[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2576 Engrossed Amendment Senate (EAS)]
<DOC>
In the Senate of the United States,
December 17, 2015.
Resolved, That the bill from the House of Representatives (H.R.
2576) entitled ``An Act to modernize the Toxic Substances Control Act,
and for other purposes.'', do pass with the following
AMENDMENT:
Strike all after the enacting clause and insert the
following:
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 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 existing relevant policies, procedures, and guidance, as
appropriate and consistent with this Act.
``(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, procedures, and guidance for the testing of chemical
substances or mixtures under section 4.
``(2) Goal.--A goal of the policies, procedures, and
guidance established under paragraph (1) shall be to make the
basis of decisions clear to the public.
``(3) Contents.--The policies, procedures, and guidance
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; and
``(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.
``(4) Epidemiological studies.--Before prescribing
epidemiological studies of employees, the Administrator shall
consult with the Director of the National Institute for
Occupational Safety and Health.
``(h) Safety Assessments and Safety Determinations.--
``(1) Schedule.--
``(A) In general.--The Administrator shall inform
the public regarding the schedule and the resources
necessary 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.--
``(i) In general.--At the beginning of each
calendar year, the Administrator shall publish
an annual plan.
``(ii) Inclusions.--The annual plan shall--
``(I) identify the substances
subject to safety assessments and
safety determinations to be completed
that year;
``(II) describe the status of each
safety assessment and safety
determination that has been initiated
but not yet completed, including
milestones achieved since the previous
annual report; and
``(III) if the schedule for
completion of a safety assessment and
safety determination prepared pursuant
to subparagraph (A) has changed,
include an updated schedule for that
safety assessment and safety
determination.
``(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.--The policies and
procedures under this paragraph shall, at a minimum--
``(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
information submitted by interested
individuals or entities will be
evaluated;
``(ii) require that each draft and final
safety assessment and safety determination of
the Administrator include a description of--
``(I)(aa) the scope of the safety
assessment and safety determination to
be conducted under section 6, including
the hazards, exposures, and conditions
of use of the chemical substance, and
potentially exposed and susceptible
populations that the Administrator has
identified as relevant; and
``(bb) the basis for the scope of
the safety assessment and safety
determination;
``(II) the manner in which
aggregate exposures, or significant
subsets of exposures, to a chemical
substance under the conditions of use
were considered, and the basis for that
consideration;
``(III) the weight of the
scientific evidence of risk; and
``(IV) 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;
``(iii) 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
``(iv) when relevant information is
provided or otherwise made available to the
Administrator, require the Administrator to
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 by 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), (e), and
(g);
(2) in subsection (f)--
(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
(3) by inserting before subsection (f) 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;
``(ii) the reasonably foreseeable
availability of facilities and personnel
required to perform the testing; and
``(iii) the deadlines applicable to the
Administrator under section 6(a).
``(5) Consideration of federal agency recommendations.--The
Administrator shall consider the recommendations of other
Federal agencies regarding the chemical substances and mixtures
to which the Administrator shall give priority consideration
under this section.
``(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) prior to making a request or adopting a
requirement for testing using vertebrate animals,
taking 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;
``(B) 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
``(C) 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) persons that begin to manufacture or process
the chemical substance or mixture after the effective
date of the rule, testing consent agreement, or order.
``(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 submission of
information by the applicant on the chemical substance
or mixture would be duplicative of--
``(i) information on the chemical substance
or mixture that--
``(I) has been submitted to the
Administrator pursuant to a rule,
consent agreement, or order under this
section; or
``(II) is being developed by a
person designated under paragraph (2);
or
``(ii) information on an equivalent
chemical substance or mixture that--
``(I) has been submitted to the
Administrator pursuant to a rule,
consent agreement, or order under this
section; or
``(II) 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), before the end of the
reimbursement period described in clause (iii),
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.
``(iii) Reimbursement period.--For the
purposes of this subparagraph, the
reimbursement period for any information for a
chemical substance or mixture is a period--
``(I) beginning on the date the
information is submitted in accordance
with a rule, testing consent agreement,
or order under this section; and
``(II) ending on the later of--
``(aa) 5 years after the
date referred to in subclause
(I); or
``(bb) the last day of the
period that begins on the date
referred to in subclause (I)
and that is equal to the period
that the Administrator
determines was necessary to
develop the information.
``(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
inserting ``(as in effect on the day before the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st Century Act)''
after ``Toxic Substances Control Act''.
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 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 and subsequent lists 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 shall publish an initial list of high-
priority substances and low-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) Preferences.--
``(I) In general.--In developing
the initial list and in identifying
additional high-priority substances,
the Administrator shall give preference
to--
``(aa) chemical substances
that, with respect to
persistence and
bioaccumulation, score high for
1 and either high or moderate
for the other, pursuant to the
TSCA Work Plan Chemicals
Methods Document published by
the Administrator in February
2012; and
``(bb) chemical substances
listed in the October 2014 TSCA
Work Plan and subsequent
updates that are known human
carcinogens and have high acute
and chronic toxicity.
``(II) Metals and metal
compounds.--In prioritizing and
assessing metals and metal compounds,
the Administrator shall use the
Framework for Metals Risk Assessment of
the Office of the Science Advisor, Risk
Assessment Forum, and dated March 2007
(or a successor document), and may use
other applicable information consistent
with the best available science.
``(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 implementing
the prioritization screening process
established under 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
implementing the prioritization screening
process established under 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 chemical substances
not designated as high-priority.
``(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
consistent with the ability of the
Administrator to schedule and complete
safety assessments and safety
determinations under section 6 in
accordance with the deadlines under
subsection (a) of that section.
``(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 includes and identifies
substances--
``(i) that are being considered in the
prioritization screening process and the status
of the substances in the prioritization
process;
``(ii) for which prioritization decisions
have been postponed pursuant to subsection
(b)(5), including the basis for the
postponement; and
``(iii) that 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 and storage near significant sources of
drinking water;
``(E) the volume of a chemical substance
manufactured or processed;
``(F) whether the volume of a chemical substance as
reported pursuant to a rule promulgated pursuant to
section 8(a) has significantly increased or decreased;
``(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.--In implementing the prioritization
screening process developed under subsection (a), 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) Reasonably available information.--The prioritization
screening decision regarding a chemical substance shall
consider any hazard and exposure information relating to the
chemical substance that is reasonably 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) Postponing a decision.--If the Administrator
determines that additional information is needed to establish
the priority of a chemical substance under this section, the
Administrator may postpone a 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;
``(B) identify the information and analysis on
which the decisions are based; and
``(C) provide 90 days for public comment.
``(8) Revisions of prior designations.--
``(A) In general.--At any time, 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) Post-prioritization notice.--If, after the
date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, a State proposes or
takes an administrative action or enacts a statute to
prohibit or otherwise restrict the manufacturing,
processing, distribution in commerce, or use of a high-
priority substance, after the date on which the
deadline established pursuant to subsection (a) of
section 6 for completion of the safety determination
under that subsection expires but before the date on
which the Administrator publishes the safety
determination under that subsection, the Governor or
State agency with responsibility for implementing the
statute or administrative action shall--
``(i) notify the Administrator; and
``(ii) provide the scientific and legal
basis for the action.
``(E) 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.
``(F) 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 rule promulgated 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)(D);
``(ii) specify the information to be
provided in such requests; and
``(iii) specify the criteria (which may
include criteria identified in subsection
(a)(4)) that 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) the number of substances designated to
undergo safety assessments and safety determinations
under the process and criteria pursuant to paragraph
(1) is 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)
(except that if less than 25 percent are received by
the Administrator, the Administrator shall grant each
request that meets the requirements of 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 currently 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 TSCA 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
notification under this section 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) all known or reasonably ascertainable
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 a 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), then notwithstanding any
remaining portion 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) consider 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 that does
not conform to 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,
with respect to persistence and bioaccumulation, scores
high for 1 and either high or moderate for the other,
pursuant to the TSCA Work Plan Chemicals Methods
Document published by the Administrator in February
2012, 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.--To the extent
practicable, 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 submitted under this section or made by the
Administrator under this section; 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
(h) and (i), 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 and publish 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 any necessary final rule pursuant to
subsection (d) by not later than 2 years after the date on
which the safety determination is completed;
``(6) may extend any deadline under paragraph (4) for not
more than 1 year, if information relating to the high-priority
substance, required to be developed in a rule, order, or
consent agreement under section 4--
``(A) has not yet been submitted to the
Administrator; or
``(B) was submitted to the Administrator--
``(i) within the time specified in the
rule, order, or consent agreement pursuant to
section 4(a)(4)(A)(iv); and
``(ii) on or after the date that is 120
days before the expiration of the deadline
described in paragraph (4); and
``(7) may extend the deadline under paragraph (5) for not
more than 2 years, subject to the condition that the aggregate
length of all extensions of deadlines under this subsection
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, prior to the effective date of
the policies, procedures, and guidance 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 pursuant to section
3A(h)(2)(D), and subject to section 18(g), the Administrator
shall determine--
``(A) by order, that the relevant chemical
substance meets the safety standard;
``(B) that 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 other restrictions
under subsection (d)(3), ban or phase out the
chemical substance, as appropriate; or
``(C) that 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, but not later than 4 years
after the date of promulgation of the
rule, except in the case of a use
exempted under paragraph (5);
``(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;
``(III) as determined by the
Administrator, may vary for different
affected persons; and
``(IV) following a determination by
the Administrator that compliance is
technologically or economically
infeasible within the timeframe
specified in subclause (I), shall
provide up to an additional 18 months
for compliance to be mandatory;
``(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;
``(iv) shall, in selecting among
prohibitions and other restrictions, apply such
prohibitions or other restrictions to an
article or category of articles containing the
chemical substance only to the extent necessary
to address the identified risks from exposure
to the chemical substance from the article or
category of articles, in order to determine
that the chemical substance meets the safety
standard; and
``(v) shall, when the Administrator
determines that the chemical substance does not
meet the safety standard for a potentially
exposed or susceptible population, apply
prohibitions or other restrictions necessary to
ensure that the substance meets the safety
standard for that population.
``(B) Persistent and bioaccumulative substances.--
For a chemical substance the Administrator determines,
with respect to persistence and bioaccumulation, scores
high for 1 and either high or moderate for the other,
pursuant to the TSCA Work Plan Chemicals Methods
Document published by the Administrator in February
2012, 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.--Subject to section 18, a restriction
under paragraph (1) may include, as appropriate--
``(A) 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
otherwise restrict 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, as part
of a rule promulgated under paragraph (1) or in a
separate rule, 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 restriction 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 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 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 included in a proposed or final
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 1 or more
alternatives to the chemical substance the
Administrator determines to be technically and
economically feasible and most likely to be used in
place of the chemical substance under the conditions of
use.
``(E) Conditions.--As part of a rule promulgated
under this paragraph, the Administrator shall include
conditions, 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 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 an 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
under paragraph (1) 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.
``(g) Extension of Deadlines for Certain Chemical Substances.--The
Administrator may not extend any deadline under subsection (a) for a
chemical substance designated as a high priority that is listed in the
2014 update of the TSCA Work Plan without adequate public justification
that demonstrates, following a review of the information reasonably
available to the Administrator, that the Administrator cannot
adequately complete a safety assessment and safety determination, or a
final rule pursuant to subsection (d), without additional information
regarding the chemical substance.''; and
(4) in subsection (h) (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)--
(i) in subparagraph (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
(ii) by adding at the end the following:
``(C) Not later than 180 days after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st Century
Act, and not less frequently than once every 10 years
thereafter, the Administrator, after consultation with the
Administrator of the Small Business Administration, shall--
``(i) review the adequacy of the standards
prescribed according to subparagraph (B);
``(ii) after providing public notice and an
opportunity for comment, make a determination as to
whether revision of the standards is warranted; and
``(iii) revise the standards if the Administrator
so determines.''; 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 additional information known or
reasonably ascertainable by the person making
the report, including rules applicable to
processors so that the Administrator has the
information necessary to carry out this title.
``(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.'';
(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 designate chemical
substances for which notices are received under
clause (i) to be active substances on the list
published under paragraph (1).
``(iii) Inactive substances.--The
Administrator shall designate chemical
substances for which no notices are received
under clause (i) to be inactive substances on
the list published under paragraph (1).
``(B) Confidential chemical substances.--In
promulgating the rule established pursuant to
subparagraph (A), the Administrator shall--
``(i) maintain the list under paragraph
(1), which shall include a confidential portion
and a nonconfidential portion consistent with
this section and section 14;
``(ii) require 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) require 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 asserted pursuant to
subparagraph (B).
``(D) Requirements of review plan.--Under the
review plan under subparagraph (C), the Administrator
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) in accordance with section 14--
``(I) 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
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 claims needing review and the
available resources.
``(II) Annual review goal and
results.--At the beginning of each
year, the Administrator shall publish
an annual goal for reviews and the
number of reviews completed in the
prior year.
``(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) 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 10
years, unless, prior to the expiration
of the period--
``(aa) the person notifies
the Administrator that the
person is withdrawing the
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.
``(C) 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 (as in
effect on the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act), 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 information.--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
``(C) subject to subsections (f) and (g) of section
14, the specific identity of any active substance for
which--
``(i) a claim for protection against
disclosure of the specific identity of the
active chemical substance was not asserted, as
required under this subsection or subsection
(d) or (f) of section 14;
``(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 notice or substantiation
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) Additional information.--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 or will
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)--
(i) in subparagraph (A), by inserting
``within the time period specified by the
Administrator in the report'' after ``issues an
order'';
(ii) in subparagraph (B), by inserting
``responds within the time period specified by
the Administrator in the report and'' before
``initiates, within 90 days''; and
(iii) in the matter following subparagraph
(B), by striking ``section 6 or 7'' and
inserting ``section 6(d) or section 7'';
(C) by redesignating paragraph (3) as paragraph
(6);
(D) in paragraph (6) (as so redesignated), by
striking ``section 6 or 7'' and inserting ``section
6(d) or 7''; and
(E) by inserting after paragraph (2) the following:
``(3) The Administrator shall take the actions described in
paragraph (4) if the Administrator makes a report under
paragraph (1) with respect to a chemical substance or mixture
and the agency to which the report was made does not--
``(A) issue the order described in paragraph (2)(A)
within the time period specified by the Administrator
in the report; or
``(B)(i) respond under paragraph (1) within the
time frame specified by the Administrator in the
report; and
``(ii) initiate action within 90 days of
publication in the Federal Register of the response
described in clause (i).
``(4) If an agency to which a report under paragraph (1)
does not take the actions described in subparagraphs (A) or (B)
of paragraph (3), the Administrator shall--
``(A) if a safety assessment and safety
determination for the substance under section 6 has not
been completed, complete the safety assessment and
safety determination;
``(B) if the Administrator has determined or
determines that the chemical substance does not meet
the safety standard, initiate action under section 6(d)
with respect to the risk; or
``(C) take any action authorized or required under
section 7, as appropriate.
``(5) This subsection shall not relieve the Administrator
of any obligation to complete a safety assessment and safety
determination or take any required action under section 6(d) or
7 to address risks from the manufacture, processing,
distribution in commerce, use, or disposal of a chemical
substance or mixture, or any combination of those activities,
that are not identified in a report issued by the Administrator
under paragraph (1).'';
(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--
``(A) any new chemical substance that the
Administrator determines is likely to present an
unreasonable risk of injury to health within the United
States or to the environment of the United States,
without taking into account cost or other non-risk
factors;
``(B) any chemical substance that the Administrator
determines presents or will present an unreasonable
risk of injury to health within the United States or to
the environment of the United States, without taking
into account cost or other non-risk factors; or
``(C) any chemical substance that--
``(i) the Administrator determines is
likely to present an unreasonable risk of
injury to health within the United States or to
the environment of the United States, without
taking into account cost or other non-risk
factors; and
``(ii) is subject to restriction under
section 5(d)(4).
``(3) Waivers for certain mixtures and articles.--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 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 containing a
chemical substance subject to a proposed or promulgated
significant new use rule, or a prohibition or other
restriction pursuant to a rule, order, or consent
agreement in effect under this Act;
``(E) a chemical substance or mixture for which the
submission of information is required under section 4;
or
``(F) a chemical substance or mixture for which an
action is pending or for which relief has been granted
under section 7.
``(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), (D), or (F) of paragraph (1),
a notice of the determination, rule, order, consent
agreement, action, relief, or requirement;
``(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), by striking paragraph (3).
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.
``(7) Specific aggregated volumes across manufacturers, if
the Administrator determines that disclosure of the specific
aggregated volumes would reveal confidential information.
``(8) 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 the specific
identity was claimed as confidential information at the time it
was submitted in a notice under section 5.
``(c) Information Not Protected From Disclosure.--
``(1) In general.--Notwithstanding subsections (a) and (b),
the following information shall not be protected from
disclosure:
``(A) Information from health and safety studies.--
``(i) In general.--Subject to clause (ii)--
``(I) any health and safety study
that is submitted under this Act with
respect to--
``(aa) any chemical
substance or mixture that, on
the date on which the study is
to be disclosed, has been
offered for commercial
distribution; or
``(bb) 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 item (aa) or
(bb) of subclause (I).
``(ii) Effect of subparagraph.--Nothing in
this subparagraph 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.
``(B) Other information not protected from
disclosure.--
``(i) 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).
``(ii) A safety assessment developed, or a
safety determination made, under section 6.
``(iii) 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.
``(iv) 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.
``(2) Mixed confidential and nonconfidential information.--
Any information that is eligible for protection under this
section and is submitted with 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.
``(3) 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.
``(4) Certain requests.--If a request is made to the
Administrator under section 552(a) of title 5, United States
Code, for information that is subject to disclosure under this
subsection, the Administrator may not deny the request on the
basis of section 552(b)(4) of title 5, United States Code.
``(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) be consistent with guidance issued 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 cause substantial
harm to 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 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 consistent with the 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 statement
required to assert a claim submitted pursuant to paragraph
(1)(B) and any information required to substantiate a claim
submitted pursuant to paragraph (2) are 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 1 or more
applicable agreements with the Administrator that are
consistent 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;
``(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 are consistent 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 not subject to time limit for
protection from disclosure.--Subject to paragraph (2),
the Administrator shall protect from disclosure
information described in subsection (b) that meets the
requirements of subsections (a) and (d), unless--
``(i) the person that asserted the claim
notifies the Administrator that the person is
withdrawing the claim, in which case the
Administrator shall promptly make the
information available to the public; or
``(ii) the Administrator otherwise becomes
aware that the information does not qualify or
no longer qualifies for protection against
disclosure under subsection (a), in which case
the Administrator shall take any actions
required under subsection (g)(2).
``(B) Information subject to time limit for
protection from disclosure.--Subject to paragraph (2),
the Administrator shall protect from disclosure
information, other than information described in
subsection (b), that meets the requirements of
subsections (a) and (d) for a period of 10 years,
unless, prior to the expiration of the period--
``(i) the person that asserted the claim
notifies the Administrator that the person is
withdrawing the claim, in which case the
Administrator shall promptly make the
information available to the public; or
``(ii) the Administrator otherwise becomes
aware that the information does not qualify or
no longer qualifies for protection against
disclosure under subsection (a), in which case
the Administrator shall take any actions
required under subsection (g)(2).
``(C) Extensions.--
``(i) In general.--Not later than the date
that is 60 days before the expiration of the
period described in subparagraph (B), 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 (B), a person reasserting
the relevant claim shall submit to the
Administrator a request for extension
substantiating, in accordance with
subsection (d)(2), the need to extend
the period.
``(II) Action by administrator.--
Not later than the date of expiration
of the period described in subparagraph
(B), the Administrator shall, in
accordance with subsection (g)(1)(C)--
``(aa) review the request
submitted under subclause (I);
``(bb) make a determination
regarding whether the claim for
which the request was submitted
continues to meet the relevant
criteria established under this
section; and
``(cc)(AA) grant an
extension of 10 years; or
``(BB) deny the request.
``(D) No limit on number of extensions.--There
shall be no limit on the number of extensions granted
under subparagraph (C), if the Administrator determines
that the relevant request under subparagraph
(C)(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 of information against disclosure under
subsection (a) 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).
``(B) Review required.--The Administrator shall
review a claim for protection of information against
disclosure under subsection (a) 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 determine whether the
information qualifies for an exemption from
disclosure in connection with a request for
information received by the Administrator under
section 552 of title 5, United States Code;
``(ii) if the Administrator has a
reasonable basis to believe that the
information does not qualify for protection
against disclosure under subsection (a); 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 or 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) Reasons for denial or modification.--If the
Administrator denies or modifies a claim or request
under subparagraph (A), the Administrator shall provide
to the person that submitted the claim or request a
written statement of the reasons for the denial or
modification of the claim or request.
``(C) Subsets.--The Administrator shall--
``(i) except for claims described in
subsection (b)(8), review all claims or
requests 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 or requests for protection against
disclosure.
``(D) Effect of failure to act.--The failure of the
Administrator to make a decision regarding a claim or
request for protection against disclosure or extension
under this section shall not be the basis for denial or
elimination of a claim or request 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 or request
under paragraph (1), intends to release information
pursuant to subsection (e), 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.--Except as provided
in subparagraph (C), 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).
``(C) 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 or request 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) Notification as soon as
practicable.--For information under paragraphs
(4) and (6) of subsection (e), the
Administrator shall notify the person that
submitted the information that the information
has been disclosed as soon as practicable after
disclosure of the information.
``(iii) No notification required.--
Notification shall not be required--
``(I) for the disclosure of
information under paragraph (1), (2),
(7), or (9) of subsection (e); or
``(II) for the disclosure of
information for which--
``(aa) a notice under
subsection (f)(1)(C)(i) was
received; and
``(bb) no request was
received by the Administrator
on or before the date of
expiration of the period for
which protection from
disclosure applies.
``(3) Rebuttable presumption.--
``(A) In general.--With respect to notifications
provided by the Administrator under paragraph (2) with
respect to information pertaining to a chemical
substance subject to a rule as described in subsection
(c)(3), 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 pursuant to
paragraph (2)(B), 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 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 pursuant to paragraph (2)(B), 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 pursuant to paragraph
(2)(B), 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) Request and notification system.--The Administrator,
in consultation with the Director of the Centers for Disease
Control and Prevention, shall develop a request and
notification system that allows for expedient and swift access
to information disclosed pursuant to paragraphs (5) and (6) of
subsection (e) in a format and language that is readily
accessible and understandable.
``(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 reported to or otherwise
obtained by 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) Actions prior to promulgation of rules.--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, 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 ``$25,000'' and inserting
``$50,000''; and
(C) 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 section 15 or 409,
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.
``(C) Incorporation of corresponding provisions.--
Subparagraphs (B) through (F) of section 113(c)(5) of
the Clean Air Act (42 U.S.C. 7413(c)(5)) shall apply to
the prosecution of a violation under this paragraph.''.
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.--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 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), (e), (f), and (g), beginning on the date on which the
Administrator defines and publishes the scope of a safety
assessment and safety determination under section 6(a)(2) and
ending on the date on which the deadline established pursuant
to section 6(a) for completion of the safety determination
expires, or on the date on which the Administrator publishes
the safety determination under section 6(a), whichever is
earlier, 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
statute enacted, or administrative action taken, prior
to the date on which the Administrator defines and
publishes 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 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 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 hazards, exposures, risks, and 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 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 a law of a State or
political subdivision of a State 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--
``(I) a State or political
subdivision of a State may not assess a
penalty for a specific violation for
which the Administrator has assessed an
adequate penalty under section 16; and
``(II) if a State or political
subdivision of a State has assessed a
penalty for a specific violation, the
Administrator may not assess a penalty
for that violation in an amount that
would cause the total of the penalties
assessed for the violation by the State
or political subdivision of a State and
the Administrator combined to exceed
the maximum amount that may be assessed
for that violation by the Administrator
under section 16.
``(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 subsection (b) or (c) of
section 4A or as an additional priority for safety
assessment and safety determination under section
4A(c).
``(e) Preservation of Certain Laws.--
``(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 law of the
State or political subdivision of the State 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 Federal law
and laws of a State or political subdivision of a State
pursuant to any other Federal law.
``(f) 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 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) in the judgment of the Administrator, the
proposed requirement of the State or political
subdivision of the State is designed to address a risk
of a chemical substance, under the conditions of use,
that was identified--
``(i) consistent with the best available
science;
``(ii) using supporting studies conducted
in accordance with sound and objective
scientific practices; and
``(iii) based on the weight of the
scientific evidence.
``(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 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;
``(B) 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
``(C) the State or political subdivision of the
State has a concern about the chemical substance or use
of the chemical substance based in peer-reviewed
science.
``(3) Determination of a 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 110 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
110-day period beginning on the date on which an application
under paragraph (2) is submitted, the statute or administrative
action of the State or political subdivision of the State 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 a 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 a State shall be--
``(A) considered to be a final agency action; and
``(B) subject to judicial review.
``(7) Duration of waivers.--A waiver granted under
paragraph (2) or approved under paragraph (9) shall remain in
effect until such time as the Administrator publishes the
safety determination under section 6(a)(4).
``(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 a
State under paragraph (1) or (2), 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) Automatic approval.--If the Administrator
fails to meet 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, effective on the date that is
10 days after the deadline.
``(B) Requirements.--Notwithstanding paragraph (6),
approval of a waiver application under subparagraph (A)
for failure to meet the deadline under paragraph (3)(B)
shall not be considered final agency action or be
subject to judicial review or public notice and
comment.
``(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)--
(I) in the first sentence--
(aa) by striking ``Not''
and inserting ``Except as
otherwise provided in this
title, not'';
(bb) 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 ``this
title or title II or IV, or an
order under section
6(c)(1)(A)''; and
(cc) by striking ``judicial
review of such rule'' and
inserting ``judicial review of
such rule or order''; and
(II) in the second sentence, by
striking ``such a rule'' and inserting
``such a rule or order''; and
(ii) in subparagraph (B)--
(I) by striking ``Courts'' and
inserting ``Except as otherwise
provided in this title, courts''; and
(II) by striking ``an order issued
under subparagraph (A) or (B) of
section 6(b)(1)'' and inserting ``an
order issued under this title'';
(B) in paragraph (2), in the second sentence, by
striking ``the filing of the rulemaking record of
proceedings on which the Administrator based the rule
being reviewed'' and inserting ``the filing of the
record of proceedings on which the Administrator based
the rule or order being reviewed''; and
(C) by striking paragraph (3) and inserting the
following:
``(3) 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), or
a designation under section 4A(b)(8) of a chemical
substance as a low-priority substance, 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.''; 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),
6(d), or 6(g), or an order under section
6(c)(1)(A)''; 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' CIVIL ACTIONS.
Section 20 of the Toxic Substances Control Act (15 U.S.C. 2619) is
amended--
(1) in subsection (a)(1), by striking ``or order issued
under section 5'' and inserting ``or order issued under section
4 or 5''; and
(2) in subsection (b)--
(A) in paragraph (1)(B), by striking ``or'' at the
end;
(B) in paragraph (2), by striking the period at the
end and inserting ``, except that no prior notification
shall be required in the case of a civil action brought
to compel a decision by the Administrator pursuant to
section 18(f)(3)(B); or''; and
(C) by adding at the end the following:
``(3) in the case of a civil action brought to compel a
decision by the Administrator pursuant to section 18(f)(3)(B),
after the date that is 60 days after the deadline specified in
section 18(f)(3)(B).''.
SEC. 20. CITIZENS' PETITIONS.
Section 21 of the Toxic Substances Control Act (15 U.S.C. 2620) is
amended--
(1) in subsection (a), by striking ``an order under section
5(e) or 6(b)(2)'' and inserting ``an order under section 4 or
5(d)''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``an order under
section 5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting
``an order under section 4 or 5(d)''; and
(B) in paragraph (4), by striking subparagraph (B)
and inserting the following:
``(B) De novo proceeding.--
``(i) In general.--In an action under
subparagraph (A) to initiate a proceeding to
issue 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 is needed
for a purpose identified in
section 4(a);
``(bb) in the case of a
petition to issue an order
under section 5(d), 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), the
chemical substance does 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. 21. EMPLOYMENT EFFECTS.
Section 24(b)(2)(B)(ii) of the Toxic Substances Control Act (15
U.S.C. 2623(b)(2)(B)(ii)) is amended by striking ``section 6(c)(3),''
and inserting ``the applicable requirements of this Act;''.
SEC. 22. STUDIES.
Section 25 of the Toxic Substances Control Act (15 U.S.C. 2624) is
repealed.
SEC. 23. ADMINISTRATION.
Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is
amended--
(1) by striking subsection (b) and inserting the following:
``(b) Fees.--
``(1) In general.--The Administrator shall establish, not
later than 1 year after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, by rule--
``(A) the payment of 1 or more reasonable fees as a
condition of submitting a notice or requesting an
exemption under section 5; and
``(B) the payment of 1 or more reasonable fees by a
manufacturer or processor that--
``(i) is required to submit a notice
pursuant to the rule promulgated under section
8(b)(4)(A)(i) identifying a chemical substance
as active;
``(ii) is required to submit a notice
pursuant to section 8(b)(5)(B)(i) changing the
status of a chemical substance from inactive to
active;
``(iii) is required to report information
pursuant to the rules promulgated under
paragraph (1) or (4) of section 8(a); or
``(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) insofar as possible, 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) prescribe lower fees for small business
concerns, after consultation with the Administrator of
the Small Business Administration;
``(B) set the fees established under paragraph (1)
at levels such that the fees will, in aggregate,
provide a sustainable source of funds to annually
defray--
``(i) the lower of--
``(I) 25 percent of the costs of
conducting the activities identified in
paragraph (2)(A), other than the costs
to conduct and complete safety
assessments and determinations under
section 6 for chemical substances
identified pursuant to section 4A(c);
or
``(II) $25,000,000 (subject to
adjustment pursuant to subparagraph
(F)); and
``(ii) the full costs and the 50-percent
portion of the costs of safety assessments and
safety determinations specified in subparagraph
(D);
``(C) 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;
``(D) notwithstanding subparagraph (B) and
paragraph (4)(D)--
``(i) for substances designated pursuant to
section 4A(c)(1), establish the fee at a level
sufficient to defray the full annual costs to
the Administrator of conducting the safety
assessment and safety determination under
section 6; and
``(ii) for substances designated pursuant
to section 4A(c)(3), establish the fee at a
level sufficient to defray 50 percent of the
annual costs to the Administrator of conducting
the safety assessment and safety determination
under section 6;
``(E) 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;
``(F) 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 pursuant to subparagraph (E), increase
or decrease the fees established under paragraph (1) as
necessary to adjust for inflation and to ensure, based
on the audit analysis required under paragraph (5)(B),
that funds deposited in the Fund are sufficient to
defray--
``(i) approximately but not more than 25
percent of the annual costs to conduct the
activities identified in paragraph (2)(A),
other than the costs to conduct and complete
safety assessments and determinations under
section 6 for chemical substances identified
pursuant to section 4A(c); and
``(ii) the full annual costs and the 50-
percent portion of the annual costs of safety
assessments and safety determinations specified
in subparagraph (D);
``(G) 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
``(H) 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 the Chemical
Risk Review and Reduction program project 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 that program project for fiscal year
2014.
``(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. 24. DEVELOPMENT AND EVALUATION OF TEST METHODS AND SUSTAINABLE
CHEMISTRY.
(a) In General.--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) National Coordinating Entity for Sustainable Chemistry.--
``(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 Director of the Office of Science
and Technology Policy shall convene an entity under the
National Science and Technology Council with the responsibility
to coordinate Federal programs and activities in support of
sustainable chemistry, including, as appropriate, at the
National Science Foundation, the Department of Energy, the
Department of Agriculture, the Environmental Protection Agency,
the National Institute of Standards and Technology, the
Department of Defense, the National Institutes of Health, and
other related Federal agencies.
``(2) Chairman.--The entity described in paragraph (1)
shall be chaired by the Director of the National Science
Foundation and the Assistant Administrator for the Office of
Research and Development of the Environmental Protection
Agency, or their designees.
``(3) Duties.--
``(A) In general.--The entity described in
paragraph (1) shall--
``(i) develop a working definition of
sustainable chemistry, after seeking advice and
input from stakeholders as described in clause
(v);
``(ii) oversee the planning, management,
and coordination of the Sustainable Chemistry
Initiative described in subsection (d);
``(iii) develop a national strategy for
sustainable chemistry as described in
subsection (f);
``(iv) develop an implementation plan for
sustainable chemistry as described in
subsection (g); and
``(v) consult and coordinate with
stakeholders qualified to provide advice and
information on the development of the
initiative, national strategy, and
implementation plan for sustainable chemistry,
at least once per year, to carry out activities
that may include workshops, requests for
information, and other efforts as necessary.
``(B) Stakeholders.--The stakeholders described in
subparagraph (A)(v) shall include representatives
from--
``(i) industry (including small- and
medium-sized enterprises from across the value
chain);
``(ii) the scientific community (including
the National Academy of Sciences, scientific
professional societies, and academia);
``(iii) the defense community;
``(iv) State, tribal, and local
governments;
``(v) State or regional sustainable
chemistry programs;
``(vi) nongovernmental organizations; and
``(vii) other appropriate organizations.
``(4) Sunset.--
``(A) In general.--On completion of the national
strategy and accompanying implementation plan for
sustainable chemistry as described in paragraph (3),
the Director of the Office of Science and Technology
Policy--
``(i) shall review the need for further
work; and
``(ii) may disband the entity described in
paragraph (1) if no further efforts are
determined to be necessary.
``(B) Notice and justification.--The Director of
the Office of Science and Technology Policy shall
provide notice and justification, including an analysis
of options to establish the Sustainable Chemistry
Initiative described in subsection (d) and the
partnerships described in subsection (e) within 1 or
more appropriate Federal agencies, regarding a decision
to disband the entity not less than 90 days prior to
the termination date to the Committee on Science,
Space, and Technology and the 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.
``(d) Sustainable Chemistry Initiative.--The entity described in
subsection (c)(1) shall oversee the establishment of an interagency
Sustainable Chemistry Initiative to promote and coordinate activities
designed--
``(1) to provide sustained support for sustainable
chemistry research, development, demonstration, technology
transfer, commercialization, education, and training through--
``(A) coordination and promotion of sustainable
chemistry research, development, demonstration, and
technology transfer conducted at Federal and national
laboratories and Federal agencies and at public and
private institutions of higher education; and
``(B) to the extent practicable, encouragement of
consideration of sustainable chemistry in, as
appropriate--
``(i) the conduct of Federal, State, and
private science and engineering research and
development; and
``(ii) the solicitation and evaluation of
applicable proposals for science and
engineering research and development;
``(2) to examine methods by which the Federal Government
can offer incentives for consideration and use of sustainable
chemistry processes and products that encourage competition and
overcoming market barriers, including grants, loans, loan
guarantees, and innovative financing mechanisms;
``(3) to expand the education and training of undergraduate
and graduate students and professional scientists and
engineers, including through partnerships with industry as
described in subsection (e), in sustainable chemistry science
and engineering;
``(4) to collect and disseminate information on sustainable
chemistry research, development, and technology transfer,
including information on--
``(A) incentives and impediments to development,
manufacturing, and commercialization;
``(B) accomplishments;
``(C) best practices; and
``(D) costs and benefits; and
``(5) to 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) Partnerships in Sustainable Chemistry.--
``(1) In general.--The entity described in subsection
(c)(1), itself or through an appropriate subgroup designated or
established by the entity, shall work through the agencies
described in subsection (c)(1) to support, through financial,
technical, or other assistance, the establishment of
partnerships between institutions of higher education,
nongovernmental organizations, consortia, and companies across
the value chain in the chemical industry, including small- and
medium-sized enterprises--
``(A) to establish collaborative research,
development, demonstration, technology transfer, and
commercialization programs; and
``(B) to train students and retrain professional
scientists and engineers in the use of sustainable
chemistry concepts and strategies by methods
including--
``(i) developing curricular materials and
courses for undergraduate and graduate levels
and for the professional development of
scientists and engineers; and
``(ii) publicizing the availability of
professional development courses in sustainable
chemistry and recruiting scientists and
engineers to pursue those courses.
``(2) Private sector entities.--To be eligible for support
under this section, a partnership in sustainable chemistry
shall include at least 1 private sector entity.
``(3) Selection of partnerships.--In selecting partnerships
for support under this section, the entity and the agencies
described in subsection (c)(1) shall also consider the extent
to which the applicants are willing and able to demonstrate
evidence of support for, and commitment--
``(A) to achieving the goals of the Sustainable
Chemistry Initiative described in subsection (d); and
``(B) to sustaining any new innovations, tools, and
resources generated from funding under the program.
``(4) Prohibited use of funds.--Financial support provided
under this section may not be used--
``(A) to support or expand a regulatory chemical
management program at an implementing agency under a
State law; or
``(B) to construct or renovate a building or
structure.
``(f) National Strategy 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 entity described in subsection (c)(1)
shall submit to the Committee on Science, Space, and Technology
and the 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, a national strategy 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 Sustainable
Chemistry Initiative described in subsection (d), and
recommendations for future initiative activities,
including consideration of options to establish the
Sustainable Chemistry Initiative and the partnerships
described in subsection (e) within 1 or more
appropriate Federal agencies;
``(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 establishment of 1 or more
dedicated sustainable chemistry centers of excellence
or hubs;
``(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 Sustainable Chemistry
Initiative; and
``(F) a framework for advancing sustainable
chemistry research, development, technology transfer,
commercialization, and education and training.
``(2) Submission to gao.--The entity described in
subsection (c)(1) shall submit the national strategy described
in paragraph (1) to the Government Accountability Office for
consideration in future Congressional inquiries.
``(g) Implementation Plan.--Not later than 3 years after the date
of enactment of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, the entity described in subsection (c)(1) shall submit to
the Committee on Science, Space, and Technology and the 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, an implementation plan, based on the
findings of the national strategy and other assessments, as
appropriate, for sustainable chemistry.''.
(b) Sustainable Chemistry Basic Research.--Subject to the
availability of appropriated funds, the Director of the National
Science Foundation shall continue to carry out the Green Chemistry
Basic Research program authorized under section 509 of the National
Science Foundation Authorization Act of 2010 (42 U.S.C. 1862p-3).
SEC. 25. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is
amended--
(1) in subsection (b)(1)--
(A) in subparagraphs (A) through (D), by striking
the comma at the end of each subparagraph and inserting
a semicolon; and
(B) in subparagraph (E), by striking ``, and'' and
inserting ``; and''; and
(2) by striking subsections (c) and (d).
SEC. 26. AUTHORIZATION OF APPROPRIATIONS.
Section 29 of the Toxic Substances Control Act (15 U.S.C. 2628) is
repealed.
SEC. 27. ANNUAL REPORT.
Section 30 of the Toxic Substances Control Act (15 U.S.C. 2629) is
amended by striking paragraph (2) and inserting the following:
``(2)(A) the number of notices received during each year
under section 5; and
``(B) the number of the notices described in subparagraph
(A) for chemical substances subject to a rule, testing consent
agreement, or order under section 4;''.
SEC. 28. EFFECTIVE DATE.
Section 31 of the Toxic Substances Control Act (15 U.S.C. 2601
note; Public Law 94-469) is amended--
(1) by striking ``Except as provided in section 4(f),
this'' and inserting the following:
``(a) In General.--This''; and
(2) by adding at the end the following:
``(b) Retroactive Applicability.--Nothing in this Act shall be
interpreted to apply retroactively to any State, Federal, or maritime
legal action commenced prior to the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.''.
SEC. 29. ELEMENTAL MERCURY.
(a) Temporary Generator Accumulation.--Section 5 of the Mercury
Export Ban Act of 2008 (42 U.S.C. 6939f) is amended--
(1) in subsection (a)(2), by striking ``2013'' and
inserting ``2019'';
(2) in subsection (b)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A),
(B), and (C), as clauses (i), (ii), and (iii),
respectively and indenting appropriately;
(ii) in the first sentence, by striking
``After consultation'' and inserting the
following:
``(A) Assessment and collection.--After
consultation'';
(iii) in the second sentence, by striking
``The amount of such fees'' and inserting the
following:
``(B) Amount.--The amount of the fees described in
subparagraph (A)'';
(iv) in subparagraph (B) (as so
designated)--
(I) in clause (i) (as so
redesignated), by striking ``publically
available not later than October 1,
2012'' and inserting ``publicly
available not later than October 1,
2018'';
(II) in clause (ii) (as so
redesignated), by striking ``and'';
(III) in clause (iii) (as so
redesignated), by striking the period
at the end and inserting ``, subject to
clause (iv); and''; and
(IV) by adding at the end the
following:
``(iv) for generators temporarily
accumulating elemental mercury in a facility
subject to subparagraphs (B) and (D)(iv) of
subsection (g)(2) if the facility designated in
subsection (a) is not operational by January 1,
2019, shall be adjusted to subtract the cost of
the temporary accumulation during the period in
which the facility designated under subsection
(a) is not operational.''; and
(v) by adding at the end the following:
``(C) Conveyance of title and permitting.--If the
facility designated in subsection (a) is not
operational by January 1, 2020, the Secretary--
``(i) shall immediately accept the
conveyance of title to all elemental mercury
that has accumulated in facilities in
accordance with subsection (g)(2)(D), before
January 1, 2020, and deliver the accumulated
mercury to the facility designated under
subsection (a) on the date on which the
facility becomes operational;
``(ii) shall pay any applicable Federal
permitting costs, including the costs for
permits issued under section 3005(c) of the
Solid Waste Disposal Act (42 U.S.C. 6925(c));
and
``(iii) shall store, or pay the cost of
storage of, until the time at which a facility
designated in subsection (a) is operational,
accumulated mercury to which the Secretary has
title under this subparagraph in a facility
that has been issued a permit under section
3005(c) of the Solid Waste Disposal Act (42
U.S.C. 6925(c)).''; and
(B) in paragraph (2), in the first sentence, by
striking ``paragraph (1)(C)'' and inserting ``paragraph
(1)(B)(iii)''; and
(3) in subsection (g)(2)--
(A) in the undesignated material at the end, by
striking ``This subparagraph'' and inserting the
following:
``(C) Subparagraph (B)'';
(B) in subparagraph (C) (as added by paragraph
(1)), by inserting ``of that subparagraph'' before the
period at the end; and
(C) by adding at the end the following:
``(D) A generator producing elemental mercury
incidentally from the beneficiation or processing of
ore or related pollution control activities, may
accumulate the mercury produced onsite that is destined
for a facility designated by the Secretary under
subsection (a), for more than 90 days without a permit
issued under section 3005(c) of the Solid Waste
Disposal Act (42 U.S.C. 6925(c)), and shall not be
subject to the storage prohibition of section 3004(j)
of that Act (42 U.S.C. 6924(j)), if--
``(i) the Secretary is unable to accept the
mercury at a facility designated by the
Secretary under subsection (a) for reasons
beyond the control of the generator;
``(ii) the generator certifies in writing
to the Secretary that the generator will ship
the mercury to a designated facility when the
Secretary is able to accept the mercury;
``(iii) the generator certifies in writing
to the Secretary that the generator is storing
only mercury the generator has produced or
recovered onsite and will not sell, or
otherwise place into commerce, the mercury; and
``(iv) the generator has obtained an
identification number under section 262.12 of
title 40, Code of Federal Regulations, and
complies with the requirements described in
paragraphs (1) through (4) of section 262.34(a)
of title 40, Code of Federal Regulations (as in
effect on the date of enactment of this
subparagraph).
``(E) Management standards for temporary storage.--
Not later than January 1, 2017, the Secretary, after
consultation with the Administrator of the
Environmental Protection Agency and State agencies in
affected States, shall develop and make available
guidance that establishes procedures and standards for
the management and short-term storage of elemental
mercury at a generator covered under subparagraph (D),
including requirements to ensure appropriate use of
flasks or other suitable containers. Such procedures
and standards shall be protective of human health and
the environment and shall ensure that the elemental
mercury is stored in a safe, secure, and effective
manner. A generator may accumulate mercury in
accordance with subparagraph (D) immediately upon
enactment of this Act, and notwithstanding that
guidance called for by this paragraph (E) has not been
developed or made available.''.
(b) Interim Status.--Section 5(d)(1) of the Mercury Export Ban Act
of 2008 (42 U.S.C. 6939f(d)(1)) is amended--
(1) in the fourth sentence, by striking ``in existence on
or before January 1, 2013,''; and
(2) in the last sentence, by striking ``January 1, 2015''
and inserting ``January 1, 2020''.
(c) Mercury Inventory.--Section 8(b) of the Toxic Substances
Control Act (15 U.S.C. 2607(b)) (as amended by section 10(2)) is
amended by adding at the end the following:
``(10) Mercury.--
``(A) Definition of mercury.--In this paragraph,
notwithstanding section 3(2)(B), the term `mercury'
means--
``(i) elemental mercury; and
``(ii) a mercury compound.
``(B) Publication.--Not later than April 1, 2017,
and every 3 years thereafter, the Administrator shall
publish in the Federal Register an inventory of mercury
supply, use, and trade in the United States.
``(C) Process.--In carrying out the inventory under
subparagraph (B), the Administrator shall--
``(i) identify any remaining manufacturing
processes or products that intentionally add
mercury; and
``(ii) recommend actions, including
proposed revisions of Federal law (including
regulations), to achieve further reductions in
mercury use.
``(D) Reporting.--
``(i) In general.--To assist in the
preparation of the inventory under subparagraph
(B), any person who manufactures mercury or
mercury-added products or otherwise
intentionally uses mercury in a manufacturing
process shall make periodic reports to the
Administrator, at such time and including such
information as the Administrator shall
determine by rule promulgated not later than 2
years after the date of enactment of this
paragraph.
``(ii) Coordination.--To avoid duplication,
the Administrator shall coordinate the
reporting under this subparagraph with the
Interstate Mercury Education and Reduction
Clearinghouse.
``(iii) Exemption.--This subparagraph shall
not apply to a person engaged in the
generation, handling, or management of mercury-
containing waste, unless that person
manufactures or recovers mercury in the
management of that waste.''.
(d) Prohibition on Export of Certain Mercury Compounds.--Section
12(c) of the Toxic Substances Control Act (15 U.S.C. 2611(c)) (as
amended by section 13(3)) is amended--
(1) in the subsection heading, by inserting ``and Mercury
Compounds'' after ``Mercury''; and
(2) by inserting after paragraph (2) the following:
``(3) Prohibition on export of certain mercury compounds.--
``(A) In general.--Effective January 1, 2020, the
export of the following mercury compounds is
prohibited:
``(i) Mercury (I) chloride or calomel.
``(ii) Mercury (II) oxide.
``(iii) Mercury (II) sulfate.
``(iv) Mercury (II) nitrate.
``(v) Cinnabar or mercury sulphide.
``(vi) Any mercury compound that the
Administrator, at the discretion of the
Administrator, adds to the list by rule, on
determining that exporting that mercury
compound for the purpose of regenerating
elemental mercury is technically feasible.
``(B) Publication.--Not later than 90 days after
the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, and as
appropriate thereafter, the Administrator shall publish
in the Federal Register a list of the mercury compounds
that are prohibited from export under this paragraph.
``(C) Petition.--Any person may petition the
Administrator to add to the list of mercury compounds
prohibited from export.
``(D) Environmentally sound disposal.--This
paragraph does not prohibit the export of mercury (I)
chloride or calomel for environmentally sound disposal
to member countries of the Organization for Economic
Cooperation and Development, on the condition that no
mercury or mercury compounds are to be recovered,
recycled, or reclaimed for use, or directly reused.
``(E) Report.--Not later than 5 years after the
date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the Administrator
shall evaluate any exports of calomel for disposal that
occurred since that date of enactment and shall submit
to Congress a report that contains the following:
``(i) volumes and sources of calomel
exported for disposal;
``(ii) receiving countries of such exports;
``(iii) methods of disposal used;
``(iv) issues, if any, presented by the
export of calomel;
``(v) evaluation of calomel management
options in the United States, if any, that are
commercially available and comparable in cost
and efficacy to methods being utilized in the
receiving countries; and
``(vi) a recommendation regarding whether
Congress should further limit or prohibit the
export of calomel for disposal.
``(F) Effect on other law.--Nothing in this
paragraph shall be construed to affect the authority of
the Administrator under Solid Waste Disposal Act (42
U.S.C. 6901 et seq.).''.
SEC. 30. TREVOR'S LAW.
(a) Purposes.--The purposes of this section are--
(1) to provide the appropriate Federal agencies with the
authority to help conduct investigations into potential cancer
clusters;
(2) to ensure that Federal agencies have the authority to
undertake actions to help address cancer clusters and factors
that may contribute to the creation of potential cancer
clusters; and
(3) to enable Federal agencies to coordinate with other
Federal, State, and local agencies, institutes of higher
education, and the public in investigating and addressing
cancer clusters.
(b) Designation and Investigation of Potential Cancer Clusters.--
Part P of title III of the Public Health Service Act (42 U.S.C. 280g et
seq.) is amended by adding at the end the following:
``SEC. 399V-6. DESIGNATION AND INVESTIGATION OF POTENTIAL CANCER
CLUSTERS.
``(a) Definitions.--In this section:
``(1) Cancer cluster.--The term `cancer cluster' means the
incidence of a particular cancer within a population group, a
geographical area, or a period of time that is greater than
expected for such group, area, or period.
``(2) Particular cancer.--The term `particular cancer'
means one specific type of cancer or a type of cancers
scientifically proven to have the same cause.
``(3) Population group.--The term `population group' means
a group, for purposes of calculating cancer rates, defined by
factors such as race, ethnicity, age, or gender.
``(b) Criteria for Designation of Potential Cancer Clusters.--
``(1) Development of criteria.--The Secretary shall develop
criteria for the designation of potential cancer clusters.
``(2) Requirements.--The criteria developed under paragraph
(1) shall consider, as appropriate--
``(A) a standard for cancer cluster identification
and reporting protocols used to determine when cancer
incidence is greater than would be typically observed;
``(B) scientific screening standards that ensure
that a cluster of a particular cancer involves the same
type of cancer, or types of cancers;
``(C) the population in which the cluster of a
particular cancer occurs by factors such as race,
ethnicity, age, and gender, for purposes of calculating
cancer rates;
``(D) the boundaries of a geographic area in which
a cluster of a particular cancer occurs so as not to
create or obscure a potential cluster by selection of a
specific area; and
``(E) the time period over which the number of
cases of a particular cancer, or the calculation of an
expected number of cases, occurs.
``(c) Guidelines for Investigation of Potential Cancer Clusters.--
The Secretary, in consultation with the Council of State and
Territorial Epidemiologists and representatives of State and local
health departments, shall develop, publish, and periodically update
guidelines for investigating potential cancer clusters. The guidelines
shall--
``(1) require that investigations of cancer clusters--
``(A) use the criteria developed under subsection
(b);
``(B) use the best available science; and
``(C) rely on a weight of the scientific evidence;
``(2) provide standardized methods of reviewing and
categorizing data, including from health surveillance systems
and reports of potential cancer clusters; and
``(3) provide guidance for using appropriate
epidemiological and other approaches for investigations.
``(d) Investigation of Cancer Clusters.--
``(1) Secretary discretion.--The Secretary--
``(A) in consultation with representatives of the
relevant State and local health departments, shall
consider whether it is appropriate to conduct an
investigation of a potential cancer cluster; and
``(B) in conducting investigations shall have the
discretion to prioritize certain potential cancer
clusters, based on the availability of resources.
``(2) Coordination.--In investigating potential cancer
clusters, the Secretary shall coordinate with agencies within
the Department of Health and Human Services and other Federal
agencies, such as the Environmental Protection Agency.
``(3) Biomonitoring.--In investigating potential cancer
clusters, the Secretary shall rely on all appropriate
biomonitoring information collected under other Federal
programs, such as the National Health and Nutrition Examination
Survey. The Secretary may provide technical assistance for
relevant biomonitoring studies of other Federal agencies.
``(e) Duties.--The Secretary shall--
``(1) ensure that appropriate staff of agencies within the
Department of Health and Human Services are prepared to provide
timely assistance, to the extent practicable, upon receiving a
request to investigate a potential cancer cluster from a State
or local health authority;
``(2) maintain staff expertise in epidemiology, toxicology,
data analysis, environmental health and cancer surveillance,
exposure assessment, pediatric health, pollution control,
community outreach, health education, laboratory sampling and
analysis, spatial mapping, and informatics;
``(3) consult with community members as investigations into
potential cancer clusters are conducted, as the Secretary
determines appropriate;
``(4) collect, store, and disseminate reports on
investigations of potential cancer clusters, the possible
causes of such clusters, and the actions taken to address such
clusters; and
``(5) provide technical assistance for investigating cancer
clusters to State and local health departments through existing
programs, such as the Epi-Aids program of the Centers for
Disease Control and Prevention and the Assessments of Chemical
Exposures program of the Agency for Toxic Substances and
Disease Registry.''.
Attest:
Secretary.
114th CONGRESS
1st Session
H.R. 2576
_______________________________________________________________________
AMENDMENT