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