[Congressional Record Volume 161, Number 184 (Thursday, December 17, 2015)]
[Senate]
[Pages S8796-S8816]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2932. Mr. INHOFE (for himself, Mr. Udall, and Mr. Vitter) proposed
an amendment to the bill H.R. 2576, to modernize the Toxic Substances
Control Act, and for other purposes; as follows:
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
[[Page S8797]]
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
[[Page S8798]]
``(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
[[Page S8799]]
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,
[[Page S8800]]
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
[[Page S8801]]
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
[[Page S8802]]
(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
[[Page S8803]]
``(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
[[Page S8804]]
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
[[Page S8805]]
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
[[Page S8806]]
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
[[Page S8807]]
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.
[[Page S8808]]
``(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
[[Page S8809]]
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.
[[Page S8810]]
``(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
[[Page S8811]]
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
[[Page S8812]]
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
[[Page S8813]]
``(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.
[[Page S8814]]
``(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)'';
[[Page S8815]]
(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:
[[Page S8816]]
``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.''.
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