,,ii #aadth ,,congress #ast ,session ,s4 #fig ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #aj1 #bjae,mr4 ,udall 7for himself1 ,mr4 ,vitter1 ,mr4 ,manchin1 ,mr4 ,inhofe1 ,mr4 ,carper1 ,mr4 ,blunt1 ,mr4 ,coons1 ,mr4 ,boozman1 ,mr4 ,donnelly1 ,mrs4 ,capito1 ,mr4 ,heinrich1 ,mr4 ,cassidy1 ,ms4 ,heitkamp1 ,mr4 ,crapo1 ,ms4 ,stabenow1 ,mr4 ,hoeven1 and ,mr4 ,portman7 introduced the following bill2 which was read twice and referred to the ,committee on ,environment and ,public ,works ,a ,,bill ,to amend the ,toxic ,substances ,control ,act to reauthorize and modernize that ,act1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act4 #b4 ,findings1 policy1 and intent ,section #b7;c7 of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfja7;c77 is amended-- 7#a7 by striking ,it is the intent and inserting the following3 7#a7 ,administration ,it is the intent 2 7#b7 in paragraph 7#a7 7as so redesignated71 by inserting 1 as provided under this ,act before the period at the end2 and 7#c7 by adding at the following3 7#b7 ,reform ,it is the intent of ,congress that reform of this ,act in accordance with the amendments made by the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act-- 7,a7 shall be administered in a manner that-- 7i7 protects the health of children1 pregnant women1 the elderly1 workers1 consumers1 the general public1 and the environment from the risks of harmful exposures to chemical substances and mixtures2 and 7ii7 ensures that appropriate information on chemical substances and mixtures is available to public health officials and first responders in the event of an emergency2 and 7,b7 shall not displace or supplant common law rights of action or remedies for civil relief4 4 #c4 ,definitions ,section #c of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjb7 is amended-- 7#a7 by redesignating paragraphs 7#d71 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 7#ac71 and 7#ad7 as paragraphs 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#ab71 7#ac71 7#ag71 7#ah71 and 7#ai71 respectively2 7#b7 by inserting after paragraph 7#c7 the following3 7#d7 ,conditions of use ,the term conditions of use means the intended1 known1 or reasonably foreseeable circumstances the ,administrator determines a chemical substance is manufactured1 processed1 distributed in commerce1 used1 or disposed of4 2 7#c7 by inserting after paragraph 7#aj7 7as so redesignated7 the following3 7#aa7 ,potentially exposed or susceptible population ,the term potentially exposed or susceptible population means #a or more groups-- 7,a7 of individuals within the general population who may be-- 7i7 differentially exposed to chemical substances under the conditions of use2 or 7ii7 susceptible to greater adverse health consequences from chemical exposures than the general population2 and 7,b7 that when identified by the ,administrator may include such groups as infants1 children1 pregnant women1 workers1 and the elderly4 2 and 7#d7 by inserting after paragraph 7#ac7 7as so redesignated7 the following3 7#ad7 ,safety assessment ,the term safety assessment means an assessment of the risk posed by a chemical substance under the conditions of use1 integrating hazard1 use1 and exposure information regarding the chemical substance4 7#ae7 ,safety determination ,the term safety determination means a determination by the ,administrator as to whether a chemical substance meets the safety standard under the conditions of use4 7#af7 ,safety standard ,the term safety standard means a standard that ensures1 without taking into consideration cost or other nonrisk factors1 that no unreasonable risk of harm to health or the environment will result from exposure to a chemical substance under the conditions of use1 including no unreasonable risk of harm to-- 7,a7 the general population2 or 7,b7 any potentially exposed or susceptible population that the ,administrator has identified as relevant to the safety assessment and safety determination for a chemical substance4 4 #d4 ,policies1 procedures1 and guidance ,the ,toxic ,substances ,control ,act is amended by inserting after section #c 7#ae ,u4,s4,c4 #bfjb7 the following3 #c;,a4 ,policies1 procedures1 and guidance 7a7 ,definition of guidance ,in this section1 the term guidance includes any significant written guidance of general applicability prepared by the ,administrator4 7b7 ,deadline ,not later than #b years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the ,administrator shall develop1 after providing public notice and an opportunity for comment1 any policies1 procedures1 and guidance the ,administrator determines to be necessary to carry out sections #d1 #d;,a1 #e1 and #f1 including the policies1 procedures1 and guidance required by this section4 7c7 ,use of science 7#a7 ,in general ,the ,administrator shall establish policies1 procedures1 and guidance on the use of science in making decisions under sections #d1 #d;,a1 #e1 and #f4 7#b7 ,goal ,a goal of the policies and procedures described in paragraph 7#a7 shall be to make the basis of decisions clear to the public4 7#c7 ,requirements ,the policies1 procedures1 and guidance issued under this section shall describe the manner in which the ,administrator shall ensure that-- 7,a7 decisions made by the ,administrator-- 7i7 are based on information1 procedures1 measures1 methods1 and models employed in a manner consistent with the best available science2 7ii7 take into account the extent to which-- 7,i7 assumptions and methods are clearly and completely described and documented2 7,,ii7 variability and uncertainty are evaluated and characterized2 and 7,,iii7 the information has been subject to independent verification and peer review2 and 7iii7 are based on the weight of the scientific evidence1 by which the ,administrator considers all information in a systematic and integrative framework to consider the relevance of different information2 7,b7 to the extent practicable and if appropriate1 the use of peer review1 standardized test design and methods1 consistent data evaluation procedures1 and good laboratory practices will be encouraged2 7,c7 a clear description of each individual and entity that funded the generation or assessment of information1 and the degree of control those individuals and entities had over the generation1 assessment1 and dissemination of information 7including control over the design of the work and the publication of information7 is made available2 and 7,d7 if appropriate1 the recommendations in reports of the ,national ,academy of ,sciences that provide advice regarding assessing the hazards1 exposures1 and risks of chemical substances are considered4 7d7 ,existing ,,epa policies1 procedures1 and guidance ,the policies1 procedures1 and guidance described in subsection 7b7 shall incorporate1 as appropriate1 existing relevant hazard1 exposure1 and risk assessment guidelines and methodologies1 data evaluation and quality criteria1 testing methodologies1 and other relevant guidelines and policies of the ,environmental ,protection ,agency4 7e7 ,review ,not later than #e years after the date of enactment of this section1 and not less frequently than once every #e years thereafter1 the ,administrator shall-- 7#a7 review the adequacy of any policies1 procedures1 and guidance developed under this section1 including animal1 nonanimal1 and epidemiological test methods and procedures for assessing and determining risk under this ,act2 and 7#b7 after providing public notice and an opportunity for comment1 revise the policies1 procedures1 and guidance if necessary to reflect new scientific developments or understandings4 7f7 ,sources of information ,in making any decision with respect to a chemical substance under section #d1 #d;,a1 #e1 or #f1 the ,administrator shall take into consideration information relating to the hazards and exposures of a chemical substance under the conditions of use that is reasonably available to the ,administrator1 including information that is-- 7#a7 submitted to the ,administrator pursuant to any rule1 consent agreement1 order1 or other requirement of this ,act1 or on a voluntary basis1 including pursuant to any request made under this ,act1 by-- 7,a7 manufacturers or processors of a substance2 7,b7 the public2 7,c7 other ,federal departments or agencies2 or 7,d7 the ,governor of a ,state or a ,state agency with responsibility for protecting health or the environment2 7#b7 submitted to a governmental entity in any jurisdiction pursuant to a governmental requirement relating to the protection of health or the environment2 or 7#c7 identified through an active search by the ,administrator of information sources that are publicly available or otherwise accessible by the ,administrator4 7g7 ,testing of chemical substances and mixtures 7#a7 ,in general ,the ,administrator shall establish policies and procedures for the testing of chemical substances or mixtures under section #d4 7#b7 ,goal ,a goal of the policies and procedures established under paragraph 7#a7 shall be to make the basis of decisions clear to the public4 7#c7 ,contents ,the policies and procedures established under paragraph 7#a7 shall-- 7,a7 address how and when the exposure level or exposure potential of a chemical substance would factor into decisions to require new testing1 subject to the condition that the ,administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential2 7,b7 describe the manner in which the ,administrator will determine that additional information is necessary to carry out this ,act1 including information relating to potentially exposed or susceptible populations2 7,c7 require the ,administrator to consult with the ,director of the ,national ,institute for ,occupational ,safety and ,health prior to prescribing epidemiologic studies of employees2 and 7,d7 prior to adopting a requirement for testing using vertebrate animals1 require the ,administrator to take into consideration1 as appropriate and to the extent practicable1 reasonably available-- 7i7 toxicity information2 7ii7 computational toxicology and bioinformatics2 7iii7 high-throughput screening methods and the prediction models of those methods2 and 7iv7 scientifically reliable and relevant alternatives to tests on animals that would provide equivalent information4 7#d7 ,tiered testing 7,a7 ,in general ,except as provided in subparagraph 7,d71 the ,administrator shall employ a tiered screening and testing process1 under which the results of screening-level tests or assessments of available information inform the decision as to whether #a or more additional tests are necessary4 7,b7 ,screening-level tests 7i7 ,in general ,the screening-level tests required for a chemical substance or mixture may include tests for hazard 7which may include in silico1 in vitro1 and in vivo tests71 environmental and biological fate and transport1 and measurements or modeling of exposure or exposure potential1 as appropriate4 7ii7 ,use ,screening-level tests shall be used-- 7,i7 to screen chemical substances or mixtures for potential adverse effects2 and 7,,ii7 to inform a decision of the ,administrator regarding whether more complex or targeted additional testing is necessary4 7,c7 ,additional testing ,if the ,administrator determines under subparagraph 7,b7 that additional testing is necessary to provide more definitive information for safety assessments or safety determinations1 the ,administrator may require more advanced tests for potential health or environmental effects or exposure potential4 7,d7 ,advanced testing without screening ,the ,administrator may require more advanced testing without conducting screening-level testing when other information available to the ,administrator justifies the advanced testing1 pursuant to guidance developed by the ,administrator under this section4 7h7 ,safety assessments and safety determinations 7#a7 ,schedule 7,a7 ,in general ,the ,administrator shall inform the public regarding the schedule for the completion of each safety assessment and safety determination as soon as practicable after designation as a high-priority substance pursuant to section #d;,a4 7,b7 ,differing times ,the ,administrator may allot different times for different chemical substances in the schedules under this paragraph1 subject to the condition that all schedules shall comply with the deadlines established under section #f4 7,c7 ,annual plan ,at the beginning of each calendar year1 the ,administrator shall identify the substances subject to safety assessments and safety determinations to be completed that year4 7#b7 ,policies and procedures for safety assessments and safety determinations 7,a7 ,in general ,the ,administrator shall establish1 by rule1 policies and procedures regarding the manner in which the ,administrator shall carry out section #f4 7,b7 ,goal ,a goal of the policies and procedures under this paragraph shall be to make the basis of decisions of the ,administrator clear to the public4 7,c7 ,minimum requirements ,at a minimum1 the policies and procedures under this paragraph shall-- 7i7 describe-- 7,i7 the manner in which the ,administrator will identify informational needs and seek that information from the public2 7,,ii7 the information 7including draft safety assessments7 that may be submitted by interested individuals or entities1 including ,states2 and 7,,iii7 the criteria by which that information will be evaluated2 7ii7 require the ,administrator-- 7,i7 7aa7 to define the scope of the safety assessment and safety determination to be conducted under section #f1 including the hazards1 exposures1 conditions of use1 and potentially exposed and susceptible populations that the ,administrator expects to consider in a safety assessment2 7bb7 to explain the basis for the scope of the safety assessment and safety determination2 and 7cc7 to accept comments regarding the scope of the safety assessment and safety determination2 and 7,,ii7 7aa7 to identify the items described in subclause 7,i7 that the ,administrator has considered in the final safety assessment2 and 7bb7 to explain the basis for the consideration of those items2 7iii7 describe the manner in which aggregate exposures1 or significant subsets of exposures1 to a chemical substance under the conditions of use will be considered1 and explain the basis for that consideration in the final safety assessment2 7iv7 require that each safety assessment and safety determination shall include-- 7,i7 a description of the weight of the scientific evidence of risk2 and 7,,ii7 a summary of the information regarding the impact on health and the environment of the chemical substance that was used to make the assessment or determination1 including1 as available1 mechanistic1 animal toxicity1 and epidemiology studies2 7v7 establish a timely and transparent process for evaluating whether new information submitted or obtained after the date of a final safety assessment or safety determination warrants reconsideration of the safety assessment or safety determination2 and 7vi7 when relevant information is provided or otherwise made available to the ,administrator1 shall consider the extent of ,federal regulation under other ,federal laws4 7,d7 ,guidance 7i7 ,in general ,not later than #a year after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the ,administrator shall develop guidance to assist interested persons in developing draft safety assessments and other information for submission to the ,administrator1 which may be considered at the discretion of the ,administrator4 7ii7 ,requirement ,the guidance shall1 at a minimum1 address the quality of the information submitted and the process to be followed in developing a draft assessment for consideration by the ,administrator4 7#c7 ,articles ,if the ,administrator intends to prohibit or otherwise restrict an article on the basis of a chemical substance contained in that article1 the ,administrator shall have evidence of significant exposure to the chemical substance from such article4 7i7 ,publicly available information ,subject to section #ad1 the ,administrator shall-- 7#a7 make publicly available a nontechnical summary1 and the final version1 of each safety assessment and safety determination2 7#b7 provide public notice and an opportunity for comment on each proposed safety assessment and safety determination2 and 7#c7 make public in a final safety assessment and safety determination-- 7,a7 the list of studies considered by the ,administrator in carrying out the safety assessment or safety determination2 and 7,b7 the list of policies1 procedures1 and guidance that were followed in carrying out the safety assessment or safety determination4 7j7 ,consultation with ,science ,advisory ,committee on ,chemicals 7#a7 ,establishment ,not later than #a year after the date of enactment of this section1 the ,administrator shall establish an advisory committee1 to be known as the ,science ,advisory ,committee on ,chemicals 7referred to in this subsection as the ,committee74 7#b7 ,purpose ,the purpose of the ,committee shall be to provide independent advice and expert consultation1 on the request of the ,administrator1 with respect to the scientific and technical aspects of issues relating to the implementation of this title4 7#c7 ,composition ,the ,committee shall be composed of representatives of such science1 government1 labor1 public health1 public interest1 animal protection1 industry1 and other groups as the ,administrator determines to be advisable1 including1 at a minimum1 representatives that have specific scientific expertise in the relationship of chemical exposures to women1 children1 and other potentially exposed or susceptible populations4 7#d7 ,schedule ,the ,administrator shall convene the ,committee in accordance with such schedule as the ,administrator determines to be appropriate1 but not less frequently than once every #b years4 7#e7 ,relationship to other law ,all proceedings and meetings of the ,committee shall be subject to the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 4 #e4 ,testing of chemical substances or mixtures 7a7 ,in general ,section #d of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjc7 is amended-- 7#a7 by striking subsections 7a71 7b71 7c71 7d71 and 7g72 7#b7 by redesignating subsections 7e7 and 7f7 as subsections 7f7 and 7g71 respectively2 7#c7 in subsection 7f7 7as so redesignated7-- 7,a7 by striking rule each place it appears and inserting rule1 testing consent agreement1 or order2 7,b7 by striking under subsection 7a7 each place it appears and inserting under this subsection2 and 7,c7 in paragraph 7#a77;,b71 in the last sentence1 by striking rulemaking2 7#d7 in subsection 7g7 7as so redesignated7-- 7,a7 in the first sentence1 by striking from cancer1 gene mutations1 or birth defects2 and 7,b7 by striking the last sentence2 and 7#e7 by inserting before subsection 7f7 7as so redesignated7 the following3 7a7 ,development of new information on chemical substances and mixtures 7#a7 ,in general ,the ,administrator may require the development of new information relating to a chemical substance or mixture in accordance with this section if the ,administrator determines that the information is necessary-- 7,a7 to review a notice under section #e7;d7 or to perform a safety assessment or safety determination under section #f2 7,b7 to implement a requirement imposed in a consent agreement or order issued under section #e7;d77#d7 or under a rule promulgated under section #f7;d77#c72 7,c7 pursuant to section #ab7;a77#d72 or 7,d7 at the request of the implementing authority under another ,federal law1 to meet the regulatory testing needs of that authority4 7#b7 ,limited testing for prioritization purposes 7,a7 ,in general ,except as provided in subparagraph 7,b71 the ,administrator may require the development of new information for the purposes of section #d;,a4 7,b7 ,prohibition ,testing required under subparagraph 7,a7 shall not be required for the purpose of establishing or implementing a minimum information requirement4 7,c7 ,limitation ,the ,administrator may require the development of new information pursuant to subparagraph 7,a7 only if the ,administrator determines that additional information is necessary to establish the priority of a chemical substance4 7#c7 ,form ,subject to section #c;,a7h71 the ,administrator may require the development of information described in paragraph 7#a7 or 7#b7 by-- 7,a7 promulgating a rule2 7,b7 entering into a testing consent agreement2 or 7,c7 issuing an order4 7#d7 ,contents 7,a7 ,in general ,a rule1 testing consent agreement1 or order issued under this subsection shall include-- 7i7 identification of the chemical substance or mixture for which testing is required2 7ii7 identification of the persons required to conduct the testing2 7iii7 test protocols and methodologies for the development of test data and information for the chemical substance or mixture1 including specific reference to reliable nonanimal test procedures2 and 7iv7 specification of the period within which individuals and entities required to conduct the testing shall submit to the ,administrator the information developed in accordance with the procedures described in clause 7iii74 7,b7 ,considerations ,in determining the procedures and period to be required under subparagraph 7,a71 the ,administrator shall take into consideration-- 7i7 the relative costs of the various test protocols and methodologies that may be required2 and 7ii7 the reasonably foreseeable availability of facilities and personnel required to perform the testing4 7b7 ,statement of need 7#a7 ,in general ,in promulgating a rule1 entering into a testing consent agreement1 or issuing an order for the development of additional information 7including information on exposure or exposure potential7 pursuant to this section1 the ,administrator shall-- 7,a7 identify the need intended to be met by the rule1 agreement1 or order2 7,b7 explain why information reasonably available to the ,administrator at that time is inadequate to meet that need1 including a reference1 as appropriate1 to the information identified in paragraph 7#b77;,b72 and 7,c7 explain the basis for any decision that requires the use of vertebrate animals4 7#b7 ,explanation in case of order 7,a7 ,in general ,if the ,administrator issues an order under this section1 the ,administrator shall issue a statement providing a justification for why issuance of an order is warranted instead of promulgating a rule or entering into a testing consent agreement4 7,b7 ,contents ,a statement described in subparagraph 7,a7 shall contain a description of-- 7i7 information that is readily accessible to the ,administrator1 including information submitted under any other provision of law2 7ii7 the extent to which the ,administrator has obtained or attempted to obtain the information through voluntary submissions2 and 7iii7 any information relied on in safety assessments for other chemical substances relevant to the chemical substances that would be the subject of the order4 7c7 ,reduction of testing on vertebrates 7#a7 ,in general ,the ,administrator shall minimize1 to the extent practicable1 the use of vertebrate animals in testing of chemical substances or mixtures1 by-- 7,a7 encouraging and facilitating-- 7i7 the use of integrated and tiered testing and assessment strategies2 7ii7 the use of best available science in existence on the date on which the test is conducted2 7iii7 the use of test methods that eliminate or reduce the use of animals while providing information of high scientific quality2 7iv7 the grouping of #b or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide reliable and useful information on other chemical substances in the category2 7v7 the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests2 and 7vi7 the submission of information from-- 7,i7 animal-based studies2 and 7,,ii7 emerging methods and models2 and 7,b7 funding research and validation studies to reduce1 refine1 and replace the use of animal tests in accordance with this subsection4 7#b7 ,implementation of alternative testing methods ,to promote the development and timely incorporation of new testing methods that are not based on vertebrate animals1 the ,administrator shall-- 7,a7 after providing an opportunity for public comment1 develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information under this title that can reduce1 refine1 or replace the use of vertebrate animals1 including toxicity pathway-based risk assessment1 in vitro studies1 systems biology1 computational toxicology1 bioinformatics1 and high-throughput screening2 7,b7 as practicable1 ensure that the strategic plan developed under subparagraph 7,a7 is reflected in the development of requirements for testing under this section2 7,c7 beginning on the date that is #e years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act and every #e years thereafter1 submit to ,congress a report that describes the progress made in implementing this subsection and goals for future alternative test methods implementation2 and 7,d7 fund and carry out research1 development1 performance assessment1 and translational studies to accelerate the development of test methods and testing strategies that reduce1 refine1 or replace the use of vertebrate animals in any testing under this title4 7#c7 ,criteria for adapting or waiving animal testing requirements ,on request from a manufacturer or processor that is required to conduct testing of a chemical substance or mixture on vertebrate animals under this section1 the ,administrator may adapt or waive the requirement1 if the ,administrator determines that-- 7,a7 there is sufficient evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has1 or does not have1 a particular property if the information from each individual source alone is insufficient to support the conclusion2 7,b7 as a result of #a or more physical or chemical properties of the chemical substance or mixture or other toxicokinetic considerations-- 7i7 the substance cannot be absorbed2 or 7ii7 testing for a specific endpoint is technically not practicable to conduct2 or 7,c7 a chemical substance or mixture cannot be tested in vertebrate animals at concentrations that do not result in significant pain or distress1 because of physical or chemical properties of the chemical substance or mixture1 such as a potential to cause severe corrosion or severe irritation to the tissues of the animal4 7d7 ,testing requirements 7#a7 ,in general ,the ,administrator may require the development of information by-- 7,a7 manufacturers and processors of the chemical substance or mixture2 and 7,b7 persons that begin to manufacture or process the chemical substance or mixture-- 7i7 after the effective date of the rule1 testing consent agreement1 or order2 but 7ii7 subject to paragraph 7#c71 before the period ending on the date that is #ahj days after the end of the period described in this section4 7#b7 ,designation ,the ,administrator may permit #b or more persons identified in subparagraph 7,a7 or 7,b7 of paragraph 7#a7 to designate #a of the persons or a qualified third party-- 7,a7 to develop the information2 and 7,b7 to submit the information on behalf of the persons making the designation4 7#c7 ,exemptions 7,a7 ,in general ,a person otherwise subject to a rule1 testing consent agreement1 or order under this section may submit to the ,administrator an application for an exemption on the basis that the information is being developed by a person designated under paragraph 7#b74 7,b7 ,fair and equitable reimbursement to designee 7i7 ,in general ,if the ,administrator accepts an application submitted under subparagraph 7,a71 the ,administrator shall direct the applicant to provide to the person designated under paragraph 7#b7 fair and equitable reimbursement1 as agreed to between the applicant and the designee4 7ii7 ,arbitration ,if the applicant and a person designated under paragraph 7#b7 cannot reach agreement on the amount of fair and equitable reimbursement1 the amount shall be determined by arbitration4 7,c7 ,termination ,if1 after granting an exemption under this paragraph1 the ,administrator determines that a person covered by the exemption has failed to comply with the rule1 testing consent agreement1 or order1 the ,administrator shall-- 7i7 by order1 terminate the exemption2 and 7ii7 notify in writing each person that received an exemption of the requirements with respect to which the exemption was granted4 7e7 ,transparency ,subject to section #ad1 the ,administrator shall make available to the public all testing consent agreements and orders and all information submitted under this section4 4 7b7 ,conforming amendment ,section #ajd7;i77#e77;,a7 of the ,comprehensive ,environmental ,response1 ,compensation1 and ,liability ,act of #aihj 7#db ,u4,s4,c4 #ifjd7;i77#e77;,a77 is amended in the third sentence by striking section #d7;e7 and inserting section #d7;f74 #f4 ,prioritization screening ,the ,toxic ,substances ,control ,act is amended by inserting after section #d 7#ae ,u4,s4,c4 #bfjc7 the following3 #d;,a4 ,prioritization screening 7a7 ,establishment and list of substances 7#a7 ,in general ,not later than #a year after the date of enactment of this section1 the ,administrator shall establish1 by rule1 a risk-based screening process and explicit criteria for identifying existing chemical substances that are-- 7,a7 a high priority for a safety assessment and safety determination under section #f 7referred to in this ,act as high-priority substances72 and 7,b7 a low priority for a safety assessment and safety determination 7referred to in this ,act as low-priority substances74 7#b7 ,initial list of high- and low-priority substances 7,a7 ,in general ,before the date of promulgation of the rule under paragraph 7#a7 and not later than #ahj days after the date of enactment of this section1 the ,administrator-- 7i7 shall take into consideration and publish an initial list of high-priority substances and low-priority substances2 and 7ii7 pursuant to section #f7;b71 may initiate or continue safety assessments and safety determinations for those high-priority substances4 7,b7 ,requirements 7i7 ,in general ,the initial list of chemical substances shall contain at least #aj high-priority substances1 at least #e of which are drawn from the list of chemical substances identified by the ,administrator in the ,october1 #bjad ,,tsca ,work ,plan and subsequent updates1 and at least #aj low-priority substances4 7ii7 ,subsequently identified substances ,insofar as possible1 at least #ej percent of all substances subsequently identified by the ,administrator as high-priority substances shall be drawn from the list of chemical substances identified by the ,administrator in the ,october1 #bjad ,,tsca ,work ,plan and subsequent updates1 until all ,work ,plan chemicals have been designated under this subsection4 7,c7 ,additional chemical reviews ,the ,administrator shall-- 7i7 #c years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 add additional high-priority substances sufficient to ensure that at least a total of #bj high-priority substances have undergone or are undergoing the process established in section #f7;a71 and additional low-priority substances sufficient to ensure that at least a total of #bj low-priority substances have been designated2 and 7ii7 as soon as practicable and not later than #e years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 add additional high-priority substances sufficient to ensure that at least a total of #be high-priority substances have undergone or are undergoing the process established in section #f7;a71 and additional low-priority substances sufficient to ensure that at least a total of #be low-priority substances have been designated4 7#c7 ,implementation 7,a7 ,consideration of active and inactive substances 7i7 ,active substances ,in carrying out paragraph 7#a71 the ,administrator shall take into consideration active substances1 as determined under section #h1 which may include chemical substances on the interim list of active substances established under that section4 7ii7 ,inactive substances ,in carrying out paragraph 7#a71 the ,administrator may take into consideration inactive substances1 as determined under section #h1 that the ,administrator determines-- 7,i7 7aa7 have not been subject to a regulatory or other enforceable action by the ,administrator to ban or phase out the substances2 and 7bb7 have the potential for high hazard and widespread exposure2 or 7,,ii7 7aa7 have been subject to a regulatory or other enforceable action by the ,administrator to ban or phase out the substances2 and 7bb7 with respect to which there exists the potential for residual high hazards or widespread exposures not otherwise addressed by the regulatory or other action4 7iii7 ,repopulation 7,i7 ,in general ,on the completion of a safety determination under section #f for a chemical substance1 the ,administrator shall remove the chemical substance from the list of high-priority substances established under this subsection4 7,,ii7 ,additions ,the ,administrator shall add at least #a chemical substance to the list of high-priority substances for each chemical substance removed from the list of high-priority substances established under this subsection1 until a safety assessment and safety determination is completed for all high-priority substances4 7,,iii7 ,low-priority substances ,if a low-priority substance is subsequently designated as a high-priority substance1 the ,administrator shall remove that substance from the list of low-priority substances4 7,b7 ,timely completion of prioritization screening process 7i7 ,in general ,the ,administrator shall-- 7,i7 not later than #ahj days after the effective date of the final rule under paragraph 7#a71 begin the prioritization screening process2 and 7,,ii7 make every effort to complete the designation of all active substances as high-priority substances or low-priority substances in a timely manner4 7ii7 ,decisions on substances subject to testing for prioritization purposes ,not later than #ij days after the date of receipt of information regarding a chemical substance complying with a rule1 testing consent agreement1 or order issued under section #d7;a77#b71 the ,administrator shall designate the chemical substance as a high-priority substance or low-priority substance4 7iii7 ,consideration 7,i7 ,in general ,the ,administrator shall screen substances and designate high-priority substances taking into consideration the ability of the ,administrator to schedule and complete safety assessments and safety determinations under section #f in a timely manner4 7,,ii7 ,annual goal ,the ,administrator shall publish an annual goal for the number of chemical substances to be subject to the prioritization screening process4 7,c7 ,screening of categories of substances ,the ,administrator may screen categories of chemical substances to ensure an efficient prioritization screening process to allow for timely and adequate designations of high-priority substances and low-priority substances and safety assessments and safety determinations for high-priority substances4 7,d7 ,publication of list of chemical substances ,not less frequently than once each year1 the ,administrator shall publish a list of chemical substances that-- 7i7 are being considered in the prioritization screening process and the status of the chemical substances in the prioritization process1 including those chemical substances for which prioritization decisions have been deferred2 and 7ii7 are designated as high-priority substances or low-priority substances1 including the bases for such designations4 7#d7 ,criteria ,the criteria described in paragraph 7#a7 shall account for-- 7,a7 the recommendation of the ,governor of a ,state or a ,state agency with responsibility for protecting health or the environment from chemical substances appropriate for prioritization screening2 7,b7 the hazard and exposure potential of the chemical substance 7or category of substances71 including specific scientific classifications and designations by authoritative governmental entities2 7,c7 the conditions of use or significant changes in the conditions of use of the chemical substance2 7,d7 evidence and indicators of exposure potential to humans or the environment from the chemical substance1 including potentially exposed or susceptible populations2 7,e7 the volume of a chemical substance manufactured or processed2 7,f7 whether the volume of a chemical substance as reported under a rule promulgated pursuant to section #h7;a7 has significantly increased or decreased during the period beginning on the date of a previous report or the date on which a notice has been submitted under section #e7;b7 for that chemical substance2 7,g7 the availability of information regarding potential hazards and exposures required for conducting a safety assessment or safety determination1 with limited availability of relevant information to be a sufficient basis for designating a chemical substance as a high-priority substance1 subject to the condition that limited availability shall not require designation as a high-priority substance2 and 7,h7 the extent of ,federal or ,state regulation of the chemical substance or the extent of the impact of ,state regulation of the chemical substance on the ,united ,states1 with existing ,federal or ,state regulation of any uses evaluated in the prioritization screening process as a factor in designating a chemical substance to be a low-priority substance4 7b7 ,prioritization screening process and decisions 7#a7 ,in general ,the prioritization screening process developed under subsection 7a7 shall include a requirement that the ,administrator shall-- 7,a7 identify the chemical substances being considered for prioritization2 7,b7 request interested persons to supply information regarding the chemical substances being considered2 7,c7 apply the criteria identified in subsection 7a77#d72 and 7,d7 subject to paragraph 7#e7 and using the information available to the ,administrator at the time of the decision1 identify a chemical substance as a high-priority substance or a low-priority substance4 7#b7 ,integration of information ,the prioritization screening decision regarding a chemical substance shall integrate any hazard and exposure information relating to the chemical substance that is available to the ,administrator4 7#c7 ,identification of high-priority substances ,the ,administrator-- 7,a7 shall identify as a high-priority substance a chemical substance that1 relative to other chemical substances1 the ,administrator determines has the potential for high hazard and widespread exposure2 7,b7 may identify as a high-priority substance a chemical substance that1 relative to other chemical substances1 the ,administrator determines has the potential for high hazard or widespread exposure2 and 7,c7 may identify as a high-priority substance an inactive substance1 as determined under subsection 7a77#c77;,a77ii7 and section #h7;b71 that the ,administrator determines warrants a safety assessment and safety determination under section #f4 7#d7 ,identification of low-priority substances ,the ,administrator shall identify as a low-priority substance a chemical substance that the ,administrator concludes has information sufficient to establish that the chemical substance is likely to meet the applicable safety standard4 7#e7 ,deferring a decision ,if the ,administrator determines that additional information is required to establish the priority of a chemical substance under this section1 the ,administrator may defer the prioritization screening decision for a reasonable period-- 7,a7 to allow for the submission of additional information by an interested person and for the ,administrator to evaluate the additional information2 or 7,b7 to require the development of information pursuant to a rule1 testing consent agreement1 or order issued under section #d7;a77#b74 7#f7 ,deadlines for submission of information ,if the ,administrator requests the development or submission of information under this section1 the ,administrator shall establish a deadline for submission of the information4 7#g7 ,notice and comment ,the ,administrator shall-- 7,a7 publish the proposed decisions made under paragraphs 7#c71 7#d71 and 7#e7 and the basis for the decisions2 and 7,b7 provide an opportunity for public comment4 7#h7 ,revisions of prior designations 7,a7 ,in general ,at any time1 and at the discretion of the ,administrator1 the ,administrator may revise the designation of a chemical substance as a high-priority substance or a low-priority substance based on information available to the ,administrator after the date of the determination under paragraph 7#c7 or 7#d74 7,b7 ,limited availability ,if limited availability of relevant information was a basis in the designation of a chemical substance as a high-priority substance1 the ,administrator shall reevaluate the prioritization screening of the chemical substance on receiving the relevant information4 7#i7 ,other information relevant to prioritization 7,a7 ,in general ,if1 after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 a ,state proposes an administrative action or enacts a statute or takes an administrative action to prohibit or otherwise restrict the manufacturing1 processing1 distribution in commerce1 or use of a chemical substance that the ,administrator has not as designated a high-priority substance1 the ,governor or ,state agency with responsibility for implementing the statute or administrative action shall notify the ,administrator4 7,b7 ,requests for information ,following receipt of a notification provided under subparagraph 7,a71 the ,administrator may request any available information from the ,governor or the ,state agency with respect to-- 7i7 scientific evidence related to the hazards1 exposures and risks of the chemical substance under the conditions of use which the statute or administrative action is intended to address2 7ii7 any ,state or local conditions which warranted the statute or administrative action2 7iii7 the statutory or administrative authority on which the action is based2 and 7iv7 any other available information relevant to the prohibition or other restriction1 including information on any alternatives considered and their hazards1 exposures1 and risks4 7,c7 ,prioritization screening ,the ,administrator shall conduct a prioritization screening under this subsection for all substances that-- 7i7 are the subject of notifications received under subparagraph 7,a72 and 7ii7 the ,administrator determines-- 7,i7 are likely to have significant health or environmental impacts2 7,,ii7 are likely to have significant impact on interstate commerce2 or 7,,iii7 have been subject to a prohibition or other restriction under a statute or administrative action in #b or more ,states4 7,d7 ,availability to public ,subject to section #ad and any applicable ,state law regarding the protection of confidential information provided to the ,state or to the ,administrator1 the ,administrator shall make information received from a ,governor or ,state agency under subparagraph 7,a7 publicly available4 7,e7 ,effect of paragraph ,nothing in this paragraph shall preempt a ,state statute or administrative action1 require approval of a ,state statute or administrative action1 or apply section #ae to a ,state4 7#aj7 ,review ,not less frequently than once every #e years after the date on which the process under this subsection is established1 the ,administrator shall-- 7,a7 review the process on the basis of experience and taking into consideration resources available to efficiently and effectively screen and prioritize chemical substances2 and 7,b7 if necessary1 modify the prioritization screening process4 7#aa7 ,effect ,subject to section #ah1 a designation by the ,administrator under this section with respect to a chemical substance shall not affect-- 7,a7 the manufacture1 processing1 distribution in commerce1 use1 or disposal of the chemical substance2 or 7,b7 the regulation of those activities4 7c7 ,additional priorities for safety assessments and determinations 7#a7 ,in general ,the prioritization screening process developed under subsection 7a7 shall-- 7,a7 include a process by which a manufacturer or processor of an active chemical substance that has not been designated a high-priority substance1 or that has not been subject to or is not in the process of a prioritization screening by the ,administrator1 may request that the ,administrator designate the substance for a safety assessment and safety determination1 subject to the payment of fees pursuant to section #bf7;b77#c77;,e72 and 7,b7 provide guidance to submitters on the information to be provided in such requests1 and specify the criteria the ,administrator shall use to determine whether or not to grant such a request1 which shall include whether the substance is subject to restrictions imposed by statutes enacted or administrative actions taken by #a or more ,states on the manufacture1 processing1 distribution in commerce1 or use of the substance4 7#b7 ,preference ,subject to paragraph 7#c71 in deciding whether to grant requests under this subsection the ,administrator shall give a preference to requests concerning substances for which the ,administrator determines that restrictions imposed by #a or more ,states have the potential to have a significant impact on interstate commerce or health or the environment4 7#c7 ,limitations ,in considering whether to grant a request submitted under paragraph 7#a71 the ,administrator shall ensure that-- 7,a7 not more than #ae percent of the total number of substances designated to undergo safety assessments and safety determinations under this section are substances designated under the process and criteria pursuant to paragraph 7#a72 and 7,b7 the resources allocated to conducting safety assessments and safety determinations for additional priorities designated under this subsection are proportionate to the number of such substances relative to the total number of substances designated to undergo safety assessments and safety determinations under this section4 7#d7 ,requirements 7,a7 ,in general ,the public shall be provided notice and an opportunity to comment on requests submitted under this subsection4 7,b7 ,decision by ,administrator ,not later than #ahj days after the date on which the ,administrator receives a request under this subsection1 the ,administrator shall decide whether or not to grant the request4 7,c7 ,assessment and determination ,if the ,administrator grants a request under this subsection1 the safety assessment and safety determination-- 7i7 shall be conducted in accordance with the deadlines and other requirements of sections #c;,a7i7 and #f2 and 7ii7 shall not be expedited or otherwise subject to special treatment relative to high-priority substances designated pursuant to subsection 7b77#c7 that are undergoing safety assessments and safety determinations4 7#e7 ,exceptions ,requests granted under this subsection shall not be subject to subsection 7a77#c77;,a77iii7 or section #ah7;b74 4 #g4 ,new chemicals and significant new uses ,section #e of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjd7 is amended-- 7#a7 by striking the section designation and heading and inserting the following3 #e4 ,new chemicals and significant new uses 2 7#b7 by striking subsection 7b72 7#c7 by redesignating subsection 7a7 as subsection 7b72 7#d7 by redesignating subsection 7i7 as subsection 7a7 and moving the subsection so as to appear at the beginning of the section2 7#e7 in subsection 7b7 7as so redesignated7-- 7,a7 in the subsection heading1 by striking ,in general and inserting ,notices2 and 7,b7 in paragraph 7#a71 in the matter following subparagraph 7,b7-- 7i7 by striking subsection 7d7 and inserting subsection 7b72 and 7ii7 by striking and such person complies with any applicable requirement of subsection 7b72 7#f7 by redesignating subsections 7c7 and 7d7 as subsection 7d7 and 7c71 respectively1 and moving subsection 7c7 7as so redesigned7 so as appear after subsection 7b7 7as redesignated by paragraph 7#c772 7#g7 in subsection 7c7 7as so redesignated7-- 7,a7 by striking paragraph 7#a7 and inserting the following3 7#a7 ,in general ,the notice required by subsection 7a7 shall include1 with respect to a chemical substance-- 7,a7 the information required by sections #gbj4de and #gbj4ej of title #dj1 ,code of ,federal ,regulations 7or successor regulations72 and 7,b7 information regarding conditions of use and reasonably anticipated exposures4 2 7,b7 in paragraph 7#b7-- 7i7 in the matter preceding subparagraph 7,a71 by striking or of data under subsection 7b72 7ii7 in subparagraph 7,a71 by adding and after the semicolon at the end2 7iii7 in subparagraph 7,b71 by striking 2 and and inserting a period2 and 7iv7 by striking subparagraph 7,c72 and 7,c7 in paragraph 7#c71 by striking subsection 7a7 and for which the notification period prescribed by subsection 7a71 7b71 or 7c7 and inserting subsection 7b7 and for which the notification period prescribed by subsection 7b7 or 7d72 7#h7 by striking subsection 7d7 7as redesignated by paragraph 7#f77 and inserting the following3 7d7 ,review of notice 7#a7 ,initial review 7,a7 ,in general ,subject to subparagraph 7,b71 not later than #ij days after the date of receipt of a notice submitted under subsection 7b71 the ,administrator shall-- 7i7 conduct an initial review of the notice2 7ii7 as needed1 develop a profile of the relevant chemical substance and the potential for exposure to humans and the environment2 and 7iii7 make any necessary determination under paragraph 7#c74 7,b7 ,extension ,except as provided in paragraph 7#e71 the ,administrator may extend the period described in subparagraph 7,a7 for good cause for #a or more periods1 the total of which shall be not more than #ij days4 7#b7 ,information sources ,in evaluating a notice under paragraph 7#a71 the ,administrator shall take into consideration-- 7,a7 any relevant information identified in subsection 7c77#a72 and 7,b7 any other relevant additional information available to the ,administrator4 7#c7 ,determinations ,before the end of the applicable period for review under paragraph 7#a71 based on the information described in paragraph 7#b71 and subject to section #ah7;g71 the ,administrator shall determine that-- 7,a7 the relevant chemical substance or significant new use is not likely to meet the safety standard1 in which case the ,administrator shall take appropriate action under paragraph 7#d72 7,b7 the relevant chemical substance or significant new use is likely to meet the safety standard1 in which case the ,administrator shall allow the review period to expire without additional restrictions2 or 7,c7 additional information is necessary in order to make a determination under subparagraph 7,a7 or 7,b71 in which case the ,administrator shall take appropriate action under paragraph 7#e74 7#d7 ,restrictions 7,a7 ,determination by ,administrator 7i7 ,in general ,if the ,administrator makes a determination under subparagraph 7,a7 or 7,c7 of paragraph 7#c7 with respect to a notice submitted under subsection 7b7-- 7,i7 the ,administrator1 before the end of the applicable period for review under paragraph 7#a7 and by consent agreement or order1 as appropriate1 shall prohibit or otherwise restrict the manufacture1 processing1 use1 distribution in commerce1 or disposal 7as applicable7 of the chemical substance1 or of the chemical substance for a significant new use1 without compliance with the restrictions specified in the consent agreement or order that the ,administrator determines are sufficient to ensure that the chemical substance or significant new use is likely to meet the safety standard2 and 7,,ii7 no person may commence manufacture of the chemical substance1 or manufacture or processing of the chemical substance for a significant new use1 except in compliance with the restrictions specified in the consent agreement or order4 7ii7 ,likely to meet standard ,if the ,administrator makes a determination under subparagraph 7,b7 of paragraph 7#c7 with respect to a chemical substance or significant new use for which a notice was submitted under subsection 7b71 at the end of the applicable period for review under paragraph 7#a71 the submitter of the notice may commence manufacture for commercial purposes of the chemical substance or manufacture or processing of the chemical substance for a significant new use4 7,b7 ,requirements ,not later than #ij days after issuing a consent agreement or order under subparagraph 7,a71 the ,administrator shall-- 7i7 take into consideration whether to promulgate a rule pursuant to subsection 7b77#b7 that identifies as a significant new use any manufacturing1 processing1 use1 distribution in commerce1 or disposal of the chemical substance1 or of the chemical substance for a new use1 that is not in compliance with the restrictions imposed by the consent agreement or order2 and 7ii7 7,i7 initiate a rulemaking described in clause 7i72 or 7,,ii7 publish a statement describing the reasons of the ,administrator for not initiating a rulemaking4 7,c7 ,inclusions ,a prohibition or other restriction under subparagraph 7,a7 may include1 as appropriate-- 7i7 subject to section #ah7;g71 a requirement that a chemical substance shall be marked with1 or accompanied by1 clear and adequate minimum warnings and instructions with respect to use1 distribution in commerce1 or disposal1 or any combination of those activities1 with the form and content of the minimum warnings and instructions to be prescribed by the ,administrator2 7ii7 a requirement that manufacturers or processors of the chemical substance shall-- 7,i7 make and retain records of the processes used to manufacture or process1 as applicable1 the chemical substance2 or 7,,ii7 monitor or conduct such additional tests as are reasonably necessary to address potential risks from the manufacture1 processing1 distribution in commerce1 use1 or disposal1 as applicable1 of the chemical substance1 subject to section #d2 7iii7 a restriction on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce-- 7,i7 in general2 or 7,,ii7 for a particular use2 7iv7 a prohibition or other restriction of-- 7,i7 the manufacture1 processing1 or distribution in commerce of the chemical substance for a significant new use2 7,,ii7 any method of commercial use of the chemical substance2 or 7,,iii7 any method of disposal of the chemical substance2 or 7v7 a prohibition or other restriction on the manufacture1 processing1 or distribution in commerce of the chemical substance-- 7,i7 in general2 or 7,,ii7 for a particular use4 7,d7 ,workplace exposures ,the ,administrator shall consult with the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health prior to adopting any prohibition or other restriction under this subsection to address workplace exposures4 7,e7 ,definition of requirement ,for purposes of this ,act1 the term requirement as used in this section does not displace common law4 7#e7 ,additional information ,if the ,administrator determines under paragraph 7#c77;,c7 that additional information is necessary to conduct a review under this subsection1 the ,administrator-- 7,a7 shall provide an opportunity for the submitter of the notice to submit the additional information2 7,b7 may1 by agreement with the submitter1 extend the review period for a reasonable time to allow the development and submission of the additional information2 7,c7 may promulgate a rule1 enter into a testing consent agreement1 or issue an order under section #d to require the development of the information2 and 7,d7 on receipt of information the ,administrator finds supports the determination under paragraph 7#c71 shall promptly make the determination4 2 7#i7 by striking subsections 7e7 through 7g7 and inserting the following3 7e7 ,notice of commencement 7#a7 ,in general ,not later than #cj days after the date on which a manufacturer that has submitted a notice under subsection 7b7 commences nonexempt commercial manufacture of a chemical substance1 the manufacturer shall submit to the ,administrator a notice of commencement that identifies-- 7,a7 the name of the manufacturer2 and 7,b7 the initial date of nonexempt commercial manufacture4 7#b7 ,withdrawal ,a manufacturer or processor that has submitted a notice under subsection 7b71 but that has not commenced nonexempt commercial manufacture or processing of the chemical substance1 may withdraw the notice4 7f7 ,further evaluation ,the ,administrator may review a chemical substance under section #d;,a at any time after the ,administrator receives-- 7#a7 a notice of commencement for a chemical substance under subsection 7c72 or 7#b7 new information regarding the chemical substance4 7g7 ,transparency ,subject to section #ad1 the ,administrator shall make available to the public-- 7#a7 all notices1 determinations1 consent agreements1 rules1 and orders of the ,administrator2 and 7#b7 all information submitted or issued under this section4 2 and 7#aj7 in subsection 7h7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking 7a7 or2 7,b7 by striking paragraph 7#b72 7,c7 by redesignating paragraphs 7#c7 through 7#f7 as paragraphs 7#b7 through 7#e71 respectively2 7,d7 in paragraph 7#b7 7as so redesignated71 in the matter preceding subparagraph 7,a71 by striking subsections 7a7 and 7b7 and inserting subsection 7b72 7,e7 in paragraph 7#c7 7as so redesignated7-- 7i7 in the first sentence1 by striking will not present an unreasonable risk of injury to health or the environment and inserting will meet the safety standard2 and 7ii7 by striking the second sentence2 7,f7 in paragraph 7#d7 7as so redesignated71 by striking subsections 7a7 and 7b7 and inserting subsection 7b72 and 7,g7 in paragraph 7#e7 7as so redesignated71 in the first sentence1 by striking paragraph 7#a7 or 7#e7 and inserting paragraph 7#a7 or 7#d74 #h4 ,safety assessments and safety determinations ,section #f of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfje7 is amended-- 7#a7 by striking the section designation and heading and inserting the following3 #f4 ,safety assessments and safety determinations 2 7#b7 by redesignating subsections 7e7 and 7f7 as subsections 7g7 and 7h71 respectively2 7#c7 by striking subsections 7a7 through 7d7 and inserting the following3 7a7 ,in general ,the ,administrator-- 7#a7 shall conduct a safety assessment and make a safety determination of each high-priority substance in accordance with subsections 7b7 and 7c72 7#b7 shall1 as soon as practicable and not later than #f months after the date on which a chemical substance is designated as a high-priority substance1 define the scope of the safety assessment and safety determination to be conducted pursuant to this section1 including the hazards1 exposures1 conditions of use1 and potentially exposed or susceptible populations that the ,administrator expects to consider2 7#c7 as appropriate based on the results of a safety determination1 shall establish restrictions pursuant to subsection 7d72 7#d7 shall complete a safety assessment and safety determination not later than #c years after the date on which a chemical substance is designated as a high-priority substance2 7#e7 shall promulgate a final rule pursuant to subsection 7d7 by not later than #b years after the date on which the safety determination is completed2 and 7#f7 may extend any deadline under this subsection for a reasonable period of time after an adequate public justification1 subject to the condition that the aggregate length of all extensions of deadlines under paragraphs 7#d7 and 7#e7 and any deferral under subsection 7c77#b7 does not exceed #b years4 7b7 ,prior actions 7#a7 ,prior-initiated assessments 7,a7 ,in general ,nothing in this ,act prevents the ,administrator from initiating a safety assessment or safety determination regarding a chemical substance1 or from continuing or completing such a safety assessment or safety determination that was initiated before the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 prior to the effective date of the policies and procedures required to be established by the ,administrator under section #c;,a or #d;,a4 7,b7 ,integration of prior policies and procedures ,as policies and procedures under section #c;,a and #d;,a are established1 to the maximum extent practicable1 the ,administrator shall integrate the policies and procedures into ongoing safety assessments and safety determinations4 7#b7 ,actions completed prior to completion of policies and procedures ,nothing in this ,act requires the ,administrator to revise or withdraw a completed safety assessment1 safety determination1 or rule solely because the action was completed prior to the completion of a policy or procedure established under section #c;,a or #d;,a1 and the validity of a completed assessment1 determination1 or rule shall not be determined based on the content of such a policy or procedure4 7c7 ,safety determinations 7#a7 ,in general ,based on a review of the information available to the ,administrator1 including draft safety assessments submitted by interested persons1 and subject to section #ah1 the ,administrator shall determine that-- 7,a7 the relevant chemical substance meets the safety standard2 7,b7 the relevant chemical substance does not meet the safety standard1 in which case the ,administrator shall1 by rule under subsection 7d7-- 7i7 impose restrictions necessary to ensure that the chemical substance meets the safety standard under the conditions of use2 or 7ii7 if the safety standard cannot be met with the application of restrictions1 ban or phase out the chemical substance1 as appropriate2 or 7,c7 additional information is necessary in order to make a determination under subparagraph 7,a7 or 7,b71 in which case the ,administrator shall take appropriate action under paragraph 7#b74 7#b7 ,additional information ,if the ,administrator determines that additional information is necessary to make a safety assessment or safety determination for a high-priority substance1 the ,administrator-- 7,a7 shall provide an opportunity for interested persons to submit the additional information2 7,b7 may promulgate a rule1 enter into a testing consent agreement1 or issue an order under section #d to require the development of the information2 7,c7 may defer1 for a reasonable period consistent with the deadlines described in subsection 7a71 a safety assessment and safety determination until after receipt of the information2 and 7,d7 consistent with the deadlines described in subsection 7a71 on receipt of information the ,administrator finds supports the safety assessment and safety determination1 shall make a determination under paragraph 7#a74 7#c7 ,establishment of deadline ,in requesting the development or submission of information under this section1 the ,administrator shall establish a deadline for the submission of the information4 7d7 ,rule 7#a7 ,implementation ,if the ,administrator makes a determination under subsection 7c77#a77;,b7 with respect to a chemical substance1 the ,administrator shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard4 7#b7 ,scope ,the rule promulgated pursuant to this subsection-- 7,a7 may-- 7i7 apply to mixtures containing the chemical substance1 as appropriate2 and 7ii7 exempt replacement parts for articles manufactured prior to the applicable compliance deadline2 and 7,b7 shall include dates by which compliance is mandatory1 which-- 7i7 shall be as soon as practicable2 and 7ii7 as determined by the ,administrator1 may vary for different affected persons4 7,c7 ,workplace exposures ,the ,administrator shall consult with the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health before adopting any prohibition or other restriction under this subsection to address workplace exposures4 7,d7 ,definition of requirement ,for the purposes of this ,act1 the term requirement as used in this section does not displace common law4 7#c7 ,restrictions ,a restriction under paragraph 7#a7 may include1 as appropriate-- 7,a7 subject to section #ah1 a requirement that a chemical substance shall be marked with1 or accompanied by1 clear and adequate minimum warnings and instructions with respect to use1 distribution in commerce1 or disposal1 or any combination of those activities1 with the form and content of the minimum warnings and instructions to be prescribed by the ,administrator2 7,b7 a requirement that manufacturers or processors of the chemical substance shall-- 7i7 make and retain records of the processes used to manufacture or process the chemical substance2 7ii7 describe and apply the relevant quality control procedures followed in the manufacturing or processing of the substance2 or 7iii7 monitor or conduct tests that are reasonably necessary to ensure compliance with the requirements of any rule under this subsection2 7,c7 a restriction on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce2 7,d7 a requirement to ban or phase out1 or any other rule regarding1 the manufacture1 processing1 or distribution in commerce of the chemical substance for-- 7i7 a particular use2 7ii7 a particular use at a concentration in excess of a level specified by the ,administrator2 or 7iii7 all uses2 7,e7 a restriction on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce for-- 7i7 a particular use2 or 7ii7 a particular use at a concentration in excess of a level specified by the ,administrator2 7,f7 a requirement to ban1 phase out1 or otherwise restrict any method of commercial use of the chemical substance2 7,g7 a requirement to ban1 phase out1 or otherwise restrict any method of disposal of the chemical substance or any article containing the chemical substance2 and 7,h7 a requirement directing manufacturers or processors of the chemical substance to give notice of the ,administrator's determination under subsection 7c77#a77;,b7 to distributors in commerce of the chemical substance and1 to the extent reasonably ascertainable1 to other persons in the chain of commerce in possession of the chemical substance4 7#d7 ,analysis for rulemaking 7,a7 ,considerations ,in deciding which restrictions to impose under paragraph 7#c7 as part of developing a rule under paragraph 7#a71 the ,administrator shall take into consideration1 to the extent practicable based on reasonably available information1 the quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the #a or more primary alternative regulatory actions considered by the ,administrator4 7,b7 ,alternatives ,as part of the analysis1 the ,administrator shall review any #a or more technically and economically feasible alternatives to the chemical substance that the ,administrator determines are relevant to the rulemaking4 7,c7 ,public availability ,in proposing a rule under paragraph 7#a71 the ,administrator shall make publicly available any analysis conducted under this paragraph4 7,d7 ,statement required ,in making final a rule under paragraph 7#a71 the ,administrator shall include a statement describing how the analysis considered under subparagraph 7,a7 was taken into account4 7#e7 ,exemptions 7,a7 ,in general ,the ,administrator may exempt #a or more uses of a chemical substance from any restriction in a rule promulgated under paragraph 7#a7 if the ,administrator determines that-- 7i7 the rule cannot be complied with1 without-- 7,i7 harming national security2 7,,ii7 causing significant disruption in the national economy due to the lack of availability of a chemical substance2 or 7,,iii7 interfering with a critical or essential use for which no technically and economically feasible safer alternative is available1 taking into consideration hazard and exposure2 or 7ii7 the use of the chemical substance1 as compared to reasonably available alternatives1 provides a substantial benefit to health1 the environment1 or public safety4 7,b7 ,exemption analysis ,in proposing a rule under paragraph 7#a7 that includes an exemption under this paragraph1 the ,administrator shall make publicly available any analysis conducted under this paragraph to assess the need for the exemption4 7,c7 ,statement required ,in making final a rule under paragraph 7#a7 that includes an exemption under this paragraph1 the ,administrator shall include a statement describing how the analysis considered under subparagraph 7,b7 was taken into account4 7,d7 ,analysis in case of ban or phase-out ,in determining whether an exemption should be granted under this paragraph for a chemical substance for which a ban or phase-out is proposed1 the ,administrator shall take into consideration1 to the extent practicable based on reasonably available information1 the quantifiable and nonquantifiable costs and benefits of the #a or more technically and economically feasible alternatives to the chemical substance most likely to be used in place of the chemical substance under the conditions of use if the rule is promulgated4 7,e7 ,conditions ,as part of a rule promulgated under paragraph 7#a71 the ,administrator shall include conditions in any exemption established under this paragraph1 including reasonable recordkeeping1 monitoring1 and reporting requirements1 to the extent that the ,administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption4 7,f7 ,duration 7i7 ,in general ,the ,administrator shall establish1 as part of a rule under paragraph 7#a7 that contains an exemption under this paragraph1 a time limit on any exemption for a time to be determined by the ,administrator as reasonable on a case-by-case basis4 7ii7 ,authority of ,administrator ,the ,administrator1 by rule1 may extend1 modify1 or eliminate the exemption if the ,administrator determines1 on the basis of reasonably available information and after adequate public justification1 the exemption warrants extension or is no longer necessary4 7iii7 ,considerations 7,i7 ,in general ,subject to subclause 7,,ii71 the ,administrator shall issue exemptions and establish time periods by considering factors determined by the ,administrator to be relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard4 7,,ii7 ,limitation ,any renewal of an exemption in the case of a rule requiring the ban or phase-out of a chemical substance shall not exceed #e years4 7e7 ,immediate effect ,the ,administrator may declare a proposed rule under subsection 7d7 to be effective on publication of the rule in the ,federal ,register and until the effective date of final action taken respecting the rule1 if-- 7#a7 the ,administrator determines that-- 7,a7 the manufacture1 processing1 distribution in commerce1 use1 or disposal of the chemical substance or mixture subject to the proposed rule or any combination of those activities is likely to result in an unreasonable risk of serious or widespread harm to health or the environment before the effective date2 and 7,b7 making the proposed rule so effective is necessary to protect the public interest2 and 7#b7 in the case of a proposed rule to prohibit the manufacture1 processing1 or distribution of a chemical substance or mixture because of the risk determined under paragraph 7#a77;,a71 a court has granted relief in an action under section #g with respect to that risk associated with the chemical substance or mixture4 7f7 ,final agency action ,under this section and subject to section #ah-- 7#a7 a safety determination1 and the associated safety assessment1 for a chemical substance that the ,administrator determines under subsection 7c7 meets the safety standard1 shall be considered to be a final agency action1 effective beginning on the date of issuance of the final safety determination2 and 7#b7 a final rule promulgated under subsection 7d71 and the associated safety assessment and safety determination that a chemical substance does not meet the safety standard1 shall be considered to be a final agency action1 effective beginning on the date of promulgation of the final rule4 2 and 7#d7 in subsection 7g7 7as redesignated by paragraph 7#b77-- 7,a7 by striking paragraph 7#d72 and 7,b7 by redesignating paragraph 7#e7 as paragraph 7#d74 #i4 ,imminent hazards ,section #g of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjf7 is amended-- 7#a7 by striking subsection 7a7 and inserting the following3 7a7 ,civil actions 7#a7 ,in general ,the ,administrator may commence a civil action in an appropriate ,united ,states district court for-- 7,a7 seizure of an imminently hazardous chemical substance or mixture or any article containing the chemical substance or mixture2 7,b7 relief 7as authorized by subsection 7b77 against any person that manufactures1 processes1 distributes in commerce1 uses1 or disposes of1 an imminently hazardous chemical substance or mixture or any article containing the chemical substance or mixture2 or 7,c7 both seizure described in subparagraph 7,a7 and relief described in subparagraph 7,b74 7#b7 ,rule1 order1 or other proceeding ,a civil action may be commenced under this paragraph1 notwithstanding-- 7,a7 the existence of-- 7i7 a decision by the ,administrator under section #d;,a1 #e7;d77#c71 or #f7;c77#a72 or 7ii7 a rule1 testing consent agreement1 or order under section #d1 #e7;d77#d71 #f7;d71 or #f7;h72 or 7,b7 the pendency of any administrative or judicial proceeding under any provision of this ,act4 2 7#b7 in subsection 7d71 by striking section #f7;a7 and inserting section #f7;c72 and 7#c7 in subsection 7f71 in the first sentence1 by striking and unreasonable4 #aj4 ,information collection and reporting ,section #h of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjg7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#c77;,a77ii77,i7-- 7i7 by striking #e7;b77#d7 and inserting #e2 7ii7 by inserting section #d or after in effect under2 and 7iii7 by striking #e7;e71 and inserting #e7;d77#d722 and 7,b7 by adding at the end the following3 7#d7 ,rules 7,a7 ,deadline 7i7 ,in general ,not later than #b years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the ,administrator shall promulgate rules requiring the maintenance of records and the reporting of information known or reasonably ascertainable by the person making the report1 including rules requiring processors to report information1 so that the ,administrator has the information necessary to carry out sections #d and #f4 7ii7 ,modification of prior rules ,in carrying out this subparagraph1 the ,administrator may modify1 as appropriate1 rules promulgated before the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act4 7,b7 ,contents ,the rules promulgated pursuant to subparagraph 7,a7-- 7i7 may impose different reporting and recordkeeping requirements on manufacturers and processors2 and 7ii7 shall include the level of detail necessary to be reported1 including the manner by which use and exposure information may be reported4 7,c7 ,administration ,in implementing the reporting and recordkeeping requirements under this paragraph1 the ,administrator shall take measures-- 7i7 to limit the potential for duplication in reporting requirements2 7ii7 to minimize the impact of the rules on small manufacturers and processors2 and 7iii7 to apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title4 7#e7 ,guidance ,the ,administrator shall develop guidance relating to the information required to be reported under the rules promulgated under this subsection4 2 7#b7 in subsection 7b71 by adding at the end the following3 7#c7 ,nomenclature 7,a7 ,in general ,in carrying out paragraph 7#a71 the ,administrator shall-- 7i7 maintain the use of ,class #b nomenclature in use on the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act2 7ii7 maintain the use of the ,soap and ,detergent ,association ,nomenclature ,system1 published in ,march #aigh by the ,administrator in section #a of addendum ,,iii of the document entitled ,candidate ,list of ,chemical ,substances1 and further described in the appendix ,a of volume ,i of the #aihe edition of the ,toxic ,substances ,control ,act ,substances ,inventory 7,,epa ,document ,no4 ,,epa-#efj_/g-he-jjb;a72 and 7iii7 treat all components of categories that are considered to be statutory mixtures under this ,act as being included on the list published under paragraph 7#a7 under the ,chemical ,abstracts ,service numbers for the respective categories1 including1 without limitation-- 7,i7 cement1 ,portland1 chemicals1 ,,cas ,no4 #feiig-ae-a2 7,,ii7 cement1 alumina1 chemicals1 ,,cas ,no4 #feiig-af-b2 7,,iii7 glass1 oxide1 chemicals1 ,,cas ,no4 #feiig-ag-c2 7,,iv7 frits1 chemicals1 ,,cas ,no4 #feiig-ah-d2 7,v7 steel manufacture1 chemicals1 ,,cas ,no4 #feiig-ai-e2 and 7,,vi7 ceramic materials and wares1 chemicals1 ,,cas ,no4 #ffdjb-fh-d4 7,b7 ,multiple nomenclature conventions 7i7 ,in general ,if an existing guidance allows for multiple nomenclature conventions1 the ,administrator shall-- 7,i7 maintain the nomenclature conventions for substances2 and 7,,ii7 develop new guidance that-- 7aa7 establishes equivalency between the nomenclature conventions for chemical substances on the list published under paragraph 7#a72 and 7bb7 permits persons to rely on the new guidance for purposes of determining whether a chemical substance is on the list published under paragraph 7#a74 7ii7 ,multiple ,,cas numbers ,for any chemical substance appearing multiple times on the list under different ,chemical ,abstracts ,service numbers1 the ,administrator shall develop guidance recognizing the multiple listings as a single chemical substance4 7#d7 ,chemical substances in commerce 7,a7 ,rules 7i7 ,in general ,not later than #a year after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the ,administrator1 by rule1 shall require manufacturers and processors to notify the ,administrator1 by not later than #ahj days after the date of promulgation of the rule1 of each chemical substance on the list published under paragraph 7#a7 that the manufacturer or processor1 as applicable1 has manufactured or processed for a nonexempt commercial purpose during the #aj-year period ending on the day before the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act4 7ii7 ,active substances ,the ,administrator shall1 pursuant to paragraph 7#e77;,a71 designate chemical substances for which notices are received under clause 7i7 to be active substances on the list published under paragraph 7#a74 7,b7 ,confidential chemical substances ,the rule promulgated by the ,administrator pursuant to subparagraph 7,a7 shall require-- 7i7 the ,administrator to maintain the list under paragraph 7#a71 which shall include a confidential portion and a nonconfidential portion consistent with this section and section #ad2 7ii7 a manufacturer or processor that is submitting a notice pursuant to subparagraph 7,a7 for a chemical substance on the confidential portion of the list published under paragraph 7#a7 to indicate in the notice whether the manufacturer or processor seeks to maintain any existing claim for protection against disclosure of the specific identity of the substance as confidential pursuant to section #ad2 and 7iii7 the substantiation of those claims pursuant to section #ad and in accordance with the review plan described in subparagraph 7,c74 7,c7 ,review plan ,not later than #a year after the date on which the ,administrator compiles the initial list of active substances pursuant to subparagraph 7,a71 the ,administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific identities of chemical substances on the confidential portion of the list published under paragraph 7#a7 that are notified pursuant to subparagraph 7,a7 or identified as active substances under subsection 7f77#a74 7,d7 ,requirements of review plan ,the review plan under subparagraph 7,c7 shall-- 7i7 require1 at the time requested by the ,administrator1 all manufacturers or processors asserting claims under subparagraph 7,b7 to substantiate the claim unless the manufacturer or processor has substantiated the claim in a submission made to the ,administrator during the #e-year period ending on the date of the request by the ,administrator2 7ii7 require the ,administrator1 in accordance with section #ad-- 7,i7 to review each substantiation-- 7aa7 submitted pursuant to clause 7i7 to determine if the claim warrants protection from disclosure2 and 7bb7 submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause 7i71 if the substantiation has not been previously reviewed by the ,administrator1 to determine if the claim warrants protection from disclosure2 7,,ii7 approve1 modify1 or deny each claim2 and 7,,iii7 except as provided in this section and section #ad1 protect from disclosure information for which the ,administrator approves such a claim for a period of #aj years1 unless1 prior to the expiration of the period-- 7aa7 the person notifies the ,administrator that the person is withdrawing the confidentiality claim1 in which case the ,administrator shall promptly make the information available to the public2 or 7bb7 the ,administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated1 in which case the ,administrator shall take the actions described in section #ad7;g77#b72 and 7iii7 encourage manufacturers or processors that have previously made claims to protect the specific identities of chemical substances identified as inactive pursuant to subsection 7f77#b7 to review and either withdraw or substantiate the claims4 7,e7 ,timeline for completion of reviews 7i7 ,in general ,the ,administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph 7,c7 not later than #e years after the date on which the ,administrator compiles the initial list of active substances pursuant to subparagraph 7,a74 7ii7 ,considerations 7,i7 ,in general ,the ,administrator may extend the deadline for completion of the reviews for not more than #b additional years1 after an adequate public justification1 if the ,administrator determines that the extension is necessary based on the number of applicable claims needing review and the available resources4 7,,ii7 ,annual goal ,the ,administrator shall publish an annual goal for the number of reviews to be completed over the course of implementation of the plan4 7#e7 ,active and inactive substances 7,a7 ,in general ,the ,administrator shall maintain and keep current designations of active substances and inactive substances on the list published under paragraph 7#a74 7,b7 ,update ,the ,administrator shall update the list of chemical substances designated as active substances as soon as practicable after the date of publication of the most recent data reported under-- 7i7 part #gaa of title #dj1 ,code of ,federal ,regulations 7or successor regulations72 and 7ii7 the rules promulgated pursuant to subsection 7a77#d74 7,c7 ,change to active status 7i7 ,in general ,any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the ,administrator before the date on which the inactive substance is manufactured or processed4 7ii7 ,confidential chemical identity claims ,if a person submitting a notice under clause 7i7 for an inactive substance on the confidential portion of the list published under paragraph 7#a7 seeks to maintain an existing claim for protection against disclosure of the specific identity of the inactive substance as confidential1 the person shall-- 7,i7 in the notice submitted under clause 7i71 assert the claim2 and 7,,ii7 by not later than #cj days after providing the notice under clause 7i71 substantiate the claim4 7iii7 ,active status ,on receiving a notification under clause 7i71 the ,administrator shall-- 7,i7 designate the applicable chemical substance as an active substance2 7,,ii7 pursuant to section #ad1 promptly review any claim and associated substantiation submitted pursuant to clause 7ii7 for protection against disclosure of the specific identity of the chemical substance and approve1 modify1 or deny the claim2 7,,iii7 except as provided in this section and section #ad1 protect from disclosure the specific identity of the chemical substance for which the ,administrator approves a claim under subclause 7,,ii7 for a period of not less than #aj years1 unless1 prior to the expiration of the period-- 7aa7 the person notifies the ,administrator that the person is withdrawing the confidentiality claim1 in which case the ,administrator shall promptly make the information available to the public2 or 7bb7 the ,administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated1 in which case the ,administrator shall take the actions described in section #ad7;g77#b72 and 7,,iv7 pursuant to section #d;,a1 review the priority of the chemical substance as the ,administrator determines to be necessary4 7,d7 ,category status ,the list of inactive substances shall not be considered to be a category for purposes of section #bf7;c74 7#f7 ,interim list of active substances ,prior to the promulgation of the rule required under this subsection1 the ,administrator shall designate the chemical substances reported under part #gaa of title #dj1 ,code of ,federal ,regulations 7or successor regulations71 during the reporting period that most closely preceded the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 as the interim list of active substances for the purposes of section #d;,a4 7#g7 ,public participation ,subject to this subsection1 the ,administrator shall make available to the public-- 7,a7 the specific identity of each chemical substance on the nonconfidential portion of the list published under paragraph 7#a7 that the ,administrator has designated as-- 7i7 an active substance2 or 7ii7 an inactive substance2 7,b7 the accession number1 generic name1 and1 if applicable1 premanufacture notice case number for each chemical substance on the confidential portion of the list published under paragraph 7#a7 for which a claim of confidentiality was received and approved by the ,administrator pursuant to section #ad2 and 7,c7 subject to section #ad7;g71 the specific identity of any active substance for which-- 7i7 no claim of protection against disclosure of the specific identity of the active substance pursuant to this subsection was received2 7ii7 a claim for protection against disclosure of the specific identity of the active substance has been denied by the ,administrator2 or 7iii7 the time period for protection against disclosure of the specific identity of the active substance has expired4 7#h7 ,limitation ,no person may assert a new claim under this subsection for protection from disclosure of a specific identity of any active or inactive chemical substance for which a notice is received under paragraph 7#d77;,a77i7 or 7#e77;,c77i7 that is not on the confidential portion of the list published under paragraph 7#a74 7#i7 ,certification ,under the rule promulgated under this subsection1 manufacturers and processors shall be required-- 7,a7 to certify that each report the manufacturer or processor submits complies with the requirements of the rule1 and that any confidentiality claims are true and correct2 and 7,b7 to retain a record supporting the certification for a period of #e years beginning on the last day of the submission period4 2 7#c7 in subsection 7e7-- 7,a7 by striking ,any person and inserting the following3 7#a7 ,in general ,any person 2 and 7,b7 by adding at the end the following3 7#b7 ,applicability ,any person may submit to the ,administrator information reasonably supporting the conclusion that a chemical substance or mixture presents1 will present1 or does not present a substantial risk of harm to health and the environment4 2 and 7#d7 in subsection 7f71 by striking ,for purposes of this section1 the and inserting the following3 ,in this section3 7#a7 ,active substance ,the term active substance means a chemical substance-- 7,a7 that has been manufactured or processed for a nonexempt commercial purpose at any point during the #aj-year period ending on the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act2 7,b7 that is added to the list published under subsection 7b77#a7 after that date of enactment2 or 7,c7 for which a notice is received under subsection 7b77#e77;,c74 7#b7 ,inactive substance ,the term inactive substance means a chemical substance on the list published under subsection 7b77#a7 that does not meet any of the criteria described in paragraph 7#a74 7#c7 ,manufacture2 process ,the 4 #aa4 ,relationship to other ,federal laws ,section #i of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjh7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 in the first sentence-- 7i7 by striking presents or will present an unreasonable risk to health or the environment and inserting does not meet the safety standard2 and 7ii7 by striking such risk the first place it appears and inserting the risk posed by the substance or mixture2 7,b7 in paragraph 7#b71 in the matter following subparagraph 7,b71 by striking section #f or #g and inserting section #f7;d7 or section #g2 and 7,c7 in paragraph 7#c71 by striking section #f or #g and inserting section #f7;d7 or #g2 7#b7 in subsection 7d71 in the first sentence1 by striking ,health1 ,education1 and ,welfare and inserting ,health and ,human ,services2 and 7#c7 by adding at the end the following3 7e7 ,exposure information ,if the ,administrator obtains information related to exposures or releases of a chemical substance that may be prevented or reduced under another ,federal law1 including laws not administered by the ,administrator1 the ,administrator shall make such information available to the relevant ,federal agency or office of the ,environmental ,protection ,agency4 4 #ab4 ,research1 development1 collection1 dissemination1 and utilization of data ,section #aj of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfji7 is amended by striking ,health1 ,education1 and ,welfare each place it appears and inserting ,health and ,human ,services4 #ac4 ,exports ,section #ab of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfaa7 is amended-- 7#a7 in subsection 7a71 by striking paragraph 7#b7 and inserting the following3 7#b7 ,exception ,paragraph 7#a7 shall not apply to any chemical substance that the ,administrator determines-- 7,a7 under section #e is not likely to meet the safety standard2 or 7,b7 under section #f does not meet the safety standard4 7#c7 ,waivers ,for a mixture or article containing a chemical substance described in paragraph 7#b71 the ,administrator may-- 7,a7 determine that paragraph 7#a7 shall not apply to the mixture or article2 or 7,b7 establish a threshold concentration in a mixture or article at which paragraph 7#a7 shall not apply4 7#d7 ,testing ,the ,administrator may require testing under section #d of any chemical substance or mixture exempted from this ,act under paragraph 7#a7 for the purpose of determining whether the chemical substance or mixture meets the safety standard within the ,united ,states4 2 7#b7 by striking subsection 7b7 and inserting the following3 7b7 ,notice 7#a7 ,in general ,a person shall notify the ,administrator that the person is exporting or intends to export to a foreign country-- 7,a7 a chemical substance or a mixture containing a chemical substance that the ,administrator has determined under section #e is not likely to meet the safety standard and for which a prohibition or other restriction has been proposed or established under that section2 7,b7 a chemical substance or a mixture containing a chemical substance that the ,administrator has determined under section #f does not meet the safety standard and for which a prohibition or other restriction has been proposed or established under that section2 7,c7 a chemical substance for which the ,united ,states is obligated by treaty to provide export notification2 7,d7 a chemical substance or mixture subject to a prohibition or other restriction pursuant to a rule1 order1 or consent agreement in effect under this ,act2 or 7,e7 a chemical substance or mixture for which the submission of information is required under section #d4 7#b7 ,rules 7,a7 ,in general ,the ,administrator shall promulgate rules to carry out paragraph 7#a74 7,b7 ,contents ,the rules promulgated pursuant to subparagraph 7,a7 shall-- 7i7 include such exemptions as the ,administrator determines to be appropriate1 which may include exemptions identified under section #e7;h72 and 7ii7 indicate whether1 or to what extent1 the rules apply to articles containing a chemical substance or mixture described in paragraph 7#a74 7#c7 ,notification ,the ,administrator shall submit to the government of each country to which a chemical substance or mixture is exported-- 7,a7 for a chemical substance or mixture described in subparagraph 7,a71 7,b71 or 7,d7 of paragraph 7#a71 a notice of the determination1 rule1 order1 consent agreement1 requirement1 or designation2 7,b7 for a chemical substance described in paragraph 7#a77;,c71 a notice that satisfies the obligation of the ,united ,states under the applicable treaty2 and 7,c7 for a chemical substance or mixture described in paragraph 7#a77;,e71 a notice of availability of the information on the chemical substance or mixture submitted to the ,administrator4 2 and 7#c7 in subsection 7c7-- 7,a7 by striking paragraph 7#c72 and 7,b7 by redesignating paragraphs 7#d7 through 7#f7 as paragraphs 7#c7 through 7#e71 respectively4 #ad4 ,imports ,section #ac of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfab7 is amended to read as follows3 #ac4 ,imports 7a7 ,refusal of entry 7#a7 ,in general ,the ,secretary of ,homeland ,security shall refuse entry into the customs territory of the ,united ,states 7as defined in general note #b to the ,harmonized ,tariff ,schedule of the ,united ,states7 any chemical substance1 mixture1 or article containing a chemical substance or mixture offered for such entry1 if-- 7,a7 the ,administrator-- 7i7 has determined under section #f7;c7 that the chemical substance or mixture does not meet the safety standard2 and 7ii7 has promulgated a rule pursuant to section #f7;d7 banning the chemical substance or mixture1 as of the effective date of the rule2 7,b7 the chemical substance-- 7i7 is not included on the list under section #h7;b77#a72 and 7ii7 is not exempt from any requirement to be included on that list by this title or a rule promulgated by the ,administrator pursuant to this title2 or 7,c7 the chemical substance1 mixture1 or any article containing the chemical substance or mixture is offered for entry in violation of-- 7i7 a rule1 consent agreement1 or order in effect under this ,act2 or 7ii7 an order issued in a civil action brought under section #g or title ,,iv4 7#b7 ,procedure 7,a7 ,in general ,subject to subparagraph 7,b71 if a chemical substance1 mixture1 or article containing a chemical substance or mixture is refused entry under paragraph 7#a71 the ,secretary of ,homeland ,security-- 7i7 shall notify the consignee of the entry of the refusal2 7ii7 shall not release the chemical substance or mixture to the consignee2 and 7iii7 shall cause the disposal or storage of the chemical substance or mixture under such rules as the ,secretary may prescribe1 if the chemical substance or mixture has not been exported by the consignee during the #ij-;day period beginning on the date of receipt of the notice of the refused entry4 7,b7 ,exception 7i7 ,in general ,the ,secretary of ,homeland ,security1 pending a review by the ,administrator1 may release to the consignee the chemical substance or mixture if the consignee-- 7,i7 executes a bond for the amount of the full invoice of the chemical substance or mixture 7as set forth in the customs entry72 and 7,,ii7 pays a duty on the chemical substance or mixture4 7ii7 ,administration ,if a consignee fails to return a chemical substance or mixture released to that consignee under clause 7i7 for any cause to the custody of the ,secretary of ,homeland ,security on demand1 the consignee shall be liable to the ,united ,states for liquidated damages equal to the full amount of the bond executed under clause 7i77,i74 7,c7 ,storage ,all charges for storage1 cartage1 and labor on or for the disposal of a chemical substance or mixture that is refused entry or released under this subsection shall be paid by the owner or consignee1 and a default on that payment shall constitute a lien against any future entry made by the owner or consignee4 7b7 ,certification 7#a7 ,in general ,a person offering a chemical substance or mixture subject to this ,act for entry into the customs territory of the ,united ,states shall certify to the ,secretary of ,homeland ,security that-- 7,a7 after reasonable inquiry and to the best knowledge and belief of the person1 the chemical substance or mixture is in compliance with any applicable rule1 consent agreement1 or order under section #e or #f2 and 7,b7 the chemical substance-- 7i7 is included on the list under section #h7;b77#a72 or 7ii7 is exempt from any requirement to be included on that list by this title or a rule promulgated by the ,administrator pursuant to this title4 7#b7 ,articles 7,a7 ,in general ,the ,administrator1 by rule1 may require certification under paragraph 7#a7 for an article containing a chemical substance or mixture that is subject to rule under section #e or #f4 7,b7 ,requirement ,the rule under subparagraph 7,a7 shall identify1 with reasonable specificity1 the types of articles1 including parts or components of articles1 that will be subject to the certification requirement4 7,c7 ,factors for consideration ,in determining the need for and content of a certification rule under this paragraph1 the ,administrator shall take into consideration-- 7i7 the utility of the certification to enforcement of the applicable rule1 consent agreement1 or order under section #e or #f2 7ii7 the contribution of imported articles to the potential risk presented by exposure to the chemical substance or mixture subject to rule under section #e or #f2 7iii7 the impact on commerce and potential for the certification to impede or disrupt import of articles2 7iv7 the frequency or duration of the certification requirement2 and 7v7 specification of the concentration of a chemical substance in an article that would subject the article to the certification requirement4 7#c7 ,reasonable inquiry 7,a7 ,in general ,for purposes of a certification under paragraph 7#a71 reasonable inquiry shall include good faith reliance by an importer on-- 7i7 a safety data sheet or similar declaration provided by a supplier that documents the specific identity of the chemical substance or the specific identities of all chemical substances in a mixture2 or 7ii7 for chemical substances or mixtures claimed by the supplier as confidential1 or not otherwise disclosed by the supplier1 a certification by the supplier that the imported chemical substance or mixture satisfies the applicable certification requirements under paragraph 7#a74 7,b7 ,articles ,for purposes of a certification under paragraph 7#b71 reasonable inquiry shall include good faith reliance by an importer on a certification by the supplier that the imported article satisfies the applicable certification requirements in a rule promulgated pursuant to paragraph 7#b74 7#d7 ,information regarding identity ,for purposes of this subsection1 the ,administrator shall provide publicly accessible information regarding the identity of a chemical substance or mixture subject to rule under this ,act that would be readily understood in import transactions4 7c7 ,notice ,a person offering a chemical substance for entry into the customs territory of the ,united ,states shall notify the ,secretary of ,homeland ,security if-- 7#a7 the chemical substance or chemical substance in a mixture is a high-priority substance2 7#b7 the chemical substance or chemical substance in a mixture is #a for which the ,united ,states is obligated to provide export notification by treaty2 or 7#c7 the chemical substance or chemical substance in a mixture-- 7,a7 is the subject of a safety assessment and safety determination conducted pursuant to section #f2 and 7,b7 has been found not to meet the safety standard4 7d7 ,rules 7#a7 ,in general ,the ,secretary of ,homeland ,security1 after consultation with the ,administrator1 shall promulgate rules to carry out this section4 7#b7 ,application ,the rules under paragraph 7#a7 may modify the application of any requirement of this section1 as appropriate for the efficient and effective implementation of this ,act4 4 #ae4 ,confidential information ,section #ad of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfac7 is amended to read as follows3 #ad4 ,confidential information 7a7 ,in general ,except as otherwise provided in this section1 the ,administrator shall not disclose information that is exempt from disclosure pursuant to subsection 7a7 of section #eeb of title #e1 ,united ,states ,code1 under subsection 7b77#d7 of that section-- 7#a7 that is reported to1 or otherwise obtained by1 the ,administrator under this ,act2 and 7#b7 for which the requirements of subsection 7d7 are met4 7b7 ,information generally protected from disclosure ,the following information specific to1 and submitted by1 a manufacturer1 processor1 or distributor that meets the requirements of subsections 7a7 and 7d7 shall be presumed to be protected from disclosure1 subject to the condition that nothing in this ,act prohibits the disclosure of any such information through discovery1 subpoena1 other court order1 or any other judicial process otherwise allowed under applicable ,federal or ,state law3 7#a7 ,specific information describing the processes used in manufacture or processing of a chemical substance1 mixture1 or article4 7#b7 ,marketing and sales information4 7#c7 ,information identifying a supplier or customer4 7#d7 ,details of the full composition of a mixture and the respective percentages of constituents4 7#e7 ,specific information regarding the use1 function1 or application of a chemical substance or mixture in a process1 mixture1 or product4 7#f7 ,specific production or import volumes of the manufacturer and specific aggregated volumes across manufacturers1 if the ,administrator determines that disclosure of the specific aggregated volumes would reveal confidential information4 7#g7 ,except as otherwise provided in this section1 the specific identity of a chemical substance prior to the date on which the chemical substance is first offered for commercial distribution1 including the chemical name1 molecular formula1 ,chemical ,abstracts ,service number1 and other information that would identify a specific chemical substance1 if-- 7,a7 the specific identity was claimed as confidential information at the time it was submitted in a notice under section #e2 and 7,b7 the claim-- 7i7 is not subject to an exception under subsection 7e72 or 7ii7 has not subsequently been withdrawn or found by the ,administrator not to warrant protection as confidential information under subsection 7f77#b7 or 7g74 7c7 ,information not protected from disclosure ,notwithstanding subsections 7a7 and 7b71 the following information shall not be protected from disclosure3 7#a7 ,information from health and safety studies 7,a7 ,in general ,subject to subparagraph 7,b71 subsection 7a7 does not prohibit the disclosure of-- 7i7 any health and safety study that is submitted under this ,act with respect to-- 7,i7 any chemical substance or mixture that1 on the date on which the study is to be disclosed1 has been offered for commercial distribution2 or 7,,ii7 any chemical substance or mixture for which-- 7aa7 testing is required under section #d2 or 7bb7 a notification is required under section #e2 or 7ii7 any information reported to1 or otherwise obtained by1 the ,administrator from a health and safety study relating to a chemical substance or mixture described in subclause 7,i7 or 7,,ii7 of clause 7i74 7,b7 ,effect of paragraph ,nothing in this paragraph authorizes the release of any information that discloses-- 7i7 a process used in the manufacturing or processing of a chemical substance or mixture2 or 7ii7 in the case of a mixture1 the portion of the mixture comprised by any chemical substance in the mixture4 7#b7 ,certain requests ,if a request is made to the ,administrator under section #eeb7;a7 of title #e1 ,united ,states ,code1 for information that is described in paragraph 7#a7 that is not described in paragraph 7#a77;,b71 the ,administrator may not deny the request on the basis of section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7#c7 ,other information not protected from disclosure ,the following information is not protected from disclosure under this section3 7,a7 ,for information submitted after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the specific identity of a chemical substance as of the date on which the chemical substance is first offered for commercial distribution1 if the person submitting the information does not meet the requirements of subsection 7d74 7,b7 ,a safety assessment developed1 or a safety determination made1 under section #f4 7,c7 ,any general information describing the manufacturing volumes1 expressed as specific aggregated volumes or1 if the ,administrator determines that disclosure of specific aggregated volumes would reveal confidential information1 expressed in ranges4 7,d7 ,a general description of a process used in the manufacture or processing and industrial1 commercial1 or consumer functions and uses of a chemical substance1 mixture1 or article containing a chemical substance or mixture1 including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector4 7#d7 ,mixed confidential and nonconfidential information ,any information that is otherwise eligible for protection under this section and contained in a submission of information described in this subsection shall be protected from disclosure1 if the submitter complies with subsection 7d71 subject to the condition that information in the submission that is not eligible for protection against disclosure shall be disclosed4 7#e7 ,ban or phase-out ,if the ,administrator promulgates a rule pursuant to section #f7;d7 that establishes a ban or phase-out of the manufacture1 processing1 or distribution in commerce of a chemical substance-- 7,a7 any protection from disclosure provided under this section with respect to information relating to the chemical substance shall no longer apply2 and 7,b7 the ,administrator promptly shall make the information public4 7d7 ,requirements for confidentiality claims 7#a7 ,assertion of claims 7,a7 ,in general ,a person seeking to protect any information submitted under this ,act from disclosure 7including information described in subsection 7b77 shall assert to the ,administrator a claim for protection concurrent with submission of the information1 in accordance with such rules regarding a claim for protection from disclosure as the ,administrator has promulgated or may promulgate pursuant to this title4 7,b7 ,inclusion ,an assertion of a claim under subparagraph 7,a7 shall include a statement that the person has-- 7i7 taken reasonable measures to protect the confidentiality of the information2 7ii7 determined that the information is not required to be disclosed or otherwise made available to the public under any other ,federal law2 7iii7 a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person2 and 7iv7 a reasonable basis to believe that the information is not readily discoverable through reverse engineering4 7,c7 ,specific chemical identity ,in the case of a claim under subparagraph 7,a7 for protection against disclosure of a specific chemical identity1 the claim shall include a structurally descriptive generic name for the chemical substance that the ,administrator may disclose to the public1 subject to the condition that the generic name shall-- 7i7 conform with guidance prescribed by the ,administrator under paragraph 7#c77;,a72 and 7ii7 describe the chemical structure of the substance as specifically as practicable while protecting those features of the chemical structure-- 7,i7 that are considered to be confidential2 and 7,,ii7 the disclosure of which would be likely to harm the competitive position of the person4 7,d7 ,public information ,no person may assert a claim under this section for protection from disclosure of information that is already publicly available4 7#b7 ,additional requirements for confidentiality claims ,except for information described in paragraphs 7#a7 through 7#g7 of subsection 7b71 a person asserting a claim to protect information from disclosure under this ,act shall substantiate the claim1 in accordance with the rules promulgated and guidance issued by the ,administrator4 7#c7 ,guidance ,the ,administrator shall develop guidance regarding-- 7,a7 the determination of structurally descriptive generic names1 in the case of claims for the protection against disclosure of specific chemical identity2 and 7,b7 the content and form of the statements of need and agreements required under paragraphs 7#d71 7#e71 and 7#f7 of subsection 7e74 7#d7 ,certification ,an authorized official of a person described in paragraph 7#a77;,a7 shall certify that the information that has been submitted is true and correct4 7e7 ,exceptions to protection from disclosure ,information described in subsection 7a7 shall be disclosed if-- 7#a7 the information is to be disclosed to an officer or employee of the ,united ,states in connection with the official duties of the officer or employee-- 7,a7 under any law for the protection of health or the environment2 or 7,b7 for a specific law enforcement purpose2 7#b7 the information is to be disclosed to a contractor of the ,united ,states and employees of that contractor-- 7,a7 if1 in the opinion of the ,administrator1 the disclosure is necessary for the satisfactory performance by the contractor of a contract with the ,united ,states for the performance of work in connection with this ,act2 and 7,b7 subject to such conditions as the ,administrator may specify2 7#c7 the ,administrator determines that disclosure is necessary to protect health or the environment2 7#d7 the information is to be disclosed to a ,state or political subdivision of a ,state1 on written request1 for the purpose of development1 administration1 or enforcement of a law1 if-- 7,a7 #a or more applicable agreements with the ,administrator that conform with the guidance issued under subsection 7d77#c77;,b7 ensure that the recipient will take appropriate measures1 and has adequate authority1 to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the ,administrator to safeguard the information2 and 7,b7 the ,administrator notifies the person that submitted the information that the information has been disclosed to the ,state or political subdivision of a ,state2 7#e7 a health or environmental professional employed by a ,federal or ,state agency or a treating physician or nurse in a nonemergency situation provides a written statement of need and agrees to sign a written confidentiality agreement with the ,administrator1 subject to the conditions that-- 7,a7 the statement of need and confidentiality agreement shall conform with the guidance issued under subsection 7d77#c77;,b72 7,b7 the written statement of need shall be a statement that the person has a reasonable basis to suspect that-- 7i7 the information is necessary for1 or will assist in-- 7,i7 the diagnosis or treatment of #a or more individuals2 or 7,,ii7 responding to an environmental release or exposure2 and 7ii7 #a or more individuals being diagnosed or treated have been exposed to the chemical substance concerned1 or an environmental release or exposure has occurred2 and 7,c7 the confidentiality agreement shall provide that the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need1 except as otherwise may be authorized by the terms of the agreement or by the person submitting the information to the ,administrator1 except that nothing in this ,act prohibits the disclosure of any such information through discovery1 subpoena1 other court order1 or any other judicial process otherwise allowed under applicable ,federal or ,state law2 7#f7 in the event of an emergency1 a treating physician1 nurse1 agent of a poison control center1 public health or environmental official of a ,state or political subdivision of a ,state1 or first responder 7including any individual duly authorized by a ,federal agency1 ,state1 or political subdivision of a ,state who is trained in urgent medical care or other emergency procedures1 including a police officer1 firefighter1 or emergency medical technician7 requests the information1 subject to the conditions that-- 7,a7 the treating physician1 nurse1 agent1 public health or environmental official of a ,state or a political subdivision of a ,state1 or first responder shall have a reasonable basis to suspect that-- 7i7 a medical or public health or environmental emergency exists2 7ii7 the information is necessary for1 or will assist in1 emergency or first-aid diagnosis or treatment2 or 7iii7 #a or more individuals being diagnosed or treated have likely been exposed to the chemical substance concerned1 or a serious environmental release of or exposure to the chemical substance concerned has occurred2 7,b7 if requested by the person submitting the information to the ,administrator1 the treating physician1 nurse1 agent1 public health or environmental official of a ,state or a political subdivision of a ,state1 or first responder shall1 as described in paragraph 7#e7-- 7i7 provide a written statement of need2 and 7ii7 agree to sign a confidentiality agreement2 and 7,c7 the written confidentiality agreement or statement of need shall be submitted as soon as practicable1 but not necessarily before the information is disclosed2 7#g7 the ,administrator determines that disclosure is relevant in a proceeding under this ,act1 subject to the condition that the disclosure shall be made in such a manner as to preserve confidentiality to the maximum extent practicable without impairing the proceeding2 7#h7 the information is to be disclosed1 on written request of any duly authorized congressional committee1 to that committee2 or 7#i7 the information is required to be disclosed or otherwise made public under any other provision of ,federal law4 7f7 ,duration of protection from disclosure 7#a7 ,in general 7,a7 ,information protected from disclosure ,subject to paragraph 7#b71 the ,administrator shall protect from disclosure information that meets the requirements of subsection 7d7 for a period of #aj years1 unless1 prior to the expiration of the period-- 7i7 an affected person notifies the ,administrator that the person is withdrawing the confidentiality claim1 in which case the ,administrator shall promptly make the information available to the public2 or 7ii7 the ,administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated1 in which case the ,administrator shall take the actions described in subsection 7g77#b74 7,b7 ,extensions 7i7 ,in general ,not later than the date that is #fj days before the expiration of the period described in subparagraph 7,a71 the ,administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period4 7ii7 ,statement 7,i7 ,in general ,not later than the date that is #cj days before the expiration of the period described in subparagraph 7,a71 a person reasserting the relevant claim shall submit to the ,administrator a statement substantiating1 in accordance with subsection 7d77#b71 the need to extend the period4 7,,ii7 ,action by ,administrator ,not later than the date that is #cj days after the date of receipt of a statement under subclause 7,i71 the ,administrator shall-- 7aa7 review the request2 7bb7 make a determination regarding whether the information for which the request is made continues to meet the relevant criteria established under this section2 and 7cc7 7,,aa7 grant an extension of not more than #aj years2 or 7,,bb7 deny the claim4 7,c7 ,no limit on number of extensions ,there shall be no limit on the number of extensions granted under subparagraph 7,b71 if the ,administrator determines that the relevant statement under subparagraph 7,b77ii77,i7-- 7i7 establishes the need to extend the period2 and 7ii7 meets the requirements established by the ,administrator4 7#b7 ,review and resubstantiation 7,a7 ,discretion of ,administrator ,the ,administrator may review1 at any time1 a claim for protection against disclosure under subsection 7a7 for information submitted to the ,administrator regarding a chemical substance and require any person that has claimed protection for that information1 whether before1 on1 or after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section-- 7i7 after the chemical substance is identified as a high-priority substance under section #d;,a2 7ii7 for any chemical substance for which the ,administrator has made a determination under section #f7;c77#a77;,c72 7iii7 for any inactive chemical substance identified under section #h7;b77#e72 or 7iv7 in limited circumstances1 if the ,administrator determines that disclosure of certain information currently protected from disclosure would assist the ,administrator in conducting safety assessments and safety determinations under subsections 7b7 and 7c7 of section #f or promulgating rules pursuant to section #f7;d71 subject to the condition that the information shall not be disclosed unless the claimant withdraws the claim or the ,administrator determines that the information does not meet the requirements of subsection 7d74 7,b7 ,review required ,the ,administrator shall review a claim for protection from disclosure under subsection 7a7 for information submitted to the ,administrator regarding a chemical substance and require any person that has claimed protection for that information1 whether before1 on1 or after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section-- 7i7 as necessary to comply with a request for information received by the ,administrator under section #eeb of title #e1 ,united ,states ,code2 7ii7 if information available to the ,administrator provides a basis that the requirements of section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 are no longer met2 or 7iii7 for any substance for which the ,administrator has made a determination under section #f7;c77#a77;,b74 7,c7 ,action by recipient ,if the ,administrator makes a request under subparagraph 7,a7 or 7,b71 the recipient of the request shall-- 7i7 reassert and substantiate or resubstantiate the claim2 or 7ii7 withdraw the claim4 7,d7 ,period of protection ,protection from disclosure of information subject to a claim that is reviewed and approved by the ,administrator under this paragraph shall be extended for a period of #aj years from the date of approval1 subject to any subsequent request by the ,administrator under this paragraph4 7#c7 ,unique identifier ,the ,administrator shall-- 7,a7 7i7 develop a system to assign a unique identifier to each specific chemical identity for which the ,administrator approves a request for protection from disclosure1 other than a specific chemical identity or structurally descriptive generic term2 and 7ii7 apply that identifier consistently to all information relevant to the applicable chemical substance2 7,b7 annually publish and update a list of chemical substances1 referred to by unique identifier1 for which claims to protect the specific chemical identity from disclosure have been approved1 including the expiration date for each such claim2 7,c7 ensure that any nonconfidential information received by the ,administrator with respect to such a chemical substance during the period of protection from disclosure-- 7i7 is made public2 and 7ii7 identifies the chemical substance using the unique identifier2 and 7,d7 for each claim for protection of specific chemical identity that has been denied by the ,administrator on expiration of the period for appeal under subsection 7g77#c71 that has expired1 or that has been withdrawn by the submitter1 provide public access to the specific chemical identity clearly linked to all nonconfidential information received by the ,administrator with respect to the chemical substance4 7g7 ,duties of ,administrator 7#a7 ,determination 7,a7 ,in general ,except as provided in subsection 7b71 the ,administrator shall1 subject to subparagraph 7,c71 not later than #ij days after the receipt of a claim under subsection 7d71 and not later than #cj days after the receipt of a request for extension of a claim under subsection 7f71 review and approve1 modify1 or deny the claim or request4 7,b7 ,denial or modification 7i7 ,in general ,except as provided in subsections 7c7 and 7f71 the ,administrator shall deny a claim to protect a chemical identity from disclosure only if the person that has submitted the claim fails to meet the requirements of subsections 7a7 and 7d74 7ii7 ,reasons for denial or modification ,the ,administrator shall provide to a person that has submitted a claim described in clause 7i7 a written statement of the reasons for the denial or modification of the claim4 7,c7 ,subsets ,the ,administrator shall-- 7i7 except for claims described in subsection 7b77#g71 review all claims under this section for the protection against disclosure of the specific identity of a chemical substance2 and 7ii7 review a representative subset1 comprising at least #be percent1 of all other claims for protection against disclosure4 7,d7 ,effect of failure to act ,the failure of the ,administrator to make a decision regarding a claim for protection against disclosure or extension under this section shall not be the basis for denial or elimination of a claim for protection against disclosure4 7#b7 ,notification 7,a7 ,in general ,except as provided in subparagraph 7,b7 and subsections 7c71 7e71 and 7f71 if the ,administrator denies or modifies a claim under paragraph 7#a71 the ,administrator shall notify1 in writing and by certified mail1 the person that submitted the claim of the intent of the ,administrator to release the information4 7,b7 ,release of information 7i7 ,in general ,except as provided in clause 7ii71 the ,administrator shall not release information under this subsection until the date that is #cj days after the date on which the person that submitted the request receives notification under subparagraph 7,a74 7ii7 ,exceptions 7,i7 ,in general ,for information under paragraph 7#c7 or 7#h7 of subsection 7e71 the ,administrator shall not release that information until the date that is #ae days after the date on which the person that submitted the claim receives a notification1 unless the ,administrator determines that release of the information is necessary to protect against an imminent and substantial harm to health or the environment1 in which case no prior notification shall be necessary4 7,,ii7 ,no notification ,for information under paragraph 7#a71 7#b71 7#f71 7#g71 or 7#i7 of subsection 7e71 no prior notification shall be necessary4 7#c7 ,appeals 7,a7 ,in general ,if a person receives a notification under paragraph 7#b7 and believes disclosure of the information is prohibited under subsection 7a71 before the date on which the information is to be released1 the person may bring an action to restrain disclosure of the information in-- 7i7 the ,united ,states district court of the district in which the complainant resides or has the principal place of business2 or 7ii7 the ,united ,states ,district ,court for the ,district of ,columbia4 7,b7 ,no disclosure ,the ,administrator shall not disclose any information that is the subject of an appeal under this section before the date on which the applicable court rules on an action under subparagraph 7,a74 7#d7 ,administration ,in carrying out this subsection1 the ,administrator shall use the procedures described in part #b of title #dj1 ,code of ,federal ,regulations 7or successor regulations74 7h7 ,criminal penalty for wrongful disclosure 7#a7 ,officers and employees of ,united ,states 7,a7 ,in general ,subject to paragraph 7#b71 a current or former officer or employee of the ,united ,states described in subparagraph 7,b7 shall be guilty of a misdemeanor and fined under title #ah1 ,united ,states ,code1 or imprisoned for not more than #a year1 or both4 7,b7 ,description ,a current or former officer or employee of the ,united ,states referred to in subparagraph 7,a7 is a current or former officer or employee of the ,united ,states who-- 7i7 by virtue of that employment or official position has obtained possession of1 or has access to1 material the disclosure of which is prohibited by subsection 7a72 and 7ii7 knowing that disclosure of that material is prohibited by subsection 7a71 willfully discloses the material in any manner to any person not entitled to receive that material4 7#b7 ,other laws ,section #aije of title #ah1 ,united ,states ,code1 shall not apply with respect to the publishing1 divulging1 disclosure1 making known of1 or making available1 information reported or otherwise obtained under this ,act4 7#c7 ,contractors ,for purposes of this subsection1 any contractor of the ,united ,states that is provided information in accordance with subsection 7e77#b71 including any employee of that contractor1 shall be considered to be an employee of the ,united ,states4 7i7 ,applicability 7#a7 ,in general ,except as otherwise provided in this section1 section #h1 or any other applicable ,federal law1 the ,administrator shall have no authority-- 7,a7 to require the substantiation or resubstantiation of a claim for the protection from disclosure of information submitted to the ,administrator under this ,act before the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act2 or 7,b7 to impose substantiation or resubstantiation requirements under this ,act that are more extensive than those required under this section4 7#b7 ,prior actions ,nothing in this ,act prevents the ,administrator from reviewing1 requiring substantiation or resubstantiation for1 or approving1 modifying or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the ,administrator may promulgate after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act4 4 #af4 ,prohibited acts ,section #ae of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfad7 is amended by striking paragraph 7#a7 and inserting the following3 7#a7 fail or refuse to comply with-- 7,a7 any rule promulgated1 consent agreement entered into1 or order issued under section #d2 7,b7 any requirement under section #e or #f2 7,c7 any rule promulgated1 consent agreement entered into1 or order issued under section #e or #f2 or 7,d7 any requirement of1 or any rule promulgated or order issued pursuant to title ,,ii2 4 #ag4 ,penalties ,section #af of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfae7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 in the first sentence-- 7i7 by inserting this ,act or a rule or order promulgated or issued pursuant to this ,act1 including after a provision of2 and 7ii7 by striking #be1jjj and inserting #cg1ejj2 and 7,b7 in the second sentence1 by striking violation of section #ae or #dji and inserting violation of this ,act2 and 7#b7 in subsection 7b7-- 7,a7 by striking ,any person who and inserting the following3 7#a7 ,in general ,any person that 2 7,b7 by striking section #ae or #dji and inserting this ,act2 7,c7 by striking #be1jjj and inserting #ej1jjj2 and 7,d7 by adding at the end the following3 7#b7 ,imminent danger of death or serious bodily injury 7,a7 ,in general ,any person that knowingly or willfully violates any provision of this ,act1 and that knows at the time of the violation that the violation places an individual in imminent danger of death or serious bodily injury1 shall be subject on conviction to a fine of not more than #bej1jjj1 or imprisonment for not more than #ae years1 or both4 7,b7 ,organizations ,an organization that commits a violation described in subparagraph 7,a7 shall be subject on conviction to a fine of not more than #a1jjj1jjj for each violation4 7#c7 ,knowledge of imminent danger or injury ,for purposes of determining whether a defendant knew that the violation placed another individual in imminent danger of death or serious bodily injury-- 7,a7 the defendant shall be responsible only for actual awareness or actual belief possessed2 and 7,b7 knowledge possessed by an individual may not be attributed to the defendant4 4 #ah4 ,state-,federal relationship ,section #ah of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfag7 is amended by striking subsections 7a7 and 7b7 and inserting the following3 7a7 ,in general 7#a7 ,establishment or enforcement ,except as provided in subsections 7c71 7d71 7e71 7f71 and 7g71 and subject to paragraph 7#b71 no ,state or political subdivision of a ,state may establish or continue to enforce any of the following3 7,a7 ,testing and information collection ,a statute or administrative action to require the development of information on a chemical substance or category of substances that is reasonably likely to produce the same information required under section #d1 #e1 or #f in-- 7i7 a rule promulgated by the ,administrator2 7ii7 a testing consent agreement entered into by the ,administrator2 or 7iii7 an order issued by the ,administrator4 7,b7 ,chemical substances found to meet the safety standard or restricted ,a statute or administrative action to prohibit or otherwise restrict the manufacture1 processing1 or distribution in commerce or use of a chemical substance-- 7i7 found to meet the safety standard and consistent with the scope of the determination made under section #f2 or 7ii7 found not to meet the safety standard1 after the effective date of the rule issued under section #f7;d7 for the substance1 consistent with the scope of the determination made by the ,administrator4 7,c7 ,significant new use ,a statute or administrative action requiring the notification of a use of a chemical substance that the ,administrator has specified as a significant new use and for which the ,administrator has required notification pursuant to a rule promulgated under section #e4 7#b7 ,effective date of preemption ,under this subsection1 ,federal preemption of ,state statutes and administrative actions applicable to specific substances shall not occur until the effective date of the applicable action described in paragraph 7#a7 taken by the ,administrator4 7b7 ,new statutes or administrative actions creating prohibitions or other restrictions ,except as provided in subsections 7c71 7d71 and 7e71 no ,state or political subdivision of a ,state may establish 7after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act7 a statute or administrative action prohibiting or restricting the manufacture1 processing1 distribution in commerce or use of a chemical substance that is a high-priority substance designated under section #d;,a1 as of the date on which the ,administrator commences a safety assessment under section #f4 7c7 ,scope of preemption ,federal preemption under subsections 7a7 and 7b7 of ,state statutes and administrative actions applicable to specific substances shall apply only to-- 7#a7 the chemical substances or category of substances subject to a rule1 order1 or consent agreement under section #d2 7#b7 the uses or conditions of use of such substances that are identified by the ,administrator as subject to review in a safety assessment and included in the scope of the safety determination made by the ,administrator for the substance1 or of any rule the ,administrator promulgates pursuant to section #f7;d72 or 7#c7 the uses of such substances that the ,administrator has specified as significant new uses and for which the ,administrator has required notification pursuant to a rule promulgated under section #e4 7d7 ,exceptions 7#a7 ,in general ,subsections 7a7 and 7b7 shall not apply to a statute or administrative action of a ,state or a political subdivision of a ,state applicable to a specific chemical substance that-- 7,a7 is adopted under the authority of1 or authorized to comply with1 any other ,federal law2 7,b7 implements a reporting1 monitoring1 or other information collection obligation for the chemical substance not otherwise required by the ,administrator under this ,act or required under any other ,federal law2 or 7,c7 is adopted pursuant to authority under a law of the ,state or political subdivision of the ,state related to water quality1 air quality1 or waste treatment or disposal1 unless the action taken by the ,state or political subdivision of a ,state-- 7i7 imposes a restriction on the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 and 7ii7 7,i7 is already required by a decision by the ,administrator under section #e or #f2 7,,ii7 is taken to address a health or environmental concern that applies to the uses or conditions of use that are included in the scope of a safety determination pursuant to section #f or the scope of a significant new use rule promulgated pursuant to section #e1 but is inconsistent with the action of the ,administrator2 or 7,,iii7 would cause a violation of the applicable action by the ,administrator under section #e or #f4 7#b7 ,no preemption of ,state statutes and administrative actions ,nothing in this ,act1 nor any amendment made by this ,act1 nor any rule1 standard of performance1 safety determination1 or scientific assessment implemented pursuant to this ,act1 shall affect the right of a ,state or a political subdivision of a ,state to adopt or enforce any rule1 standard of performance1 safety determination1 scientific assessment1 or any protection for public health or the environment that-- 7,a7 is adopted under the authority of1 or authorized to comply with1 any other ,federal law2 7,b7 implements a reporting1 monitoring1 or other information collection obligation for the chemical substance not otherwise required by the ,administrator under this ,act or required under any other ,federal law2 or 7,c7 is adopted pursuant to authority under a law of the ,state or political subdivision of the ,state related to water quality1 air quality1 or waste treatment or disposal1 unless the action taken by the ,state or political subdivision of a ,state-- 7i7 imposes a restriction on the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 and 7ii7 7,i7 is already required by a decision by the ,administrator under section #e or #f2 7,,ii7 is taken to address a health or environmental concern that applies to the uses or conditions of use that are included in the scope of a safety determination pursuant to section #f or the scope of a significant new use rule promulgated pursuant to section #e1 but is inconsistent with the action of the ,administrator2 or 7,,iii7 would cause a violation of the applicable action by the ,administrator under section #e or #f4 7#c7 ,applicability to certain rules or orders ,notwithstanding subsection 7e7-- 7,a7 nothing in this section shall be construed as modifying the effect under this section1 as in effect on the day before the effective date of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 of any rule or order promulgated or issued under this ,act prior to that effective date2 and 7,b7 with respect to a chemical substance or mixture for which any rule or order was promulgated or issued under section #f prior to the effective date of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act with regards to manufacturing1 processing1 distribution in commerce1 use1 or disposal of a chemical substance1 this section 7as in effect on the day before the effective date of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act7 shall govern the preemptive effect of any rule or order that is promulgated or issued respecting such chemical substance or mixture under section #f of this ,act after that effective date1 unless the latter rule or order is with respect to a chemical substance or mixture containing a chemical substance and follows a designation of that chemical substance as a high-priority substance under subsection 7b7 or 7c7 of section #d;,a or as an additional priority for safety assessment and safety determination under section #d;,a7d74 7e7 ,preservation of certain ,state law 7#a7 ,in general ,nothing in this ,act1 subject to subsection 7g7 of this section1 shall-- 7,a7 be construed to preempt or otherwise affect any action taken before ,january #a1 #bjae1 under the authority of a ,state law that prohibits or otherwise restricts manufacturing1 processing1 distribution in commerce1 use1 or disposal of a chemical substance2 or 7,b7 be construed to preempt or otherwise affect any action taken pursuant to a ,state law that was in effect on ,august #ca1 #bjjc4 7#b7 ,effect of subsection ,this subsection does not affect1 modify1 or alter the relationship between ,state and ,federal law pursuant to any other ,federal law4 7f7 ,state waivers 7#a7 ,in general ,upon application of a ,state or political subdivision of a ,state1 the ,administrator may-- 7,a7 by rule1 exempt from subsection 7a71 under such conditions as may be prescribed in the rule1 a statute or administrative action of that ,state or political subdivision of the ,state that relates to the effects of1 or exposure to1 a chemical substance under the conditions of use if the ,administrator determines that-- 7i7 compelling ,state or local conditions warrant granting the waiver to protect health or the environment2 7ii7 compliance with the proposed requirement of the ,state or political subdivision of the ,state would not unduly burden interstate commerce in the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 7iii7 compliance with the proposed requirement of the ,state or political subdivision of the ,state would not cause a violation of any applicable ,federal law1 rule1 or order2 and 7iv7 based on the judgment of the ,administrator1 the proposed requirement of the ,state or political subdivision of the ,state is consistent with sound objective scientific practices1 the weight of the evidence1 and the best available science2 or 7,b7 exempt from subsection 7b7 a statute or administrative action of a ,state or political subdivision of a ,state that relates to the effects of exposure to a chemical substance under the conditions of use if the ,administrator determines that-- 7i7 the ,state has a compelling local interest that warrants granting the waiver to protect health or the environment2 7ii7 compliance with the proposed requirement of the ,state will not unduly burden interstate commerce in the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 7iii7 compliance with the proposed requirement would not cause a violation of any applicable ,federal law1 rule1 or order2 and 7iv7 the proposed requirement is grounded in reasonable scientific concern4 7#b7 ,approval of a ,state waiver request ,the ,administrator shall grant or deny a waiver application-- 7,a7 not later than #ahj days after the date on which an application under paragraph 7#a77;,a7 is submitted2 and 7,b7 not later than #ij days after the date on which an application under paragraph 7#a77;,b7 is submitted4 7#c7 ,notice and comment ,the application of a ,state or political subdivision of the ,state shall be subject to public notice and comment4 7#d7 ,final agency action ,the decision of the ,administrator on the application of a ,state or political subdivision of the ,state shall be-- 7,a7 considered to be a final agency action2 and 7,b7 subject to judicial review4 7#e7 ,duration of waivers ,a waiver granted under paragraph 7#a77;,b7 shall remain in effect until the later of-- 7,a7 such time as the safety assessment and safety determination is completed2 and 7,b7 the date on which compliance with an applicable rule issued under section #f7;d7 is required4 7#f7 ,judicial review of waivers ,not later than #fj days after the date on which the ,administrator makes a determination on an application of a ,state or political subdivision of the ,state under subparagraph 7,a7 or 7,b7 of paragraph 7#a71 any person may file a petition for judicial review in the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit1 which shall have exclusive jurisdiction over the determination4 7#g7 ,judicial review of prioritization screening decision ,not later than #fj days after the date on which the ,administrator makes a decision on a recommendation made under section #d;,a7b77#d7 to designate a chemical substance as a low priority1 the ,governor of a ,state or a ,state agency with responsibility for protecting health and the environment that submitted the recommendation under section #d;,a7a77#d77;,a71 as applicable1 may file a petition for judicial review in the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit1 which shall have exclusive jurisdiction over the determination4 7g7 ,savings 7#a7 ,no preemption of common law or statutory causes of action for civil relief or criminal conduct 7,a7 ,in general ,nothing in this ,act1 nor any amendment made by this ,act1 nor any safety standard1 rule1 requirement1 standard of performance1 safety determination1 or scientific assessment implemented pursuant to this ,act1 shall be construed to preempt1 displace1 or supplant any state or ,federal common law rights or any state or ,federal statute creating a remedy for civil relief1 including those for civil damage1 or a penalty for a criminal conduct4 7,b7 ,clarification of no preemption ,notwithstanding any other provision of this ,act1 nothing in this ,act1 nor any amendments made by this ,act1 shall preempt or preclude any cause of action for personal injury1 wrongful death1 property damage1 or other injury based on negligence1 strict liability1 products liability1 failure to warn1 or any other legal theory of liability under any ,state law1 maritime law1 or ,federal common law or statutory theory4 7#b7 ,no effect on private remedies 7,a7 ,nothing in this ,act1 nor any amendments made by this ,act1 nor any rules1 regulations1 requirements1 safety assessments1 safety determinations1 scientific assessments1 or orders issued pursuant to this ,act shall be interpreted as1 in either the plaintiff's or defendant's favor1 dispositive in any civil action4 7,b7 ,this ,act does not affect the authority of any court to make a determination in an adjudicatory proceeding under applicable ,state or ,federal law with respect to the admission into evidence or any other use of this ,act or rules1 regulations1 requirements1 standards of performance1 safety assessments1 scientific assessments1 or orders issued pursuant to this ,act4 4 #ai4 ,judicial review ,section #ai of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfah7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,a71 by striking section #d7;a71 #e7;a77#b71 #e7;b77#d71 #f7;a71 #f7;e71 or #h1 or under title ,,ii or ,,iv and inserting section #d7;a71 #e7;d71 #f7;c71 #f7;d71 #f7;g71 or #h1 or title ,,ii or ,,iv2 and 7ii7 in subparagraph 7,b71 by striking an order issued under subparagraph 7,a7 or 7,b7 of section #f7;b77#a7 and inserting an order issued under this title2 and 7,b7 in paragraph 7#b71 in the first sentence1 by striking paragraph 7#a77;,a7 and inserting paragraph 7#a72 and 7,c7 by striking paragraph 7#c72 and 7#b7 in subsection 7c77#a77;,b7-- 7,a7 in clause 7i7-- 7i7 by striking section #d7;a71 #e7;b77#d71 #f7;a71 or #f7;e7 and inserting section #d7;a71 #e7;d71 #f7;d71 or #f7;g72 and 7ii7 by striking evidence in the rulemaking record 7as defined in subsection 7a77#c77 taken as a whole2 and inserting evidence 7including any matter7 in the rulemaking record1 taken as a whole2 and2 and 7,b7 by striking clauses 7ii7 and 7iii7 and the matter following clause 7iii7 and inserting the following3 7ii7 the court may not review the contents and adequacy of any statement of basis and purpose required by section #eec7;c7 of title #e1 ,united ,states ,code1 to be incorporated in the rule1 except as part of the rulemaking record1 taken as a whole4 4 #bj4 ,citizens' petitions ,section #ba of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbj7 is amended-- 7#a7 in subsection 7a71 by striking an order under section #e7;e7 or #f7;b77#b7 and inserting an order under section #d or #e7;d72 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking an order under section #e7;e71 #f7;b77#a77;,a71 or #f7;b77#a77;,b7 and inserting an order under section #d or #e7;d72 and 7,b7 in paragraph 7#d71 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,de novo proceeding 7i7 ,in general ,in an action under subparagraph 7,a7 to initiate a proceeding to promulgate a rule pursuant to section #d1 #e1 #f1 or #h or an order issued under section #d or #e1 the petitioner shall be provided an opportunity to have the petition considered by the court in a de novo proceeding4 7ii7 ,demonstration 7,i7 ,in general ,the court in a de novo proceeding under this subparagraph shall order the ,administrator to initiate the action requested by the petitioner if the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that-- 7aa7 in the case of a petition to initiate a proceeding for the issuance of a rule or order under section #d1 the information available to the ,administrator is insufficient for the ,administrator to perform an action described in section #d1 #d;,a1 #e1 or #f7;d72 7bb7 in the case of a petition to issue an order under section #e7;d71 there is a reasonable basis to conclude that the chemical substance is not likely to meet the safety standard2 7cc7 in the case of a petition to initiate a proceeding for the issuance of a rule under section #f7;d71 there is a reasonable basis to conclude that the chemical substance will not meet the safety standard2 or 7dd7 in the case of a petition to initiate a proceeding for the issuance of a rule under section #h1 there is a reasonable basis to conclude that the rule is necessary to protect health or the environment or ensure that the chemical substance meets the safety standard4 7,,ii7 ,deferment ,the court in a de novo proceeding under this subparagraph may permit the ,administrator to defer initiating the action requested by the petitioner until such time as the court prescribes1 if the court finds that-- 7aa7 the extent of the risk to health or the environment alleged by the petitioner is less than the extent of risks to health or the environment with respect to which the ,administrator is taking action under this ,act2 and 7bb7 there are insufficient resources available to the ,administrator to take the action requested by the petitioner4 4 #ba4 ,employment effects ,section #bd7;b77#b77;,b77ii7 of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbc7;b77#b77;,b77ii77 is amended by striking section #f7;c77#c71 and inserting the applicable requirements of this ,act24 #bb4 ,studies ,section #be of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbd7 is repealed4 #bc4 ,administration ,section #bf of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbe7 is amended-- 7#a7 by striking subsection 7b7 and inserting the following3 7b7 ,fees 7#a7 ,in general ,the ,administrator shall establish1 not later than #a year after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 by rule-- 7,a7 the payment of #a or more reasonable fees as a condition of submitting a notice or requesting an exemption under section #e2 and 7,b7 the payment of #a or more reasonable fees by a manufacturer or processor that-- 7i7 is required to submit a notice pursuant to the rule promulgated under section #h7;b77#d77;,a77i7 identifying a chemical substance as active2 7ii7 is required to submit a notice pursuant to section #h7;b77#e77;,b77i7 changing the status of a chemical substance from inactive to active2 7iii7 is required to report information pursuant to the rules promulgated under section #h7;a77#d72 and 7iv7 manufactures or processes a chemical substance subject to a safety assessment and safety determination pursuant to section #f4 7#b7 ,utilization and collection of fees ,the ,administrator shall-- 7,a7 utilize the fees collected under paragraph 7#a7 only to defray costs associated with the actions of the ,administrator-- 7i7 to collect1 process1 review1 provide access to1 and protect from disclosure 7where appropriate7 information on chemical substances under this ,act2 7ii7 to review notices and make determinations for chemical substances under paragraphs 7#a7 and 7#c7 of section #e7;d7 and impose any necessary restrictions under section #e7;d77#d72 7iii7 to make prioritization decisions under section #d;,a2 7iv7 to conduct and complete safety assessments and determinations under section #f2 and 7v7 to conduct any necessary rulemaking pursuant to section #f7;d72 7,b7 insofar as possible1 collect the fees described in paragraph 7#a7 in advance of conducting any fee-supported activity2 7,c7 deposit the fees in the ,fund established by paragraph 7#d77;,a72 and 7,d7 not collect excess fees or retain a significant amount of unused fees4 7#c7 ,amount and adjustment of fees2 refunds ,in setting fees under this section1 the ,administrator shall-- 7,a7 take into account the cost to the ,administrator of conducting the activities described in paragraph 7#b72 7,b7 prescribe lower fees for small business concerns1 after consultation with the ,administrator of the ,small ,business ,administration2 7,c7 set the fees established under paragraph 7#a7 at levels such that the fees will1 in aggregate1 provide a sustainable source of funds to defray approximately #be percent of the costs of conducting the activities identified in paragraph 7#b77;,a71 not to exceed #ah1jjj1jjj1 not including fees under subparagraph 7,e7 of this paragraph2 7,d7 reflect an appropriate balance in the assessment of fees between manufacturers and processors1 and allow the payment of fees by consortia of manufacturers or processors2 7,e7 for substances designated as additional priorities pursuant to section #d;,a7c71 establish the fee at a level sufficient to defray the full costs to the ,administrator of conducting the safety assessment and safety determination under section #f2 7,f7 prior to the establishment or amendment of any fees under paragraph 7#a71 consult and meet with parties potentially subject to the fees or their representatives1 subject to the condition that no obligation under the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 or subchapter ,,iii of chapter #e of title #e1 ,united ,states ,code1 is applicable with respect to such meetings2 7,g7 beginning with the fiscal year that is #c years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 and every #c years thereafter1 after consultation with parties potentially subject to the fees and their representatives1 increase or decrease the fees established under paragraph 7#a7 as necessary-- 7i7 to ensure that funds deposited in the ,fund are sufficient to conduct the activities identified in paragraph 7#b77;,a7 and the full costs of safety assessments and safety determinations pursuant to subparagraph 7,e72 and 7ii7 to account for inflation2 7,h7 adjust fees established under paragraph 7#a7 as necessary to vary on account of differing circumstances1 including reduced fees or waivers in appropriate circumstances1 to reduce the burden on manufacturing or processing1 remove barriers to innovation1 or where the costs to the ,administrator of collecting the fees exceed the fee revenue anticipated to be collected2 and 7,i7 if a notice submitted under section #e is refused or subsequently withdrawn1 refund the fee or a portion of the fee if no substantial work was performed on the notice4 7#d7 ,,tsca ,implementation ,fund 7,a7 ,establishment ,there is established in the ,treasury of the ,united ,states a fund1 to be known as the ,,tsca ,implementation ,fund 7referred to in this subsection as the ,fund71 consisting of-- 7i7 such amounts as are deposited in the ,fund under paragraph 7#b77;,c72 and 7ii7 any interest earned on the investment of amounts in the ,fund2 and 7iii7 any proceeds from the sale or redemption of investments held in the ,fund4 7,b7 ,crediting and availability of fees 7i7 ,in general ,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 ,acts1 and shall be available without fiscal year limitation4 7ii7 ,requirements ,fees collected under this section shall not-- 7,i7 be made available or obligated for any purpose other than to defray the costs of conducting the activities identified in paragraph 7#b77;,a72 7,,ii7 otherwise be available for any purpose other than implementation of this ,act2 and 7,,iii7 so long as amounts in the ,fund remain available1 be subject to restrictions on expenditures applicable to the ,federal government as a whole4 7,c7 ,unused funds ,amounts in the ,fund not currently needed to carry out this subsection shall be-- 7i7 maintained readily available or on deposit2 7ii7 invested in obligations of the ,united ,states or guaranteed by the ,united ,states2 or 7iii7 invested in obligations1 participations1 or other instruments that are lawful investments for fiduciary1 trust1 or public funds4 7,d7 ,minimum amount of appropriations ,fees may not be assessed for a fiscal year under this section unless the amount of appropriations for salaries1 contracts1 and expenses for the functions 7as in existence in fiscal year #bjae7 of the ,office of ,pollution ,prevention and ,toxics of the ,environmental ,protection ,agency for the fiscal year 7excluding the amount of any fees appropriated for the fiscal year7 are equal to or greater than the amount of appropriations for covered functions for fiscal year #bjae 7excluding the amount of any fees appropriated for the fiscal year74 7#e7 ,auditing 7,a7 ,financial statements of agencies ,for the purpose of section #ceae7;c7 of title #ca1 ,united ,states ,code1 the ,fund shall be considered a component of an executive agency4 7,b7 ,components ,the annual audit required under sections #ceae7;b7 and #ceba of that title of the financial statements of activities under this subsection shall include an analysis of-- 7i7 the fees collected under paragraph 7#a7 and disbursed2 7ii7 compliance with the deadlines established in section #f of this ,act2 7iii7 the amounts budgeted1 appropriated1 collected from fees1 and disbursed to meet the requirements of sections #d1 #d;,a1 #e1 #f1 #h1 and #ad1 including the allocation of full time equivalent employees to each such section or activity2 and 7iv7 the reasonableness of the allocation of the overhead associated with the conduct of the activities described in paragraph 7#b77;,a74 7,c7 ,inspector ,general ,the ,inspector ,general of the ,environmental ,protection ,agency shall-- 7i7 conduct the annual audit required under this subsection2 and 7ii7 report the findings and recommendations of the audit to the ,administrator and to the appropriate committees of ,congress4 7#f7 ,termination ,the authority provided by this section shall terminate at the conclusion of the fiscal year that is #aj years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 unless otherwise reauthorized or modified by ,congress4 2 7#b7 in subsection 7e71 by striking ,health1 ,education1 and ,welfare each place it appears and inserting ,health and ,human ,services2 and 7#c7 adding at the end the following3 7h7 ,prior actions ,nothing in this ,act eliminates1 modifies1 or withdraws any rule promulgated1 order issued1 or exemption established pursuant to this ,act before the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act4 4 #bd4 ,development and evaluation of test methods and sustainable chemistry ,section #bg of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbf7 is amended-- 7#a7 in subsection 7a71 in the first sentence by striking ,health1 ,education1 and ,welfare and inserting ,health and ,human ,services2 and 7#b7 by adding at the end the following3 7c7 ,sustainable ,chemistry ,program ,the ,president shall establish an interagency ,sustainable ,chemistry ,program to promote and coordinate ,federal sustainable chemistry research1 development1 demonstration1 technology transfer1 commercialization1 education1 and training activities4 7d7 ,program activities ,the activities of the ,program shall be designed to-- 7#a7 provide sustained support for sustainable chemistry research1 development1 demonstration1 technology transfer1 commercialization1 education1 and training through-- 7,a7 coordination of sustainable chemistry research1 development1 demonstration1 and technology transfer conducted at ,federal laboratories and agencies2 and 7,b7 to the extent practicable1 encouragement of consideration of sustainable chemistry in1 as appropriate-- 7i7 the conduct of ,federal and ,state science and engineering research and development2 and 7ii7 the solicitation and evaluation of applicable proposals for science and engineering research and development2 7#b7 examine methods by which the ,federal ,government can create incentives for consideration and use of sustainable chemistry processes and products1 including innovative financing mechanisms2 7#c7 expand the education and training of undergraduate and graduate students and professional scientists and engineers1 including through partnerships with industry1 in sustainable chemistry science and engineering2 7#d7 collect and disseminate information on sustainable chemistry research1 development1 and technology transfer including information on-- 7,a7 incentives and impediments to development1 manufacturing1 and commercialization2 7,b7 accomplishments2 7,c7 best practices2 and 7,d7 costs and benefits2 and 7#e7 support 7including through technical assistance1 participation1 financial support1 or other forms of support7 economic1 legal1 and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry4 7e7 ,interagency working group 7#a7 ,establishment ,not later than #ahj days after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the ,president1 in consultation with the ,office of ,science and ,technology ,policy1 shall establish an ,interagency ,working ,group that shall include representatives from the ,national ,science ,foundation1 the ,national ,institute of ,standards and ,technology1 the ,department of ,energy1 the ,environmental ,protection ,agency1 the ,department of ,agriculture1 the ,department of ,defense1 the ,national ,institutes of ,health1 and any other agency that the ,president may designate to oversee the planning1 management1 and coordination of the ,program4 7#b7 ,governance ,the ,director of the ,national ,science ,foundation and the ,assistant ,administrator for ,research and ,development of the ,environmental ,protection ,agency1 or their designees1 shall serve as co-chairs of the ,interagency ,working ,group4 7#c7 ,responsibilities ,in overseeing the planning1 management1 and coordination of the ,program1 the ,interagency ,working ,group shall-- 7,a7 establish goals and priorities for the ,program1 in consultation with the ,advisory ,council2 7,b7 provide for interagency coordination1 including budget coordination1 of activities under the ,program2 7,c7 meet not later than #ij days from its establishment and periodically thereafter2 and 7,d7 establish and consult with an ,advisory ,council on a regular basis4 7#d7 ,membership ,the ,advisory ,council members shall not be employees of the ,federal ,government and shall include a diverse representation of knowledgeable individuals from the private sector 7including small- and medium-sized enterprises from across the value chain71 academia1 ,state and tribal governments1 and nongovernmental organizations and others who are in a position to provide expertise4 7f7 ,agency budget requests 7#a7 ,in general ,each ,federal agency and department participating in the ,program shall1 as part of its annual request for appropriations to the ,office of ,management and ,budget1 submit a report to the ,office of ,management and ,budget that-- 7,a7 identifies the activities of the agency or department that contribute directly to the ,program2 and 7,b7 states the portion of the agency or department's request for appropriations that is allocated to those activities4 7#b7 ,annual budget request to congress ,the ,president shall include in the annual budget request to ,congress a statement of the portion of the annual budget request for each agency or department that will be allocated to activities undertaken pursuant to the ,program4 7g7 ,report to congress 7#a7 ,in general ,not later than #b years after the date of enactment of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act1 the ,interagency ,working ,group shall submit a report to the ,committee on ,science1 ,space1 and ,technology and ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,environment and ,public ,works and the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate that shall include-- 7,a7 a summary of federally funded sustainable chemistry research1 development1 demonstration1 technology transfer1 commercialization1 education1 and training activities2 7,b7 a summary of the financial resources allocated to sustainable chemistry initiatives2 7,c7 an analysis of the progress made toward achieving the goals and priorities of this ,act1 and recommendations for future program activities2 7,d7 an assessment of the benefits of expanding existing1 federally supported regional innovation and manufacturing hubs to include sustainable chemistry and the value of directing the creation of #a or more dedicated sustainable chemistry centers of excellence or hubs2 and 7,e7 an evaluation of steps taken and future strategies to avoid duplication of efforts1 streamline interagency coordination1 facilitate information sharing1 and spread best practices between participating agencies in the ,program4 7#b7 ,submission to ,,gao ,the ,interagency ,working ,group shall also submit the report described in paragraph 7#a7 to the ,government ,accountability ,office for consideration in future ,congressional inquiries4 4 #be4 ,state programs ,section #bh of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbg7 is amended-- 7#a7 in subsection 7b77#a7-- 7,a7 in subparagraphs 7,a7 through 7,d71 by striking the comma at the end of each subparagraph and inserting a semicolon2 and 7,b7 in subparagraph 7,e71 by striking 1 and and inserting 2 and2 and 7#b7 by striking subsections 7c7 and 7d74 #bf4 ,authorization of appropriations ,section #bi of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbh7 is repealed4 #bg4 ,annual report ,section #cj of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfbi7 is amended by striking paragraph 7#b7 and inserting the following3 7#b7 7,a7 the number of notices received during each year under section #e2 and 7,b7 the number of the notices described in subparagraph 7,a7 for chemical substances subject to a rule1 testing consent agreement1 or order under section #d2 4 #bh4 ,effective date ,section #ca of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfja note2 ,public ,law #id-dfi7 is amended-- 7#a7 by striking ,except as provided in section #d7;f71 this and inserting the following3 7a7 ,in general ,this 2 and 7#b7 by adding at the end the following3 7b7 ,retroactive applicability ,nothing in this ,act shall be interpreted to apply retroactively to any ,state1 ,federal1 or maritime legal action commenced prior to the effective date of the ,frank ,r4 ,lautenberg ,chemical ,safety for the #bast ,century ,act4 4