[114th Congress Public Law 182]
[From the U.S. Government Publishing Office]
[[Page 447]]
FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 21ST CENTURY ACT
[[Page 130 STAT. 448]]
Public Law 114-182
114th Congress
An Act
To modernize the Toxic Substances Control Act, and for other
purposes. <<NOTE: June 22, 2016 - [H.R. 2576]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Frank R.
Lautenberg Chemical Safety for the 21st Century Act. 15 USC 2601
note.>>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Frank R. Lautenberg
Chemical Safety for the 21st Century Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--CHEMICAL SAFETY
Sec. 2. Findings, policy, and intent.
Sec. 3. Definitions.
Sec. 4. Testing of chemical substances and mixtures.
Sec. 5. Manufacturing and processing notices.
Sec. 6. Prioritization, risk evaluation, and regulation of chemical
substances and mixtures.
Sec. 7. Imminent hazards.
Sec. 8. Reporting and retention of information.
Sec. 9. Relationship to other Federal laws.
Sec. 10. Exports of elemental mercury.
Sec. 11. Confidential information.
Sec. 12. Penalties.
Sec. 13. State-Federal relationship.
Sec. 14. Judicial review.
Sec. 15. Citizens' civil actions.
Sec. 16. Studies.
Sec. 17. Administration of the Act.
Sec. 18. State programs.
Sec. 19. Conforming amendments.
Sec. 20. No retroactivity.
Sec. 21. Trevor's Law.
TITLE II--RURAL HEALTHCARE CONNECTIVITY
Sec. 201. Short title.
Sec. 202. Telecommunications services for skilled nursing facilities.
TITLE I--CHEMICAL SAFETY
SEC. 2. FINDINGS, POLICY, AND INTENT.
Section 2(c) of the Toxic Substances Control Act (15 U.S.C. 2601(c))
is amended by striking ``proposes to take'' and inserting ``proposes as
provided''.
SEC. 3. DEFINITIONS.
Section 3 of the Toxic Substances Control Act (15 U.S.C. 2602) is
amended--
[[Page 130 STAT. 449]]
(1) by redesignating paragraphs (4) through (14) as
paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15),
(16), and (17), respectively;
(2) by inserting after paragraph (3) the following:
``(4) The term `conditions of use' means the circumstances, as
determined by the Administrator, under which a chemical substance is
intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of.'';
(3) by inserting after paragraph (6), as so redesignated,
the following:
``(7) The term `guidance' means any significant written guidance of
general applicability prepared by the Administrator.''; and
(4) by inserting after paragraph (11), as so redesignated,
the following:
``(12) The term `potentially exposed or susceptible subpopulation'
means a group of individuals within the general population identified by
the Administrator who, due to either greater susceptibility or greater
exposure, may be at greater risk than the general population of adverse
health effects from exposure to a chemical substance or mixture, such as
infants, children, pregnant women, workers, or the elderly.''.
SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.
Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is
amended--
(1) by striking ``standards'' each place it appears and
inserting ``protocols and methodologies'';
(2) in subsection (a)--
(A) by striking ``If the Administrator finds'' and
inserting ``(1) If the Administrator finds'';
(B) in paragraph (1), as so designated--
(i) by striking ``(1)(A)(i)'' and inserting
``(A)(i)(I)'';
(ii) by striking ``(ii)'' each place it
appears and inserting ``(II)'';
(iii) by striking ``are insufficient data''
and inserting ``is insufficient information'' each
place it appears;
(iv) by striking ``(iii)'' each place it
appears and inserting ``(III)'';
(v) by striking ``such data'' and inserting
``such information'' each place it appears;
(vi) by striking ``(B)(i)'' and inserting
``(ii)(I)'';
(vii) by striking ``(I)'' and inserting
``(aa)'';
(viii) by striking ``(II)'' and inserting
``(bb)'';
(ix) by striking ``(2)'' and inserting
``(B)''; and
(x) in the matter following subparagraph (B),
as so redesignated--
(I) by inserting ``, or, in the case
of a chemical substance or mixture
described in subparagraph (A)(i), by
rule, order, or consent agreement,''
after ``rule'';
(II) by striking ``data'' each place
it appears and inserting
``information''; and
(III) by striking ``and which are
relevant'' and inserting ``and which is
relevant''; and
(C) by adding at the end the following:
[[Page 130 STAT. 450]]
``(2) <<NOTE: Determination.>> Additional testing
authority.--In addition to the authority provided under
paragraph (1), the Administrator may, by rule, order, or consent
agreement--
``(A) require the development of new information
relating to a chemical substance or mixture if the
Administrator determines that the information is
necessary--
``(i) <<NOTE: Review. Notice. Evaluation.>>
to review a notice under section 5 or to perform a
risk evaluation under section 6(b);
``(ii) to implement a requirement imposed in a
rule, order, or consent agreement under subsection
(e) or (f) of section 5 or in a rule promulgated
under section 6(a);
``(iii) at the request of a Federal
implementing authority under another Federal law,
to meet the regulatory testing needs of that
authority with regard to toxicity and exposure; or
``(iv) pursuant to section 12(a)(2); and
``(B) require the development of new information for
the purposes of prioritizing a chemical substance under
section 6(b) only if the Administrator determines that
such information is necessary to establish the priority
of the substance, subject to the limitations that--
``(i) <<NOTE: Deadline.>> not later than 90
days after the date of receipt of information
regarding a chemical substance complying with a
rule, order, or consent agreement under this
subparagraph, the Administrator shall designate
the chemical substance as a high-priority
substance or a low-priority substance; and
``(ii) information required by the
Administrator under this subparagraph shall not be
required for the purposes of establishing or
implementing a minimum information requirement of
broader applicability.
``(3) Statement of need.--When requiring the development of
new information relating to a chemical substance or mixture
under paragraph (2), the Administrator shall identify the need
for the new information, describe how information reasonably
available to the Administrator was used to inform the decision
to require new information, explain the basis for any decision
that requires the use of vertebrate animals, and, as applicable,
explain why issuance of an order is warranted instead of
promulgating a rule or entering into a consent agreement.
``(4) Tiered testing.--When requiring the development of new
information under this subsection, the Administrator shall
employ a tiered screening and testing process, under which the
results of screening-level tests or assessments of available
information inform the decision as to whether 1 or more
additional tests are necessary, unless information available to
the Administrator justifies more advanced testing of potential
health or environmental effects or potential exposure without
first conducting screening-level testing.'';
(3) in subsection (b)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking ``test
data'' and inserting ``information'';
(ii) in subparagraph (C), by striking ``data''
and inserting ``information''; and
[[Page 130 STAT. 451]]
(iii) in the matter following subparagraph
(C), by striking ``data'' and inserting
``information'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``test data'' and
inserting ``information'';
(II) by inserting ``Protocols and
methodologies for the development of
information may also be prescribed for
the assessment of exposure or exposure
potential to humans or the
environment.'' after the first sentence;
and
(III) by striking ``hierarchical
tests'' and inserting ``tiered
testing''; and
(ii) in subparagraph (B), by striking ``data''
and inserting ``information'';
(C) in paragraph (3)--
(i) by striking ``data'' each place it appears
and inserting ``information'';
(ii) in subparagraph (A), by inserting ``or
(C), as applicable,'' after ``subparagraph (B)'';
(iii) by striking ``(a)(1)(A)(ii) or
(a)(1)(B)(ii)'' each place it appears in
subparagraph (B) and inserting ``(a)(1)(A)(i)(II)
or (a)(1)(A)(ii)(II)'';
(iv) in subparagraph (B), in the matter before
clause (i), by striking ``subsection (a)'' and
inserting ``subsection (a)(1)''; and
(v) by adding at the end the following:
``(C) A rule or order under paragraph (1) or (2) of subsection (a)
may require the development of information by any person who
manufactures or processes, or intends to manufacture or process, a
chemical substance or mixture subject to the rule or order.'';
(D) in paragraph (4)--
(i) by striking ``of data'' each place it
appears and inserting ``of information''; and
(ii) by striking ``test data'' each place it
appears and inserting ``information''; and
(E) by striking paragraph (5);
(4) in subsection (c)--
(A) in paragraph (1), by striking ``data'' and
inserting ``information'';
(B) in paragraph (2), by striking ``data'' each
place it appears and inserting ``information'';
(C) in paragraph (3)--
(i) by striking ``test data'' each place it
appears and inserting ``information''; and
(ii) by striking ``such data'' each place it
appears and inserting ``such information''; and
(D) in paragraph (4) by striking ``test data'' each
place it appears and inserting ``information'';
(5) in subsection (d)--
(A) by striking ``test data'' each place it appears
and inserting ``information'';
(B) by striking ``such data'' each place it appears
and inserting ``such information''; and
(C) by striking ``for which data have'' and
inserting ``for which information has'';
[[Page 130 STAT. 452]]
(6) in subsection (e)--
(A) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``promulgation of a
rule'' and inserting ``development of
information''; and
(II) by striking ``data'' each place
it appears and inserting
``information''; and
(ii) <<NOTE: Federal Register, publication.>>
in subparagraph (B), by striking ``either initiate
a rulemaking proceeding under subsection (a) or if
such a proceeding is not initiated within such
period, publish in the Federal Register the
Administrator's reason for not initiating such a
proceeding'' and insert ``issue an order, enter
into a consent agreement, or initiate a rulemaking
proceeding under subsection (a), or, if such an
order or consent agreement is not issued or such a
proceeding is not initiated within such period,
publish in the Federal Register the
Administrator's reason for not issuing such an
order, entering into such a consent agreement, or
initiating such a proceeding''; and
(B) in paragraph (2)(A)--
(i) by striking ``eight members'' and
inserting ``ten members''; and
(ii) by adding at the end the following:
``(ix) One member appointed by the Chairman of the Consumer
Product Safety Commission from Commissioners or employees of the
Commission.
``(x) One member appointed by the Commissioner of Food and
Drugs from employees of the Food and Drug Administration.'';
(7) in subsection (f)--
(A) in paragraph (1), by striking ``test data'' and
inserting ``information''; and
(B) in the matter following paragraph (2)--
(i) by striking ``or will present'';
(ii) by striking ``from cancer, gene
mutations, or birth defects'';
(iii) by striking ``data or'';
(iv) by striking ``appropriate'' and inserting
``applicable''; and
(v) by inserting ``, made without
consideration of costs or other nonrisk factors,''
after ``publish in the Federal Register a
finding'';
(8) in subsection (g)--
(A) by amending the subsection heading to read as
follows: ``Petition for Protocols and Methodologies for
the Development of Information'';
(B) by striking ``test data'' each place it appears
and inserting ``information''; and
(C) by striking ``submit data'' and inserting
``submit information''; and
(9) by adding at the end the following:
``(h) Reduction of Testing on Vertebrates.--
``(1) In general.--The Administrator shall reduce and
replace, to the extent practicable, scientifically justified,
and consistent with the policies of this title, the use of
vertebrate
[[Page 130 STAT. 453]]
animals in the testing of chemical substances or mixtures under
this title by--
``(A) prior to making a request or adopting a
requirement for testing using vertebrate animals, and in
accordance with subsection (a)(3), taking into
consideration, as appropriate and to the extent
practicable and scientifically justified, reasonably
available existing information, including--
``(i) toxicity information;
``(ii) computational toxicology and
bioinformatics; and
``(iii) high-throughput screening methods and
the prediction models of those methods; and
``(B) encouraging and facilitating--
``(i) the use of scientifically valid test
methods and strategies that reduce or replace the
use of vertebrate animals while providing
information of equivalent or better scientific
quality and relevance that will support regulatory
decisions under this title;
``(ii) the grouping of 2 or more chemical
substances into scientifically appropriate
categories in cases in which testing of a chemical
substance would provide scientifically valid and
useful information on other chemical substances in
the category; and
``(iii) the formation of industry consortia to
jointly conduct testing to avoid unnecessary
duplication of tests, provided that such consortia
make all information from such testing available
to the Administrator.
``(2) Implementation of alternative testing methods.--To
promote the development and timely incorporation of new
scientifically valid test methods and strategies that are not
based on vertebrate animals, the Administrator shall--
``(A) <<NOTE: Deadline. Strategic plan.>> not later
than 2 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act,
develop a strategic plan to promote the development and
implementation of alternative test methods and
strategies to reduce, refine, or replace vertebrate
animal testing and provide information of equivalent or
better scientific quality and relevance for assessing
risks of injury to health or the environment of chemical
substances or mixtures through, for example--
``(i) computational toxicology and
bioinformatics;
``(ii) high-throughput screening methods;
``(iii) testing of categories of chemical
substances;
``(iv) tiered testing methods;
``(v) in vitro studies;
``(vi) systems biology;
``(vii) new or revised methods identified by
validation bodies such as the Interagency
Coordinating Committee on the Validation of
Alternative Methods or the Organization for
Economic Co-operation and Development; or
``(viii) industry consortia that develop
information submitted under this title;
``(B) as practicable, ensure that the strategic plan
developed under subparagraph (A) is reflected in the
development of requirements for testing under this
section;
[[Page 130 STAT. 454]]
``(C) <<NOTE: List.>> include in the strategic plan
developed under subparagraph (A) a list, which the
Administrator shall update on a regular basis, of
particular alternative test methods or strategies the
Administrator has identified that do not require new
vertebrate animal testing and are scientifically
reliable, relevant, and capable of providing information
of equivalent or better scientific reliability and
quality to that which would be obtained from vertebrate
animal testing;
``(D) <<NOTE: Public information.>> provide an
opportunity for public notice and comment on the
contents of the plan developed under subparagraph (A),
including the criteria for considering scientific
reliability and relevance of the test methods and
strategies that may be identified pursuant to
subparagraph (C);
``(E) <<NOTE: Effective date. Deadlines. Reports.>>
beginning on the date that is 5 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, and every 5 years thereafter,
submit to Congress a report that describes the progress
made in implementing the plan developed under
subparagraph (A) and goals for future alternative test
methods and strategies implementation; and
``(F) <<NOTE: Assessment.>> prioritize and, to the
extent consistent with available resources and the
Administrator's other responsibilities under this title,
carry out performance assessment, validation, and
translational studies to accelerate the development of
scientifically valid test methods and strategies that
reduce, refine, or replace the use of vertebrate
animals, including minimizing duplication, in any
testing under this title.
``(3) Voluntary testing.--
``(A) In general.--Any person developing information
for submission under this title on a voluntary basis and
not pursuant to any request or requirement by the
Administrator shall first attempt to develop the
information by means of an alternative test method or
strategy identified by the Administrator pursuant to
paragraph (2)(C), if the Administrator has identified
such a test method or strategy for the development of
such information, before conducting new vertebrate
animal testing.
``(B) Effect of paragraph.--Nothing in this
paragraph shall, under any circumstance, limit or
restrict the submission of any existing information to
the Administrator.
``(C) Relationship to other law.--A violation of
this paragraph shall not be a prohibited act under
section 15.
``(D) Review of means.--This paragraph authorizes,
but does not require, the Administrator to review the
means by which a person conducted testing described in
subparagraph (A).''.
SEC. 5. MANUFACTURING AND PROCESSING NOTICES.
Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
[[Page 130 STAT. 455]]
(i) by striking ``Except as provided in'' and
inserting ``(A) Except as provided in subparagraph
(B) of this paragraph and'';
(ii) by redesignating subparagraphs (A) and
(B) as clauses (i) and (ii), respectively;
(iii) by striking all that follows
``significant new use'' and inserting a period;
and
(iv) by adding at the end the following:
``(B) A person may take the actions described in
subparagraph (A) if--
``(i) <<NOTE: Deadline.>> such person submits to
the Administrator, at least 90 days before such
manufacture or processing, a notice, in accordance with
subsection (d), of such person's intention to
manufacture or process such substance and such person
complies with any applicable requirement of, or imposed
pursuant to, subsection (b), (e), or (f); and
``(ii) the Administrator--
``(I) <<NOTE: Review.>> conducts a review of
the notice; and
``(II) <<NOTE: Determination.>> makes a
determination under subparagraph (A), (B), or (C)
of paragraph (3) and takes the actions required in
association with that determination under such
subparagraph within the applicable review
period.''; and
(B) by adding at the end the following new
paragraphs:
``(3) Review and determination.--Within the applicable
review period, subject to section 18, the Administrator shall
review such notice and determine--
``(A) that the relevant chemical substance or
significant new use presents an unreasonable risk of
injury to health or the environment, without
consideration of costs or other nonrisk factors,
including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant by
the Administrator under the conditions of use, in which
case the Administrator shall take the actions required
under subsection (f);
``(B) that--
``(i) the information available to the
Administrator is insufficient to permit a reasoned
evaluation of the health and environmental effects
of the relevant chemical substance or significant
new use; or
``(ii)(I) in the absence of sufficient
information to permit the Administrator to make
such an evaluation, the manufacture, processing,
distribution in commerce, use, or disposal of such
substance, or any combination of such activities,
may present an unreasonable risk of injury to
health or the environment, without consideration
of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant
by the Administrator; or
``(II) such substance is or will be produced
in substantial quantities, and such substance
either enters or may reasonably be anticipated to
enter the environment in substantial quantities or
there is or may be significant or substantial
human exposure to the substance,
[[Page 130 STAT. 456]]
in which case the Administrator shall take the actions
required under subsection (e); or
``(C) that the relevant chemical substance or
significant new use is not likely to present an
unreasonable risk of injury to health or the
environment, without consideration of costs or other
nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation
identified as relevant by the Administrator under the
conditions of use, in which case the submitter of the
notice may commence manufacture of the chemical
substance or manufacture or processing for a significant
new use.
``(4) Failure to render determination.--
``(A) <<NOTE: Refund.>> Failure to render
determination.--If the Administrator fails to make a
determination on a notice under paragraph (3) by the end
of the applicable review period and the notice has not
been withdrawn by the submitter, the Administrator shall
refund to the submitter all applicable fees charged to
the submitter for review of the notice pursuant to
section 26(b), and the Administrator shall not be
relieved of any requirement to make such determination.
``(B) Limitations.--(i) A refund of applicable fees
under subparagraph (A) shall not be made if the
Administrator certifies that the submitter has not
provided information required under subsection (b) or
has otherwise unduly delayed the process such that the
Administrator is unable to render a determination within
the applicable review period.
``(ii) A failure of the Administrator to render a
decision shall not be deemed to constitute a withdrawal
of the notice.
``(iii) Nothing in this paragraph shall be construed
as relieving the Administrator or the submitter of the
notice from any requirement of this section.
``(5) Article consideration.--The Administrator may require
notification under this section for the import or processing of
a chemical substance as part of an article or category of
articles under paragraph (1)(A)(ii) if the Administrator makes
an affirmative finding in a rule under paragraph (2) that the
reasonable potential for exposure to the chemical substance
through the article or category of articles subject to the rule
justifies notification.'';
(2) in subsection (b)--
(A) in the subsection heading, by striking ``Test
Data'' and inserting ``Information'';
(B) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``test data'' and
inserting ``information''; and
(II) by striking ``such data'' and
inserting ``such information''; and
(ii) in subparagraph (B)--
(I) by striking ``test data'' and
inserting ``information'';
(II) by striking ``subsection
(a)(1)(A)'' and inserting ``subsection
(a)(1)(A)(i)''; and
[[Page 130 STAT. 457]]
(III) by striking ``subsection
(a)(1)(B)'' and inserting ``subsection
(a)(1)(A)(ii)'';
(C) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``test data'' in
clause (ii) and inserting
``information'';
(II) by striking ``shall'' and
inserting ``may''; and
(III) by striking ``data
prescribed'' and inserting ``information
prescribed''; and
(ii) in subparagraph (B)--
(I) by striking ``Data'' and
inserting ``Information'';
(II) by striking ``data'' both
places it appears and inserting
``information'';
(III) by striking ``show'' and
inserting ``shows'';
(IV) by striking ``subsection
(a)(1)(A)'' in clause (i) and inserting
``subsection (a)(1)(A)(i)''; and
(V) by striking ``subsection
(a)(1)(B)'' in clause (ii) and inserting
``subsection (a)(1)(A)(ii)'';
(D) in paragraph (3)--
(i) by striking ``Data'' and inserting
``Information''; and
(ii) by striking ``paragraph (1) or (2)'' and
inserting ``paragraph (1) or (2) of this
subsection or under subsection (e)''; and
(E) in paragraph (4)--
(i) in subparagraph (A)(i), by inserting ``,
without consideration of costs or other nonrisk
factors'' after ``health or the environment''; and
(ii) in subparagraph (C), by striking ``,
except that'' and all that follows through
``subparagraph (A)'';
(3) in subsection (c)--
(A) in the subsection heading, by striking
``Notice'' and inserting ``Review''; and
(B) by striking ``before which'' and all that
follows through ``subsection may begin'';
(4) in subsection (d)--
(A) by striking ``test data'' in paragraph (1)(B)
and inserting ``information'';
(B) by striking ``data'' each place it appears in
paragraph (1)(C) and paragraph (2) and inserting
``information'';
(C) in paragraph (2)(B), by striking ``uses or
intended uses of such substance'' and inserting ``uses
of such substance identified in the notice''; and
(D) in paragraph (3)--
(i) by striking ``for which the notification
period prescribed by subsection (a), (b), or (c)''
and inserting ``for which the applicable review
period''; and
(ii) by striking ``such notification period''
and inserting ``such period'';
(5) in subsection (e)--
(A) in paragraph (1)(A)--
(i) in clause (i), by striking ``; and'' and
inserting ``; or'';
(ii) in clause (ii)(I), by inserting ``without
consideration of costs or other nonrisk factors,
including an
[[Page 130 STAT. 458]]
unreasonable risk to a potentially exposed
subpopulation identified as relevant by the
Administrator under the conditions of use;'' after
``health or the environment,''; and
(iii) in the matter after clause (ii)(II)--
(I) by striking ``may issue a
proposed order'' and inserting ``shall
issue an order'';
(II) by striking ``notification
period applicable to the manufacturing
or processing of such substance under
subsection (a), (b), (c)'' and inserting
``applicable review period''; and
(III) by inserting ``to the extent
necessary to protect against an
unreasonable risk of injury to health or
the environment, without consideration
of costs or other nonrisk factors,
including an unreasonable risk to a
potentially exposed or susceptible
subpopulation identified as relevant by
the Administrator under the conditions
of use, and the submitter of the notice
may commence manufacture of the chemical
substance, or manufacture or processing
of the chemical substance for a
significant new use, including while any
required information is being developed,
only in compliance with the order''
before the period at the end;
(B) in paragraph (1)(B)--
(i) by striking ``A proposed order'' and
inserting ``An order'';
(ii) by striking ``notification period
applicable to the manufacture or processing of
such substance under subsection (a), (b), (c)''
and inserting ``applicable review period''; and
(iii) by striking ``of the proposed order''
and inserting ``of the order'';
(C) by striking paragraph (1)(C); and
(D) by striking paragraph (2);
(6) in subsection (f)--
(A) in paragraph (1)--
(i) by striking ``finds that there is a
reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use, or
disposal of a chemical substance with'' and
inserting ``determines that a chemical substance
or significant new use with'';
(ii) by striking ``, or that any combination
of such activities,'';
(iii) by striking ``or will present'';
(iv) by striking ``before a rule promulgated
under section 6 can protect against such risk,''
and inserting ``, without consideration of costs
or other nonrisk factors, including an
unreasonable risk to a potentially exposed
subpopulation identified as relevant by the
Administrator under the conditions of use,''; and
(v) by striking ``notification period
applicable under subsection (a), (b), or (c) to
the manufacturing or processing of such
substance'' and inserting ``applicable review
period'';
[[Page 130 STAT. 459]]
(B) in paragraph (2), the matter following
subparagraph (C), by striking ``Section 6(d)(2)(B)'' and
inserting ``Section 6(d)(3)(B)'';
(C) in paragraph (3)--
(i) in subparagraph (A)--
(I) by striking ``Administrator
may'' and all that follows through
``issue a proposed order to prohibit
the'' and inserting ``Administrator may
issue an order to prohibit or limit
the''; and
(II) by striking ``under paragraph
(1)'' and all that follows through
``processing of such substance.'' and
inserting ``under paragraph (1). Such
order shall take effect on the
expiration of the applicable review
period.'';
(ii) by striking subparagraph (B) and
redesignating subparagraph (C) as subparagraph
(B);
(iii) in subparagraph (B), as so
redesignated--
(I) by striking ``subparagraphs (B)
and (C)'' and inserting ``subparagraph
(B)'';
(II) by striking ``clause (i) of'';
and
(III) by striking ``; and the
provisions of subparagraph (C) of
subsection (e)(2) shall apply with
respect to an injunction issued under
subparagraph (B)''; and
(iv) by striking subparagraph (D); and
(D) by adding at the end the following:
``(4) <<NOTE: Deadline. Regulations. Publication.>>
Treatment of nonconforming uses.--Not later than 90 days after
taking an action under paragraph (2) or (3) or issuing an order
under subsection (e) relating to a chemical substance with
respect to which the Administrator has made a determination
under subsection (a)(3)(A) or (B), the Administrator shall
consider whether to promulgate a rule pursuant to subsection
(a)(2) that identifies as a significant new use any
manufacturing, processing, use, distribution in commerce, or
disposal of the chemical substance that does not conform to the
restrictions imposed by the action or order, and, as applicable,
initiate such a rulemaking or publish a statement describing the
reasons of the Administrator for not initiating such a
rulemaking.
``(5) <<NOTE: Consultation.>> Workplace exposures.--To the
extent practicable, the Administrator shall consult with the
Assistant Secretary of Labor for Occupational Safety and Health
prior to adopting any prohibition or other restriction relating
to a chemical substance with respect to which the Administrator
has made a determination under subsection (a)(3)(A) or (B) to
address workplace exposures.'';
(7) by amending subsection (g) to read as follows:
``(g) <<NOTE: Public information.>> Statement on Administrator
Finding.--If the Administrator finds in accordance with subsection
(a)(3)(C) that a chemical substance or significant new use is not likely
to present an unreasonable risk of injury to health or the environment,
then notwithstanding any remaining portion of the applicable review
period, the submitter of the notice may commence manufacture of the
chemical substance or manufacture or processing for the significant new
use, and the Administrator shall make public a statement of the
Administrator's finding. <<NOTE: Federal Register, publication.>> Such a
statement shall be submitted for publication in the Federal Register as
soon as
[[Page 130 STAT. 460]]
is practicable before the expiration of such period. Publication of such
statement in accordance with the preceding sentence is not a
prerequisite to the manufacturing or processing of the substance with
respect to which the statement is to be published.'';
(8) in subsection (h)--
(A) in paragraph (1)(A), by inserting ``, including
an unreasonable risk to a potentially exposed or
susceptible subpopulation identified by the
Administrator for the specific conditions of use
identified in the application'' after ``health or the
environment'';
(B) in paragraph (2), by striking ``data'' each
place it appears and inserting ``information''; and
(C) in paragraph (4), by striking ``. A rule
promulgated'' and all that follows through ``section
6(c)'' and inserting ``, including an unreasonable risk
to a potentially exposed or susceptible subpopulation
identified by the Administrator under the conditions of
use''; and
(9) by amending subsection (i) to read as follows:
``(i) Definitions.--(1) For purposes of this section, the terms
`manufacture' and `process' mean manufacturing or processing for
commercial purposes.
``(2) For purposes of this Act, the term `requirement' as used in
this section shall not displace any statutory or common law.
``(3) For purposes of this section, the term `applicable review
period' means the period starting on the date the Administrator receives
a notice under subsection (a)(1) and ending 90 days after that date, or
on such date as is provided for in subsection (b)(1) or (c).''.
SEC. 6. PRIORITIZATION, RISK EVALUATION, AND REGULATION OF
CHEMICAL SUBSTANCES AND MIXTURES.
Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) is
amended--
(1) by striking the section heading and inserting
``prioritization, risk evaluation, and regulation of chemical
substances and mixtures'';
(2) in subsection (a)--
(A) by striking ``finds that there is a reasonable
basis to conclude'' and inserting ``determines in
accordance with subsection (b)(4)(A)'';
(B) by striking ``or will present'';
(C) by inserting ``and subject to section 18, and in
accordance with subsection (c)(2),'' after ``shall by
rule'';
(D) by striking ``to protect adequately against such
risk using the least burdensome requirements'' and
inserting ``so that the chemical substance or mixture no
longer presents such risk'';
(E) by inserting ``or otherwise restricting'' after
``prohibiting'' in paragraphs (1)(A) and (2)(A);
(F) by inserting ``minimum'' before ``warnings''
both places it appears in paragraph (3);
(G) by striking ``and monitor or conduct tests'' and
inserting ``or monitor or conduct tests'' in paragraph
(4); and
(H) in paragraph (7)--
(i) by striking ``such unreasonable risk of
injury'' and inserting ``such determination''; and
[[Page 130 STAT. 461]]
(ii) by striking ``such risk of injury'' and
inserting ``such determination'';
(3) by amending subsection (b) to read as follows:
``(b) Risk Evaluations.--
``(1) Prioritization for risk evaluations.--
``(A) <<NOTE: Deadline. Criteria.>> Establishment
of process.--Not later than 1 year after the date of
enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, the Administrator shall establish,
by rule, a risk-based screening process, including
criteria for designating chemical substances as high-
priority substances for risk evaluations or low-priority
substances for which risk evaluations are not warranted
at the time. The process to designate the priority of
chemical substances shall include a consideration of the
hazard and exposure potential of a chemical substance or
a category of chemical substances (including
consideration of persistence and bioaccumulation,
potentially exposed or susceptible subpopulations and
storage near significant sources of drinking water), the
conditions of use or significant changes in the
conditions of use of the chemical substance, and the
volume or significant changes in the volume of the
chemical substance manufactured or processed.
``(B) Identification of priorities for risk
evaluation.--
``(i) High-priority substances.--The
Administrator shall designate as a high-priority
substance a chemical substance that the
Administrator concludes, without consideration of
costs or other nonrisk factors, may present an
unreasonable risk of injury to health or the
environment because of a potential hazard and a
potential route of exposure under the conditions
of use, including an unreasonable risk to a
potentially exposed or susceptible subpopulation
identified as relevant by the Administrator.
``(ii) Low-priority substances.--The
Administrator shall designate a chemical substance
as a low-priority substance if the Administrator
concludes, based on information sufficient to
establish, without consideration of costs or other
nonrisk factors, that such substance does not meet
the standard identified in clause (i) for
designating a chemical substance a high-priority
substance.
``(C) <<NOTE: Time periods.>> Information request
and review and proposed and final prioritization
designation.--The rulemaking required in subparagraph
(A) shall ensure that the time required to make a
priority designation of a chemical substance be no
shorter than nine months and no longer than 1 year, and
that the process for such designations includes--
``(i) a requirement that the Administrator
request interested persons to submit relevant
information on a chemical substance that the
Administrator has initiated the prioritization
process on, before proposing a priority
designation for the chemical substance, and
provide 90 days for such information to be
provided;
[[Page 130 STAT. 462]]
``(ii) <<NOTE: Publication. Public
information.>> a requirement that the
Administrator publish each proposed designation of
a chemical substance as a high- or low-priority
substance, along with an identification of the
information, analysis, and basis used to make the
proposed designations, and provide 90 days for
public comment on each such proposed designation;
and
``(iii) a process by which the Administrator
may extend the deadline in clause (i) for up to
three months in order to receive or evaluate
information required to be submitted in accordance
with section 4(a)(2)(B), subject to the limitation
that if the information available to the
Administrator at the end of such an extension
remains insufficient to enable the designation of
the chemical substance as a low-priority
substance, the Administrator shall designate the
chemical substance as a high-priority substance.
``(2) Initial risk evaluations and subsequent designations
of high- and low-priority substances.--
``(A) <<NOTE: Deadline. Publication. Lists. Time
period.>> Initial risk evaluations.--Not later than 180
days after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, the
Administrator shall ensure that risk evaluations are
being conducted on 10 chemical substances drawn from the
2014 update of the TSCA Work Plan for Chemical
Assessments and shall publish the list of such chemical
substances during the 180 day period.
``(B) <<NOTE: Deadline.>> Additional risk
evaluations.--Not later than three and one half years
after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, the
Administrator shall ensure that risk evaluations are
being conducted on at least 20 high-priority substances
and that at least 20 chemical substances have been
designated as low-priority substances, subject to the
limitation that at least 50 percent of all chemical
substances on which risk evaluations are being conducted
by the Administrator are drawn from the 2014 update of
the TSCA Work Plan for Chemical Assessments.
``(C) Continuing designations and risk
evaluations.--The Administrator shall continue to
designate priority substances and conduct risk
evaluations in accordance with this subsection at a pace
consistent with the ability of the Administrator to
complete risk evaluations in accordance with the
deadlines under paragraph (4)(G).
``(D) Preference.--In designating high-priority
substances, the Administrator shall give preference to--
``(i) chemical substances that are listed in
the 2014 update of the TSCA Work Plan for Chemical
Assessments as having a Persistence and
Bioaccumulation Score of 3; and
``(ii) chemical substances that are listed in
the 2014 update of the TSCA Work Plan for Chemical
Assessments that are known human carcinogens and
have high acute and chronic toxicity.
``(E) Metals and metal compounds.--In identifying
priorities for risk evaluation and conducting risk
evaluations of metals and metal compounds, the
Administrator
[[Page 130 STAT. 463]]
shall use the Framework for Metals Risk Assessment of
the Office of the Science Advisor, Risk Assessment
Forum, and dated March 2007, or a successor document
that addresses metals risk assessment and is peer
reviewed by the Science Advisory Board.
``(3) Initiation of risk evaluations; designations.--
``(A) Risk evaluation initiation.--Upon designating
a chemical substance as a high-priority substance, the
Administrator shall initiate a risk evaluation on the
substance.
``(B) Revision.--The Administrator may revise the
designation of a low-priority substance based on
information made available to the Administrator.
``(C) Ongoing designations.--The Administrator shall
designate at least one high-priority substance upon the
completion of each risk evaluation (other than risk
evaluations for chemical substances designated under
paragraph (4)(C)(ii)).
``(4) Risk evaluation process and deadlines.--
``(A) <<NOTE: Determination.>> In general.--The
Administrator shall conduct risk evaluations pursuant to
this paragraph to determine whether a chemical substance
presents an unreasonable risk of injury to health or the
environment, without consideration of costs or other
nonrisk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.
``(B) <<NOTE: Deadline.>> Establishment of
process.--Not later than 1 year after the date of
enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, the Administrator shall establish,
by rule, a process to conduct risk evaluations in
accordance with subparagraph (A).
``(C) <<NOTE: Publication.>> Requirement.--The
Administrator shall conduct and publish risk
evaluations, in accordance with the rule promulgated
under subparagraph (B), for a chemical substance--
``(i) that has been identified under paragraph
(2)(A) or designated under paragraph (1)(B)(i);
and
``(ii) subject to subparagraph (E), that a
manufacturer of the chemical substance has
requested, in a form and manner and using the
criteria prescribed by the Administrator in the
rule promulgated under subparagraph (B), be
subjected to a risk evaluation.
``(D) <<NOTE: Deadlines. Publications.>> Scope.--
The Administrator shall, not later than 6 months after
the initiation of a risk evaluation, publish the scope
of the risk evaluation to be conducted, including the
hazards, exposures, conditions of use, and the
potentially exposed or susceptible subpopulations the
Administrator expects to consider, and, for each
designation of a high-priority substance, ensure not
less than 12 months between the initiation of the
prioritization process for the chemical substance and
the publication of the scope of the risk evaluation for
the chemical substance, and for risk evaluations
conducted on chemical substances that have been
identified under paragraph (2)(A) or selected under
subparagraph (E)(iv)(II) of this paragraph, ensure
[[Page 130 STAT. 464]]
not less than 3 months before the Administrator
publishes the scope of the risk evaluation.
``(E) Limitation and criteria.--
``(i) Percentage requirements.--The
Administrator shall ensure that, of the number of
chemical substances that undergo a risk evaluation
under clause (i) of subparagraph (C), the number
of chemical substances undergoing a risk
evaluation under clause (ii) of subparagraph (C)
is--
``(I) not less than 25 percent, if
sufficient requests are made under
clause (ii) of subparagraph (C); and
``(II) not more than 50 percent.
``(ii) Requested risk evaluations.--Requests
for risk evaluations under subparagraph (C)(ii)
shall be subject to the payment of fees pursuant
to section 26(b), and the Administrator shall not
expedite or otherwise provide special treatment to
such risk evaluations.
``(iii) Preference.--In deciding whether to
grant requests under subparagraph (C)(ii), the
Administrator shall give preference to requests
for risk evaluations on chemical substances for
which the Administrator determines that
restrictions imposed by 1 or more States have the
potential to have a significant impact on
interstate commerce or health or the environment.
``(iv) Exceptions.--(I) Chemical substances
for which requests have been granted under
subparagraph (C)(ii) shall not be subject to
section 18(b).
``(II) Requests for risk evaluations on
chemical substances which are made under
subparagraph (C)(ii) and that are drawn from the
2014 update of the TSCA Work Plan for Chemical
Assessments shall be granted at the discretion of
the Administrator and not be subject to clause
(i)(II).
``(F) Requirements.--In conducting a risk evaluation
under this subsection, the Administrator shall--
``(i) <<NOTE: Assessment.>> integrate and
assess available information on hazards and
exposures for the conditions of use of the
chemical substance, including information that is
relevant to specific risks of injury to health or
the environment and information on potentially
exposed or susceptible subpopulations identified
as relevant by the Administrator;
``(ii) describe whether aggregate or sentinel
exposures to a chemical substance under the
conditions of use were considered, and the basis
for that consideration;
``(iii) not consider costs or other nonrisk
factors;
``(iv) take into account, where relevant, the
likely duration, intensity, frequency, and number
of exposures under the conditions of use of the
chemical substance; and
``(v) describe the weight of the scientific
evidence for the identified hazard and exposure.
``(G) Deadlines.--The Administrator--
[[Page 130 STAT. 465]]
``(i) shall complete a risk evaluation for a
chemical substance as soon as practicable, but not
later than 3 years after the date on which the
Administrator initiates the risk evaluation under
subparagraph (C); and
``(ii) may extend the deadline for a risk
evaluation for not more than 6 months.
``(H) <<NOTE: Time period.>> Notice and comment.--
The Administrator shall provide no less than 30 days
public notice and an opportunity for comment on a draft
risk evaluation prior to publishing a final risk
evaluation.'';
(4) by amending subsection (c) to read as follows:
``(c) Promulgation of Subsection (a) Rules.--
``(1) <<NOTE: Determination. Federal Register,
publication.>> Deadlines.--If the Administrator determines that
a chemical substance presents an unreasonable risk of injury to
health or the environment in accordance with subsection
(b)(4)(A), the Administrator--
``(A) shall propose in the Federal Register a rule
under subsection (a) for the chemical substance not
later than 1 year after the date on which the final risk
evaluation regarding the chemical substance is
published;
``(B) shall publish in the Federal Register a final
rule not later than 2 years after the date on which the
final risk evaluation regarding the chemical substance
is published; and
``(C) may extend the deadlines under this paragraph
for not more than 2 years, subject to the condition that
the aggregate length of extensions under this
subparagraph and subsection (b)(4)(G)(ii) does not
exceed 2 years, and subject to the limitation that the
Administrator may not extend a deadline for the
publication of a proposed or final rule regarding a
chemical substance drawn from the 2014 update of the
TSCA Work Plan for Chemical Assessments or a chemical
substance that, with respect to persistence and
bioaccumulation, scores high for 1 and either high or
moderate for the other, pursuant to the TSCA Work Plan
Chemicals Methods Document published by the
Administrator in February 2012 (or a successor scoring
system), without adequate public justification that
demonstrates, following a review of the information
reasonably available to the Administrator, that the
Administrator cannot complete the proposed or final rule
without additional information regarding the chemical
substance.
``(2) Requirements for rule.--
``(A) <<NOTE: Publication.>> Statement of
effects.--In proposing and promulgating a rule under
subsection (a) with respect to a chemical substance or
mixture, the Administrator shall consider and publish a
statement based on reasonably available information with
respect to--
``(i) the effects of the chemical substance or
mixture on health and the magnitude of the
exposure of human beings to the chemical substance
or mixture;
``(ii) the effects of the chemical substance
or mixture on the environment and the magnitude of
the exposure of the environment to such substance
or mixture;
[[Page 130 STAT. 466]]
``(iii) the benefits of the chemical substance
or mixture for various uses; and
``(iv) the reasonably ascertainable economic
consequences of the rule, including consideration
of--
``(I) the likely effect of the rule
on the national economy, small business,
technological innovation, the
environment, and public health;
``(II) the costs and benefits of the
proposed and final regulatory action and
of the 1 or more primary alternative
regulatory actions considered by the
Administrator; and
``(III) the cost effectiveness of
the proposed regulatory action and of
the 1 or more primary alternative
regulatory actions considered by the
Administrator.
``(B) Selecting requirements.--In selecting among
prohibitions and other restrictions, the Administrator
shall factor in, to the extent practicable, the
considerations under subparagraph (A) in accordance with
subsection (a).
``(C) Consideration of alternatives.--Based on the
information published under subparagraph (A), in
deciding whether to prohibit or restrict in a manner
that substantially prevents a specific condition of use
of a chemical substance or mixture, and in setting an
appropriate transition period for such action, the
Administrator shall consider, to the extent practicable,
whether technically and economically feasible
alternatives that benefit health or the environment,
compared to the use so proposed to be prohibited or
restricted, will be reasonably available as a substitute
when the proposed prohibition or other restriction takes
effect.
``(D) Replacement parts.--
``(i) <<NOTE: Exemption.>> In general.--The
Administrator shall exempt replacement parts for
complex durable goods and complex consumer goods
that are designed prior to the date of publication
in the Federal Register of the rule under
subsection (a), unless the Administrator finds
that such replacement parts contribute
significantly to the risk, identified in a risk
evaluation conducted under subsection (b)(4)(A),
to the general population or to an identified
potentially exposed or susceptible subpopulation.
``(ii) Definitions.--In this subparagraph--
``(I) the term `complex consumer
goods' means electronic or mechanical
devices composed of multiple
manufactured components, with an
intended useful life of 3 or more years,
where the product is typically not
consumed, destroyed, or discarded after
a single use, and the components of
which would be impracticable to redesign
or replace; and
``(II) the term `complex durable
goods' means manufactured goods composed
of 100 or more manufactured components,
with an intended useful life of 5 or
more years, where the product is
typically not consumed, destroyed, or
discarded after a single use.
[[Page 130 STAT. 467]]
``(E) <<NOTE: Applicability.>> Articles.--In
selecting among prohibitions and other restrictions, the
Administrator shall apply such prohibitions or other
restrictions to an article or category of articles
containing the chemical substance or mixture only to the
extent necessary to address the identified risks from
exposure to the chemical substance or mixture from the
article or category of articles so that the substance or
mixture does not present an unreasonable risk of injury
to health or the environment identified in the risk
evaluation conducted in accordance with subsection
(b)(4)(A).
``(3) Procedures.--When prescribing a rule under subsection
(a) the Administrator shall proceed in accordance with section
553 of title 5, United States Code (without regard to any
reference in such section to sections 556 and 557 of such
title), and shall also--
``(A) <<NOTE: Publication. Notice.>> publish a
notice of proposed rulemaking stating with particularity
the reason for the proposed rule;
``(B) <<NOTE: Public information.>> allow
interested persons to submit written data, views, and
arguments, and make all such submissions publicly
available;
``(C) promulgate a final rule based on the matter in
the rulemaking record; and
``(D) <<NOTE: Publication.>> make and publish with
the rule the determination described in subsection
(a).'';
(5) in subsection (d)--
(A) by redesignating paragraph (2) as paragraph (3);
(B) by striking paragraph (1) and inserting the
following:
``(1) <<NOTE: Compliance dates. Deadline. Effective date.>>
In general.--In any rule under subsection (a), the Administrator
shall--
``(A) specify the date on which it shall take
effect, which date shall be as soon as practicable;
``(B) except as provided in subparagraphs (C) and
(D), specify mandatory compliance dates for all of the
requirements under a rule under subsection (a), which
shall be as soon as practicable, but not later than 5
years after the date of promulgation of the rule, except
in a case of a use exempted under subsection (g);
``(C) specify mandatory compliance dates for the
start of ban or phase-out requirements under a rule
under subsection (a), which shall be as soon as
practicable, but not later than 5 years after the date
of promulgation of the rule, except in the case of a use
exempted under subsection (g);
``(D) specify mandatory compliance dates for full
implementation of ban or phase-out requirements under a
rule under subsection (a), which shall be as soon as
practicable; and
``(E) provide for a reasonable transition period.
``(2) <<NOTE: Determination.>> Variability.--As determined
by the Administrator, the compliance dates established under
paragraph (1) may vary for different affected persons.''; and
(C) in paragraph (3), as so redesignated by
subparagraph (A) of this paragraph--
(i) in subparagraph (A)--
(I) by striking ``upon its
publication'' and all that follows
through ``respecting such rule if'' and
[[Page 130 STAT. 468]]
inserting ``, and compliance with the
proposed requirements to be mandatory,
upon publication in the Federal Register
of the proposed rule and until the
compliance dates applicable to such
requirements in a final rule promulgated
under section 6(a) or until the
Administrator revokes such proposed
rule, in accordance with subparagraph
(B), if''; and
(II) in clause (i)(I), by inserting
``without consideration of costs or
other non-risk factors'' after
``effective date''; and
(ii) in subparagraph (B), by striking ``,
provide reasonable opportunity'' and all that
follows through the period at the end and
inserting ``in accordance with subsection (c), and
either promulgate such rule (as proposed or with
modifications) or revoke it.'';
(6) in subsection (e)(4), by striking ``paragraphs (2), (3),
and (4)'' and inserting ``paragraph (3)''; and
(7) by adding at the end the following new subsections:
``(g) Exemptions.--
``(1) Criteria for exemption.--The Administrator may, as
part of a rule promulgated under subsection (a), or in a
separate rule, grant an exemption from a requirement of a
subsection (a) rule for a specific condition of use of a
chemical substance or mixture, if the Administrator finds that--
``(A) the specific condition of use is a critical or
essential use for which no technically and economically
feasible safer alternative is available, taking into
consideration hazard and exposure;
``(B) compliance with the requirement, as applied
with respect to the specific condition of use, would
significantly disrupt the national economy, national
security, or critical infrastructure; or
``(C) the specific condition of use of the chemical
substance or mixture, as compared to reasonably
available alternatives, provides a substantial benefit
to health, the environment, or public safety.
``(2) <<NOTE: Public information.>> Exemption analysis and
statement.--In proposing an exemption under this subsection, the
Administrator shall analyze the need for the exemption, and
shall make public the analysis and a statement describing how
the analysis was taken into account.
``(3) <<NOTE: Determination.>> Period of exemption.--The
Administrator shall establish, as part of a rule under this
subsection, a time limit on any exemption for a time to be
determined by the Administrator as reasonable on a case-by-case
basis, and, by rule, may extend, modify, or eliminate an
exemption if the Administrator determines, on the basis of
reasonably available information and after adequate public
justification, the exemption warrants extension or modification
or is no longer necessary.
``(4) <<NOTE: Records. Reports. Determination.>>
Conditions.--As part of a rule promulgated under this
subsection, the Administrator shall include conditions,
including reasonable recordkeeping, monitoring, and reporting
requirements, to the extent that the Administrator determines
the conditions are necessary to protect health and the
environment while achieving the purposes of the exemption.
[[Page 130 STAT. 469]]
``(h) Chemicals That Are Persistent, Bioaccumulative, and Toxic.--
``(1) <<NOTE: Deadline.>> Expedited action.--Not later than
3 years after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, the Administrator
shall propose rules under subsection (a) with respect to
chemical substances identified in the 2014 update of the TSCA
Work Plan for Chemical Assessments--
``(A) that the Administrator has a reasonable basis
to conclude are toxic and that with respect to
persistence and bioaccumulation score high for one and
either high or moderate for the other, pursuant to the
TSCA Work Plan Chemicals Methods Document published by
the Administrator in February 2012 (or a successor
scoring system), and are not a metal or a metal
compound, and for which the Administrator has not
completed a Work Plan Problem Formulation, initiated a
review under section 5, or entered into a consent
agreement under section 4, prior to the date of
enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act; and
``(B) exposure to which under the conditions of use
is likely to the general population or to a potentially
exposed or susceptible subpopulation identified by the
Administrator, or the environment, on the basis of an
exposure and use assessment conducted by the
Administrator.
``(2) No risk evaluation required.--The Administrator shall
not be required to conduct risk evaluations on chemical
substances that are subject to paragraph (1).
``(3) <<NOTE: Deadline.>> Final rule.--Not later than 18
months after proposing a rule pursuant to paragraph (1), the
Administrator shall promulgate a final rule under subsection
(a).
``(4) Selecting restrictions.--In selecting among
prohibitions and other restrictions promulgated in a rule under
subsection (a) pursuant to paragraph (1), the Administrator
shall address the risks of injury to health or the environment
that the Administrator determines are presented by the chemical
substance and shall reduce exposure to the substance to the
extent practicable.
``(5) <<NOTE: Time period.>> Relationship to subsection
(b).--If, at any time prior to the date that is 90 days after
the date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the Administrator makes a designation
under subsection (b)(1)(B)(i), or receives a request under
subsection (b)(4)(C)(ii), such chemical substance shall not be
subject to this subsection, except that in selecting among
prohibitions and other restrictions promulgated in a rule
pursuant to subsection (a), the Administrator shall both ensure
that the chemical substance meets the rulemaking standard under
subsection (a) and reduce exposure to the substance to the
extent practicable.
``(i) Final Agency Action.--Under this section and subject to
section 18--
``(1) <<NOTE: Determination. Effective date.>> a
determination by the Administrator under subsection (b)(4)(A)
that a chemical substance does not present an unreasonable risk
of injury to health or the environment shall be issued by order
and considered to be a final agency action, effective beginning
on the date of issuance of the order; and
[[Page 130 STAT. 470]]
``(2) a final rule promulgated under subsection (a),
including the associated determination by the Administrator
under subsection (b)(4)(A) that a chemical substance presents an
unreasonable risk of injury to health or the environment, shall
be considered to be a final agency action, effective beginning
on the date of promulgation of the final rule.
``(j) Definition.--For the purposes of this Act, the term
`requirement' as used in this section shall not displace statutory or
common law.''.
SEC. 7. IMMINENT HAZARDS.
Section 7 of the Toxic Substances Control Act (15 U.S.C. 2606) is
amended--
(1) in subsection (b)(1), by inserting ``(as identified by
the Administrator without consideration of costs or other
nonrisk factors)'' after ``from the unreasonable risk''; and
(2) in subsection (f), by inserting ``, without
consideration of costs or other nonrisk factors'' after
``widespread injury to health or the environment''.
SEC. 8. REPORTING AND RETENTION OF INFORMATION.
(a) In General.--Section 8 of the Toxic Substances Control Act (15
U.S.C. 2607) is amended--
(1) in subsection (a)--
(A) in paragraph (2), by striking the matter that
follows subparagraph (G);
(B) in paragraph (3), by adding at the end the
following:
``(C) <<NOTE: Time period. Consultation.>> Not later than 180 days
after the date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, and not less frequently than once every 10
years thereafter, the Administrator, after consultation with the
Administrator of the Small Business Administration, shall--
``(i) <<NOTE: Review.>> review the adequacy of the
standards prescribed under subparagraph (B); and
``(ii) <<NOTE: Public information. Determination.>> after
providing public notice and an opportunity for comment, make a
determination as to whether revision of the standards is
warranted.''; and
(C) by adding at the end the following:
``(4) Contents.--The rules promulgated pursuant to paragraph
(1)--
``(A) may impose differing reporting and
recordkeeping requirements on manufacturers and
processors; and
``(B) shall include the level of detail necessary to
be reported, including the manner by which use and
exposure information may be reported.
``(5) Administration.--In carrying out this section, the
Administrator shall, to the extent feasible--
``(A) not require reporting which is unnecessary or
duplicative;
``(B) minimize the cost of compliance with this
section and the rules issued thereunder on small
manufacturers and processors; and
``(C) <<NOTE: Applicability.>> apply any reporting
obligations to those persons likely to have information
relevant to the effective implementation of this title.
``(6) <<NOTE: Publications.>> Negotiated rulemaking.--(A)
The Administrator shall enter into a negotiated rulemaking
pursuant to subchapter III of chapter 5 of title 5, United
States Code, to develop
[[Page 130 STAT. 471]]
and publish, not later than 3 years after the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st Century
Act, a proposed rule providing for limiting the reporting
requirements, under this subsection, for manufacturers of any
inorganic byproducts, when such byproducts, whether by the
byproduct manufacturer or by any other person, are subsequently
recycled, reused, or reprocessed.
``(B) Not later than 3 and one-half years after such date of
enactment, the Administrator shall publish a final rule
resulting from such negotiated rulemaking.''; and
(2) in subsection (b), by adding at the end the following:
``(3) Nomenclature.--
``(A) In general.--In carrying out paragraph (1),
the Administrator shall--
``(i) maintain the use of Class 2 nomenclature
in use on the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act;
``(ii) maintain the use of the Soap and
Detergent Association Nomenclature System,
published in March 1978 by the Administrator in
section 1 of addendum III of the document entitled
`Candidate List of Chemical Substances', and
further described in the appendix A of volume I of
the 1985 edition of the Toxic Substances Control
Act Substances Inventory (EPA Document No. EPA-
560/7-85-002a); and
``(iii) treat the individual members of the
categories of chemical substances identified by
the Administrator as statutory mixtures, as
defined in Inventory descriptions established by
the Administrator, as being included on the list
established under paragraph (1).
``(B) Multiple nomenclature listings.--If a
manufacturer or processor demonstrates to the
Administrator that a chemical substance appears multiple
times on the list published under paragraph (1) under
different CAS numbers, the Administrator may recognize
the multiple listings as a single chemical substance.
``(4) Chemical substances in commerce.--
``(A) Rules.--
``(i) <<NOTE: Notification. Federal Register,
publication. Time period.>> In general.--Not
later than 1 year after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator, by rule,
shall require manufacturers, and may require
processors, subject to the limitations under
subsection (a)(5)(A), to notify the Administrator,
by not later than 180 days after the date on which
the final rule is published in the Federal
Register, of each chemical substance on the list
published under paragraph (1) that the
manufacturer or processor, as applicable, has
manufactured or processed for a nonexempt
commercial purpose during the 10-year period
ending on the day before the date of enactment of
the Frank R. Lautenberg Chemical Safety for the
21st Century Act.
``(ii) Active substances.--The Administrator
shall designate chemical substances for which
notices are received under clause (i) to be active
substances on the list published under paragraph
(1).
[[Page 130 STAT. 472]]
``(iii) Inactive substances.--The
Administrator shall designate chemical substances
for which no notices are received under clause (i)
to be inactive substances on the list published
under paragraph (1).
``(iv) Limitation.--No chemical substance on
the list published under paragraph (1) shall be
removed from such list by reason of the
implementation of this subparagraph, or be subject
to section 5(a)(1)(A)(i) by reason of a change to
active status under paragraph (5)(B).
``(B) <<NOTE: Claims.>> Confidential chemical
substances.--In promulgating a rule under subparagraph
(A), the Administrator shall--
``(i) <<NOTE: List.>> maintain the list under
paragraph (1), which shall include a confidential
portion and a nonconfidential portion consistent
with this section and section 14;
``(ii) <<NOTE: Notice.>> require any
manufacturer or processor of a chemical substance
on the confidential portion of the list published
under paragraph (1) that seeks to maintain an
existing claim for protection against disclosure
of the specific chemical identity of the chemical
substance as confidential pursuant to section 14
to submit a notice under subparagraph (A) that
includes such request;
``(iii) require the substantiation of those
claims pursuant to section 14 and in accordance
with the review plan described in subparagraph
(C); and
``(iv) move any active chemical substance for
which no request was received to maintain an
existing claim for protection against disclosure
of the specific chemical identity of the chemical
substance as confidential from the confidential
portion of the list published under paragraph (1)
to the nonconfidential portion of that list.
``(C) <<NOTE: Regulations.>> Review plan.--Not
later than 1 year after the date on which the
Administrator compiles the initial list of active
substances pursuant to subparagraph (A), the
Administrator shall promulgate a rule that establishes a
plan to review all claims to protect the specific
chemical identities of chemical substances on the
confidential portion of the list published under
paragraph (1) that are asserted pursuant to subparagraph
(B).
``(D) <<NOTE: Claims.>> Requirements of review
plan.--In establishing the review plan under
subparagraph (C), the Administrator shall--
``(i) <<NOTE: Time period.>> require, at a
time specified by the Administrator, all
manufacturers or processors asserting claims under
subparagraph (B) to substantiate the claim, in
accordance with section 14, unless the
manufacturer or processor has substantiated the
claim in a submission made to the Administrator
during the 5-year period ending on the last day of
the of the time period specified by the
Administrator; and
``(ii) in accordance with section 14--
``(I) review each substantiation--
[[Page 130 STAT. 473]]
``(aa) submitted pursuant to
clause (i) to determine if the
claim qualifies for protection
from disclosure; and
``(bb) <<NOTE: Determination.>>
submitted previously by a
manufacturer or processor and
relied on in lieu of the
substantiation required pursuant
to clause (i), if the
substantiation has not been
previously reviewed by the
Administrator, to determine if
the claim warrants protection
from disclosure;
``(II) approve, approve in part and
deny in part, or deny each claim; and
``(III) <<NOTE: Time period.>>
except as provided in this section and
section 14, protect from disclosure
information for which the Administrator
approves such a claim for a period of 10
years, unless, prior to the expiration
of the period--
``(aa) <<NOTE: Notification.>>
the person notifies the
Administrator that the person is
withdrawing the claim, in which
case the Administrator shall not
protect the information from
disclosure; or
``(bb) the Administrator
otherwise becomes aware that the
information does not qualify for
protection from disclosure, in
which case the Administrator
shall take the actions described
in section 14(g)(2).
``(E) <<NOTE: Claims.>> Timeline for completion of
reviews.--
``(i) In general.--The Administrator shall
implement the review plan so as to complete
reviews of all claims specified in subparagraph
(C) not later than 5 years after the date on which
the Administrator compiles the initial list of
active substances pursuant to subparagraph (A).
``(ii) Considerations.--
``(I) <<NOTE: Determination.>> In
general.--The Administrator may extend
the deadline for completion of the
reviews for not more than 2 additional
years, after an adequate public
justification, if the Administrator
determines that the extension is
necessary based on the number of claims
needing review and the available
resources.
``(II) <<NOTE: Publication.>>
Annual review goal and results.--At the
beginning of each year, the
Administrator shall publish an annual
goal for reviews and the number of
reviews completed in the prior year.
``(5) Active and inactive substances.--
``(A) In general.--The Administrator shall keep
designations of active substances and inactive
substances on the list published under paragraph (1)
current.
``(B) Change to active status.--
``(i) <<NOTE: Notification.>> In general.--
Any person that intends to manufacture or process
for a nonexempt commercial purpose a chemical
substance that is designated as an inactive
substance shall notify the Administrator before
the date on which the inactive substance is
manufactured or processed.
[[Page 130 STAT. 474]]
``(ii) <<NOTE: Claims.>> Confidential
chemical identity.--If a person submitting a
notice under clause (i) for an inactive substance
on the confidential portion of the list published
under paragraph (1) seeks to maintain an existing
claim for protection against disclosure of the
specific chemical identity of the inactive
substance as confidential, the person shall,
consistent with the requirements of section 14--
``(I) in the notice submitted under
clause (i), assert the claim; and
``(II) by not later than 30 days
after providing the notice under clause
(i), substantiate the claim.
``(iii) Active status.--On receiving a
notification under clause (i), the Administrator
shall--
``(I) designate the applicable
chemical substance as an active
substance;
``(II) <<NOTE: Review.>> pursuant
to section 14, promptly review any claim
and associated substantiation submitted
pursuant to clause (ii) for protection
against disclosure of the specific
chemical identity of the chemical
substance and approve, approve in part
and deny in part, or deny the claim;
``(III) <<NOTE: Time period.>>
except as provided in this section and
section 14, protect from disclosure the
specific chemical identity of the
chemical substance for which the
Administrator approves a claim under
subclause (II) for a period of 10 years,
unless, prior to the expiration of the
period--
``(aa) <<NOTE: Notification.>>
the person notifies the
Administrator that the person is
withdrawing the claim, in which
case the Administrator shall not
protect the information from
disclosure; or
``(bb) the Administrator
otherwise becomes aware that the
information does not qualify for
protection from disclosure, in
which case the Administrator
shall take the actions described
in section 14(g)(2); and
``(IV) <<NOTE: Review.>> pursuant
to section 6(b), review the priority of
the chemical substance as the
Administrator determines to be
necessary.
``(C) Category status.--The list of inactive
substances shall not be considered to be a category for
purposes of section 26(c).
``(6) Interim list of active substances.--Prior to the
promulgation of the rule required under paragraph (4)(A), the
Administrator shall designate the chemical substances reported
under part 711 of title 40, Code of Federal Regulations (as in
effect on the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act), during the reporting
period that most closely preceded the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st Century Act, as
the interim list of active substances for the purposes of
section 6(b).
``(7) Public information.--Subject to this subsection and
section 14, the Administrator shall make available to the
public--
[[Page 130 STAT. 475]]
``(A) each specific chemical identity on the
nonconfidential portion of the list published under
paragraph (1) along with the Administrator's designation
of the chemical substance as an active or inactive
substance;
``(B) the unique identifier assigned under section
14, accession number, generic name, and, if applicable,
premanufacture notice case number for each chemical
substance on the confidential portion of the list
published under paragraph (1) for which a claim of
confidentiality was received; and
``(C) the specific chemical identity of any active
substance for which--
``(i) a claim for protection against
disclosure of the specific chemical identity of
the active substance was not asserted, as required
under this subsection or section 14;
``(ii) all claims for protection against
disclosure of the specific chemical identity of
the active substance have been denied by the
Administrator; or
``(iii) the time period for protection against
disclosure of the specific chemical identity of
the active substance has expired.
``(8) Limitation.--No person may assert a new claim under
this subsection or section 14 for protection from disclosure of
a specific chemical identity of any active or inactive substance
for which a notice is received under paragraph (4)(A)(i) or
(5)(B)(i) that is not on the confidential portion of the list
published under paragraph (1).
``(9) Certification.--Under the rules promulgated under this
subsection, manufacturers and processors, as applicable, shall
be required--
``(A) to certify that each notice or substantiation
the manufacturer or processor submits complies with the
requirements of the rule, and that any confidentiality
claims are true and correct; and
``(B) <<NOTE: Records. Time period. Effective
date.>> to retain a record documenting compliance with
the rule and supporting confidentiality claims for a
period of 5 years beginning on the last day of the
submission period.''.
(b) Mercury Inventory.--Section 8(b) of the Toxic Substances Control
Act (15 U.S.C. 2607(b)) (as amended by subsection (a)) is further
amended by adding at the end the following:
``(10) Mercury.--
``(A) Definition of mercury.--In this paragraph,
notwithstanding section 3(2)(B), the term `mercury'
means--
``(i) elemental mercury; and
``(ii) a mercury compound.
``(B) <<NOTE: Federal Register, publication.>>
Publication.--Not later than April 1, 2017, and every 3
years thereafter, the Administrator shall carry out and
publish in the Federal Register an inventory of mercury
supply, use, and trade in the United States.
``(C) Process.--In carrying out the inventory under
subparagraph (B), the Administrator shall--
``(i) identify any manufacturing processes or
products that intentionally add mercury; and
[[Page 130 STAT. 476]]
``(ii) recommend actions, including proposed
revisions of Federal law or regulations, to
achieve further reductions in mercury use.
``(D) Reporting.--
``(i) <<NOTE: Determination. Regulations.>>
In general.--To assist in the preparation of the
inventory under subparagraph (B), any person who
manufactures mercury or mercury-added products or
otherwise intentionally uses mercury in a
manufacturing process shall make periodic reports
to the Administrator, at such time and including
such information as the Administrator shall
determine by rule promulgated not later than 2
years after the date of enactment of this
paragraph.
``(ii) Coordination.--To avoid duplication,
the Administrator shall coordinate the reporting
under this subparagraph with the Interstate
Mercury Education and Reduction Clearinghouse.
``(iii) Exemption.--Clause (i) shall not apply
to a person engaged in the generation, handling,
or management of mercury-containing waste, unless
that person manufactures or recovers mercury in
the management of that waste.''.
SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.
Section 9 of the Toxic Substances Control Act (15 U.S.C. 2608) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``has reasonable basis to
conclude'' and inserting ``determines'';
(ii) by striking ``or will present''; and
(iii) by inserting ``, without consideration
of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant
by the Administrator, under the conditions of
use,'' after ``or the environment'';
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``,
within the time period specified by the
Administrator in the report,'' after ``issues an
order''; and
(ii) in subparagraph (B), by inserting
``responds within the time period specified by the
Administrator in the report and'' before
``initiates, within 90'';
(C) by redesignating paragraph (3) as paragraph (6);
and
(D) by inserting after paragraph (2) the following:
``(3) <<NOTE: Reports. Time period. Deadline.>> The Administrator
shall take the actions described in paragraph (4) if the Administrator
makes a report under paragraph (1) with respect to a chemical substance
or mixture and the agency to which the report was made does not--
``(A) issue the order described in paragraph (2)(A) within
the time period specified by the Administrator in the report; or
``(B)(i) respond under paragraph (1) within the timeframe
specified by the Administrator in the report; and
``(ii) initiate action within 90 days of publication in the
Federal Register of the response described in clause (i).
[[Page 130 STAT. 477]]
``(4) If an agency to which a report is submitted under paragraph
(1) does not take the actions described in subparagraph (A) or (B) of
paragraph (3), the Administrator shall--
``(A) initiate or complete appropriate action under section
6; or
``(B) take any action authorized or required under section
7, as applicable.
``(5) This subsection shall not relieve the Administrator of any
obligation to take any appropriate action under section 6(a) or 7 to
address risks from the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance or mixture, or any
combination of those activities, that are not identified in a report
issued by the Administrator under paragraph (1).'';
(2) in subsection (b)--
(A) by striking ``The Administrator shall
coordinate'' and inserting ``(1) The Administrator shall
coordinate''; and
(B) by adding at the end the following:
``(2) <<NOTE: Determination.>> In making a determination under
paragraph (1) that it is in the public interest for the Administrator to
take an action under this title with respect to a chemical substance or
mixture rather than under another law administered in whole or in part
by the Administrator, the Administrator shall consider, based on
information reasonably available to the Administrator, all relevant
aspects of the risk described in paragraph (1) and a comparison of the
estimated costs and efficiencies of the action to be taken under this
title and an action to be taken under such other law to protect against
such risk.''; and
(3) by adding at the end the following:
``(e) Exposure Information.--In addition to the requirements of
subsection (a), if the Administrator obtains information related to
exposures or releases of a chemical substance or mixture that may be
prevented or reduced under another Federal law, including a law not
administered by the Administrator, the Administrator shall make such
information available to the relevant Federal agency or office of the
Environmental Protection Agency.''.
SEC. 10. EXPORTS.
(a) In General.--Section 12(a)(2) of the Toxic Substances Control
Act (15 U.S.C. 2611(a)(2)) is amended by striking ``will present'' and
inserting ``presents''.
(b) Prohibition on Export of Certain Mercury Compounds.--Section
12(c) of the Toxic Substances Control Act (15 U.S.C. 2611(c)) is
amended--
(1) in the subsection heading, by inserting ``and Mercury
Compounds'' after ``Mercury''; and
(2) by adding at the end the following:
``(7) Prohibition on export of certain mercury compounds.--
``(A) <<NOTE: Effective date.>> In general.--
Effective January 1, 2020, the export of the following
mercury compounds is prohibited:
``(i) Mercury (I) chloride or calomel.
``(ii) Mercury (II) oxide.
``(iii) Mercury (II) sulfate.
``(iv) Mercury (II) nitrate.
``(v) Cinnabar or mercury sulphide.
``(vi) Any mercury compound that the
Administrator adds to the list published under
subparagraph
[[Page 130 STAT. 478]]
(B) by rule, on determining that exporting that
mercury compound for the purpose of regenerating
elemental mercury is technically feasible.
``(B) <<NOTE: Deadline. Federal Register,
publication. List.>> Publication.--Not later than 90
days after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, and
as appropriate thereafter, the Administrator shall
publish in the Federal Register a list of the mercury
compounds that are prohibited from export under this
paragraph.
``(C) Petition.--Any person may petition the
Administrator to add a mercury compound to the list
published under subparagraph (B).
``(D) Environmentally sound disposal.--This
paragraph does not prohibit the export of mercury
compounds on the list published under subparagraph (B)
to member countries of the Organization for Economic Co-
operation and Development for environmentally sound
disposal, on the condition that no mercury or mercury
compounds so exported are to be recovered, recycled, or
reclaimed for use, or directly reused, after such
export.
``(E) <<NOTE: Evaluation.>> Report.--Not later than
5 years after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, the
Administrator shall evaluate any exports of mercury
compounds on the list published under subparagraph (B)
for disposal that occurred after such date of enactment
and shall submit to Congress a report that--
``(i) describes volumes and sources of mercury
compounds on the list published under subparagraph
(B) exported for disposal;
``(ii) identifies receiving countries of such
exports;
``(iii) describes methods of disposal used
after such export;
``(iv) identifies issues, if any, presented by
the export of mercury compounds on the list
published under subparagraph (B);
``(v) includes an evaluation of management
options in the United States for mercury compounds
on the list published under subparagraph (B), if
any, that are commercially available and
comparable in cost and efficacy to methods being
utilized in such receiving countries; and
``(vi) <<NOTE: Recommenda- tion.>> makes a
recommendation regarding whether Congress should
further limit or prohibit the export of mercury
compounds on the list published under subparagraph
(B) for disposal.
``(F) Effect on other law.--Nothing in this
paragraph shall be construed to affect the authority of
the Administrator under the Solid Waste Disposal Act (42
U.S.C. 6901 et seq.).''.
(c) Temporary Generator Accumulation.--Section 5 of the Mercury
Export Ban Act of 2008 (42 U.S.C. 6939f) is amended--
(1) in subsection (a)(2), by striking ``2013'' and inserting
``2019'';
(2) in subsection (b)--
(A) in paragraph (1)--
[[Page 130 STAT. 479]]
(i) by redesignating subparagraphs (A), (B),
and (C), as clauses (i), (ii), and (iii),
respectively and indenting appropriately;
(ii) in the first sentence, by striking
``After consultation'' and inserting the
following:
``(A) Assessment and collection.--After
consultation'';
(iii) in the second sentence, by striking
``The amount of such fees'' and inserting the
following:
``(B) Amount.--The amount of the fees described in
subparagraph (A)'';
(iv) in subparagraph (B) (as so designated)--
(I) in clause (i) (as so
redesignated), by striking ``publically
available not later than October 1,
2012'' and inserting ``publicly
available not later than October 1,
2018'';
(II) in clause (ii) (as so
redesignated), by striking ``and'';
(III) in clause (iii) (as so
redesignated), by striking the period at
the end and inserting ``, subject to
clause (iv); and''; and
(IV) by adding at the end the
following:
``(iv) for generators temporarily accumulating
elemental mercury in a facility subject to
subparagraphs (B) and (D)(iv) of subsection (g)(2)
if the facility designated in subsection (a) is
not operational by January 1, 2019, shall be
adjusted to subtract the cost of the temporary
accumulation during the period in which the
facility designated under subsection (a) is not
operational.''; and
(v) by adding at the end the following:
``(C) <<NOTE: Deadline.>> Conveyance of title and
permitting.--If the facility designated in subsection
(a) is not operational by January 1, 2020, the
Secretary--
``(i) shall immediately accept the conveyance
of title to all elemental mercury that has
accumulated in facilities in accordance with
subsection (g)(2)(D), before January 1, 2020, and
deliver the accumulated mercury to the facility
designated under subsection (a) on the date on
which the facility becomes operational;
``(ii) shall pay any applicable Federal
permitting costs, including the costs for permits
issued under section 3005(c) of the Solid Waste
Disposal Act (42 U.S.C. 6925(c)); and
``(iii) shall store, or pay the cost of
storage of, until the time at which a facility
designated in subsection (a) is operational,
accumulated mercury to which the Secretary has
title under this subparagraph in a facility that
has been issued a permit under section 3005(c) of
the Solid Waste Disposal Act (42 U.S.C.
6925(c)).''; and
(B) in paragraph (2), in the first sentence, by
striking ``paragraph (1)(C)'' and inserting ``paragraph
(1)(B)(iii)''; and
(3) in subsection (g)(2)--
(A) in the undesignated material at the end, by
striking ``This subparagraph'' and inserting the
following:
[[Page 130 STAT. 480]]
``(C) Subparagraph (B)'';
(B) in subparagraph (C) (as designated by
subparagraph (A)), by inserting ``of that subparagraph''
before the period at the end; and
(C) by adding at the end the following:
``(D) <<NOTE: Time period. Certification.>> A
generator producing elemental mercury incidentally from
the beneficiation or processing of ore or related
pollution control activities may accumulate the mercury
produced onsite that is destined for a facility
designated by the Secretary under subsection (a) for
more than 90 days without a permit issued under section
3005(c) of the Solid Waste Disposal Act (42 U.S.C.
6925(c)), and shall not be subject to the storage
prohibition of section 3004(j) of that Act (42 U.S.C.
6924(j)), if--
``(i) the Secretary is unable to accept the
mercury at a facility designated by the Secretary
under subsection (a) for reasons beyond the
control of the generator;
``(ii) the generator certifies in writing to
the Secretary that the generator will ship the
mercury to a designated facility when the
Secretary is able to accept the mercury;
``(iii) the generator certifies in writing to
the Secretary that the generator is storing only
mercury the generator has produced or recovered
onsite and will not sell, or otherwise place into
commerce, the mercury; and
``(iv) <<NOTE: Compliance.>> the generator
has obtained an identification number under
section 262.12 of title 40, Code of Federal
Regulations, and complies with the requirements
described in paragraphs (1) through (4) of section
262.34(a) of title 40, Code of Federal Regulations
(as in effect on the date of enactment of this
subparagraph).
``(E) <<NOTE: Deadline. Consultation. Guidance. Procedure
s.>> Management standards for temporary storage.--Not
later than January 1, 2017, the Secretary, after
consultation with the Administrator of the Environmental
Protection Agency and State agencies in affected States,
shall develop and make available guidance that
establishes procedures and standards for the management
and short-term storage of elemental mercury at a
generator covered under subparagraph (D), including
requirements to ensure appropriate use of flasks or
other suitable containers. Such procedures and standards
shall be protective of health and the environment and
shall ensure that the elemental mercury is stored in a
safe, secure, and effective manner. A generator may
accumulate mercury in accordance with subparagraph (D)
immediately upon enactment of this subparagraph, and
notwithstanding that guidance called for by this
paragraph has not been developed or made available.''.
(d) Interim Status.--Section 5(d)(1) of the Mercury Export Ban Act
of 2008 (42 U.S.C. 6939f(d)(1)) is amended--
(1) in the fourth sentence, by striking ``in existence on or
before January 1, 2013,''; and
(2) in the last sentence, by striking ``January 1, 2015''
and inserting ``January 1, 2020''.
[[Page 130 STAT. 481]]
SEC. 11. CONFIDENTIAL INFORMATION.
Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is
amended to read as follows:
``SEC. 14. CONFIDENTIAL INFORMATION.
``(a) In General.--Except as provided in this section, the
Administrator shall not disclose information that is exempt from
disclosure pursuant to subsection (a) of section 552 of title 5, United
States Code, by reason of subsection (b)(4) of that section--
``(1) that is reported to, or otherwise obtained by, the
Administrator under this Act; and
``(2) for which the requirements of subsection (c) are met.
In any proceeding under section 552(a) of title 5, United States Code,
to obtain information the disclosure of which has been denied because of
the provisions of this subsection, the Administrator may not rely on
section 552(b)(3) of such title to sustain the Administrator's action.
``(b) Information Not Protected From Disclosure.--
``(1) Mixed confidential and nonconfidential information.--
Information that is protected from disclosure under this
section, and which is mixed with information that is not
protected from disclosure under this section, does not lose its
protection from disclosure notwithstanding that it is mixed with
information that is not protected from disclosure.
``(2) Information from health and safety studies.--
Subsection (a) does not prohibit the disclosure of--
``(A) any health and safety study which is submitted
under this Act with respect to--
``(i) any chemical substance or mixture which,
on the date on which such study is to be disclosed
has been offered for commercial distribution; or
``(ii) any chemical substance or mixture for
which testing is required under section 4 or for
which notification is required under section 5;
and
``(B) any information reported to, or otherwise
obtained by, the Administrator from a health and safety
study which relates to a chemical substance or mixture
described in clause (i) or (ii) of subparagraph (A).
This paragraph does not authorize the disclosure of any
information, including formulas (including molecular structures)
of a chemical substance or mixture, that discloses processes
used in the manufacturing or processing of a chemical substance
or mixture or, in the case of a mixture, the portion of the
mixture comprised by any of the chemical substances in the
mixture.
``(3) Other information not protected from disclosure.--
Subsection (a) does not prohibit the disclosure of--
``(A) <<NOTE: Determination.>> any general
information describing the manufacturing volumes,
expressed as specific aggregated volumes or, if the
Administrator determines that disclosure of specific
aggregated volumes would reveal confidential
information, expressed in ranges; or
``(B) a general description of a process used in the
manufacture or processing and industrial, commercial, or
consumer functions and uses of a chemical substance,
mixture, or article containing a chemical substance or
mixture, including information specific to an industry
or industry
[[Page 130 STAT. 482]]
sector that customarily would be shared with the general
public or within an industry or industry sector.
``(4) Bans and phase-outs.--
``(A) <<NOTE: Regulation. Applicability.>> In
general.--If the Administrator promulgates a rule
pursuant to section 6(a) that establishes a ban or
phase-out of a chemical substance or mixture, the
protection from disclosure of any information under this
section with respect to the chemical substance or
mixture shall be presumed to no longer apply, subject to
subsection (g)(1)(E) and subparagraphs (B) and (C) of
this paragraph.
``(B) Limitations.--
``(i) <<NOTE: Applicability.>> Critical
use.--In the case of a chemical substance or
mixture for which a specific condition of use is
subject to an exemption pursuant to section 6(g),
if the Administrator establishes a ban or phase-
out described in subparagraph (A) with respect to
the chemical substance or mixture, the presumption
against protection under such subparagraph shall
only apply to information that relates solely to
any conditions of use of the chemical substance or
mixture to which the exemption does not apply.
``(ii) Export.--In the case of a chemical
substance or mixture for which there is
manufacture, processing, or distribution in
commerce that meets the conditions of section
12(a)(1), if the Administrator establishes a ban
or phase-out described in subparagraph (A) with
respect to the chemical substance or mixture, the
presumption against protection under such
subparagraph shall only apply to information that
relates solely to any other manufacture,
processing, or distribution in commerce of the
chemical substance or mixture for the conditions
of use subject to the ban or phase-out, unless the
Administrator makes the determination in section
12(a)(2).
``(iii) <<NOTE: Applicability.>> Specific
conditions of use.--In the case of a chemical
substance or mixture for which the Administrator
establishes a ban or phase-out described in
subparagraph (A) with respect to a specific
condition of use of the chemical substance or
mixture, the presumption against protection under
such subparagraph shall only apply to information
that relates solely to the condition of use of the
chemical substance or mixture for which the ban or
phase-out is established.
``(C) Request for nondisclosure.--
``(i) <<NOTE: Deadline. Records. Review.>> In
general.--A manufacturer or processor of a
chemical substance or mixture subject to a ban or
phase-out described in this paragraph may submit
to the Administrator, within 30 days of receiving
a notification under subsection (g)(2)(A), a
request, including documentation supporting such
request, that some or all of the information to
which the notice applies should not be disclosed
or that its disclosure should be delayed, and the
Administrator shall review the request under
subsection (g)(1)(E).
``(ii) Effect of no request or denial.--If no
request for nondisclosure or delay is submitted to
the Administrator under this subparagraph, or the
[[Page 130 STAT. 483]]
Administrator denies such a request under
subsection (g)(1)(A), the information shall not be
protected from disclosure under this section.
``(5) Certain requests.--If a request is made to the
Administrator under section 552(a) of title 5, United States
Code, for information reported to or otherwise obtained by the
Administrator under this Act that is not protected from
disclosure under this subsection, the Administrator may not deny
the request on the basis of section 552(b)(4) of title 5, United
States Code.
``(c) Requirements for Confidentiality Claims.--
``(1) Assertion of claims.--
``(A) In general.--A person seeking to protect from
disclosure any information that person submits under
this Act (including information described in paragraph
(2)) shall assert to the Administrator a claim for
protection from disclosure concurrent with submission of
the information, in accordance with such rules regarding
a claim for protection from disclosure as the
Administrator has promulgated or may promulgate pursuant
to this title.
``(B) Inclusion.--An assertion of a claim under
subparagraph (A) shall include a statement that the
person has--
``(i) taken reasonable measures to protect the
confidentiality of the information;
``(ii) determined that the information is not
required to be disclosed or otherwise made
available to the public under any other Federal
law;
``(iii) a reasonable basis to conclude that
disclosure of the information is likely to cause
substantial harm to the competitive position of
the person; and
``(iv) a reasonable basis to believe that the
information is not readily discoverable through
reverse engineering.
``(C) Additional requirements for claims regarding
chemical identity information.--In the case of a claim
under subparagraph (A) for protection from disclosure of
a specific chemical identity, the claim shall include a
structurally descriptive generic name for the chemical
substance that the Administrator may disclose to the
public, subject to the condition that such generic name
shall--
``(i) be consistent with guidance developed by
the Administrator under paragraph (4)(A); and
``(ii) describe the chemical structure of the
chemical substance as specifically as practicable
while protecting those features of the chemical
structure--
``(I) that are claimed as
confidential; and
``(II) the disclosure of which would
be likely to cause substantial harm to
the competitive position of the person.
``(2) Information generally not subject to substantiation
requirements.--Subject to subsection (f), the following
information shall not be subject to substantiation requirements
under paragraph (3):
[[Page 130 STAT. 484]]
``(A) Specific information describing the processes
used in manufacture or processing of a chemical
substance, mixture, or article.
``(B) Marketing and sales information.
``(C) Information identifying a supplier or
customer.
``(D) In the case of a mixture, details of the full
composition of the mixture and the respective
percentages of constituents.
``(E) Specific information regarding the use,
function, or application of a chemical substance or
mixture in a process, mixture, or article.
``(F) Specific production or import volumes of the
manufacturer or processor.
``(G) Prior to the date on which a chemical
substance is first offered for commercial distribution,
the specific chemical identity of the chemical
substance, including the chemical name, molecular
formula, Chemical Abstracts Service number, and other
information that would identify the specific chemical
substance, if the specific chemical identity was claimed
as confidential at the time it was submitted in a notice
under section 5.
``(3) Substantiation requirements.--Except as provided in
paragraph (2), a person asserting a claim to protect information
from disclosure under this section shall substantiate the claim,
in accordance with such rules as the Administrator has
promulgated or may promulgate pursuant to this section.
``(4) Guidance.--The Administrator shall develop guidance
regarding--
``(A) the determination of structurally descriptive
generic names, in the case of claims for the protection
from disclosure of specific chemical identity; and
``(B) the content and form of the statements of need
and agreements required under paragraphs (4), (5), and
(6) of subsection (d).
``(5) Certification.--An authorized official of a person
described in paragraph (1)(A) shall certify that the statement
required to assert a claim submitted pursuant to paragraph
(1)(B), and any information required to substantiate a claim
submitted pursuant to paragraph (3), are true and correct.
``(d) <<NOTE: Contracts.>> Exceptions to Protection From
Disclosure.--Information described in subsection (a)--
``(1) shall be disclosed to an officer or employee of the
United States--
``(A) in connection with the official duties of that
person under any Federal law for the protection of
health or the environment; or
``(B) for a specific Federal law enforcement
purpose;
``(2) shall be disclosed to a contractor of the United
States and employees of that contractor--
``(A) if, in the opinion of the Administrator, the
disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United States
for the performance of work in connection with this Act;
and
``(B) subject to such conditions as the
Administrator may specify;
``(3) <<NOTE: Determination.>> shall be disclosed if the
Administrator determines that disclosure is necessary to protect
health or the environment
[[Page 130 STAT. 485]]
against an unreasonable risk of injury to health or the
environment, without consideration of costs or other nonrisk
factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant by the
Administrator under the conditions of use;
``(4) shall be disclosed to a State, political subdivision
of a State, or tribal government, on written request, for the
purpose of administration or enforcement of a law, if such
entity has 1 or more applicable agreements with the
Administrator that are consistent with the guidance developed
under subsection (c)(4)(B) and ensure that the entity will take
appropriate measures, and has adequate authority, to maintain
the confidentiality of the information in accordance with
procedures comparable to the procedures used by the
Administrator to safeguard the information;
``(5) shall be disclosed to a health or environmental
professional employed by a Federal or State agency or tribal
government or a treating physician or nurse in a nonemergency
situation if such person provides a written statement of need
and agrees to sign a written confidentiality agreement with the
Administrator, subject to the conditions that--
``(A) the statement of need and confidentiality
agreement are consistent with the guidance developed
under subsection (c)(4)(B);
``(B) the statement of need shall be a statement
that the person has a reasonable basis to suspect that--
``(i) the information is necessary for, or
will assist in--
``(I) the diagnosis or treatment of
1 or more individuals; or
``(II) responding to an
environmental release or exposure; and
``(ii) 1 or more individuals being diagnosed
or treated have been exposed to the chemical
substance or mixture concerned, or an
environmental release of or exposure to the
chemical substance or mixture concerned has
occurred; and
``(C) the person will not use the information for
any purpose other than the health or environmental needs
asserted in the statement of need, except as otherwise
may be authorized by the terms of the agreement or by
the person who has a claim under this section with
respect to the information;
``(6) shall be disclosed in the event of an emergency to a
treating or responding physician, nurse, agent of a poison
control center, public health or environmental official of a
State, political subdivision of a State, or tribal government,
or first responder (including any individual duly authorized by
a Federal agency, State, political subdivision of a State, or
tribal government who is trained in urgent medical care or other
emergency procedures, including a police officer, firefighter,
or emergency medical technician) if such person requests the
information, subject to the conditions that such person shall--
``(A) have a reasonable basis to suspect that--
``(i) a medical, public health, or
environmental emergency exists;
[[Page 130 STAT. 486]]
``(ii) the information is necessary for, or
will assist in, emergency or first-aid diagnosis
or treatment; or
``(iii) 1 or more individuals being diagnosed
or treated have likely been exposed to the
chemical substance or mixture concerned, or a
serious environmental release of or exposure to
the chemical substance or mixture concerned has
occurred; and
``(B) if requested by a person who has a claim with
respect to the information under this section--
``(i) provide a written statement of need and
agree to sign a confidentiality agreement, as
described in paragraph (5); and
``(ii) submit to the Administrator such
statement of need and confidentiality agreement as
soon as practicable, but not necessarily before
the information is disclosed;
``(7) <<NOTE: Determination.>> may be disclosed if the
Administrator determines that disclosure is relevant in a
proceeding under this Act, subject to the condition that the
disclosure is made in such a manner as to preserve
confidentiality to the extent practicable without impairing the
proceeding;
``(8) shall be disclosed if the information is required to
be made public under any other provision of Federal law; and
``(9) shall be disclosed as required pursuant to discovery,
subpoena, other court order, or any other judicial process
otherwise allowed under applicable Federal or State law.
``(e) Duration of Protection From Disclosure.--
``(1) In general.--Subject to paragraph (2), subsection
(f)(3), and section 8(b), the Administrator shall protect from
disclosure information described in subsection (a)--
``(A) in the case of information described in
subsection (c)(2), until such time as--
``(i) <<NOTE: Notification.>> the person that
asserted the claim notifies the Administrator that
the person is withdrawing the claim, in which case
the information shall not be protected from
disclosure under this section; or
``(ii) the Administrator becomes aware that
the information does not qualify for protection
from disclosure under this section, in which case
the Administrator shall take any actions required
under subsections (f) and (g); and
``(B) in the case of information other than
information described in subsection (c)(2)--
``(i) <<NOTE: Time period.>> for a period of
10 years from the date on which the person asserts
the claim with respect to the information
submitted to the Administrator; or
``(ii) if applicable before the expiration of
such 10-year period, until such time as--
``(I) <<NOTE: Notification.>> the
person that asserted the claim notifies
the Administrator that the person is
withdrawing the claim, in which case the
information shall not be protected from
disclosure under this section; or
``(II) the Administrator becomes
aware that the information does not
qualify for protection from disclosure
under this section, in which case the
[[Page 130 STAT. 487]]
Administrator shall take any actions
required under subsections (f) and (g).
``(2) <<NOTE: Deadlines.>> Extensions.--
``(A) <<NOTE: Notice.>> In general.--In the case of
information other than information described in
subsection (c)(2), not later than the date that is 60
days before the expiration of the period described in
paragraph (1)(B)(i), the Administrator shall provide to
the person that asserted the claim a notice of the
impending expiration of the period.
``(B) Request.--
``(i) In general.--Not later than the date
that is 30 days before the expiration of the
period described in paragraph (1)(B)(i), a person
reasserting the relevant claim shall submit to the
Administrator a request for extension
substantiating, in accordance with subsection
(c)(3), the need to extend the period.
``(ii) Action by administrator.--Not later
than the date of expiration of the period
described in paragraph (1)(B)(i), the
Administrator shall, in accordance with subsection
(g)(1)--
``(I) <<NOTE: Review.>> review the
request submitted under clause (i);
``(II) <<NOTE: Determination.>>
make a determination regarding whether
the claim for which the request was
submitted continues to meet the relevant
requirements of this section; and
``(III)(aa) grant an extension of 10
years; or
``(bb) deny the request.
``(C) <<NOTE: Determination.>> No limit on number
of extensions.--There shall be no limit on the number of
extensions granted under this paragraph, if the
Administrator determines that the relevant request under
subparagraph (B)(i)--
``(i) establishes the need to extend the
period; and
``(ii) meets the requirements established by
the Administrator.
``(f) Review and Resubstantiation.--
``(1) Discretion of administrator.--The Administrator may
require any person that has claimed protection for information
from disclosure under this section, whether before, on, or after
the date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, to reassert and substantiate or
resubstantiate the claim in accordance with this section--
``(A) after the chemical substance is designated as
a high-priority substance under section 6(b);
``(B) for any chemical substance designated as an
active substance under section 8(b)(5)(B)(iii); or
``(C) <<NOTE: Determination.>> if the Administrator
determines that disclosure of certain information
currently protected from disclosure would be important
to assist the Administrator in conducting risk
evaluations or promulgating rules under section 6.
``(2) Review required.--The Administrator shall review a
claim for protection of information from disclosure under this
section and require any person that has claimed protection for
that information, whether before, on, or after the date of
enactment of the Frank R. Lautenberg Chemical Safety
[[Page 130 STAT. 488]]
for the 21st Century Act, to reassert and substantiate or
resubstantiate the claim in accordance with this section--
``(A) as necessary to determine whether the
information qualifies for an exemption from disclosure
in connection with a request for information received by
the Administrator under section 552 of title 5, United
States Code;
``(B) if the Administrator has a reasonable basis to
believe that the information does not qualify for
protection from disclosure under this section; or
``(C) for any chemical substance the Administrator
determines under section 6(b)(4)(A) presents an
unreasonable risk of injury to health or the
environment.
``(3) <<NOTE: Claims. Determination.>> Period of
protection.--If the Administrator requires a person to reassert
and substantiate or resubstantiate a claim under this
subsection, and determines that the claim continues to meet the
relevant requirements of this section, the Administrator shall
protect the information subject to the claim from disclosure for
a period of 10 years from the date of such determination,
subject to any subsequent requirement by the Administrator under
this subsection.
``(g) Duties of Administrator.--
``(1) Determination.--
``(A) <<NOTE: Claims. Deadlines.>> In general.--
Except for claims regarding information described in
subsection (c)(2), the Administrator shall, subject to
subparagraph (C), not later than 90 days after the
receipt of a claim under subsection (c), and not later
than 30 days after the receipt of a request for
extension of a claim under subsection (e) or a request
under subsection (b)(4)(C), review and approve, approve
in part and deny in part, or deny the claim or request.
``(B) Reasons for denial.--If the Administrator
denies or denies in part a claim or request under
subparagraph (A) the Administrator shall provide to the
person that asserted the claim or submitted the request
a written statement of the reasons for the denial or
denial in part of the claim or request.
``(C) Subsets.--The Administrator shall--
``(i) except with respect to information
described in subsection (c)(2)(G), review all
claims or requests under this section for the
protection from disclosure of the specific
chemical identity of a chemical substance; and
``(ii) review a representative subset,
comprising at least 25 percent, of all other
claims or requests for protection from disclosure
under this section.
``(D) Effect of failure to act.--The failure of the
Administrator to make a decision regarding a claim or
request for protection from disclosure or extension
under this section shall not have the effect of denying
or eliminating a claim or request for protection from
disclosure.
``(E) Determination of requests under subsection
(b)(4)(C).--With respect to a request submitted under
subsection (b)(4)(C), the Administrator shall, with the
objective of ensuring that information relevant to the
protection of health and the environment is disclosed to
the extent practicable, determine whether the
documentation provided by the person rebuts what shall
be the presumption of
[[Page 130 STAT. 489]]
the Administrator that the public interest in the
disclosure of the information outweighs the public or
proprietary interest in maintaining the protection for
all or a portion of the information that the person has
requested not be disclosed or for which disclosure be
delayed.
``(2) <<NOTE: Claims.>> Notification.--
``(A) In general.--Except as provided in
subparagraph (B) and subsections (b), (d), and (e), if
the Administrator denies or denies in part a claim or
request under paragraph (1), concludes, in accordance
with this section, that the information does not qualify
for protection from disclosure, intends to disclose
information pursuant to subsection (d), or promulgates a
rule under section 6(a) establishing a ban or phase-out
with respect to a chemical substance or mixture, the
Administrator shall notify, in writing, the person that
asserted the claim or submitted the request of the
intent of the Administrator to disclose the information
or not protect the information from disclosure under
this section. The notice shall be furnished by certified
mail (return receipt requested), by personal delivery,
or by other means that allows verification of the fact
and date of receipt.
``(B) <<NOTE: Deadline.>> Disclosure of
information.--Except as provided in subparagraph (C),
the Administrator shall not disclose information under
this subsection until the date that is 30 days after the
date on which the person that asserted the claim or
submitted the request receives notification under
subparagraph (A).
``(C) Exceptions.--
``(i) <<NOTE: Determination.>> Fifteen day
notification.--For information the Administrator
intends to disclose under subsections (d)(3),
(d)(4), (d)(5), and (j), the Administrator shall
not disclose the information until the date that
is 15 days after the date on which the person that
asserted the claim or submitted the request
receives notification under subparagraph (A),
except that, with respect to information to be
disclosed under subsection (d)(3), if the
Administrator determines that disclosure of the
information is necessary to protect against an
imminent and substantial harm to health or the
environment, no prior notification shall be
necessary.
``(ii) Notification as soon as practicable.--
For information the Administrator intends to
disclose under paragraph (6) of subsection (d),
the Administrator shall notify the person that
submitted the information that the information has
been disclosed as soon as practicable after
disclosure of the information.
``(iii) No notification required.--
Notification shall not be required--
``(I) for the disclosure of
information under paragraphs (1), (2),
(7), or (8) of subsection (d); or
``(II) for the disclosure of
information for which--
[[Page 130 STAT. 490]]
``(aa) the Administrator has
provided to the person that
asserted the claim a notice
under subsection (e)(2)(A); and
``(bb) such person does not
submit to the Administrator a
request under subsection
(e)(2)(B) on or before the
deadline established in
subsection (e)(2)(B)(i).
``(D) Appeals.--
``(i) Action to restrain disclosure.--If a
person receives a notification under this
paragraph and believes the information is
protected from disclosure under this section,
before the date on which the information is to be
disclosed pursuant to subparagraph (B) or (C) the
person may bring an action to restrain disclosure
of the information in--
``(I) the United States district
court of the district in which the
complainant resides or has the principal
place of business; or
``(II) the United States District
Court for the District of Columbia.
``(ii) No disclosure.--
``(I) In general.--Subject to
subsection (d), the Administrator shall
not disclose information that is the
subject of an appeal under this
paragraph before the date on which the
applicable court rules on an action
under clause (i).
``(II) Exception.--Subclause (I)
shall not apply to disclosure of
information described under subsections
(d)(4) and (j).
``(3) <<NOTE: Consultation.>> Request and notification
system.--The Administrator, in consultation with the Director of
the Centers for Disease Control and Prevention, shall develop a
request and notification system that, in a format and language
that is readily accessible and understandable, allows for
expedient and swift access to information disclosed pursuant to
paragraphs (5) and (6) of subsection (d).
``(4) Unique identifier.--The Administrator shall--
``(A)(i) develop a system to assign a unique
identifier to each specific chemical identity for which
the Administrator approves a request for protection from
disclosure, which shall not be either the specific
chemical identity or a structurally descriptive generic
term; and
``(ii) <<NOTE: Applicability.>> apply that
identifier consistently to all information relevant to
the applicable chemical substance;
``(B) <<NOTE: Deadline. Publication. List.>>
annually publish and update a list of chemical
substances, referred to by their unique identifiers, for
which claims to protect the specific chemical identity
from disclosure have been approved, including the
expiration date for each such claim;
``(C) ensure that any nonconfidential information
received by the Administrator with respect to a chemical
substance included on the list published under
subparagraph (B) while the specific chemical identity of
the chemical substance is protected from disclosure
under this section identifies the chemical substance
using the unique identifier; and
[[Page 130 STAT. 491]]
``(D) for each claim for protection of a specific
chemical identity that has been denied by the
Administrator or expired, or that has been withdrawn by
the person who asserted the claim, and for which the
Administrator has used a unique identifier assigned
under this paragraph to protect the specific chemical
identity in information that the Administrator has made
public, clearly link the specific chemical identity to
the unique identifier in such information to the extent
practicable.
``(h) Criminal Penalty for Wrongful Disclosure.--
``(1) Individuals subject to penalty.--
``(A) In general.--Subject to subparagraph (C) and
paragraph (2), an individual described in subparagraph
(B) shall be fined under title 18, United States Code,
or imprisoned for not more than 1 year, or both.
``(B) Description.--An individual referred to in
subparagraph (A) is an individual who--
``(i) pursuant to this section, obtained
possession of, or has access to, information
protected from disclosure under this section; and
``(ii) knowing that the information is
protected from disclosure under this section,
willfully discloses the information in any manner
to any person not entitled to receive that
information.
``(C) Exception.--This paragraph shall not apply to
any medical professional (including an emergency medical
technician or other first responder) who discloses any
information obtained under paragraph (5) or (6) of
subsection (d) to a patient treated by the medical
professional, or to a person authorized to make medical
or health care decisions on behalf of such a patient, as
needed for the diagnosis or treatment of the patient.
``(2) Other laws.--Section 1905 of title 18, United States
Code, shall not apply with respect to the publishing, divulging,
disclosure, or making known of, or making available, information
reported to or otherwise obtained by the Administrator under
this Act.
``(i) Applicability.--
``(1) In general.--Except as otherwise provided in this
section, section 8, or any other applicable Federal law, the
Administrator shall have no authority--
``(A) to require the substantiation or
resubstantiation of a claim for the protection from
disclosure of information reported to or otherwise
obtained by the Administrator under this Act prior to
the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act; or
``(B) to impose substantiation or resubstantiation
requirements, with respect to the protection of
information described in subsection (a), under this Act
that are more extensive than those required under this
section.
``(2) Actions prior to promulgation of rules.--Nothing in
this Act prevents the Administrator from reviewing, requiring
substantiation or resubstantiation of, or approving, approving
in part, or denying any claim for the protection from disclosure
of information before the effective date of such rules
applicable to those claims as the Administrator may
[[Page 130 STAT. 492]]
promulgate after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.
``(j) Access by Congress.--Notwithstanding any limitation contained
in this section or any other provision of law, all information reported
to or otherwise obtained by the Administrator (or any representative of
the Administrator) under this Act shall be made available, upon written
request of any duly authorized committee of the Congress, to such
committee.''.
SEC. 12. PENALTIES.
Section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) is
amended--
(1) in subsection (a)(1), by striking ``$25,000'' and
inserting ``$37,500''; and
(2) in subsection (b)--
(A) by striking ``Any person'' and inserting the
following:
``(1) In general.--Any person'';
(B) by striking ``$25,000'' and inserting
``$50,000''; and
(C) by adding at the end the following:
``(2) Imminent danger of death or serious bodily injury.--
``(A) In general.--Any person who knowingly and
willfully violates any provision of section 15 or 409,
and who knows at the time of the violation that the
violation places an individual in imminent danger of
death or serious bodily injury, shall be subject on
conviction to a fine of not more than $250,000, or
imprisonment for not more than 15 years, or both.
``(B) Organizations.--Notwithstanding the penalties
described in subparagraph (A), an organization that
commits a knowing violation described in subparagraph
(A) shall be subject on conviction to a fine of not more
than $1,000,000 for each violation.
``(C) <<NOTE: Applicability.>> Incorporation of
corresponding provisions.--Subparagraphs (B) through (F)
of section 113(c)(5) of the Clean Air Act (42 U.S.C.
7413(c)(5)(B)-(F)) shall apply to the prosecution of a
violation under this paragraph.''.
SEC. 13. STATE-FEDERAL RELATIONSHIP.
Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is
amended--
(1) by amending subsection (a) to read as follows:
``(a) In General.--
``(1) Establishment or enforcement.--Except as otherwise
provided in subsections (c), (d), (e), (f), and (g), and subject
to paragraph (2), no State or political subdivision of a State
may establish or continue to enforce any of the following:
``(A) Development of information.--A statute or
administrative action to require the development of
information about a chemical substance or category of
chemical substances that is reasonably likely to produce
the same information required under section 4, 5, or 6
in--
``(i) a rule promulgated by the Administrator;
``(ii) a consent agreement entered into by the
Administrator; or
``(iii) an order issued by the Administrator.
[[Page 130 STAT. 493]]
``(B) Chemical substances found not to present an
unreasonable risk or restricted.--A statute, criminal
penalty, or administrative action to prohibit or
otherwise restrict the manufacture, processing, or
distribution in commerce or use of a chemical
substance--
``(i) for which the determination described in
section 6(i)(1) is made, consistent with the scope
of the risk evaluation under section (6)(b)(4)(D);
or
``(ii) for which a final rule is promulgated
under section 6(a), after the effective date of
the rule issued under section 6(a) for the
chemical substance, consistent with the scope of
the risk evaluation under section (6)(b)(4)(D).
``(C) Significant new use.--A statute or
administrative action requiring the notification of a
use of a chemical substance that the Administrator has
specified as a significant new use and for which the
Administrator has required notification pursuant to a
rule promulgated under section 5.
``(2) Effective date of preemption.--Under this subsection,
Federal preemption of statutes and administrative actions
applicable to specific chemical substances shall not occur until
the effective date of the applicable action described in
paragraph (1) taken by the Administrator.'';
(2) by amending subsection (b) to read as follows:
``(b) New Statutes, Criminal Penalties, or Administrative Actions
Creating Prohibitions or Other Restrictions.--
``(1) <<NOTE: Time period.>> In general.--Except as
provided in subsections (c), (d), (e), (f), and (g), beginning
on the date on which the Administrator defines the scope of a
risk evaluation for a chemical substance under section
6(b)(4)(D) and ending on the date on which the deadline
established pursuant to section 6(b)(4)(G) for completion of the
risk evaluation expires, or on the date on which the
Administrator publishes the risk evaluation under section
6(b)(4)(C), whichever is earlier, no State or political
subdivision of a State may establish a statute, criminal
penalty, or administrative action prohibiting or otherwise
restricting the manufacture, processing, distribution in
commerce, or use of such chemical substance that is a high-
priority substance designated under section 6(b)(1)(B)(i).
``(2) Effect of subsection.--This subsection does not
restrict the authority of a State or political subdivision of a
State to continue to enforce any statute enacted, criminal
penalty assessed, or administrative action taken, prior to the
date on which the Administrator defines and publishes the scope
of a risk evaluation under section 6(b)(4)(D).''; and
(3) by adding at the end the following:
``(c) <<NOTE: Applicability.>> Scope of Preemption.--Federal
preemption under subsections (a) and (b) of statutes, criminal
penalties, and administrative actions applicable to specific chemical
substances shall apply only to--
``(1) with respect to subsection (a)(1)(A), the chemical
substances or category of chemical substances subject to a rule,
order, or consent agreement under section 4, 5, or 6;
``(2) with respect to subsection (b), the hazards,
exposures, risks, and uses or conditions of use of such chemical
substances
[[Page 130 STAT. 494]]
included in the scope of the risk evaluation pursuant to section
6(b)(4)(D);
``(3) with respect to subsection (a)(1)(B), the hazards,
exposures, risks, and uses or conditions of use of such chemical
substances included in any final action the Administrator takes
pursuant to section 6(a) or 6(i)(1); or
``(4) with respect to subsection (a)(1)(C), the uses of such
chemical substances that the Administrator has specified as
significant new uses and for which the Administrator has
required notification pursuant to a rule promulgated under
section 5.
``(d) Exceptions.--
``(1) No preemption of statutes and administrative
actions.--
``(A) In general.--Nothing in this Act, nor any
amendment made by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, nor any rule, standard
of performance, risk evaluation, or scientific
assessment implemented pursuant to this Act, shall
affect the right of a State or a political subdivision
of a State to adopt or enforce any rule, standard of
performance, risk evaluation, scientific assessment, or
any other protection for public health or the
environment that--
``(i) is adopted or authorized under the
authority of any other Federal law or adopted to
satisfy or obtain authorization or approval under
any other Federal law;
``(ii) implements a reporting, monitoring, or
other information obligation for the chemical
substance not otherwise required by the
Administrator under this Act or required under any
other Federal law;
``(iii) is adopted pursuant to authority under
a law of the State or political subdivision of the
State related to water quality, air quality, or
waste treatment or disposal, except to the extent
that the action--
``(I) imposes a restriction on the
manufacture, processing, distribution in
commerce, or use of a chemical
substance; and
``(II)(aa) addresses the same
hazards and exposures, with respect to
the same conditions of use as are
included in the scope of the risk
evaluation published pursuant to section
6(b)(4)(D), but is inconsistent with the
action of the Administrator; or
``(bb) would cause a violation of
the applicable action by the
Administrator under section 5 or 6; or
``(iv) subject to subparagraph (B), is
identical to a requirement prescribed by the
Administrator.
``(B) Identical requirements.--
``(i) In general.--The penalties and other
sanctions applicable under a law of a State or
political subdivision of a State in the event of
noncompliance with the identical requirement shall
be no more stringent than the penalties and other
sanctions available to the Administrator under
section 16 of this Act.
``(ii) Penalties.--In the case of an identical
requirement--
[[Page 130 STAT. 495]]
``(I) a State or political
subdivision of a State may not assess a
penalty for a specific violation for
which the Administrator has assessed an
adequate penalty under section 16; and
``(II) if a State or political
subdivision of a State has assessed a
penalty for a specific violation, the
Administrator may not assess a penalty
for that violation in an amount that
would cause the total of the penalties
assessed for the violation by the State
or political subdivision of a State and
the Administrator combined to exceed the
maximum amount that may be assessed for
that violation by the Administrator
under section 16.
``(2) Applicability to certain rules or orders.--
``(A) Prior rules and orders.--Nothing in this
section shall be construed as modifying the preemptive
effect under this section, as in effect on the day
before the effective date of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, of any rule or
order promulgated or issued under this Act prior to that
effective date.
``(B) Certain chemical substances and mixtures.--
With respect to a chemical substance or mixture for
which any rule or order was promulgated or issued under
section 6 prior to the effective date of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act with
respect to manufacturing, processing, distribution in
commerce, use, or disposal of the chemical substance or
mixture, nothing in this section shall be construed as
modifying the preemptive effect of this section as in
effect prior to the enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act of any rule or
order that is promulgated or issued with respect to such
chemical substance or mixture under section 6 after that
effective date, unless the latter rule or order is with
respect to a chemical substance or mixture containing a
chemical substance and follows a designation of that
chemical substance as a high-priority substance under
section 6(b)(1)(B)(i), the identification of that
chemical substance under section 6(b)(2)(A), or the
selection of that chemical substance for risk evaluation
under section 6(b)(4)(E)(iv)(II).
``(e) Preservation of Certain Laws.--
``(1) In general.--Nothing in this Act, subject to
subsection (g) of this section, shall--
``(A) be construed to preempt or otherwise affect
the authority of a State or political subdivision of a
State to continue to enforce any action taken or
requirement imposed or requirement enacted relating to a
specific chemical substance before April 22, 2016, under
the authority of a law of the State or political
subdivision of the State that prohibits or otherwise
restricts manufacturing, processing, distribution in
commerce, use, or disposal of a chemical substance; or
``(B) be construed to preempt or otherwise affect
any action taken pursuant to a State law that was in
effect on August 31, 2003.
``(2) Effect of subsection.--This subsection does not
affect, modify, or alter the relationship between Federal law
[[Page 130 STAT. 496]]
and laws of a State or political subdivision of a State pursuant
to any other Federal law.
``(f) Waivers.--
``(1) <<NOTE: Determination.>> Discretionary exemptions.--
Upon application of a State or political subdivision of a State,
the Administrator may, by rule, exempt from subsection (a),
under such conditions as may be prescribed in the rule, a
statute, criminal penalty, or administrative action of that
State or political subdivision of the State that relates to the
effects of exposure to a chemical substance under the conditions
of use if the Administrator determines that--
``(A) compelling conditions warrant granting the
waiver to protect health or the environment;
``(B) compliance with the proposed requirement of
the State or political subdivision of the State would
not unduly burden interstate commerce in the
manufacture, processing, distribution in commerce, or
use of a chemical substance;
``(C) compliance with the proposed requirement of
the State or political subdivision of the State would
not cause a violation of any applicable Federal law,
rule, or order; and
``(D) in the judgment of the Administrator, the
proposed requirement of the State or political
subdivision of the State is designed to address a risk
of a chemical substance, under the conditions of use,
that was identified--
``(i) consistent with the best available
science;
``(ii) using supporting studies conducted in
accordance with sound and objective scientific
practices; and
``(iii) based on the weight of the scientific
evidence.
``(2) <<NOTE: Determination.>> Required exemptions.--Upon
application of a State or political subdivision of a State, the
Administrator shall exempt from subsection (b) a statute or
administrative action of a State or political subdivision of a
State that relates to the effects of exposure to a chemical
substance under the conditions of use if the Administrator
determines that--
``(A)(i) compliance with the proposed requirement of
the State or political subdivision of the State would
not unduly burden interstate commerce in the
manufacture, processing, distribution in commerce, or
use of a chemical substance;
``(ii) compliance with the proposed requirement of
the State or political subdivision of the State would
not cause a violation of any applicable Federal law,
rule, or order; and
``(iii) the State or political subdivision of the
State has a concern about the chemical substance or use
of the chemical substance based in peer-reviewed
science; or
``(B) <<NOTE: Deadline.>> no later than the date
that is 18 months after the date on which the
Administrator has initiated the prioritization process
for a chemical substance under the rule promulgated
pursuant to section 6(b)(1)(A), or the date on which the
Administrator publishes the scope of the risk evaluation
for a chemical substance under section 6(b)(4)(D),
whichever is sooner, the State or political subdivision
of the State has enacted a statute or proposed or
finalized an administrative action intended to prohibit
[[Page 130 STAT. 497]]
or otherwise restrict the manufacture, processing,
distribution in commerce, or use of the chemical
substance.
``(3) <<NOTE: Deadlines.>> Determination of a waiver
request.--The duty of the Administrator to grant or deny a
waiver application shall be nondelegable and shall be
exercised--
``(A) not later than 180 days after the date on
which an application under paragraph (1) is submitted;
and
``(B) not later than 110 days after the date on
which an application under paragraph (2) is submitted.
``(4) <<NOTE: Time period.>> Failure to make a
determination.--If the Administrator fails to make a
determination under paragraph (3)(B) during the 110-day period
beginning on the date on which an application under paragraph
(2) is submitted, the statute or administrative action of the
State or political subdivision of the State that was the subject
of the application shall not be considered to be an existing
statute or administrative action for purposes of subsection (b)
by reason of the failure of the Administrator to make a
determination.
``(5) Notice and comment.--Except in the case of an
application approved under paragraph (9), the application of a
State or political subdivision of a State under this subsection
shall be subject to public notice and comment.
``(6) Final agency action.--The decision of the
Administrator on the application of a State or political
subdivision of a State shall be--
``(A) considered to be a final agency action; and
``(B) subject to judicial review.
``(7) Duration of waivers.--A waiver granted under paragraph
(2) or approved under paragraph (9) shall remain in effect until
such time as the Administrator publishes the risk evaluation
under section 6(b).
``(8) <<NOTE: Deadline.>> Judicial review of waivers.--Not
later than 60 days after the date on which the Administrator
makes a determination on an application of a State or political
subdivision of a State under paragraph (1) or (2), any person
may file a petition for judicial review in the United States
Court of Appeals for the District of Columbia Circuit, which
shall have exclusive jurisdiction over the determination.
``(9) Approval.--
``(A) <<NOTE: Effective date.>> Automatic
approval.--If the Administrator fails to meet the
deadline established under paragraph (3)(B), the
application of a State or political subdivision of a
State under paragraph (2) shall be automatically
approved, effective on the date that is 10 days after
the deadline.
``(B) Requirements.--Notwithstanding paragraph (6),
approval of a waiver application under subparagraph (A)
for failure to meet the deadline under paragraph (3)(B)
shall not be considered final agency action or be
subject to judicial review or public notice and comment.
``(g) Savings.--
``(1) No preemption of common law or statutory causes of
action for civil relief or criminal conduct.--
``(A) In general.--Nothing in this Act, nor any
amendment made by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, nor any standard, rule,
requirement, standard of performance, risk evaluation,
or scientific assessment implemented pursuant to this
Act, shall be
[[Page 130 STAT. 498]]
construed to preempt, displace, or supplant any State or
Federal common law rights or any State or Federal
statute creating a remedy for civil relief, including
those for civil damage, or a penalty for a criminal
conduct.
``(B) Clarification of no preemption.--
Notwithstanding any other provision of this Act, nothing
in this Act, nor any amendments made by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act,
shall preempt or preclude any cause of action for
personal injury, wrongful death, property damage, or
other injury based on negligence, strict liability,
products liability, failure to warn, or any other legal
theory of liability under any State law, maritime law,
or Federal common law or statutory theory.
``(2) No effect on private remedies.--
``(A) In general.--Nothing in this Act, nor any
amendments made by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, nor any rules,
regulations, requirements, risk evaluations, scientific
assessments, or orders issued pursuant to this Act shall
be interpreted as, in either the plaintiff's or
defendant's favor, dispositive in any civil action.
``(B) Authority of courts.--This Act does not affect
the authority of any court to make a determination in an
adjudicatory proceeding under applicable State or
Federal law with respect to the admission into evidence
or any other use of this Act or rules, regulations,
requirements, standards of performance, risk
evaluations, scientific assessments, or orders issued
pursuant to this Act.''.
SEC. 14. JUDICIAL REVIEW.
Section 19(a) of the Toxic Substances Control Act (15 U.S.C.
2618(a)) is amended--
(1) in paragraph (1), by adding at the end the following:
``(C)(i) <<NOTE: Deadline.>> Not later than 60 days after
the publication of a designation under section 6(b)(1)(B)(ii),
any person may commence a civil action to challenge the
designation.
``(ii) The United States Court of Appeals for the District
of Columbia Circuit shall have exclusive jurisdiction over a
civil action filed under this subparagraph.''; and
(2) by striking paragraph (3).
SEC. 15. CITIZENS' CIVIL ACTIONS.
Section 20(b) of the Toxic Substances Control Act (15 U.S.C.
2619(b)) is amended--
(1) in paragraph (1)(B), by striking ``or'' at the end; and
(2) in paragraph (2), by striking the period at the end and
inserting the following: ``, except that no prior notification
shall be required in the case of a civil action brought to
compel a decision by the Administrator pursuant to section
18(f)(3)(B); or
``(3) <<NOTE: Time period.>> in the case of a civil action
brought to compel a decision by the Administrator pursuant to
section 18(f)(3)(B), after the date that is 60 days after the
deadline specified in section 18(f)(3)(B).''.
[[Page 130 STAT. 499]]
SEC. 16. STUDIES.
Section 25 of the Toxic Substances Control Act (15 U.S.C. 2624) is
repealed. <<NOTE: Repeal.>>
SEC. 17. ADMINISTRATION OF THE ACT.
Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is
amended--
(1) in subsection (b)(1)--
(A) by striking ``of a reasonable fee'';
(B) by striking ``data under section 4 or 5 to
defray the cost of administering this Act'' and
inserting ``information under section 4 or a notice or
other information to be reviewed by the Administrator
under section 5, or who manufactures or processes a
chemical substance that is the subject of a risk
evaluation under section 6(b), of a fee that is
sufficient and not more than reasonably necessary to
defray the cost related to such chemical substance of
administering sections 4, 5, and 6, and collecting,
processing, reviewing, and providing access to and
protecting from disclosure as appropriate under section
14 information on chemical substances under this title,
including contractor costs incurred by the
Administrator'';
(C) by striking ``Such rules shall not provide for
any fee in excess of $2,500 or, in the case of a small
business concern, any fee in excess of $100.''; and
(D) by striking ``submit the data and the cost to
the Administrator of reviewing such data'' and inserting
``pay such fee and the cost to the Administrator of
carrying out the activities described in this
paragraph'';
(2) in subsection (b)--
(A) in paragraph (2), by striking ``paragraph (1)''
and inserting ``paragraph (4)''; and
(B) by adding at the end the following:
``(3) Fund.--
``(A) Establishment.--There is established in the Treasury
of the United States a fund, to be known as the TSCA Service Fee
Fund (in this paragraph referred to as the `Fund'), consisting
of such amounts as are deposited in the Fund under this
paragraph.
``(B) Collection and deposit of fees.--Subject to the
conditions of subparagraph (C), the Administrator shall collect
the fees described in this subsection and deposit those fees in
the Fund.
``(C) Use of funds by administrator.--Fees authorized under
this section shall be collected and available for obligation
only to the extent and in the amount provided in advance in
appropriations Acts, and shall be available without fiscal year
limitation for use in defraying the costs of the activities
described in paragraph (1).
``(D) Accounting and auditing.--
``(i) <<NOTE: Deadline. Reports.>> Accounting.--The
Administrator shall biennially prepare and submit to the
Committee on Environment and Public Works of the Senate
and the Committee on Energy and Commerce of the House of
Representatives a report that includes an accounting of
the fees paid to the Administrator under this paragraph
and amounts disbursed from the Fund for the period
covered by the report,
[[Page 130 STAT. 500]]
as reflected by financial statements provided in
accordance with sections 3515 and 3521 of title 31,
United States Code.
``(ii) Auditing.--
``(I) In general.--For the purpose of section
3515(c) of title 31, United States Code, the Fund
shall be considered a component of a covered
executive agency.
``(II) <<NOTE: Analysis.>> Components of
audit.--The annual audit required in accordance
with sections 3515 and 3521 of title 31, United
States Code, of the financial statements of
activities carried out using amounts from the Fund
shall include an analysis of--
``(aa) the fees collected and
amounts disbursed under this subsection;
``(bb) the reasonableness of the
fees in place as of the date of the
audit to meet current and projected
costs of administering the provisions of
this title for which the fees may be
used; and
``(cc) the number of requests for a
risk evaluation made by manufacturers
under section 6(b)(4)(C)(ii).
``(III) <<NOTE: Reports.>> Federal
responsibility.--The Inspector General of the
Environmental Protection Agency shall conduct the
annual audit described in subclause (II) and
submit to the Administrator a report that
describes the findings and any recommendations of
the Inspector General resulting from the audit.
``(4) Amount and Adjustment of Fees; Refunds.--In setting fees under
this section, the Administrator shall--
``(A) <<NOTE: Consultation.>> prescribe lower fees for
small business concerns, after consultation with the
Administrator of the Small Business Administration;
``(B) set the fees established under paragraph (1) at levels
such that the fees will, in aggregate, provide a sustainable
source of funds to annually defray--
``(i) the lower of--
``(I) 25 percent of the costs to the
Administrator of carrying out sections 4, 5, and
6, and of collecting, processing, reviewing, and
providing access to and protecting from disclosure
as appropriate under section 14 information on
chemical substances under this title, other than
the costs to conduct and complete risk evaluations
under section 6(b); or
``(II) $25,000,000 (subject to adjustment
pursuant to subparagraph (F)); and
``(ii) the costs of risk evaluations specified in
subparagraph (D);
``(C) reflect an appropriate balance in the assessment of
fees between manufacturers and processors, and allow the payment
of fees by consortia of manufacturers or processors;
``(D) notwithstanding subparagraph (B)--
``(i) except as provided in clause (ii), for
chemical substances for which the Administrator has
granted a request from a manufacturer pursuant to
section 6(b)(4)(C)(ii), establish the fee at a level
sufficient to defray the full
[[Page 130 STAT. 501]]
costs to the Administrator of conducting the risk
evaluation under section 6(b);
``(ii) for chemical substances for which the
Administrator has granted a request from a manufacturer
pursuant to section 6(b)(4)(C)(ii), and which are
included in the 2014 update of the TSCA Work Plan for
Chemical Assessments, establish the fee at a level
sufficient to defray 50 percent of the costs to the
Administrator of conducting the risk evaluation under
section 6(b); and
``(iii) <<NOTE: Applicability.>> apply fees
collected pursuant to clauses (i) and (ii) only to
defray the costs described in those clauses;
``(E) <<NOTE: Consultation.>> prior to the establishment or
amendment of any fees under paragraph (1), consult and meet with
parties potentially subject to the fees or their
representatives, subject to the condition that no obligation
under the Federal Advisory Committee Act (5 U.S.C. App.) or
subchapter II of chapter 5 of title 5, United States Code, is
applicable with respect to such meetings;
``(F) <<NOTE: Effective date. Deadline. Consultation.>>
beginning with the fiscal year that is 3 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, and every 3 years thereafter, after
consultation with parties potentially subject to the fees and
their representatives pursuant to subparagraph (E), increase or
decrease the fees established under paragraph (1) as necessary
to adjust for inflation and to ensure that funds deposited in
the Fund are sufficient to defray--
``(i) approximately but not more than 25 percent of
the costs to the Administrator of carrying out sections
4, 5, and 6, and of collecting, processing, reviewing,
and providing access to and protecting from disclosure
as appropriate under section 14 information on chemical
substances under this title, other than the costs to
conduct and complete risk evaluations requested under
section 6(b)(4)(C)(ii); and
``(ii) the costs of risk evaluations specified in
subparagraph (D); and
``(G) <<NOTE: Notice.>> if a notice submitted under section
5 is not reviewed or such a notice is withdrawn, refund the fee
or a portion of the fee if no substantial work was performed on
the notice.
``(5) Minimum Amount of Appropriations.--Fees may not be assessed
for a fiscal year under this section unless the amount of appropriations
for the Chemical Risk Review and Reduction program project of the
Environmental Protection Agency for the fiscal year (excluding the
amount of any fees appropriated for the fiscal year) are equal to or
greater than the amount of appropriations for that program project for
fiscal year 2014.
``(6) Termination.--The authority provided by this subsection shall
terminate at the conclusion of the fiscal year that is 10 years after
the date of enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act unless otherwise reauthorized or modified by
Congress.''; and
(3) by adding at the end the following:
``(h) <<NOTE: Applicability.>> Scientific Standards.--In carrying
out sections 4, 5, and 6, to the extent that the Administrator makes a
decision based on science, the Administrator shall use scientific
information, technical procedures, measures, methods, protocols,
methodologies, or models, employed in a manner consistent with the best
available science, and shall consider as applicable--
[[Page 130 STAT. 502]]
``(1) the extent to which the scientific information,
technical procedures, measures, methods, protocols,
methodologies, or models employed to generate the information
are reasonable for and consistent with the intended use of the
information;
``(2) the extent to which the information is relevant for
the Administrator's use in making a decision about a chemical
substance or mixture;
``(3) the degree of clarity and completeness with which the
data, assumptions, methods, quality assurance, and analyses
employed to generate the information are documented;
``(4) the extent to which the variability and uncertainty in
the information, or in the procedures, measures, methods,
protocols, methodologies, or models, are evaluated and
characterized; and
``(5) the extent of independent verification or peer review
of the information or of the procedures, measures, methods,
protocols, methodologies, or models.
``(i) Weight of Scientific Evidence.--The Administrator shall make
decisions under sections 4, 5, and 6 based on the weight of the
scientific evidence.
``(j) <<NOTE: Public information.>> Availability of Information.--
Subject to section 14, the Administrator shall make available to the
public--
``(1) all notices, determinations, findings, rules, consent
agreements, and orders of the Administrator under this title;
``(2) any information required to be provided to the
Administrator under section 4;
``(3) a nontechnical summary of each risk evaluation
conducted under section 6(b);
``(4) <<NOTE: List.>> a list of the studies considered by
the Administrator in carrying out each such risk evaluation,
along with the results of those studies; and
``(5) each designation of a chemical substance under section
6(b), along with an identification of the information, analysis,
and basis used to make the designations.
``(k) Reasonably Available Information.--In carrying out sections 4,
5, and 6, the Administrator shall take into consideration information
relating to a chemical substance or mixture, including hazard and
exposure information, under the conditions of use, that is reasonably
available to the Administrator.
``(l) <<NOTE: Deadlines.>> Policies, Procedures, and Guidance.--
``(1) Development.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall develop any policies,
procedures, and guidance the Administrator determines are
necessary to carry out the amendments to this Act made by the
Frank R. Lautenberg Chemical Safety for the 21st Century Act.
``(2) Review.--Not later than 5 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, and not less frequently than once every 5
years thereafter, the Administrator shall--
``(A) review the adequacy of the policies,
procedures, and guidance developed under paragraph (1),
including with respect to animal, nonanimal, and
epidemiological test methods and procedures for
assessing and determining risk under this title; and
[[Page 130 STAT. 503]]
``(B) revise such policies, procedures, and guidance
as the Administrator determines necessary to reflect new
scientific developments or understandings.
``(3) <<NOTE: Applicability.>> Testing of chemical
substances and mixtures.--The policies, procedures, and guidance
developed under paragraph (1) applicable to testing chemical
substances and mixtures shall--
``(A) address how and when the exposure level or
exposure potential of a chemical substance or mixture
would factor into decisions to require new testing,
subject to the condition that the Administrator shall
not interpret the lack of exposure information as a lack
of exposure or exposure potential; and
``(B) describe the manner in which the Administrator
will determine that additional information is necessary
to carry out this title, including information relating
to potentially exposed or susceptible populations.
``(4) Chemical substances with completed risk assessments.--
With respect to a chemical substance listed in the 2014 update
to the TSCA Work Plan for Chemical Assessments for which the
Administrator has published a completed risk assessment prior to
the date of enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the Administrator may publish proposed
and final rules under section 6(a) that are consistent with the
scope of the completed risk assessment for the chemical
substance and consistent with other applicable requirements of
section 6.
``(5) <<NOTE: Deadline.>> Guidance.--Not later than 1 year
after the date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the Administrator shall develop
guidance to assist interested persons in developing and
submitting draft risk evaluations which shall be considered by
the Administrator. The guidance shall, at a minimum, address the
quality of the information submitted and the process to be
followed in developing draft risk evaluations for consideration
by the Administrator.
``(m) Report to Congress.--
``(1) <<NOTE: Estimate.>> Initial report.--Not later than 6
months after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, the Administrator
shall submit to the Committees on Energy and Commerce and
Appropriations of the House of Representatives and the
Committees on Environment and Public Works and Appropriations of
the Senate a report containing an estimation of--
``(A) the capacity of the Environmental Protection
Agency to conduct and publish risk evaluations under
section 6(b)(4)(C)(i), and the resources necessary to
conduct the minimum number of risk evaluations required
under section 6(b)(2);
``(B) the capacity of the Environmental Protection
Agency to conduct and publish risk evaluations under
section 6(b)(4)(C)(ii), the likely demand for such risk
evaluations, and the anticipated schedule for
accommodating that demand;
``(C) the capacity of the Environmental Protection
Agency to promulgate rules under section 6(a) as
required
[[Page 130 STAT. 504]]
based on risk evaluations conducted and published under
section 6(b); and
``(D) the actual and anticipated efforts of the
Environmental Protection Agency to increase the Agency's
capacity to conduct and publish risk evaluations under
section 6(b).
``(2) Subsequent reports.--The Administrator shall update
and resubmit the report described in paragraph (1) not less
frequently than once every 5 years.
``(n) Annual Plan.--
``(1) In general.--The Administrator shall inform the public
regarding the schedule and the resources necessary for the
completion of each risk evaluation as soon as practicable after
initiating the risk evaluation.
``(2) Publication of plan.--At the beginning of each
calendar year, the Administrator shall publish an annual plan
that--
``(A) identifies the chemical substances for which
risk evaluations are expected to be initiated or
completed that year and the resources necessary for
their completion;
``(B) describes the status of each risk evaluation
that has been initiated but not yet completed; and
``(C) if the schedule for completion of a risk
evaluation has changed, includes an updated schedule for
that risk evaluation.
``(o) Consultation With Science Advisory Committee on Chemicals.--
``(1) <<NOTE: Deadline.>> Establishment.--Not later than 1
year after the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, the Administrator
shall establish an advisory committee, to be known as the
Science Advisory Committee on Chemicals (referred to in this
subsection as the `Committee').
``(2) Purpose.--The purpose of the Committee shall be to
provide independent advice and expert consultation, at the
request of the Administrator, with respect to the scientific and
technical aspects of issues relating to the implementation of
this title.
``(3) Composition.--The Committee shall be composed of
representatives of such science, government, labor, public
health, public interest, animal protection, industry, and other
groups as the Administrator determines to be advisable,
including representatives that have specific scientific
expertise in the relationship of chemical exposures to women,
children, and other potentially exposed or susceptible
subpopulations.
``(4) Schedule.--The Administrator shall convene the
Committee in accordance with such schedule as the Administrator
determines to be appropriate, but not less frequently than once
every 2 years.
``(p) Prior Actions.--
``(1) Rules, orders, and exemptions.--Nothing in the Frank
R. Lautenberg Chemical Safety for the 21st Century Act
eliminates, modifies, or withdraws any rule promulgated, order
issued, or exemption established pursuant to this Act before the
date of enactment of the Frank R. Lautenberg Chemical Safety for
the 21st Century Act.
``(2) Prior-initiated evaluations.--Nothing in this Act
prevents the Administrator from initiating a risk evaluation
[[Page 130 STAT. 505]]
regarding a chemical substance, or from continuing or completing
such risk evaluation, prior to the effective date of the
policies, procedures, and guidance required to be developed by
the Administrator pursuant to the amendments made by the Frank
R. Lautenberg Chemical Safety for the 21st Century Act.
``(3) Actions completed prior to completion of policies,
procedures, and guidance.--Nothing in this Act requires the
Administrator to revise or withdraw a completed risk evaluation,
determination, or rule under this Act solely because the action
was completed prior to the development of a policy, procedure,
or guidance pursuant to the amendments made by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.''.
SEC. 18. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is
amended by striking subsections (c) and (d).
SEC. 19. CONFORMING AMENDMENTS.
(a) Table of Contents.--The table of contents in section 1 of the
Toxic Substances Control Act is amended--
(1) by striking the item relating to section 6 and inserting
the following:
``Sec. 6. Prioritization, risk evaluation, and regulation of chemical
substances and mixtures.'';
(2) by striking the item relating to section 10 and
inserting the following:
``Sec. 10. Research, development, collection, dissemination, and
utilization of information.'';
(3) by striking the item relating to section 14 and
inserting the following:
``Sec. 14. Confidential information.''; and
(4) by striking the item relating to section 25.
(b) Section 2.--Section 2(b)(1) of the Toxic Substances Control Act
(15 U.S.C. 2601(b)(1)) is amended by striking ``data'' both places it
appears and inserting ``information''.
(c) Section 3.--Section 3 of the Toxic Substances Control Act (15
U.S.C. 2602) is amended--
(1) in paragraph (8) (as redesignated by section 3 of this
Act), by striking ``data'' and inserting ``information''; and
(2) in paragraph (15) (as redesignated by section 3 of this
Act)--
(A) by striking ``standards'' and inserting
``protocols and methodologies'';
(B) by striking ``test data'' both places it appears
and inserting ``information''; and
(C) by striking ``data'' each place it appears and
inserting ``information''.
(d) Section 4.--Section 4 of the Toxic Substances Control Act (15
U.S.C. 2603) is amended--
(1) in subsection (b)--
(A) in paragraph (1)--
[[Page 130 STAT. 506]]
(i) in the paragraph heading, by adding ``,
order, or consent agreement'' at the end; and
(ii) by striking ``rule'' each place it
appears and inserting ``rule, order, or consent
agreement'';
(B) in paragraph (2)(B), by striking ``rules'' and
inserting ``rules, orders, and consent agreements'';
(C) in paragraph (3)(A), by striking ``rule'' and
inserting ``rule or order''; and
(D) in paragraph (4)--
(i) by striking ``rule under subsection (a)''
each place it appears and inserting ``rule, order,
or consent agreement under subsection (a)'';
(ii) by striking ``repeals the rule'' each
place it appears and inserting ``repeals the rule
or order or modifies the consent agreement to
terminate the requirement''; and
(iii) by striking ``repeals the application of
the rule'' and inserting ``repeals or modifies the
application of the rule, order, or consent
agreement'';
(2) in subsection (c)--
(A) in paragraph (1), by striking ``rule'' and
inserting ``rule or order'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``a rule
under subsection (a) or for which data is being
developed pursuant to such a rule'' and inserting
``a rule, order, or consent agreement under
subsection (a) or for which information is being
developed pursuant to such a rule, order, or
consent agreement'';
(ii) in subparagraph (B), by striking ``such
rule or which is being developed pursuant to such
rule'' and inserting ``such rule, order, or
consent agreement or which is being developed
pursuant to such rule, order, or consent
agreement''; and
(iii) in the matter following subparagraph
(B), by striking ``the rule'' and inserting ``the
rule or order'';
(C) in paragraph (3)(B)(i), by striking ``rule
promulgated'' and inserting ``rule, order, or consent
agreement''; and
(D) in paragraph (4)--
(i) by striking ``rule promulgated'' each
place it appears and inserting ``rule, order, or
consent agreement'';
(ii) by striking ``such rule'' each place it
appears and inserting ``such rule, order, or
consent agreement''; and
(iii) in subparagraph (B), by striking ``the
rule'' and inserting ``the rule or order'';
(3) in subsection (d), by striking ``rule'' and inserting
``rule, order, or consent agreement''; and
(4) in subsection (g), by striking ``rule'' and inserting
``rule, order, or consent agreement''.
(e) Section 5.--Section 5 of the Toxic Substances Control Act (15
U.S.C. 2604) is amended--
(1) in subsection (b)--
(A) in paragraph (1)(A)--
[[Page 130 STAT. 507]]
(i) by striking ``rule promulgated'' and
inserting ``rule, order, or consent agreement'';
and
(ii) by striking ``such rule'' and inserting
``such rule, order, or consent agreement'';
(B) in paragraph (1)(B), by striking ``rule
promulgated'' and inserting ``rule or order''; and
(C) in paragraph (2)(A)(ii), by striking ``rule
promulgated'' and inserting ``rule, order, or consent
agreement''; and
(2) in subsection (d)(2)(C), by striking ``rule'' and
inserting ``rule, order, or consent agreement''.
(f) Section 7.--Section 7(a) of the Toxic Substances Control Act (15
U.S.C. 2606(a)) is amended--
(1) in paragraph (1), in the matter following subparagraph
(C), by striking ``a rule under section 4, 5, 6, or title IV or
an order under section 5 or title IV'' and inserting ``a
determination under section 5 or 6, a rule under section 4, 5,
or 6 or title IV, an order under section 4, 5, or 6 or title IV,
or a consent agreement under section 4''; and
(2) in paragraph (2), by striking ``subsection
6(d)(2)(A)(i)'' and inserting ``section 6(d)(3)(A)(i)''.
(g) Section 8.--Section 8(a) of the Toxic Substances Control Act (15
U.S.C. 2607(a)) is amended--
(1) in paragraph (2)(E), by striking ``data'' and inserting
``information''; and
(2) in paragraph (3)(A)(ii)(I), by striking ``or an order in
effect under section 5(e)'' and inserting ``, an order in effect
under section 4 or 5(e), or a consent agreement under section
4''.
(h) Section 9.--Section 9 of the Toxic Substances Control Act (15
U.S.C. 2608) is amended--
(1) in subsection (a), by striking ``section 6'' each place
it appears and inserting ``section 6(a)''; and
(2) in subsection (d), by striking ``Health, Education, and
Welfare'' and inserting ``Health and Human Services''.
(i) Section 10.--Section 10 of the Toxic Substances Control Act (15
U.S.C. 2609) is amended--
(1) in the section heading, by striking ``data'' and
inserting ``information'';
(2) by striking ``Health, Education, and Welfare'' each
place it appears and inserting ``Health and Human Services'';
(3) in subsection (b)--
(A) in the subsection heading, by striking ``Data''
and inserting ``Information'';
(B) by striking ``data'' and inserting
``information'' in paragraph (1);
(C) by striking ``data'' and inserting
``information'' in paragraph (2)(A); and
(D) by striking ``a data'' and inserting ``an
information'' in paragraph (2)(B); and
(4) in subsection (g), by striking ``data'' and inserting
``information''.
(j) Section 11.--Section 11(b)(2) of the Toxic Substances Control
Act (15 U.S.C. 2610(b)(2)) is amended--
(1) by striking ``data'' each place it appears and inserting
``information''; and
[[Page 130 STAT. 508]]
(2) in subparagraph (E), by striking ``rule promulgated''
and inserting ``rule promulgated, order issued, or consent
agreement entered into''.
(k) Section 12.--Section 12(b)(1) of the Toxic Substances Control
Act (15 U.S.C. 2611(b)(1)) is amended by striking ``data'' both places
it appears and inserting ``information''.
(l) Section 15.--Section 15(1) of the Toxic Substances Control Act
(15 U.S.C. 2614(1)) is amended by striking ``(A) any rule'' and all that
follows through ``or (D)'' and inserting ``any requirement of this title
or any rule promulgated, order issued, or consent agreement entered into
under this title, or''.
(m) Section 19.--Section 19 of the Toxic Substances Control Act (15
U.S.C. 2618) is amended--
(1) in subsection (a)--
(A) in paragraph (1)(A)--
(i) by striking ``Not later than 60 days after
the date of the promulgation of a rule under
section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8,
or under title II or IV'' and inserting ``Except
as otherwise provided in this title, not later
than 60 days after the date on which a rule is
promulgated under this title, title II, or title
IV, or the date on which an order is issued under
section 4, 5(e), 5(f), or 6(i)(1),'';
(ii) by striking ``such rule'' and inserting
``such rule or order''; and
(iii) by striking ``such a rule'' and
inserting ``such a rule or order'';
(B) in paragraph (1)(B)--
(i) by striking ``Courts'' and inserting
``Except as otherwise provided in this title,
courts''; and
(ii) by striking ``subparagraph (A) or (B) of
section 6(b)(1)'' and inserting ``this title,
other than an order under section 4, 5(e), 5(f),
or 6(i)(1),''; and
(C) in paragraph (2)--
(i) by striking ``rulemaking record'' and
inserting ``record''; and
(ii) by striking ``based the rule'' and
inserting ``based the rule or order'';
(2) in subsection (b)--
(A) by striking ``review a rule'' and inserting
``review a rule, or an order under section 4, 5(e),
5(f), or 6(i)(1),'';
(B) by striking ``such rule'' and inserting ``such
rule or order'';
(C) by striking ``the rule'' and inserting ``the
rule or order'';
(D) by striking ``new rule'' each place it appears
and inserting ``new rule or order''; and
(E) by striking ``modified rule'' and inserting
``modified rule or order''; and
(3) in subsection (c)--
(A) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``a rule'' and
inserting ``a rule or order''; and
(II) by striking ``such rule'' and
inserting ``such rule or order'';
(ii) in subparagraph (B)--
[[Page 130 STAT. 509]]
(I) in the matter preceding clause
(i), by striking ``a rule'' and
inserting ``a rule or order'';
(II) by amending clause (i) to read
as follows:
``(i) in the case of review of--
``(I) a rule under section 4(a), 5(b)(4), 6(a)
(including review of the associated determination under
section 6(b)(4)(A)), or 6(e), the standard for review
prescribed by paragraph (2)(E) of such section 706 shall
not apply and the court shall hold unlawful and set
aside such rule if the court finds that the rule is not
supported by substantial evidence in the rulemaking
record taken as a whole; and
``(II) an order under section 4, 5(e), 5(f), or
6(i)(1), the standard for review prescribed by paragraph
(2)(E) of such section 706 shall not apply and the court
shall hold unlawful and set aside such order if the
court finds that the order is not supported by
substantial evidence in the record taken as a whole;
and''; and
(III) by striking clauses (ii) and
(iii) and the matter after clause (iii)
and inserting the following:
``(ii) the court may not review the contents and adequacy of
any statement of basis and purpose required by section 553(c) of
title 5, United States Code, to be incorporated in the rule or
order, except as part of the record, taken as a whole.''; and
(iii) by striking subparagraph (C); and
(B) in paragraph (2), by striking ``any rule'' and
inserting ``any rule or order''.
(n) Section 20.--Section 20(a)(1) of the Toxic Substances Control
Act (15 U.S.C. 2619(a)(1)) is amended by striking ``order issued under
section 5'' and inserting ``order issued under section 4 or 5''.
(o) Section 21.--Section 21 of the Toxic Substances Control Act (15
U.S.C. 2620) is amended--
(1) in subsection (a), by striking ``order under section
5(e) or (6)(b)(2)'' and inserting ``order under section 4 or
5(e) or (f)''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``order under
section 5(e), 6(b)(1)(A), or 6(b)(1)(B)'' and inserting
``order under section 4 or 5(e) or (f)''; and
(B) in paragraph (4)(B)--
(i) in the matter preceding clause (i), by
striking ``order under section 5(e) or 6(b)(2)''
and inserting ``order under section 4 or 5(e) or
(f)'';
(ii) in clause (i), by striking ``order under
section 5(e)'' and inserting ``order under section
4 or 5(e)''; and
(iii) in clause (ii), by striking ``section 6
or 8 or an order under section 6(b)(2), there is a
reasonable basis to conclude that the issuance of
such a rule or order is necessary to protect
health or the environment against an unreasonable
risk of injury to health or the environment'' and
inserting ``section 6(a) or 8 or an order under
section 5(f), the chemical substance or mixture to
be subject to such rule or order presents an
unreasonable risk of injury to health or the
environment, without consideration of costs or
other nonrisk
[[Page 130 STAT. 510]]
factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation,
under the conditions of use''.
(p) Section 24.--Section 24(b)(2)(B) of the Toxic Substances Control
Act (15 U.S.C. 2623(b)(2)(B)) is amended--
(1) by inserting ``and'' at the end of clause (i);
(2) by striking clause (ii); and
(3) by redesignating clause (iii) as clause (ii).
(q) Section 26.--Section 26 of the Toxic Substances Control Act (15
U.S.C. 2625) is amended--
(1) in subsection (e), by striking ``Health, Education, and
Welfare'' each place it appears and inserting ``Health and Human
Services''; and
(2) in subsection (g)(1), by striking ``data'' and inserting
``information''.
(r) Section 27.--Section 27(a) of the Toxic Substances Control Act
(15 U.S.C. 2626(a)) is amended--
(1) by striking ``Health, Education, and Welfare'' and
inserting ``Health and Human Services'';
(2) by striking ``test data'' both places it appears and
inserting ``information'';
(3) by striking ``rules promulgated'' and inserting ``rules,
orders, or consent agreements''; and
(4) by striking ``standards'' and inserting ``protocols and
methodologies''.
(s) Section 30.--Section 30(2) of the Toxic Substances Control Act
(15 U.S.C. 2629(2)) is amended by striking ``rule'' and inserting
``rule, order, or consent agreement''.
SEC. 20. <<NOTE: 15 USC 2601 note.>> NO RETROACTIVITY.
Nothing in sections 1 through 19, or the amendments made by sections
1 through 19, shall be interpreted to apply retroactively to any State,
Federal, or maritime legal action filed before the date of enactment of
this Act.
SEC. 21. <<NOTE: 42 USC 280g-17 note.>> TREVOR'S LAW.
(a) Purposes.--The purposes of this section are--
(1) to provide the appropriate Federal agencies with the
authority to help conduct investigations into potential cancer
clusters;
(2) to ensure that Federal agencies have the authority to
undertake actions to help address cancer clusters and factors
that may contribute to the creation of potential cancer
clusters; and
(3) to enable Federal agencies to coordinate with other
Federal, State, and local agencies, institutes of higher
education, and the public in investigating and addressing cancer
clusters.
(b) Designation and Investigation of Potential Cancer Clusters.--
Part P of title III of the Public Health Service Act (42 U.S.C. 280g et
seq.) is amended by adding at the end the following:
``SEC. 399V-6. <<NOTE: 42 USC 280g-17.>> DESIGNATION AND
INVESTIGATION OF POTENTIAL CANCER
CLUSTERS.
``(a) Definitions.--In this section:
``(1) Cancer cluster.--The term `cancer cluster' means the
incidence of a particular cancer within a population group,
[[Page 130 STAT. 511]]
a geographical area, and a period of time that is greater than
expected for such group, area, and period.
``(2) Particular cancer.--The term `particular cancer' means
one specific type of cancer or a type of cancers scientifically
proven to have the same cause.
``(3) Population group.--The term `population group' means a
group, for purposes of calculating cancer rates, defined by
factors such as race, ethnicity, age, or gender.
``(b) Criteria for Designation of Potential Cancer Clusters.--
``(1) Development of criteria.--The Secretary shall develop
criteria for the designation of potential cancer clusters.
``(2) Requirements.--The criteria developed under paragraph
(1) shall consider, as appropriate--
``(A) a standard for cancer cluster identification
and reporting protocols used to determine when cancer
incidence is greater than would be typically observed;
``(B) scientific screening standards that ensure
that a cluster of a particular cancer involves the same
type of cancer, or types of cancers;
``(C) the population in which the cluster of a
particular cancer occurs by factors such as race,
ethnicity, age, and gender, for purposes of calculating
cancer rates;
``(D) the boundaries of a geographic area in which a
cluster of a particular cancer occurs so as not to
create or obscure a potential cluster by selection of a
specific area; and
``(E) the time period over which the number of cases
of a particular cancer, or the calculation of an
expected number of cases, occurs.
``(c) Guidelines for Investigation of Potential Cancer Clusters.--
The Secretary, <<NOTE: Consultation. Publication.>> in consultation
with the Council of State and Territorial Epidemiologists and
representatives of State and local health departments, shall develop,
publish, and periodically update guidelines for investigating potential
cancer clusters. The guidelines shall--
``(1) <<NOTE: Recommenda- tion.>> recommend that
investigations of cancer clusters--
``(A) use the criteria developed under subsection
(b);
``(B) use the best available science; and
``(C) rely on a weight of the scientific evidence;
``(2) provide standardized methods of reviewing and
categorizing data, including from health surveillance systems
and reports of potential cancer clusters; and
``(3) provide guidance for using appropriate epidemiological
and other approaches for investigations.
``(d) Investigation of Cancer Clusters.--
``(1) Secretary discretion.--The Secretary--
``(A) <<NOTE: Consultation.>> in consultation with
representatives of the relevant State and local health
departments, shall consider whether it is appropriate to
conduct an investigation of a potential cancer cluster;
and
``(B) in conducting investigations shall have the
discretion to prioritize certain potential cancer
clusters, based on the availability of resources.
``(2) Coordination.--In investigating potential cancer
clusters, the Secretary shall coordinate with agencies within
the
[[Page 130 STAT. 512]]
Department of Health and Human Services and other Federal
agencies, such as the Environmental Protection Agency.
``(3) Biomonitoring.--In investigating potential cancer
clusters, the Secretary shall rely on all appropriate
biomonitoring information collected under other Federal
programs, such as the National Health and Nutrition Examination
Survey. The Secretary may provide technical assistance for
relevant biomonitoring studies of other Federal agencies.
``(e) Duties.--The Secretary shall--
``(1) ensure that appropriate staff of agencies within the
Department of Health and Human Services are prepared to provide
timely assistance, to the extent practicable, upon receiving a
request to investigate a potential cancer cluster from a State
or local health authority;
``(2) maintain staff expertise in epidemiology, toxicology,
data analysis, environmental health and cancer surveillance,
exposure assessment, pediatric health, pollution control,
community outreach, health education, laboratory sampling and
analysis, spatial mapping, and informatics;
``(3) consult with community members as investigations into
potential cancer clusters are conducted, as the Secretary
determines appropriate;
``(4) collect, store, and disseminate reports on
investigations of potential cancer clusters, the possible causes
of such clusters, and the actions taken to address such
clusters; and
``(5) provide technical assistance for investigating cancer
clusters to State and local health departments through existing
programs, such as the Epi-Aids program of the Centers for
Disease Control and Prevention and the Assessments of Chemical
Exposures Program of the Agency for Toxic Substances and Disease
Registry.''.
TITLE <<NOTE: Rural Healthcare Connectivity Act of 2016.>> II--RURAL
HEALTHCARE CONNECTIVITY
SEC. 201. <<NOTE: 47 USC 609 note.>> SHORT TITLE.
This title may be cited as the ``Rural Healthcare Connectivity Act
of 2016''.
SEC. 202. TELECOMMUNICATIONS SERVICES FOR SKILLED NURSING
FACILITIES.
(a) In General.--Section 254(h)(7)(B) of the Communications Act of
1934 (47 U.S.C. 254(h)(7)(B)) is amended--
(1) in clause (vi), by striking ``and'' at the end;
(2) by redesignating clause (vii) as clause (viii);
(3) by inserting after clause (vi) the following:
``(vii) skilled nursing facilities (as defined
in section 1819(a) of the Social Security Act (42
U.S.C. 1395i-3(a))); and''; and
(4) in clause (viii), as redesignated, by striking ``clauses
(i) through (vi)'' and inserting ``clauses (i) through (vii)''.
(b) <<NOTE: 47 USC 254 note.>> Savings Clause.--Nothing in
subsection (a) shall be construed to affect the aggregate annual cap on
Federal universal service support for health care providers under
section 54.675 of title 47, Code of Federal Regulations, or any
successor regulation.
[[Page 130 STAT. 513]]
(c) <<NOTE: 47 USC 254 note.>> Effective Date.--The amendments made
by subsection (a) shall apply beginning on the date that is 180 days
after the date of the enactment of this Act.
Approved June 22, 2016.
LEGISLATIVE HISTORY--H.R. 2576:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 114-176 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD:
Vol. 161 (2015):
June 23, considered and passed
House.
Dec. 17, considered and passed
Senate, amended.
Vol. 162 (2016):
May 24, House concurred in Senate
amendment with an amendment.
June 7, Senate concurred in House
amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016):
June 22, Presidential remarks.
<all>