[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 725 Introduced in Senate (IS)]
114th CONGRESS
1st Session
S. 725
To amend the Toxic Substances Control Act, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 12, 2015
Mrs. Boxer (for herself, Mr. Markey, and Mr. Sanders) introduced the
following bill; which was read twice and referred to the Committee on
Environment and Public Works
_______________________________________________________________________
A BILL
To amend the Toxic Substances Control Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Alan Reinstein and
Trevor Schaefer Toxic Chemical Protection Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. References.
TITLE I--AMENDMENTS TO THE TOXIC SUBSTANCES CONTROL ACT
Sec. 101. Findings, policy, and intent.
Sec. 102. Definitions.
Sec. 103. Policies, procedures and guidance.
Sec. 104. Testing of chemical substances or mixtures.
Sec. 105. Prioritization screening.
Sec. 106. New chemicals and significant new uses.
Sec. 107. Safety assessments and determinations.
Sec. 108. Imminent hazards.
Sec. 109. Information collection and reporting.
Sec. 110. Relationship to other Federal laws.
Sec. 111. Research, development, collection, dissemination, and
utilization of data.
Sec. 112. Exports.
Sec. 113. Imports.
Sec. 114. Confidential information.
Sec. 115. Prohibited acts.
Sec. 116. Penalties.
Sec. 117. Preemption.
Sec. 118. Judicial review.
Sec. 119. Citizens' petitions.
Sec. 120. Studies.
Sec. 121. Administration.
Sec. 122. Development and evaluation of test methods.
Sec. 123. State programs.
Sec. 124. Authorization of appropriations.
Sec. 125. Annual report.
TITLE II--STRENGTHENING PROTECTIONS FOR CHILDREN AND COMMUNITIES FROM
DISEASE CLUSTERS
Sec. 201. Purposes.
Sec. 202. Definitions.
Sec. 203. Guidelines for environmental investigations of disease
clusters.
Sec. 204. Enhanced support for environmental investigations of disease
clusters.
Sec. 205. Federal reports to Congress.
Sec. 206. Authorization of appropriations.
Sec. 207. Effect on other law.
TITLE III--COMMUNITY DISEASE CLUSTER TECHNICAL ASSISTANCE GRANTS
Sec. 301. Community disease cluster technical assistance grants.
Sec. 302. Authorization of appropriations.
SEC. 2. REFERENCES.
Except as otherwise expressly provided, wherever in this Act an
amendment or repeal is expressed in terms of an amendment to, or repeal
of, a section or other provision, the reference shall be considered to
be made to a section or other provision of the Toxic Substances Control
Act (15 U.S.C. 2601 et seq.).
TITLE I--AMENDMENTS TO THE TOXIC SUBSTANCES CONTROL ACT
SEC. 101. FINDINGS, POLICY, AND INTENT.
Section 2(a) (15 U.S.C. 2601(a)) is amended--
(1) In paragraph (2)--
(A) by striking ``injury'' and inserting ``harm'';
and
(B) by striking ``and'' at the end;
(2) by redesignating paragraph (3) as paragraph (6); and
(3) by inserting after paragraph (2) the following:
``(3) reform of this Act shall be administered to protect
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;
``(4) reform of this Act shall not displace or supplant
common law rights of action or remedies for civil relief;
``(5) reform of this Act shall be administered to ensure
that appropriate information on chemical substances and
mixtures should be available to public health officials and
first responders in the event of an emergency; and''.
SEC. 102. DEFINITIONS.
Section 3 (15 U.S.C. 2602) is amended--
(1) by redesignating paragraphs (7), (8), (9), (10), (11),
(12), (13), and (14) as paragraphs (9), (10), (11), (13), (14),
(19), (20), and (21), respectively;
(2) by inserting after paragraph (6) the following:
``(7) Information.--Except in section 14, the term
`information' means any qualitative, quantitative or
descriptive facts, data, analysis or assessment related to
chemical hazards, use, or exposure (including the nature and
extent of exposure to a chemical substance), including from
health and safety studies.
``(8) Intended or reasonably foreseeable conditions of
use.--The term `intended or reasonably foreseeable conditions
of use' means the circumstances under which a chemical
substance is intended, reasonably known, or reasonably
anticipated to be manufactured, processed, distributed in
commerce, used, disposed of, and released into the environment,
including reasonably foreseeable but unintended exposure
conditions from unplanned releases into the environment.'';
(3) by inserting after paragraph 11 (as so redesignated)
the following:
``(12) Potentially exposed or susceptible population.--The
term `potentially exposed or susceptible population' means a
group or groups of individuals within the general population
who may be--
``(A) differentially exposed to chemical substances
under the intended or reasonably foreseeable conditions
of use; or
``(B) more susceptible to adverse health
consequences from chemical exposures than the general
population, which when identified by the Administrator
may include such groups as infants, children, pregnant
women, workers, and the elderly.''; and
(4) by inserting after paragraph (14) (as so redesignated)
the following:
``(15) Publicly available information.--The term `publicly
available information' means information that is generally
accessible and available to the general public or in the public
domain, including information that has been published in
periodicals, books, print, or electronic or other media
available for general distribution to any member of the public.
``(16) Safety assessment.--The term `safety assessment'
means an assessment of the risk posed by a chemical substance
under the intended or reasonably foreseeable conditions of use,
integrating hazard, use, and exposure information about the
chemical substance.
``(17) Safety determination.--The term `safety
determination' means a determination by the Administrator as to
whether a chemical substance meets the safety standard under
the intended or reasonably foreseeable conditions of use.
``(18) Safety standard.--The term `safety standard' means a
standard that ensures with reasonable certainty, without taking
into consideration cost or other non-risk factors, that no harm
to human health or the environment will result from exposure to
a chemical substance under the intended or reasonably
foreseeable conditions of use, including no harm to the general
population or to any potentially exposed or susceptible
subpopulation that the Administrator has identified as relevant
to the safety assessment and determination for a chemical
substance.''.
SEC. 103. POLICIES, PROCEDURES AND GUIDANCE.
The Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is
amended by adding after section 3 the following:
``SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE.
``(a) Deadline.--Not later than 2 years after the date of enactment
of the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection
Act, the Administrator shall, after providing an opportunity for public
notice and comment, develop the policies, procedures and guidance
required by this section. As used in this section, the term `guidance'
includes any significant written guidance of general applicability
prepared by the Administrator.
``(b) Use of Science.--In establishing any policies, procedures,
and guidance, on the use of science in making decisions under this
section and sections 4, 4A, 5, and 6, the Administrator shall have the
goal of making the basis of decisions clear to the public. The
policies, procedures and any guidance issued under this subsection
shall describe how the Administrator will ensure that--
``(1) decisions by the Administrator--
``(A) are based on the best available science; and
``(B) take into account the extent to which--
``(i) assumptions and methods used to
develop information considered by the
Administrator are clearly and completely
described and documented;
``(ii) variability and uncertainty in such
information are evaluated and characterized;
and
``(iii) the information has been subject to
independent peer review;
``(2) to the extent practicable and where appropriate, the
use of peer review, standardized test design and methods,
consistent data evaluation procedures, and appropriate
laboratory practices will be encouraged;
``(3) the names of the organizations or individuals funding
the generation and assessment of information and the degree of
control they had over the generation, assessment, and
dissemination of information (including control over the design
of the work and the publication of information) will be made
clear; and
``(4) decisions by the Administrator follow the applicable
recommendations in relevant National Academy of Sciences
reports, including the reports titled: Science and Decisions:
Advancing Risk Assessment, Phthalates and Cumulative Risk
Assessment: The Task Ahead, Review of EPA's Integrated Risk
Information System (IRIS) Process, Review of the Formaldehyde
Assessment in the National Toxicology Program 12th Report on
Carcinogens, and Review of the Styrene Assessment in the
National Toxicology Program 12th Report on Carcinogens.
``(c) Existing EPA Policies, Procedures and Guidance.--The
policies, procedures, and guidance described in subsections (a) and (b)
shall incorporate, as appropriate, existing relevant hazard, exposure,
and risk assessment guidelines and methodologies, data evaluation and
quality criteria, testing methodologies and other relevant guidelines
and policies previously issued by the Administrator.
``(d) Review.--Not less than 5 years after the date of enactment of
this Act, and not less frequently than every 5 years thereafter, the
Administrator shall--
``(1) review the adequacy of any policies, procedures, and
guidance developed under this section, including procedures for
assessing and determining risk under this Act; and
``(2) after providing an opportunity for public notice and
comment, revise the policies, procedures, and guidance if
necessary to reflect new scientific developments or
understandings.
``(e) Sources of Information.--In making any decision with respect
to a chemical substance under sections 4, 4A, 5, and 6, the
Administrator shall consider information on the hazards and exposures
of a chemical substance under the intended or reasonably foreseeable
conditions of use that is reasonably available to the Administrator,
including information that is--
``(1) submitted to the Administrator pursuant to any rule,
consent agreement, order, or other requirement of this Act, or
on a voluntary basis (including pursuant to any request made
under this Act) by--
``(A) manufacturers and processors of a substance;
``(B) the public;
``(C) other Federal agencies and departments; or
``(D) a Governor of a State or a State agency with
responsibility for protecting health or the
environment;
``(2) submitted to a governmental body in any jurisdiction
under a governmental requirement relating to the protection of
human health and 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.
``(f) Testing of Chemical Substances and Mixtures.--
``(1) In general.--The Administrator shall establish
policies and procedures for the testing of chemical substances
or mixtures under section 4. A goal of the policies and
procedures shall be to make the basis of decisions clear to the
public.
``(2) Contents.--The policies and procedures established
under paragraph (1) shall--
``(A) address how and when the exposure level or
exposure potential of a chemical substance would factor
into decisions to require new testing, provided that
the Administrator shall not interpret the lack of
exposure information as a lack of exposure or exposure
potential and that lack of information on exposure or
exposure potential shall not, by itself, be a reason
not to require testing;
``(B) describe how the Administrator will determine
that additional testing is needed to carry out this
Act, including testing related to potentially exposed
or susceptible populations and testing related to the
accumulation of chemical substances in the human body;
``(C) require the Administrator to consult with the
Director of the National Institute for Occupational
Safety and Health prior to prescribing epidemiologic
studies of employees; and
``(D) prior to adopting a requirement for testing
using mammals, require the Administrator to consider,
as appropriate and to the extent practicable,
reasonably available--
``(i) toxicity information;
``(ii) computational toxicology and
bioinformatics;
``(iii) high-throughput screening methods
and their prediction models; and
``(iv) scientifically reliable and relevant
alternatives to tests on mammals that would
provide equivalent information.
``(3) Tiered testing.--Except as provided in subparagraph
(C), the Administrator shall employ a tiered screening and
testing process, in 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.
``(A) Screening level.--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, as appropriate. Screening level
tests shall be used--
``(i) to screen chemical substances or
mixtures for potential adverse effects; and
``(ii) to inform the decision of the
Administrator whether additional testing is
necessary.
``(B) Additional testing.--If the Administrator
determines under subparagraph (A) that additional
testing is necessary to provide more definitive
information for prioritization or safety assessments
and safety determinations, the Administrator may
require more advanced tests for potential human health
or environmental effects or exposure.
``(C) 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 test, pursuant to policies or procedures
developed by the Administrator under this subsection.
``(g) Safety Assessments and Safety Determinations.--
``(1) Schedule.--The Administrator shall inform the public
regarding the schedule for the completion of each safety
assessment and safety determination as soon as possible after
designation as a high priority substance pursuant to section
4A. The time allotted may be different for different chemicals,
provided that all schedules shall comply with the deadlines
established under section 6.
``(2) Policies and procedures for safety assessments and
safety determinations.--The Administrator shall establish
policies and procedures on how the Administrator shall carry
out section 6. A goal of the policies and procedures shall be
to make the basis of decisions clear to the public. At a
minimum, the policies and procedures shall--
``(A) describe--
``(i) how the Administrator will identify
informational needs and seek such information
from the public;
``(ii) what information (including draft
safety assessments) may be submitted by
interested persons, including States; and
``(iii) the criteria by which that
information will be evaluated;
``(B) require the Administrator, in each safety
assessment and safety determination, to--
``(i) identify the substance's intended or
reasonably foreseeable conditions of use based
on information provided by its manufacturers
and processors or otherwise available to the
Administrator;
``(ii) identify all potentially exposed or
susceptible populations that the Administrator
determines are pertinent to the substance;
``(iii) identify the hazards of the
substance and its metabolites and breakdown
products and any differences in the magnitude
or nature of these hazards for potentially
exposed or susceptible populations, including
the potential for chemical substances to
accumulate in the human body;
``(iv) determine the nature and extent of
exposures to the chemical substance by the
general population and each potentially exposed
or susceptible population, including aggregate
exposures resulting from multiple pathways or
routes of exposure;
``(v) to the extent practicable, review and
incorporate any available scientific
information on the cumulative effects of
exposure to the chemical substance and other
chemical substances posing similar hazards to
human health and the environment; and
``(vi) characterize the nature and extent
of the risk presented by the chemical
substance, taking into account aggregate
exposures resulting from multiple pathways or
routes of exposure and the cumulative effects
of exposure to the chemical substance and other
chemicals posing similar hazards; and
``(C) 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
assessment or determination.
``(h) Release of Safety Assessments.--Subject to section 14, the
Administrator shall--
``(1) make available to the public 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 the list of studies considered by the
Administrator in carrying out the safety assessment and safety
determination, as well as the list of policies and procedures
that were followed in carrying out the safety assessment and
safety determination.
``(i) Consultation With Science Advisory Committee on Chemicals.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act, the Administrator shall establish a
Science Advisory Committee on Chemicals (referred to in this
subsection as the `Committee') to provide independent advice
and expert consultation, upon the request of the Administrator,
with respect to the scientific and technical aspects of issues
relating to the implementation of this title.
``(2) Composition of committee.--The Committee shall be
composed of representatives of such science, government, labor,
public health, public interest, industry, and other groups as
the Administrator deems 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.
``(3) Meetings.--The Administrator shall convene the
Committee on a schedule the Administrator determines
appropriate, but not less frequently than once every 2 years.
``(4) Federal advisory committee act.--All proceedings and
meetings of the Committee shall be subject to the Federal
Advisory Committee Act (5 U.S.C. App.).
``(5) Conflict of interest policies.--The Administrator
shall establish and make public conflict of interest policies
that shall apply to the Committee members, who shall be
appointed as Special Government Employees.
``(j) National Academy of Sciences Reports.--Not later than 120
days after the issuance of any report by the National Academy of
Sciences concerning hazards, exposures, or risks of chemical
substances, the Administrator shall issue a public response to the
principal recommendations of the report.''.
SEC. 104. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES.
(a) In General.--Section 4 (15 U.S.C. 2603) is amended--
(1) by striking subsection (g) and redesignating
subsections (e) and subsection (f) as subsections (f) and (g),
respectively;
(2) in subsection (f) (as so redesignated)--
(A) by striking ``rule'' each place it appears and
inserting ``rule, testing consent agreement, or
order'';
(B) by striking ``under subsection (a)'' each place
it appears and inserting ``under this subsection''; and
(C) in paragraph (1)(B), by striking
``rulemaking'';
(3) in subsection (g) (as so redesignated)--
(A) by striking ``from cancer, gene mutations, or
birth defects'';
(B) by striking ``unreasonable'' each place it
appears and inserting ``significant''; and
(C) by striking the last sentence; and
(4) by striking subsections (a) through (d) and inserting
the following:
``(a) Development of New Information on Chemical Substances and
Mixtures.--
``(1) In general.--The Administrator may require the
development of new information related to a chemical substance
or mixture in accordance with this section if the
Administration determines that the information is needed--
``(A) to perform a safety assessment or make a
safety determination under section 6;
``(B) to implement a requirement imposed in a
consent agreement or order issued under section
5(c)(4);
``(C) pursuant to section 12(a)(4); or
``(D) at the request of the implementing authority
under any other Federal law.
``(2) Testing for prioritization purposes.--The
Administrator may require the development of new information
for the purposes of section 4A, provided that any such testing
shall not be based on a set of uniform minimum information
requirements for all or large groups of chemical substances.
Use of this authority shall be limited to cases where the
Administrator determines additional information is needed to
establish the priority of a chemical substance.
``(3) Form.--Subject to section 3A(f), the Administrator
may require the development of test data and information
described in paragraph (1) or (2) by--
``(A) promulgating a rule;
``(B) entering into a testing consent agreement; or
``(C) issuing an order.
``(4) Contents.--
``(A) In general.--A rule, testing consent
agreement, or order issued under this subsection shall
include--
``(i) identification of the chemical
substance or mixture for which testing is
required;
``(ii) identification of the persons
required to conduct the testing;
``(iii) to the extent practicable, test
protocols and methodologies for the development
of information for the chemical substance or
mixture, including specific reference to
reliable nonmammal test procedures; and
``(iv) specification of the period within
which persons required to conduct the testing
shall submit to the Administrator the
information developed in accordance with the
procedures described in clause (iii).
``(B) Duration.--The period described in
subparagraph (A)(iv) shall not be of an unreasonable
duration.
``(C) Considerations.--In determining the
procedures and period to be required under subparagraph
(A), the Administrator shall consider--
``(i) the relative costs of the various
test protocols and methodologies that may be
required; and
``(ii) the reasonably foreseeable
availability of facilities and personnel needed
to perform the testing.
``(b) Statement of Need.--
``(1) In general.--In promulgating a rule, entering into a
testing consent agreement, or issuing an order for development
of additional information (including information on exposure or
exposure potential) under 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 mammals.
``(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 issuance of
an order instead of promulgating a rule or entering
into a testing consent agreement.
``(B) Contents.--The statement described in
subparagraph (A) shall contain a discussion 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 Mammals.--
``(1) In general.--The Administrator shall minimize, to the
extent practicable, the use of mammals in testing of chemical
substances or mixtures, by--
``(A) encouraging and facilitating--
``(i) the use of integrated and tiered
testing and assessment strategies;
``(ii) the use of best available science in
existence on the date on which the test is
conducted;
``(iii) the use of test methods that
eliminate or reduce the use of mammals while
providing information of high scientific
quality;
``(iv) the grouping of 2 or more chemical
substances into scientifically appropriate
categories in cases where testing of a chemical
substance would provide reliable and useful
information on others 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
animal-based studies and emerging methods and
models; and
``(B) funding research and validation studies to
reduce, refine, and replace the use of animal tests in
accordance with this subsection.
``(2) Implementation of alternative testing methods.--To
promote the development and timely incorporation of new testing
methods that are not based on mammals, the Administrator
shall--
``(A) after providing an opportunity for public
comment, develop a strategic plan to promote the
development and implementation of alternative test
methods and testing strategies to generate information
used in safety assessments and determinations under
section 6 that can reduce, refine, or replace the use
of mammals, including toxicity pathway-based risk
assessment, in vitro studies, systems biology,
computational toxicology, bioinformatics, and high-
throughput screening;
``(B) beginning on the date that is 5 years after
the date of enactment of the Alan Reinstein and Trevor
Schaefer Toxic Chemical Protection Act and every 5
years thereafter, submit to Congress a report that
describes the progress made in implementing this
subsection and goals for future alternative test
methods implementation; and
``(C) to the extent practicable, 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 mammals in any safety
assessment or determination made under section 6.
``(d) Testing Requirements.--
``(1) In general.--The Administrator may require the
following persons to develop information:
``(A) Manufacturers and processors of the chemical
substance or mixture.
``(B) Persons who begin to manufacture or process
such chemical substance or mixture--
``(i) after the effective date of the rule,
testing consent agreement, or order; but
``(ii) subject to paragraph (3), not later
than 180 days after the completion of the
period for submitting information specified
under subsection (a)(4)(A)(iv).
``(2) Designation.--The Administrator may permit 2 or more
of the persons identified in subparagraphs (A) and (B) of
paragraph (1) to designate a person or a qualified third
party--
``(A) to develop the information; and
``(B) to submit the information on behalf of the
persons making the designation.
``(3) Exemptions.--
``(A) In general.--A person otherwise subject to a
rule, testing consent agreement, or order under this
section may submit to the Administrator an application
for an exemption on the basis that the information is
being developed by a person designated under paragraph
(2).
``(B) Fair and equitable reimbursement to
designee.--
``(i) In general.--If the Administrator
accepts an application submitted under
subparagraph (A), the Administrator shall
direct the applicant to provide to the person
designated under paragraph (2) fair and
equitable reimbursement, as agreed to between
the applicant and the person designated.
``(ii) Arbitration.--If the applicant and a
person designated under paragraph (2) cannot
reach agreement on the amount of fair and
equitable reimbursement, the amount shall be
determined by arbitration.
``(C) Termination.--If, after granting an exemption
under this paragraph, the Administrator determines that
no person has complied with the rule, testing consent
agreement, or order, the Administrator shall--
``(i) by order terminate the exemption; and
``(ii) notify in writing each person who
received an exemption of the requirements with
respect to which the exemption was granted.
``(e) Transparency.--Subject to section 14, the Administrator shall
make available to the public all testing consent agreements and orders
under this section.''.
(b) Conforming Amendments.--Section 104(i)(5)(A) of the
Comprehensive Environmental Response, Compensation, and Liability Act
of 1980 (42 U.S.C. 9604(i)(5)(A)) is amended by striking ``section
4(e)'' and inserting ``section 4(f)''.
SEC. 105. PRIORITIZATION SCREENING.
The Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is
amended by adding after section 4 the following:
``SEC. 4A. PRIORITIZATION SCREENING.
``(a) Prioritization Screening.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act, the Administrator shall by rule
establish a 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, to be known as
`high-priority substances'; and
``(B) a low priority for a safety assessment and
safety determination, to be known as `low-priority
substances'.
``(2) Initial list of high priority substances.--Prior to
promulgation of the rule established under paragraph (1) and
not later than 6 months after the date of enactment of the Alan
Reinstein and Trevor Schaefer Toxic Chemical Protection Act,
the Administrator shall consider and publish an initial list of
high priority substances, which shall contain not less than 15
chemical substances, and pursuant to sections 6(a) and 6(b)(2),
initiate or continue safety assessments and safety
determinations for such substances.
``(3) Additions to priority list.--Starting 1 year after
publication of the initial priority list under paragraph (2)
and at 1 year intervals thereafter for the following 4 years,
the Administrator shall add at least 15 high-priority
substances to the list and, pursuant to sections 6(a) and
6(b)(2), initiate or continue safety assessments and safety
determinations for those substances.
``(4) Workplan and action plan chemicals.--The
Administration may list as high-priority substances under
paragraphs (2) and (3) those chemical substances or categories
of chemical substances that are included in the Administrator's
March 2012 Workplan (as updated in October 2014 and by
subsequent updates) or are the subject of Existing Chemical
Action Plans published by the Administrator before the date of
enactment of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act without providing further justification
for listing or meeting the requirements of this section.
``(5) Implementation.--
``(A) Consideration of active and inactive
substances.--
``(i) Consideration of active substances.--
In implementing the process described in
paragraph (1), the Administrator shall consider
active substances, as determined under section
8, which may include substances on the interim
list of active substances established under
that section.
``(ii) Consideration of inactive
substances.--In implementing the process
described in paragraph (1), the Administrator
may consider 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 substance; 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 substance; and
``(bb) there is the potential for
residual high hazards or widespread
exposures not otherwise addressed by
the regulatory or other action.
``(iii) Repopulation.--Upon the completion
of a safety determination under section 6 for a
chemical substance, the Administrator shall
remove the substance from the list of high-
priority substances. The Administrator shall
add not less than 1 chemical substance to the
list of high-priority substances for each
chemical substance removed from the list, until
a safety assessment and safety determination is
completed for all active substances, except
that not less than 3 chemical substances shall
be added for each chemical substance removed
from the list, subject to section 21, when fees
are in place.
``(B) Timely completion of prioritization screening
process.--
``(i) In general.--In addition to the
decisions required by paragraphs (1) and (2),
not later than 6 months after the effective
date of the final rule under paragraph (1), the
Administrator shall begin the prioritization
screening process.
``(ii) Decisions on substances subject to
testing for prioritization purposes.--Not later
than 120 days after receipt of the information
complying with a rule, testing consent
agreement, or order issued under section
4(a)(2), the Administrator shall designate the
substance as either a high or low priority.
``(iii) Consideration.--The Administrator
shall screen substances, taking into
consideration the requirement to meet the
deadlines under section 6 of this Act.
``(iv) Annual goal.--The Administrator
shall publish an annual goal for the number of
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
safety assessments and determinations.
``(D) Publication of list of chemical substances.--
Not less frequently than annually, the Administrator
shall--
``(i) publish a list of chemical substances
being considered in the prioritization
screening process and their status in the
prioritization process, including those
substances for which a prioritization decision
has been deferred; and
``(ii) publish a list of those substances
designated as high-priority and low-priority
substances and the basis for the designations.
``(6) Criteria.--The criteria described in paragraph (1)
shall include--
``(A) the recommendation of a Governor of a State
or a State agency with responsibility for protecting
health or the environment from chemical substances
appropriate for prioritization screening, and the
recommendations of the public;
``(B) the hazard of the chemical substance (or
category of substances), including specific scientific
classifications and designations by authoritative
governmental entities;
``(C) the intended or reasonably foreseeable
conditions of use of a chemical substance or
significant changes in the intended or reasonably
foreseeable conditions of use of the chemical
substance;
``(D) evidence and indicators of exposure and
potential exposure to humans or the environment from
the chemical substance including potentially exposed or
susceptible populations;
``(E) the volume of a chemical substance
manufactured or processed, and past and anticipated
future changes in volume;
``(F) whether the volume of a chemical substance as
reported under a regulation issued under section 8(a)
has significantly increased or decreased since a
previous report or since the date on which a notice has
been submitted under section 5(a) for that chemical
substance;
``(G) the availability of information about
potential hazards and exposures needed for conducting a
safety assessment or determination, provided that
limited availability of relevant information shall not
be a sufficient basis for failing to designate a
substance as a high priority;
``(H) the potential threat the chemical substance
poses to drinking water supplies, based on hazard,
exposure, or exposure potential (including whether the
chemical substance is stored near sources of drinking
water);
``(I) the extent to which a chemical substance
accumulates in the human body; and
``(J) other relevant criteria identified by the
Administrator.
``(b) Prioritization Screening Process and Decisions.--
``(1) In general.--The prioritization screening process
developed under subsection (a) shall include a requirement that
the Administrator--
``(A) identify the chemicals being considered for
prioritization;
``(B) request interested persons to supply
information on the substances being considered;
``(C) apply the criteria identified in subsection
(a)(5); and
``(D) subject to paragraph (4) 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) Identification of high-priority substances.--The
Administrator--
``(A) shall identify as a high-priority substance a
chemical substance that the Administrator determines
has, or has the potential for, significant hazard and
significant or substantial exposure;
``(B) may identify as a high-priority substance a
chemical substance that the Administrator determines
has, or has the potential for, significant hazard or
significant or substantial exposure;
``(C) may identify as a high-priority substance an
inactive substance, as determined under section 8(b),
that the Administrator determines warrants a safety
assessment and determination under section 6; and
``(D) may identify as a high-priority substance a
chemical substance that accumulates in the body.
``(3) Identification of low-priority substances.--The
Administrator shall identify as a low-priority substance a
chemical substance if the Administrator--
``(A) concludes that sufficient hazard and exposure
information is available for an informed evaluation of
the substance's risks to human health and the
environment;
``(B) determines, based on a review of the
information available, that the substance is likely to
meet the safety standard under the intended or
reasonably foreseeable conditions of use; and
``(C) identifies the information on which the
determination is based and describes the
Administrator's analysis of this information.
``(4) Deferring a decision.--If the Administrator
determines that additional information is needed to establish
the priority of a chemical substance, the Administrator may
defer the prioritization screening decision for a reasonable
period to--
``(A) allow for the submission and evaluation of
additional information by an interested person; or
``(B) require the development of information
pursuant to a rule, testing consent agreement, or order
issued under section 4(a)(2).
``(5) 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 such information, which
deadline shall be of reasonable duration.
``(6) Notice and comment.--Except as provided in subsection
(a)(4), the Administrator shall publish the proposed decisions
made under paragraphs (2), (3) and (4) and the basis for the
decisions, and provide an opportunity for public comment.
``(7) Revision based on new information.--The Administrator
may, at any time, revise the designation of a chemical
substance as a high-priority or a low-priority substance based
on new information made available to the Administrator after
the date of the determination under paragraph (2) or (3),
following the procedures in this section.
``(8) Review.--Not less frequently than once every 5 years
after the date on which the process under this subsection is
established, the Administrator shall review the process on the
basis of experience and consider the resources available to
efficiently and effectively screen and prioritize substances,
and if necessary modify the prioritization screening process in
a manner that complies with this Act.
``(9) Effect.--Subject to section 18, a decision by the
Administrator under this subsection with respect to a chemical
substance shall not be construed to affect the manufacture,
processing, distribution, use, or disposal of the chemical
substance, or regulation of those activities.
``(c) Final Agency Action.--Except for the designation of a
substance as low priority under subsection (b)(3), any action by the
Administrator under this section shall not be--
``(1) considered to be a final agency action; or
``(2) subject to judicial review.''.
SEC. 106. NEW CHEMICALS AND SIGNIFICANT NEW USES.
Section 5 (15 U.S.C. 2604) is amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.'';
(2) in subsection (a)(1), in the matter following
subparagraph (B)--
(A) by striking ``subsection (d)'' and inserting
``subsection (b)''; and
(B) by striking ``and such person complies with any
applicable requirement of subsection (b)'';
(3) by striking subsection (b);
(4) by redesignating subsection (d) as subsection (b) and
moving the subsection so as to appear after subsection (a);
(5) in subsection (b) (as so redesignated)--
(A) by striking paragraph (1) and inserting the
following:
``(1) In general.--The notice required under subsection (a)
shall include, with respect to a chemical substance--
``(A) the information required by sections 720.45
and 720.50 of title 40, Code of Federal Regulations (or
successor regulations); and
``(B) information regarding intended or reasonably
foreseeable conditions of use and reasonably
foreseeable exposures.'';
(B) in paragraph (2)--
(i) in the matter preceding subparagraph
(A), by striking ``or of data under subsection
(b)'';
(ii) in subparagraph (A), by adding ``and''
after the semicolon at the end;
(iii) in subparagraph (B), by striking ``;
and'' and inserting a period; and
(iv) by striking subparagraph (C); and
(C) in paragraph (3), by striking ``, (b),'';
(6) by striking subsection (c) and inserting the following:
``(c) Review of Notice.--
``(1) Initial review.--
``(A) In general.--Subject to subparagraph (B), not
later than 90 days after the date of receipt of a
notice submitted under subsection (a), the
Administrator shall--
``(i) conduct an initial review of the
notice;
``(ii) as needed, develop a profile of the
relevant chemical substance and the potential
for exposure to humans and the environment; and
``(iii) make any necessary determination
under paragraph (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 (b)(1); and
``(B) any other relevant information available to,
or submitted to, the Administrator.
``(3) Determinations.--Before the end of the applicable
period for review under paragraph (1), and based on the
information described in paragraph (2), the Administrator shall
determine that--
``(A) the relevant chemical substance or a
significant new use is not likely to meet the safety
standard, in which case the Administrator shall take
appropriate action under paragraph (5);
``(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 paragraph (5).
``(4) Restrictions.--
``(A) In general.--If the Administrator makes a
determination under paragraph (3)(A) or (C) with
respect to a notice submitted under subsection (a), the
Administrator shall before the end of the applicable
period for review under paragraph (1) and by consent
agreement or order, as appropriate, prohibit or
restrict the manufacture, processing, use, distribution
in commerce, or disposal (as applicable) of the
chemical substance, or of the 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.
``(B) Rulemaking.--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
under subsection (a)(2) that identifies as a
significant new use any manufacturing,
processing, use, distribution in commerce, or
disposal of the chemical substance, or of the
chemical substance for a new use that is not in
compliance with the restrictions imposed by the
consent agreement or order; and
``(ii)(I) initiate such rulemaking; or
``(II) publish a statement of the
Administrator's reasons for not initiating such
action.
``(C) Inclusions.--A prohibition, restriction, or
requirement under subparagraph (A) shall include, as
appropriate, 1 or more of the following requirements:
``(i) A requirement that a chemical
substance or mixture or article containing the
substance be marked with, or accompanied by,
clear and adequate warnings and instructions
with respect to use, distribution in commerce,
or disposal, or any combination of those
activities, with the form and content of the
warnings and instructions to be prescribed by
the Administrator.
``(ii) A requirement that manufacturers or
processors, as applicable, of the chemical
substance or mixture make and retain records of
the processes used to manufacture or process
the chemical substance.
``(iii) A requirement that manufacturers or
processors, as applicable, monitor or conduct
such additional tests as are reasonably
necessary to address potential risks from the
manufacture, processing, distribution in
commerce, use, or disposal of the chemical
substance, subject to section 4.
``(iv) A restriction on the quantity of the
chemical substance or a mixture or article
containing the substance that may be
manufactured, processed, or distributed in
commerce.
``(v) A restriction on the quantity of the
chemical substance or a mixture or article
containing the substance that may be
manufactured, processed, or distributed in
commerce--
``(I) for a particular use; or
``(II) for a particular use in a
concentration in excess of a level
specified by the Administrator in the
consent agreement or order imposing the
requirement.
``(vi) A prohibition or other regulation of
the manufacture, processing, or distribution in
commerce of the chemical substance or a mixture
or article containing the substance for a
significant new use.
``(vii) A prohibition or other regulation
of any manner or method of commercial use of
the chemical substance or a mixture or article
containing the substance.
``(viii) A prohibition or other regulation
of any manner or method of disposal of or
environmental release of the chemical substance
or a mixture or article containing the
substance, by its manufacturer or processor or
by any other person who uses, or disposes of
it, for commercial purposes.
``(ix) A prohibition or other appropriate
restriction or requirement on the manufacture,
processing, or distribution in commerce of the
chemical substance or a mixture or article
containing the substance.
``(x) A prohibition or other appropriate
restriction or requirement on the manufacture,
processing, or distribution in commerce of the
chemical substance or a mixture or article
containing the substance for a particular use.
``(D) Rule of construction.--The requirement,
warning, or instruction required under subparagraph (C)
does not establish a uniform national standard for the
purpose of supplanting, displacing, or preempting State
law.
``(E) Workplace exposures.--The Administrator shall
consult with the Assistant Secretary of Labor for
Occupational Safety and Health prior to adopting any
prohibition or restriction adopted under this
subsection to address workplace exposures.
``(5) Additional information.--If the Administrator
determines under paragraph (3)(C) that additional information
is needed in order to conduct a review under this subsection,
the Administrator--
``(A) shall provide an opportunity for the
submitter of the notice to submit such additional
information;
``(B) may, by agreement with the submitter, extend
the review period for a reasonable time to allow the
development and submission of the additional
information;
``(C) 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) shall, after receiving information the
Administrator finds supports the determination under
paragraph (3), promptly make the determination.
``(6) Regulation pending development of information.--
Subject to paragraph (4)(B), the Administrator may permit
manufacture for commercial purposes to commence pending receipt
of the additional information, subject to compliance with any
restrictions under paragraph (4) determined by the
Administrator to be sufficient to ensure that the chemical
substance is likely to meet the safety standard.
``(7) Commencement of manufacture.--Subject to paragraphs
(4), (5), and (6), at the end of the applicable period for
review under paragraph (1)(A) the submitter of a notice under
subsection (a) may commence manufacture for commercial purposes
a chemical substance, or a chemical substance for a significant
new use.'';
(7) by striking subsections (e) through (g) and inserting
the following:
``(d) Notice of Commencement.--
``(1) In general.--Not later than 30 days after the date on
which a manufacturer or processor that has submitted a notice
under subsection (a) commences nonexempt commercial manufacture
of a chemical substance, the manufacturer or processor shall
submit to the Administrator a notice of commencement that
identifies--
``(A) the name of the manufacturer or processor;
``(B) the initial date of nonexempt commercial
manufacture; and
``(C) additional information specified in section
720.102(c)(1) of title 40, Code of Federal Regulations
(or successor regulations).
``(2) Withdrawal.--A manufacturer or processor that has
submitted a notice under subsection (a), but that has not
commenced nonexempt commercial manufacture or processing of the
chemical substance, may withdraw the notice.
``(e) Further Evaluation.--The Administrator may screen a chemical
substance under section 4A or require testing under section 4 at any
time after the Administrator receives--
``(1) a notice of commencement for a chemical substance
under subsection (d); or
``(2) new information regarding the chemical substance.
``(f) Transparency.--Subject to section 14, the Administrator shall
make available to the public all notices, determinations, consent
agreements, rules and orders of the Administrator issued under this
section.'';
(8) by redesignating subsections (h) and (i) as subsections
(g) and (h), respectively;
(9) in subsection (g) (as so redesignated)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``or (b)'';
(B) by striking paragraph (2);
(C) by redesignating paragraphs (3) through (6) as
paragraphs (2) through (5), respectively;
(D) in paragraph (2) (as so redesignated), by
striking ``subsections (a) and (b)'' and inserting
``subsection (a)'';
(E) in paragraph (3) (as so redesignated), in the
first sentence, by striking ``will not present an
unreasonable risk of injury to health or the
environment'' and inserting ``will meet the safety
standard'';
(F) in paragraph (4) (as so redesignated), by
striking ``subsections (a) and (b)'' and inserting
``subsection (a)''; and
(G) in paragraph (5) (as so redesignated), in the
first sentence, by striking ``paragraph (1) or (5)''
and inserting ``paragraph (1) or (4),''; and
(10) by inserting after subsection (h) (as so redesignated)
the following:
``(i) Prior Actions.--Nothing in this section requires the
Administrator to modify or withdraw any rule or order promulgated under
section 5 of this title prior to the enactment of the Alan Reinstein
and Trevor Schaefer Toxic Chemical Protection Act.''.
SEC. 107. SAFETY ASSESSMENTS AND DETERMINATIONS.
Section 6 (15 U.S.C. 2605) is amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 6. SAFETY ASSESSMENTS AND DETERMINATIONS.'';
(2) by redesignating subsection (b) as subsection (m) and
moving the subsection so as to appear after subsection (l) (as
added by paragraph (6));
(3) in subsection (m) (as so redesignated), by striking
``unreasonable'' each place it appears and inserting
``significant'';
(4) by striking subsections (a), (c) and (d) and inserting
in lieu thereof the following, and by redesignating subsection
(b) as subsection (i):
``(a) In General.--The Administrator--
``(1) shall conduct a safety assessment and make a safety
determination of each high-priority substance designated under
section 4A in accordance with subsections (b) and (c);
``(2) shall, when a safety determination concludes that a
substance does not meet the safety standard, establish
restrictions pursuant to subsection (d);
``(3) shall complete a safety assessment and safety
determination not later than 2 years after the date on which a
substance is designated as a high priority;
``(4) shall promulgate a final rule pursuant to subsection
(d) not later than 2 years after the date on which the safety
determination is completed; and
``(5) may extend any deadline under this subsection for a
reasonable period of time after an adequate public
justification, subject to the condition that the aggregate
length of all extensions of deadlines under paragraphs (3) and
(4) of this subsection and any deferrals under subsection
(c)(2) does not exceed 2 years.
``(b) Safety Assessments and Determinations.--
``(1) In general.--The Administrator shall conduct a risk-
based safety assessment and make a risk-based safety
determination of each high-priority substance.
``(2) Already initiated assessments.--
``(A) In general.--Nothing in this Act prevents the
Administrator from initiating safety assessments and
safety determinations of chemical substances, or from
continuing or completing safety assessments and safety
determinations initiated prior to the date of enactment
of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act, prior to the date on which the
policies and procedures the Administrator is directed
to establish under section 3A and 4A are effective.
``(B) Integration.--As policies and procedures
under section 3A and 4A are established, the
Administrator shall integrate them into ongoing
assessments and determinations to the maximum extent
practicable.
``(3) 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 merely because such action was completed
prior to the completion of a policy or procedure established
under section 3A or 4A, and the validity of such assessment,
determination, or rule shall not be determined based on the
content of such policy or procedure.
``(c) Safety Determinations.--
``(1) In general.--Based on a review of the information
before the Administrator, including draft safety assessments,
if any, submitted by interested persons, the Administrator
shall determine that--
``(A) the relevant chemical substance meets the
safety standard;
``(B) the relevant chemical substance does not meet
the safety standard, in which case the Administrator
shall by rule under subsection (d) impose restrictions
necessary to assure that the substance meets the safety
standard under the intended or reasonably foreseeable
conditions of use, or, where the safety standard cannot
be met with the application of restrictions, to ban or
phase out the substance, as appropriate; or
``(C) additional information is necessary in order
to make a safety 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 needed in order to
carry out a safety assessment and 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 that
complies with the deadlines in subsection (a), a safety
assessment and determination until after receipt of the
information; and
``(D) in compliance with the deadlines in
subsection (a), shall, upon receipt of information the
Administrator finds supports the assessment and
determination, make a determination under paragraph
(1).
``(3) Deadline for submission of information.--When
requesting the development or submission of information under
this section the Administrator shall establish a deadline for
the submission of such information, which deadline shall be of
reasonable duration and shall comply with the deadlines under
subsection (a).
``(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 rule promulgated under this subsection--
``(A) may--
``(i) apply to a mixture or article
containing the chemical substance, as
appropriate; and
``(ii) exempt a replacement part
manufactured prior to the applicable compliance
deadline; and
``(B) shall include dates by which compliance is
mandatory, which shall be as soon as feasible and may
vary for different affected persons, as the
Administrator determines to be appropriate, but which
shall be no later than 2 years after the date on which
the rule is promulgated.
``(3) Workplace exposures.--The Administrator shall consult
with the Assistant Secretary of Labor for Occupational Safety
and Health prior to adopting any prohibition or restriction
adopted under this subsection to address workplace exposures.
``(4) Restrictions.--A restriction under paragraph (1)
shall include, as appropriate, 1 or more of the following
requirements:
``(A) A requirement that a chemical substance or a
mixture or article containing the substance be marked
with, or accompanied by, clear and adequate warnings
and instructions with respect to use, distribution in
commerce, or disposal, or any combination of those
activities, with the form and content of the warnings
and instructions to be prescribed by the Administrator.
``(B) A requirement that manufacturers and
processors of the chemical substance or a mixture or
article containing the substance--
``(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;
and
``(iii) monitor or conduct tests which are
reasonably necessary to assure compliance with
the requirements of any rule under this
subsection.
``(C) A restriction on the quantity of the chemical
substance or a mixture or article containing the
substance that may be manufactured, processed, or
distributed in commerce.
``(D) A requirement to ban or phase out or other
regulation on the manufacture, processing, distribution
in commerce, use, or disposal of the chemical substance
or a mixture or article containing the substance--
``(i) for a particular use;
``(ii) for a particular use at a
concentration in excess of a level specified by
the Administrator; or
``(iii) for all uses.
``(E) A restriction on the quantity of the chemical
substance or mixture or article containing the
substance that may be manufactured, processed, or
distributed in commerce--
``(i) for a particular use; or
``(ii) for a particular use at a
concentration in excess of a level specified by
the Administrator.
``(F) A requirement to restrict, ban, or phase out
or other regulation of any manner or method of
commercial use or environmental release of the chemical
substance or mixture or article containing the
substance.
``(G) A requirement to restrict, ban, or phase out
or other regulation of any manner or method of disposal
of the chemical substance or any mixture or article
containing the chemical substance, by its manufacturer
or processor or by any person who uses, or disposes of
it, for commercial purposes, provided that such a
requirement may not require any person to take any
action that would be in violation of any law or
requirement of, or in effect for, a State or political
subdivision, and that such a requirement shall require
each person subject to the requirement to notify each
State and political subdivision in which a required
disposal may occur of such disposal.
``(H) A requirement directing manufacturers or
processors of the chemical substance or mixture or
article containing the substance to give notice of
significant risks of harm (without taking into
consideration cost or other non-risk factors) 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 or mixture, and to give public
notice of such significant risks of harm.
``(5) Rule of construction.--The requirement, warning, or
instruction, under paragraph (4) does not establish a uniform
national standard for the purpose of supplanting, displacing,
or preempting State law.
``(6) Analysis for rulemaking.--
``(A) In general.--Where the Administrator
determines that a rule under paragraph (1) is likely to
have an annual effect on the economy of more than
$100,000,000, then when deciding which restrictions to
impose under paragraph (3) as part of developing a rule
under paragraph (1) to ensure that a chemical substance
meets the safety standard, the Administrator shall
consider, to the extent practicable based on reasonably
available information, the quantifiable and non-
quantifiable costs and benefits of the proposed
regulatory action and of the primary alternative
regulatory action or actions that the Administrator
determines will ensure that the substance meets the
safety standard. As part of the analysis, the
Administrator shall review such technically and
economically feasible alternative or alternatives to
the chemical substance that the Administrator
determines are relevant to the rulemaking.
``(B) Public disclosure of analysis.--When
proposing a rule under paragraph (1), the Administrator
shall make publicly available any analysis conducted
under subparagraph (A).
``(C) Consideration of analysis.--When 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.
``(7) Exemptions.--
``(A) In general.--The Administrator, as part of a
rulemaking under this subsection--
``(i) may exempt a use of a chemical
substance from any restriction in a rule
promulgated under paragraph (1) if the
Administrator determines, based on reasonably
available information, that the rule cannot be
complied with without--
``(I) harming national security;
``(II) causing significant
disruption in the national economy due
to the lack of availability of a
chemical substance for the exempted
use; or
``(III) interfering with a critical
or essential use for which no
technically and economically feasible
safer alternative is available,
considering hazard and exposure; and
``(ii) may exempt a particular use of a
chemical substance from a restriction in a rule
issued under paragraph (1) if available
information demonstrates that the risks to
health or the environment from continued use of
the substance are substantially lower than the
risks to health or the environment of replacing
that use of the substance with reasonably
available alternatives.
``(B) Exemption analysis.--When proposing a rule
under paragraph (1) that includes an exemption under
this paragraph, the Administrator shall make publicly
available any analysis conducted under this paragraph
to assess the need for such exemption.
``(C) Consideration of analysis.--When making final
a rule under paragraph (1) that includes an exemption
under this paragraph, the Administrator shall include a
statement describing how the analysis was taken into
account.
``(D) Conditions.--As part of a rule issued under
paragraph (1), the Administrator shall include
conditions in any exemption established under this
paragraph, including reasonable recordkeeping,
monitoring, and reporting requirements, to the extent
that the Administrator determines the conditions are
necessary to protect human health and the environment
while achieving the purposes of the exemption.
``(E) Duration.--
``(i) In general.--The Administrator shall,
as part of a rule under paragraph (1) that
contains an exemption under this paragraph, set
a time limit on any exemption not to exceed 5
years.
``(ii) Extension.--The Administrator may,
by rule, extend, modify, or eliminate the
exemption when 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) Consideration for extension.--The
Administrator shall issue exemptions and
establish time periods under this subparagraph
by considering factors determined by the
Administrator as relevant to the goals of
fostering innovation and the development of
alternatives that meet the safety standard.
``(iv) Exception for rule requiring ban or
phase out.--Any renewal of an exemption in the
case of a rule requiring the ban or phase out
of a chemical substance shall not exceed 5
years.
``(e) Immediate Effect.--The Administrator may declare a proposed
rule under subsection (d) of this section to be effective upon
publication of the proposed rule in the Federal Register and until the
effective date of a final action taken respecting such 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 such proposed rule or any
combination of such activities is likely to result in a
significant risk of serious or widespread injury
(without taking into consideration cost or other non-
risk factors) to health or the environment before such
effective date; and
``(B) making the proposed rule effective is
necessary to protect the public interest; and
``(2) in the case of a proposed rule to prohibit the
manufacture, processing, or distribution of a chemical
substance or mixture because of the risk determined under
paragraph (1)(A), a court has in an action under section 7 of
this title granted relief with respect to the risk associated
with the substance or mixture.
``(f) Expedited Action on PBTs.--
``(1) List of pbts.--In addition to carrying out section
4A, not later than 180 days after the date of enactment of the
Alan Reinstein and Trevor Schaefer Toxic Chemical Protection
Act, the Administrator shall publish a list of chemical
substances that the Administrator determines are persistent,
bio-accumulative, and toxic and have the potential for high or
widespread exposure (referred to in this subsection as `PBTs').
``(2) Use and exposure assessment.--
``(A) In general.--Not later than 60 days after
publishing the PBT list required under paragraph (1),
the Administrator shall require by order the submission
by manufacturers or processors of chemical substances
included in the list of any additional information the
Administrator determines to be necessary to conduct an
expedited assessment of the intended, known, or
reasonably foreseeable uses of, and exposures to, such
chemical substances.
``(B) Publication.--Not later than 1 year after
receiving the information which manufacturers and
processors are required to submit under subparagraph
(A), the Administrator shall complete and publish an
identification and assessment of the intended or
reasonably foreseeable conditions of use of, and
exposures to, substances on the PBT list.
``(3) Exposure reduction.--
``(A) Rule.--As soon as practicable, but not later
than 2 years after the date on which the Administrator
completes the use and exposure assessment required
under paragraph (2), the Administrator shall impose, by
rule, restrictions that the Administrator determines to
be necessary to achieve the maximum practicable
reduction in human or environmental exposure to
chemical substances included in the PBT list.
``(B) Contents of rules.--A rule promulgated under
subparagraph (A) may include any of the restrictions on
manufacturing, processing, use, distribution in
commerce, and disposal described in subsection (d)(4)
which the Administrator determines are necessary to
achieve maximum practicable reduction in exposure to
the listed PBT substance.
``(C) Effective date.--A rule promulgated under
subparagraph (A) shall include an effective date in
accordance with subsection (d)(2)(B) and may be made
effective upon publication of a proposed rule in
accordance with subsection (f).
``(4) Exemptions.--
``(A) Scope and basis.--A rule imposing a
restriction on a listed PBT substance in accordance
with subparagraph (3) may exempt a use of the substance
from such restriction upon a showing satisfactory to
the Administrator that the use meets the exemption
criteria in subsection (d)(7).
``(B) Conditions.--The Administrator shall include
conditions in any exemption established under this
paragraph, including reasonable recordkeeping,
monitoring, and reporting requirements, to the extent
necessary to protect health or the environment while
achieving the purposes of the exemption.
``(C) Duration.--An exemption established under
this paragraph shall be in effect for a period
determined by the Administrator but not to exceed 5
years and, after public notice and an opportunity for
comment, may be renewed by the Administrator for 1 or
more periods not exceeding a total of 5 years by order
following submission of an application justifying the
continuing need for the exemption and containing such
information as the Administrator may require.
``(g) Report on Public Buildings.--Not later than 6 months after
the date of enactment of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act, the Administrator shall submit to Congress a
report on how data on exposure in public buildings will be gathered to
carry out subsection (f) and on what testing is necessary to protect
the public from exposures to chemical substances identified under
subsection (f) in public buildings.
``(h) Final Agency Action.--Under this section--
``(1) a safety determination, together with the associated
safety assessment, for a substance that the Administrator
determines under subsection (c) meets the safety standard,
shall be considered to be a final agency action on the date of
the final safety determination; and
``(2) a final rule promulgated under subsection (d),
together with the associated safety assessment and safety
determination that a substance does not meet the safety
standard, shall be considered to be final agency action on the
date of promulgation of the final rule.'';
(5) by redesignating subsections (e) and (f) as subsections
(i) and (j), respectively; and
(6) in subsection (i) (as so redesignated)--
(A) by striking paragraph (4); and
(B) by redesignating paragraph (5) as paragraph
(4); and
(7) by inserting after subsection (j) (as so redesignated)
the following:
``(k) Prior Actions.--Nothing in this section shall be construed as
requiring the Administrator to modify or withdraw any rule or order
promulgated under section 6 of this title promulgated prior to the
enactment of the Alan Reinstein and Trevor Schaefer Toxic Chemical
Protection Act.''.
``(l) Asbestos.--
``(1) Listing.--The Administrator shall include all forms
of asbestos as 1 high-priority chemical substance under section
4A(a)(2) in accordance with section 4A(a)(4).
``(2) Schedule.--Notwithstanding paragraphs (3), (4) and
(5) of subsection (a), the Administrator shall--
``(A) complete a safety assessment and safety
determination of all forms of asbestos not later than 2
years after the date of enactment of the Alan Reinstein
and Trevor Schaefer Toxic Chemical Protection Act; and
``(B) promulgate a final rule not later than 3
years after the date of enactment of that Act.''.
SEC. 108. IMMINENT HAZARDS.
Section 7 (15 U.S.C. 2606) is amended--
(1) by striking subsection (a) and inserting the following:
``(a) Civil Actions.--
``(1) In general.--The Administrator may commence a civil
action in an appropriate district court of the United States
for--
``(A) seizure of an imminently hazardous chemical
substance or mixture or any article containing the
substance or mixture;
``(B) relief (as authorized by subsection (b))
against any person who manufactures, processes,
distributes in commerce, uses, or disposes of an
imminently hazardous chemical substance or mixture or
any article containing the substance or mixture; or
``(C) both seizure described in subparagraph (A)
and relief described in subparagraph (B).
``(2) Rule, order, or other proceeding.--A civil action may
be commenced under this subsection notwithstanding--
``(A) the existence of--
``(i) a decision by the Administrator under
section 4, 5(c)(6), 6(c)(2) or 6(h); or
``(ii) a rule, testing consent agreement,
or order under section 4(d), 5(c)(4), 6(d), or
title IV; 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. 109. INFORMATION COLLECTION AND REPORTING.
Section 8 (15 U.S.C. 2607) is amended--
(1) in subsection (a), by adding at the end the following:
``(4) Regulations.--
``(A) Deadline.--
``(i) In general.--Not later than 2 years
after the date of enactment of the Alan
Reinstein and Trevor Schaefer Toxic Chemical
Protection Act, the Administrator shall
promulgate rules requiring the maintenance of
records and the reporting of information known
by, or reasonably ascertainable by, the person
making the report, including rules requiring
processors to report information, so that the
Administrator has the information necessary to
carry out sections 4 and 6.
``(ii) Prior regulations.--In carrying out
this subparagraph, the Administrator may
modify, as appropriate, the regulations
promulgated prior to the date of enactment of
the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act.
``(B) Contents.--The rules promulgated under
subparagraph (A)--
``(i) may impose different reporting and
record retention requirements on manufacturers
and processors;
``(ii) shall include the level of detail
necessary to be reported, including the manner
by which use and exposure information may be
reported; and
``(iii) shall require reporting of
information or maintenance of records where the
Administrator determines the submission of
reports would assist in the effective
implementation of this Act.
``(C) Administration.--In implementing this
paragraph, the Administrator shall take measures to--
``(i) limit the potential for duplication
in reporting requirements;
``(ii) minimize the impact of the rules on
small manufacturers and processors; and
``(iii) apply any reporting requirements to
those persons likely to have information
relevant to the effective implementation of
this title.
``(5) Guidance.--The Administrator shall develop guidance
relating to the information required to be reported under a
rule promulgated under this subsection.'';
(2) in subsection (b), by adding at the end the following:
``(3) Chemical substances in commerce.--
``(A) Rule.--
``(i) In general.--Not later than 1 year
after the date of enactment of the Alan
Reinstein and Trevor Schaefer Toxic Chemical
Protection Act, the Administrator shall by rule
require manufacturers and processors to notify
the Administrator, 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 prior to the date of
enactment of the Alan Reinstein and Trevor
Schaefer Toxic Chemical Protection Act.
``(ii) Consideration as active substance.--
The Administrator shall consider chemical
substances for which notices are received under
clause (i) to be active substances and shall,
pursuant to paragraph (4)(C), designate the
chemical substance as an active substance on
the list published under paragraph (1).
``(B) Confidential chemical substances.--
``(i) In general.--The Administrator shall
maintain the list under paragraph (1), which
shall include a confidential portion and a
nonconfidential portion consistent with this
section and section 14.
``(ii) Existing claim of confidentiality.--
The rule promulgated under subparagraph (A)
shall 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.
``(iii) Substantiation.--The rule
promulgated under subparagraph (A) shall
require the substantiation of a claim described
in clause (ii) pursuant to section 14 and in
accordance with the review plan described in
subparagraph (C).
``(C) Review plan and requirements.--
``(i) In general.--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 develop a plan to review all claims to
protect the specific identity of a chemical
substance on the confidential portion of the
list published under paragraph (1) that is
identified as an active substance in a report
submitted pursuant to subparagraph (A) or
identified as active substances under paragraph
(4)(A).
``(ii) Contents.--The plan shall describe
how the Administrator will carry out the
requirements of this subparagraph.
``(iii) Requirements.--The Administrator
shall--
``(I) require, at a time determined
by the Administrator, all manufacturers
or processors asserting a claim under
subparagraph (B) to substantiate each
such claim unless the manufacturer or
processor has substantiated the claim
in a submission made to the
Administrator within 5 years of the
date of the Administrator's request;
``(II) in accordance with the
requirements of section 14--
``(aa) review each
substantiation--
``(AA) submitted
pursuant to subclause
(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 subclause
(I), if such
substantiation has not
been previously
reviewed by the
Administrator, to
determine if the claim
warrants protection
from disclosure;
``(bb) approve, modify or
deny each claim; and
``(cc) 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--
``(AA) prior to the
expiration of the
period, the person
notifies the
Administrator that the
person is withdrawing
the confidentiality
claim, in which case,
the Administrator shall
promptly make the
information available
to the public; or
``(BB) prior to the
expiration of the
period, the
Administrator otherwise
becomes aware that the
need for protection
from disclosure can no
longer be
substantiated, in which
case the Administrator
shall take the actions
described in subsection
(g)(2); and
``(III) encourage manufacturers and
processors that have previously made
claims to protect the specific
identities of chemical substances
identified as inactive pursuant to
paragraph (4)(B) to review and either
withdraw or substantiate such claims.
``(D) Timeline for completion of reviews.--
``(i) In general.--The Administrator shall
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) Extension.--The Administrator may
extend the deadline for completion of the
reviews described in subparagraph (C) for up to
a maximum of 2 additional years, after an
adequate public justification, if the
Administrator finds the extension is necessary
based on the number of such claims needing
review and the available resources.
``(iii) Annual goal.--The Administrator
shall publish an annual goal for the number of
reviews to be completed over the course of
implementation of the plan.
``(E) No confidentiality for unlisted chemicals.--
The specific identity of any chemical that is not on
the confidential portion of the list published under
paragraph (1) or subsequently added to the confidential
portion of the list pursuant to section 14 shall not be
eligible for protection from disclosure.
``(F) Certification.--The Administrator shall
require a manufacturer or processor--
``(i) to certify the accuracy of each
report submitted or record maintained under
this section; and
``(ii) to retain documentation supporting
certification under clause (i) for a period of
5 years beginning on the last day of the
submission period.
``(4) Active and inactive substances.--
``(A) Active substances.--For the purposes of this
section, the term `active substance' means a chemical
substance that--
``(i) has been manufactured or processed
for a nonexempt commercial purpose at any point
during the 10-year period prior to the date of
enactment of the Alan Reinstein and Trevor
Schaefer Toxic Chemical Protection Act; or
``(ii) that is added to the list published
under paragraph (1) after the date of enactment
of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act.
``(B) Inactive substances.--For purposes of this
section, the term `inactive substance' means a chemical
substance on the list published under paragraph (1)
that does not meet any of the criteria in subparagraph
(A).
``(C) List of designations.--The Administrator
shall maintain and keep current designations of active
and inactive substances on the list published under
paragraph (1).
``(D) Update.--The Administrator shall update the
list of chemicals designated as active as soon as
practicable following the publication of the most
recent data reported under part 711 of title 40, Code
of Federal Regulations, and the rule promulgated under
subsection (a)(4).
``(E) Change to active status.--
``(i) In general.--Any person who intends
to manufacture or process for a nonexempt
commercial purpose a chemical substance that is
designated as an inactive substance shall
notify the Administrator not less than 90 days
before the date on which the substance is
manufactured or processed.
``(ii) Confidential chemical identity
claims.--
``(I) In general.--If a person
submitting a notice under clause (i)
for an inactive chemical 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 substance as
confidential, the person shall--
``(aa) in the notice
submitted under clause (i),
assert the claim; and
``(bb) substantiate the
claim.
``(II) No confidentiality for
unlisted chemicals.--The specific
identity of any inactive chemical that
is not on the confidential portion of
the list published under paragraph (1)
or subsequently added to the
confidential portion of the list
pursuant to section 14 shall not be
eligible for protection from
disclosure.
``(iii) Active status.--After receiving
notification under clause (i), the
Administrator shall--
``(I) designate the 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 substance and approve,
modify, or deny the claim;
``(III) except as provided in this
section and section 14, protect from
disclosure information for which the
Administrator approves a claim under
subclause (II) for a period of 10 years
unless--
``(aa) prior to the
expiration of the 10-year
period, the person notifies the
Administrator that the person
is withdrawing the
confidentiality claim, in which
case, the Administrator shall
promptly make the information
available to the public; or
``(bb) prior to the
expiration of the 10-year
period, the Administrator
otherwise becomes aware that
the need for protection from
disclosure can no longer be
substantiated, in which case
the Administrator shall take
the actions described in
subsection (g)(2); and
``(IV) pursuant to section 4A,
review the priority of the chemical
substance as the Administrator
determines necessary.
``(F) Category status.--The list of inactive
chemical substances shall not be considered a category
for purposes of section 26(c).
``(5) Interim list of active substances.--Prior to the
promulgation of the rule required under this subsection, the
Administrator shall designate those substances reported under
part 711 of title 40, Code of Federal Regulations, during the
reporting period that most closely preceded the date of
enactment of the Alan Reinstein and Trevor Schaefer Toxic
Chemical Protection Act, as the initial list of active
substances for the purposes of section 4A.
``(6) Public participation.--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 an active substance;
``(B) the specific identity of each chemical
substance on the nonconfidential portion of the list
published under paragraph (1) that the Administrator
has designated as an inactive substance;
``(C) the accession number, generic name, and, if
applicable, premanufacture notice case number for each
chemical substance on the confidential portion of the
list published under paragraph (1) for which a claim of
confidentiality was received and approved by the
Administrator pursuant to section 14;
``(D) subject to section 14, the specific identity
of any active substance--
``(i) for which no claim of protection
against disclosure of the specific identity
pursuant to this subsection was received;
``(ii) for which a claim for protection
against disclosure of the specific identity of
the substance has been denied by the
Administrator; or
``(iii) for which the time period for
protection against disclosure of the specific
identity of the substance has expired; and
``(E) any substance previously classified as an
inactive substance that has been reclassified as an
active substance.''; and
(3) in subsection (e)--
(A) by striking ``Any person'' and inserting the
following:
``(1) In general.--Any person''; and
(B) by adding at the end the following:
``(2) Applicability.--Any person may submit to the
Administrator 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.''.
SEC. 110. RELATIONSHIP TO OTHER FEDERAL LAWS.
Section 9 (15 U.S.C. 2608) is amended--
(1) in subsection (a)--
(A) in the first sentence of paragraph (1)--
(i) by striking ``presents or will present
an unreasonable risk to health or the
environment'' and inserting ``does not meet the
safety standard''; and
(ii) by striking ``such risk'' the first
place it appears and inserting ``the risk posed
by the substance or mixture'';
(B) in paragraph (2), in the matter following
subparagraph (B), by striking ``section 6 or 7'' and
inserting ``subsections (b) or (c) of section 6, or
section 7''; and
(C) in paragraph (3), by striking ``section 6 or
7'' and inserting ``section 6(d) or section 7''; and
(2) in subsection (d), in the first sentence, by striking
``Health, Education, and Welfare'' and inserting ``Health and
Human Services''.
SEC. 111. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION, AND
UTILIZATION OF DATA.
Section 10 (15 U.S.C. 2609) is amended by striking ``Health,
Education, and Welfare'' each place it appears and inserting ``Health
and Human Services''.
SEC. 112. EXPORTS.
Section 12 (15 U.S.C. 2611) is amended--
(1) in subsection (a), by striking paragraph (2) and
inserting the following:
``(2) Exception.--Paragraph (1) shall not apply to any
chemical substance, mixture, or article that the Administrator
determines--
``(A) under section 5 is not likely to meet the
safety standard; or
``(B) under section 6 does not meet the safety
standard.
``(3) Waivers.--For a mixture or article containing a
chemical substance described in paragraph (2), the
Administrator may--
``(A) determine that paragraph (1) shall not apply
to the mixture or article if the Administrator finds
that the chemical substance as contained in the mixture
or article will meet the safety standard; and
``(B) establish a threshold concentration of the
chemical substance in a mixture or article at which
paragraph (1) shall not apply if the Administrator
finds that at or below this concentration the substance
as contained in the article or mixture will meet the
safety standard.
``(4) Testing.--The Administrator may require testing under
section 4 of any chemical substance or mixture exempted from
this Act by paragraph (1) for the purpose of determining
whether or not the substance or mixture meets the safety
standard within the United States.'';
(2) by striking subsection (b) and inserting the following:
``(b) Notice.--
``(1) In general.--A person shall notify the Administrator
that the person is exporting or intends to export to a foreign
country--
``(A) a chemical substance or a mixture containing
a chemical substance that the Administrator has
determined under section 5 is not likely to meet the
safety standard and for which a notification,
prohibition, or 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 notification, prohibition, or
restriction has been proposed or established under that
section;
``(C) a chemical substance for which the United
States is obligated by treaty to provide export
notification;
``(D) a chemical substance or mixture subject to a
prohibition or 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 containing a
chemical substance with respect to which an action is
pending, or relief has been granted under section 7.
``(2) Regulations.--
``(A) In general.--The Administrator shall
promulgate regulations to carry out paragraph (1).
``(B) Contents.--The regulations promulgated under
subparagraph (A) shall include any exemptions the
Administrator determines to be appropriate, which may
include exemptions identified under section 5(g).
``(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 paragraph (1)(E), a notice of availability of the
information on the chemical substance or mixture
submitted to the Administrator;
``(B) for a chemical substance or mixture described
in subparagraph (A), (B) or (D) of paragraph (1), a
notice of the determination, rule, order, consent
agreement, requirement, designation, action, or relief;
and
``(C) for a chemical substance described in
paragraph (1)(C), a notice that satisfies the
obligation of the United States under the applicable
treaty.''; and
(3) in subsection (c)--
(A) by striking paragraph (3); and
(B) by redesignating paragraphs (4) through (6) as
paragraphs (3) through (5), respectively.
SEC. 113. IMPORTS.
Section 13 (15 U.S.C. 2612) is amended to read as follows:
``SEC. 13. IMPORTS.
``(a) Refusal of Entry.--
``(1) In general.--The Secretary of Homeland Security shall
refuse entry into the customs territory of the United States
(as defined in general note 2 to the Harmonized Tariff Schedule
of the United States) any chemical substance, mixture, or
article containing a chemical substance or mixture offered for
entry if--
``(A) the Administrator--
``(i) has determined under section 6(c)
that the chemical substance, mixture or article
does not meet the safety standard; and
``(ii) has promulgated a rule under section
6(d) banning the chemical substance, mixture,
or article, as of the effective date of the
rule;
``(B) the chemical substance--
``(i) is not included on the list under
section 8(b)(1); and
``(ii) is not exempt from any requirement
to be included on the list under section
8(b)(1) by this title or a rule issued by the
Administrator under this title; or
``(C) the chemical substance, mixture, or any
article containing the chemical substance or mixture
fails to comply with any requirement in effect under
this Act or is offered for entry in violation of a
rule, consent agreement, or order in effect under this
Act or an order issued in a civil action brought under
section 7 or title IV.
``(2) Procedure.--
``(A) In general.--Subject to subparagraph (B), if
a chemical substance, mixture, or article containing a
chemical substance or mixture is refused entry under
paragraph (1), the Secretary of Homeland Security--
``(i) shall notify the consignee of the
entry of the refusal;
``(ii) shall not release the chemical
substance or mixture to the consignee; and
``(iii) shall cause the disposal or storage
of the chemical substance or mixture under such
rules as the Secretary may prescribe, if the
chemical substance or mixture has not been
exported by the consignee in the 90-day period
beginning on the date of receipt of the notice
of the refused entry.
``(B) Exception.--
``(i) In general.--The Secretary of
Homeland Security may, pending a review by the
Administrator, release to the consignee the
chemical substance or mixture if the
consignee--
``(I) executes a bond for the
amount of the full invoice of the
chemical substance or mixture (as set
forth in the customs entry); and
``(II) pays a duty on the chemical
substance or mixture.
``(ii) Administration.--If a consignee
fails to return a chemical substance or mixture
released to that consignee under clause (i) for
any cause to the custody of the Secretary of
Homeland Security when demanded, the consignee
shall be liable to the United States for
liquidated damages equal to the full amount of
the bond.
``(C) Storage.--All charges for storage, cartage,
and labor on and for the disposal of a chemical
substance or mixture that is refused entry or released
under this subsection shall be paid by the owner or
consignee, and a default on that payment shall
constitute a lien against any future entry made by the
owner or consignee.
``(b) Certification.--
``(1) In general.--A person offering a chemical substance
or mixture subject to this Act for entry into the customs
territory of the United States shall certify to the Secretary
of Homeland Security that the chemical substance or mixture is
in compliance with any applicable rule, consent agreement, or
order under section 5 or 6, and that the chemical substance--
``(A) is included on the list under section
8(b)(1); or
``(B) is exempt from any requirement to be included
on the list under section 8(b)(1) by this title or a
rule issued by the Administrator under this title.
``(2) Articles.--The Administrator may, by rule, require
certification under paragraph (1) for an article containing a
chemical substance or mixture that is subject to regulation
under section 5 or 6.
``(3) Content of certification rule.--In determining the
need for and content of a certification rule under this
subsection, the Administrator may consider--
``(A) the utility of such certification to the
enforcement of the applicable rule, consent agreement,
or order under section 5 or 6;
``(B) the frequency of the certification
requirement; and
``(C) if applicable, specification of the
concentration of a chemical substance in an article
that would subject the article to the certification
requirement.
``(4) Public information.--For purposes of this section,
the Administrator shall provide publicly accessible information
on the identity of a chemical substance or mixture subject to
regulation under this Act that would be readily understood in
import transactions.
``(c) Notice.--A person offering a chemical substance for entry
into the customs territory of the United States shall notify the
Secretary of Homeland Security if--
``(1) the chemical substance or chemical substance in a
mixture is a high-priority substance;
``(2) the chemical substance or chemical substance in a
mixture is one for which the United States is obligated to
provide export notification by treaty; or
``(3) the chemical substance or chemical substance in a
mixture is the subject of a safety assessment and safety
determination conducted pursuant to section 6(d) and has been
found not to meet the safety standard.
``(d) Rules.--
``(1) In general.--The Secretary of Homeland Security,
after consultation with the Administrator, shall issue rules
for the administration of this section.
``(2) Content.--A rule issued under paragraph (1) may
tailor the application of any requirement in this section, as
appropriate for the efficient and effective implementation of
this Act.''.
SEC. 114. CONFIDENTIAL INFORMATION.
Section 14 (15 U.S.C. 2613) is amended--
(1) by striking the heading ``disclosure of data'' and
inserting ``confidential information'';
(2) by striking subsection (c) and redesignating subsection
(b) as subsection (c);
(3) by striking subsection (a) and inserting the following:
``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 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.--
``(1) In general.--The information described in paragraph
(2) specific to and submitted by a manufacturer, processor, or
distributor that meets the requirements of subsection (d) shall
be protected from disclosure, except that--
``(A) such information may be disclosed in
accordance with subsection (e);
``(B) such information is subject to the review and
substantiation requirements in subsection (f)(2); and
``(C) nothing in this Act shall operate to prohibit
the disclosure of such information through discovery,
subpoena, other court orders, or any other judicial
process otherwise allowed under applicable State or
Federal laws.
``(2) Protected information.--Information subject to
paragraph (1) shall include--
``(A) specific information describing the processes
used in manufacture or processing of a chemical
substance, mixture, or article;
``(B) marketing and sales plans and strategies;
``(C) information identifying suppliers or
customers;
``(D) the percentages of the components of a
mixture;
``(E) specific information about the use, function,
or application of a chemical substance or mixture in a
process, mixture, or product;
``(F) specific production or import volumes of the
manufacturer, and specific aggregated volumes across
manufacturers if the Administrator determines that
disclosure of the specific aggregated volumes would
reveal confidential information; and
``(G) except as otherwise provided in this section,
the specific identity of a chemical substance prior to
the date on which it was included on the list under
section 8(b)(1), including the chemical name, molecular
formula, Chemical Abstracts Service number, and other
information that would identify a specific chemical
substance, if--
``(i) the specific identity was claimed as
confidential information at the time it was
submitted to the Administrator in a notice
under section 5;
``(ii) the claim has not subsequently been
withdrawn or found by the Administrator not to
warrant protection as confidential information
under subsection (e), (f)(2), or (g); and
``(iii) the substance is not an active
substance under section 8(b)(4) of this Act.'';
(4) by striking the heading ``Data From Health and Safety
Studies'' in subsection (c) (as so redesignated) and inserting
``Information Not Protected From Disclosure.--Notwithstanding
subsections (a) and (b), the following information shall not be
protected from disclosure:'';
(5) by inserting at the end of subsection (c) (as so
redesignated) the following:
``(3) Other information not protected from disclosure.--
Information shall not be protected from disclosure under this
section if it is--
``(A) for information submitted after the date of
enactment of the Alan Reinstein and Trevor Schaefer
Toxic Chemical Protection Act, the specific identity of
a chemical substance as of the date on which it is
included on the list under section 8(b)(1), if the
person submitting the information does not meet the
requirements of subsection (d);
``(B) a safety assessment developed or a safety
determination made under section 6;
``(C) general information describing the
manufacturing volumes, expressed as specific aggregated
volumes or, when the Administrator determines that
disclosure of specific aggregated volumes would reveal
confidential information, expressed in ranges; or
``(D) general descriptions of the processes used in
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 would be customarily shared
with the general public or within an industry or
industry sector.
``(4) Exception.--Information elements that are otherwise
eligible for protection under this section that are contained
in submissions of information described in paragraph (1) shall
be protected from disclosure if the submitter complies with
subsection (d), but information in such submissions described
in paragraph (1) that is not eligible for protection against
disclosure shall be disclosed.
``(5) No confidentiality for unlisted chemicals.--Except as
provided in the second sentence of paragraph (1), the specific
identity of any chemical that is not on the confidential
portion of the list published under section 8(b)(1) or
subsequently added to the confidential portion of the list
pursuant to this section shall not be eligible for protection
from disclosure.
``(6) Ban or phase-out.--If the Administrator promulgates a
rule pursuant to section 6(d) that establishes a ban or phase
out on the manufacture, processing, or distribution in commerce
of a chemical substance, any protection from disclosure
provided under section 14 applicable for information on the
chemical substance shall no longer apply and the Administrator
shall promptly make the information public.
``(d) Requirements for Confidentiality Claims.--
``(1) Assertion of claims.--
``(A) In general.--A person seeking to protect any
information submitted under this Act from disclosure
(including information described in subsection (b))
shall assert a claim for such protection to the
Administrator at the time of the submission of the
information, pursuant to rules applicable to a claim
for protection from disclosure that the Administrator
has promulgated under this title.
``(B) Contents of claim.--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 in connection with 1 or more uses
subject to this Act;
``(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 otherwise
publicly available or 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 conditions
that--
``(i) the generic name conforms with
guidance prescribed by the Administrator under
paragraph (3)(A); and
``(ii) describes the chemical structure of
the substance as specifically as possible while
protecting those features of the chemical
structure that are considered confidential and
the disclosure of which would potentially harm
the competitive position of the person.
``(2) Additional requirements for confidentiality claims.--
Except for information described in subsection (b)(2), a person
asserting a claim to protect information from disclosure under
this Act shall, in accordance with the rules promulgated and
guidance issued by the Administrator, substantiate that the
information meets the requirements for protection pursuant to
section 552 of title 5, United States Code, under subsection
(b)(4) of that section.
``(3) Guidance.--The Administrator shall develop guidance
on--
``(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 the person
described in paragraph (1)(A) shall certify that the statements
and information included in assertions and substantiations of
claims for protection submitted under this subsection are true
and correct.
``(e) Exceptions to Protection From Disclosure.--Information
described in subsection (a) (including information subject to
subsection (b)) shall be disclosed if--
``(1) the information is to be disclosed to an officer or
employee of the United States in connection with the official
duties of that person under any law for the protection of human
health or the environment or for specific law enforcement
purposes;
``(2) the information is to be disclosed to a contractor
with the United States and employees of that contractor if, in
the opinion of the Administrator, the disclosure is necessary
for the satisfactory performance by the contractor of a
contract with the United States for the performance of work in
connection with this Act and under such conditions as the
Administrator shall specify;
``(3) the Administrator determines that disclosure is
necessary to protect human health or the environment;
``(4) the information is to be disclosed to a State or
political subdivision of a State, on written request, for the
purpose of development, administration, or enforcement of a
law, if--
``(A) 1 or more applicable agreements with the
Administrator that conform with the guidance issued
under subsection (d)(3)(B) ensure that the recipient
government will take appropriate steps, and has
adequate authority, to maintain the confidentiality of
the information in accordance with procedures
comparable to those which the Administrator uses to
safeguard the information; and
``(B) the Administrator notifies the person who
submitted the information that the information has been
disclosed to a State or political subdivision of a
State;
``(5) a health 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 that conforms with the guidance issued under
subsection (d)(3)(B), subject to the conditions that--
``(A) the written statement of need is a statement
that the person has a reasonable basis to suspect
that--
``(i) the information is necessary for or
will assist in diagnosis or treatment of 1 or
more individuals or in 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
``(B) the confidentiality agreement provides 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 may otherwise be
authorized by the terms of the agreement or by the
person submitting the information to the Administrator,
except that nothing in this Act shall operate to
prohibit the disclosure of such information through
discovery, subpoena, and other court orders, or any
other judicial process otherwise allowed under
applicable State or Federal laws;
``(6) in the event of an emergency, a treating physician,
nurse, agent of a poison control center, public health or
environmental official of a State or political subdivision of a
State, or first responder 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
has 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; and
``(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;
and
``(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 provides a written statement
of need and agrees to sign a confidentiality agreement
as described in paragraph (5); and
``(C) the written confidentiality agreement or
statement of need is submitted as soon as practicable,
but not necessarily before the information is
disclosed;
``(7) the Administrator determines that disclosure is
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 maximum extent practicable
without impairing the proceeding;
``(8) the information is to be disclosed, on written
request of any duly authorized committee of the Congress, to
that committee;
``(9) the information is publicly available; or
``(10) the information is required to be disclosed or
otherwise made public under any other Federal law.
``(f) Duration of Protection From Disclosure.--
``(1) In general.--
``(A) Information protected from disclosure.--
Subject to paragraph (2) and except as allowed under
subsection (e), the Administrator shall protect from
disclosure information that meets the requirements of
subsection (d) for a period of 10 years, unless--
``(i) prior to the expiration of the 10-
year period, the person notifies the
Administrator that the person is withdrawing
the confidentiality claim, in which case, the
Administrator shall promptly make the
information available to the public;
``(ii) prior to the expiration of the 10-
year period, the Administrator otherwise
becomes aware that the need for protection from
disclosure can no longer be substantiated, in
which case the Administrator shall take the
actions described in subsection (g)(2); or
``(iii) the Administrator denies the claim
under subsection (g)(1).
``(B) Extensions.--
``(i) In general.--Not less than 60 days
prior to the expiration of the period described
in subparagraph (A), the Administrator shall
provide notice of the impending expiration of
the period to the person who asserted the
claim.
``(ii) Submission to reassert a claim.--Not
less than 30 days prior to expiration of the
period described in subparagraph (A), the
person reasserting the claim shall submit a
statement substantiating, in accordance with
subsection (d)(2), the need to extend the
period.
``(iii) Review.--Not later than 30 days of
receipt of the statement described in clause
(ii), the Administrator shall--
``(I) review the request and make a
determination as to whether the
information for which the request is
made continues to meet the relevant
criteria established in this section;
and
``(II)(aa) grant an extension not
to exceed 10 years; or
``(bb) deny the claim.
``(C) Limit on number of extensions.--There shall
be no limit on the number of extensions granted under
subparagraph (B) as long as the Administrator finds
that the substantiation establishes the need to extend
the period and meets the requirements established by
the Administrator, and that the length of any extension
does not exceed 10 years.
``(2) Review and resubstantiation.--
``(A) In general.--The Administrator may at any
time review a claim for protection against disclosure
under subsection (a) for information submitted to the
Administrator on a chemical substance (including
information described in subsection (b)(2)), and may
require any person who has claimed protection for that
information, whether before or after the date of
enactment of the Alan Reinstein and Trevor Schaefer
Toxic Chemical Protection Act, to withdraw or reassert
and substantiate or resubstantiate the claim in
conformance with the requirements of 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) (B) or (C);
``(iii) for any inactive chemical substance
identified pursuant to section 8(b)(4);
``(iv) if the Administrator determines that
disclosure of certain information currently
protected from disclosure would assist the
Administrator in conducting safety assessments
and determinations under section 6 (b) and (c)
or promulgating rules under section 6(d);
``(v) if necessary to comply with a request
for information the Administrator receives
pursuant to section 552 of title 5, United
States Code;
``(vi) if information available to the
Administrator provides a basis that the
requirements of subsection (b)(4) of section
552 of title 5, United States Code, are no
longer met; or
``(vii) for information contained in a
notice of substantial risk submitted under
section 8(e).
``(B) Resubstantiation.--If the Administrator makes
a request under subparagraph (A), the person receiving
the request shall--
``(i) resubstantiate the claim; or
``(ii) withdraw the claim.
``(C) Extension.--Protection from disclosure of the
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) 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
apply such identifier consistently to all information
relevant to such substance;
``(B) annually publish and update a list of
substances for which claims to protect specific
chemical identity from disclosure have been approved,
referred to by unique identifier, including the
expiration date for each such claim;
``(C) ensure that any nonconfidential information
received by the Administrator with respect to such a
substance during the period of protection from
disclosure is made public and identifies the substance
using the unique identifier; and
``(D) for each claim for protection of specific
chemical identity that has been denied by the
Administrator, upon expiration of the period for appeal
under subsection (g)(3), that has expired, or that has
been withdrawn by the submitter, provide public access
to the specific chemical identity clearly linked to all
nonconfidential information received by the
Administrator with respect to the substance.
``(g) Duties of the Administrator.--
``(1) Determination.--
``(A) In general.--Except as provided in subsection
(b), the Administrator shall, subject to subparagraph
(C), not later than 90 days after the receipt of a
claim under subsection (d), and not later than 30 days
after the receipt of a request for extension of a claim
under subsection (f), review and approve, modify, or
deny the claim or request.
``(B) Denial or modification.--
``(i) In general.--Except as provided in
subsections (c) and (f), the Administrator
shall deny a claim to protect a chemical
identity from disclosure only if the person who
has submitted the claim fails to meet the
requirements of subsections (a) and (d).
``(ii) Reasons for denial or
modification.--The Administrator shall provide
to the person who has submitted the claim a
written statement of the reasons for the denial
or modification of the claim.
``(C) Subsets.--The Administrator shall--
``(i) except for claims described in
subsection (b)(7), review all claims under this
section for the protection against disclosure
of the specific identity of a chemical
substance; and
``(ii) review a representative subset,
comprising at least 25 percent, of all other
claims for protection against disclosure.
``(D) Effect of failure to act.--The failure of the
Administrator to make a decision on a claim for
protection against disclosure or extension under this
section shall not be the basis for denial or
elimination of a claim for protection against
disclosure.
``(2) Notification.--
``(A) In general.--Except as provided in
subparagraph (B) and subsections (c), (e), and (f), if
the Administrator denies or modifies a claim under
paragraph (1), the Administrator shall notify, in
writing and by certified mail, the person who submitted
the claim of the intent of the Administrator to release
the information.
``(B) Release of information.--
``(i) In general.--Except as provided in
clause (ii), the Administrator shall not
release information under this subsection until
the date that is 30 days after the date on
which the person who submitted the request
receives notification under subparagraph (A).
``(ii) Exceptions.--
``(I) In general.--For information
under paragraph (3) or (8) of
subsection (e), the Administrator shall
not release that information until the
date that is 15 days after the date on
which the person who submitted the
claim receives a notification, unless
the Administrator determines that
release of the information is necessary
to protect against an imminent and
substantial harm to human health or the
environment, in which case, no prior
notification is necessary.
``(II) No notification.--For
information under paragraph (1), (2),
(6), (7), (9) or (10) of subsection
(e), no prior notification is
necessary.
``(3) Appeals.--
``(A) In general.--A person who receives a
notification under paragraph (2) may, if the person
believes disclosure of the information is prohibited
under subsection (a), before the date on which the
information is to be released, bring an action to
restrain disclosure of the information in--
``(i) the district court of the United
States in the district in which 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 prior to the date on which
the applicable court rules on an action under
subparagraph (A).
``(4) Administration.--In carrying out this subsection, the
Administrator shall employ the procedures in part 2 of title
40, Code of Federal Regulations (or successor regulations).
``(h) Criminal Penalty for Wrongful Disclosure.--
``(1) In general.--Subject to paragraph (2), any officer or
employee of the United States or former officer or employee of
the United States who--
``(A) by virtue of that employment or official
position has obtained possession of, or has access to,
material the disclosure of which is prohibited by
subsection (a); and
``(B) knowing that disclosure of that material is
prohibited by subsection (a), willfully discloses the
material in any manner to any person not entitled to
receive that material, shall be guilty of a misdemeanor
and fined under title 18, United States Code,
imprisoned for not more than 1 year, or both.
``(2) Other laws.--Section 1905 of title 18, United States
Code, shall not apply with respect to the publishing,
divulging, disclosure, making known of, or making available,
information reported or otherwise obtained under this Act.
``(3) Contractors.--For the purposes of this subsection,
any contractor of the United States who is furnished
information in accordance with subsection (e)(2), including any
employee of that contractor, shall be considered to be an
employee of the United States.
``(i) Applicability.--
``(1) Except as otherwise provided by this section, section
8, or any other Federal law, the Administrator shall have no
authority--
``(A) to require the substantiation or
resubstantiation of a claim for the protection from
disclosure of information submitted to the
Administrator under this Act prior to the date of
enactment of the Alan Reinstein and Trevor Schaefer
Toxic Chemical Protection Act; or
``(B) to impose substantiation or resubstantiation
requirements under this Act that are more extensive
than those required under this section.
``(2) Prior actions.--Nothing in this Act prevents the
Administrator from reviewing, requiring substantiation or
resubstantiation for, or approving, modifying or denying any
claim for the protection from disclosure of information prior
to the effective date of rules applicable to such claims that
the Administrator may promulgate after the date of enactment of
the Alan Reinstein and Trevor Schaefer Toxic Chemical
Protection Act.
``(j) Definition of First Responder.--For the purposes of this
section, the term `first responder' means a person duly authorized by a
State or political subdivision of a State or a Federal agency, trained
in urgent medical care or other emergency procedures, including a
police officer, firefighter, or emergency medical technician.''.
SEC. 115. PROHIBITED ACTS.
Section 15 (15 U.S.C. 2614) is amended by striking paragraph (1)
and inserting the following:
``(1) fail or refuse to comply with--
``(A) any rule promulgated, consent agreement
entered into, or order issued under section 4;
``(B) any requirement prescribed by section 5 or 6;
``(C) any rule promulgated, consent agreement
entered into, or order issued under section 5 or 6;
``(D) any requirement of title II or any rule
promulgated or order issued under title II; or
``(E) any requirement of title VI or any rule
promulgated or order issued under title VI;''.
SEC. 116. PENALTIES.
Section 16 (15 U.S.C. 2615) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in the first sentence--
(I) by inserting ``this Act or a
rule or order promulgated or issued
pursuant to this Act, as described in''
after ``a provision of''; and
(II) by striking ``$25,000'' and
inserting ``$37,500''; and
(ii) 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'' and inserting the
following:
``(1) In general.--Any person'';
(B) by striking ``section 15 or 409'' and inserting
``this Act'';
(C) by striking ``$25,000'' and inserting
``$50,000''; and
(D) by adding at the end the following:
``(2) Imminent danger of death or serious bodily injury.--
Any person who knowingly or willfully violates any provision of
this Act, and who knows at the time of the violation that the
violation places another person in imminent danger of death or
serious bodily injury shall be subject, upon conviction, to a
fine of not more than $250,000, imprisonment for not more than
15 years, or both. Any person committing such violation which
is an organization shall, upon conviction under this paragraph,
be subject to a fine of not more than $1,000,000 for each
violation.
``(3) Knowledge of imminent danger or injury.--In
determining whether a defendant knew that the violation placed
another person in imminent danger of death or serious bodily
injury, the defendant is responsible only for actual awareness
or actual belief possessed, and knowledge possessed by another
person that is not the defendant may not be attributed to the
defendant.''.
SEC. 117. PREEMPTION.
Section 18 (15 U.S.C. 2617) is amended--
(1) in subsection (a)(1), by striking ``(1) Except as
provided in paragraph (2), nothing'' and inserting ``Nothing'';
(2) by striking subsection (a)(2); and
(3) by striking subsection (b) and inserting the following:
``(b) Savings.--
``(1) No preemption of common law or statutory causes of
action for civil relief or criminal conduct.--Nothing in this
Act, nor any amendment made by this Act, nor any regulation,
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.
``(2) Clarification of no preemption.--Notwithstanding any
other provision in 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, maritime, or Federal common law
or statutory theory.
``(3) 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) No effect on authority of court.--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.
``(4) No preemption of state laws.--Nothing in this Act,
nor any amendment made by this Act, nor any regulation,
requirement, 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 regulation, requirement, standard
of performance, safety determination, scientific assessment, or
any protection for public health or the environment that is
different from, or in addition to, any regulation, requirement,
standard of performance, safety determination, or scientific
assessment implemented pursuant to this Act.''.
SEC. 118. JUDICIAL REVIEW.
Section 19 (15 U.S.C. 2618) is amended--
(1) in subsection (a)--
(A) in subparagraph (1)(A), by striking ``section
4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under
title II or IV'' and inserting ``section 4(a), 5(c)(4),
6(d), or 8'';
(B) in subparagraph (1)(B), by striking
``subparagraph (A)'' and inserting ``paragraph (1)'';
and
(C) by striking paragraph (3); and
(2) in subsection (c)--
(A) in subparagraph (1)(B), by striking clauses (i)
and (ii) and the last sentence of the subparagraph;
(B) by redesignating paragraph (1)(B)(iii) as
paragraph (1)(B)(i); and
(C) in paragraph (1)(B)(i) as so redesignated), by
striking ``(I) any statement required to be made
pursuant to section 6(c)(1) of this title, or (II)''.
SEC. 119. CITIZENS' PETITIONS.
Section 21 (15 U.S.C. 2620) is amended--
(1) in subsection (a), by striking ``an order under section
5(e)'' and inserting ``an order under section 4, 5(c),''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``an order under
section 5(e)'' and inserting ``an order under section
4, 5(c),''; 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 under section 4, 5(c), 6(d), or 8
or an order issued under section 4 or 5(c), the
petitioner shall be provided an opportunity to
have the petition considered by the court in a
de novo proceeding.
``(ii) Demonstration.--
``(I) In general.--The court shall
order the Administrator to initiate the
action requested by the petitioner if
the petitioner demonstrates to the
satisfaction of the court by a
preponderance of the evidence that--
``(aa) in the case of a
petition to initiate a
proceeding for the issuance of
a rule or order under section
4, the information available to
the Administrator is
insufficient for the
Administrator to perform an
action described in section 4,
4A, or 6(b);
``(bb) in the case of a
petition to issue an order
under section 5(c), there is a
reasonable basis to conclude
that the substance is not
likely to meet the safety
standard;
``(cc) in the case of a
petition to initiate a
proceeding for the issuance of
a rule under section 6(d),
there is a reasonable basis to
conclude that the substance
will not meet the safety
standard; or
``(dd) in the case of a
petition to initiate a
proceeding for the issuance of
a rule under section 8, there
is a reasonable basis to
conclude that the rule is
necessary to require reporting
or recordkeeping to obtain
information relevant to
determining whether a substance
or mixture may fail to meet the
safety standard.
``(II) Deferment.--The court may
permit the Administrator to defer
initiating the action requested by the
petitioner until such time as the court
prescribes if the court finds that--
``(aa) the extent of the
risk to human health or the
environment alleged by the
petitioner is less than the
extent of risks to human health
or the environment with respect
to which the Administrator is
taking action under this Act;
and
``(bb) there are
insufficient resources
available to the Administrator
to take the action requested by
the petitioner.''.
SEC. 120. STUDIES.
Section 25 (15 U.S.C. 2624) is repealed.
SEC. 121. ADMINISTRATION.
Section 26(e) (15 U.S.C. 2625(e)) is amended--
(1) by striking ``Health, Education, and Welfare'' each
place it appears and inserting ``Health and Human Services'';
and
(2) by striking subsection (b) and inserting--
``(b) Fees.--
``(1) In general.--The Administrator shall, by rule,
require manufacturers of chemical substances to pay reasonable
fees to defray the costs of administering this title, including
but not limited to costs resulting from--
``(A) issuing rules and orders to conduct testing
under section 4 and reviewing data submitted under
these requirements;
``(B) developing the priority list and designating
substances as high-priority under section 4A;
``(C) reviewing notices submitted under section 5;
``(D) conducting safety assessments and making
safety determinations under section 6;
``(E) promulgating rules and issuing orders to
restrict chemical substances under section 6;
``(F) promulgating rules and issuing orders to
report information and data and maintain records under
section 8; and
``(G) reviewing confidentiality claims under
section 14.
``(2) Apportionment.--
``(A) In general.--The Administrator shall
apportion fees among individual manufacturers in
relation to the costs of administering this title which
are attributable to each manufacturer's production or
importation of chemical substances subject to action
under sections 4, 4A, 5, 6 and 8.
``(B) Multiple manufacturers.--If there is more
than 1 manufacturer of such substance, the
Administrator shall provide for the sharing of fees in
proportion to each manufacturer's contribution to total
production of such substance, unless there is some
other basis for apportionment that better reflects
considerations of hazard and exposure.
``(3) Small business concerns.--The rule promulgated under
paragraph (1) may set separate fees for manufacturers of
chemical substances that are small business concerns based on
their ability to pay.
``(4) Limitation.--Fees collected under this subsection
shall only be used to defray the costs of administering this
title and not for any other purpose.''.
``(5) Level of fees.--The Administrator shall ensure that
fees are set at a level sufficient to enable the Administrator
to perform all of the responsibilities described in paragraph
(1) and add not less than 3 chemical substances to the list of
high-priority substances for each chemical substance removed
from the list under section 4A(a)(5)(iii) and to complete
safety assessments and determinations and any necessary
rulemaking for these high-priority substances in accordance
with section 6(a).''.
SEC. 122. DEVELOPMENT AND EVALUATION OF TEST METHODS.
Section 27(a) (15 U.S.C. 2626(a)) is amended by striking ``Health,
Education, and Welfare'' and inserting ``Health and Human Services''.
SEC. 123. STATE PROGRAMS.
Section 28 (15 U.S.C. 2627) is amended by striking subsections (c)
and (d).
SEC. 124. AUTHORIZATION OF APPROPRIATIONS.
Section 29 (15 U.S.C. 2628) is repealed.
SEC. 125. ANNUAL REPORT.
Section 30 (15 U.S.C. 2629) is amended by striking paragraph (2)
and inserting the following:
``(2)(A) the number of notices received during each year
under section 5; and
``(B) the number of the notices described in subparagraph
(A) for chemical substances subject to a rule, testing consent
agreement, or order under section 4;''.
TITLE II--STRENGTHENING PROTECTIONS FOR CHILDREN AND COMMUNITIES FROM
DISEASE CLUSTERS
SEC. 201. PURPOSES.
The purposes of this title are--
(1) to provide to the Administrator the authority to help
conduct investigations into the potential for environmental
pollutants or toxic substances to cause disease clusters;
(2) to ensure that the Administrator has the authority to
undertake actions to help address existing and potential
environmental pollution and toxic substances that may
contribute to the creation of disease clusters; and
(3) to enable the Administrator to integrate and work in
conjunction with other Federal, State, and local agencies,
institutions of higher education, and the public in
investigating and helping to address the possible causes of
disease clusters.
SEC. 202. DEFINITIONS.
In this title:
(1) Administrator.--The term ``Administrator'' means the
Administrator of the Environmental Protection Agency.
(2) Agency.--The term ``Agency'' means the Environmental
Protection Agency.
(3) Director.--The term ``Director'' means the Director of
the National Institute of Environmental Health Sciences.
(4) Disease cluster.--The term ``disease cluster'' means--
(A) the occurrence of a greater-than-expected
number of cases of a particular disease within a group
of individuals, a geographical area, or a period of
time; or
(B) the occurrence of a particular disease in such
number of cases, or meeting such other criteria, as the
Administrator, in consultation with the Administrator
of the Agency for Toxic Substances and Disease Registry
and the Director, may determine.
(5) Environmental pollutants or toxic substances.--The term
``environmental pollutants or toxic substances'' includes the
substances described in paragraph (7).
(6) Federal agency.--The term ``Federal agency'' means--
(A) any department, agency, or other
instrumentality of the Federal Government;
(B) any independent agency or establishment of the
Federal Government (including any Government
corporation); and
(C) the Government Publishing Office.
(7) Potential causes of a disease cluster.--The term
``potential causes of a disease cluster'' includes
environmental and public health factors that could increase the
possibility of disease clusters, including environmental
pollutants or toxic substances and sources of those pollutants
and substances, including--
(A) emissions of air pollutants that are regulated
under the Clean Air Act (42 U.S.C. 7401 et seq.);
(B) water pollutants that are regulated under the
Federal Water Pollution Control Act (33 U.S.C. 1251 et
seq.);
(C) a contaminant, as that term is defined in
section 1401 of the Safe Drinking Water Act (42 U.S.C.
300f);
(D) a hazardous substance, as that term is defined
in section 101 of the Comprehensive Environmental
Response, Compensation, and Liability Act (42 U.S.C.
9601);
(E) solid waste and hazardous waste, as those terms
are defined in section 1004 of the Solid Waste Disposal
Act (42 U.S.C. 6903);
(F) a chemical substance, as that term is defined
in section 3 of the Toxic Substances Control Act (15
U.S.C. 2602);
(G) a substance that is regulated under the
Emergency Planning and Community Right-To-Know Act of
1986 (42 U.S.C. 11001 et seq.); and
(H) any other form of environmental pollution or
toxic substance that is a known or potential cause of
an adverse health effect, including a developmental,
reproductive, neurotoxic, or carcinogenic effect.
(8) Regional response center.--The term ``Regional Response
Center'' means a Regional Disease Cluster Information and
Response Center established under section 204.
(9) Response team.--The term ``Response Team'' means a
Regional Disease Cluster Information and Response Team
established under section 204.
(10) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 203. GUIDELINES FOR ENVIRONMENTAL INVESTIGATIONS OF DISEASE
CLUSTERS.
(a) Establishment.--
(1) In general.--The Administrator, in consultation with
the Administrator of the Agency for Toxic Substances and
Disease Registry, the Secretary, and the Director, shall
develop, publish, and periodically update guidelines that
describe a systematic, integrated approach that uses the best
available science to investigate--
(A) 1 or more suspected or potential disease
clusters;
(B) environmental pollutants or toxic substances
associated with 1 or more suspected or potential
disease clusters; or
(C) potential causes of 1 or more disease clusters.
(2) Coordination.--The Administrator shall ensure that the
Office of Children's Health Protection, in consultation with
appropriate advisory committees, such as the Children's Health
Protection Advisory Committee, has a prominent role on behalf
of the Agency in developing and updating guidelines under
paragraph (1).
(b) Requirements.--Guidelines developed under this section shall
include--
(1) definitions of key concepts and actions;
(2) disease cluster identification and reporting protocols;
(3) standardized methods of reviewing and categorizing
data, including from health surveillance systems and disease
cluster reports;
(4) guidance for using, in a health-protective way, an
appropriate epidemiological, statistical, or other approach for
the circumstances of an investigation;
(5) procedures for peer review of key documents by
individuals who have no direct or indirect conflict of
interest; and
(6) a description of roles and responsibilities of the
Administrator and the Administrator of the Agency for Toxic
Substances and Disease Registry in conducting investigations
described in those guidelines, in accordance with this title.
(c) Timing.--
(1) In general.--Draft guidelines developed under this
section shall be available for public review and comment for a
period of not less than 60 days.
(2) Final guidelines.--Not later than 1 year after the date
of enactment of this Act, the Administrator, in consultation
with the Administrator of the Agency for Toxic Substances and
Disease Registry, the Secretary, and the Director, shall
publish in the Federal Register final guidelines under this
section.
SEC. 204. ENHANCED SUPPORT FOR ENVIRONMENTAL INVESTIGATIONS OF DISEASE
CLUSTERS.
(a) Establishment of Regional Disease Cluster Information and
Response Centers and Teams.--
(1) Establishment.--
(A) In general.--The Administrator, in consultation
with the Administrator of the Agency for Toxic
Substances and Disease Registry, the Secretary, and the
Director, and other appropriate Federal agencies, shall
establish and operate Regional Disease Cluster
Information and Response Centers and Regional Disease
Cluster Information and Response Teams.
(B) Principal responsibility.--The Administrator
shall be principally responsible for directing,
coordinating, and approving Federal efforts and
assistance authorized under this section.
(2) Coordination.--
(A) In general.--The Administrator shall ensure
that the Office of Children's Health Protection, in
consultation with appropriate advisory committees, such
as the Children's Health Protection Advisory Committee,
has a prominent role on behalf of the Agency in
establishing and operating the Regional Response
Centers and the Response Teams.
(B) Grants and cooperative agreements.--
(i) In general.--The Administrator shall
provide support (including research, program
implementation, and operational support
activities) to individuals on Response Teams
described in subsection (b) and Community
Disease Cluster Advisory Committees described
in subsection (c) through grants and
cooperative agreements with institutions of
higher education that have programs or
individuals with demonstrated expertise in
research, training, studies, and technical
assistance.
(ii) Authorization of appropriations.--
There are authorized to be appropriated to
carry out this subparagraph such sums as are
necessary.
(3) Timing.--Not later than 1 year after the date of
enactment of this Act, the Administrator shall establish at
least--
(A) 2 Regional Response Centers; and
(B) 2 Response Teams.
(b) Response Teams.--
(1) Membership.--Each Response Team shall include
individuals who--
(A) have expertise in epidemiology, toxicogenomics,
molecular biology, toxicology, pollution control
requirements, data analysis, environmental health and
disease surveillance, exposure assessment, pediatric
health, community outreach and involvement, and other
relevant fields; and
(B) have no direct or indirect conflict of
interest.
(2) Leadership.--Each Response Team shall have--
(A) an individual who is the leader of the Response
Team and who reports to the Administrator, the
Administrator of the Agency for Toxic Substances and
Disease Registry, and the Director; and
(B) an individual who has the skills or experience
necessary to carry out community outreach and
involvement activities, including--
(i) the establishment of Community Disease
Cluster Advisory Committees under subsection
(c); and
(ii) the facilitation of activities of
those Committees.
(3) Activities.--
(A) In general.--The Administrator, in consultation
with the Administrator of the Agency for Toxic
Substances and Disease Registry and the Director, shall
establish the scope of activities for Response Teams to
ensure that the activities are consistent with
achieving the purposes of this title.
(B) Requirements.--The activities of the Response
Teams shall include--
(i) making guidelines, protocols, data, and
other relevant information and expertise
available to State and local officials and the
public to assist in efforts--
(I) to investigate suspected or
potential disease clusters,
environmental pollutants or toxic
substances associated with those
disease clusters, and potential causes
of disease clusters; and
(II) to address potential causes of
disease clusters;
(ii) responding rapidly to a petition
described in subparagraph (C) from any person,
including a State or local official, regarding
the need--
(I) to investigate suspected or
potential disease clusters,
environmental pollutants or toxic
substances associated with those
disease clusters, and potential causes
of disease clusters; and
(II) to address the potential
causes of disease clusters;
(iii) providing the best available
environmental sampling and laboratory equipment
to collect, analyze, and interpret monitoring,
health surveillance, and other relevant
information at scales and timelines appropriate
to an action;
(iv) involving community members, in
accordance with established scientific methods
and norms (including the preservation of the
confidentiality of individuals), in--
(I) investigations of suspected or
potential disease clusters,
environmental pollutants or toxic
substances associated with those
disease clusters, or potential causes
of disease clusters, including
through--
(aa) environmental exposure
assessments;
(bb) biomonitoring
activities; and
(cc) community-based
participatory research
initiatives; and
(II) other efforts to address the
potential causes of disease clusters;
(v) working with State and local agencies--
(I) to help make the use and
management of integrated environmental
health data consistent and timely; and
(II) to fill data gaps; and
(vi) investigating suspected or potential
disease clusters, environmental pollutants or
toxic substances associated with those disease
clusters, and potential causes of disease
clusters, and addressing the potential causes
of disease clusters that the Administrator
determines State and local officials need
assistance in investigating or addressing, or
that the Administrator determines should be
investigated or addressed.
(C) Petition.--
(i) In general.--Any person, including a
State or local official, may submit a petition
referred to in subparagraph (B)(ii) to the
Administrator, the Administrator of the Agency
for Toxic Substances and Disease Registry, and
the Director that requests that a Response Team
conduct an investigation or take other action
to address the potential causes of disease
clusters in accordance with this title.
(ii) Requirements.--Each petition submitted
under clause (i) shall clearly describe the
basis for the requested investigation or
action, including any data supporting the
request.
(iii) Consideration.--The Administrator, in
consultation with the Administrator of the
Agency for Toxic Substances and Disease
Registry and the Director, shall establish
criteria for the consideration of petitions
submitted under this section using health-
protective factors, including--
(I) evidence of the release of
environmental pollutants or toxic
substances;
(II) the locations in which there
appear to be potentially significant
health threats from the potential
causes of disease clusters;
(III) cases in which existing data
appear to be inadequate to fully assess
the potential risks to public health;
and
(IV) such other factors as the
Administrator determines are necessary.
(iv) Response.--Not later than 60 days
after the date of receipt of a petition under
clause (iii), the Administrator, in
consultation with the Administrator of the
Agency for Toxic Substances and Disease
Registry and the Director, shall provide a
written response that describes--
(I) the investigation or actions
that will be undertaken in response to
the petition, including the timeline
and basis for the investigation or
actions; and
(II) the reasons for any denial or
deferral in providing such a response.
(v) Timing of issuance of criteria.--
(I) In general.--The Administrator,
in consultation with the Administrator
of the Agency for Toxic Substances and
Disease Registry and the Director,
shall provide for public notice of
draft criteria established under this
subparagraph for a period of not less
than 60 days.
(II) Final criteria.--Not later
than 1 year after the date of enactment
of this Act, the Administrator, in
consultation with the Administrator of
the Agency for Toxic Substances and
Disease Registry and the Director,
shall publish in the Federal Register
final criteria required under this
subparagraph.
(4) Use of publicly available reports.--Response Team
investigations and actions shall--
(A) include publicly available reports prepared by
the Response Team that contain statements of facts,
findings, and recommendations for actions, to the
extent appropriate; and
(B) be prepared in a manner that preserves the
confidentiality of individuals.
(5) Transparency and accountability.--Response Team
activities shall include measures to ensure--
(A) transparency and accountability to potentially
affected individuals, State and local officials, the
public, and other persons and agencies, while
preserving the confidentiality of individuals;
(B) that consistent, accurate, and meaningful
information is provided to potentially affected
individuals, State and local officials, the public, and
other persons and agencies through the use of
comprehensive, community-based communications plans;
and
(C) accountability to meeting goals and timetables.
(6) Database.--
(A) In general.--The Administrator, in consultation
with the Administrator of the Agency for Toxic
Substances and Disease Registry, the Secretary, and the
Director, shall compile and regularly update
information in a comprehensive electronic database
that--
(i) is publicly accessible through the
Internet;
(ii) provides a centralized location for
information relating to--
(I) disease cluster reports and
investigations;
(II) environmental pollutants or
toxic substances that are associated
with suspected or potential disease
clusters;
(III) illnesses associated with
suspected or potential disease
clusters, including locally generated
information;
(IV) systematic tracking of
environmental pollutants or toxic
substances and illnesses associated
with suspected or potential disease
clusters;
(V) actions to help address the
potential causes of disease clusters;
and
(VI) any other information that the
Administrator determines to be
necessary; and
(iii) facilitates the rapid reporting and
analysis of information described in clause
(ii).
(B) Confidentiality.--A database described in
subparagraph (A) shall be maintained in a manner that
preserves the confidentiality of individuals.
(c) Community Disease Cluster Advisory Committees.--
(1) In general.--The Administrator shall establish
Community Disease Cluster Advisory Committees to provide
oversight, guidance, and advice relating to--
(A) the investigation of suspected and potential
disease clusters;
(B) the investigation of environmental pollutants
or toxic substances associated with suspected or
potential disease clusters;
(C) the investigation of potential causes of
disease clusters;
(D) efforts to address the potential causes of
disease clusters; and
(E) the most effective means of ensuring outreach
to and involvement of community members.
(2) Membership.--Membership on Community Disease Cluster
Advisory Committees shall be comprised of representatives that
include--
(A) individuals who are or may be impacted by a
suspected or potential disease cluster, and the
designee of such an individual who may participate with
or in the place of such an individual;
(B) State or local government health or
environmental agencies;
(C) at least 2 individuals, appointed by the
Administrator in consultation with the Administrator of
the Agency for Toxic Substances and Disease Registry
and the Director, with demonstrated knowledge of the
activities described in paragraph (1); and
(D) other appropriate individuals, as determined by
the Administrator, in consultation with the
Administrator of the Agency for Toxic Substances and
Disease Registry and the Director.
(3) Prohibition.--No member of a Committee may have any
direct or indirect conflict of interest.
(4) Technical assistance.--
(A) In general.--The Administrator, in consultation
with the Administrator of the Agency for Toxic
Substances and Disease Registry and the Director, may
make grants available to any group of individuals that
may be affected by a suspected or potential disease
cluster.
(B) Use of funds.--Grants made available under
subparagraph (A) may be used to facilitate active
involvement in all aspects of Committee activities and
to assist Committee members in obtaining technical
assistance in interpreting information with regard to--
(i) the investigation of--
(I) suspected or potential disease
clusters;
(II) environmental pollutants or
toxic substances that are associated
with suspected or potential disease
clusters; and
(III) the potential causes of
disease clusters;
(ii) addressing the potential causes of
disease clusters;
(iii) understanding the health concerns
associated with suspected or potential disease
clusters; and
(iv) understanding other scientific and
technical issues relating to the activities of
a Regional Response Team and Community Disease
Cluster Advisory Committee, including the
potential need for and interpretation of any
biomonitoring of individuals in the area.
(d) Environmental Research and Analysis.--The Administrator, in
consultation with the Administrator of the Agency for Toxic Substances
and Disease Registry, the Secretary, and the Director, shall use
available authorities and programs to compile, research, and analyze
information generated by actions authorized under this section,
including by--
(1) using those authorities to test environmental
pollutants or toxic substances identified under subsection
(b)(6); and
(2) incorporating environmental pollutants or toxic
substances identified under subsection (b)(6) in appropriate
national biomonitoring initiatives.
SEC. 205. FEDERAL REPORTS TO CONGRESS.
(a) In General.--Not later than 1 year after the date of enactment
of this Act and annually thereafter, the Administrator, in consultation
with the Administrator of the Agency for Toxic Substances and Disease
Registry, the Secretary, and the Director, shall prepare a report that
describes--
(1) the status of activities under this title to
investigate and address the suspected and potential causes of
disease clusters;
(2) environmental pollutants or toxic substances that are
associated with suspected or potential disease clusters;
(3) the potential causes of disease clusters; and
(4) ways to address the potential causes of those disease
clusters.
(b) Requirements.--The report shall include a description of--
(1) outreach activities to State and local officials and
communities;
(2) actions that the Administrator has taken to prioritize
the testing of environmental pollutants or toxic substances;
(3) actions that the Administrator has taken to include
environmental pollutants or toxic substances identified under
section 204(b)(7) in appropriate national biomonitoring
initiatives;
(4) actions that the Administrator is taking or plans to
take to address problems in implementing this title;
(5) actions that the Secretary is taking or plans to take
to address problems in implementing this title;
(6) actions that the Administrator of the Agency for Toxic
Substances and Disease Registry has undertaken or is
considering taking with respect to any disease clusters under
subparagraphs (D) and (E) of section 104(i)(1) of Comprehensive
Environmental Response, Compensation, and Liability Act (42
U.S.C. 9604(i)(1)) and other provisions of that section;
(7) actions that the Director is taking or plans to take to
address problems in implementing this title; and
(8) other relevant information.
(c) Submission and Availability.--The Administrator shall--
(1) submit the report under this subsection to--
(A) the Committees on Environment and Public Works
and Health, Education, Labor, and Pensions of the
Senate; and
(B) the Committee on Energy and Commerce of the
House of Representatives; and
(2) make the report available to the public.
SEC. 206. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are necessary
to carry out this title.
SEC. 207. EFFECT ON OTHER LAW.
Nothing in this title modifies, limits, or otherwise affects the
application of, or obligation to comply with, any law, including any
environmental or public health law.
TITLE III--COMMUNITY DISEASE CLUSTER TECHNICAL ASSISTANCE GRANTS
SEC. 301. COMMUNITY DISEASE CLUSTER TECHNICAL ASSISTANCE GRANTS.
(a) In General.--The Administrator of the Environmental Protection
Agency (referred to in this title as the ``Administrator''), in
coordination with the Secretary of Health and Human Services (referred
to in this title as the ``Secretary'') may award grants in accordance
with this title to any individual or group of individuals that may be
affected by a reported community-based disease cluster--
(1) to pay the Federal share of the technical assistance
described in subsection (d);
(2) to protect public health and the environment;
(3) to promote healthy and safe environments; and
(4) to prevent and address harmful exposures to hazardous
substances.
(b) Application.--
(1) In general.--To be eligible for a grant under this
title, an individual or group of individuals shall submit to
the Administrator and the Secretary an application that
contains a description of the--
(A) need for technical assistance, including the
need to procure independent technical advisors to help
grant recipients interpret the information described in
subsection (d);
(B) expected outputs, including results, effects,
or consequences that will occur from the technical
assistance; and
(C) expected outcomes, including activity, effort,
or associated work products that will be produced or
provided over a period of time or by a specific date.
(2) Response.--Not later than 120 days after the date on
which an application is submitted under paragraph (1), the
Administrator and the Secretary shall respond to each applicant
in writing and describe whether the application is approved,
denied, or will be considered after the applicant modifies the
application.
(3) Criteria.--The Administrator, in coordination with the
Secretary, shall develop criteria that, if satisfied, would
result in the Administrator and the Secretary accepting an
application submitted under paragraph (1).
(c) Amount.--
(1) In general.--Except as provided in paragraph (2), each
grant awarded under this title shall not exceed $50,000.
(2) Waiver.--The Administrator, in coordination with the
Secretary, may waive the limitation described in paragraph (1)
if the waiver is necessary to provide the technical assistance
described in subsection (d).
(d) Use of Funds.--Grants awarded under this title shall be used to
obtain technical assistance in interpreting information regarding--
(1) investigating reported community-based disease clusters
associated with 1 or more hazardous chemicals;
(2) the potential hazardous chemicals associated with a
reported community-based disease cluster;
(3) providing individuals or groups of individuals with
community-based tools to educate the individuals on the
mitigation of hazardous chemicals associated with reported
community-based disease clusters; or
(4) other scientific and technical issues related to
reported community-based disease clusters.
(e) Number of Grants.--No individual or group of individuals shall
be awarded more than 1 grant under this title.
(f) Non-Federal Share.--
(1) In general.--Except as provided in paragraph (2), the
non-Federal share for each grant awarded under this title is 20
percent.
(2) Waiver.--The Administrator, in coordination with the
Secretary, may waive the non-Federal share described in
paragraph (1) if--
(A) the recipient of the grant demonstrates
financial need; and
(B) the waiver is necessary to provide the
technical assistance described in subsection (d).
(g) Renewal of Grant.--
(1) In general.--Any grant awarded under this title may be
renewed to facilitate technical assistance to any group of
individuals that may be affected by a reported community-based
disease cluster.
(2) Conditions.--Each renewal of a grant awarded under this
title is subject to the same conditions that apply to an
initial grant.
(h) Reports.--Any recipient of a grant awarded under this title
shall submit to the Administrator and the Secretary a report that
describes the progress in addressing the needs and achieving the
outputs and outcomes described in subsection (b).
SEC. 302. AUTHORIZATION OF APPROPRIATIONS.
For each of fiscal years 2016 through 2021, there are authorized to
be appropriated to the Administrator and the Secretary from any funds
made available to the Administrator and the Secretary for the purpose
of providing community members with technical assistance and engagement
on environmental health issues from the Hazardous Substance Superfund
established under section 9507 of the Internal Revenue Code of 1986
such sums as are necessary to carry out section 301.
<all>