1、Designation: E2081 00 (Reapproved 2015)Standard Guide forRisk-Based Corrective Action1This standard is issued under the fixed designation E2081; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in
2、 parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis guide provides guidance for the development of a Risk-Based Corrective Action (RBCA)program that integrates the sciences of ecological and
3、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 frameworkincorporates a tiered analytical approach, applying incr
4、easingly 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 technically defensibleprocess for achieving “No Further Action.” The succ
5、essful 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 policy decisionsprior to beginning the process (see 3.2.60). There are
6、 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 defineappropriate technical policy decisions. The RBCA process i
7、s 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 agencyrequirements to identify the appropriate technical policy decisions
8、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 provides appendixes for possible applications and examples.The ap
9、pendixes 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 a guide for conducting risk-based correctiveaction (RBCA) at che
10、mical 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, physical and chemical characteristics, and in therisk that they may
11、 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 for remedial action and to tailor corrective actionactivities to si
12、te-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 evaluating data is conducted in a scaled fashion.Consequently, only the
13、 data that are necessary for a particulartiers decision-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 process and to complement but not tosupersede federal, state and local r
14、egulations. 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 in voluntary cleanup programs orunder Brownfields initiatives. In
15、addition, it can also be used asa unifying framework when several different agency programsaffect the site. Furthermore, the user should be aware of thefederal, state and local corrective action programs that are1This guide is under the jurisdiction ofASTM Committee E50 on EnvironmentalAssessment, R
16、isk Management and Corrective Action and is the direct responsibil-ity of Subcommittee E50.04 on Corrective Action.Current edition approved April 1, 2015. Published May 2015. Originallyapproved in 1998. Last previous edition approved in 2010 as E2081-00 (2010)1.DOI: 10.1520/E2081-00R5.Copyright ASTM
17、 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1applicable for the site and, regardless of the program, federal,state and local agency approvals may be required to implementthe processes outlined in this guide. Finally, regardless ofwhether a corre
18、ctive 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 technical policy decisions that mustbe made to implement the RBC
19、A 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 how to account for cumu-lative risks and additive effects amon
20、g 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 standard for this guide re-quires that:1.4.1 Technical policy d
21、ecisions 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 sufficientquantity and quality to answer the questions posed by and thedecis
22、ions 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 management requirements,ground water designations, worker pro
23、tection) 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.1.6 The RBCA process is not limited to a particular class ofco
24、mpounds. This guide is intended to be a companion to GuideE1739, 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.1.7 The United States Environmental Protection Agency(USEPA) ha
25、s developed guidance for human health riskevaluation (see Appendix 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 the science is applied, however, are not aswell defined and agr
26、eed 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 information regarding the development of a RBCAframework for prot
27、ection 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 of human health and the envi-ronment. The following general se
28、quence 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 complete exposure pathways, then no further action iswarranted,1.8.2
29、 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 site during the site response actionevaluation,1.8.4 Define da
30、ta requirements, develop data qualityobjectives, and perform a site assessment for the Tier 1evaluation if the site conceptual model indicates that the tieredevaluation is appropriate,1.8.5 Conduct an exposure pathway analysis to determine ifrelevant ecological receptors and habitats are present and
31、 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 andhabitats is warranted,1.8.6 For potential human exposure pathways
32、, 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 (ORMC), asapplicable. Collectively these are the Tier 1 correct
33、ive 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 action is warranted,1.8.9 If site conditions do not meet correc
34、tive 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 corrective action goals.1.8.10 Define Tier 2 data requirements, da
35、ta qualityobjectives, collect additional site-specific information andupdate the site conceptual model, as necessary, if further tierevaluation is warranted,1.8.11 Develop point(s) of demonstration and Tier 2 correc-tive action goals based on Site-Specific Target Levels (SSTL),Site-Specific Ecologic
36、al 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 2 correctiveaction goals determined to be applicable to the site
37、;1.8.13 If site conditions meet corrective action goals forchemical(s) of concern, then no further action is warranted,E2081 00 (2015)21.8.14 If site conditions do not meet corrective action goalsfor chemical(s) of concern then, one or more of the followingactions is appropriate:1.8.14.1 Further tie
38、r 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-specific information and updatethe site conceptual model, as necess
39、ary, 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 goals,1.8.18 If site conditions meet corrective action goals forchem
40、ical(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 action to facilitatereassessment of the tier evaluation;1.8.19.2 Design
41、 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 effectiveness of theremedial action, as applicable.1.9 For chemical relea
42、se 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 sequence of events outlined in this guide.1.10 This Guide is Organized
43、as FollowsSection 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 RBCA procedures in a step-by-stepprocess. Appendix X1 provides guidance
44、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, Appendix X4describes the use of predictive modeling, Appendix X5 pro
45、-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 in-cludes references that may be helpful to the user. The Appen-dixes
46、are provided for additional information and are NOTincluded as mandatory sections of this guide.1.11 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2D5447 Guide forApplication of a Grou
47、ndwater Flow Modelto a Site-Specific ProblemD5490 Guide for Comparing Groundwater Flow ModelSimulations to Site-Specific InformationD5610 Guide for Defining Initial Conditions in GroundwaterFlow ModelingD5611 Guide for Conducting a Sensitivity Analysis for aGroundwater Flow Model ApplicationD5612 Gu
48、ide for Quality Planning and Field Implementa-tion of a Water Quality Measurement ProgramD5718 Guide for Documenting a Groundwater Flow ModelApplicationD5880 Guide for Subsurface Flow and Transport Modeling(Withdrawn 2015)3D6235 Practice for Expedited Site Characterization of Va-dose Zone and Ground
49、water Contamination at HazardousWaste Contaminated SitesE978 Practice for Evaluating Mathematical Models for theEnvironmental Fate of Chemicals (Withdrawn 2002)3E1527 Practice for Environmental SiteAssessments: Phase IEnvironmental Site Assessment ProcessE1599 Guide for Corrective Action for Petroleum Releases(Withdrawn 2002)3E1689 Guide for Developing Conceptual Site Models forContaminated SitesE1739 Guide for Risk-Based Corrective Action Applied atPetroleum Release SitesE1903 Practice for Environmental Site Assessments: PhaseII Environmental Site Assessment ProcessE1912 Guide for A
