Regulatory Determinations made under Section 5 of theToxic Substances Control Act (TSCA)
根据“有毒物质控制法”（TSCA）第5节作出的法规确定
EPA审查和确定
TSCA requires EPA to review submitters' section 5 notices andmake an affirmative finding on the safety of new chemical substances orsignificant new uses of chemicals (identified by EPA in rulemaking) submittedunder section 5(a) of TSCA before they can proceed to the marketplace. The law sets forth five possible determinations under section 5 with relatedactions:
TSCA要求EPA审查提交者的第5节通知，并根据TSCA第5（a）节提交的新化学物质的安全性或化学品的重要新用途（由EPA在规则制定中确定）作出肯定性调查结果，然后才能进入市场。法律在第5节中提出了五项可能的决定，并采取了相关行动：
· If EPA determines a new chemical substance or significant newuse presents an unreasonable risk of injury to health or the environment,without consideration of costs or other nonrisk factors, including anunreasonable risk to a potentially exposed or susceptible subpopulation underthe conditions of use, theAgency must take action under section 5(f) to protect against the unreasonablerisk.
· 如果EPA确定新的化学物质或重大新用途会对健康或环境造成不合理的伤害风险，而不考虑成本或其他非风险因素，包括在使用条件下对潜在暴露或易感亚群的不合理风险，代理机构必须根据第5（f）节采取行动，以防止不合理的风险。
· If EPA determines that the available information isinsufficient to allow the Agency to make a reasoned evaluation of the healthand environmental effects of the new chemical substance or significant newuse, EPAmust issue an order under section 5(e). A section 5(e) orderprohibits or limits the manufature, processing, distribution in commerce, use,or disposal to the extent necessary to protect against an unreasonable risk,and may include testing requirements.
· 如果EPA确定可用信息不足以使代理机构对新化学物质的健康和环境影响或重大新用途进行合理评估，EPA必须根据第5（e）节发布命令。第5（e）条命令禁止或限制制造，加工，分销商业，使用或处置，以防止不合理的风险，并可能包括测试要求。
· If EPA determines that, in the absence ofsufficient information, the manufacture, processing, distribution incommerce, use or disposal of the chemical may present an unreasonable risk ofinjury to health or the environment, without consideration of costs or othernon-risk factors, including an unreasonable risk to a potentially exposed orsusceptible subpopulation identified as relevant to the EPAAdministrator, EPAmust issue an order under section 5(e). A section 5(e) orderprohibits or limits the manufacture, processing, distribution in commerce, use,or disposal to the extent necessary to protect against an unreasonable risk,and may include testing requirements.
· 如果EPA确定，在没有足够信息的情况下，制造，加工，分销商业，使用或处置化学品可能会对健康或环境造成不合理的伤害风险，而不考虑成本或其他无风险 EPA必须根据第5（e）条发布命令，包括与EPA管理员相关的潜在暴露或易感亚群的不合理风险因素。第5（e）条命令禁止或限制在必要范围内制造，加工，分销商业，使用或处置以防止不合理的风险，并可包括测试要求。
· If EPA determines that the substance is or will beproduced in substantial quantities and either enters or may enter theenvironment in substantial quantities or there is or may be significant orsubstantial exposure to the substance, EPAmust issue an order under section 5(e). A section 5(e) orderprohibits or limits the manufacture, processing, distribution in commerce, use,or disposal to the extent necessary to protect against an unreasonable risk,and may include testing requirements.
· 如果EPA确定该物质已经或将要大量生产，并且大量进入或可能进入该环境，或者该物质存在或可能存在重大或实质性接触，EPA必须根据第5节（e）发出命令）。第5（e）条命令禁止或限制在必要范围内制造，加工，分销商业，使用或处置以防止不合理的风险，并可包括测试要求。
· If EPA determines that a new chemical or significant new useis not likely to present an unreasonable risk of injury to health or theenvironment, without consideration of costs or other nonrisk factors, includingan unreasonable risk to a potentially exposed or susceptible subpopulationunder the conditions of use, the Agency will notify the submitter and thesubmitter may commence manufacture of the chemical or manufacture or processingfor a significant new use notwithstanding any remaining portion of the 90-dayreview period. EPA will notify the submitter of its decision and publish itsfindings in a statement in the Federal Register.
· 如果EPA确定新的化学品或重要的新用途不太可能对健康或环境造成不合理的伤害风险，不考虑成本或其他非风险因素，包括在使用条件下对潜在暴露或易感亚群的不合理风险，尽管90天审查期间有任何剩余部分，代理机构将通知提交者，提交者可以开始制造化学品或制造或加工以进行重大新用途。EPA将通知提交者其决定，并在联邦公报的声明中公布其调查结果。
o Learnhow to check on the status of your section 5 notice.
o 了解如何检查第5部分通知的状态。
If EPA fails to make a determination by the end of the reviewperiod and the notice has not been withdrawn by the submitter, EPA must refundthe submitter all applicable fees charged for review of the notice, but theAgency must still make the determination. A refund of applicable fees will notbe made if the submitter has not provided information required or has otherwiseunduly delayed the process such that EPA is unable to render a determinationwithin the applicable review period.
如果EPA未能在审核期结束时做出决定且提交者未撤回通知，则EPA必须向提交者退还收到的通知审核费用，但代理机构仍必须作出决定。如果提交者未提供所需信息或以其他方式不当地延迟流程以致EPA无法在适用的审核期内作出决定，则不会退还适用的费用。
Note: No person may manufacture a new chemical substance ormanufacture or process a chemical substance for a significant new use until EPAmakes a determination as described in section 5(a) and takes any requiredaction.
注意：在EPA根据第5（a）条所述做出决定并采取任何必要措施之前，任何人不得制造或处理化学物质以用于重大新用途。
Learnmore about EPA’s Decision-Making Framework and EPA Actions Following a Section5 Determination.
在第5节确定后，了解有关EPA决策框架和EPA行动的更多信息。
TSCA第5（h）（4）条豁免类别
EPA has made some categories of chemical substances eligiblefor exemption, and the sections of the Code of Federal Regulations (CFR) atwhich they are described, include:
EPA已经使某些类别的化学物质有资格获得豁免，而描述它们的联邦法规（CFR）的部分包括：
· Some polymers (under the requirements at 40 CFR 723.250),
· 某些聚合物（根据40CFR 723.250的要求），
· Chemical substances with production volumes less than orequal to 10,000 kilograms/year and which have been reviewed by the NewChemicals Program (Low Volume Exemption) (under the requirements at 40 CFR723.50),
· 生产量小于或等于10,000公斤/年并且已经过新化学品计划（低容量豁免）审查的化学物质（根据40CFR 723.50的要求），
· Chemical substances with low release to the environmentand low human exposure (Low Release/Low Exposure, LoREX) and which havebeen reviewed by the New Chemicals Program (under the requirements at 40 CFR723.50).
· 对环境低释放和低人体暴露的化学物质（低释放/低暴露，低温暴露），并且已经过新化学品计划（根据40 CFR 723.50的要求）审查。
· Chemicals that are manufactured (including imported) for testmarketing (Test Marketing Exemption) (under the requirements at 40 CFR 720.38and 720.78).
· 制造（包括进口）用于测试营销的化学品（测试营销豁免）（根据40 CFR 720.38和720.78的要求）。
· Chemical substances manufactured or processed only in smallquantities and for research and development (under the requirements at 40 CFR720.36 and 720.78).
· 仅少量生产或加工的化学物质，用于研究和开发（根据40 CFR 720.36和720.78的要求）。
EPA has determined that these are appropriate categoriesunder TSCA sections 26(c) and 5(h)(4). For each of these categories, EPA hasmade a finding that new chemical substances eligible for the exemptions willnot present an unreasonable risk of injury to human health or the environmentwhen manufactured, processed, used, distributed in commerce, or disposed ofunder the terms of the exemptions.
EPA已根据TSCA第26（c）和5（h）（4）条确定这些是适当的类别。对于这些类别中的每一类，EPA已经发现，符合豁免条件的新化学物质在制造，加工，使用，分销商业时不会对人类健康或环境造成不合理的伤害风险，或根据豁免条款处置。
