Toxic Chemicals Safety Act of 2010 - Amends the Toxic Substances Control Act to direct the Administrator of the Environmental Protection Agency (EPA) to promulgate a rule that: (1) establishes the data that constitute the minimum data set for chemical substances (chemicals) and mixtures; and (2) requires chemical manufacturers and processors to submit their minimum data sets. Requires such manufacturers and processors to submit such minimum data sets for chemicals placed on the priority list and new chemicals. Authorizes the Administrator to require the testing of chemicals and mixtures.
Requires the Interagency Testing Committee, in forming a list of chemicals and mixtures that the Administrator should test, to give priority attention to those chemicals and mixtures which are known to cause or contribute to adverse affects on health or the environment. Revokes the limit on the number of chemicals and mixtures that may be placed on such a list.
Prohibits any person from manufacturing or processing a new chemical or a chemical for a new use unless: (1) the person notifies the Administrator about the person's intention to manufacture or process the chemical; (2) such use is a critical use; and (3) the chemical or mixture meets the safety standard under such Act.
Requires a priority list to be established that contains specified chemicals for which safety determinations shall first be made. Requires the: (1) Administrator to update and publish the list; and (2) updated list to consist of at least 300 chemicals. Authorizes the Administrator to add chemical mixtures to the list.
Requires the Administrator to apply a safety standard that takes into account aggregate exposure to chemicals or mixtures and ensures that, for all intended uses, there is a reasonable certainty that no harm will result to the public health and that the public welfare is protected. Requires: (1) manufacturers and processors to bear the burden of proving that chemicals or mixtures meet such safety standard; and (2) the Administrator to determine whether such burden has been met.
Sets forth provisions concerning: (1) biomonitoring studies regarding chemicals or any metabolite or degradation byproducts of chemicals; (2) the manufacture, processing, distribution or use of polychlorinated biphenyl; (3) declarations of manufacturing or processing chemicals or mixtures; (4) a public database of information relating to the toxicity and use of, and exposure to, chemicals and mixtures; (5) disclosures to commercial purchasers of information about the chemicals and mixtures they purchase; (6) a survey by the Administrator about mixtures; (7) exportation and importation of chemicals or mixtures; (8) conditions under which data about chemicals may be designated as confidential business information; and (9) civil actions and penalties for violations of such Act.
Prohibits any person from: (1) manufacturing, processing, distributing, using for commercial purposes, or disposing of chemicals, mixtures, or articles containing chemicals or mixtures that such person knew or had reason to know were manufactured, processed, or distributed in violation of such Act; and (2) introducing or knowingly distributing chemicals, mixtures, or articles containing chemicals or mixtures that fail to comply with labeling requirements.
Requires the Administrator to: (1) establish criteria to identify chemicals and mixtures that are persistent, bioaccumulative, and toxic; (2) list chemicals and mixtures that meet such criteria; and (3) impose conditions on manufacturing, processing, using, distributing, or disposing such chemicals and mixtures.
Requires the Administrator to: (1) enter into contracts and make grants to further understanding of the vulnerability of children to chemical substances; (2) establish the Science Advisory Board on Children's Health and Toxic Substances; and (3) conduct, not later than two years after identifying a chemical substance which is likely to be present in human biological media at a level above that normally found and which is likely to have adverse effects on early childhood development, a biomonitoring study to determine the presence of such substance in the biological media of pregnant women and infants.
Requires the Administrator to: (1) take action to minimize the use of animals in testing of chemical substances or mixtures; (2) establish a program to create incentives for the development of safer alternatives to existing chemicals and mixtures that reduce or avoid the use and generation of hazardous chemical substances or mixtures; (3) cooperate with international efforts to develop a common protocol or electronic database relating to chemical substances and mixtures or to develop safer alternatives; (4) implement the provisions of international agreements related to chemicals and mixtures to which the U.S. becomes a party; and (5) promulgate a rule to establish criteria for the determination of disproportionate exposure to toxic chemicals, establish criteria to identify any locality that is disproportionately exposed, develop a method for data collection on and categorization of patterns of disproportionate exposure and associated adverse effects, identify and publish a list localities within the United States subject to disproportionate exposure, and develop action plans to reduce such disproportionate exposure.
Prohibits any person from manufacturing, processing, distributing, using for commercial purposes, or disposing of hexabromobiphenyl, hexachlorobenzene, hexabromodiphenyl ether and heptabromodiphenyl ether and congeners in the commercial OctaBDE mixture, pentachlorobenzene, and tetrabromodiphenyl ether and pentabromodiphenyl ether and congeners in the commercial PentaBDE mixture.
Authorizes the Administrator to exempt a substance or mixture, or particular uses of the substance or mixture, from requirements of such Act if the Administrator determines that the scientific consensus is that it does not and would not pose any risk of injury to health or the environment under any current, proposed, or anticipated levels of production, patterns of use, or exposures arising at any stage across its lifecycle.
[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5820 Introduced in House (IH)]
111th CONGRESS
2d Session
H. R. 5820
To amend the Toxic Substances Control Act to ensure that the public and
the environment are protected from risks of chemical exposure, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 22, 2010
Mr. Rush (for himself, Mr. Waxman, Ms. Castor of Florida, Ms. DeGette,
Ms. Schakowsky, and Mr. Sarbanes) introduced the following bill; which
was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Toxic Substances Control Act to ensure that the public and
the environment are protected from risks of chemical exposure, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Toxic Chemicals Safety Act of
2010''.
SEC. 2. FINDINGS, POLICY, AND GOAL.
(a) Findings, Policy, and Goal.--Section 2 of the Toxic Substances
Control Act (15 U.S.C. 2601) is amended--
(1) by striking ``intent'' in the section heading and
inserting ``goal''; and
(2) by striking subsections (a) through (c) and inserting
the following:
``(a) Findings.--Congress finds that--
``(1) the chemical industry is an important part of the
United States economy and provides valuable products that are
used in diverse manufacturing industries and other commercial,
institutional, and consumer applications;
``(2) more than 3 decades after the enactment of the Toxic
Substances Control Act, the public and the environment in the
United States are still exposed to thousands of chemicals whose
safety has not been adequately reviewed;
``(3) biomonitoring reveals that people in the United
States have many hazardous chemicals in their bodies;
``(4) the potential for adverse effects from chemical
exposures is modulated by developmental changes in metabolism,
physiology, and pathways of exposure, with increased potential
for adverse effects from exposures that occur in utero, during
infancy, and during other critical periods of development;
``(5) there is significant global trade in the chemical
sector and many of the companies that conduct business in the
United States must also comply with chemical safety regulatory
programs in other countries, and the data that are generated to
comply with these other regulatory programs may be useful in
understanding the hazards of and exposures to chemicals in the
United States; and
``(6) a revised policy on the safety of chemicals will
assist in renewing the manufacturing sector of the United
States, create new and safer jobs, spur innovations in green
chemistry, restore confidence domestically and internationally
in the safety of products of the United States, and ensure that
products of the United States remain competitive in the global
market.
``(b) Policy.--It is the policy of the United States--
``(1) to protect the health of children, workers,
consumers, and the public, and to protect the environment from
adverse effects of exposures to chemicals;
``(2) to promote the use of safer alternatives and other
actions that reduce use of and exposure to hazardous chemicals
and reward innovation in developing safer chemicals, processes,
and products;
``(3) to require that all chemicals in commerce meet a
risk-based safety standard that protects disproportionately
vulnerable and affected populations and the environment;
``(4) to require manufacturers and processors to provide
sufficient health and environmental information for the
chemicals which they manufacture or process as a condition of
allowing distribution of such chemicals in commerce;
``(5) to improve the quality of information on chemical
safety and use;
``(6) to guarantee the right of the public and workers to
know about the risks associated with chemicals that they may be
exposed to by maximizing public access to information on such
chemicals;
``(7) to strengthen cooperation between and among the
Federal Government and State, municipal, tribal, and foreign
governments;
``(8) to ensure the Administrator has the authority to
develop sufficient information to assess chemical safety, and
to act effectively when the Administrator obtains information
that indicates there are risks of harmful chemical exposure;
and
``(9) to replace, reduce, and refine testing on animals by
promoting and funding the development of more efficient test
methods and strategies.
``(c) Goal.--It is the goal of the United States to protect health
and the environment by addressing exposure to harmful chemicals
distributed in commerce, including exposure of vulnerable or
disproportionately affected populations, by--
``(1) determining whether all chemicals in commerce meet
the safety standard under this title;
``(2) restricting the manufacture, processing, use,
distribution in commerce, or disposal of a chemical, where
warranted; and
``(3) encouraging the replacement of harmful chemicals and
processes with safer alternatives.''.
(b) Conforming Amendment.--The table of contents for the Toxic
Substances Control Act is amended by amending the item relating to
section 2 to read as follows:
``Sec. 2. Findings, policy, and goal.''.
SEC. 3. DEFINITIONS AND DETERMINATIONS.
(a) Definitions and Determinations.--Section 3 of the Toxic
Substances Control Act (15 U.S.C. 2602) is amended--
(1) by striking--
``SEC. 3. DEFINITIONS.
``As used in this Act:'' and inserting the following:
``SEC. 3. DEFINITIONS AND DETERMINATIONS.
``(a) Definitions.--As used in this Act:'';
(2) in subsection (a), (relating to definitions, as
designated by paragraph (1))--
(A) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``Except as
provided in subparagraph (B), the
term'' and inserting ``The term'';
(II) in clause (i), by striking
``and'' after ``nature,'';
(III) in clause (ii), by striking
the period at the end and inserting ``,
and''; and
(IV) by adding at the end the
following new clause:
``(iii) any form of a substance determined by the
Administrator to be a chemical substance under
subsection (b)(1).''; and
(ii) in subparagraph (B)--
(I) by striking clause (ii) and
inserting the following:
``(ii) any alcoholic beverage (as defined
in section 214 of the Federal Alcohol
Administration Act),'';
(II) in clause (iii), by striking
``product,'' inserting ``product (as
defined in section 201 of the Federal
Food, Drug, and Cosmetic Act), and'';
and
(III) by striking clauses (v) and
(vi) and the matter following clause
(vi);
(B) in paragraph (4)--
(i) by striking ``or'' after ``or
article;''; and
(ii) by inserting ``; or to export or offer
for export the substance, mixture, or article,
except for demonstrated use solely as a
pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act),
food, food additive, drug, cosmetic, or device
(as such terms are defined in section 201 of
the Federal Food, Drug, and Cosmetic Act) and
including poultry, poultry products, meat, meat
food products (as defined in section 1(j) of
the Federal Meat Inspection Act), eggs, and egg
products (as defined in section 4 of the Egg
Products Inspection Act)'' after ``article
after its introduction into commerce'';
(C) in paragraph (5), by inserting ``ambient and
indoor'' after ``includes water,'';
(D) in paragraph (7), by inserting ``, except for
demonstrated use solely as a pesticide (as defined in
the Federal Insecticide, Fungicide, and Rodenticide
Act), food, food additive, drug, cosmetic, or device
(as such terms are defined in section 201 of the
Federal Food, Drug, and Cosmetic Act) and including
poultry, poultry products, meat, meat food products (as
defined in section 1(j) of the Federal Meat Inspection
Act), eggs, and egg products (as defined in section 4
of the Egg Products Inspection Act)'' after ``produce,
or manufacture'';
(E) in paragraph (9), by striking ``which is not
included in the chemical substance list compiled and
published under section 8(b)'' and inserting ``for
which no declaration has been submitted under section
8(a)(2), except that, with respect to the first year
after the date of enactment of the Toxic Chemicals
Safety Act of 2010, such term shall not include a
chemical substance distributed in commerce as of such
date of enactment'';
(F) in paragraph (10), after subparagraph (B), by
adding the following:
``Except such term shall not include preparation for
demonstrated use solely as a pesticide (as defined in the
Federal Insecticide, Fungicide, and Rodenticide Act), food,
food additive, drug, cosmetic, or device (as such terms are
defined in section 201 of the Federal Food, Drug, and Cosmetic
Act) and including poultry, poultry products, meat, meat food
products (as defined in section 1(j) of the Federal Meat
Inspection Act), eggs, and egg products (as defined in section
4 of the Egg Products Inspection Act). Relabeling or
redistributing a container holding a chemical substance or
mixture where no repackaging of the chemical substance or
mixture occurs does not constitute processing of the chemical
substance or mixture. Relabeling, redistributing, or
repackaging an article containing a chemical substance or
mixture, including incorporating the article into another
article, does not constitute processing of the chemical
substance or mixture.''.
(G) by striking paragraph (12) and redesignating
paragraphs (13) and (14) as paragraphs (12) and (13),
respectively; and
(H) by adding at the end the following new
paragraphs:
``(14) The term `adverse effect' means a chemical or
biochemical change, anatomic change, or functional impairment,
or a known precursor to such a change or impairment, that--
``(A) has the potential to impair the performance
of an anatomic structure of a vital system of an
organism or progeny of an organism;
``(B) causes irreversible change in the homeostasis
of an organism;
``(C) increases the susceptibility of an organism
or progeny of an organism to other chemical or
biological stressors or reduces the ability of an
organism or progeny of an organism to respond to
additional health or environmental challenges; or
``(D) affects, alters, or harms the environment
such that the health of humans or other organisms is
directly or indirectly threatened.
In order to reflect best available science, the Administrator
may, by rule, revise the definition of such term for purposes
of this Act in such a way that reflects the state of the
science and provides for equal or greater protection of health
and the environment.
``(15) The term `aggregate exposure' means all exposure
from--
``(A) manufacture, processing, distribution, use,
and disposal;
``(B) manufacturing or processing of the substance
for use as a pesticide, food, food additive, drug,
cosmetic, or device;
``(C) contamination of food, air, water, soil,
house dust, and any other environmental media from
current or prior uses or activity;
``(D) permitted sources of pollution;
``(E) nonpoint sources of pollution; and
``(F) documented background levels from natural and
anthropogenic sources.
``(16) The term `bioaccumulative' means, with respect to a
chemical substance or mixture, that the chemical substance or
mixture, as determined by the Administrator, can significantly
accumulate in biota, as indicated through monitoring data, or
is highly likely to accumulate in biota, as indicated by other
evidence. In order to reflect best available science, the
Administrator may, by rule, revise the definition of such term
for purposes of this Act in such a way that reflects the state
of the science and provides for equal or greater protection of
health and the environment.
``(17) The term `chemical identity' means, with respect to
a chemical substance--
``(A) each common and trade name of the chemical
substance;
``(B) the name of the chemical substance appearing
in International Union of Pure and Applied Chemistry
nomenclature and 9th Collective Index format;
``(C) the Chemical Abstracts Service registration
number of the chemical substance; and
``(D) the molecular structure and the molecular
identity of the chemical substance.
``(18) The term `cumulative exposure' means the sum of
aggregate exposure to--
``(A) each of the chemical substances that are
known or, where supported by scientific consensus,
suspected to contribute appreciably to the risk of the
same adverse effect; and
``(B) mixtures containing chemical substances
described in subparagraph (A).
``(19) The term `Federal agency' means any department,
agency, or other instrumentality of the Federal Government, any
independent agency or establishment of the Federal Government
including any Government corporation, and the Government
Printing Office.
``(20) The term `importer' means any person who imports a
chemical substance or mixture, or any article containing a
chemical substance or mixture, for distribution in commerce.
``(21) The term `persistent' means, with respect to a
chemical substance or mixture, that the chemical substance or
mixture, as determined by the Administrator, significantly
persists in 1 or more environmental media, as indicated by
monitoring data or other evidence. In order to reflect best
available science, the Administrator may, by rule, revise the
definition of such term for purposes of this Act in such a way
that reflects the state of the science and provides for equal
or greater protection of health and the environment.
``(22) The term `substance characteristic' means, with
respect to a particular chemical substance, the physical and
chemical characteristics that may vary for such substance, and
whose variation may bear on the toxicological properties or the
exposure potential of the substance, including--
``(A) structure and composition;
``(B) size or size distribution;
``(C) shape;
``(D) surface structure;
``(E) reactivity; and
``(F) other characteristics and properties that may
bear on toxicological properties or exposure potential.
``(23) The term `toxic', with respect to a chemical
substance or mixture, means that the chemical substance or
mixture, or a metabolite or degradation product of such
substance or mixture, has a toxicological property--
``(A) that causes an adverse effect that has been
demonstrated in humans or other organisms; or
``(B) for which the weight of evidence (such as
demonstration of such an adverse effect as described in
subparagraph (A) in laboratory studies or data for a
chemical from the same chemical class that exhibits
such an adverse effect) demonstrates the potential for
an adverse effect in humans or other organisms.
``(24) The term `toxicological property' means established
toxicity, adverse effects, or established precursors to such
toxicity or adverse effects, including effects of exposure to a
chemical substance or mixture on--
``(A) mortality;
``(B) morbidity, including carcinogenesis;
``(C) genetics, including mutagenicity,
genotoxicity, and epigenetics;
``(D) reproduction;
``(E) growth and development;
``(F) the immune system;
``(G) the endocrine system;
``(H) the brain or nervous system;
``(I) other organ systems; or
``(J) any other biological functions in humans or
other organisms.
``(25) The term `use' means any utilization of a chemical
substance or mixture that is not otherwise covered by the terms
manufacture or process, and may include--
``(A) any composition of the chemical substance
with other chemical substances;
``(B) any group of utilizations determined by the
Administrator to be a single use under subsection
(b)(2).
Relabeling or redistributing a container holding a chemical
substance or mixture where no repackaging of the chemical
substance or mixture occurs does not constitute use of the
chemical substance or mixture.
``(26) The term `vulnerable population' means a population
that is subject to a disproportionate exposure to, or potential
for a disproportionate adverse effect from exposure to, a
chemical substance or mixture, including--
``(A) infants, children, and adolescents;
``(B) pregnant women (including effects on fetal
development);
``(C) the elderly;
``(D) individuals with preexisting medical
conditions;
``(E) workers; and
``(F) members of any other appropriate population
identified by the Administrator based on consideration
of--
``(i) socioeconomic status;
``(ii) racial or ethnic background;
``(iii) culturally influenced dietary or
other practices or factors; or
``(iv) other similar factors identified by
the Administrator.''; and
(3) by adding at the end the following new subsection:
``(b) Determinations.--
``(1) The Administrator may determine different forms of a
chemical substance with a particular molecular identity to be
different chemical substances for purposes of this Act, based
on variations in the substance characteristics. New forms of
existing chemical substances so determined shall be considered
new chemical substances for purposes of this Act.
``(2) The Administrator may determine different uses of a
chemical substance or mixture to be the same use for purposes
of this Act, based on industry classification systems or
factors determined by the Administrator to indicate similarity
in use and exposure, provided that such systems or factors
ensure that the different uses treated as the same use under
this paragraph do not involve materially different patterns,
pathways, or degrees of exposure.''.
(b) Conforming Amendment.--The table of contents for the Toxic
Substances Control Act is amended by amending the item relating to
section 3 to read as follows:
``Sec. 3. Definitions and Determinations.''.
SEC. 4. MINIMUM DATA SET AND TESTING OF CHEMICAL SUBSTANCES AND
MIXTURES.
Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is
amended as follows:
(1) By amending subsection (a) to read as follows:
``(a) Minimum Data Set.--
``(1) Not later than 1 year after the date of enactment of
the Toxic Chemicals Safety Act of 2010, the Administrator shall
establish, by rule, the data that constitute the minimum data
set for substances described in paragraph (2). The rule shall--
``(A) require manufacturers and processors to
submit a minimum data set that the Administrator
determines will be useful in conducting safety standard
determinations pursuant to section 6(b) or carrying out
any provision of this Act, and shall include
information on--
``(i) chemical identity;
``(ii) substance characteristics;
``(iii) biological and environmental fate
and transport;
``(iv) toxicological properties;
``(v) volume manufactured, processed, or
imported;
``(vi) intended uses; and
``(vii) exposures from all stages of the
chemical substance or mixture's lifecycle that
are known or reasonably foreseeable to the
party submitting the data set;
``(B) provide for varied or tiered testing;
``(C) establish requirements for manufacturers and
processors to update their minimum data set
submissions, as appropriate; and
``(D) be updated by the Administrator not less
often than once every 5 years.
``(2) Except as provided in paragraph (3), the
manufacturers and processors of a chemical substance or mixture
shall submit the minimum data set established by the rule under
paragraph (1), accompanied by the certification described in
section 8(i), to the Administrator--
``(A) for an existing chemical substance or
mixture, not later than the earlier of--
``(i) 18 months after the date on which the
Administrator lists the chemical substance or
mixture on the priority list under section
6(a); or
``(ii) for chemical substances produced--
``(I) at high volumes, as
determined by the Administrator, 3
years after the date of enactment of
the Toxic Chemicals Safety Act of 2010;
``(II) at moderate volumes, as
determined by the Administrator, 4
years after the date of enactment of
the Toxic Chemicals Safety Act of 2010;
or
``(III) at low volumes, as
determined by the Administrator, 5
years after the date of enactment of
the Toxic Chemicals Safety Act of 2010;
or
``(B) for a new chemical substance, the date on
which the notice required under section 5(a)(1)(A) is
submitted.
``(3) No minimum data set shall be required to be submitted
by manufacturers and processors of a chemical substance listed
under section 6(a)(1)(A) or exempted from the requirement
pursuant to section 39 or section 32 or for a safer alternative
approved pursuant to section 35.
``(4) If a manufacturer or processor is in violation of
paragraph (2), the Administrator may impose penalties, pursuant
to section 16, on such manufacturer or processor, or, by order,
impose conditions, including prohibitions, on the manufacture,
processing, or distribution in commerce of the chemical
substance, or any mixture or article containing the chemical
substance, by such manufacturer or processor.''.
(2) In subsection (b)--
(A) by redesignating paragraphs (2) and (3) as
paragraphs (4) and (5), respectively;
(B) by redesignating paragraphs (4) and (5) as
paragraphs (7) and (8), respectively;
(C) in paragraph (1)--
(i) by striking ``A rule under subsection
(a) shall include'' and all that follows
through ``during the period prescribed under
subparagraph (C)''; and
(D) by striking the following:
``(b)(1) Testing requirement rule.--'' and inserting the following:
``(b) Testing Rules and Orders.--
``(1) The Administrator may, by rule or order, after notice
and opportunity for comment, require testing in addition to the
requirements for the minimum data set under subsection (a) with
respect to any chemical substance or mixture and the submission
of test results by a specified date, as necessary for making a
safety standard determination under section 6(b) or carrying
out any provision of this Act.
``(2) If a manufacturer or processor is in violation of
paragraph (1), the Administrator may impose penalties, pursuant
to section 16, on such manufacturer or processor, or, by order,
impose conditions, including prohibitions, on the manufacture,
processing, or distribution in commerce of the chemical
substance, or any mixture or article containing the chemical
substance, by such manufacturer or processor.
``(3) A rule or order under paragraph (1) shall include--
``(A) identification of the chemical substance or
mixture for which testing is required;
``(B) the testing required and justification for
such testing, and may specify test protocols and
methodology for testing for such substance or mixture
in accordance with section 34(c); and
``(C) a specification of the period (which period
may not be of unreasonable duration) within which the
persons required to conduct the testing shall submit to
the Administrator data developed in accordance with a
methodology referred to in subparagraph (B).
In determining the testing, test protocols, and methodology,
and period to be included, pursuant to subparagraphs (B) and
(C), in a rule or order under paragraph (1), the Administrator
shall consider the relative costs of the various test protocols
and methodologies which may be required under the rule or order
and the reasonably foreseeable availability of the facilities
and personnel needed to perform the testing required under the
rule or order. Any such rule or order may require the
submission to the Administrator of preliminary data during the
period prescribed under subparagraph (C).'';
(E) by amending paragraph (4), as redesignated by
subparagraph (A) of this paragraph, to read as follows:
``(4)(A)(i) The health and environmental effects for which testing
may be prescribed include any toxicological property and any other
adverse effect which may be considered in a safety standard
determination under section 6(b).
``(ii) The exposure information for which testing may be
prescribed includes biological or environmental fate and
transport, monitoring for the presence of the chemical
substance or mixture (or a metabolite or degradation byproduct
of the chemical substance or mixture) in animal or human
biological media or environmental media, and any other exposure
information which may be considered in a safety standard
determination under section 6(b).
``(iii) The characteristics of chemical substances and
mixtures for which testing may be prescribed include
persistence, bioaccumulation, and any other relevant substance
characteristic which may be considered in a safety standard
determination under section 6(b).
``(B) The methodologies that may be prescribed in testing include
epidemiologic studies, industrial hygiene surveys, biomonitoring
studies, serial or hierarchical tests, in vitro tests, and whole animal
tests consistent with section 34, except that before prescribing
epidemiologic studies or industrial hygiene surveys of employees, the
Administrator shall consult with the Director of the National Institute
for Occupational Safety and Health.
``(C) From time to time, but not less than once each 12 months, the
Administrator shall review the adequacy of the methodology for testing
prescribed in rules or orders under paragraph (1) and shall, if
necessary, institute proceedings to make appropriate revisions of such
methodology.'';
(F) in paragraph (5), as redesignated by
subparagraph (A) of this paragraph--
(i) by striking subparagraph (B);
(ii) by striking ``(A) A rule under
subsection (a) respecting a chemical substance
or mixture shall require the persons described
in subparagraph (B)'' and inserting ``A rule or
order under paragraph (1) respecting a chemical
substance or mixture shall specify the persons
required''; and
(iii) by inserting ``in which case all
parties remain individually liable for the
testing requirements'' after ``on behalf of the
persons making the designation'';
(G) by inserting after paragraph (5), as
redesignated by subparagraph (A) of this paragraph, the
following new paragraph:
``(6) Any biomonitoring study of the public regarding a chemical
substance or any metabolite or degradation byproduct of such substance
shall be conducted by the Director of the Centers for Disease Control
and Prevention in collaboration with the Administrator, at the expense
of the manufacturers and processors of the chemical substance. Any
biomonitoring study of employees regarding a chemical substance or any
metabolite or degradation byproduct of such substance may be conducted
by the relevant employer, at the expense of the manufacturers and
processors of the chemical substance, in collaboration with the
Director of the National Institute of Occupational Safety and Health
and the Administrator.'';
(H) in paragraph (7), as redesignated by
subparagraph (B) of this paragraph--
(i) by striking ``under subsection (a)'' in
both places it appears and inserting ``or order
under paragraph (1)'';
(ii) by striking ``repeals the rule'' in
both places it appears and inserting
``withdraws the rule or order''; and
(iii) by striking ``repeals the application
of the rule'' and inserting ``withdraws the
rule or order as applied''; and
(I) by amending paragraph (8), as redesignated by
subparagraph (B) of this paragraph, to read as follows:
``(8) Rules issued under subsection (a) and paragraph (1) (and any
substantive amendment thereto or repeal thereof) shall be promulgated
pursuant to section 553 of title 5, United States Code.''.
(3) In subsection (c)--
(A) in paragraph (1)--
(i) by inserting ``or order'' after
``rule''; and
(ii) by striking ``subsection (a)'' and
inserting ``subsection (a) or (b)(1)'';
(B) in paragraph (2)--
(i) by striking ``under subsection (a)''
and inserting ``under subsection (b)(1)''; and
(ii) by inserting ``or order'' after
``rule'' each place it appears;
(C) in paragraph (3)(B)(i), by striking
``promulgated under subsection (a)'' and inserting ``or
order issued under subsection (b)(1)'';
(D) in paragraph (4)--
(i) in subparagraph (A)--
(I) by striking ``promulgated under
subsection (a)'' and inserting ``issued
under subsection (b)(1)''; and
(II) by inserting ``or order''
after ``rule'' each place it appears;
and
(ii) in subparagraph (B)--
(I) by striking ``promulgated under
subsection (a)'' and inserting ``or
order issued under subsection (b)(1)'';
and
(II) by inserting ``or order''
after ``such rule''; and
(III) by inserting ``or order''
after ``requirements of the rule''; and
(E) by adding at the end the following new
paragraph:
``(5) If a manufacturer or processor has submitted a
declaration of permanent cessation of manufacture or processing
under section 8(a)(3) for a chemical substance or mixture, the
manufacturer or processor shall be exempted from the
requirements of this section with regard to such chemical
substance or mixture.''.
(4) In subsection (d)--
(A) by striking ``under subsection (a)'' and
inserting ``or order issued under subsection (a) or
(b)(1)'';
(B) by inserting ``Such notice shall not be
interpreted as meeting the requirements of the rule or
order, unless otherwise indicated.'' before ``Subject
to section 14, each notice shall''; and
(C) by inserting ``and be added to the public
database established pursuant to section 8(d)'' after
``Administrator for examination by any person''.
(5) In subsection (e)--
(A) in the subsection heading, by striking
``Priority List'' and inserting ``Interagency Testing
Committee'';
(B) in paragraph (1)--
(i) in subparagraph (A)--
(I) by striking ``for the
promulgation of a rule under subsection
(a)'' and inserting ``for listing under
section 6(a)(1) and promulgation of
testing rules or orders under
subsection (b)(1)'';
(II) in clause (v), by striking
``an unreasonable'' and inserting ``a
substantial''; and
(III) in the matter following
clause (viii)--
(aa) by striking ``cancer,
gene mutations, or birth
defects'' and inserting
``adverse effects on health or
the environment'';
(bb) by striking ``under
subsection (a)'' each place it
appears and inserting ``under
subsection (b)(1)''; and
(cc) by striking ``The
total number of chemical
substances and mixtures on the
list which are designated under
the preceding sentence may not,
at any time, exceed 50.''; and
(ii) in subparagraph (B), by striking
``rulemaking proceeding under subsection (a)''
and inserting ``proceeding to promulgate a rule
or issue an order under subsection (b)(1)'';
and
(C) in paragraph (2)(A)--
(i) by striking ``eight members'' and
inserting ``10 members''; and
(ii) by adding at the end the following new
clauses:
``(ix) One member appointed by the Commissioner of
the Food and Drug Administration from officers or
employees of the Administration.
``(x) One member appointed by the Chairman of the
Consumer Product Safety Commission from officers or
employees of the Commission.''.
(6) By amending subsection (f) to read as follows:
``(f) Requests From Other Federal Agencies for Additional
Information or Testing.--
``(1) In general.--If a Federal agency determines that
information relating to a chemical substance or mixture,
including data derived from new testing or monitoring, would
assist such agency in carrying out duties or exercising
authority of such agency, but such information is not available
to the agency, such agency may request the Administrator to
seek such information on its behalf.
``(2) Duty of administrator.--Not later than 60 days after
the date of receipt of a request under paragraph (1), the
Administrator shall--
``(A) if in possession of the requested data, make
such data available to the requesting agency, subject
to section 14;
``(B) issue an order, under section 8(b)(1),
requiring the submission of existing data to the
requesting agency and to the Administrator;
``(C) issue a rule or order, under subsection (b),
to develop such data, and require such data be
furnished to the requesting agency and to the
Administrator; or
``(D) publish in the Federal Register the reason
for not taking any of the actions described in
subparagraphs (A) through (C).''.
(7) By striking subsection (g).
SEC. 5. MANUFACTURING AND PROCESSING NOTICES.
Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is
amended as follows:
(1) By amending subsection (a) to read as follows:
``(a) New Chemical Substances and Mixtures and New Uses of Chemical
Substances and Mixtures.--
``(1) Except as provided in subsection (d), no person may
manufacture or process a new chemical substance or mixture, or
manufacture or process any chemical substance or mixture for a
use which the Administrator has determined, in accordance with
paragraph (2), is a new use, unless--
``(A) such person submits to the Administrator, at
least 90 days before such manufacture or processing, a
notice, in accordance with subsection (c) and section
8(i), of such person's intention to manufacture or
process such chemical substance or mixture and such
person complies with any applicable requirement of
subsection (b); and
``(B) the Administrator finds that--
``(i) such use is a critical use as
determined pursuant to section 6(e);
``(ii) in the case of a chemical substance
or mixture that has not already been determined
to meet the safety standard under section 6(b),
the chemical substance or mixture meets the
safety standard under section 6(b), with or
without conditions; or
``(iii) in the case of a chemical substance
or mixture that has already been determined to
meet the safety standard under section 6(b)
without inclusion of the proposed new use, the
chemical substance or mixture continues to meet
the safety standard under section 6 for all
intended uses including the new use, with or
without conditions.
``(2) A use shall be determined by the Administrator to be
new if--
``(A) the chemical substance or mixture has already
received a safety standard determination under section
6(b) which did not include the use; or
``(B) the proposed use will result in manufacturing
or processing of the chemical substance or mixture at a
significantly increased volume, as determined by the
Administrator, above that considered in the safety
standard determination under section 6(b).
``(3) Not later than 30 days after the date on which a
manufacturer or processor commences manufacturing or processing
of a new chemical substance or mixture or commences
manufacturing or processing of a chemical substance or mixture
for a new use, the manufacturer or processor shall submit to
the Administrator a notice of commencement of manufacture or
processing.''.
(2) By amending subsection (b) to read as follows:
``(b) Submission of Data for Uses and Manufacturers or Processors
Not Previously Declared.--
``(1) For a chemical substance or mixture which is not new
that has not yet received a safety standard determination under
section 6(b), any manufacturer or processor who manufactures,
processes, or distributes in commerce the chemical substance or
mixture for a use that has not previously been declared under
section 8(a), shall submit the declaration required by section
8(a) within 6 months of initiating manufacture, processing, or
distribution, for that use.
``(2) Any manufacturer or processor who manufactures,
processes, or distributes in commerce a chemical substance for
a use that the particular manufacturer or processor has not
previously declared under section 8(a), even where such use has
previously been declared by another party, shall submit the
declaration required by section 8(a) within 6 months of
initiating manufacture, processing, or distribution for that
use.
``(3) For any chemical substance subject to a Significant
New Use Rule pursuant to part 721 of title 40, Code of Federal
Regulations, as of the date of enactment of the Toxic Chemicals
Safety Act of 2010, the requirements of that rule shall apply
to all manufacturers and processors of the chemical substance
whether or not the Administrator determines a use to be new
pursuant to subsection (a), unless and until the chemical
substance receives a safety standard determination and, if
appropriate, conditions or prohibitions are imposed pursuant to
section 6, after which the Significant New Use Rule shall cease
to apply.
``(4) For a chemical substance or mixture that is subject
to a rule or order under section 4, the manufacturer or
processor of such chemical for any use which has not previously
been declared under section 8 shall submit to the Administrator
any data required in accordance with such rule or order with
the notice under subsection (a)(1)(A) or the declaration under
this subsection, as appropriate.
``(5) Not later than 90 days after submission of a notice
under subsection (a)(1)(A), and data under paragraph (4), if
required, the Administrator shall determine, pursuant to
subsection (a)(1)(B), whether the use is a critical use or
whether a safety standard determination is required by that
paragraph. Not later than 9 months after the date of such
determination, the Administrator shall complete any such
required safety standard determination. The Administrator's
failure to make a determination pursuant to this paragraph in a
timely manner shall not be deemed to satisfy subsection
(a)(1)(B).''.
(3) By striking subsection (c) and redesignating subsection
(d) as subsection (c).
(4) By amending subsection (c), as redesignated by
paragraph (3) of this section, to read as follows:
``(c) Content of Notice; Publications.--The notice required by
subsection (a)(1)(A) shall include--
``(1) the declaration under section 8(a)(2);
``(2) the minimum data set, as defined pursuant to section
4(a); and
``(3) a statement that the chemical substance or mixture is
reasonably anticipated to meet or continue to meet the safety
standard under section 6(b), and a justification for such
statement.
Such a notice shall be made available, subject to section 14,
in the public database established pursuant to section 8(d).'';
(5) By striking subsections (e), (f), and (g), and
redesignating subsections (h) and (i) as subsections (d) and
(e), respectively.
(6) In subsection (d), as redesignated by paragraph (5) of
this section--
(A) by redesignating paragraphs (1) through (3) as
paragraphs (3) through (5), respectively;
(B) by redesignating paragraphs (5) and (6) as
paragraphs (6) and (7), respectively;
(C) by striking paragraph (4);
(D) by inserting, before paragraph (3), as
redesignated by subparagraph (A) of this paragraph, the
following new paragraphs:
``(1) Any new chemical substance or new use of a chemical
substance or mixture approved pursuant to section 35 as a safer
alternative shall be exempt from the requirements of this
section.
``(2) The Administrator may exempt any new chemical
substance or new use of a chemical substance or mixture from
the requirements of this section pursuant to section 39.'';
(E) in paragraph (3), as redesignated by
subparagraph (A) of this paragraph--
(i) by inserting ``and by order,'' after
``upon application,''; and
(ii) by striking ``any unreasonable'' and
inserting ``a substantial'';
(F) in paragraph (4), as redesignated by
subparagraph (A) of this paragraph--
(i) by amending subparagraph (A) to read as
follows:
``(A) The Administrator shall exempt any person from the
requirement to submit data for a chemical substance or mixture
pursuant to subsection (b)(4), if upon receipt of an
application from such person, the Administrator determines
that--
``(i) the chemical substance or mixture with
respect to which such application was submitted is
equivalent to a chemical substance or mixture for which
data has been submitted to the Administrator as
required by this Act; and
``(ii) submission of data by the applicant on such
substance or mixture would be duplicative of data which
has been submitted to the Administrator in accordance
with subsection (b)(4).
No exemption which is granted under this subparagraph with
respect to the submission of data for a chemical substance or
mixture may take effect before the beginning of the
reimbursement period applicable to such data.''; and
(ii) in subparagraph (B), by striking
``subsection (b)(2)'' each place it appears and
inserting ``subsection (b)(4)'';
(G) in paragraph (6), as redesignated by
subparagraph (B) or this paragraph, by inserting ``,
including occupational exposure'' after ``human or
environmental exposure''; and
(H) in paragraph (7), as redesignated by
subparagraph (B) of this paragraph, by striking ``(1)
or (5)'' and inserting ``(3) or (6)''.
SEC. 6. PRIORITIZATION, SAFETY STANDARD DETERMINATION, AND RISK
MANAGEMENT.
(a) Safety Standard Determination.--Section 6 of the Toxic
Substances Control Act (15 U.S.C. 2605) is amended as follows:
(1) By amending the section heading to read as follows:
``prioritization, safety standard determination, and risk
management''.
(2) By striking subsection (d).
(3) By redesignating subsections (e) and (f) as subsections
(f) and (g), respectively.
(4) By redesignating subsections (a) through (c) as
subsections (c) through (e), respectively.
(5) By inserting before subsection (c), as redesignated by
paragraph (4) of this subsection, the following new
subsections:
``(a) Priority List for Safety Standard Determinations.--
``(1) Establishment of list.--
``(A) As of the date of enactment of the Toxic
Chemicals Safety Act of 2010, there shall be
established a list of chemical substances for which
safety standard determinations under this section shall
first be made, which shall consist of the following
chemical substances:
``(i) Bisphenol A.
``(ii) Formaldehyde.
``(iii) N-Hexane.
``(iv) Hexavalent chromium.
``(v) Methylene chloride.
``(vi) Trichloroethylene.
``(vii) Vinyl chloride.
``(viii) The following phthalates:
``(I) Benzylbutyl phthalate.
``(II) Dibutyl phthalate.
``(III) Diethylhexyl phthalate.
``(IV) Di-isodecyl phthalate.
``(V) Di-isononyl phthalate.
``(VI) Di-n-hexyl phthalate.
``(VII) Di-n-octyl phthalate.
``(ix) Perchlorate.
``(x) Tetrachloroethylene.
``(xi) Tris (1,3-dichloro-2-propyl)
phosphate.
``(xii) Tris (2-chloroethyl) phosphate.
``(xiii) Tris (2,3-dibromopropyl)
phosphate.
``(B) Not later than 12 months after the date of
enactment of the Toxic Chemicals Safety Act of 2010,
the Administrator shall update the list established in
subparagraph (A) and publish in the Federal Register,
after notice and opportunity for comment, the updated
list which shall consist of not fewer than 300 chemical
substances, along with a justification for such
listing. Chemical substances shall be listed at the
Administrator's discretion, based on available
scientific evidence and consideration of their hazard,
exposure, or risk relative to other chemical
substances, aggregate or cumulative exposure, evidence
of exposure to humans including presence in human or
animal biological and environmental media including in
the workplace, use, volume of manufacture,
toxicological properties, persistence, bioaccumulation,
or other properties indicating risk.
``(2) Updating of list.--The Administrator shall--
``(A) remove a chemical substance from the list
under paragraph (1) only after the safety standard
determination has been made for such chemical substance
pursuant to subsection (b); and
``(B) add chemical substances to the list
periodically so that the number of chemical substances
on the list will not be fewer than 300 at any given
time, until such time as all chemical substances
manufactured, processed, or distributed in commerce
have been listed, have received a safety standard
determination, or have been exempted from the
requirement to receive a safety standard determination
pursuant to section 35 or section 39. Additions to the
list shall be consistent with paragraph (1) and, to the
extent practicable, based on consideration of hazard,
exposure, or risk relative to listed chemical
substances. Such additions to the list may be made in
response to petitions under section 21 or
recommendations from the Interagency Testing Committee
under section 4(e).
``(3) Mixtures.--The Administrator may add a mixture to the
priority list based on available scientific evidence and the
considerations for listing described in paragraph (1).
``(b) Safety Standard Determinations.--
``(1) Safety standard.--
``(A) The Administrator shall apply, as the safety
standard under this title, a standard that takes into
account aggregate exposure to a chemical substance or
mixture and ensures that, for all intended uses--
``(i) with regard to public health, there
is a reasonable certainty that no harm will
result, including to vulnerable populations;
and
``(ii) the public welfare is protected.
``(B) In making a determination under this
subsection, the Administrator shall consider, among
other relevant factors---
``(i) the lifecycle of the chemical
substance or mixture; and
``(ii) available information concerning the
cumulative effects of exposure to chemical
substances or mixtures.
``(2) Burden of proof.--The manufacturers and processors of
a chemical substance or mixture shall bear the burden of
proving that the chemical substance or mixture meets the safety
standard.
``(3) Determination.--
``(A) For each chemical substance or mixture listed
under subsection (a), the Administrator shall determine
whether the chemical substance or mixture meets the
safety standard, taking into account any existing
conditions or controls already in effect, or can be
made to meet the safety standard through the imposition
of additional conditions under subsection (c), and
whether intended uses that do not meet the safety
standard are critical. In making this determination,
the Administrator may consider exposures associated
with known or foreseeable uses that are not intended
uses identified by the manufacturers and processors of
the substance or mixture.
``(B) The determination under subparagraph (A)
shall be made in keeping with standards for assessment
developed under paragraph (4).
``(C) Except as provided in subparagraph (D), the
determination under subparagraph (A) shall be completed
and published not later than 30 months after the date
on which the chemical substance or mixture is placed on
the priority list, or, for a chemical substance listed
in subsection (a)(1)(A), not later than 18 months after
the date of enactment of the Toxic Chemicals Safety Act
of 2010.
``(D) In assessing risk to make the determination
under subparagraph (A), the Administrator may require
the submission of additional information by the
manufacturer or processor. If additional information is
required, the determination shall be completed and
published not later than 12 months after the submission
of all required information. Failure to submit required
information in the period specified in section
4(b)(3)(C), as applicable, or by such other reasonable
deadlines as the Administrator shall establish shall
constitute grounds for determining that the chemical
substance or mixture does not meet the safety standard.
``(4) Standards for assessment of data.--
``(A) Not later than 18 months after the date of
enactment of the Toxic Chemicals Safety Act of 2010,
the Administrator shall, after providing for notice and
opportunity for comment, develop and publish guidance
regarding the use of science in making determinations
under this subsection. In developing such guidance, the
Administrator shall rely upon the recommendations of
the National Academy of Sciences report entitled
`Science and Decisions'.
``(B) Not later than 5 years after the date of
enactment of the Toxic Chemicals Safety Act of 2010,
and not less often than once every 5 years thereafter,
the Administrator shall review the guidance under this
paragraph and may revise the guidance to reflect new
scientific developments or understanding.
``(5) Publication.--The Administrator shall make publicly
available, and enter into the public database established
pursuant to section 8(d), the determination made pursuant to
paragraph (3) with a list of allowed uses and any conditions on
those uses necessary to ensure that the safety standard is met.
``(6) Renewal and redetermination.--The determination made
pursuant to paragraph (3) regarding a chemical substance or
mixture shall remain in effect for 15 years, except that the
Administrator shall make a redetermination pursuant to
paragraph (3) if a new use of such chemical substance or
mixture is proposed under section 5, or new information related
to such chemical substance or mixture raises a credible
question as to whether the chemical substance or mixture
continues to meet the safety standard. The Administrator may
renew a determination made pursuant to paragraph (3) for
additional 15 year periods. The burden of proof for renewal of
a determination or redetermination shall remain with the
manufacturers and processors of each chemical substance or
mixture.
``(7) Failure to meet deadlines.--If the Administrator
fails to publish or renew a determination or publish a
redetermination by the applicable deadline pursuant to this
subsection, the Administrator shall promptly publish notice of
such failure in the Federal Register, identifying the chemical
substance or mixture and any information gaps that have impeded
the determination, shall prohibit new manufacturers or
processors or new uses of the chemical substance or mixture
until the determination is published, and shall require
manufacturers and processors of the chemical substance or
mixture to provide, within a reasonable timeframe as determined
by the Administrator, written notice to the public, their
employees and their commercial customers that a safety standard
determination of the chemical substance or mixture is
pending.''.
(6) By amending subsection (c), as redesignated by
paragraph (4) of this subsection, to read as follows:
``(c) Risk Management.--
``(1) Chemical substances and mixtures determined to meet
the safety standard without conditions.--A chemical substance
or mixture, for which the Administrator has determined,
pursuant to subsection (b)(3), that the chemical substance or
mixture meets the safety standard without imposition of
conditions under this subsection, may be manufactured,
processed, and distributed in commerce for uses identified and
included in the safety standard determination. The
Administrator may make such determination contingent on the
continuation of conditions or controls already in effect, if
any.
``(2) Chemical substances and mixtures determined to meet
the safety standard with conditions.--Except as the
Administrator determines pursuant to subsection (e), a chemical
substance or mixture, for which the Administrator has
determined, pursuant to subsection (b)(3), that imposition of
conditions under this subsection is required to ensure that the
chemical substance or mixture meets the safety standard, shall
be subject to conditions on manufacture, processing, use,
distribution in commerce, or disposal, as specified by the
Administrator. Such conditions shall be identified in a manner
that ensures effective and efficient protection of health and
the environment and may include:
``(A) A requirement--
``(i) prohibiting the manufacturing,
processing, or distribution in commerce of such
substance or mixture; or
``(ii) limiting the amount of such
substance or mixture which may be manufactured,
processed, or distributed in commerce.
``(B) A requirement--
``(i) prohibiting the manufacture,
processing, or distribution in commerce of such
substance or mixture for--
``(I) a particular use; or
``(II) a particular use in a
concentration in excess of a level
specified by the Administrator in the
safety standard determination; or
``(ii) limiting the amount of such
substance or mixture which may be manufactured,
processed, or distributed in commerce for--
``(I) a particular use; or
``(II) a particular use in a
concentration in excess of a level
specified by the Administrator in the
safety standard determination.
``(C) A requirement that such substance or mixture,
or any article containing such substance or mixture, be
marked with or accompanied by clear and adequate
warnings and instructions with respect to its use,
distribution in commerce, or disposal or with respect
to any combination of such activities. The form and
content of such warnings and instructions shall be
prescribed by the Administrator or by the appropriate
agency as determined under section 9, and shall be
consistent with the Globally Harmonized System of
Labeling and Classification of Chemicals.
``(D) A requirement that manufacturers and
processors of such substance or mixture make and retain
records of the processes used to manufacture or process
such substance or mixture, or any article containing
such substance or mixture, and monitor or conduct tests
which are reasonable and necessary to assure compliance
with the requirements of any rule applicable under this
paragraph.
``(E) A requirement prohibiting or otherwise
regulating any manner or method of manufacturing,
processing, distribution in commerce or commercial use
of such substance or mixture.
``(F) A requirement that prescribes specific
control measures to reduce occupational exposures shall
reflect the industrial hygiene hierarchy of controls.
``(G)(i) A requirement prohibiting or otherwise
regulating any manner or method of disposal of such
substance or mixture, or of any article containing such
substance or mixture, by its manufacturer or processor
or by any other person who uses, or disposes of, it for
commercial purposes.
``(ii) A requirement under clause (i) may not
require any person to take any action which would be in
violation of any law or requirement of, or in effect
for, a State or political subdivision, and shall
require each person subject to it to notify each State
and political subdivision or tribe in which a required
disposal may occur of such disposal.
``(H) A requirement that the manufacturers and
processors of such chemical substance or mixture, or
article containing such chemical substance or mixture,
develop a risk reduction management plan to achieve a
risk reduction specified by the Administrator. For all
cases in which a risk reduction management plan
requires a reduction in occupational exposure, the
specified level or risk reduction is to be achieved
through application of the industrial hygiene hierarchy
of controls.
Where the Administrator determines that conditions under this
subsection are necessary to ensure that a chemical substance or
mixture meets the safety standard, the Administrator shall
require that such conditions be met within one year after
publication of the determination under subsection (b), or as
quickly as feasible and in no case later than 3 years after
such publication. The Administrator, in determining the
deadline for compliance with conditions pursuant to this
subsection, shall consider human health and the environment as
the primary and paramount concern, and shall also consider the
technological feasibility of compliance, the economic impact of
compliance, the benefits of earlier compliance, and other
relevant considerations. After the date or dates on which
conditions become effective, no person shall manufacture,
process, use for commercial purposes, distribute in commerce,
or dispose of the chemical substance or mixture, or any article
containing such substance or mixture, unless the applicable
conditions of the determination are met with respect to that
person's activities.
``(3) Chemical substances and mixtures determined not to
meet the safety standard.--Except as the Administrator
determines pursuant to subsection (e):
``(A) If the Administrator determines that an
existing chemical substance or mixture has not been
proven to meet the safety standard, pursuant to
subsection (b)(3), effective 1 year after publication
of that determination, or as quickly as feasible and in
no case later than 3 years after such publication, no
person shall manufacture, process, use for commercial
purposes or distribute in commerce the chemical
substance or mixture. The Administrator, in determining
the deadline for compliance with this subsection, shall
consider human health and the environment as the
primary and paramount concern, and shall also consider
the technological feasibility of compliance, the
economic impact of compliance, and other relevant
considerations.
``(B) If the Administrator determines that a new
chemical substance or mixture has not been proven to
meet the safety standard, no person shall manufacture,
process, or distribute in commerce the new chemical
substance or mixture.
``(C) If the Administrator determines that an
existing chemical substance or mixture has not been
proven to meet the safety standard for a new use, no
person shall manufacture, process, use, or distribute
in commerce the existing chemical substance or mixture
for the new use.''.
(7) In subsection (d), as redesignated by paragraph (4) of
this subsection, by striking ``present an unreasonable'' each
place it appears and inserting ``present a significant''.
(8) By amending subsection (e), as redesignated by
paragraph (4) of this subsection, to read as follows:
``(e) Critical Use Exemptions.--
``(1) Exemptions from restrictions on manufacture,
processing, use, distribution in commerce, or disposal imposed
under subsection (c) may be requested for a specific use by a
manufacturer or processor of a chemical substance or mixture,
and may be granted by the Administrator, after providing public
notice and opportunity for comment, if the Administrator
determines that the manufacturer or processor has demonstrated
by clear and convincing evidence that--
``(A)(i) an exemption for the specific use is in
the paramount interest of national security as
determined under section 22;
``(ii) the restriction would significantly disrupt
the national economy; or
``(iii) the specific use is a critical or essential
use; and
``(B)(i) no feasible safer alternative for the
specified use is available; or
``(ii) the specified use of the chemical substance
or mixture provides a net benefit to health or the
environment when compared to all available
alternatives.
``(2) Exemptions granted under paragraph (1) shall expire
after a period not to exceed 5 years, but may be renewed for
one or more additional 5 year periods if the Administrator
finds that the use continues to meet the requirements of
paragraph (1).
``(3) Notice of any exemption granted under this subsection
shall be provided--
``(A) to known commercial purchasers by the
manufacturers and processors of the subject chemical
substance or mixture; and
``(B) to the public by the Administrator.
``(4) The Administrator shall impose conditions on any use
receiving an exemption under this subsection to reduce risk
from the chemical substance or mixture to the greatest extent
feasible. Such conditions shall take effect upon the granting
of such exemption under paragraph (1). For cases in which such
conditions are related to occupational exposure, exposure shall
be controlled through application of the industrial hygiene
hierarchy of controls.''.
(9) In subsection (f), as redesignated by paragraph (3) of
this subsection--
(A) in paragraph (2), by striking ``an unreasonable
risk of injury to health or the environment'' and
inserting ``a substantial risk of injury to health or
the environment, and will comply with section 37 and
any regulations prescribed thereunder'';
(B) in paragraph (3)(B)--
(i) in clause (i)--
(I) by striking ``an unreasonable''
and inserting ``a substantial''; and
(II) by striking ``, and'' and
inserting a semicolon;
(ii) in clause (ii)--
(I) by striking ``which does not
present an unreasonable risk of injury
to health or the environment'' and
inserting ``that meets the safety
standard under subsection (b)''; and
(II) by inserting ``and'' after
``biphenyl;''; and
(iii) by adding at the end the following
new clause:
``(iii) the terms of the exemption will
comply with section 37 and any regulations
prescribed thereunder.'';
(C) by striking paragraph (4); and
(D) by redesignating paragraph (5) as paragraph
(4).
(b) Conforming Amendment.--The table of contents for the Toxic
Substances Control Act is amended by amending the item relating to
section 6 to read as follows:
``Sec. 6. Prioritization, safety standard determination, and risk
management.''.
SEC. 7. IMMINENT HAZARDS.
Section 7 of the Toxic Substances Control Act (15 U.S.C. 2606) is
amended as follows:
(1) By amending subsection (a) to read as follows:
``(a) Actions Authorized and Required.--
``(1) Civil action.--The Administrator may commence a civil
action in an appropriate district court of the United States
for--
``(A) seizure of a chemical substance or mixture or
any article containing such a substance or mixture,
that may present an imminent and substantial
endangerment to health or the environment;
``(B) relief (as authorized by subsection (b))
against any person who manufactures, processes,
distributes in commerce, uses, or disposes of, a
chemical substance or mixture or any article containing
such a substance or mixture, that may present an
imminent and substantial endangerment to health or the
environment; or
``(C) both such seizure described in subparagraph
(A) and relief described in subparagraph (B).
``(2) Other actions.--The Administrator may issue such
orders as may be necessary to protect health or the environment
from a chemical substance or mixture or article containing such
substance or mixture that may present an imminent and
substantial endangerment to health or the environment. Such
orders may include any requirements on the manufacture,
processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or article containing such
substance or mixture, as the Administrator determines are
necessary to protect health or the environment, including the
conditions that may be imposed under section 6(c)(2) and the
relief authorized in subsection (b) of this section.
``(3) Relationship to existing rules, orders, and
proceedings.--A civil action may be commenced under paragraph
(1) or other action may be taken under paragraph (2),
notwithstanding the existence of a rule or order under this Act
and notwithstanding the pendency of any administrative or
judicial proceeding under this Act.''.
(2) In subsection (b)--
(A) in paragraph (1)--
(i) by striking ``subsection (a)'' and
inserting ``subsection (a)(1)''; and
(ii) by striking ``unreasonable risk'' and
inserting ``imminent and substantial
endangerment'';
(B) in paragraph (2)--
(i) by striking ``subsection (a)'' and
inserting ``subsection (a)(1)'';
(ii) by striking ``or distributes in
commerce'' and inserting ``distributes in
commerce, uses, or disposes of'';
(iii) by striking ``risk'' each place it
appears and inserting ``hazard''; and
(iv) by striking ``or (E)'' and inserting
``(E) conditions that may be imposed under
section 6(c); or (F)''; and
(C) in paragraph (3), by striking ``subsection
(a)'' and inserting ``subsection (a)(1)''.
(3) In subsection (c), by striking ``subsection (a)'' each
place it appears and inserting ``subsection (a)(1)''.
(4) By amending subsection (d) to read as follows:
``(d) Action Under Section 6.--As appropriate, concurrently with
the filing of an action under subsection (a)(1) or as soon thereafter
as may be practicable, the Administrator shall add the subject chemical
substance or mixture to the priority list under section 6(a) or
initiate a redetermination of whether the subject chemical substance or
mixture meets the safety standard under section 6(b).''.
(5) In subsection (e), by striking ``subsection (a)'' and
inserting ``subsection (a)(1)''.
(6) By striking subsection (f).
SEC. 8. REPORTING AND RETENTION OF INFORMATION.
Section 8 of the Toxic Substances Control Act (15 U.S.C. 2607) is
amended--
(1) by striking subsection (a) and redesignating subsection
(b) as subsection (c);
(2) by redesignating subsection (e) as subsection (h);
(3) by redesignating subsection (c) as subsection (e);
(4) by striking subsection (d);
(5) by redesignating subsection (f) as subsection (j);
(6) by inserting before subsection (c), as redesignated by
paragraph (1) of this section, the following new subsections:
``(a) Declarations.--
``(1) In general.--(A) Each manufacturer or processor of a
chemical substance distributed in commerce shall submit to the
Administrator a declaration described in paragraph (2) or (3),
accompanied by the certification described in subsection (i),
not later than 1 year after the date of enactment of the Toxic
Chemicals Safety Act of 2010 or 1 year after commencement of
such manufacturing or processing, whichever is earlier.
``(B) The Administrator may additionally require submission
of a declaration described in paragraph (2) or (3), accompanied
by the certification described in subsection (i), from any
manufacturer or processor of a mixture determined by the
Administrator to have substance characteristics different from
the substance characteristics of the constituent chemical
substances, in kind or degree.
``(2) Declaration of current manufacture or processing.--A
declaration described in this paragraph is a statement that
includes, for each chemical substance or mixture that is
manufactured or processed by a manufacturer or processor--
``(A) the chemical identity of the chemical
substance or mixture;
``(B) the name and location of each facility under
the control of the manufacturer or processor at which
the chemical substance or mixture is manufactured or
processed or from which the chemical substance or
mixture is distributed in commerce;
``(C) the number of individuals exposed, and
reasonable estimates of the number who will be exposed,
to such substance or mixture in their places of
employment and the duration of such exposure;
``(D) a list of health and safety studies conducted
or initiated by or for, known to, or reasonably
ascertainable by the manufacturer or processor with
respect to the chemical substance or mixture, and
copies of any such studies that have not previously
been submitted to the Administrator by the manufacturer
or processor; and
``(E) all other information known to, in the
possession or control of, or reasonably ascertainable
by the manufacturer or processor that has not
previously been submitted to the Administrator by the
manufacturer or processor regarding--
``(i) the physical, chemical, and
toxicological properties of the chemical
substance or mixture, including classification
of the toxicity of the chemical in accordance
with the Globally Harmonized System for Hazard
Communication;
``(ii) the categories or proposed
categories of intended use of each such
substance or mixture;
``(iii) the total amount of each substance
and mixture manufactured or processed,
reasonable estimates of the total amount to be
manufactured or processed, the amount
manufactured or processed for each of its
categories of use, and reasonable estimates of
the amount to be manufactured or processed for
each of its categories of use or proposed
categories of use;
``(iv) a description of the byproducts
resulting from the manufacture, processing,
use, or disposal of each such substance or
mixture;
``(v) exposure information relating to the
chemical substance or mixture;
``(vi) any condition or conditions
currently placed on the chemical substance or
mixture due to regulation under any Federal law
or due to voluntary action; and
``(vii) for a processor of a chemical
substance, any information indicating that a
mixture including the chemical substance has
substance characteristics that are different
from the substance characteristics of the named
chemical substances, in kind or degree.
To the extent feasible, the Administrator shall not
require under paragraph (1), any reporting which is
unnecessary or duplicative.
``(3) Declaration of permanent cessation of manufacturing
or processing.--A manufacturer or processor that permanently
ceases manufacture or processing of a chemical substance or
mixture shall file a declaration certifying that the
manufacturer or processor has permanently ceased all
manufacturing or processing of the chemical substance or
mixture, not later than 180 days after cessation is complete. A
declaration under this paragraph may be filed based on an
intention to permanently cease manufacture or processing, in
which case such cessation must be completed not later than 180
days after the declaration is filed.
``(4) Updating of declaration.--Each manufacturer or
processor of a chemical substance or mixture that submits to
the Administrator a declaration required under paragraph (2)
shall submit an update of the previously submitted declaration
to the Administrator, at a minimum, once every 3 years, and
immediately, at any time at which there becomes known or
available to, in the possession or control of, or reasonably
ascertainable by the manufacturer or processor, significant new
information regarding a physical, chemical, toxicological
property or use of, or exposure to, the chemical substance or
mixture, indicating a new potential adverse effect of the
chemical substance or mixture, suggesting an adverse effect at
a lower dose than previously demonstrated, or otherwise
reasonably relevant to an analysis of whether the chemical
substance or mixture meets the safety standard under section 6.
``(5) Records to support declarations.--Each manufacturer
or processor of a chemical substance, substance, or mixture, as
applicable, distributed in commerce shall maintain records of
the information described in subparagraphs (A) through (E) of
paragraph (2).
``(6) Prohibition.--The Administrator may impose penalties,
pursuant to section 16, on a manufacturer or processor in
violation of paragraphs (1) or (4), or, by order, prohibit, or
otherwise impose conditions under section 6(c), on the
manufacture, processing, or distribution in commerce of a
chemical substance or mixture, or any article containing such
chemical substance or mixture, by a manufacturer or processor
in violation of such paragraphs.
``(b) Recordkeeping and Reports.--
``(1) The Administrator may, by rule or order, require any
person who manufactures, processes, distributes in commerce,
uses for commercial purposes, repackages, or disposes of a
chemical substance, mixture, or article containing such
substance or mixture (other than as described in paragraph (2))
to maintain records of and submit reports by a specified date,
to supply any information concerning the chemical substance,
mixture, or article containing such substance or mixture that,
in the judgment of the Administrator, would assist the
Administrator in--
``(A) making a safety standard determination with
respect to a chemical substance or mixture under this
title; or
``(B) administering any other provision of this
Act.
``(2) With respect to the manufacture, processing,
distribution in commerce, use, or disposal of a chemical
substance or mixture in small quantities (as defined by the
Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research, including any
such research or analysis for the development of a product, the
Administrator may require a person to maintain records or
submit a report under paragraph (1) only to the extent the
Administrator determines the maintenance of records or
submission of reports, or both, is necessary for the effective
enforcement of this Act.
``(3) The Administrator may impose penalties, pursuant to
section 16, on a person in violation of a requirement of a rule
or order under paragraph (1) or, by order, prohibit, or
otherwise impose conditions under section 6(c), on the
manufacture, processing, or distribution in commerce of a
chemical substance or mixture, or any article containing such
chemical substance or mixture, by a person in violation of such
a requirement.'';
(7) in subsection (c), as redesignated by paragraph (1) of
this section--
(A) in the subsection heading, by inserting ``and
Categorization'' after ``Inventory'';
(B) by amending paragraph (1) to read as follows:
``(1) Inventory.--The Administrator shall compile, keep
current, publish and enter into the public database established
pursuant to subsection (d) a list of each chemical substance,
and each mixture for which a declaration is received, which is
manufactured or processed in the United States. Such list shall
at least include each such chemical substance or mixture which
any person reports, under section 5 or subsection (a)(2) of
this section, is manufactured or processed in the United
States, but shall not include any chemical substance or mixture
for which all manufacturers and processors have submitted
declarations under subsection (a)(3). In the case of a chemical
substance or mixture for which a notice is submitted in
accordance with section 5, the date of such notice shall be
included in the list under this section, in addition to the
date on which the chemical substance or mixture was first added
to the list. The Administrator shall first publish such a list
not later than 24 months after the effective date of the Toxic
Chemicals Safety Act of 2010. The Administrator shall not
include in such list any chemical substance or mixture which is
manufactured or processed only in small quantities (as defined
by the Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research on, or
analysis of, such substance or mixture or another substance or
mixture, including such research or analysis for the
development of a product.''; and
(C) by amending paragraph (2) to read as follows:
``(2) Categorized inventory.--Not later than 5 years after
the date of enactment of the Toxic Chemicals Safety Act of
2010, and no less than every 3 years thereafter, the
Administrator shall publish in the Federal Register and enter
in the public database established pursuant to subsection (d) a
list of all chemical substances and mixtures manufactured,
processed, or distributed in commerce that categorizes the
chemical substances and mixtures, based on existing information
available to the Administrator, based upon health or
environmental adverse effects, exposure, or other criteria that
the Administrator determine appropriate.'';
(8) by inserting after subsection (c), as redesignated by
paragraph (1) of this section, the following new subsection:
``(d) Public Database and Access to Significant Information.--
``(1) Public database.--Not later than 1 year after the
date of the enactment of Toxic Chemicals Safety Act of 2010,
the Administrator shall establish--
``(A) an electronic database that is searchable,
sortable, downloadable, and publicly accessible on the
Internet for storing and sharing of information
relating to the toxicity and use of, and exposure to,
chemical substances and mixtures; and
``(B) procedures for use in maintaining and
updating the database.
``(2) Public access to significant information.--Not later
than 90 days after the date of any significant decision made by
the Administrator or receipt by the Administrator of any
significant information submitted pursuant to this title, the
Administrator shall, subject to section 14, make available to
the public on the public database established pursuant to
paragraph (1) such significant decision made by the
Administrator under this title or such significant information
submitted pursuant to this title.'';
(9) in subsection (e), as redesignated by paragraph (3) of
this section--
(A) in the subsection heading, by inserting ``of
Significant Adverse Reactions'' after ``Records''; and
(B) by inserting ``Such records shall be submitted
to the Administrator on an annual basis, or immediately
upon request by the Administrator.'' after the first
sentence;
(10) by inserting after subsection (e), as redesignated by
paragraph (3) of this section, the following new subsections:
``(f) Disclosures to Commercial Purchasers.--Effective 1 year after
the date of enactment of the Toxic Chemicals Safety Act of 2010, all
manufacturers and processors of chemical substances and mixtures
subject to this section shall provide, with shipment or promptly
thereafter and by request, to all known commercial purchasers of the
chemical substances and mixtures they manufacture or process a
disclosure, subject to section 14, of--
``(1) the chemical identity of the chemical substance or,
for mixtures, the chemical identity of all chemical
ingredients;
``(2) all information regarding toxicological properties of
the chemical substance or mixture submitted to the
Administrator under subsection (a);
``(3) the list of health and safety studies submitted to
the Administrator under subsection (a), with copies of the
individual studies available upon request; and
``(4) any records of significant adverse reactions
submitted to the Administrator under subsection (e).
``(g) Information in the Possession of Other Federal Agencies.--
``(1) The Administrator may request, and upon such request
a Federal agency shall submit to the Administrator, any
information in the possession or control of such Federal agency
relating to a hazard of, use of, exposure to, or risk of a
chemical substance or mixture, or a report, including copies of
the data and records in the possession or control of such
Federal agency that may be useful to the Administrator in
carrying out the purposes of this Act.
``(2) The Administrator shall specify the format, content,
and level of detail of any report requested under paragraph
(1).
``(3) Each Federal agency shall make its initial submission
to the Administrator within 60 days of receipt of the
specification under paragraph (2).
``(4) The Administrator shall issue a request pursuant to
paragraph (1) to each Federal agency which the Administrator
reasonably expects may have information on chemical substances
or mixtures that would assist the Administrator in making a
safety standard determination for a chemical substance or
mixture under this title. Such requests shall be issued by the
Administrator not later than 12 months after the date on which
the Administrator lists a chemical substance or mixture on the
priority list under section 6(a), or, for chemical substances
identified in section 6(a)(1)(A), 12 months after enactment of
the Toxic Chemicals Safety Act of 2010.''; and
(11) by inserting after subsection (h), as redesignated by
paragraph (2) of this section, the following new subsection:
``(i) Certification.--Each submission required pursuant to this
title, or pursuant to a rule or an order promulgated or issued by the
Administrator under this title, other than a submission under
subsection (g), shall be accompanied by a certification signed by a
responsible official of the submitting party that each statement
contained in the submission--
``(1) is accurate and reliable; and
``(2) includes all material facts known to, in the
possession or control of, or reasonably ascertainable by the
manufacturer or processor.''.
SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.
Section 9(a)(1) of the Toxic Substances Control Act (15 U.S.C.
2608(a)(1)) is amended--
(1) by striking ``the manufacture, processing, distribution
in commerce, use, or disposal of'' after ``If the Administrator
has reasonable basis to conclude that'';
(2) by striking ``, or that any combination of such
activities, presents or will present an unreasonable risk of
injury to health or the environment'' and inserting ``does not
meet the safety standard under section 6(b)'';
(3) by striking ``such risk may be prevented'' and
inserting ``that the risk associated with the chemical
substance or mixture may be prevented'';
(4) by striking ``describes such risk'' and inserting
``describes the risk associated with the chemical substance or
mixture''; and
(5) in the matter following subparagraph (B)--
(A) by striking ``Any report'' and inserting ``Any
such report'';
(B) by striking ``information on which it is based
and shall be published in the Federal Register'' and
inserting ``information on which it is based and shall
be promptly published in the Federal Register and
entered into the public database established pursuant
to section 8(d)'';
(C) by inserting ``and not more than 180 days''
after ``but such time specified may not be less than 90
days''; and
(D) by inserting ``and entered into the public
database established pursuant to section 8(d)'' after
``conclusions of the agency and shall be published in
the Federal Register''.
SEC. 10. MIXTURES.
(a) Mixture Definition and Determination.--Section 3 of the Toxic
Substances Control Act (15 U.S.C. 2602), as amended by section 3 of
this Act, is further amended--
(1) by amending paragraph (8) to read as follows:
``(8) The term `mixture' means any composition of two or
more chemical substances if the composition does not occur in
nature, and is not, in whole or in part, the result of a
chemical reaction.''; and
(2) by inserting after paragraph (b)(2) the following new
paragraph:
``(3) The Administrator may determine different mixtures
comprised of the same chemical substances to be the same
mixture for purposes of this Act, if the substance
characteristics of the mixtures are identical. Mixtures which
would be considered new mixtures but for grouping under this
paragraph shall not be considered new mixtures for purposes of
this Act.''.
(b) Quantification.--Subsection (c) of section 8 of the Toxic
Substances Control Act (15 U.S.C. 2607), as amended by section 8 of
this Act, is further amended by adding at the end the following new
paragraph:
``(3) Mixture survey.--Not later than 6 years after the
date of enactment of the Toxic Chemicals Safety Act of 2010,
the Administrator shall, based on declarations under this
section and a survey of processors as necessary and
appropriate, characterize the number of mixtures, including
mixtures grouped pursuant to paragraph (b)(3) of section 3,
introduced into commerce in the United States, and the number
of such mixtures that have or may have substance
characteristics that are different, in kind or degree, from the
substance characteristics of the constituent chemical
substances, and shall publish such characterization in the
Federal Register and enter it in the public database
established in subsection (d).''.
SEC. 11. INSPECTIONS AND SUBPOENAS.
Section 11 of the Toxic Substances Control Act (15 U.S.C. 2610) is
amended--
(1) in subsection (a)--
(A) by inserting ``commercial'' after
``establishment, facility, or other'';
(B) by striking ``premises in which chemical
substances, mixtures'' and inserting ``premises in
which chemical substances or mixtures subject to this
Act, articles containing such substances or mixtures'';
(C) by inserting ``and any place where records
relating to such chemical substances, mixtures,
articles, or products or otherwise relating to
compliance with this Act, are held'' after ``or such
articles in connection with distribution in commerce'';
and
(D) by adding at the end the following:
``The Administrator, and any duly designated representative of the
Administrator, may also inspect and obtain samples of any such chemical
substances, mixtures, or articles, and any containers or labeling of
such chemical substances, mixtures, or articles.''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``chemical
substances, mixtures, or products'' and inserting
``chemical substances or mixtures subject to this Act,
articles containing such substances or mixtures, or
products''; and
(B) in paragraph (2)(E), by inserting ``or order''
after ``rule''.
SEC. 12. EXPORTS.
Section 12 of the Toxic Substances Control Act (15 U.S.C. 2611) is
amended--
(1) by striking subsection (a) and redesignating
subsections (b) and (c) as subsections (a) and (b),
respectively;
(2) in subsection (a), as redesignated by paragraph (1) of
this section--
(A) in paragraph (1)--
(i) by striking ``or intends to export'';
(ii) by striking ``or 5(b)'';
(iii) by striking ``or intent to export''
and inserting ``not later than 30 days after
the date of exportation of the substance or
mixture''; and
(iv) by inserting ``promptly thereafter''
before ``furnish'';
(B) in paragraph (2)--
(i) by striking ``or intends to export'';
(ii) by striking ``an order has been issued
under section 5 or a rule has been proposed or
promulgated under section 5 or 6, or with
respect to which an action is pending, or
relief has been granted under section 5 or 7''
and inserting ``a condition has been imposed
pursuant to section 6(c)(2) or an action has
been taken pursuant to section 7'';
(iii) by striking ``or intent to export''
and inserting ``not later than 30 days after
the date of exportation of the substance or
mixture'';
(iv) by inserting ``promptly thereafter''
before ``furnish''; and
(v) by striking ``such rule, order, action,
or relief'' and inserting ``such condition
imposed pursuant to section 6(c)(2) or such
action taken pursuant to section 7''; and
(C) by adding at the end the following new
paragraph:
``(3)(A) Any person that has previously notified the
Administrator of the exportation of a chemical substance or
mixture under this section shall notify the Administrator of
any change in the information provided in the original notice
not later than 30 days after such a change.
``(B) The Administrator shall furnish, as promptly as
feasible, an updated notice to the governments that have been
notified pursuant to paragraphs (1) and (2) regarding the
exportation of any chemical substance or mixture subject to
this section if--
``(i) new data for such substance or mixture have
been received by the Administrator pursuant to section
4, section 5(b), section 8(e), or section 8(h);
``(ii) the Administrator has received notice under
subparagraph (A) of a change in the information
provided in the original notice; or
``(iii) a change has been made in any conditions
imposed pursuant to section 6(c) or section 7 for such
substance or mixture.'';
(3) in subsection (b), as redesignated by paragraph (1), by
striking paragraph (2) and redesignating paragraphs (3), (4),
(5), and (6) as paragraphs (2), (3), (4), and (5),
respectively; and
(4) by adding at the end the following new subsections:
``(c) Chemicals Listed Under the PIC Convention.--If any person
intends to export to a foreign country a chemical substance or mixture
listed in Annex III of the PIC Convention as of the date of enactment
of the Toxic Chemicals Safety Act of 2010, such person shall file the
notice required under subsection (a) not later than 30 days prior to
the date of exportation of such substance or mixture and shall include
therein the information required for export under such Convention as of
the date of enactment of the Toxic Chemicals Safety Act of 2010.
``(d) Public Records.--The Administrator shall maintain copies of
all current notices provided to other governments under this section,
and make such copies available to the public in electronic format.
``(e) Definition.--For purposes of this title, the term `PIC
Convention' means the Rotterdam Convention on the Prior Informed
Consent Procedure for Certain Hazardous Chemicals and Pesticides in
International Trade, adopted in Rotterdam on September 10, 1998, and
any subsequent amendment or protocol.''.
SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES.
Section 13 of the Toxic Substances Control Act (15 U.S.C. 2612) is
amended--
(1) by redesignating subsections (a) and (b) as subsections
(b) and (c), respectively;
(2) by inserting, before subsection (b), as redesignated by
paragraph (1) of this section, the following new subsection:
``(a) Duties of Importers.--The importer of any chemical substance,
mixture, or article containing a chemical substance or mixture for
distribution in commerce shall satisfy all requirements under sections
4, 5, 6, and 8 of this Act, without regard to whether the chemical
substance or mixture has been formed into or contained in an article
prior to importation.'';
(3) in subsection (b), as redesignated by paragraph (1) of
this section--
(A) by amending the subsection heading to read as
follows:
``(b) Entry.--'';
(B) by striking ``Secretary of the Treasury'' each
place it appears and inserting ``Secretary of Homeland
Security''; and
(C) in paragraph (1), by striking the em dash and
subparagraphs (A) and (B) and inserting ``the
substance, mixture, or article fails to comply with or
is offered for entry in violation of any rule or order
in effect under this Act.''; and
(4) in subsection (c), as redesignated by paragraph (1) of
this section--
(A) by striking ``Secretary of the Treasury'' and
inserting ``Secretary of Homeland Security''; and
(B) by striking ``subsection (a)'' and inserting
``subsection (b)''.
SEC. 14. DISCLOSURE OF DATA.
Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is
amended--
(1) by redesignating subsections (a) and (b) as subsections
(c) and (d), respectively;
(2) by redesignating subsections (c) through (e) as
subsections (f) through (h), respectively;
(3) by inserting, before subsection (c), as redesignated by
paragraph (1) of this section, the following new subsections:
``(a) Administrator Responsibilities.--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 Administrator's possession
that is releasable pursuant to an appropriate request under
section 552 of title 5, United States Code (commonly referred
to as the `Freedom of Information Act'), is made available to
members of the public.
``(b) Rule of Construction.--Nothing in this section shall be
construed to prevent or discourage the Administrator from voluntarily
releasing to the public any unclassified information that is not exempt
from disclosure under section 552 of title 5, United States Code
(commonly referred to as the `Freedom of Information Act').'';
(4) in subsection (c), as redesignated by paragraph (1) of
this subsection--
(A) by striking ``Except as provided by subsection
(b)'' and all that follows through ``subsection (b)(4)
of such section,'' and inserting ``Except as provided
by subsection (d), information submitted to the
Administrator pursuant to this Act may be designated
for information protection by the submitter of such
information based on the submitter's reasonable belief
that the information is eligible for protection under
section 552 of title 5, United States Code. Information
designated for protection under this section'';
(B) by inserting ``unless the designation is
determined to be inappropriate,'' after ``Administrator
or by any officer or employee of the United States,'';
(C) by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively;
(D) by adding after paragraph (2) the following new
paragraph:
``(3) shall be disclosed upon request to a State, tribal,
or municipal government, including identification of the
location of the manufacture, processing, or storage of a
chemical substance upon the request of the government for the
purpose of administration or enforcement of a law, if one or
more applicable agreements ensure that the recipient government
will take appropriate steps to maintain the confidentiality of
the information in accordance with this section and section
350.27 of title 40, Code of Federal Regulations, or any
successor to such regulation;''; and
(E) in paragraph (4), as redesignated by
subparagraph (C) of this paragraph, by striking ``an
unreasonable'' and inserting ``a substantial'';
(5) in subsection (d), as redesignated by paragraph (1) of
this section--
(A) in the subsection heading, by striking ``Data
From Health and Safety Studies'' and inserting
``Information Not Eligible for Protection'';
(B) by amending paragraph (1) to read as follows:
``(1) The following types of information shall not be
eligible for protection under this section, and the
Administrator shall not approve a request to protect
information of the following types under this section:
``(A) The identity of a chemical substance when
included in a health and safety study, safety standard
determination under section 6(b), or information
indicating the presence of the chemical substance in a
consumer article intended for use or reasonably
expected to be used by children or indicating exposure
to the chemical substance in children.
``(B) The components of a mixture, when included in
a health and safety study, safety standard
determination under section 6(b), or information
indicating the presence of the mixture in a consumer
article intended for use or reasonably expected to be
used by children or indicating exposure to the mixture
in children.
``(C) Any safety standard developed under section
6(b).
``(D) Any health and safety study which is
submitted under this Act with respect to--
``(i) any chemical substance or mixture--
``(I) which, on the date on which
such study is to be disclosed has been
offered for commercial distribution; or
``(II) for which testing is
required under section 4 or for which
notification is required under section
5 of this title; and
``(ii) any data reported to, or otherwise
obtained by, the Administrator from a health
and safety study which relates to a chemical
substance or mixture described in clause (i).
``(E) Any information indicating the presence of a
chemical substance or mixture in a consumer article
intended for use or reasonably expected to be used by
children or indicating exposure to the chemical
substance or mixture in children.
This paragraph does not authorize the release of any data which
discloses processes used in the manufacturing or processing of
a chemical substance or mixture or, in the case of a mixture,
the release of data disclosing the portion of the mixture
comprised by any of the chemical substances in the mixture.'';
and
(C) in paragraph (2)--
(i) by striking ``the first sentence of
paragraph (1)'' and inserting ``paragraph
(1)(D)''; and
(ii) by striking ``in the second sentence
of such paragraph'' and inserting ``in the last
sentence of paragraph (1)'';
(6) by inserting after subsection (d), as redesignated by
paragraph (1) of this section, the following new subsection:
``(e) Guidance.--Not later than 1 year after the date of enactment
of the Toxic Chemicals Safety Act of 2010, the Administrator shall by
order develop and make publicly available guidance that specifies--
``(1) the format for and manner for designating information
for protection;
``(2) the acceptable bases on which written requests to
protect information under this section may be approved, which
shall be no more restrictive of public disclosure than section
552 of title 5, United States Code; and
``(3) the documentation that must accompany such
requests.'';
(7) by amending subsection (f), as redesignated by
paragraph (2) of this section, to read as follows:
``(f) Designation and Release of Confidential Information.--
``(1) Duties of manufacturers and processors.--In
submitting information under this Act, a manufacturer,
processor, or distributor in commerce may designate the
information which such person believes is entitled to
protection under this section, and submit such designated
information separately from other information submitted under
this Act. A designation under this paragraph shall be
accompanied by the appropriate fee under subsection (i), shall
be made in writing and in such manner as the Administrator may
prescribe, and shall include--
``(A) justification for each claim of
confidentiality;
``(B) a certification that the information is not
otherwise publicly available; and
``(C) separate copies of all submitted information,
with 1 copy containing and 1 copy excluding the
information to which the request applies.
Designations shall last for 5 years, at which time the
information shall be made public unless the manufacturer or
processor has submitted a request for renewal, accompanied by
the appropriate fee under subsection (i), made in writing and
in such manner as the Administrator may prescribe, including
all of the elements required for the initial submission.
``(2) Duties of the administrator.--The Administrator
shall--
``(A) evaluate a representative sample of all
submitted designations and requests for renewal within
60 days of their submission to determine whether--
``(i) each claim of confidentiality is
justified under section 552 of title 5, United
States Code, and any applicable guidance
published under subsection (e);
``(ii) the designation was accompanied by
the appropriate fee, made in writing and in
such manner as prescribed by the Administrator,
and included the necessary components; and
``(iii) the information is not publicly
available;
``(B) release all information previously designated
for protection if one or more of the criteria in
subparagraph (A) are not found;
``(C) determine whether the criteria in
subparagraph (A) were met at the time the designation
was made; and
``(D) make such determinations publicly available.
``(3) Notification.--(A) Except as provided by subparagraph
(B), if the Administrator proposes to release for inspection
data which has been designated under paragraph (1) but not
released under paragraph (2), the Administrator shall notify,
in writing and by certified mail, the manufacturer, processor,
or distributor in commerce who submitted such information of
the intent to release such data. If the release of such data is
to be made pursuant to a request made under section 552(a) of
title 5, such notice shall be given immediately upon approval
of such request by the Administrator. The Administrator shall
release the information in accordance with the disclosure and
procedural requirements of section 552 of title 5, United
States Code.
``(B)(i) Subparagraph (A) shall not apply to the release of
information under paragraph (1), (2), (3), (4), or (5) of
subsection (c) of this section, except that the Administrator
may not release data under paragraph (4) of subsection (c) of
this section unless the Administrator has notified each
manufacturer, processor, and distributor in commerce who
submitted such data of such release. Such notice shall be made
in writing by certified mail at least 15 days before the
release of such data, except if the Administrator determines
that the release of such data is necessary to protect against
an imminent risk of injury to health or the environment.
``(ii) Subparagraph (A) shall not apply to the release of
information described in subsection (c)(1) of this section
other than information described in the last sentence of such
subsection.'';
(8) in subsection (g), as redesignated by paragraph (2) of
this section--
(A) by amending the subsection heading to read as
follows:
``(g) Penalties for Wrongful Designation or Disclosure.--'';
(B) by redesignating paragraphs (1) and (2) as
paragraphs (3) and (4), respectively;
(C) by inserting before paragraph (3), as
redesignated by subparagraph (B) of this paragraph, the
following new paragraphs:
``(1) Any manufacturer or processor whose designation of
information for protection under this section is found by the
Administrator not to have met the criteria for protection under
this section at the time the designation was made may be
subject to administrative penalties under section 15.
``(2) Any manufacturer or processor who, knowing that
information does not meet the criteria for protection under
this section, willfully designates such information for
protection, shall be guilty of a misdemeanor and fined not more
than $5,000 or imprisoned for not more than one year, or
both.''; and
(D) in paragraph (4), as redesignated by
subparagraph (B) of this paragraph--
(i) by striking ``paragraph (1)'' and
inserting ``paragraph (3)''; and
(ii) by striking ``subsection (a)(2)'' and
inserting ``subsection (c)(2)''; and
(9) by adding at the end the following new subsections:
``(i) Fees.--The Administrator may, by rule, require the payment of
a reasonable fee from any person designating information for protection
under this section or seeking to renew such a designation to defray the
cost of administering this section. In setting a fee under this
subsection, the Administrator shall take into account the ability to
pay of the person designating or seeking renewal and the cost to the
Administrator of reviewing such designations.
``(j) Risk Information for Workers.--The Administrator shall
provide standards for and facilitate the provision of the chemical
identity, safety standard determination, health and safety data, and
any other information determined by the Administrator to be necessary
to ensure worker safety, that pertains to chemical substances or
mixtures, that workers may come into contact with or otherwise be
exposed to during the course of their work, to such workers and
representatives of each certified or recognized bargaining agent
representing such workers.''.
SEC. 15. PROHIBITED ACTS.
Section 15 of the Toxic Substances Control Act (15 U.S.C. 2614) is
amended--
(1) in paragraph (1), by striking ``(A)'' and all that
follows through ``under title II'' and inserting ``any rule,
order, prohibition, restriction, or other requirement imposed
by this Act or by the Administrator under this Act'';
(2) by amending paragraphs (2) and (3) to read as follows:
``(2) manufacture, process, distribute in commerce, use for
commercial purposes, or dispose of a chemical substance or
mixture, or an article containing a chemical substance or
mixture, which such person knew or had reason to know was
manufactured, processed, or distributed in commerce in
violation of any rule, order, prohibition, restriction, or
other requirement imposed by this Act or by the Administrator
under this Act;
``(3) fail or refuse to (A) establish or maintain accurate
and complete records, (B) submit or make accurate and complete
reports, notices, disclosures, declarations, certifications, or
other information, or (C) permit access to or copying of
records, as required by this Act or a rule thereunder;'';
(3) in paragraph (4), by striking the final period and
inserting ``; or''; and
(4) by adding at the end the following new paragraphs:
``(5) make or submit a statement, declaration, disclosure,
certification, data set, or any oral, written, or electronic
representation that is materially false, in whole or in part,
or to falsify or conceal any material fact, in taking any
action or making any communication pursuant to this Act or
pursuant to any rule or order promulgated or issued under this
Act;
``(6) introduce or deliver for introduction into commerce
or knowingly distribute in commerce a chemical substance or
mixture, or an article containing a chemical substance or
mixture--
``(A) that lacks or fails to comply in any material
respect with any applicable labeling requirements
imposed pursuant to section 6(c); or
``(B) the label, labeling or advertising of which
is misleading in any material respect, including by
reason of representations, either explicit or implicit,
that the chemical substance or mixture is available for
a use other than an intended use; or
``(7) forge, counterfeit, simulate, falsely represent, or
use without proper authority any mark, stamp, tag, label, or
other identification device authorized or required by this Act
or by the Administrator under this Act.''.
SEC. 16. PENALTIES.
Section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``provision of section 15
or 409'' and inserting ``provision of this Act
or a rule promulgated or order issued pursuant
to this Act, as described in section 15'';
(ii) by striking ``$25,000'' and inserting
``$37,500''; and
(iii) by striking ``violation of section 15
or 409'' and inserting ``violation of this
Act'';
(B) by redesignating paragraphs (2), (3), and (4)
as paragraphs (3), (4), and (5), respectively;
(C) by inserting after paragraph (1) the following
new paragraph:
``(2) In the case of any violation described in paragraph
(1), the Administrator may commence a civil action in the
appropriate United States district court to assess penalties
pursuant to paragraph (1) or commence administrative action to
assess penalties pursuant to paragraph (3).'';
(D) in subparagraph (A) of paragraph (3), as
redesignated by subparagraph (B) of this paragraph--
(i) by striking ``A civil penalty for a
violation of section 15 or 409'' and inserting
``In any administrative action to assess
penalties for a violation described in
paragraph (1), a civil penalty for a
violation''; and
(ii) by striking ``within 15 days of'' and
inserting ``not later than 15 days after'';
(E) in paragraph (4), as redesignated by
subparagraph (B) of this paragraph--
(i) by striking ``paragraph (2)(A)'' and
inserting ``paragraph (3)(A)''; and
(ii) by striking ``the United States Court
of Appeals for the District of Columbia Circuit
or for any other circuit'' and inserting ``the
appropriate district court of the United States
for the district''; and
(F) in paragraph (5), as redesignated by
subparagraph (B) of this paragraph, by striking
``paragraph (3)'' each place it appears and inserting
``paragraph (4)''; and
(2) in subsection (b)--
(A) by inserting ``(1)'' before ``Any person who'';
(B) by inserting ``this Act, as described in''
before ``section 15'';
(C) by striking ``or 409'';
(D) by striking ``$25,000'' and inserting
``$50,000'';
(E) by striking ``one year'' and inserting ``5
years''; and
(F) by adding at the end the following new
paragraph:
``(2) Any person who knowingly or willfully violates any provision
of this Act and who knows that such violation may result in imminent
danger of death or serious bodily injury to any person shall, upon
conviction, be subject to a fine of not more than $250,000 or
imprisonment of not more than 15 years, or both. A person that is not
an individual shall, upon conviction of violating this paragraph, be
subject to a fine of not more than $1,000,000.''.
SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE.
Section 17 of the Toxic Substances Control Act (15 U.S.C. 2616) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking ``or
409'';
(ii) in subparagraph (B), by striking
``section 5, 6, or title IV, or by a rule or
order under section 5, 6, or title IV'' and
inserting ``this Act or a rule or order
promulgated or issued under this Act''; and
(iii) in subparagraph (D)--
(I) by striking ``chemical
substance, mixture, or product'' and
inserting `` chemical substance or
mixture subject to this Act, article
containing such substance or mixture,
or product'';
(II) by striking ``of section 5, 6,
or title IV'' and inserting ``of this
Act'';
(III) by striking ``under section
5, 6, or title IV'' and inserting
``promulgated or issued under this Act,
as described in section 15'';
(IV) by inserting ``, article''
before ``, or product and, to the
extent'';
(V) by inserting ``, article''
before ``, or product or exposed to
such substance'';
(VI) by inserting ``, article''
before ``, or product, (ii) to give'';
and
(VII) by inserting ``, article''
before ``, or product, whichever the
person to which the requirement''; and
(B) in paragraph (2)--
(i) by striking ``A civil action described
in paragraph (1)'' and inserting ``The district
courts of the United States shall have
jurisdiction over a civil action described in
paragraph (1). A civil action''; and
(ii) in subparagraph (A), by inserting
``this Act, as described in'' before ``section
15''; and
(2) in subsection (b), by striking ``chemical substance,
mixture, or product'' and inserting ``chemical substance or
mixture subject to this Act, or product''.
SEC. 18. PREEMPTION.
Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is
amended to read as follows:
``SEC. 18. PREEMPTION.
``Nothing in this Act affects the right of a State or political
subdivision of a State or a tribe to adopt or enforce any regulation,
requirement, or standard of performance that is different from or in
addition to a regulation, requirement, liability, or standard of
performance established pursuant to this Act unless compliance with
both this Act and the State or political subdivision of a State or
tribe regulation, requirement, or standard of performance is
impossible.''.
SEC. 19. JUDICIAL REVIEW.
Section 19 of the Toxic Substances Control Act (15 U.S.C. 2618) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking subparagraph (B);
(ii) by striking ``(A)'';
(iii) by inserting ``or issuance'' after
``promulgation'';
(iv) by striking ``section 4(a), 5(a)(2),
5(b)(4), 6(a), 6(e), or 8, or under title II or
IV'' and inserting ``this Act'';
(v) by inserting ``or order'' after
``rule'' each place it appears;
(vi) by inserting ``except that if such
petition is based solely on grounds arising
after such sixtieth day, then any petition for
judicial review of such rule or order shall be
filed within 60 days after such grounds arise''
after ``such person's principal place of
business is located'';
(vii) by striking ``(other than in an
enforcement proceeding)''; and
(viii) by striking ``subparagraph'' and
inserting ``paragraph'';
(B) in paragraph (2)--
(i) by striking ``paragraph (1)(A)'' and
inserting ``paragraph (1)'';
(ii) by striking ``rulemaking''; and
(iii) by inserting ``or order'' after
``rule''; and
(C) by striking paragraph (3);
(2) in subsection (b), by inserting ``or order'' after
``rule'' each place it appears; and
(3) in subsection (c)--
(A) by amending paragraph (1) to read as follows:
``(1) Upon the filing of a petition under subsection (a)(1)
for judicial review of a rule or order, the court shall have
jurisdiction--
``(A) to grant appropriate relief, including
interim relief, as provided in chapter 7 of title 5,
United States Code; and
``(B) to review such rule or order in accordance
with chapter 7 of title 5, United States Code.''; and
(B) in paragraph (2), by inserting ``or order''
after ``rule''.
SEC. 20. CITIZENS' CIVIL ACTION.
Section 20 of the Toxic Substances Control Act (15 U.S.C. 2619) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``under section 4, 5, or 6,
or title II or IV,''; and
(ii) by striking ``section 5 or title II or
IV to restrain such violation'' and inserting
``this Act''; and
(B) in the matter following paragraph (2), by
inserting ``, to enforce this Act or any rule
promulgated or order issued under this Act, or to order
the Administrator to perform an act or duty under this
Act which is not discretionary, as the case may be''
after ``citizenship of the parties''; and
(2) in subsection (b)(1), by striking ``to restrain'' and
inserting ``respecting''.
SEC. 21. CITIZENS' PETITIONS.
Section 21 of the Toxic Substances Control Act (15 U.S.C. 2620) is
amended--
(1) in subsection (a), by striking ``under section 4, 6, or
8 or an order under section 5(e) or (6)(b)(2)'' and inserting
``, order, or any other action authorized under this Act''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``under section
4, 6, or 8 or an order under section 5(e), 6(b)(1)(A),
or 6(b)(1)(B)'' and inserting ``or order or to initiate
other action authorized under this Act'';
(B) in paragraph (3), by striking ``section 4, 5,
6, or 8'' and inserting ``the applicable provisions of
this Act''; and
(C) in paragraph (4)--
(i) in subparagraph (A), by striking ``a
rulemaking proceeding'' and inserting ``a
proceeding authorized under this Act''; and
(ii) in subparagraph (B)--
(I) by striking ``a proceeding to
issue a rule under section 4, 6, or 8
or an order under section 5(e) or
6(b)(2)'' and inserting ``a proceeding
authorized under this Act'';
(II) in clause (i)--
(aa) by inserting ``or
order'' after ``issuance of a
rule'';
(bb) by striking ``or an
order under section 5(e)''; and
(cc) by striking ``an
unreasonable'' and inserting
``a substantial''; and
(III) in clause (ii)--
(aa) by inserting ``except
as provided in clause (i)''
before ``in the case of'';
(bb) by striking ``issuance
of a rule under section 6 or 8
or an order under section
6(b)(2)'' and inserting
``promulgation of a rule,
issuance of an order, or
imposition or issuance of a
restriction or use condition
under this Act''; and
(cc) by striking ``an
unreasonable'' and inserting
``a substantial''.
SEC. 22. EMPLOYEE PROTECTION.
Section 23 of the Toxic Substances Control Act (15 U.S.C. 2622) is
amended as follows:
(1) In subsection (a)--
(A) by striking ``employer may discharge'' and
inserting ``manufacturer, processor, or distributor may
discharge'';
(B) by redesignating paragraphs (1), (2), and (3)
as paragraphs (2), (3), and (4), respectively;
(C) by inserting before paragraph (2), as
redesignated by subparagraph (B) of this paragraph, the
following new paragraph:
``(1) provided, caused to be provided, or is about to
provide or cause to be provided to the employer, the Federal
Government, the appropriate official of the tribe, or the
attorney general of a State information relating to any
violation of, or any act or omission the employee reasonably
believes to be a violation of any provision of this Act;'';
(D) in paragraph (3), as redesignated by
subparagraph (B) of this paragraph--
(i) by inserting ``concerning any such
violation or'' after ``testified or is about to
testify''; and
(ii) by striking ``or'' after ``Act;'';
(E) in paragraph (4), as redesignated by
subparagraph (B) of this paragraph, by inserting ``or''
after ``Act;''; and
(F) by adding at the end the following new
paragraph:
``(5) objected to, or refused to participate in, any
activity, policy, practice, or assigned task that the employee
(or other such person) reasonably believed to be in violation
of any provision of this Act.''.
(2) By striking subsection (e) and amending subsections
(b), (c), and (d) to read as follows:
``(b) Remedy.--(1) Any employee who believes that the employee has
been discharged or otherwise discriminated against by any person in
violation of subsection (a) of this section may, not later than 180
days after the date on which such alleged violation occurs, file (or
have any person file on the employee's behalf) a complaint with the
Secretary of Labor (hereinafter in this section referred to as the
`Secretary') alleging such discharge or discrimination and identifying
the person responsible for such act. Upon receipt of such a complaint,
the Secretary shall notify, in writing, the person named in the
complaint of the filing of the complaint, of the allegations contained
in the complaint, of the substance of evidence supporting the
complaint, and of the opportunities that will be afforded to such
person under paragraph (2).
``(2)(A) Not later than 60 days after the date of receipt
of a complaint filed under paragraph (1) and after affording
the complainant and the person named in the complaint an
opportunity to submit to the Secretary a written response to
the complaint and an opportunity to meet with a representative
of the Secretary to present statements from witnesses, the
Secretary shall initiate an investigation and determine whether
there is reasonable cause to believe that the complaint has
merit and notify, in writing, the complainant and the person
alleged to have committed a violation of subsection (a) of the
Secretary's findings. If the Secretary concludes that there is
reasonable cause to believe that a violation of subsection (a)
of this section has occurred, the Secretary shall accompany the
Secretary's findings with a preliminary order providing the
relief prescribed by paragraph (3)(B). Not later than 30 days
after the date of notification of findings under this
paragraph, either the person alleged to have committed the
violation or the complainant may file objections to the
findings or preliminary order, or both, and request a hearing
on the record. The filing of such objections shall not operate
to stay any reinstatement remedy contained in the preliminary
order. Any such hearing shall be conducted expeditiously. If a
hearing is not requested in such 30-day period, the preliminary
order shall be deemed a final order that is not subject to
judicial review.
``(B)(i) The Secretary shall dismiss a complaint
filed under this subsection and shall not conduct an
investigation otherwise required under subparagraph (A)
unless the complainant makes a prima facie showing that
any behavior described in paragraphs (1) through (5) of
subsection (a) was a contributing factor in the
unfavorable personnel action alleged in the complaint.
``(ii) Notwithstanding a finding by the Secretary
that the complainant has made the prima facie showing
required under clause (i), no investigation otherwise
required under subparagraph (A) shall be conducted if
the employer demonstrates, by clear and convincing
evidence, that the employer would have taken the same
unfavorable personnel action in the absence of that
behavior.
``(iii) The Secretary may determine that a
violation of subsection (a) has occurred only if the
complainant demonstrates that any behavior described in
paragraphs (1) through (5) of subsection (a) was a
contributing factor in the unfavorable personnel action
alleged in the complaint.
``(iv) Relief may not be ordered under subparagraph
(A) if the employer demonstrates by clear and
convincing evidence that the employer would have taken
the same unfavorable personnel action in the absence of
that behavior.
``(3)(A) Not later than 120 days after the date of
conclusion of any hearing under paragraph (2), the Secretary
shall issue a final order providing the relief prescribed by
this paragraph or denying the complaint. At any time before
issuance of a final order, a proceeding under this subsection
may be terminated on the basis of a settlement agreement
entered into by the Secretary, the complainant, and the person
alleged to have committed the violation.
``(B) If, in response to a complaint filed under paragraph
(1), the Secretary determines that a violation of subsection
(a) has occurred, the Secretary shall order the person who
committed such violation--
``(i) to take affirmative action to abate the
violation;
``(ii) to reinstate the complainant to the
complainant's former position together with the
compensation (including back pay), terms, conditions,
and privileges of the complainant's employment;
``(iii) to provide compensatory damages; and
``(iv) where appropriate, exemplary damages.
If such an order is issued, the Secretary, at the request of
the complainant, shall assess against the person against whom
the order is issued a sum equal to the aggregate amount of all
costs and expenses (including attorney's and expert witness
fees) reasonably incurred, as determined by the Secretary, by
the complainant for, or in connection with, the bringing of the
complaint upon which the order was issued.
``(C) If the Secretary finds that a complaint under
paragraph (1) is frivolous or has been brought in bad faith,
the Secretary may award to the prevailing employer a reasonable
attorney's fee, not exceeding $1,000, to be paid by the
complainant.
``(4) If the Secretary has not issued a final decision
within 210 days after the filing of the complaint, the
complainant may bring an action at law or equity for de novo
review in the appropriate district court of the United States
with jurisdiction, which shall have jurisdiction over such an
action without regard to the amount in controversy, and which
action shall, at the request of either party to such action, be
tried by the court with a jury. The proceedings shall be
governed by the same legal burdens of proof specified in
paragraph (2)(B). The court shall have jurisdiction to grant
all relief necessary to make the employee whole, including
injunctive relief and compensatory damages, including--
``(A) reinstatement with the same seniority status
that the employee would have had, but for the discharge
or discrimination;
``(B) the amount of back pay, with interest; and
``(C) compensation for any special damages
sustained as a result of the discharge or
discrimination, including litigation costs, expert
witness fees, and reasonable attorney's fees.
``(5)(A) Unless the complainant brings an action under
paragraph (4), any employee or employer adversely affected or
aggrieved by a final order issued under paragraph (3) may
obtain review of the order in the United States Court of
Appeals for the circuit in which the violation, with respect to
which the order was issued, allegedly occurred or the circuit
in which the complainant resided on the date of such violation.
The petition for review must be filed within 60 days from the
issuance of the final order of the Secretary. Such review shall
conform to chapter 7 of title 5, United States Code. The
commencement of proceedings under this subparagraph shall not,
unless ordered by the court, operate as a stay of the order.
``(B) An order of the Secretary, with respect to which
review could have been obtained under subparagraph (A) shall
not be subject to judicial review in any criminal or other
civil proceeding.
``(6) Whenever a person has failed to comply with an order
issued under paragraph (3), the Secretary shall file a civil
action in the United States district court for the district in
which the violation was found to occur, or in the United States
district court for the District of Columbia, to enforce such
order. In actions brought under this paragraph, the district
courts shall have jurisdiction to grant all appropriate relief,
including injunctive relief and compensatory damages.
``(7)(A) A person on whose behalf an order was issued under
paragraph (3) may commence a civil action against the person to
whom such order was issued to require compliance with such
order. The appropriate United States district court shall have
jurisdiction, without regard to the amount in controversy or
the citizenship of the parties, to enforce such order.
``(B) The court, in issuing any final order under this
paragraph, may award costs of litigation (including reasonable
attorney's and expert witness fees) to any party whenever the
court determines such award is appropriate.
``(c) Nondiscretionary Duty.--Any nondiscretionary duty imposed by
this section shall be enforceable in a mandamus proceeding brought
under section 1361 of title 28, United States Code.
``(d) Deliberate Violation.--Subsection (a) shall not apply with
respect to an employee of a manufacturer, processor, or distributor
who, acting without direction from such manufacturer, processor, or
distributor (or such person's agent), deliberately causes a violation
or alleged violation of any rule, order, regulation, or safety standard
under this Act or any other law enforced by the Administrator.''.
SEC. 23. EMPLOYMENT EFFECTS.
Section 24 of the Toxic Substances Control Act (15 U.S.C. 2623) is
amended--
(1) in subsection (a)--
(A) by striking ``continuing'' and inserting
``periodic''; and
(B) by striking the em dash and paragraphs (1) and
(2) and inserting ``the implementation of this Act.'';
and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``section 4, 5,
or 6 or a requirement of section 5 or 6'' and inserting
``this Act'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``by
order issued'' and inserting ``in writing,'';
and
(ii) in subparagraph (B)--
(I) in clause (i), by inserting
``and'' after the ``such request,'';
and
(II) by striking clause (ii) and
redesignating clause (iii) as clause
(ii); and
(C) by amending paragraph (4) to read as follows:
``(4) This section shall not be construed--
``(A) to require the Administrator to amend or
repeal any rule or order under this Act; or
``(B) to impose a condition on the Administrator's
authority to issue orders or promulgate rules under
this Act.''.
SEC. 24. ADMINISTRATION OF THE ACT.
Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is
amended--
(1) by amending subsection (b) to read as follows:
``(b) Fees.--The Administrator shall, by rule, require the payment
of a reasonable fee from any person required to submit data under this
Act to defray the cost of administering this Act. In setting a fee
under this subsection, the Administrator shall take into account the
ability to pay of the person required to submit the data and the cost
to the Administrator of reviewing such data. Such rules may provide for
sharing such a fee in any case in which the expenses of data production
are shared under this Act.''; and
(2) by redesignating subsections (d) through (g) as
subsections (f) through (i), respectively;
(3) by inserting after subsection (c) the following new
subsections:
``(d) Action With Respect to Specific Chemical Substances.--Any
action authorized under this Act to be taken by the Administrator
through rule or order shall be made through order if the action applies
to a single chemical substance or single category of chemical
substances.
``(e) Action With Respect to Articles Containing a Chemical
Substance or Mixture.--No action taken under this title with respect to
articles containing a chemical substance or mixture shall apply to
articles already introduced or delivered for introduction into
commerce, unless the action is taken pursuant to section 7 to address
an imminent hazard and the Administrator has determined that action
against articles introduced or delivered for introduction into commerce
is necessary to protect health or the environment.''; and
(4) by adding at the end the following new subsection:
``(j) Rulemaking.--In carrying out this Act, the Administrator is
authorized to prescribe such regulations as are necessary to carry out
this Act.''.
SEC. 25. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is
amended--
(1) in subsection (a)--
(A) by amending the subsection heading to read as
follows:
``(a) State Grants.--'';
(B) before ``For the purpose of complementing'', by
inserting the following:
``(1) In general.--'';
(C) by inserting ``and tribes'' after ``may make
grants to States'';
(D) by striking ``unreasonable risks within the
States'' and inserting ``risks within the States and
tribes'';
(E) by striking ``is unable or is not likely to
take'' and inserting ``has not taken''; and
(F) by inserting ``or tribe'' after ``no grant for
any State'';
(2) by redesignating subsections (b), (c), and (d) as
paragraphs (2), (3), and (4), respectively;
(3) in paragraph (2), as redesignated by paragraph (2) of
this section--
(A) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;
(B) in subparagraph (A), as redesignated by
subparagraph (A) of this paragraph--
(i) by redesignating subparagraphs (A)
through (F) as clauses (i) through (vi),
respectively;
(ii) in clause (ii), as redesignated by
clause (i), by inserting ``or tribe''; and
(iii) by striking ``subsection (a)'' each
place it appears and inserting ``paragraph
(1)'';
(C) in subparagraph (B), as redesignated by
subparagraph (B) of this paragraph--
(i) by striking ``paragraph (1)'' and
inserting ``subparagraph (A)'';
(ii) by inserting ``or tribe'' after
``State'' each place it appears; and
(iii) by striking ``including cancer, birth
defects, and gene mutations,'';
(4) in paragraph (3), as redesignated by paragraph (2) of
this section, by striking ``subsection (a)'' and inserting
``this subsection'';
(5) in paragraph (4), as redesignated by paragraph (2) of
this section, by striking ``subsection (a)'' and inserting
``this subsection''; and
(6) by inserting at the end the following new subsection:
``(b) State Coordination.--Not later than 18 months after enactment
of the Toxic Chemicals Safety Act of 2010, the Administrator shall
establish a process to coordinate with State and tribal governments, on
an on-going basis, to share data and priorities relating to the
management of chemical substances and mixtures under this title and
under programs operated by States and tribes, in keeping with
requirements of section 14. The areas for coordination shall include
the following:
``(1) Grant funding under subsection (a).
``(2) Design and development of the public database
established pursuant to section 8(d).
``(3) Development of a process by which confidential
business information may be shared with the States under
section 14.
``(4) Development of action plans under section 38(d).''.
SEC. 26. AUTHORIZATION FOR APPROPRIATIONS.
(a) Authorization.--Section 29 of the Toxic Substances Control Act
(15 U.S.C. 2628) is amended to read as follows:
``SEC. 29. AUTHORIZATION FOR APPROPRIATIONS.
``There are authorized to be appropriated to the Administrator to
carry out this Act such sums as necessary for each of fiscal years 2011
through 2018.''.
SEC. 27. ADDITIONAL REQUIREMENTS.
(a) Additional Requirements.--The Toxic Substances Control Act (15
U.S.C. 2601 et seq.) is amended by adding after section 31 the
following new sections:
``SEC. 32. CHEMICAL SUBSTANCES AND MIXTURES THAT ARE PERSISTENT,
BIOACCUMULATIVE, AND TOXIC.
``(a) Identification.--Not later than 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the Administrator
shall by rule establish criteria to identify chemical substances and
mixtures that are persistent, bioaccumulative, and toxic, or are
degraded or metabolized into chemical substances that are persistent,
bioaccumulative, and toxic, and for which there is documented evidence
of exposure to humans or the environment.
``(b) Publication.--Not later than 6 months after the promulgation
of the rule under subsection (a), and every 3 years thereafter, the
Administrator shall publish a list of all chemical substances and
mixtures that meet those criteria, based on available scientific
information.
``(c) Risk Management.--
``(1) Expedited exposure reduction.--As promptly as
feasible and not later than 18 months after the listing of a
chemical substance or mixture under subsection (b), the
Administrator shall impose conditions authorized under section
6(c) on the manufacture, processing, use, distribution in
commerce, and disposal of such chemical substance or mixture
necessary to achieve the greatest practicable reductions in
exposure to the chemical substance or mixture.
``(2) Residual risk assessment.--Within one year after the
effective date of such conditions, the Administrator shall
determine whether the chemical substance or mixture meets the
safety standard with the conditions imposed, taking into
account the residual risk posed by continued exposure to the
chemical substance or mixture, and shall impose any further
conditions authorized under section 6(c) necessary to ensure
that the chemical substance or mixture meets the safety
standard.
``(d) Manufacturer Duties.--
``(1) No minimum data set.--Notwithstanding the
requirements of section 4(a) of this title, manufacturers and
processors of chemical substances or mixtures listed pursuant
to subsection (b) shall not be required to submit a minimum
data set for such chemical substances or mixtures, unless
requested to do so by the Administrator.
``(2) Declaration.--Not later than 6 months after a
chemical substance or mixture is listed under subsection (b),
manufacturers and processors of such chemical substance or
mixture shall submit the declaration required by section
8(a)(2).
``(e) New Chemical Substances and New Uses.--
``(1) For each new chemical substance subject to section
5(a)(1), the Administrator shall determine whether the chemical
substance or mixture, or a degradation product or metabolite of
the chemical substance or mixture, meets the criteria
established under subsection (a) of this section.
``(2) For each chemical substance or mixture identified in
paragraph (1), and for any proposed new use of a chemical
substance subject to section 5(a)(1) that is identified in
subsection (b), the Administrator shall allow manufacture,
processing, and distribution in commerce of the substance only
for a use which the Administrator determines meets the
requirements of section 6(e).
``SEC. 33. CHILDREN'S ENVIRONMENTAL HEALTH.
``(a) Children's Environmental Health Research.--
``(1) In general.--Subject to amounts made available in
advance in appropriations Acts, the Administrator shall enter
into contracts and make grants to further understanding of the
vulnerability of children to chemical substances.
``(2) Consultation.--Contracts and grants under this
section shall be made in consultation with Science Advisory
Board on Children's Health and Toxic Substances established
under subsection (b) and the Children's Health Protection
Advisory Committee established in response to Executive Order
13045.
``(b) Science Advisory Board on Children's Health and Toxic
Substances.--
``(1) Establishment.--Not later than 90 days after the date
of enactment of the Toxic Chemicals Safety Act of 2010, the
Administrator shall consult with the head of any other
appropriate Federal agency to establish an advisory board to be
known as the `Science Advisory Board on Children's Health and
Toxic Substances'. The Board, and any subcommittee thereof,
shall be subject to the Federal Advisory Committee Act (5
U.S.C. App.).
``(2) Purposes.--The purposes of the Science Advisory Board
on Children's Health and Toxic Substances shall be to provide
independent advice, expert consultation, and peer review upon
the request of the Administrator on the scientific and
technical aspects of issues relating to the implementation of
this title with respect to protecting children's health under
this Act.
``(3) Composition.--The Administrator shall--
``(A) appoint the members of the Board, including,
at a minimum, one employee of--
``(i) the National Institute of
Environmental Health Sciences;
``(ii) the Centers for Disease Control and
Prevention;
``(iii) the National Toxicology Program;
``(iv) the National Cancer Institute;
``(v) the National Tribal Science Council;
and
``(vi) not fewer than 3 centers of
children's health at leading universities;
``(B) ensure that at least \1/3\ of the members of
the Board have specific scientific expertise in the
relationship of chemical exposures to prenatal, infant,
and children's health; and
``(C) ensure that all appointments shall be made
without regard to political affiliation or political
activity, unless required by Federal statute.
``(4) Disclosure.--
``(A) The Administrator shall make publicly
available in accordance with subparagraph (B) the
following information:
``(i) A description of the process used to
establish and appoint the members of the
advisory committee, including the following:
``(I) The process for identifying
prospective members.
``(II) The process of selecting
members for balance of viewpoints or
expertise.
``(ii) A list of all current members,
including, for each member, the following:
``(I) The name of any person or
entity that nominated the member.
``(II) The reason the member was
appointed to the committee.
``(III) Whether the member is
designated as a special government
employee or a representative.
``(IV) In the case of a
representative, the individuals or
entity whose viewpoint the member
represents.
``(iii) A list of all members designated as
special government employees for whom written
certifications were made under section 208(b)
of title 18, United States Code, a summary
description of the conflict necessitating the
certification, and the reason for granting the
certification.
``(iv) Transcripts or audio or video
recordings of all meetings of the committee.
``(v) Any additional information considered
relevant by the head of the agency to which the
advisory committee reports.
``(B)(i) Except as provided in clause (ii), the
Administrator shall make the information required to be
disclosed under subparagraph (A) available
electronically on the official public internet site of
the agency at least 15 calendar days before each
meeting of an advisory committee. If the Administrator
determines that such timing is not practicable for any
required information, the information shall be made
available as soon as practicable but no later than 48
hours before the next meeting of the committee. The
Administrator may withhold from disclosure any
information that would be exempt from disclosure under
section 552 of title 5, United States Code.
``(ii) The Administrator shall make available
electronically, on the official public internet site of
the agency, a transcript or audio or video recording of
each advisory committee meeting not later than 30
calendar days after the meeting.
``(c) Biomonitoring.--
``(1) Study.--
``(A) If, through studies performed pursuant to
grants and contracts under subsection (a), testing or
biomonitoring under section 4, or other available
research, the Administrator identifies a chemical
substance (or a metabolite or degradation product of
such substance) that is likely to be present in human
biological media at a level above that normally found
in such media that is likely to have adverse effects on
early childhood development, the Administrator shall,
except as provided in subparagraph (B), coordinate with
the Secretary of Health and Human Services to conduct,
not later than 2 years after the date on which the
Administrator makes such identification, a
biomonitoring study to determine the presence of the
chemical substance in human biological media in, at a
minimum, pregnant women and infants.
``(B) A biomonitoring study under subparagraph (A)
shall not be required if--
``(i) the Administrator determines that the
chemical substance is already subject to
equivalent testing;
``(ii) the Administrator has determined
that the chemical substance meets the safety
standard; or
``(iii) a safety standard determination is
pending, and the Administrator determines that
such a study is not required to complete the
determination.
``(2) Publication.--Upon completion of any biomonitoring
study conducted pursuant to paragraph (1), the Administrator
shall publish the results of the study on the public database
established pursuant to section 8(d).
``(3) Positive results.--
``(A) Disclosure.--Whenever a chemical substance or
mixture (or a metabolite or degradation product of such
substance or mixture) is determined to be present in
human biological media in a biomonitoring study
conducted pursuant to paragraph (1), the manufacturers
and processors of such chemical substance or mixture
shall, not later than 180 days after the date of
publication of such study, disclose to the
Administrator, commercial customers of the
manufacturers and processors, consumers, and the
public--
``(i) all known uses of the chemical
substance or mixture; and
``(ii) all articles in which the chemical
substance or mixture is or is expected to be
present.
``(B) Cost and form of disclosure.--Information
under clauses (i) and (ii) of subparagraph (A) shall
be--
``(i) added to the public database
established pursuant to section 8(d); and
``(ii) made readily accessible and free of
charge by each applicable manufacturer and
processor in electronic format to the
commercial customers of such manufacturer or
processor, consumers, and the public.
``SEC. 34. REDUCTION OF ANIMAL-BASED TESTING.
``(a) Duties of the Administrator.--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;
``(2) funding research and validation studies to reduce,
refine, and replace the use of animal tests in accordance with
this subsection;
``(3) in consultation with the Interagency Coordinating
Committee on the Validation of Alternative Methods, and after
providing an opportunity for public comment, developing a
strategic plan to promote the development and implementation of
alternative test methods and testing strategies to generate
information used for safety standard determinations under
section 6(b) that do not use animals, including toxicity
pathway-based risk assessment, in vitro studies, systems
biology, computational toxicology, bioinformatics, and high-
throughput screening; and
``(4) biennially reporting to Congress on progress made in
implementing this section.
``(b) List of Methods.--Not later than 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, and triennially
thereafter, the Administrator, in consultation with the Interagency
Coordinating Committee on the Validation of Alternative Methods, shall
publish a list of demonstrated testing methods that reduce the use of
animals in testing.
``(c) Criteria for Adapting or Waiving Animal Testing
Requirements.--Upon request from a manufacturer or processor that is
required to conduct animal-based testing of a chemical substance or
mixture under this title, the Administrator may adapt or waive such
requirement in part or in whole if the Administrator determines that--
``(1) there is sufficient weight-of-evidence that a
chemical substance or mixture has, or does not have, a
particular property for which such testing would be required;
``(2) testing for a specific adverse effect is technically
not practicable to conduct as a consequence of the substance
characteristics; or
``(3) a chemical substance or mixture cannot be tested in
animals at concentrations that do not result in significant
pain or distress as a consequence of the substance
characteristics, such as potential to cause severe corrosion or
severe irritation to tissues.
A waiver under this subsection does not waive the duty of the
manufacturer or processor to demonstrate that the chemical substance or
mixture meets the safety standard under section 5(a) or section 6(b).
``SEC. 35. SAFER ALTERNATIVES AND GREEN CHEMISTRY AND ENGINEERING.
``(a) Safer Alternatives.--
``(1) Incentives.--Not later than 1 year after the date of
enactment of the Toxic Chemicals Safety Act of 2010, the
Administrator shall, after notice and opportunity for comment,
establish a program to create incentives for the development of
safer alternatives to existing chemical substances and mixtures
that reduce or avoid the use and generation of hazardous
chemical substances or mixtures. The program under this
paragraph shall include--
``(A) recognition for a chemical substance or
mixture, an article containing such substance or
mixture, or a non-chemical alternative, determined by
the Administrator under paragraph (2) to be a safer
alternative for all intended uses or for a particular
use of an existing chemical substance or mixture by
means of a special designation intended for use in
marketing the safer alternative, and periodic public
awards; and
``(B) such other financial or non-financial
incentives as the Administrator considers to be
appropriate to encourage the development, marketing,
and use of chemical substances or mixtures, articles
containing such substances or mixtures, or non-chemical
alternatives, determined by the Administrator to be
safer alternatives for all uses or for particular uses
of existing chemical substances or mixtures.
``(2) Safer alternative assessment.--Any person seeking
approval for a safer alternative under this section shall
submit to the Administrator an application, including the safer
alternative data set described in subparagraph (A) and shall
bear the burden of demonstrating that the safer alternative
standard is met, pursuant to subparagraph (B).
``(A) Safer alternative data set.--Not later than
one year after the date of enactment of the Toxic
Chemicals Safety Act of 2010, the Administrator shall
establish, by rule, the data that constitute the safer
alternative data set. The rule shall identify the
information that the Administrator determines will be
useful for the safer alternative standard determination
under subparagraph (B) and shall include--
``(i) chemical identity for the applicant
alternative chemical substance or mixture,
article containing such substance or mixture,
or non-chemical alternative and the chemical
substance or mixture targeted for substitution;
``(ii) the proposed use, if applicable, or
all intended uses of the applicant alternative;
``(iii) substance characteristics,
toxicological properties, and biological and
environmental fate and transport data for the
applicant alternative;
``(iv) known and potential exposures for
the applicant alternative;
``(v) a comparative analysis of the
applicant alternative and the chemical
substance or mixture targeted for substitution
based on the best publicly-available science on
the targeted substance demonstrating that the
applicant alternative will involve lower
hazard, lower exposure, or both; and
``(vi) a demonstration that the applicant
alternative is effective for the proposed use
or for all intended uses, as applicable.
The rule shall require any person applying for approval
of a safer alternative to submit the safer alternative
data set, and may provide a form for such application.
``(B) Safer alternative standard determination.--
The Administrator shall, following the submission of a
safer alternative data set pursuant to subparagraph
(A), approve the applicant alternative chemical
substance or mixture, article containing such substance
or mixture, or non-chemical alternative for the
proposed use or uses if the Administrator determines
that the proposed alternative is effective for the
proposed use or uses and--
``(i) provides a reasonable certainty of no
harm from the aggregate exposure to the
alternative substance from intended uses,
including to vulnerable populations, and
protects the public welfare, considering the
lifecycle of the alternative substance and
cumulative exposures and other relevant
considerations, and, when compared to the
chemical substance or mixture targeted for
substitution--
``(I) reduces the potential for
harm to human health or the
environment;
``(II) has been shown not to be
persistent or bioaccumulative, while
the chemical substance or mixture
targeted for substitution has not; or
``(III) does not require the use of
hazardous, persistent, or
bioaccumulative substances during its
manufacture or processing, while the
chemical substance or mixture targeted
for substitution does; or
``(ii) in the case that the applicant
alternative cannot provide a reasonable
certainty of no harm from the aggregate
exposure to the alternative substance from
intended uses, including to vulnerable
populations, and protect the public welfare,
considering the lifecycle of the alternative
substance and cumulative exposures and other
relevant considerations, the chemical substance
or mixture targeted for substitution had been
granted or would qualify for a critical use
exemption under section 6(e) and the applicant
alternative chemical substance or mixture,
article containing such substance or mixture,
or non-chemical alternative, when compared to
the chemical substance or mixture targeted for
substitution--
``(I) reduces the potential for
harm to human health or the
environment;
``(II) has been shown not to be
persistent or bioaccumulative, while
the chemical substance or mixture
targeted for substitution has not; or
``(III) does not require the use of
hazardous, persistent, or
bioaccumulative substances during its
manufacture or processing, while the
chemical substance or mixture targeted
for substitution does.
Any applicant alternative approved under this
section shall be exempt from the requirements
of sections 4, 5, and 6 for the uses considered
and approved in the approval under this
section, except that any approval under this
section shall expire after 15 years, at which
time a renewal will be required pursuant to
section 6(b).
``(C) Consideration in determination.--Any safer
alternative standard determination made under this
subsection shall be considered by the Administrator in
making a safety standard determination under section
6(b) or in granting an exemption under section 6(e) for
the chemical substance or mixture targeted for
substitution by the application under this subsection.
``(b) Green Chemistry.--
``(1) Green chemistry research network.--Not later than 2
years after the date of enactment of the Toxic Chemicals Safety
Act of 2010, and subject to amounts made available in advance
in appropriations Acts, the Administrator shall establish an
interdisciplinary network of regional centers, to support the
research, development, and adoption of safer alternatives to
existing chemical substances and mixtures, particularly
chemical substances and mixtures listed on the priority list
under section 6(a).
``(2) Green chemistry and engineering research.--Subject to
amounts made available in advance in appropriations Acts, the
Administrator shall make grants and enter into contracts to
promote and support the research, development, and adoption of
safer alternatives to existing chemical substances and
mixtures.
``(3) Green chemistry workforce education and training
program.--
``(A) Establishment of program.--The Administrator
shall establish a program to facilitate the development
of a workforce, including industrial and scientific
workers, that produces safer alternatives to existing
chemical substances and mixtures.
``(B) Goals.--The goals of the program established
under subparagraph (A) are to provide workforce
training on skills that will--
``(i) facilitate the expansion of green
chemistry in the United States to create new
and safer jobs;
``(ii) develop a scientifically and
technically trained green chemistry workforce
in the United States;
``(iii) inform and engage communities about
green chemistry; and
``(iv) promote innovation and strong public
health and environmental protections.
``(C) Implementation.--The Administrator shall,
subject to amounts made available in advance in
appropriations Acts, implement the program established
under subparagraph (A) to achieve the goals under
subparagraph (B), including by--
``(i) promoting the development of a broad
range of skills relevant to the production and
use of safer alternatives to existing chemical
substances and mixtures, including their
design, manufacturing, and use and disposal;
``(ii) developing partnerships with
educational institutions, training
organizations, private sector companies,
community organizations, labor unions, and
other non-profit organizations; and
``(iii) in coordination with the Secretary
of Labor and the Secretary of Energy, providing
grants to State and local governments and to
the partnerships established pursuant to clause
(ii) to promote and support activities
consistent with achieving the goals under
subparagraph (B).
``SEC. 36. INTERNATIONAL COOPERATION AND AGREEMENTS.
``(a) Cooperation.--In coordination with the Secretary of State and
the head of any other Federal agency, as appropriate, the Administrator
shall cooperate with any international effort which the Administrator
determines has broad international support and a reasonable expectation
of success--
``(1) to develop a common protocol or electronic database
relating to chemical substances and mixtures; or
``(2) to develop safer alternatives for chemical substances
and mixtures.
``(b) Prohibition.--
``(1) Prohibition.--Except as provided in paragraph (2),
notwithstanding any other provision of law, effective 3 years
after the date of enactment of the Toxic Chemicals Safety Act
of 2010, no person shall manufacture, process, distribute in
commerce, use for commercial purposes, or dispose of the
following chemical substances, except in a manner determined by
the Administrator to be protective of health and the
environment:
``(A) Hexabromobiphenyl.
``(B) Hexachlorobenzene.
``(C) Hexabromodiphenyl ether and
Heptabromodiphenyl ether and congeners in the
commercial OctaBDE mixture.
``(D) Pentachlorobenzene.
``(E) Tetrabromodiphenyl ether and
pentabromodiphenyl ether and congeners in the
commercial PentaBDE mixture.
``(2) Exception.--If the United States deposits its
instrument of ratification for the Stockholm Convention, the
PIC Convention, or the LRTAP POPs Protocol before the
prohibition under paragraph (1) has taken effect, the effective
date of the prohibition shall be determined in keeping with the
requirements of the applicable agreement.
``(c) Notice of Restrictions Under International Agreements.--Not
later than 60 days after the enactment of the Toxic Chemicals Safety
Act of 2010, the Administrator, in consultation with the Secretary of
State, shall publish in the Federal Register a notice of the chemical
substances or mixtures that are subject to the Stockholm Convention,
the PIC Convention, and the LRTAP POPs Protocol, including conditions
or restrictions relating to such chemical substances or mixtures
imposed by such agreements or by foreign governments pursuant to such
agreements.
``(d) Implementing Agreements.--In consultation with the Secretary
of State and the head of any other appropriate Federal agency (as
determined by the Administrator), the Administrator shall implement the
provisions of international agreements (and any subsequent amendment to
such agreements) related to chemical substances and mixtures to which
the United States becomes a party. Such implementation shall provide
notice at each step in the listing and delisting process as required in
such agreements and include requirements that:
``(1) Not later than 30 days after the United States
deposits its instrument of ratification for the Stockholm
Convention, the PIC Convention, the LRTAP POPs Protocol, or any
other international agreement related to chemical substances
and mixtures, or not later than 30 days after the listing of
any chemical substance or mixture subsequently added under such
an instrument has entered into force for the United States,
(whichever occurs earlier), the Administrator shall provide
public notice of the chemical substances or mixtures that are
subject to that agreement, and shall provide similar public
notice of any chemical substance or mixture subsequently added
under such agreement. In providing such notice, the
Administrator may specify the applicable requirements for
individual chemical substances or mixtures.
``(2) Whenever a chemical substance or mixture is proposed
for listing under an international agreement to which the
United States is a party, the Administrator shall publish in
the Federal Register a notice that--
``(A) includes any relevant toxicity, exposure, and
risk information related to the chemical substance or
mixture known to the Administrator, as well as any
domestic activities involving the chemical substance or
mixture known to the Administrator;
``(B) includes a summary of the process, under the
international agreement, for the listing or delisting
step that was taken, including criteria applied in that
process and records generated by the international body
during that process;
``(C) requires any person that manufactures,
processes, distributes in commerce, uses, or disposes
of the chemical substance or mixture to provide to the
Administrator any information that the Administrator
determines to be necessary to assist the United States
in its consideration of the proposal; and
``(D) provides an opportunity for public comment on
the proposed listing of the chemical substance or
mixture.
The comments and information received under this paragraph
shall be placed in a public docket and shall be considered in
the Administrator's review of the proposal.
``(3) Any chemical substance or mixture listed under an
international agreement to which the United States is a party
that is not already subject to conditions under section 6(c) or
already listed on the priority list under section 6(a) shall be
promptly added to the priority list under section 6(a).
``(4) If there are applicable obligations for a chemical
substance or mixture under more than one international
agreement to which the United States is a party, the most
stringent of such obligations shall apply to ensure compliance
with each of those agreements.
``(e) Rules.--The Administrator may promulgate such rules as the
Administrator determines necessary to cooperate with international
efforts pursuant to subsection (a) and to implement international
agreements related to chemical substances and mixtures pursuant to
subsection (d).
``(f) Effect on Other Provisions of Law.--Nothing in this section
shall affect the authority of the Administrator to regulate a chemical
substance or mixture under any other provision of law, provided that
such regulation--
``(1) is not less stringent than actions prescribed by this
section; and
``(2) does not impair the ability of the United States to
comply with obligations under international agreements (and any
subsequent amendment to such agreements) related to chemical
substances and mixtures to which the United States becomes a
party.
``(g) Definitions.--In this section:
``(1) LRTAP convention.--The term `LRTAP Convention' means
the Convention on Long-Range Transboundary Air Pollution,
adopted in Geneva on November 13, 1979, and any subsequent
amendment or protocol.
``(2) LRTAP pops protocol.--The term `LRTAP POPs Protocol'
means the Protocol on Persistent Organic Pollutants to the
LRTAP Convention, adopted in Aarhus on June 24, 1998, and any
subsequent amendment.
``(3) Stockholm convention.--The term `Stockholm
Convention' means the Stockholm Convention on Persistent
Organic Pollutants adopted in Stockholm on May 22, 2001, and
any subsequent amendment or protocol.
``SEC. 37. DATA QUALITY.
``Not later than 18 months after the date of enactment of the Toxic
Chemicals Safety Act of 2010, the Administrator shall, by order, after
notice and opportunity for comment, establish and implement procedures
to ensure data quality under this Act including, at a minimum,
requirements that--
``(1) not less than annually, the Administrator randomly
inspect commercial and private laboratories that develop the
data required under this title;
``(2) annually, the Administrator perform a comprehensive
data audit on a subset, as selected by the Administrator, of
the data submissions under this title;
``(3) the Administrator have access to all records of
privately sponsored health and safety studies initiated in
response to requirements under this title; and
``(4) the submitter of any study conducted by a third party
in response to requirements under this title disclose to the
Administrator and the public, at the time of submission, the
sources of any funding used for the conduct or publication of
the study received by the researchers who conducted the study.
``SEC. 38. HOT SPOTS.
``(a) Criteria.--Not later than 1 year after the date of enactment
of the Toxic Chemicals Safety Act of 2010, the Administrator shall
promulgate a rule to--
``(1) establish criteria for the determination of
disproportionate exposure, which shall include criteria for
identification of average exposure levels in the United States
and criteria for identification of exceedences that are
significant based on their potential impact on health or the
environment;
``(2) establish criteria to identify any locality that is
disproportionately exposed; and
``(3) develop a method for data collection on and
categorization of patterns of disproportionate exposure and
associated adverse effects.
``(b) Identification.--
``(1) In general.--Not later than 18 months after
promulgation of the rule under subsection (a), the
Administrator shall identify localities within the United
States subject to disproportionate exposure.
``(2) Use of data.--In identifying localities under
paragraph (1), the Administrator--
``(A) shall use data contained in the National Air
Toxic Assessment Database; and
``(B) may use other data available to the
Administrator, including data developed pursuant to--
``(i) the Safe Drinking Water Act (42
U.S.C. 300f et seq.);
``(ii) the Solid Waste Disposal Act (42
U.S.C. 6901 et seq.);
``(iii) the Comprehensive Environmental
Response, Compensation, and Liability Act of
1980 (42 U.S.C. 9601 et seq.);
``(iv) the Emergency Planning and Community
Right-to-Know Act of 1986 (42 U.S.C. 11001 et
seq.); and
``(v) the National Environmental Public
Health Tracking program at the Centers for
Disease Control and Prevention.
``(3) Public participation.--The Administrator shall
provide an opportunity for State, local, and tribal governments
and members of the public to nominate localities for which
there may be disproportionate exposure for inclusion in the
identification of localities under paragraph (1).
``(c) Hot Spot List.--
``(1) In general.--Not later than 180 days after completing
the identification of localities under subsection (b)(1), the
Administrator shall, after notice and consultation with all
applicable State, local, and tribal health and environmental
officials, legislators and other elected officials, and members
of the public, publish a list of the localities subject to
disproportionate exposure identified pursuant to such
subsection in the Federal Register and make such list available
electronically. The initial list shall include at least 20
localities.
``(2) Updating.--Not later than 5 years after the date of
publication of the list under paragraph (1), and at least once
every 5 years thereafter, the Administrator shall update and
republish such list. The Administrator may update and republish
such list to add new localities that meet the criteria under
subsection (a), or to remove localities when the Administrator
determines that the percentage exposure reduction goal for such
a locality established pursuant to subsection (d) has been
achieved and no further action is needed. The Administrator
shall notify all applicable State, local, and tribal health and
environmental officials, legislators and other elected
officials, and members of the public of such an updated
listing.
``(d) Action Plans.--Not later than 1 year after publishing or
updating the list under subsection (c), the Administrator shall
coordinate with State, local, and tribal governments and members of the
public to develop, for each locality identified on the list, an action
plan to reduce disproportionate exposure within such locality. Each
such action plan shall include--
``(1) identification of the chemical substances and
mixtures that contribute to the disproportionate exposure
(including exposure levels, sources, and pathways);
``(2) a description of actions to be undertaken by the
Administrator or State, local, or tribal governments, to reduce
disproportionate exposure within the locality;
``(3) a percentage exposure reduction goal for each
chemical substance and mixture identified under paragraph (1);
and
``(4) a timeline to achieve the percentage exposure
reduction goal under paragraph (3).
``(e) Report to Congress.--Beginning on the date that is one year
after the development of the first action plan under subsection (d),
and annually thereafter, the Administrator shall--
``(1) prepare and submit to Congress an annual report
identifying--
``(A) each locality added to the list in the prior
year under subsection (c);
``(B) each action plan developed in the prior year
under subsection (d);
``(C) the progress on each action plan to date; and
``(D) the reasons why any timelines for percentage
exposure reductions were not met and the revised
timeline for meeting those reductions; and
``(2) make the report available to the public in the public
database established under section 8(d).
``(f) Locality.--In this section, the term `locality' means any
geographical area in which the Administrator identifies
disproportionate exposure and may include a county, city, town,
neighborhood, census tract, zip code, or other commonly understood
political or geographical subdivision.
``SEC. 39. EXEMPTION FOR CHEMICAL SUBSTANCES OR MIXTURES BASED ON
INTRINSIC PROPERTIES.
``(a) Authority to Exempt Certain Chemical Substances and Mixtures
Based on Intrinsic Properties.--If the Administrator determines that
scientific consensus exists that the intrinsic properties of a chemical
substance or mixture are such that it does not and would not pose any
risk of injury to health or the environment under any current,
proposed, or anticipated levels of production, patterns of use, or
exposures arising at any stage across the lifecycle of the substance or
mixture, the Administrator may, by order, exempt the substance or
mixture, or particular uses of the substance or mixture, from one or
more of the requirements of sections 4, 5, 6 and 8 of this Act. A
determination under this section shall be based on consideration of the
intrinsic properties of the substance or mixture, and shall not be
based on findings or assumptions of low human or environmental exposure
to the substance or mixture.
``(b) Notice of Determination and Exemption.--Within 30 days of
determining and exempting, pursuant to subsection (a), a chemical
substance or mixture, or a particular use of a chemical substance or
mixture, the Administrator shall publish in the Federal Register, and
shall add to the public database established pursuant to section 8(d),
a notice that provides the specific identity of the chemical substance
or mixture, and, for a particular use determined and exempted under
subsection (a), the particular use of the substance or mixture, that
the Administrator has determined and exempted under subsection (a) and
that explains and documents the basis for the Administrator's
determination and exemption.
``(c) Reconsideration of Determination and Exemption.--
``(1) In general.--The Administrator may reconsider and
revoke or modify any determination or exemption under
subsection (a) at any time if the Administrator determines that
the conditions of subsection (a) are no longer met, or that
such action is necessary to protect human health or the
environment or is otherwise in the public interest. In the
event of such revocation or modification, the Administrator
shall provide public notice of the grounds for that
determination and publish such notice on the public database
established pursuant to section 8(d).
``(2) Effective date.--Any revocation or modification
undertaken pursuant to this subsection shall not take effect
prior to the date that is one year after public notice of the
determination, unless an earlier effective date is necessary to
protect human health or the environment.
``(d) Prior Regulatory Exemptions.--Not later than one year after
the date of enactment of the Toxic Chemicals Safety Act of 2010,
exemptions granted by the Administrator pursuant to section 5(h)(4) of
this Act prior to the date of enactment of the Toxic Chemicals Safety
Act of 2010, as such section was in effect before such date of
enactment, shall be reviewed by the Administrator and continued in
effect under the authority granted by this section, as appropriate.
Such an exemption shall continue to be in effect until such date as the
Administrator determines, by order, that--
``(1) the exemption is not authorized or not appropriate
under this section, at which time the exemption shall cease to
be in effect; or
``(2) the exemption is authorized and appropriate under
this section, at which time the Administrator may issue an
order to modify or continue in effect the exemption pursuant to
subsection (a).
``(e) No Limitation on Authority.--Nothing in this section shall be
construed to limit or otherwise affect the Administrator's authority
under any other provision of this Act.
``SEC. 40. APPLICATION OF THIS ACT TO FEDERAL AGENCIES.
``(a) In General.--Except as provided in subsection (e), each
Federal agency, and any officer, agent, or employee thereof, shall be
subject to, and comply with, all applicable requirements of this Act,
both substantive and procedural, in the same manner, and to the same
extent, as any person subject to such requirements. The substantive and
procedural requirements referred to in this subsection include--
``(1) any rule or order;
``(2) any civil or administrative penalty or fine,
regardless of whether such penalty or fine is punitive or
coercive in nature or is imposed for isolated, intermittent, or
continuing violations;
``(3) any requirement for reporting;
``(4) any provision for injunctive relief and such
sanctions as may be imposed by a court to enforce such relief;
and
``(5) payment of user fees under section 26(b).
``(b) Waiver of Immunity.--The United States hereby expressly
waives any immunity otherwise applicable to the United States with
respect to any substantive or procedural requirement referred to under
subsection (a).
``(c) Civil Penalties.--No agent, employee, or officer of the
United States shall be personally liable for any civil penalty under
this Act with respect to any act or omission within the scope of the
official duties of the agent, employee, or officer.
``(d) Criminal Sanctions.--An agent, employee, or officer of the
United States shall be subject to any criminal sanction (including any
fine or imprisonment) under this Act, but no Federal agency shall be
subject to any such sanction.
``(e) Exemption.--
``(1) In general.--If the President determines it is in the
paramount interest of the United States, the President may
grant an exemption for any Federal agency from compliance with
any requirement of this Act.
``(2) Lack of appropriation.--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) Period of exemption.--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) Report.--Annually after the date of enactment of the
Toxic Chemicals Safety Act of 2010, the President shall report
to the Congress all exemptions under this subsection granted
during the preceding calendar year, together with the reason
for granting each such exemption.
``(f) Administrative Enforcement Actions.--
``(1) In general.--The Administrator may commence an
administrative enforcement action against any Federal agency
pursuant to the enforcement authorities contained in this Act.
The Administrator shall initiate an administrative enforcement
action against such agency in the same manner and under the
same circumstances as an action would be initiated against
another person. Any voluntary resolution or settlement of an
administrative enforcement action shall be set forth in a
consent order.
``(2) Final.--No administrative order issued to a Federal
agency shall become final until such agency has had the
opportunity to confer with the Administrator.''.
(b) Conforming Amendment.--The table of contents for the Toxic
Substances Control Act is amended by adding after the item relating to
section 31, the following new items:
``Sec. 32. Chemical substances and mixtures that are persistent,
bioaccumulative, and toxic.
``Sec. 33. Children's environmental health.
``Sec. 34. Reduction of animal-based testing.
``Sec. 35. Safer alternatives and green chemistry and engineering.
``Sec. 36. International cooperation and agreements.
``Sec. 37. Data quality.
``Sec. 38. Hot spots.
``Sec. 39. Exemption for chemical substances or mixtures based on
intrinsic properties.
``Sec. 40. Application of this Act to Federal agencies.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
Subcommittee Hearings Held.
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