Sec. 17. Administration of the Act
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Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— in subsection (b)(1)— by striking of a reasonable fee ; by striking data under section 4 or 5 to defray the cost of administering this Act and inserting information under section 4 or a notice or other information to be reviewed by the Administrator under section 5, or who manufactures or processes a chemical substance that is the subject of a risk evaluation under section 6(b), of a fee that is sufficient and not more than reasonably necessary to defray the cost related to such chemical substance of administering sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, including contractor costs incurred by the Administrator ; by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. ; and by striking submit the data and the cost to the Administrator of reviewing such data and inserting pay such fee and the cost to the Administrator of carrying out the activities described in this paragraph ; in subsection (b)— in paragraph (2), by striking paragraph
(1)and inserting paragraph
(4); and by adding at the end the following: There is established in the Treasury of the United States a fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. Subject to the conditions of subparagraph (C), the Administrator shall collect the fees described in this subsection and deposit those fees in the Fund. Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use in defraying the costs of the activities described in paragraph (1). The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— the fees collected and amounts disbursed under this subsection; the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of this title for which the fees may be used; and the number of requests for a risk evaluation made by manufacturers under section 6(b)(4)(C)(ii). The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause
(II)and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. In setting fees under this section, the Administrator shall— prescribe lower fees for small business concerns, after consultation with the Administrator of the Small Business Administration; set the fees established under paragraph
(1)at levels such that the fees will, in aggregate, provide a sustainable source of funds to annually defray— the lower of— 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations under section 6(b); or $25,000,000 (subject to adjustment pursuant to subparagraph (F)); and the costs of risk evaluations specified in subparagraph (D); reflect an appropriate balance in the assessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; notwithstanding subparagraph (B)— except as provided in clause (ii), for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), establish the fee at a level sufficient to defray the full costs to the Administrator of conducting the risk evaluation under section 6(b); for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), and which are included in the 2014 update of the TSCA Work Plan for Chemical Assessments, establish the fee at a level sufficient to defray 50 percent of the costs to the Administrator of conducting the risk evaluation under section 6(b); and apply fees collected pursuant to clauses
(i)and
(ii)only to defray the costs described in those clauses; prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee Act (5 U.S.C. App.) or subchapter II of chapter 5 of title 5, United States Code, is applicable with respect to such meetings; beginning with the fiscal year that is 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives pursuant to subparagraph (E), increase or decrease the fees established under paragraph
(1)as necessary to adjust for inflation and to ensure that funds deposited in the Fund are sufficient to defray— approximately but not more than 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations requested under section 6(b)(4)(C)(ii); and the costs of risk evaluations specified in subparagraph (D); and if a notice submitted under section 5 is not reviewed or such a notice is withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice. Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for the Chemical Risk Review and Reduction program project of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014. The authority provided by this subsection shall terminate at the conclusion of the fiscal year that is 10 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act unless otherwise reauthorized or modified by Congress. ; and by adding at the end the following: In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and shall consider as applicable— the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information; the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models. The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. Subject to section 14, the Administrator shall make available to the public— all notices, determinations, findings, rules, consent agreements, and orders of the Administrator under this title; any information required to be provided to the Administrator under section 4; a nontechnical summary of each risk evaluation conducted under section 6(b); a list of the studies considered by the Administrator in carrying out each such risk evaluation, along with the results of those studies; and each designation of a chemical substance under section 6(b), along with an identification of the information, analysis, and basis used to make the designations. In carrying out sections 4, 5, and 6, the Administrator shall take into consideration information relating to a chemical substance or mixture, including hazard and exposure information, under the conditions of use, that is reasonably available to the Administrator. Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 5 years thereafter, the Administrator shall— review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. The policies, procedures, and guidance developed under paragraph
(1)applicable to testing chemical substances and mixtures shall— address how and when the exposure level or exposure potential of a chemical substance or mixture would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; and describe the manner in which the Administrator will determine that additional information is necessary to carry out this title, including information relating to potentially exposed or susceptible populations. With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which the Administrator has published a completed risk assessment prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator may publish proposed and final rules under section 6(a) that are consistent with the scope of the completed risk assessment for the chemical substance and consistent with other applicable requirements of section 6. Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator. The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing draft risk evaluations for consideration by the Administrator. Not later than 6 months after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(i), and the resources necessary to conduct the minimum number of risk evaluations required under section 6(b)(2); the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). The Administrator shall update and resubmit the report described in paragraph
(1)not less frequently than once every 5 years. The Administrator shall inform the public regarding the schedule and the resources necessary for the completion of each risk evaluation as soon as practicable after initiating the risk evaluation. At the beginning of each calendar year, the Administrator shall publish an annual plan that— identifies the chemical substances for which risk evaluations are expected to be initiated or completed that year and the resources necessary for their completion; describes the status of each risk evaluation that has been initiated but not yet completed; and if the schedule for completion of a risk evaluation has changed, includes an updated schedule for that risk evaluation. Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the Committee ). The purpose of the Committee shall be to provide independent advice and expert consultation, at the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title. The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years. Nothing in the Frank R. Lautenberg Chemical Safety for the 21st Century Act eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . Nothing in this Act prevents the Administrator from initiating a risk evaluation regarding a chemical substance, or from continuing or completing such risk evaluation, prior to the effective date of the policies, procedures, and guidance required to be developed by the Administrator pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . Nothing in this Act requires the Administrator to revise or withdraw a completed risk evaluation, determination, or rule under this Act solely because the action was completed prior to the development of a policy, procedure, or guidance pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . .
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Sec. 17
Administration of the Act
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