Sec. 26. Additional requirements
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The Toxic Substances Control Act is amended by inserting after section 28 ( 15 U.S.C. 2627 ) the following: Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall establish within the Environmental Protection Agency a program to be known as the Children s Environmental Health Research Program’ (referred to in this subsection as the Program ). Subject to amounts made available in advance in appropriations Acts, the Administrator may enter into contracts and make grants under the Program to further understanding of the vulnerability of children to chemical substances and mixtures.
Contracts and grants under this section shall be provided in consultation with the Interagency Science Advisory Board on Children’s Health Research established under subsection (b)(1). Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Children s Health Research’ (referred to in this subsection as the Board ). The purpose of the Board shall be to provide independent advice, expert consultation, and peer review, on request of the Administrator or Congress, with respect to the scientific and technical aspects of issues relating to the implementation of this title with respect to research on protecting children’s health.
The Administrator shall— appoint the members of the Board, including, at a minimum, representatives of— the National Institute of Environmental Health Sciences; the Centers for Disease Control and Prevention; the National Toxicology Program; the National Cancer Institute; the National EPA-Tribal Science Council; and not fewer than 3 centers of children’s health at leading institutions of higher education; ensure that at least 1/3 of the members of the Board have specific scientific expertise in the relationship of chemical exposures to prenatal, infant, and children’s health; and ensure that no individual appointed to serve on the Board has a conflict of interest that is relevant to the functions performed by the Board, unless— the individual promptly and publicly discloses the conflict; and the Administrator determines that the conflict is unavoidable.
The Board shall be subject to subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act ). If, through studies performed under subsection
(a)or section 4 or in any other available research, the Administrator identifies a chemical substance that may be present in human biological media that may have adverse effects on early childhood development, the Administrator shall coordinate with the Secretary of Health and Human Services to conduct, not later than 2 years after the date on which the Administrator identifies the chemical substance, a biomonitoring study to determine the presence of the chemical substance in human biological media in, at a minimum, pregnant women and infants. On completion of any study conducted under paragraph (1), the Secretary of Health and Human Services shall— notify the Administrator of the results of the study; and publish the results of the study in a publicly available electronic format. If a chemical substance or mixture is determined to be present in a study conducted under paragraph (1), the manufacturers and processors of the chemical substance or mixture shall, not later than 180 days after the date of publication of the study, disclose to the Administrator, commercial customers of the manufacturers and processors, consumers, and the public— all known uses of the chemical substance or mixture; and all articles in which the chemical substance or mixture is, or is expected to be, present. Information under clauses
(i)and
(ii)of subparagraph
(A)shall be— made available by the Administrator in electronic format; and made readily accessible and free of charge by each applicable manufacturer and processor in electronic format to the commercial customers of such manufacturer or processor, consumers, and the public. The Administrator shall take action to minimize the use of animals in testing of chemical substances or mixtures, including— encouraging and facilitating, to the maximum extent practicable— the use of existing data of sufficient scientific quality; the use of test methods that eliminate or reduce the use of animals while providing data of high scientific quality; the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of 1 chemical substance would provide reliable and useful data on others in the category; the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; and the parallel submission of data from animal-based studies and from emerging methods and models; and funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection. Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Alternative Testing Methods (referred to in this subsection and subsection
(c)as the Board ). The Administrator shall— appoint the members of the Board, including, at a minimum, representatives of— the National Institute of Environmental Health Sciences; the Centers for Disease Control and Prevention; the National Toxicology Program; the National Cancer Institute; and the National EPA-Tribal Science Council; and ensure that no individual appointed to serve on the Board has a conflict of interest that is relevant to the functions to be performed, unless— the individual promptly and publicly discloses the conflict; and the Administrator determines that the conflict is unavoidable. The purpose of the Board shall be to provide independent advice and peer review to Congress and the Administrator on the scientific and technical aspects of issues relating to the implementation of this title with respect to minimizing the use of animals in testing chemical substances or mixtures. The Board shall be subject to subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act ). Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , and every 3 years thereafter, the Administrator, in consultation with the Board, shall publish in the Federal Register a list of testing methods that reduce the use of animals in testing under section 4. To promote the development and timely incorporation of new testing methods that are not animal-based, the Administrator shall— in consultation with the Board, and after providing an opportunity for public comment, develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information used for safety standard determinations under section 6(b) that do not use animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening; beginning on the date that is 2 years after the date of enactment of the Safe Chemicals Act of 2013 and every 2 years thereafter, submit to Congress a report that describes the progress made in implementing this section; and fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and testing strategies that are not animal-based for use in safety standard determinations under section 6(b). On request from a manufacturer or processor that is required to conduct animal-based testing of a chemical substance or mixture under this title, the Administrator may adapt or waive the animal testing requirement if the Administrator determines that— there is a sufficient weight of evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property, in any case in which the information from each individual source alone is regarded as insufficient to support the conclusion; because of 1 or more physical or chemical properties of the chemical substance or mixture, testing for a specific endpoint is technically not practicable to conduct; or a chemical substance or mixture cannot be tested in animals at concentrations that do not result in significant pain or distress, because of physical or chemical properties of the chemical substance or mixture, such as potential to cause severe corrosion or severe irritation to tissues. Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall establish a program to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances. The program established under paragraph
(1)shall include— expedited review of new chemical substances for which the manufacturer or processor submits an alternatives analysis indicating that the new chemical substance is the safer alternative for a particular use than existing chemical substances used for the same purpose; recognition for a chemical substance or product determined by the Administrator to be a safer alternative for a particular use by means of a special designation intended for use in marketing the safer alternative, and periodic public awards or rewards; and such other incentives, as the Administrator considers to be appropriate to encourage the development, marketing, and use of chemical substances or products determined by the Administrator to be safer alternatives for the particular uses, such as job training and worker assistance. The Administrator shall establish a network of not less than 4 green chemistry and engineering centers, located in various regions of the United States, to support the development and adoption of safer alternatives to chemical substances, particularly chemical substances listed under section 6(a). The Administrator shall make grants to promote and support the research, development, and adoption of safer alternatives to hazardous substances. The Administrator shall establish a program to facilitate the development of a workforce, including industrial and scientific workers, that produces safer alternatives to existing chemical substances. The goals of the program established under paragraph
(1)are to provide workforce training on skills that would— facilitate the expansion of green chemistry; develop scientific and technical leadership in green chemistry; facilitate the successful and safe integration of green chemistry into infrastructure projects; inform and engage communities about green chemistry; and promote innovation and strong public health and environmental protections. The Administrator shall implement the program to achieve the goals of this Act, including by— helping to develop a broad range of skills relevant to the production and use of the safer alternatives, including the design, manufacturing, use, and disposal of the alternatives; offering to develop partnerships with educational institutions, training organizations, private sector companies, and community organizations; and providing grants to States, units of local government, and the partnerships developed under subparagraph
(B)to promote and support activities consistent with achieving the goals of the program established under this subsection. In cooperation with the Secretary of State and the head of any other appropriate Federal agency (as determined by the Administrator), the Administrator shall cooperate with international efforts as appropriate— to develop a common protocol or electronic database relating to chemical substances; or to develop safer alternatives for chemical substances. Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall, by order, establish and implement procedures to ensure data reliability including, at a minimum, requirements that the Administrator— not less than annually randomly inspect laboratories that develop the data required under this title on the various properties and characteristics of a chemical substance; annually perform a comprehensive data audit on a subset, as chosen by the Administrator, of the data submissions under this title; establish and maintain a registry of all health- and safety-related studies initiated in response to requirements under this title; have access to all records of health- and safety-related studies initiated in response to requirements under this title; and require the submitter of any research study conducted by a third party in response to requirements under this title to disclose to the Administrator and the public, at the time of submission, the sources of any funding used for the conduct or publication of the study received by the researchers who conducted the study. In this section: The term disproportionate exposure means residential population exposure to 1 or more toxic chemical substances or mixtures at levels that are significantly greater than the average exposure in the United States, as defined and identified by the Administrator in accordance with the criteria established under subsection (b). The term locality means any geographical area (including a county, city, town, neighborhood, census tract, zip code area, or other commonly understood political or geographical subdivision) in which the Administrator identifies disproportionate exposure. Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall promulgate a rule to establish criteria consistent with this section that— defines disproportionate exposure; and identifies any locality that is disproportionately exposed. Not later than 120 days after the date on which the rule is promulgated under subsection (b), the Administrator shall identify localities in the United States that are subject to disproportionate exposure. In identifying localities under paragraph (1), the Administrator— shall use data contained in the National Air Toxic Assessment Database; and may use other data available to the Administrator, including data developed under— the Safe Drinking Water Act ( 42 U.S.C. 300f et seq. ); the Solid Waste Disposal Act ( 42 U.S.C. 6901 et seq. ); the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( 42 U.S.C. 9601 et seq. ); and the Emergency Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11001 et seq.). The Administrator shall provide an opportunity for members of the public to nominate localities in which disproportionate exposure may be found for inclusion in the identification of localities under paragraph (1). Not later than 180 days after completing the identification of localities under subsection (c)(1), the Administrator, after notice and consultation with applicable State, local, county health, and environmental officials, State, local, and county legislators, and other elected officials, shall— publish a list of the localities subject to disproportionate exposure identified under that subsection in the Federal Register; and make the list published under subparagraph
(A)available electronically. Subject to subparagraph (B), not later than 5 years after the date on which the list is published under paragraph (1)(A), and at least once every 5 years thereafter, the Administrator shall update and republish the list. The Administrator may update and republish the list under paragraph
(1)more frequently than every 5 years— to add new localities that meet the criteria established under subsection (b); or to remove localities, if the Administrator determines that the exposure reduction has been achieved and no further action is needed after actions are taken under subsection (f). The Administrator shall notify all applicable State, local, county health, and environmental officials, State, local, and county legislators, and other elected officials of the updated listing. The following actions under this section shall not be subject to judicial review: A decision to include on the list published under subsection (d)(1) a locality identified under subsection (c)(1). A decision in response to nominations submitted under subsection (c)(3). A decision to list localities under subsection (d)(1) or update the list under subsection (d)(2). Notwithstanding paragraph (1), the failure of the Administrator to publish or update the list of localities in accordance with this section shall be— considered to be a failure to perform a nondiscretionary duty; and subject to judicial review. Not later than 1 year after the date on which the list is published or updated under subsection (d), the Administrator shall develop and publish, for each locality identified on the list, an action plan that includes— an identification of the chemical substances and mixtures that contribute to the disproportionate exposure (including exposure levels, sources, and pathways); and a description of actions planned by the Administrator to reduce disproportionate exposure in the locality. The goal of each action plan under this subsection shall be to reduce disproportionate exposure in the locality by establishing— a percentage exposure reduction goal for each chemical substance and mixture; and a timeline to achieve the percentage exposure reduction goal. The Administrator shall— submit to Congress an annual report that identifies— each locality added to the list in the prior year under subsection (d); each action plan developed in the prior year under subsection (f); and the progress on each action plan to date; and make the report available to the public in electronic format. Except as provided in subsection (e), each Federal agency, and any officer, agent, or employee of a Federal agency, shall be subject to, and comply with, all applicable requirements of this Act described in subsection (b), both substantive and procedural, in the same manner, and to the same extent, as any person subject to the requirements. The substantive and procedural requirements referred to in this subsection include— any administrative order; any civil or administrative penalty or fine, regardless of whether the penalty or fine is— punitive or coercive in nature; or imposed for isolated, intermittent, or continuing violations; any requirement for reporting; any provision for injunctive relief and sanctions that may be imposed by a court to enforce such relief; and payment of reasonable service charges. The United States expressly waives any immunity otherwise applicable to the United States with respect to any substantive or procedural requirement referred to under subsection (a). No agent, employee, or officer of the United States shall be personally liable for any civil penalty under this title with respect to any act or omission within the scope of the official duties of the agent, employee, or officer. An agent, employee, or officer of the United States shall be subject to any criminal sanction (including any fine or imprisonment) under this Act, but no department, agency, or instrumentality of the executive, legislative, or judicial branch of the Federal Government shall be subject to such sanction. If the President determines it is in the paramount interest of the United States, the President may grant an exemption for any Federal agency from compliance with any requirement of this Act. No exemption shall be granted under paragraph
(1)due to lack of appropriation unless— the President has specifically requested the appropriation as a part of the budgetary process; and Congress has failed to make the requested appropriation available. Any exemption granted under paragraph
(1)shall be for a period of not more than 1 year, but additional exemptions may be granted for periods not to exceed 1 year, if the President makes a subsequent determination that the exemption is in the paramount interest of the United States. Each January after the date of enactment of this section, the President shall submit to Congress a report that describes— all exemptions granted under this subsection during the preceding calendar year; and the reason for granting each exemption. The Administrator may initiate an administrative enforcement action against any Federal agency— in accordance with the enforcement authorities of this Act; and in the same manner and under the same circumstances as an action would be initiated against another person. Any voluntary resolution or settlement of an administrative enforcement action initiated under this subsection shall be set forth in a consent order. No administrative order issued to a Federal department, agency, or instrumentality under this subsection shall become final until the Federal department, agency, or instrumentality has had the opportunity to confer with the Administrator. In this section: The term chemical includes any substance or mixture of substances, including a substance that is part of an article. The term LRTAP Convention means the Convention on Long-Range Transboundary Air Pollution, done at Geneva on November 13, 1979 (TIAS 10541), and any subsequent amendments to which the United States is a party. The term LRTAP POPs chemical means any chemical listed on any Annex of the LRTAP POPs Protocol, if such listing has entered into force for the United States. The term LRTAP POPs Protocol means the Protocol on Persistent Organic Pollutants to the LRTAP Convention, done at Aarhus on June 24, 1998, and any subsequent amendment to which the United States is a party. The term meeting of the parties means— the Conference of the Parties established by and operating under Article 19 of the Stockholm Convention; the Executive Body established by and operating under Article 10 of the LRTAP POPs Convention; and the Conference of the Parties established by and operating under Article 18 of the Rotterdam Convention. The term PIC chemical means any chemical identified by notification to the Secretariat of the Rotterdam Convention by the United States as banned or severely restricted in the United States, and any chemical listed on any Annex of the Rotterdam Convention, if such listing has entered into force for the United States. The term POPs chemical means any chemical that is listed on any Annex of the Stockholm Convention, if such listing has entered into force for the United States. The term Rotterdam Convention means the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, done at Rotterdam on September 10, 1998, and any subsequent amendment to which the United States is a party. The term Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants, done at Stockholm on May 22, 2001, and any subsequent amendment to which the United States is a party. The Administrator, in cooperation with appropriate Federal agencies, shall implement and support the implementation by the United States of the provisions of the Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam Convention that have entered into effect for the United States. Notwithstanding any other provision of law, no person may manufacture, process, distribute in commerce, use, dispose of, or take any other action with respect to a POPs chemical, LRTAP POPs chemical, or PIC chemical in a manner inconsistent with applicable obligations for that chemical under the Stockholm Convention, LRTAP POPs Protocol, or Rotterdam Convention. The Administrator shall provide timely public notice and opportunity to comment on a chemical proposed for listing to any Annex to the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention. The Administrator shall identify in the notice under subparagraph
(A)any relevant toxicity, exposure, and risk information on the chemical known to the Administrator, and any domestic activities involving the chemical known to the Administrator. Any interested person may provide relevant comment and information on the chemical in response to the notice under subparagraph (A). The Administrator may require the provision of relevant information related to a proposed chemical from any person, as the Administrator determines necessary to assist the United States in the review. The Administrator shall consider all comments and information received under this subparagraph in the review of the proposal and include the comments and information in an established public docket. The Administrator shall provide timely public notice and opportunity to comment after a recommendation is made to list a chemical on any Annex to the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention. The Administrator shall provide the notice under clause
(i)in advance of the meeting of the Parties at which the recommendation is to be considered. The Administrator shall request comment and information on all aspects of the recommendation and may, if the Administrator determines it to be necessary to assist the United States in the review, require the provision of relevant information related to a proposed chemical from any person. The Administrator shall consider all comments and information received under this subparagraph in the review of the proposal and include the comments and information in an established public docket. Not later than 30 days after a decision by the meeting of the parties, the Administrator shall provide timely public notice and opportunity to comment on any decision by the meeting of the parties to list a chemical on any Annex to the Stockholm Convention. The Administrator shall provide in the notice under clause
(i)a description of the amendments to the instruments and identify the changes to the domestic activities that the Administrator believes, based on information available to the Administrator, would be necessary if the United States chose to be bound by the listing decision. Any interested person may provide relevant comment and information in response to the notice under clause (i). The Administrator shall consider all comments and information received under this subparagraph in the review of the proposal and include the comments and information in an established public docket. Not later than 30 days after the United States deposits the instrument of ratification for the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, or not later than 30 days after the listing of any chemical subsequently added under those instruments has entered into force for the United States (whichever date is earlier), the Administrator— shall provide public notice of— the chemicals that are subject to those instruments; and any chemical subsequently added under those instruments; and may specify the requirements that are applicable for individual chemicals in a public notice under this subparagraph. The Administrator may promulgate regulations necessary to carry out the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, or to ensure compliance with any obligations under such instruments. If a chemical is subject to obligations under more than 1 of the instruments that includes the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention, the most stringent of the obligations shall apply to ensure compliance with each of the instruments. The prohibitions and any other requirements of this section shall be enforced in the same manner as final rules or orders under section 6. . The table of contents for the Toxic Substances Control Act ( 15 U.S.C. 2601 et seq. ) is amended— by striking the item relating to section 2 and inserting the following: Sec. 2. Findings, policy, and goal. ; by striking the item relating to section 4 and inserting the following: Sec. 4. Minimum data set and testing of chemical substances. ; by striking the item relating to section 6 and inserting the following: Sec. 6. Prioritization, safety standard determination, and risk management. ; by striking the items relating to sections 29 through 31; and by adding after the item relating to section 28 the following: Sec. 29. Children’s Environmental Health Research Program. Sec. 30. Reduction of animal-based testing. Sec. 31. Safer alternatives and green chemistry and engineering. Sec. 32. Cooperation with international efforts. Sec. 33. Reliable information and advice. Sec. 34. Hot spots. Sec. 35. Application of this Act to Federal agencies. Sec. 36. Implementation of Stockholm Convention, the LRTAP Pops Protocol, and the Rotterdam Convention. Sec. 37. Annual report. Sec. 38. Authorization of appropriations. .
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Sec. 26
Additional requirements
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