,,ii #aadth ,,congress #ast ,session ,s4 #gbe ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ab1 #bjae,mrs4 ,boxer 7for herself1 ,mr4 ,markey1 and ,mr4 ,sanders7 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 ,act1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,references4 ,,title ,i--,amendments to the ,toxic ,substances ,control ,act ,sec4 #aja4 ,findings1 policy1 and intent4 ,sec4 #ajb4 ,definitions4 ,sec4 #ajc4 ,policies1 procedures and guidance4 ,sec4 #ajd4 ,testing of chemical substances or mixtures4 ,sec4 #aje4 ,prioritization screening4 ,sec4 #ajf4 ,new chemicals and significant new uses4 ,sec4 #ajg4 ,safety assessments and determinations4 ,sec4 #ajh4 ,imminent hazards4 ,sec4 #aji4 ,information collection and reporting4 ,sec4 #aaj4 ,relationship to other ,federal laws4 ,sec4 #aaa4 ,research1 development1 collection1 dissemination1 and utilization of data4 ,sec4 #aab4 ,exports4 ,sec4 #aac4 ,imports4 ,sec4 #aad4 ,confidential information4 ,sec4 #aae4 ,prohibited acts4 ,sec4 #aaf4 ,penalties4 ,sec4 #aag4 ,preemption4 ,sec4 #aah4 ,judicial review4 ,sec4 #aai4 ,citizens' petitions4 ,sec4 #abj4 ,studies4 ,sec4 #aba4 ,administration4 ,sec4 #abb4 ,development and evaluation of test methods4 ,sec4 #abc4 ,state programs4 ,sec4 #abd4 ,authorization of appropriations4 ,sec4 #abe4 ,annual report4 ,,title ,,ii--,strengthening protections for children and communities from disease clusters ,sec4 #bja4 ,purposes4 ,sec4 #bjb4 ,definitions4 ,sec4 #bjc4 ,guidelines for environmental investigations of disease clusters4 ,sec4 #bjd4 ,enhanced support for environmental investigations of disease clusters4 ,sec4 #bje4 ,federal reports to ,congress4 ,sec4 #bjf4 ,authorization of appropriations4 ,sec4 #bjg4 ,effect on other law4 ,,title ,,iii--,community disease cluster technical assistance grants ,sec4 #cja4 ,community disease cluster technical assistance grants4 ,sec4 #cjb4 ,authorization of appropriations4 #b4 ,references ,except as otherwise expressly provided1 wherever in this ,act an amendment or repeal is expressed in terms of an amendment to1 or repeal of1 a section or other provision1 the reference shall be considered to be made to a section or other provision of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq474 ,i ,amendments to the ,toxic ,substances ,control ,act #aja4 ,findings1 policy1 and intent ,section #b7;a7 7#ae ,u4,s4,c4 #bfja7;a77 is amended-- 7#a7 ,in paragraph 7#b7-- 7,a7 by striking injury and inserting harm2 and 7,b7 by striking and at the end2 7#b7 by redesignating paragraph 7#c7 as paragraph 7#f72 and 7#c7 by inserting after paragraph 7#b7 the following3 7#c7 reform of this ,act shall be administered to protect the health of children1 pregnant women1 the elderly1 workers1 consumers1 the general public and the environment from the risks of harmful exposures to chemical substances and mixtures2 7#d7 reform of this ,act shall not displace or supplant common law rights of action or remedies for civil relief2 7#e7 reform of this ,act shall be administered to ensure that appropriate information on chemical substances and mixtures should be available to public health officials and first responders in the event of an emergency2 and 4 #ajb4 ,definitions ,section #c 7#ae ,u4,s4,c4 #bfjb7 is amended-- 7#a7 by redesignating paragraphs 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 7#ac71 and 7#ad7 as paragraphs 7#i71 7#aj71 7#aa71 7#ac71 7#ad71 7#ai71 7#bj71 and 7#ba71 respectively2 7#b7 by inserting after paragraph 7#f7 the following3 7#g7 ,information ,except in section #ad1 the term information means any qualitative1 quantitative or descriptive facts1 data1 analysis or assessment related to chemical hazards1 use1 or exposure 7including the nature and extent of exposure to a chemical substance71 including from health and safety studies4 7#h7 ,intended or reasonably foreseeable conditions of use ,the term intended or reasonably foreseeable conditions of use means the circumstances under which a chemical substance is intended1 reasonably known1 or reasonably anticipated to be manufactured1 processed1 distributed in commerce1 used1 disposed of1 and released into the environment1 including reasonably foreseeable but unintended exposure conditions from unplanned releases into the environment4 2 7#c7 by inserting after paragraph #aa 7as so redesignated7 the following3 7#ab7 ,potentially exposed or susceptible population ,the term potentially exposed or susceptible population means a group or groups of individuals within the general population who may be-- 7,a7 differentially exposed to chemical substances under the intended or reasonably foreseeable conditions of use2 or 7,b7 more susceptible to adverse health consequences from chemical exposures than the general population1 which 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#ad7 7as so redesignated7 the following3 7#ae7 ,publicly available information ,the term publicly available information means information that is generally accessible and available to the general public or in the public domain1 including information that has been published in periodicals1 books1 print1 or electronic or other media available for general distribution to any member of the public4 7#af7 ,safety assessment ,the term safety assessment means an assessment of the risk posed by a chemical substance under the intended or reasonably foreseeable conditions of use1 integrating hazard1 use1 and exposure information about the chemical substance4 7#ag7 ,safety determination ,the term safety determination means a determination by the ,administrator as to whether a chemical substance meets the safety standard under the intended or reasonably foreseeable conditions of use4 7#ah7 ,safety standard ,the term safety standard means a standard that ensures with reasonable certainty1 without taking into consideration cost or other non-risk factors1 that no harm to human health or the environment will result from exposure to a chemical substance under the intended or reasonably foreseeable conditions of use1 including no harm to the general population or to any potentially exposed or susceptible subpopulation that the ,administrator has identified as relevant to the safety assessment and determination for a chemical substance4 4 #ajc4 ,policies1 procedures and guidance ,the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq47 is amended by adding after section #c the following3 #c;,a4 ,policies1 procedures1 and guidance 7a7 ,deadline ,not later than #b years after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall1 after providing an opportunity for public notice and comment1 develop the policies1 procedures and guidance required by this section4 ,as used in this section1 the term guidance includes any significant written guidance of general applicability prepared by the ,administrator4 7b7 ,use of science ,in establishing any policies1 procedures1 and guidance1 on the use of science in making decisions under this section and sections #d1 #d;,a1 #e1 and #f1 the ,administrator shall have the goal of making the basis of decisions clear to the public4 ,the policies1 procedures and any guidance issued under this subsection shall describe how the ,administrator will ensure that-- 7#a7 decisions by the ,administrator-- 7,a7 are based on the best available science2 and 7,b7 take into account the extent to which-- 7i7 assumptions and methods used to develop information considered by the ,administrator are clearly and completely described and documented2 7ii7 variability and uncertainty in such information are evaluated and characterized2 and 7iii7 the information has been subject to independent peer review2 7#b7 to the extent practicable and where appropriate1 the use of peer review1 standardized test design and methods1 consistent data evaluation procedures1 and appropriate laboratory practices will be encouraged2 7#c7 the names of the organizations or individuals funding the generation and assessment of information and the degree of control they had over the generation1 assessment1 and dissemination of information 7including control over the design of the work and the publication of information7 will be made clear2 and 7#d7 decisions by the ,administrator follow the applicable recommendations in relevant ,national ,academy of ,sciences reports1 including the reports titled3 ,science and ,decisions3 ,advancing ,risk ,assessment1 ,phthalates and ,cumulative ,risk ,assessment3 ,the ,task ,ahead1 ,review of ,,epa's ,integrated ,risk ,information ,system 7,,iris7 ,process1 ,review of the ,formaldehyde ,assessment in the ,national ,toxicology ,program #abth ,report on ,carcinogens1 and ,review of the ,styrene ,assessment in the ,national ,toxicology ,program #abth ,report on ,carcinogens4 7c7 ,existing ,,epa policies1 procedures and guidance ,the policies1 procedures1 and guidance described in subsections 7a7 and 7b7 shall incorporate1 as appropriate1 existing relevant hazard1 exposure1 and risk assessment guidelines and methodologies1 data evaluation and quality criteria1 testing methodologies and other relevant guidelines and policies previously issued by the ,administrator4 7d7 ,review ,not less than #e years after the date of enactment of this ,act1 and not less frequently than every #e years thereafter1 the ,administrator shall-- 7#a7 review the adequacy of any policies1 procedures1 and guidance developed under this section1 including procedures for assessing and determining risk under this ,act2 and 7#b7 after providing an opportunity for public notice and comment1 revise the policies1 procedures1 and guidance if necessary to reflect new scientific developments or understandings4 7e7 ,sources of information ,in making any decision with respect to a chemical substance under sections #d1 #d;,a1 #e1 and #f1 the ,administrator shall consider information on the hazards and exposures of a chemical substance under the intended or reasonably foreseeable 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 basis 7including pursuant to any request made under this ,act7 by-- 7,a7 manufacturers and processors of a substance2 7,b7 the public2 7,c7 other ,federal agencies and departments2 or 7,d7 a ,governor of a ,state or a ,state agency with responsibility for protecting health or the environment2 7#b7 submitted to a governmental body in any jurisdiction under a governmental requirement relating to the protection of human health and 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 7f7 ,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 ,a goal of the policies and procedures shall be to make the basis of decisions clear to the public4 7#b7 ,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 provided that the ,administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential and that lack of information on exposure or exposure potential shall not1 by itself1 be a reason not to require testing2 7,b7 describe how the ,administrator will determine that additional testing is needed to carry out this ,act1 including testing related to potentially exposed or susceptible populations and testing related to the accumulation of chemical substances in the human body2 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 mammals1 require the ,administrator to consider1 as appropriate and to the extent practicable1 reasonably available-- 7i7 toxicity information2 7ii7 computational toxicology and bioinformatics2 7iii7 high-throughput screening methods and their prediction models2 and 7iv7 scientifically reliable and relevant alternatives to tests on mammals that would provide equivalent information4 7#c7 ,tiered testing ,except as provided in subparagraph 7,c71 the ,administrator shall employ a tiered screening and testing process1 in 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,a7 ,screening level ,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 exposure1 as appropriate4 ,screening level tests shall be used-- 7i7 to screen chemical substances or mixtures for potential adverse effects2 and 7ii7 to inform the decision of the ,administrator whether additional testing is necessary4 7,b7 ,additional testing ,if the ,administrator determines under subparagraph 7,a7 that additional testing is necessary to provide more definitive information for prioritization or safety assessments and safety determinations1 the ,administrator may require more advanced tests for potential human health or environmental effects or exposure4 7,c7 ,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 test1 pursuant to policies or procedures developed by the ,administrator under this subsection4 7g7 ,safety assessments and safety determinations 7#a7 ,schedule ,the ,administrator shall inform the public regarding the schedule for the completion of each safety assessment and safety determination as soon as possible after designation as a high priority substance pursuant to section #d;,a4 ,the time allotted may be different for different chemicals1 provided that all schedules shall comply with the deadlines established under section #f4 7#b7 ,policies and procedures for safety assessments and safety determinations ,the ,administrator shall establish policies and procedures on how the ,administrator shall carry out section #f4 ,a goal of the policies and procedures shall be to make the basis of decisions clear to the public4 ,at a minimum1 the policies and procedures shall-- 7,a7 describe-- 7i7 how the ,administrator will identify informational needs and seek such information from the public2 7ii7 what information 7including draft safety assessments7 may be submitted by interested persons1 including ,states2 and 7iii7 the criteria by which that information will be evaluated2 7,b7 require the ,administrator1 in each safety assessment and safety determination1 to-- 7i7 identify the substance's intended or reasonably foreseeable conditions of use based on information provided by its manufacturers and processors or otherwise available to the ,administrator2 7ii7 identify all potentially exposed or susceptible populations that the ,administrator determines are pertinent to the substance2 7iii7 identify the hazards of the substance and its metabolites and breakdown products and any differences in the magnitude or nature of these hazards for potentially exposed or susceptible populations1 including the potential for chemical substances to accumulate in the human body2 7iv7 determine the nature and extent of exposures to the chemical substance by the general population and each potentially exposed or susceptible population1 including aggregate exposures resulting from multiple pathways or routes of exposure2 7v7 to the extent practicable1 review and incorporate any available scientific information on the cumulative effects of exposure to the chemical substance and other chemical substances posing similar hazards to human health and the environment2 and 7vi7 characterize the nature and extent of the risk presented by the chemical substance1 taking into account aggregate exposures resulting from multiple pathways or routes of exposure and the cumulative effects of exposure to the chemical substance and other chemicals posing similar hazards2 and 7,c7 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 assessment or determination4 7h7 ,release of safety assessments ,subject to section #ad1 the ,administrator shall-- 7#a7 make available to the public a nontechnical summary and the final version 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 the list of studies considered by the ,administrator in carrying out the safety assessment and safety determination1 as well as the list of policies and procedures that were followed in carrying out the safety assessment and safety determination4 7i7 ,consultation with science advisory committee on chemicals 7#a7 ,in general ,not later than #a year after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall establish a ,science ,advisory ,committee on ,chemicals 7referred to in this subsection as the ,committee7 to provide independent advice and expert consultation1 upon the request of the ,administrator1 with respect to the scientific and technical aspects of issues relating to the implementation of this title4 7#b7 ,composition of committee ,the ,committee shall be composed of representatives of such science1 government1 labor1 public health1 public interest1 industry1 and other groups as the ,administrator deems 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#c7 ,meetings ,the ,administrator shall convene the ,committee on a schedule the ,administrator determines appropriate1 but not less frequently than once every #b years4 7#d7 ,federal ,advisory ,committee ,act ,all proceedings and meetings of the ,committee shall be subject to the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7#e7 ,conflict of interest policies ,the ,administrator shall establish and make public conflict of interest policies that shall apply to the ,committee members1 who shall be appointed as ,special ,government ,employees4 7j7 ,national academy of sciences reports ,not later than #abj days after the issuance of any report by the ,national ,academy of ,sciences concerning hazards1 exposures1 or risks of chemical substances1 the ,administrator shall issue a public response to the principal recommendations of the report4 4 #ajd4 ,testing of chemical substances or mixtures 7a7 ,in general ,section #d 7#ae ,u4,s4,c4 #bfjc7 is amended-- 7#a7 by striking subsection 7g7 and redesignating subsections 7e7 and subsection 7f7 as subsections 7f7 and 7g71 respectively2 7#b7 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 by striking rulemaking2 7#c7 in subsection 7g7 7as so redesignated7-- 7,a7 by striking from cancer1 gene mutations1 or birth defects2 7,b7 by striking unreasonable each place it appears and inserting significant2 and 7,c7 by striking the last sentence2 and 7#d7 by striking subsections 7a7 through 7d7 and inserting 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 related to a chemical substance or mixture in accordance with this section if the ,administration determines that the information is needed-- 7,a7 to perform a safety assessment or make a safety determination under section #f2 7,b7 to implement a requirement imposed in a consent agreement or order issued under section #e7;c77#d72 7,c7 pursuant to section #ab7;a77#d72 or 7,d7 at the request of the implementing authority under any other ,federal law4 7#b7 ,testing for prioritization purposes ,the ,administrator may require the development of new information for the purposes of section #d;,a1 provided that any such testing shall not be based on a set of uniform minimum information requirements for all or large groups of chemical substances4 ,use of this authority shall be limited to cases where the ,administrator determines additional information is needed to establish the priority of a chemical substance4 7#c7 ,form ,subject to section #c;,a7f71 the ,administrator may require the development of test data and 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 to the extent practicable1 test protocols and methodologies for the development of information for the chemical substance or mixture1 including specific reference to reliable nonmammal test procedures2 and 7iv7 specification of the period within which persons required to conduct the testing shall submit to the ,administrator the information developed in accordance with the procedures described in clause 7iii74 7,b7 ,duration ,the period described in subparagraph 7,a77iv7 shall not be of an unreasonable duration4 7,c7 ,considerations ,in determining the procedures and period to be required under subparagraph 7,a71 the ,administrator shall consider-- 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 needed 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 development of additional information 7including information on exposure or exposure potential7 under 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 mammals4 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 issuance of an order instead of promulgating a rule or entering into a testing consent agreement4 7,b7 ,contents ,the statement described in subparagraph 7,a7 shall contain a discussion 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 mammals 7#a7 ,in general ,the ,administrator shall minimize1 to the extent practicable1 the use of mammals 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 mammals while providing information of high scientific quality2 7iv7 the grouping of #b or more chemical substances into scientifically appropriate categories in cases where testing of a chemical substance would provide reliable and useful information on others 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 animal-based studies and 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 mammals1 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 used in safety assessments and determinations under section #f that can reduce1 refine1 or replace the use of mammals1 including toxicity pathway-based risk assessment1 in vitro studies1 systems biology1 computational toxicology1 bioinformatics1 and high-throughput screening2 7,b7 beginning on the date that is #e years after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,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,c7 to the extent practicable1 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 mammals in any safety assessment or determination made under section #f4 7d7 ,testing requirements 7#a7 ,in general ,the ,administrator may require the following persons to develop information3 7,a7 ,manufacturers and processors of the chemical substance or mixture4 7,b7 ,persons who begin to manufacture or process such chemical substance or mixture-- 7i7 after the effective date of the rule1 testing consent agreement1 or order2 but 7ii7 subject to paragraph 7#c71 not later than #ahj days after the completion of the period for submitting information specified under subsection 7a77#d77;,a77iv74 7#b7 ,designation ,the ,administrator may permit #b or more of the persons identified in subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 to designate a person 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 person designated4 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 no person has complied with the rule1 testing consent agreement1 or order1 the ,administrator shall-- 7i7 by order terminate the exemption2 and 7ii7 notify in writing each person who 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 under this section4 4 7b7 ,conforming amendments ,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 by striking section #d7;e7 and inserting section #d7;f74 #aje4 ,prioritization screening ,the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq47 is amended by adding after section #d the following3 #d;,a4 ,prioritization screening 7a7 ,prioritization screening 7#a7 ,in general ,not later than #a year after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall by rule establish a screening process and criteria for identifying existing chemical substances that are-- 7,a7 a high priority for a safety assessment and safety determination under section #f1 to be known as high-priority substances2 and 7,b7 a low priority for a safety assessment and safety determination1 to be known as low-priority substances4 7#b7 ,initial list of high priority substances ,prior to promulgation of the rule established under paragraph 7#a7 and not later than #f months after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall consider and publish an initial list of high priority substances1 which shall contain not less than #ae chemical substances1 and pursuant to sections #f7;a7 and #f7;b77#b71 initiate or continue safety assessments and safety determinations for such substances4 7#c7 ,additions to priority list ,starting #a year after publication of the initial priority list under paragraph 7#b7 and at #a year intervals thereafter for the following #d years1 the ,administrator shall add at least #ae high-priority substances to the list and1 pursuant to sections #f7;a7 and #f7;b77#b71 initiate or continue safety assessments and safety determinations for those substances4 7#d7 ,workplan and action plan chemicals ,the ,administration may list as high-priority substances under paragraphs 7#b7 and 7#c7 those chemical substances or categories of chemical substances that are included in the ,administrator's ,march #bjab ,workplan 7as updated in ,october #bjad and by subsequent updates7 or are the subject of ,existing ,chemical ,action ,plans published by the ,administrator before the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act without providing further justification for listing or meeting the requirements of this section4 7#e7 ,implementation 7,a7 ,consideration of active and inactive substances 7i7 ,consideration of active substances ,in implementing the process described in paragraph 7#a71 the ,administrator shall consider active substances1 as determined under section #h1 which may include substances on the interim list of active substances established under that section4 7ii7 ,consideration of inactive substances ,in implementing the process described in paragraph 7#a71 the ,administrator may consider 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 substance2 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 substance2 and 7bb7 there is the potential for residual high hazards or widespread exposures not otherwise addressed by the regulatory or other action4 7iii7 ,repopulation ,upon the completion of a safety determination under section #f for a chemical substance1 the ,administrator shall remove the substance from the list of high-priority substances4 ,the ,administrator shall add not less than #a chemical substance to the list of high-priority substances for each chemical substance removed from the list1 until a safety assessment and safety determination is completed for all active substances1 except that not less than #c chemical substances shall be added for each chemical substance removed from the list1 subject to section #ba1 when fees are in place4 7,b7 ,timely completion of prioritization screening process 7i7 ,in general ,in addition to the decisions required by paragraphs 7#a7 and 7#b71 not later than #f months after the effective date of the final rule under paragraph 7#a71 the ,administrator shall begin the prioritization screening process4 7ii7 ,decisions on substances subject to testing for prioritization purposes ,not later than #abj days after receipt of the information complying with a rule1 testing consent agreement1 or order issued under section #d7;a77#b71 the ,administrator shall designate the substance as either a high or low priority4 7iii7 ,consideration ,the ,administrator shall screen substances1 taking into consideration the requirement to meet the deadlines under section #f of this ,act4 7iv7 ,annual goal ,the ,administrator shall publish an annual goal for the number of 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 safety assessments and determinations4 7,d7 ,publication of list of chemical substances ,not less frequently than annually1 the ,administrator shall-- 7i7 publish a list of chemical substances being considered in the prioritization screening process and their status in the prioritization process1 including those substances for which a prioritization decision has been deferred2 and 7ii7 publish a list of those substances designated as high-priority and low-priority substances and the basis for the designations4 7#f7 ,criteria ,the criteria described in paragraph 7#a7 shall include-- 7,a7 the recommendation of a ,governor of a ,state or a ,state agency with responsibility for protecting health or the environment from chemical substances appropriate for prioritization screening1 and the recommendations of the public2 7,b7 the hazard of the chemical substance 7or category of substances71 including specific scientific classifications and designations by authoritative governmental entities2 7,c7 the intended or reasonably foreseeable conditions of use of a chemical substance or significant changes in the intended or reasonably foreseeable conditions of use of the chemical substance2 7,d7 evidence and indicators of exposure and potential exposure to humans or the environment from the chemical substance including potentially exposed or susceptible populations2 7,e7 the volume of a chemical substance manufactured or processed1 and past and anticipated future changes in volume2 7,f7 whether the volume of a chemical substance as reported under a regulation issued under section #h7;a7 has significantly increased or decreased since a previous report or since the date on which a notice has been submitted under section #e7;a7 for that chemical substance2 7,g7 the availability of information about potential hazards and exposures needed for conducting a safety assessment or determination1 provided that limited availability of relevant information shall not be a sufficient basis for failing to designate a substance as a high priority2 7,h7 the potential threat the chemical substance poses to drinking water supplies1 based on hazard1 exposure1 or exposure potential 7including whether the chemical substance is stored near sources of drinking water72 7,i7 the extent to which a chemical substance accumulates in the human body2 and 7,j7 other relevant criteria identified by the ,administrator4 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-- 7,a7 identify the chemicals being considered for prioritization2 7,b7 request interested persons to supply information on the substances being considered2 7,c7 apply the criteria identified in subsection 7a77#e72 and 7,d7 subject to paragraph 7#d7 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 ,identification of high-priority substances ,the ,administrator-- 7,a7 shall identify as a high-priority substance a chemical substance that the ,administrator determines has1 or has the potential for1 significant hazard and significant or substantial exposure2 7,b7 may identify as a high-priority substance a chemical substance that the ,administrator determines has1 or has the potential for1 significant hazard or significant or substantial exposure2 7,c7 may identify as a high-priority substance an inactive substance1 as determined under section #h7;b71 that the ,administrator determines warrants a safety assessment and determination under section #f2 and 7,d7 may identify as a high-priority substance a chemical substance that accumulates in the body4 7#c7 ,identification of low-priority substances ,the ,administrator shall identify as a low-priority substance a chemical substance if the ,administrator-- 7,a7 concludes that sufficient hazard and exposure information is available for an informed evaluation of the substance's risks to human health and the environment2 7,b7 determines1 based on a review of the information available1 that the substance is likely to meet the safety standard under the intended or reasonably foreseeable conditions of use2 and 7,c7 identifies the information on which the determination is based and describes the ,administrator's analysis of this information4 7#d7 ,deferring a decision ,if the ,administrator determines that additional information is needed to establish the priority of a chemical substance1 the ,administrator may defer the prioritization screening decision for a reasonable period to-- 7,a7 allow for the submission and evaluation of additional information by an interested person2 or 7,b7 require the development of information pursuant to a rule1 testing consent agreement1 or order issued under section #d7;a77#b74 7#e7 ,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 such information1 which deadline shall be of reasonable duration4 7#f7 ,notice and comment ,except as provided in subsection 7a77#d71 the ,administrator shall publish the proposed decisions made under paragraphs 7#b71 7#c7 and 7#d7 and the basis for the decisions1 and provide an opportunity for public comment4 7#g7 ,revision based on new information ,the ,administrator may1 at any time1 revise the designation of a chemical substance as a high-priority or a low-priority substance based on new information made available to the ,administrator after the date of the determination under paragraph 7#b7 or 7#c71 following the procedures in this section4 7#h7 ,review ,not less frequently than once every #e years after the date on which the process under this subsection is established1 the ,administrator shall review the process on the basis of experience and consider the resources available to efficiently and effectively screen and prioritize substances1 and if necessary modify the prioritization screening process in a manner that complies with this ,act4 7#i7 ,effect ,subject to section #ah1 a decision by the ,administrator under this subsection with respect to a chemical substance shall not be construed to affect the manufacture1 processing1 distribution1 use1 or disposal of the chemical substance1 or regulation of those activities4 7c7 ,final agency action ,except for the designation of a substance as low priority under subsection 7b77#c71 any action by the ,administrator under this section shall not be-- 7#a7 considered to be a final agency action2 or 7#b7 subject to judicial review4 4 #ajf4 ,new chemicals and significant new uses ,section #e 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 in subsection 7a77#a71 in the matter following subparagraph 7,b7-- 7,a7 by striking subsection 7d7 and inserting subsection 7b72 and 7,b7 by striking and such person complies with any applicable requirement of subsection 7b72 7#c7 by striking subsection 7b72 7#d7 by redesignating subsection 7d7 as subsection 7b7 and moving the subsection so as to appear after subsection 7a72 7#e7 in subsection 7b7 7as so redesignated7-- 7,a7 by striking paragraph 7#a7 and inserting the following3 7#a7 ,in general ,the notice required under 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 intended or reasonably foreseeable conditions of use and reasonably foreseeable 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 1 7b712 7#f7 by striking subsection 7c7 and inserting the following3 7c7 ,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 7a71 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 7b77#a72 and 7,b7 any other relevant information available to1 or submitted to1 the ,administrator4 7#c7 ,determinations ,before the end of the applicable period for review under paragraph 7#a71 and based on the information described in paragraph 7#b71 the ,administrator shall determine that-- 7,a7 the relevant chemical substance or a significant new use is not likely to meet the safety standard1 in which case the ,administrator shall take appropriate action under paragraph 7#e72 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 ,in general ,if the ,administrator makes a determination under paragraph 7#c77;,a7 or 7,c7 with respect to a notice submitted under subsection 7a71 the ,administrator shall before the end of the applicable period for review under paragraph 7#a7 and by consent agreement or order1 as appropriate1 prohibit or restrict the manufacture1 processing1 use1 distribution in commerce1 or disposal 7as applicable7 of the chemical substance1 or of the substance for a significant new use 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 standard4 7,b7 ,rulemaking ,not later than #ij days after issuing a consent agreement or order under subparagraph 7,a71 the ,administrator shall-- 7i7 consider whether to promulgate a rule under subsection 7a77#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 use that is not in compliance with the restrictions imposed by the consent agreement or order2 and 7ii7 7,i7 initiate such rulemaking2 or 7,,ii7 publish a statement of the ,administrator's reasons for not initiating such action4 7,c7 ,inclusions ,a prohibition1 restriction1 or requirement under subparagraph 7,a7 shall include1 as appropriate1 #a or more of the following requirements3 7i7 ,a requirement that a chemical substance or mixture or article containing the substance be marked with1 or accompanied by1 clear and adequate 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 warnings and instructions to be prescribed by the ,administrator4 7ii7 ,a requirement that manufacturers or processors1 as applicable1 of the chemical substance or mixture make and retain records of the processes used to manufacture or process the chemical substance4 7iii7 ,a requirement that manufacturers or processors1 as applicable1 monitor or conduct such additional tests as are reasonably necessary to address potential risks from the manufacture1 processing1 distribution in commerce1 use1 or disposal of the chemical substance1 subject to section #d4 7iv7 ,a restriction on the quantity of the chemical substance or a mixture or article containing the substance that may be manufactured1 processed1 or distributed in commerce4 7v7 ,a restriction on the quantity of the chemical substance or a mixture or article containing the substance that may be manufactured1 processed1 or distributed in commerce-- 7,i7 for a particular use2 or 7,,ii7 for a particular use in a concentration in excess of a level specified by the ,administrator in the consent agreement or order imposing the requirement4 7vi7 ,a prohibition or other regulation of the manufacture1 processing1 or distribution in commerce of the chemical substance or a mixture or article containing the substance for a significant new use4 7vii7 ,a prohibition or other regulation of any manner or method of commercial use of the chemical substance or a mixture or article containing the substance4 7viii7 ,a prohibition or other regulation of any manner or method of disposal of or environmental release of the chemical substance or a mixture or article containing the substance1 by its manufacturer or processor or by any other person who uses1 or disposes of it1 for commercial purposes4 7ix7 ,a prohibition or other appropriate restriction or requirement on the manufacture1 processing1 or distribution in commerce of the chemical substance or a mixture or article containing the substance4 7x7 ,a prohibition or other appropriate restriction or requirement on the manufacture1 processing1 or distribution in commerce of the chemical substance or a mixture or article containing the substance for a particular use4 7,d7 ,rule of construction ,the requirement1 warning1 or instruction required under subparagraph 7,c7 does not establish a uniform national standard for the purpose of supplanting1 displacing1 or preempting ,state law4 7,e7 ,workplace exposures ,the ,administrator shall consult with the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health prior to adopting any prohibition or restriction adopted under this subsection to address workplace exposures4 7#e7 ,additional information ,if the ,administrator determines under paragraph 7#c77;,c7 that additional information is needed in order to conduct a review under this subsection1 the ,administrator-- 7,a7 shall provide an opportunity for the submitter of the notice to submit such 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 shall1 after receiving information the ,administrator finds supports the determination under paragraph 7#c71 promptly make the determination4 7#f7 ,regulation pending development of information ,subject to paragraph 7#d77;,b71 the ,administrator may permit manufacture for commercial purposes to commence pending receipt of the additional information1 subject to compliance with any restrictions under paragraph 7#d7 determined by the ,administrator to be sufficient to ensure that the chemical substance is likely to meet the safety standard4 7#g7 ,commencement of manufacture ,subject to paragraphs 7#d71 7#e71 and 7#f71 at the end of the applicable period for review under paragraph 7#a77;,a7 the submitter of a notice under subsection 7a7 may commence manufacture for commercial purposes a chemical substance1 or a chemical substance for a significant new use4 2 7#g7 by striking subsections 7e7 through 7g7 and inserting the following3 7d7 ,notice of commencement 7#a7 ,in general ,not later than #cj days after the date on which a manufacturer or processor that has submitted a notice under subsection 7a7 commences nonexempt commercial manufacture of a chemical substance1 the manufacturer or processor shall submit to the ,administrator a notice of commencement that identifies-- 7,a7 the name of the manufacturer or processor2 7,b7 the initial date of nonexempt commercial manufacture2 and 7,c7 additional information specified in section #gbj4ajb7;c77#a7 of title #dj1 ,code of ,federal ,regulations 7or successor regulations74 7#b7 ,withdrawal ,a manufacturer or processor that has submitted a notice under subsection 7a71 but that has not commenced nonexempt commercial manufacture or processing of the chemical substance1 may withdraw the notice4 7e7 ,further evaluation ,the ,administrator may screen a chemical substance under section #d;,a or require testing under section #d at any time after the ,administrator receives-- 7#a7 a notice of commencement for a chemical substance under subsection 7d72 or 7#b7 new information regarding the chemical substance4 7f7 ,transparency ,subject to section #ad1 the ,administrator shall make available to the public all notices1 determinations1 consent agreements1 rules and orders of the ,administrator issued under this section4 2 7#h7 by redesignating subsections 7h7 and 7i7 as subsections 7g7 and 7h71 respectively2 7#i7 in subsection 7g7 7as so redesignated7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking or 7b72 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 by striking subsections 7a7 and 7b7 and inserting subsection 7a72 7,e7 in paragraph 7#c7 7as so redesignated71 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 7,f7 in paragraph 7#d7 7as so redesignated71 by striking subsections 7a7 and 7b7 and inserting subsection 7a72 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#d712 and 7#aj7 by inserting after subsection 7h7 7as so redesignated7 the following3 7i7 ,prior actions ,nothing in this section requires the ,administrator to modify or withdraw any rule or order promulgated under section #e of this title prior to the enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 4 #ajg4 ,safety assessments and determinations ,section #f 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 determinations 2 7#b7 by redesignating subsection 7b7 as subsection 7m7 and moving the subsection so as to appear after subsection 7l7 7as added by paragraph 7#f772 7#c7 in subsection 7m7 7as so redesignated71 by striking unreasonable each place it appears and inserting significant2 7#d7 by striking subsections 7a71 7c7 and 7d7 and inserting in lieu thereof the following1 and by redesignating subsection 7b7 as subsection 7i73 7a7 ,in general ,the ,administrator-- 7#a7 shall conduct a safety assessment and make a safety determination of each high-priority substance designated under section #d;,a in accordance with subsections 7b7 and 7c72 7#b7 shall1 when a safety determination concludes that a substance does not meet the safety standard1 establish restrictions pursuant to subsection 7d72 7#c7 shall complete a safety assessment and safety determination not later than #b years after the date on which a substance is designated as a high priority2 7#d7 shall promulgate a final rule pursuant to subsection 7d7 not later than #b years after the date on which the safety determination is completed2 and 7#e7 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#c7 and 7#d7 of this subsection and any deferrals under subsection 7c77#b7 does not exceed #b years4 7b7 ,safety assessments and determinations 7#a7 ,in general ,the ,administrator shall conduct a risk-based safety assessment and make a risk-based safety determination of each high-priority substance4 7#b7 ,already initiated assessments 7,a7 ,in general ,nothing in this ,act prevents the ,administrator from initiating safety assessments and safety determinations of chemical substances1 or from continuing or completing safety assessments and safety determinations initiated prior to the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 prior to the date on which the policies and procedures the ,administrator is directed to establish under section #c;,a and #d;,a are effective4 7,b7 ,integration ,as policies and procedures under section #c;,a and #d;,a are established1 the ,administrator shall integrate them into ongoing assessments and determinations to the maximum extent practicable4 7#c7 ,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 merely because such action was completed prior to the completion of a policy or procedure established under section #c;,a or #d;,a1 and the validity of such assessment1 determination1 or rule shall not be determined based on the content of such policy or procedure4 7c7 ,safety determinations 7#a7 ,in general ,based on a review of the information before the ,administrator1 including draft safety assessments1 if any1 submitted by interested persons1 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 shall by rule under subsection 7d7 impose restrictions necessary to assure that the substance meets the safety standard under the intended or reasonably foreseeable conditions of use1 or1 where the safety standard cannot be met with the application of restrictions1 to ban or phase out the substance1 as appropriate2 or 7,c7 additional information is necessary in order to make a safety 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 needed in order to carry out a safety assessment and 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 that complies with the deadlines in subsection 7a71 a safety assessment and determination until after receipt of the information2 and 7,d7 in compliance with the deadlines in subsection 7a71 shall1 upon receipt of information the ,administrator finds supports the assessment and determination1 make a determination under paragraph 7#a74 7#c7 ,deadline for submission of information ,when requesting the development or submission of information under this section the ,administrator shall establish a deadline for the submission of such information1 which deadline shall be of reasonable duration and shall comply with the deadlines under subsection 7a74 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 ,a rule promulgated under this subsection-- 7,a7 may-- 7i7 apply to a mixture or article containing the chemical substance1 as appropriate2 and 7ii7 exempt a replacement part manufactured prior to the applicable compliance deadline2 and 7,b7 shall include dates by which compliance is mandatory1 which shall be as soon as feasible and may vary for different affected persons1 as the ,administrator determines to be appropriate1 but which shall be no later than #b years after the date on which the rule is promulgated4 7#c7 ,workplace exposures ,the ,administrator shall consult with the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health prior to adopting any prohibition or restriction adopted under this subsection to address workplace exposures4 7#d7 ,restrictions ,a restriction under paragraph 7#a7 shall include1 as appropriate1 #a or more of the following requirements3 7,a7 ,a requirement that a chemical substance or a mixture or article containing the substance be marked with1 or accompanied by1 clear and adequate 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 warnings and instructions to be prescribed by the ,administrator4 7,b7 ,a requirement that manufacturers and processors of the chemical substance or a mixture or article containing the substance-- 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 and 7iii7 monitor or conduct tests which are reasonably necessary to assure compliance with the requirements of any rule under this subsection4 7,c7 ,a restriction on the quantity of the chemical substance or a mixture or article containing the substance that may be manufactured1 processed1 or distributed in commerce4 7,d7 ,a requirement to ban or phase out or other regulation on the manufacture1 processing1 distribution in commerce1 use1 or disposal of the chemical substance or a mixture or article containing the substance-- 7i7 for a particular use2 7ii7 for a particular use at a concentration in excess of a level specified by the ,administrator2 or 7iii7 for all uses4 7,e7 ,a restriction on the quantity of the chemical substance or mixture or article containing the substance that may be manufactured1 processed1 or distributed in commerce-- 7i7 for a particular use2 or 7ii7 for a particular use at a concentration in excess of a level specified by the ,administrator4 7,f7 ,a requirement to restrict1 ban1 or phase out or other regulation of any manner or method of commercial use or environmental release of the chemical substance or mixture or article containing the substance4 7,g7 ,a requirement to restrict1 ban1 or phase out or other regulation of any manner or method of disposal of the chemical substance or any mixture or article containing the chemical substance1 by its manufacturer or processor or by any person who uses1 or disposes of it1 for commercial purposes1 provided that such a requirement may not require any person to take any action that would be in violation of any law or requirement of1 or in effect for1 a ,state or political subdivision1 and that such a requirement shall require each person subject to the requirement to notify each ,state and political subdivision in which a required disposal may occur of such disposal4 7,h7 ,a requirement directing manufacturers or processors of the chemical substance or mixture or article containing the substance to give notice of significant risks of harm 7without taking into consideration cost or other non-risk factors7 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 substance or mixture1 and to give public notice of such significant risks of harm4 7#e7 ,rule of construction ,the requirement1 warning1 or instruction1 under paragraph 7#d7 does not establish a uniform national standard for the purpose of supplanting1 displacing1 or preempting ,state law4 7#f7 ,analysis for rulemaking 7,a7 ,in general ,where the ,administrator determines that a rule under paragraph 7#a7 is likely to have an annual effect on the economy of more than #ajj1jjj1jjj1 then when deciding which restrictions to impose under paragraph 7#c7 as part of developing a rule under paragraph 7#a7 to ensure that a chemical substance meets the safety standard1 the ,administrator shall consider1 to the extent practicable based on reasonably available information1 the quantifiable and non-quantifiable costs and benefits of the proposed regulatory action and of the primary alternative regulatory action or actions that the ,administrator determines will ensure that the substance meets the safety standard4 ,as part of the analysis1 the ,administrator shall review such technically and economically feasible alternative or alternatives to the chemical substance that the ,administrator determines are relevant to the rulemaking4 7,b7 ,public disclosure of analysis ,when proposing a rule under paragraph 7#a71 the ,administrator shall make publicly available any analysis conducted under subparagraph 7,a74 7,c7 ,consideration of analysis ,when 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#g7 ,exemptions 7,a7 ,in general ,the ,administrator1 as part of a rulemaking under this subsection-- 7i7 may exempt a use of a chemical substance from any restriction in a rule promulgated under paragraph 7#a7 if the ,administrator determines1 based on reasonably available information1 that the rule cannot be complied with without-- 7,i7 harming national security2 7,,ii7 causing significant disruption in the national economy due to the lack of availability of a chemical substance for the exempted use2 or 7,,iii7 interfering with a critical or essential use for which no technically and economically feasible safer alternative is available1 considering hazard and exposure2 and 7ii7 may exempt a particular use of a chemical substance from a restriction in a rule issued under paragraph 7#a7 if available information demonstrates that the risks to health or the environment from continued use of the substance are substantially lower than the risks to health or the environment of replacing that use of the substance with reasonably available alternatives4 7,b7 ,exemption analysis ,when 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 such exemption4 7,c7 ,consideration of analysis ,when 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 was taken into account4 7,d7 ,conditions ,as part of a rule issued 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 human health and the environment while achieving the purposes of the exemption4 7,e7 ,duration 7i7 ,in general ,the ,administrator shall1 as part of a rule under paragraph 7#a7 that contains an exemption under this paragraph1 set a time limit on any exemption not to exceed #e years4 7ii7 ,extension ,the ,administrator may1 by rule1 extend1 modify1 or eliminate the exemption when 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 ,consideration for extension ,the ,administrator shall issue exemptions and establish time periods under this subparagraph by considering factors determined by the ,administrator as relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard4 7iv7 ,exception for rule requiring ban or phase out ,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 of this section to be effective upon publication of the proposed rule in the ,federal ,register and until the effective date of a final action taken respecting such rule 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 such proposed rule or any combination of such activities is likely to result in a significant risk of serious or widespread injury 7without taking into consideration cost or other non-risk factors7 to health or the environment before such effective date2 and 7,b7 making the proposed rule 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 in an action under section #g of this title granted relief with respect to the risk associated with the substance or mixture4 7f7 ,expedited action on ,p,b,ts 7#a7 ,list of ,p,b,ts ,in addition to carrying out section #d;,a1 not later than #ahj days after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall publish a list of chemical substances that the ,administrator determines are persistent1 bio-accumulative1 and toxic and have the potential for high or widespread exposure 7referred to in this subsection as ,p,b,ts74 7#b7 ,use and exposure assessment 7,a7 ,in general ,not later than #fj days after publishing the ,,pbt list required under paragraph 7#a71 the ,administrator shall require by order the submission by manufacturers or processors of chemical substances included in the list of any additional information the ,administrator determines to be necessary to conduct an expedited assessment of the intended1 known1 or reasonably foreseeable uses of1 and exposures to1 such chemical substances4 7,b7 ,publication ,not later than #a year after receiving the information which manufacturers and processors are required to submit under subparagraph 7,a71 the ,administrator shall complete and publish an identification and assessment of the intended or reasonably foreseeable conditions of use of1 and exposures to1 substances on the ,,pbt list4 7#c7 ,exposure reduction 7,a7 ,rule ,as soon as practicable1 but not later than #b years after the date on which the ,administrator completes the use and exposure assessment required under paragraph 7#b71 the ,administrator shall impose1 by rule1 restrictions that the ,administrator determines to be necessary to achieve the maximum practicable reduction in human or environmental exposure to chemical substances included in the ,,pbt list4 7,b7 ,contents of rules ,a rule promulgated under subparagraph 7,a7 may include any of the restrictions on manufacturing1 processing1 use1 distribution in commerce1 and disposal described in subsection 7d77#d7 which the ,administrator determines are necessary to achieve maximum practicable reduction in exposure to the listed ,,pbt substance4 7,c7 ,effective date ,a rule promulgated under subparagraph 7,a7 shall include an effective date in accordance with subsection 7d77#b77;,b7 and may be made effective upon publication of a proposed rule in accordance with subsection 7f74 7#d7 ,exemptions 7,a7 ,scope and basis ,a rule imposing a restriction on a listed ,,pbt substance in accordance with subparagraph 7#c7 may exempt a use of the substance from such restriction upon a showing satisfactory to the ,administrator that the use meets the exemption criteria in subsection 7d77#g74 7,b7 ,conditions ,the ,administrator shall include conditions in any exemption established under this paragraph1 including reasonable recordkeeping1 monitoring1 and reporting requirements1 to the extent necessary to protect health or the environment while achieving the purposes of the exemption4 7,c7 ,duration ,an exemption established under this paragraph shall be in effect for a period determined by the ,administrator but not to exceed #e years and1 after public notice and an opportunity for comment1 may be renewed by the ,administrator for #a or more periods not exceeding a total of #e years by order following submission of an application justifying the continuing need for the exemption and containing such information as the ,administrator may require4 7g7 ,report on public buildings ,not later than #f months after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall submit to ,congress a report on how data on exposure in public buildings will be gathered to carry out subsection 7f7 and on what testing is necessary to protect the public from exposures to chemical substances identified under subsection 7f7 in public buildings4 7h7 ,final agency action ,under this section-- 7#a7 a safety determination1 together with the associated safety assessment1 for a substance that the ,administrator determines under subsection 7c7 meets the safety standard1 shall be considered to be a final agency action on the date of the final safety determination2 and 7#b7 a final rule promulgated under subsection 7d71 together with the associated safety assessment and safety determination that a substance does not meet the safety standard1 shall be considered to be final agency action on the date of promulgation of the final rule4 2 7#e7 by redesignating subsections 7e7 and 7f7 as subsections 7i7 and 7j71 respectively2 and 7#f7 in subsection 7i7 7as so redesignated7-- 7,a7 by striking paragraph 7#d72 and 7,b7 by redesignating paragraph 7#e7 as paragraph 7#d72 and 7#g7 by inserting after subsection 7j7 7as so redesignated7 the following3 7k7 ,prior actions ,nothing in this section shall be construed as requiring the ,administrator to modify or withdraw any rule or order promulgated under section #f of this title promulgated prior to the enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 4 7l7 ,asbestos 7#a7 ,listing ,the ,administrator shall include all forms of asbestos as #a high-priority chemical substance under section #d;,a7a77#b7 in accordance with section #d;,a7a77#d74 7#b7 ,schedule ,notwithstanding paragraphs 7#c71 7#d7 and 7#e7 of subsection 7a71 the ,administrator shall-- 7,a7 complete a safety assessment and safety determination of all forms of asbestos not later than #b years after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act2 and 7,b7 promulgate a final rule not later than #c years after the date of enactment of that ,act4 4 #ajh4 ,imminent hazards ,section #g 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 district court of the ,united ,states for-- 7,a7 seizure of an imminently hazardous chemical substance or mixture or any article containing the substance or mixture2 7,b7 relief 7as authorized by subsection 7b77 against any person who manufactures1 processes1 distributes in commerce1 uses1 or disposes of an imminently hazardous chemical substance or mixture or any article containing the 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 subsection notwithstanding-- 7,a7 the existence of-- 7i7 a decision by the ,administrator under section #d1 #e7;c77#f71 #f7;c77#b7 or #f7;h72 or 7ii7 a rule1 testing consent agreement1 or order under section #d7;d71 #e7;c77#d71 #f7;d71 or title ,,iv2 or 7,b7 the pendency of any administrative or judicial proceeding under any provision of this ,act4 2 7#b7 in subsection 7b77#a71 by striking unreasonable2 7#c7 in subsection 7d71 by striking section #f7;a7 and inserting section #f7;d72 and 7#d7 in subsection 7f71 in the first sentence1 by striking and unreasonable4 #aji4 ,information collection and reporting ,section #h 7#ae ,u4,s4,c4 #bfjg7 is amended-- 7#a7 in subsection 7a71 by adding at the end the following3 7#d7 ,regulations 7,a7 ,deadline 7i7 ,in general ,not later than #b years after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall promulgate rules requiring the maintenance of records and the reporting of information known by1 or reasonably ascertainable by1 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 ,prior regulations ,in carrying out this subparagraph1 the ,administrator may modify1 as appropriate1 the regulations promulgated prior to the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 7,b7 ,contents ,the rules promulgated under subparagraph 7,a7-- 7i7 may impose different reporting and record retention requirements on manufacturers and processors2 7ii7 shall include the level of detail necessary to be reported1 including the manner by which use and exposure information may be reported2 and 7iii7 shall require reporting of information or maintenance of records where the ,administrator determines the submission of reports would assist in the effective implementation of this ,act4 7,c7 ,administration ,in implementing this paragraph1 the ,administrator shall take measures to-- 7i7 limit the potential for duplication in reporting requirements2 7ii7 minimize the impact of the rules on small manufacturers and processors2 and 7iii7 apply any reporting requirements 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 a rule promulgated under this subsection4 2 7#b7 in subsection 7b71 by adding at the end the following3 7#c7 ,chemical substances in commerce 7,a7 ,rule 7i7 ,in general ,not later than #a year after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the ,administrator shall by rule require manufacturers and processors to notify the ,administrator1 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 prior to the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 7ii7 ,consideration as active substance ,the ,administrator shall consider chemical substances for which notices are received under clause 7i7 to be active substances and shall1 pursuant to paragraph 7#d77;,c71 designate the chemical substance as an active substance on the list published under paragraph 7#a74 7,b7 ,confidential chemical substances 7i7 ,in general ,the ,administrator shall maintain the list under paragraph 7#a71 which shall include a confidential portion and a nonconfidential portion consistent with this section and section #ad4 7ii7 ,existing claim of confidentiality ,the rule promulgated under subparagraph 7,a7 shall require 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 #ad4 7iii7 ,substantiation ,the rule promulgated under subparagraph 7,a7 shall require the substantiation of a claim described in clause 7ii7 pursuant to section #ad and in accordance with the review plan described in subparagraph 7,c74 7,c7 ,review plan and requirements 7i7 ,in general ,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 develop a plan to review all claims to protect the specific identity of a chemical substance on the confidential portion of the list published under paragraph 7#a7 that is identified as an active substance in a report submitted pursuant to subparagraph 7,a7 or identified as active substances under paragraph 7#d77;,a74 7ii7 ,contents ,the plan shall describe how the ,administrator will carry out the requirements of this subparagraph4 7iii7 ,requirements ,the ,administrator shall-- 7,i7 require1 at a time determined by the ,administrator1 all manufacturers or processors asserting a claim under subparagraph 7,b7 to substantiate each such claim unless the manufacturer or processor has substantiated the claim in a submission made to the ,administrator within #e years of the date of the ,administrator's request2 7,,ii7 in accordance with the requirements of section #ad-- 7aa7 review each substantiation-- 7,,aa7 submitted pursuant to subclause 7,i7 to determine if the claim warrants protection from disclosure2 and 7,,bb7 submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to subclause 7,i71 if such substantiation has not been previously reviewed by the ,administrator1 to determine if the claim warrants protection from disclosure2 7bb7 approve1 modify or deny each claim2 and 7cc7 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 years unless-- 7,,aa7 prior to the expiration of the period1 the person notifies the ,administrator that the person is withdrawing the confidentiality claim1 in which case1 the ,administrator shall promptly make the information available to the public2 or 7,,bb7 prior to the expiration of the period1 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#b72 and 7,,iii7 encourage manufacturers and processors that have previously made claims to protect the specific identities of chemical substances identified as inactive pursuant to paragraph 7#d77;,b7 to review and either withdraw or substantiate such claims4 7,d7 ,timeline for completion of reviews 7i7 ,in general ,the ,administrator shall 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 ,extension ,the ,administrator may extend the deadline for completion of the reviews described in subparagraph 7,c7 for up to a maximum of #b additional years1 after an adequate public justification1 if the ,administrator finds the extension is necessary based on the number of such claims needing review and the available resources4 7iii7 ,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 ,no confidentiality for unlisted chemicals ,the specific identity of any chemical that is not on the confidential portion of the list published under paragraph 7#a7 or subsequently added to the confidential portion of the list pursuant to section #ad shall not be eligible for protection from disclosure4 7,f7 ,certification ,the ,administrator shall require a manufacturer or processor-- 7i7 to certify the accuracy of each report submitted or record maintained under this section2 and 7ii7 to retain documentation supporting certification under clause 7i7 for a period of #e years beginning on the last day of the submission period4 7#d7 ,active and inactive substances 7,a7 ,active substances ,for the purposes of this section1 the term active substance means a chemical substance that-- 7i7 has been manufactured or processed for a nonexempt commercial purpose at any point during the #aj-year period prior to the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act2 or 7ii7 that is added to the list published under paragraph 7#a7 after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 7,b7 ,inactive substances ,for purposes of this section1 the term inactive substance means a chemical substance on the list published under paragraph 7#a7 that does not meet any of the criteria in subparagraph 7,a74 7,c7 ,list of designations ,the ,administrator shall maintain and keep current designations of active and inactive substances on the list published under paragraph 7#a74 7,d7 ,update ,the ,administrator shall update the list of chemicals designated as active as soon as practicable following the publication of the most recent data reported under part #gaa of title #dj1 ,code of ,federal ,regulations1 and the rule promulgated under subsection 7a77#d74 7,e7 ,change to active status 7i7 ,in general ,any person who intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the ,administrator not less than #ij days before the date on which the substance is manufactured or processed4 7ii7 ,confidential chemical identity claims 7,i7 ,in general ,if a person submitting a notice under clause 7i7 for an inactive chemical 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 substance as confidential1 the person shall-- 7aa7 in the notice submitted under clause 7i71 assert the claim2 and 7bb7 substantiate the claim4 7,,ii7 ,no confidentiality for unlisted chemicals ,the specific identity of any inactive chemical that is not on the confidential portion of the list published under paragraph 7#a7 or subsequently added to the confidential portion of the list pursuant to section #ad shall not be eligible for protection from disclosure4 7iii7 ,active status ,after receiving notification under clause 7i71 the ,administrator shall-- 7,i7 designate the 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 substance and approve1 modify1 or deny the claim2 7,,iii7 except as provided in this section and section #ad1 protect from disclosure information for which the ,administrator approves a claim under subclause 7,,ii7 for a period of #aj years unless-- 7aa7 prior to the expiration of the #aj-year period1 the person notifies the ,administrator that the person is withdrawing the confidentiality claim1 in which case1 the ,administrator shall promptly make the information available to the public2 or 7bb7 prior to the expiration of the #aj-year period1 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#b72 and 7,,iv7 pursuant to section #d;,a1 review the priority of the chemical substance as the ,administrator determines necessary4 7,f7 ,category status ,the list of inactive chemical substances shall not be considered a category for purposes of section #bf7;c74 7#e7 ,interim list of active substances ,prior to the promulgation of the rule required under this subsection1 the ,administrator shall designate those substances reported under part #gaa of title #dj1 ,code of ,federal ,regulations1 during the reporting period that most closely preceded the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 as the initial list of active substances for the purposes of section #d;,a4 7#f7 ,public participation ,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 an active substance2 7,b7 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 an inactive substance2 7,c7 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 7,d7 subject to section #ad1 the specific identity of any active substance-- 7i7 for which no claim of protection against disclosure of the specific identity pursuant to this subsection was received2 7ii7 for which a claim for protection against disclosure of the specific identity of the substance has been denied by the ,administrator2 or 7iii7 for which the time period for protection against disclosure of the specific identity of the substance has expired2 and 7,e7 any substance previously classified as an inactive substance that has been reclassified as an active substance4 2 and 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 injury to health and the environment4 4 #aaj4 ,relationship to other ,federal laws ,section #i 7#ae ,u4,s4,c4 #bfjh7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the first sentence of paragraph 7#a7-- 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 subsections 7b7 or 7c7 of section #f1 or section #g2 and 7,c7 in paragraph 7#c71 by striking section #f or #g and inserting section #f7;d7 or section #g2 and 7#b7 in subsection 7d71 in the first sentence1 by striking ,health1 ,education1 and ,welfare and inserting ,health and ,human ,services4 #aaa4 ,research1 development1 collection1 dissemination1 and utilization of data ,section #aj 7#ae ,u4,s4,c4 #bfji7 is amended by striking ,health1 ,education1 and ,welfare each place it appears and inserting ,health and ,human ,services4 #aab4 ,exports ,section #ab 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 substance1 mixture1 or article 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 article if the ,administrator finds that the chemical substance as contained in the mixture or article will meet the safety standard2 and 7,b7 establish a threshold concentration of the chemical substance in a mixture or article at which paragraph 7#a7 shall not apply if the ,administrator finds that at or below this concentration the substance as contained in the article or mixture will meet the safety standard4 7#d7 ,testing ,the ,administrator may require testing under section #d of any chemical substance or mixture exempted from this ,act by paragraph 7#a7 for the purpose of determining whether or not the 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 notification1 prohibition1 or 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 notification1 prohibition1 or 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 restriction pursuant to a rule1 order1 or consent agreement in effect under this ,act2 7,e7 a chemical substance or mixture for which the submission of information is required under section #d2 or 7,f7 a chemical substance or mixture containing a chemical substance with respect to which an action is pending1 or relief has been granted under section #g4 7#b7 ,regulations 7,a7 ,in general ,the ,administrator shall promulgate regulations to carry out paragraph 7#a74 7,b7 ,contents ,the regulations promulgated under subparagraph 7,a7 shall include any exemptions the ,administrator determines to be appropriate1 which may include exemptions identified under section #e7;g74 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 paragraph 7#a77;,e71 a notice of availability of the information on the chemical substance or mixture submitted to the ,administrator2 7,b7 for a chemical substance or mixture described in subparagraph 7,a71 7,b7 or 7,d7 of paragraph 7#a71 a notice of the determination1 rule1 order1 consent agreement1 requirement1 designation1 action1 or relief2 and 7,c7 for a chemical substance described in paragraph 7#a77;,c71 a notice that satisfies the obligation of the ,united ,states under the applicable treaty4 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 #aac4 ,imports ,section #ac 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 entry if-- 7,a7 the ,administrator-- 7i7 has determined under section #f7;c7 that the chemical substance1 mixture or article does not meet the safety standard2 and 7ii7 has promulgated a rule under section #f7;d7 banning the chemical substance1 mixture1 or article1 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 the list under section #h7;b77#a7 by this title or a rule issued by the ,administrator under this title2 or 7,c7 the chemical substance1 mixture1 or any article containing the chemical substance or mixture fails to comply with any requirement in effect under this ,act or is offered for entry in violation of a rule1 consent agreement1 or order in effect under this ,act or 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 in 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 ,security may1 pending a review by the ,administrator1 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 when demanded1 the consignee shall be liable to the ,united ,states for liquidated damages equal to the full amount of the bond4 7,c7 ,storage ,all charges for storage1 cartage1 and labor on and 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 the chemical substance or mixture is in compliance with any applicable rule1 consent agreement1 or order under section #e or #f1 and that the chemical substance-- 7,a7 is included on the list under section #h7;b77#a72 or 7,b7 is exempt from any requirement to be included on the list under section #h7;b77#a7 by this title or a rule issued by the ,administrator under this title4 7#b7 ,articles ,the ,administrator may1 by rule1 require certification under paragraph 7#a7 for an article containing a chemical substance or mixture that is subject to regulation under section #e or #f4 7#c7 ,content of certification rule ,in determining the need for and content of a certification rule under this subsection1 the ,administrator may consider-- 7,a7 the utility of such certification to the enforcement of the applicable rule1 consent agreement1 or order under section #e or #f2 7,b7 the frequency of the certification requirement2 and 7,c7 if applicable1 specification of the concentration of a chemical substance in an article that would subject the article to the certification requirement4 7#d7 ,public information ,for purposes of this section1 the ,administrator shall provide publicly accessible information on the identity of a chemical substance or mixture subject to regulation 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 one 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 is the subject of a safety assessment and safety determination conducted pursuant to section #f7;d7 and 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 issue rules for the administration of this section4 7#b7 ,content ,a rule issued under paragraph 7#a7 may tailor the application of any requirement in this section1 as appropriate for the efficient and effective implementation of this ,act4 4 #aad4 ,confidential information ,section #ad 7#ae ,u4,s4,c4 #bfac7 is amended-- 7#a7 by striking the heading ,disclosure of ,data and inserting ,confidential ,information2 7#b7 by striking subsection 7c7 and redesignating subsection 7b7 as subsection 7c72 7#c7 by striking subsection 7a7 and inserting the following3 #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 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 7#a7 ,in general ,the information described in paragraph 7#b7 specific to and submitted by a manufacturer1 processor1 or distributor that meets the requirements of subsection 7d7 shall be protected from disclosure1 except that-- 7,a7 such information may be disclosed in accordance with subsection 7e72 7,b7 such information is subject to the review and substantiation requirements in subsection 7f77#b72 and 7,c7 nothing in this ,act shall operate to prohibit the disclosure of such information through discovery1 subpoena1 other court orders1 or any other judicial process otherwise allowed under applicable ,state or ,federal laws4 7#b7 ,protected information ,information subject to paragraph 7#a7 shall include-- 7,a7 specific information describing the processes used in manufacture or processing of a chemical substance1 mixture1 or article2 7,b7 marketing and sales plans and strategies2 7,c7 information identifying suppliers or customers2 7,d7 the percentages of the components of a mixture2 7,e7 specific information about the use1 function1 or application of a chemical substance or mixture in a process1 mixture1 or product2 7,f7 specific production or import volumes of the manufacturer1 and specific aggregated volumes across manufacturers if the ,administrator determines that disclosure of the specific aggregated volumes would reveal confidential information2 and 7,g7 except as otherwise provided in this section1 the specific identity of a chemical substance prior to the date on which it was included on the list under section #h7;b77#a71 including the chemical name1 molecular formula1 ,chemical ,abstracts ,service number1 and other information that would identify a specific chemical substance1 if-- 7i7 the specific identity was claimed as confidential information at the time it was submitted to the ,administrator in a notice under section #e2 7ii7 the claim has not subsequently been withdrawn or found by the ,administrator not to warrant protection as confidential information under subsection 7e71 7f77#b71 or 7g72 and 7iii7 the substance is not an active substance under section #h7;b77#d7 of this ,act4 2 7#d7 by striking the heading ,data from health and safety studies in subsection 7c7 7as so redesignated7 and inserting ,information not protected from disclosure4--,notwithstanding subsections 7a7 and 7b71 the following information shall not be protected from disclosure32 7#e7 by inserting at the end of subsection 7c7 7as so redesignated7 the following3 7#c7 ,other information not protected from disclosure ,information shall not be protected from disclosure under this section if it is-- 7,a7 for information submitted after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 the specific identity of a chemical substance as of the date on which it is included on the list under section #h7;b77#a71 if the person submitting the information does not meet the requirements of subsection 7d72 7,b7 a safety assessment developed or a safety determination made under section #f2 7,c7 general information describing the manufacturing volumes1 expressed as specific aggregated volumes or1 when the ,administrator determines that disclosure of specific aggregated volumes would reveal confidential information1 expressed in ranges2 or 7,d7 general descriptions of the processes used in 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 would be customarily shared with the general public or within an industry or industry sector4 7#d7 ,exception ,information elements that are otherwise eligible for protection under this section that are contained in submissions of information described in paragraph 7#a7 shall be protected from disclosure if the submitter complies with subsection 7d71 but information in such submissions described in paragraph 7#a7 that is not eligible for protection against disclosure shall be disclosed4 7#e7 ,no confidentiality for unlisted chemicals ,except as provided in the second sentence of paragraph 7#a71 the specific identity of any chemical that is not on the confidential portion of the list published under section #h7;b77#a7 or subsequently added to the confidential portion of the list pursuant to this section shall not be eligible for protection from disclosure4 7#f7 ,ban or phase-out ,if the ,administrator promulgates a rule pursuant to section #f7;d7 that establishes a ban or phase out on the manufacture1 processing1 or distribution in commerce of a chemical substance1 any protection from disclosure provided under section #ad applicable for information on the chemical substance shall no longer apply and the ,administrator shall promptly 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 a claim for such protection to the ,administrator at the time of the submission of the information1 pursuant to rules applicable to a claim for protection from disclosure that the ,administrator has promulgated under this title4 7,b7 ,contents of claim ,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 disclosed1 or otherwise made available1 to the public under any other ,federal law in connection with #a or more uses subject to this ,act2 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 otherwise publicly available or 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 conditions that-- 7i7 the generic name conforms with guidance prescribed by the ,administrator under paragraph 7#c77;,a72 and 7ii7 describes the chemical structure of the substance as specifically as possible while protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the competitive position of the person4 7#b7 ,additional requirements for confidentiality claims ,except for information described in subsection 7b77#b71 a person asserting a claim to protect information from disclosure under this ,act shall1 in accordance with the rules promulgated and guidance issued by the ,administrator1 substantiate that the information meets the requirements for protection pursuant to section #eeb of title #e1 ,united ,states ,code1 under subsection 7b77#d7 of that section4 7#c7 ,guidance ,the ,administrator shall develop guidance on-- 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#e7 and 7#f7 of subsection 7e74 7#d7 ,certification ,an authorized official of the person described in paragraph 7#a77;,a7 shall certify that the statements and information included in assertions and substantiations of claims for protection submitted under this subsection are true and correct4 7e7 ,exceptions to protection from disclosure ,information described in subsection 7a7 7including information subject to subsection 7b77 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 that person under any law for the protection of human health or the environment or for specific law enforcement purposes2 7#b7 the information is to be disclosed to a contractor with the ,united ,states and employees of that contractor 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 ,act and under such conditions as the ,administrator shall specify2 7#c7 the ,administrator determines that disclosure is necessary to protect human 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 government will take appropriate steps1 and has adequate authority1 to maintain the confidentiality of the information in accordance with procedures comparable to those which the ,administrator uses to safeguard the information2 and 7,b7 the ,administrator notifies the person who submitted the information that the information has been disclosed to a ,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 ,administrator that conforms with the guidance issued under subsection 7d77#c77;,b71 subject to the conditions that-- 7,a7 the written statement of need is a statement that the person has a reasonable basis to suspect that-- 7i7 the information is necessary for or will assist in diagnosis or treatment of #a or more individuals or in 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,b7 the confidentiality agreement provides 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 may otherwise be authorized by the terms of the agreement or by the person submitting the information to the ,administrator1 except that nothing in this ,act shall operate to prohibit the disclosure of such information through discovery1 subpoena1 and other court orders1 or any other judicial process otherwise allowed under applicable ,state or ,federal laws2 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 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 has a reasonable basis to suspect that-- 7i7 a medical or public health or environmental emergency exists2 7ii7 the information is necessary for or will assist in emergency or first-aid diagnosis or treatment2 and 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 and 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 provides a written statement of need and agrees to sign a confidentiality agreement as described in paragraph 7#e72 and 7,c7 the written confidentiality agreement or statement of need is 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 is 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 committee of the ,congress1 to that committee2 7#i7 the information is publicly available2 or 7#aj7 the information is required to be disclosed or otherwise made public under any other ,federal law4 7f7 ,duration of protection from disclosure 7#a7 ,in general 7,a7 ,information protected from disclosure ,subject to paragraph 7#b7 and except as allowed under subsection 7e71 the ,administrator shall protect from disclosure information that meets the requirements of subsection 7d7 for a period of #aj years1 unless-- 7i7 prior to the expiration of the #aj-year period1 the person notifies the ,administrator that the person is withdrawing the confidentiality claim1 in which case1 the ,administrator shall promptly make the information available to the public2 7ii7 prior to the expiration of the #aj-year period1 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#b72 or 7iii7 the ,administrator denies the claim under subsection 7g77#a74 7,b7 ,extensions 7i7 ,in general ,not less than #fj days prior to the expiration of the period described in subparagraph 7,a71 the ,administrator shall provide notice of the impending expiration of the period to the person who asserted the claim4 7ii7 ,submission to reassert a claim ,not less than #cj days prior to expiration of the period described in subparagraph 7,a71 the person reasserting the claim shall submit a statement substantiating1 in accordance with subsection 7d77#b71 the need to extend the period4 7iii7 ,review ,not later than #cj days of receipt of the statement described in clause 7ii71 the ,administrator shall-- 7,i7 review the request and make a determination as to whether the information for which the request is made continues to meet the relevant criteria established in this section2 and 7,,ii7 7aa7 grant an extension not to exceed #aj years2 or 7bb7 deny the claim4 7,c7 ,limit on number of extensions ,there shall be no limit on the number of extensions granted under subparagraph 7,b7 as long as the ,administrator finds that the substantiation establishes the need to extend the period and meets the requirements established by the ,administrator1 and that the length of any extension does not exceed #aj years4 7#b7 ,review and resubstantiation 7,a7 ,in general ,the ,administrator may at any time review a claim for protection against disclosure under subsection 7a7 for information submitted to the ,administrator on a chemical substance 7including information described in subsection 7b77#b771 and may require any person who has claimed protection for that information1 whether before or after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act1 to withdraw or reassert and substantiate or resubstantiate the claim in conformance with the requirements of 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#a7 7,b7 or 7,c72 7iii7 for any inactive chemical substance identified pursuant to section #h7;b77#d72 7iv7 if the ,administrator determines that disclosure of certain information currently protected from disclosure would assist the ,administrator in conducting safety assessments and determinations under section #f 7b7 and 7c7 or promulgating rules under section #f7;d72 7v7 if necessary to comply with a request for information the ,administrator receives pursuant to section #eeb of title #e1 ,united ,states ,code2 7vi7 if information available to the ,administrator provides a basis that the requirements of subsection 7b77#d7 of section #eeb of title #e1 ,united ,states ,code1 are no longer met2 or 7vii7 for information contained in a notice of substantial risk submitted under section #h7;e74 7,b7 ,resubstantiation ,if the ,administrator makes a request under subparagraph 7,a71 the person receiving the request shall-- 7i7 resubstantiate the claim2 or 7ii7 withdraw the claim4 7,c7 ,extension ,protection from disclosure of the 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 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 term1 and apply such identifier consistently to all information relevant to such substance2 7,b7 annually publish and update a list of substances for which claims to protect specific chemical identity from disclosure have been approved1 referred to by unique identifier1 including the expiration date for each such claim2 7,c7 ensure that any nonconfidential information received by the ,administrator with respect to such a substance during the period of protection from disclosure is made public and identifies the substance using the unique identifier2 and 7,d7 for each claim for protection of specific chemical identity that has been denied by the ,administrator1 upon 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 substance4 7g7 ,duties of the 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 who 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 the person who has submitted the claim 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 on 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 who 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 who 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 who 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 human health or the environment1 in which case1 no prior notification is necessary4 7,,ii7 ,no notification ,for information under paragraph 7#a71 7#b71 7#f71 7#g71 7#i7 or 7#aj7 of subsection 7e71 no prior notification is necessary4 7#c7 ,appeals 7,a7 ,in general ,a person who receives a notification under paragraph 7#b7 may1 if the person believes disclosure of the information is prohibited under subsection 7a71 before the date on which the information is to be released1 bring an action to restrain disclosure of the information in-- 7i7 the district court of the ,united ,states in 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 prior to 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 employ the procedures in part #b of title #dj1 ,code of ,federal ,regulations 7or successor regulations74 7h7 ,criminal penalty for wrongful disclosure 7#a7 ,in general ,subject to paragraph 7#b71 any officer or employee of the ,united ,states or former officer or employee of the ,united ,states who-- 7,a7 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 7,b7 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 material1 shall be guilty of a misdemeanor and fined under title #ah1 ,united ,states ,code1 imprisoned for not more than #a year1 or both4 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 the purposes of this subsection1 any contractor of the ,united ,states who is furnished 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 ,except as otherwise provided by this section1 section #h1 or any other ,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 prior to the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,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 prior to the effective date of rules applicable to such claims that the ,administrator may promulgate after the date of enactment of the ,alan ,reinstein and ,trevor ,schaefer ,toxic ,chemical ,protection ,act4 7j7 ,definition of first responder ,for the purposes of this section1 the term first responder means a person duly authorized by a ,state or political subdivision of a ,state or a ,federal agency1 trained in urgent medical care or other emergency procedures1 including a police officer1 firefighter1 or emergency medical technician4 4 #aae4 ,prohibited acts ,section #ae 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 prescribed by section #e or #f2 7,c7 any rule promulgated1 consent agreement entered into1 or order issued under section #e or #f2 7,d7 any requirement of title ,,ii or any rule promulgated or order issued under title ,,ii2 or 7,e7 any requirement of title ,,vi or any rule promulgated or order issued under title ,,vi2 4 #aaf4 ,penalties ,section #af 7#ae ,u4,s4,c4 #bfae7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 in the first sentence-- 7,i7 by inserting this ,act or a rule or order promulgated or issued pursuant to this ,act1 as described in after a provision of2 and 7,,ii7 by striking #be1jjj and inserting #cg1ejj2 and 7ii7 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 and inserting the following3 7#a7 ,in general ,any person 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 ,any person who knowingly or willfully violates any provision of this ,act1 and who knows at the time of the violation that the violation places another person in imminent danger of death or serious bodily injury shall be subject1 upon conviction1 to a fine of not more than #bej1jjj1 imprisonment for not more than #ae years1 or both4 ,any person committing such violation which is an organization shall1 upon conviction under this paragraph1 be subject to a fine of not more than #a1jjj1jjj for each violation4 7#c7 ,knowledge of imminent danger or injury ,in determining whether a defendant knew that the violation placed another person in imminent danger of death or serious bodily injury1 the defendant is responsible only for actual awareness or actual belief possessed1 and knowledge possessed by another person that is not the defendant may not be attributed to the defendant4 4 #aag4 ,preemption ,section #ah 7#ae ,u4,s4,c4 #bfag7 is amended-- 7#a7 in subsection 7a77#a71 by striking 7#a7 ,except as provided in paragraph 7#b71 nothing and inserting ,nothing2 7#b7 by striking subsection 7a77#b72 and 7#c7 by striking subsection 7b7 and inserting the following3 7b7 ,savings 7#a7 ,no preemption of common law or statutory causes of action for civil relief or criminal conduct ,nothing in this ,act1 nor any amendment made by this ,act1 nor any regulation1 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 in 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 ,state1 maritime1 or ,federal common law or statutory theory4 7#c7 ,no effect on private remedies 7,a7 ,in general ,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 ,no effect on authority of court ,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 7#d7 ,no preemption of state laws ,nothing in this ,act1 nor any amendment made by this ,act1 nor any regulation1 requirement1 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 regulation1 requirement1 standard of performance1 safety determination1 scientific assessment1 or any protection for public health or the environment that is different from1 or in addition to1 any regulation1 requirement1 standard of performance1 safety determination1 or scientific assessment implemented pursuant to this ,act4 4 #aah4 ,judicial review ,section #ai 7#ae ,u4,s4,c4 #bfah7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in subparagraph 7#a77;,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;c77#d71 #f7;d71 or #h2 7,b7 in subparagraph 7#a77;,b71 by striking subparagraph 7,a7 and inserting paragraph 7#a72 and 7,c7 by striking paragraph 7#c72 and 7#b7 in subsection 7c7-- 7,a7 in subparagraph 7#a77;,b71 by striking clauses 7i7 and 7ii7 and the last sentence of the subparagraph2 7,b7 by redesignating paragraph 7#a77;,b77iii7 as paragraph 7#a77;,b77i72 and 7,c7 in paragraph 7#a77;,b77i7 as so redesignated71 by striking 7,i7 any statement required to be made pursuant to section #f7;c77#a7 of this title1 or 7,,ii74 #aai4 ,citizens' petitions ,section #ba 7#ae ,u4,s4,c4 #bfbj7 is amended-- 7#a7 in subsection 7a71 by striking an order under section #e7;e7 and inserting an order under section #d1 #e7;c712 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking an order under section #e7;e7 and inserting an order under section #d1 #e7;c712 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 issue a rule under section #d1 #e7;c71 #f7;d71 or #h or an order issued under section #d or #e7;c71 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 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 or #f7;b72 7bb7 in the case of a petition to issue an order under section #e7;c71 there is a reasonable basis to conclude that the 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 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 require reporting or recordkeeping to obtain information relevant to determining whether a substance or mixture may fail to meet the safety standard4 7,,ii7 ,deferment ,the court may permit the ,administrator to defer initiating the action requested by the petitioner until such time as the court prescribes if the court finds that-- 7aa7 the extent of the risk to human health or the environment alleged by the petitioner is less than the extent of risks to human 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 #abj4 ,studies ,section #be 7#ae ,u4,s4,c4 #bfbd7 is repealed4 #aba4 ,administration ,section #bf7;e7 7#ae ,u4,s4,c4 #bfbe7;e77 is amended-- 7#a7 by striking ,health1 ,education1 and ,welfare each place it appears and inserting ,health and ,human ,services2 and 7#b7 by striking subsection 7b7 and inserting-- 7b7 ,fees 7#a7 ,in general ,the ,administrator shall1 by rule1 require manufacturers of chemical substances to pay reasonable fees to defray the costs of administering this title1 including but not limited to costs resulting from-- 7,a7 issuing rules and orders to conduct testing under section #d and reviewing data submitted under these requirements2 7,b7 developing the priority list and designating substances as high-priority under section #d;,a2 7,c7 reviewing notices submitted under section #e2 7,d7 conducting safety assessments and making safety determinations under section #f2 7,e7 promulgating rules and issuing orders to restrict chemical substances under section #f2 7,f7 promulgating rules and issuing orders to report information and data and maintain records under section #h2 and 7,g7 reviewing confidentiality claims under section #ad4 7#b7 ,apportionment 7,a7 ,in general ,the ,administrator shall apportion fees among individual manufacturers in relation to the costs of administering this title which are attributable to each manufacturer's production or importation of chemical substances subject to action under sections #d1 #d;,a1 #e1 #f and #h4 7,b7 ,multiple manufacturers ,if there is more than #a manufacturer of such substance1 the ,administrator shall provide for the sharing of fees in proportion to each manufacturer's contribution to total production of such substance1 unless there is some other basis for apportionment that better reflects considerations of hazard and exposure4 7#c7 ,small business concerns ,the rule promulgated under paragraph 7#a7 may set separate fees for manufacturers of chemical substances that are small business concerns based on their ability to pay4 7#d7 ,limitation ,fees collected under this subsection shall only be used to defray the costs of administering this title and not for any other purpose4 4 7#e7 ,level of fees ,the ,administrator shall ensure that fees are set at a level sufficient to enable the ,administrator to perform all of the responsibilities described in paragraph 7#a7 and add not less than #c chemical substances to the list of high-priority substances for each chemical substance removed from the list under section #d;,a7a77#e77;iii7 and to complete safety assessments and determinations and any necessary rulemaking for these high-priority substances in accordance with section #f7;a74 4 #abb4 ,development and evaluation of test methods ,section #bg7;a7 7#ae ,u4,s4,c4 #bfbf7;a77 is amended by striking ,health1 ,education1 and ,welfare and inserting ,health and ,human ,services4 #abc4 ,state programs ,section #bh 7#ae ,u4,s4,c4 #bfbg7 is amended by striking subsections 7c7 and 7d74 #abd4 ,authorization of appropriations ,section #bi 7#ae ,u4,s4,c4 #bfbh7 is repealed4 #abe4 ,annual report ,section #cj 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 ,,ii ,strengthening protections for children and communities from disease clusters #bja4 ,purposes ,the purposes of this title are-- 7#a7 to provide to the ,administrator the authority to help conduct investigations into the potential for environmental pollutants or toxic substances to cause disease clusters2 7#b7 to ensure that the ,administrator has the authority to undertake actions to help address existing and potential environmental pollution and toxic substances that may contribute to the creation of disease clusters2 and 7#c7 to enable the ,administrator to integrate and work in conjunction with other ,federal1 ,state1 and local agencies1 institutions of higher education1 and the public in investigating and helping to address the possible causes of disease clusters4 #bjb4 ,definitions ,in this title3 7#a7 ,administrator ,the term ,administrator means the ,administrator of the ,environmental ,protection ,agency4 7#b7 ,agency ,the term ,agency means the ,environmental ,protection ,agency4 7#c7 ,director ,the term ,director means the ,director of the ,national ,institute of ,environmental ,health ,sciences4 7#d7 ,disease cluster ,the term disease cluster means-- 7,a7 the occurrence of a greater-than-expected number of cases of a particular disease within a group of individuals1 a geographical area1 or a period of time2 or 7,b7 the occurrence of a particular disease in such number of cases1 or meeting such other criteria1 as the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 may determine4 7#e7 ,environmental pollutants or toxic substances ,the term environmental pollutants or toxic substances includes the substances described in paragraph 7#g74 7#f7 ,federal agency ,the term ,federal agency means-- 7,a7 any department1 agency1 or other instrumentality of the ,federal ,government2 7,b7 any independent agency or establishment of the ,federal ,government 7including any ,government corporation72 and 7,c7 the ,government ,publishing ,office4 7#g7 ,potential causes of a disease cluster ,the term potential causes of a disease cluster includes environmental and public health factors that could increase the possibility of disease clusters1 including environmental pollutants or toxic substances and sources of those pollutants and substances1 including-- 7,a7 emissions of air pollutants that are regulated under the ,clean ,air ,act 7#db ,u4,s4,c4 #gdja et seq472 7,b7 water pollutants that are regulated under the ,federal ,water ,pollution ,control ,act 7#cc ,u4,s4,c4 #abea et seq472 7,c7 a contaminant1 as that term is defined in section #adja of the ,safe ,drinking ,water ,act 7#db ,u4,s4,c4 #cjj;f72 7,d7 a hazardous substance1 as that term is defined in section #aja of the ,comprehensive ,environmental ,response1 ,compensation1 and ,liability ,act 7#db ,u4,s4,c4 #ifja72 7,e7 solid waste and hazardous waste1 as those terms are defined in section #ajjd of the ,solid ,waste ,disposal ,act 7#db ,u4,s4,c4 #fijc72 7,f7 a chemical substance1 as that term is defined in section #c of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfjb72 7,g7 a substance that is regulated under the ,emergency ,planning and ,community ,right-,to-,know ,act of #aihf 7#db ,u4,s4,c4 #aajja et seq472 and 7,h7 any other form of environmental pollution or toxic substance that is a known or potential cause of an adverse health effect1 including a developmental1 reproductive1 neurotoxic1 or carcinogenic effect4 7#h7 ,regional ,response ,center ,the term ,regional ,response ,center means a ,regional ,disease ,cluster ,information and ,response ,center established under section #bjd4 7#i7 ,response ,team ,the term ,response ,team means a ,regional ,disease ,cluster ,information and ,response ,team established under section #bjd4 7#aj7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 #bjc4 ,guidelines for environmental investigations of disease clusters 7a7 ,establishment 7#a7 ,in general ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 the ,secretary1 and the ,director1 shall develop1 publish1 and periodically update guidelines that describe a systematic1 integrated approach that uses the best available science to investigate-- 7,a7 #a or more suspected or potential disease clusters2 7,b7 environmental pollutants or toxic substances associated with #a or more suspected or potential disease clusters2 or 7,c7 potential causes of #a or more disease clusters4 7#b7 ,coordination ,the ,administrator shall ensure that the ,office of ,children's ,health ,protection1 in consultation with appropriate advisory committees1 such as the ,children's ,health ,protection ,advisory ,committee1 has a prominent role on behalf of the ,agency in developing and updating guidelines under paragraph 7#a74 7b7 ,requirements ,guidelines developed under this section shall include-- 7#a7 definitions of key concepts and actions2 7#b7 disease cluster identification and reporting protocols2 7#c7 standardized methods of reviewing and categorizing data1 including from health surveillance systems and disease cluster reports2 7#d7 guidance for using1 in a health-protective way1 an appropriate epidemiological1 statistical1 or other approach for the circumstances of an investigation2 7#e7 procedures for peer review of key documents by individuals who have no direct or indirect conflict of interest2 and 7#f7 a description of roles and responsibilities of the ,administrator and the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry in conducting investigations described in those guidelines1 in accordance with this title4 7c7 ,timing 7#a7 ,in general ,draft guidelines developed under this section shall be available for public review and comment for a period of not less than #fj days4 7#b7 ,final guidelines ,not later than #a year after the date of enactment of this ,act1 the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 the ,secretary1 and the ,director1 shall publish in the ,federal ,register final guidelines under this section4 #bjd4 ,enhanced support for environmental investigations of disease clusters 7a7 ,establishment of ,regional ,disease ,cluster ,information and ,response ,centers and ,teams 7#a7 ,establishment 7,a7 ,in general ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 the ,secretary1 and the ,director1 and other appropriate ,federal agencies1 shall establish and operate ,regional ,disease ,cluster ,information and ,response ,centers and ,regional ,disease ,cluster ,information and ,response ,teams4 7,b7 ,principal responsibility ,the ,administrator shall be principally responsible for directing1 coordinating1 and approving ,federal efforts and assistance authorized under this section4 7#b7 ,coordination 7,a7 ,in general ,the ,administrator shall ensure that the ,office of ,children's ,health ,protection1 in consultation with appropriate advisory committees1 such as the ,children's ,health ,protection ,advisory ,committee1 has a prominent role on behalf of the ,agency in establishing and operating the ,regional ,response ,centers and the ,response ,teams4 7,b7 ,grants and cooperative agreements 7i7 ,in general ,the ,administrator shall provide support 7including research1 program implementation1 and operational support activities7 to individuals on ,response ,teams described in subsection 7b7 and ,community ,disease ,cluster ,advisory ,committees described in subsection 7c7 through grants and cooperative agreements with institutions of higher education that have programs or individuals with demonstrated expertise in research1 training1 studies1 and technical assistance4 7ii7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this subparagraph such sums as are necessary4 7#c7 ,timing ,not later than #a year after the date of enactment of this ,act1 the ,administrator shall establish at least-- 7,a7 #b ,regional ,response ,centers2 and 7,b7 #b ,response ,teams4 7b7 ,response ,teams 7#a7 ,membership ,each ,response ,team shall include individuals who-- 7,a7 have expertise in epidemiology1 toxicogenomics1 molecular biology1 toxicology1 pollution control requirements1 data analysis1 environmental health and disease surveillance1 exposure assessment1 pediatric health1 community outreach and involvement1 and other relevant fields2 and 7,b7 have no direct or indirect conflict of interest4 7#b7 ,leadership ,each ,response ,team shall have-- 7,a7 an individual who is the leader of the ,response ,team and who reports to the ,administrator1 the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 and the ,director2 and 7,b7 an individual who has the skills or experience necessary to carry out community outreach and involvement activities1 including-- 7i7 the establishment of ,community ,disease ,cluster ,advisory ,committees under subsection 7c72 and 7ii7 the facilitation of activities of those ,committees4 7#c7 ,activities 7,a7 ,in general ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 shall establish the scope of activities for ,response ,teams to ensure that the activities are consistent with achieving the purposes of this title4 7,b7 ,requirements ,the activities of the ,response ,teams shall include-- 7i7 making guidelines1 protocols1 data1 and other relevant information and expertise available to ,state and local officials and the public to assist in efforts-- 7,i7 to investigate suspected or potential disease clusters1 environmental pollutants or toxic substances associated with those disease clusters1 and potential causes of disease clusters2 and 7,,ii7 to address potential causes of disease clusters2 7ii7 responding rapidly to a petition described in subparagraph 7,c7 from any person1 including a ,state or local official1 regarding the need-- 7,i7 to investigate suspected or potential disease clusters1 environmental pollutants or toxic substances associated with those disease clusters1 and potential causes of disease clusters2 and 7,,ii7 to address the potential causes of disease clusters2 7iii7 providing the best available environmental sampling and laboratory equipment to collect1 analyze1 and interpret monitoring1 health surveillance1 and other relevant information at scales and timelines appropriate to an action2 7iv7 involving community members1 in accordance with established scientific methods and norms 7including the preservation of the confidentiality of individuals71 in-- 7,i7 investigations of suspected or potential disease clusters1 environmental pollutants or toxic substances associated with those disease clusters1 or potential causes of disease clusters1 including through-- 7aa7 environmental exposure assessments2 7bb7 biomonitoring activities2 and 7cc7 community-based participatory research initiatives2 and 7,,ii7 other efforts to address the potential causes of disease clusters2 7v7 working with ,state and local agencies-- 7,i7 to help make the use and management of integrated environmental health data consistent and timely2 and 7,,ii7 to fill data gaps2 and 7vi7 investigating suspected or potential disease clusters1 environmental pollutants or toxic substances associated with those disease clusters1 and potential causes of disease clusters1 and addressing the potential causes of disease clusters that the ,administrator determines ,state and local officials need assistance in investigating or addressing1 or that the ,administrator determines should be investigated or addressed4 7,c7 ,petition 7i7 ,in general ,any person1 including a ,state or local official1 may submit a petition referred to in subparagraph 7,b77ii7 to the ,administrator1 the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 and the ,director that requests that a ,response ,team conduct an investigation or take other action to address the potential causes of disease clusters in accordance with this title4 7ii7 ,requirements ,each petition submitted under clause 7i7 shall clearly describe the basis for the requested investigation or action1 including any data supporting the request4 7iii7 ,consideration ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 shall establish criteria for the consideration of petitions submitted under this section using health-protective factors1 including-- 7,i7 evidence of the release of environmental pollutants or toxic substances2 7,,ii7 the locations in which there appear to be potentially significant health threats from the potential causes of disease clusters2 7,,iii7 cases in which existing data appear to be inadequate to fully assess the potential risks to public health2 and 7,,iv7 such other factors as the ,administrator determines are necessary4 7iv7 ,response ,not later than #fj days after the date of receipt of a petition under clause 7iii71 the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 shall provide a written response that describes-- 7,i7 the investigation or actions that will be undertaken in response to the petition1 including the timeline and basis for the investigation or actions2 and 7,,ii7 the reasons for any denial or deferral in providing such a response4 7v7 ,timing of issuance of criteria 7,i7 ,in general ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 shall provide for public notice of draft criteria established under this subparagraph for a period of not less than #fj days4 7,,ii7 ,final criteria ,not later than #a year after the date of enactment of this ,act1 the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 shall publish in the ,federal ,register final criteria required under this subparagraph4 7#d7 ,use of publicly available reports ,response ,team investigations and actions shall-- 7,a7 include publicly available reports prepared by the ,response ,team that contain statements of facts1 findings1 and recommendations for actions1 to the extent appropriate2 and 7,b7 be prepared in a manner that preserves the confidentiality of individuals4 7#e7 ,transparency and accountability ,response ,team activities shall include measures to ensure-- 7,a7 transparency and accountability to potentially affected individuals1 ,state and local officials1 the public1 and other persons and agencies1 while preserving the confidentiality of individuals2 7,b7 that consistent1 accurate1 and meaningful information is provided to potentially affected individuals1 ,state and local officials1 the public1 and other persons and agencies through the use of comprehensive1 community-based communications plans2 and 7,c7 accountability to meeting goals and timetables4 7#f7 ,database 7,a7 ,in general ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 the ,secretary1 and the ,director1 shall compile and regularly update information in a comprehensive electronic database that-- 7i7 is publicly accessible through the ,internet2 7ii7 provides a centralized location for information relating to-- 7,i7 disease cluster reports and investigations2 7,,ii7 environmental pollutants or toxic substances that are associated with suspected or potential disease clusters2 7,,iii7 illnesses associated with suspected or potential disease clusters1 including locally generated information2 7,,iv7 systematic tracking of environmental pollutants or toxic substances and illnesses associated with suspected or potential disease clusters2 7,v7 actions to help address the potential causes of disease clusters2 and 7,,vi7 any other information that the ,administrator determines to be necessary2 and 7iii7 facilitates the rapid reporting and analysis of information described in clause 7ii74 7,b7 ,confidentiality ,a database described in subparagraph 7,a7 shall be maintained in a manner that preserves the confidentiality of individuals4 7c7 ,community ,disease ,cluster ,advisory ,committees 7#a7 ,in general ,the ,administrator shall establish ,community ,disease ,cluster ,advisory ,committees to provide oversight1 guidance1 and advice relating to-- 7,a7 the investigation of suspected and potential disease clusters2 7,b7 the investigation of environmental pollutants or toxic substances associated with suspected or potential disease clusters2 7,c7 the investigation of potential causes of disease clusters2 7,d7 efforts to address the potential causes of disease clusters2 and 7,e7 the most effective means of ensuring outreach to and involvement of community members4 7#b7 ,membership ,membership on ,community ,disease ,cluster ,advisory ,committees shall be comprised of representatives that include-- 7,a7 individuals who are or may be impacted by a suspected or potential disease cluster1 and the designee of such an individual who may participate with or in the place of such an individual2 7,b7 ,state or local government health or environmental agencies2 7,c7 at least #b individuals1 appointed by the ,administrator in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 with demonstrated knowledge of the activities described in paragraph 7#a72 and 7,d7 other appropriate individuals1 as determined by the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director4 7#c7 ,prohibition ,no member of a ,committee may have any direct or indirect conflict of interest4 7#d7 ,technical ,assistance 7,a7 ,in general ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry and the ,director1 may make grants available to any group of individuals that may be affected by a suspected or potential disease cluster4 7,b7 ,use of funds ,grants made available under subparagraph 7,a7 may be used to facilitate active involvement in all aspects of ,committee activities and to assist ,committee members in obtaining technical assistance in interpreting information with regard to-- 7i7 the investigation of-- 7,i7 suspected or potential disease clusters2 7,,ii7 environmental pollutants or toxic substances that are associated with suspected or potential disease clusters2 and 7,,iii7 the potential causes of disease clusters2 7ii7 addressing the potential causes of disease clusters2 7iii7 understanding the health concerns associated with suspected or potential disease clusters2 and 7iv7 understanding other scientific and technical issues relating to the activities of a ,regional ,response ,team and ,community ,disease ,cluster ,advisory ,committee1 including the potential need for and interpretation of any biomonitoring of individuals in the area4 7d7 ,environmental research and analysis ,the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 the ,secretary1 and the ,director1 shall use available authorities and programs to compile1 research1 and analyze information generated by actions authorized under this section1 including by-- 7#a7 using those authorities to test environmental pollutants or toxic substances identified under subsection 7b77#f72 and 7#b7 incorporating environmental pollutants or toxic substances identified under subsection 7b77#f7 in appropriate national biomonitoring initiatives4 #bje4 ,federal reports to ,congress 7a7 ,in general ,not later than #a year after the date of enactment of this ,act and annually thereafter1 the ,administrator1 in consultation with the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry1 the ,secretary1 and the ,director1 shall prepare a report that describes-- 7#a7 the status of activities under this title to investigate and address the suspected and potential causes of disease clusters2 7#b7 environmental pollutants or toxic substances that are associated with suspected or potential disease clusters2 7#c7 the potential causes of disease clusters2 and 7#d7 ways to address the potential causes of those disease clusters4 7b7 ,requirements ,the report shall include a description of-- 7#a7 outreach activities to ,state and local officials and communities2 7#b7 actions that the ,administrator has taken to prioritize the testing of environmental pollutants or toxic substances2 7#c7 actions that the ,administrator has taken to include environmental pollutants or toxic substances identified under section #bjd7;b77#g7 in appropriate national biomonitoring initiatives2 7#d7 actions that the ,administrator is taking or plans to take to address problems in implementing this title2 7#e7 actions that the ,secretary is taking or plans to take to address problems in implementing this title2 7#f7 actions that the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry has undertaken or is considering taking with respect to any disease clusters under subparagraphs 7,d7 and 7,e7 of section #ajd7;i77#a7 of ,comprehensive ,environmental ,response1 ,compensation1 and ,liability ,act 7#db ,u4,s4,c4 #ifjd7;i77#a77 and other provisions of that section2 7#g7 actions that the ,director is taking or plans to take to address problems in implementing this title2 and 7#h7 other relevant information4 7c7 ,submission and availability ,the ,administrator shall-- 7#a7 submit the report under this subsection to-- 7,a7 the ,committees on ,environment and ,public ,works and ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 and 7,b7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7#b7 make the report available to the public4 #bjf4 ,authorization of appropriations ,there are authorized to be appropriated such sums as are necessary to carry out this title4 #bjg4 ,effect on other law ,nothing in this title modifies1 limits1 or otherwise affects the application of1 or obligation to comply with1 any law1 including any environmental or public health law4 ,,iii ,community disease cluster technical assistance grants #cja4 ,community disease cluster technical assistance grants 7a7 ,in general ,the ,administrator of the ,environmental ,protection ,agency 7referred to in this title as the ,administrator71 in coordination with the ,secretary of ,health and ,human ,services 7referred to in this title as the ,secretary7 may award grants in accordance with this title to any individual or group of individuals that may be affected by a reported community-based disease cluster-- 7#a7 to pay the ,federal share of the technical assistance described in subsection 7d72 7#b7 to protect public health and the environment2 7#c7 to promote healthy and safe environments2 and 7#d7 to prevent and address harmful exposures to hazardous substances4 7b7 ,application 7#a7 ,in general ,to be eligible for a grant under this title1 an individual or group of individuals shall submit to the ,administrator and the ,secretary an application that contains a description of the-- 7,a7 need for technical assistance1 including the need to procure independent technical advisors to help grant recipients interpret the information described in subsection 7d72 7,b7 expected outputs1 including results1 effects1 or consequences that will occur from the technical assistance2 and 7,c7 expected outcomes1 including activity1 effort1 or associated work products that will be produced or provided over a period of time or by a specific date4 7#b7 ,response ,not later than #abj days after the date on which an application is submitted under paragraph 7#a71 the ,administrator and the ,secretary shall respond to each applicant in writing and describe whether the application is approved1 denied1 or will be considered after the applicant modifies the application4 7#c7 ,criteria ,the ,administrator1 in coordination with the ,secretary1 shall develop criteria that1 if satisfied1 would result in the ,administrator and the ,secretary accepting an application submitted under paragraph 7#a74 7c7 ,amount 7#a7 ,in general ,except as provided in paragraph 7#b71 each grant awarded under this title shall not exceed #ej1jjj4 7#b7 ,waiver ,the ,administrator1 in coordination with the ,secretary1 may waive the limitation described in paragraph 7#a7 if the waiver is necessary to provide the technical assistance described in subsection 7d74 7d7 ,use of funds ,grants awarded under this title shall be used to obtain technical assistance in interpreting information regarding-- 7#a7 investigating reported community-based disease clusters associated with #a or more hazardous chemicals2 7#b7 the potential hazardous chemicals associated with a reported community-based disease cluster2 7#c7 providing individuals or groups of individuals with community-based tools to educate the individuals on the mitigation of hazardous chemicals associated with reported community-based disease clusters2 or 7#d7 other scientific and technical issues related to reported community-based disease clusters4 7e7 ,number of grants ,no individual or group of individuals shall be awarded more than #a grant under this title4 7f7 ,non-,federal share 7#a7 ,in general ,except as provided in paragraph 7#b71 the non-,federal share for each grant awarded under this title is #bj percent4 7#b7 ,waiver ,the ,administrator1 in coordination with the ,secretary1 may waive the non-,federal share described in paragraph 7#a7 if-- 7,a7 the recipient of the grant demonstrates financial need2 and 7,b7 the waiver is necessary to provide the technical assistance described in subsection 7d74 7g7 ,renewal of grant 7#a7 ,in general ,any grant awarded under this title may be renewed to facilitate technical assistance to any group of individuals that may be affected by a reported community-based disease cluster4 7#b7 ,conditions ,each renewal of a grant awarded under this title is subject to the same conditions that apply to an initial grant4 7h7 ,reports ,any recipient of a grant awarded under this title shall submit to the ,administrator and the ,secretary a report that describes the progress in addressing the needs and achieving the outputs and outcomes described in subsection 7b74 #cjb4 ,authorization of appropriations ,for each of fiscal years #bjaf through #bjba1 there are authorized to be appropriated to the ,administrator and the ,secretary from any funds made available to the ,administrator and the ,secretary for the purpose of providing community members with technical assistance and engagement on environmental health issues from the ,hazardous ,substance ,superfund established under section #iejg of the ,internal ,revenue ,code of #aihf such sums as are necessary to carry out section #cja4