S 3209 ISCommentsClose 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

April 15, 2010CommentsClose CommentsPermalink

Mr. LAUTENBERG introduced the following bill; which was read twice and referred to the Committee on Environment and Public WorksCommentsClose 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 2010’.CommentsClose CommentsPermalink

SEC. 2. PURPOSES.

It is the purpose of this Act 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) by striking ‘intent’ in the heading 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 and mixtures;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 the Toxic Substances Control Act, people and the environment in the United States are still exposed to thousands of chemicals whose safety has not been adequately reviewed and may harm health and the environment;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 exposures that occur 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 and mixtures;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 these other regulatory programs may be useful in understanding hazards and exposures of chemical substances and mixtures presented in the United States; andCommentsClose CommentsPermalink





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





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





‘(3) to require that all 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 which they manufacture, process, or import as a condition of allowing such companies to distribute such chemicals 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 they 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 such 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 all chemical substances in commerce meet the safety standard under this subchapter;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) in paragraph (2)--CommentsClose CommentsPermalink





(A) in subparagraph (A)--CommentsClose CommentsPermalink





(i) by striking ‘subparagraph (B)’ and inserting ‘subparagraphs (B) and (C)’;CommentsClose CommentsPermalink





(ii) in clause (i), by striking ‘and’ after ‘nature,’;CommentsClose CommentsPermalink





(iii) in clause (ii), by striking the period at the end and inserting ‘, and’; andCommentsClose CommentsPermalink





(iv) by adding at the end the following new clause:CommentsClose CommentsPermalink





‘(iii) any chemical substance contained in or formed into an article.’;CommentsClose CommentsPermalink





(B) by adding at the end the following new subparagraph:CommentsClose CommentsPermalink





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





(2) in paragraph (4)--CommentsClose CommentsPermalink





(A) by striking ‘or’ after ‘or article;’; andCommentsClose CommentsPermalink





(B) by inserting ‘; or to export or offer for export the substance, mixture, or article’ after ‘article after its introduction into commerce’;CommentsClose CommentsPermalink





(3) in paragraph (5), by inserting ‘ambient and indoor’ after ‘includes water,’;CommentsClose CommentsPermalink





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





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





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





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





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





(9) by adding at the end the following new paragraphs:CommentsClose CommentsPermalink





‘(14) ADVERSE EFFECT- The term ‘adverse effect’ means a biochemical change, anatomic change, functional impairment, or pathological lesion, or its known precursor, that--CommentsClose CommentsPermalink





‘(A) affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism;CommentsClose CommentsPermalink





‘(B) causes irreversible change in the homeostasis of an organism;CommentsClose CommentsPermalink





‘(C) increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; orCommentsClose CommentsPermalink





‘(D) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.CommentsClose CommentsPermalink





‘(15) AGGREGATE EXPOSURE- The term ‘aggregate exposure’ means all exposure to--CommentsClose CommentsPermalink





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





‘(B) all other sources of the chemical substance under subparagraph (A), 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; andCommentsClose CommentsPermalink





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





‘(C) any mixture containing the chemical substance under subparagraph (A).CommentsClose CommentsPermalink





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





‘(17) CHEMICAL IDENTITY- The term ‘chemical identity’ includes the following--CommentsClose CommentsPermalink





‘(A) with respect to a chemical substance, each common and trade name of the chemical substance;CommentsClose CommentsPermalink





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





‘(C) with respect to a chemical substance, each Chemical Abstracts Service registration number of the chemical substance;CommentsClose CommentsPermalink





‘(D) with respect to a chemical substance, the molecular structure of the chemical substance;CommentsClose CommentsPermalink





‘(E) with respect to a mixture, the chemical identities of the mixture’s component chemical substances; andCommentsClose CommentsPermalink





‘(F) with respect to a mixture, the proportions the mixture’s component chemical substances.CommentsClose CommentsPermalink





‘(18) CUMULATIVE EXPOSURE- The term ‘cumulative exposure’ means the sum of aggregate exposure to--CommentsClose CommentsPermalink





‘(A) each of the chemical substances that are known or suspected to contribute appreciably to the risk of an adverse effect; andCommentsClose CommentsPermalink





‘(B) mixtures containing chemical substances described under subparagraph (A).CommentsClose CommentsPermalink





‘(19) END CONSUMER- The term ‘end consumer’ means an individual or other entity that purchases and uses or consumes a chemical substance, mixture, or article.CommentsClose CommentsPermalink





‘(20) 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





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





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





‘(23) REASONABLE CERTAINTY OF NO HARM- The term ‘reasonable certainty of no harm’ means, in establishing whether a chemical substance or mixture meets the safety standard under this subchapter, that aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect on the general population or a vulnerable population.CommentsClose CommentsPermalink





‘(24) SPECIAL SUBSTANCE CHARACTERISTICS- The term ‘special substance characteristics’ means, such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider--CommentsClose CommentsPermalink





‘(A) size or size distribution;CommentsClose CommentsPermalink





‘(B) shape and surface structure;CommentsClose CommentsPermalink





‘(C) reactivity; andCommentsClose CommentsPermalink





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





‘(25) 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 such an adverse effect as described in clause (i) in laboratory studies or data for a chemical from the same chemical class that exhibits such an adverse effect) demonstrates the potential for an adverse effect in humans or other exposed organisms.CommentsClose CommentsPermalink





‘(26) 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.CommentsClose CommentsPermalink





‘(27) VULNERABLE POPULATION- The term ‘vulnerable population’ means a population that is subject to a disproportionate exposure to, or potential for a disproportionate adverse effect from exposure to, a chemical substance or mixture, including--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 substance and mixtures; andCommentsClose CommentsPermalink





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

SEC. 5. MINIMUM DATA SET AND TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.

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

‘SEC. 4. MINIMUM DATA SET AND TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.

‘(a) Minimum Data Set-CommentsClose CommentsPermalink





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





‘(2) SUBMISSION OF MINIMUM DATA SET- The manufacturers and processors of a chemical substance shall submit the minimum data set for the chemical substance to the Administrator by--CommentsClose CommentsPermalink





‘(A) 18 months after the date on which the Administrator places the chemical substance on the priority list; orCommentsClose CommentsPermalink





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





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





‘(b) Testing-CommentsClose CommentsPermalink





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





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





‘(3) PROHIBITION- The Administrator may, by order, prohibit a manufacturer or processor in violation of a rule or order under paragraph (1) from manufacturing, processing, or distributing in commerce the chemical substance or any mixture or article containing the chemical substance, except as authorized under section 6(e).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) A rule or order under subsection (b) shall include--CommentsClose CommentsPermalink





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





‘(B) standards for the development of test data for such substance or mixture; andCommentsClose CommentsPermalink





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





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





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





‘(A) IN GENERAL- The types of health and environmental information for which standards for the development of test data may be prescribed include--CommentsClose CommentsPermalink





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





‘(ii) information pertaining to exposure to the chemical substance or mixture, including information regarding the presence of the chemical or mixture in human blood, fluids, or tissue; 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 which 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 31.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 in rules under subsection (a); andCommentsClose CommentsPermalink





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





‘(3) 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 or mixture shall specify the persons required to conduct tests and submit data to the Administrator on the substance or mixture.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





‘(4) 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 with respect to a particular chemical substance or mixture shall expire at the end of the reimbursement period (as defined in subsection (d)(3)) that is applicable to test data with respect to the substance or mixture unless, prior to that date, the Administrator withdraws the rule or order.CommentsClose CommentsPermalink





‘(B) CATEGORY OF CHEMICAL SUBSTANCES OR MIXTURES- A rule or order under subsection (b) that requires the testing and submission of data with respect to a category of chemical substances or mixtures shall expire with respect to a chemical substance or mixture included in the category at the end of the reimbursement period (as defined in subsection (d)(3)) that is applicable to test data with respect to the substance or mixture unless, prior to that date, the Administrator withdraws the rule or order with respect the substance or mixture or in its entirety.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 with respect to a chemical substance or mixture may apply to the Administrator (in such form and manner as the Administrator shall prescribe) for an exemption from the requirement.CommentsClose CommentsPermalink





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





‘(A) the chemical substance or mixture with respect to which the application was submitted is equivalent to a chemical substance or mixture 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 with respect to the substance or mixture 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 FOR PREVIOUSLY SUBMITTED TEST DATA-CommentsClose CommentsPermalink





‘(A) DEFINITION OF REIMBURSEMENT PERIOD- In this paragraph, the term ‘reimbursement period’, with respect to any test data for a chemical substance or mixture, means a period--CommentsClose CommentsPermalink





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





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





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





‘(II) at the expiration of a period that--CommentsClose CommentsPermalink

‘(aa) begins on the date referred to in clause (i); andCommentsClose CommentsPermalink

‘(bb) is equal to the period that the Administrator determines was necessary to develop the test data.CommentsClose CommentsPermalink

‘(B) REIMBURSEMENT-CommentsClose CommentsPermalink





‘(i) IN GENERAL- Except as provided in clause (ii), if the exemption under paragraph (2) of any person from the requirement to conduct tests and submit test data with respect to a chemical substance or mixture is granted on the basis of the existence of previously submitted test data and the exemption is granted during the reimbursement period for the test data, the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator) to--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 requirement to submit the data; 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 or mixture, 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 or mixture of the person required to provide reimbursement in relation to the share of the market of the persons to be reimbursed.CommentsClose CommentsPermalink





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





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





‘(i) to each such person who is developing the test data, for a portion of the costs incurred by each person in complying with the rule or order; andCommentsClose CommentsPermalink





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





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





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





‘(D) 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 such person has complied with the rule or order, the Administrator shall--CommentsClose CommentsPermalink





‘(i) after providing written notice to the person who holds the exemption and an opportunity for a hearing, 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 or mixture with respect to which data have been received;CommentsClose CommentsPermalink





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





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





‘(3) AVAILABILITY- Subject to section 14, test data described in this subsection shall be made available on the internet by the Administrator.CommentsClose CommentsPermalink





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





‘(1) IN GENERAL- If another Federal agency determines that information relating to a chemical substance or mixture, including data derived from new testing or monitoring, would assist the agency in carrying out duties or exercising authority of the agency, but that information is not available to the agency, the agency may request the Administrator to seek the information on behalf of the requesting agency.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 rule or order under section 8(f) to require--CommentsClose CommentsPermalink





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





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





‘(D) publish in the Federal Register the reason for not taking any of the actions described in this paragraph.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 Mixtures and New Uses of Chemical Substances and Mixtures-CommentsClose CommentsPermalink





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





‘(A)(i) the person submits to the Administrator a notice, in accordance with subsection (c), of the intention of the person to manufacture or process the substance; andCommentsClose CommentsPermalink





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





‘(B) the Administrator--CommentsClose CommentsPermalink





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





‘(ii) finds that the new chemical substance, or a metabolite or degradation product of the chemical substance, as applicable, is not, and is not expected to be--CommentsClose CommentsPermalink





‘(I) manufactured in a volume of more than 1,000,000 pounds annually or released into the environment in a volume of more than 100,000 pounds annually;CommentsClose CommentsPermalink





‘(II) a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor, or has other toxicological properties of concern;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 or 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 or 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 DETERMINATION-CommentsClose CommentsPermalink





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





‘(i) for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2010;CommentsClose CommentsPermalink





‘(ii) at a significantly increased volume above the level on the date of enactment; orCommentsClose CommentsPermalink





‘(iii) if the person had not previously manufactured or processed the chemical substance on the date of enactment of the Safe Chemicals Act of 2010.CommentsClose CommentsPermalink





‘(B) HEADER NEEDED- The person--CommentsClose CommentsPermalink





‘(i) submits to the Administrator a new or updated declaration referred to in 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- With respect to an existing chemical substance for which the Administrator has determined under section 6(b) that the manufacturers and processors of the chemical substance have established that the substance meets the safety standard, no person may manufacture or process the chemical substance for a use, at a production volume, or in a manner other than those the Administrator specified in the safety determination, unless--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 the new use or at the new production volume, or in such other manner that is inconsistent with a specified condition or term for such substance; 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, allowed production volume, or other specified conditions or terms for such chemical substance are revised to encompass the new use or new production volume, or other new manner of manufacturing or processing; 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 or allowed production volume, or other specified conditions or terms for such substance, are revised to encompass the new use or new production volume or other new manner of manufacturing or processing.CommentsClose CommentsPermalink





‘(B) AMENDMENT TO SAFETY DETERMINATION- If the conditions described in clause (i) through (iii) of subparagraph (A) are satisfied, the Administrator shall, by order, amend the safety determination for the chemical substance to include the new use or new production volume among the allowed uses or production volumes of the chemical substance.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 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)(B)(ii).CommentsClose CommentsPermalink





‘(C) EXTENSION- The Administrator may extend the determination deadline under subparagraph (A) by 1 or more additional periods not to exceed 12 months in aggregate, by action in accordance with section 5(b) or section 6(b)(2)(A)(i)(I)(bb), or other means, as necessary to secure additional relevant data for the determination.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 paragraph (1)(B)(ii) 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 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 one 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 such 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 which the Administrator determines to be a separate use based on its special substance characteristics, the manufacturer or processor shall satisfy such further conditions as the Administrator establishes, by order or rule.CommentsClose CommentsPermalink





‘(b) Submission of Data-CommentsClose CommentsPermalink





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





‘(2) AVAILABILITY- Subject to section 14, test data submitted under paragraph (1) shall be made available on the internet by the Administrator.CommentsClose CommentsPermalink





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





‘(1) CONTENT OF NOTICE- The notice required by subsection (b)(1) shall include--CommentsClose CommentsPermalink





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





‘(B) the minimum data set, as defined in accordance with section 4(a); andCommentsClose CommentsPermalink





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





‘(2) AVAILABILITY- Subject to section 14, a notice described in paragraph (1) shall be made available on the internet by the Administrator.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 the internet 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 the internet 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 satisfactory to the Administrator that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substance, and that any combination of those activities, will not endanger the health or the environment; 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 any data otherwise required with respect to a chemical substance for which notice is submitted under subsection (a) if, on receipt of an application, the Administrator determines that--CommentsClose CommentsPermalink





‘(i) the chemical substance with respect to which the application was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by this chapter; 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 chapter.CommentsClose CommentsPermalink





‘(iii) EFFECTIVE DATE- No exemption granted under this subparagraph with respect to the submission of data for a chemical substance may take effect before the beginning of the reimbursement period applicable to the data.CommentsClose CommentsPermalink





‘(B) 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 a period--CommentsClose CommentsPermalink





‘(I) beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of the chemical substance by the person who submitted the data to the Administrator; andCommentsClose CommentsPermalink





‘(II) ending 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 beginning on the date referred to in subclause (I) that is equal in length to the period that the Administrator determines to be necessary to develop the data.CommentsClose CommentsPermalink

‘(ii) REIMBURSEMENT- Except as provided in clause (iii), if the Administrator exempts any person, under subparagraph (A), from submitting data required under subsection (a) or (b) for a chemical substance because of the existence of previously submitted data and the exemption is granted during the reimbursement period for that data, the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)--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 subchapter 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 Commissioners of 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 such substance or another substance, including such research or analysis for the development of a product.CommentsClose CommentsPermalink





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





‘(5) PUBLICATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- As soon as practicable after receipt of an application under paragraph (1) or (4), the Administrator shall publish in the Federal Register notice of the receipt of the application.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 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 mixture, or an article containing a chemical substance or mixture, 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) ESTABLISHMENT OF PRIORITY LIST- Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall by order develop and publish a priority list containing the names of not less than 300 chemical substances for which safety determinations under this section shall first be made. Chemical substances shall be selected to be on the list at the Administrator’s discretion, based on available scientific evidence, and consideration of their risk relative to other chemical substances, based upon presence in biological and environmental media, use, production volume, toxicity, persistence, bioaccumulation, or other properties indicating risk.CommentsClose CommentsPermalink





‘(2) UPDATING OF LIST- The Administrator shall--CommentsClose CommentsPermalink





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





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





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





‘(3) 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(b); andCommentsClose CommentsPermalink





‘(ii) the placement of chemical substances on the priority list 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(b), the committee shall consider all factors relevant to risk; andCommentsClose CommentsPermalink





‘(II) placement on the priority list under subsection (a), the committee shall consider the criteria identified pursuant to subsection (a)(1).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 groups 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(b); orCommentsClose CommentsPermalink





‘(II) the recommendations of the committee that particular chemical substances, or groups of chemical substances, be placed on the priority list.CommentsClose CommentsPermalink





‘(iii) ADDITIONS OR REVISIONS-CommentsClose CommentsPermalink





‘(I) IN GENERAL- At least once every year, the committee shall--CommentsClose CommentsPermalink

‘(aa) make such additions or revisions to the recommendations of the commission as the commission 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) consideration such comments; andCommentsClose CommentsPermalink

‘(cc) make the comments 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 officers or employees of the Environmental Protection Agency.CommentsClose CommentsPermalink





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





‘(iii) One member appointed by the Chairman of the Council on Environmental Quality from 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 officers or employees of the Institute.CommentsClose CommentsPermalink





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





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





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





‘(viii) One member appointed by the Secretary of Commerce from 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 from 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 4 years in the aggregate.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 to be 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 the member, shall accept employment or compensation from any person subject to any requirement of this chapter or of any rule promulgated or order issued under this chapter, for a period of at least 1 year after the date of termination of service on the committee.CommentsClose CommentsPermalink





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





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





‘(4) NO JUDICIAL REVIEW; NONDISCRETIONARY DUTY-CommentsClose CommentsPermalink





‘(A) NO JUDICIAL REVIEW- The following actions shall not be subject to judicial review, including when a prioritization decision or recommendation coincides with or is based on other decisions under this chapter that are subject to judicial review:CommentsClose CommentsPermalink





‘(i) A decision whether to place a particular chemical substance on the priority list pursuant to this subsection;CommentsClose CommentsPermalink





‘(ii) A response to a petition to place a particular chemical on the priority list; andCommentsClose CommentsPermalink





‘(iii) The issuance of a recommendation pursuant to paragraph (3).CommentsClose CommentsPermalink





‘(B) NONDISCRETIONARY DUTY- The failure of the Administrator to establish the priority list required in subparagraph (1), or to update the list as required by paragraph (2), shall be--CommentsClose CommentsPermalink





‘(i) considered to be a failure to perform a nondiscretionary duty; andCommentsClose CommentsPermalink





‘(ii) subject to judicial review.CommentsClose CommentsPermalink





‘(b) Safety 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 safety standards of this subchapter.CommentsClose CommentsPermalink





‘(B) BURDEN OF PROOF- Under this subchapter, it shall be the duty of--CommentsClose CommentsPermalink





‘(i) the manufacturers and processors of a chemical substance to, at all times, bear the burden of proving that the chemical substance meets the applicable safety standard; andCommentsClose CommentsPermalink





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





‘(C) ASSESSMENT OF RISK-CommentsClose CommentsPermalink





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





‘(ii) 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





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





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





‘(v) 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





‘(vi) 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 manufacturer or processor has met the burden of proof pursuant to subparagraph (B)(i), the Administrator shall take into account such risks as the chemical substance may pose in the United States, including risks involving long-range transport of the chemical substance in the environment and risks involving the import of articles and mixtures containing the chemical substance.CommentsClose CommentsPermalink





‘(vii) 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)(i).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 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 DETERMINATION SUBMISSION-CommentsClose CommentsPermalink





‘(I) IN GENERAL- By the earlier of the date that is 30 months after the date on which a chemical substance is placed on the priority list or the date that is 14 years after the date of enactment of the Safe Chemicals Act of 2010, the manufacturers and processors of a chemical substance shall--CommentsClose CommentsPermalink

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

‘(bb) submit to the Administrator, and develop by testing as necessary, all other information the Administrator may require, including information developed through testing or otherwise, in order to make a safety determination; 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 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 the minimum dataset 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, their employees and recognized bargaining agents of any employees who are represented by bargaining agents, and each known customer who has purchased the chemical substance within a reasonable timeframe as determined by the Administrator by rule or order, or mixture or article containing the chemical substance, a written notice that a determination by the Administrator of the safety of the chemical substance is pending.CommentsClose CommentsPermalink





‘(iv) FAILURE OF MANUFACTURER OR PROCESSOR TO MEET DUTIES- If a manufacturer or processor fails to meet duties under this subparagraph for a chemical substance, the Administrator may, by order, prohibit a manufacturer or processor, in violation of a duty under this subparagraph, from manufacturing, processing, or distributing in commerce the chemical substance, or any mixture or article containing the chemical substance, except as authorized under subsection (e).CommentsClose CommentsPermalink





‘(B) ADMINISTRATOR DUTIES-CommentsClose CommentsPermalink





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





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





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





‘(1) a requirement limiting the quantity of the substance, mixture, or article 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, mixture, or article for a particular use in a concentration in excess of a level specified by the Administrator in conditions under subsection (b)(2)(B)(ii)(II); orCommentsClose CommentsPermalink





‘(B) limiting the quantity of the substance, mixture, or article 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 section 6(b)(2)(B)(ii)(II);CommentsClose CommentsPermalink





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





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





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





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





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





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





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





‘(B) any other person that uses, or disposes of, the substance, mixture, or article 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 or mixture in a manner that may present a substantial endangerment to health or the environment, the Administrator may by order require the manufacturer or processor to submit a description of the quality control procedures followed in the manufacturing or processing of the chemical substance or mixture.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 or mixture from presenting a risk of injury, the Administrator may order the manufacturer or processor to revise the quality control procedures to the extent necessary to remedy the inadequacy.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 or mixture that may present a substantial endangerment to 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 or mixture; andCommentsClose CommentsPermalink





‘(II) to the extent reasonably ascertainable, any other person in possession of or exposed to the substance or mixture;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 or mixture as is necessary to adequately protect health or the environment.CommentsClose CommentsPermalink





‘(e) Exceptions to Restrictions-CommentsClose CommentsPermalink





‘(1) APPLICATION- This subsection applies to the restrictions established under sections 4(a)(3), 4(b)(3), 8(b)(6), 8(c)(3), and 29, and paragraphs (2)(A)(iv) and (3) of subsection (b).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--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 benefit to 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--CommentsClose CommentsPermalink





‘(I) each known purchaser of the chemical substance; andCommentsClose CommentsPermalink





‘(II) each known purchaser of 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 on the use of a chemical substance exempted under this paragraph.CommentsClose CommentsPermalink





‘(ii) COMPLIANCE- Effective immediately after the Administrator establishes conditions on exempted use under clause (i), the manufacturing, processing, or distribution in commerce of the chemical substance, or any mixture or article containing the chemical substance, shall be prohibited except to the extent that the conditions are satisfied.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, mixture, or article that is subject to a restriction described in paragraph (1), the Administrator may by order extend the effective date of the restriction by a period of not to exceed 3 years, if the Administrator determines that the extension--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 will ensure that any exposure of human beings or the environment to the polychlorinated biphenyl will be insignificant, as determined by the Administrator by order or rule.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 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 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 from the date it 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 -period beginning on October 11, 1976.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 of not to exceed 60 days for the purpose of authorizing the Secretary of Defense and the Secretaries of the military departments to provide for the transportation into the customs territory of the United States of polychlorinated biphenyls generated by or under the control of the Department of Defense for purposes of the disposal, treatment, or storage of the polychlorinated biphenyls in the customs territory of the United States if the polychlorinated biphenyls are already in transit from storage locations but the Administrator determines, in the sole discretion of the Administrator, the polychlorinated biphenyls would not otherwise arrive in the customs territory of the United States within the period of the original exemption.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 chapter; 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 date shall be as soon as feasible.’.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 (as authorized by subsection (b)) against any person that manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance or mixture, or any article containing a chemical substance or mixture, if the manufacture, processing, distribution in commerce, use, or disposal may present an imminent and substantial endangerment to health or the environment, or any person that contributes to the activities; 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 may be necessary to protect health or the environment from any manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance or mixture or any article containing such a substance or mixture that may present an imminent and substantial endangerment to health or the environment.CommentsClose CommentsPermalink





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





‘(3) RELATIONSHIP TO EXISTING RULES, ORDERS, AND PROCEEDINGS- A civil action may be commenced, under paragraph (1), or other action taken under paragraph (2), notwithstanding--CommentsClose CommentsPermalink





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





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





‘(b) Relief Authorized-CommentsClose CommentsPermalink





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





‘(2) TYPES OF RELIEF- In the case of an action under subsection (a)(1) brought against a person that manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance or mixture or an article containing a chemical substance or mixture, the relief authorized by paragraph (1) may include--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 clauses (i) through (iv) or section 6(c); orCommentsClose CommentsPermalink





‘(C) any other relief as may be necessary to protect health or the environment from the risk involved in the action.CommentsClose CommentsPermalink





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





‘(c) Venue and Consolidation-CommentsClose CommentsPermalink





‘(1) VENUE-CommentsClose CommentsPermalink





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





‘(D) MULTIPLE JUDICIAL DISTRICTS- In determining the judicial district in which an action may be brought under subsection (a)(1) in instances in which the action may be brought in more than 1 judicial district, the Administrator shall take into account the convenience of the parties.CommentsClose CommentsPermalink





‘(E) SUBPOENAS- Subpoenas requiring attendance of witnesses in an 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

SEC. 9. REPORTING AND RETENTION OF INFORMATION.

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

‘SEC. 8. REPORTING AND RETENTION OF INFORMATION.

‘(a) Substance Identification, Declaration, and Information-CommentsClose CommentsPermalink





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





‘(2) DECLARATION OF CURRENT MANUFACTURE OR PROCESSING- A declaration described in this paragraph is a statement that includes, for each chemical substance manufactured or processed by a manufacturer or processor--CommentsClose CommentsPermalink





‘(A) the chemical identity and any special substance characteristics of the chemical substance;CommentsClose CommentsPermalink





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





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





‘(D) all other information known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor that has not previously been submitted to the Administrator regarding--CommentsClose CommentsPermalink





‘(i) the physical, chemical, and toxicological properties of the chemical substance;CommentsClose CommentsPermalink





‘(ii) the annual production volume and known uses of, and exposure and fate information relating to, the chemical substance; andCommentsClose CommentsPermalink





‘(iii) the name and location of each facility to which the chemical substance is sent, after manufacture and processing, for subsequent processing, distribution, or use.CommentsClose CommentsPermalink





‘(3) DECLARATION OF CESSATION OF MANUFACTURING OR PROCESSING- A declaration described in this paragraph is a statement certifying that the manufacturer or processor has ceased, or will cease not later than 180 days after the date of submission of the declaration, all production, importation, processing, and export of the chemical substance.CommentsClose CommentsPermalink





‘(4) UPDATING OF INFORMATION- Each manufacturer or processor of a chemical substance that submits to the Administrator a declaration described in paragraph (2) shall update and submit to the Administrator a new declaration--CommentsClose CommentsPermalink





‘(A) at a minimum every 3 years; andCommentsClose CommentsPermalink





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





‘(i) demonstrates a new potential toxic effect of the chemical substance;CommentsClose CommentsPermalink





‘(ii) corroborates previous information demonstrating or suggesting a toxic effect; orCommentsClose CommentsPermalink





‘(iii) suggests a toxic effect at a lower dose than previously demonstrated.CommentsClose CommentsPermalink





‘(5) RECORDS TO SUPPORT DECLARATIONS- Each manufacturer or processor of a chemical substance distributed in commerce shall maintain records of the information described in subparagraphs (A) through (D) of paragraph (2).CommentsClose CommentsPermalink





‘(6) PROHIBITION ON MANUFACTURING, PROCESSING, OR DISTRIBUTION- The Administrator may, by order, prohibit a manufacturer or processor in violation of this subsection from manufacturing, processing, or distributing in commerce the chemical substance or any article containing the chemical substance, except as authorized under section 6(e).CommentsClose CommentsPermalink





‘(b) Reports-CommentsClose CommentsPermalink





‘(1) IN GENERAL-CommentsClose CommentsPermalink





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





‘(i) making a safety determination with respect to a chemical substance under this subchapter; orCommentsClose CommentsPermalink





‘(ii) any other aspect of administering this chapter.CommentsClose CommentsPermalink





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





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





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





‘(3) PROHIBITION ON MANUFACTURING, PROCESSING, OR DISTRIBUTION- The Administrator may, by order, prohibit a manufacturer or processor in violation of a requirement of a rule or order under paragraph (1) from manufacturing, processing, or distributing in commerce the chemical substance or any article containing the chemical substance, except as authorized under subsection 6(e).CommentsClose CommentsPermalink





‘(c) Inventory and Categorization-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Administrator shall compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States.CommentsClose CommentsPermalink





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





‘(3) TIMING-CommentsClose CommentsPermalink





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





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





‘(4) SMALL QUANTITIES FOR RESEARCH OR ANALYSIS- The Administrator shall not include in the list any chemical substance that is manufactured or processed only in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, the substance or another substance, including such research or analysis for the development of a product.CommentsClose CommentsPermalink





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





‘(d) Public Access to Significant Information-CommentsClose CommentsPermalink





‘(1) ELECTRONIC DATABASE- Not later than 1 year after the date of enactment of Safe Chemicals Act of 2010, the Administrator, through collaboration as appropriate, shall establish--CommentsClose CommentsPermalink





‘(A) an electronic, Internet-accessible database for storing and sharing of information relating to the toxicity and use of, and exposure to, chemical substances; andCommentsClose CommentsPermalink





‘(B) procedures for use in maintaining and updating the database.CommentsClose CommentsPermalink





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





‘(e) Records-CommentsClose CommentsPermalink





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





‘(2) DURATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Records of the adverse reactions to the health of employees shall be retained for a period of 30 years after the date the reactions were first reported to or known by the person maintaining the records.CommentsClose CommentsPermalink





‘(B) OTHER RECORDS- Any other record of the adverse reactions shall be retained for a period of 5 years after the date the information contained in the record was first reported to or known by the person maintaining the record.CommentsClose CommentsPermalink





‘(3) CONTENTS- Records required to be maintained under this subsection shall include--CommentsClose CommentsPermalink





‘(A) records of consumer allegations of personal injury or harm to health;CommentsClose CommentsPermalink





‘(B) reports of occupational disease or injury; andCommentsClose CommentsPermalink





‘(C) reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce from any source.CommentsClose CommentsPermalink





‘(f) Information in the Possession of Other Federal Agencies-CommentsClose CommentsPermalink





‘(1) SYNOPSES-CommentsClose CommentsPermalink





‘(A) IN GENERAL- From time to time, each Federal agency and Federal institution shall submit to the Administrator a synopsis of the data and records in the possession or control of the agency and institution, respectively, that may be useful to the Administrator in carrying out this chapter.CommentsClose CommentsPermalink





‘(B) FORMAT AND CONTENT- Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall prescribe, by order, the format, content, and level of detail of the synopses.CommentsClose CommentsPermalink





‘(C) INITIAL SUBMISSION- Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2010, each Federal agency and Federal institution shall make the initial submission of a synopsis of the agency and institution, respectively, to the Administrator.CommentsClose CommentsPermalink





‘(D) UPDATES- At least once every 3 years, each Federal agency and Federal institution shall--CommentsClose CommentsPermalink





‘(i) update and keep current the synopsis of the agency and institution, respectively; andCommentsClose CommentsPermalink





‘(ii) submit the updated synopsis to the Administrator.CommentsClose CommentsPermalink





‘(2) REQUESTS BY ADMINISTRATOR- On the request of the Administrator, any information in the possession or control of an agency or institution relating to a hazard of, use of, exposure to, or risk of, a chemical substance or mixture shall be provided to the Administrator.CommentsClose CommentsPermalink





‘(g) Notice to Administrator of Substantial Risks- Any person that manufactures, processes, or distributes in commerce a chemical substance or mixture and that obtains information that reasonably supports the conclusion that the substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of the information unless the person has actual knowledge that the Administrator has been adequately informed of the information.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, other than a submission under subsection (f), shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission--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) Definition of Manufacture and Process- In this section, the terms ‘manufacture’ and ‘process’ mean manufacture and process, respectively, for commercial purposes.’.CommentsClose CommentsPermalink

SEC. 10. RELATIONSHIP TO OTHER FEDERAL LAWS.

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





(1) in subsection (a)--CommentsClose CommentsPermalink





(A) by amending paragraph (1) to read as follows:CommentsClose CommentsPermalink





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





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





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





‘(C) respond to the Administrator with respect to the matters described in the report.CommentsClose CommentsPermalink





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





(B) by amending paragraph (2) to read as follows:CommentsClose CommentsPermalink





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





(C) by redesignating paragraph (3) as paragraph (4);CommentsClose CommentsPermalink





(D) by inserting after paragraph (2) the following new paragraph:CommentsClose CommentsPermalink





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





‘(A) determines that action cannot be taken under the authorities of the agency;CommentsClose CommentsPermalink





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





‘(C) does not complete the action within the timeframe provided by such agency; orCommentsClose CommentsPermalink





‘(D) fails to respond,CommentsClose CommentsPermalink





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





(E) in paragraph (4), as redesignated by subparagraph (C) of this paragraph--CommentsClose CommentsPermalink





(i) by striking ‘section 6 or 7’ and inserting ‘this chapter’; andCommentsClose CommentsPermalink





(ii) by striking ‘against such risk’ after ‘Federal action’;CommentsClose CommentsPermalink





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





(3) in subsection (d)--CommentsClose CommentsPermalink





(A) by striking ‘while imposing the least burdens of duplicative requirements on those subject to the Act and for other purposes’; andCommentsClose CommentsPermalink





(B) by striking ‘, in the report required by section 30,’.CommentsClose CommentsPermalink