1、Designation: E 2081 00 (Reapproved 2004)e1Standard Guide forRisk-Based Corrective Action1This standard is issued under the fixed designation E 2081; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numbe
2、r in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTETable X3.3 was corrected editorially in December 2004.INTRODUCTIONThis guide provides guidance for the development of a Risk-Based Corrective Act
3、ion (RBCA)program that integrates the sciences of ecological and human health risk-based decision making intothe corrective action process. The RBCA provides a flexible, technically defensible framework forcorrective action that is applicable to a wide range of sites and chemical(s) of concern. The
4、frameworkincorporates a tiered analytical approach, applying increasingly complex levels of data collection andanalysis as the user proceeds through the process. It provides a starting point for the integration ofmultiple regulatory programs into a site-wide corrective action activity and a technica
5、lly defensibleprocess for achieving “No Further Action.” The successful implementation of the RBCA frameworkis dependent on an understanding by the user of the technical policy decisions that are critical to therisk management process and the identification and determination of these technical polic
6、y decisionsprior to beginning the process (see 3.2.60). There are numerous technical policy decisions that mustbe made to implement the RBCA process, for example, defining data quality objectives, determiningtarget risk levels and addressing resource protection. It is not the intent of this guide to
7、 defineappropriate technical policy decisions. The RBCA process is not intended to replace existingregulatory programs, but rather to complement these programs. Regardless of whether a correctiveaction is specifically governed by a regulatory program, the user should consult the regulatory agencyreq
8、uirements to identify the appropriate technical policy decisions prior to implementing the RBCAprocess. The RBCA process encourages user-led initiatives and stakeholder involvement in both thedevelopment of the technical policy decisions and the RBCA program. It recognizes the diversity ofsites and
9、provides appendixes for possible applications and examples.The appendixes are provided foradditional information and are not mandatory sections of this standard guide.ASTM standards are notfederal or state regulations; they are consensus standards that can voluntarily be followed.1. Scope1.1 This is
10、 a guide for conducting risk-based correctiveaction (RBCA) at chemical release sites based on protectinghuman health and the environment. The RBCA is a consistentdecision-making process for the assessment and response tochemical releases. Chemical release sites vary greatly in termsof complexity, ph
11、ysical and chemical characteristics, and in therisk that they may pose to human health and the environment.The RBCA process recognizes this diversity by using a tieredapproach that integrates site assessment and response actionswith human health and ecological risk assessment to determinethe need fo
12、r remedial action and to tailor corrective actionactivities to site-specific conditions and risks. The evaluationsand methods used in the RBCA process begin with simpleanalyses in Tier 1 and move to more complex evaluations ineither Tier 2 or Tier 3, as applicable. The process of gatheringand evalua
13、ting data is conducted in a scaled fashion. Conse-quently, only the data that are necessary for a particular tiersdecision-making are collected at that tier.1.2 This guide describes an approach for risk-based correc-tive action. It is intended to help direct and streamline thecorrective action proce
14、ss and to complement but not tosupersede federal, state and local regulations. It can be em-ployed at sites where corrective action is being conductedincluding sites where there may not be a regulatory frameworkfor corrective action, or where the user wishes to conductcorrective action such as sites
15、 in voluntary cleanup programs orunder Brownfields initiatives. In addition, it can also be used as1This guide is under the jurisdiction ofASTM Committee E50 on EnvironmentalAssessment and is the direct responsibility of Subcommittee E50.04 on PerformanceStandards Related to Environmental Regulatory
16、 Programs.Current edition approved Oct. 1, 2004. Published December 2004. Originallyapproved in 1998 as PS 104-98. Last previous edition approved in 2000 asE 2081-00.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.a unifying framewor
17、k when several different agency programsaffect the site. Furthermore, the user should be aware of thefederal, state and local corrective action programs that areapplicable for the site and, regardless of the program, federal,state and local agency approvals may be required to implementthe processes
18、outlined in this guide. Finally, regardless ofwhether a corrective action is specifically governed by aregulatory program, the user should consult the regulatoryagency requirements to identify the appropriate technicalpolicy decisions prior to implementing the RBCA process.1.3 There are numerous tec
19、hnical policy decisions that mustbe made to implement the RBCA process, for example,defining data quality objectives, determining target risk levels,specifying the appropriate statistics and sample sizes forcalculating exposure concentrations, selection of exposureassumptions, determining when and h
20、ow to account for cumu-lative risks and additive effects among chemical(s) of concernand addressing resource protection. It is not the intent of thisguide to define appropriate technical policy decisions. The usermust identify the appropriate technical policy decisions.1.4 The general performance st
21、andard for this guide re-quires that:1.4.1 Technical policy decisions be identified before begin-ning the process,1.4.2 Data and information collected during the RBCAprocess, including historical data as well as new data collectedduring the site assessment, will be relevant to and of sufficientquant
22、ity and quality to answer the questions posed by and thedecisions to be made in the RBCA process,1.4.3 Actions taken during the risk-based decision processwill be protective of human health and the environment,1.4.4 Applicable federal, state and local regulations will befollowed (for example, waste
23、management requirements,ground water designations, worker protection) and,1.4.5 Remedial actions implemented will not result inhigher risk levels than existed before taking actions.1.5 ASTM standards are not federal or state regulations,they are consensus standards that can voluntarily be followed.1
24、.6 The RBCA process is not limited to a particular class ofcompounds. This guide is intended to be a companion to GuideE 1739, and does not supersede that document for petroleumreleases. If a release site contains a mixture of releases ofpetroleum and other chemicals, this guide should be followed.1
25、.7 The United States Environmental Protection Agency(USEPA) has developed guidance for human health riskevaluation (seeAppendix X8 for other resources). Many of thecomponents of this guidance have been integrated into theRBCA framework. The science of ecological evaluation andthe process by which th
26、e science is applied, however, are not aswell defined and agreed upon as human health risk assessment.Therefore, the information provided in this guide for each tierevaluation for relevant ecological receptors and habitats isgeneral. The user is referred to Appendix X5, which providesadditional info
27、rmation regarding the development of a RBCAframework for protection of ecological resources.1.8 The decision process described in this guide integratesexposure and risk assessment practices with site assessmentactivities and remedial action selection to ensure that thechosen actions are protective o
28、f human health and the envi-ronment. The following general sequence of events is pre-scribed in RBCA:1.8.1 Perform an initial site assessment and develop the firstiteration of the site conceptual model. If the information issufficient to demonstrate that there are no complete or poten-tially complet
29、e exposure pathways, then no further action iswarranted,1.8.2 Evaluate the site (see definition of site 3.2.50) forresponse actions (multiple sites at a single facility may requiredifferent response actions and times),1.8.3 Implement a response action that is appropriate forconditions found at the s
30、ite during the site response actionevaluation,1.8.4 Define data requirements, develop data quality objec-tives, and perform a site assessment for the Tier 1 evaluation ifthe site conceptual model indicates that the tiered evaluation isappropriate,1.8.5 Conduct an exposure pathway analysis to determi
31、ne ifrelevant ecological receptors and habitats are present and ifcomplete and potentially complete exposure pathways arepresent. If no relevant ecological receptors or habitats orcomplete and potentially complete exposure pathways exist,then no further action for relevant ecological receptors andha
32、bitats is warranted,1.8.6 For potential human exposure pathways, identify theapplicable Risk Based Screening Levels (RBSL) and forpotential ecological exposure pathways, identify the applicableRelevant Ecological Screening Criteria (RESC). In addition,identify any Other Relevant Measurable Criteria
33、(ORMC), asapplicable. Collectively these are the Tier 1 corrective actiongoals for the site;1.8.7 Compare site conditions to the Tier 1 corrective actiongoals determined to be applicable to the site;1.8.8 If site conditions meet the corrective action goals forchemical(s) of concern then, no further
34、action is warranted,1.8.9 If site conditions do not meet corrective action goalsfor chemical(s) of concern then, one or more of the followingactions is appropriate:1.8.9.1 Further tier evaluation;1.8.9.2 Implement interim remedial action;1.8.9.3 Design and implement remedial action to achievethe cor
35、rective action goals.1.8.10 Define Tier 2 data requirements, data quality objec-tives, collect additional site-specific information and update thesite conceptual model, as necessary, if further tier evaluation iswarranted,1.8.11 Develop point(s) of demonstration and Tier 2 correc-tive action goals b
36、ased on Site-Specific Target Levels (SSTL),Site-Specific Ecological Criteria (SSEC) or ORMC, whereappropriate, for complete and potentially complete exposurepathways, including exposure pathways for which no RBSL,RESC or ORMC, as applicable, were determined;1.8.12 Compare site conditions to the Tier
37、 2 correctiveaction goals determined to be applicable to the site;1.8.13 If site conditions meet corrective action goals forchemical(s) of concern, then no further action is warranted,E 2081 00 (2004)e121.8.14 If site conditions do not meet corrective action goalsfor chemical(s) of concern then, one
38、 or more of the followingactions is appropriate:1.8.14.1 Further tier evaluation;1.8.14.2 Implement interim remedial action;1.8.14.3 Design and implement remedial action to achievethe corrective action goals.1.8.15 Define Tier 3 data requirements, data quality objec-tives and collect additional site
39、-specific information and updatethe site conceptual model, as necessary, if further tier evalua-tion is warranted,1.8.16 Develop point(s) of demonstration and Tier 3 correc-tive action goals based on SSTL, SSEC, or ORMC, whereappropriate;1.8.17 Compare site conditions to the Tier 3 correctiveaction
40、goals,1.8.18 If site conditions meet corrective action goals forchemical(s) of concern, then no further action is warranted,1.8.19 If site conditions do not meet corrective action goalsfor chemical(s) of concern, then one of the following actions isappropriate:1.8.19.1 Implement interim remedial act
41、ion to facilitatereassessment of the tier evaluation;1.8.19.2 Design and implement remedial action to achievethe corrective action goals.1.8.20 Develop and implement a monitoring plan based onthe corrective action goals to validate the assumptions used forthe tier evaluation and to demonstrate effec
42、tiveness of theremedial action, as applicable.1.9 For chemical release sites currently in corrective action,the user should review information and data available for thesite and determine the most appropriate entry point into theRBCA framework consistent with the general performancestandards and seq
43、uence of events outlined in this guide.1.10 This Guide is Organized as Follows Section 2 listsreferenced documents, Section 3 defines terminology used inthis guide, Section 4 describes the significance and use of thisguide, Section 5 is a summary of the tiered approach, andSection 6 presents the RBC
44、A procedures in a step-by-stepprocess. Appendix X1 provides guidance on developing tech-nical policy decisions and building a RBCA program, Appen-dix X2 provides examples of chemical properties and effectsdata that may be useful for a RBCA evaluation, Appendix X3provides EXAMPLE development of RBSL,
45、 Appendix X4describes the use of predictive modeling, Appendix X5 pro-vides an outline of the process of the ecological evaluation,Appendix X6 provides information about activity and uselimitations, Appendix X7 includes illustrative examples of theapplication of the RBCA framework, and Appendix X8 i
46、n-cludes references that may be helpful to the user. The Appen-dixes are provided for additional information and are NOTincluded as mandatory sections of this guide.2. Referenced Documents2.1 ASTM Standards:2D 5447 Guide for Application of a Ground-Water FlowModel to a Site-Specific ProblemD 5490 Gu
47、ide for Comparing Ground-Water Flow ModelSimulations to Site-Specific InformationD 5610 Guide for Defining Initial Conditions in Ground-Water Flow ModelingD 5611 Guide for Conducting a Sensitivity Analysis for aGround Water Flow Model ApplicationD 5612 Guide for Quality lanning and Field Implementa-
48、tion of a Water Quality Measurement ProgramD 5718 Guide for Documenting a Ground-Water FlowModel ApplicationD 5880 Guide for Subsurface Flow and Transport ModelingD 6235 Practice for Expedited Site Characterization ofVadose Zone and Ground Water Contamination at Hazard-ous Waste Contaminated SitesE
49、978 Practice for Evaluating Mathematical Models for theEnvironmental Fate of ChemicalsE 1527 Practice for Environmental SiteAssessments: PhaseI Environmental Site Assessment ProcessE 1599 Guide for CorrectiveAction for Petroleum ReleasesE 1689 Guide for Developing Conceptual Site Models forContaminated SitesE 1739 Standard Guide for Risk-Based Corrective ActionApplied at Petroleum Release SitesE 1903 Guide for Environmental SiteAssessments: Phase IIEnvironmental Site Assessment ProcessE 1912 Guide for Accelerated Site Characterization forConfirmed or Suspected Petroleum ReleasesE 1943
