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Standard Guide for Risk-Based Corrective Action for Protection of Ecological Resources 生态资源保护的基于风险的纠正措施标准指南
发布日期: 2022-10-01
1.1 这是基于风险的生态资源保护纠正措施指南,补充了RBCA流程(指南 2008年 ). 生态RBCA过程的主要目标是为化学品释放场所的ERA和风险管理决策提供一个灵活的框架。为此,审查了各联邦和州机构的可用指导文件,并在可能的情况下将其共同属性纳入本指南。生态RBCA流程补充了现有的技术和监管生态风险指南(参见 4.2 ). 特别是,它旨在与美国环保局的ERA计划指南兼容 ( 1. ) 2. ,超级基金计划指南 ( 2. ) 和其他USEPA ( 3. ) 风险评估和纠正措施计划。生态RBCA也可与包括人类健康问题的纠正行动战略结合使用(例如,指南 2008年 ). 1.2 化学品释放地点在复杂性、物理和化学特性以及可能对生态资源造成的风险方面差异很大。生态RBCA流程,如指南所述 2008年 ,认识到这种可变性,并采用分层方法,将现场评估、响应行动和补救行动与ERA相结合。该过程从一级相对简单的分析开始,如有必要,在二级或三级进行更详细的评估。收集和评估数据的过程是以这样的方式进行的,即在每一层只收集给定层决策所需的数据。因此,这可以促进资源的有效利用并减少初始数据需求。 1.3 生态RBCA旨在为监管计划未涵盖的场所和监管计划中缺乏具体指导的场所提供框架。生态RBCA还可以提供一个有用的框架,帮助在多个监管计划适用时将几种可能的方法合并为一种方法。用户应了解适用于现场的联邦、州和地方纠正行动计划和政策,并且无论计划如何,可能需要机构批准才能实施完成电子逆向拍卖的流程。 1.4 需要就生态RBCA的各个方面制定各种TPD。这些TPD可能涵盖哲学和方法学方面,从要保护的价值观到生态RBCA过程的具体实施方式。TPD可能影响过程的每个阶段,从最初的现场评估到补救措施的制定和监测。用户有责任确定适当的TPD。部分 7. , 附录X2 、和指南 2008年 提供有关生态RBCA过程中TPD的更多详细信息。 1.5 本文件的一般性能标准要求: 1.5.1 从生态RBCA流程开始,并酌情在后期阶段确定适用的TPD; 1.5.2 生态RBCA过程中使用的数据数量和质量足以回答问题并支持调查层的决策; 1.5.3 现场评估分为适当级别的评估; 1.5.4 所采取的行动应将保护相关生态受体和栖息地的生态RBCA过程与保护人类健康的RBCA结合起来(见指南 2008年 ),视情况而定; 1.5.5 遵守适用的联邦、州和地方法律法规;和 1.5.6 在选择补救行动替代方案时,应考虑对相关生态受体和栖息地的潜在不利影响。补救措施备选方案应与TPD和RBCA流程一致(参见指南 2008年 ). 1.6 生态资源是本指南的重点;其他ASTM RBCA标准(指南 1739年 和 2008年 ). 三种RBCA指南都有许多共同的功能。这三个指南共享RBCA的基本要素:( 1. )现场评估;( 2. )暴露、影响和风险的分级评估;( 3. )基于风险的决策;以及( 4. )响应、补救措施和监测。人类健康和生态风险评估之间有许多区别。例如,虽然人类健康风险评估侧重于个人,但生态风险评估通常侧重于人口、社区或生态系统。例外情况是指定用于特殊保护的物种或关键栖息地(例如,濒危或文化- 重要物种)。与人类暴露和流行病学数据相比,支持ERA的生物数据更易于进行直接现场观察。 1.7 生态RBCA过程解决了化学品释放场所相关生态受体和栖息地的当前和潜在未来风险。它不适用于当前的许可释放和许可申请。 1.8 生态RBCA侧重于化学应激。然而,用户可能需要考虑现场的生物或物理压力源或与现场无关的化学源的影响。 1.9 本指南中描述的过程将当前ERA实践的原则与现场评估活动和补救措施选择相结合,以确保风险管理决策保护生态资源。 图1 说明了生态RBCA中的以下活动以及第节中所述的活动 7. ( 7.1 – 7.10 ): 1.9.1 步骤1- 初始现场评估; 1.9.2 步骤2- 决策点; 1.9.3 步骤3- 一级生态风险评估; 1.9.4 步骤4- 一级决策点; 1.9.5 步骤5- 二级生态风险评估; 1.9. 6. 步骤6- 二级决策点; 1.9.7 步骤7- 第三级生态风险评估; 1.9.8 步骤8- 三级决策点; 1.9.9 步骤9- 实施补救行动计划;和 1.9.10 步骤10- 监控程序( 7.10 ). 1.9.11 可以以灵活的方式应用上述步骤。如果现有站点信息表明后续级别更适用于解决特定站点的问题,则可能无需进行完整级别的评估。如果经验表明需要在现场进行更复杂的评估,则用户可以选择从概念上通过任何早期层次进行现场评估- 2级或3级的典型具体评估。此外,步骤4、6和8中的决策点允许用户退出分层评估过程,并在有足够的信息可供决策时选择适当的补救措施。 1.10 本指南组织如下: 1.10.1 部分 2. 列出了引用的ASTM文件; 1.10.2 部分 3. 定义本指南中使用的术语; 1.10.3 部分 4. 说明本指南的意义和用途; 1.10.4 部分 5. 描述了生态RBCA过程的分层方法; 1.10.5 小节 6和 7. 以循序渐进的方式介绍生态RBCA程序;和 1.10.6 参考部分提供了本指南中引用的所有文件。 1.11 本指南还包括以下附录,这些附录作为补充信息提供,不作为本指南的强制性章节: 1.11.1 附录X1 提供与风险管理问题相关的信息; 1.11.2 附录X2 提出了有关TPD的问题; 1.11.3 附录X3 介绍了生态RBCA流程每一层中发生的活动信息; 1.11.4 附录X4 描述了筛选标准及其如何在生态RBCA框架内应用; 1.11.5 附录X5 介绍了相关生态筛选基准的选择和使用; 1.11.6 附录X6 包括生态RBCA框架的两个应用示例;和 1.11.7 附录X7 介绍了不确定性及其在生态RBCA中的作用。 1.12 以国际单位制或英寸磅单位表示的数值应单独视为标准值。每个系统中规定的值可能不完全相等; 因此,每个系统应独立使用。合并两个系统的值可能导致不符合标准。 1.13 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 本指南中介绍的生态RBCA流程是一个简化的决策- 制定实施纠正措施的过程,以一致的方式保护化学释放场所的生态资源。生态RBCA为监管计划中未涵盖的站点、监管计划中缺乏指导的站点或监管计划中缺少详细指导的站点提供了一个框架。生态RBCA还可以提供一个有用的框架,帮助在多个监管计划适用时合并一种方法。 4.2 生态风险评估是一个基于科学的过程,可用于为风险管理决策提供洞察力- 制作许多联邦和州项目都有开展ERA的指导。为编制本生态RBCA指南,对ERA的可用监管方法进行了审查。生态RBCA旨在适应各种方法的使用,以考虑相关生态受体和栖息地的风险。标准的一些属性包括: 4.2.1 使用分层方法,包括过程流程图,以确定关键步骤,并促进整个过程的概述; 4.2.2 从第1步开始,在整个生态系统中识别、开发和使用TPD- RBCA过程; 4.2.3 表明利益相关者参与的价值和时间,认识到某些法规需要与联邦、州、部落和自然资源受托人以及其他利益相关者协调; 4.2.4 确定可能需要或不需要ERA的情况;和 4.2.5 确定ERA结果用于风险管理决策的决策点。 4.3 本指南中描述的活动应包括具有适当技能和专业知识的人员。用户可依赖于修复科学技术、生态学/生物学、生态毒理学、ERA实践和现场表征技术方面的专家。 4.4 本指南和支持性附录为正确应用生态RBCA流程提供了示例和技术支持。用户应避免采取不当行动或使用生态RBCA,例如: 4.4.1 将1级RESC规定为推定的补救清理目标,而不是作为筛选标准,或在适当情况下,作为特定地点的补救清理目的; 4.4.2 将生态RBCA流程的使用仅限于一级评估,如果需要进一步分级评估,则不继续进行二级或三级评估; 4.4.3 对纠正行动过程设置任意时间限制,不反映现场造成的实际紧迫性和风险; 4.4.4 仅在技术上不可行的现场使用生态RBCA; 4.4.5 在确定适用的纠正措施目标之前,采取补救措施; 4.4.6 将所有现场的补救措施限制为单一类别; 4.4.7 使用不合理或不适当的暴露因子; 4.4.8 使用不合理或不适当的毒性参数; 4.4.9 使用不受可用数据或现场条件知识支持的建模; 4.4.10 使用不明确或定义不充分的测量或评估终点; 4.4.11 得出没有可用数据支持的结论; 4.4.12 未能监测工程或机构控制的有效性; 4.4.13 使用临时补救措施不是为了降低风险,而是为了延迟生态RBCA流程; 4.4.14 未能考虑潜在补救行动方案的长期有效性、可靠性和对相关生态受体和栖息地的风险;或 4.4.15 在达到补救措施目标的现场继续监测或采取补救措施(除非工程或机构控制或其他监管要求特别需要监测)。
1.1 This is a guide to risk-based corrective action for the protection of ecological resources and supplements the RBCA process (Guide E2081 ). The primary objective of the Eco-RBCA process is to provide a flexible framework for a tiered approach to ERA and risk management decision making at chemical release sites. To this end, available guidance documents from various federal and state agencies were reviewed and their common attributes incorporated into this guide, where possible. The Eco-RBCA process complements existing technical and regulatory ecological risk guidance (see 4.2 ). In particular, it is intended to be compatible with the USEPA programmatic guidelines for ERA ( 1 ) 2 , guidance for the Superfund program ( 2 ) , and other USEPA ( 3 ) risk assessment and corrective-action programs. Eco-RBCA might also be used in conjunction with corrective action strategies that include human health issues (for example, Guide E2081 ). 1.2 Chemical release sites vary greatly in terms of complexity, physical and chemical characteristics, and the risk that they might pose to ecological resources. The Eco-RBCA process, as described in Guide E2081 , recognizes this variability and incorporates a tiered approach that integrates site assessment, response actions, and remedial actions with ERA. The process begins with relatively simple analyses in Tier 1 and, if necessary, proceeds to more detailed evaluations in Tier 2 or Tier 3. The process of gathering and evaluating data is conducted in such a manner that only those data that are necessary for a given tier's decision making are collected at each tier. Hence, this can facilitate effective use of resources and reduce initial data requirements. 1.3 Eco-RBCA is intended to provide a framework for sites not covered under regulatory programs and for sites under regulatory programs that lack specific guidance. Eco-RBCA may also provide a useful framework to help merge several possible approaches into a single approach when multiple regulatory programs apply. The user should be aware of the federal, state, and local corrective action programs and policies that are applicable for the site and, regardless of the program, that agency approvals might be required to implement the process for completing ERAs. 1.4 Various TPDs will need to be made regarding the aspects of Eco-RBCA. These TPDs may cover both the philosophical and methodological aspects, from what values to protect to exactly how the Eco-RBCA process will be performed. TPDs may affect every stage of the process, from the initial site assessment to development and monitoring of the remedy. It is the responsibility of the user to identify the appropriate TPDs. Section 7 , Appendix X2 , and Guide E2081 provide more detail regarding TPDs in the Eco-RBCA process. 1.5 The general performance standard for this document requires that: 1.5.1 Applicable TPDs be identified, beginning at the initiation of the Eco-RBCA process, and as appropriate, at later stages; 1.5.2 Data used in the Eco-RBCA process be of sufficient quantity and quality to answer the questions and support the decisions made at the tier of investigation; 1.5.3 Site assessments be distinguished into tiers of appropriate levels of evaluation; 1.5.4 Actions taken should integrate the Eco-RBCA process for the protection of relevant ecological receptors and habitats and RBCA for the protection of human health (see Guide E2081 ), as appropriate; 1.5.5 Applicable federal, state, and local laws and regulations be followed; and 1.5.6 Potential adverse effects on relevant ecological receptors and habitats be considered when selecting remedial action alternatives. The remedial action alternatives should be consistent with the TPDs and the RBCA process (see Guide E2081 ). 1.6 Ecological resources are the focus of this guide; risks to human health are addressed for petroleum releases and chemical releases in other ASTM RBCA standards (Guides E1739 and E2081 ). There are many features common to all three of the RBCA guides. These three guides share the basic elements of RBCA: ( 1 ) site assessment; ( 2 ) tiered evaluations of exposure, effects, and risk; ( 3 ) risk-based decision making; and ( 4 ) response, remedial action, and monitoring. There are a number of distinctions between human health and ecological risk assessments. For example, while human health risk assessments focus on individuals, evaluations of ecological risk typically focus on populations, communities, or ecosystems. Exceptions are species or critical habitats designated for special protection (for example, endangered or culturally-important species). Biological data to support an ERA are more amenable to direct field observation than are human exposure and epidemiological data. 1.7 The Eco-RBCA process addresses current and potential future risks to relevant ecological receptors and habitats at chemical release sites. It is not intended to apply to current permitted releases and permit applications. 1.8 Eco-RBCA focuses on chemical stressors. However, the user may need to consider biological or physical stressors at the site or effects from chemical sources unrelated to the site. 1.9 The process described in this guide integrates the principles of current ERA practices with site assessment activities and remedial-action selection to ensure that the risk management decision protects ecological resources. Fig. 1 illustrates the following activities in Eco-RBCA and those described in Section 7 ( 7.1 – 7.10 ): 1.9.1 Step 1— Initial Site Assessment; 1.9.2 Step 2— Decision Point; 1.9.3 Step 3— Tier 1 Ecological Risk Assessment; 1.9.4 Step 4— Tier 1 Decision Point; 1.9.5 Step 5— Tier 2 Ecological Risk Assessment; 1.9.6 Step 6— Tier 2 Decision Point; 1.9.7 Step 7— Tier 3 Ecological Risk Assessment; 1.9.8 Step 8— Tier 3 Decision Point; 1.9.9 Step 9— Implementing the Remedial Action Program; and 1.9.10 Step 10— Monitoring Programs ( 7.10 ). 1.9.11 The above steps can be applied in a flexible manner. It may not be necessary to conduct a full tier of evaluation if existing site information indicates that a subsequent tier is more applicable to address site-specific concerns. Where experience indicates that a more sophisticated assessment is warranted at a site, the user may elect to proceed conceptually through any earlier tiers to conduct a site-specific assessment typical of Tier 2 or Tier 3. Additionally, the decision points in Steps 4, 6, and 8 allow the user to exit the tiered evaluation process and select the appropriate remedial action once adequate information is available for decision making. 1.10 This guide is organized as follows: 1.10.1 Section 2 lists referenced ASTM documents; 1.10.2 Section 3 defines terminology used in this guide; 1.10.3 Section 4 describes the significance and use of this guide; 1.10.4 Section 5 describes the tiered approach to the Eco-RBCA process; 1.10.5 Sections 6 and 7 presents Eco-RBCA procedures in a step-by-step process; and 1.10.6 The reference section provides all documents cited in this guide. 1.11 This guide also includes the following appendices, which are provided as supplemental information and are not included as mandatory sections of this guide: 1.11.1 Appendix X1 presents information related to risk management issues; 1.11.2 Appendix X2 presents issues regarding TPDs; 1.11.3 Appendix X3 presents information on the activities occurring in each tier of the Eco-RBCA process; 1.11.4 Appendix X4 describes screening criteria and how they can be applied within the Eco-RBCA framework; 1.11.5 Appendix X5 presents the selection and use of relevant ecological screening benchmarks; 1.11.6 Appendix X6 includes two examples of the application of the Eco-RBCA framework; and 1.11.7 Appendix X7 presents information on uncertainty and its role in Eco-RBCA. 1.12 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.13 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 The Eco-RBCA process presented in this guide is a streamlined decision-making process for implementing corrective action protective of ecological resources at chemical release sites in a consistent manner. Eco-RBCA provides a framework for sites not covered under regulatory programs, for sites under regulatory programs that lack guidance, or for sites under programs with guidance that lack detail. Eco-RBCA may also provide a useful framework to help merge an approach when multiple regulatory programs apply. 4.2 Ecological risk assessment is a science-based process that can be used to provide insight for risk management decision-making. Numerous federal and state programs have guidance for conducting ERA. Available regulatory approaches to ERA were reviewed in preparation for the development of this Eco-RBCA guide. Eco-RBCA was designed to be adaptable to the use of a variety of methods for considering risks to relevant ecological receptors and habitats. Some attributes of the standard are: 4.2.1 Use of a tiered approach, including process flow charts to identify critical steps and facilitate the development of an overview of the entire process; 4.2.2 Identification, development, and use of TPDs from Step 1 and throughout the entire Eco-RBCA process; 4.2.3 Indications of the value and timing of stakeholder involvement, recognizing that some regulations require coordination with federal, state, tribal, and natural-resource trustees, and other stakeholders; 4.2.4 Identification of situations under which an ERA may or may not be necessary; and 4.2.5 Identification of decision points where ERA results are used for risk management decision making. 4.3 Activities described in this guide should involve persons with the appropriate skills and expertise. The user may rely on individuals expert in remediation science and technology, ecology/biology, ecotoxicology, ERA practices, and site characterization techniques. 4.4 This guide and supporting appendices provide examples and technical support for the proper application of the Eco-RBCA process. The user should avoid inappropriate actions or use of Eco-RBCA such as: 4.4.1 Prescribing Tier 1 RESC as presumptive remediation cleanup goals rather than as screening criteria or, when appropriate, as site-specific remediation cleanup goals; 4.4.2 Limiting the use of the Eco-RBCA process to Tier 1 evaluation only and not continuing with Tier 2 or Tier 3 evaluations for sites where further tiered evaluation is appropriate; 4.4.3 Placing arbitrary time constraints on the corrective action process that do not reflect the actual urgency and risk posed by the site; 4.4.4 Using Eco-RBCA only at sites where active remedial action is not technically feasible; 4.4.5 Initiating remedial action(s) before determining applicable corrective action goals; 4.4.6 Limiting options to a single class of remedial action for all sites; 4.4.7 Using unjustified or inappropriate exposure factors; 4.4.8 Using unjustified or inappropriate toxicity parameters; 4.4.9 Using modeling that is not supported by the available data or knowledge of site conditions; 4.4.10 Using measurement or assessment endpoints that are ambiguous or insufficiently defined; 4.4.11 Drawing conclusions that are not supported by available data; 4.4.12 Failing to monitor the effectiveness of engineering or institutional controls; 4.4.13 Using an interim remedial action not to reduce risk but solely to delay the Eco-RBCA process; 4.4.14 Failing to consider the long-term effectiveness, reliability, and risks to relevant ecological receptors and habitats of potential remedial action options; or, 4.4.15 Continuing monitoring or remedial action at sites that have achieved remedial action goals (unless monitoring is specifically required for an engineering or institutional control or other regulatory requirements).
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