1.This Act may be cited as
the Safe Chemicals Act of
2010
.
2.It is the purpose of this Act to ensure that
risks from chemicals are adequately understood and managed.
3.Findings,
policy, and goalSection 2 of
the Toxic Substances Control Act (15 U.S.C. 2601) is amended—
(1)by striking
Intent
in the heading and inserting
Goal
; and
(2)by striking
subsections (a) through (c) and inserting the following:
(a)Congress
finds that—
(1)each year human
beings and the environment are exposed to a large number of chemical substances
and mixtures;
(2)the chemical
industry, an important part of the United States economy, provides valuable
products that are used in diverse manufacturing industries and other
commercial, institutional, and consumer applications;
(3)more than 3
decades after the enactment of the Toxic Substances Control Act, people and the
environment in the United States are still exposed to thousands of chemicals
whose safety has not been adequately reviewed and may harm health and the
environment;
(4)the incidence of
some diseases and disorders linked to chemical substance exposures is on the
rise;
(5)biomonitoring of
chemical substances in humans reveals that people in the United States carry
hundreds of hazardous chemicals in their bodies;
(6)the
concentrations of certain chemical substances that persist and accumulate are
increasing in the environment and in human bodies and are found across the
world, including in the remote Arctic in which Native Americans face increasing
contamination of traditional foods;
(7)differences in
metabolism and physiology at certain stages of development can make infants and
children more vulnerable than adults to the effects of chemical exposure,
especially exposures that occur in utero, during infancy, and during other
critical periods of development;
(8)manufacturers and
processors of chemicals should supply sufficient health and environmental
information before distributing products in commerce;
(9)the Administrator
must have and exercise 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 exposure to chemical
substances and mixtures;
(10)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 is generated to
comply with these other regulatory programs may be useful in understanding
hazards and exposures of chemical substances and mixtures presented in the
United States; and
(11)a revised policy
on the safety of chemical substances and mixtures 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 harmful exposures to chemical substances and mixtures;
(2)to promote the
use of safer alternatives and other actions that reduce use of and exposure to
hazardous chemical substances and reward innovation toward safer chemicals,
processes, and products;
(3)to require that
all chemicals in commerce meet a risk-based safety standard that protects
vulnerable and affected populations and the environment;
(4)to require
companies to provide sufficient health and environmental information for the
chemical substances which they manufacture, process, or import as a condition
of allowing such companies to distribute 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 hazards and uses of chemical
substances that they may be exposed to by maximizing public access to
information on chemical safety and use; and
(7)to strengthen
cooperation between and among the Federal Government and State, municipal,
tribal, and foreign governments.
(c)It
is the goal of the United States to address the harmful exposure of vulnerable
or affected populations to chemical substances caused by the distribution of
such substances in commerce by—
(1)reviewing all
chemical substances for safety and identifying the highest priority chemical
substances for expedited review;
(2)determining
whether all chemical substances in commerce meet the safety standard under this
subchapter;
(3)applying
appropriate restrictions to the use of a chemical substance, where warranted;
and
(4)encouraging the
replacement of harmful chemicals and processes with safer
alternatives.
.
4.Section 3 of the Toxic Substances Control
Act (15 U.S.C. 2602) is amended—
(1)in paragraph
(2)—
(A)in subparagraph
(A)—
(i)by
striking subparagraph (B)
and inserting subparagraphs (B)
and (C)
;
(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 chemical
substance contained in or formed into an
article.
;
(B)by adding at the
end the following new subparagraph:
(C)Notwithstanding
molecular identity, the Administrator may determine, under section 5(a)(6),
that a variant of a chemical substance is a new chemical
substance.
.
(2)in paragraph
(4)—
(A)by striking
or
after or article;
; and
(B)by inserting
; or to export or offer for export the substance, mixture, or
article
after article after its introduction into
commerce
;
(3)in paragraph (5),
by inserting ambient and indoor
after includes water,
;
(4)in paragraph (6),
by inserting relating to a chemical substance or mixture or to the
specific chemical identity of the chemical substance or mixture
after
test
;
(5)in paragraph (8),
by inserting The term ‘mixture’ includes any mixture contained in or
formed into an article.
after combination were
combined.
;
(6)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 the manufacturer or processor of the chemical substance has not submitted
a declaration under section 8(a)
;
(7)by striking
paragraph (12);
(8)by redesignating
paragraphs (13) and (14) as paragraphs (12) and (13), respectively; and
(9)by adding at the
end the following new paragraphs:
(14)The term adverse effect means a biochemical
change, anatomic change, functional impairment, or pathological lesion, or its
known precursor, that—
(A)affects or alters
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.
(15)The term aggregate exposure means all
exposure to—
(A)a chemical
substance or mixture from the manufacture, processing, distribution, use, and
disposal of a chemical substance that is not considered to be a chemical
substance under this chapter solely because of the use of the substance as or
in a food, food additive, cosmetic, or device (as such terms are defined in
section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321));
(B)all other sources
of the chemical substance under subparagraph (A), including—
(i)contamination of
food, air, water, soil, and house dust from current or prior uses or
activity;
(ii)accidental
releases;
(iii)permitted
sources of pollution;
(iv)nonpoint sources
of pollution; and
(v)documented
background levels from natural and anthropogenic sources; and
(C)any mixture
containing the chemical substance under subparagraph (A).
(16)The
term bioaccumulative has the meaning given to such term in the
policy statement entitled Category for Persistent, Bioaccumulative, and
Toxic New Chemical Substances
(64 Fed. Reg. 60194, Nov. 4, 1999). The
Administrator may issue a rule to update the definition of such term for
purposes of this chapter.
(17)The term chemical identity includes the
following—
(A)with respect to a
chemical substance, each common and trade name of the chemical
substance;
(B)with respect to a
chemical substance, the name of the chemical substance appearing in
International Union of Pure and Applied Chemistry nomenclature and the most
current Collective Index format;
(C)with respect to a
chemical substance, each Chemical Abstracts Service registration number of the
chemical substance;
(D)with respect to a
chemical substance, the molecular structure of the chemical substance;
(E)with respect to a
mixture, the chemical identities of the mixture’s component chemical
substances; and
(F)with respect to a
mixture, the proportions the mixture’s component chemical substances.
(18)The term cumulative exposure means the sum
of aggregate exposure to—
(A)each of the
chemical substances that are known or suspected to contribute appreciably to
the risk of an adverse effect; and
(B)mixtures
containing chemical substances described under subparagraph (A).
(19)The term end consumer means an individual
or other entity that purchases and uses or consumes a chemical substance,
mixture, or article.
(20)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.
(21)The
term persistent has the meaning given to such term in the policy
statement entitled Category for Persistent, Bioaccumulative, and Toxic
New Chemical Substances
(64 Fed. Reg. 60194, Nov. 4, 1999). The
Administrator may issue a rule to update the definition of such term for
purposes of this chapter.
(22)The
term person means an individual, trust, firm, joint stock company,
corporation (including a Government corporation), partnership, association,
State, municipality, commission, political subdivision of a State, or any
interstate body and shall include each Federal agency and any officer, agent,
or employee thereof.
(23)Reasonable
certainty of no harmThe term reasonable certainty of no
harm means, in establishing whether a chemical substance or mixture
meets the safety standard under this subchapter, that aggregate exposure and
cumulative exposure of the general population or of any vulnerable population
to the chemical substance or mixture presents a negligible risk of any adverse
effect on the general population or a vulnerable population.
(24)Special
substance characteristicsThe term special substance
characteristics means, such physical, chemical, or biological
characteristics, other than molecular identity, that the Administrator
determines, by order or rule, may significantly affect the risks posed by
substances exhibiting those characteristics. In determining the existence of
special substance characteristics, the Administrator may consider—
(A)size or size
distribution;
(B)shape and surface
structure;
(C)reactivity;
and
(D)any other
properties that may significantly affect the risks posed.
(25)The
term toxic, with respect to a chemical substance or mixture, means
that the chemical substance or mixture has a toxicological property—
(A)meeting the
criteria for Category 1 or Category 2 for any of the toxicity endpoints
established by the Globally Harmonized System for the Classification and
Labeling of Hazardous Substances;
(B)that causes an
adverse effect that has been demonstrated in humans or other exposed organisms;
or
(C)for which the
weight of evidence (such as demonstration of such an adverse effect as
described in clause (i) 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 exposed organisms.
(26)The term toxicological property means
actual or potential toxicity or other adverse effects of a chemical substance
or mixture, including actual or potential effects of exposure to a chemical
substance or mixture on—
(A)mortality;
(B)morbidity,
including carcinogenesis;
(C)reproduction;
(D)growth and
development;
(E)the immune
system;
(F)the endocrine
system;
(G)the brain or
nervous system;
(H)other organ
systems; or
(I)any other
biological functions in humans or nonhuman organisms.
(27)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;
(C)elderly;
(D)individuals with
preexisting medical conditions;
(E)workers that work
with chemical substance and mixtures; and
(F)members of any
other appropriate population identified by the
Administrator.
.
5.Minimum data set
and testing of chemical substances and mixturesSection 4 of the Toxic Substances Control
Act (15 U.S.C. 2603) is amended to read as follows:
4.Minimum data set
and testing of chemical substances and mixtures
(a)
(1)Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2010, the Administrator shall establish, by rule, the
data that constitute the minimum data set for chemical substances and mixtures.
The rule shall require submission of a minimum data set including information
on substance characteristics and on hazard, exposure, and use of chemical
substances and mixtures that the Administrator anticipates will be useful in
conducting safety standard determinations pursuant to section 6(b) or carrying
out any provision of this chapter. The rule shall also establish requirements
for manufacturers and processors to update their minimum data set submissions,
as appropriate. The rule may provide for varied or tiered testing for different
chemical substances, mixtures or categories of chemical substances and
mixtures. Studies conducted to satisfy such data requirements shall be
conducted in accordance with section 31.
(2)Submission of
minimum data setThe manufacturers and processors of a chemical
substance shall submit the minimum data set for the chemical substance to the
Administrator by—
(A)18 months after
the date on which the Administrator places the chemical substance on the
priority list; or
(B)for a new
chemical substance, the date on which the notice required in section 5(b)(1) is
filed.
(3)The
Administrator may, by order, prohibit a manufacturer or processor in violation
of paragraph (2) from manufacturing, processing, or distributing in commerce
the chemical substance or any mixture or article containing the chemical
substance, except as authorized under section 6(e).
(b)
(1)The Administrator may, by rule or order, require testing
with respect to any chemical substance or mixture, and the submission of test
results by a specified date, as necessary for making any determination or
carrying out any provision of this chapter. Nothing in this paragraph shall be
construed as limiting the Administrator’s authority under paragraph (2).
(2)The Administrator may, by rule or order require the
submission of a sample of any chemical substance or mixture in such manner as
enables the Administrator to conduct such tests as are necessary for making any
determination or carrying out any provision of this chapter. Nothing in this
paragraph shall be construed as limiting the Administrator’s authority under
paragraph (1).
(3)The
Administrator may, by order, prohibit a manufacturer or processor in violation
of a rule or order under paragraph (1) from manufacturing, processing, or
distributing in commerce the chemical substance or any mixture or article
containing the chemical substance, except as authorized under section
6(e).
(4)If
a manufacturer or processor has submitted a declaration of cessation of
manufacture or processing under section 8(a)(3) for a chemical substance, the
manufacturer or processor shall be exempted from the requirements of this
subsection.
(c)
(1)A rule or order
under subsection (b) shall include—
(A)identification of
the chemical substance or mixture for which testing is required under the rule
or order;
(B)standards for the
development of test data for such substance or mixture; 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 the standards referred to in subparagraph
(B).
In
determining the standards and period to be included, pursuant to subparagraphs
(B) and (C), in a rule or order under subsection (b), the Administrator’s
considerations shall include 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. Any such rule or order may require
the submission to the Administrator of preliminary data during the period
prescribed under subparagraph (C).(2)Types of health
and environmental information
(A)The types of health and environmental information for
which standards for the development of test data may be prescribed
include—
(i)information
pertaining to carcinogenesis, mutagenesis, teratogenesis, behavioral disorders,
cumulative or synergistic effects, and any other effect which may be considered
in a safety determination;
(ii)information
pertaining to exposure to the chemical substance or mixture, including
information regarding the presence of the chemical or mixture in human blood,
fluids, or tissue; and
(iii)information
pertaining to—
(I)bioaccumulation;
(II)persistence;
(III)acute
toxicity;
(IV)subacute
toxicity;
(V)chronic toxicity;
and
(VI)any other
characteristic which may present an adverse effect.
(B)
(i)The Administrator may prescribe methodologies in
standards for the development of test data including—
(I)epidemiologic
studies;
(II)biomonitoring
studies;
(III)serial or
hierarchical tests;
(IV)in vitro tests;
and
(V)whole animal
tests, consistent with section 31.
(ii)Prior
to prescribing epidemiologic studies of employees, the Administrator shall
consult with the Director of the National Institute for Occupational Safety and
Health.
(C)Periodically,
but not less frequently than once every 3 years, the Administrator
shall—
(i)review the
adequacy of the standards for development of data prescribed in rules under
subsection (a); and
(ii)if necessary,
institute proceedings to make appropriate revisions of the standards.
(3)Persons
required to conduct tests and submit data
(A)Except as provided in subparagraph (B), a rule or order
under subsection (b) respecting a chemical substance or mixture shall specify
the persons required to conduct tests and submit data to the Administrator on
the substance or mixture.
(B)The
Administrator may permit 2 or more of the persons described in subparagraph (A)
to designate 1 of the persons or a qualified third party to conduct the tests
and submit the data on behalf of the persons making the designation.
(C)All
persons described in subparagraphs (A) and (B) shall remain liable for
compliance with any requirements subject to the designation.
(4)Expiration of
rules and orders
(A)Any rule or order under subsection (b) that requires the
testing and submission of data with respect to a particular chemical substance
or mixture shall expire at the end of the reimbursement period (as defined in
subsection (d)(3)) that is applicable to test data with respect to the
substance or mixture unless, prior to that date, the Administrator withdraws
the rule or order.
(B)Category of
chemical substances or mixturesA rule or order under subsection
(b) that requires the testing and submission of data with respect to a category
of chemical substances or mixtures shall expire with respect to a chemical
substance or mixture included in the category at the end of the reimbursement
period (as defined in subsection (d)(3)) that is applicable to test data with
respect to the substance or mixture unless, prior to that date, the
Administrator withdraws the rule or order with respect the substance or mixture
or in its entirety.
(d)
(1)Any person required by a rule or order under subsections
(a) or (b) to conduct tests and submit data with respect to a chemical
substance or mixture may apply to the Administrator (in such form and manner as
the Administrator shall prescribe) for an exemption from the
requirement.
(2)In accordance with paragraph (3) or (4), the
Administrator shall exempt an applicant under paragraph (1) from conducting
tests and submitting data with respect to the substance or mixture under the
rule or order with respect to which the application was submitted, if, on
receipt of the application, the Administrator determines that—
(A)the chemical
substance or mixture with respect to which the application was submitted is
equivalent to a chemical substance or mixture for which—
(i)data has been
submitted to the Administrator in accordance with a rule or order under
subsection (a) or (b); or
(ii)data is being
developed in accordance with the rule or order; and
(B)submission of
data by the applicant with respect to the substance or mixture would be
duplicative of data that—
(i)has been
submitted to the Administrator in accordance with the rule or order under
subsection (a) or (b); or
(ii)is being
developed in accordance with the rule or order.
(3)Reimbursement
due to exemption for previously submitted test data
(A)Definition of
reimbursement periodIn this paragraph, the term
reimbursement period, with respect to any test data for a chemical
substance or mixture, means a period—
(i)beginning on the
date on which the test data is submitted in accordance with a rule or order
issued under subsection (a) or (b); and
(ii)ending on the
later of—
(I)5 years after the
date referred to in clause (i); or
(II)at the
expiration of a period that—
- (aa)begins on the
date referred to in clause (i); and
- (bb)is
equal to the period that the Administrator determines was necessary to develop
the test data.
(B)
(i)Except as provided in clause (ii), if the exemption under
paragraph (2) of any person from the requirement to conduct tests and submit
test data with respect to a chemical substance or mixture is granted on the
basis of the existence of previously submitted test data and the exemption is
granted during the reimbursement period for the test data, the Administrator
shall order the person granted the exemption to provide fair and equitable
reimbursement (in an amount determined under rules of the Administrator)
to—
(I)the person who
previously submitted the test data, for a portion of the costs incurred by the
person in complying with the requirement to submit the data; and
(II)any other person
who has been required under this subsection to contribute with respect to the
costs, for a portion of the amount the person was required to
contribute.
(ii)Clause
(i) shall not apply if there is agreement on the amount and method of
reimbursement between an exempted person described in clause (i) and the
persons described in subclauses (I) and (II) of that clause.
(iii)In
promulgating rules for the determination of fair and equitable reimbursement to
the persons described in subclauses (I) and (II) of clause (i) for costs
incurred with respect to a chemical substance or mixture, the Administrator
shall, after consultation with the Attorney General and the Federal Trade
Commission, consider all relevant factors, including—
(I)the effect on the
competitive position of the person required to provide reimbursement in
relation to the person to be reimbursed; and
(II)the share of the
market for the substance or mixture of the person required to provide
reimbursement in relation to the share of the market of the persons to be
reimbursed.
(4)Reimbursement
due to exemption for test data being developed in accordance with a rule or
order
(A)Except as provided in subparagraph (B), if the exemption
under paragraph (2) of any person from the requirement to conduct tests and
submit test data with respect to a chemical substance or mixture is granted on
the basis of the fact that test data is being developed by 1 or more persons in
accordance with a rule or order issued under subsection (a) or (b), the
Administrator shall order the person granted the exemption to provide fair and
equitable reimbursement (in an amount determined under rules of the
Administrator)—
(i)to each such
person who is developing the test data, for a portion of the costs incurred by
each person in complying with the rule or order; and
(ii)to any other
person who has been required under this subsection to contribute with respect
to the costs of complying with the rule or order, for a portion of the amount
the person was required to contribute.
(B)Subparagraph
(A) shall not apply if there is agreement on the amount and method of
reimbursement between an exempted person described in subparagraph (A) and the
persons described in clauses (i) and (ii) of that subparagraph.
(C)In
promulgating rules for the determination of fair and equitable reimbursement to
the persons described in clauses (i) and (ii) of subparagraph (A) for costs
incurred with respect to a chemical substance or mixture, the Administrator
shall, after consultation with the Attorney General and the Commissioners of
the Federal Trade Commission, consider the factors described in paragraph
(3)(B)(iii).
(D)If any exemption is granted under paragraph (2) on the
basis that 1 or more persons are developing test data pursuant to a rule or
order promulgated or issued under subsection (a) or (b), and after the
exemption is granted, the Administrator determines that no such person has
complied with the rule or order, the Administrator shall—
(i)after providing
written notice to the person who holds the exemption and an opportunity for a
hearing, by order terminate the exemption; and
(ii)notify in
writing the person of the requirements of the rule or order with respect to
which the exemption was granted.
(e)
(1)Not later than 15 days after the date of receipt of any
test data pursuant to a rule or order under subsection (a) or (b), the
Administrator shall publish in the Federal Register a notice of the receipt of
the test data.
(2)Subject
to section 14, each notice shall—
(A)identify the
chemical substance or mixture with respect to which data have been
received;
(B)list the
commercial and consumer uses or intended commercial and consumer uses of the
substance or mixture known to the Administrator and the information required by
the applicable standards for the development of test data; and
(C)describe the
nature of the test data developed.
(3)Subject
to section 14, test data described in this subsection shall be made available
on the internet by the Administrator.
(f)Requests from
other agencies for additional information or testing
(1)If another Federal agency determines that information
relating to a chemical substance or mixture, including data derived from new
testing or monitoring, would assist the agency in carrying out duties or
exercising authority of the agency, but that information is not available to
the agency, the agency may request the Administrator to seek the information on
behalf of the requesting agency.
(2)Not later than 60 days after the date of receipt of
a request under paragraph (1), the Administrator shall—
(A)subject to
section 14, make the data available to the requesting agency;
(B)issue a rule or
order under section 8(f) to require—
(i)the submission of
existing pertinent data to the Administrator; and
(ii)that a copy of
any such submission also be furnished to the requesting agency;
(C)issue a rule or
order under subsection (b)—
(i)to develop the
data; and
(ii)to require the
developed data be furnished to the requesting agency; or
(D)publish in the
Federal Register the reason for not taking any of the actions described in this
paragraph.
(g)Each
submission required under this section or under a rule or an order promulgated
or issued by the Administrator under this section shall be accompanied by a
certification signed by a responsible official of the manufacturer or processor
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.
.
6.Manufacturing
and processing noticesSection
5 of the Toxic Substances Control Act (15 U.S.C. 2604) is amended to read as
follows:
5.Manufacturing
and processing notices
(a)New chemical
substances and mixtures and new uses of chemical substances and
mixtures
(1)New chemical
substances and mixturesExcept as provided in subsection (d), no
person may manufacture or process a new chemical substance unless—
(A)(i)the person submits to
the Administrator a notice, in accordance with subsection (c), of the intention
of the person to manufacture or process the substance; and
(ii)the person complies with
subsection (b); and
(B)the
Administrator—
(i)finds that the
manufacturers and processors have established that the chemical substance meets
the safety standard under section 6(b); or
(ii)finds that the
new chemical substance, or a metabolite or degradation product of the chemical
substance, as applicable, is not, and is not expected to be—
(I)manufactured in a
volume of more than 1,000,000 pounds annually or released into the environment
in a volume of more than 100,000 pounds annually;
(II)a known,
probable, or suspected reproductive, developmental, neurological, or
immunological toxicant, carcinogen, mutagen, or endocrine disruptor, or has
other toxicological properties of concern;
(III)persistent and
bioaccumulative;
(IV)found in human
cord blood, or otherwise found in human blood, fluids, or tissue, unless the
chemical substance or metabolite or degradation product is naturally present at
the level commonly found in that medium; or
(V)found in food,
drinking water, ambient or indoor air, residential soil, or house dust, unless
the chemical substance or metabolite or degradation product is naturally
present at the level commonly found in that medium.
(2)New uses of
existing chemical substances prior to safety determination
(A)Except as provided in subparagraph (B), with respect to
an existing chemical substance which the Administrator has not made a safety
determination under section 6, no person may manufacture or process the
chemical substance—
(i)for a use that
was not ongoing on the date of enactment of the Safe Chemicals Act of
2010;
(ii)at a
significantly increased volume above the level on the date of enactment;
or
(iii)if the person
had not previously manufactured or processed the chemical substance on the date
of enactment of the Safe Chemicals Act of 2010.
(B)The person—
(i)submits to the
Administrator a new or updated declaration referred to in section 8(a);
and
(ii)complies with
subsection (b).
(3)New uses of
existing chemical substances that meet the safety standard
(A)With respect to an existing chemical substance for which
the Administrator has determined under section 6(b) that the manufacturers and
processors of the chemical substance have established that the substance meets
the safety standard, no person may manufacture or process the chemical
substance for a use, at a production volume, or in a manner other than those
the Administrator specified in the safety determination, unless—
(i)the manufacturer
or processor submits to the Administrator—
(I)a notice of the
intention of the manufacturer or processor to manufacture or process the
substance for the new use or at the new production volume, or in such other
manner that is inconsistent with a specified condition or term for such
substance; and
(II)all updates to
the minimum data set relevant to the new use, new production volume, or other
new manner of manufacturing or processing;
(ii)the notice under
clause (i)(I) indicates that the chemical substance will continue to meet the
safety standard if the allowed uses, allowed production volume, or other
specified conditions or terms for such chemical substance are revised to
encompass the new use or new production volume, or other new manner of
manufacturing or processing; and
(iii)the
Administrator determines that the manufacturer or processor submitting the
notice has established that the chemical substance will continue to meet the
safety standard if the allowed uses or allowed production volume, or other
specified conditions or terms for such substance, are revised to encompass the
new use or new production volume or other new manner of manufacturing or
processing.
(B)Amendment to
safety determinationIf the conditions described in clause (i)
through (iii) of subparagraph (A) are satisfied, the Administrator shall, by
order, amend the safety determination for the chemical substance to include the
new use or new production volume among the allowed uses or production volumes
of the chemical substance.
(4)Safety standard
determination
(A)Except as provided in subparagraphs (B) and (C), not
later than 180 days after the date of receipt of a notice and supporting data
that satisfies paragraph (1)(A) or paragraph (3)(A), the Administrator shall
determine whether the person submitting the notice has established that the
chemical substance will meet, or continue to meet, the safety standard under
section 6(b).
(B)In
the case of a notice under paragraph (1)(A), the Administrator shall not be
subject to the deadline described in subparagraph (A) if the Administrator
first makes the finding specified under paragraph (1)(B)(ii).
(C)The
Administrator may extend the determination deadline under subparagraph (A) by 1
or more additional periods not to exceed 12 months in aggregate, by action in
accordance with section 5(b) or section 6(b)(2)(A)(i)(I)(bb), or other means,
as necessary to secure additional relevant data for the determination.
(D)Failure to make
a timely determinationThe failure of the Administrator to make a
timely determination in accordance with this paragraph shall not be sufficient
to satisfy paragraph (1)(B)(ii) or paragraph (3)(A)(iii).
(5)Not later than 30 days after the date on which a
manufacturer or processor commences manufacturing or processing of a new
chemical substance, the manufacturer or processor shall submit to the
Administrator a notice of commencement of manufacture or processing.
(6)Chemical
substances exhibiting special substance characteristics
(A)The
Administrator shall determine by order or rule that a variant of a chemical
substance exhibiting one or more special substance characteristics—
(i)is a use that is
separate from any use of the chemical substance that does not exhibit such
special substance characteristics; or
(ii)is a new
chemical substance.
(B)Requirements
for variants that are separate usesIn the case of a chemical
substance which the Administrator determines to be a separate use based on its
special substance characteristics, the manufacturer or processor shall satisfy
such further conditions as the Administrator establishes, by order or
rule.
(b)
(1)If a person is required by subsection (a) to submit to
the Administrator a notice before beginning the manufacture or processing of a
chemical substance, and is required by a rule or order under section 4(b) to
submit test data for the chemical substance before the submission of the
notice, the person shall submit to the Administrator the data in accordance
with the rule or order at the time the notice is submitted under subsection
(b).
(2)Subject
to section 14, test data submitted under paragraph (1) shall be made available
on the internet by the Administrator.
(c)Content and
availability of notice
(1)The notice required by subsection (b)(1) shall
include—
(A)the declaration
described in section 8(a)(2);
(B)the minimum data
set, as defined in accordance with section 4(a); and
(C)a statement that
the chemical substance will meet the safety standard.
(2)Subject
to section 14, a notice described in paragraph (1) shall be made available on
the internet by the Administrator.
(3)Subject to section 14, not later than 5 days
(excluding Saturdays, Sundays, and legal holidays) after the date of the
receipt of a notice under subsection (a) or of data under subsection (b), the
Administrator shall make available on the internet information that—
(A)identifies the
chemical substance for which notice or data has been received;
(B)lists the uses or
intended uses of the chemical substance;
(C)in the case of
the receipt of data under subsection (b), describes—
(i)the nature of the
tests performed with respect to the chemical substance; and
(ii)any data that
were received under subsection (b) or a rule or order under section 4;
and
(D)references the
availability of the minimum data set.
(4)At the beginning of each month, the Administrator shall
make available on the internet a list of each chemical substance for which
notice has been received under subsection (a).
(d)
(1)The Administrator may, upon application, exempt any
person from any requirement of subsection (a) or (b) to permit the person to
manufacture or process a chemical substance for test marketing purposes—
(A)upon a showing by
the person satisfactory to the Administrator that the manufacture, processing,
distribution in commerce, use, and disposal of the chemical substance, and that
any combination of those activities, will not endanger the health or the
environment; and
(B)under such
restrictions as the Administrator considers appropriate.
(2)Equivalent
chemical substances
(A)The Administrator shall, upon application, fully or
partially exempt any person from the requirement to submit any data otherwise
required with respect to a chemical substance for which notice is submitted
under subsection (a) if, on receipt of an application, the Administrator
determines that—
(i)the chemical
substance with respect to which the application was submitted is equivalent to
a chemical substance for which data has been submitted to the Administrator as
required by this chapter; and
(ii)submission of
data by the applicant on the chemical substance would be duplicative of data
which has been submitted to the Administrator in accordance with this
chapter.
(iii)No exemption granted under this subparagraph with respect to
the submission of data for a chemical substance may take effect before the
beginning of the reimbursement period applicable to the data.
(B)Fair and
equitable reimbursement
(i)Definition of
reimbursement periodIn this subparagraph, the term
reimbursement period, with respect to any previously submitted
data for a chemical substance, means a period—
(I)beginning on the
date of the termination of the prohibition, imposed under this section, on the
manufacture or processing of the chemical substance by the person who submitted
the data to the Administrator; and
(II)ending on the
later of—
- (aa)the date that is
5 years after the date referred to in subclause (I); or
- (bb)at
the expiration of a period beginning on the date referred to in subclause (I)
that is equal in length to the period that the Administrator determines to be
necessary to develop the data.
(ii)Except
as provided in clause (iii), if the Administrator exempts any person, under
subparagraph (A), from submitting data required under subsection (a) or (b) for
a chemical substance because of the existence of previously submitted data and
the exemption is granted during the reimbursement period for that data, the
Administrator shall order the person granted the exemption to provide fair and
equitable reimbursement (in an amount determined under rules of the
Administrator)—
(I)to the person who
previously submitted the data on which the exemption was based, for a portion
of the costs incurred by the person in complying with the requirement under
this subchapter to submit the data; and
(II)to any other
person who has been required under this subparagraph to contribute with respect
to the costs, for a portion of the amount the person was required to
contribute.
(iii)Clause
(ii) shall not apply if the person exempted under that clause and the persons
described in subclauses (I) and (II) of that clause agree on the amount and
method of reimbursement.
(iv)In
promulgating rules for the determination of fair and equitable reimbursement to
the persons described in subclauses (I) and (II) of clause (ii) for costs
incurred with respect to a chemical substance, the Administrator shall, after
consultation with the Attorney General and the Commissioners of the Federal
Trade Commission, consider all relevant factors, including—
(I)the effect on the
competitive position of the person required to provide reimbursement in
relation to the persons to be reimbursed; and
(II)the share of the
market for the chemical substance of the person required to provide
reimbursement in relation to the share of the market of the persons to be
reimbursed.
(3)
(A)If the conditions described in subparagraph (B) are met,
subsections (a) and (b) shall not apply with respect to the manufacturing or
processing of any chemical substance that is manufactured or processed, or
proposed to be manufactured or processed, only in small quantities (as defined
by the Administrator by rule) solely for purposes of—
(i)scientific
experimentation or analysis; or
(ii)chemical
research on, or analysis of such substance or another substance, including such
research or analysis for the development of a product.
(B)The
conditions referred to in subparagraph (A) are that all persons engaged in the
experimentation, research, or analysis for a manufacturer or processor are
notified (in such form and manner as the Administrator may prescribe) of any
risk to health which the manufacturer, processor, or the Administrator has
reason to believe may be associated with such chemical substance.
(4)The Administrator may, upon application, exempt from
subsections (a) and (b) the manufacturing or processing of any chemical
substance—
(A)that exists
temporarily as a result of a chemical reaction in the manufacturing or
processing of a mixture or another chemical substance; and
(B)to which there is
no, and will not be, human or environmental exposure.
(5)
(A)As soon as practicable after receipt of an application
under paragraph (1) or (4), the Administrator shall publish in the Federal
Register notice of the receipt of the application.
(B)The
Administrator shall—
(i)give interested
persons an opportunity to comment upon any application described in
subparagraph (A);
(ii)not later than
45 days after the date of receipt of an application, approve or deny the
application; and
(iii)publish in the
Federal Register notice of the approval or denial of the application.
(e)Each
submission required under this section or under a rule or an order promulgated
or issued by the Administrator under this section shall be accompanied by a
certification signed by a responsible official of the manufacturer or processor
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.
(f)In
this section:
(1)The terms manufacture and
process mean manufacture or process, respectively, for commercial
purposes.
(2)The term test marketing does not include
any provision of a chemical substance or mixture, or an article containing a
chemical substance or mixture, to an end consumer of the chemical substance,
mixture, or
article.
.
7.Prioritization,
safety standard determination, and risk managementSection
6 of the Toxic Substances Control Act (15 U.S.C. 2605) is amended to read as
follows:
6.Prioritization,
safety standard determination, and risk management
(a)Prioritization
of chemical substances
(1)Establishment
of priority listNot later than 18 months after the date of
enactment of the Safe Chemicals Act of 2010, the Administrator shall by order
develop and publish a priority list containing the names of not less than 300
chemical substances for which safety determinations under this section shall
first be made. Chemical substances shall be selected to be on the list at the
Administrator’s discretion, based on available scientific evidence, and
consideration of their risk relative to other chemical substances, based upon
presence in biological and environmental media, use, production volume,
toxicity, persistence, bioaccumulation, or other properties indicating
risk.
(2)The Administrator shall—
(A)remove a chemical
substance or mixture from the list under paragraph (1) only after a safety
standard determination has been made for such chemical substance or mixture
pursuant to subsection (b);
(B)add chemical
substances or mixtures 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 and mixtures distributed in commerce have had a
safety standard determination. Additions to the list shall be consistent with
paragraph (1) and based on consideration generally of risk relative to listed
chemical substances and mixtures to the extent practicable. Such additions to
the list may be made in response to petitions under section 21; and
(C)give due
consideration to any recommendation provided by the committee established under
paragraph (3).
(3)Interagency
prioritization and testing committee
(A)There
is established an interagency committee (referred to in this section as the
committee
) to make recommendations to the Administrator
concerning—
(i)the issuance of
test rules or orders for chemical substances and mixtures under section 4(b);
and
(ii)the placement of
chemical substances on the priority list under this subsection.
(B)
(i)In
making a recommendation concerning—
(I)the issuance of
test rules or orders under section 4(b), the committee shall consider all
factors relevant to risk; and
(II)placement on the
priority list under subsection (a), the committee shall consider the criteria
identified pursuant to subsection (a)(1).
(ii)The
recommendations of the committee shall be in the form of 1 or more lists of
chemical substances and mixtures that shall specify, either by individual
substance or mixture or by groups of substances or mixtures—
(I)the
recommendations of the committee that particular chemical substances, mixtures,
or categories of chemical substances or mixtures be the subject of a test rule
or order under section 4(b); or
(II)the
recommendations of the committee that particular chemical substances, or groups
of chemical substances, be placed on the priority list.
(iii)
(I)At least once every year, the committee shall—
- (aa)make such
additions or revisions to the recommendations of the commission as the
commission determines to be necessary; and
- (bb)submit to the
Administrator the recommendations and a statement of the reasons of the
committee for any additions or revisions.
(II)On
receipt of any new or revised recommendations, the Administrator shall publish
in the Federal Register the recommendations and the statement of the reasons
for the additions or revisions.
(III)The
Administrator shall—
- (aa)provide
reasonable opportunity to any interested person to file with the Administrator
written comments on the recommendations of the committee, and any additions or
revisions to the recommendations by the committee;
- (bb)consideration
such comments; and
- (cc)make the
comments available to the public.
(C)The
committee shall consist of the following 8 members:
(i)One member
appointed by the Administrator from officers or employees of the Environmental
Protection Agency.
(ii)One member
appointed by the Secretary of Labor from officers or employees of the
Department of Labor engaged in the activities of the Secretary of Labor under
the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.).
(iii)One member
appointed by the Chairman of the Council on Environmental Quality from the
Council or the officers or employees of the Council.
(iv)One member
appointed by the Director of the National Institute for Occupational Safety and
Health from officers or employees of the Institute.
(v)One member
appointed by the Director of the National Institute of Environmental Health
Sciences from officers or employees of the Institute.
(vi)One member
appointed by the Director of the National Cancer Institute from officers or
employees of the Institute.
(vii)One member
appointed by the Director of the National Science Foundation from officers or
employees of the Foundation.
(viii)One member
appointed by the Secretary of Commerce from officers or employees of the
Department of Commerce.
(D)
(i)
(I)An appointed member may designate an individual to serve
on the committee on behalf of the member.
(II)A
designation may be made only—
- (aa)with the
approval of the applicable appointing authority; and
- (bb)if
the individual is from the entity from which the member was appointed.
(ii)
(I)No individual may serve as a member of the committee for
more than 4 years in the aggregate.
(II)Members
leaving appointing entitiesIf any member of the committee leaves
the entity from which the member was appointed—
- (aa)the member may
not continue as a member of the committee; and
- (bb)the position of
the member shall be considered to be vacant.
(III)A
vacancy on the committee shall be filled in the same manner in which the
original appointment was made.
(E)
(i)Post-termination
employment or compensationNo member of the committee, or
designee of the member, shall accept employment or compensation from any person
subject to any requirement of this chapter or of any rule promulgated or order
issued under this chapter, for a period of at least 1 year after the date of
termination of service on the committee.
(ii)No person, while serving as a member of the committee
or designee of the member, may own any stocks or bonds, or have any pecuniary
interest, of substantial value in any person engaged in the manufacture,
processing, or distribution in commerce of any chemical substance or mixture
subject to this chapter or of any rule promulgated or order issued under this
chapter.
(iii)The
Administrator, acting through attorneys of the Environmental Protection Agency,
or the Attorney General may bring an action in the appropriate district court
of the United States to restrain any violation of this subparagraph.
(F)The Administrator shall provide the committee such
administrative support services as may be necessary to enable the committee to
carry out the functions of the committee under this subsection.
(4)No judicial
review; nondiscretionary duty
(A)The following actions shall not be subject to judicial
review, including when a prioritization decision or recommendation coincides
with or is based on other decisions under this chapter that are subject to
judicial review:
(i)A
decision whether to place a particular chemical substance on the priority list
pursuant to this subsection;
(ii)A response to a
petition to place a particular chemical on the priority list; and
(iii)The issuance of
a recommendation pursuant to paragraph (3).
(B)The failure of the Administrator to establish the priority
list required in subparagraph (1), or to update the list as required by
paragraph (2), shall be—
(i)considered to be
a failure to perform a nondiscretionary duty; and
(ii)subject to
judicial review.
(b)Safety
determinations for chemical substances
(1)
(A)This
paragraph applies to the determination, or redetermination, of whether a
chemical substance meets the safety standards of this subchapter.
(B)Under this subchapter, it shall be the duty of—
(i)the manufacturers
and processors of a chemical substance to, at all times, bear the burden of
proving that the chemical substance meets the applicable safety standard;
and
(ii)the
Administrator to determine whether the manufacturers and processors of a
chemical substance have met the burden of proof under clause (i).
(C)
(i)Any determination that a manufacturer or processor of a
chemical substance has met the burden of proof pursuant to subparagraph (B)(i)
shall be supported by an assessment of risk conducted by an employee or
contractor of the Environmental Protection Agency.
(ii)No participant or peer reviewer in an assessment
described in clause (i) shall have a direct or indirect financial interest in
the outcome of the assessment.
(iii)The
Administrator shall use the best available science when conducting an
assessment described in clause (i). For the purpose of determining the current
best available science the Administrator shall consider the most recent
recommendations of the National Academy of Sciences on ways to better protect
people, including pregnant women, infants, children and other vulnerable
populations from harm by exposure to toxic substances when assessing such
potential risks.
(iv)An
assessment described in clause (i) shall address health or environmental
impacts including potential or demonstrated cancer and noncancer
endpoints.
(v)In
carrying out this subsection, the Administrator shall ensure that the
approaches and resulting assessments are communicated in a manner that is
transparent and understandable to the public and to risk managers.
(vi)Manufacture or
processing for exportIn the case of a chemical substance that is
manufactured or processed in whole or in part for export, in determining
whether the manufacturer or processor has met the burden of proof pursuant to
subparagraph (B)(i), the Administrator shall take into account such risks as
the chemical substance may pose in the United States, including risks involving
long-range transport of the chemical substance in the environment and risks
involving the import of articles and mixtures containing the chemical
substance.
(vii)Risk
assessment not requiredThe Administrator shall not be required
to conduct a risk assessment to determine that a manufacturer or processor has
not met the burden of proof under subparagraph (B)(i).
(D)A determination by the Administrator that a manufacturer
or processor has not established that the chemical substance meets the safety
standard under this subsection shall not be subject to judicial review.
(2)
(A)Manufacturer
and processor duties
(i)Initial safety
determination submission
(I)By the earlier of the date that is 30 months after the
date on which a chemical substance is placed on the priority list or the date
that is 14 years after the date of enactment of the Safe Chemicals Act of 2010,
the manufacturers and processors of a chemical substance shall—
- (aa)submit to the
Administrator the minimum dataset for the chemical substance, as established
under section 4(a), or update the dataset if the dataset was submitted during
the preceding 30-month period in response to the placement of the chemical
substance on the priority list;
- (bb)submit to the
Administrator, and develop by testing as necessary, all other information the
Administrator may require, including information developed through testing or
otherwise, in order to make a safety determination; and
- (cc)indicate whether
the chemical substance, including specified uses to be evaluated and any
proposed conditions on the specified uses meets the safety standard.
(II)Submitting
manufacturers and processorsThe Administrator may permit the
manufacturers and processors of a chemical substance to designate 1 or more
manufacturers or processors to submit the information required under subclause
(I) on behalf of the manufacturers and processors making the
designation.
(III)All
manufacturers and processors described in subclause (II) shall remain liable
for compliance with any requirements subject to the designation.
(ii)Renewal of
safety determination submission
(I)Not later than 15 years after the date of the previous
submission under clause (i), this clause, or section 5(c)(1), the manufacturers
and processors of each chemical substance shall—
- (aa)submit to the
Administrator the minimum dataset for the chemical substance, as established
under section 4(a); and
- (bb)indicate whether
the chemical substance, including specified uses to be evaluated and any
proposed conditions on the specified use meets the safety standard.
(II)Submitting
manufacturers and processorsThe Administrator may permit the
manufacturers and processors of a chemical substance to designate 1 or more
manufacturers or processors to submit the information required under subclause
(I) on behalf of the manufacturers and processors making the
designation.
(III)All
manufacturers and processors described in subclause (II) shall remain liable
for compliance with any requirements subject to the designation.
(iii)Notice of
pending determinationIf the Administrator fails to act by an
applicable deadline under subparagraph (B)(i), each manufacturer and processor
of a chemical substance for which the Administrator has failed to act shall
provide to the Administrator, the public, their employees and recognized
bargaining agents of any employees who are represented by bargaining agents,
and each known customer who has purchased the chemical substance within a
reasonable timeframe as determined by the Administrator by rule or order, or
mixture or article containing the chemical substance, a written notice that a
determination by the Administrator of the safety of the chemical substance is
pending.
(iv)Failure of
manufacturer or processor to meet dutiesIf a manufacturer or
processor fails to meet duties under this subparagraph for a chemical
substance, the Administrator may, by order, prohibit a manufacturer or
processor, in violation of a duty under this subparagraph, from manufacturing,
processing, or distributing in commerce the chemical substance, or any mixture
or article containing the chemical substance, except as authorized under
subsection (e).
(B)
(i)Not later than 180 days after the earlier of the
date of receipt of a complete submission or the applicable submission deadline
under clause (i) or (ii) of subparagraph (A), or after initiating a
redetermination under clause (iii) of this subparagraph, with respect to a
chemical substance, the Administrator shall by order determine, or redetermine,
as the case may be, whether the manufacturers and processors of the substance
have established that the substance meets the safety standard.
(ii)If the Administrator determines that the substance
meets the safety standard, the Administrator shall in the order specify—
(I)the allowed uses
of the substance, which shall be limited to the uses evaluated in the
determination; and
(II)any conditions
on the specified uses to ensure the safety standard is met, including
conditions that relate to the manufacture, processing, use, distribution in
commerce, or disposal of a chemical substance, or mixture or article containing
such chemical substance, and any conditions described in subsection (c).
(iii)The
Administrator shall initiate a redetermination of whether the manufacturers and
processors of a chemical substance distributed in commerce have established
that the chemical substance meets the safety standard—
(I)if new
information raises a credible question as to whether the chemical substance
continues to meet the safety standard;
(II)on the receipt
of a renewal submission under subparagraph (A)(ii); or
(III)after the
15-year period beginning on the date of the previous applicable determination
of the Administrator under this subparagraph, if a redetermination has not
already been initiated subsequent to the determination.
(iv)Petition for
redetermination
(I)Any person may petition the Administrator for a
redetermination of whether a chemical substance continues to meet the
applicable safety standard.
(II)The
person shall include in the petition a description of the basis for requesting
the redetermination.
(III)On receipt of the petition, the Administrator
shall—
- (aa)not later than
30 days after the date of receipt, publish in the Federal Register a notice of
receipt of the petition that specifies the chemical identity of the chemical
substance to which the petition pertains;
- (bb)make the
petition available on request;
- (cc)provide a
reasonable opportunity for public review and comment on the petition and give
due consideration to any comments received;
- (dd)decide whether
to make the requested redetermination; and
- (ee)not later than
180 days after the date of receipt, publish in the Federal Register the
decision and the basis for the decision.
(3)
(A)Except as provided under subsection (e), the risk
reduction measures described in this paragraph shall apply to a chemical
substance in accordance with this paragraph.
(B)Negative safety
determinationNo person shall manufacture, process, or distribute
in commerce a chemical substance, or any mixture or article containing a
chemical substance, for—
(i)any new chemical
substance for which notice is required under section 5(a), effective
immediately after the Administrator makes a safety determination for a chemical
substance under paragraph (2)(B)(i) and does not determine that the
manufacturer or processor has established that the chemical substance meets the
applicable safety standard; or
(ii)any other
chemical substance, effective 1 year after the Administrator makes a safety
determination for a chemical substance under paragraph (2)(B)(i) and does not
determine that the chemical substance meets the applicable safety
standard.
(C)Positive safety
determinationEffective beginning 1 year after the date the
Administrator determines under paragraph (2)(B)(i) that a chemical substance
meets the safety standard or immediately after such a determination is made for
a new chemical substance for which notice is required under section 5(a), no
person shall manufacture, process, or distribute in commerce the chemical
substance, or any mixture or article containing the chemical substance, for any
use other than those specified in the determination established under paragraph
(2)(B)(ii).
(c)Conditions in
safety determinationsThe Administrator in a safety determination
may impose conditions on the manufacture, processing, use, distribution in
commerce, or disposal of a chemical substance, or mixture or article containing
a chemical substance, in accordance with subsection (b)(2)(B)(ii)(II),
including—
(1)a requirement
limiting the quantity of the substance, mixture, or article that may be
manufactured, processed, or distributed in commerce:
(2)a
requirement—
(A)prohibiting the
manufacture, processing, or distribution in commerce of the substance, mixture,
or article for a particular use in a concentration in excess of a level
specified by the Administrator in conditions under subsection
(b)(2)(B)(ii)(II); or
(B)limiting the
quantity of the substance, mixture, or article that 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
conditions established under section 6(b)(2)(B)(ii)(II);
(3)a requirement
that the substance, mixture, or article be marked with or accompanied by clear
and adequate warnings and instructions with respect to use, distribution in
commerce, or disposal, or any combination of such activities, with the form and
content of the warnings and instructions prescribed by the
Administrator;
(4)a requirement
that manufacturers and processors of the substance, mixture, or article—
(A)make and retain
records of the processes used to manufacture or process the substance, mixture,
or article; and
(B)monitor or
conduct tests that are reasonable and necessary to ensure compliance with this
chapter;
(5)a requirement
prohibiting or otherwise regulating any manner or method of commercial use of
the substance, mixture, or article;
(6)a requirement
prohibiting or otherwise regulating any manner or method of disposal of the
substance, mixture, or article, by—
(A)the manufacturer
or processor of the substance, mixture, or article; or
(B)any other person
that uses, or disposes of, the substance, mixture, or article for commercial
purposes; and
(7)a requirement
that the manufacturers and processors of the substance, mixture, or article
develop a risk reduction management plan to achieve a risk reduction specified
by the Administrator.
(d)
(1)If the Administrator has a reasonable basis to conclude
that a particular manufacturer or processor is manufacturing or processing a
chemical substance or mixture in a manner that may present a substantial
endangerment to health or the environment, the Administrator may by order
require the manufacturer or processor to submit a description of the quality
control procedures followed in the manufacturing or processing of the chemical
substance or mixture.
(2)
(A)If the Administrator determines that quality control
procedures described in paragraph (1) are inadequate to prevent the chemical
substance or mixture from presenting a risk of injury, the Administrator may
order the manufacturer or processor to revise the quality control procedures to
the extent necessary to remedy the inadequacy.
(B)If the Administrator determines that quality control
procedures described in paragraph (1) have resulted in the distribution in
commerce of a chemical substance or mixture that may present a substantial
endangerment to health or the environment, the Administrator may order the
manufacturer or processor—
(i)to give notice of
the endangerment to—
(I)processors or
distributors (or both) in commerce of the substance or mixture; and
(II)to the extent
reasonably ascertainable, any other person in possession of or exposed to the
substance or mixture;
(ii)to give public
notice of the endangerment; and
(iii)to provide for
the replacement or repurchase, as prescribed by the Administrator, of the
substance or mixture as is necessary to adequately protect health or the
environment.
(e)Exceptions to
restrictions
(1)This
subsection applies to the restrictions established under sections 4(a)(3),
4(b)(3), 8(b)(6), 8(c)(3), and 29, and paragraphs (2)(A)(iv) and (3) of
subsection (b).
(2)
(A)
(i)The
manufacturers and processors of a chemical substance may request an exemption
from any restriction described in paragraph (1) for a specified use of the
chemical substance.
(ii)The
Administrator may by order grant an exemption from any restriction described in
paragraph (1) for a period of not to exceed 5 years if the manufacturers and
processors of the chemical substance have established by clear and convincing
evidence that the uses to be exempted meet the exemption criteria described in
subparagraph (B).
(B)The
Administrator may grant an exemption for the use of a chemical substance under
subparagraph (A)(ii) if—
(i)the exemption is
in the paramount interest of national security;
(ii)the lack of
availability of the chemical substance would cause significant disruption in
the national economy; or
(iii)the use for
which the exemption is sought is a critical or essential use—
(I)no feasible safer
alternative for the specified use of the chemical substance is available;
or
(II)the specified
use of the chemical substance when compared to all available alternatives,
provides benefit to health, the environment, or public safety.
(C)If the Administrator grants an exemption for a chemical
substance under this paragraph—
(i)the manufacturers
and processors of the chemical substance shall, for the exempted use, provide
notice of the exemption to—
(I)each known
purchaser of the chemical substance; and
(II)each known
purchaser of a mixture or article containing the chemical substance; and
(ii)the
Administrator shall provide the public with a notice of the exemption.
(D)The
Administrator may by order renew an exemption under this paragraph for 1 or
more additional 5-year periods if the Administrator concludes, after providing
public notice and an opportunity for comment, that the use of the chemical
substance continues to meet the criteria described in subparagraph (B).
(E)
(i)The Administrator shall by order impose any condition on
an exemption issued under this paragraph that the Administrator determines to
be necessary to ensure the protection of human health and the environment on
the use of a chemical substance exempted under this paragraph.
(ii)Effective
immediately after the Administrator establishes conditions on exempted use
under clause (i), the manufacturing, processing, or distribution in commerce of
the chemical substance, or any mixture or article containing the chemical
substance, shall be prohibited except to the extent that the conditions are
satisfied.
(3)The restrictions described in paragraph (1) shall not
apply to the resale of an article subject to a restriction under subsection (b)
if the article has previously been used by an end consumer.
(4)Extensions of
effective dates for retail sale of articles to end consumers
(A)Except as provided in subparagraph (B), in the case of
the retail sale to an end consumer of a chemical substance, mixture, or article
that is subject to a restriction described in paragraph (1), the Administrator
may by order extend the effective date of the restriction by a period of not to
exceed 3 years, if the Administrator determines that the extension—
(i)is necessary and
appropriate to allow for depletion of the existing retail inventory; and
(ii)will not present
a substantial endangerment to human health or the environment.
(B)An
extension under subparagraph (A) shall not apply to any retailer that the
Administrator determines has failed to comply with an order requesting
information issued by the Administrator pursuant to section 8.
(f)Polychlorinated
biphenyls
(1)The Administrator shall act by order or rule consistent
with paragraphs (2) and (3)—
(A)to prescribe
methods for the disposal of polychlorinated biphenyls; and
(B)to require
polychlorinated biphenyls to be marked with clear and adequate warnings and
instructions with respect to the processing, distribution in commerce, use, or
disposal (or any combination of such activities) of polychlorinated
biphenyls.
(2)Manufacture,
process, or distribution in totally enclosed manner
(A)Definition of
totally enclosed mannerIn this paragraph, the term totally
enclosed manner means any manner that will ensure that any exposure of
human beings or the environment to the polychlorinated biphenyl will be
insignificant, as determined by the Administrator by order or rule.
(B)Except
as provided in subparagraph (C), no person may manufacture, process, distribute
in commerce, or use any polychlorinated biphenyl in any manner other than in a
totally enclosed manner.
(C)The Administrator may by order or rule authorize the
manufacture, processing, distribution in commerce, or use (or any combination
of such activities) of any polychlorinated biphenyl in a manner other than in a
totally enclosed manner if the Administrator finds that the manufacture,
processing, distribution in commerce, or use (or combination of such
activities) will not present a substantial endangerment to health or the
environment.
(3)Prohibition on
manufacture, process, or distribution
(A)Except as provided in subparagraphs (B), (C), and
(D)—
(i)no person may
manufacture any polychlorinated biphenyl; and
(ii)no person may
process or distribute in commerce any polychlorinated biphenyl.
(B)
(i)Any person may petition the Administrator for an
exemption from the requirements of subparagraph (A), and the Administrator may
grant by rule the exemption, if the Administrator finds that—
(I)a substantial
endangerment to health or environment would not result; and
(II)good faith
efforts have been made to develop a chemical substance that meets the safety
standard and that may be substituted for such polychlorinated biphenyl.
(ii)An
exemption granted under this subparagraph shall be—
(I)subject to such
terms and conditions as the Administrator may prescribe; and
(II)be in effect for
such period (but not more than 1 year from the date it is granted, except as
provided in subparagraph (D)) as the Administrator may prescribe.
(C)Subparagraph (A) shall not apply to the distribution in
commerce of any polychlorinated biphenyl if the polychlorinated biphenyl was
sold for purposes other than resale before the expiration of the
21/2-period beginning on October 11, 1976.
(D)
(i)The Administrator may by order or rule extend an
exemption granted under subparagraph (B) that has not yet expired for a period
of not to exceed 60 days for the purpose of authorizing the Secretary of
Defense and the Secretaries of the military departments to provide for the
transportation into the customs territory of the United States of
polychlorinated biphenyls generated by or under the control of the Department
of Defense for purposes of the disposal, treatment, or storage of the
polychlorinated biphenyls in the customs territory of the United States if the
polychlorinated biphenyls are already in transit from storage locations but the
Administrator determines, in the sole discretion of the Administrator, the
polychlorinated biphenyls would not otherwise arrive in the customs territory
of the United States within the period of the original exemption.
(ii)The
Administrator shall promptly publish in the Federal Register notice of the
extension.
(g)
(1)Except as provided in paragraph (2), no Federal agency
shall convey, sell, or distribute to any other Federal agency, any State or
local government agency, or any private individual or entity any elemental
mercury under the control or jurisdiction of the Federal agency.
(2)Paragraph
(1) shall not apply to—
(A)a transfer
between Federal agencies of elemental mercury for the sole purpose of
facilitating storage of mercury to carry out this chapter; or
(B)a conveyance,
sale, distribution, or transfer of coal.
(3)Nothing in this subsection prohibits the leasing of
coal.
(h)Each
submission required pursuant to this section or pursuant to a rule or an order
promulgated or issued by the Administrator under this section shall be
accompanied by a certification signed by a responsible official of the
manufacturer or processor 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.
(i)In any rule or order under this section, the Administrator
shall specify the date on which the rule or order shall take effect, which date
shall be as soon as
feasible.
.
8.Section 7 of the Toxic
Substances Control Act (15 U.S.C. 2606) is amended to read as follows:
7.
(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 a chemical 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 that manufactures, processes,
distributes in commerce, uses, or disposes of a chemical substance or mixture,
or any article containing a chemical substance or mixture, if the manufacture,
processing, distribution in commerce, use, or disposal may present an imminent
and substantial endangerment to health or the environment, or any person that
contributes to the activities; or
(C)both seizure and
relief described in subparagraphs (A) and (B), respectively.
(2)
(A)The Administrator may issue such orders as may be
necessary to protect health or the environment from any manufacturing,
processing, distribution in commerce, use, or disposal 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)An
order under subparagraph (A) may include any requirements imposed on the
manufacture, processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or article containing the chemical substance or
mixture, as the Administrator determines is necessary to protect health or the
environment, including the requirements described in section 6(c) and the
relief authorized under subsection (b).
(3)Relationship to
existing rules, orders, and proceedingsA civil action may be
commenced, under paragraph (1), or other action taken under paragraph (2),
notwithstanding—
(A)the existence of
a rule or order under this chapter; and
(B)the pendency of
any administrative or judicial proceeding under this chapter.
(b)
(1)The district court of the United States in which an
action under subsection (a)(1) is brought shall have jurisdiction to grant such
temporary or permanent relief as may be necessary to protect health or the
environment from the risk associated with the activity involved in the
action.
(2)In the case of an action under subsection (a)(1) brought
against a person that manufactures, processes, distributes in commerce, uses,
or disposes of a chemical substance or mixture or an article containing a
chemical substance or mixture, the relief authorized by paragraph (1) may
include—
(A)the issuance of a
mandatory order imposing any of the requirements described in section 6(c);
and
(B)in the case of
purchasers of the substance, mixture, or article known to the defendant—
(i)notification to
the purchasers of the risk associated with the substance, mixture, or
article;
(ii)public notice of
the risk;
(iii)recall;
(iv)the replacement
or repurchase of the substance, mixture, or article; or
(v)any combination
of the actions described in clauses (i) through (iv) or section 6(c); or
(C)any other relief
as may be necessary to protect health or the environment from the risk involved
in the action.
(3)An action under subsection (a)(1) against a chemical
substance, mixture, or article may be proceeded against by process of libel for
its seizure and condemnation. Proceedings in such an action described in this
subparagraph shall conform as nearly as possible to proceedings in rem in
admiralty.
(c)
(1)
(A)An action under subsection (a)(1) against a person that
manufactures, processes, or distributes a chemical substance or mixture or an
article containing a chemical substance or mixture may be brought in the United
States District Court for the District of Columbia, or for any judicial
district in which any of the defendants is found, resides, or transacts
business.
(B)Process
in an action described in subparagraph (A) may be served on a defendant in any
other district in which the defendant resides or may be found.
(C)Chemical
substances, mixtures, or articlesAn action under subsection
(a)(1) against a chemical substance, mixture, or article may be brought in any
United States district court within the jurisdiction of which the chemical
substance, mixture, or article is found.
(D)Multiple
judicial districtsIn determining the judicial district in which
an action may be brought under subsection (a)(1) in instances in which the
action may be brought in more than 1 judicial district, the Administrator shall
take into account the convenience of the parties.
(E)Subpoenas
requiring attendance of witnesses in an action brought under subsection (a)(1)
may be served in any judicial district.
(2)If
proceedings under subsection (a)(1) involving identical chemical substances,
mixtures, or articles are pending in courts in 2 or more judicial districts,
the proceedings shall be consolidated for trial by order of any such court on
application reasonably made by any party in interest, on notice to all parties
in
interest.
.
9.Reporting and
retention of informationSection 8 of the Toxic Substances Control
Act (15 U.S.C. 2607) is amended to read as follows:
8.Reporting and
retention of information
(a)Substance
identification, declaration, and information
(1)Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2010, each manufacturer or processor of a chemical
substance distributed in commerce shall submit to the Administrator the
declaration described in paragraph (2) or (3), accompanied by the certification
described in subsection (i).
(2)Declaration of
current manufacture or processingA declaration described in this
paragraph is a statement that includes, for each chemical substance
manufactured or processed by a manufacturer or processor—
(A)the chemical
identity and any special substance characteristics of the chemical
substance;
(B)the name and
location of each facility under the control of the manufacturer or processor at
which the chemical substance is manufactured or processed or from which the
chemical substance is distributed in commerce;
(C)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, and copies of any such studies that have not previously been
submitted to the Administrator; and
(D)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 regarding—
(i)the physical,
chemical, and toxicological properties of the chemical substance;
(ii)the annual
production volume and known uses of, and exposure and fate information relating
to, the chemical substance; and
(iii)the name and
location of each facility to which the chemical substance is sent, after
manufacture and processing, for subsequent processing, distribution, or
use.
(3)Declaration of
cessation of manufacturing or processingA declaration described
in this paragraph is a statement certifying that the manufacturer or processor
has ceased, or will cease not later than 180 days after the date of submission
of the declaration, all production, importation, processing, and export of the
chemical substance.
(4)Each manufacturer or processor of a chemical
substance that submits to the Administrator a declaration described in
paragraph (2) shall update and submit to the Administrator a new
declaration—
(A)at a minimum
every 3 years; and
(B)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, including any
information that—
(i)demonstrates a
new potential toxic effect of the chemical substance;
(ii)corroborates
previous information demonstrating or suggesting a toxic effect; or
(iii)suggests a
toxic effect at a lower dose than previously demonstrated.
(5)Records to
support declarationsEach manufacturer or processor of a chemical
substance distributed in commerce shall maintain records of the information
described in subparagraphs (A) through (D) of paragraph (2).
(6)Prohibition on
manufacturing, processing, or distributionThe Administrator may,
by order, prohibit a manufacturer or processor in violation of this subsection
from manufacturing, processing, or distributing in commerce the chemical
substance or any article containing the chemical substance, except as
authorized under section 6(e).
(b)
(1)
(A)Except as
provided in paragraph (2), the Administrator may by rule or order require any
person who manufactures, processes, distributes in commerce, uses, or disposes
of a chemical substance, mixture, or article to maintain records of and report
by a specified date any information concerning the substance, mixture, or
article that, in the judgment of the Administrator, would assist the
Administrator in—
(i)making a safety
determination with respect to a chemical substance under this subchapter;
or
(ii)any other aspect
of administering this chapter.
(B)The Administrator
may by rule or order require that any report or information submitted pursuant
to this chapter include chemical identity and special substance
characteristics, as appropriate to the chemical substance or mixture that is
the subject of the report or information.
(C)The Administrator
shall by rule or order further specify or modify the information that must be
submitted with a particular report or information submission to establish the
chemical identity and special substance characteristics of the subject chemical
substance or mixture for the purposes of such report or information submission
.
(2)Small
quantities for research or analysisIn the case of the
manufacture, processing, distribution in commerce, use, or disposal of a
chemical substance 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 issue a rule or order 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 chapter.
(3)Prohibition on
manufacturing, processing, or distributionThe Administrator may,
by order, prohibit a manufacturer or processor in violation of a requirement of
a rule or order under paragraph (1) from manufacturing, processing, or
distributing in commerce the chemical substance or any article containing the
chemical substance, except as authorized under subsection 6(e).
(c)Inventory and
categorization
(1)The Administrator shall compile, keep current, and
publish a list of each chemical substance that is manufactured or processed in
the United States.
(2)The
list shall at least include the name of each chemical substance that any person
reports, under section 5 or subsection (b), is manufactured or processed in the
United States.
(3)
(A)In the case of a chemical substance for which a notice is
submitted in accordance with section 5, the chemical substance shall be
included on the list as of the earliest date (as determined by the
Administrator) on which the substance was manufactured or processed in the
United States.
(B)The
Administrator shall first publish a list under subparagraph (A) not later than
18 months after the effective date of this Act.
(4)Small
quantities for research or analysisThe Administrator shall not
include in the list any chemical substance that 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, the substance or another substance, including such research or
analysis for the development of a product.
(5)Not
later than 5 years after the date of enactment of the Safe Chemicals Act of
2010 and from time to time thereafter, the Administrator shall publish in the
Federal Register a list of all chemical substances distributed in commerce that
categorizes the chemical substances, based on existing information available to
the Administrator, into categories based on known health or environmental
effects, exposure, insufficient data, or other category that the Administrator
considers appropriate.
(d)Public access
to significant information
(1)Not later than 1 year after the date of enactment of
Safe Chemicals Act of 2010, the Administrator, through collaboration as
appropriate, shall establish—
(A)an electronic,
Internet-accessible database for storing and sharing of information relating to
the toxicity and use of, and exposure to, chemical substances; and
(B)procedures for
use in maintaining and updating the database.
(2)Not later than 18 months after the date of enactment of
the Safe Chemicals Act of 2010 or not later than 90 days after the date of
decisions made by the Administrator or receipt by the Administrator of
information submitted pursuant to this subchapter, the Administrator shall,
subject to section 14, make available to the public via the Internet-accessible
database described in paragraph (1) a description of all significant decisions
made by the Administrator under this subchapter or significant information
submitted pursuant to this subchapter.
(e)
(1)Any person that manufactures, processes, or distributes
in commerce any chemical substance or mixture shall maintain and submit to the
Administrator records of significant adverse reactions to health or the
environment, as determined by the Administrator by rule, alleged to have been
caused by the substance or mixture.
(2)
(A)Records of the adverse reactions to the health of
employees shall be retained for a period of 30 years after the date the
reactions were first reported to or known by the person maintaining the
records.
(B)Any other record of the adverse reactions shall be
retained for a period of 5 years after the date the information contained in
the record was first reported to or known by the person maintaining the
record.
(3)Records
required to be maintained under this subsection shall include—
(A)records of
consumer allegations of personal injury or harm to health;
(B)reports of
occupational disease or injury; and
(C)reports or
complaints of injury to the environment submitted to the manufacturer,
processor, or distributor in commerce from any source.
(f)Information in
the possession of other Federal agencies
(1)
(A)From time to time, each Federal agency and Federal
institution shall submit to the Administrator a synopsis of the data and
records in the possession or control of the agency and institution,
respectively, that may be useful to the Administrator in carrying out this
chapter.
(B)Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2010, the Administrator shall prescribe, by order, the
format, content, and level of detail of the synopses.
(C)Not later than 18 months after the date of enactment
of the Safe Chemicals Act of 2010, each Federal agency and Federal institution
shall make the initial submission of a synopsis of the agency and institution,
respectively, to the Administrator.
(D)At
least once every 3 years, each Federal agency and Federal institution
shall—
(i)update and keep
current the synopsis of the agency and institution, respectively; and
(ii)submit the
updated synopsis to the Administrator.
(2)Requests by
AdministratorOn the request of the Administrator, any
information in the possession or control of an agency or institution relating
to a hazard of, use of, exposure to, or risk of, a chemical substance or
mixture shall be provided to the Administrator.
(g)Notice to
Administrator of substantial risksAny person that manufactures,
processes, or distributes in commerce a chemical substance or mixture and that
obtains information that reasonably supports the conclusion that the substance
or mixture presents a substantial risk of injury to health or the environment
shall immediately inform the Administrator of the information unless the person
has actual knowledge that the Administrator has been adequately informed of the
information.
(h)Each
submission required pursuant to this section or pursuant to a rule or an order
promulgated or issued by the Administrator under this section, other than a
submission under subsection (f), shall be accompanied by a certification signed
by a responsible official of the manufacturer or processor 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.”
(i)Definition of
manufacture and processIn this section, the terms
manufacture and process mean manufacture and process,
respectively, for commercial
purposes.
.
10.Relationship to
other Federal lawsSection 9
of the Toxic Substances Control Act (15 U.S.C. 2608) is amended—
(1)in subsection
(a)—
(A)by amending
paragraph (1) to read as follows:
(1)If the
Administrator determines that the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance or mixture, or that any
combination of such activities either does not meet the safety standard under
this subchapter, or requires conditions or restrictions in order to the meet
the safety standard, and the Administrator determines that action may be taken
under a Federal law not administered by the Administrator to address the uses
of, or aggregate and cumulative exposure to, such chemical substance or
mixture, the Administrator shall submit to the agency which administers such
law a report that describes with specification the activity or combination of
activities that prevent the chemical substance or mixture from meeting the
safety standard or restrictions or conditions required to meet the safety
standard under this subchapter. Such report shall also request that such
agency—
(A)determine if the
action or actions may be taken under such law (or laws) administered by such
agency;
(B)if the agency
determines under subparagraph (A) that such action or actions may be taken,
initiate such action or actions and provide a timetable for such action or
actions; and
(C)respond to the
Administrator with respect to the matters described in the report.
Any report
of the Administrator shall include a detailed statement of the information on
which it is based and shall be promptly published in the Federal Register. The
agency receiving a request under such a report shall make the requested
determination, take the action or actions necessary to ensure that the chemical
substance or mixture meets the safety standard under this subchapter, if
appropriate, and respond to the Administrator’s request within such time as the
Administrator specifies in the request, but such time specified may not be less
than 90 days from the date the request was made. The response of an agency
shall be accompanied by a detailed statement of the findings and conclusions of
the agency and shall be promptly published in the Federal
Register.;
(B)by amending
paragraph (2) to read as follows:
(2)If the
Administrator submits a report under paragraph (1) with respect to a chemical
substance or mixture and the agency to which such report was made initiates,
within such time specified in the request under paragraph (1), action or
actions under the law (or laws) administered by such agency to ensure that a
chemical substance or mixture including an restrictions or conditions meets the
safety standard under this subchapter, the Administrator may not take action
under this chapter with respect to that action or actions except that the
Administrator may take actions pursuant to section 7 of this
subchapter.
;
(C)by redesignating
paragraph (3) as paragraph (4);
(D)by inserting
after paragraph (2) the following new paragraph:
(3)If the
Administrator submits a report under paragraph (1) with respect to a chemical
substance or mixture and the agency to which such report was submitted
either—
(A)determines that
action cannot be taken under the authorities of the agency;
(B)does not initiate
action, if appropriate, within such time specified in the request under
paragraph (1);
(C)does not complete
the action within the timeframe provided by such agency; or
(D)fails to
respond,
the
Administrator may, by order, initiate action or a combination of actions under
this chapter to ensure compliance with the safety standard for the chemical
substance or mixture under this
subchapter.;
and
(E)in paragraph (4),
as redesignated by subparagraph (C) of this paragraph—
(i)by
striking section 6 or 7
and inserting this
chapter
; and
(ii)by
striking against such risk
after Federal
action
;
(2)in subsection
(c), by inserting at the end the following: In exercising any authority
under this title, the Administrator shall ensure that any actions to address
workplace exposures that the Administrator takes or requires be taken by
manufacturers or processors of a chemical substance or mixture are consistent
with the industrial hygiene hierarchy of controls.
; and
(3)in subsection
(d)—
(A)by striking
while imposing the least burdens of duplicative requirements on those
subject to the Act and for other purposes
; and
(B)by striking
, in the report required by section 30,
.
11.Inspections and
subpoenasSection 11 of the
Toxic Substances Control Act (15 U.S.C. 2610) is amended to read as
follows:
11.Inspections and subpoenas
(a)For purposes of
administering this chapter, the Administrator, and any duly designated
representative of the Administrator, may inspect any establishment, facility,
or other premises in which chemical substances, mixtures or articles subject to
this chapter are manufactured, processed, stored, or held before or after their
distribution in commerce; any conveyance being used to transport such chemical
substances, mixtures, or articles in connection with distribution in commerce;
and any place where records relating to such chemical substances, mixtures, or
articles, or otherwise relating to compliance with this chapter, are held. Each
such inspection shall be commenced and completed with reasonable promptness and
shall be conducted at reasonable times, within reasonable limits, and in a
reasonable manner. 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.
(b)Except
as provided in paragraph (2), an inspection conducted under subsection (a) of
this section shall extend to all things within the premises or conveyance
inspected (including records, files, papers, processes, controls, and
facilities) bearing on whether the requirements of this chapter applicable to
the chemical substances, mixtures, articles or records subject to this chapter
have been complied with.
(c)In carrying out this chapter, the Administrator may
require the attendance and testimony of witnesses and the production of such
reports, papers, documents, items, answers to questions, and other information,
including the development of analyses and other information, that the
Administrator deems necessary. Witnesses shall be paid the same fees and
mileage that are paid witnesses in the courts of the United States.
(d)For
purposes of enforcing the provisions of this chapter and upon a showing to an
officer or court of competent jurisdiction that there is reason to believe that
the provisions of this chapter have been violated, officers or employees duly
designated by the Administrator are empowered to obtain and to execute warrants
authorizing—
(1)entry,
inspection, and copying of records for purposes of this chapter; and
(2)the seizure of
any chemical substance, mixture or article which is in violation of this
chapter.
.
12.Section 12 of the Toxic Substances Control
Act (15 U.S.C. 2611) is amended—
(1)by striking
subsection (a);
(2)by redesignating
subsections (b) and (c) as subsections (a) and (b), respectively;
(3)in subsection
(a), as redesignated by paragraph (2) of this section—
(A)in paragraph
(1)—
(i)by
striking or intends to export
;
(ii)by
striking section 4 or 5(b)
and inserting section 5 or
6(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 an action has been taken pursuant to section 6 or 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 action taken pursuant to section 6 or section 7
; and
(C)by adding at the
end the following new paragraph:
(3)(A)Any person that has
notified the Administrator of the exportation of a chemical substance or
mixture under this section shall notify the Administrator of any change in the
export status of the substance or mixture not later than 30 days after such a
change in status.
(B)The Administrator shall promptly
furnish 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)data for such substance or mixture
have been received by the Administrator pursuant to section 4, 6(b), or
8;
(ii)a change has occurred in the
export status of such substance or mixture; or
(iii)a change has been made in any
risk management action taken pursuant to section 6 or 7 for such substance or
mixture.
;
(4)in subsection
(b), as redesignated by paragraph (2) of this section—
(A)by striking
paragraph (2); and
(B)by redesignating
paragraphs (3), (4), (5), and (6) as paragraphs (2), (3), (4), and (5),
respectively; and
(5)by adding at the
end the following new subsection:
(c)The Administrator shall—
(1)maintain copies
of all current notices provided to other governments under this section;
and
(2)make such copies
available to the public in electronic
format.
.
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 striking
Secretary of the Treasury
each place it appears and inserting
Secretary of Homeland Security
; and
(2)in subsection
(a)(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
chapter.
.
14.Section 14 of the Toxic
Substances Control Act (15 U.S.C. 2613) is amended—
(1)by redesignating
subsections (a) through (e) as subsections (c) through (g),
respectively;
(2)by inserting
before subsection (c), as redesignated by paragraph (1) of this section, the
following new subsections:
(a)The 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 agency'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
).
;
(3)in subsection
(c), as redesignated by paragraph (1) of this subsection—
(A)by striking
subsection (b)
and inserting subsection
(d)
;
(B)by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively;
(C)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—
(A)for the purpose
of administration or enforcement of a law; and
(B)in accordance
with any applicable agreements that ensure that the recipient government takes
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
(D)in paragraph (4),
as redesignated by subparagraph (B) of this paragraph, by striking an
unreasonable risk of injury
and inserting an imminent and
substantial endangerment
;
(4)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 treat information of the
following types as confidential under this section:
(A)The identity of a
chemical substance, except as provided in section 5.
(B)Any safety
standard determination developed under section 6, including supporting
information developed by the Administrator.
(C)Any health and
safety study which is submitted under this chapter 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 subchapter; 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) or (ii) of subparagraph (C).
(D)Any information
indicating the presence of a chemical substance in a consumer article intended
for use or reasonably expected to be used by children or to which children can
otherwise be reasonably expected to be exposed.
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
clause (i) or (ii) of subparagraph (C) of paragraph (1)
;
and
(ii)by
striking in the second sentence of such paragraph
and inserting
in the last sentence of paragraph (1)
;
(5)in subsection
(e), as redesignated by paragraph (1) of this section—
(A)by amending
paragraph (1) to read as follows:
(1)Duties of
manufacturers and processorsIn submitting data under this
chapter, a manufacturer, processor, or distributor in commerce may—
(A)designate the
data which such person believes is entitled to confidential treatment under
subsection (a) of this section; and
(B)submit such
designated data separately from other data submitted under this chapter. A
designation under this paragraph shall be made in writing and in such manner as
the Administrator may prescribe, and shall include—
(i)justification for
each claim for confidentiality;
(ii)a certification
that the information is not otherwise publicly available; and
(iii)separate copies
of all submitted information, with 1 copy containing and 1 copy excluding the
information to which the request
applies.
;
(B)by redesignating
paragraph (2) as paragraph (3);
(C)by inserting
after paragraph (1) the following new paragraph:
(2)Duties of the
AdministratorThe Administrator shall—
(A)not later than 1
year after the date of enactment of the Safe Chemicals Act of 2010, by order
develop and make publicly available standards that specify—
(i)the acceptable
bases on which written requests to maintain confidentiality of information may
be approved, which shall be no more restrictive of public disclosure than
section 552 of title 5, United States Code; and
(ii)the
documentation that must accompany those requests;
(B)not later than 90
days after the date of receipt of information designated under paragraph (1),
review all requests to maintain confidentiality of the submitted information
and decide whether to approve or deny such request based on whether the request
and accompanying documentation comply with those standards that are developed
under paragraph (1) (except that if a request for the information is received
under section 552 of title 5, United States Code, before the 90-day review and
decision period has elapsed, the disclosure requirements, procedures, and
judicial review provisions under that section shall apply);
(C)in the event such
a request is denied, make the information available to the public in accordance
with section 8(b)(3); and
(D)if such a request
is approved, specify a time period of not greater than 5 years for which the
submitted information shall be kept
confidential.
;
and
(D)in paragraph (3),
as redesignated by subparagraph (B) of this paragraph—
(i)in
subparagraph (A)—
(I)by striking
paragraph (1)(A)
and inserting paragraph (1) and approved
by the Administrator under paragraph (2)(B)
; and
(II)by striking
The Administrator may not release such data until the expiration of 30
days after the manufacture, processor, or distributor in commerce submitting
such data has received the notice required by this subparagraph.
and
inserting The Administrator shall release the information in accordance
with the disclosure and procedural requirements of section 552 of title 5,
United States Code.
; and
(ii)in
subparagraph (B)(i)—
(I)by striking
or (4)
and inserting (4), or (5)
;
(II)by striking
subsection (a)
each place it appears and inserting
subsection (c)
;
(III)by striking
paragraph (3)
and inserting paragraph (4)
;
(IV)by striking
that
before if the Administrator determines that the
release of such data
;
(V)by striking
, unreasonable risk of injury
before to health or the
environment
and inserting and substantial endangerment then no
notice is required.
; and
(VI)by striking
, such notice may be made by such means as the Administrator determines
will provide notice at least 24 hours before such release is made
;
and
(6)by adding at the
end the following new subsection:
(h)Risk
information for workersThe Administrator shall provide standards
for and facilitate the sharing of chemical identity, safety standard
determination, health and safety data described in subsection (d) that pertains
to chemical substances or mixtures, or articles containing chemical substances,
that workers may come into contact with or otherwise be exposed to during the
course of work, with those workers and representatives of each certified or
recognized bargaining agent representing such
employees.
.
15.Section 15 of the Toxic
Substances Control Act (15 U.S.C. 2614) is amended—
(1)by striking
paragraph (1) and inserting the following:
(1)fail or refuse to
comply with any rule, order, prohibition, restriction, or other requirement
imposed by this chapter or by the Administrator under this
chapter;
;
(2)in paragraph
(2)—
(A)by striking
use
and inserting manufacture, process, distribute in
commerce, use, or dispose of
;
(B)by striking
, or mixture
and inserting mixture or article
;
and
(C)by striking
section 5 or 6, a rule or order under section 5 or 6, or an order issued
in action brought under section 5 or 7
and inserting any rule,
order, prohibition, restriction, or other requirement imposed by this chapter
or by the Administrator under this chapter
;
(3)in paragraph
(3)—
(A)in subparagraph
(A), by inserting accurate and complete
before
records
;
(B)in subparagraph
(B)—
(i)by
inserting or make accurate and complete
before
reports
; and
(ii)by
inserting information submissions, disclosures, declarations,
certifications,
after notices,
; and
(C)in subparagraph
(C), by striking or
after the semicolon;
(4)in paragraph (4),
by striking the period at the end and inserting a semicolon; and
(5)by adding at the
end the following new paragraphs:
(5)make or submit a
statement, declaration, disclosure, certification, writing, data set, or
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 chapter or pursuant to any rule or order promulgated or issued
under this chapter; or
(6)take any action
prohibited by this
chapter.
.
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
inserting this chapter or a rule or order promulgated or issued pursuant
to this chapter, as described in
before section 15 or 409 shall
be
;
(ii)by
striking $25,000
and inserting $37,500
;
and
(iii)by striking
violation of section 15 or 409
and inserting violation of
this chapter
;
(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).
;
(D)in paragraph
(3)(A), as redesignated by subparagraph (B) of this paragraph—
(i)by
inserting this chapter, as described in
before section 15
or 409
; 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
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 striking
or willfully
before violates any
provision
;
(C)by inserting
this chapter, as described in
before section 15 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 violates any provision of this chapter and who knows at the time that
he thereby places another person 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 subparagraph, 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)by
striking The district courts of the United States shall have
jurisdiction over civil actions to
and inserting The
Administrator may commence a civil action in the appropriate United States
district court to compel compliance of any person with any provision of this
chapter or any rule or order promulgated pursuant to this chapter. The
Administrator’s authority to enforce this chapter includes the authority
to
;
(ii)by
striking subparagraphs (A) through (C) and inserting the following
subparagraphs:
(A)seek civil or
criminal penalties under section 16 for any violation of this chapter, as
described in sections 15 and 409;
(B)enjoin any
violation of this chapter, or of a rule or order promulgated or issued under
this chapter, as described in sections 15 and 409; and
(C)order the
compliance of any person with any provision of this chapter, or with any rule
or order promulgated or issued under this chapter, through an administrative
proceeding (which may proceed concurrently with action under this section), in
which the Administrator may levy penalties under section
16;
;
and
(iii)in subparagraph
(D)—
(I)by striking
product
wherever it appears and inserting
article
;
(II)by striking
direct
and inserting order
;
(III)by striking
product subject to title IV
and inserting article subject
to this chapter
;
(IV)by striking
of section 5, 6, or title IV
and inserting this
chapter
; and
(V)by striking
under section 5, 6, or title IV
and inserting promulgated
and issued under this chapter, as described in section 15 or 409,
;
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
;
(ii)in
subparagraph (A)—
(I)by striking
subparagraph (A) of such paragraph
and inserting
subparagraphs (A) and (B) of paragraph (1)
;
(II)by inserting
this chapter, as described in
before section 15
;
and
(III)by inserting
or 409
after section 15
; and
(iii)in subparagraph
(B) by striking such paragraph
and inserting paragraph
(1)
; and
(2)in subsection
(b)—
(A)by striking
title IV
and inserting this chapter
; and
(B)by striking
product
each place it appears and inserting
article
.
18.Section 18 of the Toxic Substances Control
Act (15 U.S.C. 2617) is amended to read as follows:
18.Nothing in this chapter, or any rule,
regulation, or order issued or promulgated pursuant to this chapter shall be
construed, interpreted, or applied to preempt, displace or supplant any
provision of any law, including common law, of any State or political
subdivision of a State relating to any chemical substance or mixture, or any
article that contains a chemical substance or mixture, which is more stringent
than is provided for under this
chapter.
.
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
redesignating subparagraph (A) as paragraph (1);
(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 chapter
; (v) by
inserting or order
after rule
each place it
appears; and
(v)by
striking (other than in an enforcement proceeding)
before “of
such a rule);
(B)in paragraph
(2)—
(i)by
striking paragraph (1)(A)
and inserting paragraph
(1)
; and
(ii)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), 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 such chapter
7.
.
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 chapter
; and
(B)in the flush
language following paragraph (2), by inserting , to enforce this chapter
or any rule promulgated or order issued under this chapter, or to order the
Administrator to perform an act or duty described in this chapter, 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 chapter
; 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 chapter
;
(B)in paragraph (3),
by striking section 4, 5, 6, or 8
and inserting the
applicable provisions of this chapter
; and
(C)in paragraph
(4)—
(i)in
subparagraph (A), by striking a rulemaking proceeding
and
inserting proceedings authorized under this chapter
; 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 proceedings authorized
under this Act
;
(II)in clause
(i)—
- (aa)by
inserting
except as provided in clause (ii),
before in
the case of
; and
- (bb)in
subclause (II), by striking
present an unreasonable risk to
and
inserting substantial endangerment
; and
(III)in clause
(ii)—
- (aa)by
striking
issuance of a rule under section 6 or 8 or an order under
section 6(b)(2)
and inserting imposition or issuance of a
restriction, use condition, or order under this chapter
; and
- (bb)by
striking
an unreasonable
and inserting a substantial
endangerment
.
22.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 chapter.
;
(2)in subsection
(b)—
(A)in paragraph (1),
in the flush language after subparagraph (B), by striking section 4, 5,
or 6 or a requirement of section 5 or 6
and inserting this
chapter
;
(B)in paragraph
(2)—
(i)in
subparagraph (A)(ii), 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,
;
(II)by striking
clause (ii); and
(III)by
redesignating clause (iii) as clause (ii); and
(C)by striking
paragraph (4); and
(3)by adding at the
end the following new subsection:
(c)Nothing
in this section shall be construed—
(1)to require the
Administrator to amend or repeal any rule or order in effect under this
chapter; or
(2)to condition the
Administrator’s authority to issue orders or promulgate rules under this
chapter.
.
23.Administration
of the Toxic Substances Control 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 may, by rule, require the payment of a reasonable fee from any
person required to submit data to defray the cost of administering this
chapter. In setting a fee under this paragraph, 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 testing are shared
under this chapter.
;
and
(2)by adding at the
end the following new subsection:
(h)In carrying out this chapter, the Administrator is
authorized to issue such orders and prescribe such regulations as are necessary
to carry out this
chapter.
.
24.Section 28 of the
Toxic Substances Control Act (15 U.S.C. 2627) is amended—
(1)in subsection
(a)—
(A)by striking
unreasonable
before risk within the States
;
and
(B)by striking
is unable or is not likely to take
and inserting has not
taken
;
(2)by redesignating
subsections (b), (c), and (d) as subsections (c), (d), and (e),
respectively;
(3)by inserting
after subsection (a) the following new subsection:
(b)The
Administrator shall establish a process to coordinate with States, on an
on-going basis, to share data and priorities relating to the management of
chemical substances under this title and under programs operated by States, in
accordance with requirements under section
14.
;
and
(4)in subsection
(c)(2), as redesignated by paragraph (2) of this section, by striking
including cancer, birth defects, and gene mutations,
.
25.Authorization
of appropriationsTitle I of
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is amended—
(1)by redesignating section 29 as section
39;
(2)by redesignating section 30 as section
38;
(3)by striking
section 31; and
(4)by amending section 39, as redesignated, to
read as follows:
39.Authorization
of appropriationsThere are
authorized to be appropriated to the Administrator such sums as may be
necessary for each of the fiscal years 2011 through 2018 to carry out this
chapter.
.
26.
(a)Restrictions on
certain chemical substancesThe Toxic Substances Control Act (15
U.S.C. 2601 et seq.) is amended by inserting after section 28 the following new
sections:
29.Expedited
action on chemicals of highest concernThe Administrator shall act quickly to
manage risks from chemical substances that clearly pose the highest risks to
human health or the environment.
30.Children’s
Environmental Health Research Program
(a)Children’s
Environmental Health Research Program
(1)Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2010, the
Administrator shall establish a Children
s Environmental Health
Research Program’ within the Environmental Protection Agency.
(2)Subject
to amounts made available in advance in appropriations Acts, under the
Children’s Environmental Health Research Program established under paragraph
(1), the Administrator may enter into contracts and make grants to further
understanding of the vulnerability of children to chemical substances and
mixtures.
(3)Contracts
and grants under this section shall be provided in consultation with
Interagency Science Advisory Board on Children’s Health and Toxic Substances
established under subsection (b).
(b)Interagency
Science Advisory Board on Children’s Health Research
(1)Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2010, the
Administrator shall establish an advisory board to be known as the
Interagency Science Advisory Board on Children
s Health
Research’. The Board shall be subject to the Federal Advisory Committee Act (5
U.S.C. App.).
(2)The
purposes of the Board shall be to provide independent advice, expert
consultation, and peer review upon request of the Administrator or Congress on
the scientific and technical aspects of issues relating to the implementation
of this subchapter with respect to protecting children’s health and
research.
(3)The
Administrator shall—
(A)appoint the
members of the Board, including, at a minimum, representatives 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 no
individual appointed to serve on the Board has a conflict of interest that is
relevant to the functions performed, unless such conflict is promptly and
publicly disclosed and the Administrator determines that the conflict is
unavoidable.
(c)Prenatal and
infant exposures
(1)If,
through studies performed pursuant to subsection (a), section 4, or other
available research, the Administrator identifies a chemical substance that may
be present in human biological media that may have adverse effects on early
childhood development, the Administrator shall 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.
(2)Upon
completion of any study conducted pursuant to paragraph (1), the Secretary of
Health and Human Services shall—
(A)inform the
Administrator of the results of the study; and
(B)publish the
results of the study in a publicly available electronic format.
(3)
(A)Whenever a chemical substance or mixture is determined
to be present in a study conducted pursuant to paragraph (1), the manufacturers
and processors of the 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)made available by
the Administrator in electronic format; 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.
31.Reduction of
animal-based testing
(a)The
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; and
(2)funding research
and validation studies to reduce, refine, and replace the use of animal tests
in accordance with this subsection.
(b)Interagency
science advisory board on alternative testing methods
(1)Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2010, the
Administrator shall establish an advisory board to be known as the
Interagency Science Advisory Board on Alternative Testing
Methods
. The Board shall be subject to the Federal Advisory Committee
Act (5 U.S.C. App.).
(2)The
Administrator shall—
(A)appoint the
members of the Interagency Science Advisory Board on Alternative Testing
Methods, including, at a minimum, representatives 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; and
(v)the National
Tribal Science Council; and
(B)ensure that no
individual appointed to serve on the Interagency Science Advisory Board on
Alternative Testing Methods has a conflict of interest that is relevant to the
functions to be performed, unless such conflict is promptly and publicly
disclosed and the Administrator determines that the conflict is
unavoidable.
(3)The
purpose of the Interagency Science Advisory Board on Alternative Testing
Methods shall be to provide independent advice and peer review to the
Administrator and Congress on the scientific and technical aspects of issues
relating to the implementation of this subchapter with respect to minimizing
the use of animals in testing of chemical substances or mixtures.
(4)Not
later than 1 year after the date of enactment of the
Safe Chemicals Act of 2010, and
triennially thereafter, the Administrator, in consultation with the Interagency
Science Advisory Board on Alternative Testing Methods established under
paragraph (1), shall publish a list of testing methods that reduce the use of
animals in testing under section 4.
(c)Implementation
of alternative testing methodsTo promote the development and
timely incorporation of new testing methods that are not animal-based, the
Administrator shall—
(1)in consultation
with the Interagency Science Advisory Board on Alternative Testing Methods
established under subsection (b)(1), and after providing an opportunity for
public comment, develop a strategic plan to promote the development and
implementation of alternative test methods and testing strategies to generate
information used 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;
(2)biennially report
to Congress on progress made in implementing this section; and
(3)fund and carry
out research, development, performance assessment, and translational studies to
accelerate the development of test methods and testing strategies that are not
animal-based for use in safety standard determinations under section
6(b).
(d)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 subchapter, the Administrator may
adapt or waive such requirement if the Administrator determines that—
(1)there is
sufficient weight-of-evidence from several independent sources of information
to support a conclusion that a chemical substance or mixture has, or does not
have, a particular property, in any case in which the information from each
individual source alone is regarded as insufficient to support the
conclusion;
(2)testing for a
specific endpoint is technically not practicable to conduct as a consequence of
1 or more physical or chemical properties of the chemical substance or mixture;
or
(3)a chemical
substance or mixture cannot be tested in animals at concentrations that do not
result in significant pain or distress, due to physical or chemical properties
of the chemical substance or mixture, such as potential to cause severe
corrosion or severe irritation to tissues.
32.Safer
alternatives and green chemistry and engineering
(a)Safer
alternatives program
(1)Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2010, the
Administrator shall establish a program to create market incentives for the
development of safer alternatives to existing chemical substances that reduce
or avoid the use and generation of hazardous substances.
(2)The
program under paragraph (1) shall include—
(A)expedited review
of new chemical substances for which the manufacturer or processor submits an
alternatives analysis indicating that the new chemical substance is the safer
alternative for a particular use than existing chemical substances used for the
same purpose;
(B)recognition for a
chemical substance or product determined by the Administrator to be a safer
alternative for a particular use by means of a special designation intended for
use in marketing the safer alternative, and periodic public awards or rewards;
and
(C)such other
incentives, as the Administrator considers to be appropriate to encourage the
development, marketing, and use of chemical substances or products determined
by the Administrator to be safer alternatives for the particular uses, such as
job training and worker assistance.
(b)Green chemistry
research networkThe Administrator shall establish a network of
not fewer than 4 green chemistry and engineering centers, located in various
regions of the United States, to support the development and adoption of safer
alternatives to chemical substances, particularly chemical substances placed on
the priority list under section 6(a).
(c)Green chemistry
and engineering research grantsThe Administrator shall make
grants to promote and support the research, development, and adoption of safer
alternatives to hazardous substances.
(d)Green chemistry
workforce education and training program
(1)The Administrator shall create a program to facilitate
the development of a workforce, including industrial and scientific workers,
that produces safer alternatives to existing chemical substances.
(2)The
goals of the program are to provide workforce training on skills that
will—
(A)facilitate the
expansion of green chemistry;
(B)develop
scientific and technical leadership in green chemistry;
(C)facilitate the
successful and safe integration of green chemistry into infrastructure
projects;
(D)inform and engage
communities about green chemistry; and
(E)promote
innovation and strong public health and environmental protections.
(3)The
Administration shall implement the program to achieve its goals as described in
this Act, including by—
(A)helping to
develop a broad range of skills relevant to the production and use of such
safer alternatives, including their design, manufacturing, and use and
disposal;
(B)offering to
develop partnerships with educational institutions, training organizations,
private sector companies, and community organizations; and
(C)provide grants to
state and local governments and to the partnerships established pursuant to
paragraph (B) to promote and support activities consistent with achieving the
goals of this program.
33.Cooperation
with international effortsIn
cooperation with the Secretary of State and the head of any other appropriate
Federal agency (as determined by the Administrator), the Administrator shall
cooperate with international efforts as appropriate—
(1)to develop a
common protocol or electronic database relating to chemical substances;
or
(2)to develop safer
alternatives for chemical substances.
34.Reliable
information and adviceNot
later than 18 months after the date of enactment of the
Safe Chemicals Act of 2010, the
Administrator shall, by order, establish and implement procedures to ensure
data reliability 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 subchapter on the
various properties and characteristics of a chemical substance;
(2)annually, the
Administrator perform a comprehensive data audit on a subset, as chosen by the
Administrator, of the data submissions submitted by manufacturers and
processors under this subchapter;
(3)the Administrator
establish and maintain a registry of all health- and safety-related studies
initiated in response to requirements under this subchapter;
(4)the Administrator
have access to all records of health- and safety-related studies initiated in
response to requirements under this subchapter; and
(5)the Administrator
require the submitter of any research study conducted by a third party in
response to requirements under this subchapter to 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.
35.
(a)In
this section:
(1)Disproportionate
exposureThe term disproportionate exposure means
residential population exposure to 1 or more toxic chemical substances and
mixtures at levels that are significantly greater than the average exposure in
the United States, as defined and identified by the Administrator in accordance
with the criteria under subsection (b).
(2)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.
(b)Not
later than 180 days after the date of enactment of the
Safe Chemicals Act of 2010, the
Administrator shall promulgate a rule to establish criteria consistent with
this section to—
(1)define
disproportionate exposure; and
(2)identify any
locality that is disproportionately exposed.
(c)
(1)Not later than 120 days after promulgation of the rule
under subsection (b), 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.); and
(iv)the Emergency
Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11001 et
seq.).
(3)The Administrator shall provide an opportunity for
members of the public to nominate localities for which there may be
disproportionate exposure for inclusion in the identification of localities
under paragraph (1).
(d)
(1)Not later than 6 months after completing the
identification of localities under subsection (c)(1), the Administrator shall,
after notice and consultation with all applicable State, local, county health,
and environmental officials, and State, local, and county legislators and other
elected officials, publish a list of the localities subject to disproportionate
exposure identified pursuant to such subsection in the Federal Register and
make the list available electronically.
(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 the list as necessary. The Administrator may update and republish
the list more frequently than every 5 years to add new localities that meet the
criteria under subsection (b), or to remove localities when the Administrator
has determined that the exposure reduction has been achieved and no further
action is needed after actions are taken under subsection (e). The
Administrator shall notify all applicable State, local, county health, and
environmental officials, and State, local, and county legislators and other
elected officials of the updated listing.
(e)No judicial
review; nondiscretionary duty
(1)The following actions shall not be subject to judicial
review:
(A)A decision to
identify a locality pursuant to subsection (c)(1) to be included on the list
published pursuant to subsection (d)(1).
(B)A decision in
response to nominations submitted pursuant to subsection (c)(3).
(C)A decision to
list localities or update the list pursuant to subsection (d)(2).
(2)Notwithstanding paragraph (1), the failure of the
Administrator to publish the list of list localities or update the list in
accordance with this section shall be—
(A)considered to be
a failure to perform a nondiscretionary duty; and
(B)subject to
judicial review.
(f)
(1)Not later than 1 year after publishing or updating the
list under subsection (d), the Administrator shall develop and publish, for
each locality identified on the list, an action plan that includes—
(A)an identification
of the chemical substances and mixtures that contribute to the disproportionate
exposure (including exposure levels, sources, and pathways); and
(B)a description of
actions to be undertaken by the Administrator, to reduce disproportionate
exposure within the locality.
(2)The
goal of each action plan under this subsection shall be to reduce
disproportionate exposure within the locality by establishing the
following:
(A)A percentage
exposure reduction goal for each chemical substance and mixture.
(B)A timeline to
achieve such a percentage exposure reduction goal.
(g)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 (d);
(B)each action plan
developed in the prior year under subsection (e); and
(C)the progress on
each action plan to date; and
(2)make the report
available to the public in electronic format.
36.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 chapter, 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
administrative 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
reasonable service charges.
(b)The United States 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 chapter 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 chapter, but no department, agency, or instrumentality of the
executive, legislative, or judicial branch of the Federal Government 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 chapter.
(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)Each
January after the date of enactment of this section, 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 chapter. The Administrator shall initiate an
administrative enforcement action against such a department, agency, or
instrumentality 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 department, agency, or instrumentality
shall become final until such department, agency, or instrumentality has had
the opportunity to confer with the Administrator.
37.Implementation
of Stockholm Convention, the LRTAP Pops Protocol, and the Rotterdam
Convention
(a)
(1)The
term chemical includes any substance or mixture of substances,
including as part of an article.
(2)The phrase meeting of the parties
means—
(A)the Conference of
the Parties established by and operating under Article 19 of the Stockholm
Convention;
(B)the Executive
Body established by and operating under Article 10 of the LRTAP POPs
Convention; and
(C)the Conference of
the Parties established by and operating under Article 18 of the Rotterdam
Convention.
(3)The term LRTAP Convention means the
Convention on Long-Range Transboundary Air Pollution, done at Geneva on
November 13, 1979 (TIAS 10541), and any subsequent amendments to which the
United States is a party.
(4)The term LRTAP POPs chemical means any
chemical listed on any Annex of the LRTAP POPs Protocol, if such listing has
entered into force for the United States.
(5)The term LRTAP POPs Protocol means the
Protocol on Persistent Organic Pollutants to the LRTAP Convention, done at
Aarhus on June 24, 1998, and any subsequent amendment to which the United
States is a party.
(6)The term PIC chemical means any chemical
identified by notification to the Secretariat of the Rotterdam Convention by
the United States as banned or severely restricted in the United States, and
any chemical listed on any Annex of the Rotterdam Convention, if such listing
has entered into force for the United States.
(7)The term POPs chemical means any chemical
that is listed on any Annex of the Stockholm Convention, if such listing has
entered into force for the United States.
(8)The term Rotterdam Convention means the
Rotterdam Convention on the Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in International Trade, done at Rotterdam on
September 10, 1998, and any subsequent amendment to which the United States is
a party.
(9)The term Stockholm Convention means the
Stockholm Convention on Persistent Organic Pollutants, done at Stockholm on May
22, 2001, and any subsequent amendment to which the United States is a
party.
(b)Core
implementation provisions
(1)The Administrator, in cooperation with any appropriate
Federal agency, shall implement and support the implementation by the United
States of the provisions, that have entered into force for the United States,
of the Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam
Convention.
(2)Notwithstanding
any other provision of law, no person may manufacture, process, distribute in
commerce, use, dispose of, or take any other action with respect to a POPs
chemical, LRTAP POPs chemical, or PIC chemical in a manner inconsistent with
applicable obligations for that chemical under the Stockholm Convention, LRTAP
POPs Protocol, or Rotterdam Convention.
(3)Public notice
and comment
(A)The Administrator
shall provide timely public notice and opportunity to comment on a chemical
proposed for listing to any Annex to the Stockholm Convention, the LRTAP POPs
Protocol, or the Rotterdam Convention. The Administrator shall identify in the
notice any relevant toxicity, exposure, and risk information on the chemical
known to the Administrator, and any domestic activities involving the chemical
known to the Administrator. Any interested person may provide relevant comment
and information on the chemical in response to that notice. The Administrator
may, if the Administrator determines it to be necessary to assist the United
States in its review, require the provision of relevant information related to
a proposed chemical from any person. Such comment and information shall be
considered in the Administrator’s review of the proposal and shall be placed in
an established public docket.
(B)The Administrator
shall also provide timely public notice and opportunity to comment after a
recommendation is made to list a chemical on any Annex to the Stockholm
Convention, the LRTAP POPs Protocol, or the Rotterdam Convention. The
Administrator shall provide such notice in advance of the Meeting of the
Parties at which the recommendation is to be considered. The Administrator
shall request comment and information on all aspects of such recommendation and
may, if the Administrator determines it to be necessary to assist the United
States in its review, require the provision of relevant information related to
a proposed chemical from any person. Such comment and information shall be
considered in the Administrator’s review of the listing recommendation and
shall be placed in an established public docket.
(C)The Administrator
shall also provide public notice and opportunity to comment on any decision by
the Meeting of the Parties to list a chemical on any Annex to the Stockholm
Convention. No later than 30 days after such decision becomes available, the
Administrator shall provide in the notice a description of the amendments to
the instruments and shall identify changes to any current domestic activities
that the Administrator believes, based on information available to the
Administrator, would be necessary should the United States choose to be bound
by the listing decision. Any interested person may provide relevant comment and
information in response to that notice. Such comment and information shall be
considered in the Administrator’s review of the decision and shall be placed in
an established public docket.
(D)No later than 30
days after the United States deposits its instrument of ratification for the
Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, or
no later than 30 days after the listing of any chemical subsequently added
under those instruments has entered into force for the United States (whichever
comes sooner), the Administrator shall provide notice of the chemicals that are
subject to those instruments and shall provide similar public notice of any
chemical subsequently added under those instruments. In providing such notice,
the Administrator may specify the requirements that are applicable for
individual chemicals.
(4)General
rulemaking authorityThe Administrator may prescribe regulations
to carry out the provisions of the Stockholm Convention, the LRTAP POPs
Protocol, and the Rotterdam Convention, or to ensure compliance with any
obligations under such instruments.
(5)If a chemical is subject to obligations under more
than one of the instruments listed in paragraph (4), the most stringent of such
obligations shall apply to ensure compliance with each of those
instruments.
(c)The
prohibitions and any other requirements of this part shall be enforced in the
same manner as final rules or orders under section 2605 of the Toxic Substances
Control
Act.
.
(b)The table of contents for the Toxic Substances Control
Act (15 U.S.C. 2601 et seq.) is amended—
(1)by striking the
item relating to section 2 and inserting the following:
Sec. 2. Findings, policy, and
goal.
;
(2)by striking the item relating to section 4
and inserting the following:
Sec. 4. Minimum data set and testing of chemical substances and
mixtures.
;
(3)by striking the
item relating to section 6 and inserting the following:
Sec. 6. Prioritization, safety standard determination, and risk
management.
;
(4)by striking the
items relating to sections 29 through 31; and
(5)by adding after
the item relating to section 28 the following:
Sec. 29. Expedited action on chemicals of highest
concern.
Sec. 30. Children’s Environmental Health Research
Program.
Sec. 31. Reduction of animal-based testing.
Sec. 32. Safer alternatives and green chemistry and
engineering.
Sec. 33. Cooperation with international efforts.
Sec. 34. Reliable information and advice.
Sec. 35. Hot spots.
Sec. 36. Application of this Act to Federal
agencies.
Sec. 37. Implementation of Stockholm Convention, the LRTAP Pops
Protocol, and the Rotterdam Convention.
Sec. 38. Annual report.
Sec. 39. Authorization of
appropriations.
.