[Congressional Record Volume 162, Number 82 (Tuesday, May 24, 2016)]
[House]
[Pages H2989-H3031]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
TSCA MODERNIZATION ACT OF 2015
Mr. SHIMKUS. Mr. Speaker, pursuant to House Resolution 742, I call up
the bill (H.R. 2576) to modernize the Toxic Substances Control Act, and
for other purposes, with the Senate amendment thereto, and ask for its
immediate consideration.
The Clerk read the title of the bill.
The SPEAKER pro tempore. The Clerk will designate the Senate
amendment.
Senate amendment:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Frank R. Lautenberg Chemical
Safety for the 21st Century Act''.
SEC. 2. FINDINGS, POLICY, AND INTENT.
Section 2(c) of the Toxic Substances Control Act (15 U.S.C.
2601(c)) is amended--
(1) by striking ``It is the intent'' and inserting the
following:
``(1) Administration.--It is the intent'';
(2) in paragraph (1) (as so redesignated), by inserting ``,
as provided under this Act'' before the period at the end;
and
(3) by adding at the end the following:
``(2) Reform.--This Act, including reforms in accordance
with the amendments made by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act--
``(A) shall be administered in a manner that--
``(i) protects the health of children, pregnant women, the
elderly, workers, consumers, the general public, and the
environment from the risks of harmful exposures to chemical
substances and mixtures; and
``(ii) ensures that appropriate information on chemical
substances and mixtures is available to public health
officials and first responders in the event of an emergency;
and
``(B) shall not displace or supplant common law rights of
action or remedies for civil relief.''.
SEC. 3. DEFINITIONS.
Section 3 of the Toxic Substances Control Act (15 U.S.C.
2602) is amended--
(1) by redesignating paragraphs (4), (5), (6), (7), (8),
(9), (10), (11), (12), (13), and (14) as paragraphs (5), (6),
(7), (8), (9), (10), (12), (13), (17), (18), and (19),
respectively;
(2) by inserting after paragraph (3) the following:
``(4) Conditions of use.--The term `conditions of use'
means the intended, known, or reasonably foreseeable
circumstances the Administrator determines a chemical
substance is manufactured, processed, distributed in
commerce, used, or disposed of.'';
(3) by inserting after paragraph (10) (as so redesignated)
the following:
``(11) Potentially exposed or susceptible population.--The
term `potentially exposed or susceptible population' means 1
or more groups--
``(A) of individuals within the general population who may
be--
``(i) differentially exposed to chemical substances under
the conditions of use; or
``(ii) susceptible to greater adverse health consequences
from chemical exposures than the general population; and
``(B) that when identified by the Administrator may include
such groups as infants, children, pregnant women, workers,
and the elderly.''; and
(4) by inserting after paragraph (13) (as so redesignated)
the following:
``(14) Safety assessment.--The term `safety assessment'
means an assessment of the risk posed by a chemical substance
under the conditions of use, integrating hazard, use, and
exposure information regarding the chemical substance.
``(15) Safety determination.--The term `safety
determination' means a determination by the Administrator as
to whether a chemical substance meets the safety standard
under the conditions of use.
``(16) Safety standard.--The term `safety standard' means a
standard that ensures, without taking into consideration cost
or other nonrisk factors, that no unreasonable risk of injury
to health or the environment will result from exposure to a
chemical substance under the conditions of use, including no
unreasonable risk of injury to--
``(A) the general population; or
``(B) any potentially exposed or susceptible population
that the Administrator has identified as relevant to the
safety assessment and safety determination for a chemical
substance.''.
SEC. 4. POLICIES, PROCEDURES, AND GUIDANCE.
The Toxic Substances Control Act is amended by inserting
after section 3 (15 U.S.C. 2602) the following:
``SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE.
``(a) Definition of Guidance.--In this section, the term
`guidance' includes any significant written guidance of
general applicability prepared by the Administrator.
``(b) Deadline.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall develop, after
providing public notice and an opportunity for comment, any
policies, procedures, and guidance the Administrator
determines to be necessary to carry out sections 4, 4A, 5,
and 6, including the policies, procedures, and guidance
required by this section.
``(c) Use of Science.--
``(1) In general.--The Administrator shall establish
policies, procedures, and guidance on the use of science in
making decisions under sections 4, 4A, 5, and 6.
``(2) Goal.--A goal of the policies, procedures, and
guidance described in paragraph (1) shall be to make the
basis of decisions clear to the public.
``(3) Requirements.--The policies, procedures, and guidance
issued under this section shall ensure that--
``(A) decisions made by the Administrator--
``(i) are based on information, procedures, measures,
methods, and models employed in a manner consistent with the
best available science;
``(ii) take into account the extent to which--
``(I) assumptions and methods are clearly and completely
described and documented;
``(II) variability and uncertainty are evaluated and
characterized; and
``(III) the information has been subject to independent
verification and peer review; and
``(iii) are based on the weight of the scientific evidence,
by which the Administrator considers all information in a
systematic and integrative framework to consider the
relevance of different information;
``(B) to the extent practicable and if appropriate, the use
of peer review, standardized test design and methods,
consistent data evaluation procedures, and good laboratory
practices will be encouraged;
``(C) a clear description of each individual and entity
that funded the generation or assessment of information, and
the degree of control those individuals and entities had over
the generation, assessment, and dissemination of information
(including control over the design of the work and the
publication of information) is made available; and
``(D) if appropriate, the recommendations in reports of the
National Academy of Sciences that provide advice regarding
assessing the hazards, exposures, and risks of chemical
substances are considered.
``(d) Existing EPA Policies, Procedures, and Guidance.--The
policies, procedures, and guidance described in subsection
(b) shall incorporate existing relevant policies, procedures,
and guidance, as appropriate and consistent with this Act.
``(e) Review.--Not later than 5 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, and not less frequently than once every 5
years thereafter, the Administrator shall--
``(1) review the adequacy of any policies, procedures, and
guidance developed under this section, including animal,
nonanimal, and epidemiological test methods and procedures
for assessing and determining risk under this Act; and
``(2) after providing public notice and an opportunity for
comment, revise the policies, procedures, and guidance if
necessary to reflect new scientific developments or
understandings.
``(f) Sources of Information.--In carrying out sections 4,
4A, 5, and 6, the Administrator shall take into consideration
information relating to a chemical substance, including
hazard and exposure information, under the conditions of use
that is reasonably available to the Administrator, including
information that is--
``(1) submitted to the Administrator pursuant to any rule,
consent agreement, order, or other
[[Page H2990]]
requirement of this Act, or on a voluntary basis, including
pursuant to any request made under this Act, by--
``(A) manufacturers or processors of a substance;
``(B) the public;
``(C) other Federal departments or agencies; or
``(D) the Governor of a State or a State agency with
responsibility for protecting health or the environment;
``(2) submitted to a governmental entity in any
jurisdiction pursuant to a governmental requirement relating
to the protection of health or the environment; or
``(3) identified through an active search by the
Administrator of information sources that are publicly
available or otherwise accessible by the Administrator.
``(g) Testing of Chemical Substances and Mixtures.--
``(1) In general.--The Administrator shall establish
policies, procedures, and guidance for the testing of
chemical substances or mixtures under section 4.
``(2) Goal.--A goal of the policies, procedures, and
guidance established under paragraph (1) shall be to make the
basis of decisions clear to the public.
``(3) Contents.--The policies, procedures, and guidance
established under paragraph (1) shall--
``(A) address how and when the exposure level or exposure
potential of a chemical substance would factor into decisions
to require new testing, subject to the condition that the
Administrator shall not interpret the lack of exposure
information as a lack of exposure or exposure potential; and
``(B) describe the manner in which the Administrator will
determine that additional information is necessary to carry
out this Act, including information relating to potentially
exposed or susceptible populations.
``(4) Epidemiological studies.--Before prescribing
epidemiological studies of employees, the Administrator shall
consult with the Director of the National Institute for
Occupational Safety and Health.
``(h) Safety Assessments and Safety Determinations.--
``(1) Schedule.--
``(A) In general.--The Administrator shall inform the
public regarding the schedule and the resources necessary for
the completion of each safety assessment and safety
determination as soon as practicable after designation as a
high-priority substance pursuant to section 4A.
``(B) Differing times.--The Administrator may allot
different times for different chemical substances in the
schedules under this paragraph, subject to the condition that
all schedules shall comply with the deadlines established
under section 6.
``(C) Annual plan.--
``(i) In general.--At the beginning of each calendar year,
the Administrator shall publish an annual plan.
``(ii) Inclusions.--The annual plan shall--
``(I) identify the substances subject to safety assessments
and safety determinations to be completed that year;
``(II) describe the status of each safety assessment and
safety determination that has been initiated but not yet
completed, including milestones achieved since the previous
annual report; and
``(III) if the schedule for completion of a safety
assessment and safety determination prepared pursuant to
subparagraph (A) has changed, include an updated schedule for
that safety assessment and safety determination.
``(2) Policies and procedures for safety assessments and
safety determinations.--
``(A) In general.--The Administrator shall establish, by
rule, policies and procedures regarding the manner in which
the Administrator shall carry out section 6.
``(B) Goal.--A goal of the policies and procedures under
this paragraph shall be to make the basis of decisions of the
Administrator clear to the public.
``(C) Minimum requirements.--The policies and procedures
under this paragraph shall, at a minimum--
``(i) describe--
``(I) the manner in which the Administrator will identify
informational needs and seek that information from the
public;
``(II) the information (including draft safety assessments)
that may be submitted by interested individuals or entities,
including States; and
``(III) the criteria by which information submitted by
interested individuals or entities will be evaluated;
``(ii) require that each draft and final safety assessment
and safety determination of the Administrator include a
description of--
``(I)(aa) the scope of the safety assessment and safety
determination to be conducted under section 6, including the
hazards, exposures, and conditions of use of the chemical
substance, and potentially exposed and susceptible
populations that the Administrator has identified as
relevant; and
``(bb) the basis for the scope of the safety assessment and
safety determination;
``(II) the manner in which aggregate exposures, or
significant subsets of exposures, to a chemical substance
under the conditions of use were considered, and the basis
for that consideration;
``(III) the weight of the scientific evidence of risk; and
``(IV) the information regarding the impact on health and
the environment of the chemical substance that was used to
make the assessment or determination, including, as
available, mechanistic, animal toxicity, and epidemiology
studies;
``(iii) establish a timely and transparent process for
evaluating whether new information submitted or obtained
after the date of a final safety assessment or safety
determination warrants reconsideration of the safety
assessment or safety determination; and
``(iv) when relevant information is provided or otherwise
made available to the Administrator, require the
Administrator to consider the extent of Federal regulation
under other Federal laws.
``(D) Guidance.--
``(i) In general.--Not later than 1 year after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall develop guidance to
assist interested persons in developing their own draft
safety assessments and other information for submission to
the Administrator, which may be considered by the
Administrator.
``(ii) Requirement.--The guidance shall, at a minimum,
address the quality of the information submitted and the
process to be followed in developing a draft safety
assessment for consideration by the Administrator.
``(i) Publicly Available Information.--Subject to section
14, the Administrator shall--
``(1) make publicly available a nontechnical summary, and
the final version, of each safety assessment and safety
determination;
``(2) provide public notice and an opportunity for comment
on each proposed safety assessment and safety determination;
and
``(3) make public in a final safety assessment and safety
determination--
``(A) the list of studies considered by the Administrator
in carrying out the safety assessment or safety
determination; and
``(B) the list of policies, procedures, and guidance that
were followed in carrying out the safety assessment or safety
determination.
``(j) Consultation With Science Advisory Committee on
Chemicals.--
``(1) Establishment.--Not later than 1 year after the date
of enactment of this section, the Administrator shall
establish an advisory committee, to be known as the `Science
Advisory Committee on Chemicals' (referred to in this
subsection as the `Committee').
``(2) Purpose.--The purpose of the Committee shall be to
provide independent advice and expert consultation, on the
request of the Administrator, with respect to the scientific
and technical aspects of issues relating to the
implementation of this title.
``(3) Composition.--The Committee shall be composed of
representatives of such science, government, labor, public
health, public interest, animal protection, industry, and
other groups as the Administrator determines to be advisable,
including, at a minimum, representatives that have specific
scientific expertise in the relationship of chemical
exposures to women, children, and other potentially exposed
or susceptible populations.
``(4) Schedule.--The Administrator shall convene the
Committee in accordance with such schedule as the
Administrator determines to be appropriate, but not less
frequently than once every 2 years.
``(5) Relationship to other law.--All proceedings and
meetings of the Committee shall be subject to the Federal
Advisory Committee Act (5 U.S.C. App.).''.
SEC. 5. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES.
(a) In General.--Section 4 of the Toxic Substances Control
Act (15 U.S.C. 2603) is amended--
(1) by striking subsections (a), (b), (c), (d), (e), and
(g);
(2) in subsection (f)--
(A) in the first sentence--
(i) by striking ``from cancer, gene mutations, or birth
defects''; and
(ii) by inserting ``, without taking into account cost or
other nonrisk factors'' before the period at the end; and
(B) by striking the last sentence; and
(3) by inserting before subsection (f) the following:
``(a) Development of New Information on Chemical Substances
and Mixtures.--
``(1) In general.--The Administrator may require the
development of new information relating to a chemical
substance or mixture in accordance with this section if the
Administrator determines that the information is necessary--
``(A) to review a notice under section 5(d) or to perform a
safety assessment or safety determination under section 6;
``(B) to implement a requirement imposed in a consent
agreement or order issued under section 5(d)(4) or under a
rule promulgated under section 6(d)(3);
``(C) pursuant to section 12(a)(4); or
``(D) at the request of the implementing authority under
another Federal law, to meet the regulatory testing needs of
that authority.
``(2) Limited testing for prioritization purposes.--
``(A) In general.--Except as provided in subparagraph (B),
the Administrator may require the development of new
information for the purposes of section 4A.
``(B) Prohibition.--Testing required under subparagraph (A)
shall not be required for the purpose of establishing or
implementing a minimum information requirement.
``(C) Limitation.--The Administrator may require the
development of new information pursuant to subparagraph (A)
only if the Administrator determines that additional
information is necessary to establish the priority of a
chemical substance.
``(3) Form.--The Administrator may require the development
of information described in paragraph (1) or (2) by--
``(A) promulgating a rule;
``(B) entering into a testing consent agreement; or
``(C) issuing an order.
``(4) Contents.--
``(A) In general.--A rule, testing consent agreement, or
order issued under this subsection shall include--
``(i) identification of the chemical substance or mixture
for which testing is required;
[[Page H2991]]
``(ii) identification of the persons required to conduct
the testing;
``(iii) test protocols and methodologies for the
development of information for the chemical substance or
mixture, including specific reference to any reliable
nonanimal test procedures; and
``(iv) specification of the period within which individuals
and entities required to conduct the testing shall submit to
the Administrator the information developed in accordance
with the procedures described in clause (iii).
``(B) Considerations.--In determining the procedures and
period to be required under subparagraph (A), the
Administrator shall take into consideration--
``(i) the relative costs of the various test protocols and
methodologies that may be required;
``(ii) the reasonably foreseeable availability of
facilities and personnel required to perform the testing; and
``(iii) the deadlines applicable to the Administrator under
section 6(a).
``(5) Consideration of federal agency recommendations.--The
Administrator shall consider the recommendations of other
Federal agencies regarding the chemical substances and
mixtures to which the Administrator shall give priority
consideration under this section.
``(b) Statement of Need.--
``(1) In general.--In promulgating a rule, entering into a
testing consent agreement, or issuing an order for the
development of additional information (including information
on exposure or exposure potential) pursuant to this section,
the Administrator shall--
``(A) identify the need intended to be met by the rule,
agreement, or order;
``(B) explain why information reasonably available to the
Administrator at that time is inadequate to meet that need,
including a reference, as appropriate, to the information
identified in paragraph (2)(B); and
``(C) explain the basis for any decision that requires the
use of vertebrate animals.
``(2) Explanation in case of order.--
``(A) In general.--If the Administrator issues an order
under this section, the Administrator shall issue a statement
providing a justification for why issuance of an order is
warranted instead of promulgating a rule or entering into a
testing consent agreement.
``(B) Contents.--A statement described in subparagraph (A)
shall contain a description of--
``(i) information that is readily accessible to the
Administrator, including information submitted under any
other provision of law;
``(ii) the extent to which the Administrator has obtained
or attempted to obtain the information through voluntary
submissions; and
``(iii) any information relied on in safety assessments for
other chemical substances relevant to the chemical substances
that would be the subject of the order.
``(c) Reduction of Testing on Vertebrates.--
``(1) In general.--The Administrator shall minimize, to the
extent practicable, the use of vertebrate animals in testing
of chemical substances or mixtures, by--
``(A) prior to making a request or adopting a requirement
for testing using vertebrate animals, taking into
consideration, as appropriate and to the extent practicable,
reasonably available--
``(i) toxicity information;
``(ii) computational toxicology and bioinformatics;
``(iii) high-throughput screening methods and the
prediction models of those methods; and
``(iv) scientifically reliable and relevant alternatives to
tests on animals that would provide equivalent information;
``(B) encouraging and facilitating--
``(i) the use of integrated and tiered testing and
assessment strategies;
``(ii) the use of best available science in existence on
the date on which the test is conducted;
``(iii) the use of test methods that eliminate or reduce
the use of animals while providing information of high
scientific quality;
``(iv) the grouping of 2 or more chemical substances into
scientifically appropriate categories in cases in which
testing of a chemical substance would provide reliable and
useful information on other chemical substances in the
category;
``(v) the formation of industry consortia to jointly
conduct testing to avoid unnecessary duplication of tests;
and
``(vi) the submission of information from--
``(I) animal-based studies; and
``(II) emerging methods and models; and
``(C) funding research and validation studies to reduce,
refine, and replace the use of animal tests in accordance
with this subsection.
``(2) Implementation of alternative testing methods.--To
promote the development and timely incorporation of new
testing methods that are not based on vertebrate animals, the
Administrator shall--
``(A) not later than 2 years after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act, develop a strategic plan to promote the development and
implementation of alternative test methods and testing
strategies to generate information under this title that can
reduce, refine, or replace the use of vertebrate animals,
including toxicity pathway-based risk assessment, in vitro
studies, systems biology, computational toxicology,
bioinformatics, and high-throughput screening;
``(B) as practicable, ensure that the strategic plan
developed under subparagraph (A) is reflected in the
development of requirements for testing under this section;
``(C) identify in the strategic plan developed under
subparagraph (A) particular alternative test methods or
testing strategies that do not require new vertebrate animal
testing and are scientifically reliable, relevant, and
capable of providing information of equivalent scientific
reliability and quality to that which would be obtained from
vertebrate animal testing;
``(D) provide an opportunity for public notice and comment
on the contents of the plan developed under subparagraph (A),
including the criteria for considering scientific
reliability, relevance, and equivalent information and the
test methods and strategies identified in subparagraph (C);
``(E) beginning on the date that is 5 years after the date
of enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act and every 5 years thereafter, submit to
Congress a report that describes the progress made in
implementing this subsection and goals for future alternative
test methods implementation;
``(F) fund and carry out research, development, performance
assessment, and translational studies to accelerate the
development of test methods and testing strategies that
reduce, refine, or replace the use of vertebrate animals in
any testing under this title; and
``(G) identify synergies with the related information
requirements of other jurisdictions to minimize the potential
for additional or duplicative testing.
``(3) Criteria for adapting or waiving animal testing
requirements.--On request from a manufacturer or processor
that is required to conduct testing of a chemical substance
or mixture on vertebrate animals under this section, the
Administrator may adapt or waive the requirement, if the
Administrator determines that--
``(A) there is sufficient evidence from several independent
sources of information to support a conclusion that a
chemical substance or mixture has, or does not have, a
particular property if the information from each individual
source alone is insufficient to support the conclusion;
``(B) as a result of 1 or more physical or chemical
properties of the chemical substance or mixture or other
toxicokinetic considerations--
``(i) the substance cannot be absorbed; or
``(ii) testing for a specific endpoint is technically not
practicable to conduct; or
``(C) a chemical substance or mixture cannot be tested in
vertebrate animals at concentrations that do not result in
significant pain or distress, because of physical or chemical
properties of the chemical substance or mixture, such as a
potential to cause severe corrosion or severe irritation to
the tissues of the animal.
``(4) Voluntary testing.--
``(A) In general.--Any person developing information for
submission under this title on a voluntary basis and not
pursuant to any request or requirement by the Administrator
shall first attempt to develop the information by means of an
alternative or nonanimal test method or testing strategy that
the Administrator has determined under paragraph (2)(C) to be
scientifically reliable, relevant, and capable of providing
equivalent information, before conducting new animal testing.
``(B) Effect of paragraph.--Nothing in this paragraph--
``(i) requires the Administrator to review the basis on
which the person is conducting testing described in
subparagraph (A);
``(ii) prohibits the use of other test methods or testing
strategies by any person for purposes other than developing
information for submission under this title on a voluntary
basis; or
``(iii) prohibits the use of other test methods or testing
strategies by any person, subsequent to the attempt to
develop information using the test methods and testing
strategies identified by the Administrator under paragraph
(2)(C).
``(d) Testing Requirements.--
``(1) In general.--The Administrator may require the
development of information by--
``(A) manufacturers and processors of the chemical
substance or mixture; and
``(B) persons that begin to manufacture or process the
chemical substance or mixture after the effective date of the
rule, testing consent agreement, or order.
``(2) Designation.--The Administrator may permit 2 or more
persons identified in subparagraph (A) or (B) of paragraph
(1) to designate 1 of the persons or a qualified third
party--
``(A) to develop the information; and
``(B) to submit the information on behalf of the persons
making the designation.
``(3) Exemptions.--
``(A) In general.--A person otherwise subject to a rule,
testing consent agreement, or order under this section may
submit to the Administrator an application for an exemption
on the basis that submission of information by the applicant
on the chemical substance or mixture would be duplicative
of--
``(i) information on the chemical substance or mixture
that--
``(I) has been submitted to the Administrator pursuant to a
rule, consent agreement, or order under this section; or
``(II) is being developed by a person designated under
paragraph (2); or
``(ii) information on an equivalent chemical substance or
mixture that--
``(I) has been submitted to the Administrator pursuant to a
rule, consent agreement, or order under this section; or
``(II) is being developed by a person designated under
paragraph (2).
``(B) Fair and equitable reimbursement to designee.--
``(i) In general.--If the Administrator accepts an
application submitted under subparagraph (A), before the end
of the reimbursement period described in clause (iii), the
Administrator shall direct the applicant to provide to the
person designated under paragraph (2) fair and equitable
reimbursement, as agreed to between the applicant and the
designee.
``(ii) Arbitration.--If the applicant and a person
designated under paragraph (2) cannot reach agreement on the
amount of fair and equitable reimbursement, the amount shall
be determined by arbitration.
[[Page H2992]]
``(iii) Reimbursement period.--For the purposes of this
subparagraph, the reimbursement period for any information
for a chemical substance or mixture is a period--
``(I) beginning on the date the information is submitted in
accordance with a rule, testing consent agreement, or order
under this section; and
``(II) ending on the later of--
``(aa) 5 years after the date referred to in subclause (I);
or
``(bb) the last day of the period that begins on the date
referred to in subclause (I) and that is equal to the period
that the Administrator determines was necessary to develop
the information.
``(C) Termination.--If, after granting an exemption under
this paragraph, the Administrator determines that no person
designated under paragraph (2) has complied with the rule,
testing consent agreement, or order, the Administrator
shall--
``(i) by order, terminate the exemption; and
``(ii) notify in writing each person that received an
exemption of the requirements with respect to which the
exemption was granted.
``(4) Tiered testing.--
``(A) In general.--Except as provided in subparagraph (D),
the Administrator shall employ a tiered screening and testing
process, under which the results of screening-level tests or
assessments of available information inform the decision as
to whether 1 or more additional tests are necessary.
``(B) Screening-level tests.--
``(i) In general.--The screening-level tests required for a
chemical substance or mixture may include tests for hazard
(which may include in silico, in vitro, and in vivo tests),
environmental and biological fate and transport, and
measurements or modeling of exposure or exposure potential,
as appropriate.
``(ii) Use.--Screening-level tests shall be used--
``(I) to screen chemical substances or mixtures for
potential adverse effects; and
``(II) to inform a decision of the Administrator regarding
whether more complex or targeted additional testing is
necessary.
``(C) Additional testing.--If the Administrator determines
under subparagraph (B) that additional testing is necessary
to provide more definitive information for safety assessments
or safety determinations, the Administrator may require more
advanced tests for potential health or environmental effects
or exposure potential.
``(D) Advanced testing without screening.--The
Administrator may require more advanced testing without
conducting screening-level testing when other information
available to the Administrator justifies the advanced
testing, pursuant to guidance developed by the Administrator
under this section.
``(e) Transparency.--Subject to section 14, the
Administrator shall make available to the public all testing
consent agreements and orders and all information submitted
under this section.''.
(b) Conforming Amendment.--Section 104(i)(5)(A) of the
Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (42 U.S.C. 9604(i)(5)(A)) is amended in
the third sentence by inserting ``(as in effect on the day
before the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act)'' after ``Toxic
Substances Control Act''.
SEC. 6. PRIORITIZATION SCREENING.
The Toxic Substances Control Act is amended by inserting
after section 4 (15 U.S.C. 2603) the following:
``SEC. 4A. PRIORITIZATION SCREENING.
``(a) Prioritization Screening Process and List of
Substances.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Administrator shall establish,
by rule, a risk-based screening process and criteria for
identifying existing chemical substances that are--
``(A) a high priority for a safety assessment and safety
determination under section 6 (referred to in this Act as
`high-priority substances'); and
``(B) a low priority for a safety assessment and safety
determination (referred to in this Act as `low-priority
substances').
``(2) Initial and subsequent lists of high- and low-
priority substances.--
``(A) In general.--Before the date of promulgation of the
rule under paragraph (1) and not later than 180 days after
the date of enactment of this section, the Administrator
shall publish an initial list of high-priority substances and
low-priority substances.
``(B) Requirements.--
``(i) In general.--The initial list of chemical substances
shall contain at least 10 high-priority substances, at least
5 of which are drawn from the list of chemical substances
identified by the Administrator in the October 2014 TSCA Work
Plan and subsequent updates, and at least 10 low-priority
substances.
``(ii) Subsequently identified substances.--Insofar as
possible, at least 50 percent of all substances subsequently
identified by the Administrator as high-priority substances
shall be drawn from the list of chemical substances
identified by the Administrator in the October 2014 TSCA Work
Plan and subsequent updates, until all Work Plan chemicals
have been designated under this subsection.
``(iii) Preferences.--
``(I) In general.--In developing the initial list and in
identifying additional high-priority substances, the
Administrator shall give preference to--
``(aa) chemical substances that, with respect to
persistence and bioaccumulation, score high for 1 and either
high or moderate for the other, pursuant to the TSCA Work
Plan Chemicals Methods Document published by the
Administrator in February 2012; and
``(bb) chemical substances listed in the October 2014 TSCA
Work Plan and subsequent updates that are known human
carcinogens and have high acute and chronic toxicity.
``(II) Metals and metal compounds.--In prioritizing and
assessing metals and metal compounds, the Administrator shall
use the Framework for Metals Risk Assessment of the Office of
the Science Advisor, Risk Assessment Forum, and dated March
2007 (or a successor document), and may use other applicable
information consistent with the best available science.
``(C) Additional chemical reviews.--The Administrator
shall, as soon as practicable and not later than--
``(i) 3 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, add
additional high-priority substances sufficient to ensure that
at least a total of 20 high-priority substances have
undergone or are undergoing the process established in
section 6(a), and additional low-priority substances
sufficient to ensure that at least a total of 20 low-priority
substances have been designated; and
``(ii) 5 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, add
additional high-priority substances sufficient to ensure that
at least a total of 25 high-priority substances have
undergone or are undergoing the process established in
section 6(a), and additional low-priority substances
sufficient to ensure that at least a total of 25 low-priority
substances have been designated.
``(3) Implementation.--
``(A) Consideration of active and inactive substances.--
``(i) Active substances.--In implementing the
prioritization screening process established under paragraph
(1), the Administrator shall take into consideration active
substances, as determined under section 8, which may include
chemical substances on the interim list of active substances
established under that section.
``(ii) Inactive substances.--In implementing the
prioritization screening process established under paragraph
(1), the Administrator may take into consideration inactive
substances, as determined under section 8, that the
Administrator determines--
``(I)(aa) have not been subject to a regulatory or other
enforceable action by the Administrator to ban or phase out
the substances; and
``(bb) have the potential for high hazard and widespread
exposure; or
``(II)(aa) have been subject to a regulatory or other
enforceable action by the Administrator to ban or phase out
the substances; and
``(bb) with respect to which there exists the potential for
residual high hazards or widespread exposures not otherwise
addressed by the regulatory or other action.
``(iii) Repopulation.--
``(I) In general.--On the completion of a safety
determination under section 6 for a chemical substance, the
Administrator shall remove the chemical substance from the
list of high-priority substances established under this
subsection.
``(II) Additions.--The Administrator shall add at least 1
chemical substance to the list of high-priority substances
for each chemical substance removed from the list of high-
priority substances established under this subsection, until
a safety assessment and safety determination is completed for
all chemical substances not designated as high-priority.
``(B) Timely completion of prioritization screening
process.--
``(i) In general.--The Administrator shall--
``(I) except as provided under paragraph (2), not later
than 180 days after the effective date of the final rule
under paragraph (1), begin the prioritization screening
process; and
``(II) make every effort to complete the designation of all
active substances as high-priority substances or low-priority
substances in a timely manner.
``(ii) Decisions on substances subject to testing for
prioritization purposes.--Not later than 90 days after the
date of receipt of information regarding a chemical substance
complying with a rule, testing consent agreement, or order
issued under section 4(a)(2), the Administrator shall
designate the chemical substance as a high-priority substance
or low-priority substance.
``(iii) Consideration.--
``(I) In general.--The Administrator shall screen
substances and designate high-priority substances consistent
with the ability of the Administrator to schedule and
complete safety assessments and safety determinations under
section 6 in accordance with the deadlines under subsection
(a) of that section.
``(II) Annual goal.--The Administrator shall publish an
annual goal for the number of chemical substances to be
subject to the prioritization screening process.
``(C) Screening of categories of substances.--The
Administrator may screen categories of chemical substances to
ensure an efficient prioritization screening process to allow
for timely and adequate designations of high-priority
substances and low-priority substances and safety assessments
and safety determinations for high-priority substances.
``(D) Publication of list of chemical substances.--The
Administrator shall keep current and publish a list of
chemical substances that includes and identifies substances--
``(i) that are being considered in the prioritization
screening process and the status of the substances in the
prioritization process;
``(ii) for which prioritization decisions have been
postponed pursuant to subsection (b)(5), including the basis
for the postponement; and
``(iii) that are designated as high-priority substances or
low-priority substances, including the bases for such
designations.
``(4) Criteria.--The criteria described in paragraph (1)
shall account for--
[[Page H2993]]
``(A) the recommendation of the Governor of a State or a
State agency with responsibility for protecting health or the
environment from chemical substances appropriate for
prioritization screening;
``(B) the hazard and exposure potential of the chemical
substance (or category of substances), including persistence,
bioaccumulation, and specific scientific classifications and
designations by authoritative governmental entities;
``(C) the conditions of use or significant changes in the
conditions of use of the chemical substance;
``(D) evidence and indicators of exposure potential to
humans or the environment from the chemical substance,
including potentially exposed or susceptible populations and
storage near significant sources of drinking water;
``(E) the volume of a chemical substance manufactured or
processed;
``(F) whether the volume of a chemical substance as
reported pursuant to a rule promulgated pursuant to section
8(a) has significantly increased or decreased;
``(G) the availability of information regarding potential
hazards and exposures required for conducting a safety
assessment or safety determination, with limited availability
of relevant information to be a sufficient basis for
designating a chemical substance as a high-priority
substance, subject to the condition that limited availability
shall not require designation as a high-priority substance;
and
``(H) the extent of Federal or State regulation of the
chemical substance or the extent of the impact of State
regulation of the chemical substance on the United States,
with existing Federal or State regulation of any uses
evaluated in the prioritization screening process as a factor
in designating a chemical substance to be a high-priority or
a low-priority substance.
``(b) Prioritization Screening Process and Decisions.--
``(1) In general.--In implementing the prioritization
screening process developed under subsection (a), the
Administrator shall--
``(A) identify the chemical substances being considered for
prioritization;
``(B) request interested persons to supply information
regarding the chemical substances being considered;
``(C) apply the criteria identified in subsection (a)(4);
and
``(D) subject to paragraph (5) and using the information
available to the Administrator at the time of the decision,
identify a chemical substance as a high-priority substance or
a low-priority substance.
``(2) Reasonably available information.--The prioritization
screening decision regarding a chemical substance shall
consider any hazard and exposure information relating to the
chemical substance that is reasonably available to the
Administrator.
``(3) Identification of high-priority substances.--The
Administrator--
``(A) shall identify as a high-priority substance a
chemical substance that, relative to other active chemical
substances, the Administrator determines has the potential
for significant hazard and significant exposure;
``(B) may identify as a high-priority substance a chemical
substance that, relative to other active chemical substances,
the Administrator determines has the potential for
significant hazard or significant exposure; and
``(C) may identify as a high-priority substance an inactive
substance, as determined under subsection (a)(3)(A)(ii) and
section 8(b), that the Administrator determines warrants a
safety assessment and safety determination under section 6.
``(4) Identification of low-priority substances.--The
Administrator shall identify as a low-priority substance a
chemical substance that the Administrator concludes has
information sufficient to establish that the chemical
substance is likely to meet the safety standard.
``(5) Postponing a decision.--If the Administrator
determines that additional information is needed to establish
the priority of a chemical substance under this section, the
Administrator may postpone a prioritization screening
decision for a reasonable period--
``(A) to allow for the submission of additional information
by an interested person and for the Administrator to evaluate
the additional information; or
``(B) to require the development of information pursuant to
a rule, testing consent agreement, or order issued under
section 4(a)(2).
``(6) Deadlines for submission of information.--If the
Administrator requests the development or submission of
information under this section, the Administrator shall
establish a deadline for submission of the information.
``(7) Notice and comment.--The Administrator shall--
``(A) publish, including in the Federal Register, the
proposed decisions made under paragraphs (3), (4), and (5)
and the basis for the decisions;
``(B) identify the information and analysis on which the
decisions are based; and
``(C) provide 90 days for public comment.
``(8) Revisions of prior designations.--
``(A) In general.--At any time, the Administrator may
revise the designation of a chemical substance as a high-
priority substance or a low-priority substance based on
information available to the Administrator after the date of
the determination under paragraph (3) or (4).
``(B) Limited availability.--If limited availability of
relevant information was a basis in the designation of a
chemical substance as a high-priority substance, the
Administrator shall reevaluate the prioritization screening
of the chemical substance on receiving the relevant
information.
``(9) Other information relevant to prioritization.--
``(A) In general.--If, after the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st Century Act,
a State proposes an administrative action or enacts a statute
or takes an administrative action to prohibit or otherwise
restrict the manufacturing, processing, distribution in
commerce, or use of a chemical substance that the
Administrator has not designated as a high-priority
substance, the Governor or State agency with responsibility
for implementing the statute or administrative action shall
notify the Administrator.
``(B) Requests for information.--Following receipt of a
notification provided under subparagraph (A), the
Administrator may request any available information from the
Governor or the State agency with respect to--
``(i) scientific evidence related to the hazards, exposures
and risks of the chemical substance under the conditions of
use which the statute or administrative action is intended to
address;
``(ii) any State or local conditions which warranted the
statute or administrative action;
``(iii) the statutory or administrative authority on which
the action is based; and
``(iv) any other available information relevant to the
prohibition or other restriction, including information on
any alternatives considered and their hazards, exposures, and
risks.
``(C) Prioritization screening.--The Administrator shall
conduct a prioritization screening under this subsection for
all substances that--
``(i) are the subject of notifications received under
subparagraph (A); and
``(ii) the Administrator determines--
``(I) are likely to have significant health or
environmental impacts;
``(II) are likely to have significant impact on interstate
commerce; or
``(III) have been subject to a prohibition or other
restriction under a statute or administrative action in 2 or
more States.
``(D) Post-prioritization notice.--If, after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, a State proposes or takes an administrative
action or enacts a statute to prohibit or otherwise restrict
the manufacturing, processing, distribution in commerce, or
use of a high-priority substance, after the date on which the
deadline established pursuant to subsection (a) of section 6
for completion of the safety determination under that
subsection expires but before the date on which the
Administrator publishes the safety determination under that
subsection, the Governor or State agency with responsibility
for implementing the statute or administrative action shall--
``(i) notify the Administrator; and
``(ii) provide the scientific and legal basis for the
action.
``(E) Availability to public.--Subject to section 14 and
any applicable State law regarding the protection of
confidential information provided to the State or to the
Administrator, the Administrator shall make information
received from a Governor or State agency under subparagraph
(A) publicly available.
``(F) Effect of paragraph.--Nothing in this paragraph shall
preempt a State statute or administrative action, require
approval of a State statute or administrative action, or
apply section 15 to a State.
``(10) Review.--Not less frequently than once every 5 years
after the date on which the process under this subsection is
established, the Administrator shall--
``(A) review the process on the basis of experience and
taking into consideration resources available to efficiently
and effectively screen and prioritize chemical substances;
and
``(B) if necessary, modify the prioritization screening
process.
``(11) Effect.--Subject to section 18, a designation by the
Administrator under this section with respect to a chemical
substance shall not affect--
``(A) the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance; or
``(B) the regulation of those activities.
``(c) Additional Priorities for Safety Assessments and
Determinations.--
``(1) Requirements.--
``(A) In general.--The rule promulgated under subsection
(a) shall--
``(i) include a process by which a manufacturer or
processor of an active chemical substance that has not been
designated a high-priority substance or is not in the process
of a prioritization screening by the Administrator, may
request that the Administrator designate the substance as an
additional priority for a safety assessment and safety
determination, subject to the payment of fees pursuant to
section 26(b)(3)(D);
``(ii) specify the information to be provided in such
requests; and
``(iii) specify the criteria (which may include criteria
identified in subsection (a)(4)) that the Administrator shall
use to determine whether or not to grant such a request,
which shall include whether the substance is subject to
restrictions imposed by statutes enacted or administrative
actions taken by 1 or more States on the manufacture,
processing, distribution in commerce, or use of the
substance.
``(B) Preference.--Subject to paragraph (2), in deciding
whether to grant requests under this subsection the
Administrator shall give a preference to requests concerning
substances for which the Administrator determines that
restrictions imposed by 1 or more States have the potential
to have a significant impact on interstate commerce or health
or the environment.
``(C) Exceptions.--Chemical substances for which requests
have been granted under this subsection shall not be subject
to subsection (a)(3)(A)(iii) or section 18(b).
``(2) Limitations.--In considering whether to grant a
request submitted under paragraph (1), the Administrator
shall ensure that--
[[Page H2994]]
``(A) the number of substances designated to undergo safety
assessments and safety determinations under the process and
criteria pursuant to paragraph (1) is not less than 25
percent, or more than 30 percent, of the cumulative number of
substances designated to undergo safety assessments and
safety determinations under subsections (a)(2) and (b)(3)
(except that if less than 25 percent are received by the
Administrator, the Administrator shall grant each request
that meets the requirements of paragraph (1));
``(B) the resources allocated to conducting safety
assessments and safety determinations for additional
priorities designated under this subsection are proportionate
to the number of such substances relative to the total number
of substances currently designated to undergo safety
assessments and safety determinations under this section; and
``(C) the number of additional priority requests stipulated
under subparagraph (A) is in addition to the total number of
high-priority substances identified under subsections (a)(2)
and (b)(3).
``(3) Additional review of work plan chemicals for safety
assessment and safety determination.--In the case of a
request under paragraph (1) with respect to a chemical
substance identified by the Administrator in the October 2014
TSCA Work Plan--
``(A) the 30-percent cap specified in paragraph (2)(A)
shall not apply and the addition of Work Plan chemicals shall
be at the discretion of the Administrator; and
``(B) notwithstanding paragraph (1)(C), requests for
additional Work Plan chemicals under this subsection shall be
considered high-priority chemicals subject to section 18(b)
but not subsection (a)(3)(A)(iii).
``(4) Requirements.--
``(A) In general.--The public shall be provided notice and
an opportunity to comment on requests submitted under this
subsection.
``(B) Decision by administrator.--Not later than 180 days
after the date on which the Administrator receives a request
under this subsection, the Administrator shall decide whether
or not to grant the request.
``(C) Assessment and determination.--If the Administrator
grants a request under this subsection, the safety assessment
and safety determination--
``(i) shall be conducted in accordance with the deadlines
and other requirements of sections 3A(i) and 6; and
``(ii) shall not be expedited or otherwise subject to
special treatment relative to high-priority substances
designated pursuant to subsection (b)(3) that are undergoing
safety assessments and safety determinations.''.
SEC. 7. NEW CHEMICALS AND SIGNIFICANT NEW USES.
Section 5 of the Toxic Substances Control Act (15 U.S.C.
2604) is amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.'';
(2) by striking subsection (b);
(3) by redesignating subsection (a) as subsection (b);
(4) by redesignating subsection (i) as subsection (a) and
moving the subsection so as to appear at the beginning of the
section;
(5) in subsection (b) (as so redesignated)--
(A) in the subsection heading, by striking ``In General''
and inserting ``Notices'';
(B) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by striking
``subsection (h)'' and inserting ``paragraph (3) and
subsection (h)''; and
(ii) in the matter following subparagraph (B)--
(I) by striking ``subsection (d)'' and inserting
``subsection (c)''; and
(II) by striking ``and such person complies with any
applicable requirement of subsection (b)''; and
(C) by adding at the end the following:
``(3) Article consideration.--The Administrator may require
notification under this section for the import or processing
of a chemical substance as part of an article or category of
articles under paragraph (1)(B) if the Administrator makes an
affirmative finding in a rule under paragraph (2) that the
reasonable potential for exposure to the chemical substance
through the article or category of articles subject to the
rule warrants notification.'';
(6) by redesignating subsections (c) and (d) as subsections
(d) and (c), respectively, and moving subsection (c) (as so
redesigned) so as appear after subsection (b) (as
redesignated by paragraph (3));
(7) in subsection (c) (as so redesignated)--
(A) by striking paragraph (1) and inserting the following:
``(1) In general.--The notice required by subsection (b)
shall include, with respect to a chemical substance--
``(A) the information required by sections 720.45 and
720.50 of title 40, Code of Federal Regulations (or successor
regulations); and
``(B) all known or reasonably ascertainable information
regarding conditions of use and reasonably anticipated
exposures.'';
(B) in paragraph (2)--
(i) in the matter preceding subparagraph (A)--
(I) by striking ``subsection (a)'' and inserting
``subsection (b)''; and
(II) by striking ``or of data under subsection (b)'';
(ii) in subparagraph (A), by adding ``and'' after the
semicolon at the end;
(iii) in subparagraph (B), by striking ``; and'' and
inserting a period; and
(iv) by striking subparagraph (C); and
(C) in paragraph (3), by striking ``subsection (a) and for
which the notification period prescribed by subsection (a),
(b), or (c)'' and inserting ``subsection (b) and for which
the notification period prescribed by subsection (b) or
(d)'';
(8) by striking subsection (d) (as redesignated by
paragraph (6)) and inserting the following:
``(d) Review of Notice.--
``(1) Initial review.--
``(A) In general.--Subject to subparagraph (B), not later
than 90 days after the date of receipt of a notice submitted
under subsection (b), the Administrator shall--
``(i) conduct an initial review of the notice;
``(ii) as needed, develop a profile of the relevant
chemical substance and the potential for exposure to humans
and the environment; and
``(iii) make a determination under paragraph (3).
``(B) Extension.--Except as provided in paragraph (5), the
Administrator may extend the period described in subparagraph
(A) for good cause for 1 or more periods, the total of which
shall be not more than 90 days.
``(2) Information sources.--In evaluating a notice under
paragraph (1), the Administrator shall take into
consideration--
``(A) any relevant information identified in subsection
(c)(1); and
``(B) any other relevant additional information available
to the Administrator.
``(3) Determinations.--Before the end of the applicable
period for review under paragraph (1), based on the
information described in paragraph (2), and subject to
section 18(g), the Administrator shall determine that--
``(A) the relevant chemical substance or significant new
use is not likely to meet the safety standard, in which case
the Administrator shall take appropriate action under
paragraph (4);
``(B) the relevant chemical substance or significant new
use is likely to meet the safety standard, in which case the
Administrator shall allow the review period to expire without
additional restrictions; or
``(C) additional information is necessary in order to make
a determination under subparagraph (A) or (B), in which case
the Administrator shall take appropriate action under
paragraphs (4) and (5).
``(4) Restrictions.--
``(A) Determination by administrator.--
``(i) In general.--If the Administrator makes a
determination under subparagraph (A) or (C) of paragraph (3)
with respect to a notice submitted under subsection (b)--
``(I) the Administrator, before the end of the applicable
period for review under paragraph (1) and by consent
agreement or order, as appropriate, shall prohibit or
otherwise restrict the manufacture, processing, use,
distribution in commerce, or disposal (as applicable) of the
chemical substance, or of the chemical substance for a
significant new use, without compliance with the restrictions
specified in the consent agreement or order that the
Administrator determines are sufficient to ensure that the
chemical substance or significant new use is likely to meet
the safety standard; and
``(II) no person may commence manufacture of the chemical
substance, or manufacture or processing of the chemical
substance for a significant new use, except in compliance
with the restrictions specified in the consent agreement or
order.
``(ii) Likely to meet standard.--If the Administrator makes
a determination under subparagraph (B) of paragraph (3) with
respect to a chemical substance or significant new use for
which a notice was submitted under subsection (b), then
notwithstanding any remaining portion of the applicable
period for review under paragraph (1), the submitter of the
notice may commence manufacture for commercial purposes of
the chemical substance or manufacture or processing of the
chemical substance for a significant new use.
``(B) Requirements.--Not later than 90 days after issuing a
consent agreement or order under subparagraph (A), the
Administrator shall--
``(i) consider whether to promulgate a rule pursuant to
subsection (b)(2) that identifies as a significant new use
any manufacturing, processing, use, distribution in commerce,
or disposal of the chemical substance that does not conform
to the restrictions imposed by the consent agreement or
order; and
``(ii)(I) initiate a rulemaking described in clause (i); or
``(II) publish a statement describing the reasons of the
Administrator for not initiating a rulemaking.
``(C) Inclusions.--A prohibition or other restriction under
subparagraph (A) may include, as appropriate--
``(i) subject to section 18(g), a requirement that a
chemical substance shall be marked with, or accompanied by,
clear and adequate minimum warnings and instructions with
respect to use, distribution in commerce, or disposal, or any
combination of those activities, with the form and content of
the minimum warnings and instructions to be prescribed by the
Administrator
``(ii) a requirement that manufacturers or processors of
the chemical substance shall--
``(I) make and retain records of the processes used to
manufacture or process, as applicable, the chemical
substance; or
``(II) monitor or conduct such additional tests as are
reasonably necessary to address potential risks from the
manufacture, processing, distribution in commerce, use, or
disposal, as applicable, of the chemical substance, subject
to section 4;
``(iii) a restriction on the quantity of the chemical
substance that may be manufactured, processed, or distributed
in commerce--
``(I) in general; or
``(II) for a particular use;
``(iv) a prohibition or other restriction of--
``(I) the manufacture, processing, or distribution in
commerce of the chemical substance for a significant new use;
``(II) any method of commercial use of the chemical
substance; or
``(III) any method of disposal of the chemical substance;
or
[[Page H2995]]
``(v) a prohibition or other restriction on the
manufacture, processing, or distribution in commerce of the
chemical substance--
``(I) in general; or
``(II) for a particular use.
``(D) Persistent and bioaccumulative substances.--For a
chemical substance the Administrator determines, with respect
to persistence and bioaccumulation, scores high for 1 and
either high or moderate for the other, pursuant to the TSCA
Work Plan Chemicals Methods Document published by the
Administrator in February 2012, the Administrator shall, in
selecting among prohibitions and other restrictions that the
Administrator determines are sufficient to ensure that the
chemical substance is likely to meet the safety standard,
reduce potential exposure to the substance to the maximum
extent practicable.
``(E) Workplace exposures.--To the extent practicable, the
Administrator shall consult with the Assistant Secretary of
Labor for Occupational Safety and Health prior to adopting
any prohibition or other restriction under this subsection to
address workplace exposures.
``(F) Definition of requirement.--For purposes of this Act,
the term `requirement' as used in this section does not
displace common law.
``(5) Additional information.--If the Administrator
determines under paragraph (3)(C) that additional information
is necessary to conduct a review under this subsection, the
Administrator--
``(A) shall provide an opportunity for the submitter of the
notice to submit the additional information;
``(B) may, by agreement with the submitter, extend the
review period for a reasonable time to allow the development
and submission of the additional information;
``(C) may promulgate a rule, enter into a testing consent
agreement, or issue an order under section 4 to require the
development of the information; and
``(D) on receipt of information the Administrator finds
supports the determination under paragraph (3), shall
promptly make the determination.'';
(9) by striking subsections (e) through (g) and inserting
the following:
``(e) Notice of Commencement.--
``(1) In general.--Not later than 30 days after the date on
which a manufacturer that has submitted a notice under
subsection (b) commences nonexempt commercial manufacture of
a chemical substance, the manufacturer shall submit to the
Administrator a notice of commencement that identifies--
``(A) the name of the manufacturer; and
``(B) the initial date of nonexempt commercial manufacture.
``(2) Withdrawal.--A manufacturer or processor that has
submitted a notice under subsection (b), but that has not
commenced nonexempt commercial manufacture or processing of
the chemical substance, may withdraw the notice.
``(f) Further Evaluation.--The Administrator may review a
chemical substance under section 4A at any time after the
Administrator receives--
``(1) a notice of commencement for a chemical substance
under subsection (e); or
``(2) new information regarding the chemical substance.
``(g) Transparency.--Subject to section 14, the
Administrator shall make available to the public--
``(1) all notices, determinations, consent agreements,
rules, and orders submitted under this section or made by the
Administrator under this section; and
``(2) all information submitted or issued under this
section.''; and
(10) in subsection (h)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by striking
``(a) or''; and
(ii) in subparagraph (A), by inserting ``, without taking
into account cost or other nonrisk factors'' after ``the
environment'';
(B) by striking paragraph (2);
(C) by redesignating paragraphs (3) through (6) as
paragraphs (2) through (5), respectively;
(D) in paragraph (2) (as so redesignated), in the matter
preceding subparagraph (A), by striking ``subsections (a) and
(b)'' and inserting ``subsection (b)'';
(E) in paragraph (3) (as so redesignated)--
(i) in the first sentence, by striking ``will not present
an unreasonable risk of injury to health or the environment''
and inserting ``will meet the safety standard''; and
(ii) by striking the second sentence;
(F) in paragraph (4) (as so redesignated), by striking
``subsections (a) and (b)'' and inserting ``subsection (b)'';
and
(G) in paragraph (5) (as so redesignated), in the first
sentence, by striking ``paragraph (1) or (5)'' and inserting
``paragraph (1) or (4)''.
SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.
Section 6 of the Toxic Substances Control Act (15 U.S.C.
2605) is amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.'';
(2) by redesignating subsections (e) and (f) as subsections
(h) and (i), respectively;
(3) by striking subsections (a) through (d) and inserting
the following:
``(a) In General.--The Administrator--
``(1) shall conduct a safety assessment and make a safety
determination of each high-priority substance in accordance
with subsections (b) and (c);
``(2) shall, as soon as practicable and not later than 6
months after the date on which a chemical substance is
designated as a high-priority substance, define and publish
the scope of the safety assessment and safety determination
to be conducted pursuant to this section, including the
hazards, exposures, conditions of use, and potentially
exposed or susceptible populations that the Administrator
expects to consider;
``(3) as appropriate based on the results of a safety
determination, shall establish restrictions pursuant to
subsection (d);
``(4) shall complete and publish a safety assessment and
safety determination not later than 3 years after the date on
which a chemical substance is designated as a high-priority
substance;
``(5) shall promulgate any necessary final rule pursuant to
subsection (d) by not later than 2 years after the date on
which the safety determination is completed;
``(6) may extend any deadline under paragraph (4) for not
more than 1 year, if information relating to the high-
priority substance, required to be developed in a rule,
order, or consent agreement under section 4--
``(A) has not yet been submitted to the Administrator; or
``(B) was submitted to the Administrator--
``(i) within the time specified in the rule, order, or
consent agreement pursuant to section 4(a)(4)(A)(iv); and
``(ii) on or after the date that is 120 days before the
expiration of the deadline described in paragraph (4); and
``(7) may extend the deadline under paragraph (5) for not
more than 2 years, subject to the condition that the
aggregate length of all extensions of deadlines under this
subsection does not exceed 2 years.
``(b) Prior Actions and Notice of Existing Information.--
``(1) Prior-initiated assessments.--
``(A) In general.--Nothing in this Act prevents the
Administrator from initiating a safety assessment or safety
determination regarding a chemical substance, or from
continuing or completing such a safety assessment or safety
determination, prior to the effective date of the policies,
procedures, and guidance required to be established by the
Administrator under section 3A or 4A.
``(B) Integration of prior policies and procedures.--As
policies and procedures under section 3A and 4A are
established, to the maximum extent practicable, the
Administrator shall integrate the policies and procedures
into ongoing safety assessments and safety determinations.
``(2) Actions completed prior to completion of policies and
procedures.--Nothing in this Act requires the Administrator
to revise or withdraw a completed safety assessment, safety
determination, or rule solely because the action was
completed prior to the completion of a policy or procedure
established under section 3A or 4A, and the validity of a
completed assessment, determination, or rule shall not be
determined based on the content of such a policy or
procedure.
``(3) Notice of existing information.--
``(A) In general.--The Administrator shall, where such
information is available, take notice of existing information
regarding hazard and exposure published by other Federal
agencies and the National Academies and incorporate the
information in safety assessments and safety determinations
with the objective of increasing the efficiency of the safety
assessments and safety determinations.
``(B) Inclusion of information.--Existing information
described in subparagraph (A) should be included to the
extent practicable and where the Administrator determines the
information is relevant and scientifically reliable.
``(c) Safety Determinations.--
``(1) In general.--Based on a review of the information
available to the Administrator, including draft safety
assessments submitted by interested persons pursuant to
section 3A(h)(2)(D), and subject to section 18(g), the
Administrator shall determine--
``(A) by order, that the relevant chemical substance meets
the safety standard;
``(B) that the relevant chemical substance does not meet
the safety standard, in which case the Administrator shall,
by rule under subsection (d)--
``(i) impose restrictions necessary to ensure that the
chemical substance meets the safety standard under the
conditions of use; or
``(ii) if the safety standard cannot be met with the
application of other restrictions under subsection (d)(3),
ban or phase out the chemical substance, as appropriate; or
``(C) that additional information is necessary in order to
make a determination under subparagraph (A) or (B), in which
case the Administrator shall take appropriate action under
paragraph (2).
``(2) Additional information.--If the Administrator
determines that additional information is necessary to make a
safety assessment or safety determination for a high-priority
substance, the Administrator--
``(A) shall provide an opportunity for interested persons
to submit the additional information;
``(B) may promulgate a rule, enter into a testing consent
agreement, or issue an order under section 4 to require the
development of the information;
``(C) may defer, for a reasonable period consistent with
the deadlines described in subsection (a), a safety
assessment and safety determination until after receipt of
the information; and
``(D) consistent with the deadlines described in subsection
(a), on receipt of information the Administrator finds
supports the safety assessment and safety determination,
shall make a determination under paragraph (1).
``(3) Establishment of deadline.--In requesting the
development or submission of information under this section,
the Administrator shall establish a deadline for the
submission of the information.
[[Page H2996]]
``(d) Rule.--
``(1) Implementation.--If the Administrator makes a
determination under subsection (c)(1)(B) with respect to a
chemical substance, the Administrator shall promulgate a rule
establishing restrictions necessary to ensure that the
chemical substance meets the safety standard.
``(2) Scope.--
``(A) In general.--The rule promulgated pursuant to this
subsection--
``(i) may apply to mixtures containing the chemical
substance, as appropriate;
``(ii) shall include dates by which compliance is
mandatory, which--
``(I) shall be as soon as practicable, but not later than 4
years after the date of promulgation of the rule, except in
the case of a use exempted under paragraph (5);
``(II) in the case of a ban or phase-out of the chemical
substance, shall implement the ban or phase-out in as short a
period as practicable;
``(III) as determined by the Administrator, may vary for
different affected persons; and
``(IV) following a determination by the Administrator that
compliance is technologically or economically infeasible
within the timeframe specified in subclause (I), shall
provide up to an additional 18 months for compliance to be
mandatory;
``(iii) shall exempt replacement parts that are
manufactured prior to the effective date of the rule for
articles that are first manufactured prior to the effective
date of the rule unless the Administrator finds the
replacement parts contribute significantly to the identified
risk;
``(iv) shall, in selecting among prohibitions and other
restrictions, apply such prohibitions or other restrictions
to an article or category of articles containing the chemical
substance only to the extent necessary to address the
identified risks from exposure to the chemical substance from
the article or category of articles, in order to determine
that the chemical substance meets the safety standard; and
``(v) shall, when the Administrator determines that the
chemical substance does not meet the safety standard for a
potentially exposed or susceptible population, apply
prohibitions or other restrictions necessary to ensure that
the substance meets the safety standard for that population.
``(B) Persistent and bioaccumulative substances.--For a
chemical substance the Administrator determines, with respect
to persistence and bioaccumulation, scores high for 1 and
either high or moderate for the other, pursuant to the TSCA
Work Plan Chemicals Methods Document published by the
Administrator in February 2012, the Administrator shall, in
selecting among prohibitions and other restrictions that the
Administrator determines are sufficient to ensure that the
chemical substance meets the safety standard, reduce exposure
to the substance to the maximum extent practicable.
``(C) Workplace exposures.--The Administrator shall consult
with the Assistant Secretary of Labor for Occupational Safety
and Health before adopting any prohibition or other
restriction under this subsection to address workplace
exposures.
``(D) Definition of requirement.--For the purposes of this
Act, the term `requirement' as used in this section does not
displace common law.
``(3) Restrictions.--Subject to section 18, a restriction
under paragraph (1) may include, as appropriate--
``(A) a requirement that a chemical substance shall be
marked with, or accompanied by, clear and adequate minimum
warnings and instructions with respect to use, distribution
in commerce, or disposal, or any combination of those
activities, with the form and content of the minimum warnings
and instructions to be prescribed by the Administrator;
``(B) a requirement that manufacturers or processors of the
chemical substance shall--
``(i) make and retain records of the processes used to
manufacture or process the chemical substance;
``(ii) describe and apply the relevant quality control
procedures followed in the manufacturing or processing of the
substance; or
``(iii) monitor or conduct tests that are reasonably
necessary to ensure compliance with the requirements of any
rule under this subsection;
``(C) a restriction on the quantity of the chemical
substance that may be manufactured, processed, or distributed
in commerce;
``(D) a requirement to ban or phase out, or otherwise
restrict the manufacture, processing, or distribution in
commerce of the chemical substance for--
``(i) a particular use;
``(ii) a particular use at a concentration in excess of a
level specified by the Administrator; or
``(iii) all uses;
``(E) a restriction on the quantity of the chemical
substance that may be manufactured, processed, or distributed
in commerce for--
``(i) a particular use; or
``(ii) a particular use at a concentration in excess of a
level specified by the Administrator;
``(F) a requirement to ban, phase out, or otherwise
restrict any method of commercial use of the chemical
substance;
``(G) a requirement to ban, phase out, or otherwise
restrict any method of disposal of the chemical substance or
any article containing the chemical substance; and
``(H) a requirement directing manufacturers or processors
of the chemical substance to give notice of the
Administrator's determination under subsection (c)(1)(B) to
distributors in commerce of the chemical substance and, to
the extent reasonably ascertainable, to other persons in the
chain of commerce in possession of the chemical substance.
``(4) Analysis for rulemaking.--
``(A) Considerations.--In deciding which restrictions to
impose under paragraph (3) as part of developing a rule under
paragraph (1), the Administrator shall take into
consideration, to the extent practicable based on reasonably
available information, the quantifiable and nonquantifiable
costs and benefits of the proposed regulatory action and of
the 1 or more primary alternative regulatory actions
considered by the Administrator.
``(B) Alternatives.--As part of the analysis, the
Administrator shall review any 1 or more technically and
economically feasible alternatives to the chemical substance
that the Administrator determines are relevant to the
rulemaking.
``(C) Public availability.--In proposing a rule under
paragraph (1), the Administrator shall make publicly
available any analysis conducted under this paragraph.
``(D) Statement required.--In making final a rule under
paragraph (1), the Administrator shall include a statement
describing how the analysis considered under subparagraph (A)
was taken into account.
``(5) Exemptions.--
``(A) In general.--The Administrator may, as part of a rule
promulgated under paragraph (1) or in a separate rule, exempt
1 or more uses of a chemical substance from any restriction
in a rule promulgated under paragraph (1) if the
Administrator determines that--
``(i) the restriction cannot be complied with, without--
``(I) harming national security;
``(II) causing significant disruption in the national
economy due to the lack of availability of a chemical
substance; or
``(III) interfering with a critical or essential use for
which no technically and economically feasible safer
alternative is available, taking into consideration hazard
and exposure; or
``(ii) the use of the chemical substance, as compared to
reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety.
``(B) Exemption analysis.--In proposing a rule under this
paragraph, the Administrator shall make publicly available
any analysis conducted under this paragraph to assess the
need for the exemption.
``(C) Statement required.--In making final a rule under
this paragraph, the Administrator shall include a statement
describing how the analysis considered under subparagraph (B)
was taken into account.
``(D) Analysis in case of ban or phase-out.--In determining
whether an exemption should be granted under this paragraph
for a chemical substance for which a ban or phase-out is
included in a proposed or final rule under paragraph (1), the
Administrator shall take into consideration, to the extent
practicable based on reasonably available information, the
quantifiable and nonquantifiable costs and benefits of the 1
or more alternatives to the chemical substance the
Administrator determines to be technically and economically
feasible and most likely to be used in place of the chemical
substance under the conditions of use.
``(E) Conditions.--As part of a rule promulgated under this
paragraph, the Administrator shall include conditions,
including reasonable recordkeeping, monitoring, and reporting
requirements, to the extent that the Administrator determines
the conditions are necessary to protect health and the
environment while achieving the purposes of the exemption.
``(F) Duration.--
``(i) In general.--The Administrator shall establish, as
part of a rule under this paragraph, a time limit on any
exemption for a time to be determined by the Administrator as
reasonable on a case-by-case basis.
``(ii) Authority of administrator.--The Administrator, by
rule, may extend, modify, or eliminate an exemption if the
Administrator determines, on the basis of reasonably
available information and after adequate public
justification, the exemption warrants extension or is no
longer necessary.
``(iii) Considerations.--
``(I) In general.--Subject to subclause (II), the
Administrator shall issue exemptions and establish time
periods by considering factors determined by the
Administrator to be relevant to the goals of fostering
innovation and the development of alternatives that meet the
safety standard.
``(II) Limitation.--Any renewal of an exemption in the case
of a rule under paragraph (1) requiring the ban or phase-out
of a chemical substance shall not exceed 5 years.
``(e) Immediate Effect.--The Administrator may declare a
proposed rule under subsection (d)(1) to be effective on
publication of the rule in the Federal Register and until the
effective date of final action taken respecting the rule,
if--
``(1) the Administrator determines that--
``(A) the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance or
mixture subject to the proposed rule or any combination of
those activities is likely to result in a risk of serious or
widespread injury to health or the environment before the
effective date; and
``(B) making the proposed rule so effective is necessary to
protect the public interest; and
``(2) in the case of a proposed rule to prohibit the
manufacture, processing, or distribution in commerce of a
chemical substance or mixture because of the risk determined
under paragraph (1)(A), a court has granted relief in an
action under section 7 with respect to that risk associated
with the chemical substance or mixture.
``(f) Final Agency Action.--Under this section and subject
to section 18--
``(1) a safety determination, and the associated safety
assessment, for a chemical substance that the Administrator
determines under subsection (c) meets the safety standard,
shall be considered to be a final agency action, effective
beginning on the date of issuance of the final safety
determination; and
``(2) a final rule promulgated under subsection (d)(1), and
the associated safety assessment and
[[Page H2997]]
safety determination that a chemical substance does not meet
the safety standard, shall be considered to be a final agency
action, effective beginning on the date of promulgation of
the final rule.
``(g) Extension of Deadlines for Certain Chemical
Substances.--The Administrator may not extend any deadline
under subsection (a) for a chemical substance designated as a
high priority that is listed in the 2014 update of the TSCA
Work Plan without adequate public justification that
demonstrates, following a review of the information
reasonably available to the Administrator, that the
Administrator cannot adequately complete a safety assessment
and safety determination, or a final rule pursuant to
subsection (d), without additional information regarding the
chemical substance.''; and
(4) in subsection (h) (as redesignated by paragraph (2))--
(A) by striking paragraph (4); and
(B) by redesignating paragraph (5) as paragraph (4).
SEC. 9. IMMINENT HAZARDS.
Section 7 of the Toxic Substances Control Act (15 U.S.C.
2606) is amended--
(1) by striking subsection (a) and inserting the following:
``(a) Civil Actions.--
``(1) In general.--The Administrator may commence a civil
action in an appropriate United States district court for--
``(A) seizure of an imminently hazardous chemical substance
or mixture or any article containing the chemical substance
or mixture;
``(B) relief (as authorized by subsection (b)) against any
person that manufactures, processes, distributes in commerce,
uses, or disposes of, an imminently hazardous chemical
substance or mixture or any article containing the chemical
substance or mixture; or
``(C) both seizure described in subparagraph (A) and relief
described in subparagraph (B).
``(2) Rule, order, or other proceeding.--A civil action may
be commenced under this paragraph, notwithstanding--
``(A) the existence of a decision, rule, consent agreement,
or order by the Administrator under section 4, 4A, 5, or 6 or
title IV or VI; or
``(B) the pendency of any administrative or judicial
proceeding under any provision of this Act.'';
(2) in subsection (b)(1), by striking ``unreasonable'';
(3) in subsection (d), by striking ``section 6(a)'' and
inserting ``section 6(d)''; and
(4) in subsection (f), in the first sentence, by striking
``and unreasonable''.
SEC. 10. INFORMATION COLLECTION AND REPORTING.
Section 8 of the Toxic Substances Control Act (15 U.S.C.
2607) is amended--
(1) in subsection (a)--
(A) in paragraph (3)--
(i) in subparagraph (A)(ii)(I)--
(I) by striking ``5(b)(4)'' and inserting ``5'';
(II) by inserting ``section 4 or'' after ``in effect
under''; and
(III) by striking ``5(e),'' and inserting ``5(d)(4);''; and
(ii) by adding at the end the following:
``(C) Not later than 180 days after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, and not less frequently than once every 10 years
thereafter, the Administrator, after consultation with the
Administrator of the Small Business Administration, shall--
``(i) review the adequacy of the standards prescribed
according to subparagraph (B);
``(ii) after providing public notice and an opportunity for
comment, make a determination as to whether revision of the
standards is warranted; and
``(iii) revise the standards if the Administrator so
determines.''; and
(B) by adding at the end the following:
``(4) Rules.--
``(A) Deadline.--
``(i) In general.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall promulgate rules
requiring the maintenance of records and the reporting of
additional information known or reasonably ascertainable by
the person making the report, including rules applicable to
processors so that the Administrator has the information
necessary to carry out this title.
``(ii) Modification of prior rules.--In carrying out this
subparagraph, the Administrator may modify, as appropriate,
rules promulgated before the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st Century Act.
``(B) Contents.--The rules promulgated pursuant to
subparagraph (A)--
``(i) may impose different reporting and recordkeeping
requirements on manufacturers and processors; and
``(ii) shall include the level of detail necessary to be
reported, including the manner by which use and exposure
information may be reported.
``(C) Administration.--In implementing the reporting and
recordkeeping requirements under this paragraph, the
Administrator shall take measures--
``(i) to limit the potential for duplication in reporting
requirements;
``(ii) to minimize the impact of the rules on small
manufacturers and processors; and
``(iii) to apply any reporting obligations to those persons
likely to have information relevant to the effective
implementation of this title.'';
(2) in subsection (b), by adding at the end the following:
``(3) Nomenclature.--
``(A) In general.--In carrying out paragraph (1), the
Administrator shall--
``(i) maintain the use of Class 2 nomenclature in use on
the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act;
``(ii) maintain the use of the Soap and Detergent
Association Nomenclature System, published in March 1978 by
the Administrator in section 1 of addendum III of the
document entitled `Candidate List of Chemical Substances',
and further described in the appendix A of volume I of the
1985 edition of the Toxic Substances Control Act Substances
Inventory (EPA Document No. EPA-560/7-85-002a); and
``(iii) treat all components of categories that are
considered to be statutory mixtures under this Act as being
included on the list published under paragraph (1) under the
Chemical Abstracts Service numbers for the respective
categories, including, without limitation--
``(I) cement, Portland, chemicals, CAS No. 65997-15-1;
``(II) cement, alumina, chemicals, CAS No. 65997-16-2;
``(III) glass, oxide, chemicals, CAS No. 65997-17-3;
``(IV) frits, chemicals, CAS No. 65997-18-4;
``(V) steel manufacture, chemicals, CAS No. 65997-19-5; and
``(VI) ceramic materials and wares, chemicals, CAS No.
66402-68-4.
``(B) Multiple nomenclature conventions.--
``(i) In general.--If an existing guidance allows for
multiple nomenclature conventions, the Administrator shall--
``(I) maintain the nomenclature conventions for substances;
and
``(II) develop new guidance that--
``(aa) establishes equivalency between the nomenclature
conventions for chemical substances on the list published
under paragraph (1); and
``(bb) permits persons to rely on the new guidance for
purposes of determining whether a chemical substance is on
the list published under paragraph (1).
``(ii) Multiple cas numbers.--For any chemical substance
appearing multiple times on the list under different Chemical
Abstracts Service numbers, the Administrator shall develop
guidance recognizing the multiple listings as a single
chemical substance.
``(4) Chemical substances in commerce.--
``(A) Rules.--
``(i) In general.--Not later than 1 year after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator, by rule, shall require
manufacturers and processors to notify the Administrator, by
not later than 180 days after the date of promulgation of the
rule, of each chemical substance on the list published under
paragraph (1) that the manufacturer or processor, as
applicable, has manufactured or processed for a nonexempt
commercial purpose during the 10-year period ending on the
day before the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act.
``(ii) Active substances.--The Administrator shall
designate chemical substances for which notices are received
under clause (i) to be active substances on the list
published under paragraph (1).
``(iii) Inactive substances.--The Administrator shall
designate chemical substances for which no notices are
received under clause (i) to be inactive substances on the
list published under paragraph (1).
``(B) Confidential chemical substances.--In promulgating
the rule established pursuant to subparagraph (A), the
Administrator shall--
``(i) maintain the list under paragraph (1), which shall
include a confidential portion and a nonconfidential portion
consistent with this section and section 14;
``(ii) require a manufacturer or processor that is
submitting a notice pursuant to subparagraph (A) for a
chemical substance on the confidential portion of the list
published under paragraph (1) to indicate in the notice
whether the manufacturer or processor seeks to maintain any
existing claim for protection against disclosure of the
specific identity of the substance as confidential pursuant
to section 14; and
``(iii) require the substantiation of those claims pursuant
to section 14 and in accordance with the review plan
described in subparagraph (C).
``(C) Review plan.--Not later than 1 year after the date on
which the Administrator compiles the initial list of active
substances pursuant to subparagraph (A), the Administrator
shall promulgate a rule that establishes a plan to review all
claims to protect the specific identities of chemical
substances on the confidential portion of the list published
under paragraph (1) that are asserted pursuant to
subparagraph (B).
``(D) Requirements of review plan.--Under the review plan
under subparagraph (C), the Administrator shall--
``(i) require, at the time requested by the Administrator,
all manufacturers or processors asserting claims under
subparagraph (B) to substantiate the claim unless the
manufacturer or processor has substantiated the claim in a
submission made to the Administrator during the 5-year period
ending on the date of the request by the Administrator;
``(ii) in accordance with section 14--
``(I) review each substantiation--
``(aa) submitted pursuant to clause (i) to determine if the
claim warrants protection from disclosure; and
``(bb) submitted previously by a manufacturer or processor
and relied on in lieu of the substantiation required pursuant
to clause (i), if the substantiation has not been previously
reviewed by the Administrator, to determine if the claim
warrants protection from disclosure;
``(II) approve, modify, or deny each claim; and
``(III) except as provided in this section and section 14,
protect from disclosure information
[[Page H2998]]
for which the Administrator approves such a claim for a
period of 10 years, unless, prior to the expiration of the
period--
``(aa) the person notifies the Administrator that the
person is withdrawing the claim, in which case the
Administrator shall promptly make the information available
to the public; or
``(bb) the Administrator otherwise becomes aware that the
need for protection from disclosure can no longer be
substantiated, in which case the Administrator shall take the
actions described in section 14(g)(2); and
``(iii) encourage manufacturers or processors that have
previously made claims to protect the specific identities of
chemical substances identified as inactive pursuant to
subsection (f)(2) to review and either withdraw or
substantiate the claims.
``(E) Timeline for completion of reviews.--
``(i) In general.--The Administrator shall implement the
review plan so as to complete reviews of all claims specified
in subparagraph (C) not later than 5 years after the date on
which the Administrator compiles the initial list of active
substances pursuant to subparagraph (A).
``(ii) Considerations.--
``(I) In general.--The Administrator may extend the
deadline for completion of the reviews for not more than 2
additional years, after an adequate public justification, if
the Administrator determines that the extension is necessary
based on the number of claims needing review and the
available resources.
``(II) Annual review goal and results.--At the beginning of
each year, the Administrator shall publish an annual goal for
reviews and the number of reviews completed in the prior
year.
``(5) Active and inactive substances.--
``(A) In general.--The Administrator shall maintain and
keep current designations of active substances and inactive
substances on the list published under paragraph (1).
``(B) Change to active status.--
``(i) In general.--Any person that intends to manufacture
or process for a nonexempt commercial purpose a chemical
substance that is designated as an inactive substance shall
notify the Administrator before the date on which the
inactive substance is manufactured or processed.
``(ii) Confidential chemical identity claims.--If a person
submitting a notice under clause (i) for an inactive
substance on the confidential portion of the list published
under paragraph (1) seeks to maintain an existing claim for
protection against disclosure of the specific identity of the
inactive substance as confidential, the person shall--
``(I) in the notice submitted under clause (i), assert the
claim; and
``(II) by not later than 30 days after providing the notice
under clause (i), substantiate the claim.
``(iii) Active status.--On receiving a notification under
clause (i), the Administrator shall--
``(I) designate the applicable chemical substance as an
active substance;
``(II) pursuant to section 14, promptly review any claim
and associated substantiation submitted pursuant to clause
(ii) for protection against disclosure of the specific
identity of the chemical substance and approve, modify, or
deny the claim;
``(III) except as provided in this section and section 14,
protect from disclosure the specific identity of the chemical
substance for which the Administrator approves a claim under
subclause (II) for a period of 10 years, unless, prior to the
expiration of the period--
``(aa) the person notifies the Administrator that the
person is withdrawing the claim, in which case the
Administrator shall promptly make the information available
to the public; or
``(bb) the Administrator otherwise becomes aware that the
need for protection from disclosure can no longer be
substantiated, in which case the Administrator shall take the
actions described in section 14(g)(2); and
``(IV) pursuant to section 4A, review the priority of the
chemical substance as the Administrator determines to be
necessary.
``(C) Category status.--The list of inactive substances
shall not be considered to be a category for purposes of
section 26(c).
``(6) Interim list of active substances.--Prior to the
promulgation of the rule required under paragraph (4)(A), the
Administrator shall designate the chemical substances
reported under part 711 of title 40, Code of Federal
Regulations (as in effect on the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st Century
Act), during the reporting period that most closely preceded
the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, as the interim list of
active substances for the purposes of section 4A.
``(7) Public information.--Subject to this subsection, the
Administrator shall make available to the public--
``(A) the specific identity of each chemical substance on
the nonconfidential portion of the list published under
paragraph (1) that the Administrator has designated as--
``(i) an active substance; or
``(ii) an inactive substance;
``(B) the accession number, generic name, and, if
applicable, premanufacture notice case number for each
chemical substance on the confidential portion of the list
published under paragraph (1) for which a claim of
confidentiality was received; and
``(C) subject to subsections (f) and (g) of section 14, the
specific identity of any active substance for which--
``(i) a claim for protection against disclosure of the
specific identity of the active chemical substance was not
asserted, as required under this subsection or subsection (d)
or (f) of section 14;
``(ii) a claim for protection against disclosure of the
specific identity of the active substance has been denied by
the Administrator; or
``(iii) the time period for protection against disclosure
of the specific identity of the active substance has expired.
``(8) Limitation.--No person may assert a new claim under
this subsection for protection from disclosure of a specific
identity of any active or inactive chemical substance for
which a notice is received under paragraph (4)(A)(i) or
(5)(C)(i) that is not on the confidential portion of the list
published under paragraph (1).
``(9) Certification.--Under the rules promulgated under
this subsection, manufacturers and processors shall be
required--
``(A) to certify that each notice or substantiation the
manufacturer or processor submits complies with the
requirements of the rule, and that any confidentiality claims
are true and correct; and
``(B) to retain a record supporting the certification for a
period of 5 years beginning on the last day of the submission
period.'';
(3) in subsection (e)--
(A) by striking ``Any person'' and inserting the following:
``(1) In general.--Any person''; and
(B) by adding at the end the following:
``(2) Additional information.--Any person may submit to the
Administrator information reasonably supporting the
conclusion that a chemical substance or mixture presents,
will present, or does not present a substantial risk of
injury to health and the environment.''; and
(4) in subsection (f), by striking ``For purposes of this
section, the'' and inserting the following: ``In this
section:
``(1) Active substance.--The term `active substance' means
a chemical substance--
``(A) that has been manufactured or processed for a
nonexempt commercial purpose at any point during the 10-year
period ending on the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act;
``(B) that is added to the list published under subsection
(b)(1) after that date of enactment; or
``(C) for which a notice is received under subsection
(b)(5)(C).
``(2) Inactive substance.--The term `inactive substance'
means a chemical substance on the list published under
subsection (b)(1) that does not meet any of the criteria
described in paragraph (1).
``(3) Manufacture; process.--The''.
SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS.
Section 9 of the Toxic Substances Control Act (15 U.S.C.
2608) is amended--
(1) in subsection (a)--
(A) in paragraph (1), in the first sentence--
(i) by striking ``presents or will present an unreasonable
risk to health or the environment'' and inserting ``does not
or will not meet the safety standard''; and
(ii) by striking ``such risk'' the first place it appears
and inserting ``the risk posed by the substance or mixture'';
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``within the time
period specified by the Administrator in the report'' after
``issues an order'';
(ii) in subparagraph (B), by inserting ``responds within
the time period specified by the Administrator in the report
and'' before ``initiates, within 90 days''; and
(iii) in the matter following subparagraph (B), by striking
``section 6 or 7'' and inserting ``section 6(d) or section
7'';
(C) by redesignating paragraph (3) as paragraph (6);
(D) in paragraph (6) (as so redesignated), by striking
``section 6 or 7'' and inserting ``section 6(d) or 7''; and
(E) by inserting after paragraph (2) the following:
``(3) The Administrator shall take the actions described in
paragraph (4) if the Administrator makes a report under
paragraph (1) with respect to a chemical substance or mixture
and the agency to which the report was made does not--
``(A) issue the order described in paragraph (2)(A) within
the time period specified by the Administrator in the report;
or
``(B)(i) respond under paragraph (1) within the time frame
specified by the Administrator in the report; and
``(ii) initiate action within 90 days of publication in the
Federal Register of the response described in clause (i).
``(4) If an agency to which a report under paragraph (1)
does not take the actions described in subparagraphs (A) or
(B) of paragraph (3), the Administrator shall--
``(A) if a safety assessment and safety determination for
the substance under section 6 has not been completed,
complete the safety assessment and safety determination;
``(B) if the Administrator has determined or determines
that the chemical substance does not meet the safety
standard, initiate action under section 6(d) with respect to
the risk; or
``(C) take any action authorized or required under section
7, as appropriate.
``(5) This subsection shall not relieve the Administrator
of any obligation to complete a safety assessment and safety
determination or take any required action under section 6(d)
or 7 to address risks from the manufacture, processing,
distribution in commerce, use, or disposal of a chemical
substance or mixture, or any combination of those activities,
that are not identified in a report issued by the
Administrator under paragraph (1).'';
(2) in subsection (d), in the first sentence, by striking
``Health, Education, and Welfare'' and inserting ``Health and
Human Services''; and
(3) by adding at the end the following:
``(e) Exposure Information.--If the Administrator obtains
information related to exposures or releases of a chemical
substance that may be
[[Page H2999]]
prevented or reduced under another Federal law, including
laws not administered by the Administrator, the Administrator
shall make such information available to the relevant Federal
agency or office of the Environmental Protection Agency.''.
SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION,
AND UTILIZATION OF DATA.
Section 10 of the Toxic Substances Control Act (15 U.S.C.
2609) is amended by striking ``Health, Education, and
Welfare'' each place it appears and inserting ``Health and
Human Services''.
SEC. 13. EXPORTS.
Section 12 of the Toxic Substances Control Act (15 U.S.C.
2611) is amended--
(1) in subsection (a), by striking paragraph (2) and
inserting the following:
``(2) Exception.--Paragraph (1) shall not apply to--
``(A) any new chemical substance that the Administrator
determines is likely to present an unreasonable risk of
injury to health within the United States or to the
environment of the United States, without taking into account
cost or other non-risk factors;
``(B) any chemical substance that the Administrator
determines presents or will present an unreasonable risk of
injury to health within the United States or to the
environment of the United States, without taking into account
cost or other non-risk factors; or
``(C) any chemical substance that--
``(i) the Administrator determines is likely to present an
unreasonable risk of injury to health within the United
States or to the environment of the United States, without
taking into account cost or other non-risk factors; and
``(ii) is subject to restriction under section 5(d)(4).
``(3) Waivers for certain mixtures and articles.--For a
mixture or article containing a chemical substance described
in paragraph (2), the Administrator may--
``(A) determine that paragraph (1) shall not apply to the
mixture or article; or
``(B) establish a threshold concentration in a mixture or
article at which paragraph (1) shall not apply.
``(4) Testing.--The Administrator may require testing under
section 4 of any chemical substance or mixture exempted from
this Act under paragraph (1) for the purpose of determining
whether the chemical substance meets the safety standard
within the United States.'';
(2) by striking subsection (b) and inserting the following:
``(b) Notice.--
``(1) In general.--A person shall notify the Administrator
that the person is exporting or intends to export to a
foreign country--
``(A) a chemical substance or a mixture containing a
chemical substance that the Administrator has determined
under section 5 is not likely to meet the safety standard and
for which a prohibition or other restriction has been
proposed or established under that section;
``(B) a chemical substance or a mixture containing a
chemical substance that the Administrator has determined
under section 6 does not meet the safety standard and for
which a prohibition or other restriction has been proposed or
established under that section;
``(C) a chemical substance for which the United States is
obligated by treaty to provide export notification;
``(D) a chemical substance or mixture containing a chemical
substance subject to a proposed or promulgated significant
new use rule, or a prohibition or other restriction pursuant
to a rule, order, or consent agreement in effect under this
Act;
``(E) a chemical substance or mixture for which the
submission of information is required under section 4; or
``(F) a chemical substance or mixture for which an action
is pending or for which relief has been granted under section
7.
``(2) Rules.--
``(A) In general.--The Administrator shall promulgate rules
to carry out paragraph (1).
``(B) Contents.--The rules promulgated pursuant to
subparagraph (A) shall--
``(i) include such exemptions as the Administrator
determines to be appropriate, which may include exemptions
identified under section 5(h); and
``(ii) indicate whether, or to what extent, the rules apply
to articles containing a chemical substance or mixture
described in paragraph (1).
``(3) Notification.--The Administrator shall submit to the
government of each country to which a chemical substance or
mixture is exported--
``(A) for a chemical substance or mixture described in
subparagraph (A), (B), (D), or (F) of paragraph (1), a notice
of the determination, rule, order, consent agreement, action,
relief, or requirement;
``(B) for a chemical substance described in paragraph
(1)(C), a notice that satisfies the obligation of the United
States under the applicable treaty; and
``(C) for a chemical substance or mixture described in
paragraph (1)(E), a notice of availability of the information
on the chemical substance or mixture submitted to the
Administrator.''; and
(3) in subsection (c), by striking paragraph (3).
SEC. 14. CONFIDENTIAL INFORMATION.
Section 14 of the Toxic Substances Control Act (15 U.S.C.
2613) is amended to read as follows:
``SEC. 14. CONFIDENTIAL INFORMATION.
``(a) In General.--Except as otherwise provided in this
section, the Administrator shall not disclose information
that is exempt from disclosure pursuant to subsection (a) of
section 552 of title 5, United States Code, under subsection
(b)(4) of that section--
``(1) that is reported to, or otherwise obtained by, the
Administrator under this Act; and
``(2) for which the requirements of subsection (d) are met.
``(b) Information Generally Protected From Disclosure.--The
following information specific to, and submitted by, a
manufacturer, processor, or distributor that meets the
requirements of subsections (a) and (d) shall be presumed to
be protected from disclosure, subject to the condition that
nothing in this Act prohibits the disclosure of any such
information, or information that is the subject of subsection
(g)(3), through discovery, subpoena, other court order, or
any other judicial process otherwise allowed under applicable
Federal or State law:
``(1) Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture,
or article.
``(2) Marketing and sales information.
``(3) Information identifying a supplier or customer.
``(4) Details of the full composition of a mixture and the
respective percentages of constituents.
``(5) Specific information regarding the use, function, or
application of a chemical substance or mixture in a process,
mixture, or product.
``(6) Specific production or import volumes of the
manufacturer.
``(7) Specific aggregated volumes across manufacturers, if
the Administrator determines that disclosure of the specific
aggregated volumes would reveal confidential information.
``(8) Except as otherwise provided in this section, the
specific identity of a chemical substance prior to the date
on which the chemical substance is first offered for
commercial distribution, including the chemical name,
molecular formula, Chemical Abstracts Service number, and
other information that would identify a specific chemical
substance, if the specific identity was claimed as
confidential information at the time it was submitted in a
notice under section 5.
``(c) Information Not Protected From Disclosure.--
``(1) In general.--Notwithstanding subsections (a) and (b),
the following information shall not be protected from
disclosure:
``(A) Information from health and safety studies.--
``(i) In general.--Subject to clause (ii)--
``(I) any health and safety study that is submitted under
this Act with respect to--
``(aa) any chemical substance or mixture that, on the date
on which the study is to be disclosed, has been offered for
commercial distribution; or
``(bb) any chemical substance or mixture for which--
``(AA) testing is required under section 4; or
``(BB) a notification is required under section 5; or
``(II) any information reported to, or otherwise obtained
by, the Administrator from a health and safety study relating
to a chemical substance or mixture described in item (aa) or
(bb) of subclause (I).
``(ii) Effect of subparagraph.--Nothing in this
subparagraph authorizes the release of any information that
discloses--
``(I) a process used in the manufacturing or processing of
a chemical substance or mixture; or
``(II) in the case of a mixture, the portion of the mixture
comprised by any chemical substance in the mixture.
``(B) Other information not protected from disclosure.--
``(i) For information submitted after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, the specific identity of a chemical substance as
of the date on which the chemical substance is first offered
for commercial distribution, if the person submitting the
information does not meet the requirements of subsection (d).
``(ii) A safety assessment developed, or a safety
determination made, under section 6.
``(iii) Any general information describing the
manufacturing volumes, expressed as specific aggregated
volumes or, if the Administrator determines that disclosure
of specific aggregated volumes would reveal confidential
information, expressed in ranges.
``(iv) A general description of a process used in the
manufacture or processing and industrial, commercial, or
consumer functions and uses of a chemical substance, mixture,
or article containing a chemical substance or mixture,
including information specific to an industry or industry
sector that customarily would be shared with the general
public or within an industry or industry sector.
``(2) Mixed confidential and nonconfidential information.--
Any information that is eligible for protection under this
section and is submitted with information described in this
subsection shall be protected from disclosure, if the
submitter complies with subsection (d), subject to the
condition that information in the submission that is not
eligible for protection against disclosure shall be
disclosed.
``(3) Ban or phase-out.--If the Administrator promulgates a
rule pursuant to section 6(d) that establishes a ban or
phase-out of the manufacture, processing, or distribution in
commerce of a chemical substance, subject to paragraphs (2),
(3), and (4) of subsection (g), any protection from
disclosure provided under this section with respect to the
specific identity of the chemical substance and other
information relating to the chemical substance shall no
longer apply.
``(4) Certain requests.--If a request is made to the
Administrator under section 552(a) of title 5, United States
Code, for information that is subject to disclosure under
this subsection, the Administrator may not deny the request
on the basis of section 552(b)(4) of title 5, United States
Code.
``(d) Requirements for Confidentiality Claims.--
[[Page H3000]]
``(1) Assertion of claims.--
``(A) In general.--A person seeking to protect any
information submitted under this Act from disclosure
(including information described in subsection (b)) shall
assert to the Administrator a claim for protection concurrent
with submission of the information, in accordance with such
rules regarding a claim for protection from disclosure as the
Administrator has promulgated or may promulgate pursuant to
this title.
``(B) Inclusion.--An assertion of a claim under
subparagraph (A) shall include a statement that the person
has--
``(i) taken reasonable measures to protect the
confidentiality of the information;
``(ii) determined that the information is not required to
be disclosed or otherwise made available to the public under
any other Federal law;
``(iii) a reasonable basis to conclude that disclosure of
the information is likely to cause substantial harm to the
competitive position of the person; and
``(iv) a reasonable basis to believe that the information
is not readily discoverable through reverse engineering.
``(C) Specific chemical identity.--In the case of a claim
under subparagraph (A) for protection against disclosure of a
specific chemical identity, the claim shall include a
structurally descriptive generic name for the chemical
substance that the Administrator may disclose to the public,
subject to the condition that the generic name shall--
``(i) be consistent with guidance issued by the
Administrator under paragraph (3)(A); and
``(ii) describe the chemical structure of the substance as
specifically as practicable while protecting those features
of the chemical structure--
``(I) that are considered to be confidential; and
``(II) the disclosure of which would be likely to cause
substantial harm to the competitive position of the person.
``(D) Public information.--No person may assert a claim
under this section for protection from disclosure of
information that is already publicly available.
``(2) Additional requirements for confidentiality claims.--
Except for information described in subsection (b), a person
asserting a claim to protect information from disclosure
under this Act shall substantiate the claim, in accordance
with the rules promulgated and consistent with the guidance
issued by the Administrator.
``(3) Guidance.--The Administrator shall develop guidance
regarding--
``(A) the determination of structurally descriptive generic
names, in the case of claims for the protection against
disclosure of specific chemical identity; and
``(B) the content and form of the statements of need and
agreements required under paragraphs (4), (5), and (6) of
subsection (e).
``(4) Certification.--An authorized official of a person
described in paragraph (1)(A) shall certify that the
statement required to assert a claim submitted pursuant to
paragraph (1)(B) and any information required to substantiate
a claim submitted pursuant to paragraph (2) are true and
correct.
``(e) Exceptions to Protection From Disclosure.--
Information described in subsection (a)--
``(1) shall be disclosed if the information is to be
disclosed to an officer or employee of the United States in
connection with the official duties of the officer or
employee--
``(A) under any law for the protection of health or the
environment; or
``(B) for a specific law enforcement purpose;
``(2) shall be disclosed if the information is to be
disclosed to a contractor of the United States and employees
of that contractor--
``(A) if, in the opinion of the Administrator, the
disclosure is necessary for the satisfactory performance by
the contractor of a contract with the United States for the
performance of work in connection with this Act; and
``(B) subject to such conditions as the Administrator may
specify;
``(3) shall be disclosed if the Administrator determines
that disclosure is necessary to protect health or the
environment;
``(4) shall be disclosed if the information is to be
disclosed to a State or political subdivision of a State, on
written request, for the purpose of development,
administration, or enforcement of a law, if 1 or more
applicable agreements with the Administrator that are
consistent with the guidance issued under subsection
(d)(3)(B) ensure that the recipient will take appropriate
measures, and has adequate authority, to maintain the
confidentiality of the information in accordance with
procedures comparable to the procedures used by the
Administrator to safeguard the information;
``(5) shall be disclosed if a health or environmental
professional employed by a Federal or State agency or a
treating physician or nurse in a nonemergency situation
provides a written statement of need and agrees to sign a
written confidentiality agreement with the Administrator,
subject to the conditions that--
``(A) the statement of need and confidentiality agreement
are consistent with the guidance issued under subsection
(d)(3)(B);
``(B) the written statement of need shall be a statement
that the person has a reasonable basis to suspect that--
``(i) the information is necessary for, or will assist in--
``(I) the diagnosis or treatment of 1 or more individuals;
or
``(II) responding to an environmental release or exposure;
and
``(ii) 1 or more individuals being diagnosed or treated
have been exposed to the chemical substance concerned, or an
environmental release or exposure has occurred; and
``(C) the confidentiality agreement shall provide that the
person will not use the information for any purpose other
than the health or environmental needs asserted in the
statement of need, except as otherwise may be authorized by
the terms of the agreement or by the person submitting the
information to the Administrator, except that nothing in this
Act prohibits the disclosure of any such information through
discovery, subpoena, other court order, or any other judicial
process otherwise allowed under applicable Federal or State
law;
``(6) shall be disclosed if in the event of an emergency, a
treating physician, nurse, agent of a poison control center,
public health or environmental official of a State or
political subdivision of a State, or first responder
(including any individual duly authorized by a Federal
agency, State, or political subdivision of a State who is
trained in urgent medical care or other emergency procedures,
including a police officer, firefighter, or emergency medical
technician) requests the information, subject to the
conditions that--
``(A) the treating physician, nurse, agent, public health
or environmental official of a State or a political
subdivision of a State, or first responder shall have a
reasonable basis to suspect that--
``(i) a medical or public health or environmental emergency
exists;
``(ii) the information is necessary for, or will assist in,
emergency or first-aid diagnosis or treatment; or
``(iii) 1 or more individuals being diagnosed or treated
have likely been exposed to the chemical substance concerned,
or a serious environmental release of or exposure to the
chemical substance concerned has occurred;
``(B) if requested by the person submitting the information
to the Administrator, the treating physician, nurse, agent,
public health or environmental official of a State or a
political subdivision of a State, or first responder shall,
as described in paragraph (5)--
``(i) provide a written statement of need; and
``(ii) agree to sign a confidentiality agreement; and
``(C) the written confidentiality agreement or statement of
need shall be submitted as soon as practicable, but not
necessarily before the information is disclosed;
``(7) may be disclosed if the Administrator determines that
disclosure is relevant in a proceeding under this Act,
subject to the condition that the disclosure shall be made in
such a manner as to preserve confidentiality to the maximum
extent practicable without impairing the proceeding;
``(8) shall be disclosed if the information is to be
disclosed, on written request of any duly authorized
congressional committee, to that committee; or
``(9) shall be disclosed if the information is required to
be disclosed or otherwise made public under any other
provision of Federal law.
``(f) Duration of Protection From Disclosure.--
``(1) In general.--
``(A) Information not subject to time limit for protection
from disclosure.--Subject to paragraph (2), the Administrator
shall protect from disclosure information described in
subsection (b) that meets the requirements of subsections (a)
and (d), unless--
``(i) the person that asserted the claim notifies the
Administrator that the person is withdrawing the claim, in
which case the Administrator shall promptly make the
information available to the public; or
``(ii) the Administrator otherwise becomes aware that the
information does not qualify or no longer qualifies for
protection against disclosure under subsection (a), in which
case the Administrator shall take any actions required under
subsection (g)(2).
``(B) Information subject to time limit for protection from
disclosure.--Subject to paragraph (2), the Administrator
shall protect from disclosure information, other than
information described in subsection (b), that meets the
requirements of subsections (a) and (d) for a period of 10
years, unless, prior to the expiration of the period--
``(i) the person that asserted the claim notifies the
Administrator that the person is withdrawing the claim, in
which case the Administrator shall promptly make the
information available to the public; or
``(ii) the Administrator otherwise becomes aware that the
information does not qualify or no longer qualifies for
protection against disclosure under subsection (a), in which
case the Administrator shall take any actions required under
subsection (g)(2).
``(C) Extensions.--
``(i) In general.--Not later than the date that is 60 days
before the expiration of the period described in subparagraph
(B), the Administrator shall provide to the person that
asserted the claim a notice of the impending expiration of
the period.
``(ii) Statement.--
``(I) In general.--Not later than the date that is 30 days
before the expiration of the period described in subparagraph
(B), a person reasserting the relevant claim shall submit to
the Administrator a request for extension substantiating, in
accordance with subsection (d)(2), the need to extend the
period.
``(II) Action by administrator.--Not later than the date of
expiration of the period described in subparagraph (B), the
Administrator shall, in accordance with subsection
(g)(1)(C)--
``(aa) review the request submitted under subclause (I);
``(bb) make a determination regarding whether the claim for
which the request was submitted continues to meet the
relevant criteria established under this section; and
``(cc)(AA) grant an extension of 10 years; or
``(BB) deny the request.
``(D) No limit on number of extensions.--There shall be no
limit on the number of extensions granted under subparagraph
(C), if the
[[Page H3001]]
Administrator determines that the relevant request under
subparagraph (C)(ii)(I)--
``(i) establishes the need to extend the period; and
``(ii) meets the requirements established by the
Administrator.
``(2) Review and resubstantiation.--
``(A) Discretion of administrator.--The Administrator may
review, at any time, a claim for protection of information
against disclosure under subsection (a) and require any
person that has claimed protection for that information,
whether before, on, or after the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st Century Act,
to withdraw or reassert and substantiate or resubstantiate
the claim in accordance with this section--
``(i) after the chemical substance is identified as a high-
priority substance under section 4A;
``(ii) for any chemical substance for which the
Administrator has made a determination under section
6(c)(1)(C);
``(iii) for any inactive chemical substance identified
under section 8(b)(5); or
``(iv) in limited circumstances, if the Administrator
determines that disclosure of certain information currently
protected from disclosure would assist the Administrator in
conducting safety assessments and safety determinations under
subsections (b) and (c) of section 6 or promulgating rules
pursuant to section 6(d).
``(B) Review required.--The Administrator shall review a
claim for protection of information against disclosure under
subsection (a) and require any person that has claimed
protection for that information, whether before, on, or after
the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, to withdraw or reassert and
substantiate or resubstantiate the claim in accordance with
this section--
``(i) as necessary to determine whether the information
qualifies for an exemption from disclosure in connection with
a request for information received by the Administrator under
section 552 of title 5, United States Code;
``(ii) if the Administrator has a reasonable basis to
believe that the information does not qualify for protection
against disclosure under subsection (a); or
``(iii) for any substance for which the Administrator has
made a determination under section 6(c)(1)(B).
``(C) Action by recipient.--If the Administrator makes a
request under subparagraph (A) or (B), the recipient of the
request shall--
``(i) reassert and substantiate or resubstantiate the
claim; or
``(ii) withdraw the claim.
``(D) Period of protection.--Protection from disclosure of
information subject to a claim that is reviewed and approved
by the Administrator under this paragraph shall be extended
for a period of 10 years from the date of approval, subject
to any subsequent request by the Administrator under this
paragraph.
``(3) Unique identifier.--The Administrator shall--
``(A)(i) develop a system to assign a unique identifier to
each specific chemical identity for which the Administrator
approves a request for protection from disclosure, other than
a specific chemical identity or structurally descriptive
generic term; and
``(ii) apply that identifier consistently to all
information relevant to the applicable chemical substance;
``(B) annually publish and update a list of chemical
substances, referred to by unique identifier, for which
claims to protect the specific chemical identity from
disclosure have been approved, including the expiration date
for each such claim;
``(C) ensure that any nonconfidential information received
by the Administrator with respect to such a chemical
substance during the period of protection from disclosure--
``(i) is made public; and
``(ii) identifies the chemical substance using the unique
identifier; and
``(D) for each claim for protection of specific chemical
identity that has been denied by the Administrator or
expired, or that has been withdrawn by the submitter, provide
public access to the specific chemical identity clearly
linked to all nonconfidential information received by the
Administrator with respect to the chemical substance.
``(g) Duties of Administrator.--
``(1) Determination.--
``(A) In general.--Except as provided in subsection (b),
the Administrator shall, subject to subparagraph (C), not
later than 90 days after the receipt of a claim under
subsection (d), and not later than 30 days after the receipt
of a request for extension of a claim under subsection (f),
review and approve, modify, or deny the claim or request.
``(B) Reasons for denial or modification.--If the
Administrator denies or modifies a claim or request under
subparagraph (A), the Administrator shall provide to the
person that submitted the claim or request a written
statement of the reasons for the denial or modification of
the claim or request.
``(C) Subsets.--The Administrator shall--
``(i) except for claims described in subsection (b)(8),
review all claims or requests under this section for the
protection against disclosure of the specific identity of a
chemical substance; and
``(ii) review a representative subset, comprising at least
25 percent, of all other claims or requests for protection
against disclosure.
``(D) Effect of failure to act.--The failure of the
Administrator to make a decision regarding a claim or request
for protection against disclosure or extension under this
section shall not be the basis for denial or elimination of a
claim or request for protection against disclosure.
``(2) Notification.--
``(A) In general.--Except as provided in subparagraph (B)
and subsections (c), (e), and (f), if the Administrator
denies or modifies a claim or request under paragraph (1),
intends to release information pursuant to subsection (e), or
promulgates a rule under section 6(d) establishing a ban or
phase-out of a chemical substance, the Administrator shall
notify, in writing and by certified mail, the person that
submitted the claim of the intent of the Administrator to
release the information.
``(B) Release of information.--Except as provided in
subparagraph (C), the Administrator shall not release
information under this subsection until the date that is 30
days after the date on which the person that submitted the
request receives notification under subparagraph (A).
``(C) Exceptions.--
``(i) In general.--For information under paragraph (3) or
(8) of subsection (e), the Administrator shall not release
that information until the date that is 15 days after the
date on which the person that submitted the claim or request
receives a notification, unless the Administrator determines
that release of the information is necessary to protect
against an imminent and substantial harm to health or the
environment, in which case no prior notification shall be
necessary.
``(ii) Notification as soon as practicable.--For
information under paragraphs (4) and (6) of subsection (e),
the Administrator shall notify the person that submitted the
information that the information has been disclosed as soon
as practicable after disclosure of the information.
``(iii) No notification required.--Notification shall not
be required--
``(I) for the disclosure of information under paragraph
(1), (2), (7), or (9) of subsection (e); or
``(II) for the disclosure of information for which--
``(aa) a notice under subsection (f)(1)(C)(i) was received;
and
``(bb) no request was received by the Administrator on or
before the date of expiration of the period for which
protection from disclosure applies.
``(3) Rebuttable presumption.--
``(A) In general.--With respect to notifications provided
by the Administrator under paragraph (2) with respect to
information pertaining to a chemical substance subject to a
rule as described in subsection (c)(3), there shall be a
rebuttable presumption that the public interest in disclosing
confidential information related to a chemical substance
subject to a rule promulgated under section 6(d) that
establishes a ban or phase-out of the manufacture,
processing, or distribution in commerce of the substance
outweighs the proprietary interest in maintaining the
protection from disclosure of that information.
``(B) Request for nondisclosure.--A person that receives a
notification under paragraph (2) with respect to the
information described in subparagraph (A) may submit to the
Administrator, before the date on which the information is to
be released pursuant to paragraph (2)(B), a request with
supporting documentation describing why the person believes
some or all of that information should not be disclosed.
``(C) Determination by administrator.--
``(i) In general.--Not later than 30 days after the
Administrator receives a request under subparagraph (B), the
Administrator shall determine whether the documentation
provided by the person making the request rebuts or does not
rebut the presumption described in subparagraph (A), for all
or a portion of the information that the person has requested
not be disclosed.
``(ii) Objective.--The Administrator shall make the
determination with the objective of ensuring that information
relevant to protection of health and the environment is
disclosed to the maximum extent practicable.
``(D) Timing.--Not later than 30 days after making the
determination described in subparagraph (C), the
Administrator shall make public the information the
Administrator has determined is not to be protected from
disclosure.
``(E) No timely request received.--If the Administrator
does not receive, before the date on which the information
described in subparagraph (A) is to be released pursuant to
paragraph (2)(B), a request pursuant to subparagraph (B), the
Administrator shall promptly make public all of the
information.
``(4) Appeals.--
``(A) In general.--If a person receives a notification
under paragraph (2) and believes disclosure of the
information is prohibited under subsection (a), before the
date on which the information is to be released pursuant to
paragraph (2)(B), the person may bring an action to restrain
disclosure of the information in--
``(i) the United States district court of the district in
which the complainant resides or has the principal place of
business; or
``(ii) the United States District Court for the District of
Columbia.
``(B) No disclosure.--The Administrator shall not disclose
any information that is the subject of an appeal under this
section before the date on which the applicable court rules
on an action under subparagraph (A).
``(5) Request and notification system.--The Administrator,
in consultation with the Director of the Centers for Disease
Control and Prevention, shall develop a request and
notification system that allows for expedient and swift
access to information disclosed pursuant to paragraphs (5)
and (6) of subsection (e) in a format and language that is
readily accessible and understandable.
``(h) Criminal Penalty for Wrongful Disclosure.--
``(1) Officers and employees of united states.--
``(A) In general.--Subject to paragraph (2), a current or
former officer or employee of the United States described in
subparagraph (B) shall be guilty of a misdemeanor and fined
under title 18, United States Code, or imprisoned for not
more than 1 year, or both.
[[Page H3002]]
``(B) Description.--A current or former officer or employee
of the United States referred to in subparagraph (A) is a
current or former officer or employee of the United States
who--
``(i) by virtue of that employment or official position has
obtained possession of, or has access to, material the
disclosure of which is prohibited by subsection (a); and
``(ii) knowing that disclosure of that material is
prohibited by subsection (a), willfully discloses the
material in any manner to any person not entitled to receive
that material.
``(2) Other laws.--Section 1905 of title 18, United States
Code, shall not apply with respect to the publishing,
divulging, disclosure, making known of, or making available,
information reported or otherwise obtained under this Act.
``(3) Contractors.--For purposes of this subsection, any
contractor of the United States that is provided information
in accordance with subsection (e)(2), including any employee
of that contractor, shall be considered to be an employee of
the United States.
``(i) Applicability.--
``(1) In general.--Except as otherwise provided in this
section, section 8, or any other applicable Federal law, the
Administrator shall have no authority--
``(A) to require the substantiation or resubstantiation of
a claim for the protection from disclosure of information
reported to or otherwise obtained by the Administrator under
this Act before the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act; or
``(B) to impose substantiation or resubstantiation
requirements under this Act that are more extensive than
those required under this section.
``(2) Actions prior to promulgation of rules.--Nothing in
this Act prevents the Administrator from reviewing, requiring
substantiation or resubstantiation for, or approving,
modifying or denying any claim for the protection from
disclosure of information before the effective date of such
rules applicable to those claims as the Administrator may
promulgate after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.''.
SEC. 15. PROHIBITED ACTS.
Section 15 of the Toxic Substances Control Act (15 U.S.C.
2614) is amended by striking paragraph (1) and inserting the
following:
``(1) fail or refuse to comply with--
``(A) any rule promulgated, consent agreement entered into,
or order issued under section 4;
``(B) any requirement under section 5 or 6;
``(C) any rule promulgated, consent agreement entered into,
or order issued under section 5 or 6; or
``(D) any requirement of, or any rule promulgated or order
issued pursuant to title II;''.
SEC. 16. PENALTIES.
Section 16 of the Toxic Substances Control Act (15 U.S.C.
2615) is amended--
(1) in subsection (a)(1)--
(A) in the first sentence, by striking ``$25,000'' and
inserting ``$37,500''; and
(B) in the second sentence, by striking`` violation of
section 15 or 409'' and inserting ``violation of this Act'';
and
(2) in subsection (b)--
(A) by striking ``Any person who'' and inserting the
following:
``(1) In general.--Any person that'';
(B) by striking ``$25,000'' and inserting ``$50,000''; and
(C) by adding at the end the following:
``(2) Imminent danger of death or serious bodily injury.--
``(A) In general.--Any person that knowingly or willfully
violates any provision of section 15 or 409, and that knows
at the time of the violation that the violation places an
individual in imminent danger of death or serious bodily
injury, shall be subject on conviction to a fine of not more
than $250,000, or imprisonment for not more than 15 years, or
both.
``(B) Organizations.--An organization that commits a
violation described in subparagraph (A) shall be subject on
conviction to a fine of not more than $1,000,000 for each
violation.
``(C) Incorporation of corresponding provisions.--
Subparagraphs (B) through (F) of section 113(c)(5) of the
Clean Air Act (42 U.S.C. 7413(c)(5)) shall apply to the
prosecution of a violation under this paragraph.''.
SEC. 17. STATE-FEDERAL RELATIONSHIP.
Section 18 of the Toxic Substances Control Act (15 U.S.C.
2617) is amended by striking subsections (a) and (b) and
inserting the following:
``(a) In General.--
``(1) Establishment or enforcement.--Except as provided in
subsections (c), (d), (e), (f), and (g), and subject to
paragraph (2), no State or political subdivision of a State
may establish or continue to enforce any of the following:
``(A) Testing.--A statute or administrative action to
require the development of information on a chemical
substance or category of substances that is reasonably likely
to produce the same information required under section 4, 5,
or 6 in--
``(i) a rule promulgated by the Administrator;
``(ii) a testing consent agreement entered into by the
Administrator; or
``(iii) an order issued by the Administrator.
``(B) Chemical substances found to meet the safety standard
or restricted.--A statute or administrative action to
prohibit or otherwise restrict the manufacture, processing,
or distribution in commerce or use of a chemical substance--
``(i) found to meet the safety standard and consistent with
the scope of the determination made under section 6; or
``(ii) found not to meet the safety standard, after the
effective date of the rule issued under section 6(d) for the
substance, consistent with the scope of the determination
made by the Administrator.
``(C) Significant new use.--A statute or administrative
action requiring the notification of a use of a chemical
substance that the Administrator has specified as a
significant new use and for which the Administrator has
required notification pursuant to a rule promulgated under
section 5.
``(2) Effective date of preemption.--Under this subsection,
Federal preemption of statutes and administrative actions
applicable to specific substances shall not occur until the
effective date of the applicable action described in
paragraph (1) taken by the Administrator.
``(b) New Statutes or Administrative Actions Creating
Prohibitions or Other Restrictions.--
``(1) In general.--Except as provided in subsections (c),
(d), (e), (f), and (g), beginning on the date on which the
Administrator defines and publishes the scope of a safety
assessment and safety determination under section 6(a)(2) and
ending on the date on which the deadline established pursuant
to section 6(a) for completion of the safety determination
expires, or on the date on which the Administrator publishes
the safety determination under section 6(a), whichever is
earlier, no State or political subdivision of a State may
establish a statute or administrative action prohibiting or
restricting the manufacture, processing, distribution in
commerce or use of a chemical substance that is a high-
priority substance designated under section 4A.
``(2) Effect of subsection.--
``(A) In general.--This subsection does not restrict the
authority of a State or political subdivision of a State to
continue to enforce any statute enacted, or administrative
action taken, prior to the date on which the Administrator
defines and publishes the scope of a safety assessment and
safety determination under section 6(a)(2).
``(B) Limitation.--Subparagraph (A) does not allow a State
or political subdivision of a State to enforce any new
prohibition or restriction under a statute or administrative
action described in that subparagraph, if the prohibition or
restriction is established after the date described in that
subparagraph.
``(c) Scope of Preemption.--Federal preemption under
subsections (a) and (b) of statutes and administrative
actions applicable to specific substances shall apply only
to--
``(1) the chemical substances or category of substances
subject to a rule, order, or consent agreement under section
4;
``(2) the hazards, exposures, risks, and uses or conditions
of use of such substances that are identified by the
Administrator as subject to review in a safety assessment and
included in the scope of the safety determination made by the
Administrator for the substance, or of any rule the
Administrator promulgates pursuant to section 6(d); or
``(3) the uses of such substances that the Administrator
has specified as significant new uses and for which the
Administrator has required notification pursuant to a rule
promulgated under section 5.
``(d) Exceptions.--
``(1) No preemption of statutes and administrative
actions.--
``(A) In general.--Nothing in this Act, nor any amendment
made by this Act, nor any rule, standard of performance,
safety determination, or scientific assessment implemented
pursuant to this Act, shall affect the right of a State or a
political subdivision of a State to adopt or enforce any
rule, standard of performance, safety determination,
scientific assessment, or any protection for public health or
the environment that--
``(i) is adopted or authorized under the authority of any
other Federal law or adopted to satisfy or obtain
authorization or approval under any other Federal law;
``(ii) implements a reporting, monitoring, disclosure, or
other information obligation for the chemical substance not
otherwise required by the Administrator under this Act or
required under any other Federal law;
``(iii) is adopted pursuant to authority under a law of the
State or political subdivision of the State related to water
quality, air quality, or waste treatment or disposal, except
to the extent that the action--
``(I) imposes a restriction on the manufacture, processing,
distribution in commerce, or use of a chemical substance; and
``(II)(aa) addresses the same hazards and exposures, with
respect to the same conditions of use as are included in the
scope of the safety determination pursuant to section 6, but
is inconsistent with the action of the Administrator; or
``(bb) would cause a violation of the applicable action by
the Administrator under section 5 or 6; or
``(iv) subject to subparagraph (B), is identical to a
requirement prescribed by the Administrator.
``(B) Identical requirements.--
``(i) In general.--The penalties and other sanctions
applicable under a law of a State or political subdivision of
a State in the event of noncompliance with the identical
requirement shall be no more stringent than the penalties and
other sanctions available to the Administrator under section
16 of this Act.
``(ii) Penalties.--In the case of an identical
requirement--
``(I) a State or political subdivision of a State may not
assess a penalty for a specific violation for which the
Administrator has assessed an adequate penalty under section
16; and
``(II) if a State or political subdivision of a State has
assessed a penalty for a specific violation, the
Administrator may not assess a penalty for that violation in
an amount that would cause the total of the penalties
assessed for the violation by the State or political
subdivision of a State and the Administrator combined to
exceed the maximum amount that may be assessed
[[Page H3003]]
for that violation by the Administrator under section 16.
``(2) Applicability to certain rules or orders.--
Notwithstanding subsection (e)--
``(A) nothing in this section shall be construed as
modifying the effect under this section, as in effect on the
day before the effective date of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, of any rule or
order promulgated or issued under this Act prior to that
effective date; and
``(B) with respect to a chemical substance or mixture for
which any rule or order was promulgated or issued under
section 6 prior to the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act with
regards to manufacturing, processing, distribution in
commerce, use, or disposal of a chemical substance, this
section (as in effect on the day before the effective date of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act) shall govern the preemptive effect of any rule or order
that is promulgated or issued respecting such chemical
substance or mixture under section 6 of this Act after that
effective date, unless the latter rule or order is with
respect to a chemical substance or mixture containing a
chemical substance and follows a designation of that chemical
substance as a high-priority substance under subsection (b)
or (c) of section 4A or as an additional priority for safety
assessment and safety determination under section 4A(c).
``(e) Preservation of Certain Laws.--
``(1) In general.--Nothing in this Act, subject to
subsection (g) of this section, shall--
``(A) be construed to preempt or otherwise affect the
authority of a State or political subdivision of a State to
continue to enforce any action taken before August 1, 2015,
under the authority of a law of the State or political
subdivision of the State that prohibits or otherwise
restricts manufacturing, processing, distribution in
commerce, use, or disposal of a chemical substance; or
``(B) be construed to preempt or otherwise affect any
action taken pursuant to a State law that was in effect on
August 31, 2003.
``(2) Effect of subsection.--This subsection does not
affect, modify, or alter the relationship between Federal law
and laws of a State or political subdivision of a State
pursuant to any other Federal law.
``(f) Waivers.--
``(1) Discretionary exemptions.--Upon application of a
State or political subdivision of a State, the Administrator
may by rule, exempt from subsection (a), under such
conditions as may be prescribed in the rule, a statute or
administrative action of that State or political subdivision
of the State that relates to the effects of, or exposure to,
a chemical substance under the conditions of use if the
Administrator determines that--
``(A) compelling conditions warrant granting the waiver to
protect health or the environment;
``(B) compliance with the proposed requirement of the State
or political subdivision of the State would not unduly burden
interstate commerce in the manufacture, processing,
distribution in commerce, or use of a chemical substance;
``(C) compliance with the proposed requirement of the State
or political subdivision of the State would not cause a
violation of any applicable Federal law, rule, or order; and
``(D) in the judgment of the Administrator, the proposed
requirement of the State or political subdivision of the
State is designed to address a risk of a chemical substance,
under the conditions of use, that was identified--
``(i) consistent with the best available science;
``(ii) using supporting studies conducted in accordance
with sound and objective scientific practices; and
``(iii) based on the weight of the scientific evidence.
``(2) Required exemptions.--Upon application of a State or
political subdivision of a State, the Administrator shall
exempt from subsection (b) a statute or administrative action
of a State or political subdivision of a State that relates
to the effects of exposure to a chemical substance under the
conditions of use if the Administrator determines that--
``(A) compliance with the proposed requirement of the State
or political subdivision of the State would not unduly burden
interstate commerce in the manufacture, processing,
distribution in commerce, or use of a chemical substance;
``(B) compliance with the proposed requirement of the State
or political subdivision of the State would not cause a
violation of any applicable Federal law, rule, or order; and
``(C) the State or political subdivision of the State has a
concern about the chemical substance or use of the chemical
substance based in peer-reviewed science.
``(3) Determination of a waiver request.--The duty of the
Administrator to grant or deny a waiver application shall be
nondelegable and shall be exercised--
``(A) not later than 180 days after the date on which an
application under paragraph (1) is submitted; and
``(B) not later than 110 days after the date on which an
application under paragraph (2) is submitted.
``(4) Failure to make determination.--If the Administrator
fails to make a determination under paragraph (3)(B) during
the 110-day period beginning on the date on which an
application under paragraph (2) is submitted, the statute or
administrative action of the State or political subdivision
of the State that was the subject of the application shall
not be considered to be an existing statute or administrative
action for purposes of subsection (b) by reason of the
failure of the Administrator to make a determination.
``(5) Notice and comment.--Except in the case of an
application approved under paragraph (9), the application of
a State or political subdivision of a State shall be subject
to public notice and comment.
``(6) Final agency action.--The decision of the
Administrator on the application of a State or political
subdivision of a State shall be--
``(A) considered to be a final agency action; and
``(B) subject to judicial review.
``(7) Duration of waivers.--A waiver granted under
paragraph (2) or approved under paragraph (9) shall remain in
effect until such time as the Administrator publishes the
safety determination under section 6(a)(4).
``(8) Judicial review of waivers.--Not later than 60 days
after the date on which the Administrator makes a
determination on an application of a State or political
subdivision of a State under paragraph (1) or (2), any person
may file a petition for judicial review in the United States
Court of Appeals for the District of Columbia Circuit, which
shall have exclusive jurisdiction over the determination.
``(9) Approval.--
``(A) Automatic approval.--If the Administrator fails to
meet the deadline established under paragraph (3)(B), the
application of a State or political subdivision of a State
under paragraph (2) shall be automatically approved,
effective on the date that is 10 days after the deadline.
``(B) Requirements.--Notwithstanding paragraph (6),
approval of a waiver application under subparagraph (A) for
failure to meet the deadline under paragraph (3)(B) shall not
be considered final agency action or be subject to judicial
review or public notice and comment.
``(g) Savings.--
``(1) No preemption of common law or statutory causes of
action for civil relief or criminal conduct.--
``(A) In general.--Nothing in this Act, nor any amendment
made by this Act, nor any safety standard, rule, requirement,
standard of performance, safety determination, or scientific
assessment implemented pursuant to this Act, shall be
construed to preempt, displace, or supplant any state or
Federal common law rights or any state or Federal statute
creating a remedy for civil relief, including those for civil
damage, or a penalty for a criminal conduct.
``(B) Clarification of no preemption.--Notwithstanding any
other provision of this Act, nothing in this Act, nor any
amendments made by this Act, shall preempt or preclude any
cause of action for personal injury, wrongful death, property
damage, or other injury based on negligence, strict
liability, products liability, failure to warn, or any other
legal theory of liability under any State law, maritime law,
or Federal common law or statutory theory.
``(2) No effect on private remedies.--
``(A) In general.--Nothing in this Act, nor any amendments
made by this Act, nor any rules, regulations, requirements,
safety assessments, safety determinations, scientific
assessments, or orders issued pursuant to this Act shall be
interpreted as, in either the plaintiff's or defendant's
favor, dispositive in any civil action.
``(B) Authority of courts.--This Act does not affect the
authority of any court to make a determination in an
adjudicatory proceeding under applicable State or Federal law
with respect to the admission into evidence or any other use
of this Act or rules, regulations, requirements, standards of
performance, safety assessments, scientific assessments, or
orders issued pursuant to this Act.''.
SEC. 18. JUDICIAL REVIEW.
Section 19 of the Toxic Substances Control Act (15 U.S.C.
2618) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (A)--
(I) in the first sentence--
(aa) by striking ``Not'' and inserting ``Except as
otherwise provided in this title, not'';
(bb) by striking ``section 4(a), 5(a)(2), 5(b)(4), 6(a),
6(e), or 8, or under title II or IV'' and inserting ``this
title or title II or IV, or an order under section
6(c)(1)(A)''; and
(cc) by striking ``judicial review of such rule'' and
inserting ``judicial review of such rule or order''; and
(II) in the second sentence, by striking ``such a rule''
and inserting ``such a rule or order''; and
(ii) in subparagraph (B)--
(I) by striking ``Courts'' and inserting ``Except as
otherwise provided in this title, courts''; and
(II) by striking ``an order issued under subparagraph (A)
or (B) of section 6(b)(1)'' and inserting ``an order issued
under this title'';
(B) in paragraph (2), in the second sentence, by striking
``the filing of the rulemaking record of proceedings on which
the Administrator based the rule being reviewed'' and
inserting ``the filing of the record of proceedings on which
the Administrator based the rule or order being reviewed'';
and
(C) by striking paragraph (3) and inserting the following:
``(3) Judicial review of low-priority decisions.--
``(A) In general.--Not later than 60 days after the
publication of a designation under section 4A(b)(4), or a
designation under section 4A(b)(8) of a chemical substance as
a low-priority substance, any person may commence a civil
action to challenge the designation.
``(B) Jurisdiction.--The United States Court of Appeals for
the District of Columbia Circuit shall have exclusive
jurisdiction over a civil action filed under this
paragraph.''; and
(2) in subsection (c)(1)(B)--
(A) in clause (i)--
(i) by striking ``section 4(a), 5(b)(4), 6(a), or 6(e)''
and inserting ``section 4(a), 6(d), or 6(g), or an order
under section 6(c)(1)(A)''; and
(ii) by striking ``evidence in the rulemaking record (as
defined in subsection (a)(3)) taken as
[[Page H3004]]
a whole;'' and inserting ``evidence (including any matter) in
the rulemaking record, taken as a whole; and''; and
(B) by striking clauses (ii) and (iii) and the matter
following clause (iii) and inserting the following:
``(ii) the court may not review the contents and adequacy
of any statement of basis and purpose required by section
553(c) of title 5, United States Code, to be incorporated in
the rule, except as part of the rulemaking record, taken as a
whole.''.
SEC. 19. CITIZENS' CIVIL ACTIONS.
Section 20 of the Toxic Substances Control Act (15 U.S.C.
2619) is amended--
(1) in subsection (a)(1), by striking ``or order issued
under section 5'' and inserting ``or order issued under
section 4 or 5''; and
(2) in subsection (b)--
(A) in paragraph (1)(B), by striking ``or'' at the end;
(B) in paragraph (2), by striking the period at the end and
inserting ``, except that no prior notification shall be
required in the case of a civil action brought to compel a
decision by the Administrator pursuant to section
18(f)(3)(B); or''; and
(C) by adding at the end the following:
``(3) in the case of a civil action brought to compel a
decision by the Administrator pursuant to section
18(f)(3)(B), after the date that is 60 days after the
deadline specified in section 18(f)(3)(B).''.
SEC. 20. CITIZENS' PETITIONS.
Section 21 of the Toxic Substances Control Act (15 U.S.C.
2620) is amended--
(1) in subsection (a), by striking ``an order under section
5(e) or 6(b)(2)'' and inserting ``an order under section 4 or
5(d)''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``an order under section
5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting ``an order
under section 4 or 5(d)''; and
(B) in paragraph (4), by striking subparagraph (B) and
inserting the following:
``(B) De novo proceeding.--
``(i) In general.--In an action under subparagraph (A) to
initiate a proceeding to issue a rule pursuant to section 4,
5, 6, or 8 or issue an order under section 4 or 5(d), the
petitioner shall be provided an opportunity to have the
petition considered by the court in a de novo proceeding.
``(ii) Demonstration.--
``(I) In general.--The court in a de novo proceeding under
this subparagraph shall order the Administrator to initiate
the action requested by the petitioner if the petitioner
demonstrates to the satisfaction of the court by a
preponderance of the evidence that--
``(aa) in the case of a petition to initiate a proceeding
for the issuance of a rule or order under section 4, the
information is needed for a purpose identified in section
4(a);
``(bb) in the case of a petition to issue an order under
section 5(d), the chemical substance is not likely to meet
the safety standard;
``(cc) in the case of a petition to initiate a proceeding
for the issuance of a rule under section 6(d), the chemical
substance does not meet the safety standard; or
``(dd) in the case of a petition to initiate a proceeding
for the issuance of a rule under section 8, there is a
reasonable basis to conclude that the rule is necessary to
protect health or the environment or ensure that the chemical
substance meets the safety standard.
``(II) Deferment.--The court in a de novo proceeding under
this subparagraph may permit the Administrator to defer
initiating the action requested by the petitioner until such
time as the court prescribes, if the court finds that--
``(aa) the extent of the risk to health or the environment
alleged by the petitioner is less than the extent of risks to
health or the environment with respect to which the
Administrator is taking action under this Act; and
``(bb) there are insufficient resources available to the
Administrator to take the action requested by the
petitioner.''.
SEC. 21. EMPLOYMENT EFFECTS.
Section 24(b)(2)(B)(ii) of the Toxic Substances Control Act
(15 U.S.C. 2623(b)(2)(B)(ii)) is amended by striking
``section 6(c)(3),'' and inserting ``the applicable
requirements of this Act;''.
SEC. 22. STUDIES.
Section 25 of the Toxic Substances Control Act (15 U.S.C.
2624) is repealed.
SEC. 23. ADMINISTRATION.
Section 26 of the Toxic Substances Control Act (15 U.S.C.
2625) is amended--
(1) by striking subsection (b) and inserting the following:
``(b) Fees.--
``(1) In general.--The Administrator shall establish, not
later than 1 year after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, by
rule--
``(A) the payment of 1 or more reasonable fees as a
condition of submitting a notice or requesting an exemption
under section 5; and
``(B) the payment of 1 or more reasonable fees by a
manufacturer or processor that--
``(i) is required to submit a notice pursuant to the rule
promulgated under section 8(b)(4)(A)(i) identifying a
chemical substance as active;
``(ii) is required to submit a notice pursuant to section
8(b)(5)(B)(i) changing the status of a chemical substance
from inactive to active;
``(iii) is required to report information pursuant to the
rules promulgated under paragraph (1) or (4) of section 8(a);
or
``(iv) manufactures or processes a chemical substance
subject to a safety assessment and safety determination
pursuant to section 6.
``(2) Utilization and collection of fees.--The
Administrator shall--
``(A) utilize the fees collected under paragraph (1) only
to defray costs associated with the actions of the
Administrator--
``(i) to collect, process, review, provide access to, and
protect from disclosure (where appropriate) information on
chemical substances under this Act;
``(ii) to review notices and make determinations for
chemical substances under paragraphs (1) and (3) of section
5(d) and impose any necessary restrictions under section
5(d)(4);
``(iii) to make prioritization decisions under section 4A;
``(iv) to conduct and complete safety assessments and
determinations under section 6; and
``(v) to conduct any necessary rulemaking pursuant to
section 6(d);
``(B) insofar as possible, collect the fees described in
paragraph (1) in advance of conducting any fee-supported
activity;
``(C) deposit the fees in the Fund established by paragraph
(4)(A); and
``(D) insofar as possible, not collect excess fees or
retain a significant amount of unused fees.
``(3) Amount and adjustment of fees; refunds.--In setting
fees under this section, the Administrator shall--
``(A) prescribe lower fees for small business concerns,
after consultation with the Administrator of the Small
Business Administration;
``(B) set the fees established under paragraph (1) at
levels such that the fees will, in aggregate, provide a
sustainable source of funds to annually defray--
``(i) the lower of--
``(I) 25 percent of the costs of conducting the activities
identified in paragraph (2)(A), other than the costs to
conduct and complete safety assessments and determinations
under section 6 for chemical substances identified pursuant
to section 4A(c); or
``(II) $25,000,000 (subject to adjustment pursuant to
subparagraph (F)); and
``(ii) the full costs and the 50-percent portion of the
costs of safety assessments and safety determinations
specified in subparagraph (D);
``(C) reflect an appropriate balance in the assessment of
fees between manufacturers and processors, and allow the
payment of fees by consortia of manufacturers or processors;
``(D) notwithstanding subparagraph (B) and paragraph
(4)(D)--
``(i) for substances designated pursuant to section
4A(c)(1), establish the fee at a level sufficient to defray
the full annual costs to the Administrator of conducting the
safety assessment and safety determination under section 6;
and
``(ii) for substances designated pursuant to section
4A(c)(3), establish the fee at a level sufficient to defray
50 percent of the annual costs to the Administrator of
conducting the safety assessment and safety determination
under section 6;
``(E) prior to the establishment or amendment of any fees
under paragraph (1), consult and meet with parties
potentially subject to the fees or their representatives,
subject to the condition that no obligation under the Federal
Advisory Committee Act (5 U.S.C. App.) or subchapter III of
chapter 5 of title 5, United States Code, is applicable with
respect to such meetings;
``(F) beginning with the fiscal year that is 3 years after
the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, and every 3 years
thereafter, after consultation with parties potentially
subject to the fees and their representatives pursuant to
subparagraph (E), increase or decrease the fees established
under paragraph (1) as necessary to adjust for inflation and
to ensure, based on the audit analysis required under
paragraph (5)(B), that funds deposited in the Fund are
sufficient to defray--
``(i) approximately but not more than 25 percent of the
annual costs to conduct the activities identified in
paragraph (2)(A), other than the costs to conduct and
complete safety assessments and determinations under section
6 for chemical substances identified pursuant to section
4A(c); and
``(ii) the full annual costs and the 50-percent portion of
the annual costs of safety assessments and safety
determinations specified in subparagraph (D);
``(G) adjust fees established under paragraph (1) as
necessary to vary on account of differing circumstances,
including reduced fees or waivers in appropriate
circumstances, to reduce the burden on manufacturing or
processing, remove barriers to innovation, or where the costs
to the Administrator of collecting the fees exceed the fee
revenue anticipated to be collected; and
``(H) if a notice submitted under section 5 is refused or
subsequently withdrawn, refund the fee or a portion of the
fee if no substantial work was performed on the notice.
``(4) TSCA implementation fund.--
``(A) Establishment.--There is established in the Treasury
of the United States a fund, to be known as the `TSCA
Implementation Fund' (referred to in this subsection as the
`Fund'), consisting of--
``(i) such amounts as are deposited in the Fund under
paragraph (2)(C); and
``(ii) any interest earned on the investment of amounts in
the Fund; and
``(iii) any proceeds from the sale or redemption of
investments held in the Fund.
``(B) Crediting and availability of fees.--
``(i) In general.--Fees authorized under this section shall
be collected and available for obligation only to the extent
and in the amount provided in advance in appropriations Acts,
and shall be available without fiscal year limitation.
``(ii) Requirements.--Fees collected under this section
shall not--
``(I) be made available or obligated for any purpose other
than to defray the costs of conducting the activities
identified in paragraph (2)(A);
``(II) otherwise be available for any purpose other than
implementation of this Act; and
``(III) so long as amounts in the Fund remain available, be
subject to restrictions on expenditures applicable to the
Federal government as a whole.
[[Page H3005]]
``(C) Unused funds.--Amounts in the Fund not currently
needed to carry out this subsection shall be--
``(i) maintained readily available or on deposit;
``(ii) invested in obligations of the United States or
guaranteed by the United States; or
``(iii) invested in obligations, participations, or other
instruments that are lawful investments for fiduciary, trust,
or public funds.
``(D) Minimum amount of appropriations.--Fees may not be
assessed for a fiscal year under this section unless the
amount of appropriations for the Chemical Risk Review and
Reduction program project of the Environmental Protection
Agency for the fiscal year (excluding the amount of any fees
appropriated for the fiscal year) are equal to or greater
than the amount of appropriations for that program project
for fiscal year 2014.
``(5) Auditing.--
``(A) Financial statements of agencies.--For the purpose of
section 3515(c) of title 31, United States Code, the Fund
shall be considered a component of an executive agency.
``(B) Components.--The annual audit required under sections
3515(b) and 3521 of that title of the financial statements of
activities under this subsection shall include an analysis
of--
``(i) the fees collected under paragraph (1) and disbursed;
``(ii) compliance with the deadlines established in section
6 of this Act;
``(iii) the amounts budgeted, appropriated, collected from
fees, and disbursed to meet the requirements of sections 4,
4A, 5, 6, 8, and 14, including the allocation of full time
equivalent employees to each such section or activity; and
``(iv) the reasonableness of the allocation of the overhead
associated with the conduct of the activities described in
paragraph (2)(A).
``(C) Inspector general.--The Inspector General of the
Environmental Protection Agency shall--
``(i) conduct the annual audit required under this
subsection; and
``(ii) report the findings and recommendations of the audit
to the Administrator and to the appropriate committees of
Congress.
``(6) Termination.--The authority provided by this section
shall terminate at the conclusion of the fiscal year that is
10 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, unless
otherwise reauthorized or modified by Congress.'';
(2) in subsection (e), by striking ``Health, Education, and
Welfare'' each place it appears and inserting ``Health and
Human Services''; and
(3) adding at the end the following:
``(h) Prior Actions.--Nothing in this Act eliminates,
modifies, or withdraws any rule promulgated, order issued, or
exemption established pursuant to this Act before the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act.''.
SEC. 24. DEVELOPMENT AND EVALUATION OF TEST METHODS AND
SUSTAINABLE CHEMISTRY.
(a) In General.--Section 27 of the Toxic Substances Control
Act (15 U.S.C. 2626) is amended--
(1) in subsection (a), in the first sentence by striking
``Health, Education, and Welfare'' and inserting ``Health and
Human Services''; and
(2) by adding at the end the following:
``(c) National Coordinating Entity for Sustainable
Chemistry.--
``(1) Establishment.--Not later than 180 days after the
date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the Director of the Office of
Science and Technology Policy shall convene an entity under
the National Science and Technology Council with the
responsibility to coordinate Federal programs and activities
in support of sustainable chemistry, including, as
appropriate, at the National Science Foundation, the
Department of Energy, the Department of Agriculture, the
Environmental Protection Agency, the National Institute of
Standards and Technology, the Department of Defense, the
National Institutes of Health, and other related Federal
agencies.
``(2) Chairman.--The entity described in paragraph (1)
shall be chaired by the Director of the National Science
Foundation and the Assistant Administrator for the Office of
Research and Development of the Environmental Protection
Agency, or their designees.
``(3) Duties.--
``(A) In general.--The entity described in paragraph (1)
shall--
``(i) develop a working definition of sustainable
chemistry, after seeking advice and input from stakeholders
as described in clause (v);
``(ii) oversee the planning, management, and coordination
of the Sustainable Chemistry Initiative described in
subsection (d);
``(iii) develop a national strategy for sustainable
chemistry as described in subsection (f);
``(iv) develop an implementation plan for sustainable
chemistry as described in subsection (g); and
``(v) consult and coordinate with stakeholders qualified to
provide advice and information on the development of the
initiative, national strategy, and implementation plan for
sustainable chemistry, at least once per year, to carry out
activities that may include workshops, requests for
information, and other efforts as necessary.
``(B) Stakeholders.--The stakeholders described in
subparagraph (A)(v) shall include representatives from--
``(i) industry (including small- and medium-sized
enterprises from across the value chain);
``(ii) the scientific community (including the National
Academy of Sciences, scientific professional societies, and
academia);
``(iii) the defense community;
``(iv) State, tribal, and local governments;
``(v) State or regional sustainable chemistry programs;
``(vi) nongovernmental organizations; and
``(vii) other appropriate organizations.
``(4) Sunset.--
``(A) In general.--On completion of the national strategy
and accompanying implementation plan for sustainable
chemistry as described in paragraph (3), the Director of the
Office of Science and Technology Policy--
``(i) shall review the need for further work; and
``(ii) may disband the entity described in paragraph (1) if
no further efforts are determined to be necessary.
``(B) Notice and justification.--The Director of the Office
of Science and Technology Policy shall provide notice and
justification, including an analysis of options to establish
the Sustainable Chemistry Initiative described in subsection
(d) and the partnerships described in subsection (e) within 1
or more appropriate Federal agencies, regarding a decision to
disband the entity not less than 90 days prior to the
termination date to the Committee on Science, Space, and
Technology and the Committee on Energy and Commerce of the
House of Representatives and the Committee on Environment and
Public Works and the Committee on Commerce, Science, and
Transportation of the Senate.
``(d) Sustainable Chemistry Initiative.--The entity
described in subsection (c)(1) shall oversee the
establishment of an interagency Sustainable Chemistry
Initiative to promote and coordinate activities designed--
``(1) to provide sustained support for sustainable
chemistry research, development, demonstration, technology
transfer, commercialization, education, and training
through--
``(A) coordination and promotion of sustainable chemistry
research, development, demonstration, and technology transfer
conducted at Federal and national laboratories and Federal
agencies and at public and private institutions of higher
education; and
``(B) to the extent practicable, encouragement of
consideration of sustainable chemistry in, as appropriate--
``(i) the conduct of Federal, State, and private science
and engineering research and development; and
``(ii) the solicitation and evaluation of applicable
proposals for science and engineering research and
development;
``(2) to examine methods by which the Federal Government
can offer incentives for consideration and use of sustainable
chemistry processes and products that encourage competition
and overcoming market barriers, including grants, loans, loan
guarantees, and innovative financing mechanisms;
``(3) to expand the education and training of undergraduate
and graduate students and professional scientists and
engineers, including through partnerships with industry as
described in subsection (e), in sustainable chemistry science
and engineering;
``(4) to collect and disseminate information on sustainable
chemistry research, development, and technology transfer,
including information on--
``(A) incentives and impediments to development,
manufacturing, and commercialization;
``(B) accomplishments;
``(C) best practices; and
``(D) costs and benefits; and
``(5) to support (including through technical assistance,
participation, financial support, or other forms of support)
economic, legal, and other appropriate social science
research to identify barriers to commercialization and
methods to advance commercialization of sustainable
chemistry.
``(e) Partnerships in Sustainable Chemistry.--
``(1) In general.--The entity described in subsection
(c)(1), itself or through an appropriate subgroup designated
or established by the entity, shall work through the agencies
described in subsection (c)(1) to support, through financial,
technical, or other assistance, the establishment of
partnerships between institutions of higher education,
nongovernmental organizations, consortia, and companies
across the value chain in the chemical industry, including
small- and medium-sized enterprises--
``(A) to establish collaborative research, development,
demonstration, technology transfer, and commercialization
programs; and
``(B) to train students and retrain professional scientists
and engineers in the use of sustainable chemistry concepts
and strategies by methods including--
``(i) developing curricular materials and courses for
undergraduate and graduate levels and for the professional
development of scientists and engineers; and
``(ii) publicizing the availability of professional
development courses in sustainable chemistry and recruiting
scientists and engineers to pursue those courses.
``(2) Private sector entities.--To be eligible for support
under this section, a partnership in sustainable chemistry
shall include at least 1 private sector entity.
``(3) Selection of partnerships.--In selecting partnerships
for support under this section, the entity and the agencies
described in subsection (c)(1) shall also consider the extent
to which the applicants are willing and able to demonstrate
evidence of support for, and commitment--
``(A) to achieving the goals of the Sustainable Chemistry
Initiative described in subsection (d); and
``(B) to sustaining any new innovations, tools, and
resources generated from funding under the program.
``(4) Prohibited use of funds.--Financial support provided
under this section may not be used--
[[Page H3006]]
``(A) to support or expand a regulatory chemical management
program at an implementing agency under a State law; or
``(B) to construct or renovate a building or structure.
``(f) National Strategy to Congress.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the entity described in subsection (c)(1)
shall submit to the Committee on Science, Space, and
Technology and the Committee on Energy and Commerce of the
House of Representatives and the Committee on Environment and
Public Works and the Committee on Commerce, Science, and
Transportation of the Senate, a national strategy that shall
include--
``(A) a summary of federally funded sustainable chemistry
research, development, demonstration, technology transfer,
commercialization, education, and training activities;
``(B) a summary of the financial resources allocated to
sustainable chemistry initiatives;
``(C) an analysis of the progress made toward achieving the
goals and priorities of the Sustainable Chemistry Initiative
described in subsection (d), and recommendations for future
initiative activities, including consideration of options to
establish the Sustainable Chemistry Initiative and the
partnerships described in subsection (e) within 1 or more
appropriate Federal agencies;
``(D) an assessment of the benefits of expanding existing,
federally supported regional innovation and manufacturing
hubs to include sustainable chemistry and the value of
directing the establishment of 1 or more dedicated
sustainable chemistry centers of excellence or hubs;
``(E) an evaluation of steps taken and future strategies to
avoid duplication of efforts, streamline interagency
coordination, facilitate information sharing, and spread best
practices between participating agencies in the Sustainable
Chemistry Initiative; and
``(F) a framework for advancing sustainable chemistry
research, development, technology transfer,
commercialization, and education and training.
``(2) Submission to gao.--The entity described in
subsection (c)(1) shall submit the national strategy
described in paragraph (1) to the Government Accountability
Office for consideration in future Congressional inquiries.
``(g) Implementation Plan.--Not later than 3 years after
the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the entity described in
subsection (c)(1) shall submit to the Committee on Science,
Space, and Technology and the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Environment and Public Works and the Committee on Commerce,
Science, and Transportation of the Senate, an implementation
plan, based on the findings of the national strategy and
other assessments, as appropriate, for sustainable
chemistry.''.
(b) Sustainable Chemistry Basic Research.--Subject to the
availability of appropriated funds, the Director of the
National Science Foundation shall continue to carry out the
Green Chemistry Basic Research program authorized under
section 509 of the National Science Foundation Authorization
Act of 2010 (42 U.S.C. 1862p-3).
SEC. 25. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (15 U.S.C.
2627) is amended--
(1) in subsection (b)(1)--
(A) in subparagraphs (A) through (D), by striking the comma
at the end of each subparagraph and inserting a semicolon;
and
(B) in subparagraph (E), by striking ``, and'' and
inserting ``; and''; and
(2) by striking subsections (c) and (d).
SEC. 26. AUTHORIZATION OF APPROPRIATIONS.
Section 29 of the Toxic Substances Control Act (15 U.S.C.
2628) is repealed.
SEC. 27. ANNUAL REPORT.
Section 30 of the Toxic Substances Control Act (15 U.S.C.
2629) is amended by striking paragraph (2) and inserting the
following:
``(2)(A) the number of notices received during each year
under section 5; and
``(B) the number of the notices described in subparagraph
(A) for chemical substances subject to a rule, testing
consent agreement, or order under section 4;''.
SEC. 28. EFFECTIVE DATE.
Section 31 of the Toxic Substances Control Act (15 U.S.C.
2601 note; Public Law 94-469) is amended--
(1) by striking ``Except as provided in section 4(f),
this'' and inserting the following:
``(a) In General.--This''; and
(2) by adding at the end the following:
``(b) Retroactive Applicability.--Nothing in this Act shall
be interpreted to apply retroactively to any State, Federal,
or maritime legal action commenced prior to the effective
date of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act.''.
SEC. 29. ELEMENTAL MERCURY.
(a) Temporary Generator Accumulation.--Section 5 of the
Mercury Export Ban Act of 2008 (42 U.S.C. 6939f) is amended--
(1) in subsection (a)(2), by striking ``2013'' and
inserting ``2019'';
(2) in subsection (b)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A), (B), and (C), as
clauses (i), (ii), and (iii), respectively and indenting
appropriately;
(ii) in the first sentence, by striking ``After
consultation'' and inserting the following:
``(A) Assessment and collection.--After consultation'';
(iii) in the second sentence, by striking ``The amount of
such fees'' and inserting the following:
``(B) Amount.--The amount of the fees described in
subparagraph (A)'';
(iv) in subparagraph (B) (as so designated)--
(I) in clause (i) (as so redesignated), by striking
``publically available not later than October 1, 2012'' and
inserting ``publicly available not later than October 1,
2018'';
(II) in clause (ii) (as so redesignated), by striking
``and'';
(III) in clause (iii) (as so redesignated), by striking the
period at the end and inserting ``, subject to clause (iv);
and''; and
(IV) by adding at the end the following:
``(iv) for generators temporarily accumulating elemental
mercury in a facility subject to subparagraphs (B) and
(D)(iv) of subsection (g)(2) if the facility designated in
subsection (a) is not operational by January 1, 2019, shall
be adjusted to subtract the cost of the temporary
accumulation during the period in which the facility
designated under subsection (a) is not operational.''; and
(v) by adding at the end the following:
``(C) Conveyance of title and permitting.--If the facility
designated in subsection (a) is not operational by January 1,
2020, the Secretary--
``(i) shall immediately accept the conveyance of title to
all elemental mercury that has accumulated in facilities in
accordance with subsection (g)(2)(D), before January 1, 2020,
and deliver the accumulated mercury to the facility
designated under subsection (a) on the date on which the
facility becomes operational;
``(ii) shall pay any applicable Federal permitting costs,
including the costs for permits issued under section 3005(c)
of the Solid Waste Disposal Act (42 U.S.C. 6925(c)); and
``(iii) shall store, or pay the cost of storage of, until
the time at which a facility designated in subsection (a) is
operational, accumulated mercury to which the Secretary has
title under this subparagraph in a facility that has been
issued a permit under section 3005(c) of the Solid Waste
Disposal Act (42 U.S.C. 6925(c)).''; and
(B) in paragraph (2), in the first sentence, by striking
``paragraph (1)(C)'' and inserting ``paragraph (1)(B)(iii)'';
and
(3) in subsection (g)(2)--
(A) in the undesignated material at the end, by striking
``This subparagraph'' and inserting the following:
``(C) Subparagraph (B)'';
(B) in subparagraph (C) (as added by paragraph (1)), by
inserting ``of that subparagraph'' before the period at the
end; and
(C) by adding at the end the following:
``(D) A generator producing elemental mercury incidentally
from the beneficiation or processing of ore or related
pollution control activities, may accumulate the mercury
produced onsite that is destined for a facility designated by
the Secretary under subsection (a), for more than 90 days
without a permit issued under section 3005(c) of the Solid
Waste Disposal Act (42 U.S.C. 6925(c)), and shall not be
subject to the storage prohibition of section 3004(j) of that
Act (42 U.S.C. 6924(j)), if--
``(i) the Secretary is unable to accept the mercury at a
facility designated by the Secretary under subsection (a) for
reasons beyond the control of the generator;
``(ii) the generator certifies in writing to the Secretary
that the generator will ship the mercury to a designated
facility when the Secretary is able to accept the mercury;
``(iii) the generator certifies in writing to the Secretary
that the generator is storing only mercury the generator has
produced or recovered onsite and will not sell, or otherwise
place into commerce, the mercury; and
``(iv) the generator has obtained an identification number
under section 262.12 of title 40, Code of Federal
Regulations, and complies with the requirements described in
paragraphs (1) through (4) of section 262.34(a) of title 40,
Code of Federal Regulations (as in effect on the date of
enactment of this subparagraph).
``(E) Management standards for temporary storage.--Not
later than January 1, 2017, the Secretary, after consultation
with the Administrator of the Environmental Protection Agency
and State agencies in affected States, shall develop and make
available guidance that establishes procedures and standards
for the management and short-term storage of elemental
mercury at a generator covered under subparagraph (D),
including requirements to ensure appropriate use of flasks or
other suitable containers. Such procedures and standards
shall be protective of human health and the environment and
shall ensure that the elemental mercury is stored in a safe,
secure, and effective manner. A generator may accumulate
mercury in accordance with subparagraph (D) immediately upon
enactment of this Act, and notwithstanding that guidance
called for by this paragraph (E) has not been developed or
made available.''.
(b) Interim Status.--Section 5(d)(1) of the Mercury Export
Ban Act of 2008 (42 U.S.C. 6939f(d)(1)) is amended--
(1) in the fourth sentence, by striking ``in existence on
or before January 1, 2013,''; and
(2) in the last sentence, by striking ``January 1, 2015''
and inserting ``January 1, 2020''.
(c) Mercury Inventory.--Section 8(b) of the Toxic
Substances Control Act (15 U.S.C. 2607(b)) (as amended by
section 10(2)) is amended by adding at the end the following:
``(10) Mercury.--
``(A) Definition of mercury.--In this paragraph,
notwithstanding section 3(2)(B), the term `mercury' means--
``(i) elemental mercury; and
``(ii) a mercury compound.
``(B) Publication.--Not later than April 1, 2017, and every
3 years thereafter, the Administrator shall publish in the
Federal Register an inventory of mercury supply, use, and
trade in the United States.
``(C) Process.--In carrying out the inventory under
subparagraph (B), the Administrator shall--
[[Page H3007]]
``(i) identify any remaining manufacturing processes or
products that intentionally add mercury; and
``(ii) recommend actions, including proposed revisions of
Federal law (including regulations), to achieve further
reductions in mercury use.
``(D) Reporting.--
``(i) In general.--To assist in the preparation of the
inventory under subparagraph (B), any person who manufactures
mercury or mercury-added products or otherwise intentionally
uses mercury in a manufacturing process shall make periodic
reports to the Administrator, at such time and including such
information as the Administrator shall determine by rule
promulgated not later than 2 years after the date of
enactment of this paragraph.
``(ii) Coordination.--To avoid duplication, the
Administrator shall coordinate the reporting under this
subparagraph with the Interstate Mercury Education and
Reduction Clearinghouse.
``(iii) Exemption.--This subparagraph shall not apply to a
person engaged in the generation, handling, or management of
mercury-containing waste, unless that person manufactures or
recovers mercury in the management of that waste.''.
(d) Prohibition on Export of Certain Mercury Compounds.--
Section 12(c) of the Toxic Substances Control Act (15 U.S.C.
2611(c)) (as amended by section 13(3)) is amended--
(1) in the subsection heading, by inserting ``and Mercury
Compounds'' after ``Mercury''; and
(2) by inserting after paragraph (2) the following:
``(3) Prohibition on export of certain mercury compounds.--
``(A) In general.--Effective January 1, 2020, the export of
the following mercury compounds is prohibited:
``(i) Mercury (I) chloride or calomel.
``(ii) Mercury (II) oxide.
``(iii) Mercury (II) sulfate.
``(iv) Mercury (II) nitrate.
``(v) Cinnabar or mercury sulphide.
``(vi) Any mercury compound that the Administrator, at the
discretion of the Administrator, adds to the list by rule, on
determining that exporting that mercury compound for the
purpose of regenerating elemental mercury is technically
feasible.
``(B) Publication.--Not later than 90 days after the date
of enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, and as appropriate thereafter, the
Administrator shall publish in the Federal Register a list of
the mercury compounds that are prohibited from export under
this paragraph.
``(C) Petition.--Any person may petition the Administrator
to add to the list of mercury compounds prohibited from
export.
``(D) Environmentally sound disposal.--This paragraph does
not prohibit the export of mercury (I) chloride or calomel
for environmentally sound disposal to member countries of the
Organization for Economic Cooperation and Development, on the
condition that no mercury or mercury compounds are to be
recovered, recycled, or reclaimed for use, or directly
reused.
``(E) Report.--Not later than 5 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall evaluate any
exports of calomel for disposal that occurred since that date
of enactment and shall submit to Congress a report that
contains the following:
``(i) volumes and sources of calomel exported for disposal;
``(ii) receiving countries of such exports;
``(iii) methods of disposal used;
``(iv) issues, if any, presented by the export of calomel;
``(v) evaluation of calomel management options in the
United States, if any, that are commercially available and
comparable in cost and efficacy to methods being utilized in
the receiving countries; and
``(vi) a recommendation regarding whether Congress should
further limit or prohibit the export of calomel for disposal.
``(F) Effect on other law.--Nothing in this paragraph shall
be construed to affect the authority of the Administrator
under Solid Waste Disposal Act (42 U.S.C. 6901 et seq.).''.
SEC. 30. TREVOR'S LAW.
(a) Purposes.--The purposes of this section are--
(1) to provide the appropriate Federal agencies with the
authority to help conduct investigations into potential
cancer clusters;
(2) to ensure that Federal agencies have the authority to
undertake actions to help address cancer clusters and factors
that may contribute to the creation of potential cancer
clusters; and
(3) to enable Federal agencies to coordinate with other
Federal, State, and local agencies, institutes of higher
education, and the public in investigating and addressing
cancer clusters.
(b) Designation and Investigation of Potential Cancer
Clusters.--Part P of title III of the Public Health Service
Act (42 U.S.C. 280g et seq.) is amended by adding at the end
the following:
``SEC. 399V-6. DESIGNATION AND INVESTIGATION OF POTENTIAL
CANCER CLUSTERS.
``(a) Definitions.--In this section:
``(1) Cancer cluster.--The term `cancer cluster' means the
incidence of a particular cancer within a population group, a
geographical area, or a period of time that is greater than
expected for such group, area, or period.
``(2) Particular cancer.--The term `particular cancer'
means one specific type of cancer or a type of cancers
scientifically proven to have the same cause.
``(3) Population group.--The term `population group' means
a group, for purposes of calculating cancer rates, defined by
factors such as race, ethnicity, age, or gender.
``(b) Criteria for Designation of Potential Cancer
Clusters.--
``(1) Development of criteria.--The Secretary shall develop
criteria for the designation of potential cancer clusters.
``(2) Requirements.--The criteria developed under paragraph
(1) shall consider, as appropriate--
``(A) a standard for cancer cluster identification and
reporting protocols used to determine when cancer incidence
is greater than would be typically observed;
``(B) scientific screening standards that ensure that a
cluster of a particular cancer involves the same type of
cancer, or types of cancers;
``(C) the population in which the cluster of a particular
cancer occurs by factors such as race, ethnicity, age, and
gender, for purposes of calculating cancer rates;
``(D) the boundaries of a geographic area in which a
cluster of a particular cancer occurs so as not to create or
obscure a potential cluster by selection of a specific area;
and
``(E) the time period over which the number of cases of a
particular cancer, or the calculation of an expected number
of cases, occurs.
``(c) Guidelines for Investigation of Potential Cancer
Clusters.--The Secretary, in consultation with the Council of
State and Territorial Epidemiologists and representatives of
State and local health departments, shall develop, publish,
and periodically update guidelines for investigating
potential cancer clusters. The guidelines shall--
``(1) require that investigations of cancer clusters--
``(A) use the criteria developed under subsection (b);
``(B) use the best available science; and
``(C) rely on a weight of the scientific evidence;
``(2) provide standardized methods of reviewing and
categorizing data, including from health surveillance systems
and reports of potential cancer clusters; and
``(3) provide guidance for using appropriate
epidemiological and other approaches for investigations.
``(d) Investigation of Cancer Clusters.--
``(1) Secretary discretion.--The Secretary--
``(A) in consultation with representatives of the relevant
State and local health departments, shall consider whether it
is appropriate to conduct an investigation of a potential
cancer cluster; and
``(B) in conducting investigations shall have the
discretion to prioritize certain potential cancer clusters,
based on the availability of resources.
``(2) Coordination.--In investigating potential cancer
clusters, the Secretary shall coordinate with agencies within
the Department of Health and Human Services and other Federal
agencies, such as the Environmental Protection Agency.
``(3) Biomonitoring.--In investigating potential cancer
clusters, the Secretary shall rely on all appropriate
biomonitoring information collected under other Federal
programs, such as the National Health and Nutrition
Examination Survey. The Secretary may provide technical
assistance for relevant biomonitoring studies of other
Federal agencies.
``(e) Duties.--The Secretary shall--
``(1) ensure that appropriate staff of agencies within the
Department of Health and Human Services are prepared to
provide timely assistance, to the extent practicable, upon
receiving a request to investigate a potential cancer cluster
from a State or local health authority;
``(2) maintain staff expertise in epidemiology, toxicology,
data analysis, environmental health and cancer surveillance,
exposure assessment, pediatric health, pollution control,
community outreach, health education, laboratory sampling and
analysis, spatial mapping, and informatics;
``(3) consult with community members as investigations into
potential cancer clusters are conducted, as the Secretary
determines appropriate;
``(4) collect, store, and disseminate reports on
investigations of potential cancer clusters, the possible
causes of such clusters, and the actions taken to address
such clusters; and
``(5) provide technical assistance for investigating cancer
clusters to State and local health departments through
existing programs, such as the Epi-Aids program of the
Centers for Disease Control and Prevention and the
Assessments of Chemical Exposures program of the Agency for
Toxic Substances and Disease Registry.''.
Motion Offered by Mr. Shimkus
Mr. SHIMKUS. Mr. Speaker, I have a motion at the desk.
The SPEAKER pro tempore. The Clerk will designate the motion.
The text of the motion is as follows:
Mr. Shimkus moves that the House concur in the Senate
amendment to H.R. 2576 with an amendment inserting the text
of Rules Committee Print 114-54, modified by the amendment
printed in House Report 114-590, in lieu of the matter
proposed to be inserted by the Senate.
The text of the House amendment to the Senate amendment to the text
is as follows:
In lieu of the matter proposed to be inserted by the
Senate, insert the following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Frank R.
Lautenberg Chemical Safety for the 21st Century Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--CHEMICAL SAFETY
Sec. 2. Findings, policy, and intent.
[[Page H3008]]
Sec. 3. Definitions.
Sec. 4. Testing of chemical substances and mixtures.
Sec. 5. Manufacturing and processing notices.
Sec. 6. Prioritization, risk evaluation, and regulation of chemical
substances and mixtures.
Sec. 7. Imminent hazards.
Sec. 8. Reporting and retention of information.
Sec. 9. Relationship to other Federal laws.
Sec. 10. Exports of elemental mercury.
Sec. 11. Confidential information.
Sec. 12. Penalties.
Sec. 13. State-Federal relationship.
Sec. 14. Judicial review.
Sec. 15. Citizens' civil actions.
Sec. 16. Studies.
Sec. 17. Administration of the Act.
Sec. 18. State programs.
Sec. 19. Conforming amendments.
Sec. 20. No retroactivity.
Sec. 21. Trevor's Law.
TITLE II--RURAL HEALTHCARE CONNECTIVITY
Sec. 201. Short title.
Sec. 202. Telecommunications services for skilled nursing facilities.
TITLE I--CHEMICAL SAFETY
SEC. 2. FINDINGS, POLICY, AND INTENT.
Section 2(c) of the Toxic Substances Control Act (15 U.S.C.
2601(c)) is amended by striking ``proposes to take'' and
inserting ``proposes as provided''.
SEC. 3. DEFINITIONS.
Section 3 of the Toxic Substances Control Act (15 U.S.C.
2602) is amended--
(1) by redesignating paragraphs (4) through (14) as
paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15),
(16), and (17), respectively;
(2) by inserting after paragraph (3) the following:
``(4) The term `conditions of use' means the circumstances,
as determined by the Administrator, under which a chemical
substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or
disposed of.'';
(3) by inserting after paragraph (6), as so redesignated,
the following:
``(7) The term `guidance' means any significant written
guidance of general applicability prepared by the
Administrator.''; and
(4) by inserting after paragraph (11), as so redesignated,
the following:
``(12) The term `potentially exposed or susceptible
subpopulation' means a group of individuals within the
general population identified by the Administrator who, due
to either greater susceptibility or greater exposure, may be
at greater risk than the general population of adverse health
effects from exposure to a chemical substance or mixture,
such as infants, children, pregnant women, workers, or the
elderly.''.
SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.
Section 4 of the Toxic Substances Control Act (15 U.S.C.
2603) is amended--
(1) by striking ``standards'' each place it appears and
inserting ``protocols and methodologies'';
(2) in subsection (a)--
(A) by striking ``If the Administrator finds'' and
inserting ``(1) If the Administrator finds'';
(B) in paragraph (1), as so designated--
(i) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
(ii) by striking ``(ii)'' each place it appears and
inserting ``(II)'';
(iii) by striking ``are insufficient data'' and inserting
``is insufficient information'' each place it appears;
(iv) by striking ``(iii)'' each place it appears and
inserting ``(III)'';
(v) by striking ``such data'' and inserting ``such
information'' each place it appears;
(vi) by striking ``(B)(i)'' and inserting ``(ii)(I)'';
(vii) by striking ``(I)'' and inserting ``(aa)'';
(viii) by striking ``(II)'' and inserting ``(bb)'';
(ix) by striking ``(2)'' and inserting ``(B)''; and
(x) in the matter following subparagraph (B), as so
redesignated--
(I) by inserting ``, or, in the case of a chemical
substance or mixture described in subparagraph (A)(i), by
rule, order, or consent agreement,'' after ``rule'';
(II) by striking ``data'' each place it appears and
inserting ``information''; and
(III) by striking ``and which are relevant'' and inserting
``and which is relevant''; and
(C) by adding at the end the following:
``(2) Additional testing authority.--In addition to the
authority provided under paragraph (1), the Administrator
may, by rule, order, or consent agreement--
``(A) require the development of new information relating
to a chemical substance or mixture if the Administrator
determines that the information is necessary--
``(i) to review a notice under section 5 or to perform a
risk evaluation under section 6(b);
``(ii) to implement a requirement imposed in a rule, order,
or consent agreement under subsection (e) or (f) of section 5
or in a rule promulgated under section 6(a);
``(iii) at the request of a Federal implementing authority
under another Federal law, to meet the regulatory testing
needs of that authority with regard to toxicity and exposure;
or
``(iv) pursuant to section 12(a)(2); and
``(B) require the development of new information for the
purposes of prioritizing a chemical substance under section
6(b) only if the Administrator determines that such
information is necessary to establish the priority of the
substance, subject to the limitations that--
``(i) not later than 90 days after the date of receipt of
information regarding a chemical substance complying with a
rule, order, or consent agreement under this subparagraph,
the Administrator shall designate the chemical substance as a
high-priority substance or a low-priority substance; and
``(ii) information required by the Administrator under this
subparagraph shall not be required for the purposes of
establishing or implementing a minimum information
requirement of broader applicability.
``(3) Statement of need.--When requiring the development of
new information relating to a chemical substance or mixture
under paragraph (2), the Administrator shall identify the
need for the new information, describe how information
reasonably available to the Administrator was used to inform
the decision to require new information, explain the basis
for any decision that requires the use of vertebrate animals,
and, as applicable, explain why issuance of an order is
warranted instead of promulgating a rule or entering into a
consent agreement.
``(4) Tiered testing.--When requiring the development of
new information under this subsection, 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, unless information
available to the Administrator justifies more advanced
testing of potential health or environmental effects or
potential exposure without first conducting screening-level
testing.'';
(3) in subsection (b)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking ``test data'' and
inserting ``information'';
(ii) in subparagraph (C), by striking ``data'' and
inserting ``information''; and
(iii) in the matter following subparagraph (C), by striking
``data'' and inserting ``information'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``test data'' and inserting
``information'';
(II) by inserting ``Protocols and methodologies for the
development of information may also be prescribed for the
assessment of exposure or exposure potential to humans or the
environment.'' after the first sentence; and
(III) by striking ``hierarchical tests'' and inserting
``tiered testing''; and
(ii) in subparagraph (B), by striking ``data'' and
inserting ``information'';
(C) in paragraph (3)--
(i) by striking ``data'' each place it appears and
inserting ``information'';
(ii) in subparagraph (A), by inserting ``or (C), as
applicable,'' after ``subparagraph (B)'';
(iii) by striking ``(a)(1)(A)(ii) or (a)(1)(B)(ii)'' each
place it appears in subparagraph (B) and inserting
``(a)(1)(A)(i)(II) or (a)(1)(A)(ii)(II)'';
(iv) in subparagraph (B), in the matter before clause (i),
by striking ``subsection (a)'' and inserting ``subsection
(a)(1)''; and
(v) by adding at the end the following:
``(C) A rule or order under paragraph (1) or (2) of
subsection (a) may require the development of information by
any person who manufactures or processes, or intends to
manufacture or process, a chemical substance or mixture
subject to the rule or order.'';
(D) in paragraph (4)--
(i) by striking ``of data'' each place it appears and
inserting ``of information''; and
(ii) by striking ``test data'' each place it appears and
inserting ``information''; and
(E) by striking paragraph (5);
(4) in subsection (c)--
(A) in paragraph (1), by striking ``data'' and inserting
``information'';
(B) in paragraph (2), by striking ``data'' each place it
appears and inserting ``information'';
(C) in paragraph (3)--
(i) by striking ``test data'' each place it appears and
inserting ``information''; and
(ii) by striking ``such data'' each place it appears and
inserting ``such information''; and
(D) in paragraph (4) by striking ``test data'' each place
it appears and inserting ``information'';
(5) in subsection (d)--
(A) by striking ``test data'' each place it appears and
inserting ``information'';
(B) by striking ``such data'' each place it appears and
inserting ``such information''; and
(C) by striking ``for which data have'' and inserting ``for
which information has'';
(6) in subsection (e)--
(A) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``promulgation of a rule'' and inserting
``development of information''; and
(II) by striking ``data'' each place it appears and
inserting ``information''; and
(ii) in subparagraph (B), by striking ``either initiate a
rulemaking proceeding under subsection (a) or if such a
proceeding is not initiated within such period, publish in
the Federal Register the Administrator's reason for not
initiating such a proceeding'' and insert ``issue an order,
enter into a consent agreement, or initiate a rulemaking
proceeding under subsection (a), or, if such an order or
consent agreement is not issued or such a proceeding is not
initiated within
[[Page H3009]]
such period, publish in the Federal Register the
Administrator's reason for not issuing such an order,
entering into such a consent agreement, or initiating such a
proceeding''; and
(B) in paragraph (2)(A)--
(i) by striking ``eight members'' and inserting ``ten
members''; and
(ii) by adding at the end the following:
``(ix) One member appointed by the Chairman of the Consumer
Product Safety Commission from Commissioners or employees of
the Commission.
``(x) One member appointed by the Commissioner of Food and
Drugs from employees of the Food and Drug Administration.'';
(7) in subsection (f)--
(A) in paragraph (1), by striking ``test data'' and
inserting ``information''; and
(B) in the matter following paragraph (2)--
(i) by striking ``or will present'';
(ii) by striking ``from cancer, gene mutations, or birth
defects'';
(iii) by striking ``data or'';
(iv) by striking ``appropriate'' and inserting
``applicable''; and
(v) by inserting ``, made without consideration of costs or
other nonrisk factors,'' after ``publish in the Federal
Register a finding'';
(8) in subsection (g)--
(A) by amending the subsection heading to read as
follows:``Petition for Protocols and Methodologies for the
Development of Information'';
(B) by striking ``test data'' each place it appears and
inserting ``information''; and
(C) by striking ``submit data'' and inserting ``submit
information''; and
(9) by adding at the end the following:
``(h) Reduction of Testing on Vertebrates.--
``(1) In general.--The Administrator shall reduce and
replace, to the extent practicable, scientifically justified,
and consistent with the policies of this title, the use of
vertebrate animals in the testing of chemical substances or
mixtures under this title by--
``(A) prior to making a request or adopting a requirement
for testing using vertebrate animals, and in accordance with
subsection (a)(3), taking into consideration, as appropriate
and to the extent practicable and scientifically justified,
reasonably available existing information, including--
``(i) toxicity information;
``(ii) computational toxicology and bioinformatics; and
``(iii) high-throughput screening methods and the
prediction models of those methods; and
``(B) encouraging and facilitating--
``(i) the use of scientifically valid test methods and
strategies that reduce or replace the use of vertebrate
animals while providing information of equivalent or better
scientific quality and relevance that will support regulatory
decisions under this title;
``(ii) the grouping of 2 or more chemical substances into
scientifically appropriate categories in cases in which
testing of a chemical substance would provide scientifically
valid and useful information on other chemical substances in
the category; and
``(iii) the formation of industry consortia to jointly
conduct testing to avoid unnecessary duplication of tests,
provided that such consortia make all information from such
testing available to the Administrator.
``(2) Implementation of alternative testing methods.--To
promote the development and timely incorporation of new
scientifically valid test methods and strategies 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 strategies to
reduce, refine, or replace vertebrate animal testing and
provide information of equivalent or better scientific
quality and relevance for assessing risks of injury to health
or the environment of chemical substances or mixtures
through, for example--
``(i) computational toxicology and bioinformatics;
``(ii) high-throughput screening methods;
``(iii) testing of categories of chemical substances;
``(iv) tiered testing methods;
``(v) in vitro studies;
``(vi) systems biology;
``(vii) new or revised methods identified by validation
bodies such as the Interagency Coordinating Committee on the
Validation of Alternative Methods or the Organization for
Economic Co-operation and Development; or
``(viii) industry consortia that develop information
submitted under this title;
``(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) include in the strategic plan developed under
subparagraph (A) a list, which the Administrator shall update
on a regular basis, of particular alternative test methods or
strategies the Administrator has identified that do not
require new vertebrate animal testing and are scientifically
reliable, relevant, and capable of providing information of
equivalent or better 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
and relevance of the test methods and strategies that may be
identified pursuant to subparagraph (C);
``(E) beginning on the date that is 5 years after the date
of enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, and every 5 years thereafter, submit to
Congress a report that describes the progress made in
implementing the plan developed under subparagraph (A) and
goals for future alternative test methods and strategies
implementation; and
``(F) prioritize and, to the extent consistent with
available resources and the Administrator's other
responsibilities under this title, carry out performance
assessment, validation, and translational studies to
accelerate the development of scientifically valid test
methods and strategies that reduce, refine, or replace the
use of vertebrate animals, including minimizing duplication,
in any testing under this title.
``(3) 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 test method or strategy identified by the
Administrator pursuant to paragraph (2)(C), if the
Administrator has identified such a test method or strategy
for the development of such information, before conducting
new vertebrate animal testing.
``(B) Effect of paragraph.--Nothing in this paragraph
shall, under any circumstance, limit or restrict the
submission of any existing information to the Administrator.
``(C) Relationship to other law.--A violation of this
paragraph shall not be a prohibited act under section 15.
``(D) Review of means.--This paragraph authorizes, but does
not require, the Administrator to review the means by which a
person conducted testing described in subparagraph (A).''.
SEC. 5. MANUFACTURING AND PROCESSING NOTICES.
Section 5 of the Toxic Substances Control Act (15 U.S.C.
2604) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``Except as provided in'' and inserting
``(A) Except as provided in subparagraph (B) of this
paragraph and'';
(ii) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively;
(iii) by striking all that follows ``significant new use''
and inserting a period; and
(iv) by adding at the end the following:
``(B) A person may take the actions described in
subparagraph (A) if--
``(i) such person submits to the Administrator, at least 90
days before such manufacture or processing, a notice, in
accordance with subsection (d), of such person's intention to
manufacture or process such substance and such person
complies with any applicable requirement of, or imposed
pursuant to, subsection (b), (e), or (f); and
``(ii) the Administrator--
``(I) conducts a review of the notice; and
``(II) makes a determination under subparagraph (A), (B),
or (C) of paragraph (3) and takes the actions required in
association with that determination under such subparagraph
within the applicable review period.''; and
(B) by adding at the end the following new paragraphs:
``(3) Review and determination.--Within the applicable
review period, subject to section 18, the Administrator shall
review such notice and determine--
``(A) that the relevant chemical substance or significant
new use presents an unreasonable risk of injury to health or
the environment, without consideration of costs or other
nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified
as relevant by the Administrator under the conditions of use,
in which case the Administrator shall take the actions
required under subsection (f);
``(B) that--
``(i) the information available to the Administrator is
insufficient to permit a reasoned evaluation of the health
and environmental effects of the relevant chemical substance
or significant new use; or
``(ii)(I) in the absence of sufficient information to
permit the Administrator to make such an evaluation, the
manufacture, processing, distribution in commerce, use, or
disposal of such substance, or any combination of such
activities, may present an unreasonable risk of injury to
health or the environment, without consideration of costs or
other nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified
as relevant by the Administrator; or
``(II) such substance is or will be produced in substantial
quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in
substantial quantities or there is or may be significant or
substantial human exposure to the substance,
in which case the Administrator shall take the actions
required under subsection (e); or
``(C) that the relevant chemical substance or significant
new use is not likely to present an unreasonable risk of
injury to health or the environment, without consideration of
costs or other nonrisk factors, including an unreasonable
risk to a potentially
[[Page H3010]]
exposed or susceptible subpopulation identified as relevant
by the Administrator under the conditions of use, in which
case the submitter of the notice may commence manufacture of
the chemical substance or manufacture or processing for a
significant new use.
``(4) Failure to render determination.--
``(A) Failure to render determination.--If the
Administrator fails to make a determination on a notice under
paragraph (3) by the end of the applicable review period and
the notice has not been withdrawn by the submitter, the
Administrator shall refund to the submitter all applicable
fees charged to the submitter for review of the notice
pursuant to section 26(b), and the Administrator shall not be
relieved of any requirement to make such determination.
``(B) Limitations.--(i) A refund of applicable fees under
subparagraph (A) shall not be made if the Administrator
certifies that the submitter has not provided information
required under subsection (b) or has otherwise unduly delayed
the process such that the Administrator is unable to render a
determination within the applicable review period.
``(ii) A failure of the Administrator to render a decision
shall not be deemed to constitute a withdrawal of the notice.
``(iii) Nothing in this paragraph shall be construed as
relieving the Administrator or the submitter of the notice
from any requirement of this section.
``(5) 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)(A)(ii) 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 justifies notification.'';
(2) in subsection (b)--
(A) in the subsection heading, by striking ``Test Data''
and inserting ``Information'';
(B) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``test data'' and inserting
``information''; and
(II) by striking ``such data'' and inserting ``such
information''; and
(ii) in subparagraph (B)--
(I) by striking ``test data'' and inserting
``information'';
(II) by striking ``subsection (a)(1)(A)'' and inserting
``subsection (a)(1)(A)(i)''; and
(III) by striking ``subsection (a)(1)(B)'' and inserting
``subsection (a)(1)(A)(ii)'';
(C) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``test data'' in clause (ii) and inserting
``information'';
(II) by striking ``shall'' and inserting ``may''; and
(III) by striking ``data prescribed'' and inserting
``information prescribed''; and
(ii) in subparagraph (B)--
(I) by striking ``Data'' and inserting ``Information'';
(II) by striking ``data'' both places it appears and
inserting ``information'';
(III) by striking ``show'' and inserting ``shows'';
(IV) by striking ``subsection (a)(1)(A)'' in clause (i) and
inserting ``subsection (a)(1)(A)(i)''; and
(V) by striking ``subsection (a)(1)(B)'' in clause (ii) and
inserting ``subsection (a)(1)(A)(ii)'';
(D) in paragraph (3)--
(i) by striking ``Data'' and inserting ``Information''; and
(ii) by striking ``paragraph (1) or (2)'' and inserting
``paragraph (1) or (2) of this subsection or under subsection
(e)''; and
(E) in paragraph (4)--
(i) in subparagraph (A)(i), by inserting ``, without
consideration of costs or other nonrisk factors'' after
``health or the environment''; and
(ii) in subparagraph (C), by striking ``, except that'' and
all that follows through ``subparagraph (A)'';
(3) in subsection (c)--
(A) in the subsection heading, by striking ``Notice'' and
inserting ``Review''; and
(B) by striking ``before which'' and all that follows
through ``subsection may begin'';
(4) in subsection (d)--
(A) by striking ``test data'' in paragraph (1)(B) and
inserting ``information'';
(B) by striking ``data'' each place it appears in paragraph
(1)(C) and paragraph (2) and inserting ``information'';
(C) in paragraph (2)(B), by striking ``uses or intended
uses of such substance'' and inserting ``uses of such
substance identified in the notice''; and
(D) in paragraph (3)--
(i) by striking ``for which the notification period
prescribed by subsection (a), (b), or (c)'' and inserting
``for which the applicable review period''; and
(ii) by striking ``such notification period'' and inserting
``such period'';
(5) in subsection (e)--
(A) in paragraph (1)(A)--
(i) in clause (i), by striking ``; and'' and inserting ``;
or'';
(ii) in clause (ii)(I), by inserting ``without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed subpopulation
identified as relevant by the Administrator under the
conditions of use;'' after ``health or the environment,'';
and
(iii) in the matter after clause (ii)(II)--
(I) by striking ``may issue a proposed order'' and
inserting ``shall issue an order'';
(II) by striking ``notification period applicable to the
manufacturing or processing of such substance under
subsection (a), (b), (c)'' and inserting ``applicable review
period''; and
(III) by inserting ``to the extent necessary to protect
against an unreasonable risk of injury to health or the
environment, without consideration of costs or other nonrisk
factors, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant
by the Administrator under the conditions of use, and the
submitter of the notice may commence manufacture of the
chemical substance, or manufacture or processing of the
chemical substance for a significant new use, including while
any required information is being developed, only in
compliance with the order'' before the period at the end;
(B) in paragraph (1)(B)--
(i) by striking ``A proposed order'' and inserting ``An
order'';
(ii) by striking ``notification period applicable to the
manufacture or processing of such substance under subsection
(a), (b), (c)'' and inserting ``applicable review period'';
and
(iii) by striking ``of the proposed order'' and inserting
``of the order'';
(C) by striking paragraph (1)(C); and
(D) by striking paragraph (2);
(6) in subsection (f)--
(A) in paragraph (1)--
(i) by striking ``finds that there is a reasonable basis to
conclude that the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance with'' and
inserting ``determines that a chemical substance or
significant new use with'';
(ii) by striking ``, or that any combination of such
activities,'';
(iii) by striking ``or will present'';
(iv) by striking ``before a rule promulgated under section
6 can protect against such risk,'' and inserting ``, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed subpopulation
identified as relevant by the Administrator under the
conditions of use,''; and
(v) by striking ``notification period applicable under
subsection (a), (b), or (c) to the manufacturing or
processing of such substance'' and inserting ``applicable
review period'';
(B) in paragraph (2), the matter following subparagraph
(C), by striking ``Section 6(d)(2)(B)'' and inserting
``Section 6(d)(3)(B)'';
(C) in paragraph (3)--
(i) in subparagraph (A)--
(I) by striking ``Administrator may'' and all that follows
through ``issue a proposed order to prohibit the'' and
inserting ``Administrator may issue an order to prohibit or
limit the''; and
(II) by striking ``under paragraph (1)'' and all that
follows through ``processing of such substance.'' and
inserting ``under paragraph (1). Such order shall take effect
on the expiration of the applicable review period.'';
(ii) by striking subparagraph (B) and redesignating
subparagraph (C) as subparagraph (B);
(iii) in subparagraph (B), as so redesignated--
(I) by striking ``subparagraphs (B) and (C)'' and inserting
``subparagraph (B)'';
(II) by striking ``clause (i) of''; and
(III) by striking ``; and the provisions of subparagraph
(C) of subsection (e)(2) shall apply with respect to an
injunction issued under subparagraph (B)''; and
(iv) by striking subparagraph (D); and
(D) by adding at the end the following:
``(4) Treatment of nonconforming uses.--Not later than 90
days after taking an action under paragraph (2) or (3) or
issuing an order under subsection (e) relating to a chemical
substance with respect to which the Administrator has made a
determination under subsection (a)(3)(A) or (B), the
Administrator shall consider whether to promulgate a rule
pursuant to subsection (a)(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 action or order, and, as applicable, initiate such a
rulemaking or publish a statement describing the reasons of
the Administrator for not initiating such a rulemaking.
``(5) 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 relating to a chemical
substance with respect to which the Administrator has made a
determination under subsection (a)(3)(A) or (B) to address
workplace exposures.'';
(7) by amending subsection (g) to read as follows:
``(g) Statement on Administrator Finding.--If the
Administrator finds in accordance with subsection (a)(3)(C)
that a chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or
the environment, then notwithstanding any remaining portion
of the applicable review period, the submitter of the notice
may commence manufacture of the chemical substance or
manufacture or processing for the significant new use, and
the Administrator shall make public a statement of the
Administrator's finding. Such a statement shall be submitted
for publication in the Federal Register as soon as is
practicable before the expiration of such period. Publication
of such statement in accordance
[[Page H3011]]
with the preceding sentence is not a prerequisite to the
manufacturing or processing of the substance with respect to
which the statement is to be published.'';
(8) in subsection (h)--
(A) in paragraph (1)(A), by inserting ``, including an
unreasonable risk to a potentially exposed or susceptible
subpopulation identified by the Administrator for the
specific conditions of use identified in the application''
after ``health or the environment'';
(B) in paragraph (2), by striking ``data'' each place it
appears and inserting ``information''; and
(C) in paragraph (4), by striking ``. A rule promulgated''
and all that follows through ``section 6(c)'' and inserting
``, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified by the Administrator
under the conditions of use''; and
(9) by amending subsection (i) to read as follows:
``(i) Definitions.--(1) For purposes of this section, the
terms `manufacture' and `process' mean manufacturing or
processing for commercial purposes.
``(2) For purposes of this Act, the term `requirement' as
used in this section shall not displace any statutory or
common law.
``(3) For purposes of this section, the term `applicable
review period' means the period starting on the date the
Administrator receives a notice under subsection (a)(1) and
ending 90 days after that date, or on such date as is
provided for in subsection (b)(1) or (c).''.
SEC. 6. PRIORITIZATION, RISK EVALUATION, AND REGULATION OF
CHEMICAL SUBSTANCES AND MIXTURES.
Section 6 of the Toxic Substances Control Act (15 U.S.C.
2605) is amended--
(1) by striking the section heading and inserting
``prioritization, risk evaluation, and regulation of chemical
substances and mixtures'';
(2) in subsection (a)--
(A) by striking ``finds that there is a reasonable basis to
conclude'' and inserting ``determines in accordance with
subsection (b)(4)(A)'';
(B) by striking ``or will present'';
(C) by inserting ``and subject to section 18, and in
accordance with subsection (c)(2),'' after ``shall by rule'';
(D) by striking ``to protect adequately against such risk
using the least burdensome requirements'' and inserting ``so
that the chemical substance or mixture no longer presents
such risk'';
(E) by inserting ``or otherwise restricting'' after
``prohibiting'' in paragraphs (1)(A) and (2)(A);
(F) by inserting ``minimum'' before ``warnings'' both
places it appears in paragraph (3);
(G) by striking ``and monitor or conduct tests'' and
inserting ``or monitor or conduct tests'' in paragraph (4);
and
(H) in paragraph (7)--
(i) by striking ``such unreasonable risk of injury'' and
inserting ``such determination''; and
(ii) by striking ``such risk of injury'' and inserting
``such determination'';
(3) by amending subsection (b) to read as follows:
``(b) Risk Evaluations.--
``(1) Prioritization for risk evaluations.--
``(A) Establishment of process.--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 establish, by rule, a risk-based screening process,
including criteria for designating chemical substances as
high-priority substances for risk evaluations or low-priority
substances for which risk evaluations are not warranted at
the time. The process to designate the priority of chemical
substances shall include a consideration of the hazard and
exposure potential of a chemical substance or a category of
chemical substances (including consideration of persistence
and bioaccumulation, potentially exposed or susceptible
subpopulations and storage near significant sources of
drinking water), the conditions of use or significant changes
in the conditions of use of the chemical substance, and the
volume or significant changes in the volume of the chemical
substance manufactured or processed.
``(B) Identification of priorities for risk evaluation.--
``(i) High-priority substances.--The Administrator shall
designate as a high-priority substance a chemical substance
that the Administrator concludes, without consideration of
costs or other nonrisk factors, may present an unreasonable
risk of injury to health or the environment because of a
potential hazard and a potential route of exposure under the
conditions of use, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified
as relevant by the Administrator.
``(ii) Low-priority substances.--The Administrator shall
designate a chemical substance as a low-priority substance if
the Administrator concludes, based on information sufficient
to establish, without consideration of costs or other nonrisk
factors, that such substance does not meet the standard
identified in clause (i) for designating a chemical substance
a high-priority substance.
``(C) Information request and review and proposed and final
prioritization designation.--The rulemaking required in
subparagraph (A) shall ensure that the time required to make
a priority designation of a chemical substance be no shorter
than nine months and no longer than 1 year, and that the
process for such designations includes--
``(i) a requirement that the Administrator request
interested persons to submit relevant information on a
chemical substance that the Administrator has initiated the
prioritization process on, before proposing a priority
designation for the chemical substance, and provide 90 days
for such information to be provided;
``(ii) a requirement that the Administrator publish each
proposed designation of a chemical substance as a high- or
low-priority substance, along with an identification of the
information, analysis, and basis used to make the proposed
designations, and provide 90 days for public comment on each
such proposed designation; and
``(iii) a process by which the Administrator may extend the
deadline in clause (i) for up to three months in order to
receive or evaluate information required to be submitted in
accordance with section 4(a)(2)(B), subject to the limitation
that if the information available to the Administrator at the
end of such an extension remains insufficient to enable the
designation of the chemical substance as a low-priority
substance, the Administrator shall designate the chemical
substance as a high-priority substance.
``(2) Initial risk evaluations and subsequent designations
of high- and low-priority substances.--
``(A) Initial risk evaluations.--Not later than 180 days
after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, the Administrator
shall ensure that risk evaluations are being conducted on 10
chemical substances drawn from the 2014 update of the TSCA
Work Plan for Chemical Assessments and shall publish the list
of such chemical substances during the 180 day period.
``(B) Additional risk evaluations.--Not later than three
and one half years after the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st Century Act, the
Administrator shall ensure that risk evaluations are being
conducted on at least 20 high-priority substances and that at
least 20 chemical substances have been designated as low-
priority substances, subject to the limitation that at least
50 percent of all chemical substances on which risk
evaluations are being conducted by the Administrator are
drawn from the 2014 update of the TSCA Work Plan for Chemical
Assessments.
``(C) Continuing designations and risk evaluations.--The
Administrator shall continue to designate priority substances
and conduct risk evaluations in accordance with this
subsection at a pace consistent with the ability of the
Administrator to complete risk evaluations in accordance with
the deadlines under paragraph (4)(G).
``(D) Preference.--In designating high-priority substances,
the Administrator shall give preference to--
``(i) chemical substances that are listed in the 2014
update of the TSCA Work Plan for Chemical Assessments as
having a Persistence and Bioaccumulation Score of 3; and
``(ii) chemical substances that are listed in the 2014
update of the TSCA Work Plan for Chemical Assessments that
are known human carcinogens and have high acute and chronic
toxicity.
``(E) Metals and metal compounds.--In identifying
priorities for risk evaluation and conducting risk
evaluations of 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 that addresses
metals risk assessment and is peer reviewed by the Science
Advisory Board.
``(3) Initiation of risk evaluations; designations.--
``(A) Risk evaluation initiation.--Upon designating a
chemical substance as a high-priority substance, the
Administrator shall initiate a risk evaluation on the
substance.
``(B) Revision.--The Administrator may revise the
designation of a low-priority substance based on information
made available to the Administrator.
``(C) Ongoing designations.--The Administrator shall
designate at least one high-priority substance upon the
completion of each risk evaluation (other than risk
evaluations for chemical substances designated under
paragraph (4)(C)(ii)).
``(4) Risk evaluation process and deadlines.--
``(A) In general.--The Administrator shall conduct risk
evaluations pursuant to this paragraph to determine whether a
chemical substance presents an unreasonable risk of injury to
health or the environment, without consideration of costs or
other nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified
as relevant to the risk evaluation by the Administrator,
under the conditions of use.
``(B) Establishment of process.--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 establish, by rule, a process to conduct risk
evaluations in accordance with subparagraph (A).
``(C) Requirement.--The Administrator shall conduct and
publish risk evaluations, in accordance with the rule
promulgated under subparagraph (B), for a chemical
substance--
``(i) that has been identified under paragraph (2)(A) or
designated under paragraph (1)(B)(i); and
``(ii) subject to subparagraph (E), that a manufacturer of
the chemical substance has
[[Page H3012]]
requested, in a form and manner and using the criteria
prescribed by the Administrator in the rule promulgated under
subparagraph (B), be subjected to a risk evaluation.
``(D) Scope.--The Administrator shall, not later than 6
months after the initiation of a risk evaluation, publish the
scope of the risk evaluation to be conducted, including the
hazards, exposures, conditions of use, and the potentially
exposed or susceptible subpopulations the Administrator
expects to consider, and, for each designation of a high-
priority substance, ensure not less than 12 months between
the initiation of the prioritization process for the chemical
substance and the publication of the scope of the risk
evaluation for the chemical substance, and for risk
evaluations conducted on chemical substances that have been
identified under paragraph (2)(A) or selected under
subparagraph (E)(iv)(II) of this paragraph, ensure not less
than 3 months before the Administrator publishes the scope of
the risk evaluation.
``(E) Limitation and criteria.--
``(i) Percentage requirements.--The Administrator shall
ensure that, of the number of chemical substances that
undergo a risk evaluation under clause (i) of subparagraph
(C), the number of chemical substances undergoing a risk
evaluation under clause (ii) of subparagraph (C) is--
``(I) not less than 25 percent, if sufficient requests are
made under clause (ii) of subparagraph (C); and
``(II) not more than 50 percent.
``(ii) Requested risk evaluations.--Requests for risk
evaluations under subparagraph (C)(ii) shall be subject to
the payment of fees pursuant to section 26(b), and the
Administrator shall not expedite or otherwise provide special
treatment to such risk evaluations.
``(iii) Preference.--In deciding whether to grant requests
under subparagraph (C)(ii), the Administrator shall give
preference to requests for risk evaluations on chemical
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.
``(iv) Exceptions.--(I) Chemical substances for which
requests have been granted under subparagraph (C)(ii) shall
not be subject to section 18(b).
``(II) Requests for risk evaluations on chemical substances
which are made under subparagraph (C)(ii) and that are drawn
from the 2014 update of the TSCA Work Plan for Chemical
Assessments shall be granted at the discretion of the
Administrator and not be subject to clause (i)(II).
``(F) Requirements.--In conducting a risk evaluation under
this subsection, the Administrator shall--
``(i) integrate and assess available information on hazards
and exposures for the conditions of use of the chemical
substance, including information that is relevant to specific
risks of injury to health or the environment and information
on potentially exposed or susceptible subpopulations
identified as relevant by the Administrator;
``(ii) describe whether aggregate or sentinel exposures to
a chemical substance under the conditions of use were
considered, and the basis for that consideration;
``(iii) not consider costs or other nonrisk factors;
``(iv) take into account, where relevant, the likely
duration, intensity, frequency, and number of exposures under
the conditions of use of the chemical substance; and
``(v) describe the weight of the scientific evidence for
the identified hazard and exposure.
``(G) Deadlines.--The Administrator--
``(i) shall complete a risk evaluation for a chemical
substance as soon as practicable, but not later than 3 years
after the date on which the Administrator initiates the risk
evaluation under subparagraph (C); and
``(ii) may extend the deadline for a risk evaluation for
not more than 6 months.
``(H) Notice and comment.--The Administrator shall provide
no less than 30 days public notice and an opportunity for
comment on a draft risk evaluation prior to publishing a
final risk evaluation.'';
(4) by amending subsection (c) to read as follows:
``(c) Promulgation of Subsection (a) Rules.--
``(1) Deadlines.--If the Administrator determines that a
chemical substance presents an unreasonable risk of injury to
health or the environment in accordance with subsection
(b)(4)(A), the Administrator--
``(A) shall propose in the Federal Register a rule under
subsection (a) for the chemical substance not later than 1
year after the date on which the final risk evaluation
regarding the chemical substance is published;
``(B) shall publish in the Federal Register a final rule
not later than 2 years after the date on which the final risk
evaluation regarding the chemical substance is published; and
``(C) may extend the deadlines under this paragraph for not
more than two years, subject to the condition that the
aggregate length of extensions under this subparagraph and
subsection (b)(4)(G)(ii) does not exceed two years, and
subject to the limitation that the Administrator may not
extend a deadline for the publication of a proposed or final
rule regarding a chemical substance drawn from the 2014
update of the TSCA Work Plan for Chemical Assessments or a
chemical substance that, 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 (or a successor scoring system), without
adequate public justification that demonstrates, following a
review of the information reasonably available to the
Administrator, that the Administrator cannot complete the
proposed or final rule without additional information
regarding the chemical substance.
``(2) Requirements for rule.--
``(A) Statement of effects.--In proposing and promulgating
a rule under subsection (a) with respect to a chemical
substance or mixture, the Administrator shall consider and
publish a statement based on reasonably available information
with respect to--
``(i) the effects of the chemical substance or mixture on
health and the magnitude of the exposure of human beings to
the chemical substance or mixture;
``(ii) the effects of the chemical substance or mixture on
the environment and the magnitude of the exposure of the
environment to such substance or mixture;
``(iii) the benefits of the chemical substance or mixture
for various uses; and
``(iv) the reasonably ascertainable economic consequences
of the rule, including consideration of--
``(I) the likely effect of the rule on the national
economy, small business, technological innovation, the
environment, and public health;
``(II) the costs and benefits of the proposed and final
regulatory action and of the 1 or more primary alternative
regulatory actions considered by the Administrator; and
``(III) the cost effectiveness of the proposed regulatory
action and of the 1 or more primary alternative regulatory
actions considered by the Administrator.
``(B) Selecting requirements.--In selecting among
prohibitions and other restrictions, the Administrator shall
factor in, to the extent practicable, the considerations
under subparagraph (A) in accordance with subsection (a).
``(C) Consideration of alternatives.--Based on the
information published under subparagraph (A), in deciding
whether to prohibit or restrict in a manner that
substantially prevents a specific condition of use of a
chemical substance or mixture, and in setting an appropriate
transition period for such action, the Administrator shall
consider, to the extent practicable, whether technically and
economically feasible alternatives that benefit health or the
environment, compared to the use so proposed to be prohibited
or restricted, will be reasonably available as a substitute
when the proposed prohibition or other restriction takes
effect.
``(D) Replacement parts.--
``(i) In general.--The Administrator shall exempt
replacement parts for complex durable goods and complex
consumer goods that are designed prior to the date of
publication in the Federal Register of the rule under
subsection (a), unless the Administrator finds that such
replacement parts contribute significantly to the risk,
identified in a risk evaluation conducted under subsection
(b)(4)(A), to the general population or to an identified
potentially exposed or susceptible subpopulation.
``(ii) Definitions.--In this subparagraph--
``(I) the term `complex consumer goods' means electronic or
mechanical devices composed of multiple manufactured
components, with an intended useful life of 3 or more years,
where the product is typically not consumed, destroyed, or
discarded after a single use, and the components of which
would be impracticable to redesign or replace; and
``(II) the term `complex durable goods' means manufactured
goods composed of 100 or more manufactured components, with
an intended useful life of 5 or more years, where the product
is typically not consumed, destroyed, or discarded after a
single use.
``(E) Articles.--In selecting among prohibitions and other
restrictions, the Administrator shall apply such prohibitions
or other restrictions to an article or category of articles
containing the chemical substance or mixture only to the
extent necessary to address the identified risks from
exposure to the chemical substance or mixture from the
article or category of articles so that the substance or
mixture does not present an unreasonable risk of injury to
health or the environment identified in the risk evaluation
conducted in accordance with subsection (b)(4)(A).
``(3) Procedures.--When prescribing a rule under subsection
(a) the Administrator shall proceed in accordance with
section 553 of title 5, United States Code (without regard to
any reference in such section to sections 556 and 557 of such
title), and shall also--
``(A) publish a notice of proposed rulemaking stating with
particularity the reason for the proposed rule;
``(B) allow interested persons to submit written data,
views, and arguments, and make all such submissions publicly
available;
``(C) promulgate a final rule based on the matter in the
rulemaking record; and
``(D) make and publish with the rule the determination
described in subsection (a).'';
(5) in subsection (d)--
(A) by redesignating paragraph (2) as paragraph (3);
(B) by striking paragraph (1) and inserting the following:
``(1) In general.--In any rule under subsection (a), the
Administrator shall--
[[Page H3013]]
``(A) specify the date on which it shall take effect, which
date shall be as soon as practicable;
``(B) except as provided in subparagraphs (C) and (D),
specify mandatory compliance dates for all of the
requirements under a rule under subsection (a), which shall
be as soon as practicable, but not later than 5 years after
the date of promulgation of the rule, except in a case of a
use exempted under subsection (g);
``(C) specify mandatory compliance dates for the start of
ban or phase-out requirements under a rule under subsection
(a), which shall be as soon as practicable, but not later
than 5 years after the date of promulgation of the rule,
except in the case of a use exempted under subsection (g);
``(D) specify mandatory compliance dates for full
implementation of ban or phase-out requirements under a rule
under subsection (a), which shall be as soon as practicable;
and
``(E) provide for a reasonable transition period.
``(2) Variability.--As determined by the Administrator, the
compliance dates established under paragraph (1) may vary for
different affected persons.''; and
(C) in paragraph (3), as so redesignated by subparagraph
(A) of this paragraph--
(i) in subparagraph (A)--
(I) by striking ``upon its publication'' and all that
follows through ``respecting such rule if'' and inserting ``,
and compliance with the proposed requirements to be
mandatory, upon publication in the Federal Register of the
proposed rule and until the compliance dates applicable to
such requirements in a final rule promulgated under section
6(a) or until the Administrator revokes such proposed rule,
in accordance with subparagraph (B), if''; and
(II) in clause (i)(I), by inserting ``without consideration
of costs or other non-risk factors'' after ``effective
date''; and
(ii) in subparagraph (B), by striking ``, provide
reasonable opportunity'' and all that follows through the
period at the end and inserting ``in accordance with
subsection (c), and either promulgate such rule (as proposed
or with modifications) or revoke it.'';
(6) in subsection (e)(4), by striking ``paragraphs (2),
(3), and (4)'' and inserting ``paragraph (3)''; and
(7) by adding at the end the following new subsections:
``(g) Exemptions.--
``(1) Criteria for exemption.--The Administrator may, as
part of a rule promulgated under subsection (a), or in a
separate rule, grant an exemption from a requirement of a
subsection (a) rule for a specific condition of use of a
chemical substance or mixture, if the Administrator finds
that--
``(A) the specific condition of use is a critical or
essential use for which no technically and economically
feasible safer alternative is available, taking into
consideration hazard and exposure;
``(B) compliance with the requirement, as applied with
respect to the specific condition of use, would significantly
disrupt the national economy, national security, or critical
infrastructure; or
``(C) the specific condition of use of the chemical
substance or mixture, as compared to reasonably available
alternatives, provides a substantial benefit to health, the
environment, or public safety.
``(2) Exemption analysis and statement.--In proposing an
exemption under this subsection, the Administrator shall
analyze the need for the exemption, and shall make public the
analysis and a statement describing how the analysis was
taken into account.
``(3) Period of exemption.--The Administrator shall
establish, as part of a rule under this subsection, a time
limit on any exemption for a time to be determined by the
Administrator as reasonable on a case-by-case basis, and, 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
modification or is no longer necessary.
``(4) Conditions.--As part of a rule promulgated under this
subsection, 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.
``(h) Chemicals That Are Persistent, Bioaccumulative, and
Toxic.--
``(1) Expedited action.--Not later than 3 years after the
date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the Administrator shall propose
rules under subsection (a) with respect to chemical
substances identified in the 2014 update of the TSCA Work
Plan for Chemical Assessments--
``(A) that the Administrator has a reasonable basis to
conclude are toxic and that with respect to persistence and
bioaccumulation score high for one and either high or
moderate for the other, pursuant to the TSCA Work Plan
Chemicals Methods Document published by the Administrator in
February 2012 (or a successor scoring system), and are not a
metal or a metal compound, and for which the Administrator
has not completed a Work Plan Problem Formulation, initiated
a review under section 5, or entered into a consent agreement
under section 4, prior to the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st Century Act; and
``(B) exposure to which under the conditions of use is
likely to the general population or to a potentially exposed
or susceptible subpopulation identified by the Administrator,
or the environment, on the basis of an exposure and use
assessment conducted by the Administrator.
``(2) No risk evaluation required.--The Administrator shall
not be required to conduct risk evaluations on chemical
substances that are subject to paragraph (1).
``(3) Final rule.--Not later than 18 months after proposing
a rule pursuant to paragraph (1), the Administrator shall
promulgate a final rule under subsection (a).
``(4) Selecting restrictions.--In selecting among
prohibitions and other restrictions promulgated in a rule
under subsection (a) pursuant to paragraph (1), the
Administrator shall address the risks of injury to health or
the environment that the Administrator determines are
presented by the chemical substance and shall reduce exposure
to the substance to the extent practicable.
``(5) Relationship to subsection (b).--If, at any time
prior to the date that is 90 days after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, the Administrator makes a designation under
subsection (b)(1)(B)(i), or receives a request under
subsection (b)(4)(C)(ii), such chemical substance shall not
be subject to this subsection, except that in selecting among
prohibitions and other restrictions promulgated in a rule
pursuant to subsection (a), the Administrator shall both
ensure that the chemical substance meets the rulemaking
standard under subsection (a) and reduce exposure to the
substance to the extent practicable.
``(i) Final Agency Action.--Under this section and subject
to section 18--
``(1) a determination by the Administrator under subsection
(b)(4)(A) that a chemical substance does not present an
unreasonable risk of injury to health or the environment
shall be issued by order and considered to be a final agency
action, effective beginning on the date of issuance of the
order; and
``(2) a final rule promulgated under subsection (a),
including the associated determination by the Administrator
under subsection (b)(4)(A) that a chemical substance presents
an unreasonable risk of injury to health or the environment,
shall be considered to be a final agency action, effective
beginning on the date of promulgation of the final rule.
``(j) Definition.--For the purposes of this Act, the term
`requirement' as used in this section shall not displace
statutory or common law.''.
SEC. 7. IMMINENT HAZARDS.
Section 7 of the Toxic Substances Control Act (15 U.S.C.
2606) is amended--
(1) in subsection (b)(1), by inserting ``(as identified by
the Administrator without consideration of costs or other
nonrisk factors)'' after ``from the unreasonable risk''; and
(2) in subsection (f), by inserting ``, without
consideration of costs or other nonrisk factors'' after
``widespread injury to health or the environment''.
SEC. 8. REPORTING AND RETENTION OF INFORMATION.
(a) In General.--Section 8 of the Toxic Substances Control
Act (15 U.S.C. 2607) is amended--
(1) in subsection (a)--
(A) in paragraph (2), by striking the matter that follows
subparagraph (G);
(B) in paragraph (3), 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 under
subparagraph (B); and
``(ii) after providing public notice and an opportunity for
comment, make a determination as to whether revision of the
standards is warranted.''; and
(C) by adding at the end the following:
``(4) Contents.--The rules promulgated pursuant to
paragraph (1)--
``(A) may impose differing reporting and recordkeeping
requirements on manufacturers and processors; and
``(B) shall include the level of detail necessary to be
reported, including the manner by which use and exposure
information may be reported.
``(5) Administration.--In carrying out this section, the
Administrator shall, to the extent feasible--
``(A) not require reporting which is unnecessary or
duplicative;
``(B) minimize the cost of compliance with this section and
the rules issued thereunder on small manufacturers and
processors; and
``(C) apply any reporting obligations to those persons
likely to have information relevant to the effective
implementation of this title.
``(6) Negotiated rulemaking.--(A) The Administrator shall
enter into a negotiated rulemaking pursuant to subchapter III
of chapter 5 of title 5, United States Code, to develop and
publish, not later than 3 years after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, a proposed rule providing for limiting the
reporting requirements, under this subsection, for
manufacturers of any inorganic byproducts, when such
byproducts,
[[Page H3014]]
whether by the byproduct manufacturer or by any other person,
are subsequently recycled, reused, or reprocessed.
``(B) Not later than 3 and one-half years after such date
of enactment, the Administrator shall publish a final rule
resulting from such negotiated rulemaking.''; and
(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 the individual members of the categories of
chemical substances identified by the Administrator as
statutory mixtures, as defined in Inventory descriptions
established by the Administrator, as being included on the
list established under paragraph (1).
``(B) Multiple nomenclature listings.--If a manufacturer or
processor demonstrates to the Administrator that a chemical
substance appears multiple times on the list published under
paragraph (1) under different CAS numbers, the Administrator
may recognize 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 may require processors, subject to the
limitations under subsection (a)(5)(A), to notify the
Administrator, by not later than 180 days after the date on
which the final rule is published in the Federal Register, 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).
``(iv) Limitation.--No chemical substance on the list
published under paragraph (1) shall be removed from such list
by reason of the implementation of this subparagraph, or be
subject to section 5(a)(1)(A)(i) by reason of a change to
active status under paragraph (5)(B).
``(B) Confidential chemical substances.--In promulgating a
rule under 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 any manufacturer or processor of a chemical
substance on the confidential portion of the list published
under paragraph (1) that seeks to maintain an existing claim
for protection against disclosure of the specific chemical
identity of the chemical substance as confidential pursuant
to section 14 to submit a notice under subparagraph (A) that
includes such request;
``(iii) require the substantiation of those claims pursuant
to section 14 and in accordance with the review plan
described in subparagraph (C); and
``(iv) move any active chemical substance for which no
request was received to maintain an existing claim for
protection against disclosure of the specific chemical
identity of the chemical substance as confidential from the
confidential portion of the list published under paragraph
(1) to the nonconfidential portion of that list.
``(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 chemical 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.--In establishing the
review plan under subparagraph (C), the Administrator shall--
``(i) require, at a time specified by the Administrator,
all manufacturers or processors asserting claims under
subparagraph (B) to substantiate the claim, in accordance
with section 14, unless the manufacturer or processor has
substantiated the claim in a submission made to the
Administrator during the 5-year period ending on the last day
of the of the time period specified by the Administrator; and
``(ii) in accordance with section 14--
``(I) review each substantiation--
``(aa) submitted pursuant to clause (i) to determine if the
claim qualifies for 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, approve in part and deny in part, 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 not protect the information from
disclosure; or
``(bb) the Administrator otherwise becomes aware that the
information does not qualify for protection from disclosure,
in which case the Administrator shall take the actions
described in section 14(g)(2).
``(E) Timeline for completion of reviews.--
``(i) In general.--The Administrator shall implement the
review plan so as to complete reviews of all claims specified
in subparagraph (C) not later than 5 years after the date on
which the Administrator compiles the initial list of active
substances pursuant to subparagraph (A).
``(ii) Considerations.--
``(I) In general.--The Administrator may extend the
deadline for completion of the reviews for not more than 2
additional years, after an adequate public justification, if
the Administrator determines that the extension is necessary
based on the number of claims needing review and the
available resources.
``(II) Annual review goal and results.--At the beginning of
each year, the Administrator shall publish an annual goal for
reviews and the number of reviews completed in the prior
year.
``(5) Active and inactive substances.--
``(A) In general.--The Administrator shall keep
designations of active substances and inactive substances on
the list published under paragraph (1) current.
``(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.--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 chemical
identity of the inactive substance as confidential, the
person shall, consistent with the requirements of section
14--
``(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
chemical identity of the chemical substance and approve,
approve in part and deny in part, or deny the claim;
``(III) except as provided in this section and section 14,
protect from disclosure the specific chemical 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 not protect the information from
disclosure; or
``(bb) the Administrator otherwise becomes aware that the
information does not qualify for protection from disclosure,
in which case the Administrator shall take the actions
described in section 14(g)(2); and
``(IV) pursuant to section 6(b), 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 6(b).
``(7) Public information.--Subject to this subsection and
section 14, the Administrator shall make available to the
public--
``(A) each specific chemical identity on the
nonconfidential portion of the list published under paragraph
(1) along with the Administrator's designation of the
chemical substance as an active or inactive substance;
``(B) the unique identifier assigned under section 14,
accession number, generic name,
[[Page H3015]]
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) the specific chemical identity of any active
substance for which--
``(i) a claim for protection against disclosure of the
specific chemical identity of the active substance was not
asserted, as required under this subsection or section 14;
``(ii) all claims for protection against disclosure of the
specific chemical identity of the active substance have been
denied by the Administrator; or
``(iii) the time period for protection against disclosure
of the specific chemical identity of the active substance has
expired.
``(8) Limitation.--No person may assert a new claim under
this subsection or section 14 for protection from disclosure
of a specific chemical identity of any active or inactive
substance for which a notice is received under paragraph
(4)(A)(i) or (5)(B)(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, as applicable,
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 documenting compliance with the
rule and supporting confidentiality claims for a period of 5
years beginning on the last day of the submission period.''.
(b) Mercury Inventory.--Section 8(b) of the Toxic
Substances Control Act (15 U.S.C. 2607(b)) (as amended by
subsection (a)) is further 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 carry out and
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 manufacturing processes or products that
intentionally add mercury; and
``(ii) recommend actions, including proposed revisions of
Federal law or 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.--Clause (i) 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.''.
SEC. 9. 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)--
(i) by striking ``has reasonable basis to conclude'' and
inserting ``determines'';
(ii) by striking ``or will present''; and
(iii) by inserting ``, without consideration of costs or
other nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified
as relevant by the Administrator, under the conditions of
use,'' after ``or the environment'';
(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''; and
(ii) in subparagraph (B), by inserting ``responds within
the time period specified by the Administrator in the report
and'' before ``initiates, within 90'';
(C) by redesignating paragraph (3) as paragraph (6); and
(D) 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 timeframe
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 is submitted under
paragraph (1) does not take the actions described in
subparagraph (A) or (B) of paragraph (3), the Administrator
shall--
``(A) initiate or complete appropriate action under section
6; or
``(B) take any action authorized or required under section
7, as applicable.
``(5) This subsection shall not relieve the Administrator
of any obligation to take any appropriate action under
section 6(a) 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 (b)--
(A) by striking ``The Administrator shall coordinate'' and
inserting ``(1) The Administrator shall coordinate''; and
(B) by adding at the end the following:
``(2) In making a determination under paragraph (1) that it
is in the public interest for the Administrator to take an
action under this title with respect to a chemical substance
or mixture rather than under another law administered in
whole or in part by the Administrator, the Administrator
shall consider, based on information reasonably available to
the Administrator, all relevant aspects of the risk described
in paragraph (1) and a comparison of the estimated costs and
efficiencies of the action to be taken under this title and
an action to be taken under such other law to protect against
such risk.''; and
(3) by adding at the end the following:
``(e) Exposure Information.--In addition to the
requirements of subsection (a), if the Administrator obtains
information related to exposures or releases of a chemical
substance or mixture that may be prevented or reduced under
another Federal law, including a law 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. 10. EXPORTS.
(a) In General.--Section 12(a)(2) of the Toxic Substances
Control Act (15 U.S.C. 2611(a)(2)) is amended by striking
``will present'' and inserting ``presents''.
(b) Prohibition on Export of Certain Mercury Compounds.--
Section 12(c) of the Toxic Substances Control Act (15 U.S.C.
2611(c)) is amended--
(1) in the subsection heading, by inserting ``and Mercury
Compounds'' after ``Mercury''; and
(2) by adding at the end the following:
``(7) 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 adds to
the list published under subparagraph (B) 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 a mercury compound to the list published under
subparagraph (B).
``(D) Environmentally sound disposal.--This paragraph does
not prohibit the export of mercury compounds on the list
published under subparagraph (B) to member countries of the
Organization for Economic Co-operation and Development for
environmentally sound disposal, on the condition that no
mercury or mercury compounds so exported are to be recovered,
recycled, or reclaimed for use, or directly reused, after
such export.
``(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 mercury compounds on the list published under
subparagraph (B) for disposal that occurred after such date
of enactment and shall submit to Congress a report that--
``(i) describes volumes and sources of mercury compounds on
the list published under subparagraph (B) exported for
disposal;
``(ii) identifies receiving countries of such exports;
``(iii) describes methods of disposal used after such
export;
``(iv) identifies issues, if any, presented by the export
of mercury compounds on the list published under subparagraph
(B);
``(v) includes an evaluation of management options in the
United States for mercury compounds on the list published
under subparagraph (B), if any, that are commercially
available and comparable in cost and efficacy to methods
being utilized in such receiving countries; and
``(vi) makes a recommendation regarding whether Congress
should further limit or prohibit the export of mercury
compounds
[[Page H3016]]
on the list published under subparagraph (B) for disposal.
``(F) Effect on other law.--Nothing in this paragraph shall
be construed to affect the authority of the Administrator
under the Solid Waste Disposal Act (42 U.S.C. 6901 et
seq.).''.
(c) Temporary Generator Accumulation.--Section 5 of the
Mercury Export Ban Act of 2008 (42 U.S.C. 6939f) is amended--
(1) in subsection (a)(2), by striking ``2013'' and
inserting ``2019'';
(2) in subsection (b)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A), (B), and (C), as
clauses (i), (ii), and (iii), respectively and indenting
appropriately;
(ii) in the first sentence, by striking ``After
consultation'' and inserting the following:
``(A) Assessment and collection.--After consultation'';
(iii) in the second sentence, by striking ``The amount of
such fees'' and inserting the following:
``(B) Amount.--The amount of the fees described in
subparagraph (A)'';
(iv) in subparagraph (B) (as so designated)--
(I) in clause (i) (as so redesignated), by striking
``publically available not later than October 1, 2012'' and
inserting ``publicly available not later than October 1,
2018'';
(II) in clause (ii) (as so redesignated), by striking
``and'';
(III) in clause (iii) (as so redesignated), by striking the
period at the end and inserting ``, subject to clause (iv);
and''; and
(IV) by adding at the end the following:
``(iv) for generators temporarily accumulating elemental
mercury in a facility subject to subparagraphs (B) and
(D)(iv) of subsection (g)(2) if the facility designated in
subsection (a) is not operational by January 1, 2019, shall
be adjusted to subtract the cost of the temporary
accumulation during the period in which the facility
designated under subsection (a) is not operational.''; and
(v) by adding at the end the following:
``(C) Conveyance of title and permitting.--If the facility
designated in subsection (a) is not operational by January 1,
2020, the Secretary--
``(i) shall immediately accept the conveyance of title to
all elemental mercury that has accumulated in facilities in
accordance with subsection (g)(2)(D), before January 1, 2020,
and deliver the accumulated mercury to the facility
designated under subsection (a) on the date on which the
facility becomes operational;
``(ii) shall pay any applicable Federal permitting costs,
including the costs for permits issued under section 3005(c)
of the Solid Waste Disposal Act (42 U.S.C. 6925(c)); and
``(iii) shall store, or pay the cost of storage of, until
the time at which a facility designated in subsection (a) is
operational, accumulated mercury to which the Secretary has
title under this subparagraph in a facility that has been
issued a permit under section 3005(c) of the Solid Waste
Disposal Act (42 U.S.C. 6925(c)).''; and
(B) in paragraph (2), in the first sentence, by striking
``paragraph (1)(C)'' and inserting ``paragraph (1)(B)(iii)'';
and
(3) in subsection (g)(2)--
(A) in the undesignated material at the end, by striking
``This subparagraph'' and inserting the following:
``(C) Subparagraph (B)'';
(B) in subparagraph (C) (as designated by subparagraph
(A)), 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 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 subparagraph, and notwithstanding that
guidance called for by this paragraph has not been developed
or made available.''.
(d) 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''.
SEC. 11. 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 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, by reason of 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 (c) are met.
In any proceeding under section 552(a) of title 5, United
States Code, to obtain information the disclosure of which
has been denied because of the provisions of this subsection,
the Administrator may not rely on section 552(b)(3) of such
title to sustain the Administrator's action.
``(b) Information Not Protected From Disclosure.--
``(1) Mixed confidential and nonconfidential information.--
Information that is protected from disclosure under this
section, and which is mixed with information that is not
protected from disclosure under this section, does not lose
its protection from disclosure notwithstanding that it is
mixed with information that is not protected from disclosure.
``(2) Information from health and safety studies.--
Subsection (a) does not prohibit the disclosure of--
``(A) any health and safety study which is submitted under
this Act with respect to--
``(i) any chemical substance or mixture which, on the date
on which such study is to be disclosed has been offered for
commercial distribution; or
``(ii) any chemical substance or mixture for which testing
is required under section 4 or for which notification is
required under section 5; and
``(B) any information reported to, or otherwise obtained
by, the Administrator from a health and safety study which
relates to a chemical substance or mixture described in
clause (i) or (ii) of subparagraph (A).
This paragraph does not authorize the disclosure of any
information, including formulas (including molecular
structures) of a chemical substance or mixture, that
discloses processes used in the manufacturing or processing
of a chemical substance or mixture or, in the case of a
mixture, the portion of the mixture comprised by any of the
chemical substances in the mixture.
``(3) Other information not protected from disclosure.--
Subsection (a) does not prohibit the disclosure of--
``(A) 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; or
``(B) a general description of a process used in the
manufacture or processing and industrial, commercial, or
consumer functions and uses of a chemical substance, mixture,
or article containing a chemical substance or mixture,
including information specific to an industry or industry
sector that customarily would be shared with the general
public or within an industry or industry sector.
``(4) Bans and phase-outs.--
``(A) In general.--If the Administrator promulgates a rule
pursuant to section 6(a) that establishes a ban or phase-out
of a chemical substance or mixture, the protection from
disclosure of any information under this section with respect
to the chemical substance or mixture shall be presumed to no
longer apply, subject to subsection (g)(1)(E) and
subparagraphs (B) and (C) of this paragraph.
``(B) Limitations.--
``(i) Critical use.--In the case of a chemical substance or
mixture for which a specific condition of use is subject to
an exemption pursuant to section 6(g), if the Administrator
establishes a ban or phase-out described in subparagraph (A)
with respect to the chemical substance or mixture, the
presumption against protection under such subparagraph shall
only apply to information that relates solely to any
conditions of use of the chemical substance or mixture to
which the exemption does not apply.
``(ii) Export.--In the case of a chemical substance or
mixture for which there is manufacture, processing, or
distribution in commerce that meets the conditions of section
12(a)(1), if the Administrator establishes a ban or phase-out
described in subparagraph (A) with respect to the chemical
substance or mixture, the presumption against protection
under such subparagraph shall only apply to information that
relates solely to any other manufacture, processing, or
distribution in commerce of the chemical substance or mixture
for the conditions of use
[[Page H3017]]
subject to the ban or phase-out, unless the Administrator
makes the determination in section 12(a)(2).
``(iii) Specific conditions of use.--In the case of a
chemical substance or mixture for which the Administrator
establishes a ban or phase-out described in subparagraph (A)
with respect to a specific condition of use of the chemical
substance or mixture, the presumption against protection
under such subparagraph shall only apply to information that
relates solely to the condition of use of the chemical
substance or mixture for which the ban or phase-out is
established.
``(C) Request for nondisclosure.--
``(i) In general.--A manufacturer or processor of a
chemical substance or mixture subject to a ban or phase-out
described in this paragraph may submit to the Administrator,
within 30 days of receiving a notification under subsection
(g)(2)(A), a request, including documentation supporting such
request, that some or all of the information to which the
notice applies should not be disclosed or that its disclosure
should be delayed, and the Administrator shall review the
request under subsection (g)(1)(E).
``(ii) Effect of no request or denial.--If no request for
nondisclosure or delay is submitted to the Administrator
under this subparagraph, or the Administrator denies such a
request under subsection (g)(1)(A), the information shall not
be protected from disclosure under this section.
``(5) Certain requests.--If a request is made to the
Administrator under section 552(a) of title 5, United States
Code, for information reported to or otherwise obtained by
the Administrator under this Act that is not protected from
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.
``(c) Requirements for Confidentiality Claims.--
``(1) Assertion of claims.--
``(A) In general.--A person seeking to protect from
disclosure any information that person submits under this Act
(including information described in paragraph (2)) shall
assert to the Administrator a claim for protection from
disclosure 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) Additional requirements for claims regarding chemical
identity information.--In the case of a claim under
subparagraph (A) for protection from 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 such generic name shall--
``(i) be consistent with guidance developed by the
Administrator under paragraph (4)(A); and
``(ii) describe the chemical structure of the chemical
substance as specifically as practicable while protecting
those features of the chemical structure--
``(I) that are claimed as confidential; and
``(II) the disclosure of which would be likely to cause
substantial harm to the competitive position of the person.
``(2) Information generally not subject to substantiation
requirements.--Subject to subsection (f), the following
information shall not be subject to substantiation
requirements under paragraph (3):
``(A) Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture,
or article.
``(B) Marketing and sales information.
``(C) Information identifying a supplier or customer.
``(D) In the case of a mixture, details of the full
composition of the mixture and the respective percentages of
constituents.
``(E) Specific information regarding the use, function, or
application of a chemical substance or mixture in a process,
mixture, or article.
``(F) Specific production or import volumes of the
manufacturer or processor.
``(G) Prior to the date on which a chemical substance is
first offered for commercial distribution, the specific
chemical identity of the chemical substance, including the
chemical name, molecular formula, Chemical Abstracts Service
number, and other information that would identify the
specific chemical substance, if the specific chemical
identity was claimed as confidential at the time it was
submitted in a notice under section 5.
``(3) Substantiation requirements.--Except as provided in
paragraph (2), a person asserting a claim to protect
information from disclosure under this section shall
substantiate the claim, in accordance with such rules as the
Administrator has promulgated or may promulgate pursuant to
this section.
``(4) Guidance.--The Administrator shall develop guidance
regarding--
``(A) the determination of structurally descriptive generic
names, in the case of claims for the protection from
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 (d).
``(5) 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 (3), are
true and correct.
``(d) Exceptions to Protection From Disclosure.--
Information described in subsection (a)--
``(1) shall be disclosed to an officer or employee of the
United States--
``(A) in connection with the official duties of that person
under any Federal law for the protection of health or the
environment; or
``(B) for a specific Federal law enforcement purpose;
``(2) shall 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 against an unreasonable risk of injury to health
or the environment, without consideration of costs or other
nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified
as relevant by the Administrator under the conditions of use;
``(4) shall be disclosed to a State, political subdivision
of a State, or tribal government, on written request, for the
purpose of administration or enforcement of a law, if such
entity has 1 or more applicable agreements with the
Administrator that are consistent with the guidance developed
under subsection (c)(4)(B) and ensure that the entity 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 to a health or environmental
professional employed by a Federal or State agency or tribal
government or a treating physician or nurse in a nonemergency
situation if such person 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 developed under subsection
(c)(4)(B);
``(B) the 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 or mixture
concerned, or an environmental release of or exposure to the
chemical substance or mixture concerned has occurred; and
``(C) 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 who
has a claim under this section with respect to the
information;
``(6) shall be disclosed in the event of an emergency to a
treating or responding physician, nurse, agent of a poison
control center, public health or environmental official of a
State, political subdivision of a State, or tribal
government, or first responder (including any individual duly
authorized by a Federal agency, State, political subdivision
of a State, or tribal government who is trained in urgent
medical care or other emergency procedures, including a
police officer, firefighter, or emergency medical technician)
if such person requests the information, subject to the
conditions that such person shall--
``(A) have a reasonable basis to suspect that--
``(i) a medical, 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 or mixture
concerned, or a serious environmental release of or exposure
to the chemical substance or mixture concerned has occurred;
and
``(B) if requested by a person who has a claim with respect
to the information under this section--
``(i) provide a written statement of need and agree to sign
a confidentiality agreement, as described in paragraph (5);
and
[[Page H3018]]
``(ii) submit to the Administrator such statement of need
and confidentiality agreement 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 is made in such
a manner as to preserve confidentiality to the extent
practicable without impairing the proceeding;
``(8) shall be disclosed if the information is required to
be made public under any other provision of Federal law; and
``(9) shall be disclosed as required pursuant to discovery,
subpoena, other court order, or any other judicial process
otherwise allowed under applicable Federal or State law.
``(e) Duration of Protection From Disclosure.--
``(1) In general.--Subject to paragraph (2), subsection
(f)(3), and section 8(b), the Administrator shall protect
from disclosure information described in subsection (a)--
``(A) in the case of information described in subsection
(c)(2), until such time as--
``(i) the person that asserted the claim notifies the
Administrator that the person is withdrawing the claim, in
which case the information shall not be protected from
disclosure under this section; or
``(ii) the Administrator becomes aware that the information
does not qualify for protection from disclosure under this
section, in which case the Administrator shall take any
actions required under subsections (f) and (g); and
``(B) in the case of information other than information
described in subsection (c)(2)--
``(i) for a period of 10 years from the date on which the
person asserts the claim with respect to the information
submitted to the Administrator; or
``(ii) if applicable before the expiration of such 10-year
period, until such time as--
``(I) the person that asserted the claim notifies the
Administrator that the person is withdrawing the claim, in
which case the information shall not be protected from
disclosure under this section; or
``(II) the Administrator becomes aware that the information
does not qualify for protection from disclosure under this
section, in which case the Administrator shall take any
actions required under subsections (f) and (g).
``(2) Extensions.--
``(A) In general.--In the case of information other than
information described in subsection (c)(2), not later than
the date that is 60 days before the expiration of the period
described in paragraph (1)(B)(i), the Administrator shall
provide to the person that asserted the claim a notice of the
impending expiration of the period.
``(B) Request.--
``(i) In general.--Not later than the date that is 30 days
before the expiration of the period described in paragraph
(1)(B)(i), a person reasserting the relevant claim shall
submit to the Administrator a request for extension
substantiating, in accordance with subsection (c)(3), the
need to extend the period.
``(ii) Action by administrator.--Not later than the date of
expiration of the period described in paragraph (1)(B)(i),
the Administrator shall, in accordance with subsection
(g)(1)--
``(I) review the request submitted under clause (i);
``(II) make a determination regarding whether the claim for
which the request was submitted continues to meet the
relevant requirements of this section; and
``(III)(aa) grant an extension of 10 years; or
``(bb) deny the request.
``(C) No limit on number of extensions.--There shall be no
limit on the number of extensions granted under this
paragraph, if the Administrator determines that the relevant
request under subparagraph (B)(i)--
``(i) establishes the need to extend the period; and
``(ii) meets the requirements established by the
Administrator.
``(f) Review and Resubstantiation.--
``(1) Discretion of administrator.--The Administrator may
require any person that has claimed protection for
information from disclosure under this section, whether
before, on, or after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, to
reassert and substantiate or resubstantiate the claim in
accordance with this section--
``(A) after the chemical substance is designated as a high-
priority substance under section 6(b);
``(B) for any chemical substance designated as an active
substance under section 8(b)(5)(B)(iii); or
``(C) if the Administrator determines that disclosure of
certain information currently protected from disclosure would
be important to assist the Administrator in conducting risk
evaluations or promulgating rules under section 6.
``(2) Review required.--The Administrator shall review a
claim for protection of information from disclosure under
this section 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 reassert and substantiate
or resubstantiate the claim in accordance with this section--
``(A) 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;
``(B) if the Administrator has a reasonable basis to
believe that the information does not qualify for protection
from disclosure under this section; or
``(C) for any chemical substance the Administrator
determines under section 6(b)(4)(A) presents an unreasonable
risk of injury to health or the environment.
``(3) Period of protection.--If the Administrator requires
a person to reassert and substantiate or resubstantiate a
claim under this subsection, and determines that the claim
continues to meet the relevant requirements of this section,
the Administrator shall protect the information subject to
the claim from disclosure for a period of 10 years from the
date of such determination, subject to any subsequent
requirement by the Administrator under this subsection.
``(g) Duties of Administrator.--
``(1) Determination.--
``(A) In general.--Except for claims regarding information
described in subsection (c)(2), the Administrator shall,
subject to subparagraph (C), not later than 90 days after the
receipt of a claim under subsection (c), and not later than
30 days after the receipt of a request for extension of a
claim under subsection (e) or a request under subsection
(b)(4)(C), review and approve, approve in part and deny in
part, or deny the claim or request.
``(B) Reasons for denial.--If the Administrator denies or
denies in part a claim or request under subparagraph (A) the
Administrator shall provide to the person that asserted the
claim or submitted the request a written statement of the
reasons for the denial or denial in part of the claim or
request.
``(C) Subsets.--The Administrator shall--
``(i) except with respect to information described in
subsection (c)(2)(G), review all claims or requests under
this section for the protection from disclosure of the
specific chemical identity of a chemical substance; and
``(ii) review a representative subset, comprising at least
25 percent, of all other claims or requests for protection
from disclosure under this section.
``(D) Effect of failure to act.--The failure of the
Administrator to make a decision regarding a claim or request
for protection from disclosure or extension under this
section shall not have the effect of denying or eliminating a
claim or request for protection from disclosure.
``(E) Determination of requests under subsection
(b)(4)(C).--With respect to a request submitted under
subsection (b)(4)(C), the Administrator shall, with the
objective of ensuring that information relevant to the
protection of health and the environment is disclosed to the
extent practicable, determine whether the documentation
provided by the person rebuts what shall be the presumption
of the Administrator that the public interest in the
disclosure of the information outweighs the public or
proprietary interest in maintaining the protection for all or
a portion of the information that the person has requested
not be disclosed or for which disclosure be delayed.
``(2) Notification.--
``(A) In general.--Except as provided in subparagraph (B)
and subsections (b), (d), and (e), if the Administrator
denies or denies in part a claim or request under paragraph
(1), concludes, in accordance with this section, that the
information does not qualify for protection from disclosure,
intends to disclose information pursuant to subsection (d),
or promulgates a rule under section 6(a) establishing a ban
or phase-out with respect to a chemical substance or mixture,
the Administrator shall notify, in writing, the person that
asserted the claim or submitted the request of the intent of
the Administrator to disclose the information or not protect
the information from disclosure under this section. The
notice shall be furnished by certified mail (return receipt
requested), by personal delivery, or by other means that
allows verification of the fact and date of receipt.
``(B) Disclosure of information.--Except as provided in
subparagraph (C), the Administrator shall not disclose
information under this subsection until the date that is 30
days after the date on which the person that asserted the
claim or submitted the request receives notification under
subparagraph (A).
``(C) Exceptions.--
``(i) Fifteen day notification.--For information the
Administrator intends to disclose under subsections (d)(3),
(d)(4), (d)(5), and (j), the Administrator shall not disclose
the information until the date that is 15 days after the date
on which the person that asserted the claim or submitted the
request receives notification under subparagraph (A), except
that, with respect to information to be disclosed under
subsection (d)(3), if the Administrator determines that
disclosure of the information is necessary to protect against
an imminent and substantial harm to health or the
environment, no prior notification shall be necessary.
``(ii) Notification as soon as practicable.--For
information the Administrator intends to disclose under
paragraph (6) of subsection (d), 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--
[[Page H3019]]
``(I) for the disclosure of information under paragraphs
(1), (2), (7), or (8) of subsection (d); or
``(II) for the disclosure of information for which--
``(aa) the Administrator has provided to the person that
asserted the claim a notice under subsection (e)(2)(A); and
``(bb) such person does not submit to the Administrator a
request under subsection (e)(2)(B) on or before the deadline
established in subsection (e)(2)(B)(i).
``(D) Appeals.--
``(i) Action to restrain disclosure.--If a person receives
a notification under this paragraph and believes the
information is protected from disclosure under this section,
before the date on which the information is to be disclosed
pursuant to subparagraph (B) or (C) 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.
``(ii) No disclosure.--
``(I) In general.--Subject to subsection (d), the
Administrator shall not disclose information that is the
subject of an appeal under this paragraph before the date on
which the applicable court rules on an action under clause
(i).
``(II) Exception.--Subclause (I) shall not apply to
disclosure of information described under subsections (d)(4)
and (j).
``(3) 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, in a format and language that is
readily accessible and understandable, allows for expedient
and swift access to information disclosed pursuant to
paragraphs (5) and (6) of subsection (d).
``(4) 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, which
shall not be either the specific chemical identity or a
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 their unique identifiers, 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 a chemical substance
included on the list published under subparagraph (B) while
the specific chemical identity of the chemical substance is
protected from disclosure under this section identifies the
chemical substance using the unique identifier; and
``(D) for each claim for protection of a specific chemical
identity that has been denied by the Administrator or
expired, or that has been withdrawn by the person who
asserted the claim, and for which the Administrator has used
a unique identifier assigned under this paragraph to protect
the specific chemical identity in information that the
Administrator has made public, clearly link the specific
chemical identity to the unique identifier in such
information to the extent practicable.
``(h) Criminal Penalty for Wrongful Disclosure.--
``(1) Individuals subject to penalty.--
``(A) In general.--Subject to subparagraph (C) and
paragraph (2), an individual described in subparagraph (B)
shall be fined under title 18, United States Code, or
imprisoned for not more than 1 year, or both.
``(B) Description.--An individual referred to in
subparagraph (A) is an individual who--
``(i) pursuant to this section, obtained possession of, or
has access to, information protected from disclosure under
this section; and
``(ii) knowing that the information is protected from
disclosure under this section, willfully discloses the
information in any manner to any person not entitled to
receive that information.
``(C) Exception.--This paragraph shall not apply to any
medical professional (including an emergency medical
technician or other first responder) who discloses any
information obtained under paragraph (5) or (6) of subsection
(d) to a patient treated by the medical professional, or to a
person authorized to make medical or health care decisions on
behalf of such a patient, as needed for the diagnosis or
treatment of the patient.
``(2) Other laws.--Section 1905 of title 18, United States
Code, shall not apply with respect to the publishing,
divulging, disclosure, or making known of, or making
available, information reported to or otherwise obtained by
the Administrator under this Act.
``(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 prior to the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act; or
``(B) to impose substantiation or resubstantiation
requirements, with respect to the protection of information
described in subsection (a), 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 of, or approving,
approving in part, 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.
``(j) Access by Congress.--Notwithstanding any limitation
contained in this section or any other provision of law, all
information reported to or otherwise obtained by the
Administrator (or any representative of the Administrator)
under this Act shall be made available, upon written request
of any duly authorized committee of the Congress, to such
committee.''.
SEC. 12. PENALTIES.
Section 16 of the Toxic Substances Control Act (15 U.S.C.
2615) is amended--
(1) in subsection (a)(1), by striking ``$25,000'' and
inserting ``$37,500''; and
(2) in subsection (b)--
(A) by striking ``Any person'' and inserting the following:
``(1) In general.--Any person'';
(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 who knowingly and willfully
violates any provision of section 15 or 409, and who 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.--Notwithstanding the penalties
described in subparagraph (A), an organization that commits a
knowing 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)(B)-(F)) shall apply to
the prosecution of a violation under this paragraph.''.
SEC. 13. STATE-FEDERAL RELATIONSHIP.
Section 18 of the Toxic Substances Control Act (15 U.S.C.
2617) is amended--
(1) by amending subsection (a) to read as follows:
``(a) In General.--
``(1) Establishment or enforcement.--Except as otherwise
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) Development of information.--A statute or
administrative action to require the development of
information about a chemical substance or category of
chemical 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 consent agreement entered into by the
Administrator; or
``(iii) an order issued by the Administrator.
``(B) Chemical substances found not to present an
unreasonable risk or restricted.--A statute, criminal
penalty, or administrative action to prohibit or otherwise
restrict the manufacture, processing, or distribution in
commerce or use of a chemical substance--
``(i) for which the determination described in section
6(i)(1) is made, consistent with the scope of the risk
evaluation under section (6)(b)(4)(D); or
``(ii) for which a final rule is promulgated under section
6(a), after the effective date of the rule issued under
section 6(a) for the chemical substance, consistent with the
scope of the risk evaluation under section (6)(b)(4)(D).
``(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 chemical substances shall not occur
until the effective date of the applicable action described
in paragraph (1) taken by the Administrator.'';
(2) by amending subsection (b) to read as follows:
``(b) New Statutes, Criminal Penalties, 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 the scope of a risk evaluation for a
chemical substance under section 6(b)(4)(D) and ending on the
date on which the deadline established pursuant to section
6(b)(4)(G) for completion of the risk evaluation expires, or
[[Page H3020]]
on the date on which the Administrator publishes the risk
evaluation under section 6(b)(4)(C), whichever is earlier, no
State or political subdivision of a State may establish a
statute, criminal penalty, or administrative action
prohibiting or otherwise restricting the manufacture,
processing, distribution in commerce, or use of such chemical
substance that is a high-priority substance designated under
section 6(b)(1)(B)(i).
``(2) Effect of subsection.--This subsection does not
restrict the authority of a State or political subdivision of
a State to continue to enforce any statute enacted, criminal
penalty assessed, or administrative action taken, prior to
the date on which the Administrator defines and publishes the
scope of a risk evaluation under section 6(b)(4)(D).''; and
(3) by adding at the end the following:
``(c) Scope of Preemption.--Federal preemption under
subsections (a) and (b) of statutes, criminal penalties, and
administrative actions applicable to specific chemical
substances shall apply only to--
``(1) with respect to subsection (a)(1)(A), the chemical
substances or category of chemical substances subject to a
rule, order, or consent agreement under section 4, 5, or 6.
``(2) with respect to subsection (b), the hazards,
exposures, risks, and uses or conditions of use of such
chemical substances included in the scope of the risk
evaluation pursuant to section 6(b)(4)(D);
``(3) with respect to subsection (a)(1)(B), the hazards,
exposures, risks, and uses or conditions of use of such
chemical substances included in any final action the
Administrator takes pursuant to section 6(a) or 6(i)(1); or
``(4) with respect to subsection (a)(1)(C), the uses of
such chemical 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 the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, nor any rule, standard of performance, risk
evaluation, 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, risk evaluation, scientific assessment, or
any other 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, 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 risk evaluation published pursuant to section
6(b)(4)(D), 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.--
``(A) Prior rules and orders.--Nothing in this section
shall be construed as modifying the preemptive 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.
``(B) Certain chemical substances and mixtures.--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 respect to manufacturing,
processing, distribution in commerce, use, or disposal of the
chemical substance or mixture, nothing in this section shall
be construed as modifying the preemptive effect of this
section as in effect prior to the enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act of any
rule or order that is promulgated or issued with respect to
such chemical substance or mixture under section 6 after that
effective date, unless the latter rule or order is with
respect to a chemical substance or mixture containing a
chemical substance and follows a designation of that chemical
substance as a high-priority substance under section
6(b)(1)(B)(i), the identification of that chemical substance
under section 6(b)(2)(A), or the selection of that chemical
substance for risk evaluation under section
6(b)(4)(E)(iv)(II).
``(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 or requirement imposed
or requirement enacted relating to a specific chemical
substance before April 22, 2016, 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,
criminal penalty, or administrative action of that State or
political subdivision of the State that relates to the
effects of 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)(i) 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;
``(ii) 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
``(iii) 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; or
``(B) no later than the date that is 18 months after the
date on which the Administrator has initiated the
prioritization process for a chemical substance under the
rule promulgated pursuant to section 6(b)(1)(A), or the date
on which the Administrator publishes the scope of the risk
evaluation for a chemical substance under section 6(b)(4)(D),
whichever is sooner, the State or political subdivision of
the State has enacted a statute or proposed or finalized an
administrative action intended to prohibit or otherwise
restrict the manufacture, processing, distribution in
commerce, or use of the chemical substance.
``(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 a determination.--If the
Administrator fails to make a determination under paragraph
(3)(B) during the 110-day period beginning on the date on
[[Page H3021]]
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 under this
subsection 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
risk evaluation under section 6(b).
``(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 the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, nor any standard, rule, requirement, standard of
performance, risk evaluation, 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 the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, shall preempt or preclude any cause
of action for personal injury, wrongful death, property
damage, or other injury based on negligence, strict
liability, products liability, failure to warn, or any other
legal theory of liability under any State law, maritime law,
or Federal common law or statutory theory.
``(2) No effect on private remedies.--
``(A) In general.--Nothing in this Act, nor any amendments
made by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, nor any rules, regulations, requirements, risk
evaluations, 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, risk evaluations, scientific assessments, or
orders issued pursuant to this Act.''.
SEC. 14. JUDICIAL REVIEW.
Section 19(a) of the Toxic Substances Control Act (15
U.S.C. 2618(a)) is amended--
(1) in paragraph (1), by adding at the end the following:
``(C)(i) Not later than 60 days after the publication of a
designation under section 6(b)(1)(B)(ii), any person may
commence a civil action to challenge the designation.
``(ii) The United States Court of Appeals for the District
of Columbia Circuit shall have exclusive jurisdiction over a
civil action filed under this subparagraph.''; and
(2) by striking paragraph (3).
SEC. 15. CITIZENS' CIVIL ACTIONS.
Section 20(b) of the Toxic Substances Control Act (15
U.S.C. 2619(b)) is amended--
(1) in paragraph (1)(B), by striking ``or'' at the end; and
(2) in paragraph (2), by striking the period at the end and
inserting the following: ``, 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
``(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. 16. STUDIES.
Section 25 of the Toxic Substances Control Act (15 U.S.C.
2624) is repealed.
SEC. 17. ADMINISTRATION OF THE ACT.
Section 26 of the Toxic Substances Control Act (15 U.S.C.
2625) is amended--
(1) in subsection (b)(1)--
(A) by striking ``of a reasonable fee'';
(B) by striking ``data under section 4 or 5 to defray the
cost of administering this Act'' and inserting ``information
under section 4 or a notice or other information to be
reviewed by the Administrator under section 5, or who
manufactures or processes a chemical substance that is the
subject of a risk evaluation under section 6(b), of a fee
that is sufficient and not more than reasonably necessary to
defray the cost related to such chemical substance of
administering sections 4, 5, and 6, and collecting,
processing, reviewing, and providing access to and protecting
from disclosure as appropriate under section 14 information
on chemical substances under this title, including contractor
costs incurred by the Administrator'';
(C) by striking ``Such rules shall not provide for any fee
in excess of $2,500 or, in the case of a small business
concern, any fee in excess of $100.''; and
(D) by striking ``submit the data and the cost to the
Administrator of reviewing such data'' and inserting ``pay
such fee and the cost to the Administrator of carrying out
the activities described in this paragraph'';
(2) in subsection (b)--
(A) in paragraph (2), by striking ``paragraph (1)'' and
inserting ``paragraph (4)''; and
(B) by adding at the end the following:
``(3) Fund.--
``(A) Establishment.--There is established in the Treasury
of the United States a fund, to be known as the TSCA Service
Fee Fund (in this paragraph referred to as the `Fund'),
consisting of such amounts as are deposited in the Fund under
this paragraph.
``(B) Collection and deposit of fees.--Subject to the
conditions of subparagraph (C), the Administrator shall
collect the fees described in this subsection and deposit
those fees in the Fund.
``(C) Use of funds by administrator.--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 for use in defraying the costs of the
activities described in paragraph (1).
``(D) Accounting and auditing.--
``(i) Accounting.--The Administrator shall biennially
prepare and submit to the Committee on Environment and Public
Works of the Senate and the Committee on Energy and Commerce
of the House of Representatives a report that includes an
accounting of the fees paid to the Administrator under this
paragraph and amounts disbursed from the Fund for the period
covered by the report, as reflected by financial statements
provided in accordance with sections 3515 and 3521 of title
31, United States Code.
``(ii) Auditing.--
``(I) In general.--For the purpose of section 3515(c) of
title 31, United States Code, the Fund shall be considered a
component of a covered executive agency.
``(II) Components of audit.--The annual audit required in
accordance with sections 3515 and 3521 of title 31, United
States Code, of the financial statements of activities
carried out using amounts from the Fund shall include an
analysis of--
``(aa) the fees collected and amounts disbursed under this
subsection;
``(bb) the reasonableness of the fees in place as of the
date of the audit to meet current and projected costs of
administering the provisions of this title for which the fees
may be used; and
``(cc) the number of requests for a risk evaluation made by
manufacturers under section 6(b)(4)(C)(ii).
``(III) Federal responsibility.--The Inspector General of
the Environmental Protection Agency shall conduct the annual
audit described in subclause (II) and submit to the
Administrator a report that describes the findings and any
recommendations of the Inspector General resulting from the
audit.
``(4) 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 to the Administrator of
carrying out sections 4, 5, and 6, and of collecting,
processing, reviewing, and providing access to and protecting
from disclosure as appropriate under section 14 information
on chemical substances under this title, other than the costs
to conduct and complete risk evaluations under section 6(b);
or
``(II) $25,000,000 (subject to adjustment pursuant to
subparagraph (F)); and
``(ii) the costs of risk evaluations 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)--
[[Page H3022]]
``(i) except as provided in clause (ii), for chemical
substances for which the Administrator has granted a request
from a manufacturer pursuant to section 6(b)(4)(C)(ii),
establish the fee at a level sufficient to defray the full
costs to the Administrator of conducting the risk evaluation
under section 6(b);
``(ii) for chemical substances for which the Administrator
has granted a request from a manufacturer pursuant to section
6(b)(4)(C)(ii), and which are included in the 2014 update of
the TSCA Work Plan for Chemical Assessments, establish the
fee at a level sufficient to defray 50 percent of the costs
to the Administrator of conducting the risk evaluation under
section 6(b); and
``(iii) apply fees collected pursuant to clauses (i) and
(ii) only to defray the costs described in those clauses;
``(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 II 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 that funds deposited in the Fund are sufficient to
defray--
``(i) approximately but not more than 25 percent of the
costs to the Administrator of carrying out sections 4, 5, and
6, and of collecting, processing, reviewing, and providing
access to and protecting from disclosure as appropriate under
section 14 information on chemical substances under this
title, other than the costs to conduct and complete risk
evaluations requested under section 6(b)(4)(C)(ii); and
``(ii) the costs of risk evaluations specified in
subparagraph (D); and
``(G) if a notice submitted under section 5 is not reviewed
or such a notice is withdrawn, refund the fee or a portion of
the fee if no substantial work was performed on the notice.
``(5) 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.
``(6) Termination.--The authority provided by this
subsection 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.''; and
(3) by adding at the end the following:
``(h) Scientific Standards.--In carrying out sections 4, 5,
and 6, to the extent that the Administrator makes a decision
based on science, the Administrator shall use scientific
information, technical procedures, measures, methods,
protocols, methodologies, or models, employed in a manner
consistent with the best available science, and shall
consider as applicable--
``(1) the extent to which the scientific information,
technical procedures, measures, methods, protocols,
methodologies, or models employed to generate the information
are reasonable for and consistent with the intended use of
the information;
``(2) the extent to which the information is relevant for
the Administrator's use in making a decision about a chemical
substance or mixture;
``(3) the degree of clarity and completeness with which the
data, assumptions, methods, quality assurance, and analyses
employed to generate the information are documented;
``(4) the extent to which the variability and uncertainty
in the information, or in the procedures, measures, methods,
protocols, methodologies, or models, are evaluated and
characterized; and
``(5) the extent of independent verification or peer review
of the information or of the procedures, measures, methods,
protocols, methodologies, or models.
``(i) Weight of Scientific Evidence.--The Administrator
shall make decisions under sections 4, 5, and 6 based on the
weight of the scientific evidence.
``(j) Availability of Information.--Subject to section 14,
the Administrator shall make available to the public--
``(1) all notices, determinations, findings, rules, consent
agreements, and orders of the Administrator under this title;
``(2) any information required to be provided to the
Administrator under section 4;
``(3) a nontechnical summary of each risk evaluation
conducted under section 6(b);
``(4) a list of the studies considered by the Administrator
in carrying out each such risk evaluation, along with the
results of those studies; and
``(5) each designation of a chemical substance under
section 6(b), along with an identification of the
information, analysis, and basis used to make the
designations.
``(k) Reasonably Available Information.--In carrying out
sections 4, 5, and 6, the Administrator shall take into
consideration information relating to a chemical substance or
mixture, including hazard and exposure information, under the
conditions of use, that is reasonably available to the
Administrator.
``(l) Policies, Procedures, and Guidance.--
``(1) Development.--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 any
policies, procedures, and guidance the Administrator
determines are necessary to carry out the amendments to this
Act made by the Frank R. Lautenberg Chemical Safety for the
21st Century Act.
``(2) 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--
``(A) review the adequacy of the policies, procedures, and
guidance developed under paragraph (1), including with
respect to animal, nonanimal, and epidemiological test
methods and procedures for assessing and determining risk
under this title; and
``(B) revise such policies, procedures, and guidance as the
Administrator determines necessary to reflect new scientific
developments or understandings.
``(3) Testing of chemical substances and mixtures.--The
policies, procedures, and guidance developed under paragraph
(1) applicable to testing chemical substances and mixtures
shall--
``(A) address how and when the exposure level or exposure
potential of a chemical substance or mixture 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 title, including information relating to potentially
exposed or susceptible populations.
``(4) Chemical substances with completed risk
assessments.--With respect to a chemical substance listed in
the 2014 update to the TSCA Work Plan for Chemical
Assessments for which the Administrator has published a
completed risk assessment prior to the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act, the Administrator may publish proposed and final rules
under section 6(a) that are consistent with the scope of the
completed risk assessment for the chemical substance and
consistent with other applicable requirements of section 6.
``(5) Guidance.--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 and submitting draft
risk evaluations which shall be considered by the
Administrator. The guidance shall, at a minimum, address the
quality of the information submitted and the process to be
followed in developing draft risk evaluations for
consideration by the Administrator.
``(m) Report to Congress.--
``(1) Initial report.--Not later than 6 months after the
date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the Administrator shall submit to
the Committees on Energy and Commerce and Appropriations of
the House of Representatives and the Committees on
Environment and Public Works and Appropriations of the Senate
a report containing an estimation of--
``(A) the capacity of the Environmental Protection Agency
to conduct and publish risk evaluations under section
6(b)(4)(C)(i), and the resources necessary to conduct the
minimum number of risk evaluations required under section
6(b)(2);
``(B) the capacity of the Environmental Protection Agency
to conduct and publish risk evaluations under section
6(b)(4)(C)(ii), the likely demand for such risk evaluations,
and the anticipated schedule for accommodating that demand;
``(C) the capacity of the Environmental Protection Agency
to promulgate rules under section 6(a) as required based on
risk evaluations conducted and published under section 6(b);
and
``(D) the actual and anticipated efforts of the
Environmental Protection Agency to increase the Agency's
capacity to conduct and publish risk evaluations under
section 6(b).
``(2) Subsequent reports.--The Administrator shall update
and resubmit the report described in paragraph (1) not less
frequently than once every 5 years.
``(n) Annual Plan.--
``(1) In general.--The Administrator shall inform the
public regarding the schedule and the resources necessary for
the completion of each risk evaluation as soon as practicable
after initiating the risk evaluation.
``(2) Publication of plan.--At the beginning of each
calendar year, the Administrator shall publish an annual plan
that--
``(A) identifies the chemical substances for which risk
evaluations are expected to be initiated or completed that
year and the resources necessary for their completion;
``(B) describes the status of each risk evaluation that has
been initiated but not yet completed; and
``(C) if the schedule for completion of a risk evaluation
has changed, includes an updated schedule for that risk
evaluation.
``(o) Consultation With Science Advisory Committee on
Chemicals.--
[[Page H3023]]
``(1) Establishment.--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 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, at 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 representatives that have specific scientific
expertise in the relationship of chemical exposures to women,
children, and other potentially exposed or susceptible
subpopulations.
``(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.
``(p) Prior Actions.--
``(1) Rules, orders, and exemptions.--Nothing in the Frank
R. Lautenberg Chemical Safety for the 21st Century 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.
``(2) Prior-initiated evaluations.--Nothing in this Act
prevents the Administrator from initiating a risk evaluation
regarding a chemical substance, or from continuing or
completing such risk evaluation, prior to the effective date
of the policies, procedures, and guidance required to be
developed by the Administrator pursuant to the amendments
made by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act.
``(3) Actions completed prior to completion of policies,
procedures, and guidance.--Nothing in this Act requires the
Administrator to revise or withdraw a completed risk
evaluation, determination, or rule under this Act solely
because the action was completed prior to the development of
a policy, procedure, or guidance pursuant to the amendments
made by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act.''.
SEC. 18. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (15 U.S.C.
2627) is amended by striking subsections (c) and (d).
SEC. 19. CONFORMING AMENDMENTS.
(a) Table of Contents.--The table of contents in section 1
of the Toxic Substances Control Act is amended--
(1) by striking the item relating to section 6 and
inserting the following:
``Sec. 6. Prioritization, risk evaluation, and regulation of chemical
substances and mixtures.'';
(2) by striking the item relating to section 10 and
inserting the following:
``Sec. 10. Research, development, collection, dissemination, and
utilization of information.'';
(3) by striking the item relating to section 14 and
inserting the following:
``Sec. 14. Confidential information.''; and
(4) by striking the item relating to section 25.
(b) Section 2.--Section 2(b)(1) of the Toxic Substances
Control Act (15 U.S.C. 2601(b)(1)) is amended by striking
``data'' both places it appears and inserting
``information''.
(c) Section 3.--Section 3 of the Toxic Substances Control
Act (15 U.S.C. 2602) is amended--
(1) in paragraph (8) (as redesignated by section 3 of this
Act), by striking ``data'' and inserting ``information''; and
(2) in paragraph (15) (as redesignated by section 3 of this
Act)--
(A) by striking ``standards'' and inserting ``protocols and
methodologies'';
(B) by striking ``test data'' both places it appears and
inserting ``information''; and
(C) by striking ``data'' each place it appears and
inserting ``information''.
(d) Section 4.--Section 4 of the Toxic Substances Control
Act (15 U.S.C. 2603) is amended--
(1) in subsection (b)--
(A) in paragraph (1)--
(i) in the paragraph heading, by adding ``, order, or
consent agreement'' at the end; and
(ii) by striking ``rule'' each place it appears and
inserting ``rule, order, or consent agreement'';
(B) in paragraph (2)(B), by striking ``rules'' and
inserting ``rules, orders, and consent agreements'';
(C) in paragraph (3)(A), by striking ``rule'' and inserting
``rule or order''; and
(D) in paragraph (4)--
(i) by striking ``rule under subsection (a)'' each place it
appears and inserting ``rule, order, or consent agreement
under subsection (a)'';
(ii) by striking ``repeals the rule'' each place it appears
and inserting ``repeals the rule or order or modifies the
consent agreement to terminate the requirement''; and
(iii) by striking ``repeals the application of the rule''
and inserting ``repeals or modifies the application of the
rule, order, or consent agreement'';
(2) in subsection (c)--
(A) in paragraph (1), by striking ``rule'' and inserting
``rule or order'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``a rule under
subsection (a) or for which data is being developed pursuant
to such a rule'' and inserting ``a rule, order, or consent
agreement under subsection (a) or for which information is
being developed pursuant to such a rule, order, or consent
agreement'';
(ii) in subparagraph (B), by striking ``such rule or which
is being developed pursuant to such rule'' and inserting
``such rule, order, or consent agreement or which is being
developed pursuant to such rule, order, or consent
agreement''; and
(iii) in the matter following subparagraph (B), by striking
``the rule'' and inserting ``the rule or order'';
(C) in paragraph (3)(B)(i), by striking ``rule
promulgated'' and inserting ``rule, order, or consent
agreement''; and
(D) in paragraph (4)--
(i) by striking ``rule promulgated'' each place it appears
and inserting ``rule, order, or consent agreement'';
(ii) by striking ``such rule'' each place it appears and
inserting ``such rule, order, or consent agreement''; and
(iii) in subparagraph (B), by striking ``the rule'' and
inserting ``the rule or order'';
(3) in subsection (d), by striking ``rule'' and inserting
``rule, order, or consent agreement''; and
(4) in subsection (g), by striking ``rule'' and inserting
``rule, order, or consent agreement''.
(e) Section 5.--Section 5 of the Toxic Substances Control
Act (15 U.S.C. 2604) is amended--
(1) in subsection (b)--
(A) in paragraph (1)(A)--
(i) by striking ``rule promulgated'' and inserting ``rule,
order, or consent agreement''; and
(ii) by striking ``such rule'' and inserting ``such rule,
order, or consent agreement'';
(B) in paragraph (1)(B), by striking ``rule promulgated''
and inserting ``rule or order''; and
(C) in paragraph (2)(A)(ii), by striking ``rule
promulgated'' and inserting ``rule, order, or consent
agreement''; and
(2) in subsection (d)(2)(C), by striking ``rule'' and
inserting ``rule, order, or consent agreement''.
(f) Section 7.--Section 7(a) of the Toxic Substances
Control Act (15 U.S.C. 2606(a)) is amended--
(1) in paragraph (1), in the matter following subparagraph
(C), by striking ``a rule under section 4, 5, 6, or title IV
or an order under section 5 or title IV'' and inserting ``a
determination under section 5 or 6, a rule under section 4,
5, or 6 or title IV, an order under section 4, 5, or 6 or
title IV, or a consent agreement under section 4''; and
(2) in paragraph (2), by striking ``subsection
6(d)(2)(A)(i)'' and inserting ``section 6(d)(3)(A)(i)''.
(g) Section 8.--Section 8(a) of the Toxic Substances
Control Act (15 U.S.C. 2607(a)) is amended--
(1) in paragraph (2)(E), by striking ``data'' and inserting
``information''; and
(2) in paragraph (3)(A)(ii)(I), by striking ``or an order
in effect under section 5(e)'' and inserting ``, an order in
effect under section 4 or 5(e), or a consent agreement under
section 4''.
(h) Section 9.--Section 9 of the Toxic Substances Control
Act (15 U.S.C. 2608) is amended--
(1) in subsection (a), by striking ``section 6'' each place
it appears and inserting ``section 6(a)''; and
(2) in subsection (d), by striking ``Health, Education, and
Welfare'' and inserting ``Health and Human Services''.
(i) Section 10.--Section 10 of the Toxic Substances Control
Act (15 U.S.C. 2609) is amended--
(1) in the section heading, by striking ``data'' and
inserting ``information'';
(2) by striking ``Health, Education, and Welfare'' each
place it appears and inserting ``Health and Human Services'';
(3) in subsection (b)--
(A) in the subsection heading, by striking ``Data'' and
inserting ``Information'';
(B) by striking ``data'' and inserting ``information'' in
paragraph (1);
(C) by striking ``data'' and inserting ``information'' in
paragraph (2)(A); and
(D) by striking ``a data'' and inserting ``an information''
in paragraph (2)(B); and
(4) in subsection (g), by striking ``data'' and inserting
``information''.
(j) Section 11.--Section 11(b)(2) of the Toxic Substances
Control Act (15 U.S.C. 2610(b)(2)) is amended--
(1) by striking ``data'' each place it appears and
inserting ``information''; and
(2) in subparagraph (E), by striking ``rule promulgated''
and inserting ``rule promulgated, order issued, or consent
agreement entered into''.
(k) Section 12.--Section 12(b)(1) of the Toxic Substances
Control Act (15 U.S.C. 2611(b)(1)) is amended by striking
``data'' both places it appears and inserting
``information''.
(l) Section 15.--Section 15(1) of the Toxic Substances
Control Act (15 U.S.C. 2614(1)) is amended by striking ``(A)
any rule'' and all that follows through ``or (D)'' and
inserting ``any requirement of this title or any rule
promulgated, order issued, or consent agreement entered into
under this title, or''.
[[Page H3024]]
(m) Section 19.--Section 19 of the Toxic Substances Control
Act (15 U.S.C. 2618) is amended--
(1) in subsection (a)--
(A) in paragraph (1)(A)--
(i) by striking ``Not later than 60 days after the date of
the promulgation of a rule under section 4(a), 5(a)(2),
5(b)(4), 6(a), 6(e), or 8, or under title II or IV'' and
inserting ``Except as otherwise provided in this title, not
later than 60 days after the date on which a rule is
promulgated under this title, title II, or title IV, or the
date on which an order is issued under section 4, 5(e), 5(f),
or 6(i)(1),'';
(ii) by striking ``such rule'' and inserting ``such rule or
order''; and
(iii) by striking ``such a rule'' and inserting ``such a
rule or order'';
(B) in paragraph (1)(B)--
(i) by striking ``Courts'' and inserting ``Except as
otherwise provided in this title, courts''; and
(ii) by striking ``subparagraph (A) or (B) of section
6(b)(1)'' and inserting ``this title, other than an order
under section 4, 5(e), 5(f), or 6(i)(1),''; and
(C) in paragraph (2)--
(i) by striking ``rulemaking record'' and inserting
``record''; and
(ii) by striking ``based the rule'' and inserting ``based
the rule or order'';
(2) in subsection (b)--
(A) by striking ``review a rule'' and inserting ``review a
rule, or an order under section 4, 5(e), 5(f), or 6(i)(1),'';
(B) by striking ``such rule'' and inserting ``such rule or
order'';
(C) by striking ``the rule'' and inserting ``the rule or
order'';
(D) by striking ``new rule'' each place it appears and
inserting ``new rule or order''; and
(E) by striking ``modified rule'' and inserting ``modified
rule or order''; and
(3) in subsection (c)--
(A) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``a rule'' and inserting ``a rule or
order''; and
(II) by striking ``such rule'' and inserting ``such rule or
order'';
(ii) in subparagraph (B)--
(I) in the matter preceding clause (i), by striking ``a
rule'' and inserting ``a rule or order'';
(II) by amending clause (i) to read as follows:
``(i) in the case of review of--
``(I) a rule under section 4(a), 5(b)(4), 6(a) (including
review of the associated determination under section
6(b)(4)(A)), or 6(e), the standard for review prescribed by
paragraph (2)(E) of such section 706 shall not apply and the
court shall hold unlawful and set aside such rule if the
court finds that the rule is not supported by substantial
evidence in the rulemaking record taken as a whole; and
``(II) an order under section 4, 5(e), 5(f), or 6(i)(1),
the standard for review prescribed by paragraph (2)(E) of
such section 706 shall not apply and the court shall hold
unlawful and set aside such order if the court finds that the
order is not supported by substantial evidence in the record
taken as a whole; and''; and
(III) by striking clauses (ii) and (iii) and the matter
after 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 or order, except as part of the record, taken as a
whole.''; and
(iii) by striking subparagraph (C); and
(B) in paragraph (2), by striking ``any rule'' and
inserting ``any rule or order''.
(n) Section 20.--Section 20(a)(1) of the Toxic Substances
Control Act (15 U.S.C. 2619(a)(1)) is amended by striking
``order issued under section 5'' and inserting ``order issued
under section 4 or 5''.
(o) Section 21.--Section 21 of the Toxic Substances Control
Act (15 U.S.C. 2620) is amended--
(1) in subsection (a), by striking ``order under section
5(e) or (6)(b)(2)'' and inserting ``order under section 4 or
5(e) or (f)''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``order under section
5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting ``order under
section 4 or 5(e) or (f)''; and
(B) in paragraph (4)(B)--
(i) in the matter preceding clause (i), by striking ``order
under section 5(e) or 6(b)(2)'' and inserting ``order under
section 4 or 5(e) or (f)'';
(ii) in clause (i), by striking ``order under section
5(e)'' and inserting ``order under section 4 or 5(e)''; and
(iii) in clause (ii), by striking ``section 6 or 8 or an
order under section 6(b)(2), there is a reasonable basis to
conclude that the issuance of such a rule or order is
necessary to protect health or the environment against an
unreasonable risk of injury to health or the environment''
and inserting ``section 6(a) or 8 or an order under section
5(f), the chemical substance or mixture to be subject to such
rule or order presents an unreasonable risk of injury to
health or the environment, without consideration of costs or
other nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation, under the
conditions of use''.
(p) Section 24.--Section 24(b)(2)(B) of the Toxic
Substances Control Act (15 U.S.C. 2623(b)(2)(B)) is amended--
(1) by inserting ``and'' at the end of clause (i);
(2) by striking clause (ii); and
(3) by redesignating clause (iii) as clause (ii).
(q) Section 26.--Section 26 of the Toxic Substances Control
Act (15 U.S.C. 2625) is amended--
(1) in subsection (e), by striking ``Health, Education, and
Welfare'' each place it appears and inserting ``Health and
Human Services''; and
(2) in subsection (g)(1), by striking ``data'' and
inserting ``information''.
(r) Section 27.--Section 27(a) of the Toxic Substances
Control Act (15 U.S.C. 2626(a)) is amended--
(1) by striking ``Health, Education, and Welfare'' and
inserting ``Health and Human Services'';
(2) by striking ``test data'' both places it appears and
inserting ``information'';
(3) by striking ``rules promulgated'' and inserting
``rules, orders, or consent agreements''; and
(4) by striking ``standards'' and inserting ``protocols and
methodologies''.
(s) Section 30.--Section 30(2) of the Toxic Substances
Control Act (15 U.S.C. 2629(2)) is amended by striking
``rule'' and inserting ``rule, order, or consent agreement''.
SEC. 20. NO RETROACTIVITY.
Nothing in sections 1 through 19, or the amendments made by
sections 1 through 19, shall be interpreted to apply
retroactively to any State, Federal, or maritime legal action
filed before the date of enactment of this Act.
SEC. 21. TREVOR'S LAW.
(a) Purposes.--The purposes of this section are--
(1) to provide the appropriate Federal agencies with the
authority to help conduct investigations into potential
cancer clusters;
(2) to ensure that Federal agencies have the authority to
undertake actions to help address cancer clusters and factors
that may contribute to the creation of potential cancer
clusters; and
(3) to enable Federal agencies to coordinate with other
Federal, State, and local agencies, institutes of higher
education, and the public in investigating and addressing
cancer clusters.
(b) Designation and Investigation of Potential Cancer
Clusters.--Part P of title III of the Public Health Service
Act (42 U.S.C. 280g et seq.) is amended by adding at the end
the following:
``SEC. 399V-6. DESIGNATION AND INVESTIGATION OF POTENTIAL
CANCER CLUSTERS.
``(a) Definitions.--In this section:
``(1) Cancer cluster.--The term `cancer cluster' means the
incidence of a particular cancer within a population group, a
geographical area, and a period of time that is greater than
expected for such group, area, and 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) recommend 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--
[[Page H3025]]
``(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.''.
TITLE II--RURAL HEALTHCARE CONNECTIVITY
SEC. 201. SHORT TITLE.
This title may be cited as the ``Rural Healthcare
Connectivity Act of 2016''.
SEC. 202. TELECOMMUNICATIONS SERVICES FOR SKILLED NURSING
FACILITIES.
(a) In General.--Section 254(h)(7)(B) of the Communications
Act of 1934 (47 U.S.C. 254(h)(7)(B)) is amended--
(1) in clause (vi), by striking ``and'' at the end;
(2) by redesignating clause (vii) as clause (viii);
(3) by inserting after clause (vi) the following:
``(vii) skilled nursing facilities (as defined in section
1819(a) of the Social Security Act (42 U.S.C. 1395i-3(a)));
and''; and
(4) in clause (viii), as redesignated, by striking
``clauses (i) through (vi)'' and inserting ``clauses (i)
through (vii)''.
(b) Savings Clause.--Nothing in subsection (a) shall be
construed to affect the aggregate annual cap on Federal
universal service support for health care providers under
section 54.675 of title 47, Code of Federal Regulations, or
any successor regulation.
(c) Effective Date.--The amendments made by subsection (a)
shall apply beginning on the date that is 180 days after the
date of the enactment of this Act.
The SPEAKER pro tempore. The motion shall be debatable for 1 hour
equally divided and controlled by the chair and ranking minority member
of the Committee on Energy and Commerce.
The gentleman from Illinois (Mr. Shimkus) and the gentleman from New
Jersey (Mr. Pallone) each will control 30 minutes.
The Chair recognizes the gentleman from Illinois.
General Leave
Mr. SHIMKUS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and insert extraneous material on H.R. 2576.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Illinois?
There was no objection.
Mr. SHIMKUS. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 2576, the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, a bipartisan,
bicameral bill to update the way our Nation assesses and manages the
risks posed by chemicals and the products that contain them.
This is sweeping legislation, Mr. Speaker, with monumental benefits
for virtually every man, woman, and child in the United States. The
culmination of a multiyear, multi-Congress effort, this legislation on
the floor today will mark the first consequential update of the Toxic
Substances Control Act, or TSCA, in 40 years.
Mr. Speaker, I talked at a graduation event over the weekend, and I
said this in the Rules Committee last night. In 1976, I was graduating
high school. That was the year we wore plaid bell-bottoms, silk shirts,
platform shoes, and I had an Afro. It was not a pretty sight.
Much like the bill, the Toxic Substances Control Act, well
intentioned, was not a pretty sight.
When TSCA was enacted in 1976, it was not meant to examine all
chemical manufacturing and uses, but, rather, to create a backstop of
protection when potential dangers were otherwise not being addressed.
In the nearly four decades since then, concerns have mounted over the
pace of the EPA's evaluation of chemicals, the ability of the Agency to
meaningfully use its existing authority, and whether the law permits
certain regulatory actions.
In short, Mr. Speaker, there is a widespread acknowledgment and
understandable concern that nobody is well served by the current law.
This absence of workable Federal standards has also fostered a
patchwork of State regulations. While well intentioned, these State
actions have ultimately led to public confusion and a marketplace that
has become increasingly uneven, unpredictable, and incompatible with
economic and regulatory realities.
To stem the tide of uncertainty and protect Americans in every State,
almost 1 year ago this Chamber passed legislation to bring TSCA into
the 21st century by an overwhelming 398-1 vote and 6 months later our
friends in the other body moved their own package of bipartisan TSCA
reforms.
While both efforts were broadly supported, the House and Senate bills
were quite different in size and scope. These differences left many
issues that needed to be resolved, requiring many hours of complex
discussions and difficult decisions to get us where we are today.
The end result of that work is a vast improvement over current law
and a careful compromise that is good for consumers, good for jobs, and
good for the environment.
So what does the Frank R. Lautenberg Chemical Safety for the 21st
Century Act actually do?
The bill gives the EPA more direct tools to obtain testing
information on chemical substances, an improvement over the lengthy
process they now face.
It restructures the way existing chemicals are evaluated and
regulated, allowing a purely scientific evaluation to guide those
decisions.
It clarifies the treatment of trade secrets submitted to the EPA and
ensures that the Agency uses only high-quality science in their
decisionmaking.
It updates the collection of fees needed to support the EPA's
implementation of TSCA.
Finally, it organizes the Federal-State regulatory relationship in a
way that promotes interstate and global commerce while recognizing the
efforts already taken by several States.
I look forward to this afternoon's debate. I urge my colleagues to
support this landmark legislation.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of this legislation named after the
late Senator Frank R. Lautenberg from New Jersey, a great friend of
mine and a longtime environmental champion.
The Toxic Substance Control Act, or TSCA, has not been updated since
it was adopted 40 years ago. For decades we have known that the law is
broken. So this legislation is long past due, and I hope that it will
soon become law.
Had the law worked effectively from the beginning, we might never
have had BPA in baby bottles or toxic flame retardants in children's
pajamas and in our living room couches. Workers may have also been
protected from exposure to asbestos decades ago.
Let me stress that last point. In 1989, after more than 10 years of
study and analysis, the EPA banned asbestos under TSCA, but the ban was
overturned by the courts because of serious flaws in the statute and
serious limitations on the EPA's authority.
That court decision came down 25 years ago. Imagine the lives that
could
[[Page H3026]]
have been saved and the injuries that could have been prevented if that
ban had stood.
Now, reforming this law is about preventing injuries and saving
lives. It is about protecting vulnerable populations: infants,
children, workers, the elderly, and communities that are
disproportionately exposed to toxic chemicals.
It is about getting dangerous chemicals like lead, mercury, and
asbestos out of our consumer products, out of commerce, and out of the
environment.
Mr. Speaker, the bill before us today is a step forward in reaching
this important goal. Let me briefly describe some of the improvements.
This bill would make it easier for the EPA to require testing of
chemicals by allowing them to act through orders instead of
rulemakings.
It will also make it easier for the EPA to regulate chemicals by
removing procedural hurdles in current law and providing more resources
through user fees.
It will ensure that new chemicals are reviewed and regulated, if
necessary, before they go on the market, and it will improve
transparency by requiring manufacturers to substantiate their claims
that information should be protected as confidential business
information.
These are all major improvements over current law, but this is a
compromise bill. It is not the bill that Democrats would have written
if we were in the majority. I understand that some of my colleagues
will oppose this legislation today, and I certainly respect their
position.
On the substantive side, the bill could make it harder for the EPA
and citizens to use some of the tools that have proven effective under
current law, including significant new use rules and citizen petitions.
I would have preferred to leave those tools intact, but, hopefully, the
new tools we are giving the Agency will more than make up for those
changes.
We also work to reduce the role of animal testing in ensuring that
chemicals in commerce are safe. While there has long been broad
agreement that animal tests should be a last resort, I had concerns, as
did others, that past versions of this bill would keep necessary
science out of the EPA's hands.
I am pleased that the language has been improved and now states
explicitly that scientific studies should not be kept from the EPA once
they are done. If the studies are done, animals are not helped by
keeping the data from the EPA.
Now, on the issue of preemption, which is so important to so many of
my colleagues, including myself, the bill creates a significant new
type of preemption which many call pause preemption.
Under the bill, States will be barred from acting when the EPA starts
evaluating a chemical instead of when Federal regulations are in place.
This is unprecedented and has raised significant concerns from many
Members, myself included.
In recent weeks, House Democrats have secured several important
changes to reduce the impact of pause preemption. Some were included in
the Rules Committee print that was filed on Friday, and some were
included in the manager's amendment that was filed yesterday.
I just want to briefly describe these changes.
First, we have made changes to ensure that States would have lead
time and notice before EPA begins to study a chemical so that they can
propose or finalize restrictions before the pause begins. Those changes
particularly benefit States that act through regulation as opposed to
legislation.
Second, we worked to exclude from the pause the first group of
chemicals that the EPA will review. Since the EPA must begin those
reviews in the next 6 months, States will not have lead time to finish
their work on those chemicals. This change helps States that are
currently working on restrictions for chemicals that are likely to be
top EPA priorities.
Third, we were able to exclude top-priority chemicals from the pause
if the manufacturer of the chemical requests EPA review. This change is
complicated, but important. Without this change, manufacturers would be
able to abuse the system and seek EPA review as a way to cut off a
pending State action.
Finally, Mr. Speaker, we clarified the scope of preemption in order
to make clear that States are only preempted from regulating the uses
that the EPA has studied or regulated.
In total, these changes are enough to allow me to support the bill.
So, Mr. Speaker, I want to thank three of my colleagues who worked
tirelessly over the last week to get these changes included in this
final bill.
First is our Environment and the Economy Subcommittee ranking member,
Paul Tonko. I also want to thank Leader Pelosi and our whip, Mr. Hoyer.
All three of them played an integral part in strengthening the package
before us today.
I am happy to support this bill to move forward with more protection
for public health, for the environment, for vulnerable populations, and
for vulnerable communities.
While this is a compromise bill, it is a long overdue step forward in
protecting families and communities from toxic chemicals.
Mr. Speaker, I reserve the balance of my time.
Mr. SHIMKUS. Mr. Speaker, I yield 3 minutes to the gentleman from
Michigan (Mr. Upton), the chairman of the full committee.
Mr. UPTON. Mr. Speaker, today really does mark a milestone, a
milestone for our majority, a milestone for this Congress, and a
milestone for the American people, as we make great strides to update
our Nation's chemical safety laws.
Folks said it could not be done, especially with Republicans in
Congress and a Democratic President. This was a multiyear effort that
dates back to at least the last Congress. But we took the time, and we
did the hard work.
We put in countless hours of discussions and negotiations virtually
every weekend, and it paid off. This legislation will have monumental
impacts for commerce, the environment, and public health.
In 1976, under the leadership of Michigan's great President Jerry
Ford, TSCA was a novel approach to regulating interstate commercial
activity to address unreasonable risks presented by a chemical.
It was not meant to examine every piece of chemical manufacturing and
use, but, rather, to provide a backstop of protection when suspicions
about dangerous chemicals were not being addressed.
In the nearly 40 years since TSCA's enactment, there have been
persistent concerns about the pace of the EPA's work on chemicals, the
ability of the Agency to meaningfully use its existing authority, and
whether the statute prevents certain regulatory efforts.
Over the last 3 years, the House Energy and Commerce Committee has
conducted nine hearings, all on the aspects of TSCA. We learned that
there is public confusion about chemical-specific safety claims. We
learned that people think that the EPA should clear up that confusion
and be more diligent on risky chemicals.
Finally, we learned that companies and workers were disadvantaged in
a domestic and global marketplace where conflicting regulatory
standards, indeed, hamper trade.
Within the last decade, a variety of factors, including the EPA's
slow pace in regulating chemicals already on the market, have led to
several new State chemical control statutes.
Some States have passed laws ranging from specific chemical
restrictions to general chemical labeling requirements, like Prop 65 in
California. Meanwhile, some retailers have called out for an objective
scientific assessment of chemicals in consumer products.
Almost a year ago our committee unanimously reported this bill and
the House passed it 398-1. In December, the Senate approved a package
of TSCA reforms. The Senate's bill was quite different from the House,
but the compromise agreement--this one--includes many of the Senate
policy details.
{time} 1500
The resolution before us gives EPA more direct tools in obtaining
testing information on chemical substances, specifying key points in
the evaluation and regulatory process where EPA may order testing. In
addition, the compromise text reduces animal testing required under
TSCA. It restructures the
[[Page H3027]]
way existing chemicals are evaluated and regulated. The bill clarifies
the treatment of trade secrets submitted to EPA.
The SPEAKER pro tempore (Mr. Ribble). The time of the gentleman has
expired.
Mr. SHIMKUS. Mr. Speaker, I yield the gentleman an additional 2
minutes.
Mr. UPTON. The resolution specifies that EPA must protect trade
secrets submitted to it for a renewable period of 10 years. The
resolution also creates a new system to claim, substantiate and
resubstantiate, review, and adjudicate requests for protection of trade
secrets.
Finally, it organizes the Federal-State regulatory relationship in a
way that makes sense for promoting interstate and global commerce, but
also recognizes the efforts taken by a number of States. The amendment
makes accommodations for some existing State requirements and tort
actions as well.
Today, we have a landmark, bipartisan, bicameral agreement that makes
substantial changes to the existing law. This resolution is supported
by a broad coalition of stakeholders, ranging from environmental and
public health groups to large and small industrial organizations. It is
worthy of every Member's support.
Before I close, I want to say a word of thanks to my colleagues on
the other side of the aisle, Frank Pallone and Paul Tonko. I know the
last couple of weeks have not exactly been a picnic--a few ants, et
cetera--but they know that this is a better bill because of their
involvement. But the real impetus behind this whole project has been
John Shimkus. What a guy. Without his leadership, we simply never would
have reached this point.
Also, I want to thank the dedicated and hardworking staff who
tirelessly worked to get us where we are today: Dave McCarthy, Jerry
Couri, Tina Richards, and Chris Sarley. I thank them all. At times it
may not have been a labor of love, but we have got a finished product
that will indeed make a difference.
This bill is good for jobs. It is good for consumers. It is good for
the environment. It is the most meaningful and impactful update to
issues involving the environment and the economy that we have made in
many decades, and soon it will be law. The President will sign it, and
he will be grateful for all of our hard work, dedication, and
legislative achievement that every one of us can be proud of.
Mr. PALLONE. Mr. Speaker, I yield 6 minutes to the gentleman from New
York (Mr. Tonko), the ranking member of the subcommittee.
Mr. TONKO. Mr. Speaker, I thank the gentleman from New Jersey, our
ranking member, for yielding.
It is with regret that I must stand here today in opposition to this
bill to reform the Toxic Substances Control Act. We have negotiated in
good faith for many months to try to reach an agreement to fix EPA's
chemical program. While there are some positive aspects of this bill,
ultimately, I believe it falls short.
Before I go into detail about my concerns, I want to express my
appreciation for the work that has been done by both the majority and
minority colleagues on the Energy and Commerce Committee. I want to
commend the staffs, in particular those with whom I worked most closely
from the minority side.
As we just heard from Chairman Upton, the Senate passed a version in
December of last year, after we had voted nearly unanimously to support
our version of the bill. There are improvements over the bill passed by
the Senate in December with this measure.
I want to be clear that, in some ways, this bill will improve current
law: EPA gains new authorities and resources; the regulatory bar to
testing is lowered, allowing EPA to acquire more information about
chemicals; the least burdensome standard that essentially has prevented
EPA from regulating chemicals even when there was overwhelming evidence
of harm has been removed; one of our Caucus' top priorities, expediting
the review of persistent, bioaccumulative, and toxic substances, or
PBTs, was largely retained; and the bill requires the EPA to consider
the most vulnerable populations.
But for every positive step to protect public health and the
environment, there are numerous steps back that undermine those goals.
For example, this bill weakens one of the few parts of TSCA as it
stands today that actually works, Significant New Use Rules, or SNURs.
EPA can require companies to provide notice of new uses of a chemical
before a company can manufacture or import it. A chemical that might be
suitable for industrial uses should not necessarily be in consumer
products. This bill would make it more difficult to require
notification and, therefore, to track chemicals being used in new ways
or in imported products.
Also, there is language on a negotiated rulemaking to limit reporting
requirements for inorganic byproducts, a concept that was not in either
the House or Senate bills but seems to have been stuck into this
version somehow.
The section on nomenclature represents an improvement over the Senate
bill, but I still have concerns. This is just one of a number of
seemingly benign provisions that are included to create loopholes that
undermine the public health and environmental protection goals of TSCA.
The bill retains the Senate's resource-intensive prioritization
process that largely duplicates the work EPA has done already to
identify chemicals of concern and place them on the work plan.
Finally, there has been a lot of talk about the preemption section.
Currently, States are able to restrict a chemical unless EPA decides to
impose its own restrictions. Preemption has not often been an issue
because EPA has rarely acted, but States today--today--have a number of
options when it does happen. They can coenforce restrictions, apply for
a waiver, or ban the chemical. Under this bill, States lose those
rights to ban a chemical, and a waiver would be more difficult to
obtain than under current law.
Without a working Federal program, it has fallen upon States to lead
the fight to get the most harmful chemicals out of commerce, and they
have proven to be successful. They have been the champions, the driving
force.
I understand there are Members from States that have not acted to
regulate chemicals. Please do not think this provision does not apply
to you as well. When States are able to act aggressively, as they have,
they can move industry and they can move EPA to act, which benefits our
entire Nation.
Unfortunately, this bill includes provisions that would severely
inhibit States' ability to act. In January, 14 State attorneys general
expressed their concerns with the preemption section. Those concerns
were reiterated as recently as last week by some seven State
environmental commissioners. Their concerns largely revolved around
what has become known as pause preemption. During the pause period when
EPA is evaluating a chemical, up to 3.5 years, States are prohibited
from acting.
Last year's House-passed version did not--did not--include the pause.
While we accepted that States would be preempted when EPA makes a final
determination about a chemical's risks, it would be unprecedented to
prevent a State from acting before then.
Overall, and very problematically, the Senate's State preemption
framework is largely unchanged. We know a deal was struck in the Senate
a few weeks ago, but I believe it is more accurate to call it a deal on
prioritization, not preemption, because EPA would have to spend more
time going through the unnecessary prioritization process. During this
new window of time, States could rush to try to act before the pause
kicks in.
We have heard from a number of States that act by legislative action
rather than regulations. They have told us that 12 to 18 months is
simply not sufficient. The reality is, in most cases, States will not
have enough opportunity to protect their citizens from harmful
chemicals during the years it can take for EPA to do its own
evaluation.
Let us call the pause exactly what it is: unnecessary and precedent
setting. It may be decades before we see the health benefits of this
bill, but I fear it is only a matter of time before more and more bills
come to the floor that prevent State regulation before a final Federal
agency action. I can't help but ask: Will we rue the day that we gave
[[Page H3028]]
a nod of approval to the pause preemption concept?
It is a terrible policy, and we should not encourage it. It opens the
door to unwelcome and dangerous precedent.
The core tension of my evaluation of this bill is to balance between
new Federal authorities and new restrictions on States. On balance, I
do not believe that the modest improvements to the Federal program--not
to mention the carve-outs for certain industries, many of which are
unnecessarily broad--are sufficiently positive to warrant these new
restrictions.
You have heard during this debate that our system is broken and that
the improvements, of which there are some, are better than nothing,
which is what we have now for existing chemicals. But better than
nothing is a very low bar. I think we can and should do better. The
public deserves better.
I have no doubt that people on both sides of this debate genuinely
want to ensure people are protected from dangerous and toxic chemicals.
I do not begrudge my colleagues who choose to support it. However, the
Record must reflect that this bill is not without its flaws or its
controversies.
We must have a strong, national chemical program to protect American
families and workers. But the States can and should be strong partners
in this effort. This bill severely constrains the States' role in this
effort. Ultimately, I am not convinced that the program that will be
put into place by this bill justifies the unprecedented limitations of
States' authorities.
Mr. Speaker, I urge my colleagues to oppose the bill.
Mr. SHIMKUS. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Tennessee (Mrs. Blackburn), the vice chair of the full committee.
Mrs. BLACKBURN. Mr. Speaker, I do rise in support of the amendments
to H.R. 2576, and I congratulate Chairman Shimkus on the wonderful job
he has done.
Mr. Speaker, I yield to the gentleman from Illinois (Mr. Shimkus) for
the purpose of a brief colloquy to clarify one important element of the
legislation.
Mr. Chairman, it is my understanding that this bill reemphasizes
Congress' intent to avoid duplicative regulation through the TSCA law.
It does so by carrying over two important EPA constraints in section 9
of the existing law while adding a new, important provision that would
be found as new section, 9(b)(2).
It is my understanding that, as a unified whole, this language, old
and new, limits the EPA's ability to promulgate a rule under section 6
of TSCA to restrict or eliminate the use of a chemical when the Agency
either already regulates that chemical through a different statute
under its own control and that authority sufficiently protects against
a risk of injury to human health or the environment, or a different
agency already regulates that chemical in a manner that also
sufficiently protects against the risk identified by EPA.
Would the chairman please confirm my understanding of section 9?
Mr. SHIMKUS. Will the gentlewoman yield?
Mrs. BLACKBURN. I yield to the gentleman from Illinois.
Mr. SHIMKUS. The gentlewoman is correct in her understanding.
Mrs. BLACKBURN. I thank the chairman. The changes you have worked
hard to preserve in this negotiated bill are important. As the EPA's
early-stage efforts to regulate methylene chloride and TCE under TSCA
statute section 6 illustrate, they are also timely.
EPA simply has to account for why a new regulation for methylene
chloride and TCE under TSCA is necessary since its own existing
regulatory framework already appropriately addresses risk to human
health. New section 9(b)(2) will force the Agency to do just that.
I thank the chairman for his good work.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Vermont (Mr. Welch).
Mr. WELCH. Mr. Speaker, I thank the gentleman for yielding.
Number one, the starting point for analysis of this law is the
current law. The current law is a mess. It is the Wild West out there
when it comes to regulating chemicals. There are 85,000 chemicals that
are on the market that have never been tested, and bad things are going
to happen. This law changes that. The EPA is now going to have
authority to regulate and review these substances as to their health
and safety.
Number two, it requires a safety finding before a new product goes on
the market.
Number three, it replaces the cost-benefit analysis for a health-only
analysis. When it comes to health and safety, that is absolutely
essential. It is not about the cost. The cost in human terms and to
communities when you have let something go by for accounting reasons,
as opposed to looking vigilantly at health and safety, is not the way
to go. It is a very good change.
Next, it protects vulnerable populations: children, pregnant women,
and especially workers who are in plants where these products are used.
Finally, it makes the companies come clean with what information they
have that allows regulators to come to a conclusion. That is very
important.
The preemption issue is a concern. In Vermont, we have had a very
active Republican and Democratic Governor, a very active Agency of
Natural Resources secretary, and very, very active and aggressive
attorneys general. They are concerned about this. But there is, in this
legislation, flexibility so that Vermont is going to continue to have
the ability to act to protect its citizens, and I am confident they
will.
If the EPA is going to put a product on a list that they are going to
start reviewing, we are going to get a heads-up in Vermont, as every
State is, of about 9 months. I have confidence in the Vermont General
Assembly, in the Vermont Governor, in the Vermont attorney general, and
in the Vermont secretary of the Agency of Natural Resources to do what
is required to protect the public health and the public safety.
So no law is perfect, but in this institution, we have had a hard
time passing laws that we all know need to get done. I thank all the
people who have been involved.
{time} 1515
Mr. SHIMKUS. Mr. Speaker, I yield 2 minutes to the gentleman from
North Carolina (Mr. Pittenger).
Mr. PITTENGER. Mr. Speaker, I thank the chairman for this very
sensible legislation. I appreciate his efforts in leading a bipartisan
effort to reform U.S. chemical safety law that is decades in the
making.
I particularly thank him for securing amendments to section 9 of the
TSCA law that remain in the negotiated text. These amendments
reemphasize and strengthen Congress' intent that TSCA serve as an
authority of last resort for the regulation of a chemical when another
authority under EPA's jurisdiction, or another Federal agency, already
regulates the chemical and the risk identified by EPA.
As a unified whole, TSCA now makes clear that EPA may not promulgate
a rule under section 6 of TSCA to restrict or eliminate the use of a
chemical when:
Number one, the agency either already regulates that chemical through
a different statute under its own control, like the Clean Air Act, and
that authority sufficiently protects against a risk of injury to human
health or the environment; or
Number two, a different agency already regulates that chemical in a
manner that also sufficiently protects against the risk already
identified by EPA.
Mr. Speaker, in light of yet another regulatory overreach in the
rulemaking at EPA, the new amendments to section 9 of TSCA are a
welcome reform with the intent that it will help restrain the agency's
unnecessary activities. These are commonsense, but important,
protections given what EPA is likely to pursue.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Texas (Mr. Gene Green), ranking member of the Subcommittee on Health.
Mr. GENE GREEN of Texas. Mr. Speaker, I rise in support of the
amendment to H.R. 2576, the TSCA Modernization Act. That is an
abbreviation for the Toxic Substances Control Act.
This bipartisan, bicameral legislation will reform our broken
chemical safety law for the first time since 1976, and directly
addresses TSCA's fundamental flaws. This legislation is a win-
[[Page H3029]]
win for our district in East Houston and Harris County, Texas, home to
one of the largest collection of chemical facilities in the country.
The reforms contained in this proposal will enhance protections for the
workers in our chemical plants, the fence-line communities next to
these facilities, and will benefit chemical manufacturers who will have
certainty in a true, nationwide market.
Congress has worked on reforming TSCA for over a decade, and I
personally have been working on fixing the statute since 2008. Though
not perfect, the proposal before the House today is, in the words of
the Obama administration, ``a clear improvement over current TSCA and
represents a historic advancement for both chemical safety and
environmental law.''
Let me quote also from the United Steelworkers:
``Overall, the amendments to H.R. 2576, the `TSCA Modernization Act,'
do not result in a bill we would have written. However, there are
significant improvements over current law, including a fix of the 1991
`asbestos decision' that crippled the Environmental Protection Agency's
(EPA's) ability to act. Now EPA must use a health-only standard to
evaluate chemicals and reserve cost-benefit analysis for determining
restrictions of harmful chemicals. Additionally, the bill includes
increased EPA authority to review chemicals, a fee structure to fund
the program, and protection of vulnerable populations, including
workers.''
Again, that is from the United Steelworkers.
The most notable improvements in the bill are replacing current
TSCA's burdensome safety standard with a pure, health-based standard;
explicitly requiring the protection of vulnerable populations, like
children, pregnant women, and workers at the plants; requiring a safety
finding before new chemicals are allowed to go to market; and giving
EPA new authority to order testing and ensure chemicals are safe, with
a focus on the most risky chemicals.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. PALLONE. Mr. Speaker, I yield the gentleman an additional 30
seconds.
Mr. GENE GREEN of Texas. This legislation responds to the concerns of
industry to provide regulatory certainty for job creators throughout
our economy and has the support of the Environmental Defense Fund, the
Humane Society, the March of Dimes, and the National Wildlife
Federation, along with the machinists union and the building trades.
I urge my colleagues on both sides of the aisle to join me in
supporting this amendment, and help pass the first major environmental
legislation in a quarter century.
Mr. SHIMKUS. Mr. Speaker, I yield 2 minutes to the gentleman from
Georgia (Mr. Carter).
Mr. CARTER of Georgia. Mr. Speaker, I rise today in support of the
House amendment to the Senate amendment to H.R. 2576, the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.
This legislation would combine the policy priorities from H.R. 2576
and S. 697 into a bipartisan bill that would modernize the Toxic
Substances Control Act of 1976.
Recognizing the need to ensure that chemicals are safely made and
used, Congress passed the Toxic Substances Control Act 40 years ago.
This law made protecting human health and the environment a priority in
the chemical manufacturing process. However, the Toxic Substances
Control Act has not been updated since its inception, and is in dire
need of reform. Policies based on this 40-year-old law are disjointed,
confusing, and often contradictory for both manufacturers and
consumers.
Modernizing the Toxic Substances Control Act would allow for adoption
of uniform, science-based chemical safety policies. Manufacturers will
have the regulatory certainty they need to develop new and safe
products, and consumers can shop with confidence.
This version of the bill also protects intellectual property rights
of chemical manufacturers, many of which have invested millions of
dollars in research and development.
I urge my colleagues to support this bipartisan bill that greatly
improves a landmark consumer and environmental protection law.
Mr. PALLONE. Mr. Speaker, can I inquire as to how much time remains
on both sides?
The SPEAKER pro tempore. The gentleman from New Jersey has 14 minutes
remaining. The gentleman from Illinois has 16 minutes remaining.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Colorado (Ms. DeGette), the ranking member of the Subcommittee on
Oversight and Investigations.
Ms. DeGETTE. Mr. Speaker, I rise today in support of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.
We have been talking a lot about the, admittedly, very arcane details
of this bill. I want to talk for a minutes about how this bill is going
to impact the families of America.
Think about someone you know and love who will probably start a
family in the next decade. I think of my own two daughters who are in
their 20s. That future parent will be very excited about the arrival of
a child. The parents will create a nursery in their home for their new
baby, a space that is clean, warm, and safe.
Well, they think it is safe. But right now, under current law, that
rocking chair in the corner could be covered with toxic flame
retardants. The fresh paint on the walls could contain harmful volatile
organic compounds. The rug beneath the crib probably has been treated
with formaldehyde, which is a carcinogen. Parents and children should
not have to worry whether the most basic, everyday things they do are
toxic to their health.
TSCA has been a flawed piece of legislation since it passed in 1976.
Nobody liked it--the environmental community, the chemical industry, or
the parents of America. We need to bring some certainty to the
regulation of the tens of thousands of chemicals that we have out
there, and that is what this bill will do.
Did you know that under this bill, for the first time, EPA will have
access to the information it needs on a chemical? For the first time,
EPA will regulate the worst chemicals out there, like arsenic? For the
first time, the EPA will have deadlines for review so that Americans
are protected from dangerous chemicals as soon as practicable? And for
the first time, Americans will know exactly what is out there in
commerce?
For the first time, every nursery in America will be clean, warm, and
safe. That is what America deserves.
Is this bill perfect?
No. But it is what we are expected to do as Members of the House and
Senate, Democrats and Republicans--protect the safety of our children
and generations to come.
I really want to thank my colleagues. I want to thank Mr. Pallone and
Mr. Tonko on our side of the aisle. I want to thank the rock star, Mr.
Shimkus, who I have been working with, along with Mr. Green, since 2007
to bring this to reality.
This truly is a great day for the families of America, and I am
really proud that we are able to get this done. I hope my colleagues
will look at the bill in totality; I hope you will see how, finally, we
are going to be able to actually regulate these chemicals; and I hope
you will vote ``yes.''
Mr. SHIMKUS. Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
Maryland (Mr. Hoyer), the Democratic whip, who has been extremely
helpful in the last few days in dealing with this legislation.
(Mr. HOYER asked and was given permission to revise and extend his
remarks.)
Mr. HOYER. Mr. Speaker, I rise in support of this legislation, which
is the product of much negotiation--which is an understatement, I
think--in an effort to find consensus.
Congress first enacted the Toxic Substances Control Act 40 years ago
to protect Americans from the risks posed by chemicals in commerce. It
has not been reauthorized since. Since its original enactment, the law
has become outdated, and efforts to modernize it have been ongoing for
several years with great difficulty. Under current law, it has become
hard for the EPA to ban even substances that are known to cause cancer,
such as asbestos.
[[Page H3030]]
The bill before us today is a breakthrough after a significant amount
of work. It represents a compromise that, while not perfect, as
everyone has noted, is a great improvement over current law. And it
will help the EPA protect Americans from harmful, toxic substances and
safeguard our environment.
This bill will require the EPA to evaluate both existing and new
chemical substances against a new risk-based, scientific safety
standard that includes specific considerations for populations more
vulnerable to chemical exposure, such as children, seniors, and
pregnant women. It also ensures that the EPA can order testing
immediately for substances suspected of placing Americans at risk.
This bill improves public transparency of chemical information,
provides for clear and enforceable deadlines to review prioritized
chemicals, and takes action to mitigate any identified risk.
In short, this is a bill that reflects the kind of compromise across
the aisle we ought to be seeing more of in this House. It is fittingly
named after Senator Frank Lautenberg of New Jersey, who spent his
career working to make this law more functional.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. PALLONE. I yield the gentleman an additional 1 minute.
Mr. HOYER. I want to first thank the person in my office who worked
far harder than I did. I just took her phone calls and talked to Mr.
Pallone and talked to Mr. Shimkus from time to time. Mary Frances Repko
is one of the hardest working staff members. Mr. Speaker, I want to
thank Mary Frances for the work that she did to get us to where we are.
It is not perfect, as she and I agree, but it is a bill that will be
better than what we have.
I want to thank, of course, Ranking Member Pallone; my dear friend,
Chairman Upton; my friend, John Shimkus, the chairman of the committee;
and Mr. Tonko, who is not for this bill. He worked hard to get it to
this place. He didn't get there, but he worked hard on that effort.
Mr. Speaker, I urge my colleagues to support this legislation. It is
a work product that has been sincerely achieved by people of goodwill,
and it is adjudged by the President of the United States and the
administration and by the director of the administrator of the
Environmental Protection Agency as a significant and important step
forward. That is a good deal for the American people.
Mr. SHIMKUS. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Georgia (Mr. Johnson).
Mr. JOHNSON of Georgia. Mr. Speaker, I thank the gentleman.
Mr. Speaker, this body has never passed a law that denied States the
ability to act before there is a Federal standard in place. What we are
perpetrating today with this vote is a first.
Instead of being preempted to act once an established EPA standard is
in place, States are prevented from pursuing critical protections for
their communities from dangerous chemicals the moment the EPA decides
to review the chemical, not when the EPA has created a new regulation.
{time} 1530
By allowing for this so-called pause preemption, we will create an
almost 3-year limbo period in which a chemical under review is
essentially unregulated by either State or Federal laws.
Meanwhile, the public is subjected to potentially dangerous
chemicals. This is unheard of in our existing consumer protection legal
standards, and it will be to the detriment of the American people.
However, I do commend the efforts of the Energy and Commerce
Committee to take on this Herculean task of updating the existing
regulatory regime and reaching a compromise package.
However, I regret that this compromise comes at the expense of the
rights of the States to protect the health, safety, and welfare of
their citizens.
We should not be preventing local governments from exerting their
basic duty to take proactive steps that will protect our communities,
our environment, and the public health.
Federal regulations serve as a floor, not as a ceiling, and States
should be permitted to pursue laws that fill gaps in existing Federal
regulations.
Pause preemption not only increases uncertainty and delay to the
rulemaking process, but it further limits communities' abilities to
seek redress through our courts when they find themselves the victims
of dangerous and unregulated chemicals.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. PALLONE. I yield the gentleman an additional 1 minute.
Mr. JOHNSON of Georgia. I thank the gentleman.
Mr. Speaker, lastly, I thank my colleagues on both sides of the aisle
for their tremendous work on this bill and for the time and energy
spent by their staffs.
I ask my colleagues to support this bill.
Mr. SHIMKUS. Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I would just inform my colleague that I
have no additional speakers.
Mr. SHIMKUS. I have no other speakers, and I will close after the
gentleman from New Jersey has closed.
Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time.
So many people have been involved on our staffs in this bill over the
last several years, certainly prior to the time that I was the ranking
member.
I want to, in particular, thank Jackie Cohen. Jackie is sitting here
to my right. She, more than anybody else, worked on this bill and made
it possible to bring this bill to fruition. I think she knows more
about TSCA than anybody else I know; so, I want to thank her in
particular.
I also want to thank Jean Fruci, Rick Kessler, Tuley Wright, Timia
Crisp, and Alexander Ratner. From Mr. Tonko's staff, I want to thank
Brendan Larkin and Clinton Britt.
Mr. Speaker, this bill is named the Frank R. Lautenberg Chemical
Safety Act for the 21st Century. One of the things that was so
important to me in the process of negotiating this bill was that it
would live up to Senator Lautenberg's legacy.
Senator Lautenberg was always a mentor to me. I worked on his first
campaign back in 1982. He was always looking out for the little guy.
One of the most important things to him in that respect was health and
safety because he always felt that the primary function of the Federal
Government was to protect people's health and safety.
One of the biggest things that was important to him was what I call
the right to know. He always felt, if we passed laws that allowed
people to know what they were facing in the health and environment
sphere, that that would be good because they or even their
organizations that they might be involved with on an activist level
locally--citizen groups--would have the ability, if you will, to
effectuate and carry out those laws through their own efforts.
I think one of the greatest regrets that he had was that, when you
dealt with toxic chemicals over the time that he was in the Senate--he
was the longest serving Senator, actually, in New Jersey history--he
was never able to say what chemicals were dangerous and, basically,
give people the right to know about toxic chemicals.
I think that this is an important part of his legacy, and I am very
proud to say that today we can support a bill that is named in his
honor.
Mr. Speaker, I yield back the balance of my time.
Mr. SHIMKUS. Mr. Speaker, I yield myself the balance of my time.
Before us today on the floor, as you have heard, is a bipartisan,
bicameral agreement that substantially improves the safety of chemicals
that are used by everyone every day.
As you have heard, while this is not the bill that a lot of people
would have written if they had had their own way, the reality is that
this is how the legislative process is supposed to work.
I think it is very instructive as we go back to our districts and do
the ``Schoolhouse Rock!'' on how a bill becomes a law. There is a great
dynamic that is in play. That is what happened here, and that is what
brings us to the floor today.
This bill represents a balanced and thoughtful compromise that makes
long-needed improvements to an outdated and ineffective law. The
legislation before us is supported by a broad
[[Page H3031]]
coalition of stakeholders that ranges from environmental and public
health groups to large and small industrial organizations.
It has the support of the National Association of Manufacturers, the
Chamber of Commerce, the American Cleaning Institute, the National
Association of Chemical Distributors, the Society of Chemical
Manufacturers & Affiliates, and the American Chemistry Council. There
is a list of 143 different groups that have come out in support of this
bill. It is worthy of our support as well.
I want to thank the staff who worked very hard to get us here today:
Chris Sarley, in my office; Dave McCarthy; Jerry Couri; Tina Richards;
our head chief of staff of the committee, Gary Andres; along with, of
course, Chairman Fred Upton, who allowed all of these people to be at
our disposal to get this work done.
Mr. Speaker, we have with us in the Chamber legislative counsel.
These are the unknown heroes, the people who actually get the late
phone calls, who try to help us figure out the language that we are
trying to work with.
Tim Brown and Kakuti Lin are here. They have my gratitude and my
thanks. In an era when we kind of question Federal employees and their
commitment to excellence and work ethic, they are good examples of what
people really do many times.
Thank you very much for your work.
I also want to give a nod to the great work done by the House
Democratic staff. You are loyal adversaries, and I believe we will
continue to be so, but we were able to do well in this process.
I thank the Senate Republicans on Mr. Inhofe's staff and the Senate
Democrats' staff, from Senator Udall's, Senator Boxer's, Senator
Markey's, and Senator Merkley's offices, who all put in long hours and
weekends for several months to get this multiyear effort done.
It has been a multiyear effort, starting since I became chairman of
the committee. And you have seen Gene Green come down and Diana
DeGette, who worked diligently with me in the last Congress.
I also want to mention that the spiritual leader of this, kind of,
was Bonnie Lautenberg, who I know called us numerous times. Behind
every great man there is a greater woman. I think Bonnie Lautenberg
kind of falls into that category, and I know she is very happy with our
success today.
Mr. Speaker, as I said in my opening remarks, this bill is good for
consumers, it is good for jobs, and it is good for the environment. It
is imperative that we pass this bill and get it signed into law without
delay.
This is graduation time throughout our country--a lot of commencement
exercises--and we are always reminded that, really, ``commencement''
means beginning.
So even though we are kind of getting to the end of the legislative
process of the law, the real test will be the commencement by the EPA
in our trying to enact this law and in seeing if it does everything
that we say it will do.
It is our job on our committee to continue to do oversight to make
sure that the things we think are doing well are doing well and that
the things that need improvement we look at. You have my support in
doing that oversight and overview of this new law as it moves forward.
Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. All time for debate has expired.
Pursuant to House Resolution 742, the previous question is ordered.
The question is on the motion to concur by the gentleman from
Illinois (Mr. Shimkus).
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
order of the House of today, further proceedings on this question will
be postponed.
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