H.R. 2576 — what changed
Frank R. Lautenberg Chemical Safety for the 21st Century Act
From Introduced in House to Reported in House. 5 sections amended between Introduced in House and Reported in House.
Sec. 3 Testing of chemical substances and mixtures
Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is amended—
“(C) testing of a chemical substance is necessary to conduct a risk evaluation under section 6(b); and”
Sec. 4 Regulation of hazardous chemical substances and mixtures
“(b) Risk evaluations
“(1) In general—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.
“(2) Applying requirements—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 that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment.
“(3) Conducting risk evaluation
“(A) Required risk evaluations—The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if—
“(i) 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
“(ii) a manufacturer of the chemical substance requests such a risk evaluation.
“(B) TSCA Work Plan chemicals—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.
“(4) Requirements—In conducting a risk evaluation under this subsection, the Administrator shall—
“(A) 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;
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“(B) not include consider information on cost and other factors not directly related to health or the environment;
“(C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance;
“(D) describe the weight of the scientific evidence for identified hazard and exposure;
“(E) 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
“(F) 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.
“(5) Deadlines
“(A) Risk evaluations—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—
“(i) the Administrator—
“(I) makes a determination under paragraph (3)(A)(i); or
“(II) begins the risk evaluation under paragraph (3)(B); or
“(ii) a manufacturer requests the risk evaluation under paragraph (3)(A)(ii).
“(B) Subsection (a) rules—If, based on a risk evaluation conducted under this subsection, the Administrator determines 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—
“(i) propose a rule under subsection (a) for the chemical substance not later than 90 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and
“(ii) publish in the Federal Register a final rule not later than 180 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A).
“(C) Extension—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—
“(i) 90 days after receipt of such additional information; or
“(ii) 2 years after the original deadline.
“(6) Determinations of no unreasonable risk
changed “(A) Notice and comment—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.
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“(B) Potentially exposed subpopulations—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, poses presents or will present an unreasonable risk of injury to 1 or more potentially exposed subpopulations.
“(C) Final action—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.
“(7) Minimum number—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.”
“(1) Requirements for rule—In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall—
“(A) consider and publish a statement with respect to—
“(i) 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;
“(ii) 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;
“(iii) the benefits of the chemical substance or mixture for various uses; and
“(iv) 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;
“(B) 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;
changed “(C) 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;
“(D) 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
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“(E) 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 mitigate protect against the identified risk.”
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“(g) Non-Risk Non-risk factors—The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a).
“(h) Critical use exemptions
“(1) Criteria for exemption—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—
“(A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and
“(B) the Administrator finds that—
“(i) the specific use is a critical or essential use; or
“(ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure.
“(2) Procedure—An exemption granted under paragraph (1) shall be—
“(A) supported by clear and convincing evidence;
“(B) preceded by public notice of the proposed exemption and an opportunity for comment; and
“(C) followed by notice of the granted exemption—
“(i) to the public, by the Administrator; and
“(ii) 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.
“(3) Period of exemption—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.
“(4) Conditions—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.
“(i) Chemicals that are persistent, bioaccumulative, and toxic
“(1) Identification—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).
“(2) Confirmation of concern—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)—
“(A) 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
“(B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator.
“(3) Expedited action—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.
“(4) Relationship to subsection (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.”
Sec. 5 Relationship to other Federal laws
Section 9(b) of the Toxic Substances Control Act (15 U.S.C. 2608(b)) is amended—
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“(2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall compare consider the relevant risks, and compare the estimated costs, costs and efficiencies efficiencies, of the action to be taken under this title and an action to be taken under such other law to protect against such risk.”
Sec. 6 Disclosure of data
Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is amended—
“(5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and
“(6) shall be disclosed upon request—
“(A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or
“(B) to a treating physician or other health care professional to assist in the diagnosis or treatment of 1 or more individuals.”
“(1)
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“(A) In submitting information under this Act after the date of enactment of the TSCA Modernization Act of 2015, a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include—
“(i) justification for each designation of confidentiality;
“(ii) a certification that the information is not otherwise publicly available; and
“(iii) separate copies of all submitted information, with 1 copy containing and 1 copy excluding the information to which the request applies.
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“(B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has submitted a request reasserted the claim for renewal, made protection, in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission.
“(C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B).”
“(f) Prohibition—No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information.
“(g) Savings—Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding.”