,,ii #aacth ,,congress #ast ,session ,s4 #ajji ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bb1 #bjac ,mr4 ,lautenberg 7for himself1 ,mr4 ,vitter1 ,mrs4 ,gillibrand1 ,mr4 ,crapo1 ,mr4 ,durbin1 ,mr4 ,alexander1 ,mr4 ,schumer1 ,mr4 ,inhofe1 ,mr4 ,udall of ,new ,mexico1 ,ms4 ,collins1 ,ms4 ,landrieu1 ,mr4 ,rubio1 ,mr4 ,manchin1 ,mr4 ,boozman1 ,mr4 ,menendez1 ,mr4 ,hoeven1 and ,mr4 ,begich7 introduced the following bill2 which was read twice and referred to the ,committee on ,environment and ,public ,works ,a ,,bill ,to reauthorize and modernize the ,toxic ,substances ,control ,act1 and for other purposes4 #a4 ,short title2 table of contents2 references 7a7 ,short title ,this ,act may be cited as the ,chemical ,safety ,improvement ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents2 references4 ,sec4 #b4 ,findings1 policy1 and intent4 ,sec4 #c4 ,definitions4 ,sec4 #d4 ,chemical assessment framework2 prioritization screening2 testing4 ,sec4 #e4 ,new chemicals and significant new uses4 ,sec4 #f4 ,safety assessments and determinations4 ,sec4 #g4 ,imminent hazards4 ,sec4 #h4 ,information collection and reporting4 ,sec4 #i4 ,relationship to other ,federal laws4 ,sec4 #aj4 ,research1 development1 collection1 dissemination1 and utilization of data4 ,sec4 #aa4 ,exports4 ,sec4 #ab4 ,imports4 ,sec4 #ac4 ,confidential information4 ,sec4 #ad4 ,prohibited acts4 ,sec4 #ae4 ,preemption4 ,sec4 #af4 ,judicial review4 ,sec4 #ag4 ,citizens' petitions4 ,sec4 #ah4 ,studies4 ,sec4 #ai4 ,administration4 ,sec4 #bj4 ,development and evaluation of test methods4 ,sec4 #ba4 ,state programs4 ,sec4 #bb4 ,authorization of appropriations4 ,sec4 #bc4 ,annual report4 7c7 ,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 #b4 ,findings1 policy1 and intent 7a7 ,purposes ,the purposes of this ,act are-- 7#a7 to improve the safety of consumers in the ,united ,states2 and 7#b7 to ensure that risks from chemical substances are adequately understood and managed by modernizing title ,i of the ,toxic ,substances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq474 7b7 ,findings1 policy1 and intent ,section #b 7#ae ,u4,s4,c4 #bfja7 is amended by striking subsections 7a7 through 7c7 and inserting the following3 7a7 ,findings ,congress finds that-- 7#a7 chemicals should be safe for the intended use of the chemicals2 7#b7 the unmanaged risks of chemical substances may pose a danger to human health and the environment2 7#c7 public confidence in the ,federal chemical regulatory program has diminished over time2 7#d7 scientific understanding of chemicals and the possible risks of the chemicals has evolved greatly since #aigf1 requiring that ,congress update the law to ensure that chemical regulation in the ,united ,states reflects modern science1 technology and knowledge2 7#e7 this ,act should be modernized to create a robust ,federal system for assessing and managing chemical risks2 7#f7 chemicals are used in diverse manufacturing industries and other valuable commercial1 institutional1 and consumer applications that have benefitted society2 7#g7 for the purposes of promoting uniform protections through regulation of chemical substances in commerce1 to minimize undue burdens on commerce1 and to minimize burdens on ,states1 specified actions by the ,administrator should preempt requirements by ,states and political subdivisions of ,states that relate to the effects of or exposure to a chemical substance under the intended conditions of use2 and 7#h7 innovation in the development of new chemical substances1 especially safer chemical substances1 should be encouraged to reduce risk1 provide improved products1 stimulate the economy1 create jobs1 and protect interstate commerce4 7b7 ,policy ,it is the policy of the ,united ,states that-- 7#a7 this ,act-- 7,a7 should protect the health of people and the environment from the unmanaged risks of chemical substances2 and 7,b7 should be modernized to build public confidence in the ability of the ,federal regulatory system to protect health and the environment1 promote innovation1 and sustain a globally competitive chemical industry in the ,united ,states2 7#b7 the ,administrator-- 7,a7 should have the appropriate hazard1 use1 and exposure information necessary to make safety determinations2 7,b7 should minimize the use of animal testing through the use of scientifically reliable and relevant test methods1 where appropriate2 7,c7 should encourage the use of best laboratory practices to ensure high quality1 relevant1 and reliable results from test methods and studies2 7,d7 should have the authority to share confidential business information with ,states and political subdivisions of the ,states1 subject to appropriate safeguards against inappropriate disclosure2 7,e7 should have the resources and tools necessary to implement this ,act2 and 7,f7 should implement this ,act in a manner that promotes transparency of information and decisionmaking1 protects substantiated confidential business information1 and promotes innovation1 including innovation in chemical substances that have reduced hazard1 exposure1 and risk patterns2 7#c7 adequate data and information should be available with respect to the effect of and exposure to chemical substances and mixtures on health and the environment1 to the extent necessary for safety assessments and determinations1 and that1 where necessary1 the development of such test data and information should be the primary responsibility of those who manufacture or process such chemical substances and mixtures2 and 7#d7 ,states have an important role in protecting health and the environment from the unmanaged risks of chemical substances in commerce1 particularly in recommending priorities for ,federal assessment and regulation1 providing safety assessment information1 and fostering programs to protect consumers4 7c7 ,intent of ,congress ,it is the intent of ,congress that the ,administrator shall-- 7#a7 rely on robust scientific evidence to implement this ,act in a way that balances the mutual goals of promoting the safety of ,american consumers and preventing harm to ,american innovation1 manufacturing1 and the economy2 and 7#b7 implement this ,act to protect the health of the people of the ,united ,states and the environment in such a manner as not to unduly impede commerce or create unnecessary economic barriers to technological innovation1 including safer chemistry4 4 #c4 ,definitions ,section #c 7#ae ,u4,s4,c4 #bfjb7 is amended-- 7#a7 by redesignating paragraphs 7#b7 through 7#f71 7#g7 through 7#aa71 and 7#ab7 through 7#ad7 as paragraphs 7#c7 through 7#g71 7#i7 through 7#ac71 and 7#ag7 through 7#ai71 respectively2 7#b7 by inserting after paragraph 7#a7 the following3 7#b7 ,best available science ,the term best available science means science that-- 7,a7 maximizes the quality1 objectivity1 and integrity of information1 including statistical information2 7,b7 uses peer-reviewed and publically available data2 and 7,c7 clearly documents and communicates risks and uncertainties in the scientific basis for decisions4 2 7#c7 by inserting after paragraph 7#g7 7as so redesignated7 the following3 7#h7 ,intended conditions of use ,the term intended conditions of use means the circumstances under which a chemical substance is intended or reasonably anticipated to be manufactured1 processed1 distributed in commerce1 used1 and disposed of4 2 and 7#d7 by inserting after paragraph 7#ac7 7as so redesignated7 the following3 7#ad7 ,safety assessment ,the term safety assessment means a risk-based assessment of the safety of a chemical substance that-- 7,a7 integrates hazard2 use2 and exposure information about a chemical substance2 and 7,b7 includes-- 7i7 an assessment of exposure under the intended conditions of use2 and 7ii7 reference parameters that may be appropriate with regard to a specific chemical substance 7such as a margin of exposure74 7#ae7 ,safety determination ,the term safety determination means a determination by the ,administrator as to whether a chemical substance meets the safety standard under the intended conditions of use4 7#af7 ,safety standard ,the term safety standard means a standard that ensures that no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance4 4 #d4 ,chemical assessment framework2 prioritization screening2 testing 7a7 ,in general ,section #d 7#ae ,u4,s4,c4 #bfjc7 is amended-- 7#a7 in the heading1 by striking ,testing of chemical substances and mixtures and inserting ,chemical assessment framework2 prioritization screening2 testing4 7#b7 by redesignating subsection 7e7 as subsection 7l72 7#c7 in subsection 7l7 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 and 7#d7 by striking subsections 7a7 through 7d71 7f71 and 7g7 and inserting the following3 7a7 ,chemical assessment framework 7#a7 ,in general ,the ,administrator shall develop a framework in accordance with subsection 7e7 and sections #e and #f for evaluating the safety of chemical substances in commerce that shall employ the best available science and risk assessment principles in existence at the time the ,administrator is developing the framework4 7#b7 ,policies and procedures 7,a7 ,in general ,after the date of enactment of the ,chemical ,safety ,improvement ,act1 the ,administrator shall promptly develop appropriate policies and procedures for implementing the framework1 including procedures on the collection1 evaluation1 and development of data and information4 7,b7 ,contents ,the policies and procedures shall require-- 7i7 the collection of existing data and information from manufacturers and processors of chemical substances and other sources1 including the use of voluntary agreements to provide the data and information2 7ii7 an evaluation of the quality of existing data and information2 7iii7 an analysis of data and information2 7iv7 a determination of the need for additional data and information1 including information related to the exposures of different subpopulations2 and 7v7 subject to section #ad1 transparency of data and information considered by the ,administrator1 including both positive and negative findings4 7#c7 ,transparency and validity ,the ,administrator shall ensure that the evaluation framework described in subsection 7a77#a7-- 7,a7 is transparent2 7,b7 assures that data and information are valid2 7,c7 addresses the strengths and limitations of-- 7i7 the design of the framework1 7ii7 the reliability of the test methods2 and 7iii7 the quality of the data and information2 and 7,d7 pursues the goal of maximizing the quality1 objectivity1 utility1 and integrity of the data and information4 7b7 ,data and information quality 7#a7 ,in general ,the ,administrator shall establish and publish scientifically sound criteria for evaluating all of the data and information1 including the results of animal and nonanimal testing1 regardless of affiliation or funding source1 on which the ,administrator relies in making a decision under this ,act4 7#b7 ,disclosure of sources of funding ,the ,administrator shall require that the submitter of any health and safety study disclose to the ,administrator and to the public the sources of any funding used for the study or publication of the study received by the researcher who conducted the study1 to the extent reasonably ascertainable4 7#c7 ,test data ,for test data developed under this ,act1 the ,administrator shall encourage the use of good laboratory practices1 peer review1 scientifically reliable and relevant test methods1 standardized protocols1 and other methods to ensure scientific quality for all data and information submitted under this ,act4 7#d7 ,data and information that do not meet criteria 7,a7 ,in general ,nothing in this subsection shall preclude the ,administrator from considering data and information which do not meet the quality criteria established under paragraph 7#a74 7,b7 ,identification ,the ,administrator shall-- 7i7 identify any data and information described in subparagraph 7,a7 on which the ,administrator relies2 7ii7 describe the quality of the data and information described in subparagraph 7,a7 and the extent to which the data and information depart from those criteria2 7iii7 indicate any limitations on the usefulness of the data and information described in subparagraph 7,a72 and 7iv7 explain how the data and information described in subparagraph 7,a7 was used and the basis for reliance on the data and information4 7#e7 ,evaluative framework for decisionmaking 7,a7 ,in general ,the ,administrator shall develop and use a structured evaluative framework consisting of science-based criteria1 consistent with the protection of human health and the environment1 for making any decision under this ,act1 and for determining the relevance1 quality1 and reliability of data and information4 7,b7 ,contents ,the framework described in subparagraph 7,a7 shall1 at a minimum-- 7i7 use sound and objective scientific practices in assessing risks2 7ii7 consider the current best available science 7including peer-reviewed studies72 7iii7 when consistent with the underlying data1 consider1 for both cancer and noncancer endpoints1 whether available data support or do not support the identification of threshold doses of a chemical substance below which no adverse effects can be expected to occur2 and 7iv7 include a description of the weight of the scientific evidence concerning risks1 including mechanistic information 7such as appropriate modes of action74 7c7 ,data and information sources ,in making any decision with respect to a chemical substance under subsection 7e7 and sections #e and #f1 the ,administrator shall consider data and information relevant to the substance that are reasonably available to the ,administrator at that time1 including data and information that are-- 7#a7 submitted to the ,administrator by-- 7,a7 manufacturers and processors of the substance2 7,b7 the public2 or 7,c7 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 another jurisdiction under a governmental requirement relating to the protection of human health and the environment1 if the information is accessible to the ,administrator2 7#c7 derived through the application of scientifically reliable and relevant structure-activity relationship1 or other methods or models to estimate the environmental and human health effects1 environmental and biological fate and behavior1 and exposure potential for the substance2 7#d7 inferred based on the degree of structural similarity or properties of the substance1 or categories of substances1 to those of #a or more other chemical substances for which reliable information exists that is relevant to predicting the potential environmental or human health effects1 environmental or biological fate and behavior1 or exposure potential for the chemical substance2 and 7#e7 identified through an active search by the ,administrator of information sources that are publicly available or otherwise accessible to the ,administrator4 7d7 ,transparency 7#a7 ,in general ,subject to section #ad1 the data and information considered by the ,administrator in taking action under this ,act shall be available to the public4 7#b7 ,types of information available to the public ,the ,administrator shall make available to the public the guidance1 procedures1 and tools used in evaluating data and information under this section1 including models1 studies1 and1 as appropriate1 the data underlying any study4 7#c7 ,guidance ,any written guidance of general applicability prepared by the ,administrator under this ,act shall be subject to public notice and an opportunity for comment4 7e7 ,prioritization screening process 7#a7 ,in general 7,a7 ,process ,not later than #a year after the date of enactment of the ,chemical ,safety ,improvement ,act1 the ,administrator shall establish a risk-based screening process for identifying existing chemical substances that are-- 7i7 a high priority for a safety assessment and determination under section #f1 to be known as high-priority substances2 and 7ii7 a low priority for a safety assessment and determination1 to be known as low-priority substances4 7,b7 ,consideration of active and inactive substances 7i7 ,consideration of active substances ,in implementing the process described in subparagraph 7,a71 the ,administrator shall only consider active substances1 as determined under section #h7;b77#f71 as either high-priority substances or low-priority substances4 7ii7 ,consideration of inactive substances ,in implementing the process described in subparagraph 7,a71 the ,administrator shall only consider inactive substances1 as determined under section #h7;b77#g71 that the ,administrator determines1 on the basis of credible scientific evidence that-- 7,i7 have not been subject to a regulatory or other enforceable action by the ,administrator to ban or phase out the substances2 and 7,,ii7 demonstrate high hazard and high exposure4 7,c7 ,timely completion of prioritization process 7i7 ,in general ,the ,administrator shall make every effort to complete the prioritization of all active substances in a timely manner4 7ii7 ,consideration ,the ,administrator shall prioritize substances taking into consideration the ability of the ,administrator to schedule and complete safety assessments and determinations under section #f in a timely manner4 7,d7 ,use of data ,in making a decision under the prioritization screening process1 the ,administrator shall use reasonably available data and information concerning the hazard1 exposure1 and use characteristics of chemical substances on the list developed by the ,administrator under section #h7;b77#a7 at the time the decision is made4 7,e7 ,screening of categories or classes of substances ,the ,administrator may screen categories or classes of chemical substances to ensure an efficient prioritization screening process to allow for timely and adequate safety assessments and determinations4 7,f7 ,publication of list of chemical substances ,from time to time the ,administrator shall-- 7i7 publish a list of chemical substances being considered in the prioritization screening process2 and 7ii7 request the submission of data and information on the chemical substances4 7#b7 ,proposed process 7,a7 ,in general ,the ,administrator shall-- 7i7 publish for public comment a proposed prioritization screening process2 and 7ii7 establish criteria for determining whether a substance is a high or low priority for a safety assessment and determination4 7,b7 ,initial list 7i7 ,in general ,the proposal shall include an initial list of chemical substances that includes1 at a minimum1 those substances prioritized by the ,administrator before the date of enactment of the ,chemical ,safety ,improvement ,act and for which assessments or safety determinations have not been completed1 and proposed prioritization outcomes based on the proposed criteria4 7ii7 ,contents ,the initial list shall contain as many chemical substances as the ,administrator determines appropriate4 7iii7 ,modification ,the ,administrator may modify the initial list on the basis of comments received on the proposed process and criteria4 7,c7 ,criteria ,the criteria described in subparagraph 7,a7 shall consider-- 7i7 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 screening2 7ii7 the hazard and exposure potential of the chemical substance 7or category or class of substances71 including specific scientific classifications and designations by authoritative governmental entities2 7iii7 the intended conditions of use or significant changes in the conditions of use of the chemical substance2 7iv7 evidence and indicators of exposure potential to humans or the environment from the chemical substance2 7v7 the volume of a chemical substance manufactured or processed2 7vi7 whether the volume of a chemical substance as reported under a regulation issued under section #h7;a7 7as in effect on the date on which the criteria are proposed7 has significantly increased or decreased since a previous report or since the date on which a notice has been submitted under section #e7;a72 7vii7 the availability of information about potential hazards and exposures needed for conducting a safety assessment or determination1 with limited availability of relevant data and information to be a factor in designating a substance as a high priority2 and 7viii7 the extent of ,federal or ,state regulation of the chemical substance or the extent of the impact of ,state regulation of the chemical substance on the ,united ,states1 with existing ,federal or ,state regulation of any uses evaluated in the prioritization screening process as a factor in designating a chemical substance to be a low priority4 7#c7 ,prioritization screening decisions 7,a7 ,in general ,for the chemical substances considered for prioritization screening1 the ,administrator shall apply the criteria identified in paragraph 7#b71 using the information identified in subsection 7c71 to identify a chemical substance as a high-priority substance or a low-priority substance4 7,b7 ,additional test data ,if the ,administrator determines that additional test data and information are needed to establish the priority of a chemical substance1 the ,administrator shall provide an opportunity for interested persons to submit data and information to the extent that it is reasonably ascertainable4 7,c7 ,deferring a decision ,if the ,administrator determines that it is appropriate1 the ,administrator may defer a prioritization screening decision for a chemical substance under subparagraph 7,a7 for a reasonable period to allow for the submission and evaluation of additional data and information4 7,d7 ,integration of data and information ,during the prioritization screening of a chemical substance1 the ,administrator shall integrate any hazard and exposure data and information related to a chemical substance available to the ,administrator4 7,e7 ,identification of high-priority substances ,the ,administrator-- 7i7 shall identify as a high-priority substance a chemical substance that1 relative to other substances1 has the potential for high hazard and high exposure2 7ii7 may identify as a high-priority substance a chemical substance that1 relative to other substances1 has the potential for high hazard or high exposure2 and 7iii7 may identify as a high-priority substance an inactive substance1 as determined under section #h7;b77#g71 that the ,administrator determines1 on the basis of credible scientific evidence that-- 7,i7 has not been subject to a regulatory action by the ,administrator to ban or phase out the substance2 and 7,,ii7 demonstrates high hazard and high exposure4 7,f7 ,identification of low-priority substances ,the ,administrator shall identify as a low-priority substance a chemical substance that the ,administrator on the basis of the available information determines is likely to meet the safety standard under the intended conditions of use4 7,g7 ,notice and comment ,the identifications made under subparagraphs 7,e7 and 7,f7 shall be subject to notice and an opportunity for comment4 7,h7 ,order of safety assessments 7i7 ,high-priority substances ,the ,administrator-- 7,i7 shall determine the order for performing safety assessments on high-priority substances under section #f2 and 7,,ii7 may revise the order as the ,administrator determines appropriate4 7ii7 ,low-priority substance ,the ,administrator shall not perform safety assessments on low-priority substances1 unless a low-priority substance is redesignated under subparagraph 7,i74 7,i7 ,revision based on new data 7i7 ,in general ,subject to subparagraph 7,d71 at any time the ,administrator may revise the identification of a chemical substance as a high-priority substance or a low-priority substance based on consideration of data or information made available to the ,administrator after the date on which the ,administrator makes the identification under subparagraphs 7,e7 and 7,f74 7ii7 ,reevaluation 7,i7 ,in general ,the ,administrator shall evaluate the data or information described in clause 7i7 on a high-priority substance or a low-priority substance for possible reevaluation of the priority of the substance4 7,,ii7 ,limited availability ,if limited availability of relevant data and information was a factor in the original identification of a chemical substance as a high-priority substance1 the ,administrator shall reevaluate the prioritization screening of the substance on receiving the relevant data and information4 7,j7 ,publication of a list of high-priority and low-priority substances 7i7 ,in general ,the ,administrator shall publish and keep current a list of high-priority substances and a list of low-priority substances4 7ii7 ,justification ,whenever the ,administrator places a chemical substance on one of the lists described in clause 7i7 or changes the priority of the chemical substance1 the ,administrator shall include a justification for the decision in accordance with paragraph 7#b77;,c74 7,k7 ,removal ,the ,administrator shall remove a chemical substance from the list of high-priority substances on the date on which a safety determination for the chemical substance is published4 7,l7 ,effect ,subject to section #ah1 a decision by the ,administrator under this paragraph with respect to a chemical substance shall not affect the manufacture1 processing1 distribution1 use1 or disposal of the chemical substance1 or regulation of those activities4 7#d7 ,expedited prioritization screening 7,a7 ,in general ,not later than #ahj days after the date on which the ,administrator receives a recommendation and relevant data and information from a ,governor of a ,state or a ,state agency with responsibility for protecting health and the environment that an active chemical substance be identified as a high-priority or low-priority substance1 the ,administrator shall make a prioritization screening decision for the substance4 7,b7 ,notice and comment ,the public shall be provided notice and an opportunity to comment on the recommendation described in subparagraph 7,a74 7,c7 ,explanation of reasons ,the ,administrator shall-- 7i7 make available to the ,governor or the appropriate ,state agency1 as applicable1 and to the public a brief explanation of reasons for identifying a chemical substance recommended by the ,governor or the agency for prioritization screening as either a high-priority substance or a low-priority substance2 and 7ii7 identify the information relied upon in making that identification4 7#e7 ,final agency action ,any action by the ,administrator under this subsection shall not be-- 7,a7 considered to be a final agency action2 or 7,b7 subject to judicial review4 7f7 ,development of new test data and information 7#a7 ,in general ,the ,administrator may require the development of new test data and information related to a chemical substance or mixture in accordance with this section if the ,administration determines that the data and information are needed-- 7,a7 to perform a safety assessment2 7,b7 to make a safety determination2 or 7,c7 to meet the testing needs of the implementing authority under another ,federal statute4 7#b7 ,form ,the ,administrator may require the development of test data and information described in paragraph 7#a7 by-- 7,a7 promulgating a rule2 7,b7 entering into a testing consent agreement2 or 7,c7 issuing an order4 7#c7 ,requirements 7,a7 ,in general ,in promulgating a rule1 adopting a testing consent agreement1 or issuing an order described in paragraph 7#b71 the ,administrator shall require the use of-- 7i7 an evaluation framework that1 prior to requiring additional testing of vertebrate animals1 integrates relevant information from multiple sources1 including1 to the extent reliable-- 7,i7 toxicity information2 7,,ii7 computational toxicology2 7,,iii7 bioinformatics2 7,,iv7 high-throughput screening methods2 and 7,v7 scientifically reliable and relevant alternatives to vertebrate animal tests2 and 7ii7 tiered testing in accordance with subsection 7h71 wherein the results of a screening level tier of tests relating to a toxicity pathway or target organ or target system inform the decision of the ,administrator as to whether tests from a higher tier related to that pathway or organ or system are necessary4 7,b7 ,statement to the public ,the ,administrator shall explain the basis for a decision made in subparagraph 7,a77ii7 in a statement made available to the public4 7#d7 ,contents 7,a7 ,in general ,a rule1 testing consent agreement1 or order issued under paragraph 7#b7 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 procedures for the development of test data and information for the chemical substance or mixture1 including specific reference to reliable nonanimal test procedures2 and 7iv7 specification of the period within which persons required to conduct the testing shall submit to the ,administrator test data and 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 7g7 ,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 data and information 7including information on exposure or exposure potential7 under subsection 7f77#b71 the ,administrator shall issue a statement-- 7,a7 identifying the need intended to be met by the rule1 agreement1 or order2 7,b7 explaining why existing data and information reasonably available to the ,administrator at that time are inadequate to meet that need2 and 7,c7 encouraging1 to the extent possible1 the use of nonanimal test methods to develop additional data and information4 7#b7 ,contents of statement in case of order 7,a7 ,in general ,if the ,administrator issues an order1 the statement described in paragraph 7#a7 shall explain why good cause exists for issuance of an order instead of promulgating a rule or entering into a testing consent agreement4 7,b7 ,contents ,a statement described in subparagraph 7,a7 shall contain a discussion of-- 7i7 data and information that are readily accessible to the ,administrator1 including data and information submitted under any other provision of law2 7ii7 the extent to which the ,administrator has obtained or attempted to obtain the data and information through voluntary submissions2 7iii7 the extent to which the ,administrator may use available data and information for structurally related substances 7grouping or read-across71 or use valid structure-activity relationship models or nonanimal test alternatives2 and 7iv7 safety assessments1 and the data and information relied on in the assessments1 on other chemical substances to the extent relevant to the chemical substances that would be the subject of the rule or order4 7h7 ,tiered toxicity testing and evaluation 7#a7 ,in general ,the ,administrator shall develop an evidence-based review system for conducting consistent evaluations of the relevance and reliability of studies of chemical substances and their exposure 7including exposure pathways71 and a structured evaluative framework to provide a systematic and transparent approach for assessing the overall weight of the evidence for observed biological or other effects1 mechanistic information1 and exposure4 7#b7 ,tiers ,subject to subsections 7b7 and 7c71 the framework shall have #b tiers4 7,a7 ,tier #a 7i7 ,in general ,tier #a shall include both a screening level exposure assessment1 including modeling if appropriate1 and screening tests for hazard4 7ii7 ,uses of screening tests and modeling ,screening tests for hazard 7which may include1 as appropriate1 scientifically reliable and relevant in silico1 in vitro1 and focused in vivo tests7 and exposure information and modeling shall be used-- 7,i7 to screen chemical substances or mixtures for major toxic effects 7including acute toxicity1 subchronic toxicity1 chronic toxicity1 carcinogenicity1 genotoxicity1 developmental toxicity1 and neurotoxicity72 and 7,,ii7 to direct planning for more complex and targeted testing in tier #b1 if necessary4 7,b7 ,tier #b ,if the ,administrator determines that additional testing is necessary1 based on the results of tier #a testing and modeling and any other available relevant information1 tier #b shall include-- 7i7 an exposure assessment and tests for specific endpoints triggered on the basis of biologically based decisions2 and 7ii7 an assessment of potential exposure using scientifically valid approaches4 7#c7 ,guidance ,the ,administrator shall prepare guidance for implementing this subsection and review that guidance not less than once every #e years thereafter4 7i7 ,reduction of animal-,based testing 7#a7 ,in general ,the ,administrator shall minimize the use of animals in testing of chemical substances or mixtures1 including by-- 7,a7 encouraging and facilitating1 to the maximum extent practicable-- 7i7 the use of integrated and tiered testing and assessment strategies2 7ii7 the use of data and information of sufficient scientific quality in existence on the date on which the test is conducted2 7iii7 the use of test methods that eliminate or reduce the use of animals while providing test data and information of high scientific quality2 7iv7 the grouping of #b or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide reliable and useful test data and information on others in the category2 7v7 the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests2 7vi7 the submission of test data and information from animal-based studies and from emerging methods and models2 and 7vii7 the use of exposure potential as a factor in decisions to require new testing2 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 laboratory animal-based1 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 for any safety-standard determination made that reduce1 refine1 or replace the use of laboratory animals1 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 ,chemical ,safety ,improvement ,act and every #e years thereafter1 submit to ,congress a report that describes the progress made in implementing this section2 and 7,c7 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 laboratory animals in any safety-standard determination made under this section4 7#c7 ,criteria for adapting or waiving animal testing requirements ,on request from a manufacturer or processor that is required to conduct animal-based testing of a chemical substance or mixture under this title1 the ,administrator may adapt or waive the animal-testing requirement if the ,administrator determines that-- 7,a7 there is sufficient evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has1 or does not have1 a particular property if the information from each individual source alone is insufficient to support the conclusion2 7,b7 because of one or more physical or chemical properties of the chemical substance or mixture or other toxicokinetic considerations-- 7i7 the material cannot be absorbed2 or 7ii7 testing for a specific endpoint is technically not practicable to conduct2 or 7,c7 a chemical substance or mixture cannot be tested in animals at concentrations that do not result in significant pain or distress1 because of physical or chemical properties of the chemical substance or mixture1 such as a potential to cause severe corrosion or severe irritation to the tissues of the animal4 7j7 ,testing requirements 7#a7 ,persons required to develop test data and information 7,a7 ,in general ,the ,administrator may require the following persons to develop test data and information3 7i7 ,manufacturers and processors of the chemical substance or mixture identified in subsection 7f77#d77;,a77i74 7ii7 ,persons who begin to manufacture or process such chemical substance or mixture-- 7,i7 after the effective date of the rule1 testing consent agreement1 or order2 but 7,,ii7 subject to subparagraph 7,c71 before the period ending #ahj days after the end of the period identified in subsection 7f77#d77;,a77iv74 7,b7 ,designation ,the ,administrator may permit #b or more of the persons identified in subparagraph 7,a7 to designate a person or a qualified third party-- 7i7 to develop the data and information2 and 7ii7 to submit the data and information on behalf of the persons making the designation4 7,c7 ,exemptions 7i7 ,in general ,a person otherwise subject to a rule1 testing consent agreement1 or order under subsection 7f7 may submit to the ,administrator an application for an exemption on the basis that the data and information are being developed by a person designated under subparagraph 7,b74 7ii7 ,fair and equitable reimbursement to designee 7,i7 ,in general ,if the ,administrator accepts an application submitted under clause 7i71 the ,administrator shall direct the applicant to provide to the person designated under subparagraph 7,b7 fair and equitable reimbursement1 as agreed to between the applicant and the person designated4 7,,ii7 ,arbitration ,if the applicant and a person designated under subparagraph 7,b7 cannot reach agreement on the amount of fair and equitable reimbursement1 the amount shall be determined by arbitration4 7iii7 ,termination ,if1 after granting an exemption under this subparagraph1 the ,administrator determines that no person has complied with the rule1 testing consent agreement1 or order1 the ,administrator shall-- 7,i7 by order terminate the exemption2 and 7,,ii7 notify in writing each person who received an exemption of the requirements with respect to which the exemption was granted4 7#b7 ,types of health and environmental data and information 7,a7 ,in general ,the ,administrator may prescribe guidelines for the development of test data and information under subsection 7f7 for health and environmental information1 including-- 7i7 test data pertaining to acute toxicity1 subchronic toxicity1 chronic toxicity1 carcinogenicity1 genotoxicity1 developmental toxicity1 and neurotoxicity that may be indicative of an adverse effect2 7ii7 test data and information pertaining to exposure to the chemical substance or mixture1 including information regarding bioaccumulation1 persistence1 and the presence of the chemical substance or mixture in human blood1 fluids1 or tissue2 and 7iii7 information pertaining to aggregate exposure1 or other effects that may be considered in a safety assessment4 7,b7 ,methodologies 7i7 ,in general ,the ,administrator-- 7,i7 may prescribe methodologies in guidelines for the development of data and information2 and 7,,ii7 shall encourage the use of nonanimal methodologies4 7ii7 ,development of guidelines ,the ,administrator may develop guidelines for evaluating data from biomonitoring studies4 7iii7 ,requirement ,prior to prescribing epidemiologic studies of employees1 the ,administrator shall coordinate with the ,director of the ,national ,institute for ,occupational ,safety and ,health4 7,c7 ,review ,periodically1 but not less frequently than once every #e years1 the ,administrator shall-- 7i7 review the adequacy of the guidelines for development of data and information prescribed under subparagraph 7,b72 7ii7 if necessary1 institute proceedings to make appropriate revisions of the guidelines2 and 7iii7 revise the guidelines as appropriate1 particularly to-- 7,i7 reflect the availability of scientifically reliable and relevant nonanimal test methods2 and 7,,ii7 eliminate obsolete methodologies that do not produce reliable and relevant results4 7k7 ,transparency ,subject to section #ad1 the ,administrator shall make available to the public all testing consent agreements and orders and all data and information submitted 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 #d7l74 #e4 ,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 by subsection 7a7 shall include1 with respect to a chemical substance-- 7,a7 the information required by sections #gbj4de and #gbj4ej of title #dj1 ,code of ,federal ,regulations 7or successor regulations72 and 7,b7 information regarding intended conditions of use and reasonably anticipated exposure4 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#d74 7,b7 ,extension ,except as provided in paragraph 7#f71 the ,administrator may extend the period described in subparagraph 7,a7 for good cause for one or more periods1 the total of which shall be not more than #ij days4 7#b7 ,notice of commencement ,unless the ,administrator determines under paragraph 7#d77;,a7 that a chemical substance is not likely to meet the safety standard1 at the end of the applicable period for review under paragraph 7#a71 a chemical substance may be the subject of a notice of commencement under subsection 7d74 7#c7 ,information sources ,in evaluating a notice under paragraph 7#a71 the ,administrator shall take into consideration-- 7,a7 the information identified in section #d7;c72 and 7,b7 any additional information provided by the submitter4 7#d7 ,determinations ,before the end of the applicable period for review under paragraph 7#a71 based on the information described in paragraph 7#c71 the ,administrator shall determine that-- 7,a7 the relevant chemical substance is not likely to meet the safety standard under the intended conditions of use1 in which case the ,administrator shall take appropriate action under paragraph 7#e72 7,b7 the relevant chemical substance is likely to meet the safety standard under the intended conditions of use1 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#f74 7#e7 ,prohibitions and limitations 7,a7 ,in general ,if the ,administrator makes a determination under paragraph 7#d77;,a7 with respect to a notice1 before the end of the applicable period for review under paragraph 7#a71 the ,administrator shall1 by consent agreement or order1 as appropriate-- 7i7 prohibit manufacture of the chemical substance1 or prohibit such manufacture without compliance with restrictions specified in a relevant consent agreement or order2 or 7ii7 prohibit manufacture or processing of the chemical substance for a significant new use1 or prohibit such manufacture or processing without compliance with restrictions specified in a relevant consent agreement or order4 7,b7 ,inclusions ,a prohibition or limitation under subparagraph 7,a7 may include1 as appropriate-- 7i7 a requirement that a chemical 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 ,administrator2 7ii7 a requirement that manufacturers or processors1 as applicable1 of the chemical substance make and retain records of the processes used to manufacture or process the chemical substance2 7iii7 a requirement that manufacturers or processors1 as applicable1 monitor or conduct such additional tests as are reasonably necessary to ensure compliance with this ,act1 subject to section #d7;g72 7iv7 a limitation on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce2 7v7 a limitation on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce for a particular use2 7vi7 a prohibition or other regulation of the manufacture1 processing1 or distribution in commerce of the chemical substance for a significant new use2 7vii7 a prohibition or other regulation of any method of commercial use of the chemical substance2 7viii7 a prohibition or other regulation of any method of disposal of the chemical substance2 7ix7 a prohibition on the manufacture1 processing1 or distribution in commerce of the chemical substance2 7x7 a prohibition on the manufacture1 processing1 or distribution in commerce of the chemical substance for a particular use2 or 7xi7 such other requirements as the ,administrator determines to be necessary4 7#f7 ,additional data and information ,if the ,administrator determines under paragraph 7#d77;,c7 that additional data and information 7including1 for example1 information on exposure or exposure potential7 are 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 on receipt of the information1 shall promptly make a determination under paragraph 7#d72 and 7,d7 may take action under paragraph 7#e7 pending receipt of the additional data and information1 which may1 as appropriate1 permit the submitter of the notice to file a notice of commencement under subsection 7d74 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 substance or nonexempt commercial manufacture or processing of a chemical substance for a significant new use1 as applicable1 the manufacturer or processor shall submit to the ,administrator a notice of commencement that identifies-- 7,a7 the name of the manufacturer or processor2 and 7,b7 the initial date of nonexempt commercial manufacture or nonexempt commercial manufacture or processing for a significant new use4 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 review a chemical substance under section #d7;e7 at any time after the ,administrator receives-- 7#a7 a notice of commencement for a chemical substance under subsection 7d72 or 7#b7 significant new information regarding the chemical substance4 7f7 ,transparency ,subject to section #ad1 the ,administrator shall make available to the public all notices1 rules and orders of the ,administrator1 and all data and information submitted or issued under this section4 2 7#h7 by redesignating subsections 7h7 and 7i7 as subsections 7g7 and 7h71 respectively2 and 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 is expected to meet the safety standard under the intended conditions of use2 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#d714 #f4 ,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 striking subsections 7a7 through 7d7 and inserting the following3 7a7 ,in general ,the ,administrator shall-- 7#a7 conduct a safety assessment of each high-priority substance in accordance with subsection 7b72 7#b7 make a safety determination for each high-priority substance2 and 7#c7 as appropriate based on the results of a safety determination1 establish requirements for risk management of a high-priority substance4 7b7 ,safety assessments 7#a7 ,in general ,the ,administrator shall conduct a risk-based safety assessment of each high-priority substance1 in accordance with such schedule as the ,administrator establishes1 to be based solely on considerations of risk to human health and the environment4 7#b7 ,procedural rules 7,a7 ,in general ,the ,administrator shall establish procedural rules for safety assessments and determinations under this subsection1 including schedules for the submission of relevant data and information and the initiation and completion of safety assessments and safety determinations4 7,b7 ,requirements 7i7 ,in general ,the rules under subparagraph 7,a7 shall-- 7,i7 identify the basis on which the ,administrator shall decide which high-priority substances take precedence in the safety assessment and determination process2 7,,ii7 require the ,administrator to inform the public regarding-- 7aa7 the approximate order in which safety assessments and determinations will be performed2 7bb7 the informational needs of the ,administrator relating to the safety assessment and determination process2 7cc7 the importance of expeditiously completing safety assessments and determinations and the need for rigorous evaluation of the data and information2 7dd7 the schedule by which each assessment and determination will be conducted2 and 7ee7 subject to clause 7ii71 the deadline for the completion of each assessment and determination2 7,,iii7 allow interested persons1 including ,states1 to submit information1 including safety assessments1 regarding high-priority substances that may facilitate the safety assessment and determination process2 and 7,,iv7 subject to section #ad1 require the ,administrator-- 7aa7 to make available to the public the information taken into consideration in preparing each safety assessment and determination2 7bb7 to publish and provide an opportunity for comment on proposed safety assessments and determinations2 and 7cc7 to publish final safety assessments and determinations4 7ii7 ,deadlines 7,i7 ,in general ,the rules described in subparagraph 7,a7 shall also include-- 7aa7 a schedule by which each safety assessment and determination is expected to be conducted2 and 7bb7 a deadline for the completion of each assessment and determination4 7,,ii7 ,flexibility and reasonable extensions ,the deadlines described in subclause 7,i77bb7-- 7aa7 may vary among chemical substances to grant the ,administrator flexibility2 and 7bb7 shall allow for reasonable extensions after an adequate public justification4 7,c7 ,inclusions in final assessments ,each safety assessment under this subsection shall include-- 7i7 a weight-of-the evidence summary2 and 7ii7 a nontechnical summary explaining what the relevant information demonstrates in the context of the intended conditions of use and exposure patterns of the chemical substance4 7#c7 ,data and information sources ,in conducting a safety assessment under this subsection1 the ,administrator shall1 at a minimum1 take into consideration-- 7,a7 the information described in section #d7;c72 and 7,b7 any additional information submitted under paragraph 7#e74 7#d7 ,methodology 7,a7 ,in general ,the ,administrator shall-- 7i7 develop an appropriate science-based methodology for conducting safety assessments under this subsection1 which shall include consideration of the weight of the evidence for observed effects1 mechanistic information1 and exposure evaluations2 and 7ii7 make the proposed methodology available for public comment and scientific peer review4 7,b7 ,review and revisions ,not later than #e years after the date of enactment of the ,chemical ,safety ,improvement ,act1 and not less frequently than once every #e years thereafter1 the ,administrator-- 7i7 shall review the methodology developed under subparagraph 7,a72 and 7ii7 may revise the methodology to reflect new scientific developments or understandings1 in accordance with subparagraph 7,a74 7,c7 ,requirements ,the methodology shall apply scientifically recognized factors to address the following topics3 7i7 ,strengths and limitations of study design4 7ii7 ,reliability and relevance of test methods to human health and the environment4 7iii7 ,quality of data4 7iv7 ,use of good laboratory practices4 7v7 ,peer review and peer review processes4 7vi7 ,use of standardized protocols4 7vii7 ,structured evaluative frameworks to determine the overall weight of the evidence1 based on a review of positive and negative findings4 7,d7 ,hazard1 use1 and exposure information 7i7 ,in general ,a safety assessment under this subsection shall evaluate existing hazard1 use1 and exposure information for the chemical substance under the intended conditions of use of the chemical substance1 including information submitted by interested persons4 7ii7 ,exposure ,for purposes of evaluating exposure under clause 7i71 a safety assessment shall take into consideration-- 7,i7 exposures or significant subsets of exposures2 7,,ii7 exposure duration1 intensity1 frequency1 and number2 and 7,,iii7 the vulnerability of exposed subpopulations4 7,e7 ,best available science ,the ,administrator shall use the best available science in conducting a safety assessment under this subsection4 7#e7 ,additional test information ,if the ,administrator determines that additional test information is needed in order to make a safety assessment 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 and 7,c7 may defer1 for a reasonable period1 a safety assessment until after receipt of the information4 7#f7 ,treatment ,a safety assessment under this subsection-- 7,a7 shall not be considered to be a final agency action2 and 7,b7 shall not be subject to judicial review4 7c7 ,safety determination 7#a7 ,in general ,as soon as possible after the date on which the safety assessment is completed for a high-priority substance under subsection 7b71 the ,administrator shall determine whether the chemical substance meets the safety standard under the intended conditions of use of the chemical substance4 7#b7 ,determinations ,based on a review of the information described in paragraph 7#c71 the ,administrator shall determine1 based solely on considerations of risk to human health and the environment1 that-- 7,a7 the relevant chemical substance meets the safety standard under intended conditions of use2 7,b7 the relevant chemical substance does not meet the safety standard under intended conditions of use1 in which case the ,administrator shall impose additional restrictions1 as appropriate1 under paragraph 7#i72 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#h74 7#c7 ,considerations ,in making a safety determination under this subsection1 the ,administrator shall take into consideration and publish a statement that includes1 at a minimum-- 7,a7 the safety assessment for the chemical substance1 including the uses considered in the assessment and any uses that are considered critical or essential2 7,b7 the range of exposure to the chemical substance under the intended conditions of use of the chemical substance and appropriate reference parameters2 7,c7 the weight of the evidence of risk posed by the chemical substance under the intended conditions of use of the chemical substance2 and 7,d7 the magnitude of the risk posed by the chemical substance under the intended conditions of use of the chemical substance4 7#d7 ,information sources ,in making a safety determination under this subsection1 the ,administrator shall take into consideration1 at a minimum-- 7,a7 the information described in section #d7;c72 and 7,b7 the safety assessment conducted with respect to the chemical substance under subsection 7b74 7#e7 ,best available science ,the ,administrator shall use the best available science in making a safety determination under this subsection4 7#f7 ,notice and comment ,subject to section #ad1 the ,administrator shall provide notice and an opportunity for public comment on each proposed safety determination under this subsection4 7#g7 ,transparency ,subject to section #ad1 the ,administrator shall publish-- 7,a7 each safety determination under this subsection1 together with a summary of the information considered in the determination2 7,b7 a summary of the evaluation by the ,administrator of the information2 and 7,c7 an explanation of the reasons for the determination4 7#h7 ,additional test data and information ,if the ,administrator determines that additional test data and information is needed in order to make a safety determination for a high-priority substance1 the ,administrator-- 7,a7 shall provide an opportunity for interested persons to submit the additional data and 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 data and information2 7,c7 may defer1 for a reasonable period1 a safety determination until after receipt of the data and information2 and 7,d7 on receipt of the data and information1 shall make a determination under paragraph 7#b74 7#i7 ,additional restrictions 7,a7 ,in general 7i7 ,determination ,if the ,administrator makes a determination under paragraph 7#b77;,b7 with respect to a chemical substance1 the ,administrator shall promulgate a rule establishing necessary restrictions 7based on the weight of the evidence of risk and the magnitude of risk71 including if appropriate1 a ban or phase out of the manufacture1 processing1 or use of the chemical substance in accordance with subparagraph 7,c74 7ii7 ,rules ,rules promulgated under this section may apply to mixtures containing the chemical substance1 as appropriate4 7,b7 ,inclusions ,a restriction under subparagraph 7,a7 may include1 as appropriate-- 7i7 a requirement that a chemical 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 ,administrator2 7ii7 a requirement that manufacturers and processors of the chemical substance-- 7,i7 make and retain records of the processes used to manufacture or process the chemical substance2 and 7,,ii7 subject to section #d7;f71 develop test information that is reasonably necessary to ensure compliance with this ,act2 7iii7 a limitation on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce2 7iv7 a requirement to ban or phase out or other regulation on the manufacture1 processing1 or distribution in commerce of the chemical substance-- 7,i7 for a particular use2 or 7,,ii7 for a particular use at a concentration in excess of a level specified by the ,administrator2 7v7 a limitation on the quantity of the chemical substance that may be manufactured1 processed1 or distributed in commerce-- 7,i7 for a particular use2 or 7,,ii7 for a particular use at a concentration in excess of a level specified by the ,administrator2 7vi7 a requirement to ban or phase out or other regulation of any method of commercial use of the chemical substance2 7vii7 a requirement to ban or phase out or other regulation of any method of disposal of the chemical substance or any article containing the chemical substance2 7viii7 a requirement directing manufacturers or processors of the chemical substance to give notice of unreasonable risks of harm 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 substance2 and 7ix7 such other requirements as the ,administrator determines to be necessary4 7,c7 ,bans and phase outs ,the ,administrator shall base a determination under subparagraph 7,a7 that a ban or phase out of the manufacture1 processing1 or use of a chemical substance is necessary on the considerations described in subparagraph 7,d74 7,d7 ,determination that chemical substance does not meet safety standard ,if the ,administrator determines that the chemical substance does not meet the safety standard under the intended conditions of use1 the ,administrator shall consider and publish a statement on-- 7i7 the availability of technically and economically feasible alternatives for the chemical substance under the intended conditions of use2 7ii7 the risks posed by those alternatives as compared to those of the chemical substance2 7iii7 the economic and social costs and benefits of the proposed regulatory action and options considered1 and of potential alternatives2 and 7iv7 the economic and social benefits and costs of-- 7,i7 the chemical substance2 7,,ii7 alternatives to the chemical substance2 and 7,,iii7 any necessary restrictions on the chemical substance or alternatives4 7#aj7 ,exemptions ,the ,administrator may exempt the use of a chemical substance from any additional restriction established under paragraph 7#i7 if the ,administrator determines that-- 7,a7 the exemption is in the interest of national security2 7,b7 the lack of availability of the chemical substance would cause significant disruption in the national economy2 7,c7 the use for which the exemption is sought is a critical or essential use for which-- 7i7 no feasible alternative for the use would materially reduce risk to health or the environment2 or 7ii7 no feasible alternative for the use is economically1 technically1 or efficiently available2 or 7,d7 the use1 as compared to reasonably available alternatives1 provides a net benefit to human health1 the environment1 or public safety4 7#aa7 ,final agency action ,a safety determination under this subsection shall be-- 7,a7 considered to be a final agency action2 and 7,b7 subject to judicial review1 including review of the associated safety assessment under this subsection4 2 7#c7 by redesignating subsections 7e7 and 7f7 as subsections 7d7 and 7e71 respectively2 and 7#d7 in subsection 7d7 7as so redesignated7-- 7,a7 by striking paragraph 7#d72 and 7,b7 by redesignating paragraph 7#e7 as paragraph 7#d74 #g4 ,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 of1 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 paragraph notwithstanding-- 7,a7 the existence of-- 7i7 a decision by the ,administrator under section #d7;c77#c71 #e7;c77#d71 or #f7;c77#b72 or 7ii7 a rule1 testing consent agreement1 or order under section #d7;f71 #e7;g71 #f7;b77#e71 #f7;c77#h71 #f7;c77#i71 or #f7;d72 or 7,b7 the pendency of any administrative or judicial proceeding under any provision of this ,act4 2 7#b7 in subsection 7d71 by striking section #f7;a7 and inserting section #f7;c72 and 7#c7 in subsection 7f71 in the first sentence1 by striking and unreasonable4 #h4 ,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 ,in general ,the ,administrator shall promulgate rules requiring 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 7,b7 ,contents ,the rules promulgated under subparagraph 7,a7-- 7i7 may impose different reporting requirements on manufacturers and processors2 7ii7 shall be limited to active substances or mixtures containing active substances as designated under subsection 7b72 and 7iii7 shall apply only to the extent the ,administrator determines the submission of reports is necessary for the effective enforcement of this ,act4 7#e7 ,guidance ,the ,administrator shall develop guidance relating to the information required to be reported under the rules promulgated under this subsection that-- 7,a7 include the level of detail necessary to be reported2 and 7,b7 describes the manner by which manufacturers and processors may report use and exposure information on a voluntary basis4 2 7#b7 in subsection 7b71 by adding at the end the following3 7#c7 ,nomenclature 7,a7 ,in general ,in carrying out paragraph 7#a71 the ,administrator shall-- 7i7 maintain the use of ,class #b nomenclature in use on date of enactment of the ,chemical ,safety ,improvement ,act2 7ii7 maintain the use of the ,soap and ,detergent ,association ,nomenclature ,system1 published in ,march #aigh by the ,administrator in section #a of addendum ,,iii of the document entitled ,candidate ,list of ,chemical ,substances1 and further described in the appendix ,a of volume ,i of the #aihe edition of the ,toxic ,substances ,control ,act ,substances ,inventory 7,,epa ,document ,no4 ,,epa-#efj_/g-he-jjb;a72 and 7iii7 treat all components of categories that are considered to be statutory mixtures under this ,act as being included on the list published under paragraph 7#a7 under the ,chemical ,abstracts ,service numbers for the respective categories1 including1 without limitation-- 7,i7 cement1 ,portland1 chemicals1 ,,cas ,no4 #feiig-ae-a2 7,,ii7 cement1 alumina1 chemicals1 ,,cas ,no4 #feiig-af-b2 7,,iii7 glass1 oxide1 chemicals1 ,,cas ,no4 #feiig-ag-c2 7,,iv7 frits1 chemicals1 ,,cas ,no4 #feiig-ah-d2 7,v7 steel manufacture1 chemicals1 ,,cas ,no4 #feiig-ai-e2 and 7,,vi7 ceramic materials and wares1 chemicals1 ,,cas ,no4 #ffdjb-fh-d4 7,b7 ,multiple nomenclature conventions 7i7 ,in general ,in the event that existing guidance allows for multiple nomenclature conventions1 the ,administrator shall-- 7,i7 maintain the nomenclature conventions for substances2 and 7,,ii7 develop new guidance that-- 7aa7 establishes equivalency between the nomenclature conventions for chemical substances on the list published under paragraph 7#a72 and 7bb7 permits persons to rely on that new guidance for purposes of determining whether a chemical substance is on the list published under paragraph 7#a74 7ii7 ,multiple ,,cas numbers ,for any chemical substance appearing multiple times on the list under different ,chemical ,abstracts ,service numbers1 the ,administrator shall develop guidance recognizing the multiple listings as a single chemical substance4 7#d7 ,candidate list of active substances in commerce 7,a7 ,in general ,subject to section #ad1 the ,administrator shall make publicly available a candidate list of active chemical substances1 which shall include-- 7i7 any chemical substance reported under part #gaa of title #dj1 ,code of ,federal ,regulations1 as in effect on the date of enactment of the ,chemical ,safety ,improvement ,act1 during the period beginning on the date that is #aj years before the date of enactment of the ,chemical ,safety ,improvement ,act and ending on the date of enactment of the ,chemical ,safety ,improvement ,act2 7ii7 any chemical substance for which a notice of commencement of manufacture has been submitted2 7iii7 any chemical substance for which a significant new use notice has been submitted2 7iv7 any chemical substance for which an export notification has been submitted during the period beginning on the date that is #aj years before the date of enactment of the ,chemical ,safety ,improvement ,act and ending on the date of enactment of the ,chemical ,safety ,improvement ,act2 and 7v7 any other chemical substance identified by the ,administrator as likely to qualify as active4 7,b7 ,rule ,the ,administrator shall1 by rule1 require manufacturers and processors to notify the ,administrator that the manufacturer or processor1 as applicable1 has manufactured or processed a chemical substance on the list described in subparagraph 7,a71 or the list published under paragraph 7#a7 for a nonexempt commercial purpose during the #e-year period prior to the date of enactment of the ,chemical ,safety ,improvement ,act4 7,c7 ,guidance ,before issuing a final rule under subparagraph 7,a71 the ,administrator shall make publicly available guidance relating to the rule for chemical substances on the confidential portion of the candidate list of active substances and of the list published under paragraph 7#a71 including -- 7i7 accession numbers2 7ii7 premanufacture notice case numbers1 if applicable2 and 7iii7 generic names4 7,d7 ,confidential chemical substances ,the rule under subparagraph 7,b7 shall require a manufacturer or processor that is reporting information relating to a chemical substance on the confidential portion of the list published under paragraph 7#a7 to indicate whether the manufacturer or processor claims the specific identity of the substance as confidential pursuant to section #ad4 7,e7 ,certification ,the rule under subparagraph 7,b7 shall require a manufacturer or processor-- 7i7 to certify the accuracy of each report of the manufacturer or processor carried out under the rule2 and 7ii7 to retain a record supporting that certification for a period of #e years beginning on the last day of the submission period4 7,f7 ,applicability ,nothing in this paragraph requires the resubstantiation of a claim for protection against disclosure for information submitted to the ,administrator prior to the date of enactment of the ,chemical ,safety ,improvement ,act4 7#e7 ,list 7,a7 ,in general ,based on the notifications received in response to the rule under paragraph 7#d71 the ,administrator shall designate each chemical substance that is on the list published under paragraph 7#a7 on the date of enactment of the ,chemical ,safety ,improvement ,act as active or inactive4 7,b7 ,update ,the ,administrator shall update the list of chemicals designated as active or inactive as soon as practicable following the publication of the most recent data reported under part #gaa of title #dj1 ,code of ,federal ,regulations4 7#f7 ,active substances ,the ,administrator shall designate as an active substance-- 7,a7 a chemical substance that has been manufactured or processed for a nonexempt commercial purposes at any point during the #e-year period prior to the date of enactment of the ,chemical ,safety ,improvement ,act2 7,b7 a chemical substance that is added to the list published under paragraph 7#a7 after the date of enactment of the ,chemical ,safety ,improvement ,act2 7,c7 a chemical substance for which a notice is received under paragraph 7#g77;,c72 and 7,d7 a chemical substance reported under part #gaa of title #dj1 ,code of ,federal ,regulations1 after the date of enactment of the ,chemical ,safety ,improvement ,act4 7#g7 ,inactive substances 7,a7 ,in general ,the ,administrator shall designate as an inactive substance each chemical substance on the list published under paragraph 7#a7 that has not been manufactured or processed for a nonexempt commercial purpose in the #e-year period ending on the date of enactment of the ,chemical ,safety ,improvement ,act4 7,b7 ,treatment ,each inactive substance shall remain on the list published under paragraph 7#a74 7,c7 ,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 before the date on which the substance is manufactured or processed4 7ii7 ,active status ,on receiving notification under clause 7i71 the ,administrator-- 7,i7 shall designate the chemical substance as an active substance2 and 7,,ii7 shall1 pursuant to section #d7;e71 review the priority of the chemical substance as the ,administrator determines necessary4 7,d7 ,category status ,the list of inactive chemical substances shall not be considered a category for purposes of section #bf7;c74 7#h7 ,public participation 7,a7 ,in general ,subject to subparagraph 7,b71 the ,administrator shall make available to the public-- 7i7 the specific identity of each chemical substance on the nonconfidential portion of the list published under paragraph 7#e7 that the ,administrator has designated as an active substance2 7ii7 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 7iii7 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 received2 and 7iv7 the specific identity of any active or inactive substance on the confidential portion of the list published under paragraph 7#a7 for which no claim of confidentiality was received1 subject to the condition that1 before revealing the specific identity of the substance1 the ,administrator shall-- 7,i7 publish a notice in the ,federal ,register identifying the accession number1 generic name1 and1 if applicable1 premanufacture notice case number for that substance2 and 7,,ii7 provide an opportunity for any person-- 7aa7 to certify to the ,administrator that the person intends to manufacture or process the substance at any point in the subsequent #d-year period2 and 7bb7 to claim confidentiality for the specific identity of the substance4 7,b7 ,confidentiality ,subject section #ad1 the ,administrator shall not make available to the public the specific chemical identity of any substance for which the ,administrator receives a notice under subparagraph 7,a77iv74 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 data and information reasonably supporting the conclusion that a chemical substance or mixture does not present a substantial risk of injury to health and the environment4 4 #i4 ,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 standard under the intended conditions of use2 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 paragraph 7#h7 or 7#i7 of subsection 7c7 of section #f or section #g2 and 7,c7 in paragraph 7#c71 by striking section #f or #g and inserting paragraph 7#h7 or 7#i7 of subsection 7c7 of section #f 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 #aj4 ,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 #aa4 ,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 substance that the ,administrator determines-- 7,a7 under section #e is not likely to meet the safety standard under the intended conditions of use of the chemical substance2 or 7,b7 under section #f does not meet the safety standard under the intended conditions of use of the chemical substance4 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 that mixture or article2 and 7,b7 establish a threshold concentration in a mixture or article at which paragraph 7#a7 shall not apply4 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 under the intended conditions of use of the chemical substance2 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 under the intended conditions of use of the chemical substance2 or 7,c7 a chemical substance for which the ,united ,states is obligated by treaty to provide export notification4 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-- 7i7 include any exemptions the ,administrator determines to be appropriate1 which may include exemptions identified under section #e7;g72 and 7ii7 indicate whether or to what extent the regulations apply to articles containing a chemical substance or mixture described in paragraph 7#a74 7#c7 ,notification ,the ,administrator shall submit to the government of each country to which a chemical substance or mixture is exported-- 7,a7 for a chemical substance or mixture described in subparagraph 7,a7 or 7,b7 of paragraph 7#a71 a notice that information on the chemical substance or mixture can be obtained from the ,administrator1 unless the ,administrator determines that good cause exists not to provide the notice2 and 7,b7 for a chemical substance described in paragraph 7#a77;,c71 a notice that satisfies the obligation of the ,united ,states under the applicable 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 #ab4 ,imports ,section #ac 7#ae ,u4,s4,c4 #bfab7 is amended to read as follows3 #ac4 ,imports 7a7 ,definition of chemical substance or mixture ,in this section1 the term chemical substance or mixture includes-- 7#a7 a mixture containing a chemical substance or mixture2 and 7#b7 an article containing a chemical substance or mixture4 7b7 ,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 substance or mixture offered for such entry if-- 7,a7 the ,administrator has determined under section #f7;c7 that the chemical substance or mixture does not meet the safety standard under the intended conditions of use of the chemical substance2 or 7,b7 the chemical substance or mixture is offered for entry in violation of a rule or order in effect under this ,act4 7#b7 ,procedure 7,a7 ,in general ,subject to subparagraph 7,b71 if 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 7c7 ,notice 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-- 7,a7 certify to the ,secretary of ,homeland ,security that1 after reasonable inquiry and to the best knowledge and belief of the person1 the chemical substance or mixture is-- 7i7 in compliance with any applicable rule1 consent agreement1 or order under section #e or #f2 and 7ii7 7,i7 included on the list under section #h7;b72 or 7,,ii7 exempt from any requirement to be included on that list2 and 7,b7 provide to the ,secretary of ,homeland ,security any notice required under paragraph 7#b74 7#b7 ,notice ,a person offering a chemical substance or mixture for entry into the customs territory of the ,united ,states shall notify the ,secretary of ,homeland ,security if-- 7,a7 the chemical substance is a high-priority substance2 7,b7 the chemical substance is a chemical for which the ,united ,states is obligated to provide export notification by treaty2 or 7,c7 the chemical substance or mixture or any article containing the substance or mixture-- 7i7 is the subject of a safety assessment and safety determination conducted pursuant to section #f and has been found not to meet the safety standard2 and 7ii7 is identified in a rule promulgated by the ,secretary of ,homeland ,security pursuant to subsection 7c7 as meriting notification due to the potential impact of the chemical substance or mixture or any article containing the substance or mixture on human health or the environment4 7d7 ,rules ,the ,secretary of ,homeland ,security1 after consultation with the ,administrator1 shall issue rules for the administration of subsection 7c71 including whether1 or to what extent1 the provisions of subsections 7b7 and 7c7 apply4 4 #ac4 ,confidential information ,section #ad 7#ae ,u4,s4,c4 #bfac7 is amended to read as follows3 #ad4 ,confidential information 7a7 ,in general ,except as provided in subsections 7c7 and 7e71 the ,administrator shall not disclose information described in subsection 7b7-- 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 ,information referred to in subsection 7a7 includes confidential information that is exempt from disclosure pursuant to subsection 7a7 of section #eeb of title #e1 ,united ,states ,code1 under subsection 7b77#d7 of that section4 7#b7 ,presumption of protection ,the following information submitted by a manufacturer1 processor1 or distributor is presumed to be protected from disclosure3 7,a7 ,specific information describing the manufacture1 processing1 or distribution in commerce of a chemical substance1 mixture1 or article4 7,b7 ,marketing and sales information4 7,c7 ,information identifying suppliers or customers4 7,d7 ,the identity of constituents in a mixture and the respective percentages of those constituents4 7,e7 ,specific information about the use1 function1 or application of a chemical substance or mixture in a process1 mixture1 or product4 7,f7 ,specific production or import volumes of a manufacturer and specific volumes aggregated across manufacturers if the ,administrator determines that disclosure of the aggregated data could reveal confidential information4 7,g7 ,the specific identity of a chemical substance1 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 submitted2 and 7ii7 the claim has not subsequently been withdrawn or found by the ,administrator not to warrant protection as confidential information under subsection 7g74 7c7 ,information not protected from disclosure 7#a7 ,in general ,notwithstanding subsections 7a7 and 7b71 and except as provided in paragraph 7#b71 the following information shall not be protected from disclosure3 7,a7 ,for information submitted after the date of enactment of the ,chemical ,safety ,improvement ,act1 the identity of a chemical substance if the person submitting the information does not meet the requirements of subsection 7d74 7,b7 ,a safety assessment developed or a safety determination made under section #f4 7,c7 ,health and safety data that are submitted under this ,act with respect to a chemical substance or mixture that has been offered for commercial distribution as of the date on which the study is to be disclosed or for which testing is required under section #d4 7,d7 ,health and safety data in notices of substantial risk submitted under section #h7;e7 and in the underlying studies4 7,e7 ,general information describing the manufacturing volumes1 expressed in ranges would not reveal confidential information4 7,f7 ,general descriptions of industrial1 commercial1 or consumer functions and uses of a chemical substance or mixture4 7#b7 ,exception ,information elements contained in submissions described in paragraph 7#a7 that are otherwise eligible for protection under this section shall be protected from disclosure if the submitter complies with subsection 7d74 7d7 ,requirements for confidentiality claims 7#a7 ,claims 7,a7 ,in general ,for information to be protected from disclosure under this section1 a person who submits information to the ,administrator under this ,act shall-- 7i7 indicate the information that the person believes is entitled to protection from disclosure under this section in a submission to the ,administrator in such manner and at such time as the ,administrator shall prescribe2 and 7ii7 except in the case of information described in subparagraphs 7,a7 through 7,f7 of subsection 7b77#b71 submit written documentation justifying why the information qualifies for protection from disclosure4 7,b7 ,certification ,an authorized official of the person described in subparagraph 7,a7 shall certify that the information that has been submitted is true and correct4 7#b7 ,additional requirements for confidentiality claims for chemical identities ,a person submitting information under this ,act related to a chemical identity and who claims protection from disclosure for that identity shall provide the ,administrator with-- 7,a7 information establishing that-- 7i7 the person takes reasonable measures to protect the confidentiality of the chemical identity2 7ii7 the chemical identity is not required to be disclosed1 or otherwise made available1 to the public under any other ,federal law in connection with one or more uses subject to this ,act2 7iii7 disclosure of the chemical identity is likely to cause substantial harm to the competitive position of the person2 and 7iv7 the chemical identity is not reasonably believed to be readily discoverable through reverse engineering2 7,b7 the time period for which protection of the chemical identity from disclosure is necessary2 7,c7 a generic name for the chemical substance that the ,administrator may disclose to the public1 subject to the condition that the generic name discloses a maximum amount of information on the chemical structure of the substance 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 person2 and 7,d7 in the event the ,administrator makes a request under subsection 7f7-- 7i7 redocumentation and recertification of the information submitted under subsection 7a72 or 7ii7 withdrawal of the claim for protection of the chemical identity from disclosure4 7#c7 ,guidance ,the ,administrator shall develop guidance1 after notice and opportunity to comment1 on the determination of generic names for confidential chemical identities4 7e7 ,exceptions to protection from disclosure ,subsection 7a7 shall not apply 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 one or more applicable agreements with the ,administrator ensure that the recipient government will take appropriate steps1 and has adequate authority1 to maintain the confidentiality of the information in accordance with procedures as stringent as 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 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 a written confidentiality agreement1 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 needed for purposes of diagnosis or treatment of one or more individuals2 7ii7 one or more individuals being diagnosed or treated have been exposed to the chemical substance concerned2 and 7iii7 knowledge of the specific chemical identity of the chemical substance will assist in diagnosis or treatment2 and 7,b7 the confidentiality agreement provides that the person will not use the specific chemical identity for any purpose other than the health 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 specific chemical identity to the ,administrator2 7#f7 a treating physician or nurse requests the information1 subject to the conditions that-- 7,a7 the treating physician or nurse determines that-- 7i7 a medical emergency exists2 7ii7 the specific chemical identity of the chemical substance concerned is necessary for or will assist in emergency or first-aid diagnosis or treatment2 and 7iii7 the one or more individuals being diagnosed or treated have likely been exposed to the chemical substance concerned2 7,b7 if requested by the person submitting the specific chemical identity to the ,administrator1 the treating physician or nurse provides a written statement of need and 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 necessary 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 or 7#h7 the information is to be disclosed1 on written request of any duly authorized committee of the ,congress1 to that committee4 7f7 ,duration of protection from disclosure 7#a7 ,in general ,the ,administrator shall protect from disclosure information described in subsection 7b7 that meets the requirements of subsection 7d77#b7 for the period of time requested by the person submitting the claim or for such period of time as the ,administrator1 after reviewing the request for confidential treatment and the documentation1 otherwise determines to be reasonable1 unless-- 7,a7 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,b7 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#b74 7#b7 ,redocumentation ,the ,administrator may request-- 7,a7 at any time1 a person who has requested protection from disclosure for the identity of a substance under subsection 7d7 to redocument the confidentiality claim of the person2 and 7,b7 any person who has requested that confidential information be protected from disclosure under section #h7;b7 to reassert the confidentiality claim of the person after the chemical substance is identified as a high-priority substance under section #d7;e74 7g7 ,duties of the administrator 7#a7 ,determination 7,a7 ,in general ,except as provided in subsection 7b77#b71 the ,administrator shall-- 7i7 review a request received under this section to maintain the confidentiality of information submitted under this ,act2 and 7ii7 determine whether to approve1 modify1 or deny that request4 7,b7 ,denial or modification 7i7 ,in general ,the ,administrator shall deny a claim to protect a chemical identity from disclosure only if the person who has submitted the request fails to meet the requirements of subsection 7d74 7ii7 ,reasons for denial or modification ,the ,administrator shall provide to the person who has submitted the request a written statement of the reasons for the denial or modification of the claim4 7,c7 ,subsets ,if it is not feasible for the ,administrator to review each request under this section1 the ,administrator shall review a representative subset4 7#b7 ,notification 7,a7 ,in general ,except as provided in subsections 7c7 and 7e71 if the ,administrator denies a request under paragraph 7#a71 the ,administrator shall notify1 in writing and by certified mail1 the person who submitted the request 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 may 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 may not release that information until the date that is #ae days after the date on which the person who submitted the request 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#f7 or 7#g7 of subsection 7e71 no prior notification is necessary4 7#c7 ,appeals 7,a7 ,in general ,a person who receives notification under this subsection 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-- 7,i7 the complainant resides or has the principal place of business2 or 7,,ii7 the information is located2 or 7ii7 the ,united ,states ,district ,court for the ,district of ,columbia4 7,b7 ,no disclosure ,the ,administrator shall not disclose any information 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 ,states1 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-- 7i7 guilty of a misdemeanor and fined under title #ah1 ,united ,states ,code1 imprisoned for not more than #a year1 or both2 and 7ii7 removed from office or employment4 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 ,except as otherwise provided in this section1 the ,administrator shall have no authority-- 7#a7 to require the documentation or redocumentation 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 ,chemical ,safety ,improvement ,act2 or 7#b7 to impose redocumentation requirements under this ,act that are more extensive than those required under this section4 4 #ad4 ,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 ,,vii or any rule promulgated or order issued under title ,,vii2 4 #ae4 ,preemption ,section #ah 7#ae ,u4,s4,c4 #bfag7 is amended by striking subsections 7a7 and 7b7 and inserting the following3 7a7 ,in general ,except as provided in subsections 7c7 and 7d71 no ,state or political subdivision of a ,state may establish or continue to enforce-- 7#a7 a requirement for the development of test data or information on a chemical substance or category of substances that is reasonably likely to produce the same data and information required under section #d1 #e1 or #f by-- 7,a7 a rule promulgated by the ,administrator2 7,b7 a consent agreement entered into by the ,administrator2 or 7,c7 an order issued by the ,administrator2 7#b7 a prohibition or restriction on the manufacture1 processing1 or distribution in commerce or use of a chemical substance after issuance of a completed safety determination for a chemical substance under section #f1 consistent with the scope of the review and decisions addressed by the ,administrator2 or 7#c7 a requirement for the notification of a use of a chemical substance that the ,administrator has specified as a significant new use and for which the ,administrator has required notification pursuant to a rule promulgated under section #e4 7b7 ,new prohibitions or restrictions ,except as provided in subsections 7c7 and 7d71 no ,state or political subdivision of a ,state may establish 7after the date of enactment of the ,chemical ,safety ,improvement ,act7-- 7#a7 a prohibition or restriction on the manufacture1 processing1 distribution in commerce or use of a chemical substance that is a high-priority substance identified under section #d7;e77#c7 7as of the date on which the ,administrator publishes a schedule under section #f7;b772 or 7#b7 a prohibition or restriction on the manufacture1 processing1 distribution in commerce or use of a chemical substance that is a low-priority substance identified under section #d7;e77#c74 7c7 ,exceptions ,subsections 7a7 and 7b7 shall not apply to a requirement1 prohibition1 or restriction of a ,state or a political subdivision of a ,state that-- 7#a7 is adopted under the authority of any other ,federal law2 7#b7 implements a reporting or information collection requirement not otherwise required by the ,administrator under this ,act or required under any other ,federal law2 or 7#c7 is adopted pursuant to authority under a law of the ,state or political subdivision of the ,state related to water quality1 air quality1 or waste treatment or disposal that-- 7,a7 does not impose a restriction on the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 and 7,b7 is not otherwise required by or inconsistent with an action by the ,administrator under section #e or #f4 7d7 ,state waivers ,upon application of a ,state or political subdivision of a ,state1 the ,administrator may provide a waiver from subsection 7a7 and subsection 7b77#a71 regarding a requirement of that ,state or political subdivision of the ,state that relates to the effects or exposure to any chemical substance under the intended conditions of use if-- 7#a7 7,a7 the ,state or political subdivision of the ,state determines it cannot wait until the end of the period specified in the established schedule and deadline for the completion of a full safety assessment and determination established under section #f7;b77#b77;,b77ii72 and 7,b7 the ,administrator determines that-- 7i7 compelling ,state or local conditions warrant granting the waiver to protect human health or the environment2 7ii7 compliance with the proposed requirement of the ,state or political subdivision of the ,state does not unduly burden interstate and foreign commerce in the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 7iii7 compliance with the proposed requirement of the ,state or political subdivision of the ,state would not cause a violation of any applicable ,federal law1 rule1 or order2 and 7iv7 the proposed requirement of the ,state or political subdivision of the ,state is based on the best available science and is supported by the weight of the evidence2 or 7#b7 7,a7 the ,administrator finds a safety assessment or determination has been unreasonably delayed2 and 7,b7 the ,state certifies that-- 7i7 the ,state has a compelling local interest to protect human health or the environment2 7ii7 compliance with the proposed requirement of the ,state does not unduly burden interstate and foreign commerce in the manufacture1 processing1 distribution in commerce1 or use of a chemical substance2 7iii7 compliance with the proposed requirement would not cause a violation of any applicable ,federal law1 rule1 or order2 and 7iv7 the proposed requirement is grounded in reasonable scientific concern4 7#c7 ,approval of a ,state ,waiver ,request ,the ,administrator shall grant or deny a waiver application-- 7,a7 not later than #ahj days after the date on which an application under paragraph 7#a7 is submitted2 and 7,b7 not later than #ij days after the date on which an application under paragraph 7#b7 is submitted4 7#d7 ,notice and comment ,the application of a ,state or political subdivision of the ,state shall be subject to public notice and comment4 7#e7 ,final agency action ,the decision of the ,administrator on the application of a ,state or political subdivision of the ,state shall be-- 7,a7 considered to be a final agency action2 and 7,b7 subject to judicial review4 7#f7 ,duration of ,state waivers ,a ,state waiver-- 7,a7 granted under paragraph 7#a7 shall remain in effect unless the waiver is found to be in conflict with a completed safety assessment and determination2 and 7,b7 granted under paragraph 7#b7 shall remain in effect until such time as the safety assessment and determination is completed4 7#g7 ,judicial review ,not later than #fj days after the date on which the ,administrator makes a determination on an application of a ,state or political subdivision of the ,state under paragraph 7#a71 any person may file a petition for judicial review in the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit1 which shall have exclusive jurisdiction over the determination4 7e7 ,effect on private remedies 7#a7 ,in general ,if the ,administrator completes a safety determination for a high-priority substance under section #f1 the determination shall be admissible as evidence in any public or private action in any court of the ,united ,states or ,state court for recovery of damages or for equitable relief relating to injury to human health or the environment from exposure to a chemical substance4 7#b7 ,safety standard ,the safety determination shall be determinative of whether the substance meets the safety standard under the conditions of use addressed in the safety determination4 4 #af4 ,judicial review ,section #ai 7#ae ,u4,s4,c4 #bfah7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking paragraph 7#a7 and inserting the following3 7#a7 ,filing of petition 7,a7 ,in general ,not later than #fj days after the date of the promulgation of a rule under section #d7;f71 #f7;c71 #f7;e71 or #h1 any person may file a petition for judicial review of the rule in-- 7i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 7ii7 the circuit in which the person resides2 or 7iii7 the circuit in which the principal place of business of the person is located4 7,b7 ,exclusive jurisdiction of courts of appeals ,the courts of appeals of the ,united ,states shall have exclusive jurisdiction of any action to obtain judicial review 7other than in an enforcement proceeding7 under subparagraph 7,a7 if any district court of the ,united ,states would have had jurisdiction of the action but for this paragraph4 2 7,b7 in paragraph 7#b71 by striking paragraph 7#a77;,a7 and inserting paragraph 7#a72 and 7,c7 by striking paragraph 7#c72 and 7#b7 in subsection 7c77#a71 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,applicability of section #gjf of title #e1 ,united ,states ,code 7i7 ,definition of evidence ,in this subparagraph1 the term evidence means any matter in the rulemaking record4 7ii7 ,applicability ,section #gjf of title #e1 ,united ,states ,code1 shall apply to review of a rule under this section1 except that-- 7,i7 in the case of a rule under section #d7;f71 #f7;c71 or #f7;e7-- 7aa7 the standard of review prescribed in section #gjf7b77;,e7 of title #e1 ,united ,states ,code1 shall not apply2 and 7bb7 the court shall hold as unlawful and set aside the rule if the court finds that the rule is not supported by substantial evidence in the rulemaking record2 and 7,,ii7 the court shall not review the contents and adequacy of the statement of basis and purpose required by section #eec7;c7 of title #e1 ,united ,states ,code1 to be incorporated in the rule except as part of a review of the rulemaking record taken as a whole4 4 #ag4 ,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 or #f7;b77#b7 and inserting an order under section #d7;f7 or #e7;c72 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking an order under section #e7;e71 #f7;b77#a77;,a71 or #f7;b77#a77;,b7 and inserting an order under section #d7;f7 or #e7;c72 and 7,b7 by striking subparagraph 7,b7 of paragraph 7#d7 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 #d7;f71 #f7;b71 #f7;c71 #f7;d71 or #h or an order issued under section #d7;f7 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 #d7;f71 the information available to the ,administrator is insufficient for the ,administrator to perform an action described in section #d7;f71 #f7;b77#e71 or #f7;c77#h72 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 standard under the intended conditions of use2 7cc7 in the case of a petition to initiate a proceeding for the issuance of a rule under section #f7;c77#i71 there is a reasonable basis to conclude that the substance will not meet the safety standard under the intended conditions of use2 or 7dd7 in the case of a petition to initiate a proceeding for the issuance of a rule under section #f7;b77#b71 #f7;d7 or #h1 there is a reasonable basis to conclude that the rule is necessary to protect human health or the environment from an unreasonable risk of harm to human health or the environment4 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 #ah4 ,studies ,section #be 7#ae ,u4,s4,c4 #bfbd7 is repealed4 #ai4 ,administration ,section #bf7;e7 7#ae ,u4,s4,c4 #bfbe7;e77 is amended by striking ,health1 ,education1 and ,welfare each place it appears and inserting ,health and ,human ,services4 #bj4 ,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 #ba4 ,state programs ,section #bh 7#ae ,u4,s4,c4 #bfbg7 is amended by striking subsections 7c7 and 7d74 #bb4 ,authorization of appropriations ,section #bi 7#ae ,u4,s4,c4 #bfbh7 is repealed4 #bc4 ,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 #d7;f72 4