Text of S. 3209 (111th): Safe Chemicals Act of 2010 (Introduced version)

1.

This Act may be cited as the Safe Chemicals Act of 2010.

2.

It is the purpose of this Act to ensure that risks from chemicals are adequately understood and managed.

3.

Section 2 of the Toxic Substances Control Act (15 U.S.C. 2601) is amended—

(1)

by striking Intent in the heading and inserting Goal; and

(2)

by striking subsections (a) through (c) and inserting the following:

(a)

Congress finds that—

(1)

each year human beings and the environment are exposed to a large number of chemical substances and mixtures;

(2)

the chemical industry, an important part of the United States economy, provides valuable products that are used in diverse manufacturing industries and other commercial, institutional, and consumer applications;

(3)

more than 3 decades after the enactment of the Toxic Substances Control Act, people and the environment in the United States are still exposed to thousands of chemicals whose safety has not been adequately reviewed and may harm health and the environment;

(4)

the incidence of some diseases and disorders linked to chemical substance exposures is on the rise;

(5)

biomonitoring of chemical substances in humans reveals that people in the United States carry hundreds of hazardous chemicals in their bodies;

(6)

the concentrations of certain chemical substances that persist and accumulate are increasing in the environment and in human bodies and are found across the world, including in the remote Arctic in which Native Americans face increasing contamination of traditional foods;

(7)

differences in metabolism and physiology at certain stages of development can make infants and children more vulnerable than adults to the effects of chemical exposure, especially exposures that occur in utero, during infancy, and during other critical periods of development;

(8)

manufacturers and processors of chemicals should supply sufficient health and environmental information before distributing products in commerce;

(9)

the Administrator must have and exercise the authority to develop sufficient information to assess chemical safety, and to act effectively when the Administrator obtains information that indicates there are risks of harmful exposure to chemical substances and mixtures;

(10)

there is significant global trade in the chemical sector and many of the companies that conduct business in the United States must also comply with chemical safety regulatory programs in other countries, and the data that is generated to comply with these other regulatory programs may be useful in understanding hazards and exposures of chemical substances and mixtures presented in the United States; and

(11)

a revised policy on the safety of chemical substances and mixtures will assist in renewing the manufacturing sector of the United States, create new and safer jobs, spur innovations in green chemistry, restore confidence domestically and internationally in the safety of products of the United States, and ensure that products of the United States remain competitive in the global market.

(b)

It is the policy of the United States—

(1)

to protect the health of children, workers, consumers, and the public, and to protect the environment from harmful exposures to chemical substances and mixtures;

(2)

to promote the use of safer alternatives and other actions that reduce use of and exposure to hazardous chemical substances and reward innovation toward safer chemicals, processes, and products;

(3)

to require that all chemicals in commerce meet a risk-based safety standard that protects vulnerable and affected populations and the environment;

(4)

to require companies to provide sufficient health and environmental information for the chemical substances which they manufacture, process, or import as a condition of allowing such companies to distribute such chemicals in commerce;

(5)

to improve the quality of information on chemical safety and use;

(6)

to guarantee the right of the public and workers to know about the hazards and uses of chemical substances that they may be exposed to by maximizing public access to information on chemical safety and use; and

(7)

to strengthen cooperation between and among the Federal Government and State, municipal, tribal, and foreign governments.

(c)

It is the goal of the United States to address the harmful exposure of vulnerable or affected populations to chemical substances caused by the distribution of such substances in commerce by—

(1)

reviewing all chemical substances for safety and identifying the highest priority chemical substances for expedited review;

(2)

determining whether all chemical substances in commerce meet the safety standard under this subchapter;

(3)

applying appropriate restrictions to the use of a chemical substance, where warranted; and

(4)

encouraging the replacement of harmful chemicals and processes with safer alternatives.

.

4.

Section 3 of the Toxic Substances Control Act (15 U.S.C. 2602) is amended—

(1)

in paragraph (2)—

(A)

in subparagraph (A)—

(i)

by striking subparagraph (B) and inserting subparagraphs (B) and (C);

(ii)

in clause (i), by striking and after nature,;

(iii)

in clause (ii), by striking the period at the end and inserting , and; and

(iv)

by adding at the end the following new clause:

(iii)

any chemical substance contained in or formed into an article.

;

(B)

by adding at the end the following new subparagraph:

(C)

Notwithstanding molecular identity, the Administrator may determine, under section 5(a)(6), that a variant of a chemical substance is a new chemical substance.

.

(2)

in paragraph (4)—

(A)

by striking or after or article;; and

(B)

by inserting ; or to export or offer for export the substance, mixture, or article after article after its introduction into commerce;

(3)

in paragraph (5), by inserting ambient and indoor after includes water, ;

(4)

in paragraph (6), by inserting relating to a chemical substance or mixture or to the specific chemical identity of the chemical substance or mixture after test;

(5)

in paragraph (8), by inserting The term ‘mixture’ includes any mixture contained in or formed into an article. after combination were combined.;

(6)

in paragraph (9), by striking which is not included in the chemical substance list compiled and published under section 8(b) and inserting for which the manufacturer or processor of the chemical substance has not submitted a declaration under section 8(a);

(7)

by striking paragraph (12);

(8)

by redesignating paragraphs (13) and (14) as paragraphs (12) and (13), respectively; and

(9)

by adding at the end the following new paragraphs:

(14)

The term adverse effect means a biochemical change, anatomic change, functional impairment, or pathological lesion, or its known precursor, that—

(A)

affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism;

(B)

causes irreversible change in the homeostasis of an organism;

(C)

increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; or

(D)

affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.

(15)

The term aggregate exposure means all exposure to—

(A)

a chemical substance or mixture from the manufacture, processing, distribution, use, and disposal of a chemical substance that is not considered to be a chemical substance under this chapter solely because of the use of the substance as or in a food, food additive, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321));

(B)

all other sources of the chemical substance under subparagraph (A), including—

(i)

contamination of food, air, water, soil, and house dust from current or prior uses or activity;

(ii)

accidental releases;

(iii)

permitted sources of pollution;

(iv)

nonpoint sources of pollution; and

(v)

documented background levels from natural and anthropogenic sources; and

(C)

any mixture containing the chemical substance under subparagraph (A).

(16)

The term bioaccumulative has the meaning given to such term in the policy statement entitled Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances (64 Fed. Reg. 60194, Nov. 4, 1999). The Administrator may issue a rule to update the definition of such term for purposes of this chapter.

(17)

The term chemical identity includes the following—

(A)

with respect to a chemical substance, each common and trade name of the chemical substance;

(B)

with respect to a chemical substance, the name of the chemical substance appearing in International Union of Pure and Applied Chemistry nomenclature and the most current Collective Index format;

(C)

with respect to a chemical substance, each Chemical Abstracts Service registration number of the chemical substance;

(D)

with respect to a chemical substance, the molecular structure of the chemical substance;

(E)

with respect to a mixture, the chemical identities of the mixture’s component chemical substances; and

(F)

with respect to a mixture, the proportions the mixture’s component chemical substances.

(18)

The term cumulative exposure means the sum of aggregate exposure to—

(A)

each of the chemical substances that are known or suspected to contribute appreciably to the risk of an adverse effect; and

(B)

mixtures containing chemical substances described under subparagraph (A).

(19)

The term end consumer means an individual or other entity that purchases and uses or consumes a chemical substance, mixture, or article.

(20)

The term Federal agency means any department, agency, or other instrumentality of the Federal Government, any independent agency or establishment of the Federal Government including any Government corporation, and the Government Printing Office.

(21)

The term persistent has the meaning given to such term in the policy statement entitled Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances (64 Fed. Reg. 60194, Nov. 4, 1999). The Administrator may issue a rule to update the definition of such term for purposes of this chapter.

(22)

The term person means an individual, trust, firm, joint stock company, corporation (including a Government corporation), partnership, association, State, municipality, commission, political subdivision of a State, or any interstate body and shall include each Federal agency and any officer, agent, or employee thereof.

(23)

The term reasonable certainty of no harm means, in establishing whether a chemical substance or mixture meets the safety standard under this subchapter, that aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect on the general population or a vulnerable population.

(24)

The term special substance characteristics means, such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider—

(A)

size or size distribution;

(B)

shape and surface structure;

(C)

reactivity; and

(D)

any other properties that may significantly affect the risks posed.

(25)

The term toxic, with respect to a chemical substance or mixture, means that the chemical substance or mixture has a toxicological property—

(A)

meeting the criteria for Category 1 or Category 2 for any of the toxicity endpoints established by the Globally Harmonized System for the Classification and Labeling of Hazardous Substances;

(B)

that causes an adverse effect that has been demonstrated in humans or other exposed organisms; or

(C)

for which the weight of evidence (such as demonstration of such an adverse effect as described in clause (i) in laboratory studies or data for a chemical from the same chemical class that exhibits such an adverse effect) demonstrates the potential for an adverse effect in humans or other exposed organisms.

(26)

The term toxicological property means actual or potential toxicity or other adverse effects of a chemical substance or mixture, including actual or potential effects of exposure to a chemical substance or mixture on—

(A)

mortality;

(B)

morbidity, including carcinogenesis;

(C)

reproduction;

(D)

growth and development;

(E)

the immune system;

(F)

the endocrine system;

(G)

the brain or nervous system;

(H)

other organ systems; or

(I)

any other biological functions in humans or nonhuman organisms.

(27)

The term vulnerable population means a population that is subject to a disproportionate exposure to, or potential for a disproportionate adverse effect from exposure to, a chemical substance or mixture, including—

(A)

infants, children, and adolescents;

(B)

pregnant women;

(C)

elderly;

(D)

individuals with preexisting medical conditions;

(E)

workers that work with chemical substance and mixtures; and

(F)

members of any other appropriate population identified by the Administrator.

.

5.

Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is amended to read as follows:

4.

(a)

(1)

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish, by rule, the data that constitute the minimum data set for chemical substances and mixtures. The rule shall require submission of a minimum data set including information on substance characteristics and on hazard, exposure, and use of chemical substances and mixtures that the Administrator anticipates will be useful in conducting safety standard determinations pursuant to section 6(b) or carrying out any provision of this chapter. The rule shall also establish requirements for manufacturers and processors to update their minimum data set submissions, as appropriate. The rule may provide for varied or tiered testing for different chemical substances, mixtures or categories of chemical substances and mixtures. Studies conducted to satisfy such data requirements shall be conducted in accordance with section 31.

(2)

The manufacturers and processors of a chemical substance shall submit the minimum data set for the chemical substance to the Administrator by—

(A)

18 months after the date on which the Administrator places the chemical substance on the priority list; or

(B)

for a new chemical substance, the date on which the notice required in section 5(b)(1) is filed.

(3)

The Administrator may, by order, prohibit a manufacturer or processor in violation of paragraph (2) from manufacturing, processing, or distributing in commerce the chemical substance or any mixture or article containing the chemical substance, except as authorized under section 6(e).

(b)

(1)

The Administrator may, by rule or order, require testing with respect to any chemical substance or mixture, and the submission of test results by a specified date, as necessary for making any determination or carrying out any provision of this chapter. Nothing in this paragraph shall be construed as limiting the Administrator’s authority under paragraph (2).

(2)

The Administrator may, by rule or order require the submission of a sample of any chemical substance or mixture in such manner as enables the Administrator to conduct such tests as are necessary for making any determination or carrying out any provision of this chapter. Nothing in this paragraph shall be construed as limiting the Administrator’s authority under paragraph (1).

(3)

The Administrator may, by order, prohibit a manufacturer or processor in violation of a rule or order under paragraph (1) from manufacturing, processing, or distributing in commerce the chemical substance or any mixture or article containing the chemical substance, except as authorized under section 6(e).

(4)

If a manufacturer or processor has submitted a declaration of cessation of manufacture or processing under section 8(a)(3) for a chemical substance, the manufacturer or processor shall be exempted from the requirements of this subsection.

(c)

(1)

A rule or order under subsection (b) shall include—

(A)

identification of the chemical substance or mixture for which testing is required under the rule or order;

(B)

standards for the development of test data for such substance or mixture; and

(C)

a specification of the period (which period may not be of unreasonable duration) within which the persons required to conduct the testing shall submit to the Administrator data developed in accordance with the standards referred to in subparagraph (B).

In determining the standards and period to be included, pursuant to subparagraphs (B) and (C), in a rule or order under subsection (b), the Administrator’s considerations shall include the relative costs of the various test protocols and methodologies which may be required under the rule or order and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule. Any such rule or order may require the submission to the Administrator of preliminary data during the period prescribed under subparagraph (C).

(2)

(A)

The types of health and environmental information for which standards for the development of test data may be prescribed include—

(i)

information pertaining to carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may be considered in a safety determination;

(ii)

information pertaining to exposure to the chemical substance or mixture, including information regarding the presence of the chemical or mixture in human blood, fluids, or tissue; and

(iii)

information pertaining to—

(I)

bioaccumulation;

(II)

persistence;

(III)

acute toxicity;

(IV)

subacute toxicity;

(V)

chronic toxicity; and

(VI)

any other characteristic which may present an adverse effect.

(B)

(i)

The Administrator may prescribe methodologies in standards for the development of test data including—

(I)

epidemiologic studies;

(II)

biomonitoring studies;

(III)

serial or hierarchical tests;

(IV)

in vitro tests; and

(V)

whole animal tests, consistent with section 31.

(ii)

Prior to prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health.

(C)

Periodically, but not less frequently than once every 3 years, the Administrator shall—

(i)

review the adequacy of the standards for development of data prescribed in rules under subsection (a); and

(ii)

if necessary, institute proceedings to make appropriate revisions of the standards.

(3)

(A)

Except as provided in subparagraph (B), a rule or order under subsection (b) respecting a chemical substance or mixture shall specify the persons required to conduct tests and submit data to the Administrator on the substance or mixture.

(B)

The Administrator may permit 2 or more of the persons described in subparagraph (A) to designate 1 of the persons or a qualified third party to conduct the tests and submit the data on behalf of the persons making the designation.

(C)

All persons described in subparagraphs (A) and (B) shall remain liable for compliance with any requirements subject to the designation.

(4)

(A)

Any rule or order under subsection (b) that requires the testing and submission of data with respect to a particular chemical substance or mixture shall expire at the end of the reimbursement period (as defined in subsection (d)(3)) that is applicable to test data with respect to the substance or mixture unless, prior to that date, the Administrator withdraws the rule or order.

(B)

A rule or order under subsection (b) that requires the testing and submission of data with respect to a category of chemical substances or mixtures shall expire with respect to a chemical substance or mixture included in the category at the end of the reimbursement period (as defined in subsection (d)(3)) that is applicable to test data with respect to the substance or mixture unless, prior to that date, the Administrator withdraws the rule or order with respect the substance or mixture or in its entirety.

(d)

(1)

Any person required by a rule or order under subsections (a) or (b) to conduct tests and submit data with respect to a chemical substance or mixture may apply to the Administrator (in such form and manner as the Administrator shall prescribe) for an exemption from the requirement.

(2)

In accordance with paragraph (3) or (4), the Administrator shall exempt an applicant under paragraph (1) from conducting tests and submitting data with respect to the substance or mixture under the rule or order with respect to which the application was submitted, if, on receipt of the application, the Administrator determines that—

(A)

the chemical substance or mixture with respect to which the application was submitted is equivalent to a chemical substance or mixture for which—

(i)

data has been submitted to the Administrator in accordance with a rule or order under subsection (a) or (b); or

(ii)

data is being developed in accordance with the rule or order; and

(B)

submission of data by the applicant with respect to the substance or mixture would be duplicative of data that—

(i)

has been submitted to the Administrator in accordance with the rule or order under subsection (a) or (b); or

(ii)

is being developed in accordance with the rule or order.

(3)

(A)

In this paragraph, the term reimbursement period, with respect to any test data for a chemical substance or mixture, means a period—

(i)

beginning on the date on which the test data is submitted in accordance with a rule or order issued under subsection (a) or (b); and

(ii)

ending on the later of—

(I)

5 years after the date referred to in clause (i); or

(II)

at the expiration of a period that—

(aa)

begins on the date referred to in clause (i); and

(bb)

is equal to the period that the Administrator determines was necessary to develop the test data.

(B)

(i)

Except as provided in clause (ii), if the exemption under paragraph (2) of any person from the requirement to conduct tests and submit test data with respect to a chemical substance or mixture is granted on the basis of the existence of previously submitted test data and the exemption is granted during the reimbursement period for the test data, the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator) to—

(I)

the person who previously submitted the test data, for a portion of the costs incurred by the person in complying with the requirement to submit the data; and

(II)

any other person who has been required under this subsection to contribute with respect to the costs, for a portion of the amount the person was required to contribute.

(ii)

Clause (i) shall not apply if there is agreement on the amount and method of reimbursement between an exempted person described in clause (i) and the persons described in subclauses (I) and (II) of that clause.

(iii)

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in subclauses (I) and (II) of clause (i) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider all relevant factors, including—

(I)

the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed; and

(II)

the share of the market for the substance or mixture of the person required to provide reimbursement in relation to the share of the market of the persons to be reimbursed.

(4)

(A)

Except as provided in subparagraph (B), if the exemption under paragraph (2) of any person from the requirement to conduct tests and submit test data with respect to a chemical substance or mixture is granted on the basis of the fact that test data is being developed by 1 or more persons in accordance with a rule or order issued under subsection (a) or (b), the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)—

(i)

to each such person who is developing the test data, for a portion of the costs incurred by each person in complying with the rule or order; and

(ii)

to any other person who has been required under this subsection to contribute with respect to the costs of complying with the rule or order, for a portion of the amount the person was required to contribute.

(B)

Subparagraph (A) shall not apply if there is agreement on the amount and method of reimbursement between an exempted person described in subparagraph (A) and the persons described in clauses (i) and (ii) of that subparagraph.

(C)

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and (ii) of subparagraph (A) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General and the Commissioners of the Federal Trade Commission, consider the factors described in paragraph (3)(B)(iii).

(D)

If any exemption is granted under paragraph (2) on the basis that 1 or more persons are developing test data pursuant to a rule or order promulgated or issued under subsection (a) or (b), and after the exemption is granted, the Administrator determines that no such person has complied with the rule or order, the Administrator shall—

(i)

after providing written notice to the person who holds the exemption and an opportunity for a hearing, by order terminate the exemption; and

(ii)

notify in writing the person of the requirements of the rule or order with respect to which the exemption was granted.

(e)

(1)

Not later than 15 days after the date of receipt of any test data pursuant to a rule or order under subsection (a) or (b), the Administrator shall publish in the Federal Register a notice of the receipt of the test data.

(2)

Subject to section 14, each notice shall—

(A)

identify the chemical substance or mixture with respect to which data have been received;

(B)

list the commercial and consumer uses or intended commercial and consumer uses of the substance or mixture known to the Administrator and the information required by the applicable standards for the development of test data; and

(C)

describe the nature of the test data developed.

(3)

Subject to section 14, test data described in this subsection shall be made available on the internet by the Administrator.

(f)

(1)

If another Federal agency determines that information relating to a chemical substance or mixture, including data derived from new testing or monitoring, would assist the agency in carrying out duties or exercising authority of the agency, but that information is not available to the agency, the agency may request the Administrator to seek the information on behalf of the requesting agency.

(2)

Not later than 60 days after the date of receipt of a request under paragraph (1), the Administrator shall—

(A)

subject to section 14, make the data available to the requesting agency;

(B)

issue a rule or order under section 8(f) to require—

(i)

the submission of existing pertinent data to the Administrator; and

(ii)

that a copy of any such submission also be furnished to the requesting agency;

(C)

issue a rule or order under subsection (b)—

(i)

to develop the data; and

(ii)

to require the developed data be furnished to the requesting agency; or

(D)

publish in the Federal Register the reason for not taking any of the actions described in this paragraph.

(g)

Each submission required under this section or under a rule or an order promulgated or issued by the Administrator under this section shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission—

(1)

is accurate and reliable; and

(2)

includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.

.

6.

Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is amended to read as follows:

5.

(a)

(1)

Except as provided in subsection (d), no person may manufacture or process a new chemical substance unless—

(A)

(i)

the person submits to the Administrator a notice, in accordance with subsection (c), of the intention of the person to manufacture or process the substance; and

(ii)

the person complies with subsection (b); and

(B)

the Administrator—

(i)

finds that the manufacturers and processors have established that the chemical substance meets the safety standard under section 6(b); or

(ii)

finds that the new chemical substance, or a metabolite or degradation product of the chemical substance, as applicable, is not, and is not expected to be—

(I)

manufactured in a volume of more than 1,000,000 pounds annually or released into the environment in a volume of more than 100,000 pounds annually;

(II)

a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor, or has other toxicological properties of concern;

(III)

persistent and bioaccumulative;

(IV)

found in human cord blood, or otherwise found in human blood, fluids, or tissue, unless the chemical substance or metabolite or degradation product is naturally present at the level commonly found in that medium; or

(V)

found in food, drinking water, ambient or indoor air, residential soil, or house dust, unless the chemical substance or metabolite or degradation product is naturally present at the level commonly found in that medium.

(2)

(A)

Except as provided in subparagraph (B), with respect to an existing chemical substance which the Administrator has not made a safety determination under section 6, no person may manufacture or process the chemical substance—

(i)

for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2010;

(ii)

at a significantly increased volume above the level on the date of enactment; or

(iii)

if the person had not previously manufactured or processed the chemical substance on the date of enactment of the Safe Chemicals Act of 2010.

(B)

The person—

(i)

submits to the Administrator a new or updated declaration referred to in section 8(a); and

(ii)

complies with subsection (b).

(3)

(A)

With respect to an existing chemical substance for which the Administrator has determined under section 6(b) that the manufacturers and processors of the chemical substance have established that the substance meets the safety standard, no person may manufacture or process the chemical substance for a use, at a production volume, or in a manner other than those the Administrator specified in the safety determination, unless—

(i)

the manufacturer or processor submits to the Administrator—

(I)

a notice of the intention of the manufacturer or processor to manufacture or process the substance for the new use or at the new production volume, or in such other manner that is inconsistent with a specified condition or term for such substance; and

(II)

all updates to the minimum data set relevant to the new use, new production volume, or other new manner of manufacturing or processing;

(ii)

the notice under clause (i)(I) indicates that the chemical substance will continue to meet the safety standard if the allowed uses, allowed production volume, or other specified conditions or terms for such chemical substance are revised to encompass the new use or new production volume, or other new manner of manufacturing or processing; and

(iii)

the Administrator determines that the manufacturer or processor submitting the notice has established that the chemical substance will continue to meet the safety standard if the allowed uses or allowed production volume, or other specified conditions or terms for such substance, are revised to encompass the new use or new production volume or other new manner of manufacturing or processing.

(B)

If the conditions described in clause (i) through (iii) of subparagraph (A) are satisfied, the Administrator shall, by order, amend the safety determination for the chemical substance to include the new use or new production volume among the allowed uses or production volumes of the chemical substance.

(4)

(A)

Except as provided in subparagraphs (B) and (C), not later than 180 days after the date of receipt of a notice and supporting data that satisfies paragraph (1)(A) or paragraph (3)(A), the Administrator shall determine whether the person submitting the notice has established that the chemical substance will meet, or continue to meet, the safety standard under section 6(b).

(B)

In the case of a notice under paragraph (1)(A), the Administrator shall not be subject to the deadline described in subparagraph (A) if the Administrator first makes the finding specified under paragraph (1)(B)(ii).

(C)

The Administrator may extend the determination deadline under subparagraph (A) by 1 or more additional periods not to exceed 12 months in aggregate, by action in accordance with section 5(b) or section 6(b)(2)(A)(i)(I)(bb), or other means, as necessary to secure additional relevant data for the determination.

(D)

The failure of the Administrator to make a timely determination in accordance with this paragraph shall not be sufficient to satisfy paragraph (1)(B)(ii) or paragraph (3)(A)(iii).

(5)

Not later than 30 days after the date on which a manufacturer or processor commences manufacturing or processing of a new chemical substance, the manufacturer or processor shall submit to the Administrator a notice of commencement of manufacture or processing.

(6)

(A)

The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting one or more special substance characteristics—

(i)

is a use that is separate from any use of the chemical substance that does not exhibit such special substance characteristics; or

(ii)

is a new chemical substance.

(B)

In the case of a chemical substance which the Administrator determines to be a separate use based on its special substance characteristics, the manufacturer or processor shall satisfy such further conditions as the Administrator establishes, by order or rule.

(b)

(1)

If a person is required by subsection (a) to submit to the Administrator a notice before beginning the manufacture or processing of a chemical substance, and is required by a rule or order under section 4(b) to submit test data for the chemical substance before the submission of the notice, the person shall submit to the Administrator the data in accordance with the rule or order at the time the notice is submitted under subsection (b).

(2)

Subject to section 14, test data submitted under paragraph (1) shall be made available on the internet by the Administrator.

(c)

(1)

The notice required by subsection (b)(1) shall include—

(A)

the declaration described in section 8(a)(2);

(B)

the minimum data set, as defined in accordance with section 4(a); and

(C)

a statement that the chemical substance will meet the safety standard.

(2)

Subject to section 14, a notice described in paragraph (1) shall be made available on the internet by the Administrator.

(3)

Subject to section 14, not later than 5 days (excluding Saturdays, Sundays, and legal holidays) after the date of the receipt of a notice under subsection (a) or of data under subsection (b), the Administrator shall make available on the internet information that—

(A)

identifies the chemical substance for which notice or data has been received;

(B)

lists the uses or intended uses of the chemical substance;

(C)

in the case of the receipt of data under subsection (b), describes—

(i)

the nature of the tests performed with respect to the chemical substance; and

(ii)

any data that were received under subsection (b) or a rule or order under section 4; and

(D)

references the availability of the minimum data set.

(4)

At the beginning of each month, the Administrator shall make available on the internet a list of each chemical substance for which notice has been received under subsection (a).

(d)

(1)

The Administrator may, upon application, exempt any person from any requirement of subsection (a) or (b) to permit the person to manufacture or process a chemical substance for test marketing purposes—

(A)

upon a showing by the person satisfactory to the Administrator that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substance, and that any combination of those activities, will not endanger the health or the environment; and

(B)

under such restrictions as the Administrator considers appropriate.

(2)

(A)

The Administrator shall, upon application, fully or partially exempt any person from the requirement to submit any data otherwise required with respect to a chemical substance for which notice is submitted under subsection (a) if, on receipt of an application, the Administrator determines that—

(i)

the chemical substance with respect to which the application was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by this chapter; and

(ii)

submission of data by the applicant on the chemical substance would be duplicative of data which has been submitted to the Administrator in accordance with this chapter.

(iii)

No exemption granted under this subparagraph with respect to the submission of data for a chemical substance may take effect before the beginning of the reimbursement period applicable to the data.

(B)

(i)

In this subparagraph, the term reimbursement period, with respect to any previously submitted data for a chemical substance, means a period—

(I)

beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of the chemical substance by the person who submitted the data to the Administrator; and

(II)

ending on the later of—

(aa)

the date that is 5 years after the date referred to in subclause (I); or

(bb)

at the expiration of a period beginning on the date referred to in subclause (I) that is equal in length to the period that the Administrator determines to be necessary to develop the data.

(ii)

Except as provided in clause (iii), if the Administrator exempts any person, under subparagraph (A), from submitting data required under subsection (a) or (b) for a chemical substance because of the existence of previously submitted data and the exemption is granted during the reimbursement period for that data, the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)—

(I)

to the person who previously submitted the data on which the exemption was based, for a portion of the costs incurred by the person in complying with the requirement under this subchapter to submit the data; and

(II)

to any other person who has been required under this subparagraph to contribute with respect to the costs, for a portion of the amount the person was required to contribute.

(iii)

Clause (ii) shall not apply if the person exempted under that clause and the persons described in subclauses (I) and (II) of that clause agree on the amount and method of reimbursement.

(iv)

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in subclauses (I) and (II) of clause (ii) for costs incurred with respect to a chemical substance, the Administrator shall, after consultation with the Attorney General and the Commissioners of the Federal Trade Commission, consider all relevant factors, including—

(I)

the effect on the competitive position of the person required to provide reimbursement in relation to the persons to be reimbursed; and

(II)

the share of the market for the chemical substance of the person required to provide reimbursement in relation to the share of the market of the persons to be reimbursed.

(3)

(A)

If the conditions described in subparagraph (B) are met, subsections (a) and (b) shall not apply with respect to the manufacturing or processing of any chemical substance that is manufactured or processed, or proposed to be manufactured or processed, only in small quantities (as defined by the Administrator by rule) solely for purposes of—

(i)

scientific experimentation or analysis; or

(ii)

chemical research on, or analysis of such substance or another substance, including such research or analysis for the development of a product.

(B)

The conditions referred to in subparagraph (A) are that all persons engaged in the experimentation, research, or analysis for a manufacturer or processor are notified (in such form and manner as the Administrator may prescribe) of any risk to health which the manufacturer, processor, or the Administrator has reason to believe may be associated with such chemical substance.

(4)

The Administrator may, upon application, exempt from subsections (a) and (b) the manufacturing or processing of any chemical substance—

(A)

that exists temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance; and

(B)

to which there is no, and will not be, human or environmental exposure.

(5)

(A)

As soon as practicable after receipt of an application under paragraph (1) or (4), the Administrator shall publish in the Federal Register notice of the receipt of the application.

(B)

The Administrator shall—

(i)

give interested persons an opportunity to comment upon any application described in subparagraph (A);

(ii)

not later than 45 days after the date of receipt of an application, approve or deny the application; and

(iii)

publish in the Federal Register notice of the approval or denial of the application.

(e)

Each submission required under this section or under a rule or an order promulgated or issued by the Administrator under this section shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission—

(1)

is accurate and reliable; and

(2)

includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.

(f)

In this section:

(1)

The terms manufacture and process mean manufacture or process, respectively, for commercial purposes.

(2)

The term test marketing does not include any provision of a chemical substance or mixture, or an article containing a chemical substance or mixture, to an end consumer of the chemical substance, mixture, or article.

.

7.

Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) is amended to read as follows:

6.

(a)

(1)

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall by order develop and publish a priority list containing the names of not less than 300 chemical substances for which safety determinations under this section shall first be made. Chemical substances shall be selected to be on the list at the Administrator’s discretion, based on available scientific evidence, and consideration of their risk relative to other chemical substances, based upon presence in biological and environmental media, use, production volume, toxicity, persistence, bioaccumulation, or other properties indicating risk.

(2)

The Administrator shall—

(A)

remove a chemical substance or mixture from the list under paragraph (1) only after a safety standard determination has been made for such chemical substance or mixture pursuant to subsection (b);

(B)

add chemical substances or mixtures to the list periodically so that the number of chemical substances on the list will not be fewer than 300 at any given time, until such time as all chemical substances and mixtures distributed in commerce have had a safety standard determination. Additions to the list shall be consistent with paragraph (1) and based on consideration generally of risk relative to listed chemical substances and mixtures to the extent practicable. Such additions to the list may be made in response to petitions under section 21; and

(C)

give due consideration to any recommendation provided by the committee established under paragraph (3).

(3)

(A)

There is established an interagency committee (referred to in this section as the committee) to make recommendations to the Administrator concerning—

(i)

the issuance of test rules or orders for chemical substances and mixtures under section 4(b); and

(ii)

the placement of chemical substances on the priority list under this subsection.

(B)

(i)

In making a recommendation concerning—

(I)

the issuance of test rules or orders under section 4(b), the committee shall consider all factors relevant to risk; and

(II)

placement on the priority list under subsection (a), the committee shall consider the criteria identified pursuant to subsection (a)(1).

(ii)

The recommendations of the committee shall be in the form of 1 or more lists of chemical substances and mixtures that shall specify, either by individual substance or mixture or by groups of substances or mixtures—

(I)

the recommendations of the committee that particular chemical substances, mixtures, or categories of chemical substances or mixtures be the subject of a test rule or order under section 4(b); or

(II)

the recommendations of the committee that particular chemical substances, or groups of chemical substances, be placed on the priority list.

(iii)

(I)

At least once every year, the committee shall—

(aa)

make such additions or revisions to the recommendations of the commission as the commission determines to be necessary; and

(bb)

submit to the Administrator the recommendations and a statement of the reasons of the committee for any additions or revisions.

(II)

On receipt of any new or revised recommendations, the Administrator shall publish in the Federal Register the recommendations and the statement of the reasons for the additions or revisions.

(III)

The Administrator shall—

(aa)

provide reasonable opportunity to any interested person to file with the Administrator written comments on the recommendations of the committee, and any additions or revisions to the recommendations by the committee;

(bb)

consideration such comments; and

(cc)

make the comments available to the public.

(C)

The committee shall consist of the following 8 members:

(i)

One member appointed by the Administrator from officers or employees of the Environmental Protection Agency.

(ii)

One member appointed by the Secretary of Labor from officers or employees of the Department of Labor engaged in the activities of the Secretary of Labor under the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.).

(iii)

One member appointed by the Chairman of the Council on Environmental Quality from the Council or the officers or employees of the Council.

(iv)

One member appointed by the Director of the National Institute for Occupational Safety and Health from officers or employees of the Institute.

(v)

One member appointed by the Director of the National Institute of Environmental Health Sciences from officers or employees of the Institute.

(vi)

One member appointed by the Director of the National Cancer Institute from officers or employees of the Institute.

(vii)

One member appointed by the Director of the National Science Foundation from officers or employees of the Foundation.

(viii)

One member appointed by the Secretary of Commerce from officers or employees of the Department of Commerce.

(D)

(i)

(I)

An appointed member may designate an individual to serve on the committee on behalf of the member.

(II)

A designation may be made only—

(aa)

with the approval of the applicable appointing authority; and

(bb)

if the individual is from the entity from which the member was appointed.

(ii)

(I)

No individual may serve as a member of the committee for more than 4 years in the aggregate.

(II)

If any member of the committee leaves the entity from which the member was appointed—

(aa)

the member may not continue as a member of the committee; and

(bb)

the position of the member shall be considered to be vacant.

(III)

A vacancy on the committee shall be filled in the same manner in which the original appointment was made.

(E)

(i)

No member of the committee, or designee of the member, shall accept employment or compensation from any person subject to any requirement of this chapter or of any rule promulgated or order issued under this chapter, for a period of at least 1 year after the date of termination of service on the committee.

(ii)

No person, while serving as a member of the committee or designee of the member, may own any stocks or bonds, or have any pecuniary interest, of substantial value in any person engaged in the manufacture, processing, or distribution in commerce of any chemical substance or mixture subject to this chapter or of any rule promulgated or order issued under this chapter.

(iii)

The Administrator, acting through attorneys of the Environmental Protection Agency, or the Attorney General may bring an action in the appropriate district court of the United States to restrain any violation of this subparagraph.

(F)

The Administrator shall provide the committee such administrative support services as may be necessary to enable the committee to carry out the functions of the committee under this subsection.

(4)

(A)

The following actions shall not be subject to judicial review, including when a prioritization decision or recommendation coincides with or is based on other decisions under this chapter that are subject to judicial review:

(i)

A decision whether to place a particular chemical substance on the priority list pursuant to this subsection;

(ii)

A response to a petition to place a particular chemical on the priority list; and

(iii)

The issuance of a recommendation pursuant to paragraph (3).

(B)

The failure of the Administrator to establish the priority list required in subparagraph (1), or to update the list as required by paragraph (2), shall be—

(i)

considered to be a failure to perform a nondiscretionary duty; and

(ii)

subject to judicial review.

(b)

(1)

(A)

This paragraph applies to the determination, or redetermination, of whether a chemical substance meets the safety standards of this subchapter.

(B)

Under this subchapter, it shall be the duty of—

(i)

the manufacturers and processors of a chemical substance to, at all times, bear the burden of proving that the chemical substance meets the applicable safety standard; and

(ii)

the Administrator to determine whether the manufacturers and processors of a chemical substance have met the burden of proof under clause (i).

(C)

(i)

Any determination that a manufacturer or processor of a chemical substance has met the burden of proof pursuant to subparagraph (B)(i) shall be supported by an assessment of risk conducted by an employee or contractor of the Environmental Protection Agency.

(ii)

No participant or peer reviewer in an assessment described in clause (i) shall have a direct or indirect financial interest in the outcome of the assessment.

(iii)

The Administrator shall use the best available science when conducting an assessment described in clause (i). For the purpose of determining the current best available science the Administrator shall consider the most recent recommendations of the National Academy of Sciences on ways to better protect people, including pregnant women, infants, children and other vulnerable populations from harm by exposure to toxic substances when assessing such potential risks.

(iv)

An assessment described in clause (i) shall address health or environmental impacts including potential or demonstrated cancer and noncancer endpoints.

(v)

In carrying out this subsection, the Administrator shall ensure that the approaches and resulting assessments are communicated in a manner that is transparent and understandable to the public and to risk managers.

(vi)

In the case of a chemical substance that is manufactured or processed in whole or in part for export, in determining whether the manufacturer or processor has met the burden of proof pursuant to subparagraph (B)(i), the Administrator shall take into account such risks as the chemical substance may pose in the United States, including risks involving long-range transport of the chemical substance in the environment and risks involving the import of articles and mixtures containing the chemical substance.

(vii)

The Administrator shall not be required to conduct a risk assessment to determine that a manufacturer or processor has not met the burden of proof under subparagraph (B)(i).

(D)

A determination by the Administrator that a manufacturer or processor has not established that the chemical substance meets the safety standard under this subsection shall not be subject to judicial review.

(2)

(A)

(i)

(I)

By the earlier of the date that is 30 months after the date on which a chemical substance is placed on the priority list or the date that is 14 years after the date of enactment of the Safe Chemicals Act of 2010, the manufacturers and processors of a chemical substance shall—

(aa)

submit to the Administrator the minimum dataset for the chemical substance, as established under section 4(a), or update the dataset if the dataset was submitted during the preceding 30-month period in response to the placement of the chemical substance on the priority list;

(bb)

submit to the Administrator, and develop by testing as necessary, all other information the Administrator may require, including information developed through testing or otherwise, in order to make a safety determination; and

(cc)

indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified uses meets the safety standard.

(II)

The Administrator may permit the manufacturers and processors of a chemical substance to designate 1 or more manufacturers or processors to submit the information required under subclause (I) on behalf of the manufacturers and processors making the designation.

(III)

All manufacturers and processors described in subclause (II) shall remain liable for compliance with any requirements subject to the designation.

(ii)

(I)

Not later than 15 years after the date of the previous submission under clause (i), this clause, or section 5(c)(1), the manufacturers and processors of each chemical substance shall—

(aa)

submit to the Administrator the minimum dataset for the chemical substance, as established under section 4(a); and

(bb)

indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified use meets the safety standard.

(II)

The Administrator may permit the manufacturers and processors of a chemical substance to designate 1 or more manufacturers or processors to submit the information required under subclause (I) on behalf of the manufacturers and processors making the designation.

(III)

All manufacturers and processors described in subclause (II) shall remain liable for compliance with any requirements subject to the designation.

(iii)

If the Administrator fails to act by an applicable deadline under subparagraph (B)(i), each manufacturer and processor of a chemical substance for which the Administrator has failed to act shall provide to the Administrator, the public, their employees and recognized bargaining agents of any employees who are represented by bargaining agents, and each known customer who has purchased the chemical substance within a reasonable timeframe as determined by the Administrator by rule or order, or mixture or article containing the chemical substance, a written notice that a determination by the Administrator of the safety of the chemical substance is pending.

(iv)

If a manufacturer or processor fails to meet duties under this subparagraph for a chemical substance, the Administrator may, by order, prohibit a manufacturer or processor, in violation of a duty under this subparagraph, from manufacturing, processing, or distributing in commerce the chemical substance, or any mixture or article containing the chemical substance, except as authorized under subsection (e).

(B)

(i)

Not later than 180 days after the earlier of the date of receipt of a complete submission or the applicable submission deadline under clause (i) or (ii) of subparagraph (A), or after initiating a redetermination under clause (iii) of this subparagraph, with respect to a chemical substance, the Administrator shall by order determine, or redetermine, as the case may be, whether the manufacturers and processors of the substance have established that the substance meets the safety standard.

(ii)

If the Administrator determines that the substance meets the safety standard, the Administrator shall in the order specify—

(I)

the allowed uses of the substance, which shall be limited to the uses evaluated in the determination; and

(II)

any conditions on the specified uses to ensure the safety standard is met, including conditions that relate to the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, or mixture or article containing such chemical substance, and any conditions described in subsection (c).

(iii)

The Administrator shall initiate a redetermination of whether the manufacturers and processors of a chemical substance distributed in commerce have established that the chemical substance meets the safety standard—

(I)

if new information raises a credible question as to whether the chemical substance continues to meet the safety standard;

(II)

on the receipt of a renewal submission under subparagraph (A)(ii); or

(III)

after the 15-year period beginning on the date of the previous applicable determination of the Administrator under this subparagraph, if a redetermination has not already been initiated subsequent to the determination.

(iv)

(I)

Any person may petition the Administrator for a redetermination of whether a chemical substance continues to meet the applicable safety standard.

(II)

The person shall include in the petition a description of the basis for requesting the redetermination.

(III)

On receipt of the petition, the Administrator shall—

(aa)

not later than 30 days after the date of receipt, publish in the Federal Register a notice of receipt of the petition that specifies the chemical identity of the chemical substance to which the petition pertains;

(bb)

make the petition available on request;

(cc)

provide a reasonable opportunity for public review and comment on the petition and give due consideration to any comments received;

(dd)

decide whether to make the requested redetermination; and

(ee)

not later than 180 days after the date of receipt, publish in the Federal Register the decision and the basis for the decision.

(3)

(A)

Except as provided under subsection (e), the risk reduction measures described in this paragraph shall apply to a chemical substance in accordance with this paragraph.

(B)

No person shall manufacture, process, or distribute in commerce a chemical substance, or any mixture or article containing a chemical substance, for—

(i)

any new chemical substance for which notice is required under section 5(a), effective immediately after the Administrator makes a safety determination for a chemical substance under paragraph (2)(B)(i) and does not determine that the manufacturer or processor has established that the chemical substance meets the applicable safety standard; or

(ii)

any other chemical substance, effective 1 year after the Administrator makes a safety determination for a chemical substance under paragraph (2)(B)(i) and does not determine that the chemical substance meets the applicable safety standard.

(C)

Effective beginning 1 year after the date the Administrator determines under paragraph (2)(B)(i) that a chemical substance meets the safety standard or immediately after such a determination is made for a new chemical substance for which notice is required under section 5(a), no person shall manufacture, process, or distribute in commerce the chemical substance, or any mixture or article containing the chemical substance, for any use other than those specified in the determination established under paragraph (2)(B)(ii).

(c)

The Administrator in a safety determination may impose conditions on the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, or mixture or article containing a chemical substance, in accordance with subsection (b)(2)(B)(ii)(II), including—

(1)

a requirement limiting the quantity of the substance, mixture, or article that may be manufactured, processed, or distributed in commerce:

(2)

a requirement—

(A)

prohibiting the manufacture, processing, or distribution in commerce of the substance, mixture, or article for a particular use in a concentration in excess of a level specified by the Administrator in conditions under subsection (b)(2)(B)(ii)(II); or

(B)

limiting the quantity of the substance, mixture, or article that may be manufactured, processed, or distributed in commerce for—

(i)

a particular use; or

(ii)

a particular use in a concentration in excess of a level specified by the Administrator in conditions established under section 6(b)(2)(B)(ii)(II);

(3)

a requirement that the substance, mixture, or article be marked with or accompanied by clear and adequate warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of such activities, with the form and content of the warnings and instructions prescribed by the Administrator;

(4)

a requirement that manufacturers and processors of the substance, mixture, or article—

(A)

make and retain records of the processes used to manufacture or process the substance, mixture, or article; and

(B)

monitor or conduct tests that are reasonable and necessary to ensure compliance with this chapter;

(5)

a requirement prohibiting or otherwise regulating any manner or method of commercial use of the substance, mixture, or article;

(6)

a requirement prohibiting or otherwise regulating any manner or method of disposal of the substance, mixture, or article, by—

(A)

the manufacturer or processor of the substance, mixture, or article; or

(B)

any other person that uses, or disposes of, the substance, mixture, or article for commercial purposes; and

(7)

a requirement that the manufacturers and processors of the substance, mixture, or article develop a risk reduction management plan to achieve a risk reduction specified by the Administrator.

(d)

(1)

If the Administrator has a reasonable basis to conclude that a particular manufacturer or processor is manufacturing or processing a chemical substance or mixture in a manner that may present a substantial endangerment to health or the environment, the Administrator may by order require the manufacturer or processor to submit a description of the quality control procedures followed in the manufacturing or processing of the chemical substance or mixture.

(2)

(A)

If the Administrator determines that quality control procedures described in paragraph (1) are inadequate to prevent the chemical substance or mixture from presenting a risk of injury, the Administrator may order the manufacturer or processor to revise the quality control procedures to the extent necessary to remedy the inadequacy.

(B)

If the Administrator determines that quality control procedures described in paragraph (1) have resulted in the distribution in commerce of a chemical substance or mixture that may present a substantial endangerment to health or the environment, the Administrator may order the manufacturer or processor—

(i)

to give notice of the endangerment to—

(I)

processors or distributors (or both) in commerce of the substance or mixture; and

(II)

to the extent reasonably ascertainable, any other person in possession of or exposed to the substance or mixture;

(ii)

to give public notice of the endangerment; and

(iii)

to provide for the replacement or repurchase, as prescribed by the Administrator, of the substance or mixture as is necessary to adequately protect health or the environment.

(e)

(1)

This subsection applies to the restrictions established under sections 4(a)(3), 4(b)(3), 8(b)(6), 8(c)(3), and 29, and paragraphs (2)(A)(iv) and (3) of subsection (b).

(2)

(A)

(i)

The manufacturers and processors of a chemical substance may request an exemption from any restriction described in paragraph (1) for a specified use of the chemical substance.

(ii)

The Administrator may by order grant an exemption from any restriction described in paragraph (1) for a period of not to exceed 5 years if the manufacturers and processors of the chemical substance have established by clear and convincing evidence that the uses to be exempted meet the exemption criteria described in subparagraph (B).

(B)

The Administrator may grant an exemption for the use of a chemical substance under subparagraph (A)(ii) if—

(i)

the exemption is in the paramount interest of national security;

(ii)

the lack of availability of the chemical substance would cause significant disruption in the national economy; or

(iii)

the use for which the exemption is sought is a critical or essential use—

(I)

no feasible safer alternative for the specified use of the chemical substance is available; or

(II)

the specified use of the chemical substance when compared to all available alternatives, provides benefit to health, the environment, or public safety.

(C)

If the Administrator grants an exemption for a chemical substance under this paragraph—

(i)

the manufacturers and processors of the chemical substance shall, for the exempted use, provide notice of the exemption to—

(I)

each known purchaser of the chemical substance; and

(II)

each known purchaser of a mixture or article containing the chemical substance; and

(ii)

the Administrator shall provide the public with a notice of the exemption.

(D)

The Administrator may by order renew an exemption under this paragraph for 1 or more additional 5-year periods if the Administrator concludes, after providing public notice and an opportunity for comment, that the use of the chemical substance continues to meet the criteria described in subparagraph (B).

(E)

(i)

The Administrator shall by order impose any condition on an exemption issued under this paragraph that the Administrator determines to be necessary to ensure the protection of human health and the environment on the use of a chemical substance exempted under this paragraph.

(ii)

Effective immediately after the Administrator establishes conditions on exempted use under clause (i), the manufacturing, processing, or distribution in commerce of the chemical substance, or any mixture or article containing the chemical substance, shall be prohibited except to the extent that the conditions are satisfied.

(3)

The restrictions described in paragraph (1) shall not apply to the resale of an article subject to a restriction under subsection (b) if the article has previously been used by an end consumer.

(4)

(A)

Except as provided in subparagraph (B), in the case of the retail sale to an end consumer of a chemical substance, mixture, or article that is subject to a restriction described in paragraph (1), the Administrator may by order extend the effective date of the restriction by a period of not to exceed 3 years, if the Administrator determines that the extension—

(i)

is necessary and appropriate to allow for depletion of the existing retail inventory; and

(ii)

will not present a substantial endangerment to human health or the environment.

(B)

An extension under subparagraph (A) shall not apply to any retailer that the Administrator determines has failed to comply with an order requesting information issued by the Administrator pursuant to section 8.

(f)

(1)

The Administrator shall act by order or rule consistent with paragraphs (2) and (3)—

(A)

to prescribe methods for the disposal of polychlorinated biphenyls; and

(B)

to require polychlorinated biphenyls to be marked with clear and adequate warnings and instructions with respect to the processing, distribution in commerce, use, or disposal (or any combination of such activities) of polychlorinated biphenyls.

(2)

(A)

In this paragraph, the term totally enclosed manner means any manner that will ensure that any exposure of human beings or the environment to the polychlorinated biphenyl will be insignificant, as determined by the Administrator by order or rule.

(B)

Except as provided in subparagraph (C), no person may manufacture, process, distribute in commerce, or use any polychlorinated biphenyl in any manner other than in a totally enclosed manner.

(C)

The Administrator may by order or rule authorize the manufacture, processing, distribution in commerce, or use (or any combination of such activities) of any polychlorinated biphenyl in a manner other than in a totally enclosed manner if the Administrator finds that the manufacture, processing, distribution in commerce, or use (or combination of such activities) will not present a substantial endangerment to health or the environment.

(3)

(A)

Except as provided in subparagraphs (B), (C), and (D)—

(i)

no person may manufacture any polychlorinated biphenyl; and

(ii)

no person may process or distribute in commerce any polychlorinated biphenyl.

(B)

(i)

Any person may petition the Administrator for an exemption from the requirements of subparagraph (A), and the Administrator may grant by rule the exemption, if the Administrator finds that—

(I)

a substantial endangerment to health or environment would not result; and

(II)

good faith efforts have been made to develop a chemical substance that meets the safety standard and that may be substituted for such polychlorinated biphenyl.

(ii)

An exemption granted under this subparagraph shall be—

(I)

subject to such terms and conditions as the Administrator may prescribe; and

(II)

be in effect for such period (but not more than 1 year from the date it is granted, except as provided in subparagraph (D)) as the Administrator may prescribe.

(C)

Subparagraph (A) shall not apply to the distribution in commerce of any polychlorinated biphenyl if the polychlorinated biphenyl was sold for purposes other than resale before the expiration of the 21/2-period beginning on October 11, 1976.

(D)

(i)

The Administrator may by order or rule extend an exemption granted under subparagraph (B) that has not yet expired for a period of not to exceed 60 days for the purpose of authorizing the Secretary of Defense and the Secretaries of the military departments to provide for the transportation into the customs territory of the United States of polychlorinated biphenyls generated by or under the control of the Department of Defense for purposes of the disposal, treatment, or storage of the polychlorinated biphenyls in the customs territory of the United States if the polychlorinated biphenyls are already in transit from storage locations but the Administrator determines, in the sole discretion of the Administrator, the polychlorinated biphenyls would not otherwise arrive in the customs territory of the United States within the period of the original exemption.

(ii)

The Administrator shall promptly publish in the Federal Register notice of the extension.

(g)

(1)

Except as provided in paragraph (2), no Federal agency shall convey, sell, or distribute to any other Federal agency, any State or local government agency, or any private individual or entity any elemental mercury under the control or jurisdiction of the Federal agency.

(2)

Paragraph (1) shall not apply to—

(A)

a transfer between Federal agencies of elemental mercury for the sole purpose of facilitating storage of mercury to carry out this chapter; or

(B)

a conveyance, sale, distribution, or transfer of coal.

(3)

Nothing in this subsection prohibits the leasing of coal.

(h)

Each submission required pursuant to this section or pursuant to a rule or an order promulgated or issued by the Administrator under this section shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission—

(1)

is accurate and reliable; and

(2)

includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.

(i)

In any rule or order under this section, the Administrator shall specify the date on which the rule or order shall take effect, which date shall be as soon as feasible.

.

8.

Section 7 of the Toxic Substances Control Act (15 U.S.C. 2606) is amended to read as follows:

7.

(a)

(1)

The Administrator may commence a civil action in an appropriate district court of the United States for—

(A)

seizure of a chemical substance or mixture, or any article containing a chemical substance or mixture, that may present an imminent and substantial endangerment to health or the environment;

(B)

relief (as authorized by subsection (b)) against any person that manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance or mixture, or any article containing a chemical substance or mixture, if the manufacture, processing, distribution in commerce, use, or disposal may present an imminent and substantial endangerment to health or the environment, or any person that contributes to the activities; or

(C)

both seizure and relief described in subparagraphs (A) and (B), respectively.

(2)

(A)

The Administrator may issue such orders as may be necessary to protect health or the environment from any manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance or mixture or any article containing such a substance or mixture that may present an imminent and substantial endangerment to health or the environment.

(B)

An order under subparagraph (A) may include any requirements imposed on the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or article containing the chemical substance or mixture, as the Administrator determines is necessary to protect health or the environment, including the requirements described in section 6(c) and the relief authorized under subsection (b).

(3)

A civil action may be commenced, under paragraph (1), or other action taken under paragraph (2), notwithstanding—

(A)

the existence of a rule or order under this chapter; and

(B)

the pendency of any administrative or judicial proceeding under this chapter.

(b)

(1)

The district court of the United States in which an action under subsection (a)(1) is brought shall have jurisdiction to grant such temporary or permanent relief as may be necessary to protect health or the environment from the risk associated with the activity involved in the action.

(2)

In the case of an action under subsection (a)(1) brought against a person that manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance or mixture or an article containing a chemical substance or mixture, the relief authorized by paragraph (1) may include—

(A)

the issuance of a mandatory order imposing any of the requirements described in section 6(c); and

(B)

in the case of purchasers of the substance, mixture, or article known to the defendant—

(i)

notification to the purchasers of the risk associated with the substance, mixture, or article;

(ii)

public notice of the risk;

(iii)

recall;

(iv)

the replacement or repurchase of the substance, mixture, or article; or

(v)

any combination of the actions described in clauses (i) through (iv) or section 6(c); or

(C)

any other relief as may be necessary to protect health or the environment from the risk involved in the action.

(3)

An action under subsection (a)(1) against a chemical substance, mixture, or article may be proceeded against by process of libel for its seizure and condemnation. Proceedings in such an action described in this subparagraph shall conform as nearly as possible to proceedings in rem in admiralty.

(c)

(1)

(A)

An action under subsection (a)(1) against a person that manufactures, processes, or distributes a chemical substance or mixture or an article containing a chemical substance or mixture may be brought in the United States District Court for the District of Columbia, or for any judicial district in which any of the defendants is found, resides, or transacts business.

(B)

Process in an action described in subparagraph (A) may be served on a defendant in any other district in which the defendant resides or may be found.

(C)

An action under subsection (a)(1) against a chemical substance, mixture, or article may be brought in any United States district court within the jurisdiction of which the chemical substance, mixture, or article is found.

(D)

In determining the judicial district in which an action may be brought under subsection (a)(1) in instances in which the action may be brought in more than 1 judicial district, the Administrator shall take into account the convenience of the parties.

(E)

Subpoenas requiring attendance of witnesses in an action brought under subsection (a)(1) may be served in any judicial district.

(2)

If proceedings under subsection (a)(1) involving identical chemical substances, mixtures, or articles are pending in courts in 2 or more judicial districts, the proceedings shall be consolidated for trial by order of any such court on application reasonably made by any party in interest, on notice to all parties in interest.

.

9.

Section 8 of the Toxic Substances Control Act (15 U.S.C. 2607) is amended to read as follows:

8.

(a)

(1)

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, each manufacturer or processor of a chemical substance distributed in commerce shall submit to the Administrator the declaration described in paragraph (2) or (3), accompanied by the certification described in subsection (i).

(2)

A declaration described in this paragraph is a statement that includes, for each chemical substance manufactured or processed by a manufacturer or processor—

(A)

the chemical identity and any special substance characteristics of the chemical substance;

(B)

the name and location of each facility under the control of the manufacturer or processor at which the chemical substance is manufactured or processed or from which the chemical substance is distributed in commerce;

(C)

a list of health and safety studies conducted or initiated by or for, known to, or reasonably ascertainable by the manufacturer or processor with respect to the chemical substance, and copies of any such studies that have not previously been submitted to the Administrator; and

(D)

all other information known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor that has not previously been submitted to the Administrator regarding—

(i)

the physical, chemical, and toxicological properties of the chemical substance;

(ii)

the annual production volume and known uses of, and exposure and fate information relating to, the chemical substance; and

(iii)

the name and location of each facility to which the chemical substance is sent, after manufacture and processing, for subsequent processing, distribution, or use.

(3)

A declaration described in this paragraph is a statement certifying that the manufacturer or processor has ceased, or will cease not later than 180 days after the date of submission of the declaration, all production, importation, processing, and export of the chemical substance.

(4)

Each manufacturer or processor of a chemical substance that submits to the Administrator a declaration described in paragraph (2) shall update and submit to the Administrator a new declaration—

(A)

at a minimum every 3 years; and

(B)

immediately, at any time at which there becomes known or available to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor significant new information regarding a physical, chemical, toxicological property or use of, or exposure to, the chemical substance, including any information that—

(i)

demonstrates a new potential toxic effect of the chemical substance;

(ii)

corroborates previous information demonstrating or suggesting a toxic effect; or

(iii)

suggests a toxic effect at a lower dose than previously demonstrated.

(5)

Each manufacturer or processor of a chemical substance distributed in commerce shall maintain records of the information described in subparagraphs (A) through (D) of paragraph (2).

(6)

The Administrator may, by order, prohibit a manufacturer or processor in violation of this subsection from manufacturing, processing, or distributing in commerce the chemical substance or any article containing the chemical substance, except as authorized under section 6(e).

(b)

(1)

(A)

Except as provided in paragraph (2), the Administrator may by rule or order require any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, mixture, or article to maintain records of and report by a specified date any information concerning the substance, mixture, or article that, in the judgment of the Administrator, would assist the Administrator in—

(i)

making a safety determination with respect to a chemical substance under this subchapter; or

(ii)

any other aspect of administering this chapter.

(B)

The Administrator may by rule or order require that any report or information submitted pursuant to this chapter include chemical identity and special substance characteristics, as appropriate to the chemical substance or mixture that is the subject of the report or information.

(C)

The Administrator shall by rule or order further specify or modify the information that must be submitted with a particular report or information submission to establish the chemical identity and special substance characteristics of the subject chemical substance or mixture for the purposes of such report or information submission .

(2)

In the case of the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research (including any such research or analysis for the development of a product), the Administrator may issue a rule or order under paragraph (1) only to the extent the Administrator determines the maintenance of records or submission of reports, or both, is necessary for the effective enforcement of this chapter.

(3)

The Administrator may, by order, prohibit a manufacturer or processor in violation of a requirement of a rule or order under paragraph (1) from manufacturing, processing, or distributing in commerce the chemical substance or any article containing the chemical substance, except as authorized under subsection 6(e).

(c)

(1)

The Administrator shall compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States.

(2)

The list shall at least include the name of each chemical substance that any person reports, under section 5 or subsection (b), is manufactured or processed in the United States.

(3)

(A)

In the case of a chemical substance for which a notice is submitted in accordance with section 5, the chemical substance shall be included on the list as of the earliest date (as determined by the Administrator) on which the substance was manufactured or processed in the United States.

(B)

The Administrator shall first publish a list under subparagraph (A) not later than 18 months after the effective date of this Act.

(4)

The Administrator shall not include in the list any chemical substance that is manufactured or processed only in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, the substance or another substance, including such research or analysis for the development of a product.

(5)

Not later than 5 years after the date of enactment of the Safe Chemicals Act of 2010 and from time to time thereafter, the Administrator shall publish in the Federal Register a list of all chemical substances distributed in commerce that categorizes the chemical substances, based on existing information available to the Administrator, into categories based on known health or environmental effects, exposure, insufficient data, or other category that the Administrator considers appropriate.

(d)

(1)

Not later than 1 year after the date of enactment of Safe Chemicals Act of 2010, the Administrator, through collaboration as appropriate, shall establish—

(A)

an electronic, Internet-accessible database for storing and sharing of information relating to the toxicity and use of, and exposure to, chemical substances; and

(B)

procedures for use in maintaining and updating the database.

(2)

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2010 or not later than 90 days after the date of decisions made by the Administrator or receipt by the Administrator of information submitted pursuant to this subchapter, the Administrator shall, subject to section 14, make available to the public via the Internet-accessible database described in paragraph (1) a description of all significant decisions made by the Administrator under this subchapter or significant information submitted pursuant to this subchapter.

(e)

(1)

Any person that manufactures, processes, or distributes in commerce any chemical substance or mixture shall maintain and submit to the Administrator records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture.

(2)

(A)

Records of the adverse reactions to the health of employees shall be retained for a period of 30 years after the date the reactions were first reported to or known by the person maintaining the records.

(B)

Any other record of the adverse reactions shall be retained for a period of 5 years after the date the information contained in the record was first reported to or known by the person maintaining the record.

(3)

Records required to be maintained under this subsection shall include—

(A)

records of consumer allegations of personal injury or harm to health;

(B)

reports of occupational disease or injury; and

(C)

reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce from any source.

(f)

(1)

(A)

From time to time, each Federal agency and Federal institution shall submit to the Administrator a synopsis of the data and records in the possession or control of the agency and institution, respectively, that may be useful to the Administrator in carrying out this chapter.

(B)

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall prescribe, by order, the format, content, and level of detail of the synopses.

(C)

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2010, each Federal agency and Federal institution shall make the initial submission of a synopsis of the agency and institution, respectively, to the Administrator.

(D)

At least once every 3 years, each Federal agency and Federal institution shall—

(i)

update and keep current the synopsis of the agency and institution, respectively; and

(ii)

submit the updated synopsis to the Administrator.

(2)

On the request of the Administrator, any information in the possession or control of an agency or institution relating to a hazard of, use of, exposure to, or risk of, a chemical substance or mixture shall be provided to the Administrator.

(g)

Any person that manufactures, processes, or distributes in commerce a chemical substance or mixture and that obtains information that reasonably supports the conclusion that the substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of the information unless the person has actual knowledge that the Administrator has been adequately informed of the information.

(h)

Each submission required pursuant to this section or pursuant to a rule or an order promulgated or issued by the Administrator under this section, other than a submission under subsection (f), shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission—

(1)

is accurate and reliable; and

(2)

includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.”

(i)

In this section, the terms manufacture and process mean manufacture and process, respectively, for commercial purposes.

.

10.

Section 9 of the Toxic Substances Control Act (15 U.S.C. 2608) is amended—

(1)

in subsection (a)—

(A)

by amending paragraph (1) to read as follows:

(1)

If the Administrator determines that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities either does not meet the safety standard under this subchapter, or requires conditions or restrictions in order to the meet the safety standard, and the Administrator determines that action may be taken under a Federal law not administered by the Administrator to address the uses of, or aggregate and cumulative exposure to, such chemical substance or mixture, the Administrator shall submit to the agency which administers such law a report that describes with specification the activity or combination of activities that prevent the chemical substance or mixture from meeting the safety standard or restrictions or conditions required to meet the safety standard under this subchapter. Such report shall also request that such agency—

(A)

determine if the action or actions may be taken under such law (or laws) administered by such agency;

(B)

if the agency determines under subparagraph (A) that such action or actions may be taken, initiate such action or actions and provide a timetable for such action or actions; and

(C)

respond to the Administrator with respect to the matters described in the report.

Any report of the Administrator shall include a detailed statement of the information on which it is based and shall be promptly published in the Federal Register. The agency receiving a request under such a report shall make the requested determination, take the action or actions necessary to ensure that the chemical substance or mixture meets the safety standard under this subchapter, if appropriate, and respond to the Administrator’s request within such time as the Administrator specifies in the request, but such time specified may not be less than 90 days from the date the request was made. The response of an agency shall be accompanied by a detailed statement of the findings and conclusions of the agency and shall be promptly published in the Federal Register.

;

(B)

by amending paragraph (2) to read as follows:

(2)

If the Administrator submits a report under paragraph (1) with respect to a chemical substance or mixture and the agency to which such report was made initiates, within such time specified in the request under paragraph (1), action or actions under the law (or laws) administered by such agency to ensure that a chemical substance or mixture including an restrictions or conditions meets the safety standard under this subchapter, the Administrator may not take action under this chapter with respect to that action or actions except that the Administrator may take actions pursuant to section 7 of this subchapter.

;

(C)

by redesignating paragraph (3) as paragraph (4);

(D)

by inserting after paragraph (2) the following new paragraph:

(3)

If the Administrator submits a report under paragraph (1) with respect to a chemical substance or mixture and the agency to which such report was submitted either—

(A)

determines that action cannot be taken under the authorities of the agency;

(B)

does not initiate action, if appropriate, within such time specified in the request under paragraph (1);

(C)

does not complete the action within the timeframe provided by such agency; or

(D)

fails to respond,

the Administrator may, by order, initiate action or a combination of actions under this chapter to ensure compliance with the safety standard for the chemical substance or mixture under this subchapter.

; and

(E)

in paragraph (4), as redesignated by subparagraph (C) of this paragraph—

(i)

by striking section 6 or 7 and inserting this chapter; and

(ii)

by striking against such risk after Federal action;

(2)

in subsection (c), by inserting at the end the following: In exercising any authority under this title, the Administrator shall ensure that any actions to address workplace exposures that the Administrator takes or requires be taken by manufacturers or processors of a chemical substance or mixture are consistent with the industrial hygiene hierarchy of controls.; and

(3)

in subsection (d)—

(A)

by striking while imposing the least burdens of duplicative requirements on those subject to the Act and for other purposes; and

(B)

by striking , in the report required by section 30,.

11.

Section 11 of the Toxic Substances Control Act (15 U.S.C. 2610) is amended to read as follows:

11.

(a)

For purposes of administering this chapter, the Administrator, and any duly designated representative of the Administrator, may inspect any establishment, facility, or other premises in which chemical substances, mixtures or articles subject to this chapter are manufactured, processed, stored, or held before or after their distribution in commerce; any conveyance being used to transport such chemical substances, mixtures, or articles in connection with distribution in commerce; and any place where records relating to such chemical substances, mixtures, or articles, or otherwise relating to compliance with this chapter, are held. Each such inspection shall be commenced and completed with reasonable promptness and shall be conducted at reasonable times, within reasonable limits, and in a reasonable manner. The Administrator, and any duly designated representative of the Administrator, may also inspect and obtain samples of any such chemical substances, mixtures, or articles, and any containers or labeling of such chemical substances, mixtures, or articles.

(b)

Except as provided in paragraph (2), an inspection conducted under subsection (a) of this section shall extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) bearing on whether the requirements of this chapter applicable to the chemical substances, mixtures, articles or records subject to this chapter have been complied with.

(c)

In carrying out this chapter, the Administrator may require the attendance and testimony of witnesses and the production of such reports, papers, documents, items, answers to questions, and other information, including the development of analyses and other information, that the Administrator deems necessary. Witnesses shall be paid the same fees and mileage that are paid witnesses in the courts of the United States.

(d)

For purposes of enforcing the provisions of this chapter and upon a showing to an officer or court of competent jurisdiction that there is reason to believe that the provisions of this chapter have been violated, officers or employees duly designated by the Administrator are empowered to obtain and to execute warrants authorizing—

(1)

entry, inspection, and copying of records for purposes of this chapter; and

(2)

the seizure of any chemical substance, mixture or article which is in violation of this chapter.

.

12.

Section 12 of the Toxic Substances Control Act (15 U.S.C. 2611) is amended—

(1)

by striking subsection (a);

(2)

by redesignating subsections (b) and (c) as subsections (a) and (b), respectively;

(3)

in subsection (a), as redesignated by paragraph (2) of this section—

(A)

in paragraph (1)—

(i)

by striking or intends to export;

(ii)

by striking section 4 or 5(b) and inserting section 5 or 6(b);

(iii)

by striking or intent to export and inserting not later than 30 days after the date of exportation of the substance or mixture; and

(iv)

by inserting promptly thereafter before furnish;

(B)

in paragraph (2)—

(i)

by striking or intends to export;

(ii)

by striking an order has been issued under section 5 or a rule has been proposed or promulgated under section 5 or 6, or with respect to which an action is pending or relief has been granted under section 5 or 7 and inserting an action has been taken pursuant to section 6 or section 7;

(iii)

by striking or intent to export and inserting not later than 30 days after the date of exportation of the substance or mixture;

(iv)

by inserting promptly thereafter before furnish; and

(v)

by striking such rule, order, action, or relief and inserting such action taken pursuant to section 6 or section 7; and

(C)

by adding at the end the following new paragraph:

(3)

(A)

Any person that has notified the Administrator of the exportation of a chemical substance or mixture under this section shall notify the Administrator of any change in the export status of the substance or mixture not later than 30 days after such a change in status.

(B)

The Administrator shall promptly furnish an updated notice to the governments that have been notified pursuant to paragraphs (1) and (2) regarding the exportation of any chemical substance or mixture subject to this section if—

(i)

data for such substance or mixture have been received by the Administrator pursuant to section 4, 6(b), or 8;

(ii)

a change has occurred in the export status of such substance or mixture; or

(iii)

a change has been made in any risk management action taken pursuant to section 6 or 7 for such substance or mixture.

;

(4)

in subsection (b), as redesignated by paragraph (2) of this section—

(A)

by striking paragraph (2); and

(B)

by redesignating paragraphs (3), (4), (5), and (6) as paragraphs (2), (3), (4), and (5), respectively; and

(5)

by adding at the end the following new subsection:

(c)

The Administrator shall—

(1)

maintain copies of all current notices provided to other governments under this section; and

(2)

make such copies available to the public in electronic format.

.

13.

Section 13 of the Toxic Substances Control Act (15 U.S.C. 2612) is amended—

(1)

by striking Secretary of the Treasury each place it appears and inserting Secretary of Homeland Security; and

(2)

in subsection (a)(1), by striking the em dash and subparagraphs (A) and (B) and inserting the substance, mixture, or article fails to comply with or is offered for entry in violation of any rule or order in effect under this chapter..

14.

Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is amended—

(1)

by redesignating subsections (a) through (e) as subsections (c) through (g), respectively;

(2)

by inserting before subsection (c), as redesignated by paragraph (1) of this section, the following new subsections:

(a)

The Administrator shall ensure that—

(1)

information control designations under this section are not a determinant of public disclosure pursuant to section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act); and

(2)

all information in the agency's possession that is releasable pursuant to an appropriate request under section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act), is made available to members of the public.

(b)

Nothing in this section shall be construed to prevent or discourage the Administrator from voluntarily releasing to the public any unclassified information that is not exempt from disclosure under section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act).

;

(3)

in subsection (c), as redesignated by paragraph (1) of this subsection—

(A)

by striking subsection (b) and inserting subsection (d);

(B)

by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively;

(C)

by adding after paragraph (2) the following new paragraph:

(3)

shall be disclosed upon request to a State, tribal, or municipal government, including identification of the location of the manufacture, processing, or storage of a chemical substance upon the request of the government—

(A)

for the purpose of administration or enforcement of a law; and

(B)

in accordance with any applicable agreements that ensure that the recipient government takes appropriate steps to maintain the confidentiality of the information in accordance with this section and section 350.27 of title 40, Code of Federal Regulations or any successor to such regulation;

; and

(D)

in paragraph (4), as redesignated by subparagraph (B) of this paragraph, by striking an unreasonable risk of injury and inserting an imminent and substantial endangerment;

(4)

in subsection (d), as redesignated by paragraph (1) of this section—

(A)

in the subsection heading, by striking Data from health and safety studies and inserting Information not eligible for protection;

(B)

by amending paragraph (1) to read as follows:

(1)

The following types of information shall not be eligible for protection under this section, and the Administrator shall not approve a request to treat information of the following types as confidential under this section:

(A)

The identity of a chemical substance, except as provided in section 5.

(B)

Any safety standard determination developed under section 6, including supporting information developed by the Administrator.

(C)

Any health and safety study which is submitted under this chapter with respect to—

(i)

any chemical substance or mixture—

(I)

which, on the date on which such study is to be disclosed has been offered for commercial distribution; or

(II)

for which testing is required under section 4 or for which notification is required under section 5 of this subchapter; and

(ii)

any data reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (C).

(D)

Any information indicating the presence of a chemical substance in a consumer article intended for use or reasonably expected to be used by children or to which children can otherwise be reasonably expected to be exposed.

This paragraph does not authorize the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.

; and

(C)

in paragraph (2)—

(i)

by striking the first sentence of paragraph (1) and inserting clause (i) or (ii) of subparagraph (C) of paragraph (1); and

(ii)

by striking in the second sentence of such paragraph and inserting in the last sentence of paragraph (1);

(5)

in subsection (e), as redesignated by paragraph (1) of this section—

(A)

by amending paragraph (1) to read as follows:

(1)

In submitting data under this chapter, a manufacturer, processor, or distributor in commerce may—

(A)

designate the data which such person believes is entitled to confidential treatment under subsection (a) of this section; and

(B)

submit such designated data separately from other data submitted under this chapter. A designation under this paragraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include—

(i)

justification for each claim for confidentiality;

(ii)

a certification that the information is not otherwise publicly available; and

(iii)

separate copies of all submitted information, with 1 copy containing and 1 copy excluding the information to which the request applies.

;

(B)

by redesignating paragraph (2) as paragraph (3);

(C)

by inserting after paragraph (1) the following new paragraph:

(2)

The Administrator shall—

(A)

not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, by order develop and make publicly available standards that specify—

(i)

the acceptable bases on which written requests to maintain confidentiality of information may be approved, which shall be no more restrictive of public disclosure than section 552 of title 5, United States Code; and

(ii)

the documentation that must accompany those requests;

(B)

not later than 90 days after the date of receipt of information designated under paragraph (1), review all requests to maintain confidentiality of the submitted information and decide whether to approve or deny such request based on whether the request and accompanying documentation comply with those standards that are developed under paragraph (1) (except that if a request for the information is received under section 552 of title 5, United States Code, before the 90-day review and decision period has elapsed, the disclosure requirements, procedures, and judicial review provisions under that section shall apply);

(C)

in the event such a request is denied, make the information available to the public in accordance with section 8(b)(3); and

(D)

if such a request is approved, specify a time period of not greater than 5 years for which the submitted information shall be kept confidential.

; and

(D)

in paragraph (3), as redesignated by subparagraph (B) of this paragraph—

(i)

in subparagraph (A)—

(I)

by striking paragraph (1)(A) and inserting paragraph (1) and approved by the Administrator under paragraph (2)(B); and

(II)

by striking The Administrator may not release such data until the expiration of 30 days after the manufacture, processor, or distributor in commerce submitting such data has received the notice required by this subparagraph. and inserting The Administrator shall release the information in accordance with the disclosure and procedural requirements of section 552 of title 5, United States Code.; and

(ii)

in subparagraph (B)(i)—

(I)

by striking or (4) and inserting (4), or (5);

(II)

by striking subsection (a) each place it appears and inserting subsection (c);

(III)

by striking paragraph (3) and inserting paragraph (4);

(IV)

by striking that before if the Administrator determines that the release of such data;

(V)

by striking , unreasonable risk of injury before to health or the environment and inserting and substantial endangerment then no notice is required.; and

(VI)

by striking , such notice may be made by such means as the Administrator determines will provide notice at least 24 hours before such release is made; and

(6)

by adding at the end the following new subsection:

(h)

The Administrator shall provide standards for and facilitate the sharing of chemical identity, safety standard determination, health and safety data described in subsection (d) that pertains to chemical substances or mixtures, or articles containing chemical substances, that workers may come into contact with or otherwise be exposed to during the course of work, with those workers and representatives of each certified or recognized bargaining agent representing such employees.

.

15.

Section 15 of the Toxic Substances Control Act (15 U.S.C. 2614) is amended—

(1)

by striking paragraph (1) and inserting the following:

(1)

fail or refuse to comply with any rule, order, prohibition, restriction, or other requirement imposed by this chapter or by the Administrator under this chapter;

;

(2)

in paragraph (2)—

(A)

by striking use and inserting manufacture, process, distribute in commerce, use, or dispose of;

(B)

by striking , or mixture and inserting mixture or article; and

(C)

by striking section 5 or 6, a rule or order under section 5 or 6, or an order issued in action brought under section 5 or 7 and inserting any rule, order, prohibition, restriction, or other requirement imposed by this chapter or by the Administrator under this chapter;

(3)

in paragraph (3)—

(A)

in subparagraph (A), by inserting accurate and complete before records;

(B)

in subparagraph (B)—

(i)

by inserting or make accurate and complete before reports; and

(ii)

by inserting information submissions, disclosures, declarations, certifications, after notices,; and

(C)

in subparagraph (C), by striking or after the semicolon;

(4)

in paragraph (4), by striking the period at the end and inserting a semicolon; and

(5)

by adding at the end the following new paragraphs:

(5)

make or submit a statement, declaration, disclosure, certification, writing, data set, or representation that is materially false, in whole or in part, or to falsify or conceal any material fact, in taking any action or making any communication pursuant to this chapter or pursuant to any rule or order promulgated or issued under this chapter; or

(6)

take any action prohibited by this chapter.

.

16.

Section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by inserting this chapter or a rule or order promulgated or issued pursuant to this chapter, as described in before section 15 or 409 shall be;

(ii)

by striking $25,000 and inserting $37,500; and

(iii)

by striking violation of section 15 or 409 and inserting violation of this chapter;

(B)

by redesignating paragraphs (2), (3), and (4) as paragraphs (3), (4), and (5), respectively;

(C)

by inserting after paragraph (1) the following new paragraph:

(2)

In the case of any violation described in paragraph (1), the Administrator may commence a civil action in the appropriate United States district court to assess penalties pursuant to paragraph (1).

;

(D)

in paragraph (3)(A), as redesignated by subparagraph (B) of this paragraph—

(i)

by inserting this chapter, as described in before section 15 or 409; and

(ii)

by striking within 15 days of and inserting not later than 15 days after;

(E)

in paragraph (4), as redesignated by subparagraph (B) of this paragraph—

(i)

by striking paragraph (2)(A) and inserting paragraph (3)(A); and

(ii)

by striking the United States Court of Appeals for the District of Columbia or for any other circuit and inserting the appropriate district court of the United States for the district; and

(F)

in paragraph (5), as redesignated by subparagraph (B) of this paragraph, by striking paragraph (3) each place it appears and inserting paragraph (4); and

(2)

in subsection (b)—

(A)

by inserting (1) before Any person who;

(B)

by striking or willfully before violates any provision;

(C)

by inserting this chapter, as described in before section 15 or 409;

(D)

by striking $25,000 and inserting $50,000;

(E)

by striking one year and inserting 5 years; and

(F)

by adding at the end the following new paragraph:

(2)

Any person who knowingly violates any provision of this chapter and who knows at the time that he thereby places another person in imminent danger of death or serious bodily injury to any person shall upon conviction be subject to a fine of not more than $250,000 or imprisonment of not more than 15 years, or both. A person that is not an individual shall, upon conviction of violating this subparagraph, be subject to a fine of not more than $1,000,000.

.

17.

Section 17 of the Toxic Substances Control Act (15 U.S.C. 2616) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by striking The district courts of the United States shall have jurisdiction over civil actions to and inserting The Administrator may commence a civil action in the appropriate United States district court to compel compliance of any person with any provision of this chapter or any rule or order promulgated pursuant to this chapter. The Administrator’s authority to enforce this chapter includes the authority to;

(ii)

by striking subparagraphs (A) through (C) and inserting the following subparagraphs:

(A)

seek civil or criminal penalties under section 16 for any violation of this chapter, as described in sections 15 and 409;

(B)

enjoin any violation of this chapter, or of a rule or order promulgated or issued under this chapter, as described in sections 15 and 409; and

(C)

order the compliance of any person with any provision of this chapter, or with any rule or order promulgated or issued under this chapter, through an administrative proceeding (which may proceed concurrently with action under this section), in which the Administrator may levy penalties under section 16;

; and

(iii)

in subparagraph (D)—

(I)

by striking product wherever it appears and inserting article;

(II)

by striking direct and inserting order;

(III)

by striking product subject to title IV and inserting article subject to this chapter;

(IV)

by striking of section 5, 6, or title IV and inserting this chapter; and

(V)

by striking under section 5, 6, or title IV and inserting promulgated and issued under this chapter, as described in section 15 or 409,; and

(B)

in paragraph (2)—

(i)

by striking A civil action described in paragraph (1) and inserting The district courts of the United States shall have jurisdiction over a civil action described in paragraph (1). A civil action;

(ii)

in subparagraph (A)—

(I)

by striking subparagraph (A) of such paragraph and inserting subparagraphs (A) and (B) of paragraph (1);

(II)

by inserting this chapter, as described in before section 15; and

(III)

by inserting or 409 after section 15; and

(iii)

in subparagraph (B) by striking such paragraph and inserting paragraph (1); and

(2)

in subsection (b)—

(A)

by striking title IV and inserting this chapter; and

(B)

by striking product each place it appears and inserting article.

18.

Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is amended to read as follows:

18.

Nothing in this chapter, or any rule, regulation, or order issued or promulgated pursuant to this chapter shall be construed, interpreted, or applied to preempt, displace or supplant any provision of any law, including common law, of any State or political subdivision of a State relating to any chemical substance or mixture, or any article that contains a chemical substance or mixture, which is more stringent than is provided for under this chapter.

.

19.

Section 19 of the Toxic Substances Control Act (15 U.S.C. 2618) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by striking subparagraph (B);

(ii)

by redesignating subparagraph (A) as paragraph (1);

(iii)

by inserting or issuance after promulgation;

(iv)

by striking section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV and inserting this chapter; (v) by inserting or order after rule each place it appears; and

(v)

by striking (other than in an enforcement proceeding) before “of such a rule);

(B)

in paragraph (2)—

(i)

by striking paragraph (1)(A) and inserting paragraph (1); and

(ii)

by inserting or order after rule; and

(C)

by striking paragraph (3);

(2)

in subsection (b), by inserting or order after rule each place it appears; and

(3)

in subsection (c), by amending paragraph (1) to read as follows:

(1)

Upon the filing of a petition under subsection (a)(1) for judicial review of a rule or order, the court shall have jurisdiction—

(A)

to grant appropriate relief, including interim relief, as provided in chapter 7 of title 5, United States Code; and

(B)

to review such rule or order in accordance with such chapter 7.

.

20.

Section 20 of the Toxic Substances Control Act (15 U.S.C. 2619) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by striking under section 4, 5, or 6, or title II or IV,; and

(ii)

by striking section 5 or title II or IV to restrain such violation and inserting this chapter; and

(B)

in the flush language following paragraph (2), by inserting , to enforce this chapter or any rule promulgated or order issued under this chapter, or to order the Administrator to perform an act or duty described in this chapter, as the case may be after citizenship of the parties; and

(2)

in subsection (b)(1), by striking to restrain and inserting respecting.

21.

Section 21 of the Toxic Substances Control Act (15 U.S.C. 2620) is amended—

(1)

in subsection (a), by striking under section 4, 6, or 8 or an order under section 5(e) or (6)(b)(2) and inserting , order, or any other action authorized under this chapter; and

(2)

in subsection (b)—

(A)

in paragraph (1), by striking under section 4, 6, or 8 or an order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting or order or to initiate other action authorized under this chapter;

(B)

in paragraph (3), by striking section 4, 5, 6, or 8 and inserting the applicable provisions of this chapter; and

(C)

in paragraph (4)—

(i)

in subparagraph (A), by striking a rulemaking proceeding and inserting proceedings authorized under this chapter; and

(ii)

in subparagraph (B)—

(I)

by striking a proceeding to issue a rule under section 4, 6, or 8 or an order under section 5(e) or 6(b)(2) and inserting proceedings authorized under this Act;

(II)

in clause (i)—

(aa)

by inserting except as provided in clause (ii), before in the case of; and

(bb)

in subclause (II), by striking present an unreasonable risk to and inserting substantial endangerment; and

(III)

in clause (ii)—

(aa)

by striking issuance of a rule under section 6 or 8 or an order under section 6(b)(2) and inserting imposition or issuance of a restriction, use condition, or order under this chapter; and

(bb)

by striking an unreasonable and inserting a substantial endangerment.

22.

Section 24 of the Toxic Substances Control Act (15 U.S.C. 2623) is amended—

(1)

in subsection (a)—

(A)

by striking continuing and inserting periodic; and

(B)

by striking the em dash and paragraphs (1) and (2) and inserting the implementation of this chapter.;

(2)

in subsection (b)—

(A)

in paragraph (1), in the flush language after subparagraph (B), by striking section 4, 5, or 6 or a requirement of section 5 or 6 and inserting this chapter;

(B)

in paragraph (2)—

(i)

in subparagraph (A)(ii), by striking by order issued and inserting in writing,; and

(ii)

in subparagraph (B)—

(I)

in clause (i), by inserting and after the such request,;

(II)

by striking clause (ii); and

(III)

by redesignating clause (iii) as clause (ii); and

(C)

by striking paragraph (4); and

(3)

by adding at the end the following new subsection:

(c)

Nothing in this section shall be construed—

(1)

to require the Administrator to amend or repeal any rule or order in effect under this chapter; or

(2)

to condition the Administrator’s authority to issue orders or promulgate rules under this chapter.

.

23.

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)

The Administrator may, by rule, require the payment of a reasonable fee from any person required to submit data to defray the cost of administering this chapter. In setting a fee under this paragraph, the Administrator shall take into account the ability to pay of the person required to submit the data and the cost to the Administrator of reviewing such data. Such rules may provide for sharing such a fee in any case in which the expenses of testing are shared under this chapter.

; and

(2)

by adding at the end the following new subsection:

(h)

In carrying out this chapter, the Administrator is authorized to issue such orders and prescribe such regulations as are necessary to carry out this chapter.

.

24.

Section 28 of the Toxic Substances Control Act (15 U.S.C. 2627) is amended—

(1)

in subsection (a)—

(A)

by striking unreasonable before risk within the States; and

(B)

by striking is unable or is not likely to take and inserting has not taken;

(2)

by redesignating subsections (b), (c), and (d) as subsections (c), (d), and (e), respectively;

(3)

by inserting after subsection (a) the following new subsection:

(b)

The Administrator shall establish a process to coordinate with States, on an on-going basis, to share data and priorities relating to the management of chemical substances under this title and under programs operated by States, in accordance with requirements under section 14.

; and

(4)

in subsection (c)(2), as redesignated by paragraph (2) of this section, by striking including cancer, birth defects, and gene mutations,.

25.

Title I of the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is amended—

(1)

by redesignating section 29 as section 39;

(2)

by redesignating section 30 as section 38;

(3)

by striking section 31; and

(4)

by amending section 39, as redesignated, to read as follows:

39.

There are authorized to be appropriated to the Administrator such sums as may be necessary for each of the fiscal years 2011 through 2018 to carry out this chapter.

.

26.

(a)

The Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is amended by inserting after section 28 the following new sections:

29.

The Administrator shall act quickly to manage risks from chemical substances that clearly pose the highest risks to human health or the environment.

30.

(a)

(1)

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish a Childrens Environmental Health Research Program’ within the Environmental Protection Agency.

(2)

Subject to amounts made available in advance in appropriations Acts, under the Children’s Environmental Health Research Program established under paragraph (1), the Administrator may enter into contracts and make grants to further understanding of the vulnerability of children to chemical substances and mixtures.

(3)

Contracts and grants under this section shall be provided in consultation with Interagency Science Advisory Board on Children’s Health and Toxic Substances established under subsection (b).

(b)

(1)

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Childrens Health Research’. The Board shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.).

(2)

The purposes of the Board shall be to provide independent advice, expert consultation, and peer review upon request of the Administrator or Congress on the scientific and technical aspects of issues relating to the implementation of this subchapter with respect to protecting children’s health and research.

(3)

The Administrator shall—

(A)

appoint the members of the Board, including, at a minimum, representatives of—

(i)

the National Institute of Environmental Health Sciences;

(ii)

the Centers for Disease Control and Prevention;

(iii)

the National Toxicology Program;

(iv)

the National Cancer Institute;

(v)

the National Tribal Science Council; and

(vi)

not fewer than 3 centers of children’s health at leading universities;

(B)

ensure that at least 1/3 of the members of the Board have specific scientific expertise in the relationship of chemical exposures to prenatal, infant, and children’s health; and

(C)

ensure that no individual appointed to serve on the Board has a conflict of interest that is relevant to the functions performed, unless such conflict is promptly and publicly disclosed and the Administrator determines that the conflict is unavoidable.

(c)

(1)

If, through studies performed pursuant to subsection (a), section 4, or other available research, the Administrator identifies a chemical substance that may be present in human biological media that may have adverse effects on early childhood development, the Administrator shall coordinate with the Secretary of Health and Human Services to conduct, not later than 2 years after the date on which the Administrator makes such identification, a biomonitoring study to determine the presence of the chemical substance in human biological media in, at a minimum, pregnant women and infants.

(2)

Upon completion of any study conducted pursuant to paragraph (1), the Secretary of Health and Human Services shall—

(A)

inform the Administrator of the results of the study; and

(B)

publish the results of the study in a publicly available electronic format.

(3)

(A)

Whenever a chemical substance or mixture is determined to be present in a study conducted pursuant to paragraph (1), the manufacturers and processors of the chemical substance or mixture shall, not later than 180 days after the date of publication of such study, disclose to the Administrator, commercial customers of the manufacturers and processors, consumers, and the public—

(i)

all known uses of the chemical substance or mixture; and

(ii)

all articles in which the chemical substance or mixture is or is expected to be present.

(B)

Information under clauses (i) and (ii) of subparagraph (A) shall be—

(i)

made available by the Administrator in electronic format; and

(ii)

made readily accessible and free of charge by each applicable manufacturer and processor in electronic format to the commercial customers of such manufacturer or processor, consumers, and the public.

31.

(a)

The Administrator shall take action to minimize the use of animals in testing of chemical substances or mixtures, including—

(1)

encouraging and facilitating, where practicable—

(A)

use of existing data of sufficient scientific quality;

(B)

use of test methods that eliminate or reduce the use of animals but provide data of high scientific quality;

(C)

grouping of 2 or more chemical substances into scientifically appropriate categories where testing of one chemical substance will provide reliable and useful data on others in the category;

(D)

formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; and

(E)

parallel submission of data from animal-based studies and from emerging methods and models; and

(2)

funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection.

(b)

(1)

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Alternative Testing Methods. The Board shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.).

(2)

The Administrator shall—

(A)

appoint the members of the Interagency Science Advisory Board on Alternative Testing Methods, including, at a minimum, representatives of—

(i)

the National Institute of Environmental Health Sciences;

(ii)

the Centers for Disease Control and Prevention;

(iii)

the National Toxicology Program;

(iv)

the National Cancer Institute; and

(v)

the National Tribal Science Council; and

(B)

ensure that no individual appointed to serve on the Interagency Science Advisory Board on Alternative Testing Methods has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Administrator determines that the conflict is unavoidable.

(3)

The purpose of the Interagency Science Advisory Board on Alternative Testing Methods shall be to provide independent advice and peer review to the Administrator and Congress on the scientific and technical aspects of issues relating to the implementation of this subchapter with respect to minimizing the use of animals in testing of chemical substances or mixtures.

(4)

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, and triennially thereafter, the Administrator, in consultation with the Interagency Science Advisory Board on Alternative Testing Methods established under paragraph (1), shall publish a list of testing methods that reduce the use of animals in testing under section 4.

(c)

To promote the development and timely incorporation of new testing methods that are not animal-based, the Administrator shall—

(1)

in consultation with the Interagency Science Advisory Board on Alternative Testing Methods established under subsection (b)(1), and after providing an opportunity for public comment, develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information used for safety standard determinations under section 6(b) that do not use animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening;

(2)

biennially report to Congress on progress made in implementing this section; and

(3)

fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and testing strategies that are not animal-based for use in safety standard determinations under section 6(b).

(d)

Upon request from a manufacturer or processor that is required to conduct animal-based testing of a chemical substance or mixture under this subchapter, the Administrator may adapt or waive such requirement if the Administrator determines that—

(1)

there is sufficient weight-of-evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property, in any case in which the information from each individual source alone is regarded as insufficient to support the conclusion;

(2)

testing for a specific endpoint is technically not practicable to conduct as a consequence of 1 or more physical or chemical properties of the chemical substance or mixture; or

(3)

a chemical substance or mixture cannot be tested in animals at concentrations that do not result in significant pain or distress, due to physical or chemical properties of the chemical substance or mixture, such as potential to cause severe corrosion or severe irritation to tissues.

32.

(a)

(1)

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish a program to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances.

(2)

The program under paragraph (1) shall include—

(A)

expedited review of new chemical substances for which the manufacturer or processor submits an alternatives analysis indicating that the new chemical substance is the safer alternative for a particular use than existing chemical substances used for the same purpose;

(B)

recognition for a chemical substance or product determined by the Administrator to be a safer alternative for a particular use by means of a special designation intended for use in marketing the safer alternative, and periodic public awards or rewards; and

(C)

such other incentives, as the Administrator considers to be appropriate to encourage the development, marketing, and use of chemical substances or products determined by the Administrator to be safer alternatives for the particular uses, such as job training and worker assistance.

(b)

The Administrator shall establish a network of not fewer than 4 green chemistry and engineering centers, located in various regions of the United States, to support the development and adoption of safer alternatives to chemical substances, particularly chemical substances placed on the priority list under section 6(a).

(c)

The Administrator shall make grants to promote and support the research, development, and adoption of safer alternatives to hazardous substances.

(d)

(1)

The Administrator shall create a program to facilitate the development of a workforce, including industrial and scientific workers, that produces safer alternatives to existing chemical substances.

(2)

The goals of the program are to provide workforce training on skills that will—

(A)

facilitate the expansion of green chemistry;

(B)

develop scientific and technical leadership in green chemistry;

(C)

facilitate the successful and safe integration of green chemistry into infrastructure projects;

(D)

inform and engage communities about green chemistry; and

(E)

promote innovation and strong public health and environmental protections.

(3)

The Administration shall implement the program to achieve its goals as described in this Act, including by—

(A)

helping to develop a broad range of skills relevant to the production and use of such safer alternatives, including their design, manufacturing, and use and disposal;

(B)

offering to develop partnerships with educational institutions, training organizations, private sector companies, and community organizations; and

(C)

provide grants to state and local governments and to the partnerships established pursuant to paragraph (B) to promote and support activities consistent with achieving the goals of this program.

33.

In cooperation with the Secretary of State and the head of any other appropriate Federal agency (as determined by the Administrator), the Administrator shall cooperate with international efforts as appropriate—

(1)

to develop a common protocol or electronic database relating to chemical substances; or

(2)

to develop safer alternatives for chemical substances.

34.

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall, by order, establish and implement procedures to ensure data reliability including, at a minimum, requirements that—

(1)

not less than annually, the Administrator randomly inspect commercial and private laboratories that develop the data required under this subchapter on the various properties and characteristics of a chemical substance;

(2)

annually, the Administrator perform a comprehensive data audit on a subset, as chosen by the Administrator, of the data submissions submitted by manufacturers and processors under this subchapter;

(3)

the Administrator establish and maintain a registry of all health- and safety-related studies initiated in response to requirements under this subchapter;

(4)

the Administrator have access to all records of health- and safety-related studies initiated in response to requirements under this subchapter; and

(5)

the Administrator require the submitter of any research study conducted by a third party in response to requirements under this subchapter to disclose to the Administrator and the public, at the time of submission, the sources of any funding used for the conduct or publication of the study received by the researchers who conducted the study.

35.

(a)

In this section:

(1)

The term disproportionate exposure means residential population exposure to 1 or more toxic chemical substances and mixtures at levels that are significantly greater than the average exposure in the United States, as defined and identified by the Administrator in accordance with the criteria under subsection (b).

(2)

The term locality means any geographical area in which the Administrator identifies disproportionate exposure and may include a county, city, town, neighborhood, census tract, zip code, or other commonly understood political or geographical subdivision.

(b)

Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall promulgate a rule to establish criteria consistent with this section to—

(1)

define disproportionate exposure; and

(2)

identify any locality that is disproportionately exposed.

(c)

(1)

Not later than 120 days after promulgation of the rule under subsection (b), the Administrator shall identify localities within the United States subject to disproportionate exposure.

(2)

In identifying localities under paragraph (1), the Administrator—

(A)

shall use data contained in the National Air Toxic Assessment Database; and

(B)

may use other data available to the Administrator, including data developed pursuant to—

(i)

the Safe Drinking Water Act (42 U.S.C. 300f et seq.);

(ii)

the Solid Waste Disposal Act (42 U.S.C. 6901 et seq.);

(iii)

the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9601 et seq.); and

(iv)

the Emergency Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11001 et seq.).

(3)

The Administrator shall provide an opportunity for members of the public to nominate localities for which there may be disproportionate exposure for inclusion in the identification of localities under paragraph (1).

(d)

(1)

Not later than 6 months after completing the identification of localities under subsection (c)(1), the Administrator shall, after notice and consultation with all applicable State, local, county health, and environmental officials, and State, local, and county legislators and other elected officials, publish a list of the localities subject to disproportionate exposure identified pursuant to such subsection in the Federal Register and make the list available electronically.

(2)

Not later than 5 years after the date of publication of the list under paragraph (1), and at least once every 5 years thereafter, the Administrator shall update and republish the list as necessary. The Administrator may update and republish the list more frequently than every 5 years to add new localities that meet the criteria under subsection (b), or to remove localities when the Administrator has determined that the exposure reduction has been achieved and no further action is needed after actions are taken under subsection (e). The Administrator shall notify all applicable State, local, county health, and environmental officials, and State, local, and county legislators and other elected officials of the updated listing.

(e)

(1)

The following actions shall not be subject to judicial review:

(A)

A decision to identify a locality pursuant to subsection (c)(1) to be included on the list published pursuant to subsection (d)(1).

(B)

A decision in response to nominations submitted pursuant to subsection (c)(3).

(C)

A decision to list localities or update the list pursuant to subsection (d)(2).

(2)

Notwithstanding paragraph (1), the failure of the Administrator to publish the list of list localities or update the list in accordance with this section shall be—

(A)

considered to be a failure to perform a nondiscretionary duty; and

(B)

subject to judicial review.

(f)

(1)

Not later than 1 year after publishing or updating the list under subsection (d), the Administrator shall develop and publish, for each locality identified on the list, an action plan that includes—

(A)

an identification of the chemical substances and mixtures that contribute to the disproportionate exposure (including exposure levels, sources, and pathways); and

(B)

a description of actions to be undertaken by the Administrator, to reduce disproportionate exposure within the locality.

(2)

The goal of each action plan under this subsection shall be to reduce disproportionate exposure within the locality by establishing the following:

(A)

A percentage exposure reduction goal for each chemical substance and mixture.

(B)

A timeline to achieve such a percentage exposure reduction goal.

(g)

The Administrator shall—

(1)

prepare and submit to Congress an annual report identifying—

(A)

each locality added to the list in the prior year under subsection (d);

(B)

each action plan developed in the prior year under subsection (e); and

(C)

the progress on each action plan to date; and

(2)

make the report available to the public in electronic format.

36.

(a)

Except as provided in subsection (e), each Federal agency, and any officer, agent, or employee thereof, shall be subject to, and comply with, all applicable requirements of this chapter, both substantive and procedural, in the same manner, and to the same extent, as any person subject to such requirements. The substantive and procedural requirements referred to in this subsection include—

(1)

any administrative order;

(2)

any civil or administrative penalty or fine, regardless of whether such penalty or fine is punitive or coercive in nature or is imposed for isolated, intermittent, or continuing violations;

(3)

any requirement for reporting;

(4)

any provision for injunctive relief and such sanctions as may be imposed by a court to enforce such relief; and

(5)

payment of reasonable service charges.

(b)

The United States expressly waives any immunity otherwise applicable to the United States with respect to any substantive or procedural requirement referred to under subsection (a).

(c)

No agent, employee, or officer of the United States shall be personally liable for any civil penalty under this chapter with respect to any act or omission within the scope of the official duties of the agent, employee, or officer.

(d)

An agent, employee, or officer of the United States shall be subject to any criminal sanction (including any fine or imprisonment) under this chapter, but no department, agency, or instrumentality of the executive, legislative, or judicial branch of the Federal Government shall be subject to any such sanction.

(e)

(1)

If the President determines it is in the paramount interest of the United States, the President may grant an exemption for any Federal agency from compliance with any requirement of this chapter.

(2)

No exemption shall be granted under paragraph (1) due to lack of appropriation unless the President has specifically requested such appropriation as a part of the budgetary process and the Congress has failed to make available such requested appropriation.

(3)

Any exemption granted under paragraph (1) shall be for a period of not more than 1 year, but additional exemptions may be granted for periods not to exceed 1 year upon the President's making a new determination that such exemption is in the paramount interest of the United States.

(4)

Each January after the date of enactment of this section, the President shall report to the Congress all exemptions under this subsection granted during the preceding calendar year, together with the reason for granting each such exemption.

(f)

(1)

The Administrator may commence an administrative enforcement action against any Federal agency pursuant to the enforcement authorities contained in this chapter. The Administrator shall initiate an administrative enforcement action against such a department, agency, or instrumentality in the same manner and under the same circumstances as an action would be initiated against another person. Any voluntary resolution or settlement of an administrative enforcement action shall be set forth in a consent order.

(2)

No administrative order issued to a Federal department, agency, or instrumentality shall become final until such department, agency, or instrumentality has had the opportunity to confer with the Administrator.

37.

(a)

(1)

The term chemical includes any substance or mixture of substances, including as part of an article.

(2)

The phrase meeting of the parties means—

(A)

the Conference of the Parties established by and operating under Article 19 of the Stockholm Convention;

(B)

the Executive Body established by and operating under Article 10 of the LRTAP POPs Convention; and

(C)

the Conference of the Parties established by and operating under Article 18 of the Rotterdam Convention.

(3)

The term LRTAP Convention means the Convention on Long-Range Transboundary Air Pollution, done at Geneva on November 13, 1979 (TIAS 10541), and any subsequent amendments to which the United States is a party.

(4)

The term LRTAP POPs chemical means any chemical listed on any Annex of the LRTAP POPs Protocol, if such listing has entered into force for the United States.

(5)

The term LRTAP POPs Protocol means the Protocol on Persistent Organic Pollutants to the LRTAP Convention, done at Aarhus on June 24, 1998, and any subsequent amendment to which the United States is a party.

(6)

The term PIC chemical means any chemical identified by notification to the Secretariat of the Rotterdam Convention by the United States as banned or severely restricted in the United States, and any chemical listed on any Annex of the Rotterdam Convention, if such listing has entered into force for the United States.

(7)

The term POPs chemical means any chemical that is listed on any Annex of the Stockholm Convention, if such listing has entered into force for the United States.

(8)

The term Rotterdam Convention means the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, done at Rotterdam on September 10, 1998, and any subsequent amendment to which the United States is a party.

(9)

The term Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants, done at Stockholm on May 22, 2001, and any subsequent amendment to which the United States is a party.

(b)

(1)

The Administrator, in cooperation with any appropriate Federal agency, shall implement and support the implementation by the United States of the provisions, that have entered into force for the United States, of the Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam Convention.

(2)

Notwithstanding any other provision of law, no person may manufacture, process, distribute in commerce, use, dispose of, or take any other action with respect to a POPs chemical, LRTAP POPs chemical, or PIC chemical in a manner inconsistent with applicable obligations for that chemical under the Stockholm Convention, LRTAP POPs Protocol, or Rotterdam Convention.

(3)

(A)

The Administrator shall provide timely public notice and opportunity to comment on a chemical proposed for listing to any Annex to the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention. The Administrator shall identify in the notice any relevant toxicity, exposure, and risk information on the chemical known to the Administrator, and any domestic activities involving the chemical known to the Administrator. Any interested person may provide relevant comment and information on the chemical in response to that notice. The Administrator may, if the Administrator determines it to be necessary to assist the United States in its review, require the provision of relevant information related to a proposed chemical from any person. Such comment and information shall be considered in the Administrator’s review of the proposal and shall be placed in an established public docket.

(B)

The Administrator shall also provide timely public notice and opportunity to comment after a recommendation is made to list a chemical on any Annex to the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention. The Administrator shall provide such notice in advance of the Meeting of the Parties at which the recommendation is to be considered. The Administrator shall request comment and information on all aspects of such recommendation and may, if the Administrator determines it to be necessary to assist the United States in its review, require the provision of relevant information related to a proposed chemical from any person. Such comment and information shall be considered in the Administrator’s review of the listing recommendation and shall be placed in an established public docket.

(C)

The Administrator shall also provide public notice and opportunity to comment on any decision by the Meeting of the Parties to list a chemical on any Annex to the Stockholm Convention. No later than 30 days after such decision becomes available, the Administrator shall provide in the notice a description of the amendments to the instruments and shall identify changes to any current domestic activities that the Administrator believes, based on information available to the Administrator, would be necessary should the United States choose to be bound by the listing decision. Any interested person may provide relevant comment and information in response to that notice. Such comment and information shall be considered in the Administrator’s review of the decision and shall be placed in an established public docket.

(D)

No later than 30 days after the United States deposits its instrument of ratification for the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, or no later than 30 days after the listing of any chemical subsequently added under those instruments has entered into force for the United States (whichever comes sooner), the Administrator shall provide notice of the chemicals that are subject to those instruments and shall provide similar public notice of any chemical subsequently added under those instruments. In providing such notice, the Administrator may specify the requirements that are applicable for individual chemicals.

(4)

The Administrator may prescribe regulations to carry out the provisions of the Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam Convention, or to ensure compliance with any obligations under such instruments.

(5)

If a chemical is subject to obligations under more than one of the instruments listed in paragraph (4), the most stringent of such obligations shall apply to ensure compliance with each of those instruments.

(c)

The prohibitions and any other requirements of this part shall be enforced in the same manner as final rules or orders under section 2605 of the Toxic Substances Control Act.

.

(b)

The table of contents for the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is amended—

(1)

by striking the item relating to section 2 and inserting the following:

Sec. 2. Findings, policy, and goal.

;

(2)

by striking the item relating to section 4 and inserting the following:

Sec. 4. Minimum data set and testing of chemical substances and mixtures.

;

(3)

by striking the item relating to section 6 and inserting the following:

Sec. 6. Prioritization, safety standard determination, and risk management.

;

(4)

by striking the items relating to sections 29 through 31; and

(5)

by adding after the item relating to section 28 the following:

Sec. 29. Expedited action on chemicals of highest concern.

Sec. 30. Children’s Environmental Health Research Program.

Sec. 31. Reduction of animal-based testing.

Sec. 32. Safer alternatives and green chemistry and engineering.

Sec. 33. Cooperation with international efforts.

Sec. 34. Reliable information and advice.

Sec. 35. Hot spots.

Sec. 36. Application of this Act to Federal agencies.

Sec. 37. Implementation of Stockholm Convention, the LRTAP Pops Protocol, and the Rotterdam Convention.

Sec. 38. Annual report.

Sec. 39. Authorization of appropriations.

.

S. 3209 (111^th): Safe Chemicals Act of 2010

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