Sec. 4. Regulation of hazardous chemical substances and mixtures
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Section 6(a) of the Toxic Substances Control Act ( 15 U.S.C. 2605(a) ) is amended— by striking finds that there is a reasonable basis to conclude and inserting determines under subsection
(b); by inserting or designates a chemical substance under subsection (i)(2), before the Administrator shall by rule ; and by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation . Section 6(b) of the Toxic Substances Control Act ( 15 U.S.C. 2605(b) ) is amended to read as follows: The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection
(a)only if the Administrator determines through a risk evaluation under this subsection, without consideration of costs or other non-risk factors, that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if— the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or a manufacturer of the chemical substance requests such a risk evaluation in a form and manner prescribed by the Administrator. The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015 , is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator. In conducting a risk evaluation under this subsection, the Administrator shall— integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations; not consider information on cost and other factors not directly related to health or the environment; take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance; describe the weight of the scientific evidence for identified hazard and exposure; consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer. The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than— 3 years after the date on which the Administrator— makes a determination under paragraph (3)(A)(i); or begins the risk evaluation under paragraph (3)(B); or in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), 2 years after the later of the date on which— the manufacturer requests the risk evaluation; or if applicable, the risk evaluation is initiated pursuant to subparagraph (B). If the Administrator receives more requests for risk evaluations under paragraph (3)(A)(ii) than the Administrator has resources to conduct by the deadline under subparagraph (A)(ii)(I) (taking into account the requirement in paragraph (4)(F)), the Administrator shall— initiate risk evaluations that exceed the Administrator’s allotted resources as soon as resources for such risk evaluations are available; and not collect a fee under section 26 from the manufacturer for a risk evaluation until the Administrator initiates the risk evaluation.
(a)rules If, based on a risk evaluation conducted under this subsection, the Administrator determines, without consideration of costs or other non-risk factors, that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— propose a rule under subsection
(a)for the chemical substance not later than 1 year after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and publish in the Federal Register a final rule not later than 2 years after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph
(A)accordingly, except that the deadline may not be extended to a date that is later than— 90 days after receipt of such additional information; or 2 years after the deadline being extended under this subparagraph. Not later than 30 days before publishing a final determination under this subsection that a chemical substance does not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to one or more potentially exposed subpopulations. A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action. Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015 . .
(a)rules Section 6(c) of the Toxic Substances Control Act ( 15 U.S.C. 2605(c) ) is amended— by amending paragraph
(1)to read as follows: In promulgating any rule under subsection
(a)with respect to a chemical substance or mixture, the Administrator shall— consider and publish a statement with respect to— the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture; the benefits of the chemical substance or mixture for various uses; and the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection
(a)are necessary to protect against the identified risk; based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect; exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and in selecting among prohibitions and other restrictions to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to protect against the identified risk. ; in paragraph (2)— by inserting before Procedures. — When prescribing a rule ; by striking provide an opportunity for an informal hearing in accordance with paragraph (3);
(D); by striking , and
(E)and inserting ; and
(D); and by moving such paragraph 2 ems to the right; by striking paragraphs
(3)and
(4)and redesignating paragraph
(5)as paragraph (3); and in paragraph
(3)(as so redesignated)— by striking Paragraphs (1), (2), (3), and
(4)and inserting ; and Application.— Paragraphs
(1)and
(2)by moving such paragraph 2 ems to the right. Section 6(d)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2605(d)(2)(B) ) is amended by adding at the end the following: Any rule promulgated under subsection
(a)shall provide for a reasonable transition period. . Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended by adding at the end the following: The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a). The Administrator may grant an exemption from a requirement of a subsection
(a)rule for a specific use of a chemical substance or mixture, if— the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and the Administrator finds that— the specific use is a critical or essential use; or the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure. An exemption granted under paragraph
(1)shall be— supported by clear and convincing evidence; preceded by public notice of the proposed exemption and an opportunity for comment; and followed by notice of the granted exemption— to the public, by the Administrator; and to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. An exemption granted under paragraph
(1)shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph
(1)continue to be met. The Administrator shall impose conditions on any use for which an exemption is granted under paragraph
(1)to reduce risk from the chemical substance or mixture to the greatest extent feasible. Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e). Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection
(a)with respect to the chemical substance to reduce likely exposure to the extent practicable.
(b)If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection. .
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Sec. 4
Regulation of hazardous chemical substances and mixtures
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