1.This Act may be cited as the
Toxic Chemicals Safety Act of
2010
.
2.Findings, policy,
and goal
(a)Findings,
policy, and goalSection 2 of
the Toxic Substances Control Act (15 U.S.C. 2601) is amended—
(1)by striking
Intent
in the section heading and
inserting Goal
; and
(2)by striking
subsections (a) through (c) and inserting the following:
(a)Congress
finds that—
(1)the chemical
industry is an important part of the United States economy and provides
valuable products that are used in diverse manufacturing industries and other
commercial, institutional, and consumer applications;
(2)more than 3
decades after the enactment of the Toxic Substances Control Act, the public and
the environment in the United States are still exposed to thousands of
chemicals whose safety has not been adequately reviewed;
(3)biomonitoring
reveals that people in the United States have many hazardous chemicals in their
bodies;
(4)the potential for
adverse effects from chemical exposures is modulated by developmental changes
in metabolism, physiology, and pathways of exposure, with increased potential
for adverse effects from exposures that occur in utero, during infancy, and
during other critical periods of development;
(5)there is
significant global trade in the chemical sector and many of the companies that
conduct business in the United States must also comply with chemical safety
regulatory programs in other countries, and the data that are generated to
comply with these other regulatory programs may be useful in understanding the
hazards of and exposures to chemicals in the United States; and
(6)a revised policy
on the safety of chemicals will assist in renewing the manufacturing sector of
the United States, create new and safer jobs, spur innovations in green
chemistry, restore confidence domestically and internationally in the safety of
products of the United States, and ensure that products of the United States
remain competitive in the global market.
(b)It
is the policy of the United States—
(1)to protect the
health of children, workers, consumers, and the public, and to protect the
environment from adverse effects of exposures to chemicals;
(2)to promote the use
of safer alternatives and other actions that reduce use of and exposure to
hazardous chemicals and reward innovation in developing safer chemicals,
processes, and products;
(3)to require that
all chemicals in commerce meet a risk-based safety standard that protects
disproportionately vulnerable and affected populations and the
environment;
(4)to require
manufacturers and processors to provide sufficient health and environmental
information for the chemicals which they manufacture or process as a condition
of allowing distribution of such chemicals in commerce;
(5)to improve the
quality of information on chemical safety and use;
(6)to guarantee the
right of the public and workers to know about the risks associated with
chemicals that they may be exposed to by maximizing public access to
information on such chemicals;
(7)to strengthen
cooperation between and among the Federal Government and State, municipal,
tribal, and foreign governments;
(8)to ensure the
Administrator has the authority to develop sufficient information to assess
chemical safety, and to act effectively when the Administrator obtains
information that indicates there are risks of harmful chemical exposure;
and
(9)to replace, reduce, and refine testing on
animals by promoting and funding the development of more efficient test methods
and strategies.
(c)It
is the goal of the United States to protect health and the environment by
addressing exposure to harmful chemicals distributed in commerce, including
exposure of vulnerable or disproportionately affected populations, by—
(1)determining
whether all chemicals in commerce meet the safety standard under this
title;
(2)restricting the
manufacture, processing, use, distribution in commerce, or disposal of a
chemical, where warranted; and
(3)encouraging the
replacement of harmful chemicals and processes with safer
alternatives.
.
(b)The table of
contents for the Toxic Substances Control Act is amended by amending the item
relating to section 2 to read as follows:
Sec. 2. Findings, policy, and
goal.
.
3.Definitions and
Determinations
(a)Definitions and
DeterminationsSection 3 of
the Toxic Substances Control Act (15 U.S.C. 2602) is amended—
(1)by
striking—
and inserting the
following:
3.Definitions and
Determinations
(a)As used in this
Act:
;
(2)in subsection (a),
(relating to definitions, as designated by paragraph (1))—
(A)in paragraph
(2)—
(i)in subparagraph
(A)—
(I)by striking
Except as provided in subparagraph (B), the term
and inserting
The term
;
(II)in clause (i), by
striking and
after nature,
;
(III)in clause (ii),
by striking the period at the end and inserting , and
;
and
(IV)by adding at the
end the following new clause:
(iii)any form of a substance determined by the
Administrator to be a chemical substance under subsection
(b)(1).
;
and
(ii)in subparagraph
(B)—
(I)by striking clause
(ii) and inserting the following:
(ii)any alcoholic beverage (as defined in
section 214 of the Federal Alcohol Administration
Act),
;
(II)in clause (iii), by striking
product,
inserting product (as defined in section 201 of
the Federal Food, Drug, and Cosmetic Act), and
; and
(III)by striking
clauses (v) and (vi) and the matter following clause (vi);
(B)in paragraph (4)—
(i)by striking
or
after or article;
; and
(ii)by inserting
; or to export or offer for export the substance, mixture, or article,
except for demonstrated use solely as a pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act), food, food additive, drug,
cosmetic, or device (as such terms are defined in section 201 of the Federal
Food, Drug, and Cosmetic Act) and including poultry, poultry products, meat,
meat food products (as defined in section 1(j) of the Federal Meat Inspection
Act), eggs, and egg products (as defined in section 4 of the Egg Products
Inspection Act)
after article after its introduction into
commerce
;
(C)in paragraph (5),
by inserting ambient and indoor
after includes water,
;
(D)in paragraph (7),
by inserting , except for demonstrated use solely as a pesticide (as
defined in the Federal Insecticide, Fungicide, and Rodenticide Act), food, food
additive, drug, cosmetic, or device (as such terms are defined in section 201
of the Federal Food, Drug, and Cosmetic Act) and including poultry, poultry
products, meat, meat food products (as defined in section 1(j) of the Federal
Meat Inspection Act), eggs, and egg products (as defined in section 4 of the
Egg Products Inspection Act)
after produce, or
manufacture
;
(E)in paragraph (9),
by striking which is not included in the chemical substance list
compiled and published under section 8(b)
and inserting for
which no declaration has been submitted under section 8(a)(2), except that,
with respect to the first year after the date of enactment of the Toxic
Chemicals Safety Act of 2010, such term shall not include a chemical substance
distributed in commerce as of such date of enactment
;
(F)in paragraph (10),
after subparagraph (B), by adding the following:
Except
such term shall not include preparation for demonstrated use solely as a
pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide
Act), food, food additive, drug, cosmetic, or device (as such terms are defined
in section 201 of the Federal Food, Drug, and Cosmetic Act) and including
poultry, poultry products, meat, meat food products (as defined in section 1(j)
of the Federal Meat Inspection Act), eggs, and egg products (as defined in
section 4 of the Egg Products Inspection Act). Relabeling or redistributing a
container holding a chemical substance or mixture where no repackaging of the
chemical substance or mixture occurs does not constitute processing of the
chemical substance or mixture. Relabeling, redistributing, or repackaging an
article containing a chemical substance or mixture, including incorporating the
article into another article, does not constitute processing of the chemical
substance or
mixture..
(G)by striking
paragraph (12) and redesignating paragraphs (13) and (14) as paragraphs (12)
and (13), respectively; and
(H)by adding at the
end the following new paragraphs:
(14)The term
adverse effect means a chemical or biochemical change, anatomic
change, or functional impairment, or a known precursor to such a change or
impairment, that—
(A)has the potential
to impair the performance of an anatomic structure of a vital system of an
organism or progeny of an organism;
(B)causes
irreversible change in the homeostasis of an organism;
(C)increases the
susceptibility of an organism or progeny of an organism to other chemical or
biological stressors or reduces the ability of an organism or progeny of an
organism to respond to additional health or environmental challenges; or
(D)affects, alters,
or harms the environment such that the health of humans or other organisms is
directly or indirectly threatened.
In order
to reflect best available science, the Administrator may, by rule, revise the
definition of such term for purposes of this Act in such a way that reflects
the state of the science and provides for equal or greater protection of health
and the environment.(15)The term
aggregate exposure means all exposure from—
(A)manufacture,
processing, distribution, use, and disposal;
(B)manufacturing or
processing of the substance for use as a pesticide, food, food additive, drug,
cosmetic, or device;
(C)contamination of
food, air, water, soil, house dust, and any other environmental media from
current or prior uses or activity;
(D)permitted sources
of pollution;
(E)nonpoint sources
of pollution; and
(F)documented
background levels from natural and anthropogenic sources.
(16)The term bioaccumulative
means, with respect to a chemical substance or mixture, that the chemical
substance or mixture, as determined by the Administrator, can significantly
accumulate in biota, as indicated through monitoring data, or is highly likely
to accumulate in biota, as indicated by other evidence. In order to reflect
best available science, the Administrator may, by rule, revise the definition
of such term for purposes of this Act in such a way that reflects the state of
the science and provides for equal or greater protection of health and the
environment.
(17)The term
chemical identity means, with respect to a chemical
substance—
(A)each common and
trade name of the chemical substance;
(B)the name of the
chemical substance appearing in International Union of Pure and Applied
Chemistry nomenclature and 9th Collective Index format;
(C)the Chemical
Abstracts Service registration number of the chemical substance; and
(D)the molecular
structure and the molecular identity of the chemical substance.
(18)The term
cumulative exposure means the sum of aggregate exposure to—
(A)each of the
chemical substances that are known or, where supported by scientific consensus,
suspected to contribute appreciably to the risk of the same adverse effect;
and
(B)mixtures
containing chemical substances described in subparagraph (A).
(19)The term
Federal agency means any department, agency, or other
instrumentality of the Federal Government, any independent agency or
establishment of the Federal Government including any Government corporation,
and the Government Printing Office.
(20)The term
importer means any person who imports a chemical substance or
mixture, or any article containing a chemical substance or mixture, for
distribution in commerce.
(21)The term persistent means,
with respect to a chemical substance or mixture, that the chemical substance or
mixture, as determined by the Administrator, significantly persists in 1 or
more environmental media, as indicated by monitoring data or other evidence. In
order to reflect best available science, the Administrator may, by rule, revise
the definition of such term for purposes of this Act in such a way that
reflects the state of the science and provides for equal or greater protection
of health and the environment.
(22)The term
substance characteristic means, with respect to a particular
chemical substance, the physical and chemical characteristics that may vary for
such substance, and whose variation may bear on the toxicological properties or
the exposure potential of the substance, including—
(A)structure and
composition;
(B)size or size
distribution;
(C)shape;
(D)surface
structure;
(E)reactivity;
and
(F)other
characteristics and properties that may bear on toxicological properties or
exposure potential.
(23)The term
toxic, with respect to a chemical substance or mixture, means that
the chemical substance or mixture, or a metabolite or degradation product of
such substance or mixture, has a toxicological property—
(A)that causes an
adverse effect that has been demonstrated in humans or other organisms;
or
(B)for which the
weight of evidence (such as demonstration of such an adverse effect as
described in subparagraph (A) in laboratory studies or data for a chemical from
the same chemical class that exhibits such an adverse effect) demonstrates the
potential for an adverse effect in humans or other organisms.
(24)The term
toxicological property means established toxicity, adverse
effects, or established precursors to such toxicity or adverse effects,
including effects of exposure to a chemical substance or mixture on—
(A)mortality;
(B)morbidity,
including carcinogenesis;
(C)genetics,
including mutagenicity, genotoxicity, and epigenetics;
(D)reproduction;
(E)growth and
development;
(F)the immune
system;
(G)the endocrine
system;
(H)the brain or
nervous system;
(I)other organ
systems; or
(J)any other
biological functions in humans or other organisms.
(25)The term
use means any utilization of a chemical substance or mixture that
is not otherwise covered by the terms manufacture or process, and may
include—
(A)any composition of
the chemical substance with other chemical substances;
(B)any group of
utilizations determined by the Administrator to be a single use under
subsection (b)(2).
Relabeling
or redistributing a container holding a chemical substance or mixture where no
repackaging of the chemical substance or mixture occurs does not constitute use
of the chemical substance or mixture.(26)The term
vulnerable population means a population that is subject to a
disproportionate exposure to, or potential for a disproportionate adverse
effect from exposure to, a chemical substance or mixture, including—
(A)infants, children,
and adolescents;
(B)pregnant women
(including effects on fetal development);
(C)the
elderly;
(D)individuals with
preexisting medical conditions;
(E)workers;
and
(F)members of any
other appropriate population identified by the Administrator based on
consideration of—
(i)socioeconomic
status;
(ii)racial or ethnic
background;
(iii)culturally
influenced dietary or other practices or factors; or
(iv)other similar
factors identified by the
Administrator.
;
and
(3)by adding at the
end the following new subsection:
(b)
(1)The Administrator may determine different
forms of a chemical substance with a particular molecular identity to be
different chemical substances for purposes of this Act, based on variations in
the substance characteristics. New forms of existing chemical substances so
determined shall be considered new chemical substances for purposes of this
Act.
(2)The Administrator
may determine different uses of a chemical substance or mixture to be the same
use for purposes of this Act, based on industry classification systems or
factors determined by the Administrator to indicate similarity in use and
exposure, provided that such systems or factors ensure that the different uses
treated as the same use under this paragraph do not involve materially
different patterns, pathways, or degrees of
exposure.
.
(b)The table of
contents for the Toxic Substances Control Act is amended by amending the item
relating to section 3 to read as follows:
Sec. 3. Definitions and
Determinations.
.
4.Minimum Data Set
and Testing of Chemical Substances and MixturesSection 4 of the Toxic Substances Control
Act (15 U.S.C. 2603) is amended as follows:
(1)By amending subsection (a) to read as
follows:
(a)
(1)Not later than 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall
establish, by rule, the data that constitute the minimum data set for
substances described in paragraph (2). The rule shall—
(A)require
manufacturers and processors to submit a minimum data set that the
Administrator determines will be useful in conducting safety standard
determinations pursuant to section 6(b) or carrying out any provision of this
Act, and shall include information on—
(i)chemical
identity;
(ii)substance
characteristics;
(iii)biological and
environmental fate and transport;
(iv)toxicological
properties;
(v)volume
manufactured, processed, or imported;
(vi)intended uses;
and
(vii)exposures from
all stages of the chemical substance or mixture’s lifecycle that are known or
reasonably foreseeable to the party submitting the data set;
(B)provide for varied
or tiered testing;
(C)establish
requirements for manufacturers and processors to update their minimum data set
submissions, as appropriate; and
(D)be updated by the
Administrator not less often than once every 5 years.
(2)Except as provided
in paragraph (3), the manufacturers and processors of a chemical substance or
mixture shall submit the minimum data set established by the rule under
paragraph (1), accompanied by the certification described in section 8(i), to
the Administrator—
(A)for an existing
chemical substance or mixture, not later than the earlier of—
(i)18 months after the date on which the
Administrator lists the chemical substance or mixture on the priority list
under section 6(a); or
(ii)for chemical
substances produced—
(I)at high volumes,
as determined by the Administrator, 3 years after the date of enactment of the
Toxic Chemicals Safety Act of 2010;
(II)at moderate
volumes, as determined by the Administrator, 4 years after the date of
enactment of the Toxic Chemicals Safety Act of 2010; or
(III)at low volumes,
as determined by the Administrator, 5 years after the date of enactment of the
Toxic Chemicals Safety Act of 2010; or
(B)for a new chemical
substance, the date on which the notice required under section 5(a)(1)(A) is
submitted.
(3)No minimum data
set shall be required to be submitted by manufacturers and processors of a
chemical substance listed under section 6(a)(1)(A) or exempted from the
requirement pursuant to section 39 or section 32 or for a safer alternative
approved pursuant to section 35.
(4)If a manufacturer
or processor is in violation of paragraph (2), the Administrator may impose
penalties, pursuant to section 16, on such manufacturer or processor, or, by
order, impose conditions, including prohibitions, on the manufacture,
processing, or distribution in commerce of the chemical substance, or any
mixture or article containing the chemical substance, by such manufacturer or
processor.
.
(2)In subsection
(b)—
(A)by redesignating
paragraphs (2) and (3) as paragraphs (4) and (5), respectively;
(B)by redesignating
paragraphs (4) and (5) as paragraphs (7) and (8), respectively;
(C)in paragraph
(1)—
(i)by striking
A rule under subsection (a) shall include
and all that follows
through during the period prescribed under subparagraph (C)
;
and
(D)by striking the
following:
(b)(1)
and inserting the following:
(b)
(1)The Administrator
may, by rule or order, after notice and opportunity for comment, require
testing in addition to the requirements for the minimum data set under
subsection (a) with respect to any chemical substance or mixture and the
submission of test results by a specified date, as necessary for making a
safety standard determination under section 6(b) or carrying out any provision
of this Act.
(2)If a manufacturer or processor is in
violation of paragraph (1), the Administrator may impose penalties, pursuant to
section 16, on such manufacturer or processor, or, by order, impose conditions,
including prohibitions, on the manufacture, processing, or distribution in
commerce of the chemical substance, or any mixture or article containing the
chemical substance, by such manufacturer or processor.
(3)A rule or order
under paragraph (1) shall include—
(A)identification of
the chemical substance or mixture for which testing is required;
(B)the testing
required and justification for such testing, and may specify test protocols and
methodology for testing for such substance or mixture in accordance with
section 34(c); and
(C)a specification of
the period (which period may not be of unreasonable duration) within which the
persons required to conduct the testing shall submit to the Administrator data
developed in accordance with a methodology referred to in subparagraph
(B).
In determining the testing, test
protocols, and methodology, and period to be included, pursuant to
subparagraphs (B) and (C), in a rule or order under paragraph (1), the
Administrator shall consider the relative costs of the various test protocols
and methodologies which may be required under the rule or order and the
reasonably foreseeable availability of the facilities and personnel needed to
perform the testing required under the rule or order. Any such rule or order
may require the submission to the Administrator of preliminary data during the
period prescribed under subparagraph
(C).;
(E)by amending
paragraph (4), as redesignated by subparagraph (A) of this paragraph, to read
as follows:
(4)(A)(i)The health and
environmental effects for which testing may be prescribed include any
toxicological property and any other adverse effect which may be considered in
a safety standard determination under section 6(b).
(ii)The exposure information for which
testing may be prescribed includes biological or environmental fate and
transport, monitoring for the presence of the chemical substance or mixture (or
a metabolite or degradation byproduct of the chemical substance or mixture) in
animal or human biological media or environmental media, and any other exposure
information which may be considered in a safety standard determination under
section 6(b).
(iii)The characteristics of chemical
substances and mixtures for which testing may be prescribed include
persistence, bioaccumulation, and any other relevant substance characteristic
which may be considered in a safety standard determination under section
6(b).
(B)The methodologies that may be
prescribed in testing include epidemiologic studies, industrial hygiene
surveys, biomonitoring studies, serial or hierarchical tests, in vitro tests,
and whole animal tests consistent with section 34, except that before
prescribing epidemiologic studies or industrial hygiene surveys of employees,
the Administrator shall consult with the Director of the National Institute for
Occupational Safety and Health.
(C)From time to time, but not less than
once each 12 months, the Administrator shall review the adequacy of the
methodology for testing prescribed in rules or orders under paragraph (1) and
shall, if necessary, institute proceedings to make appropriate revisions of
such
methodology.
;
(F)in paragraph (5),
as redesignated by subparagraph (A) of this paragraph—
(i)by striking
subparagraph (B);
(ii)by striking (A) A rule under
subsection (a) respecting a chemical substance or mixture shall require the
persons described in subparagraph (B)
and inserting A rule or
order under paragraph (1) respecting a chemical substance or mixture shall
specify the persons required
; and
(iii)by
inserting in which case all parties remain individually liable for the
testing requirements
after on behalf of the persons making the
designation
;
(G)by inserting after
paragraph (5), as redesignated by subparagraph (A) of this paragraph, the
following new paragraph:
(6)Any biomonitoring study of the public
regarding a chemical substance or any metabolite or degradation byproduct of
such substance shall be conducted by the Director of the Centers for Disease
Control and Prevention in collaboration with the Administrator, at the expense
of the manufacturers and processors of the chemical substance. Any
biomonitoring study of employees regarding a chemical substance or any
metabolite or degradation byproduct of such substance may be conducted by the
relevant employer, at the expense of the manufacturers and processors of the
chemical substance, in collaboration with the Director of the National
Institute of Occupational Safety and Health and the
Administrator.
;
(H)in paragraph (7),
as redesignated by subparagraph (B) of this paragraph—
(i)by striking under subsection
(a)
in both places it appears and inserting or order under
paragraph (1)
;
(ii)by striking
repeals the rule
in both places it appears and inserting
withdraws the rule or order
; and
(iii)by striking
repeals the application of the rule
and inserting
withdraws the rule or order as applied
; and
(I)by amending
paragraph (8), as redesignated by subparagraph (B) of this paragraph, to read
as follows:
(8)Rules issued under subsection (a) and
paragraph (1) (and any substantive amendment thereto or repeal thereof) shall
be promulgated pursuant to section 553 of title 5, United States
Code.
.
(3)In subsection
(c)—
(A)in paragraph
(1)—
(i)by inserting
or order
after rule
; and
(ii)by striking
subsection (a)
and inserting subsection (a) or
(b)(1)
;
(B)in paragraph
(2)—
(i)by striking
under subsection (a)
and inserting under subsection
(b)(1)
; and
(ii)by inserting
or order
after rule
each place it appears;
(C)in paragraph
(3)(B)(i), by striking promulgated under subsection (a)
and
inserting or order issued under subsection (b)(1)
;
(D)in paragraph
(4)—
(i)in subparagraph
(A)—
(I)by striking
promulgated under subsection (a)
and inserting issued
under subsection (b)(1)
; and
(II)by inserting
or order
after rule
each place it appears;
and
(ii)in subparagraph
(B)—
(I)by striking
promulgated under subsection (a)
and inserting or order
issued under subsection (b)(1)
; and
(II)by inserting
or order
after such rule
; and
(III)by inserting
or order
after requirements of the rule
;
and
(E)by adding at the
end the following new paragraph:
(5)If a manufacturer or processor has
submitted a declaration of permanent cessation of manufacture or processing
under section 8(a)(3) for a chemical substance or mixture, the manufacturer or
processor shall be exempted from the requirements of this section with regard
to such chemical substance or
mixture.
.
(4)In subsection
(d)—
(A)by striking
under subsection (a)
and inserting or order issued under
subsection (a) or (b)(1)
;
(B)by inserting
Such notice shall not be interpreted as meeting the requirements of the
rule or order, unless otherwise indicated.
before Subject to
section 14, each notice shall
; and
(C)by inserting
and be added to the public database established pursuant to section
8(d)
after Administrator for examination by any
person
.
(5)In subsection
(e)—
(A)in the subsection
heading, by striking Priority list
and inserting
Interagency Testing
Committee
;
(B)in paragraph (1)—
(i)in subparagraph (A)—
(I)by striking
for the promulgation of a rule under subsection (a)
and
inserting for listing under section 6(a)(1) and promulgation of testing
rules or orders under subsection (b)(1)
;
(II)in clause (v), by
striking an unreasonable
and inserting a
substantial
; and
(III)in the matter
following clause (viii)—
- (aa)by
striking
cancer, gene mutations, or birth defects
and inserting
adverse effects on health or the environment
;
- (bb)by
striking
under subsection (a)
each place it appears and
inserting under subsection (b)(1)
; and
- (cc)by
striking
The total number of chemical substances and mixtures on the
list which are designated under the preceding sentence may not, at any time,
exceed 50.
; and
(ii)in subparagraph
(B), by striking rulemaking proceeding under subsection (a)
and
inserting proceeding to promulgate a rule or issue an order under
subsection (b)(1)
; and
(C)in paragraph
(2)(A)—
(i)by
striking eight members
and inserting 10 members
;
and
(ii)by
adding at the end the following new clauses:
(ix)One member appointed by the Commissioner of
the Food and Drug Administration from officers or employees of the
Administration.
(x)One member appointed by the
Chairman of the Consumer Product Safety Commission from officers or employees
of the
Commission.
.
(6)By amending
subsection (f) to read as follows:
(f)Requests from
other Federal agencies for additional information or testing
(1)If a Federal agency determines that information relating
to a chemical substance or mixture, including data derived from new testing or
monitoring, would assist such agency in carrying out duties or exercising
authority of such agency, but such information is not available to the agency,
such agency may request the Administrator to seek such information on its
behalf.
(2)Not later than 60 days after the date of receipt of
a request under paragraph (1), the Administrator shall—
(A)if in possession
of the requested data, make such data available to the requesting agency,
subject to section 14;
(B)issue an order,
under section 8(b)(1), requiring the submission of existing data to the
requesting agency and to the Administrator;
(C)issue a rule or
order, under subsection (b), to develop such data, and require such data be
furnished to the requesting agency and to the Administrator; or
(D)publish in the
Federal Register the reason for not taking any of the actions described in
subparagraphs (A) through
(C).
.
(7)By striking
subsection (g).
5.Manufacturing and
processing noticesSection 5
of the Toxic Substances Control Act (15 U.S.C. 2604) is amended as
follows:
(1)By amending
subsection (a) to read as follows:
(a)New Chemical
Substances and Mixtures and New Uses of Chemical Substances and
Mixtures
(1)Except as provided
in subsection (d), no person may manufacture or process a new chemical
substance or mixture, or manufacture or process any chemical substance or
mixture for a use which the Administrator has determined, in accordance with
paragraph (2), is a new use, unless—
(A)such person submits to the Administrator,
at least 90 days before such manufacture or processing, a notice, in accordance
with subsection (c) and section 8(i), of such person’s intention to manufacture
or process such chemical substance or mixture and such person complies with any
applicable requirement of subsection (b); and
(B)the Administrator
finds that—
(i)such use is a critical use as determined
pursuant to section 6(e);
(ii)in the case of a chemical substance or
mixture that has not already been determined to meet the safety standard under
section 6(b), the chemical substance or mixture meets the safety standard under
section 6(b), with or without conditions; or
(iii)in the case of a chemical substance or
mixture that has already been determined to meet the safety standard under
section 6(b) without inclusion of the proposed new use, the chemical substance
or mixture continues to meet the safety standard under section 6 for all
intended uses including the new use, with or without conditions.
(2)A use shall be determined by the
Administrator to be new if—
(A)the chemical
substance or mixture has already received a safety standard determination under
section 6(b) which did not include the use; or
(B)the proposed use
will result in manufacturing or processing of the chemical substance or mixture
at a significantly increased volume, as determined by the Administrator, above
that considered in the safety standard determination under section 6(b).
(3)Not later than 30
days after the date on which a manufacturer or processor commences
manufacturing or processing of a new chemical substance or mixture or commences
manufacturing or processing of a chemical substance or mixture for a new use,
the manufacturer or processor shall submit to the Administrator a notice of
commencement of manufacture or
processing.
.
(2)By amending
subsection (b) to read as follows:
(b)Submission of
Data for Uses and Manufacturers or Processors Not Previously Declared
(1)For a chemical
substance or mixture which is not new that has not yet received a safety
standard determination under section 6(b), any manufacturer or processor who
manufactures, processes, or distributes in commerce the chemical substance or
mixture for a use that has not previously been declared under section 8(a),
shall submit the declaration required by section 8(a) within 6 months of
initiating manufacture, processing, or distribution, for that use.
(2)Any manufacturer
or processor who manufactures, processes, or distributes in commerce a chemical
substance for a use that the particular manufacturer or processor has not
previously declared under section 8(a), even where such use has previously been
declared by another party, shall submit the declaration required by section
8(a) within 6 months of initiating manufacture, processing, or distribution for
that use.
(3)For any chemical
substance subject to a Significant New Use Rule pursuant to part 721 of title
40, Code of Federal Regulations, as of the date of enactment of the Toxic
Chemicals Safety Act of 2010, the requirements of that rule shall apply to all
manufacturers and processors of the chemical substance whether or not the
Administrator determines a use to be new pursuant to subsection (a), unless and
until the chemical substance receives a safety standard determination and, if
appropriate, conditions or prohibitions are imposed pursuant to section 6,
after which the Significant New Use Rule shall cease to apply.
(4)For a chemical
substance or mixture that is subject to a rule or order under section 4, the
manufacturer or processor of such chemical for any use which has not previously
been declared under section 8 shall submit to the Administrator any data
required in accordance with such rule or order with the notice under subsection
(a)(1)(A) or the declaration under this subsection, as appropriate.
(5)Not later than 90
days after submission of a notice under subsection (a)(1)(A), and data under
paragraph (4), if required, the Administrator shall determine, pursuant to
subsection (a)(1)(B), whether the use is a critical use or whether a safety
standard determination is required by that paragraph. Not later than 9 months
after the date of such determination, the Administrator shall complete any such
required safety standard determination. The Administrator’s failure to make a
determination pursuant to this paragraph in a timely manner shall not be deemed
to satisfy subsection
(a)(1)(B).
.
(3)By striking
subsection (c) and redesignating subsection (d) as subsection (c).
(4)By amending
subsection (c), as redesignated by paragraph (3) of this section, to read as
follows:
(c)Content of
notice; publicationsThe
notice required by subsection (a)(1)(A) shall include—
(1)the declaration
under section 8(a)(2);
(2)the minimum data
set, as defined pursuant to section 4(a); and
(3)a statement that
the chemical substance or mixture is reasonably anticipated to meet or continue
to meet the safety standard under section 6(b), and a justification for such
statement.
Such a
notice shall be made available, subject to section 14, in the public database
established pursuant to section
8(d).;
(5)By striking
subsections (e), (f), and (g), and redesignating subsections (h) and (i) as
subsections (d) and (e), respectively.
(6)In subsection (d),
as redesignated by paragraph (5) of this section—
(A)by redesignating
paragraphs (1) through (3) as paragraphs (3) through (5), respectively;
(B)by redesignating
paragraphs (5) and (6) as paragraphs (6) and (7), respectively;
(C)by striking
paragraph (4);
(D)by inserting,
before paragraph (3), as redesignated by subparagraph (A) of this paragraph,
the following new paragraphs:
(1)Any new chemical substance or new use of a
chemical substance or mixture approved pursuant to section 35 as a safer
alternative shall be exempt from the requirements of this section.
(2)The Administrator
may exempt any new chemical substance or new use of a chemical substance or
mixture from the requirements of this section pursuant to section
39.
;
(E)in paragraph (3),
as redesignated by subparagraph (A) of this paragraph—
(i)by inserting
and by order,
after upon application,
; and
(ii)by striking
any unreasonable
and inserting a
substantial
;
(F)in paragraph (4), as redesignated by
subparagraph (A) of this paragraph—
(i)by amending
subparagraph (A) to read as follows:
(A)The Administrator shall exempt any person
from the requirement to submit data for a chemical substance or mixture
pursuant to subsection (b)(4), if upon receipt of an application from such
person, the Administrator determines that—
(i)the chemical substance or mixture
with respect to which such application was submitted is equivalent to a
chemical substance or mixture for which data has been submitted to the
Administrator as required by this Act; and
(ii)submission of data by the
applicant on such substance or mixture would be duplicative of data which has
been submitted to the Administrator in accordance with subsection
(b)(4).
No
exemption which is granted under this subparagraph with respect to the
submission of data for a chemical substance or mixture may take effect before
the beginning of the reimbursement period applicable to such
data.;
and
(ii)in subparagraph
(B), by striking subsection (b)(2)
each place it appears and
inserting subsection (b)(4)
;
(G)in paragraph (6),
as redesignated by subparagraph (B) or this paragraph, by inserting ,
including occupational exposure
after human or environmental
exposure
; and
(H)in paragraph (7),
as redesignated by subparagraph (B) of this paragraph, by striking (1)
or (5)
and inserting (3) or (6)
.
6.Prioritization,
safety standard determination, and risk management
(a)Safety standard
determinationSection 6 of
the Toxic Substances Control Act (15 U.S.C. 2605) is amended as follows:
(1)By amending the
section heading to read as follows: Prioritization, safety standard determination, and risk
management
.
(2)By striking
subsection (d).
(3)By redesignating
subsections (e) and (f) as subsections (f) and (g), respectively.
(4)By redesignating
subsections (a) through (c) as subsections (c) through (e),
respectively.
(5)By inserting
before subsection (c), as redesignated by paragraph (4) of this subsection, the
following new subsections:
(a)Priority List
for safety standard determinations
(1)
(A)As of the date of
enactment of the Toxic Chemicals Safety Act of 2010, there shall be established
a list of chemical substances for which safety standard determinations under
this section shall first be made, which shall consist of the following chemical
substances:
(i)Bisphenol
A.
(ii)Formaldehyde.
(iii)N–Hexane.
(iv)Hexavalent
chromium.
(v)Methylene
chloride.
(vi)Trichloroethylene.
(vii)Vinyl
chloride.
(viii)The following
phthalates:
(I)Benzylbutyl
phthalate.
(II)Dibutyl
phthalate.
(III)Diethylhexyl
phthalate.
(IV)Di-isodecyl
phthalate.
(V)Di-isononyl
phthalate.
(VI)Di-n-hexyl
phthalate.
(VII)Di-n-octyl
phthalate.
(ix)Perchlorate.
(x)Tetrachloroethylene.
(xi)Tris
(1,3-dichloro-2-propyl) phosphate.
(xii)Tris
(2-chloroethyl) phosphate.
(xiii)Tris
(2,3-dibromopropyl) phosphate.
(B)Not later than 12 months after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall
update the list established in subparagraph (A) and publish in the Federal
Register, after notice and opportunity for comment, the updated list which
shall consist of not fewer than 300 chemical substances, along with a
justification for such listing. Chemical substances shall be listed at the
Administrator’s discretion, based on available scientific evidence and
consideration of their hazard, exposure, or risk relative to other chemical
substances, aggregate or cumulative exposure, evidence of exposure to humans
including presence in human or animal biological and environmental media
including in the workplace, use, volume of manufacture, toxicological
properties, persistence, bioaccumulation, or other properties indicating
risk.
(2)The Administrator shall—
(A)remove a chemical
substance from the list under paragraph (1) only after the safety standard
determination has been made for such chemical substance pursuant to subsection
(b); and
(B)add chemical substances to the list
periodically so that the number of chemical substances on the list will not be
fewer than 300 at any given time, until such time as all chemical substances
manufactured, processed, or distributed in commerce have been listed, have
received a safety standard determination, or have been exempted from the
requirement to receive a safety standard determination pursuant to section 35
or section 39. Additions to the list shall be consistent with paragraph (1)
and, to the extent practicable, based on consideration of hazard, exposure, or
risk relative to listed chemical substances. Such additions to the list may be
made in response to petitions under section 21 or recommendations from the
Interagency Testing Committee under section 4(e).
(3)The
Administrator may add a mixture to the priority list based on available
scientific evidence and the considerations for listing described in paragraph
(1).
(b) Safety Standard
Determinations
(1)
(A)The Administrator
shall apply, as the safety standard under this title, a standard that takes
into account aggregate exposure to a chemical substance or mixture and ensures
that, for all intended uses—
(i)with regard to
public health, there is a reasonable certainty that no harm will result,
including to vulnerable populations; and
(ii)the public
welfare is protected.
(B)In making a
determination under this subsection, the Administrator shall consider, among
other relevant factors–—
(i)the lifecycle of
the chemical substance or mixture; and
(ii)available
information concerning the cumulative effects of exposure to chemical
substances or mixtures.
(2)The manufacturers and processors of a chemical substance or
mixture shall bear the burden of proving that the chemical substance or mixture
meets the safety standard.
(3)
(A)For each chemical substance or mixture
listed under subsection (a), the Administrator shall determine whether the
chemical substance or mixture meets the safety standard, taking into account
any existing conditions or controls already in effect, or can be made to meet
the safety standard through the imposition of additional conditions under
subsection (c), and whether intended uses that do not meet the safety standard
are critical. In making this determination, the Administrator may consider
exposures associated with known or foreseeable uses that are not intended uses
identified by the manufacturers and processors of the substance or
mixture.
(B)The determination
under subparagraph (A) shall be made in keeping with standards for assessment
developed under paragraph (4).
(C)Except as provided in subparagraph (D), the
determination under subparagraph (A) shall be completed and published not later
than 30 months after the date on which the chemical substance or mixture is
placed on the priority list, or, for a chemical substance listed in subsection
(a)(1)(A), not later than 18 months after the date of enactment of the Toxic
Chemicals Safety Act of 2010.
(D)In assessing risk to make the determination
under subparagraph (A), the Administrator may require the submission of
additional information by the manufacturer or processor. If additional
information is required, the determination shall be completed and published not
later than 12 months after the submission of all required information. Failure
to submit required information in the period specified in section 4(b)(3)(C),
as applicable, or by such other reasonable deadlines as the Administrator shall
establish shall constitute grounds for determining that the chemical substance
or mixture does not meet the safety standard.
(4)Standards for
assessment of data
(A)Not later than 18
months after the date of enactment of the Toxic Chemicals Safety Act of 2010,
the Administrator shall, after providing for notice and opportunity for
comment, develop and publish guidance regarding the use of science in making
determinations under this subsection. In developing such guidance, the
Administrator shall rely upon the recommendations of the National Academy of
Sciences report entitled Science and Decisions
.
(B)Not later than 5
years after the date of enactment of the Toxic Chemicals Safety Act of 2010,
and not less often than once every 5 years thereafter, the Administrator shall
review the guidance under this paragraph and may revise the guidance to reflect
new scientific developments or understanding.
(5)The
Administrator shall make publicly available, and enter into the public database
established pursuant to section 8(d), the determination made pursuant to
paragraph (3) with a list of allowed uses and any conditions on those uses
necessary to ensure that the safety standard is met.
(6)Renewal and
RedeterminationThe
determination made pursuant to paragraph (3) regarding a chemical substance or
mixture shall remain in effect for 15 years, except that the Administrator
shall make a redetermination pursuant to paragraph (3) if a new use of such
chemical substance or mixture is proposed under section 5, or new information
related to such chemical substance or mixture raises a credible question as to
whether the chemical substance or mixture continues to meet the safety
standard. The Administrator may renew a determination made pursuant to
paragraph (3) for additional 15 year periods. The burden of proof for renewal
of a determination or redetermination shall remain with the manufacturers and
processors of each chemical substance or mixture.
(7)Failure to Meet
DeadlinesIf the Administrator fails to publish or renew a
determination or publish a redetermination by the applicable deadline pursuant
to this subsection, the Administrator shall promptly publish notice of such
failure in the Federal Register, identifying the chemical substance or mixture
and any information gaps that have impeded the determination, shall prohibit
new manufacturers or processors or new uses of the chemical substance or
mixture until the determination is published, and shall require manufacturers
and processors of the chemical substance or mixture to provide, within a
reasonable timeframe as determined by the Administrator, written notice to the
public, their employees and their commercial customers that a safety standard
determination of the chemical substance or mixture is
pending.
.
(6)By amending subsection (c), as redesignated
by paragraph (4) of this subsection, to read as follows:
(c)
(1)Chemical
Substances and Mixtures Determined to Meet the Safety Standard without
ConditionsA chemical
substance or mixture, for which the Administrator has determined, pursuant to
subsection (b)(3), that the chemical substance or mixture meets the safety
standard without imposition of conditions under this subsection, may be
manufactured, processed, and distributed in commerce for uses identified and
included in the safety standard determination. The Administrator may make such
determination contingent on the continuation of conditions or controls already
in effect, if any.
(2)Chemical
Substances and Mixtures Determined to Meet the Safety Standard with
ConditionsExcept as the Administrator determines pursuant to
subsection (e), a chemical substance or mixture, for which the Administrator
has determined, pursuant to subsection (b)(3), that imposition of conditions
under this subsection is required to ensure that the chemical substance or
mixture meets the safety standard, shall be subject to conditions on
manufacture, processing, use, distribution in commerce, or disposal, as
specified by the Administrator. Such conditions shall be identified in a manner
that ensures effective and efficient protection of health and the environment
and may include:
(A)A
requirement—
(i)prohibiting the
manufacturing, processing, or distribution in commerce of such substance or
mixture; or
(ii)limiting the
amount of such substance or mixture which may be manufactured, processed, or
distributed in commerce.
(B)A
requirement—
(i)prohibiting the
manufacture, processing, or distribution in commerce of such substance or
mixture for—
(I)a particular use;
or
(II)a particular use
in a concentration in excess of a level specified by the Administrator in the
safety standard determination; or
(ii)limiting the
amount of such substance or mixture which may be manufactured, processed, or
distributed in commerce for—
(I)a particular use;
or
(II)a particular use
in a concentration in excess of a level specified by the Administrator in the
safety standard determination.
(C)A requirement that such substance or
mixture, or any article containing such substance or mixture, be marked with or
accompanied by clear and adequate warnings and instructions with respect to its
use, distribution in commerce, or disposal or with respect to any combination
of such activities. The form and content of such warnings and instructions
shall be prescribed by the Administrator or by the appropriate agency as
determined under section 9, and shall be consistent with the Globally
Harmonized System of Labeling and Classification of Chemicals.
(D)A requirement that manufacturers and
processors of such substance or mixture make and retain records of the
processes used to manufacture or process such substance or mixture, or any
article containing such substance or mixture, and monitor or conduct tests
which are reasonable and necessary to assure compliance with the requirements
of any rule applicable under this paragraph.
(E)A requirement
prohibiting or otherwise regulating any manner or method of manufacturing,
processing, distribution in commerce or commercial use of such substance or
mixture.
(F)A requirement that
prescribes specific control measures to reduce occupational exposures shall
reflect the industrial hygiene hierarchy of controls.
(G)(i)A requirement prohibiting or otherwise
regulating any manner or method of disposal of such substance or mixture, or of
any article containing such substance or mixture, by its manufacturer or
processor or by any other person who uses, or disposes of, it for commercial
purposes.
(ii)A requirement under clause (i) may not
require any person to take any action which would be in violation of any law or
requirement of, or in effect for, a State or political subdivision, and shall
require each person subject to it to notify each State and political
subdivision or tribe in which a required disposal may occur of such
disposal.
(H)A requirement that the manufacturers and
processors of such chemical substance or mixture, or article containing such
chemical substance or mixture, develop a risk reduction management plan to
achieve a risk reduction specified by the Administrator. For all cases in which
a risk reduction management plan requires a reduction in occupational exposure,
the specified level or risk reduction is to be achieved through application of
the industrial hygiene hierarchy of controls.
Where the
Administrator determines that conditions under this subsection are necessary to
ensure that a chemical substance or mixture meets the safety standard, the
Administrator shall require that such conditions be met within one year after
publication of the determination under subsection (b), or as quickly as
feasible and in no case later than 3 years after such publication. The
Administrator, in determining the deadline for compliance with conditions
pursuant to this subsection, shall consider human health and the environment as
the primary and paramount concern, and shall also consider the technological
feasibility of compliance, the economic impact of compliance, the benefits of
earlier compliance, and other relevant considerations. After the date or dates
on which conditions become effective, no person shall manufacture, process, use
for commercial purposes, distribute in commerce, or dispose of the chemical
substance or mixture, or any article containing such substance or mixture,
unless the applicable conditions of the determination are met with respect to
that person’s activities.(3)Chemical
substances and mixtures determined not to meet the safety
standardExcept as the
Administrator determines pursuant to subsection (e):
(A)If the
Administrator determines that an existing chemical substance or mixture has not
been proven to meet the safety standard, pursuant to subsection (b)(3),
effective 1 year after publication of that determination, or as quickly as
feasible and in no case later than 3 years after such publication, no person
shall manufacture, process, use for commercial purposes or distribute in
commerce the chemical substance or mixture. The Administrator, in determining
the deadline for compliance with this subsection, shall consider human health
and the environment as the primary and paramount concern, and shall also
consider the technological feasibility of compliance, the economic impact of
compliance, and other relevant considerations.
(B)If the
Administrator determines that a new chemical substance or mixture has not been
proven to meet the safety standard, no person shall manufacture, process, or
distribute in commerce the new chemical substance or mixture.
(C)If the
Administrator determines that an existing chemical substance or mixture has not
been proven to meet the safety standard for a new use, no person shall
manufacture, process, use, or distribute in commerce the existing chemical
substance or mixture for the new
use.
.
(7)In subsection (d),
as redesignated by paragraph (4) of this subsection, by striking present
an unreasonable
each place it appears and inserting present a
significant
.
(8)By amending
subsection (e), as redesignated by paragraph (4) of this subsection, to read as
follows:
(e)
(1)Exemptions from
restrictions on manufacture, processing, use, distribution in commerce, or
disposal imposed under subsection (c) may be requested for a specific use by a
manufacturer or processor of a chemical substance or mixture, and may be
granted by the Administrator, after providing public notice and opportunity for
comment, if the Administrator determines that the manufacturer or processor has
demonstrated by clear and convincing evidence that—
(A)(i)an exemption for the
specific use is in the paramount interest of national security as determined
under section 22;
(ii)the restriction would
significantly disrupt the national economy; or
(iii)the specific use is a critical or
essential use; and
(B)(i)no feasible safer
alternative for the specified use is available; or
(ii)the specified use of the chemical
substance or mixture provides a net benefit to health or the environment when
compared to all available alternatives.
(2)Exemptions granted
under paragraph (1) shall expire after a period not to exceed 5 years, but may
be renewed for one or more additional 5 year periods if the Administrator finds
that the use continues to meet the requirements of paragraph (1).
(3)Notice of any
exemption granted under this subsection shall be provided—
(A)to known
commercial purchasers by the manufacturers and processors of the subject
chemical substance or mixture; and
(B)to the public by
the Administrator.
(4)The Administrator
shall impose conditions on any use receiving an exemption under this subsection
to reduce risk from the chemical substance or mixture to the greatest extent
feasible. Such conditions shall take effect upon the granting of such exemption
under paragraph (1). For cases in which such conditions are related to
occupational exposure, exposure shall be controlled through application of the
industrial hygiene hierarchy of
controls.
.
(9)In subsection (f),
as redesignated by paragraph (3) of this subsection—
(A)in paragraph (2),
by striking an unreasonable risk of injury to health or the
environment
and inserting a substantial risk of injury to health
or the environment, and will comply with section 37 and any regulations
prescribed thereunder
;
(B)in paragraph
(3)(B)—
(i)in
clause (i)—
(I)by striking
an unreasonable
and inserting a substantial
;
and
(II)by striking
, and
and inserting a semicolon;
(ii)in
clause (ii)—
(I)by striking
which does not present an unreasonable risk of injury to health or the
environment
and inserting that meets the safety standard under
subsection (b)
; and
(II)by inserting
and
after biphenyl;
; and
(iii)by
adding at the end the following new clause:
(iii)the terms of the exemption will comply with
section 37 and any regulations prescribed
thereunder.
;
(C)by striking
paragraph (4); and
(D)by redesignating
paragraph (5) as paragraph (4).
(b)The table of
contents for the Toxic Substances Control Act is amended by amending the item
relating to section 6 to read as follows:
Sec. 6. Prioritization, safety standard
determination, and risk
management.
.
7.Section 7 of the Toxic
Substances Control Act (15 U.S.C. 2606) is amended as follows:
(1)By amending subsection (a) to read as
follows:
(a)Actions
authorized and required
(1)The Administrator may
commence a civil action in an appropriate district court of the United States
for—
(A)seizure of a
chemical substance or mixture or any article containing such a substance or
mixture, that may present an imminent and substantial endangerment to health or
the environment;
(B)relief (as
authorized by subsection (b)) against any person who manufactures, processes,
distributes in commerce, uses, or disposes of, a chemical substance or mixture
or any article containing such a substance or mixture, that may present an
imminent and substantial endangerment to health or the environment; or
(C)both such seizure
described in subparagraph (A) and relief described in subparagraph (B).
(2)The Administrator may issue such orders as may be
necessary to protect health or the environment from a chemical substance or
mixture or article containing such substance or mixture that may present an
imminent and substantial endangerment to health or the environment. Such orders
may include any requirements on the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance or mixture, or article
containing such substance or mixture, as the Administrator determines are
necessary to protect health or the environment, including the conditions that
may be imposed under section 6(c)(2) and the relief authorized in subsection
(b) of this section.
(3)Relationship to
existing rules, orders, and proceedingsA civil action may be
commenced under paragraph (1) or other action may be taken under paragraph (2),
notwithstanding the existence of a rule or order under this Act and
notwithstanding the pendency of any administrative or judicial proceeding under
this
Act.
.
(2)In subsection
(b)—
(A)in paragraph
(1)—
(i)by striking
subsection (a)
and inserting subsection (a)(1)
;
and
(ii)by striking
unreasonable risk
and inserting imminent and substantial
endangerment
;
(B)in paragraph
(2)—
(i)by striking
subsection (a)
and inserting subsection
(a)(1)
;
(ii)by striking
or distributes in commerce
and inserting distributes in
commerce, uses, or disposes of
;
(iii)by striking
risk
each place it appears and inserting hazard
;
and
(iv)by striking
or (E)
and inserting (E) conditions that may be imposed
under section 6(c); or (F)
; and
(C)in paragraph (3),
by striking subsection (a)
and inserting subsection
(a)(1)
.
(3)In subsection (c),
by striking subsection (a)
each place it appears and inserting
subsection (a)(1)
.
(4)By amending
subsection (d) to read as follows:
(d)As appropriate,
concurrently with the filing of an action under subsection (a)(1) or as soon
thereafter as may be practicable, the Administrator shall add the subject
chemical substance or mixture to the priority list under section 6(a) or
initiate a redetermination of whether the subject chemical substance or mixture
meets the safety standard under section
6(b).
.
(5)In subsection (e),
by striking subsection (a)
and inserting subsection
(a)(1)
.
(6)By striking
subsection (f).
8.Reporting and
retention of informationSection 8 of the Toxic Substances Control
Act (15 U.S.C. 2607) is amended—
(1)by striking
subsection (a) and redesignating subsection (b) as subsection (c);
(2)by redesignating
subsection (e) as subsection (h);
(3)by redesignating
subsection (c) as subsection (e);
(4)by striking
subsection (d);
(5)by redesignating
subsection (f) as subsection (j);
(6)by inserting
before subsection (c), as redesignated by paragraph (1) of this section, the
following new subsections:
(a)
(1)(A)Each manufacturer or
processor of a chemical substance distributed in commerce shall submit to the
Administrator a declaration described in paragraph (2) or (3), accompanied by
the certification described in subsection (i), not later than 1 year after the
date of enactment of the Toxic Chemicals Safety Act of 2010 or 1 year after
commencement of such manufacturing or processing, whichever is earlier.
(B)The Administrator may additionally require
submission of a declaration described in paragraph (2) or (3), accompanied by
the certification described in subsection (i), from any manufacturer or
processor of a mixture determined by the Administrator to have substance
characteristics different from the substance characteristics of the constituent
chemical substances, in kind or degree.
(2)Declaration of
current manufacture or processingA declaration described in this
paragraph is a statement that includes, for each chemical substance or mixture
that is manufactured or processed by a manufacturer or processor—
(A)the chemical
identity of the chemical substance or mixture;
(B)the name and
location of each facility under the control of the manufacturer or processor at
which the chemical substance or mixture is manufactured or processed or from
which the chemical substance or mixture is distributed in commerce;
(C)the number of
individuals exposed, and reasonable estimates of the number who will be
exposed, to such substance or mixture in their places of employment and the
duration of such exposure;
(D)a list of health
and safety studies conducted or initiated by or for, known to, or reasonably
ascertainable by the manufacturer or processor with respect to the chemical
substance or mixture, and copies of any such studies that have not previously
been submitted to the Administrator by the manufacturer or processor;
and
(E)all other
information known to, in the possession or control of, or reasonably
ascertainable by the manufacturer or processor that has not previously been
submitted to the Administrator by the manufacturer or processor
regarding—
(i)the physical,
chemical, and toxicological properties of the chemical substance or mixture,
including classification of the toxicity of the chemical in accordance with the
Globally Harmonized System for Hazard Communication;
(ii)the categories or
proposed categories of intended use of each such substance or mixture;
(iii)the total amount
of each substance and mixture manufactured or processed, reasonable estimates
of the total amount to be manufactured or processed, the amount manufactured or
processed for each of its categories of use, and reasonable estimates of the
amount to be manufactured or processed for each of its categories of use or
proposed categories of use;
(iv)a
description of the byproducts resulting from the manufacture, processing, use,
or disposal of each such substance or mixture;
(v)exposure
information relating to the chemical substance or mixture;
(vi)any condition or
conditions currently placed on the chemical substance or mixture due to
regulation under any Federal law or due to voluntary action; and
(vii)for a processor
of a chemical substance, any information indicating that a mixture including
the chemical substance has substance characteristics that are different from
the substance characteristics of the named chemical substances, in kind or
degree.
To the
extent feasible, the Administrator shall not require under paragraph (1), any
reporting which is unnecessary or duplicative.(3)Declaration of
permanent cessation of manufacturing or processingA manufacturer
or processor that permanently ceases manufacture or processing of a chemical
substance or mixture shall file a declaration certifying that the manufacturer
or processor has permanently ceased all manufacturing or processing of the
chemical substance or mixture, not later than 180 days after cessation is
complete. A declaration under this paragraph may be filed based on an intention
to permanently cease manufacture or processing, in which case such cessation
must be completed not later than 180 days after the declaration is
filed.
(4)Each manufacturer
or processor of a chemical substance or mixture that submits to the
Administrator a declaration required under paragraph (2) shall submit an update
of the previously submitted declaration to the Administrator, at a minimum,
once every 3 years, and immediately, at any time at which there becomes known
or available to, in the possession or control of, or reasonably ascertainable
by the manufacturer or processor, significant new information regarding a
physical, chemical, toxicological property or use of, or exposure to, the
chemical substance or mixture, indicating a new potential adverse effect of the
chemical substance or mixture, suggesting an adverse effect at a lower dose
than previously demonstrated, or otherwise reasonably relevant to an analysis
of whether the chemical substance or mixture meets the safety standard under
section 6.
(5)Records to
support declarationsEach manufacturer or processor of a chemical
substance, substance, or mixture, as applicable, distributed in commerce shall
maintain records of the information described in subparagraphs (A) through (E)
of paragraph (2).
(6)The Administrator may impose penalties,
pursuant to section 16, on a manufacturer or processor in violation of
paragraphs (1) or (4), or, by order, prohibit, or otherwise impose conditions
under section 6(c), on the manufacture, processing, or distribution in commerce
of a chemical substance or mixture, or any article containing such chemical
substance or mixture, by a manufacturer or processor in violation of such
paragraphs.
(b)Recordkeeping
and reports
(1)The Administrator
may, by rule or order, require any person who manufactures, processes,
distributes in commerce, uses for commercial purposes, repackages, or disposes
of a chemical substance, mixture, or article containing such substance or
mixture (other than as described in paragraph (2)) to maintain records of and
submit reports by a specified date, to supply any information concerning the
chemical substance, mixture, or article containing such substance or mixture
that, in the judgment of the Administrator, would assist the Administrator
in—
(A)making a safety
standard determination with respect to a chemical substance or mixture under
this title; or
(B)administering any
other provision of this Act.
(2)With respect to
the manufacture, processing, distribution in commerce, use, or disposal of a
chemical substance or mixture in small quantities (as defined by the
Administrator by rule) solely for purposes of scientific experimentation or
analysis or chemical research, including any such research or analysis for the
development of a product, the Administrator may require a person to maintain
records or submit a report under paragraph (1) only to the extent the
Administrator determines the maintenance of records or submission of reports,
or both, is necessary for the effective enforcement of this Act.
(3)The Administrator may impose penalties,
pursuant to section 16, on a person in violation of a requirement of a rule or
order under paragraph (1) or, by order, prohibit, or otherwise impose
conditions under section 6(c), on the manufacture, processing, or distribution
in commerce of a chemical substance or mixture, or any article containing such
chemical substance or mixture, by a person in violation of such a
requirement.
;
(7)in subsection (c),
as redesignated by paragraph (1) of this section—
(A)in the subsection
heading, by inserting and
categorization
after Inventory
;
(B)by amending paragraph (1) to read as
follows:
(1)The Administrator shall compile, keep
current, publish and enter into the public database established pursuant to
subsection (d) a list of each chemical substance, and each mixture for which a
declaration is received, which is manufactured or processed in the United
States. Such list shall at least include each such chemical substance or
mixture which any person reports, under section 5 or subsection (a)(2) of this
section, is manufactured or processed in the United States, but shall not
include any chemical substance or mixture for which all manufacturers and
processors have submitted declarations under subsection (a)(3). In the case of
a chemical substance or mixture for which a notice is submitted in accordance
with section 5, the date of such notice shall be included in the list under
this section, in addition to the date on which the chemical substance or
mixture was first added to the list. The Administrator shall first publish such
a list not later than 24 months after the effective date of the Toxic Chemicals
Safety Act of 2010. The Administrator shall not include in such list any
chemical substance or mixture which is manufactured or processed only in small
quantities (as defined by the Administrator by rule) solely for purposes of
scientific experimentation or analysis or chemical research on, or analysis of,
such substance or mixture or another substance or mixture, including such
research or analysis for the development of a
product.
;
and
(C)by amending
paragraph (2) to read as follows:
(2)Not later than 5
years after the date of enactment of the Toxic Chemicals Safety Act of 2010,
and no less than every 3 years thereafter, the Administrator shall publish in
the Federal Register and enter in the public database established pursuant to
subsection (d) a list of all chemical substances and mixtures manufactured,
processed, or distributed in commerce that categorizes the chemical substances
and mixtures, based on existing information available to the Administrator,
based upon health or environmental adverse effects, exposure, or other criteria
that the Administrator determine
appropriate.
;
(8)by inserting after
subsection (c), as redesignated by paragraph (1) of this section, the following
new subsection:
(d)Public database
and access to significant information
(1)Not later than 1
year after the date of the enactment of Toxic Chemicals Safety Act of 2010, the
Administrator shall establish—
(A)an electronic database that is searchable,
sortable, downloadable, and publicly accessible on the Internet for storing and
sharing of information relating to the toxicity and use of, and exposure to,
chemical substances and mixtures; and
(B)procedures for use
in maintaining and updating the database.
(2)Public access to
significant informationNot later than 90 days after the date of
any significant decision made by the Administrator or receipt by the
Administrator of any significant information submitted pursuant to this title,
the Administrator shall, subject to section 14, make available to the public on
the public database established pursuant to paragraph (1) such significant
decision made by the Administrator under this title or such significant
information submitted pursuant to this
title.
;
(9)in subsection (e),
as redesignated by paragraph (3) of this section—
(A)in the subsection
heading, by inserting of
significant adverse reactions
after
records
; and
(B)by inserting
Such records shall be submitted to the Administrator on an annual basis,
or immediately upon request by the Administrator.
after the first
sentence;
(10)by inserting
after subsection (e), as redesignated by paragraph (3) of this section, the
following new subsections:
(f)Disclosures to
commercial purchasersEffective 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, all manufacturers and
processors of chemical substances and mixtures subject to this section shall
provide, with shipment or promptly thereafter and by request, to all known
commercial purchasers of the chemical substances and mixtures they manufacture
or process a disclosure, subject to section 14, of—
(1)the chemical
identity of the chemical substance or, for mixtures, the chemical identity of
all chemical ingredients;
(2)all information
regarding toxicological properties of the chemical substance or mixture
submitted to the Administrator under subsection (a);
(3)the list of health
and safety studies submitted to the Administrator under subsection (a), with
copies of the individual studies available upon request; and
(4)any records of
significant adverse reactions submitted to the Administrator under subsection
(e).
(g)Information in
the possession of other Federal agencies
(1)The Administrator may request, and upon
such request a Federal agency shall submit to the Administrator, any
information in the possession or control of such Federal agency relating to a
hazard of, use of, exposure to, or risk of a chemical substance or mixture, or
a report, including copies of the data and records in the possession or control
of such Federal agency that may be useful to the Administrator in carrying out
the purposes of this Act.
(2)The Administrator
shall specify the format, content, and level of detail of any report requested
under paragraph (1).
(3)Each Federal
agency shall make its initial submission to the Administrator within 60 days of
receipt of the specification under paragraph (2).
(4)The Administrator
shall issue a request pursuant to paragraph (1) to each Federal agency which
the Administrator reasonably expects may have information on chemical
substances or mixtures that would assist the Administrator in making a safety
standard determination for a chemical substance or mixture under this title.
Such requests shall be issued by the Administrator not later than 12 months
after the date on which the Administrator lists a chemical substance or mixture
on the priority list under section 6(a), or, for chemical substances identified
in section 6(a)(1)(A), 12 months after enactment of the Toxic Chemicals Safety
Act of 2010.
;
and
(11)by inserting
after subsection (h), as redesignated by paragraph (2) of this section, the
following new subsection:
(i)Each submission required pursuant to this
title, or pursuant to a rule or an order promulgated or issued by the
Administrator under this title, other than a submission under subsection (g),
shall be accompanied by a certification signed by a responsible official of the
submitting party that each statement contained in the submission—
(1)is accurate and
reliable; and
(2)includes all
material facts known to, in the possession or control of, or reasonably
ascertainable by the manufacturer or
processor.
.
9.Relationship to
other Federal lawsSection
9(a)(1) of the Toxic Substances Control Act (15 U.S.C. 2608(a)(1)) is
amended—
(1)by striking
the manufacture, processing, distribution in commerce, use, or disposal
of
after If the Administrator has reasonable basis to conclude
that
;
(2)by striking
, or that any combination of such activities, presents or will present
an unreasonable risk of injury to health or the environment
and
inserting does not meet the safety standard under section
6(b)
;
(3)by striking
such risk may be prevented
and inserting that the risk
associated with the chemical substance or mixture may be
prevented
;
(4)by striking
describes such risk
and inserting describes the risk
associated with the chemical substance or mixture
; and
(5)in the matter
following subparagraph (B)—
(A)by striking
Any report
and inserting Any such report
;
(B)by striking
information on which it is based and shall be published in the Federal
Register
and inserting information on which it is based and
shall be promptly published in the Federal Register and entered into the public
database established pursuant to section 8(d)
;
(C)by inserting
and not more than 180 days
after but such time specified
may not be less than 90 days
; and
(D)by inserting and entered into the
public database established pursuant to section 8(d)
after
conclusions of the agency and shall be published in the Federal
Register
.
10.
(a)Mixture
definition and determinationSection 3 of the Toxic Substances Control
Act (15 U.S.C. 2602), as amended by section 3 of this Act, is further
amended—
(1)by amending
paragraph (8) to read as follows:
(8)The term mixture means any
composition of two or more chemical substances if the composition does not
occur in nature, and is not, in whole or in part, the result of a chemical
reaction.
;
and
(2)by inserting after
paragraph (b)(2) the following new paragraph:
(3)The Administrator may determine different
mixtures comprised of the same chemical substances to be the same mixture for
purposes of this Act, if the substance characteristics of the mixtures are
identical. Mixtures which would be considered new mixtures but for grouping
under this paragraph shall not be considered new mixtures for purposes of this
Act.
.
(b)Subsection
(c) of section 8 of the Toxic Substances Control Act (15 U.S.C. 2607), as
amended by section 8 of this Act, is further amended by adding at the end the
following new paragraph:
(3)Not later than 6 years
after the date of enactment of the Toxic Chemicals Safety Act of 2010, the
Administrator shall, based on declarations under this section and a survey of
processors as necessary and appropriate, characterize the number of mixtures,
including mixtures grouped pursuant to paragraph (b)(3) of section 3,
introduced into commerce in the United States, and the number of such mixtures
that have or may have substance characteristics that are different, in kind or
degree, from the substance characteristics of the constituent chemical
substances, and shall publish such characterization in the Federal Register and
enter it in the public database established in subsection
(d).
.
11.Inspections and
subpoenasSection 11 of the
Toxic Substances Control Act (15 U.S.C. 2610) is amended—
(1)in subsection
(a)—
(A)by inserting
commercial
after establishment, facility, or
other
;
(B)by striking
premises in which chemical substances, mixtures
and inserting
premises in which chemical substances or mixtures subject to this Act,
articles containing such substances or mixtures
;
(C)by inserting
and any place where records relating to such chemical substances,
mixtures, articles, or products or otherwise relating to compliance with this
Act, are held
after or such articles in connection with
distribution in commerce
; and
(D)by adding at the
end the following:
The
Administrator, and any duly designated representative of the Administrator, may
also inspect and obtain samples of any such chemical substances, mixtures, or
articles, and any containers or labeling of such chemical substances, mixtures,
or articles.;
and
(2)in subsection
(b)—
(A)in paragraph (1),
by striking chemical substances, mixtures, or products
and
inserting chemical substances or mixtures subject to this Act, articles
containing such substances or mixtures, or products
; and
(B)in paragraph
(2)(E), by inserting or order
after rule
.
12.Section 12 of the Toxic Substances Control
Act (15 U.S.C. 2611) is amended—
(1)by striking
subsection (a) and redesignating subsections (b) and (c) as subsections (a) and
(b), respectively;
(2)in subsection (a),
as redesignated by paragraph (1) of this section—
(A)in paragraph
(1)—
(i)by striking
or intends to export
;
(ii)by
striking or 5(b)
;
(iii)by striking
or intent to export
and inserting not later than 30 days
after the date of exportation of the substance or mixture
; and
(iv)by inserting
promptly thereafter
before furnish
;
(B)in paragraph
(2)—
(i)by striking
or intends to export
;
(ii)by
striking an order has been issued under section 5 or a rule has been
proposed or promulgated under section 5 or 6, or with respect to which an
action is pending, or relief has been granted under section 5 or 7
and
inserting a condition has been imposed pursuant to section 6(c)(2) or an
action has been taken pursuant to section 7
;
(iii)by striking
or intent to export
and inserting not later than 30 days
after the date of exportation of the substance or mixture
;
(iv)by inserting
promptly thereafter
before furnish
; and
(v)by striking
such rule, order, action, or relief
and inserting such
condition imposed pursuant to section 6(c)(2) or such action taken pursuant to
section 7
; and
(C)by adding at the
end the following new paragraph:
(3)(A)Any person that has previously notified the
Administrator of the exportation of a chemical substance or mixture under this
section shall notify the Administrator of any change in the information
provided in the original notice not later than 30 days after such a
change.
(B)The Administrator shall furnish, as
promptly as feasible, an updated notice to the governments that have been
notified pursuant to paragraphs (1) and (2) regarding the exportation of any
chemical substance or mixture subject to this section if—
(i)new data for such substance or
mixture have been received by the Administrator pursuant to section 4, section
5(b), section 8(e), or section 8(h);
(ii)the Administrator has received
notice under subparagraph (A) of a change in the information provided in the
original notice; or
(iii)a change has been made in any
conditions imposed pursuant to section 6(c) or section 7 for such substance or
mixture.
;
(3)in subsection (b),
as redesignated by paragraph (1), by striking paragraph (2) and redesignating
paragraphs (3), (4), (5), and (6) as paragraphs (2), (3), (4), and (5),
respectively; and
(4)by adding at the
end the following new subsections:
(c)Chemicals listed
under the PIC ConventionIf
any person intends to export to a foreign country a chemical substance or
mixture listed in Annex III of the PIC Convention as of the date of enactment
of the Toxic Chemicals Safety Act of 2010, such person shall file the notice
required under subsection (a) not later than 30 days prior to the date of
exportation of such substance or mixture and shall include therein the
information required for export under such Convention as of the date of
enactment of the Toxic Chemicals Safety Act of 2010.
(d)The Administrator
shall maintain copies of all current notices provided to other governments
under this section, and make such copies available to the public in electronic
format.
(e)For
purposes of this title, the term PIC Convention means the
Rotterdam Convention on the Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in International Trade, adopted in Rotterdam
on September 10, 1998, and any subsequent amendment or
protocol.
.
13.Entry into
customs territory of the United StatesSection 13 of the Toxic Substances Control
Act (15 U.S.C. 2612) is amended—
(1)by redesignating
subsections (a) and (b) as subsections (b) and (c), respectively;
(2)by inserting,
before subsection (b), as redesignated by paragraph (1) of this section, the
following new subsection:
(a)The importer of any
chemical substance, mixture, or article containing a chemical substance or
mixture for distribution in commerce shall satisfy all requirements under
sections 4, 5, 6, and 8 of this Act, without regard to whether the chemical
substance or mixture has been formed into or contained in an article prior to
importation.
;
(3)in subsection (b),
as redesignated by paragraph (1) of this section—
(A)by amending the
subsection heading to read as follows:
(b)
;
(B)by striking
Secretary of the Treasury
each place it appears and inserting
Secretary of Homeland Security
; and
(C)in paragraph (1),
by striking the em dash and subparagraphs (A) and (B) and inserting the
substance, mixture, or article fails to comply with or is offered for entry in
violation of any rule or order in effect under this Act.
; and
(4)in subsection (c),
as redesignated by paragraph (1) of this section—
(A)by striking
Secretary of the Treasury
and inserting Secretary of
Homeland Security
; and
(B)by striking
subsection (a)
and inserting subsection
(b)
.
14.Section 14 of the Toxic
Substances Control Act (15 U.S.C. 2613) is amended—
(1)by redesignating
subsections (a) and (b) as subsections (c) and (d), respectively;
(2)by redesignating
subsections (c) through (e) as subsections (f) through (h),
respectively;
(3)by inserting,
before subsection (c), as redesignated by paragraph (1) of this section, the
following new subsections:
(a)Administrator
responsibilitiesThe
Administrator shall ensure that—
(1)information
control designations under this section are not a determinant of public
disclosure pursuant to section 552 of title 5, United States Code (commonly
referred to as the Freedom of Information Act
); and
(2)all information in
the Administrator's possession that is releasable pursuant to an appropriate
request under section 552 of title 5, United States Code (commonly referred to
as the Freedom of Information Act
), is made available to members
of the public.
(b)Nothing in this
section shall be construed to prevent or discourage the Administrator from
voluntarily releasing to the public any unclassified information that is not
exempt from disclosure under section 552 of title 5, United States Code
(commonly referred to as the Freedom of Information
Act
).
;
(4)in subsection (c),
as redesignated by paragraph (1) of this subsection—
(A)by striking
Except as provided by subsection (b)
and all that follows
through subsection (b)(4) of such section,
and inserting
Except as provided by subsection (d), information submitted to the
Administrator pursuant to this Act may be designated for information protection
by the submitter of such information based on the submitter’s reasonable belief
that the information is eligible for protection under section 552 of title 5,
United States Code. Information designated for protection under this
section
;
(B)by inserting
unless the designation is determined to be inappropriate,
after
Administrator or by any officer or employee of the United
States,
;
(C)by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively;
(D)by adding after
paragraph (2) the following new paragraph:
(3)shall be disclosed upon request to a State,
tribal, or municipal government, including identification of the location of
the manufacture, processing, or storage of a chemical substance upon the
request of the government for the purpose of administration or enforcement of a
law, if one or more applicable agreements ensure that the recipient government
will take appropriate steps to maintain the confidentiality of the information
in accordance with this section and section 350.27 of title 40, Code of Federal
Regulations, or any successor to such
regulation;
;
and
(E)in paragraph (4),
as redesignated by subparagraph (C) of this paragraph, by striking an
unreasonable
and inserting a substantial
;
(5)in subsection (d),
as redesignated by paragraph (1) of this section—
(A)in the subsection
heading, by striking Data
from health and safety studies
and inserting
Information not eligible
for protection
;
(B)by amending paragraph (1) to read as
follows:
(1)The following types of information shall
not be eligible for protection under this section, and the Administrator shall
not approve a request to protect information of the following types under this
section:
(A)The identity of a
chemical substance when included in a health and safety study, safety standard
determination under section 6(b), or information indicating the presence of the
chemical substance in a consumer article intended for use or reasonably
expected to be used by children or indicating exposure to the chemical
substance in children.
(B)The components of
a mixture, when included in a health and safety study, safety standard
determination under section 6(b), or information indicating the presence of the
mixture in a consumer article intended for use or reasonably expected to be
used by children or indicating exposure to the mixture in children.
(C)Any safety
standard developed under section 6(b).
(D)Any health and
safety study which is submitted under this Act with respect to—
(i)any chemical
substance or mixture—
(I)which, on the date
on which such study is to be disclosed has been offered for commercial
distribution; or
(II)for which testing
is required under section 4 or for which notification is required under section
5 of this title; and
(ii)any data 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).
(E)Any information indicating the presence of
a chemical substance or mixture in a consumer article intended for use or
reasonably expected to be used by children or indicating exposure to the
chemical substance or mixture in children.
This paragraph does not authorize the
release of any data which discloses processes used in the manufacturing or
processing of a chemical substance or mixture or, in the case of a mixture, the
release of data disclosing the portion of the mixture comprised by any of the
chemical substances in the mixture.;
and
(C)in paragraph
(2)—
(i)by striking
the first sentence of paragraph (1)
and inserting
paragraph (1)(D)
; and
(ii)by striking
in the second sentence of such paragraph
and inserting in
the last sentence of paragraph (1)
;
(6)by inserting after
subsection (d), as redesignated by paragraph (1) of this section, the following
new subsection:
(e)Not later than 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall by
order develop and make publicly available guidance that specifies—
(1)the format for and
manner for designating information for protection;
(2)the acceptable
bases on which written requests to protect information under this section may
be approved, which shall be no more restrictive of public disclosure than
section 552 of title 5, United States Code; and
(3)the documentation
that must accompany such
requests.
;
(7)by amending
subsection (f), as redesignated by paragraph (2) of this section, to read as
follows:
(f)Designation and
release of confidential information
(1)Duties of
Manufacturers and ProcessorsIn submitting information under this Act, a
manufacturer, processor, or distributor in commerce may designate the
information which such person believes is entitled to protection under this
section, and submit such designated information separately from other
information submitted under this Act. A designation under this paragraph shall
be accompanied by the appropriate fee under subsection (i), shall be made in
writing and in such manner as the Administrator may prescribe, and shall
include—
(A)justification for
each claim of confidentiality;
(B)a certification
that the information is not otherwise publicly available; and
(C)separate copies of
all submitted information, with 1 copy containing and 1 copy excluding the
information to which the request applies.
Designations shall last for 5 years,
at which time the information shall be made public unless the manufacturer or
processor has submitted a request for renewal, accompanied by the appropriate
fee under subsection (i), made in writing and in such manner as the
Administrator may prescribe, including all of the elements required for the
initial submission.(2)Duties of the
AdministratorThe Administrator shall—
(A)evaluate a
representative sample of all submitted designations and requests for renewal
within 60 days of their submission to determine whether—
(i)each claim of
confidentiality is justified under section 552 of title 5, United States Code,
and any applicable guidance published under subsection (e);
(ii)the designation
was accompanied by the appropriate fee, made in writing and in such manner as
prescribed by the Administrator, and included the necessary components;
and
(iii)the information
is not publicly available;
(B)release all
information previously designated for protection if one or more of the criteria
in subparagraph (A) are not found;
(C)determine whether
the criteria in subparagraph (A) were met at the time the designation was made;
and
(D)make such
determinations publicly available.
(3)(A)Except as provided by
subparagraph (B), if the Administrator proposes to release for inspection data
which has been designated under paragraph (1) but not released under paragraph
(2), the Administrator shall notify, in writing and by certified mail, the
manufacturer, processor, or distributor in commerce who submitted such
information of the intent to release such data. If the release of such data is
to be made pursuant to a request made under section 552(a) of title 5, such
notice shall be given immediately upon approval of such request by the
Administrator. The Administrator shall release the information in accordance
with the disclosure and procedural requirements of section 552 of title 5,
United States Code.
(B)(i)Subparagraph (A) shall
not apply to the release of information under paragraph (1), (2), (3), (4), or
(5) of subsection (c) of this section, except that the Administrator may not
release data under paragraph (4) of subsection (c) of this section unless the
Administrator has notified each manufacturer, processor, and distributor in
commerce who submitted such data of such release. Such notice shall be made in
writing by certified mail at least 15 days before the release of such data,
except if the Administrator determines that the release of such data is
necessary to protect against an imminent risk of injury to health or the
environment.
(ii)Subparagraph (A) shall not apply to
the release of information described in subsection (c)(1) of this section other
than information described in the last sentence of such
subsection.
;
(8)in subsection (g),
as redesignated by paragraph (2) of this section—
(A)by amending the
subsection heading to read as follows:
(g)Penalties for
wrongful designation or
disclosure
;
(B)by redesignating
paragraphs (1) and (2) as paragraphs (3) and (4), respectively;
(C)by inserting
before paragraph (3), as redesignated by subparagraph (B) of this paragraph,
the following new paragraphs:
(1)Any manufacturer or processor whose
designation of information for protection under this section is found by the
Administrator not to have met the criteria for protection under this section at
the time the designation was made may be subject to administrative penalties
under section 15.
(2)Any manufacturer
or processor who, knowing that information does not meet the criteria for
protection under this section, willfully designates such information for
protection, shall be guilty of a misdemeanor and fined not more than $5,000 or
imprisoned for not more than one year, or
both.
;
and
(D)in paragraph (4),
as redesignated by subparagraph (B) of this paragraph—
(i)by
striking paragraph (1)
and inserting paragraph
(3)
; and
(ii)by
striking subsection (a)(2)
and inserting subsection
(c)(2)
; and
(9)by adding at the
end the following new subsections:
(i)The Administrator may, by rule, require the
payment of a reasonable fee from any person designating information for
protection under this section or seeking to renew such a designation to defray
the cost of administering this section. In setting a fee under this subsection,
the Administrator shall take into account the ability to pay of the person
designating or seeking renewal and the cost to the Administrator of reviewing
such designations.
(j)Risk information
for workersThe Administrator
shall provide standards for and facilitate the provision of the chemical
identity, safety standard determination, health and safety data, and any other
information determined by the Administrator to be necessary to ensure worker
safety, that pertains to chemical substances or mixtures, that workers may come
into contact with or otherwise be exposed to during the course of their work,
to such workers and representatives of each certified or recognized bargaining
agent representing such
workers.
.
15.Section 15 of the Toxic
Substances Control Act (15 U.S.C. 2614) is amended—
(1)in paragraph (1), by striking
(A)
and all that follows through under title II
and inserting any rule, order, prohibition, restriction, or other
requirement imposed by this Act or by the Administrator under this
Act
;
(2)by amending
paragraphs (2) and (3) to read as follows:
(2)manufacture, process, distribute in
commerce, use for commercial purposes, or dispose of a chemical substance or
mixture, or an article containing a chemical substance or mixture, which such
person knew or had reason to know was manufactured, processed, or distributed
in commerce in violation of any rule, order, prohibition, restriction, or other
requirement imposed by this Act or by the Administrator under this Act;
(3)fail or refuse to
(A) establish or maintain accurate and complete records, (B) submit or make
accurate and complete reports, notices, disclosures, declarations,
certifications, or other information, or (C) permit access to or copying of
records, as required by this Act or a rule
thereunder;
;
(3)in paragraph (4),
by striking the final period and inserting ; or
; and
(4)by adding at the
end the following new paragraphs:
(5)make or submit a statement, declaration,
disclosure, certification, data set, or any oral, written, or electronic
representation that is materially false, in whole or in part, or to falsify or
conceal any material fact, in taking any action or making any communication
pursuant to this Act or pursuant to any rule or order promulgated or issued
under this Act;
(6)introduce or
deliver for introduction into commerce or knowingly distribute in commerce a
chemical substance or mixture, or an article containing a chemical substance or
mixture—
(A)that lacks or
fails to comply in any material respect with any applicable labeling
requirements imposed pursuant to section 6(c); or
(B)the label,
labeling or advertising of which is misleading in any material respect,
including by reason of representations, either explicit or implicit, that the
chemical substance or mixture is available for a use other than an intended
use; or
(7)forge,
counterfeit, simulate, falsely represent, or use without proper authority any
mark, stamp, tag, label, or other identification device authorized or required
by this Act or by the Administrator under this
Act.
.
16.Section 16 of the Toxic Substances Control
Act (15 U.S.C. 2615) is amended—
(1)in subsection
(a)—
(A)in paragraph
(1)—
(i)by striking
provision of section 15 or 409
and inserting provision of
this Act or a rule promulgated or order issued pursuant to this Act, as
described in section 15
;
(ii)by striking
$25,000
and inserting $37,500
; and
(iii)by striking
violation of section 15 or 409
and inserting violation of
this Act
;
(B)by redesignating
paragraphs (2), (3), and (4) as paragraphs (3), (4), and (5),
respectively;
(C)by inserting after
paragraph (1) the following new paragraph:
(2)In the case of any
violation described in paragraph (1), the Administrator may commence a civil
action in the appropriate United States district court to assess penalties
pursuant to paragraph (1) or commence administrative action to assess penalties
pursuant to paragraph
(3).
;
(D)in subparagraph
(A) of paragraph (3), as redesignated by subparagraph (B) of this
paragraph—
(i)by striking
A civil penalty for a violation of section 15 or 409
and
inserting In any administrative action to assess penalties for a
violation described in paragraph (1), a civil penalty for a violation
;
and
(ii)by striking
within 15 days of
and inserting not later than 15 days
after
;
(E)in paragraph (4),
as redesignated by subparagraph (B) of this paragraph—
(i)by striking
paragraph (2)(A)
and inserting paragraph (3)(A)
;
and
(ii)by striking
the United States Court of Appeals for the District of Columbia Circuit
or for any other circuit
and inserting the appropriate district
court of the United States for the district
; and
(F)in paragraph (5),
as redesignated by subparagraph (B) of this paragraph, by striking
paragraph (3)
each place it appears and inserting
paragraph (4)
; and
(2)in subsection
(b)—
(A)by inserting
(1)
before Any person who
;
(B)by inserting
this Act, as described in
before section
15
;
(C)by striking
or 409
;
(D)by striking
$25,000
and inserting $50,000
;
(E)by striking
one year
and inserting 5 years
; and
(F)by adding at the
end the following new paragraph:
(2)Any person who knowingly or willfully
violates any provision of this Act and who knows that such violation may result
in imminent danger of death or serious bodily injury to any person shall, upon
conviction, be subject to a fine of not more than $250,000 or imprisonment of
not more than 15 years, or both. A person that is not an individual shall, upon
conviction of violating this paragraph, be subject to a fine of not more than
$1,000,000.
.
17.Specific
enforcement and seizureSection 17 of the Toxic Substances Control
Act (15 U.S.C. 2616) is amended—
(1)in subsection
(a)—
(A)in paragraph
(1)—
(i)in subparagraph
(A), by striking or 409
;
(ii)in
subparagraph (B), by striking section 5, 6, or title IV, or by a rule or
order under section 5, 6, or title IV
and inserting this Act or
a rule or order promulgated or issued under this Act
; and
(iii)in
subparagraph (D)—
(I)by striking
chemical substance, mixture, or product
and inserting
chemical substance or mixture subject to this Act, article containing such
substance or mixture, or product
;
(II)by striking
of section 5, 6, or title IV
and inserting of this
Act
;
(III)by striking
under section 5, 6, or title IV
and inserting promulgated
or issued under this Act, as described in section 15
;
(IV)by inserting
, article
before , or product and, to the
extent
;
(V)by inserting
, article
before , or product or exposed to such
substance
;
(VI)by inserting
, article
before , or product, (ii) to give
;
and
(VII)by inserting
, article
before , or product, whichever the person to
which the requirement
; and
(B)in paragraph
(2)—
(i)by striking
A civil action described in paragraph (1)
and inserting
The district courts of the United States shall have jurisdiction over a
civil action described in paragraph (1). A civil action
; and
(ii)in subparagraph
(A), by inserting this Act, as described in
before
section 15
; and
(2)in subsection (b),
by striking chemical substance, mixture, or product
and
inserting chemical substance or mixture subject to this Act, or
product
.
18.Section 18 of the Toxic Substances Control
Act (15 U.S.C. 2617) is amended to read as follows:
18.Nothing in this Act affects the right of a
State or political subdivision of a State or a tribe to adopt or enforce any
regulation, requirement, or standard of performance that is different from or
in addition to a regulation, requirement, liability, or standard of performance
established pursuant to this Act unless compliance with both this Act and the
State or political subdivision of a State or tribe regulation, requirement, or
standard of performance is
impossible.
.
19.Section 19 of the Toxic
Substances Control Act (15 U.S.C. 2618) is amended—
(1)in subsection
(a)—
(A)in paragraph
(1)—
(i)by striking
subparagraph (B);
(ii)by striking
(A)
;
(iii)by inserting
or issuance
after promulgation
;
(iv)by striking
section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or
IV
and inserting this Act
;
(v)by inserting or order
after
rule
each place it appears;
(vi)by
inserting except that if such petition is based solely on grounds
arising after such sixtieth day, then any petition for judicial review of such
rule or order shall be filed within 60 days after such grounds arise
after such person’s principal place of business is
located
;
(vii)by
striking (other than in an enforcement proceeding)
; and
(viii)by striking
subparagraph
and inserting paragraph
;
(B)in paragraph
(2)—
(i)by
striking paragraph (1)(A)
and inserting paragraph
(1)
;
(ii)by
striking rulemaking
; and
(iii)by
inserting or order
after rule
; and
(C)by striking
paragraph (3);
(2)in subsection (b),
by inserting or order
after rule
each place it
appears; and
(3)in subsection
(c)—
(A)by amending
paragraph (1) to read as follows:
(1)Upon the filing of a petition under
subsection (a)(1) for judicial review of a rule or order, the court shall have
jurisdiction—
(A)to grant
appropriate relief, including interim relief, as provided in chapter 7 of title
5, United States Code; and
(B)to review such
rule or order in accordance with chapter 7 of title 5, United States
Code.
;
and
(B)in paragraph (2),
by inserting or order
after rule
.
20.Section 20 of the Toxic
Substances Control Act (15 U.S.C. 2619) is amended—
(1)in subsection
(a)—
(A)in paragraph
(1)—
(i)by striking
under section 4, 5, or 6, or title II or IV,
; and
(ii)by striking
section 5 or title II or IV to restrain such violation
and
inserting this Act
; and
(B)in the matter
following paragraph (2), by inserting , to enforce this Act or any rule
promulgated or order issued under this Act, or to order the Administrator to
perform an act or duty under this Act which is not discretionary, as the case
may be
after citizenship of the parties
; and
(2)in subsection (b)(1), by striking to
restrain
and inserting respecting
.
21.Section 21 of the
Toxic Substances Control Act (15 U.S.C. 2620) is amended—
(1)in subsection (a), by striking under
section 4, 6, or 8 or an order under section 5(e) or (6)(b)(2)
and
inserting , order, or any other action authorized under this
Act
; and
(2)in subsection
(b)—
(A)in paragraph (1),
by striking under section 4, 6, or 8 or an order under section 5(e),
6(b)(1)(A), or 6(b)(1)(B)
and inserting or order or to initiate
other action authorized under this Act
;
(B)in paragraph (3),
by striking section 4, 5, 6, or 8
and inserting the
applicable provisions of this Act
; and
(C)in paragraph
(4)—
(i)in
subparagraph (A), by striking a rulemaking proceeding
and
inserting a proceeding authorized under this Act
; and
(ii)in subparagraph
(B)—
(I)by striking
a proceeding to issue a rule under section 4, 6, or 8 or an order under
section 5(e) or 6(b)(2)
and inserting a proceeding authorized
under this Act
;
(II)in clause
(i)—
- (aa)by
inserting
or order
after issuance of a
rule
;
- (bb)by
striking
or an order under section 5(e)
; and
- (cc)by striking
an unreasonable
and inserting a substantial
;
and
(III)in clause
(ii)—
- (aa)by inserting
except as provided in clause (i)
before in the case
of
;
- (bb)by
striking
issuance of a rule under section 6 or 8 or an order under
section 6(b)(2)
and inserting promulgation of a rule, issuance
of an order, or imposition or issuance of a restriction or use condition under
this Act
; and
- (cc)by striking
an unreasonable
and inserting a
substantial
.
22.Section 23 of the
Toxic Substances Control Act (15 U.S.C. 2622) is amended as follows:
(1)In subsection
(a)—
(A)by striking
employer may discharge
and inserting manufacturer,
processor, or distributor may discharge
;
(B)by redesignating paragraphs (1), (2), and
(3) as paragraphs (2), (3), and (4), respectively;
(C)by inserting
before paragraph (2), as redesignated by subparagraph (B) of this paragraph,
the following new paragraph:
(1)provided, caused to be provided, or is
about to provide or cause to be provided to the employer, the Federal
Government, the appropriate official of the tribe, or the attorney general of a
State information relating to any violation of, or any act or omission the
employee reasonably believes to be a violation of any provision of this
Act;
;
(D)in paragraph (3),
as redesignated by subparagraph (B) of this paragraph—
(i)by
inserting concerning any such violation or
after
testified or is about to testify
; and
(ii)by
striking or
after Act;
;
(E)in paragraph (4),
as redesignated by subparagraph (B) of this paragraph, by inserting
or
after Act;
; and
(F)by adding at the
end the following new paragraph:
(5)objected to, or refused to participate in,
any activity, policy, practice, or assigned task that the employee (or other
such person) reasonably believed to be in violation of any provision of this
Act.
.
(2)By striking
subsection (e) and amending subsections (b), (c), and (d) to read as
follows:
(b)(1)Any employee who
believes that the employee has been discharged or otherwise discriminated
against by any person in violation of subsection (a) of this section may, not
later than 180 days after the date on which such alleged violation occurs, file
(or have any person file on the employee’s behalf) a complaint with the
Secretary of Labor (hereinafter in this section referred to as the
Secretary
) alleging such discharge or discrimination and
identifying the person responsible for such act. Upon receipt of such a
complaint, the Secretary shall notify, in writing, the person named in the
complaint of the filing of the complaint, of the allegations contained in the
complaint, of the substance of evidence supporting the complaint, and of the
opportunities that will be afforded to such person under paragraph (2).
(2)(A)Not later than 60 days
after the date of receipt of a complaint filed under paragraph (1) and after
affording the complainant and the person named in the complaint an opportunity
to submit to the Secretary a written response to the complaint and an
opportunity to meet with a representative of the Secretary to present
statements from witnesses, the Secretary shall initiate an investigation and
determine whether there is reasonable cause to believe that the complaint has
merit and notify, in writing, the complainant and the person alleged to have
committed a violation of subsection (a) of the Secretary’s findings. If the
Secretary concludes that there is reasonable cause to believe that a violation
of subsection (a) of this section has occurred, the Secretary shall accompany
the Secretary’s findings with a preliminary order providing the relief
prescribed by paragraph (3)(B). Not later than 30 days after the date of
notification of findings under this paragraph, either the person alleged to
have committed the violation or the complainant may file objections to the
findings or preliminary order, or both, and request a hearing on the record.
The filing of such objections shall not operate to stay any reinstatement
remedy contained in the preliminary order. Any such hearing shall be conducted
expeditiously. If a hearing is not requested in such 30-day period, the
preliminary order shall be deemed a final order that is not subject to judicial
review.
(B)(i)The Secretary shall
dismiss a complaint filed under this subsection and shall not conduct an
investigation otherwise required under subparagraph (A) unless the complainant
makes a prima facie showing that any behavior described in paragraphs (1)
through (5) of subsection (a) was a contributing factor in the unfavorable
personnel action alleged in the complaint.
(ii)Notwithstanding a finding by the
Secretary that the complainant has made the prima facie showing required under
clause (i), no investigation otherwise required under subparagraph (A) shall be
conducted if the employer demonstrates, by clear and convincing evidence, that
the employer would have taken the same unfavorable personnel action in the
absence of that behavior.
(iii)The Secretary may determine that
a violation of subsection (a) has occurred only if the complainant demonstrates
that any behavior described in paragraphs (1) through (5) of subsection (a) was
a contributing factor in the unfavorable personnel action alleged in the
complaint.
(iv)Relief may not be ordered under
subparagraph (A) if the employer demonstrates by clear and convincing evidence
that the employer would have taken the same unfavorable personnel action in the
absence of that behavior.
(3)(A)Not later than 120 days
after the date of conclusion of any hearing under paragraph (2), the Secretary
shall issue a final order providing the relief prescribed by this paragraph or
denying the complaint. At any time before issuance of a final order, a
proceeding under this subsection may be terminated on the basis of a settlement
agreement entered into by the Secretary, the complainant, and the person
alleged to have committed the violation.
(B)If, in response to a complaint filed
under paragraph (1), the Secretary determines that a violation of subsection
(a) has occurred, the Secretary shall order the person who committed such
violation—
(i)to take affirmative action to abate
the violation;
(ii)to reinstate the complainant to
the complainant’s former position together with the compensation (including
back pay), terms, conditions, and privileges of the complainant’s
employment;
(iii)to provide compensatory damages;
and
(iv)where appropriate, exemplary
damages.
If such
an order is issued, the Secretary, at the request of the complainant, shall
assess against the person against whom the order is issued a sum equal to the
aggregate amount of all costs and expenses (including attorney’s and expert
witness fees) reasonably incurred, as determined by the Secretary, by the
complainant for, or in connection with, the bringing of the complaint upon
which the order was issued.(C)If the Secretary finds that a
complaint under paragraph (1) is frivolous or has been brought in bad faith,
the Secretary may award to the prevailing employer a reasonable attorney’s fee,
not exceeding $1,000, to be paid by the complainant.
(4)If the Secretary
has not issued a final decision within 210 days after the filing of the
complaint, the complainant may bring an action at law or equity for de novo
review in the appropriate district court of the United States with
jurisdiction, which shall have jurisdiction over such an action without regard
to the amount in controversy, and which action shall, at the request of either
party to such action, be tried by the court with a jury. The proceedings shall
be governed by the same legal burdens of proof specified in paragraph (2)(B).
The court shall have jurisdiction to grant all relief necessary to make the
employee whole, including injunctive relief and compensatory damages,
including—
(A)reinstatement with
the same seniority status that the employee would have had, but for the
discharge or discrimination;
(B)the amount of back
pay, with interest; and
(C)compensation for
any special damages sustained as a result of the discharge or discrimination,
including litigation costs, expert witness fees, and reasonable attorney’s
fees.
(5)(A)Unless the complainant
brings an action under paragraph (4), any employee or employer adversely
affected or aggrieved by a final order issued under paragraph (3) may obtain
review of the order in the United States Court of Appeals for the circuit in
which the violation, with respect to which the order was issued, allegedly
occurred or the circuit in which the complainant resided on the date of such
violation. The petition for review must be filed within 60 days from the
issuance of the final order of the Secretary. Such review shall conform to
chapter 7 of title 5, United States Code. The commencement of proceedings under
this subparagraph shall not, unless ordered by the court, operate as a stay of
the order.
(B)An order of the Secretary, with
respect to which review could have been obtained under subparagraph (A) shall
not be subject to judicial review in any criminal or other civil
proceeding.
(6)Whenever a person
has failed to comply with an order issued under paragraph (3), the Secretary
shall file a civil action in the United States district court for the district
in which the violation was found to occur, or in the United States district
court for the District of Columbia, to enforce such order. In actions brought
under this paragraph, the district courts shall have jurisdiction to grant all
appropriate relief, including injunctive relief and compensatory
damages.
(7)(A)A person on whose behalf
an order was issued under paragraph (3) may commence a civil action against the
person to whom such order was issued to require compliance with such order. The
appropriate United States district court shall have jurisdiction, without
regard to the amount in controversy or the citizenship of the parties, to
enforce such order.
(B)The court, in issuing any final order
under this paragraph, may award costs of litigation (including reasonable
attorney’s and expert witness fees) to any party whenever the court determines
such award is appropriate.
(c)Any nondiscretionary duty imposed by this section shall be
enforceable in a mandamus proceeding brought under section 1361 of title 28,
United States Code.
(d)Subsection (a) shall not apply with respect to an
employee of a manufacturer, processor, or distributor who, acting without
direction from such manufacturer, processor, or distributor (or such person’s
agent), deliberately causes a violation or alleged violation of any rule,
order, regulation, or safety standard under this Act or any other law enforced
by the
Administrator.
.
23.Section 24 of the
Toxic Substances Control Act (15 U.S.C. 2623) is amended—
(1)in subsection (a)—
(A)by striking
continuing
and inserting periodic
; and
(B)by striking the em
dash and paragraphs (1) and (2) and inserting the implementation of this
Act.
; and
(2)in subsection
(b)—
(A)in paragraph (1),
by striking section 4, 5, or 6 or a requirement of section 5 or
6
and inserting this Act
;
(B)in paragraph
(2)—
(i)in subparagraph
(A), by striking by order issued
and inserting in
writing,
; and
(ii)in subparagraph
(B)—
(I)in clause (i), by
inserting and
after the such request,
; and
(II)by striking
clause (ii) and redesignating clause (iii) as clause (ii); and
(C)by amending
paragraph (4) to read as follows:
(4)This section shall not be construed—
(A)to require the
Administrator to amend or repeal any rule or order under this Act; or
(B)to impose a
condition on the Administrator’s authority to issue orders or promulgate rules
under this
Act.
.
24.Administration
of the ActSection 26 of the
Toxic Substances Control Act (15 U.S.C. 2625) is amended—
(1)by amending
subsection (b) to read as follows:
(b)The Administrator shall, by rule, require
the payment of a reasonable fee from any person required to submit data under
this Act to defray the cost of administering this Act. In setting a fee under
this subsection, the Administrator shall take into account the ability to pay
of the person required to submit the data and the cost to the Administrator of
reviewing such data. Such rules may provide for sharing such a fee in any case
in which the expenses of data production are shared under this
Act.
;
and
(2)by redesignating
subsections (d) through (g) as subsections (f) through (i),
respectively;
(3)by inserting after
subsection (c) the following new subsections:
(d)Action with
respect to specific chemical substancesAny action authorized under this Act to be
taken by the Administrator through rule or order shall be made through order if
the action applies to a single chemical substance or single category of
chemical substances.
(e)Action with
respect to articles containing a chemical substance or mixtureNo
action taken under this title with respect to articles containing a chemical
substance or mixture shall apply to articles already introduced or delivered
for introduction into commerce, unless the action is taken pursuant to section
7 to address an imminent hazard and the Administrator has determined that
action against articles introduced or delivered for introduction into commerce
is necessary to protect health or the
environment.
;
and
(4)by adding at the
end the following new subsection:
(j)In
carrying out this Act, the Administrator is authorized to prescribe such
regulations as are necessary to carry out this
Act.
.
25.Section 28 of the
Toxic Substances Control Act (15 U.S.C. 2627) is amended—
(1)in subsection (a)—
(A)by amending the
subsection heading to read as follows:
(a)
;
(B)before For
the purpose of complementing
, by inserting the following:
(1)
;
(C)by inserting
and tribes
after may make grants to
States
;
(D)by striking
unreasonable risks within the States
and inserting risks
within the States and tribes
;
(E)by striking
is unable or is not likely to take
and inserting has not
taken
; and
(F)by inserting
or tribe
after no grant for any State
;
(2)by redesignating
subsections (b), (c), and (d) as paragraphs (2), (3), and (4),
respectively;
(3)in paragraph (2),
as redesignated by paragraph (2) of this section—
(A)by redesignating
paragraphs (1) and (2) as subparagraphs (A) and (B), respectively;
(B)in subparagraph
(A), as redesignated by subparagraph (A) of this paragraph—
(i)by
redesignating subparagraphs (A) through (F) as clauses (i) through (vi),
respectively;
(ii)in
clause (ii), as redesignated by clause (i), by inserting or
tribe
; and
(iii)by
striking subsection (a)
each place it appears and inserting
paragraph (1)
;
(C)in subparagraph (B), as redesignated by
subparagraph (B) of this paragraph—
(i)by
striking paragraph (1)
and inserting subparagraph
(A)
;
(ii)by
inserting or tribe
after State
each place it
appears; and
(iii)by
striking including cancer, birth defects, and gene
mutations,
;
(4)in paragraph (3),
as redesignated by paragraph (2) of this section, by striking subsection
(a)
and inserting this subsection
;
(5)in paragraph (4), as redesignated by
paragraph (2) of this section, by striking subsection (a)
and
inserting this subsection
; and
(6)by inserting at
the end the following new subsection:
(b)Not later than
18 months after enactment of the Toxic Chemicals Safety Act of 2010, the
Administrator shall establish a process to coordinate with State and tribal
governments, on an on-going basis, to share data and priorities relating to the
management of chemical substances and mixtures under this title and under
programs operated by States and tribes, in keeping with requirements of section
14. The areas for coordination shall include the following:
(1)Grant funding
under subsection (a).
(2)Design and
development of the public database established pursuant to section 8(d).
(3)Development of a
process by which confidential business information may be shared with the
States under section 14.
(4)Development of
action plans under section
38(d).
.
26.Authorization
for Appropriations
(a)Section 29 of the Toxic Substances Control
Act (15 U.S.C. 2628) is amended to read as follows:
29.Authorization
for AppropriationsThere are
authorized to be appropriated to the Administrator to carry out this Act such
sums as necessary for each of fiscal years 2011 through
2018.
.
27.
(a)The Toxic
Substances Control Act (15 U.S.C. 2601 et seq.) is amended by adding after
section 31 the following new sections:
32.Chemical
substances and mixtures that are persistent, bioaccumulative, and
toxic
(a)Not
later than 1 year after the date of enactment of the Toxic Chemicals Safety Act
of 2010, the Administrator shall by rule establish criteria to identify
chemical substances and mixtures that are persistent, bioaccumulative, and
toxic, or are degraded or metabolized into chemical substances that are
persistent, bioaccumulative, and toxic, and for which there is documented
evidence of exposure to humans or the environment.
(b)Not
later than 6 months after the promulgation of the rule under subsection (a),
and every 3 years thereafter, the Administrator shall publish a list of all
chemical substances and mixtures that meet those criteria, based on available
scientific information.
(c)
(1)Expedited
exposure reductionAs promptly as feasible and not later than 18
months after the listing of a chemical substance or mixture under subsection
(b), the Administrator shall impose conditions authorized under section 6(c) on
the manufacture, processing, use, distribution in commerce, and disposal of
such chemical substance or mixture necessary to achieve the greatest
practicable reductions in exposure to the chemical substance or mixture.
(2)Within one year after the effective date of such
conditions, the Administrator shall determine whether the chemical substance or
mixture meets the safety standard with the conditions imposed, taking into
account the residual risk posed by continued exposure to the chemical substance
or mixture, and shall impose any further conditions authorized under section
6(c) necessary to ensure that the chemical substance or mixture meets the
safety standard.
(d)
(1)Notwithstanding the requirements of section 4(a) of this
title, manufacturers and processors of chemical substances or mixtures listed
pursuant to subsection (b) shall not be required to submit a minimum data set
for such chemical substances or mixtures, unless requested to do so by the
Administrator.
(2)Not
later than 6 months after a chemical substance or mixture is listed under
subsection (b), manufacturers and processors of such chemical substance or
mixture shall submit the declaration required by section 8(a)(2).
(e)New chemical
substances and new uses
(1)For each new
chemical substance subject to section 5(a)(1), the Administrator shall
determine whether the chemical substance or mixture, or a degradation product
or metabolite of the chemical substance or mixture, meets the criteria
established under subsection (a) of this section.
(2)For each chemical
substance or mixture identified in paragraph (1), and for any proposed new use
of a chemical substance subject to section 5(a)(1) that is identified in
subsection (b), the Administrator shall allow manufacture, processing, and
distribution in commerce of the substance only for a use which the
Administrator determines meets the requirements of section 6(e).
33.Children’s
environmental health
(a)Children’s
environmental health research
(1)Subject to amounts made available in advance in
appropriations Acts, the Administrator shall enter into contracts and make
grants to further understanding of the vulnerability of children to chemical
substances.
(2)Contracts
and grants under this section shall be made in consultation with Science
Advisory Board on Children’s Health and Toxic Substances established under
subsection (b) and the Children's Health Protection Advisory Committee
established in response to Executive Order 13045.
(b)Science advisory
board on children’s health and toxic substances
(1)Not later than 90 days after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall
consult with the head of any other appropriate Federal agency to establish an
advisory board to be known as the Science Advisory Board on Children’s
Health and Toxic Substances
. The Board, and any subcommittee thereof,
shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.).
(2)The
purposes of the Science Advisory Board on Children’s Health and Toxic
Substances shall be to provide independent advice, expert consultation, and
peer review upon the request of the Administrator on the scientific and
technical aspects of issues relating to the implementation of this title with
respect to protecting children’s health under this Act.
(3)The
Administrator shall—
(A)appoint the
members of the Board, including, at a minimum, one employee of—
(i)the National
Institute of Environmental Health Sciences;
(ii)the Centers for
Disease Control and Prevention;
(iii)the National
Toxicology Program;
(iv)the National
Cancer Institute;
(v)the National
Tribal Science Council; and
(vi)not fewer than 3
centers of children’s health at leading universities;
(B)ensure that at
least 1/3 of the members of the Board have specific
scientific expertise in the relationship of chemical exposures to prenatal,
infant, and children’s health; and
(C)ensure that all
appointments shall be made without regard to political affiliation or political
activity, unless required by Federal statute.
(4)
(A)The Administrator
shall make publicly available in accordance with subparagraph (B) the following
information:
(i)A
description of the process used to establish and appoint the members of the
advisory committee, including the following:
(I)The process for
identifying prospective members.
(II)The process of
selecting members for balance of viewpoints or expertise.
(ii)A
list of all current members, including, for each member, the following:
(I)The name of any
person or entity that nominated the member.
(II)The reason the
member was appointed to the committee.
(III)Whether the
member is designated as a special government employee or a
representative.
(IV)In the case of a
representative, the individuals or entity whose viewpoint the member
represents.
(iii)A list of all
members designated as special government employees for whom written
certifications were made under section 208(b) of title 18, United States Code,
a summary description of the conflict necessitating the certification, and the
reason for granting the certification.
(iv)Transcripts or
audio or video recordings of all meetings of the committee.
(v)Any additional
information considered relevant by the head of the agency to which the advisory
committee reports.
(B)(i)Except as provided in
clause (ii), the Administrator shall make the information required to be
disclosed under subparagraph (A) available electronically on the official
public internet site of the agency at least 15 calendar days before each
meeting of an advisory committee. If the Administrator determines that such
timing is not practicable for any required information, the information shall
be made available as soon as practicable but no later than 48 hours before the
next meeting of the committee. The Administrator may withhold from disclosure
any information that would be exempt from disclosure under section 552 of title
5, United States Code.
(ii)The Administrator shall make
available electronically, on the official public internet site of the agency, a
transcript or audio or video recording of each advisory committee meeting not
later than 30 calendar days after the meeting.
(c)
(1)
(A)If, through studies performed pursuant to
grants and contracts under subsection (a), testing or biomonitoring under
section 4, or other available research, the Administrator identifies a chemical
substance (or a metabolite or degradation product of such substance) that is
likely to be present in human biological media at a level above that normally
found in such media that is likely to have adverse effects on early childhood
development, the Administrator shall, except as provided in subparagraph (B),
coordinate with the Secretary of Health and Human Services to conduct, not
later than 2 years after the date on which the Administrator makes such
identification, a biomonitoring study to determine the presence of the chemical
substance in human biological media in, at a minimum, pregnant women and
infants.
(B)A biomonitoring
study under subparagraph (A) shall not be required if—
(i)the Administrator
determines that the chemical substance is already subject to equivalent
testing;
(ii)the
Administrator has determined that the chemical substance meets the safety
standard; or
(iii)a safety
standard determination is pending, and the Administrator determines that such a
study is not required to complete the determination.
(2)Upon
completion of any biomonitoring study conducted pursuant to paragraph (1), the
Administrator shall publish the results of the study on the public database
established pursuant to section 8(d).
(3)
(A)Whenever a chemical substance or mixture
(or a metabolite or degradation product of such substance or mixture) is
determined to be present in human biological media in a biomonitoring study
conducted pursuant to paragraph (1), the manufacturers and processors of such
chemical substance or mixture shall, not later than 180 days after the date of
publication of such study, disclose to the Administrator, commercial customers
of the manufacturers and processors, consumers, and the public—
(i)all known uses of
the chemical substance or mixture; and
(ii)all articles in
which the chemical substance or mixture is or is expected to be present.
(B)Cost and form of
disclosureInformation under clauses (i) and (ii) of subparagraph
(A) shall be—
(i)added to the
public database established pursuant to section 8(d); and
(ii)made readily
accessible and free of charge by each applicable manufacturer and processor in
electronic format to the commercial customers of such manufacturer or
processor, consumers, and the public.
34.Reduction of
animal-based testing
(a)Duties of the
AdministratorThe Administrator shall take action to minimize the
use of animals in testing of chemical substances or mixtures, including—
(1)encouraging and
facilitating, where practicable—
(A)use of existing
data of sufficient scientific quality;
(B)use of test
methods that eliminate or reduce the use of animals but provide data of high
scientific quality;
(C)grouping of 2 or
more chemical substances into scientifically appropriate categories where
testing of one chemical substance will provide reliable and useful data on
others in the category;
(D)formation of
industry consortia to jointly conduct testing to avoid unnecessary duplication
of tests; and
(E)parallel
submission of data from animal-based studies and from emerging methods and
models;
(2)funding research
and validation studies to reduce, refine, and replace the use of animal tests
in accordance with this subsection;
(3)in consultation
with the Interagency Coordinating Committee on the Validation of Alternative
Methods, and after providing an opportunity for public comment, developing a
strategic plan to promote the development and implementation of alternative
test methods and testing strategies to generate information used for safety
standard determinations under section 6(b) that do not use animals, including
toxicity pathway-based risk assessment, in vitro studies, systems biology,
computational toxicology, bioinformatics, and high-throughput screening;
and
(4)biennially
reporting to Congress on progress made in implementing this section.
(b)Not later than 1 year
after the date of enactment of the Toxic Chemicals Safety Act of 2010, and
triennially thereafter, the Administrator, in consultation with the Interagency
Coordinating Committee on the Validation of Alternative Methods, shall publish
a list of demonstrated testing methods that reduce the use of animals in
testing.
(c)Criteria for
adapting or waiving animal testing requirementsUpon request from
a manufacturer or processor that is required to conduct animal-based testing of
a chemical substance or mixture under this title, the Administrator may adapt
or waive such requirement in part or in whole if the Administrator determines
that—
(1)there is
sufficient weight-of-evidence that a chemical substance or mixture has, or does
not have, a particular property for which such testing would be
required;
(2)testing for a
specific adverse effect is technically not practicable to conduct as a
consequence of the substance characteristics; or
(3)a chemical
substance or mixture cannot be tested in animals at concentrations that do not
result in significant pain or distress as a consequence of the substance
characteristics, such as potential to cause severe corrosion or severe
irritation to tissues.
A waiver
under this subsection does not waive the duty of the manufacturer or processor
to demonstrate that the chemical substance or mixture meets the safety standard
under section 5(a) or section 6(b).35.Safer
alternatives and green chemistry and engineering
(a)
(1)Not
later than 1 year after the date of enactment of the
Toxic Chemicals Safety Act of
2010, the Administrator shall, after notice and opportunity for
comment, establish a program to create incentives for the development of safer
alternatives to existing chemical substances and mixtures that reduce or avoid
the use and generation of hazardous chemical substances or mixtures. The
program under this paragraph shall include—
(A)recognition for a
chemical substance or mixture, an article containing such substance or mixture,
or a non-chemical alternative, determined by the Administrator under paragraph
(2) to be a safer alternative for all intended uses or for a particular use of
an existing chemical substance or mixture by means of a special designation
intended for use in marketing the safer alternative, and periodic public
awards; and
(B)such other
financial or non-financial incentives as the Administrator considers to be
appropriate to encourage the development, marketing, and use of chemical
substances or mixtures, articles containing such substances or mixtures, or
non-chemical alternatives, determined by the Administrator to be safer
alternatives for all uses or for particular uses of existing chemical
substances or mixtures.
(2)Safer
alternative assessmentAny person seeking approval for a safer
alternative under this section shall submit to the Administrator an
application, including the safer alternative data set described in subparagraph
(A) and shall bear the burden of demonstrating that the safer alternative
standard is met, pursuant to subparagraph (B).
(A)Safer
alternative data setNot
later than one year after the date of enactment of the Toxic Chemicals Safety
Act of 2010, the Administrator shall establish, by rule, the data that
constitute the safer alternative data set. The rule shall identify the
information that the Administrator determines will be useful for the safer
alternative standard determination under subparagraph (B) and shall
include—
(i)chemical identity
for the applicant alternative chemical substance or mixture, article containing
such substance or mixture, or non-chemical alternative and the chemical
substance or mixture targeted for substitution;
(ii)the proposed use,
if applicable, or all intended uses of the applicant alternative;
(iii)substance
characteristics, toxicological properties, and biological and environmental
fate and transport data for the applicant alternative;
(iv)known and
potential exposures for the applicant alternative;
(v)a
comparative analysis of the applicant alternative and the chemical substance or
mixture targeted for substitution based on the best publicly-available science
on the targeted substance demonstrating that the applicant alternative will
involve lower hazard, lower exposure, or both; and
(vi)a
demonstration that the applicant alternative is effective for the proposed use
or for all intended uses, as applicable.
The
rule shall require any person applying for approval of a safer alternative to
submit the safer alternative data set, and may provide a form for such
application.(B)Safer
alternative standard determinationThe Administrator shall,
following the submission of a safer alternative data set pursuant to
subparagraph (A), approve the applicant alternative chemical substance or
mixture, article containing such substance or mixture, or non-chemical
alternative for the proposed use or uses if the Administrator determines that
the proposed alternative is effective for the proposed use or uses and—
(i)provides a
reasonable certainty of no harm from the aggregate exposure to the alternative
substance from intended uses, including to vulnerable populations, and protects
the public welfare, considering the lifecycle of the alternative substance and
cumulative exposures and other relevant considerations, and, when compared to
the chemical substance or mixture targeted for substitution—
(I)reduces the
potential for harm to human health or the environment;
(II)has been shown
not to be persistent or bioaccumulative, while the chemical substance or
mixture targeted for substitution has not; or
(III)does not require the use of hazardous,
persistent, or bioaccumulative substances during its manufacture or processing,
while the chemical substance or mixture targeted for substitution does;
or
(ii)in the case that the applicant alternative
cannot provide a reasonable certainty of no harm from the aggregate exposure to
the alternative substance from intended uses, including to vulnerable
populations, and protect the public welfare, considering the lifecycle of the
alternative substance and cumulative exposures and other relevant
considerations, the chemical substance or mixture targeted for substitution had
been granted or would qualify for a critical use exemption under section 6(e)
and the applicant alternative chemical substance or mixture, article containing
such substance or mixture, or non-chemical alternative, when compared to the
chemical substance or mixture targeted for substitution—
(I)reduces the
potential for harm to human health or the environment;
(II)has been shown not to be persistent or
bioaccumulative, while the chemical substance or mixture targeted for
substitution has not; or
(III)does not require the use of hazardous,
persistent, or bioaccumulative substances during its manufacture or processing,
while the chemical substance or mixture targeted for substitution does.
Any applicant
alternative approved under this section shall be exempt from the requirements
of sections 4, 5, and 6 for the uses considered and approved in the approval
under this section, except that any approval under this section shall expire
after 15 years, at which time a renewal will be required pursuant to section
6(b).(C)Consideration in
determinationAny safer alternative standard determination made
under this subsection shall be considered by the Administrator in making a
safety standard determination under section 6(b) or in granting an exemption
under section 6(e) for the chemical substance or mixture targeted for
substitution by the application under this subsection.
(b)
(1)Green chemistry
research networkNot later than 2 years after the date of
enactment of the Toxic Chemicals Safety Act of 2010, and subject to amounts
made available in advance in appropriations Acts, the Administrator shall
establish an interdisciplinary network of regional centers, to support the
research, development, and adoption of safer alternatives to existing chemical
substances and mixtures, particularly chemical substances and mixtures listed
on the priority list under section 6(a).
(2)Green chemistry
and engineering researchSubject to amounts made available in
advance in appropriations Acts, the Administrator shall make grants and enter
into contracts to promote and support the research, development, and adoption
of safer alternatives to existing chemical substances and mixtures.
(3)Green chemistry
workforce education and training program
(A)The Administrator shall establish a program to facilitate
the development of a workforce, including industrial and scientific workers,
that produces safer alternatives to existing chemical substances and
mixtures.
(B)The goals of the program established under
subparagraph (A) are to provide workforce training on skills that will—
(i)facilitate the
expansion of green chemistry in the United States to create new and safer
jobs;
(ii)develop a
scientifically and technically trained green chemistry workforce in the United
States;
(iii)inform and
engage communities about green chemistry; and
(iv)promote
innovation and strong public health and environmental protections.
(C)The
Administrator shall, subject to amounts made available in advance in
appropriations Acts, implement the program established under subparagraph (A)
to achieve the goals under subparagraph (B), including by—
(i)promoting the
development of a broad range of skills relevant to the production and use of
safer alternatives to existing chemical substances and mixtures, including
their design, manufacturing, and use and disposal;
(ii)developing
partnerships with educational institutions, training organizations, private
sector companies, community organizations, labor unions, and other non-profit
organizations; and
(iii)in coordination
with the Secretary of Labor and the Secretary of Energy, providing grants to
State and local governments and to the partnerships established pursuant to
clause (ii) to promote and support activities consistent with achieving the
goals under subparagraph (B).
36.International
cooperation and agreements
(a)In coordination with the Secretary of State
and the head of any other Federal agency, as appropriate, the Administrator
shall cooperate with any international effort which the Administrator
determines has broad international support and a reasonable expectation of
success—
(1)to develop a
common protocol or electronic database relating to chemical substances and
mixtures; or
(2)to develop safer
alternatives for chemical substances and mixtures.
(b)
(1)Except as provided in paragraph (2),
notwithstanding any other provision of law, effective 3 years after the date of
enactment of the Toxic Chemicals Safety Act of 2010, no person shall
manufacture, process, distribute in commerce, use for commercial purposes, or
dispose of the following chemical substances, except in a manner determined by
the Administrator to be protective of health and the environment:
(A)Hexabromobiphenyl.
(B)Hexachlorobenzene.
(C)Hexabromodiphenyl
ether and Heptabromodiphenyl ether and congeners in the commercial OctaBDE
mixture.
(D)Pentachlorobenzene.
(E)Tetrabromodiphenyl
ether and pentabromodiphenyl ether and congeners in the commercial PentaBDE
mixture.
(2)If
the United States deposits its instrument of ratification for the Stockholm
Convention, the PIC Convention, or the LRTAP POPs Protocol before the
prohibition under paragraph (1) has taken effect, the effective date of the
prohibition shall be determined in keeping with the requirements of the
applicable agreement.
(c)Notice of
restrictions under international agreementsNot later than 60 days after the enactment
of the Toxic Chemicals Safety Act of 2010, the Administrator, in consultation
with the Secretary of State, shall publish in the Federal Register a notice of
the chemical substances or mixtures that are subject to the Stockholm
Convention, the PIC Convention, and the LRTAP POPs Protocol, including
conditions or restrictions relating to such chemical substances or mixtures
imposed by such agreements or by foreign governments pursuant to such
agreements.
(d)In consultation with the Secretary of State and the
head of any other appropriate Federal agency (as determined by the
Administrator), the Administrator shall implement the provisions of
international agreements (and any subsequent amendment to such agreements)
related to chemical substances and mixtures to which the United States becomes
a party. Such implementation shall provide notice at each step in the listing
and delisting process as required in such agreements and include requirements
that:
(1)Not later than 30
days after the United States deposits its instrument of ratification for the
Stockholm Convention, the PIC Convention, the LRTAP POPs Protocol, or any other
international agreement related to chemical substances and mixtures, or not
later than 30 days after the listing of any chemical substance or mixture
subsequently added under such an instrument has entered into force for the
United States, (whichever occurs earlier), the Administrator shall provide
public notice of the chemical substances or mixtures that are subject to that
agreement, and shall provide similar public notice of any chemical substance or
mixture subsequently added under such agreement. In providing such notice, the
Administrator may specify the applicable requirements for individual chemical
substances or mixtures.
(2)Whenever a
chemical substance or mixture is proposed for listing under an international
agreement to which the United States is a party, the Administrator shall
publish in the Federal Register a notice that—
(A)includes any
relevant toxicity, exposure, and risk information related to the chemical
substance or mixture known to the Administrator, as well as any domestic
activities involving the chemical substance or mixture known to the
Administrator;
(B)includes a summary
of the process, under the international agreement, for the listing or delisting
step that was taken, including criteria applied in that process and records
generated by the international body during that process;
(C)requires any
person that manufactures, processes, distributes in commerce, uses, or disposes
of the chemical substance or mixture to provide to the Administrator any
information that the Administrator determines to be necessary to assist the
United States in its consideration of the proposal; and
(D)provides an
opportunity for public comment on the proposed listing of the chemical
substance or mixture.
The
comments and information received under this paragraph shall be placed in a
public docket and shall be considered in the Administrator’s review of the
proposal.(3)Any chemical
substance or mixture listed under an international agreement to which the
United States is a party that is not already subject to conditions under
section 6(c) or already listed on the priority list under section 6(a) shall be
promptly added to the priority list under section 6(a).
(4)If there are
applicable obligations for a chemical substance or mixture under more than one
international agreement to which the United States is a party, the most
stringent of such obligations shall apply to ensure compliance with each of
those agreements.
(e)The
Administrator may promulgate such rules as the Administrator determines
necessary to cooperate with international efforts pursuant to subsection (a)
and to implement international agreements related to chemical substances and
mixtures pursuant to subsection (d).
(f)Effect on other
provisions of lawNothing in this section shall affect the
authority of the Administrator to regulate a chemical substance or mixture
under any other provision of law, provided that such regulation—
(1)is not less
stringent than actions prescribed by this section; and
(2)does not impair
the ability of the United States to comply with obligations under international
agreements (and any subsequent amendment to such agreements) related to
chemical substances and mixtures to which the United States becomes a
party.
(g)In
this section:
(1)The term LRTAP Convention means the
Convention on Long-Range Transboundary Air Pollution, adopted in Geneva on
November 13, 1979, and any subsequent amendment or protocol.
(2)The term LRTAP POPs Protocol means the
Protocol on Persistent Organic Pollutants to the LRTAP Convention, adopted in
Aarhus on June 24, 1998, and any subsequent amendment.
(3)The term Stockholm Convention means the
Stockholm Convention on Persistent Organic Pollutants adopted in Stockholm on
May 22, 2001, and any subsequent amendment or protocol.
37.Not later than 18
months after the date of enactment of the Toxic Chemicals Safety Act of 2010, the
Administrator shall, by order, after notice and opportunity for comment,
establish and implement procedures to ensure data quality under this Act
including, at a minimum, requirements that—
(1)not less than
annually, the Administrator randomly inspect commercial and private
laboratories that develop the data required under this title;
(2)annually, the
Administrator perform a comprehensive data audit on a subset, as selected by
the Administrator, of the data submissions under this title;
(3)the Administrator
have access to all records of privately sponsored health and safety studies
initiated in response to requirements under this title; and
(4)the submitter of
any study conducted by a third party in response to requirements under this
title disclose to the Administrator and the public, at the time of submission,
the sources of any funding used for the conduct or publication of the study
received by the researchers who conducted the study.
38.
(a)Not later than 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall
promulgate a rule to—
(1)establish criteria
for the determination of disproportionate exposure, which shall include
criteria for identification of average exposure levels in the United States and
criteria for identification of exceedences that are significant based on their
potential impact on health or the environment;
(2)establish criteria
to identify any locality that is disproportionately exposed; and
(3)develop a method
for data collection on and categorization of patterns of disproportionate
exposure and associated adverse effects.
(b)
(1)Not later than 18 months after promulgation of the rule
under subsection (a), the Administrator shall identify localities within the
United States subject to disproportionate exposure.
(2)In identifying localities under paragraph (1), the
Administrator—
(A)shall use data
contained in the National Air Toxic Assessment Database; and
(B)may use other data
available to the Administrator, including data developed pursuant to—
(i)the Safe Drinking
Water Act (42 U.S.C. 300f et seq.);
(ii)the Solid Waste
Disposal Act (42 U.S.C. 6901 et seq.);
(iii)the
Comprehensive Environmental Response, Compensation, and Liability Act of 1980
(42 U.S.C. 9601 et seq.);
(iv)the Emergency
Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11001 et seq.);
and
(v)the National
Environmental Public Health Tracking program at the Centers for Disease Control
and Prevention.
(3)The Administrator shall provide an opportunity for
State, local, and tribal governments and members of the public to nominate
localities for which there may be disproportionate exposure for inclusion in
the identification of localities under paragraph (1).
(c)
(1)Not later than 180 days after completing the
identification of localities under subsection (b)(1), the Administrator shall,
after notice and consultation with all applicable State, local, and tribal
health and environmental officials, legislators and other elected officials,
and members of the public, publish a list of the localities subject to
disproportionate exposure identified pursuant to such subsection in the Federal
Register and make such list available electronically. The initial list shall
include at least 20 localities.
(2)Not
later than 5 years after the date of publication of the list under paragraph
(1), and at least once every 5 years thereafter, the Administrator shall update
and republish such list. The Administrator may update and republish such list
to add new localities that meet the criteria under subsection (a), or to remove
localities when the Administrator determines that the percentage exposure
reduction goal for such a locality established pursuant to subsection (d) has
been achieved and no further action is needed. The Administrator shall notify
all applicable State, local, and tribal health and environmental officials,
legislators and other elected officials, and members of the public of such an
updated listing.
(d)Not later than 1 year after publishing or updating the list
under subsection (c), the Administrator shall coordinate with State, local, and
tribal governments and members of the public to develop, for each locality
identified on the list, an action plan to reduce disproportionate exposure
within such locality. Each such action plan shall include—
(1)identification of
the chemical substances and mixtures that contribute to the disproportionate
exposure (including exposure levels, sources, and pathways);
(2)a description of
actions to be undertaken by the Administrator or State, local, or tribal
governments, to reduce disproportionate exposure within the locality;
(3)a percentage
exposure reduction goal for each chemical substance and mixture identified
under paragraph (1); and
(4)a timeline to
achieve the percentage exposure reduction goal under paragraph (3).
(e)Beginning on the date that is one year after the
development of the first action plan under subsection (d), and annually
thereafter, the Administrator shall—
(1)prepare and submit
to Congress an annual report identifying—
(A)each locality
added to the list in the prior year under subsection (c);
(B)each action plan
developed in the prior year under subsection (d);
(C)the progress on
each action plan to date; and
(D)the reasons why
any timelines for percentage exposure reductions were not met and the revised
timeline for meeting those reductions; and
(2)make the report
available to the public in the public database established under section
8(d).
(f)In
this section, the term locality means any geographical area in
which the Administrator identifies disproportionate exposure and may include a
county, city, town, neighborhood, census tract, zip code, or other commonly
understood political or geographical subdivision.
39.Exemption for
chemical substances or mixtures based on intrinsic properties
(a)Authority to
Exempt Certain Chemical Substances and Mixtures Based on Intrinsic
PropertiesIf the
Administrator determines that scientific consensus exists that the intrinsic
properties of a chemical substance or mixture are such that it does not and
would not pose any risk of injury to health or the environment under any
current, proposed, or anticipated levels of production, patterns of use, or
exposures arising at any stage across the lifecycle of the substance or
mixture, the Administrator may, by order, exempt the substance or mixture, or
particular uses of the substance or mixture, from one or more of the
requirements of sections 4, 5, 6 and 8 of this Act. A determination under this
section shall be based on consideration of the intrinsic properties of the
substance or mixture, and shall not be based on findings or assumptions of low
human or environmental exposure to the substance or mixture.
(b)Notice of
determination and exemptionWithin 30 days of determining and
exempting, pursuant to subsection (a), a chemical substance or mixture, or a
particular use of a chemical substance or mixture, the Administrator shall
publish in the Federal Register, and shall add to the public database
established pursuant to section 8(d), a notice that provides the specific
identity of the chemical substance or mixture, and, for a particular use
determined and exempted under subsection (a), the particular use of the
substance or mixture, that the Administrator has determined and exempted under
subsection (a) and that explains and documents the basis for the
Administrator’s determination and exemption.
(c)Reconsideration
of Determination and Exemption
(1)The Administrator may
reconsider and revoke or modify any determination or exemption under subsection
(a) at any time if the Administrator determines that the conditions of
subsection (a) are no longer met, or that such action is necessary to protect
human health or the environment or is otherwise in the public interest. In the
event of such revocation or modification, the Administrator shall provide
public notice of the grounds for that determination and publish such notice on
the public database established pursuant to section 8(d).
(2)Any revocation or modification undertaken pursuant to this
subsection shall not take effect prior to the date that is one year after
public notice of the determination, unless an earlier effective date is
necessary to protect human health or the environment.
(d)Prior regulatory
exemptionsNot later than one year after the date of enactment of
the Toxic Chemicals Safety Act of 2010, exemptions granted by the Administrator
pursuant to section 5(h)(4) of this Act prior to the date of enactment of the
Toxic Chemicals Safety Act of 2010, as such section was in effect before such
date of enactment, shall be reviewed by the Administrator and continued in
effect under the authority granted by this section, as appropriate. Such an
exemption shall continue to be in effect until such date as the Administrator
determines, by order, that—
(1)the exemption is
not authorized or not appropriate under this section, at which time the
exemption shall cease to be in effect; or
(2)the exemption is
authorized and appropriate under this section, at which time the Administrator
may issue an order to modify or continue in effect the exemption pursuant to
subsection (a).
(e)No limitation on
authorityNothing in this section shall be construed to limit or
otherwise affect the Administrator’s authority under any other provision of
this Act.
40.Application of
this Act to Federal agencies
(a)Except as provided in
subsection (e), each Federal agency, and any officer, agent, or employee
thereof, shall be subject to, and comply with, all applicable requirements of
this Act, both substantive and procedural, in the same manner, and to the same
extent, as any person subject to such requirements. The substantive and
procedural requirements referred to in this subsection include—
(1)any rule or
order;
(2)any civil or
administrative penalty or fine, regardless of whether such penalty or fine is
punitive or coercive in nature or is imposed for isolated, intermittent, or
continuing violations;
(3)any requirement
for reporting;
(4)any provision for
injunctive relief and such sanctions as may be imposed by a court to enforce
such relief; and
(5)payment of user
fees under section 26(b).
(b)The United States hereby expressly waives any immunity
otherwise applicable to the United States with respect to any substantive or
procedural requirement referred to under subsection (a).
(c)No agent, employee, or officer of the United States
shall be personally liable for any civil penalty under this Act with respect to
any act or omission within the scope of the official duties of the agent,
employee, or officer.
(d)An agent, employee, or officer of the United States
shall be subject to any criminal sanction (including any fine or imprisonment)
under this Act, but no Federal agency shall be subject to any such
sanction.
(e)
(1)If the President determines it is in the paramount
interest of the United States, the President may grant an exemption for any
Federal agency from compliance with any requirement of this Act.
(2)No exemption shall be granted under paragraph (1)
due to lack of appropriation unless the President has specifically requested
such appropriation as a part of the budgetary process and the Congress has
failed to make available such requested appropriation.
(3)Any exemption granted under paragraph (1) shall be for
a period of not more than 1 year, but additional exemptions may be granted for
periods not to exceed 1 year upon the President's making a new determination
that such exemption is in the paramount interest of the United States.
(4)Annually after the date of enactment of the
Toxic Chemicals Safety Act of 2010, the President shall report to the Congress
all exemptions under this subsection granted during the preceding calendar
year, together with the reason for granting each such exemption.
(f)Administrative
enforcement actions
(1)The Administrator may
commence an administrative enforcement action against any Federal agency
pursuant to the enforcement authorities contained in this Act. The
Administrator shall initiate an administrative enforcement action against such
agency in the same manner and under the same circumstances as an action would
be initiated against another person. Any voluntary resolution or settlement of
an administrative enforcement action shall be set forth in a consent
order.
(2)No
administrative order issued to a Federal agency shall become final until such
agency has had the opportunity to confer with the
Administrator.
.
(b)The table of contents for the Toxic Substances Control
Act is amended by adding after the item relating to section 31, the following
new items:
Sec. 32. Chemical substances and mixtures that are persistent,
bioaccumulative, and toxic.
Sec. 33. Children’s environmental health.
Sec. 34. Reduction of animal-based testing.
Sec. 35. Safer alternatives and green chemistry and
engineering.
Sec. 36. International cooperation and agreements.
Sec. 37. Data quality.
Sec. 38. Hot spots.
Sec. 39. Exemption for chemical substances or mixtures based on
intrinsic properties.
Sec. 40. Application of this Act to Federal
agencies.
.