S 847 ISCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

S. 847CommentsClose CommentsPermalink

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

IN THE SENATE OF THE UNITED STATESCommentsClose CommentsPermalink

April 14, 2011CommentsClose CommentsPermalink

Mr. LAUTENBERG (for himself, Ms. KLOBUCHAR, Mr. SCHUMER, Mrs. BOXER, and Mr. FRANKEN) introduced the following bill; which was read twice and referred to the Committee on Environment and Public WorksCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

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

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Safe Chemicals Act of 2011’.CommentsClose CommentsPermalink

SEC. 2. PURPOSES.

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

SEC. 3. FINDINGS, POLICY, AND GOAL.

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





(1) in the heading, by striking ‘intent’ and inserting ‘goal’; andCommentsClose CommentsPermalink





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





‘(a) Findings- Congress finds that--CommentsClose CommentsPermalink





‘(1) each year human beings and the environment are exposed to a large number of chemical substances;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(4) the incidence of some diseases and disorders linked to chemical substance exposures is on the rise;CommentsClose CommentsPermalink





‘(5) biomonitoring of chemical substances in humans reveals that people in the United States carry hundreds of hazardous chemicals in their bodies;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(8) manufacturers and processors of chemicals should supply sufficient health and environmental information before distributing products in commerce;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Policy- It is the policy of the United States--CommentsClose CommentsPermalink





‘(1) to protect the health of children, workers, consumers, and the public, and to protect the environment from harmful exposures to chemical substances;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(3) to require that chemicals in commerce meet a risk-based safety standard that protects vulnerable and affected populations and the environment;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(5) to improve the quality of information on chemical safety and use;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(7) to strengthen cooperation between and among the Federal Government and State, municipal, tribal, and foreign governments.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) reviewing all chemical substances for safety and identifying the highest priority chemical substances for expedited review;CommentsClose CommentsPermalink





‘(2) determining whether chemical substances in commerce meet the safety standard under this title;CommentsClose CommentsPermalink





‘(3) applying appropriate restrictions to the use of a chemical substance, where warranted; andCommentsClose CommentsPermalink





‘(4) encouraging the replacement of harmful chemicals and processes with safer alternatives.’.CommentsClose CommentsPermalink

SEC. 4. DEFINITIONS.

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





(1) by striking paragraph (12);CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(3) by inserting after paragraph (1) the following:CommentsClose CommentsPermalink





‘(2) AGGREGATE EXPOSURE-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Subject to subparagraph (B), the term ‘aggregate exposure’ means exposure from all sources of a chemical substance, including exposure from--CommentsClose CommentsPermalink





‘(i) the manufacture, processing, distribution, use, and disposal of that chemical substance; andCommentsClose CommentsPermalink





‘(ii) all other sources of that chemical substance, including--CommentsClose CommentsPermalink





‘(I) contamination of food, air, water, soil, and house dust from current or prior uses or activity;CommentsClose CommentsPermalink





‘(II) accidental releases;CommentsClose CommentsPermalink





‘(III) permitted sources of pollution;CommentsClose CommentsPermalink





‘(IV) nonpoint sources of pollution;CommentsClose CommentsPermalink





‘(V) documented background levels from natural and anthropogenic sources; andCommentsClose CommentsPermalink





‘(VI) a mixture or article containing that chemical substance.CommentsClose CommentsPermalink





‘(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)).CommentsClose CommentsPermalink





‘(3) BIOACCUMULATIVE-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) CHEMICAL IDENTITY- The term ‘chemical identity’ includes--CommentsClose CommentsPermalink





‘(A) each common and trade name of a chemical substance;CommentsClose CommentsPermalink





‘(B) the name of a chemical substance appearing in International Union of Pure and Applied Chemistry nomenclature and the most current Collective Index format;CommentsClose CommentsPermalink





‘(C) each Chemical Abstracts Service registration number of a chemical substance; andCommentsClose CommentsPermalink





‘(D) the molecular structure of a chemical substance.’;CommentsClose CommentsPermalink





(4) in paragraph (5) (as redesignated by paragraph (2))--CommentsClose CommentsPermalink





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





‘(5) CHEMICAL SUBSTANCE-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Except as provided in subparagraphs (B) and (C)’;CommentsClose CommentsPermalink





(B) in subparagraph (B), by striking ‘(B) Such term’ and inserting the following:CommentsClose CommentsPermalink





‘(B) EXCLUSIONS- The term ‘chemical substance’; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(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).’;CommentsClose CommentsPermalink





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





‘(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.’;CommentsClose CommentsPermalink





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





‘(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--CommentsClose CommentsPermalink





‘(A) to sell, or the sale of, the substance, mixture, or article in commerce;CommentsClose CommentsPermalink





‘(B) to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article;CommentsClose CommentsPermalink





‘(C) to hold, or the holding of, the substance, mixture, or article after its introduction into commerce; orCommentsClose CommentsPermalink





‘(D) to export or offer for export the substance, mixture, or article.’;CommentsClose CommentsPermalink





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





‘(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).’;CommentsClose CommentsPermalink





(8) in paragraph (10) (as redesignated by paragraph (2)), by inserting ‘ambient and indoor’ after ‘includes water,’;CommentsClose CommentsPermalink





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





‘(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.’;CommentsClose CommentsPermalink





(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)’;CommentsClose CommentsPermalink





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





‘(16) PERSISTENT-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(17) PERSON-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) INCLUSIONS- The term ‘person’ includes each Federal agency and any officer, agent, or employee of a Federal agency.’;CommentsClose CommentsPermalink





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





‘(20) SPECIAL SUBSTANCE CHARACTERISTIC-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) CONSIDERATIONS- In determining the existence of special substance characteristics, the Administrator may consider--CommentsClose CommentsPermalink





‘(i) size or size distribution;CommentsClose CommentsPermalink





‘(ii) shape and surface structure;CommentsClose CommentsPermalink





‘(iii) reactivity; andCommentsClose CommentsPermalink





‘(iv) any other properties that may significantly affect the risks posed.’;CommentsClose CommentsPermalink





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





‘(22) TOXIC- The term ‘toxic’, with respect to a chemical substance or mixture, means that the chemical substance or mixture has a toxicological property--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(B) that causes an adverse effect that has been demonstrated in humans or other exposed organisms; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) mortality;CommentsClose CommentsPermalink





‘(B) morbidity, including carcinogenesis;CommentsClose CommentsPermalink





‘(C) reproduction;CommentsClose CommentsPermalink





‘(D) growth and development;CommentsClose CommentsPermalink





‘(E) the immune system;CommentsClose CommentsPermalink





‘(F) the endocrine system;CommentsClose CommentsPermalink





‘(G) the brain or nervous system;CommentsClose CommentsPermalink





‘(H) other organ systems; orCommentsClose CommentsPermalink





‘(I) any other biological functions in humans or nonhuman organisms.’; andCommentsClose CommentsPermalink





(14) by adding at the end the following:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) infants, children, and adolescents;CommentsClose CommentsPermalink





‘(B) pregnant women;CommentsClose CommentsPermalink





‘(C) elderly;CommentsClose CommentsPermalink





‘(D) individuals with preexisting medical conditions;CommentsClose CommentsPermalink





‘(E) workers that work with chemical substances and mixtures; andCommentsClose CommentsPermalink





‘(F) members of any other appropriate population identified by the Administrator.’.CommentsClose CommentsPermalink

SEC. 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:CommentsClose CommentsPermalink

‘SEC. 4. MINIMUM DATA SETS AND TESTING OF CHEMICAL SUBSTANCES.

‘(a) Minimum Data Sets-CommentsClose CommentsPermalink





‘(1) MINIMUM DATA SETS RULES-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) REQUIREMENTS- Any rule promulgated under subparagraph (A) shall--CommentsClose CommentsPermalink





‘(i) provide for varied or tiered data to be provided for different chemical substances or categories of chemical substances;CommentsClose CommentsPermalink





‘(ii) identify the particular minimum data set that applies to a chemical substance or category of chemical substances;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





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





‘(B) for existing chemical substances, on the earlier of--CommentsClose CommentsPermalink





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





‘(ii) 5 years after the date of enactment of the Safe Chemicals Act of 2011.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(b) Testing-CommentsClose CommentsPermalink





‘(1) GENERAL SUBMISSIONS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) EFFECT ON OTHER AUTHORITY- Nothing in this paragraph limits the authority of the Administrator under paragraph (2).CommentsClose CommentsPermalink





‘(2) SAMPLE SUBMISSIONS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) EFFECT ON OTHER AUTHORITY- Nothing in this paragraph limits the authority of the Administrator under paragraph (1).CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(c) Test Rules or Orders-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A rule or order issued under subsection (b) shall include--CommentsClose CommentsPermalink





‘(A) identification of the chemical substance for which testing is required under the rule or order;CommentsClose CommentsPermalink





‘(B) standards for the development of test data for that substance; andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(2) CONSIDERATIONS-CommentsClose CommentsPermalink





‘(A) IN GENERAL- In determining the standards and period to be required under subparagraphs (B) and (C) of paragraph (1), the Administrator shall consider--CommentsClose CommentsPermalink





‘(i) the relative costs of the various test protocols and methodologies that may be required under the rule or order; andCommentsClose CommentsPermalink





‘(ii) the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(3) TYPES OF HEALTH AND ENVIRONMENTAL INFORMATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Administrator may prescribe standards for the development of test data under this subsection for health and environmental information, including--CommentsClose CommentsPermalink





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





‘(ii) information pertaining to exposure to the chemical substance, including information regarding the presence of the chemical substance in human blood, fluids, or tissue; andCommentsClose CommentsPermalink





‘(iii) information pertaining to--CommentsClose CommentsPermalink





‘(I) bioaccumulation;CommentsClose CommentsPermalink





‘(II) persistence;CommentsClose CommentsPermalink





‘(III) acute toxicity;CommentsClose CommentsPermalink





‘(IV) subacute toxicity;CommentsClose CommentsPermalink





‘(V) chronic toxicity; andCommentsClose CommentsPermalink





‘(VI) any other characteristic that may present an adverse effect.CommentsClose CommentsPermalink





‘(B) METHODOLOGIES-CommentsClose CommentsPermalink





‘(i) IN GENERAL- The Administrator may prescribe methodologies in standards for the development of test data, including--CommentsClose CommentsPermalink





‘(I) epidemiologic studies;CommentsClose CommentsPermalink





‘(II) biomonitoring studies;CommentsClose CommentsPermalink





‘(III) serial or hierarchical tests;CommentsClose CommentsPermalink





‘(IV) in vitro tests; andCommentsClose CommentsPermalink





‘(V) whole animal tests, consistent with section 30.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(C) REVIEW- Periodically, but not less frequently than once every 3 years, the Administrator shall--CommentsClose CommentsPermalink





‘(i) review the adequacy of the standards for development of data prescribed under subparagraph (A); andCommentsClose CommentsPermalink





‘(ii) if necessary, institute proceedings to make appropriate revisions of those standards.CommentsClose CommentsPermalink





‘(4) PERSONS REQUIRED TO CONDUCT TESTS AND SUBMIT DATA-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(C) LIABILITY- All persons described in subparagraphs (A) and (B) shall remain liable for compliance with any requirements subject to the designation.CommentsClose CommentsPermalink





‘(5) EXPIRATION OF RULES AND ORDERS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(d) Exemptions-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the chemical substance for which the application was submitted is equivalent to a chemical substance for which--CommentsClose CommentsPermalink





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





‘(ii) data is being developed in accordance with the rule or order; andCommentsClose CommentsPermalink





‘(B) submission of data by the applicant for the substance would be duplicative of data that--CommentsClose CommentsPermalink





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





‘(ii) is being developed in accordance with the rule or order.CommentsClose CommentsPermalink





‘(3) REIMBURSEMENT DUE TO EXEMPTION-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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); andCommentsClose CommentsPermalink





‘(ii) ends on the later of--CommentsClose CommentsPermalink





‘(I) 5 years after the date referred to in clause (i); orCommentsClose CommentsPermalink





‘(II) the date which, as determined by the Administrator, provides the applicant with a time period which is sufficient to develop the test data.CommentsClose CommentsPermalink





‘(B) REIMBURSEMENT FOR PREVIOUSLY SUBMITTED TEST DATA-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I) the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(C) REIMBURSEMENT DUE TO EXEMPTION FOR TEST DATA BEING DEVELOPED IN ACCORDANCE WITH A RULE OR ORDER-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I) after providing written notice and an opportunity for a hearing to the person who holds the exemption, by order, terminate the exemption; andCommentsClose CommentsPermalink





‘(II) notify in writing the person of the requirements of the rule or order with respect to which the exemption was granted.CommentsClose CommentsPermalink





‘(e) Notice-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) REQUIREMENTS- Subject to section 14, each notice shall--CommentsClose CommentsPermalink





‘(A) identify the chemical substance for which data have been received;CommentsClose CommentsPermalink





‘(B) list--CommentsClose CommentsPermalink





‘(i) the commercial and consumer uses or intended commercial and consumer uses of the substance known to the Administrator; andCommentsClose CommentsPermalink





‘(ii) the information required by the applicable standards for the development of test data; andCommentsClose CommentsPermalink





‘(C) describe the nature of the test data developed.CommentsClose CommentsPermalink





‘(3) AVAILABILITY- Subject to section 14, the Administrator shall make the test data described in this subsection available on a publicly accessible Internet site.CommentsClose CommentsPermalink





‘(f) Requests From Other Agencies for Additional Information or Testing-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; butCommentsClose CommentsPermalink





‘(B) the requested information is not available to that agency.CommentsClose CommentsPermalink





‘(2) DUTY OF ADMINISTRATOR- Not later than 60 days after the date of receipt of a request under paragraph (1), the Administrator shall--CommentsClose CommentsPermalink





‘(A) subject to section 14, make the data available to the requesting agency;CommentsClose CommentsPermalink





‘(B) issue a request under section 8(f) to require--CommentsClose CommentsPermalink





‘(i) the submission of existing pertinent data to the Administrator; andCommentsClose CommentsPermalink





‘(ii) a copy of any such submission to be furnished to the requesting agency;CommentsClose CommentsPermalink





‘(C) issue a rule or order under subsection (b)--CommentsClose CommentsPermalink





‘(i) to develop the data; andCommentsClose CommentsPermalink





‘(ii) to require the developed data to be furnished to the requesting agency; orCommentsClose CommentsPermalink





‘(D) publish in the Federal Register the reason for which none of the actions described in this paragraph were taken.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) is accurate and reliable; andCommentsClose CommentsPermalink





‘(2) includes all material facts known to, in the possession or control of, or reasonably ascertainable by, the manufacturer or processor.’.CommentsClose CommentsPermalink

SEC. 6. MANUFACTURING AND PROCESSING NOTICES.

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

‘SEC. 5. MANUFACTURING AND PROCESSING NOTICES.

‘(a) New Chemical Substances and New Uses of Chemical Substances-CommentsClose CommentsPermalink





‘(1) NEW CHEMICAL SUBSTANCES- Except as provided in subsection (d), no person may manufacture or process a new chemical substance unless--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(B) the person complies with subsection (b); andCommentsClose CommentsPermalink





‘(C) the Administrator finds that--CommentsClose CommentsPermalink





‘(i) the manufacturers and processors have established that the chemical substance meets the safety standard under section 6(b); orCommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I)(aa) manufactured in a volume of more than 1,000,000 pounds annually; orCommentsClose CommentsPermalink





‘(bb) released into the environment in a volume of more than 100,000 pounds annually;CommentsClose CommentsPermalink





‘(II) a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor;CommentsClose CommentsPermalink





‘(III) persistent and bioaccumulative;CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) NEW USES OF EXISTING CHEMICAL SUBSTANCES PRIOR TO SAFETY STANDARD DETERMINATION-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2011; orCommentsClose CommentsPermalink





‘(ii) at a volume that is significantly increased from the volume as of the date of enactment of the Safe Chemicals Act of 2011.CommentsClose CommentsPermalink





‘(B) EXCEPTION- A person may manufacture or process a chemical substance in a manner prohibited by subparagraph (A), if the person--CommentsClose CommentsPermalink





‘(i) submits to the Administrator a new or updated declaration under section 8(a); andCommentsClose CommentsPermalink





‘(ii) complies with subsection (b).CommentsClose CommentsPermalink





‘(3) NEW USES OF EXISTING CHEMICAL SUBSTANCES THAT MEET THE SAFETY STANDARD-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) the manufacturer or processor submits to the Administrator--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(II) all updates to the minimum data set relevant to the new use, new production volume, or other new manner of manufacturing or processing;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) SAFETY STANDARD DETERMINATION-CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(6) CHEMICAL SUBSTANCES EXHIBITING SPECIAL SUBSTANCE CHARACTERISTICS-CommentsClose CommentsPermalink





‘(A) DETERMINATION- The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting 1 or more special substance characteristics--CommentsClose CommentsPermalink





‘(i) is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics; orCommentsClose CommentsPermalink





‘(ii) is a new chemical substance.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Submission of Data-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) under subsection (a), a notice prior to beginning the manufacture or processing of a chemical substance; andCommentsClose CommentsPermalink





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





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





‘(c) Content and Availability of Notice-CommentsClose CommentsPermalink





‘(1) CONTENT- Notice under subsection (a)(1) shall include--CommentsClose CommentsPermalink





‘(A) the declaration described in section 8(a)(2);CommentsClose CommentsPermalink





‘(B) the minimum data set described in section 4(a); andCommentsClose CommentsPermalink





‘(C) a statement that the chemical substance will meet the applicable safety standard.CommentsClose CommentsPermalink





‘(2) AVAILABILITY- Subject to section 14, the Administrator shall make the notice under paragraph (1) available on a publicly accessible Internet site.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) identifies the chemical substance for which notice or data has been received;CommentsClose CommentsPermalink





‘(B) lists the uses or intended uses of the chemical substance;CommentsClose CommentsPermalink





‘(C) in the case of the receipt of data under subsection (b), describes--CommentsClose CommentsPermalink





‘(i) the nature of the tests performed with respect to the chemical substance; andCommentsClose CommentsPermalink





‘(ii) any data that were received under subsection (b) or a rule or order under section 4; andCommentsClose CommentsPermalink





‘(D) references the availability of the minimum data set.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(d) Exemptions-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(B) under such restrictions as the Administrator considers appropriate.CommentsClose CommentsPermalink





‘(2) EQUIVALENT CHEMICAL SUBSTANCES-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) EFFECTIVE DATE- No exemption under this paragraph may take effect before the beginning of the reimbursement period applicable to the data.CommentsClose CommentsPermalink





‘(C) FAIR AND EQUITABLE REIMBURSEMENT-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(II) ends on the later of--CommentsClose CommentsPermalink

‘(aa) the date that is 5 years after the date referred to in subclause (I); orCommentsClose CommentsPermalink

‘(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.CommentsClose CommentsPermalink

‘(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)--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I) the effect on the competitive position of the person required to provide reimbursement in relation to the persons to be reimbursed; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) SMALL QUANTITIES-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) scientific experimentation or analysis; orCommentsClose CommentsPermalink





‘(ii) chemical research on, or analysis of, the substance or another substance, including research or analysis for the development of a product.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) TEMPORARY EXISTENCE- The Administrator may, upon application, exempt from subsections (a) and (b) the manufacturing or processing of any chemical substance--CommentsClose CommentsPermalink





‘(A) that exists temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance; andCommentsClose CommentsPermalink





‘(B) to which there is no, and will not be, any human or environmental exposure.CommentsClose CommentsPermalink





‘(5) PUBLICATION-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) REQUIREMENTS- The Administrator shall--CommentsClose CommentsPermalink





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





‘(ii) not later than 45 days after the date of receipt of an application, approve or deny the application; andCommentsClose CommentsPermalink





‘(iii) publish in the Federal Register notice of the approval or denial of the application.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) is accurate and reliable; andCommentsClose CommentsPermalink





‘(2) includes all material facts known to, in the possession or control of, or reasonably ascertainable by, the manufacturer or processor.CommentsClose CommentsPermalink





‘(f) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) MANUFACTURE AND PROCESS- The terms ‘manufacture’ and ‘process’ mean to manufacture or process, respectively, for commercial purposes.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

SEC. 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:CommentsClose CommentsPermalink

‘SEC. 6. PRIORITIZATION, SAFETY STANDARD DETERMINATION, AND RISK MANAGEMENT.

‘(a) Prioritization of Chemical Substances-CommentsClose CommentsPermalink





‘(1) PRIORITIZATION LIST-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Subject to subparagraph (B), the Administrator shall, by order, develop and publish a list that--CommentsClose CommentsPermalink





‘(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); andCommentsClose CommentsPermalink





‘(ii) identifies the priority class to which each listed chemical substance or category of chemical substance has been assigned by the Administrator.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(2) CHEMICAL SUBSTANCES REQUIRING IMMEDIATE RISK MANAGEMENT (PRIORITY CLASS 1)-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(D) RISK MANAGEMENT-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) RESIDUAL RISK ASSESSMENT- Not later than 1 year after the effective date of any conditions established under clause (i), the Administrator shall--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





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





‘(E) UPDATES-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(3) CHEMICAL SUBSTANCES REQUIRING SAFETY STANDARD DETERMINATIONS (PRIORITY CLASS 2)-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) ASSIGNMENT TO PRIORITY CLASS 2-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) CONDITIONS- The Administrator shall assign chemical substances to priority class 2 subject to the conditions that--CommentsClose CommentsPermalink





‘(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); andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(4) CHEMICAL SUBSTANCES REQUIRING NO IMMEDIATE ACTION (PRIORITY CLASS 3)-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(5) INTERAGENCY PRIORITIZATION AND TESTING COMMITTEE-CommentsClose CommentsPermalink





‘(A) ESTABLISHMENT- There is established an interagency committee (referred to in this section as the ‘committee’) to make recommendations to the Administrator concerning--CommentsClose CommentsPermalink





‘(i) the issuance of test rules or orders for chemical substances and mixtures under section 4(c); andCommentsClose CommentsPermalink





‘(ii) the prioritization of chemical substances under this subsection.CommentsClose CommentsPermalink





‘(B) RECOMMENDATIONS-CommentsClose CommentsPermalink





‘(i) FACTORS- In making a recommendation concerning--CommentsClose CommentsPermalink





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





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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); orCommentsClose CommentsPermalink





‘(II) the recommendations of the committee that particular chemical substances, or categories of chemical substances, be prioritized under this subsection.CommentsClose CommentsPermalink





‘(iii) ADDITIONS OR REVISIONS-CommentsClose CommentsPermalink





‘(I) IN GENERAL- Not less frequently than once every year, the committee shall--CommentsClose CommentsPermalink

‘(aa) make such additions or revisions to the recommendations of the committee as the committee determines to be necessary; andCommentsClose CommentsPermalink

‘(bb) submit to the Administrator the recommendations and a statement of the reasons of the committee for any additions or revisions.CommentsClose CommentsPermalink

‘(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.CommentsClose CommentsPermalink





‘(III) COMMENTS- The Administrator shall--CommentsClose CommentsPermalink

‘(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;CommentsClose CommentsPermalink

‘(bb) consider any comments received under item (aa); andCommentsClose CommentsPermalink

‘(cc) make any comments received under item (aa) available to the public.CommentsClose CommentsPermalink

‘(C) COMPOSITION- The committee shall consist of the following 8 members:CommentsClose CommentsPermalink





‘(i) One member appointed by the Administrator from among officers or employees of the Environmental Protection Agency.CommentsClose CommentsPermalink





‘(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.).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(iv) One member appointed by the Director of the National Institute for Occupational Safety and Health from among officers or employees of the Institute.CommentsClose CommentsPermalink





‘(v) One member appointed by the Director of the National Institute of Environmental Health Sciences from among officers or employees of the Institute.CommentsClose CommentsPermalink





‘(vi) One member appointed by the Director of the National Cancer Institute from among officers or employees of the Institute.CommentsClose CommentsPermalink





‘(vii) One member appointed by the Director of the National Science Foundation from among officers or employees of the Foundation.CommentsClose CommentsPermalink





‘(viii) One member appointed by the Secretary of Commerce from among officers or employees of the Department of Commerce.CommentsClose CommentsPermalink





‘(D) APPOINTMENT OF MEMBERS-CommentsClose CommentsPermalink





‘(i) DESIGNEES-CommentsClose CommentsPermalink





‘(I) IN GENERAL- An appointed member may designate an individual to serve on the committee on behalf of the member.CommentsClose CommentsPermalink





‘(II) PREREQUISITES- A designation may be made only--CommentsClose CommentsPermalink

‘(aa) with the approval of the applicable appointing authority; andCommentsClose CommentsPermalink

‘(bb) if the individual is an officer or employee of the entity from which the member was appointed.CommentsClose CommentsPermalink

‘(ii) TERMS-CommentsClose CommentsPermalink





‘(I) IN GENERAL- No individual may serve as a member of the committee for more than an aggregate period of 4 years.CommentsClose CommentsPermalink





‘(II) MEMBERS LEAVING APPOINTING ENTITIES- If any member of the committee leaves the entity from which the member was appointed--CommentsClose CommentsPermalink

‘(aa) the member may not continue as a member of the committee; andCommentsClose CommentsPermalink

‘(bb) the position of the member shall be considered vacant.CommentsClose CommentsPermalink

‘(III) VACANCIES- A vacancy on the committee shall be filled in the same manner in which the original appointment was made.CommentsClose CommentsPermalink





‘(E) CONFLICTS OF INTEREST-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(6) NO JUDICIAL REVIEW- The following actions shall not be subject to judicial review:CommentsClose CommentsPermalink





‘(A) The assignment of a particular chemical substance under this subsection.CommentsClose CommentsPermalink





‘(B) A determination by the Administrator of whether a particular assignment under this subsection is warranted.CommentsClose CommentsPermalink





‘(C) A response to a petition to include a particular chemical substance on the list under this subsection.CommentsClose CommentsPermalink





‘(D) The issuance of a recommendation to list a chemical substance under this subsection.CommentsClose CommentsPermalink





‘(b) Safety Standard Determinations for Chemical Substances-CommentsClose CommentsPermalink





‘(1) IN GENERAL-CommentsClose CommentsPermalink





‘(A) APPLICATION- This paragraph applies to the determination, or redetermination, of whether a chemical substance meets the applicable safety standard of this title.CommentsClose CommentsPermalink





‘(B) BURDEN OF PROOF-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) DUTIES- Under this title, it shall be the duty of--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(II) the Administrator to determine whether the chemical substance meets the applicable safety standard.CommentsClose CommentsPermalink





‘(C) ASSESSMENT OF RISK-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) SAFETY STANDARD-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(II) CONSIDERATIONS- In making a safety standard determination under this title, for each chemical substance, the Administrator shall--CommentsClose CommentsPermalink

‘(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; andCommentsClose CommentsPermalink

‘(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.CommentsClose CommentsPermalink

‘(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.CommentsClose CommentsPermalink





‘(iv) METHODOLOGY-CommentsClose CommentsPermalink





‘(I) IN GENERAL- Subject to subclause (II), the Administrator shall use the best available science when conducting an assessment described in clause (i).CommentsClose CommentsPermalink





‘(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’.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





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





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) DUTIES-CommentsClose CommentsPermalink





‘(A) MANUFACTURER AND PROCESSOR DUTIES-CommentsClose CommentsPermalink





‘(i) INITIAL SAFETY STANDARD DETERMINATION SUBMISSION-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink

‘(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);CommentsClose CommentsPermalink

‘(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; andCommentsClose CommentsPermalink

‘(cc) indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified uses, meets the safety standard.CommentsClose CommentsPermalink

‘(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.CommentsClose CommentsPermalink





‘(III) LIABILITY- All manufacturers and processors described in subclause (II) shall remain liable for compliance with any requirements subject to the designation.CommentsClose CommentsPermalink





‘(ii) RENEWAL OF SAFETY STANDARD DETERMINATION SUBMISSION-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink

‘(aa) submit to the Administrator an updated minimum data set for the chemical substance, as established under section 4(a); andCommentsClose CommentsPermalink

‘(bb) indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified use meets the safety standard.CommentsClose CommentsPermalink

‘(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.CommentsClose CommentsPermalink





‘(III) LIABILITY- All manufacturers and processors described in subclause (II) shall remain liable for compliance with any requirements subject to the designation.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(B) ADMINISTRATOR DUTIES-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) USES AND CONDITIONS- If the Administrator determines that the chemical substance meets the safety standard, the Administrator shall specify in the order--CommentsClose CommentsPermalink





‘(I) the allowed uses of the substance, which shall be limited to the uses evaluated in the determination; andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I) if new information raises a credible question as to whether the chemical substance continues to meet the safety standard;CommentsClose CommentsPermalink





‘(II) on the receipt of a renewal submission under subparagraph (A)(ii); orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(iv) PETITION FOR REDETERMINATION-CommentsClose CommentsPermalink





‘(I) IN GENERAL- Any person may petition the Administrator for a redetermination of whether a chemical substance continues to meet the applicable safety standard.CommentsClose CommentsPermalink





‘(II) BASIS- The person shall include in the petition a description of the basis for requesting the redetermination.CommentsClose CommentsPermalink





‘(III) ACTION BY ADMINISTRATOR- On receipt of the petition, the Administrator shall--CommentsClose CommentsPermalink

‘(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;CommentsClose CommentsPermalink

‘(bb) make the petition available on request;CommentsClose CommentsPermalink

‘(cc) provide a reasonable opportunity for public review and comment on the petition and give due consideration to any comments received;CommentsClose CommentsPermalink

‘(dd) decide whether to make the requested redetermination; andCommentsClose CommentsPermalink

‘(ee) not later than 180 days after the date of receipt, publish in the Federal Register the decision and the basis for the decision.CommentsClose CommentsPermalink

‘(3) RISK REDUCTION-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) a requirement limiting the quantity of the substance that may be manufactured, processed, or distributed in commerce;CommentsClose CommentsPermalink





‘(2) a requirement--CommentsClose CommentsPermalink





‘(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); orCommentsClose CommentsPermalink





‘(B) limiting the quantity of the substance that may be manufactured, processed, or distributed in commerce for--CommentsClose CommentsPermalink





‘(i) a particular use; orCommentsClose CommentsPermalink





‘(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);CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(4) a requirement that manufacturers and processors of the substance--CommentsClose CommentsPermalink





‘(A) make and retain records of the processes used to manufacture or process the substance; andCommentsClose CommentsPermalink





‘(B) monitor or conduct tests that are reasonable and necessary to ensure compliance with this Act;CommentsClose CommentsPermalink





‘(5) a requirement prohibiting or otherwise regulating any manner or method of commercial use of the substance;CommentsClose CommentsPermalink





‘(6) a requirement prohibiting or otherwise regulating any manner or method of disposal of the substance by--CommentsClose CommentsPermalink





‘(A) the manufacturer or processor of the substance; orCommentsClose CommentsPermalink





‘(B) any other person that uses, or disposes of, the substance for commercial purposes; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(d) Quality Control Orders-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) ORDERS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) to give notice of the endangerment to--CommentsClose CommentsPermalink





‘(I) processors or distributors (or both) in commerce of the substance; andCommentsClose CommentsPermalink





‘(II) to the extent reasonably ascertainable, any other person in possession of or exposed to the substance;CommentsClose CommentsPermalink





‘(ii) to give public notice of the endangerment; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(e) Exemptions to Restrictions-CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(2) EXEMPTIONS-CommentsClose CommentsPermalink





‘(A) IN GENERAL-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(B) CRITERIA- The Administrator may grant an exemption for the use of a chemical substance under subparagraph (A)(ii) if--CommentsClose CommentsPermalink





‘(i) the exemption is in the paramount interest of national security;CommentsClose CommentsPermalink





‘(ii) the lack of availability of the chemical substance would cause significant disruption in the national economy; orCommentsClose CommentsPermalink





‘(iii) the use for which the exemption is sought is a critical or essential use for which--CommentsClose CommentsPermalink





‘(I) no feasible safer alternative for the specified use of the chemical substance is available; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(C) PUBLIC NOTICE- If the Administrator grants an exemption for a chemical substance under this paragraph--CommentsClose CommentsPermalink





‘(i) the manufacturers and processors of the chemical substance shall, for the exempted use, provide notice of the exemption to each known purchaser of--CommentsClose CommentsPermalink





‘(I) the chemical substance; andCommentsClose CommentsPermalink





‘(II) a mixture or article containing the chemical substance; andCommentsClose CommentsPermalink





‘(ii) the Administrator shall provide the public with a notice of the exemption.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(E) CONDITIONS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) EXTENSIONS OF EFFECTIVE DATES FOR RETAIL SALE OF ARTICLES TO END CONSUMERS-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) is necessary and appropriate to allow for depletion of the existing retail inventory; andCommentsClose CommentsPermalink





‘(ii) will not present a substantial endangerment to human health or the environment.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(f) Polychlorinated Biphenyls-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Administrator shall act by order or rule consistent with paragraphs (2) and (3)--CommentsClose CommentsPermalink





‘(A) to prescribe methods for the disposal of polychlorinated biphenyls; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) MANUFACTURE, PROCESS, OR DISTRIBUTION IN TOTALLY ENCLOSED MANNER-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) PROHIBITION ON MANUFACTURE, PROCESS, OR DISTRIBUTION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Except as provided in subparagraphs (B), (C), and (D)--CommentsClose CommentsPermalink





‘(i) no person may manufacture any polychlorinated biphenyl; andCommentsClose CommentsPermalink





‘(ii) no person may process or distribute in commerce any polychlorinated biphenyl.CommentsClose CommentsPermalink





‘(B) EXEMPTIONS-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I) a substantial endangerment to human health or environment would not result; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) ADMINISTRATION- An exemption granted under this subparagraph shall be--CommentsClose CommentsPermalink





‘(I) subject to such terms and conditions as the Administrator may prescribe; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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 2 1/2 - year period beginning on the date of enactment of this Act.CommentsClose CommentsPermalink





‘(D) EXTENSION OF EXEMPTIONS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) NOTICE- The Administrator shall promptly publish in the Federal Register notice of the extension.CommentsClose CommentsPermalink





‘(g) Mercury-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) EXCEPTIONS- Paragraph (1) shall not apply to--CommentsClose CommentsPermalink





‘(A) a transfer between Federal agencies of elemental mercury for the sole purpose of facilitating storage of mercury to carry out this Act; orCommentsClose CommentsPermalink





‘(B) a conveyance, sale, distribution, or transfer of coal.CommentsClose CommentsPermalink





‘(3) LEASES OF FEDERAL COAL- Nothing in this subsection prohibits the leasing of coal.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) is accurate and reliable; andCommentsClose CommentsPermalink





‘(2) includes all material facts known to, in the possession or control of, or reasonably ascertainable by, the manufacturer or processor.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

SEC. 8. IMMINENT HAZARDS.

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

‘SEC. 7. IMMINENT HAZARDS.

‘(a) Actions Authorized and Required-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Administrator may commence a civil action in an appropriate district court of the United States for--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(B) relief authorized under subsection (b) against any person that--CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(ii) contributes to an activity described in clause (i); orCommentsClose CommentsPermalink





‘(C) both seizure and relief described in subparagraphs (A) and (B), respectively.CommentsClose CommentsPermalink





‘(2) OTHER ACTIONS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) the requirements described in section 6(c); andCommentsClose CommentsPermalink





‘(ii) the relief authorized under subsection (b).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the existence of a rule or order under this Act; andCommentsClose CommentsPermalink





‘(B) the pendency of any administrative or judicial proceeding under this Act.CommentsClose CommentsPermalink





‘(b) Relief Authorized-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the issuance of a mandatory order imposing any of the requirements described in section 6(c); andCommentsClose CommentsPermalink





‘(B) in the case of purchasers of the substance, mixture, or article known to the defendant--CommentsClose CommentsPermalink





‘(i) notification to the purchasers of the risk associated with the substance, mixture, or article;CommentsClose CommentsPermalink





‘(ii) public notice of the risk;CommentsClose CommentsPermalink





‘(iii) recall;CommentsClose CommentsPermalink





‘(iv) the replacement or repurchase of the substance, mixture, or article; orCommentsClose CommentsPermalink





‘(v) any combination of the actions described in section 6(c) or in clauses (i) through (iv) of this subparagraph; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) SEIZURE AND CONDEMNATION-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) PROCEEDINGS- Proceedings in a civil action described in subparagraph (A) shall conform, to the maximum extent practicable, to proceedings in rem in admiralty.CommentsClose CommentsPermalink





‘(c) Venue and Consolidation-CommentsClose CommentsPermalink





‘(1) VENUE-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(E) SUBPOENAS- Subpoenas requiring attendance of witnesses in a civil action brought under subsection (a)(1) may be served in any judicial district.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink