S. 847 (112th): Safe Chemicals Act of 2011

112th Congress, 2011–2013. Text as of Dec 27, 2012 (Reported by Senate Committee).

Status & Summary | PDF | Source: GPO

II

Calendar No. 578

112th CONGRESS

2d Session

S. 847

[Report No. 112–264]

IN THE SENATE OF THE UNITED STATES

April 14, 2011

(for himself, Ms. Klobuchar, Mr. Schumer, Mrs. Boxer, Mr. Franken, Mr. Whitehouse, Mr. Sanders, Mrs. Gillibrand, Mr. Durbin, Mr. Menendez, Mr. Leahy, Mr. Blumenthal, Mr. Merkley, Mrs. Feinstein, Mr. Begich, Mr. Tester, Mr. Kerry, Mrs. Murray, Mr. Cardin, Mr. Harkin, Ms. Cantwell, Mr. Wyden, Mr. Baucus, Mr. Udall of New Mexico, Mr. Akaka, Mr. Nelson of Florida, Mr. Lieberman, Ms. Mikulski, Mr. Inouye, and Mr. Bennet) introduced the following bill; which was read twice and referred to the Committee on Environment and Public Works

December 27, 2012

Reported by , with amendments

Omit the part struck through and insert the part printed in italic

A BILL

To amend the Toxic Substances Control Act to ensure that risks from chemicals are adequately understood and managed, and for other purposes.

1.

Short title

This Act may be cited as the Safe Chemicals Act of 2011.

2.

Purposes

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

3.

Findings, policy, and goal

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

(1)

in the heading, by striking Intent and inserting Goal; and

(2)

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

(a)

Findings

Congress finds that—

(1)

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

(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 this 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 exposure that occurs 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;

(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 those other regulatory programs may be useful in understanding hazards and exposures of chemical substances presented in the United States; and

(11)

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

(b)

Policy

It is the policy of the United States—

(1)

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

(2)

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

(3)

to require that 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 that the companies manufacture, process, or import as a condition of allowing those companies to distribute chemical substances 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 the public and workers 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)

Goal

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 chemical substances in commerce by—

(1)

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

(2)

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

(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.

Definitions

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

(1)

by striking paragraph (12);

(2)

by redesignating paragraphs (2), (3), (4), (5), (6), (7), (8), (9), (10), (11), (13), and (14), as paragraphs (5), (6), (8), (10), (12), (13), (14), (15), (18), (19), (21), and (24), respectively;

(3)

by inserting after paragraph (1) the following:

(2)

Aggregate exposure

(A)

In general

Subject to subparagraph (B), the term aggregate exposure means exposure from all sources of a chemical substance, including exposure from—

(i)

the manufacture, processing, distribution, use, and disposal of that chemical substance; and

(ii)

all other sources of that chemical substance, 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;

(V)

documented background levels from natural and anthropogenic sources; and

(VI)

a mixture or article containing that chemical substance.

(B)

Inclusions

The term aggregate exposure includes exposure from a chemical substance that is not considered to be a chemical substance under this Act solely because of the use of that substance as, or in, a food, food additive, cosmetic, or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)).

(3)

Bioaccumulative

(A)

In general

The term bioaccumulative means, with respect to a chemical substance or mixture, that the chemical substance or mixture, as determined by the Administrator, can significantly accumulate in biota, as indicated through monitoring data, or is highly likely to accumulate in biota, as indicated by other evidence.

(B)

Update

To reflect the best available science, the Administrator may, by rule, revise the definition of the term bioaccumulative in such a way that reflects the state of the science and provides for equal or greater protection of human health and the environment.

(4)

Chemical identity

The term chemical identity includes—

(A)

each common and trade name of a chemical substance;

(B)

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

(C)

each Chemical Abstracts Service registration number of a chemical substance; and

(D)

the molecular structure of a chemical substance.

;

(4)

in paragraph (5) (as redesignated by paragraph (2))—

(A)

by striking (2)(A) Except as provided in subparagraph (B) and inserting the following:

(5)

Chemical substance

(A)

In general

Except as provided in subparagraphs (B) and (C)

;

(B)

in subparagraph (B), by striking (B) Such term and inserting the following:

(B)

Exclusions

The term chemical substance

; and

(C)

by adding at the end the following:

(C)

Inclusions

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

;

(5)

by inserting after paragraph (6) (as redesignated by paragraph (2)) the following:

(7)

Cumulative exposure

The term cumulative exposure means the sum of aggregate exposure to each of the chemical substances that are known or suspected to contribute appreciably to the risk of the same or a similar adverse effect.

;

(6)

by striking paragraph (8) (as redesignated by paragraph (2)) and inserting the following:

(8)

Distribute in commerce

The terms distribute in commerce and distribution in commerce, when used to describe an action taken with respect to a chemical substance (or mixture or article containing that chemical substance), mean—

(A)

to sell, or the sale of, the substance, mixture, or article in commerce;

(B)

to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article;

(C)

to hold, or the holding of, the substance, mixture, or article after its introduction into commerce; or

(D)

to export or offer for export the substance, mixture, or article.

;

(7)

by inserting after paragraph (8) (as redesignated by paragraph (2)) the following:

(9)

End consumer

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

;

(8)

in paragraph (10) (as redesignated by paragraph (2)), by inserting ambient and indoor after includes water,;

(9)

by inserting after paragraph (10) (as redesignated by paragraph (2)) the following:

(11)

Federal agency

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.

;

(10)

in paragraph (15) (as redesignated by paragraph (2)), 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);

(11)

by inserting after paragraph (15) (as redesignated by paragraph (2)) the following:

(16)

Persistent

(A)

In general

The term persistent means, with respect to a chemical substance or mixture, that the chemical substance or mixture, as determined by the Administrator, significantly persists in 1 or more environmental media, as indicated by monitoring data or other evidence.

(B)

Update

To reflect the best available science, the Administrator may, by rule, revise the definition of the term persistent in such a way that reflects the state of the science and provides for equal or greater protection of human health and the environment.

(17)

Person

(A)

In general

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.

(B)

Inclusions

The term person includes each Federal agency and any officer, agent, or employee of a Federal agency.

;

(12)

by inserting after paragraph (19) (as redesignated by paragraph (2)) the following:

(20)

Special substance characteristic

(A)

In general

The term special substance characteristic means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic.

(B)

Considerations

In determining the existence of special substance characteristics, the Administrator may consider—

(i)

size or size distribution;

(ii)

shape and surface structure;

(iii)

reactivity; and

(iv)

any other properties that may significantly affect the risks posed.

;

(13)

by inserting after paragraph (21) (as redesignated by paragraph (2)) the following:

(22)

Toxic

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 an adverse effect described in subparagraph (B), laboratory studies, or data for a chemical from the same chemical class that exhibits that adverse effect) demonstrates the potential for an adverse effect in humans or other exposed organisms.

(23)

Toxicological property

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.

; and

(14)

by adding at the end the following:

(25)

Vulnerable human population

The term vulnerable human population means a human population that is subject to disproportionate exposure to, or the potential for 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 substances and mixtures; and

(F)

members of any other appropriate population identified by the Administrator.

.

5.

Minimum data sets and testing of chemical substances

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

4.

Minimum data sets and testing of chemical substances

(a)

Minimum data sets

(1)

Minimum data sets rules

(A)

In general

Subject to subparagraph (B), and not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall establish, by rule, the data that constitute the minimum data sets for chemical substances.

(B)

Requirements

Any rule promulgated under subparagraph (A) shall—

(i)

provide for varied or tiered data to be provided for different chemical substances or categories of chemical substances;

(ii)

identify the particular minimum data set that applies to a chemical substance or category of chemical substances;

(iii)

require each minimum data set to include the minimum amount of information necessary for the Administrator to conduct a screening-level risk assessment of the chemical substance or category of chemical substances, including information on the characteristics, toxicological properties, exposure, and use of a chemical substance; and

(iv)

in accordance with section 30, encourage and facilitate the use of alternative testing methods and testing strategies to generate information quickly, at low cost, and without the use of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening.

(2)

Submission of minimum data set

Each manufacturer and processor of a chemical substance shall submit the minimum data set for the chemical substance to the Administrator—

(A)

for new chemical substances, concurrent with the notice required under section (5)(a)(1)(A); and

(B)

for existing chemical substances, on the earlier of—

(i)

18 months after the date on which the chemical substance is assigned to a priority class under section 6(a); and

(ii)

5 years after the date of enactment of the Safe Chemicals Act of 2011.

(3)

Prohibition

The Administrator may, by order, take any action authorized under section 6(c) if a manufacturer or processor is in violation of paragraph (2), except as authorized under section 6(e).

(b)

Testing

(1)

General submissions

(A)

In general

The Administrator may, by rule or order, require testing with respect to any chemical substance, and the submission of test results by a specified date, as necessary for making any determination or carrying out any provision of this Act.

(B)

Effect on other authority

Nothing in this paragraph limits the authority of the Administrator under paragraph (2).

(2)

Sample submissions

(A)

In general

The Administrator may, by rule or order, require the submission of a sample of any chemical substance in such manner as the Administrator determines enables the Administrator to conduct any tests necessary for making any determination or carrying out any provision of this Act.

(B)

Effect on other authority

Nothing in this paragraph limits the authority of the Administrator under paragraph (1).

(3)

Prohibition

The Administrator may, by order, take any action authorized under section 6(c) if a manufacturer or processor is in violation of a rule or order under paragraph (1), except as authorized under section 6(e).

(4)

Exemption

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)

Test rules or orders

(1)

In general

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

(A)

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

(B)

standards for the development of test data for that substance; and

(C)

a specification of the period (which 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).

(2)

Considerations

(A)

In general

In determining the standards and period to be required under subparagraphs (B) and (C) of paragraph (1), the Administrator shall consider—

(i)

the relative costs of the various test protocols and methodologies that may be required under the rule or order; and

(ii)

the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule.

(B)

Preliminary data

Any rule or order issued by the Administrator under this subsection may require a manufacturer or processor to submit preliminary data during the period described in paragraph (1)(C).

(3)

Types of health and environmental information

(A)

In general

The Administrator may prescribe standards for the development of test data under this subsection for health and environmental information, including—

(i)

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

(ii)

information pertaining to exposure to the chemical substance, including information regarding the presence of the chemical substance 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 that may present an adverse effect.

(B)

Methodologies

(i)

In general

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 30.

(ii)

Requirement

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

(C)

Review

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 under subparagraph (A); and

(ii)

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

(4)

Persons required to conduct tests and submit data

(A)

In general

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

(B)

Exception

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)

Liability

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

(5)

Expiration of rules and orders

(A)

In general

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

(B)

Category of chemical substances

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

(d)

Exemptions

(1)

In general

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

(2)

Action by Administrator

In accordance with paragraph (3) or (4), the Administrator shall exempt an applicant under paragraph (1), if, on receipt of the application, the Administrator determines that—

(A)

the chemical substance for which the application was submitted is equivalent to a chemical substance 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 for the substance would be duplicative of data that—

(i)

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

(ii)

is being developed in accordance with the rule or order.

(3)

Reimbursement due to exemption

(A)

Definition of reimbursement period

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

(i)

begins 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)

ends on the later of—

(I)

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

(II)

the date which, as determined by the Administrator, provides the applicant with a time period which is sufficient to develop the test data.

(B)

Reimbursement for previously submitted test data

(i)

In general

Except as provided in clause (ii), for an exemption under paragraph (2)(B)(i), if 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 by 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 data submission requirement; 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)

Exception

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)

Considerations

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, 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 of the person required to provide reimbursement in relation to the share of the market of the persons to be reimbursed.

(C)

Reimbursement due to exemption for test data being developed in accordance with a rule or order

(i)

In general

Except as provided in clause (ii), for an exemption under paragraph (2)(B)(ii), the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined by the Administrator) to—

(I)

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

(II)

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.

(ii)

Exception

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)

Considerations

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, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider the factors described in subparagraph (B)(iii).

(iv)

Lack of compliance

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 person has complied with the rule or order, the Administrator shall—

(I)

after providing written notice and an opportunity for a hearing to the person who holds the exemption, 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)

Notice

(1)

In general

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)

Requirements

Subject to section 14, each notice shall—

(A)

identify the chemical substance for which data have been received;

(B)

list—

(i)

the commercial and consumer uses or intended commercial and consumer uses of the substance known to the Administrator; and

(ii)

the information required by the applicable standards for the development of test data; and

(C)

describe the nature of the test data developed.

(3)

Availability

Subject to section 14, the Administrator shall make the test data described in this subsection available on a publicly accessible Internet site.

(f)

Requests from other agencies for additional information or testing

(1)

In general

The head of a Federal agency may request the Administrator to seek the information on behalf of that agency if the head of that Federal agency determines that—

(A)

information relating to a chemical substance, including data derived from new testing or monitoring, would assist that Federal agency in carrying out the duties or exercising the authority of that agency; but

(B)

the requested information is not available to that agency.

(2)

Duty of Administrator

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 request under section 8(f) to require—

(i)

the submission of existing pertinent data to the Administrator; and

(ii)

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

(D)

publish in the Federal Register the reason for which none of the actions described in this paragraph were taken.

(g)

Certification

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

(1)

is accurate and reliable; and

(2)

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

.

6.

Manufacturing and processing notices

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

5.

Manufacturing and processing notices

(a)

New chemical substances and new uses of chemical substances

(1)

New chemical substances

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

(A)

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;

(B)

the person complies with subsection (b); and

(C)

the Administrator finds that—

(i)

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

(ii)

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)
(aa)

manufactured in a volume of more than 1,000,000 pounds annually; or

(bb)

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;

(III)

persistent and bioaccumulative;

(IV)

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

(2)

New uses of existing chemical substances prior to safety standard determination

(A)

In general

Except as provided in subparagraph (B), with respect to an existing chemical substance for which the Administrator has not made a safety standard 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 2011; or

(ii)

at a volume that is significantly increased from the volume as of the date of enactment of the Safe Chemicals Act of 2011.

(B)

Exception

A person may manufacture or process a chemical substance in a manner prohibited by subparagraph (A), if the person—

(i)

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

(ii)

complies with subsection (b).

(3)

New uses of existing chemical substances that meet the safety standard

(A)

In general

For 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 applicable safety standard, no person may manufacture or process the chemical substance for uses, at production volumes, or in manners other than those the Administrator specified in the safety standard 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 a new use, at a new production volume, or in such other manner as is inconsistent with a specified condition or term for that 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, production volumes, or other specified conditions or terms for that chemical substance are revised to encompass the new use, production volume, or other 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, production volumes, or other specified conditions or terms for that substance, are revised to encompass the new use, production volume, or other manner of manufacturing or processing.

(B)

Amendment to safety standard determination

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

(4)

Safety standard determination

(A)

In general

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 will continue to meet, the safety standard under section 6(b).

(B)

Exception

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)(C)(ii).

(C)

Extension

The Administrator may extend the determination deadline under subparagraph (A) by 1 or more additional periods not to exceed 1 year in the aggregate, in such manner as the Administrator determines necessary.

(D)

Failure to make a timely determination

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

(5)

Notice of commencement

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

(6)

Chemical substances exhibiting special substance characteristics

(A)

Determination

The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting 1 or more special substance characteristics—

(i)

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

(ii)

is a new chemical substance.

(B)

Requirements for variants that are separate uses

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

(b)

Submission of data

(1)

In general

A person shall submit to the Administrator data in accordance with the rule or order at the time that notice is submitted under subsection (a) if the person is required to submit to the Administrator—

(A)

under subsection (a), a notice prior to beginning the manufacture or processing of a chemical substance; and

(B)

under section 4(b), test data for the chemical substance prior to the submission of the notice.

(2)

Availability

Subject to section 14, the Administrator shall make any test data submitted under paragraph (1) available on a publicly accessible Internet site.

(c)

Content and availability of notice

(1)

Content

Notice under subsection (a)(1) shall include—

(A)

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

(B)

the minimum data set described in section 4(a); and

(C)

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

(2)

Availability

Subject to section 14, the Administrator shall make the notice under paragraph (1) available on a publicly accessible Internet site.

(3)

Public information

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 a publicly accessible Internet site 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)

List of notices

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

(d)

Exemptions

(1)

Test marketing purposes

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, in a manner that the Administrator determines, that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substance (including any combination of those activities) will not endanger human health or the environment; and

(B)

under such restrictions as the Administrator considers appropriate.

(2)

Equivalent chemical substances

(A)

In general

The Administrator shall, upon application, fully or partially exempt any person from the requirement to submit data under subsection (a) if, on receipt of an application, the Administrator determines that—

(i)

the chemical substance for which the application was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by this Act; 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 Act.

(B)

Effective date

No exemption under this paragraph may take effect before the beginning of the reimbursement period applicable to the data.

(C)

Fair and equitable reimbursement

(i)

Definition of reimbursement period

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

(I)

begins 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)

ends 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 that begins on the date referred to in subclause (I) and ends on the date that the Administrator determines to be necessary to develop the data.

(ii)

Reimbursement

Except as provided in clause (iii), if the Administrator exempts any person under subparagraph (A)(i) 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 by 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 title 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)

Exception

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)

Considerations

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 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)

Small quantities

(A)

In general

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

(B)

Conditions

All persons engaged in the experimentation, research, or analysis carried out in accordance with subparagraph (A) for a manufacturer or processor shall be notified (in such form and manner as the Administrator may prescribe) of any risk to human health that the manufacturer, processor, or the Administrator has reason to believe may be associated with that chemical substance.

(4)

Temporary existence

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, any human or environmental exposure.

(5)

Publication

(A)

In general

As soon as practicable after the date of 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)

Requirements

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)

Certification

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)

Definitions

In this section:

(1)

Manufacture and process

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

(2)

Test marketing

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

.

7.

Prioritization, safety standard determination, and risk management

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

6.

Prioritization, safety standard determination, and risk management

(a)

Prioritization of chemical substances

(1)

Prioritization list

(A)

In general

Subject to subparagraph (B), the Administrator shall, by order, develop and publish a list that—

(i)

contains the names of the chemical substances or categories of chemical substances that the Administrator determines warrant placement within 1 of the 3 priority classes described in paragraphs (2) through (4); and

(ii)

identifies the priority class to which each listed chemical substance or category of chemical substance has been assigned by the Administrator.

(B)

Considerations

In determining which chemical substances to include in each priority class, the Administrator shall give due consideration to any prioritization recommendation that is provided by the committee established under paragraph (5).

(2)

Chemical substances requiring immediate risk management (priority class 1)

(A)

Definition of priority class 1

In this section, the term priority class 1 means a priority class that contains chemical substances that the Administrator determines require immediate risk management.

(B)

Assignment to priority class 1

The Administrator shall assign a chemical substance to priority class 1 if the Administrator determines that the chemical substance is, or is degraded and metabolized into, a persistent, bioaccumulative, and toxic substance with the potential for widespread exposure to humans or other organisms.

(C)

Initial assignment

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall assign not less than 20, but not more than 30, chemical substances to the initial priority class 1.

(D)

Risk management

(i)

Expedited exposure reduction

As soon as practicable, but not later than 18 months after the date on which a chemical substance is assigned to priority class 1 under this paragraph, the Administrator shall impose conditions in accordance with subsection (c) on the manufacturing, processing, use, distribution in commerce, and disposal of a chemical substance assigned to priority class 1 that the Administrator determines necessary to achieve the greatest practicable reductions in human or environmental exposure to the chemical substance.

(ii)

Residual risk assessment

Not later than 1 year after the effective date of any conditions established under clause (i), the Administrator shall—

(I)

determine whether the chemical substance meets the applicable safety standard for the chemical substance, taking into account the residual risk posed by continued exposure to the chemical substance; and

(II)

impose any further conditions under subsection (c) that the Administrator determines necessary to ensure that the chemical substance meets the applicable safety standard.

(E)

Updates

(i)

Revisions

The Administrator shall promptly revise the list under paragraph (1) whenever the Administrator determines that the addition or removal of a chemical substance from priority class 1 is warranted.

(ii)

Removal procedure

A chemical substance may be removed from the list under paragraph (1) only if the Administrator finds that such substance meets the safety standard under subsection (b).

(3)

Chemical substances requiring safety standard determinations (priority class 2)

(A)

Definition of priority class 2

In this section, the term priority class 2 means a priority class that contains chemical substances that Administrator determines require safety standard determinations.

(B)

Assignment to priority class 2

(i)

In general

Subject to clause (ii), if the Administrator determines, based on any more-than-theoretical concern, that there is uncertainty as to whether a chemical substance would satisfy the safety standard in a determination made under subsection (b), the Administrator shall assign that chemical substance priority class 2.

(ii)

Conditions

The Administrator shall assign chemical substances to priority class 2 subject to the conditions that—

(I)

the rate at which chemical substances are added to priority class 2 shall be expeditious, but shall not exceed the rate at which the Administrator reasonably anticipates completing safety standard determinations under subsection (b); and

(II)

the Administrator shall first assign to priority class 2 those chemical substances that present the greater risks to human health or the environment, as determined by the Administrator.

(C)

Removal procedure

The Administrator shall not remove a chemical substance from priority class 2 until the Administrator has made a safety standard determination for that chemical substance under subsection (b).

(4)

Chemical substances requiring no immediate action (priority class 3)

(A)

Definition of priority class 3

In this section, the term priority class 3 means a priority class that contains chemical substances that the Administrator determines require no immediate action.

(B)

Assignment to priority class 3

The Administrator shall assign a chemical substance to priority class 3 if the chemical substance has intrinsic properties such that the chemical substance, as determined by the Administrator, does not and would not, at any stage of the lifecycle of the chemical substance, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.

(C)

Updates

The Administrator shall promptly revise the list under paragraph (1) whenever the Administrator determines that the addition or removal of a chemical substance from priority class 3 is warranted.

(5)

Interagency prioritization and testing committee

(A)

Establishment

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(c); and

(ii)

the prioritization of chemical substances under this subsection.

(B)

Recommendations

(i)

Factors

In making a recommendation concerning—

(I)

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

(II)

prioritization of chemical substances or categories of chemical substances under this subsection, the committee shall consider the criteria described in paragraphs (2)(B), (3)(B), and (4)(B).

(ii)

Form

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 categories 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(c); or

(II)

the recommendations of the committee that particular chemical substances, or categories of chemical substances, be prioritized under this subsection.

(iii)

Additions or revisions

(I)

In general

Not less frequently than once every year, the committee shall—

(aa)

make such additions or revisions to the recommendations of the committee as the committee 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)

Publication

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)

Comments

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)

consider any comments received under item (aa); and

(cc)

make any comments received under item (aa) available to the public.

(C)

Composition

The committee shall consist of the following 8 members:

(i)

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

(ii)

One member appointed by the Secretary of Labor from among officers or employees of the Department of Labor who are 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 among 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 among officers or employees of the Institute.

(v)

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

(vi)

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

(vii)

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

(viii)

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

(D)

Appointment of members

(i)

Designees

(I)

In general

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

(II)

Prerequisites

A designation may be made only—

(aa)

with the approval of the applicable appointing authority; and

(bb)

if the individual is an officer or employee of the entity from which the member was appointed.

(ii)

Terms

(I)

In general

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

(II)

Members leaving appointing entities

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 vacant.

(III)

Vacancies

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

(E)

Conflicts of interest

(i)

Post-termination employment or compensation

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

(ii)

Financial interests

No person, while serving as a member of the committee or designee of a member, may own any stocks or bonds of, 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 Act or of any rule promulgated or order issued under this Act.

(iii)

Violations

The Administrator, acting through the Attorney General, may bring an action in the appropriate district court of the United States for any violation of this subparagraph.

(F)

Administrative support

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.

(6)

No judicial review

The following actions shall not be subject to judicial review:

(A)

The assignment of a particular chemical substance under this subsection.

(B)

A determination by the Administrator of whether a particular assignment under this subsection is warranted.

(C)

A response to a petition to include a particular chemical substance on the list under this subsection.

(D)

The issuance of a recommendation to list a chemical substance under this subsection.

(b)

safety standard determinations for chemical substances

(1)

In general

(A)

Application

This paragraph applies to the determination, or redetermination, of whether a chemical substance meets the applicable safety standard of this title.

(B)

Burden of proof

(i)

In general

Under this title, the manufacturers and processors of a chemical substance, at all times, bear the burden of proving that the chemical substance meets the applicable safety standard.

(ii)

Duties

Under this title, it shall be the duty of—

(I)

the manufacturers and processors of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the applicable safety standard; and

(II)

the Administrator to determine whether the chemical substance meets the applicable safety standard.

(C)

Assessment of risk

(i)

In general

Any determination that a chemical substance meets the applicable safety standard under subparagraph (B)(ii) shall be supported by an assessment of risk conducted by an employee of the Environmental Protection Agency.

(ii)

Safety standard

(I)

In general

The Administrator shall base the determination of whether the safety standard for a chemical substance has been met under this title solely on considerations of human health and the environment, including the health of vulnerable human populations.

(II)

Considerations

In making a safety standard determination under this title, for each chemical substance, the Administrator shall—

(aa)

to the extent practicable, review and incorporate any available scientific information relating to the effect of cumulative exposure to that chemical substance on human health and the environment; and

(bb)

find that a chemical substance meets the safety standard only if the Administrator finds that there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.

(iii)

Financial interests

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.

(iv)

Methodology

(I)

In general

Subject to subclause (II), the Administrator shall use the best available science when conducting an assessment described in clause (i).

(II)

Considerations

For the purpose of determining the current best available science, the Administrator shall base the determination on the recommendations of the National Academy of Sciences in the report entitled Science and Decisions.

(III)

Review

Not later than 5 years after the date of enactment of the Safe Chemicals Act of 2011, and not less frequently than once every 5 years thereafter, the Administrator shall review the methodology under this paragraph and may revise the methodology to reflect new scientific developments or understandings.

(v)

Scope

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

(vi)

Transparency

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.

(vii)

Manufacture or processing for export

In the case of a chemical substance that is manufactured or processed in whole or in part for export, in determining whether the chemical substance meets the applicable safety standard under subparagraph (B)(ii), the Administrator shall take into account any risks that 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.

(viii)

Risk assessment not required

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).

(D)

No judicial review

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

(2)

Duties

(A)

Manufacturer and processor duties

(i)

Initial safety standard determination submission

(I)

In general

By the date that is 30 months after the date on which a chemical substance is assigned to priority class 2 under subsection (a), the manufacturers and processors of a chemical substance shall—

(aa)

update the minimum dataset, if the data set was submitted prior to the assignment of the chemical substance to priority class 2 under subsection (a);

(bb)

submit to the Administrator any additional information the Administrator may require to make a safety standard determination, including any information the Administrator determines is necessary to be developed by testing; and

(cc)

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

(II)

Submitting manufacturers and processors

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)

Liability

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

(ii)

Renewal of safety standard determination submission

(I)

In general

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 an updated minimum data set for the chemical substance, as established under section 4(a); and

(bb)

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

(II)

Submitting manufacturers and processors

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)

Liability

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

(iii)

Notice of pending determination

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, the employees and recognized bargaining agents of any employees who are represented by bargaining agents of the manufacturer or processor, and each known customer who has purchased the chemical substance within a reasonable timeframe, as determined by the Administrator by rule or order, a written notice that a determination by the Administrator of the safety of the chemical substance is pending.

(iv)

Failure of manufacturer or processor to meet duties

If a manufacturer or processor fails to meet any duty under this subparagraph for a chemical substance, the Administrator may, by order, take any action authorized under subsection (c) if a manufacturer or processor is in violation of a duty under this subparagraph, except as authorized subsection (e).

(B)

Administrator duties

(i)

safety standard determination

Not later than 1 year 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 appropriate, whether the manufacturers and processors of the chemical substance have established that the chemical substance meets the safety standard.

(ii)

Uses and conditions

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

(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)

Redetermination

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

(I)

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

(II)

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

(III)

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

(iv)

Petition for redetermination

(I)

In general

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

(II)

Basis

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

(III)

Action by Administrator

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)

Risk reduction

(A)

In general

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

(B)

Negative safety standard determination

No person shall manufacture, process, or distribute in commerce a chemical substance, or any mixture or article containing the 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 standard 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 standard determination for a chemical substance under paragraph (2)(B)(i) and does not determine that the chemical substance meets the applicable safety standard.

(C)

Positive safety standard determination

Effective beginning 1 year after the date on which 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)

Risk management

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

(1)

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

(2)

a requirement—

(A)

prohibiting the manufacture, processing, or distribution in commerce of the substance 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 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 subsection (b)(2)(B)(ii)(II);

(3)

a requirement that the substance 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—

(A)

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

(B)

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

(5)

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

(6)

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

(A)

the manufacturer or processor of the substance; or

(B)

any other person that uses, or disposes of, the substance 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)

Quality control orders

(1)

In general

If the Administrator has a reasonable basis to conclude that a particular manufacturer or processor is manufacturing or processing a chemical substance in a manner that may present a substantial endangerment to human 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.

(2)

Orders

(A)

In general

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

(B)

Substantial endangerment

If the Administrator determines that quality control procedures described in paragraph (1) have resulted in the distribution in commerce of a chemical substance that may present a substantial endangerment to human 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; and

(II)

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

(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 as the Administrator determines necessary to adequately protect human health or the environment.

(e)

Exemptions to restrictions

(1)

Application

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

(2)

Exemptions

(A)

In general

(i)

Request

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)

Order

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)

Criteria

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 for which—

(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 a net benefit to human health, the environment, or public safety.

(C)

Public notice

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 each known purchaser of—

(I)

the chemical substance; and

(II)

a mixture or article containing the chemical substance; and

(ii)

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

(D)

Renewal

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)

Conditions

(i)

In general

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.

(ii)

Compliance

Effective immediately after the date on which 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)

Resale of used articles

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

(4)

Extensions of effective dates for retail sale of articles to end consumers

(A)

In general

Except as provided in subparagraph (B), in the case of the retail sale to an end consumer of a chemical substance (or mixture or article containing that chemical substance) 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 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)

Exception

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

(f)

Polychlorinated biphenyls

(1)

In general

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

(A)

to prescribe methods for the disposal of polychlorinated biphenyls; and

(B)

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

(2)

Manufacture, process, or distribution in totally enclosed manner

(A)

Definition of totally enclosed manner

In this paragraph, the term totally enclosed manner means any manner that ensures 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)

Prohibition

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)

Alternative manner

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 human health or the environment.

(3)

Prohibition on manufacture, process, or distribution

(A)

In general

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)

Exemptions

(i)

In general

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 human 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)

Administration

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 after the date on which the exemption is granted, except as provided in subparagraph (D)) as the Administrator may prescribe.

(C)

Prior sales

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- year period beginning on the date of enactment of this Act.

(D)

Extension of exemptions

(i)

In general

The Administrator may, by order or rule, extend an exemption granted under subparagraph (B) that has not yet expired for a period 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)

Notice

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

(g)

Mercury

(1)

In general

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)

Exceptions

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 Act; or

(B)

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

(3)

Leases of Federal coal

Nothing in this subsection prohibits the leasing of coal.

(h)

Certification

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)

Effective date

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

.

5.

Minimum information sets and testing of chemical substances

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

4.

Minimum information sets and testing of chemical substances

(a)

Minimum information sets

(1)

Rule

(A)

In general

Subject to subparagraphs (B) and (C), and not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall establish, by rule, such minimum information sets as the Administrator determines to be appropriate to evaluate chemical substances under sections 5 and 6.

(B)

General requirements

The rule promulgated pursuant to subparagraph (A) shall—

(i)

provide for varied or tiered information to be provided for different chemical substances;

(ii)

identify the particular minimum information set that applies to a chemical substance;

(iii)

require each minimum information set to include sufficient information for the Administrator to conduct a screening-level risk assessment of the chemical substance, including information on the characteristics, toxicological properties, environmental and biological fate and behavior, exposure, and use of a chemical substance;

(iv)

specify information quality and reliability requirements applicable to the information submitted in the minimum information sets; and

(v)

accommodate the use of alternative testing methods and testing strategies to generate information quickly, at low cost, and with reduced use of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening, to the extent such methods and strategies would yield information of equivalent quality and reliability.

(C)

Specific requirements

The rule promulgated pursuant to subparagraph (A) shall establish minimum information sets sufficient for the Administrator to administer this Act, including to carry out—

(i)

categorization of new chemical substances under section 5(b)(2), including the identification of information—

(I)

sufficiently robust to generally support the categorization of a new chemical substance as a substance of very low concern under section 5(b)(2)(D)(iii)(II); and

(II)

in the absence of which the Administrator shall designate a new chemical substance to be a substance with insufficient information under section 5(b)(2)(D)(iv);

(ii)

categorization of existing chemical substances under section 6(b)(3), including the identification of information—

(I)

sufficiently robust to generally support the categorization of an existing chemical substance as a substance of very low concern under section 6(b)(3)(B)(ii); and

(II)

in the absence of which the Administrator shall designate an existing chemical substance to be a substance with insufficient information under section 6(b)(3)(B)(iv);

(iii)

assignment of chemical substances to priority classes under section 6(b)(4);

(iv)

safety standard determinations—

(I)

for new uses of existing chemical substances under section 5(b)(2); and

(II)

for chemical substances under section 6(d); and

(v)

safety standard redeterminations under section 6(d)(5)(E).

(2)

Submission of minimum information set

Each manufacturer and processor of a chemical substance shall submit the minimum information set for the chemical substance to the Administrator—

(A)

for new chemical substances, concurrent with the notice required under section (5)(b)(1)(A); and

(B)

for existing chemical substances, as specified in section 6 or otherwise specified by the Administrator in the rule promulgated pursuant to paragraph (1)(A).

(3)

Prohibition

In addition to any other authorities available under this Act, the Administrator may, by order, take any action authorized under section 6(f) if a manufacturer or processor is in violation of paragraph (2).

(b)

Testing

(1)

General submissions

(A)

In general

The Administrator may, by rule or order, require testing with respect to any chemical substance, and the submission of test results by a specified date, as appropriate for making any determination or carrying out any provision of this Act. Such testing may be required—

(i)

to provide information in addition to the information specified in any applicable minimum information set under subsection (a); and

(ii)

of persons to whom the Administrator decides not to apply a requirement to submit a minimum information set under subsection (a).

(B)

Effect on other authority

Nothing in this paragraph limits the authority of the Administrator under paragraph (2).

(2)

Sample submissions

(A)

In general

The Administrator may, by rule or order, require the submission of a sample of any chemical substance in such manner as the Administrator determines enables the Administrator to conduct any tests necessary for making any determination or carrying out any provision of this Act.

(B)

Effect on other authority

Nothing in this paragraph limits the authority of the Administrator under paragraph (1).

(3)

Prohibition

In addition to any other authorities available under this Act, the Administrator may, by order, take any action authorized under section 6(f) if a manufacturer or processor is in violation of a rule or order under paragraph (1).

(4)

Exemption

If a manufacturer or processor ceases all manufacture or processing of a chemical substance pursuant to its submission of a declaration of cessation of manufacture or processing under section 8(b)(4) for the chemical substance, the manufacturer or processor shall be exempted from the requirements of this subsection.

(c)

Test rules or orders

(1)

In general

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

(A)

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

(B)

standards for the development of test information for that substance; and

(C)

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

(2)

Considerations

(A)

In general

In determining the standards and period to be required under subparagraphs (B) and (C) of paragraph (1), the Administrator shall consider—

(i)

the relative costs of the various test protocols and methodologies that may be required under the rule or order; and

(ii)

the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule.

(B)

Preliminary information

Any rule or order issued by the Administrator under this subsection may require a manufacturer or processor to submit preliminary information during the period described in paragraph (1)(C).

(3)

Types of health and environmental information

(A)

In general

The Administrator may prescribe standards for the development of test information under this subsection for health and environmental information, including—

(i)

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

(ii)

information pertaining to exposure to the chemical substance, including information regarding the presence of the chemical substance 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 that may present an adverse effect.

(B)

Methodologies

(i)

In general

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

(I)

epidemiologic studies;

(II)

biomonitoring or environmental monitoring studies;

(III)

serial or hierarchical tests;

(IV)

in vitro tests;

(V)

whole animal tests, consistent with section 30; and

(VI)

any other methodology deemed appropriate by the Administrator.

(ii)

Requirement

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

(C)

Review

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

(i)

review the adequacy of the standards for development of information prescribed under subparagraph (A); and

(ii)

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

(4)

Persons required to conduct tests and submit information

(A)

In general

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

(B)

Exception

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 information on behalf of the persons making the designation.

(C)

Liability

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

(5)

Expiration of rules and orders

(A)

In general

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

(B)

Category of chemical substances

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

(d)

Exemptions

(1)

In general

Any person required by a rule or order under subsections (a) or (b) to conduct tests and submit information for a chemical substance may apply to the Administrator (in such form and manner as the Administrator determines necessary) for an exemption from the requirement.

(2)

Action by Administrator

In accordance with paragraph (3) or (4), the Administrator shall exempt an applicant under paragraph (1), if, on receipt of the application, the Administrator determines that—

(A)

the chemical substance for which the application was submitted is equivalent to a chemical substance for which—

(i)

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

(ii)

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

(B)

submission of information by the applicant for the substance would be duplicative of information that—

(i)

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

(ii)

is being developed in accordance with the rule or order.

(3)

Reimbursement due to exemption

(A)

Definition of reimbursement period

In this paragraph, the term reimbursement period, with respect to any test information for a chemical substance, means a period that—

(i)

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

(ii)

ends on the later of—

(I)

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

(II)

the date which, as determined by the Administrator, provides the applicant with a time period which is sufficient to develop the test information.

(B)

Reimbursement for previously submitted test information

(i)

In general

Except as provided in clause (ii), for an exemption under paragraph (2)(B)(i), if the exemption is granted during the reimbursement period for the test information, the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined by the Administrator) to—

(I)

the person who previously submitted the test information, for a portion of the costs incurred by the person in complying with the information submission requirement; 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)

Exception

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)

Considerations

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, 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 of the person required to provide reimbursement in relation to the share of the market of the persons to be reimbursed.

(C)

Reimbursement due to exemption for test information being developed in accordance with rule or order

(i)

In general

Except as provided in clause (ii), for an exemption under paragraph (2)(B)(ii), the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined by the Administrator) to—

(I)

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

(II)

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.

(ii)

Exception

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)

Considerations

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, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider the factors described in subparagraph (B)(iii).

(iv)

Lack of compliance

If any exemption is granted under paragraph (2) on the basis that 1 or more persons are developing test information 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 person has complied with the rule or order, the Administrator shall—

(I)

after providing written notice and an opportunity for a hearing to the person who holds the exemption, 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)

Notice

(1)

In general

Not later than 15 days after the date of receipt of any test information 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 information.

(2)

Requirements

Subject to section 14, each notice shall—

(A)

identify the chemical substance for which information has been received;

(B)

list—

(i)

the commercial and consumer uses or intended commercial and consumer uses of the substance known to the Administrator; and

(ii)

the information required by the applicable standards for the development of test information; and

(C)

describe the nature of the test information developed.

(3)

Availability

Subject to section 14, the Administrator shall make the test information described in this subsection available on a publicly accessible Internet site.

(f)

Requests from other agencies for additional information or testing

(1)

In general

The head of a Federal agency may request the Administrator to seek the information on behalf of that agency if the head of that Federal agency determines that—

(A)

information relating to a chemical substance, including information derived from new testing or monitoring, would assist that Federal agency in carrying out the duties or exercising the authority of that agency; but

(B)

the requested information is not available to that agency.

(2)

Duty of Administrator

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 information available to the requesting agency or institution;

(B)

issue a request under section 8(k) to require—

(i)

the submission of existing pertinent information to the Administrator; and

(ii)

a copy of any such submission to be furnished to the requesting agency or institution;

(C)

issue a rule or order under subsection (b)—

(i)

to develop the information; and

(ii)

to require the developed information to be furnished to the requesting agency or institution; or

(D)

publish in the Federal Register the reason for which none of the actions described in this paragraph were taken.

(g)

Certification

Each person who submits information under this section or under a rule or an order promulgated or issued by the Administrator under this section shall accompany the information with a certification signed by a responsible official 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 person.

.

6.

New chemical substances and new uses of chemical substances

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

5.

New chemical substances and new uses of chemical substances

(a)

Definitions

In this section:

(1)

Manufacture and process

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

(2)

Test marketing

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.

(b)

New chemical substances

(1)

Notices

Except as provided in subsection (h), no person may manufacture a new chemical substance, or process the chemical substance for a use that is proposed to meet the criteria described in section 6(h)(2)(B), unless—

(A)

the person submits to the Administrator a notice, in accordance with subsection (g)(1)(A), of the intention of the person to manufacture or process the substance;

(B)

the person complies with subsection (f); and

(C)

the Administrator finds that—

(i)

the new chemical substance is likely to meet the safety standard under section 6(d), which shall be limited to substances assigned by the Administrator to 1 of the categories described in paragraph (2)(D)(iii); or

(ii)

the person has established by clear and convincing evidence that 1 or more uses of the new chemical substance meet the criteria described in section 6(h)(2)(B), in which case—

(I)

the Administrator may by order allow the person to manufacture or process the substance only for such use or uses in accordance with subparagraph (A) of section 6(h)(2);

(II)

the procedures and requirements specified in subparagraphs (A), (C), (D), and (E) of section 6(h)(2) shall apply; and

(III)

the Administrator shall not, upon receipt of a notice of commencement for the chemical substance under subsection (d), add the chemical substance to the active inventory established under section 8(h)(1).

(2)

Categorization of new chemical substances

(A)

Rule

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall promulgate a rule that—

(i)

designates the categories in accordance with subparagraph (D) and specifies the process and criteria the Administrator will use to categorize new chemical substances; and

(ii)

describes criteria and factors the Administrator will use to assess weight of evidence and the quality and reliability of information used to inform categorization decisions.

(B)

Information sources

In categorizing a new chemical substance, the Administrator shall consider information on the substance available to the Administrator at the time the categorization decision is to be made, including information—

(i)

received by the Administrator from the manufacturer or processor of the substance in accordance with subsection (f);

(ii)

submitted to a governmental body in another jurisdiction, to the extent that the information is accessible to the Administrator;

(iii)

derived through application of validated structure-activity relationship or other models developed by the Administrator to estimate the environmental and human health effects, environmental and biological fate and behavior, and exposure potential of chemical substances;

(iv)

inferred based on the degree of similarity of the structure or properties of the new chemical substance to those of 1 or more other chemical substances for which reliable information exists that is relevant to predicting the potential environmental or human health effects, environmental or biological fate and behavior, or exposure potential of the new chemical substance; and

(v)

any additional information the Administrator determines is needed to categorize the substance, including information identified as needed based on the analysis by the Administrator of estimated or inferred information described in clauses (iii) and (iv).

(C)

Timing

Not later than 90 days after the date of receipt of a notice under paragraph (1)(A), the Administrator shall assign the new chemical substance for which the notice was submitted to 1 of the categories described in subparagraph (D).

(D)

Categories

(i)

In general

The rule promulgated pursuant to subparagraph (A) shall incorporate, establish criteria for, and further specify as needed, the categories described in this subparagraph, to 1 of which each new chemical substance for which a notice is submitted pursuant to paragraph (1) shall be assigned.

(ii)

Substances of very high concern

(I)

In general

The Administrator shall designate as a substance of very high concern any new chemical substance that—

(aa)

is toxic, persists in the environment, and is bioaccumulative; or

(bb)

is highly hazardous.

(II)

Requirements

(aa)

In general

The Administrator shall allow the submitter of a notice under paragraph (1)(A) for a new chemical substance assigned to the category described in this clause to manufacture or process the new chemical substance only in accordance with paragraph (1)(C)(ii).

(bb)

Prohibition

No other person may manufacture or process the chemical substance unless the person has submitted a notice pursuant to paragraph (1) and the requirements of paragraph (1)(C)(ii) have been met with respect to that notice.

(iii)

Substances likely to meet the safety standard

(I)

In general

(aa)

The Administrator shall designate as a substance likely to meet the safety standard any new chemical substance that the Administrator determines, based on available information, would likely meet the safety standard under section 6(d)—

(AA)

for uses and under conditions specified by the submitter of the notice for the new chemical substance pursuant to paragraph (1); or

(BB)

for uses and under additional conditions that could be specified by the Administrator in making a safety standard determination for the substance.

(bb)

The Administrator shall assign to the category described in item (aa) any new chemical substance that meets the criteria specified in subclause (II) or (III).

(II)

Substances of very low concern

(aa)

In general

Within the category described in subclause (I), the Administrator shall designate as a substance of very low concern any new chemical substance that, based on robust information, the Administrator determines possesses intrinsic low-hazard properties so that no further action by the Administrator is warranted unless and until the Administrator receives new information that warrants a different categorization of the chemical substance.

(bb)

Basis of designation

In identifying new chemical substances to be placed in the category described in this subclause, the Administrator shall base the designation of a new chemical substance as a substance of very low concern on the applicable minimum information set required under section 4, unless the Administrator determines that such designation of a particular new chemical substance—

(AA)

can be made to a high degree of confidence based on less information; or

(BB)

requires information in addition to the full minimum information set to address conflicting or ambiguous findings, in which case the Administrator may require the development and submission of the additional information.

(III)

Substances to undergo safety standard determinations

Within the category described in subclause (I), the Administrator shall designate as a substance to undergo a safety standard determination any new chemical substance that the Administrator determines, based on a screening of available use, hazard, and exposure information, has information available for the chemical substance that is sufficiently robust to determine that the chemical substance does not meet the criteria for the categories described in subclause (II) or clause (ii) or (iv).

(IV)

Requirement

For a new chemical substance designated as likely to meet the safety standard pursuant to subclause (II) or (III), the Administrator shall, upon submission of a notice of commencement described in subsection (d)—

(aa)

add the chemical substance to the active inventory described in section 8(h)(1); and

(bb)

for a chemical substance designated to undergo a safety standard determination, at the discretion of the Administrator accounting for timing of the submission and workload considerations, add the chemical substance to the current batch or hold the substance until the next batch of substances to be prioritized in accordance with section 6(b)(4).

(V)

Manufacturing and processing

Pending the completion of a safety standard determination under section 6(d), a chemical substance designated as a substance likely to meet the safety standard may be manufactured or processed for uses and under conditions specified by the Administrator in determining that the chemical substance is likely to meet the safety standard—

(aa)

by the submitter of the notice for the chemical substance submitted pursuant to paragraph (1)(A), upon submission of a notice for the chemical substance pursuant to subsection (d);

(bb)

by other manufacturers of the chemical substance, once the chemical substance has been placed on the active inventory described in section 8(h)(1), upon submission of a declaration for the chemical substance pursuant to section 8(b)(1)(B); or

(cc)

by processors of the substance, upon compliance with the requirements of section 8(e).

(iv)

Substances with insufficient information

(I)

In general

The Administrator shall designate as a substance with insufficient information any new chemical substance for which the Administrator concludes, after gathering and screening available use, hazard, and exposure information, that needed information for the chemical substance is not available, is insufficient, or is not of sufficient quality and reliability to allow for an informed categorization decision.

(II)

Required submission

For substances designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under section 4 as needed to inform categorization decisionmaking for new chemical substances.

(III)

Recategorization

Following submission of the applicable minimum information set for the chemical substance pursuant to subclause (II), the Administrator shall recategorize the chemical substance using the categories and process described in this paragraph.

(IV)

Prohibition

Notwithstanding paragraph (1)(C)(ii), no person may manufacture or process a chemical substance designated under this clause until and unless the information described in subclause (II) has been submitted and the Administrator has recategorized the substance, at which time the provisions applicable to the category to which the substance has been assigned shall apply.

(v)

Substances unlikely to meet the safety standard

(I)

In general

The Administrator shall designate as a substance unlikely to meet the safety standard any new chemical substance that the Administrator determines, based on available information, would be unlikely to meet the safety standard under section 6(d)—

(aa)

for uses and under conditions specified by the submitter of the notice for the chemical substance pursuant to paragraph (1); or

(bb)

for other uses or under additional conditions that the Administrator may evaluate in making a safety standard determination for the chemical substance.

(II)

Prohibition

Except as provided under clause (ii), no person may manufacture or process a chemical substance designated under this clause.

(c)

New uses of existing chemical substances

(1)

New uses of existing chemical substances prior to safety standard determination

(A)

In general

Except as provided in subparagraph (B), with respect to an existing chemical substance for which the Administrator has not made a safety standard determination under section 6(d), 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 2011; or

(ii)

at a volume that is significantly increased from the volume as of the date of enactment of the Safe Chemicals Act of 2011.

(B)

Exception

A person may manufacture or process a chemical substance in a manner prohibited by subparagraph (A) if—

(i)

the person submits to the Administrator the notice specified in subsection (g)(1)(B);

(ii)

the person complies with subsection (f); and

(iii)

such manufacturing or processing is consistent with subsection (b)(2)(D)(iii)(V).

(C)

Guidance

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall issue guidance for the purpose of identifying what constitute new uses and significantly increased production volumes under this paragraph.

(2)

New uses of existing chemical substances that meet the safety standard

(A)

In general

For an existing chemical substance for which the Administrator has determined under section 6(d) that the manufacturers and processors of the chemical substance have established that the substance meets the applicable safety standard, no person may manufacture, process, distribute in commerce, use, or dispose of the chemical substance, or a mixture or article containing the chemical substance for uses, at production volumes, or in manners other than those the Administrator specified in the safety standard determination, unless—

(i)

the person submits to the Administrator a notice in accordance with subsection (g)(1)(C) of the intention of the person to manufacture, process, distribute in commerce, use, or dispose of the chemical substance, or a mixture or article containing the chemical substance, for the new use or at a new production volume, or in such other manner that is inconsistent with a specified condition or term in the safety standard determination made by the Administrator for that substance; and

(ii)

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

(B)

Amendment to safety standard determination

If the conditions described in clauses (i) and (ii) of subparagraph (A) are satisfied, the Administrator shall, by order, amend the safety standard determination for the chemical substance to include the new use, production volume, or other manner of manufacturing or processing among the allowed uses, production volumes, or manners of manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance.

(C)

Safety standard determination

(i)

In general

Except as provided in clauses (ii) and (iii), not later than 180 days after the date of receipt of a notice pursuant to subparagraph (A)(i), the Administrator shall determine whether the person submitting the notice has established that the chemical substance will continue to meet the safety standard under section 6(d).

(ii)

Extension

The Administrator may extend the determination deadline under clause (i) by 1 or more additional periods not to exceed 1 year in the aggregate, in such manner as the Administrator determines necessary.

(iii)

Failure to make a timely determination

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

(d)

Notice of commencement

(1)

In general

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.

(2)

Requirements

The notice of commencement shall—

(A)

be considered equivalent to the declaration required under subparagraph (A) or (C) of section 8(b)(2); and

(B)

include the information described in section 8(b)(5).

(3)

Withdrawal

A person who has submitted a notice for a chemical substance under subsection (b) or (c), and has not commenced with manufacture or processing of the substance, may withdraw the notice.

(e)

Chemical substances exhibiting special substance characteristics

(1)

Determination

The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting 1 or more special substance characteristics—

(A)

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

(B)

is a distinct chemical substance.

(2)

Requirements for variants that are separate uses

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

(3)

Requirements for variants that are distinct chemical substances

In the case of a chemical substance that the Administrator determines to be a distinct chemical substance based on the special substance characteristics of the chemical substance, and that is not listed on the active inventory established under section 8(h)(1), the manufacturer or processor shall comply with the requirements of subsection (b).

(f)

Submission of data

(1)

In general

A person shall submit to the Administrator data in accordance with the rule or order at the time that notice is submitted under subsection (b) or (c) if the person is required to submit to the Administrator—

(A)

under subsection (b) or (c), a notice prior to beginning the manufacture or processing of a chemical substance; and

(B)

under section 4(b), test data for the chemical substance prior to the submission of the notice.

(2)

Availability

Subject to section 14, the Administrator shall make any test data submitted under paragraph (1) available on a publicly accessible Internet site.

(3)

Timing

Except as provided under subsection (b)(2)(D)(iv), the Administrator may require a person subject to an information requirement for a chemical substance under this subsection or section 4 to submit the information—

(A)

prior to and as a condition of the Administrator assigning the substance to a category;

(B)

as a condition of commencement of manufacture or processing; or

(C)

as a condition of exceeding a specified manufacturing volume or expanding use of the substance.

(g)

Content and availability of notice

(1)

Content

(A)

New chemical substances

A notice under subsection (b)(1) shall include—

(i)

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

(ii)

the identity and primary business location of the manufacturer;

(iii)

the information described in section 8(h)(5)(B)(ii);

(iv)

the minimum information set described in section 4(a), where applicable; and

(v)

a statement that—

(I)

the new chemical substance is likely to meet the safety standard under section 6(d); or

(II)

the 1 or more uses proposed for the new chemical substance meet the criteria described in section 6(h)(2)(B).

(B)

New uses of existing chemical substances prior to safety standard determination

A notice under subsection (c)(1) shall include all updates to the declaration described in section 8(b)(2) and information described in section 8(h)(5)(B)(ii) that is relevant to the new use, new production volume, or other new manner of manufacturing or processing.

(C)

New uses of existing chemical substances that meet the safety standard

A notice under subsection (c)(2) shall include—

(i)

all updates to the declaration described in section 8(b)(2);

(ii)

information described in section 8(h)(5)(B)(ii) that is relevant to the new use, new production volume, or other new manner of manufacturing or processing;

(iii)

all updates to the minimum information set described in section 4(a) relevant to the new use, new production volume, or other new manner of manufacturing or processing; and

(iv)

a statement that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that chemical substance are revised to encompass the new use, production volume, or other manner of manufacturing or processing.

(2)

Availability

Subject to section 14, the Administrator shall make the notices under paragraph (1) available on a publicly accessible Internet site.

(3)

Public information

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 (b), (c), or (d), or of data under subsection (f), the Administrator shall make available on a publicly accessible Internet site a notice that—

(A)

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

(B)

lists the uses or intended uses of the chemical substance;

(C)

for substances for which a notice is submitted under subsection (b)(1), is promptly updated to specify the category to which the Administrator has assigned the substance pursuant to subsection (b)(2) once the assignment has been made;

(D)

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

(i)

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

(ii)

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

(E)

references the availability of the minimum information set, where applicable.

(4)

List of notices

At the beginning of each month, the Administrator shall make available on a publicly accessible Internet site a list of each chemical substance for which a notice has been received under subsection (b), (c), or (d).

(h)

Exemptions

(1)

Intrinsically safe substances

(A)

Exemption

(i)

In general

If the Administrator determines that scientific consensus exists that the intrinsic properties of a new chemical substance are such that the chemical substance does not and would not pose any risk of injury to human health or the environment under any intended or reasonably anticipated levels of production, patterns of use, or exposures arising at any stage across the lifecycle of the chemical substance, the Administrator may, by order, exempt the chemical substance, or particular uses of such substances, from 1 or more of the requirements of this section.

(ii)

Basis of determination

A determination under clause (i)—

(I)

shall be based on consideration of the intrinsic properties of the chemical substance; and

(II)

shall not be based on findings or assumptions of low human or environmental exposure to such substances.

(B)

Notice of determination and exemption

Not later than 30 days after providing an exemption pursuant to subparagraph (A), the Administrator shall publish in the Federal Register a notice that—

(i)

subject to section 14, provides the specific identity of the chemical substance or category;

(ii)

if a particular use of the chemical substance is exempted under subparagraph (A), describes the particular use of the chemical substance that the Administrator has exempted; and

(iii)

explains and documents the basis for the determination and exemption of the Administrator.

(C)

Reconsideration of exemption

(i)

In general

The Administrator may reconsider and revoke or modify any exemption provided under subparagraph (A) at any time if the Administrator determines that—

(I)

the conditions specified in subparagraph (A) are no longer met; or

(II)

such action is necessary to protect human health or the environment or is otherwise in the public interest.

(ii)

Publication

In the event of a revocation or modification under clause (i), the Administrator shall publish a notice of the grounds for the revocation.

(D)

Prior regulatory exemptions

(i)

Review

(I)

In general

Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall review exemptions that were granted pursuant to subsection (h)(4) of this section as in effect on the day before that date of enactment.

(II)

Effect of exemption

An exemption described in subclause (I) shall continue to be in effect until the date on which the Administrator determines, by order, that—

(aa)

the exemption is not appropriate under this section, at which time the exemption shall cease to be in effect; or

(bb)

the exemption is appropriate under this section, at which time the Administrator may issue an order to modify or continue in effect the exemption pursuant to subparagraph (A).

(ii)

Polymeric chemical substances

Notwithstanding subparagraph (A) and any previously issued exemption applicable to polymeric chemical substances—

(I)

subsection (d) shall apply to new polymeric chemical substances eligible for the previously issued exemption—

(aa)

during the period prior to a determination by the Administrator pursuant to clause (i) applicable to such substances; and

(bb)

after a determination by the Administrator pursuant to clause (i)(II)(bb) that continuation of the prior exemption is appropriate for some or all such substances, for such substances to which the continuation applies; and

(II)

all of this section shall apply to new polymeric chemical substances eligible for the previously issued exemption after a determination by the Administrator pursuant to clause (i)(II)(aa) that continuation of the prior exemption is not appropriate for some or all such substances, for such substances to which the determination applies.

(E)

No limitation on authority

Nothing in this paragraph limits or otherwise affects the authority of the Administrator under any other provision of this Act.

(2)

Test marketing purposes

Subject to paragraph (6), the Administrator may, upon application, exempt any person from any requirement of subsection (b), (c), or (f) to permit the person to manufacture or process a chemical substance for test marketing purposes—

(A)

upon a showing by the person, in a manner that the Administrator determines, that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substance (including any combination of those activities) will not endanger human health or the environment; and

(B)

under such restrictions as the Administrator considers appropriate.

(3)

Equivalent chemical substances

(A)

In general

The Administrator shall, upon application, fully or partially exempt any person from the requirement to submit any data under subsection (b) or (f) if, on receipt of an application, the Administrator determines that—

(i)

the chemical substance for which the application was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by this Act; 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 Act.

(B)

Effective date

No exemption under this paragraph may take effect before the beginning of the reimbursement period applicable to the data.

(C)

Fair and equitable reimbursement

(i)

Definition of reimbursement period

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)

the expiration of the period, which begins on the date referred to in subclause (I) and is equal to the period that the Administrator determines to be necessary to develop the data.

(ii)

Reimbursement

Except as provided in clause (iii), if the Administrator exempts any person, under subparagraph (A), 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 by 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 title 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)

Exception

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)

Considerations

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 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 to the share of the market of the persons to be reimbursed.

(4)

Small quantities solely for experimentation, research, and analysis

(A)

In general

If the conditions described in subparagraph (B) are met, subsections (b), (c), and (f) 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 the chemical substance or another chemical substance, including such research or analysis for the development of a product.

(B)

Conditions

All persons engaged in the experimentation, research, or analysis for a manufacturer or processor shall be notified (in such form and manner as the Administrator may prescribe) of any risk to human health that the manufacturer, processor, or the Administrator has reason to believe may be associated with that chemical substance.

(5)

Temporary existence

Subject to paragraph (6), the Administrator may, upon application, exempt from subsections (b), (c), and (f) 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.

(6)

Publication

(A)

In general

As soon as practicable after the date of receipt of an application under paragraph (2) or (5), the Administrator shall publish in the Federal Register notice of the receipt of the application.

(B)

Requirements

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.

(i)

Certification

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 required by the applicable provision of this section or rule or order under this section.

.

7.

Batching, categorization, prioritization, safety standard determination, and risk management

(a)

In general

Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) is amended—

(1)

by striking subsection (f);

(2)

by redesignating subsection (e) as subsection (i);

(3)

by striking the section heading and designation and all that follows through subsection (d) and inserting the following:

6.

Batching, categorization, prioritization, safety standard determination, and risk management

(a)

Batching

(1)

In general

To ensure that an efficient and orderly process and pace is established for the determination of safety of chemical substances in commerce and the application of risk management measures as needed, the Administrator shall establish a system for assigning chemical substances into batches in accordance with this subsection.

(2)

Requirements

(A)

Timing

Not later than 270 days after the date of enactment of the Safe Chemicals Act of 2011, and not less frequently than once every 5 years thereafter until all chemical substances listed on the active portion of the inventory established under section 8(h)(1) have been assigned to a batch, the Administrator shall assign chemical substances on the active portion of the inventory to batches of chemical substances under this subsection.

(B)

Number

Each batch established under this subsection shall include a number of chemical substances approximately equal to the number of chemical substances for which reports are submitted to the Administrator under the chemical data reporting rule as of the date of enactment of the Safe Chemicals Act of 2011.

(C)

Publication

The Administrator shall publish, subject to section 14, the list of chemical substances assigned to each batch promptly on designation of the chemical substances to the batch.

(3)

Initial batch

(A)

In general

Subject to subparagraph (B), the initial batch of chemical substances designated under paragraph (2)(A) shall include the chemical substances for which reports are submitted to the Administrator under the chemical data reporting rule as of the date of enactment of the Safe Chemicals Act of 2011.

(B)

Inclusions and exclusions

Notwithstanding subparagraph (A), the Administrator may—

(i)

include in the initial batch chemical substances that—

(I)

are manufactured at volumes below the threshold used under the chemical data reporting rule to designate chemical substances subject to basic reporting under that rule; but

(II)

are used or released into the environment in a manner that the Administrator determines warrants early evaluation; and

(ii)

exclude from the initial batch chemical substances that—

(I)

are reported to the Administrator under the chemical data reporting rule; but

(II)

are used or released into the environment in a manner that the Administrator determines does not warrant early evaluation.

(4)

Subsequent batches

The Administrator shall assign chemical substances to subsequent batches in a manner that the Administrator determines reflects the extent to which the chemical substances warrant earlier or later evaluation.

(b)

Categorization and prioritization

(1)

Regulations

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall promulgate regulations that—

(A)

establish the categories and specify the process and criteria the Administrator will use to categorize chemical substances, which shall be consistent with paragraph (3)(B), beginning with those chemical substances assigned to the initial batch described in subsection (a)(3);

(B)

designate the process and criteria the Administrator will use to prioritize chemical substances that are placed in the category of chemical substances to undergo safety standard determinations, which shall be consistent with the priorities described in paragraph (4);

(C)

describe how the categorization and prioritization process and criteria relate to, and take into account, the categorization and prioritization decisions made in other jurisdictions, including States and foreign governments; and

(D)

describe criteria and factors the Administrator will use to weigh evidence and assess the quality and reliability of information used to inform categorization and prioritization decisions.

(2)

Information sources

(A)

In general

In making categorization and prioritization decisions, the Administrator shall take into consideration information regarding chemical substances that is available to the Administrator at the time the decisions are made, including information that is—

(i)

received by the Administrator from manufacturers or processors pursuant to requirements under section 8(b) and (c);

(ii)

included in any minimum information set required under section 4;

(iii)

submitted to the Administrator that is relevant to the categorization or prioritization of the chemical substance; and

(iv)

identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible to the Administrator.

(B)

Information from manufacturers and processors

(i)

In general

Subject to clause (ii), on designation by the Administrator under paragraph (3)(B)(iii) of a chemical substance safety standard determination, any manufacturer or processor of a designated chemical substance and any trade association or voluntary consortium that represents a manufacturer or processor of a designated chemical substance may provide to the Administrator information that—

(I)

relates to the chemical substances manufactured or processed by the applicable manufacturer or processor;

(II)

is in the possession of, or known to, the manufacturer, processor, trade association, or consortium; and

(III)

is not already available to the Administrator.

(ii)

Requirement

If a manufacturer, processor, trade association, or consortium elects to provide information to the Administrator under clause (i), the manufacturer, processor, trade association, or consortium shall provide all relevant information in the possession of, or known to, the manufacturer, processor, trade association, or consortium for each chemical substance designated by the Administrator that is manufactured or processed by the applicable manufacturer or processor.

(iii)

Method of submission

Information described in this subparagraph may be submitted to the Administrator by—

(I)

a manufacturer or processor—

(aa)

on an individual basis; or

(bb)

through a trade association or voluntary consortium; and

(II)

a trade association or voluntary consortium that has developed relevant information on behalf of the manufacturers or processors of designated chemical substances represented by the trade association or voluntary consortium.

(3)

Categorization of chemical substances

(A)

Timing

(i)

Initial batch

Not later than 180 days after the date of promulgation of regulations pursuant to paragraph (1), the Administrator shall publish, subject to section 14, the category assignments for the initial batch of chemical substances identified under subsection (a)(3), using the categories described in subparagraph (B).

(ii)

Subsequent batches

Not later than 180 days after the date on which the Administrator designates each subsequent batch of chemical substances under subsection (a)(2)(A), the Administrator shall publish the category assignments for the chemical substances in the batch.

(B)

Categories

The regulation promulgated pursuant to paragraph (1) shall incorporate, establish criteria for, and further specify as needed, the following categories into which chemical substances in each batch shall be placed:

(i)

Substances of very high concern

(I)

In general

The Administrator shall designate as substances of very high concern those chemical substances—

(aa)

for which there is evidence of widespread exposure and that—

(AA)

are toxic, persist in the environment, and are bioaccumulative; or

(BB)

are highly hazardous;

(bb)

that are subject to regulation under section 6 or 7 of this Act (as in effect on the day before the date of enactment of the Safe Chemicals Act of 2011); or

(cc)

that are subject to a voluntary phase-out, administered by the Administrator, that has been completed or is underway at the time the category designation is made.

(II)

Information set

A minimum information set, as specified under section 4, need not be submitted or otherwise available for a chemical substance to be designated a substance of very high concern under this clause.

(ii)

Substances of very low concern

(I)

In general

The Administrator shall designate as substances of very low concern those chemical substances that, based on robust information, the Administrator determines possess intrinsic low-hazard properties such that no further action by the Administrator is warranted, unless the Administrator receives new information that warrants a different categorization of the chemical substance.

(II)

Factors for consideration

In designating chemical substances to be placed in the very low concern category under this clause, the Administrator shall—

(aa)

take into consideration whether chemical substances in commerce have received, as of the date of enactment of the Safe Chemicals Act of 2011, exemptions under section 5 of this Act (as in effect on the day before the date of enactment of the Safe Chemicals Act of 2011) based on anticipated low intrinsic hazard; and

(bb)

in general, base the designation on a minimum information set as required under section 4, unless the Administrator determines that such designation of a particular chemical substance—

(AA)

can be made to a high degree of confidence based on less information; or

(BB)

requires information in addition to the full minimum information set to address conflicting or ambiguous findings, in which case the Administrator may require the development and submission of the additional information.

(iii)

Substances to undergo safety standard determinations

The Administrator shall designate as substances to undergo safety standard determinations those chemical substances that the Administrator determines—

(I)

based on a screening of available use, hazard, and exposure information, do not meet the criteria for the categories described in clauses (i) and (ii); and

(II)

are the subject of available information that is sufficiently robust to inform prioritization decisions to be made for the chemical substances under paragraph (4).

(iv)

Substances with insufficient information

(I)

In general

The Administrator shall designate as substances with insufficient information those chemical substances for which the Administrator determines, after gathering and screening available use, hazard, and exposure information, that information is not available, is insufficient, or is not of sufficient quality and reliability to allow for an informed categorization decision.

(II)

Minimum information set

(aa)

In general

For chemical substances designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under section 4 as needed to inform categorization decisionmaking.

(bb)

Timing

The minimum information set shall be submitted to the Administrator—

(AA)

not later than 5 years after the date of enactment of the Safe Chemicals Act of 2011 for the initial batch of chemical substances identified under subsection (a)(3); and

(BB)

not later than 5 years after the assignment of a chemical substance to the category under this clause for subsequent batches.

(III)

Recategorization

(aa)

In general

After submission of the minimum information set for a chemical substance pursuant to subclause (I), the Administrator shall recategorize the chemical substance using the categories and process described in this paragraph.

(bb)

Discretion of Administrator

The Administrator, taking into account the timing of the submission and workload considerations, may—

(AA)

add a chemical substance to a current batch; or

(BB)

hold the chemical substance until the next batch of chemical substances for recategorization.

(4)

Prioritization of chemical substances

(A)

Timing

(i)

Initial batch

Not later than 270 days after the date of promulgation of regulations pursuant to paragraph (1), the Administrator shall publish, subject to section 14, the priority class assignments, using the priority classes described in subparagraph (B), for the chemical substances in the initial batch of chemical substances identified under subsection (a)(3) that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations.

(ii)

Subsequent batches

Not later than 270 days after the date on which the Administrator designates each subsequent batch of chemical substances under subsection (a)(2)(A), the Administrator shall publish the priority class assignments for the chemical substances in the batch that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations.

(B)

Criteria

The criteria used by the Administrator to assign chemical substances to priority classes shall take into account—

(i)

potential impacts of the chemical substance on human health and the environment;

(ii)

the hazard potential of the chemical substance, including classifications and designations of hazard characteristics by other authoritative entities;

(iii)

the potential for exposure to the chemical substance; and

(iv)

measurements of exposure for a given pathway of exposure, if available and reliable, in preference to less direct indicators of, or surrogates for, exposure potential for the same pathway.

(C)

Priority classes

The regulations promulgated pursuant to paragraph (1) shall establish the following priority classes and criteria, and further specify the process the Administrator will use to assign to the priority classes the chemical substances in each batch that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations:

(i)

Priority Class 1

(I)

In general

In each batch, the Administrator shall designate as Priority Class 1 those chemical substances that the Administrator determines warrant safety standard determinations in the near term.

(II)

Initial assignment

The Administrator shall in each batch initially designate as Priority Class 1 chemical substances that possess relatively greater hazard potential and for which there is evidence of more significant or widespread exposure.

(III)

Reassignment

As safety standard determinations for the chemical substance are completed, the Administrator may designate as Priority Class 1 any chemical substance initially assigned to a lower priority class, including chemical substances—

(aa)

posing significant hazard concerns but of less or unknown exposure concern;

(bb)

posing significant exposure concern but of less or unknown hazard concern; or

(cc)

posing less hazard and exposure concerns.

(IV)

Factors for consideration

In determining the number of chemical substances to be placed in Priority Class 1, the Administrator shall seek to balance considerations relating to—

(aa)

the number of chemical substances for which safety standard determinations need to be conducted;

(bb)

the resources available to the Administrator for conducting safety standard determinations; and

(cc)

the deadlines for completion of safety standard determinations specified in subsection (d)(4).

(ii)

Priority Class 2

(I)

In general

The Administrator shall designate as Priority Class 2 those chemical substances that the Administrator determines are of lower priority than Priority Class 1 substances with respect to the timing for conducting safety standard determinations.

(II)

Minimum information set

(aa)

In general

For chemical substances designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under section 4 as needed to inform prioritization decisionmaking.

(bb)

Timing

The minimum information set shall be submitted to the Administrator—

(AA)

not later than 5 years after the date of enactment of the Safe Chemicals Act of 2011 for chemical substances in the initial batch identified under subsection (a)(3) that are assigned to Priority Class 2; and

(BB)

not later than 5 years after the assignment of a chemical substance to Priority Class 2 under this clause for subsequent batches.

(III)

Reprioritization

After submission of the minimum information set for a chemical substance under subclause (II), the Administrator shall, if warranted, recategorize or otherwise reprioritize the chemical substance using the priority classes and process described in this paragraph, together with other chemical substances in the batch undergoing prioritization at the time of the submission.

(IV)

Reprioritization to Priority Class 1

As safety standard determinations are completed on Priority Class 1 chemical substances pursuant to subsection (d), the Administrator shall reprioritize Priority Class 2 substances as Priority Class 1 at a pace consistent with—

(aa)

the resources available to the Administrator for conducting safety standard determinations; and

(bb)

the deadlines for completion of safety standard determinations specified in subsection (d)(4).

(iii)

Priority Class 3

(I)

In general

The Administrator shall designate as Priority Class 3 those chemical substances that the Administrator determines may be set aside for further assessment until such time as—

(aa)

safety standard determinations are completed on all Priority Class 1 and 2 substances; or

(bb)

new information arises that warrants reprioritization of such a substance to a higher priority class.

(II)

Minimum information set

(aa)

In general

For a chemical substance designated under this clause, the Administrator shall not require submission of the applicable minimum information set specified under section 4 until such time as the chemical substance is reassigned to Priority Class 1 or 2.

(bb)

Submission

On reassignment of a chemical substance to Priority Class 1 or 2 under item (aa), the minimum information set shall be submitted to the Administrator not later than 5 years after the date of the reassignment.

(III)

Reprioritization

After submission of the minimum information set for a chemical substance pursuant to subclause (II), the Administrator shall reprioritize the chemical substance using the priority classes and process described in this paragraph, together with chemical substances in the batch undergoing prioritization at the time of the submission.

(IV)

Reprioritization to Priority Classes 1 and 2

In conjunction with the reprioritization by the Administrator of Priority Class 2 substances as Priority Class 1, the Administrator shall reprioritize Priority Class 3 substances as Priority Class 1 or 2, at a pace consistent with—

(aa)

the resources available to the Administrator for conducting safety standard determinations; and

(bb)

the deadlines for completion of safety standard determinations specified in subsection (d)(4).

(c)

Treatment as final agency action; no judicial review; nondiscretionary duty

(1)

In general

The designation by the Administrator of batches of chemical substances pursuant to subsection (a), the assignment of chemical substances to categories pursuant to subsection (b)(3), and the assignment of chemical substances to priority classes pursuant to subsection (b)(4), including any determination of the Administrator to include a specific chemical substance in, or exclude a specific chemical substance from, a designated batch, category, or priority class under this section, shall not be—

(A)

considered to be a final agency action for the purpose of subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act); or

(B)

subject to judicial review.

(2)

Failure to act

A failure by the Administrator to designate or publish a list of chemical substances assigned to a batch, category, or priority class in accordance with this subsection shall be—

(A)

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

(B)

subject to judicial review.

(d)

Safety standard determinations for chemical substances

(1)

In general

(A)

Application

This paragraph applies to any determination or redetermination regarding whether a chemical substance meets the safety standards of this Act.

(B)

Responsibilities

(i)

In general

For purposes of this Act, each manufacturer and processor of a chemical substance shall at all times bear the burden of proof in any legal proceeding relating to a decision of the Administrator regarding whether the chemical substance meets the safety standard.

(ii)

Duties

For purposes of this Act—

(I)

it shall be the duty of the manufacturer or processor of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the safety standard; and

(II)

it shall be the duty of the Administrator to determine whether a chemical substance meets the safety standard.

(2)

Assessment of risk

(A)

Assessment

(i)

In general

A chemical substance that undergoes a safety standard determination under this section may be manufactured, processed, or distributed in commerce only if the Administrator determines that the chemical substance—

(I)

meets the safety standard, taking into account any existing conditions or controls already in effect; or

(II)

can meet the safety standard for all or some uses through the imposition of additional conditions.

(ii)

Requirement

Any assessment of risk used to support a determination that a chemical substance meets the safety standard under clause (i) shall be conducted by employees of the Environmental Protection Agency who are competent to conduct such assessments.

(B)

Safety standard

(i)

In general

The Administrator shall base a determination of whether a safety standard for a chemical substance has been met under subparagraph (A) solely on considerations of human health and the environment, including the health of vulnerable populations.

(ii)

Considerations

In making a safety standard determination under this subsection, for each chemical substance, the Administrator shall—

(I)

to the extent practicable, review and incorporate any available scientific information relating to the effect of cumulative exposure relevant to that chemical substance on human health and the environment; and

(II)

find that a chemical substance meets the safety standard only if the Administrator finds that there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.

(C)

Financial interests

No person conducting an assessment described in subparagraph (A), or a peer review of such an assessment, may have a direct or indirect financial interest in the outcome of the assessment.

(D)

Methodology

(i)

In general

Subject to clause (ii), the Administrator shall use the best available science when conducting an assessment described in subparagraph (A).

(ii)

Considerations

For the purpose of determining the current best available science the Administrator shall base the determination on the recommendations of the National Academy of Sciences in the report entitled Science and Decisions.

(iii)

Review

Not later than 5 years after the date of enactment of the Safe Chemicals Act of 2011, and not less frequently than once every 5 years thereafter, the Administrator shall review the methodology under this paragraph and may revise the methodology to reflect new scientific developments or understandings.

(E)

Scope

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

(F)

Transparency

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—

(i)

the public; and

(ii)

risk managers.

(G)

Manufacture or processing for export

In the case of a chemical substance that is manufactured or processed in whole or in part for export, in determining whether the chemical substance meets the safety standard under subparagraph (A)(i), the Administrator shall take into account any risk—

(i)

that the chemical substance may pose in the United States, including risks involving long-range transport of the chemical substance in the environment; or

(ii)

involving the import of articles and mixtures containing the chemical substance.

(H)

Risk assessment not required

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 paragraph (1)(B).

(I)

No judicial review

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

(3)

Information for safety standard determinations

(A)

In general

In making a safety standard determination with respect to a chemical substance, the Administrator—

(i)

shall take into consideration information regarding the chemical substance that is already available to the Administrator at the time the determination is to be made, including information—

(I)

received by the Administrator from manufacturers or processors under this section or section 8;

(II)

contained in any minimum information sets previously required under section 4;

(III)

voluntarily submitted by manufacturers and processors in accordance with subsection (b)(2)(B);

(IV)

submitted by any other party to the Administrator that is relevant to the conduct of a safety standard determination of the chemical substance; or

(V)

identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible to the Administrator;

(ii)

shall require information needed to complete the applicable minimum information set for the chemical substance required under section 4(a);

(iii)

may require, by regulation or order pursuant to section 4(b) or 8(e), manufacturers or processors of the chemical substance to develop and submit any additional information the Administrator determines is needed to conduct the safety standard determination of the chemical substance; and

(iv)

shall take into consideration, but not rely on, assessments of safety or analyses of the effectiveness of existing control measures—

(I)

submitted to the Administrator by any party; or

(II)

conducted by a governmental entity in another jurisdiction.

(4)

Timing of safety standard determinations

(A)

Priority Class 1

(i)

In general

Beginning with chemical substances initially designated as Priority Class 1 under subsection (b)(4)(C)(i), the Administrator shall conduct safety standard determinations of all chemical substances assigned to the category of substances to undergo safety standard determinations pursuant to subsection (b)(3)(B)(iii).

(ii)

Initial batch

Not later than 5 years after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall complete and publish safety standard determinations for all chemical substances designated as Priority Class 1 substances in the initial batch of chemical substances identified under subsection (a)(3).

(iii)

Subsequent batches

Not later than 5 years after the date on which the Administrator designates chemical substances as Priority Class 1 in each subsequent batch of chemical substances under subsection (a)(2)(A), the Administrator shall complete and publish safety standard determinations for those Priority Class 1 substances in the batch.

(B)

Priority Classes 2 and 3

(i)

In general

Each chemical substance initially designated as Priority Class 2 or 3 shall become subject to reprioritization and safety standard determinations in accordance with subsection (b)(4).

(ii)

Reprioritization

Not later than 5 years after the date on which the Administrator designates a Priority Class 2 or 3 substance to be Priority Class 1, the Administrator shall complete and publish the safety standard determination on the chemical substance.

(C)

Notice of overdue determination

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

(D)

Failure of manufacturer or processor to meet duties

If a manufacturer or processor fails to meet any duty under this paragraph for a chemical substance, the Administrator, by order, may take any action authorized under subsection (f).

(5)

Outcome of safety standard determinations

(A)

Determination

(i)

In general

In making a safety standard determination for a chemical substance, the Administrator, by order, shall determine or redetermine, as appropriate, whether the manufacturers and processors of the chemical substance have established that the chemical substance meets the safety standard.

(ii)

Concurrent publication

The Administrator—

(I)

shall seek to publish safety standard determination and risk management decisions concurrently, to the maximum extent practicable; but

(II)

shall not unduly delay the issuance of any safety standard determination if more information or analysis is required to make a determination regarding risk management.

(iii)

Other requirements

The Administrator—

(I)

may publish safety standard determinations for chemical substances individually or in groups; but

(II)

shall publish completed determinations—

(aa)

not less frequently than annually; and

(bb)

at a pace sufficient to demonstrate steady progress toward completing all such safety standard determinations within the required timeframe.

(iv)

Public notice and comment

The Administrator shall provide reasonable public notice and opportunity for comment on all published safety standard determinations through any reasonable means of publication and solicitation of comments, including electronic means.

(B)

Positive safety standard determination without new conditions

If the Administrator determines that a chemical substance meets the safety standard for all current uses and under conditions currently used, the Administrator shall specify in the order—

(i)

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

(ii)

conditions on the specified uses that are currently used and are to be followed to ensure the safety standard is met, including conditions relating to the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance or mixture or article containing the chemical substance.

(C)

Positive safety standard determination with new conditions

If the Administrator determines that a chemical substance can only meet the safety standard for a subset of all current uses or only under conditions beyond those currently used, the Administrator shall specify in the order—

(i)

the allowed uses of the chemical substance, which shall be limited to the uses evaluated in the determination that the Administrator determines meet the safety standard; and

(ii)

all current and all newly required conditions on the specified uses needed to ensure the safety standard is met, including conditions relating to the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance or mixture or article containing the chemical substance, and any conditions described in subsection (f).

(D)

Effective date for positive safety standard determination

(i)

Without new conditions

Effective beginning on the date that is 90 days after the date of a determination by the Administrator under subparagraph (B), no person shall manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture or article containing the chemical substance, for any use or under any condition other than those specified in the determination order.

(ii)

With new conditions

Effective beginning on the date that is 18 months after the date of a determination by the Administrator under subparagraph (C), except as provided in clause (iii), no person shall manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture or article containing the chemical substance, for any use or under any condition other than those specified in the determination order.

(iii)

Exceptional circumstance

The Administrator may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying with a restriction under clause (ii), for a period of not longer than 5 years after the date of the determination by the Administrator under subparagraph (C), if the manufacturer or processor demonstrates—

(I)

a compelling technological need to continue a restricted activity beyond the applicable 18-month time period; or

(II)

that a factor wholly beyond the control of the manufacturer or processor prevents compliance with the restriction within that 18-month time period.

(E)

Redetermination

(i)

In general

The Administrator shall initiate a redetermination of whether a chemical substance meets the safety standard if new information or significant changes in manufacture, processing, use, or distribution in commerce of the chemical substance, or mixtures or articles containing the chemical substance, raise a credible question as to whether the chemical substance continues to meet the safety standard.

(ii)

New methodologies

The Administrator may initiate a redetermination of whether a chemical substance meets the safety standard if significant changes have occurred in the methodologies used in the initial safety standard determination such that a redetermination using the newer methodologies would provide a significantly improved determination of the safety of the chemical substance.

(iii)

New information

For a chemical substance for which a safety standard determination has been completed, the Administrator shall assess, on an ongoing basis, new information, including that obtained from reporting under section 8, to decide whether such information raises a credible question as to whether a chemical substance continues to meet the safety standard

(iv)

Petition for redetermination

(I)

In general

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

(II)

Basis

A person shall include in a petition under this clause a description of the basis for requesting the redetermination.

(III)

Action by Administrator

On receipt of a petition under this clause, 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.

(v)

Deadline for completion

Each redetermination carried out under this subparagraph shall be completed by not later than 3 years after the date of the decision to make the redetermination.

(F)

Negative safety standard determination

(i)

Restriction

Except as provided in clause (ii) and subsection (h), effective beginning on the date that is 18 months after the date on which the Administrator makes a determination under this subsection that a chemical substance fails to meet the safety standard, regardless of whether additional restrictions on use or risk management conditions are imposed, no person shall manufacture, process, or distribute in commerce that chemical substance or any mixture or article containing the chemical substance.

(ii)

Exceptional circumstance

The Administrator may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying with the restriction under clause (i), for a period of not longer than 5 years after the date of the determination by the Administrator under this subparagraph, if the manufacturer or processor demonstrates—

(I)

a compelling technological need to continue a restricted activity beyond the applicable 18-month time period; or

(II)

that a factor wholly beyond the control of the manufacturer or processor prevents compliance with the restriction within that 18-month time period.

(e)

Expedited action for substances of very high concern

(1)

Use and exposure assessment

(A)

In general

Not later than 180 days after the date on which a chemical substance is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator may require, by order pursuant to section 8(g), the submission by manufacturers or processors of the chemical substance of any additional information the Administrator determines to be necessary to conduct an expedited assessment of the known uses of, and exposures to, the chemical substance.

(B)

Publication

Not later than 1 year after the date on which a chemical substance is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator shall complete and publish an identification and assessment of the known uses of, and exposures to, the chemical substance.

(2)

Exposure reduction

(A)

Use restrictions and other conditions

As soon as practicable, but not later than 18 months, after the date on which a chemical substance is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator shall impose, by order, use restrictions and other conditions, including the conditions specified in subsection (f), on the manufacturing, processing, use, distribution in commerce, and disposal of the chemical substance that the Administrator determines to be necessary to achieve the maximum practicable reduction in human or environmental exposure to the chemical substance.

(B)

Timing

Except as provided in subparagraph (C) and subsection (h), effective beginning on the date that is 18 months after the date of issuance by the Administrator of the order described in subparagraph (A), no person shall manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture or article containing the chemical substance, for any use or under any condition other than those specified in the order issued under subparagraph (A).

(C)

Exceptional circumstance

The Administrator may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying with the restriction under subparagraph (B), for a period of not longer than 5 years after the date of the determination by the Administrator under this paragraph, if the manufacturer or processor demonstrates—

(i)

a compelling technological need to continue a restricted activity beyond the applicable 18-month time period; or

(ii)

that a factor wholly beyond the control of the manufacturer or processor prevents compliance with the restriction within that 18-month time period.

(3)

Residual risk assessment

Not later than 1 year after the deadline specified in paragraph (2)(B), or of an alternative deadline provided under paragraph (2)(C), the Administrator shall—

(A)

determine whether the chemical substance meets the safety standard for the chemical substance, taking into account the residual risk posed by continued exposure to the chemical substance; and

(B)

impose any additional restrictions on use or other conditions under subsection (f) that the Administrator determines to be necessary to ensure that the chemical substance meets the safety standard.

(f)

Risk management

In issuing an order under subsection (d) or (e), the Administrator 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, including a requirement—

(1)

limiting the quantity of the chemical substance (or mixture or article containing that chemical substance) that may be manufactured, processed, or distributed in commerce;

(2)
(A)

prohibiting the manufacturing, processing, or distribution in commerce of the chemical substance (or mixture or article containing that chemical substance) for a particular use in a concentration in excess of a level specified by the Administrator; or

(B)

limiting the quantity of the chemical substance (or mixture or article containing that chemical substance) 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;

(3)

that the chemical substance (or mixture, or article containing that chemical substance) 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)

that manufacturers and processors of the chemical substance (or mixture or article containing that chemical substance)—

(A)

make and retain records of the processes used to manufacture or process the chemical substance (or mixture or article containing that chemical substance); and

(B)

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

(5)

prohibiting or otherwise regulating any manner or method of commercial use of the chemical substance (or mixture or article containing that chemical substance);

(6)

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

(A)

the manufacturer or processor of the chemical substance (or mixture or article containing that chemical substance); or

(B)

any other person that uses or disposes of the chemical substance (or mixture or article containing that chemical substance) for commercial purposes;

(7)

that the manufacturers and processors of the chemical substance, mixture, or article develop a risk reduction management plan, under subsection (h) or (e) of this section, to achieve a risk reduction specified by the Administrator; or

(8)

that the Administrator otherwise determines is appropriate.

(g)

Quality control orders

(1)

In general

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

(2)

Orders

(A)

In general

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

(B)

Substantial endangerment

If the Administrator determines that quality control procedures described in paragraph (1) have resulted in the distribution in commerce of a chemical substance that may present a substantial endangerment to human 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 chemical substance or mixture; and

(II)

to the extent reasonably ascertainable, any other person in possession of or exposed to the chemical 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 chemical substance as the Administrator determines to be necessary to adequately protect human health or the environment.

(h)

Exemptions to restrictions

(1)

Application

This subsection applies to the restrictions established under section 5(b)(1)(C)(ii)(I), subsection (d)(5), and subsection (e).

(2)

Exemptions

(A)

In general

(i)

Request

A person who manufacturers, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing a chemical substance may request an exemption from any restriction referred to in paragraph (1) to which they are subject for a specified use of the chemical substance.

(ii)

Order

The Administrator may grant, by order, an exemption from any restriction referred to in paragraph (1) for a period of not longer than 5 years if the person has established by clear and convincing evidence that the uses to be exempted meet the exemption criteria described in subparagraph (B).

(B)

Criteria

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 for which—

(I)

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

(II)

the specified use of the chemical substance, as compared to all available alternatives, provides a substantial net benefit to human health, the environment, or public safety.

(C)

Public notice

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

(i)

the manufacturer or processor of the chemical substance shall provide a notice of the exemption to each known purchaser of—

(I)

the chemical substance; and

(II)

a mixture or article containing the chemical substance; and

(ii)

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

(D)

Renewal

The Administrator may renew, by order, 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)

Conditions

(i)

In general

The Administrator may impose, by order, 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)

Compliance

Effective immediately after the Administrator establishes conditions on an 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)

Resale of used articles

(A)

In general

The restrictions referred to 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.

(B)

Compliance

The Administrator may utilize the authorities contained in section 7 to address potential threats to public health and the environment from such articles.

(4)

Extensions of effective dates for retail sale of articles to end consumers

(A)

In general

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

Exception

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.

;

8.

Imminent hazards

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

7.

Imminent hazards

(a)

Actions authorized and required

(1)

In general

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 authorized under subsection (b) against any person that—

(i)

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

(ii)

contributes to an activity described in clause (i); or

(C)

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

(2)

Other actions

(A)

In general

The Administrator may issue such orders as are 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, as determined by the Administrator.

(B)

Requirement

An order under subparagraph (A) may include such 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 are necessary to protect health or the environment, including—

(i)

the requirements described in section 6(c); and

(ii)

the relief authorized under subsection (b).

(3)

Relationship to existing rules, orders, and proceedings

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

(A)

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

(B)

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

(b)

Relief authorized

(1)

In general

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

(2)

Types of relief

In the case of a civil 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 section 6(c) or in clauses (i) through (iv) of this subparagraph; or

(C)

such other relief as is necessary to protect health or the environment from the risk associated with the activity involved in the civil action.

(3)

Seizure and condemnation

(A)

In general

A civil action under subsection (a)(1) against a chemical substance, mixture, or article may be proceeded against by process of libel for seizure and condemnation of the chemical substance, mixture, or article.

(B)

Proceedings

Proceedings in a civil action described in subparagraph (A) shall conform, to the maximum extent practicable, to proceedings in rem in admiralty.

(c)

Venue and consolidation

(1)

Venue

(A)

In general

A civil 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 in any judicial district in which any of the defendants is found, resides, or transacts business.

(B)

Process

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

(C)

Chemical substances, mixtures, or articles

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

(D)

Multiple judicial districts

In determining the judicial district in which a civil 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

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

(2)

Consolidation

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

.

9.

Reporting and retention of information

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

8.

Reporting and retention of information

(a)

Substance identification, declaration, and information

(1)

In general

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, 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 (h).

(2)

Declaration of current manufacture or processing

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)

Declaration of cessation of manufacturing or processing

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)

Updating of information

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

(A)

at a minimum every 3 years; and

(B)

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

(i)

demonstrates a new potential toxic effect of the chemical substance;

(ii)

corroborates previous information demonstrating or suggesting a toxic effect; or

(iii)

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

(5)

Records to support declarations

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)

Prohibition on manufacturing, processing, or distribution

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)

Reports

(1)

Requirement

(A)

In general

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 to maintain records of and report by a specified date any information concerning the substance that, in the judgment of the Administrator, would assist the Administrator in—

(i)

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

(ii)

any other aspect of administering this Act.

(B)

Characteristics

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

(C)

Required information

The Administrator shall by rule or order specify or modify the information that is required to 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 or article containing that chemical substance) for the purposes of the report or information submission.

(2)

Small quantities for research or analysis

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 promulgate or issue a rule or order under paragraph (1) only to the extent that the Administrator determines the maintenance of records or submission of reports, or both, are necessary for the effective enforcement of this Act.

(3)

Prohibition on manufacturing, processing, or distribution

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 section 6(e).

(c)

Inventory

(1)

In general

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

(2)

Contents

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

(3)

Timing

(A)

In general

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)

Publication

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

(4)

Small quantities for research or analysis

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.

(d)

Public access to significant information

(1)

Electronic database

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, 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)

Public access

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2011, 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 title (for decisions made or information submitted after that 18-month period), 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—

(A)

decisions made by the Administrator under this title; and

(B)

information submitted pursuant to this title.

(e)

Records

(1)

In general

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

(2)

Duration

(A)

In general

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

(B)

Other records

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

(3)

Contents

Records required to be maintained under this subsection shall include—

(A)

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

(B)

reports of occupational disease or injury; and

(C)

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

(f)

Information in the possession of other Federal agencies

(1)

Synopses

(A)

In general

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 or institution, respectively, that may be useful to the Administrator in carrying out this Act.

(B)

Format and content

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall prescribe, by order, the format, content, and level of detail of the synopses.

(C)

Initial submission

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2011, each Federal agency and Federal institution shall make the initial submission of a synopsis of the agency and institution, respectively, to the Administrator.

(D)

Updates

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

(i)

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

(ii)

submit the updated synopsis to the Administrator.

(2)

Requests by Administrator

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 or article containing that chemical substance) shall be provided to the Administrator.

(g)

Notice to Administrator of substantial risks

Any person that manufactures, processes, or distributes in commerce a chemical substance and that obtains information that reasonably supports the conclusion that the substance 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)

Certification

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

(1)

is accurate and reliable; and

(2)

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

(i)

Definition of manufacture and process

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

.

9.

Reporting and retention of information

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

8.

Reporting and retention of information

(a)

Definitions

In this section:

(1)

Known to, or reasonably ascertainable by

The term known to, or reasonably ascertainable by has the meaning given the term in section 704.3 of title 40, Code of Federal Regulations (or successor regulations).

(2)

Manufacture and process

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

(b)

Declarations of chemical substances in commerce

(1)

Scope and criteria

(A)

Scope

The declarations described in this subsection shall apply only to chemical substances in commerce as of the date of enactment of the Safe Chemicals Act of 2011.

(B)

Criteria

The following criteria shall apply in identifying chemical substances to which the declarations described in this subsection apply:

(i)

Current commercial interest

A chemical substance in which a manufacturer or processor has a current commercial interest shall include only chemical substances that the manufacturer or processor—

(I)

is currently manufacturing or processing; or

(II)

has manufactured or processed in the recent past and expects to manufacture or process again in the near future.

(ii)

Potential commercial interest

A chemical substance in which a manufacturer or processor has a potential commercial interest shall include only a chemical substance that may serve as a reasonable substitute for a chemical substance in which the manufacturer or processor has declared a current commercial interest.

(C)

Guidance

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall issue guidance further describing the criteria described in subparagraph (B) and specifying the supporting information manufacturers and processors are to include in declarations they submit pursuant to paragraph (2) or (3) for chemical substances in which they have a current or potential commercial interest.

(2)

Declaration of current commercial interest in a chemical substance

(A)

In general

Notwithstanding any other provision of law, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, each manufacturer of a chemical substance in which the manufacturer has a current commercial interest shall submit to the Administrator a declaration of the interest for the chemical substance.

(B)

Exclusions or exemptions

Declarations are required for all chemical substances in which a manufacturer has a current commercial interest, notwithstanding any exclusions or exemptions from other notification or reporting requirements provided in any other provision of this Act.

(C)

Processors

A processor of a chemical substance in which the processor has a current commercial interest that meets the criteria described in paragraph (1)(B)(i) may voluntarily submit to the Administrator a declaration for the chemical substance. Such a declaration shall be submitted not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011.

(3)

Declaration of potential commercial interest in a chemical substance

(A)

A manufacturer or processor may voluntarily submit to the Administrator, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, a declaration for a chemical substance in which the manufacturer or processor—

(i)

does not have a current commercial interest; but

(ii)

has a potential commercial interest that meets the criteria described in paragraph (1)(B)(ii).

(B)

If a manufacturer or processor commences the manufacture or processing of a chemical substance for which it submitted a declaration under this paragraph, the manufacturer or processor shall comply with the requirements of subsection (h)(5)(B).

(4)

Declaration of cessation of manufacturing or processing

A former or current manufacturer or processor of a chemical substance in which the manufacturer or processor no longer has a commercial interest may voluntarily submit to the Administrator, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, a declaration that the manufacturer or processor has ceased, or will cease not later than 180 days after the date on which the declaration is submitted, all production, importation, processing, and export of the chemical substance.

(5)

Contents

A declaration submitted under this subsection shall include for each chemical substance—

(A)

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

(B)

the identity and primary business location of the manufacturer or processor; and

(C)

information supporting the declarant’s basis for meeting the applicable criteria under paragraph (1)(B).

(6)

Review by Administrator

(A)

In general

The Administrator shall—

(i)

review each declaration received under this subsection to determine whether the declaration conforms to the criteria and requirements of this subsection; and

(ii)
(I)

for a chemical substance for which 1 or more conforming declarations are submitted under paragraph (2), add the chemical substance to the list of active chemical substances in the inventory established under subsection (h)(1);

(II)

for a chemical substance for which the only conforming declarations submitted for the substance are submitted under paragraph (3), add the chemical substance to the list of inactive chemical substances in the inventory established under subsection (h)(5); and

(III)

for a chemical substance for which the only conforming declarations submitted for the substance are submitted under paragraph (4), or for which no declaration has been submitted, remove the chemical substance from the inventories established under subsection (h).

(B)

Revisions

The Administrator shall allow a manufacturer or processor, as applicable, to promptly revise and resubmit any declaration submitted to the Administrator under this subsection if the Administrator determines that any omission or error in the original declaration was not intentional.

(c)

Periodic reporting by manufacturers

(1)

In general

The Administrator shall—

(A)

maintain the periodic reporting program of the agency applicable to manufacturers of chemical substances set forth in part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Safe Chemicals Act of 2011), unless such reporting requirements are superseded pursuant to subparagraph (B); or

(B)

establish a new periodic reporting program consistent with this subsection.

(2)

Rulemaking

(A)

In general

Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall specify, by rule—

(i)

the chemical substances for which periodic reporting is required; and

(ii)

the information a chemical manufacturer is required to submit to the Administrator for the chemical substances included under the periodic reporting program.

(B)

Exemptions

The rule promulgated under subparagraph (A) may exempt certain manufacturers, including small manufacturers, from—

(i)

a requirement to participate in the periodic reporting program, if the Administrator determines that the participation of those manufacturers would not assist in the administration of this Act; or

(ii)

specific reporting requirements, if the Administrator determines that the value of a particular reporting requirement, for the administration of this Act, would not be commensurate with the burden of the requirement on submitters.

(C)

Contents

The rule promulgated under subparagraph (A) shall, at a minimum, require each manufacturer of a chemical substance included in the periodic reporting program to submit to the Administrator—

(i)

the chemical identity and any special substance characteristics of the chemical substance, the identity and primary business location of the manufacturer, and any updates to the supporting information submitted by the manufacturer in any declaration for an included chemical substance submitted under subsection (b);

(ii)

a list of health and safety studies conducted or initiated by or for, known to, or reasonably ascertainable by, the manufacturer with respect to each included chemical substance;

(iii)

a copy of each study described in clause (ii) in the possession or control of the manufacturer that has not previously been submitted to the Administrator; and

(iv)

all other information specified by the Administrator in the rules promulgated under this subsection that is 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 manufacturer’s annual production volume of the chemical substance;

(III)

the uses of, and exposure and fate information relating to the manufacturer’s production or import of the chemical substance; and

(IV)

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

(d)

Records to support declarations and periodic reports

(1)

In general

Each manufacturer and processor of a chemical substance that is distributed in commerce shall—

(A)

maintain records of the information submitted to the Administrator under subsections (b) and (c), as well as supporting information; and

(B)

submit those records or that information to the Administrator upon request by the Administrator.

(2)

Burden of proof

Each manufacturer and processor that submits to the Administrator a declaration under subsection (b) or a notice under subsection (h)(5)(B) shall at all times bear the burden of proving that the manufacturer or processor—

(A)

has a current or potential commercial interest in the applicable chemical substance; or

(B)

has ceased the production, importation, processing, and export of, the applicable chemical substance.

(e)

Substance identification and information for chemical processors

(1)

Rulemaking

(A)

In general

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall specify, by rule, the information that chemical processors are required to submit for chemical substances under this subsection as will assist the Administrator in the administration of this Act.

(B)

Exemptions

The rule promulgated under this paragraph may exempt certain processors, including small processors, from—

(i)

a requirement to participate in the periodic reporting program, if the Administrator determines that the participation of those processors would not assist in the administration of this Act; or

(ii)

specific reporting requirements, if the Administrator determines that the value of a particular reporting requirement, for the administration of this Act, would not be commensurate with the burden of the requirement on submitters.

(2)

Information requirements

The rule promulgated under paragraph (1) shall—

(A)

specify the information that processors are required to submit for chemical substances that are—

(i)

processed for use in 1 or more consumer or commercial product categories, as determined by the Administrator; and

(ii)

intentionally added to 1 or more products during processing and not incidental to the end uses of the products;

(B)

require each processor of a chemical substance identified under subparagraph (A) to submit the information specified in clauses (i) through (iii) of subparagraph (C) for the chemical substance, and to submit the information specified in clauses (iv) through (viii) of subparagraph (C)—

(i)

separately for each applicable consumer and commercial product category; and

(ii)

in aggregate form, taking into account the use by the processor of the chemical substance in all product categories;

(C)

require each processor of a chemical substance identified under subparagraph (A) to identify in the submission of the processor—

(i)

the corporate name and primary business location of the processor;

(ii)

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

(iii)

the applicable consumer or commercial product category or categories for which the processor processes the chemical substance;

(iv)

the annual volume of the chemical substance processed by the submitter;

(v)

any products intended for use by children aged 14 years or younger for use in which the processor processes the chemical substance;

(vi)

the concentration range within which the maximum concentration of the substance used in each consumer and commercial product category falls;

(vii)

the range within which the total number of commercial workers reasonably likely to be exposed to the chemical substance at the processing site falls; and

(viii)

any other information regarding processing activities or product descriptors relating to the processor’s processing of the chemical substance identified by the Administrator as necessary to understand the potential exposure from processed chemical substances or products in which the chemical substances are used; and

(D)

require each processor to periodically report the information described in subparagraphs (B) and (C) for the chemical substances described in subparagraph (A).

(3)

Records

The rules promulgated under paragraph (1) shall require processors of chemical substances to which those rules apply—

(A)

to maintain records of the information described in paragraph (2); and

(B)

to submit those records to the Administrator upon request by the Administrator.

(f)

Updating of information

(1)

In general

Each manufacturer or processor of a chemical substance that submits information to the Administrator under subsection (c) or (e) shall update the information—

(A)

at a minimum every 4 years; and

(B)

at any time that—

(i)

the manufacturer or processor obtains knowledge of, comes into possession of, or generates significant new information regarding the production, processing, use, distribution, hazard, or exposure potential of the chemical substance; or

(ii)

there is a significant change in the production, distribution in commerce, or use of the chemical substance by or known to the manufacturer or processor.

(2)

Guidance

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall issue guidance on what constitutes significant new information regarding or significant changes in the production, distribution in commerce, or use of a chemical substance.

(g)

Reports

(1)

Requirement

(A)

In general

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, or a mixture or article containing the chemical substance to maintain records of and report by a specified date any existing information concerning the substance that, in the judgment of the Administrator, would assist the Administrator in—

(i)

making a safety standard determination with respect to a chemical substance;

(ii)

determining testing or information needs for a chemical substance;

(iii)

assigning a chemical substance to a batch, category, or priority class pursuant to section 6;

(iv)

evaluating, developing, and implementing risk management conditions for a chemical substance;

(v)

assessing hazards, exposures, or risks related to the manufacture, use, distribution, processing, or disposal of a chemical substance;

(vi)

determining compliance with any provision of this Act; or

(vii)

any other aspect of administering this Act.

(B)

Characteristics

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

(C)

Required information

The Administrator shall by rule or order specify or modify the information that is required to 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 or article containing that chemical substance) for the purposes of the report or information submission.

(2)

Exemptions

(A)

Small quantities for research or analysis

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 promulgate a rule or order under paragraph (1) only to the extent that the Administrator determines that the maintenance of records, submission of reports, or both, is necessary for the effective enforcement of this Act.

(B)

Small business

The rules promulgated under this subsection may exempt certain small businesses from the rules promulgated under this subsection, if the Administrator determines that the participation of those small businesses would not assist in the administration of this Act.

(h)

Inventories

(1)

Active inventory

The Administrator shall compile, keep current, and, subject to section 14, publish a list of each chemical substance that is manufactured or processed in the United States.

(2)

Contents

(A)

In general

The list shall consist of those chemical substances for which—

(i)

a notice is submitted under section 5(d), consistent with the requirements of section 5(b); or

(ii)

a valid declaration is submitted under paragraph (2) of subsection (b).

(B)

Exclusions

The list shall not include—

(i)

any chemical substance for which the only declarations submitted are submitted under paragraph (3) or (4) of subsection (b), or for which no declaration has been submitted; or

(ii)

any chemical substance for which an exemption has been granted under section 5(b)(1)(C)(ii) or section 6(h)(2).

(3)

Timing

(A)

In general

Except as provided in paragraph (2)(B), for a chemical substance for which a notice is submitted under section 5(d), the chemical substance shall be included in the list established under paragraph (1) as of the earliest date (as determined by the Administrator) on which the substance was manufactured or processed in the United States.

(B)

Publication

The Administrator shall first publish a list under paragraph (1) not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011.

(4)

Small quantities for research or analysis

The Administrator shall not include in the list established under paragraph (1) 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 research or analysis for the development of a product.

(5)

Inactive inventory

(A)

In general

The Administrator shall compile, keep current, and, subject to section 14, publish an inactive list on which the Administrator shall include each chemical substance for which the only declarations submitted for the substance are submitted under subsection (b)(3).

(B)

Requirements

If a manufacturer or processor commences the manufacture or processing of a chemical substance on the inactive list, the manufacturer or processor shall—

(i)

not less than 30 days before recommencing the manufacture or processing of the chemical substance, notify the Administrator; and

(ii)

provide with the notification under clause (i)—

(I)

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

(II)

the identity and primary business location of the manufacturer;

(III)

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;

(IV)

upon request of the Administrator, a copy of each study described in subclause (III) in the possession or control of the manufacturer that has not previously been submitted to the Administrator;

(V)

the projected annual manufacturing or processing volume for the chemical substance for each of the subsequent 3 years;

(VI)

the name and location of each facility to which the chemical substance is expected to be sent, after manufacture or processing, for subsequent processing, distribution in commerce, or use; and

(VII)

all other existing 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—

(aa)

the toxicological properties of the chemical substance; and

(bb)

the uses of, and exposure and fate information relating to, the chemical substance.

(C)

Administrator actions

For any chemical substance for which the Administrator receives a valid notification under subparagraph (B), the Administrator shall promptly—

(i)

move the chemical substance to the active inventory established under paragraph (1); and

(ii)

add the chemical substance to the current batch of chemical substances identified pursuant to section 6(a), and categorize the chemical substance with other chemical substances in the batch, pursuant to section 6(b).

(D)

Administration

Disclosure of any information provided in the notice described in subparagraph (B) shall be subject to section 14.

(6)

Chemicals not listed on or removed from the inventories

If a manufacturer or processor seeks to commence the manufacture or processing of a chemical substance that is not listed on the inventories established under paragraph (1) or (5), or that has been removed from the inventories pursuant to subsection (b)(6)(A)(ii)(III), the manufacturer or processor shall comply with section 5.

(i)

Public access to significant information

(1)

Electronic database

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator, through collaboration as appropriate, shall establish—

(A)

an electronic, Internet-accessible database for the 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)

Public access

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2011 or for decisions made or information submitted after that 18-month period, not later than 90 days after the date on which a decision is made by the Administrator or information submitted under this title is received by the Administrator, 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—

(A)

decisions made by the Administrator under this title; and

(B)

information submitted pursuant to this title.

(j)

Records of significant adverse reactions

(1)

In general

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

(2)

Duration

(A)

In general

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

(B)

Other records

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

(3)

Contents

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.

(k)

Information in the possession of other federal agencies

(1)

Synopses

(A)

In general

Notwithstanding any other provision of law, 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 or institution, respectively, that may be useful to the Administrator in carrying out this Act.

(B)

Format and content

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall prescribe, by order, the format, content, and level of detail of the synopses.

(C)

Initial submission

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2011, each Federal agency and Federal institution shall make the initial submission of a synopsis of the agency and institution, respectively, to the Administrator.

(D)

Updates

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

(i)

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

(ii)

submit the updated synopsis to the Administrator.

(2)

Requests by the administrator

Notwithstanding any other provision of law, 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 or article containing that chemical substance) shall be submitted to the Administrator.

(l)

Notice to administrator of substantial risks

Any person that manufactures, processes, or distributes in commerce a chemical substance and that obtains information that reasonably supports the conclusion that the substance 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.

(m)

Certification

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 (k), shall be accompanied by a certification signed by a responsible official of the manufacturer, processor, distributor, user, or disposer of a chemical substance that each statement contained in the submission—

(1)

is accurate and reliable; and

(2)

includes all material facts required by the applicable provision of this section or rule or order under this section.

(n)

Administration

(1)

In general

Nothing in this section limits the authority of the Administrator to require reporting under any other provision of this Act by any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing a chemical substance.

(2)

Violations

In addition to all other authorities available for the enforcement of this Act, the Administrator may, by order, take any action authorized under section 6(f) if a person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing a chemical substance violates any provision of this section.

.

10.

Relationship to other Federal laws

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

(1)

in subsection (a)—

(A)

by striking paragraphs (1) and (2) and inserting the following:

(1)

Report

(A)

In general

If the Administrator determines that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, or that any combination of those activities, does not meet a safety standard under this title 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 exposure to, the chemical substance, the Administrator shall submit to the agency that administers the Federal law a report that—

(i)

describes with specification the activity or combination of activities that prevent the chemical substance from meeting the safety standard or restrictions or conditions required to meet the safety standard under this title;

(ii)

requests that the agency—

(I)

determine whether the 1 or more actions may be taken under Federal law administered by the agency;

(II)

if the agency determines under clause (i) that the 1 or more actions may be taken, initiate and provide a timetable for the 1 or more actions; and

(III)

respond to the Administrator with respect to the matters described in the report; and

(iii)

includes a detailed statement of the information on which the report is based.

(B)

Publication

A report of the Administrator submitted under subparagraph (A) shall be promptly published in the Federal Register.

(C)

Action by recipient agency

Not later than 90 days after the date of receipt of a report from the Administrator under subparagraph (A), or by such earlier date as the Administrator may specify in such a report, an agency that receives the report shall—

(i)

make all determinations requested by the Administrator in the report;

(ii)

take all action necessary to ensure that a chemical substance meets the safety standard under this title, if appropriate;

(iii)

include with the response of the agency a detailed statement of the findings and conclusions of the agency; and

(iv)

publish that statement in the Federal Register.

(2)

Initiation of action

If the Administrator submits a report under paragraph (1) with respect to a chemical substance to an agency, and the agency that receives the report initiates, within the period specified in the request under paragraph (1), a civil action under Federal law administered by the agency to ensure that a chemical substance meets the safety standard under this title, or requires restrictions or conditions to meet that safety standard, the Administrator may not take action under this Act with respect to the civil action (other than any action taken pursuant to section 7).

;

(B)

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

(C)

by inserting after paragraph (2) the following:

(3)

No action

The Administrator may, by order, initiate action or a combination of actions under this Act to ensure compliance with the safety standard for a chemical substance under this title if—

(A)

the Administrator submits a report under paragraph (1) with respect to a chemical substance; and

(B)

the agency to which the report was submitted—

(i)

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

(ii)

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

(iii)

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

(iv)

fails to respond.

; and

(D)

in paragraph (4) (as redesignated by subparagraph (B))—

(i)

by striking (4) If the Administrator has initiated action under section 6 or 7 and inserting the following:

(4)

Consultation

If the Administrator has initiated action under this Act

; and

(ii)

by striking against such risk after Federal action;

(2)

in subsection (c)—

(A)

by striking the Administrator shall not and inserting

Administrator—

(1)

shall not

; and

(B)

by striking the period at the end and inserting ; and; and

(C)

by adding at the end the following:

(2)

shall ensure that any actions to address workplace exposures that the Administrator takes or requires to be taken by manufacturers or processors of a chemical substance are consistent with the industrial hygiene hierarchy of controls.

; and

(3)

in subsection (d)—

(A)

in the first sentence, by striking while imposing the least burden of duplicative requirements on those subject to the Act and for other purposes; and

(B)

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

11.

Inspections and subpoenas

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

11.

Inspections and subpoenas

(a)

Inspections

(1)

In general

For purposes of administering this Act, the Administrator, and any duly designated representative of the Administrator, may inspect—

(A)

any establishment, facility, or other premises in which chemical substances, mixtures, or articles subject to this Act are manufactured, processed, stored, or held before or after distribution in commerce;

(B)

any conveyance being used to transport such chemical substances, mixtures, or articles in connection with distribution in commerce; and

(C)

any place at which records relating to the chemical substances, mixtures, or articles, or otherwise relating to compliance with this Act, are held.

(2)

Method

Each inspection under paragraph (1) shall be—

(A)

commenced and completed with reasonable promptness; and

(B)

conducted at reasonable times, within reasonable limits, and in a reasonable manner.

(3)

Samples

The Administrator, and any duly designated representative of the Administrator, may inspect and obtain samples of any—

(A)

chemical substance, mixture, or article; and

(B)

container or labeling of a chemical substance, mixture, or article.

(b)

Scope

An inspection conducted under subsection (a) shall extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) regarding whether the owner or operator of the premises, conveyance, or records has complied with provisions of this Act applicable to the chemical substances, mixtures, articles, or records.

(c)

Information gathering

(1)

In general

In carrying out this Act, 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, as the Administrator determines to be necessary.

(2)

Payment of witnesses

A witness described in paragraph (1) shall be paid the same fees and mileage that are paid witnesses in the courts of the United States.

(d)

Warrants

For purposes of enforcing this Act, upon a showing to an officer or court of competent jurisdiction that there is reason to believe that a provision of this Act has 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 Act; and

(2)

the seizure of any chemical substance, mixture, or article that is in violation of this Act.

.

12.

Exports

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))—

(A)

in paragraph (1)—

(i)

by striking or intends to export;

(ii)

by striking section 4 or 5(b) and inserting section 4, 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 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 the action taken pursuant to section 6 or 7; and

(C)

by adding at the end the following:

(3)

Change in export status

(A)

In general

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 by not later than 30 days after such a change in status.

(B)

Updated notice

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 the substance or mixture have been received by the Administrator pursuant to section 4, 5, 6(b), or 8;

(ii)

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

(iii)

a change has been made in any risk management action taken pursuant to section 6 or 7 for the 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:

(c)

Public records

The Administrator shall—

(1)

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

(2)

make such copies available to the public in electronic format.

.

13.

Entry into customs territory of the United States

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;

(2)

in subsection (a)—

(A)

in paragraph (1), by striking if— and subparagraphs (A) and (B) and inserting if the substance, mixture, or article fails to comply with or is offered for entry in violation of any rule or order in effect under this Act.; and

(B)

by adding at the end the following:

(3)

Import as part of an article

Chemical substances and mixtures imported as part of an article shall be subject to the same requirements under this Act as if the substances and mixtures had been imported in bulk, except as the Administrator may provide by rule under this Act, or as the Secretary of Homeland Security may provide by rule under subsection (b).

.

14.

Disclosure of data

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)), the following:

(a)

Agency responsibilities

The Administrator shall ensure that—

(1)

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

(2)

all information in the possession of the agency that is releasable pursuant to an appropriate request under that section is made available to members of the public.

(b)

Voluntary release of unclassified information not prohibited

Nothing in this section prevents or discourages 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 known as the Freedom of Information Act).

;

(3)

in subsection (c) (as redesignated by paragraph (1))—

(A)

in the subsection heading, by striking In general and inserting Disclosure of certain information;

(B)

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

(C)

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

(D)

by inserting after paragraph (2) the following:

(3)

shall be disclosed upon request to a State, tribal, or municipal government, including identification of the location of the manufacture, processing, or storage of a chemical substance upon the request of the government for the purpose of administration or enforcement of a law, if 1 or more applicable agreements ensure that the recipient government will take appropriate steps to maintain the confidentiality of the information in accordance with this section and section 350.19 of title 40, Code of Federal Regulations (or any successor regulation);

; and

(E)

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

(4)

in subsection (d) (as redesignated by paragraph (1))—

(A)

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

(B)

by striking paragraph (1) and inserting the following:

(1)

Ineligible information

(A)

In general

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:

(i)

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

(ii)

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

(iii)

Any health and safety study that is submitted under this Act with respect to—

(I)

any chemical substance or mixture—

(aa)

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

(bb)

for which testing is required under section 4 or for which notification is required under section 5; 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 item (aa) or (bb) of subclause (I).

(iv)

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.

(B)

Prohibition

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 item (aa) or (bb) of paragraph (1)(A)(iii); and

(ii)

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

(5)

in subsection (e) (as redesignated by paragraph (1))—

(A)

by striking paragraph (1) and inserting the following:

(1)

Duties of manufacturers and processors

(A)

In general

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

(i)

designate the data which the manufacturer, processor, or distributor believes is entitled to confidential treatment under subsection (a); and

(ii)

submit the designated data separately from other data submitted under this Act.

(B)

Requirements

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:

(2)

Duties of the Administrator

(A)

In general

The Administrator shall—

(i)
(I)

not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, by order develop and make publicly available standards that specify—

(aa)

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

(bb)

the documentation that must accompany those requests; and

(II)

not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, identify by rule those types of information for which the Administrator shall not prospectively specify the term of confidentiality pursuant to this subparagraph;

(ii)

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 each request based on whether the request and accompanying documentation comply with the standards that are developed under clause (i) (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);

(iii)

in the event such a request is denied, make the information available to the public in accordance with section 8(d)(2); and

(iv)

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, except with respect to claims subject to a rule issued pursuant to clause (i)(II).

(B)

Authority of Administrator

Subparagraph (A) does not limit the authority of the Administrator to determine that particular information, previously considered entitled to confidential treatment, is no longer entitled to such treatment.

; and

(D)

in paragraph (3) (as redesignated by subparagraph (B))—

(i)

in subparagraph (A)—

(I)

in the first sentence, by striking paragraph (1)(A) and inserting paragraph (1) and approved by the Administrator under paragraph (2)(A)(ii); and

(II)

by striking the last sentence 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.;

(ii)

in subparagraph (B)(i)—

(I)

in the first sentence—

(aa)

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

(bb)

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

(cc)

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

(II)

in the second sentence, by striking except that and all that follows through such release is made and inserting except if the Administrator determines that the release of such data is necessary to protect against an imminent and substantial endangerment to health or the environment then no notice is required.; and

(iii)

in subparagraph (B)(ii), by striking (b)(1) and inserting (d)(1)(A)(iii);

(6)

in subsection (f) (as redesignated by paragraph (1)), by striking subsection (a) and inserting subsection (c); and

(7)

by adding at the end the following:

(h)

Risk information for workers

The Administrator shall provide standards for, and facilitate the sharing of, chemical identity, safety standard determination, and 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, to and with those workers and representatives of each certified or recognized bargaining agent representing those employees.

.

14.

Disclosure of data

Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is amended to read as follows:

14.

Disclosure of data

(a)

Applicability

(1)

In general

Subject to paragraph (2) and except as provided under subsections (b) and (e), any information reported to, or otherwise obtained by, the Administrator (or any representative of the Administrator) that is exempt from disclosure under subsection (a) of section 552 of title 5, United States Code, (commonly known as the Freedom of Information Act) under subsection (b)(4) of that section, shall not be disclosed by the Administrator or by any officer or employee of the United States, unless the designation of the information as exempt from disclosure is prohibited under Federal law.

(2)

Exemptions

(A)

Mandatory exemptions

Notwithstanding any other provision of law, the Administrator shall disclose the information described in paragraph (1)—

(i)

to any officer or employee of the United States—

(I)

in connection with the official duties of that officer or employee under any law for the protection of human health or the environment; or

(II)

for specific law enforcement purposes;

(ii)

to a contractor with the United States and employees of that contractor if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States entered into on or after the date of enactment of the Safe Chemicals Act of 2011 for the performance of work in connection with this Act and under such conditions as the Administrator may specify;

(iii)

if the Administrator determines that the disclosure is necessary to protect human health or the environment;

(iv)

on request, to a State or tribal government for the purpose of development or potential development, administration, or enforcement of a law, if 1 or more applicable agreements ensure that the recipient government will take appropriate steps, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to those which the Administrator uses to safeguard the information;

(v)

on request, to public health or environmental health professionals or medical personnel if the Administrator determines that—

(I)

disclosure is in the public interest;

(II)

the recipient does not have a conflict of interest or competitive interest with respect to the submitter of the information; and

(III)

1 or more applicable agreements are in place to ensure that the recipient of the information provides comparable protections to those provided by the Administrator to maintain the confidentiality of the information.

(B)

Optional exemptions

Notwithstanding any other provision of law, the Administrator may disclose the information described in paragraph (1) if relevant, in any proceeding under this Act, except that disclosure in such a proceeding shall be made in such manner as to preserve confidentiality to the maximum extent practicable without impairing the proceeding.

(3)

Effect on other laws

In any proceeding under section 552(a) of title 5, United States Code (commonly referred to as the Freedom of Information Act), to obtain information, the disclosure of which has been denied pursuant to this section, the Administrator may not rely on subsection (b)(3) of that section to sustain the action of the Administrator.

(b)

Categories of confidential business information

(1)

Information that is always eligible for protection

Subject to subsection (a)(2) and any other applicable provision of Federal law, the Administrator shall review and approve a request that conforms to the requirements described in subsection (c)(2) to treat as confidential under this section the following information:

(A)

Precise information describing the manufacture, processing, or distribution of a chemical substance or mixture.

(B)

Marketing and sales information.

(C)

Information identifying the customers of a manufacturer, processor, or distributor.

(D)

Details of the full composition of a mixture of a particular manufacturer or processor.

(E)

Precise information about the use, function, or application of a chemical substance or mixture in a process, mixture, or product of a particular manufacturer or processor.

(F)

Precise production or import volumes of a particular manufacturer, processor, or distributor.

(2)

Information that may be eligible for protection

(A)

In general

Subject to subsection (a) and any other applicable provision of Federal law, and except as provided in paragraphs (1) and (3), information submitted by a manufacturer, processor, or distributor to the Administrator may be protected if the manufacturer, processor, or distributor complies with subsection (c)(2) and the Administrator determines that a request to maintain the confidentiality of the information meets the applicable requirements of this subsection and any rule promulgated by the Administrator under subsection (c)(1).

(B)

Identities of certain chemical substances

(i)

In general

Notwithstanding subparagraph (A), the Administrator shall not disclose precise information on the identity of a chemical substance if—

(I)

the manufacturer or processor of the substance has, in accordance with subsection (c)(2)—

(aa)

included in a notice under section 5(b) a request, including a justification and documentation for the request, that the identity of the substance be treated as confidential business information; or

(bb)

submitted to the Administrator not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011 a request, including a justification and documentation for the request, that the identity of a substance for which a notice has been submitted under section 5(b) as of the date of enactment of the Safe Chemicals Act of 2011 be treated as confidential business information; and

(II)

the Administrator determines that—

(aa)

the request complies with all applicable requirements of this section;

(bb)

the chemical identity is not readily discoverable through reverse engineering;

(cc)

the manufacturer or processor takes reasonable measures to protect the confidentiality of the chemical substance;

(dd)

no other Federal statute requires disclosure;

(ee)

disclosure of the identity of the chemical substance would cause financial or competitive harm to the manufacturer or processor;

(ff)

the chemical substance is not, based on information that is initially available or that later becomes available to the Administrator, a known or probable reproductive, developmental, neurological, or immunological toxicant, carcinogen, or mutagen;

(gg)

the chemical substance is not persistent, bioaccumulative, and toxic; and

(hh)

if a safety standard determination has been made for a chemical substance, the Administrator determines that the chemical substance meets the applicable safety standard either under current conditions or under additional conditions required by the Administrator.

(ii)

Notice

In cases where all of the requirements specified in clause (i) are met—

(I)

the notice required to be made public by the Administrator under section 5(f)(3) shall include a justification for the determination of the Administrator and identify the chemical substance by generic class unless the Administrator determines that more specific identification is required in the public interest; and

(II)

as part of a claim to protect the identity of a chemical substance under subsection (c)(2), a manufacturer or processor may provide a public name for the chemical substance for use by the Administrator when sharing information on the chemical substance under this subsection. The public names should disclose a maximum amount of information on the chemical structure of the substance, while protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the owner of that information.

(iii)

Duration of protection for chemical identity

Notwithstanding subsection (c)(1)(B)(iv), the identity of a chemical substance for which a request has been submitted pursuant to clause (i)(I) and meets the requirements of clause (i) shall be protected as confidential business information—

(I)

for such period of time as the Administrator, after reviewing the request, determines to be reasonable; and

(II)

upon expiration of a time period specified under this clause, for an additional 5-year period, if the Administrator, after reviewing the request, determines that the request for protection continues to meet the criteria established in this subparagraph.

(iv)

Publication requirement

The Administrator shall annually publish a notice that—

(I)

includes an updated, cumulative list of each new chemical substance for which the Administrator has approved a request to protect information under this paragraph, identified by a unique identifier, other than the precise chemical identity, and including the period of time for which the protection applies; and

(II)

for each chemical substance for which the protection provided under this paragraph has expired, provides the precise identity of the chemical substance, and provides public access to any information that had been submitted to the Administrator which concealed the identity of the chemical substance in accordance with this paragraph.

(C)

Impurities

Notwithstanding subparagraph (A), the Administrator may determine not to disclose information relating to the degree of purity or the identity of impurities present in a chemical substance or mixture if the Administrator determines that knowledge of the information would reveal processes used in the manufacturing or processing of the chemical substance or mixture.

(3)

Information that is never eligible for protection

(A)

In general

Except as provided in paragraph (2), the Administrator shall disclose the following information:

(i)

The identity of a chemical substance.

(ii)

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

(iii)

Any health and safety study data that is submitted under this Act with respect to—

(I)

any chemical substance or mixture—

(aa)

that has been offered for commercial distribution as of the date on which the study is to be disclosed; or

(bb)

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

(II)

any data reported to, or otherwise obtained by, the Administrator from a health and safety study that relates to a chemical substance or mixture described in subclause (I).

(iv)

Health and safety data in notices of substantial risk submitted pursuant to section 8(l) and in the underlying studies.

(v)

General information describing the manufacturing volumes, expressed in ranges, and industrial, commercial, or consumer functions and uses of a chemical substance or mixture.

(vi)

Any information indicating the presence of a chemical substance in consumer products intended for use, or reasonably expected to be used, by children aged 14 years or younger, if—

(I)

the Administrator, or another authoritative body, has determined that the chemical substance—

(aa)

is a known or probable reproductive, developmental, neurological, or immunological toxicant, carcinogen, or mutagen; or

(bb)

is persistent, bioaccumulative, and toxic; or

(II)

for a chemical substance for which a safety standard determination has been made, the Administrator has not found that the chemical substance meets the safety standard.

(B)

Prohibition

Nothing in this paragraph authorizes the release of any data that discloses a process 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.

(C)

Applicability of other laws

Except as provided in paragraph (2), if the Administrator receives a request for information under section 552(a) of title 5, United States Code, (commonly known as the Freedom of Information Act) for information described in subparagraph (A), which is not information described in subparagraph (B), the Administrator shall not deny the request under subsection (b)(4) of that section.

(c)

Designation and treatment of confidential business information

(1)

Duties of the administrator

(A)

Rules

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall promulgate rules that specify—

(i)

the acceptable bases on which written requests to maintain confidentiality of information may be approved, which shall be consistent with the requirements of this section;

(ii)

the nature of the documentation and justification that must accompany such a request; and

(iii)

the types of information the Administrator determines warrant protection for an indefinite period of time, for which the term of confidentiality specified in subparagraph (B)(iv)(I) shall not apply.

(B)

Review of requests

(i)

In general

Not later than 90 days after the date of receipt of information under paragraph (2), the Administrator shall review a request to maintain confidentiality of information submitted under this Act and determine whether to approve, modify, or deny that request based on the regulations promulgated by the Administrator under subparagraph (A).

(ii)

Process

The Administrator shall, in accordance with clause (i)—

(I)

review all requests received to maintain confidentiality of submitted information; or

(II)

if it is not feasible for the Administrator to review all of the requests—

(aa)

review all requests relating to information described in subsection (b)(2)(B); and

(bb)

review a representative subset that includes not less than 25 percent of all other requests received; and

(III)

publish in the Federal Register on at least an annual basis a description of the number and types of requests received and reviewed by the Administrator.

(iii)

Denials

If a request to maintain confidentiality of submitted information is denied in accordance with subparagraph (D), the Administrator shall promptly make the information available to the public in accordance with section 8(i)(2).

(iv)

Approvals

If a request to maintain confidentiality of submitted information is approved, the Administrator shall—

(I)

except with respect to requests subject to a rule issued pursuant to subparagraph (A)(iii) and requests submitted pursuant to subsection (b)(2)(B)(i)(I), specify a time period not to exceed 5 years for which the submitted information shall be kept confidential, unless the information otherwise becomes available to the public during the period; and

(II)

upon the expiration of the protection period, make the information available to the public unless the manufacturer, processor, or distributor has submitted, documented, and justified to the satisfaction of the Administrator and in accordance with this subsection the basis for a renewal of the protection, for a time period not to exceed 5 years.

(C)

Authority of the administrator

Nothing in subparagraph (A) or (B) limits the authority of the Administrator to determine that particular information, previously treated as confidential, is no longer entitled to confidential treatment.

(D)

Notifications

(i)

In general

Except as provided in clause (ii), if the Administrator proposes to release information for which a request for confidential treatment has been approved under this section, the Administrator shall electronically notify the manufacturer, processor, or distributor in commerce who submitted the request of the intent of the Administrator to release the information not less than 15 days prior to the release of the information.

(ii)

Administration

The Administrator shall release the information described in clause (i) in accordance with the disclosure and procedural requirements of section 552 of title 5, United States Code (commonly known as the ‘Freedom of Information Act’), except that—

(I)

if the release of the information is to be made pursuant to a request made under section 552(a) of title 5, United States Code, the notice shall be given immediately upon approval of the request by the Administrator;

(II)

if the Administrator determines that the release of information pursuant to subsection (a)(2)(A)(iii) is necessary to protect against imminent and substantial harm to human health or the environment, no notice shall be required; and

(III)

the requirements of this subparagraph shall not apply to the release of information under—

(aa)

clauses (i) through (iii) of subsection (a)(2)(A); or

(bb)

subsection (b)(3)(A).

(2)

Duties of manufacturers, processors, and distributors

(A)

In general

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

(i)

designate information, other than information described in subsection (b)(3), for which the manufacturer, processor, or distributor requests confidential treatment under subsection (a) or (b); and

(ii)

submit the designated data separately from other data submitted under this Act.

(B)

Requirements

A designation under this paragraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include—

(i)

documentation and justification for each request for confidentiality, except for requests relating to the information described in subsection (b)(1);

(ii)

the period of time for which maintenance of confidentiality of the information is requested except with respect to requests subject to a rule issued pursuant to subsection (c)(1)(A)(iii);

(iii)

a certification that the information is not otherwise publicly available;

(iv)

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

(v)

any additional information required by the Administrator.

(C)

Request for renewal

Prior to the expiration of the specified time period determined by the Administrator under paragraph (1)(B)(iv), a manufacturer, processor, or distributor may submit a request for renewal of protection for protected information. This request for renewal shall follow the same procedures and requirements as the initial submission under subparagraphs (A) and (B).

(d)

Civil penalty for wrongful disclosure or wrongful requests for protection

(1)

In general

Any officer or employee of the United States or former officer or employee of the United States, who, by virtue of employment or official position has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (a), and who knowing that disclosure of the material is prohibited by that subsection, willfully discloses the material in any manner to any person not entitled to receive the information, shall be subject to appropriate disciplinary action and subject to a civil money penalty of not more than $10,000 for each violation.

(2)

Applicability of other laws

Section 1905 of title 18, United States Code, shall not apply with respect to the publishing, divulging, disclosure, making known, or making available of, information reported or otherwise obtained under this Act.

(3)

Contractors

For the purposes of paragraph (1), any contractor with the United States who is furnished information as authorized by subsection (a)(2), including any employee of such a contractor, shall be considered to be an employee of the United States.

(4)

False requests

Any officer or employee of a company that submits information under this Act who willfully designates information as eligible for confidential treatment, knowing that the information is ineligible for such treatment, shall be subject to a civil money penalty of not more than $10,000 for each such violation.

(e)

Access by congress

Notwithstanding this section or any other provision of law, all information reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made available, on written request of any duly authorized committee of Congress, to that committee.

(f)

Risk information for workers

The Administrator shall facilitate the sharing of information that pertains to chemical substances or mixtures or articles containing chemical substances that workers may come into contact with or may otherwise be exposed to during the course of work with those workers and representatives of each certified or recognized bargaining agent representing those workers. Nothing in this subsection authorizes disclosure of information other than those disclosures that may be made pursuant to subsections (a) through (e).

.

15.

Prohibited acts

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 Act or by the Administrator under this Act;

;

(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 Act or by the Administrator under this Act;

(3)

in paragraph (3)—

(A)

in subparagraph (A), by inserting accurate and complete after maintain;

(B)

in subparagraph (B)—

(i)

by inserting or make accurate and complete after submit; 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:

(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 Act or pursuant to any rule or order promulgated or issued under this Act; or

(6)

take any action prohibited by this Act.

.

16.

Penalties

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

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

in the first sentence—

(I)

by inserting this Act or a rule or order promulgated or issued pursuant to this Act, as described in after a provision of; and

(II)

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

(ii)

in the second sentence, by striking violation of section 15 or 409 and inserting violation of this Act;

(B)

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

(C)

by inserting after paragraph (1) the following:

(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 that paragraph.

;

(D)

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

(i)

in the first sentence, by inserting this Act, as described in before section 15 or 409; and

(ii)

in the last sentence, by striking within 15 days of and inserting not later than 15 days after;

(E)

in the first sentence of paragraph (4) (as redesignated by subparagraph (B))—

(i)

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

(ii)

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

(F)

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

(2)

in subsection (b)—

(A)

by striking Any person and inserting the following:

(1)

In general

Any person

;

(B)

by striking or willfully;

(C)

by inserting this Act, as described in after any provision of;

(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:

(2)

Imminent danger of death or serious bodily injury

(A)

In general

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

(B)

Other persons

A person that is not an individual shall, upon conviction of violating this paragraph, be subject to a fine of not more than $1,000,000.

.

17.

Specific enforcement and seizure

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

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by striking (1) The district courts and all that follows through the end of subparagraph (C) and inserting the following:

(1)

Authority of the Administrator

(A)

In general

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 Act or any rule or order promulgated pursuant to this Act.

(B)

Enforcement

The authority of the Administrator to enforce this Act includes the authority—

(i)

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

(ii)

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

(iii)

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

; and

(ii)

in subparagraph (D)—

(I)

by redesignating clause (i) through (iii) as subclauses (I) through (III), respectively, and indenting appropriately;

(II)

by striking (D) direct any manufacturer and inserting the following:

(iv)

to order any manufacturer

;

(III)

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

(IV)

by striking product each place it appears and inserting article;

(V)

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

(VI)

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

(B)

in paragraph (2)—

(i)

by striking (2) A civil action and all that follows through described in subparagraph (A) of such paragraph in subparagraph (A) and inserting the following:

(2)

Civil actions

(A)

In general

The district courts of the United States shall have jurisdiction over a civil action described in paragraph (1).

(B)

Requirements

A civil action described in paragraph (1) may be brought—

(i)

in the case of a civil action described in subparagraphs (A) and (B) of paragraph (1)

;

(ii)

in clause (i) (as so designated), by striking of section 15 and inserting of this Act, as described in section 15 or 409;

(iii)

by redesignating subparagraph (B) as clause (ii) and indenting appropriately; and

(iv)

in clause (ii) (as so designated), by striking such paragraph and inserting paragraph (1); and

(C)

in the undesignated matter following paragraph (2), by striking In any and inserting the following:

(3)

Serving of process and subpoenas

In any

; and

(2)

in the first sentence of subsection (b)—

(A)

by striking title IV and inserting this Act;

(B)

by striking product the first place it appears and inserting article; and

(C)

by striking product, both places it appears.

18.

Preemption

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

18.

Preemption

Nothing in this Act affects the right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, or standard of performance that is different from, or in addition to, a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the applicable provisions of this Act shall control.

.

19.

Judicial review

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

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by striking subparagraph (B);

(ii)

in subparagraph (A), by striking (1)(A) Not later and all that follows through under title II or IV, and inserting the following:

(1)

Judicial review

Not later than 60 days after the date of the promulgation or issuance of a rule under of this Act,

;

(iii)

by inserting or order after rule each place it appears; and

(iv)

in the second sentence, by striking (other than in an enforcement proceeding);

(B)

in paragraph (2)—

(i)

in the first sentence, by striking paragraph (1)(A) and inserting paragraph (1); and

(ii)

in the second sentence, 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 striking paragraph (1) and inserting the following:

(1)

In general

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 the rule or order in accordance with that chapter.

.

20.

Citizens’ civil action

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

(1)

in subsection (a)—

(A)

in paragraph (1), by striking under section 4, 5, or 6, or title II or IV, or order issued under section 5 or title II or IV to restrain such violation, and inserting or order issued under this Act;; and

(B)

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

(2)

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

21.

Citizens’ petitions

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

(1)

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

(2)

in subsection (b)—

(A)

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

(B)

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

(C)

in paragraph (4)—

(i)

in the first sentence of subparagraph (A), by striking a rulemaking proceeding and inserting proceedings authorized under this Act; and

(ii)

in subparagraph (B)—

(I)

in the matter preceding clause (i)—

(aa)

in the first sentence, 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; and

(bb)

by inserting Notwithstanding the preceding sentence, in the case of a petition to delist a chemical substance under section 6(a), the delisting may not proceed except as authorized under that subsection. after the first sentence;

(II)

in clause (i)—

(aa)

in the matter preceding subclause (I), by striking in the case of a petition to initiate a proceeding for the issuance of a rule under section 4 or an order under section 5(e) and inserting except as provided in clause (ii), in the case of a petition to initiate a proceeding for the issuance of a rule or an order under this Act; and

(bb)

in subclause (II), by striking 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;

(bb)

by striking an unreasonable risk of injury and inserting a substantial endangerment; and

(cc)

by striking the period at the end and inserting a semicolon.

22.

Employment effects

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

(1)

in subsection (a), in the matter preceding paragraph (1)—

(A)

by striking continuing and inserting periodic; and

(B)

by striking plant closures) and all that follows through the end of paragraph (2) and inserting plant closures) of the implementation of this Act.;

(2)

in subsection (b)—

(A)

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

(B)

in paragraph (2)—

(i)

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

(ii)

in subparagraph (B)—

(I)

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

(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:

(c)

Effect

Nothing in this section—

(1)

requires the Administrator to amend or repeal any rule or order in effect under this Act; or

(2)

conditions the authority of the Administrator to issue orders or promulgate rules under this Act.

.

23.

Administration of the Toxic Substances Control Act

Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is amended—

(1)

by striking subsection (b) and inserting the following:

(b)

Fees

(1)

In general

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 Act.

(2)

Considerations

In setting a fee under this subsection, the Administrator shall take into account—

(A)

the ability to pay of the person required to submit the data; and

(B)

the cost to the Administrator of reviewing the data.

(3)

Fee sharing

Rules described in paragraph (1) may provide for sharing a fee in any case in which the expenses of testing are shared under this Act.

;

(2)

in subsection (c)—

(A)

in the subsection heading, by adding and mixtures after categories; and

(B)

by adding at the end the following:

(3)

Mixtures

Any action authorized or required to be taken by the Administrator or any other person under any provision of this Act with respect to a chemical substance is likewise also authorized or required with respect to a mixture, if the Administrator determines that such extension is reasonable and efficient.

; and

(3)

by adding at the end the following:

(h)

Rulemaking or orders

In carrying out this Act, the Administrator may issue such orders and prescribe such regulations as are necessary to carry out this Act.

.

24.

State programs

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

(1)

in the first sentence of subsection (a)—

(A)

by striking unreasonable; 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:

(b)

Coordination

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 section 14.

; and

(4)

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

25.

Authorization of appropriations

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

(1)

by redesignating section 29 (15 U.S.C. 2628) as section 38;

(2)

by redesignating section 30 (15 U.S.C. 2629) as section 37;

(3)

by striking section 31 (Public Law 94–469; 100 Stat. 2989); and

(4)

by amending section 38 (as redesignated by paragraph (1)) to read as follows:

38.

Authorization of appropriations

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

.

26.

Additional requirements

(a)

Restrictions on certain chemical substances

The Toxic Substances Control Act is amended by inserting after section 28 (15 U.S.C. 2627) the following:

29.

Children’s Environmental Health Research Program

(a)

Children’s Environmental Health Research Program

(1)

Establishment

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall establish within the Environmental Protection Agency a program to be known as the Childrens Environmental Health Research Program’ (referred to in this subsection as the Program).

(2)

Purpose

Subject to amounts made available in advance in appropriations Acts, the Administrator may enter into contracts and make grants under the Program to further understanding of the vulnerability of children to chemical substances and mixtures.

(3)

Consultation

Contracts and grants under this section shall be provided in consultation with the Interagency Science Advisory Board on Children’s Health Research established under subsection (b)(1).

(b)

Interagency Science Advisory Board on Children’s Health Research

(1)

Establishment

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Childrens Health Research’ (referred to in this subsection as the Board).

(2)

Purpose

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

(3)

Composition

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 EPA-Tribal Science Council; and

(vi)

not fewer than 3 centers of children’s health at leading institutions of higher education;

(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 by the Board, unless—

(i)

the individual promptly and publicly discloses the conflict; and

(ii)

the Administrator determines that the conflict is unavoidable.

(4)

Applicable law

The Board shall be subject to subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act).

(c)

Prenatal and infant exposures

(1)

Monitoring

If, through studies performed under subsection (a) or section 4 or in any 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 identifies the chemical substance, a biomonitoring study to determine the presence of the chemical substance in human biological media in, at a minimum, pregnant women and infants.

(2)

Publication

On completion of any study conducted under paragraph (1), the Secretary of Health and Human Services shall—

(A)

notify the Administrator of the results of the study; and

(B)

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

(3)

Positive results

(A)

Manufacture disclosure

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

(i)

all known uses of the chemical substance or mixture; and

(ii)

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

(B)

Cost and form of disclosure

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

(i)

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.

30.

Reduction of animal-based testing

(a)

Administration

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

(1)

encouraging and facilitating, to the maximum extent practicable—

(A)

the use of existing data of sufficient scientific quality;

(B)

the use of test methods that eliminate or reduce the use of animals while providing data of high scientific quality;

(C)

the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of 1 chemical substance would provide reliable and useful data on others in the category;

(D)

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

(E)

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

(2)

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

(b)

Interagency science advisory board on alternative testing methods

(1)

Establishment

Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Alternative Testing Methods (referred to in this subsection and subsection (c) as the Board).

(2)

Composition

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; and

(v)

the National EPA-Tribal Science Council; and

(B)

ensure that no individual appointed to serve on the Board has a conflict of interest that is relevant to the functions to be performed, unless—

(i)

the individual promptly and publicly discloses the conflict; and

(ii)

the Administrator determines that the conflict is unavoidable.

(3)

Purpose

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

(4)

Applicable law

The Board shall be subject to subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act).

(5)

Report

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, and every 3 years thereafter, the Administrator, in consultation with the Board, shall publish in the Federal Register a list of testing methods that reduce the use of animals in testing under section 4.

(c)

Implementation of alternative testing methods

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

(1)

in consultation with the Board, 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)

beginning on the date that is 2 years after the date of enactment of the Safe Chemicals Act of 2011 and every 2 years thereafter, submit to Congress a report that describes the progress made in implementing this section; and

(3)

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

(d)

Criteria for adapting or waiving animal testing requirements

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

(1)

there is a 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)

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

(3)

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

31.

Safer alternatives and green chemistry and engineering

(a)

Safer alternatives program

(1)

In general

Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, 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)

Requirements

The program established under paragraph (1) shall include—

(A)

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

(B)

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

(C)

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

(b)

Green chemistry research network

The Administrator shall establish a network of not less 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 listed under section 6(a).

(c)

Green chemistry and engineering research grants

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

(d)

Green chemistry workforce education and training program

(1)

In general

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

(2)

Goals

The goals of the program established under paragraph (1) are to provide workforce training on skills that would—

(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)

Implementation

The Administrator shall implement the program to achieve the goals of this Act, including by—

(A)

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

(B)

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

(C)

providing grants to States, units of local government, and the partnerships developed under subparagraph (B) to promote and support activities consistent with achieving the goals of the program established under this subsection.

32.

Cooperation with international efforts

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.

33.

Reliable information and advice

Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall, by order, establish and implement procedures to ensure data reliability including, at a minimum, requirements that the Administrator—

(1)

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

(2)

annually perform a comprehensive data audit on a subset, as chosen by the Administrator, of the data submissions under this title;

(3)

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

(4)

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

(5)

require the submitter of any research study conducted by a third party in response to requirements under this title 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.

34.

Hot spots

(a)

Definitions

In this section:

(1)

Disproportionate exposure

The term disproportionate exposure means residential population exposure to 1 or more toxic chemical substances or 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 established under subsection (b).

(2)

Locality

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

(b)

Criteria

Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall promulgate a rule to establish criteria consistent with this section that—

(1)

defines disproportionate exposure; and

(2)

identifies any locality that is disproportionately exposed.

(c)

Identification

(1)

In general

Not later than 120 days after the date on which the rule is promulgated under subsection (b), the Administrator shall identify localities in the United States that are subject to disproportionate exposure.

(2)

Use of data

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

(A)

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

(B)

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

(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)

Public participation

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

(d)

Locality list

(1)

In general

Not later than 180 days after completing the identification of localities under subsection (c)(1), the Administrator, after notice and consultation with applicable State, local, county health, and environmental officials, State, local, and county legislators, and other elected officials, shall—

(A)

publish a list of the localities subject to disproportionate exposure identified under that subsection in the Federal Register; and

(B)

make the list published under subparagraph (A) available electronically.

(2)

Updated list

(A)

In general

Subject to subparagraph (B), not later than 5 years after the date on which the list is published under paragraph (1)(A), and at least once every 5 years thereafter, the Administrator shall update and republish the list.

(B)

Discretionary updates

The Administrator may update and republish the list under paragraph (1) more frequently than every 5 years—

(i)

to add new localities that meet the criteria established under subsection (b); or

(ii)

to remove localities, if the Administrator determines that the exposure reduction has been achieved and no further action is needed after actions are taken under subsection (f).

(C)

Notification

The Administrator shall notify all applicable State, local, county health, and environmental officials, State, local, and county legislators, and other elected officials of the updated listing.

(e)

No judicial review; nondiscretionary duty

(1)

No judicial review

The following actions under this section shall not be subject to judicial review:

(A)

A decision to include on the list published under subsection (d)(1) a locality identified under subsection (c)(1).

(B)

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

(C)

A decision to list localities under subsection (d)(1) or update the list under subsection (d)(2).

(2)

Nondiscretionary duty

Notwithstanding paragraph (1), the failure of the Administrator to publish or update the list of localities 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)

Action plans

(1)

In general

Not later than 1 year after the date on which the list is published or updated 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 planned by the Administrator to reduce disproportionate exposure in the locality.

(2)

Goals

The goal of each action plan under this subsection shall be to reduce disproportionate exposure in the locality by establishing—

(A)

a percentage exposure reduction goal for each chemical substance and mixture; and

(B)

a timeline to achieve the percentage exposure reduction goal.

(g)

Report to Congress

The Administrator shall—

(1)

submit to Congress an annual report that identifies—

(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 (f); and

(C)

the progress on each action plan to date; and

(2)

make the report available to the public in electronic format.

35.

Application of this Act to Federal agencies

(a)

In general

Except as provided in subsection (e), each Federal agency, and any officer, agent, or employee of a Federal agency, shall be subject to, and comply with, all applicable requirements of this Act described in subsection (b), both substantive and procedural, in the same manner, and to the same extent, as any person subject to the requirements.

(b)

Description of 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 the penalty or fine is—

(A)

punitive or coercive in nature; or

(B)

imposed for isolated, intermittent, or continuing violations;

(3)

any requirement for reporting;

(4)

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

(5)

payment of reasonable service charges.

(c)

Waiver of immunity

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).

(d)

Civil penalties

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

(e)

Criminal sanctions

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

(f)

Exemption

(1)

In general

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

(2)

Lack of appropriation

No exemption shall be granted under paragraph (1) due to lack of appropriation unless—

(A)

the President has specifically requested the appropriation as a part of the budgetary process; and

(B)

Congress has failed to make the requested appropriation available.

(3)

Period of exemption

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

(4)

Report

Each January after the date of enactment of this section, the President shall submit to Congress a report that describes—

(A)

all exemptions granted under this subsection during the preceding calendar year; and

(B)

the reason for granting each exemption.

(g)

Administrative enforcement actions

(1)

In general

The Administrator may initiate an administrative enforcement action against any Federal agency—

(A)

in accordance with the enforcement authorities of this Act; and

(B)

in the same manner and under the same circumstances as an action would be initiated against another person.

(2)

Settlement

Any voluntary resolution or settlement of an administrative enforcement action initiated under this subsection shall be set forth in a consent order.

(3)

Finality of administrative order

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

36.

Implementation of Stockholm Convention, the LRTAP Pops Protocol, and the Rotterdam Convention

(a)

Definitions

In this section:

(1)

Chemical

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

(2)

LRTAP Convention

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.

(3)

LRTAP Pops chemical

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.

(4)

LRTAP POPS Protocol

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.

(5)

Meeting of the parties

The term 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.

(6)

PIC chemical

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)

POPs chemical

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)

Rotterdam convention

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)

Stockholm convention

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)

Implementation of international agreements

(1)

In general

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

(2)

Prohibitions

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

(3)

Public notice and comment

(A)

In general

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.

(B)

Contents

The Administrator shall identify in the notice under subparagraph (A) 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.

(C)

Notice and comment

(i)

In general

Any interested person may provide relevant comment and information on the chemical in response to the notice under subparagraph (A).

(ii)

Request for information

The Administrator may require the provision of relevant information related to a proposed chemical from any person, as the Administrator determines necessary to assist the United States in the review.

(iii)

Public docket

The Administrator shall consider all comments and information received under this subparagraph in the review of the proposal and include the comments and information in an established public docket.

(D)

Post-recommendation

(i)

In general

The Administrator shall 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.

(ii)

Meeting of the Parties

The Administrator shall provide the notice under clause (i) in advance of the meeting of the Parties at which the recommendation is to be considered.

(iii)

Request for information

The Administrator shall request comment and information on all aspects of the recommendation and may, if the Administrator determines it to be necessary to assist the United States in the review, require the provision of relevant information related to a proposed chemical from any person.

(iv)

Public docket

The Administrator shall consider all comments and information received under this subparagraph in the review of the proposal and include the comments and information in an established public docket.

(E)

Decisions

(i)

In general

Not later than 30 days after a decision by the meeting of the parties, the Administrator shall provide timely 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.

(ii)

Contents

The Administrator shall provide in the notice under clause (i) a description of the amendments to the instruments and identify the changes to the domestic activities that the Administrator believes, based on information available to the Administrator, would be necessary if the United States chose to be bound by the listing decision.

(iii)

Public comment

Any interested person may provide relevant comment and information in response to the notice under clause (i).

(iv)

Public docket

The Administrator shall consider all comments and information received under this subparagraph in the review of the proposal and include the comments and information in an established public docket.

(F)

Ratification

Not later than 30 days after the United States deposits the instrument of ratification for the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, or not later than 30 days after the listing of any chemical subsequently added under those instruments has entered into force for the United States (whichever date is earlier), the Administrator—

(i)

shall provide public notice of—

(I)

the chemicals that are subject to those instruments; and

(II)

any chemical subsequently added under those instruments; and

(ii)

may specify the requirements that are applicable for individual chemicals in a public notice under this subparagraph.

(4)

General rulemaking authority

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

(5)

Obligations

If a chemical is subject to obligations under more than 1 of the instruments that includes the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, the most stringent of the obligations shall apply to ensure compliance with each of the instruments.

(c)

Enforcement

The prohibitions and any other requirements of this section shall be enforced in the same manner as final rules or orders under section 6.

.

(b)

Conforming amendments

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.

;

(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. Children’s Environmental Health Research Program.

Sec. 30. Reduction of animal-based testing.

Sec. 31. Safer alternatives and green chemistry and engineering.

Sec. 32. Cooperation with international efforts.

Sec. 33. Reliable information and advice.

Sec. 34. Hot spots.

Sec. 35. Application of this Act to Federal agencies.

Sec. 36. Implementation of Stockholm Convention, the LRTAP Pops Protocol, and the Rotterdam Convention.

Sec. 37. Annual report.

Sec. 38. Authorization of appropriations.

.

December 27, 2012

Reported with amendments