applicable
treaty; and
``(C) for a chemical substance or mixture described
in paragraph (1)(E), a notice of availability of the
information on the chemical substance or mixture
submitted to the Administrator.''; and
(3) in subsection (c)--
(A) by striking paragraph (3); and
(B) by redesignating paragraphs (4) through (6) as
paragraphs (3) through (5), respectively.
SEC. 14. CONFIDENTIAL INFORMATION.
Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is
amended to read as follows:
``SEC. 14. CONFIDENTIAL INFORMATION.
``(a) In General.--Except as otherwise provided in this section,
the Administrator shall not disclose information that is exempt from
disclosure pursuant to subsection (a) of section 552 of title 5, United
States Code, under subsection (b)(4) of that section--
``(1) that is reported to, or otherwise obtained by, the
Administrator under this Act; and
``(2) for which the requirements of subsection (d) are met.
``(b) Information Generally Protected From Disclosure.--The
following information specific to, and submitted by, a manufacturer,
processor, or distributor that meets the requirements of subsections
(a) and (d) shall be presumed to be protected from disclosure, subject
to the condition that nothing in this Act prohibits the disclosure of
any such information, or information that is the subject of subsection
(g)(3), through discovery, subpoena, other court order, or any other
judicial process otherwise allowed under applicable Federal or State
law:
``(1) Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture, or
article.
``(2) Marketing and sales information.
``(3) Information identifying a supplier or customer.
``(4) Details of the full composition of a mixture and the
respective percentages of constituents.
``(5) Specific information regarding the use, function, or
application of a chemical substance or mixture in a process,
mixture, or product.
``(6) Specific production or import volumes of the
manufacturer and specific aggregated volumes across
manufacturers, if the Administrator determines that disclosure
of the specific aggregated volumes would reveal confidential
information.
``(7) Except as otherwise provided in this section, the
specific identity of a chemical substance prior to the date on
which the chemical substance is first offered for commercial
distribution, including the chemical name, molecular formula,
Chemical Abstracts Service number, and other information that
would identify a specific chemical substance, if--
``(A) the specific identity was claimed as
confidential information at the time it was submitted
in a notice under section 5; and
``(B) the claim--
``(i) is not subject to an exception under
subsection (e); or
``(ii) has not subsequently been withdrawn
or found by the Administrator not to warrant
protection as confidential information under
subsection (f)(2) or (g).
``(c) Information Not Protected From Disclosure.--Notwithstanding
subsections (a) and (b), the following information shall not be
protected from disclosure:
``(1) Information from health and safety studies.--
``(A) In general.--Subject to subparagraph (B),
subsection (a) does not prohibit the disclosure of--
``(i) any health and safety study that is
submitted under this Act with respect to--
``(I) any chemical substance or
mixture that, on the date on which the
study is to be disclosed, has been
offered for commercial distribution; or
``(II) any chemical substance or
mixture for which--
``(aa) testing is required
under section 4; or
``(bb) a notification is
required under section 5; or
``(ii) any information reported to, or
otherwise obtained by, the Administrator from a
health and safety study relating to a chemical
substance or mixture described in subclause (I)
or (II) of clause (i).
``(B) Effect of paragraph.--Nothing in this
paragraph authorizes the release of any information
that discloses--
``(i) a process used in the manufacturing
or processing of a chemical substance or
mixture; or
``(ii) in the case of a mixture, the
portion of the mixture comprised by any
chemical substance in the mixture.
``(2) Certain requests.--If a request is made to the
Administrator under section 552(a) of title 5, United States
Code, for information that is described in paragraph (1) that
is not described in paragraph (1)(B), the Administrator may not
deny the request on the basis of section 552(b)(4) of title 5,
United States Code.
``(3) Other information not protected from disclosure.--The
following information is not protected from disclosure under
this section:
``(A) For information submitted after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the specific identity of a
chemical substance as of the date on which the chemical
substance is first offered for commercial distribution,
if the person submitting the information does not meet
the requirements of subsection (d).
``(B) A safety assessment developed, or a safety
determination made, under section 6.
``(C) Any general information describing the
manufacturing volumes, expressed as specific aggregated
volumes or, if the Administrator determines that
disclosure of specific aggregated volumes would reveal
confidential information, expressed in ranges.
``(D) A general description of a process used in
the manufacture or processing and industrial,
commercial, or consumer functions and uses of a
chemical substance, mixture, or article containing a
chemical substance or mixture, including information
specific to an industry or industry sector that
customarily would be shared with the general public or
within an industry or industry sector.
``(4) Mixed confidential and nonconfidential information
.--Any information that is otherwise eligible for protection
under this section and contained in a submission of information
described in this subsection shall be protected from
disclosure, if the submitter complies with subsection (d),
subject to the condition that information in the submission
that is not eligible for protection against disclosure shall be
disclosed.
``(5) Ban or phase-out.--If the Administrator promulgates a
rule pursuant to section 6(d) that establishes a ban or phase-
out of the manufacture, processing, or distribution in commerce
of a chemical substance, subject to paragraphs (2), (3), and
(4) of subsection (g), any protection from disclosure provided
under this section with respect to the specific identity of the
chemical substance and other information relating to the
chemical substance shall no longer apply.
``(d) Requirements for Confidentiality Claims.--
``(1) Assertion of claims.--
``(A) In general.--A person seeking to protect any
information submitted under this Act from disclosure
(including information described in subsection (b))
shall assert to the Administrator a claim for
protection concurrent with submission of the
information, in accordance with such rules regarding a
claim for protection from disclosure as the
Administrator has promulgated or may promulgate
pursuant to this title.
``(B) Inclusion.--An assertion of a claim under
subparagraph (A) shall include a statement that the
person has--
``(i) taken reasonable measures to protect
the confidentiality of the information;
``(ii) determined that the information is
not required to be disclosed or otherwise made
available to the public under any other Federal
law;
``(iii) a reasonable basis to conclude that
disclosure of the information is likely to
cause substantial harm to the competitive
position of the person; and
``(iv) a reasonable basis to believe that
the information is not readily discoverable
through reverse engineering.
``(C) Specific chemical identity.--In the case of a
claim under subparagraph (A) for protection against
disclosure of a specific chemical identity, the claim
shall include a structurally descriptive generic name
for the chemical substance that the Administrator may
disclose to the public, subject to the condition that
the generic name shall--
``(i) conform with guidance prescribed by
the Administrator under paragraph (3)(A); and
``(ii) describe the chemical structure of
the substance as specifically as practicable
while protecting those features of the chemical
structure--
``(I) that are considered to be
confidential; and
``(II) the disclosure of which
would be likely to harm the competitive
position of the person.
``(D) Public information.--No person may assert a
claim under this section for protection from disclosure
of information that is already publicly available.
``(2) Additional requirements for confidentiality claims.--
Except for information described in paragraphs (1) through (7)
of subsection (b), a person asserting a claim to protect
information from disclosure under this Act shall substantiate
the claim, in accordance with the rules promulgated and
guidance issued by the Administrator.
``(3) Guidance.--The Administrator shall develop guidance
regarding--
``(A) the determination of structurally descriptive
generic names, in the case of claims for the protection
against disclosure of specific chemical identity; and
``(B) the content and form of the statements of
need and agreements required under paragraphs (4), (5),
and (6) of subsection (e).
``(4) Certification.--An authorized official of a person
described in paragraph (1)(A) shall certify that the
information that has been submitted is true and correct.
``(e) Exceptions to Protection From Disclosure.--Information
described in subsection (a)--
``(1) shall be disclosed if the information is to be
disclosed to an officer or employee of the United States in
connection with the official duties of the officer or
employee--
``(A) under any law for the protection of health or
the environment; or
``(B) for a specific law enforcement purpose;
``(2) shall be disclosed if the information is to be
disclosed to a contractor of the United States and employees of
that contractor--
``(A) if, in the opinion of the Administrator, the
disclosure is necessary for the satisfactory
performance by the contractor of a contract with the
United States for the performance of work in connection
with this Act; and
``(B) subject to such conditions as the
Administrator may specify;
``(3) shall be disclosed if the Administrator determines
that disclosure is necessary to protect health or the
environment;
``(4) shall be disclosed if the information is to be
disclosed to a State or political subdivision of a State, on
written request, for the purpose of development,
administration, or enforcement of a law, if--
``(A) 1 or more applicable agreements with the
Administrator that conform with the guidance issued
under subsection (d)(3)(B) ensure that the recipient
will take appropriate measures, and has adequate
authority, to maintain the confidentiality of the
information in accordance with procedures comparable to
the procedures used by the Administrator to safeguard
the information; and
``(B) the Administrator notifies the person that
submitted the information that the information has been
disclosed to the State or political subdivision of a
State;
``(5) shall be disclosed if a health or environmental
professional employed by a Federal or State agency or a
treating physician or nurse in a nonemergency situation
provides a written statement of need and agrees to sign a
written confidentiality agreement with the Administrator,
subject to the conditions that--
``(A) the statement of need and confidentiality
agreement shall conform with the guidance issued under
subsection (d)(3)(B);
``(B) the written statement of need shall be a
statement that the person has a reasonable basis to
suspect that--
``(i) the information is necessary for, or
will assist in--
``(I) the diagnosis or treatment of
1 or more individuals; or
``(II) responding to an
environmental release or exposure; and
``(ii) 1 or more individuals being
diagnosed or treated have been exposed to the
chemical substance concerned, or an
environmental release or exposure has occurred;
and
``(C) the confidentiality agreement shall provide
that the person will not use the information for any
purpose other than the health or environmental needs
asserted in the statement of need, except as otherwise
may be authorized by the terms of the agreement or by
the person submitting the information to the
Administrator, except that nothing in this Act
prohibits the disclosure of any such information
through discovery, subpoena, other court order, or any
other judicial process otherwise allowed under
applicable Federal or State law;
``(6) shall be disclosed if in the event of an emergency, a
treating physician, nurse, agent of a poison control center,
public health or environmental official of a State or political
subdivision of a State, or first responder (including any
individual duly authorized by a Federal agency, State, or
political subdivision of a State who is trained in urgent
medical care or other emergency procedures, including a police
officer, firefighter, or emergency medical technician) requests
the information, subject to the conditions that--
``(A) the treating physician, nurse, agent, public
health or environmental official of a State or a
political subdivision of a State, or first responder
shall have a reasonable basis to suspect that--
``(i) a medical or public health or
environmental emergency exists;
``(ii) the information is necessary for, or
will assist in, emergency or first-aid
diagnosis or treatment; or
``(iii) 1 or more individuals being
diagnosed or treated have likely been exposed
to the chemical substance concerned, or a
serious environmental release of or exposure to
the chemical substance concerned has occurred;
``(B) if requested by the person submitting the
information to the Administrator, the treating
physician, nurse, agent, public health or environmental
official of a State or a political subdivision of a
State, or first responder shall, as described in
paragraph (5)--
``(i) provide a written statement of need;
and
``(ii) agree to sign a confidentiality
agreement; and
``(C) the written confidentiality agreement or
statement of need shall be submitted as soon as
practicable, but not necessarily before the information
is disclosed;
``(7) may be disclosed if the Administrator determines that
disclosure is relevant in a proceeding under this Act, subject
to the condition that the disclosure shall be made in such a
manner as to preserve confidentiality to the maximum extent
practicable without impairing the proceeding;
``(8) shall be disclosed if the information is to be
disclosed, on written request of any duly authorized
congressional committee, to that committee; or
``(9) shall be disclosed if the information is required to
be disclosed or otherwise made public under any other provision
of Federal law.
``(f) Duration of Protection From Disclosure.--
``(1) In general.--
``(A) Information protected from disclosure.--
Subject to paragraph (2), the Administrator shall
protect from disclosure information that meets the
requirements of subsection (d) for a period of 10
years, unless, prior to the expiration of the period--
``(i) an affected person notifies the
Administrator that the person is withdrawing
the confidentiality claim, in which case the
Administrator shall promptly make the
information available to the public; or
``(ii) the Administrator otherwise becomes
aware that the need for protection from
disclosure can no longer be substantiated, in
which case the Administrator shall take the
actions described in subsection (g)(2).
``(B) Extensions.--
``(i) In general.--Not later than the date
that is 60 days before the expiration of the
period described in subparagraph (A), the
Administrator shall provide to the person that
asserted the claim a notice of the impending
expiration of the period.
``(ii) Statement.--
``(I) In general.--Not later than
the date that is 30 days before the
expiration of the period described in
subparagraph (A), a person reasserting
the relevant claim shall submit to the
Administrator a statement
substantiating, in accordance with
subsection (d)(2), the need to extend
the period.
``(II) Action by administrator.--
Not later than the date that is 30 days
after the date of receipt of a
statement under subclause (I), the
Administrator shall--
``(aa) review the request;
``(bb) make a determination
regarding whether the
information for which the
request is made continues to
meet the relevant criteria
established under this section;
and
``(cc)(AA) grant an
extension of not more than 10
years; or
``(BB) deny the claim.
``(C) No limit on number of extensions.--There
shall be no limit on the number of extensions granted
under subparagraph (B), if the Administrator determines
that the relevant statement under subparagraph
(B)(ii)(I)--
``(i) establishes the need to extend the
period; and
``(ii) meets the requirements established
by the Administrator.
``(2) Review and resubstantiation.--
``(A) Discretion of administrator.--The
Administrator may review, at any time, a claim for
protection against disclosure under subsection (a) for
information submitted to the Administrator regarding a
chemical substance and require any person that has
claimed protection for that information, whether
before, on, or after the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st Century Act,
to withdraw or reassert and substantiate or
resubstantiate the claim in accordance with this
section--
``(i) after the chemical substance is
identified as a high-priority substance under
section 4A;
``(ii) for any chemical substance for which
the Administrator has made a determination
under section 6(c)(1)(C);
``(iii) for any inactive chemical substance
identified under section 8(b)(5); or
``(iv) in limited circumstances, if the
Administrator determines that disclosure of
certain information currently protected from
disclosure would assist the Administrator in
conducting safety assessments and safety
determinations under subsections (b) and (c) of
section 6 or promulgating rules pursuant to
section 6(d), subject to the condition that the
information shall not be disclosed unless the
claimant withdraws the claim or the
Administrator determines that the information
does not meet the requirements of subsection
(d).
``(B) Review required.--The Administrator shall
review a claim for protection from disclosure under
subsection (a) for information submitted to the
Administrator regarding a chemical substance and
require any person that has claimed protection for that
information, whether before, on, or after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, to withdraw or reassert and
substantiate or resubstantiate the claim in accordance
with this section--
``(i) as necessary to comply with a request
for information received by the Administrator
under section 552 of title 5, United States
Code;
``(ii) if information available to the
Administrator provides a basis that the
requirements of section 552(b)(4) of title 5,
United States Code, are no longer met; or
``(iii) for any substance for which the
Administrator has made a determination under
section 6(c)(1)(B).
``(C) Action by recipient.--If the Administrator
makes a request under subparagraph (A) or (B), the
recipient of the request shall--
``(i) reassert and substantiate or
resubstantiate the claim; or
``(ii) withdraw the claim.
``(D) Period of protection.--Protection from
disclosure of information subject to a claim that is
reviewed and approved by the Administrator under this
paragraph shall be extended for a period of 10 years
from the date of approval, subject to any subsequent
request by the Administrator under this paragraph.
``(3) Unique identifier.--The Administrator shall--
``(A)(i) develop a system to assign a unique
identifier to each specific chemical identity for which
the Administrator approves a request for protection
from disclosure, other than a specific chemical
identity or structurally descriptive generic term; and
``(ii) apply that identifier consistently to all
information relevant to the applicable chemical
substance;
``(B) annually publish and update a list of
chemical substances, referred to by unique identifier,
for which claims to protect the specific chemical
identity from disclosure have been approved, including
the expiration date for each such claim;
``(C) ensure that any nonconfidential information
received by the Administrator with respect to such a
chemical substance during the period of protection from
disclosure--
``(i) is made public; and
``(ii) identifies the chemical substance
using the unique identifier; and
``(D) for each claim for protection of specific
chemical identity that has been denied by the
Administrator on expiration of the period for appeal
under subsection (g)(4), that has expired, or that has
been withdrawn by the submitter, provide public access
to the specific chemical identity clearly linked to all
nonconfidential information received by the
Administrator with respect to the chemical substance.
``(g) Duties of Administrator.--
``(1) Determination.--
``(A) In general.--Except as provided in subsection
(b), the Administrator shall, subject to subparagraph
(C), not later than 90 days after the receipt of a
claim under subsection (d), and not later than 30 days
after the receipt of a request for extension of a claim
under subsection (f), review and approve, modify, or
deny the claim or request.
``(B) Denial or modification.--
``(i) In general.--Except as provided in
subsections (c) and (f), the Administrator
shall deny a claim to protect a chemical
identity from disclosure only if the person
that has submitted the claim fails to meet the
requirements of subsections (a) and (d).
``(ii) Reasons for denial or
modification.--The Administrator shall provide
to a person that has submitted a claim
described in clause (i) a written statement of
the reasons for the denial or modification of
the claim.
``(C) Subsets.--The Administrator shall--
``(i) except for claims described in
subsection (b)(7), review all claims under this
section for the protection against disclosure
of the specific identity of a chemical
substance; and
``(ii) review a representative subset,
comprising at least 25 percent, of all other
claims for protection against disclosure.
``(D) Effect of failure to act.--The failure of the
Administrator to make a decision regarding a claim for
protection against disclosure or extension under this
section shall not be the basis for denial or
elimination of a claim for protection against
disclosure.
``(2) Notification.--
``(A) In general.--Except as provided in
subparagraph (B) and subsections (c), (e), and (f), if
the Administrator denies or modifies a claim under
paragraph (1), or promulgates a rule under section 6(d)
establishing a ban or phase-out of a chemical
substance, the Administrator shall notify, in writing
and by certified mail, the person that submitted the
claim of the intent of the Administrator to release the
information.
``(B) Release of information.--
``(i) In general.--Except as provided in
clause (ii), the Administrator shall not
release information under this subsection until
the date that is 30 days after the date on
which the person that submitted the request
receives notification under subparagraph (A).
``(ii) Exceptions.--
``(I) In general.--For information
under paragraph (3) or (8) of
subsection (e), the Administrator shall
not release that information until the
date that is 15 days after the date on
which the person that submitted the
claim receives a notification, unless
the Administrator determines that
release of the information is necessary
to protect against an imminent and
substantial harm to health or the
environment, in which case no prior
notification shall be necessary.
``(II) No notification.--For
information under paragraph (1), (2),
(6), (7), or (9) of subsection (e), no
prior notification shall be necessary.
``(3) Rebuttable presumption.--
``(A) In general.--With respect to notifications
provided by the Administrator pursuant to subsection
(c)(5), there shall be a rebuttable presumption that
the public interest in disclosing confidential
information related to a chemical substance subject to
a rule promulgated under section 6(d) that establishes
a ban or phase-out of the manufacture, processing, or
distribution in commerce of the substance outweighs the
proprietary interest in maintaining the protection from
disclosure of that information.
``(B) Request for nondisclosure.--A person that
receives a notification under paragraph (2) with
respect to the information described in subparagraph
(A) may submit to the Administrator, before the date on
which the information is to be released, a request with
supporting documentation describing why the person
believes some or all of that information should not be
disclosed.
``(C) Determination by administrator.--
``(i) In general.--Not later than 30 days
after the Administrator receives a request
under subparagraph (B), the Administrator shall
determine, at the discretion of the
Administrator, whether the documentation
provided by the person making the request
rebuts or does not rebut the presumption
described in subparagraph (A), for all or a
portion of the information that the person has
requested not be disclosed.
``(ii) Objective.--The Administrator shall
make the determination with the objective of
ensuring that information relevant to
protection of health and the environment is
disclosed to the maximum extent practicable.
``(D) Timing.--Not later than 30 days after making
the determination described in subparagraph (C), the
Administrator shall make public the information the
Administrator has determined is not to be protected
from disclosure.
``(E) No timely request received.--If the
Administrator does not receive, before the date on
which the information described in subparagraph (A) is
to be released, a request pursuant to subparagraph (B),
the Administrator shall promptly make public all of the
information.
``(4) Appeals.--
``(A) In general.--If a person receives a
notification under paragraph (2) and believes
disclosure of the information is prohibited under
subsection (a), before the date on which the
information is to be released, the person may bring an
action to restrain disclosure of the information in--
``(i) the United States district court of
the district in which the complainant resides
or has the principal place of business; or
``(ii) the United States District Court for
the District of Columbia.
``(B) No disclosure.--The Administrator shall not
disclose any information that is the subject of an
appeal under this section before the date on which the
applicable court rules on an action under subparagraph
(A).
``(5) Administration.--In carrying out this subsection, the
Administrator shall use the procedures described in part 2 of
title 40, Code of Federal Regulations (or successor
regulations).
``(h) Criminal Penalty for Wrongful Disclosure.--
``(1) Officers and employees of united states.--
``(A) In general.--Subject to paragraph (2), a
current or former officer or employee of the United
States described in subparagraph (B) shall be guilty of
a misdemeanor and fined under title 18, United States
Code, or imprisoned for not more than 1 year, or both.
``(B) Description.--A current or former officer or
employee of the United States referred to in
subparagraph (A) is a current or former officer or
employee of the United States who--
``(i) by virtue of that employment or
official position has obtained possession of,
or has access to, material the disclosure of
which is prohibited by subsection (a); and
``(ii) knowing that disclosure of that
material is prohibited by subsection (a),
willfully discloses the material in any manner
to any person not entitled to receive that
material.
``(2) Other laws.--Section 1905 of title 18, United States
Code, shall not apply with respect to the publishing,
divulging, disclosure, making known of, or making available,
information reported or otherwise obtained under this Act.
``(3) Contractors.--For purposes of this subsection, any
contractor of the United States that is provided information in
accordance with subsection (e)(2), including any employee of
that contractor, shall be considered to be an employee of the
United States.
``(i) Applicability.--
``(1) In general.--Except as otherwise provided in this
section, section 8, or any other applicable Federal law, the
Administrator shall have no authority--
``(A) to require the substantiation or
resubstantiation of a claim for the protection from
disclosure of information submitted to the
Administrator under this Act before the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act; or
``(B) to impose substantiation or resubstantiation
requirements under this Act that are more extensive
than those required under this section.
``(2) Prior actions.--Nothing in this Act prevents the
Administrator from reviewing, requiring substantiation or
resubstantiation for, or approving, modifying or denying any
claim for the protection from disclosure of information before
the effective date of such rules applicable to those claims as
the Administrator may promulgate after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act.''.
SEC. 15. PROHIBITED ACTS.
Section 15 of the Toxic Substances Control Act (15 U.S.C. 2614) is
amended by striking paragraph (1) and inserting the following:
``(1) fail or refuse to comply with--
``(A) any rule promulgated, consent agreement
entered into, or order issued under section 4;
``(B) any requirement under section 5 or 6;
``(C) any rule promulgated, consent agreement
entered into, or order issued under section 5 or 6; or
``(D) any requirement of, or any rule promulgated
or order issued pursuant to title II;''.
SEC. 16. PENALTIES.
Section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) is
amended--
(1) in subsection (a)(1)--
(A) in the first sentence--
(i) by inserting ``this Act or a rule or
order promulgated or issued pursuant to this
Act, including'' after ``a provision of''; and
(ii) by striking ``$25,000'' and inserting
``$37,500''; and
(B) in the second sentence, by striking`` violation
of section 15 or 409'' and inserting ``violation of
this Act''; and
(2) in subsection (b)--
(A) by striking ``Any person who'' and inserting
the following:
``(1) In general.--Any person that'';
(B) by striking ``section 15 or 409'' and inserting
``this Act'';
(C) by striking ``$25,000'' and inserting
``$50,000''; and
(D) by adding at the end the following:
``(2) Imminent danger of death or serious bodily injury.--
``(A) In general.--Any person that knowingly or
willfully violates any provision of this Act, and that
knows at the time of the violation that the violation
places an individual in imminent danger of death or
serious bodily injury, shall be subject on conviction
to a fine of not more than $250,000, or imprisonment
for not more than 15 years, or both.
``(B) Organizations.--An organization that commits
a violation described in subparagraph (A) shall be
subject on conviction to a fine of not more than
$1,000,000 for each violation.
``(3) Knowledge of imminent danger or injury.--For purposes
of determining whether a defendant knew that the violation
placed another individual in imminent danger of death or
serious bodily injury--
``(A) the defendant shall be responsible only for
actual awareness or actual belief possessed; and
``(B) knowledge possessed by an individual may not
be attributed to the defendant.''.
SEC. 17. STATE-FEDERAL RELATIONSHIP.
Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is
amended by striking subsections (a) and (b) and inserting the
following:
``(a) In General.--
``(1) Establishment or enforcement.--Except as provided in
subsections (c), (d), (e), (f), and (g), and subject to
paragraph (2), no State or political subdivision of a State may
establish or continue to enforce any of the following:
``(A) Testing and information collection.--A
statute or administrative action to require the
development of information on a chemical substance or
category of substances that is reasonably likely to
produce the same information required under section 4,
5, or 6 in--
``(i) a rule promulgated by the
Administrator;
``(ii) a testing consent agreement entered
into by the Administrator; or
``(iii) an order issued by the
Administrator.
``(B) Chemical substances found to meet the safety
standard or restricted.--A statute or administrative
action to prohibit or otherwise restrict the
manufacture, processing, or distribution in commerce or
use of a chemical substance--
``(i) found to meet the safety standard and
consistent with the scope of the determination
made under section 6; or
``(ii) found not to meet the safety
standard, after the effective date of the rule
issued under section 6(d) for the substance,
consistent with the scope of the determination
made by the Administrator.
``(C) Significant new use.--A statute or
administrative action requiring the notification of a
use of a chemical substance that the Administrator has
specified as a significant new use and for which the
Administrator has required notification pursuant to a
rule promulgated under section 5.
``(2) Effective date of preemption.--Under this subsection,
Federal preemption of State statutes and administrative actions
applicable to specific substances shall not occur until the
effective date of the applicable action described in paragraph
(1) taken by the Administrator.
``(b) New Statutes or Administrative Actions Creating Prohibitions
or Other Restrictions.--
``(1) In general.--Except as provided in subsections (c),
(d), and (e), beginning on the date on which the Administrator
defines the scope of a safety assessment and safety
determination under section 6(a)(2) and ending on the date on
which the Administrator publishes the safety determination, no
State or political subdivision of a State may establish a
statute or administrative action prohibiting or restricting the
manufacture, processing, distribution in commerce or use of a
chemical substance that is a high-priority substance designated
under section 4A.
``(2) Effect of subsection.--
``(A) In general.--This subsection does not
restrict the authority of a State or political
subdivision of a State to continue to enforce any State
statute enacted, or administrative action taken, prior
to the date on which the Administrator defines the
scope of a safety assessment and safety determination
under section 6(a)(2).
``(B) Limitation.--Subparagraph (A) does not allow
a State or political subdivision of a State to enforce
any new prohibition or restriction under a State
statute or administrative action described in that
subparagraph, if the prohibition or restriction is
established after the date described in that
subparagraph.
``(c) Scope of Preemption.--Federal preemption under subsections
(a) and (b) of State statutes and administrative actions applicable to
specific substances shall apply only to--
``(1) the chemical substances or category of substances
subject to a rule, order, or consent agreement under section 4;
``(2) the uses or conditions of use of such substances that
are identified by the Administrator as subject to review in a
safety assessment and included in the scope of the safety
determination made by the Administrator for the substance, or
of any rule the Administrator promulgates pursuant to section
6(d); or
``(3) the uses of such substances that the Administrator
has specified as significant new uses and for which the
Administrator has required notification pursuant to a rule
promulgated under section 5.
``(d) Exceptions.--
``(1) No preemption of state statutes and administrative
actions.--
``(A) In general.--Nothing in this Act, nor any
amendment made by this Act, nor any rule, standard of
performance, safety determination, or scientific
assessment implemented pursuant to this Act, shall
affect the right of a State or a political subdivision
of a State to adopt or enforce any rule, standard of
performance, safety determination, scientific
assessment, or any protection for public health or the
environment that--
``(i) is adopted or authorized under the
authority of any other Federal law or adopted
to satisfy or obtain authorization or approval
under any other Federal law;
``(ii) implements a reporting, monitoring,
disclosure, or other information obligation for
the chemical substance not otherwise required
by the Administrator under this Act or required
under any other Federal law;
``(iii) 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, except to the extent that the
action--
``(I) imposes a restriction on the
manufacture, processing, distribution
in commerce, or use of a chemical
substance; and
``(II)(aa) addresses the same
hazards and exposures, with respect to
the same conditions of use as are
included in the scope of the safety
determination pursuant to section 6,
but is inconsistent with the action of
the Administrator; or
``(bb) would cause a violation of
the applicable action by the
Administrator under section 5 or 6; or
``(iv) subject to subparagraph (B), is
identical to a requirement prescribed by the
Administrator.
``(B) Identical requirements.--
``(i) In general.--The penalties and other
sanctions applicable under State law in the
event of noncompliance with the identical
requirement shall be no more stringent than the
penalties and other sanctions available to the
Administrator under section 16 of this Act.
``(ii) Penalties.--In the case of an
identical requirement, no State may assess a
penalty for a specific violation for which the
Administrator has already assessed a penalty
under section 16, and the Administrator may not
assess a penalty under section 16 for a
specific violation for which a State has
already assessed a penalty.
``(2) Applicability to certain rules or orders.--
Notwithstanding subsection (e)--
``(A) nothing in this section shall be construed as
modifying the effect under this section, as in effect
on the day before the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, of
any rule or order promulgated or issued under this Act
prior to that effective date; and
``(B) with respect to a chemical substance or
mixture for which any rule or order was promulgated or
issued under section 6 prior to the effective date of
the Frank R. Lautenberg Chemical Safety for the 21st
Century Act with regards to manufacturing, processing,
distribution in commerce, use, or disposal of a
chemical substance, this section (as in effect on the
day before the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act)
shall govern the preemptive effect of any rule or order
that is promulgated or issued respecting such chemical
substance or mixture under section 6 of this Act after
that effective date, unless the latter rule or order is
with respect to a chemical substance or mixture
containing a chemical substance and follows a
designation of that chemical substance as a high-
priority substance under section 4A(b) or as an
additional priority for safety assessment and safety
determination under section 4A(c).
``(e) Preservation of Certain State Law.--
``(1) In general.--Nothing in this Act, subject to
subsection (g) of this section, shall--
``(A) be construed to preempt or otherwise affect
the authority of a State or political subdivision of a
State to continue to enforce any action taken before
August 1, 2015, under the authority of a State law that
prohibits or otherwise restricts manufacturing,
processing, distribution in commerce, use, or disposal
of a chemical substance; or
``(B) be construed to preempt or otherwise affect
any action taken pursuant to a State law that was in
effect on August 31, 2003.
``(2) Effect of subsection.--This subsection does not
affect, modify, or alter the relationship between State and
Federal law pursuant to any other Federal law.
``(f) State Waivers.--
``(1) Discretionary exemptions.--Upon application of a
State or political subdivision of a State, the Administrator
may by rule, exempt from subsection (a), under such conditions
as may be prescribed in the rule, a statute or administrative
action of that State or political subdivision of the State that
relates to the effects of, or exposure to, a chemical substance
under the conditions of use if the Administrator determines
that--
``(A) compelling State or local conditions warrant
granting the waiver to protect health or the
environment;
``(B) compliance with the proposed requirement of
the State or political subdivision of the State would
not unduly burden interstate commerce in the
manufacture, processing, distribution in commerce, or
use of a chemical substance;
``(C) 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
``(D) based on the judgment of the Administrator,
the proposed requirement of the State or political
subdivision of the State is consistent with sound
objective scientific practices, the weight of the
evidence, and the best available science.
``(2) Required exemptions.--Upon application of a State or
political subdivision of a State, the Administrator shall
exempt from subsection (b) a statute or administrative action
of a State or political subdivision of a State that relates to
the effects of exposure to a chemical substance under the
conditions of use if the Administrator determines that--
``(A) compliance with the proposed requirement of
the State will not unduly burden interstate commerce in
the manufacture, processing, distribution in commerce,
or use of a chemical substance;
``(B) compliance with the proposed requirement
would not cause a violation of any applicable Federal
law, rule, or order; and
``(C) the State or political subdivision of a State
has a concern about the chemical substance or use of
the chemical substance based in peer-reviewed science.
``(3) Determination of a state waiver request.--The duty of
the Administrator to grant or deny a waiver application shall
be nondelegable and shall be exercised--
``(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) Failure to make determination.--If the Administrator
fails to make a determination under paragraph (3)(B) during the
90-day period beginning on the date on which an application
under paragraph (2) is submitted, the State statute or
administrative action that was the subject of the application
shall not be considered to be an existing statute or
administrative action for purposes of subsection (b) by reason
of the failure of the Administrator to make a determination.
``(5) Notice and comment.--Except in the case of an
application approved under paragraph (9), the application of a
State or political subdivision of the State shall be subject to
public notice and comment.
``(6) 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.
``(7) Duration of waivers.--
``(A) In general.--Except as provided in
subparagraph (B), a waiver granted under paragraph (2)
or approved under paragraph (9) shall remain in
effect--
``(i) until such time as the safety
assessment and safety determination is
completed; or
``(ii) subject to subparagraph (B), until
judicial review of the failure of the
Administrator to make a determination under
paragraph (3) is sought under paragraph (8).
``(B) Reinstatement of waiver.--A waiver described
in subparagraph (A)(ii) shall again take effect upon
the earlier of--
``(i) the date of approval by the
Administrator of the waiver application;
``(ii) the effective date of a court order
directing the Administrator to approve the
waiver application; or
``(iii) 90 days after the date on which
judicial review under paragraph (8) is sought.
``(8) Judicial review of waivers.--Not later than 60 days
after the date on which the Administrator makes a determination
on an application of a State or political subdivision of the
State under paragraph (1) or (2), or not later than 60 days
after the date on which the Administrator fails to make a
determination under paragraph (3), 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.
``(9) Approval.--
``(A) In general.--If the Administrator fails to
meet the deadline under section 6(a)(4) (including an
extension granted under section 6(a)(6)), or the
deadline established under paragraph (3)(B), the
application of a State or political subdivision of a
State under paragraph (2) shall be automatically
approved.
``(B) Requirements.--Notwithstanding paragraph (6),
approval of a waiver application under subparagraph (A)
for failure to meet the deadlines under section 6(a)(4)
(including an extension granted under section 6(a)(6))
shall not be considered final agency action or be
subject to judicial review or public notice and
comment.
``(10) Judicial review of low-priority decisions.--
``(A) In general.--Not later than 60 days after the
publication of a designation under section 4A(b)(4),
any person may commence a civil action to challenge the
designation.
``(B) Jurisdiction.--The United States Court of
Appeals for the District of Columbia Circuit shall have
exclusive jurisdiction over a civil action filed under
this paragraph.
``(g) Savings.--
``(1) No preemption of common law or statutory causes of
action for civil relief or criminal conduct.--
``(A) In general.--Nothing in this Act, nor any
amendment made by this Act, nor any safety standard,
rule, requirement, standard of performance, safety
determination, or scientific assessment implemented
pursuant to this Act, shall be construed to preempt,
displace, or supplant any state or Federal common law
rights or any state or Federal statute creating a
remedy for civil relief, including those for civil
damage, or a penalty for a criminal conduct.
``(B) Clarification of no preemption.--
Notwithstanding any other provision of this Act,
nothing in this Act, nor any amendments made by this
Act, shall preempt or preclude any cause of action for
personal injury, wrongful death, property damage, or
other injury based on negligence, strict liability,
products liability, failure to warn, or any other legal
theory of liability under any State law, maritime law,
or Federal common law or statutory theory.
``(2) No effect on private remedies.--
``(A) In general.--Nothing in this Act, nor any
amendments made by this Act, nor any rules,
regulations, requirements, safety assessments, safety
determinations, scientific assessments, or orders
issued pursuant to this Act shall be interpreted as, in
either the plaintiff's or defendant's favor,
dispositive in any civil action.
``(B) Authority of courts.--This Act does not
affect the authority of any court to make a
determination in an adjudicatory proceeding under
applicable State or Federal law with respect to the
admission into evidence or any other use of this Act or
rules, regulations, requirements, standards of
performance, safety assessments, scientific
assessments, or orders issued pursuant to this Act.''.
SEC. 18. JUDICIAL REVIEW.
Section 19 of the Toxic Substances Control Act (15 U.S.C. 2618) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking
``section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e),
or 8, or under title II or IV'' and inserting
``section 4(a), 5(d), 6(c), 6(d), 6(g), or 8,
or title II or IV''; and
(ii) in subparagraph (B), by striking ``an
order issued under subparagraph (A) or (B) of
section 6(b)(1)'' and inserting ``an order
issued under this title''; and
(B) in paragraph (2), in the first sentence, by
striking ``paragraph (1)(A)'' and inserting ``paragraph
(1)''; and
(C) by striking paragraph (3); and
(2) in subsection (c)(1)(B)--
(A) in clause (i)--
(i) by striking ``section 4(a), 5(b)(4),
6(a), or 6(e)'' and inserting ``section 4(a),
5(d), 6(d), or 6(g)''; and
(ii) by striking ``evidence in the
rulemaking record (as defined in subsection
(a)(3)) taken as a whole;'' and inserting
``evidence (including any matter) in the
rulemaking record, taken as a whole; and''; and
(B) by striking clauses (ii) and (iii) and the
matter following clause (iii) and inserting the
following:
``(ii) the court may not review the
contents and adequacy of any statement of basis
and purpose required by section 553(c) of title
5, United States Code, to be incorporated in
the rule, except as part of the rulemaking
record, taken as a whole.''.
SEC. 19. CITIZENS' PETITIONS.
Section 21 of the Toxic Substances Control Act (15 U.S.C. 2620) is
amended--
(1) in subsection (a), by striking ``an order under section
5(e) or 6(b)(2)'' and inserting ``an order under section 4 or
5(d)''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``an order under
section 5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting
``an order under section 4 or 5(d)''; and
(B) in paragraph (4), by striking subparagraph (B)
and inserting the following:
``(B) De novo proceeding.--
``(i) In general.--In an action under
subparagraph (A) to initiate a proceeding to
promulgate a rule pursuant to section 4, 5, 6,
or 8 or issue an order under section 4 or 5(d),
the petitioner shall be provided an opportunity
to have the petition considered by the court in
a de novo proceeding.
``(ii) Demonstration.--
``(I) In general.--The court in a
de novo proceeding under this
subparagraph shall order the
Administrator to initiate the action
requested by the petitioner if the
petitioner demonstrates to the
satisfaction of the court by a
preponderance of the evidence that--
``(aa) in the case of a
petition to initiate a
proceeding for the issuance of
a rule or order under section
4, the information available to
the Administrator is
insufficient for the
Administrator to perform an
action described in section 4,
4A, 5, or 6(d);
``(bb) in the case of a
petition to issue an order
under section 5(d), there is a
reasonable basis to conclude
that the chemical substance is
not likely to meet the safety
standard;
``(cc) in the case of a
petition to initiate a
proceeding for the issuance of
a rule under section 6(d),
there is a reasonable basis to
conclude that the chemical
substance will not meet the
safety standard; or
``(dd) in the case of a
petition to initiate a
proceeding for the issuance of
a rule under section 8, there
is a reasonable basis to
conclude that the rule is
necessary to protect health or
the environment or ensure that
the chemical substance meets
the safety standard.
``(II) Deferment.--The court in a
de novo proceeding under this
subparagraph may permit the
Administrator to defer initiating the
action requested by the petitioner
until such time as the court
prescribes, if the court finds that--
``(aa) the extent of the
risk to health or the
environment alleged by the
petitioner is less than the
extent of risks to health or
the environment with respect to
which the Administrator is
taking action under this Act;
and
``(bb) there are
insufficient resources
available to the Administrator
to take the action requested by
the petitioner.''.
SEC. 20. EMPLOYMENT EFFECTS.
Section 24(b)(2)(B)(ii) of the Toxic Substances Control Act (15
U.S.C. 2623(b)(2)(B)(ii)) is amended by striking ``section 6(c)(3),''
and inserting ``the applicable requirements of this Act;''.
SEC. 21. STUDIES.
Section 25 of the Toxic Substances Control Act (15 U.S.C. 2624) is
repealed.
SEC. 22. ADMINISTRATION.
Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is
amended--
(1) by striking subsection (b) and inserting the following:
``(b) Fees.--
``(1) In general.--The Administrator shall establish, not
later than 1 year after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, by rule--
``(A) the payment of 1 or more reasonable fees as a
condition of submitting a notice or requesting an
exemption under section 5;
``(B) the payment of 1 or more reasonable fees by a
manufacturer or processor that--
``(i) is required to submit a notice
pursuant to the rule promulgated under section
8(b)(4)(A)(i) identifying a chemical substance
as active;
``(ii) is required to submit a notice
pursuant to section 8(b)(5)(B)(i) changing the
status of a chemical substance from inactive to
active;
``(iii) is required to report information
pursuant to the rules promulgated under section
8(a)(4); and
``(iv) manufactures or processes a chemical
substance subject to a safety assessment and
safety determination pursuant to section 6.
``(2) Utilization and collection of fees.--The
Administrator shall--
``(A) utilize the fees collected under paragraph
(1) only to defray costs associated with the actions of
the Administrator--
``(i) to collect, process, review, provide
access to, and protect from disclosure (where
appropriate) information on chemical substances
under this Act;
``(ii) to review notices and make
determinations for chemical substances under
paragraphs (1) and (3) of section 5(d) and
impose any necessary restrictions under section
5(d)(4);
``(iii) to make prioritization decisions
under section 4A;
``(iv) to conduct and complete safety
assessments and determinations under section 6;
and
``(v) to conduct any necessary rulemaking
pursuant to section 6(d);
``(B) insofar as possible, collect the fees
described in paragraph (1) in advance of conducting any
fee-supported activity;
``(C) deposit the fees in the Fund established by
paragraph (4)(A); and
``(D) not collect excess fees or retain a
significant amount of unused fees.
``(3) Amount and adjustment of fees; refunds.--In setting
fees under this section, the Administrator shall--
``(A) take into account the cost to the
Administrator of conducting the activities described in
paragraph (2);
``(B) prescribe lower fees for small business
concerns, after consultation with the Administrator of
the Small Business Administration;
``(C) set the fees established under paragraph (1)
at levels such that the fees will, in aggregate,
provide a sustainable source of funds to defray
approximately 25 percent of the costs of conducting the
activities identified in paragraph (2)(A), not to
exceed $18,000,000, not including fees under
subparagraph (E) of this paragraph;
``(D) reflect an appropriate balance in the
assessment of fees between manufacturers and
processors, and allow the payment of fees by consortia
of manufacturers or processors;
``(E) for substances designated as additional
priorities pursuant to section 4A(c), establish the fee
at a level sufficient to defray the full costs to the
Administrator of conducting the safety assessment and
safety determination under section 6, except that for
substances subject to section 4A(c)(3), the
Administrator shall establish the fee at a level
sufficient to defray 50 percent of those costs;
``(F) prior to the establishment or amendment of
any fees under paragraph (1), consult and meet with
parties potentially subject to the fees or their
representatives, subject to the condition that no
obligation under the Federal Advisory Committee Act (5
U.S.C. App.) or subchapter III of chapter 5 of title 5,
United States Code, is applicable with respect to such
meetings;
``(G) beginning with the fiscal year that is 3
years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act,
and every 3 years thereafter, after consultation with
parties potentially subject to the fees and their
representatives, increase or decrease the fees
established under paragraph (1) as necessary--
``(i) to ensure that funds deposited in the
Fund are sufficient to conduct the activities
identified in paragraph (2)(A) and the full
cost or 50-percent portion of the costs of
safety assessments and safety determinations
pursuant to subparagraph (E); and
``(ii) to account for inflation;
``(H) adjust fees established under paragraph (1)
as necessary to vary on account of differing
circumstances, including reduced fees or waivers in
appropriate circumstances, to reduce the burden on
manufacturing or processing, remove barriers to
innovation, or where the costs to the Administrator of
collecting the fees exceed the fee revenue anticipated
to be collected; and
``(I) if a notice submitted under section 5 is
refused or subsequently withdrawn, refund the fee or a
portion of the fee if no substantial work was performed
on the notice.
``(4) TSCA implementation fund.--
``(A) Establishment.--There is established in the
Treasury of the United States a fund, to be known as
the `TSCA Implementation Fund' (referred to in this
subsection as the `Fund'), consisting of--
``(i) such amounts as are deposited in the
Fund under paragraph (2)(C); and
``(ii) any interest earned on the
investment of amounts in the Fund; and
``(iii) any proceeds from the sale or
redemption of investments held in the Fund.
``(B) Crediting and availability of fees.--
``(i) In general.--Fees authorized under
this section shall be collected and available
for obligation only to the extent and in the
amount provided in advance in appropriations
Acts, and shall be available without fiscal
year limitation.
``(ii) Requirements.--Fees collected under
this section shall not--
``(I) be made available or
obligated for any purpose other than to
defray the costs of conducting the
activities identified in paragraph
(2)(A);
``(II) otherwise be available for
any purpose other than implementation
of this Act; and
``(III) so long as amounts in the
Fund remain available, be subject to
restrictions on expenditures applicable
to the Federal government as a whole.
``(C) Unused funds.--Amounts in the Fund not
currently needed to carry out this subsection shall
be--
``(i) maintained readily available or on
deposit;
``(ii) invested in obligations of the
United States or guaranteed by the United
States; or
``(iii) invested in obligations,
participations, or other instruments that are
lawful investments for fiduciary, trust, or
public funds.
``(D) Minimum amount of appropriations.--Fees may
not be assessed for a fiscal year under this section
unless the amount of appropriations for salaries,
contracts, and expenses for the functions (as in
existence in fiscal year 2015) of the Office of
Pollution Prevention and Toxics of the Environmental
Protection Agency for the fiscal year (excluding the
amount of any fees appropriated for the fiscal year)
are equal to or greater than the amount of
appropriations for covered functions for fiscal year
2015 (excluding the amount of any fees appropriated for
the fiscal year).
``(5) Auditing.--
``(A) Financial statements of agencies.--For the
purpose of section 3515(c) of title 31, United States
Code, the Fund shall be considered a component of an
executive agency.
``(B) Components.--The annual audit required under
sections 3515(b) and 3521 of that title of the
financial statements of activities under this
subsection shall include an analysis of--
``(i) the fees collected under paragraph
(1) and disbursed;
``(ii) compliance with the deadlines
established in section 6 of this Act;
``(iii) the amounts budgeted, appropriated,
collected from fees, and disbursed to meet the
requirements of sections 4, 4A, 5, 6, 8, and
14, including the allocation of full time
equivalent employees to each such section or
activity; and
``(iv) the reasonableness of the allocation
of the overhead associated with the conduct of
the activities described in paragraph (2)(A).
``(C) Inspector general.--The Inspector General of
the Environmental Protection Agency shall--
``(i) conduct the annual audit required
under this subsection; and
``(ii) report the findings and
recommendations of the audit to the
Administrator and to the appropriate committees
of Congress.
``(6) Termination.--The authority provided by this section
shall terminate at the conclusion of the fiscal year that is 10
years after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, unless otherwise
reauthorized or modified by Congress.'';
(2) in subsection (e), by striking ``Health, Education, and
Welfare'' each place it appears and inserting ``Health and
Human Services''; and
(3) adding at the end the following:
``(h) Prior Actions.--Nothing in this Act eliminates, modifies, or
withdraws any rule promulgated, order issued, or exemption established
pursuant to this Act before the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.''.
SEC. 23. DEVELOPMENT AND EVALUATION OF TEST METHODS AND SUSTAINABLE
CHEMISTRY.
Section 27 of the Toxic Substances Control Act (15 U.S.C. 2626) is
amended--
(1) in subsection (a), in the first sentence by striking
``Health, Education, and Welfare'' and inserting ``Health and
Human Services''; and
(2) by adding at the end the following:
``(c) Sustainable Chemistry Program.--The President shall establish
an interagency Sustainable Chemistry Program to promote and coordinate
Federal sustainable chemistry research, development, demonstration,
technology transfer, commercialization, education, and training
activities.
``(d) Program Activities.--The activities of the Program shall be
designed to--
``(1) provide sustained support for sustainable chemistry
research, development, demonstration, technology transfer,
commercialization, education, and training through--
``(A) coordination of sustainable chemistry
research, development, demonstration, and technology
transfer conducted at Federal laboratories and
agencies; and
``(B) to the extent practicable, encouragement of
consideration of sustainable chemistry in, as
appropriate--
``(i) the conduct of Federal and State
science and engineering research and
development; and
``(ii) the solicitation and evaluation of
applicable proposals for science and
engineering research and development;
``(2) examine methods by which the Federal Government can
create incentives for consideration and use of sustainable
chemistry processes and products, including innovative
financing mechanisms;
``(3) expand the education and training of undergraduate
and graduate students and professional scientists and
engineers, including through partnerships with industry, in
sustainable chemistry science and engineering;
``(4) collect and disseminate information on sustainable
chemistry research, development, and technology transfer
including information on--
``(A) incentives and impediments to development,
manufacturing, and commercialization;
``(B) accomplishments;
``(C) best practices; and
``(D) costs and benefits;
``(5) support (including through technical assistance,
participation, financial support, or other forms of support)
economic, legal, and other appropriate social science research
to identify barriers to commercialization and methods to
advance commercialization of sustainable chemistry.
``(e) Interagency Working Group.--
``(1) Establishment.--Not later than 180 days after the
date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the President, in consultation with
the Office of Science and Technology Policy, shall establish an
Interagency Working Group that shall include representatives
from the National Science Foundation, the National Institute of
Standards and Technology, the Department of Energy, the
Environmental Protection Agency, the Department of Agriculture,
the Department of Defense, the National Institutes of Health,
and any other agency that the President may designate to
oversee the planning, management, and coordination of the
Program.
``(2) Governance.--The Director of the National Science
Foundation and the Assistant Administrator for Research and
Development of the Environmental Protection Agency, or their
designees, shall serve as co-chairs of the Interagency Working
Group.
``(3) Responsibilities.--In overseeing the planning,
management, and coordination of the Program, the Interagency
Working Group shall--
``(A) establish goals and priorities for the
Program, in consultation with the Advisory Council;
``(B) provide for interagency coordination,
including budget coordination, of activities under the
Program;
``(C) meet not later than 90 days from its
establishment and periodically thereafter; and
``(D) establish and consult with an Advisory
Council on a regular basis.
``(4) Membership.--The Advisory Council members shall not
be employees of the Federal Government and shall include a
diverse representation of knowledgeable individuals from the
private sector (including small- and medium-sized enterprises
from across the value chain), academia, State and tribal
governments, and nongovernmental organizations and others who
are in a position to provide expertise.
``(f) Agency Budget Requests.--
``(1) In general.--Each Federal agency and department
participating in the Program shall, as part of its annual
request for appropriations to the Office of Management and
Budget, submit a report to the Office of Management and Budget
that--
``(A) identifies the activities of the agency or
department that contribute directly to the Program; and
``(B) states the portion of the agency or
department's request for appropriations that is
allocated to those activities.
``(2) Annual budget request to congress.--The President
shall include in the annual budget request to Congress a
statement of the portion of the annual budget request for each
agency or department that will be allocated to activities
undertaken pursuant to the Program.
``(g) Report to Congress.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Interagency Working Group shall submit a
report to the Committee on Science, Space, and Technology and
Committee on Energy and Commerce of the House of
Representatives and the Committee on Environment and Public
Works and the Committee on Commerce, Science, and
Transportation of the Senate that shall include--
``(A) a summary of federally funded sustainable
chemistry research, development, demonstration,
technology transfer, commercialization, education, and
training activities;
``(B) a summary of the financial resources
allocated to sustainable chemistry initiatives;
``(C) an analysis of the progress made toward
achieving the goals and priorities of the program
established pursuant to subsection (c), and
recommendations for future program activities;
``(D) an assessment of the benefits of expanding
existing, federally-supported regional innovation and
manufacturing hubs to include sustainable chemistry and
the value of directing the creation of 1 or more
dedicated sustainable chemistry centers of excellence
or hubs; and
``(E) an evaluation of steps taken and future
strategies to avoid duplication of efforts, streamline
interagency coordination, facilitate information
sharing, and spread best practices between
participating agencies in the Program.
``(2) Submission to gao.--The Interagency Working Group
shall also submit the report described in paragraph (1) to the
Government Accountability Office for consideration in future
Congressional inquiries.''.
SEC. 24. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is
amended--
(1) in subsection (b)(1)--
(A) in subparagraphs (A) through (D), by striking
the comma at the end of each subparagraph and inserting
a semicolon; and
(B) in subparagraph (E), by striking ``, and'' and
inserting ``; and''; and
(2) by striking subsections (c) and (d).
SEC. 25. AUTHORIZATION OF APPROPRIATIONS.
Section 29 of the Toxic Substances Control Act (15 U.S.C. 2628) is
repealed.
SEC. 26. ANNUAL REPORT.
Section 30 of the Toxic Substances Control Act (15 U.S.C. 2629) is
amended by striking paragraph (2) and inserting the following:
``(2)(A) the number of notices received during each year
under section 5; and
``(B) the number of the notices described in subparagraph
(A) for chemical substances subject to a rule, testing consent
agreement, or order under section 4;''.
SEC. 27. EFFECTIVE DATE.
Section 31 of the Toxic Substances Control Act (15 U.S.C. 2601
note; Public Law 94-469) is amended--
(1) by striking ``Except as provided in section 4(f),
this'' and inserting the following:
``(a) In General.--This''; and
(2) by adding at the end the following:
``(b) Retroactive Applicability.--Nothing in this Act shall be
interpreted to apply retroactively to any State, Federal, or maritime
legal action commenced prior to the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.''.
Calendar No. 121
114th CONGRESS
1st Session
S. 697
_______________________________________________________________________
A BILL
To amend the Toxic Substances Control Act to reauthorize and modernize
that Act, and for other purposes.
_______________________________________________________________________
June 17, 2015
Reported with an amendment