ASTM E2081-00(2004)e1
(Guide)Standard Guide for Risk-Based Corrective Action
Standard Guide for Risk-Based Corrective Action
SCOPE
1.1 This is a guide for conducting risk-based corrective action (RBCA) at chemical release sites based on protecting human health and the environment. The RBCA is a consistent decision-making process for the assessment and response to chemical releases. Chemical release sites vary greatly in terms of complexity, physical and chemical characteristics, and in the risk that they may pose to human health and the environment. The RBCA process recognizes this diversity by using a tiered approach that integrates site assessment and response actions with human health and ecological risk assessment to determine the need for remedial action and to tailor corrective action activities to site-specific conditions and risks. The evaluations and methods used in the RBCA process begin with simple analyses in Tier 1 and move to more complex evaluations in either Tier 2 or Tier 3, as applicable. The process of gathering and evaluating data is conducted in a scaled fashion. Consequently, only the data that are necessary for a particular tier's decision-making are collected at that tier.
1.2 This guide describes an approach for risk-based corrective action. It is intended to help direct and streamline the corrective action process and to complement but not to supersede federal, state and local regulations. It can be employed at sites where corrective action is being conducted including sites where there may not be a regulatory framework for corrective action, or where the user wishes to conduct corrective action such as sites in voluntary cleanup programs or under Brownfields initiatives. In addition, it can also be used as a unifying framework when several different agency programs affect the site. Furthermore, the user should be aware of the federal, state and local corrective action programs that are applicable for the site and, regardless of the program, federal, state and local agency approvals may be required to implement the processes outlined in this guide. Finally, regardless of whether a corrective action is specifically governed by a regulatory program, the user should consult the regulatory agency requirements to identify the appropriate technical policy decisions prior to implementing the RBCA process.
1.3 There are numerous technical policy decisions that must be made to implement the RBCA process, for example, defining data quality objectives, determining target risk levels, specifying the appropriate statistics and sample sizes for calculating exposure concentrations, selection of exposure assumptions, determining when and how to account for cumulative risks and additive effects among chemical(s) of concern and addressing resource protection. It is not the intent of this guide to define appropriate technical policy decisions. The user must identify the appropriate technical policy decisions.
1.4 The general performance standard for this guide requires that:
1.4.1 Technical policy decisions be identified before beginning the process,
1.4.2 Data and information collected during the RBCA process, including historical data as well as new data collected during the site assessment, will be relevant to and of sufficient quantity and quality to answer the questions posed by and the decisions to be made in the RBCA process,
1.4.3 Actions taken during the risk-based decision process will be protective of human health and the environment,
1.4.4 Applicable federal, state and local regulations will be followed (for example, waste management requirements, ground water designations, worker protection) and,
1.4.5 Remedial actions implemented will not result in higher 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 of compounds. This guide is intended to be a companion to Guide E1739, and does not supersede that document for petroleum releases. I...
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation: E2081 – 00 (Reapproved 2004)
Standard Guide for
Risk-Based Corrective Action
This standard is issued under the fixed designation E2081; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Table X3.3 was corrected editorially in December 2004.
INTRODUCTION
This guide provides guidance for the development of a Risk-Based Corrective Action (RBCA)
program that integrates the sciences of ecological and human health risk-based decision making into
the corrective action process. The RBCA provides a flexible, technically defensible framework for
correctiveactionthatisapplicabletoawiderangeofsitesandchemical(s)ofconcern.Theframework
incorporates a tiered analytical approach, applying increasingly complex levels of data collection and
analysis as the user proceeds through the process. It provides a starting point for the integration of
multiple regulatory programs into a site-wide corrective action activity and a technically defensible
process for achieving “No FurtherAction.” The successful implementation of the RBCAframework
is dependent on an understanding by the user of the technical policy decisions that are critical to the
risk management process and the identification and determination of these technical policy decisions
prior to beginning the process (see 3.2.60). There are numerous technical policy decisions that must
be made to implement the RBCAprocess, for example, defining data quality objectives, determining
target risk levels and addressing resource protection. It is not the intent of this guide to define
appropriate technical policy decisions. The RBCA process is not intended to replace existing
regulatory programs, but rather to complement these programs. Regardless of whether a corrective
actionisspecificallygovernedbyaregulatoryprogram,theusershouldconsulttheregulatoryagency
requirements to identify the appropriate technical policy decisions prior to implementing the RBCA
process. The RBCA process encourages user-led initiatives and stakeholder involvement in both the
development of the technical policy decisions and the RBCAprogram. It recognizes the diversity of
sitesandprovidesappendixesforpossibleapplicationsandexamples.Theappendixesareprovidedfor
additionalinformationandarenotmandatorysectionsofthisstandardguide.ASTMstandardsarenot
federal or state regulations; they are consensus standards that can voluntarily be followed.
1. Scope the need for remedial action and to tailor corrective action
activities to site-specific conditions and risks. The evaluations
1.1 This is a guide for conducting risk-based corrective
and methods used in the RBCA process begin with simple
action (RBCA) at chemical release sites based on protecting
analyses in Tier 1 and move to more complex evaluations in
human health and the environment. The RBCAis a consistent
either Tier 2 or Tier 3, as applicable. The process of gathering
decision-making process for the assessment and response to
and evaluating data is conducted in a scaled fashion. Conse-
chemical releases. Chemical release sites vary greatly in terms
quently, only the data that are necessary for a particular tier’s
ofcomplexity,physicalandchemicalcharacteristics,andinthe
decision-making are collected at that tier.
risk that they may pose to human health and the environment.
1.2 This guide describes an approach for risk-based correc-
The RBCA process recognizes this diversity by using a tiered
tive action. It is intended to help direct and streamline the
approach that integrates site assessment and response actions
corrective action process and to complement but not to
withhumanhealthandecologicalriskassessmenttodetermine
supersede federal, state and local regulations. It can be em-
ployed at sites where corrective action is being conducted
ThisguideisunderthejurisdictionofASTMCommitteeE50onEnvironmental
includingsiteswheretheremaynotbearegulatoryframework
AssessmentandisthedirectresponsibilityofSubcommitteeE50.04onPerformance
for corrective action, or where the user wishes to conduct
Standards Related to Environmental Regulatory Programs.
correctiveactionsuchassitesinvoluntarycleanupprogramsor
CurrenteditionapprovedOctober1,2004.PublishedDecember2004.Originally
approved in 1998 as PS 104-98. Last previous edition approved in 2000 as
underBrownfieldsinitiatives.Inaddition,itcanalsobeusedas
E2081-00. DOI: 10.1520/E2081-00R04E01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
´1
E2081 – 00 (2004)
a unifying framework when several different agency programs chosen actions are protective of human health and the envi-
affect the site. Furthermore, the user should be aware of the ronment. The following general sequence of events is pre-
federal, state and local corrective action programs that are scribed in RBCA:
applicable for the site and, regardless of the program, federal,
1.8.1 Performaninitialsiteassessmentanddevelopthefirst
stateandlocalagencyapprovalsmayberequiredtoimplement
iteration of the site conceptual model. If the information is
the processes outlined in this guide. Finally, regardless of
sufficient to demonstrate that there are no complete or poten-
whether a corrective action is specifically governed by a
tially complete exposure pathways, then no further action is
regulatory program, the user should consult the regulatory
warranted,
agency requirements to identify the appropriate technical
1.8.2 Evaluate the site (see definition of site 3.2.50) for
policy decisions prior to implementing the RBCA process.
response actions (multiple sites at a single facility may require
1.3 Therearenumeroustechnicalpolicydecisionsthatmust
different response actions and times),
be made to implement the RBCA process, for example,
1.8.3 Implement a response action that is appropriate for
defining data quality objectives, determining target risk levels,
conditions found at the site during the site response action
specifying the appropriate statistics and sample sizes for
evaluation,
calculating exposure concentrations, selection of exposure
1.8.4 Define data requirements, develop data quality objec-
assumptions, determining when and how to account for cumu-
tives,andperformasiteassessmentfortheTier1evaluationif
lative risks and additive effects among chemical(s) of concern
the site conceptual model indicates that the tiered evaluation is
and addressing resource protection. It is not the intent of this
appropriate,
guidetodefineappropriatetechnicalpolicydecisions.Theuser
1.8.5 Conductanexposurepathwayanalysistodetermineif
must identify the appropriate technical policy decisions.
relevant ecological receptors and habitats are present and if
1.4 The general performance standard for this guide re-
complete and potentially complete exposure pathways are
quires that:
present. If no relevant ecological receptors or habitats or
1.4.1 Technical policy decisions be identified before begin-
complete and potentially complete exposure pathways exist,
ning the process,
then no further action for relevant ecological receptors and
1.4.2 Data and information collected during the RBCA
habitats is warranted,
process, including historical data as well as new data collected
1.8.6 For potential human exposure pathways, identify the
during the site assessment, will be relevant to and of sufficient
applicable Risk Based Screening Levels (RBSL) and for
quantity and quality to answer the questions posed by and the
potentialecologicalexposurepathways,identifytheapplicable
decisions to be made in the RBCA process,
Relevant Ecological Screening Criteria (RESC). In addition,
1.4.3 Actions taken during the risk-based decision process
identify any Other Relevant Measurable Criteria (ORMC), as
will be protective of human health and the environment,
applicable. Collectively these are the Tier 1 corrective action
1.4.4 Applicable federal, state and local regulations will be
goals for the site;
followed (for example, waste management requirements,
1.8.7 ComparesiteconditionstotheTier1correctiveaction
ground water designations, worker protection) and,
goals determined to be applicable to the site;
1.4.5 Remedial actions implemented will not result in
1.8.8 If site conditions meet the corrective action goals for
higher risk levels than existed before taking actions.
chemical(s) of concern then, no further action is warranted,
1.5 ASTM standards are not federal or state regulations,
1.8.9 If site conditions do not meet corrective action goals
they are consensus standards that can voluntarily be followed.
for chemical(s) of concern then, one or more of the following
1.6 The RBCAprocess is not limited to a particular class of
actions is appropriate:
compounds.ThisguideisintendedtobeacompaniontoGuide
1.8.9.1 Further tier evaluation;
E1739, and does not supersede that document for petroleum
1.8.9.2 Implement interim remedial action;
releases. If a release site contains a mixture of releases of
1.8.9.3 Design and implement remedial action to achieve
petroleum and other chemicals, this guide should be followed.
the corrective action goals.
1.7 The United States Environmental Protection Agency
1.8.10 Define Tier 2 data requirements, data quality objec-
(USEPA) has developed guidance for human health risk
tives,collectadditionalsite-specificinformationandupdatethe
evaluation(seeAppendixX8forotherresources).Manyofthe
siteconceptualmodel,asnecessary,iffurthertierevaluationis
components of this guidance have been integrated into the
warranted,
RBCA framework. The science of ecological evaluation and
1.8.11 Develop point(s) of demonstration andTier 2 correc-
theprocessbywhichthescienceisapplied,however,arenotas
tive action goals based on Site-Specific Target Levels (SSTL),
welldefinedandagreeduponashumanhealthriskassessment.
Site-Specific Ecological Criteria (SSEC) or ORMC, where
Therefore, the information provided in this guide for each tier
appropriate, for complete and potentially complete exposure
evaluation for relevant ecological receptors and habitats is
pathways, including exposure pathways for which no RBSL,
general. The user is referred to Appendix X5, which provides
RESC or ORMC, as applicable, were determined;
additional information regarding the development of a RBCA
1.8.12 Compare site conditions to the Tier 2 corrective
framework for protection of ecological resources.
action goals determined to be applicable to the site;
1.8 The decision process described in this guide integrates
exposure and risk assessment practices with site assessment 1.8.13 If site conditions meet corrective action goals for
activities and remedial action selection to ensure that the chemical(s) of concern, then no further action is warranted,
´1
E2081 – 00 (2004)
1.8.14 If site conditions do not meet corrective action goals 2. Referenced Documents
for chemical(s) of concern then, one or more of the following
2.1 ASTM Standards:
actions is appropriate:
D5447 Guide for Application of a Ground-Water Flow
1.8.14.1 Further tier evaluation; Model to a Site-Specific Problem
D5490 Guide for Comparing Ground-Water Flow Model
1.8.14.2 Implement interim remedial action;
Simulations to Site-Specific Information
1.8.14.3 Design and implement remedial action to achieve
D5610 Guide for Defining Initial Conditions in Ground-
the corrective action goals.
Water Flow Modeling
1.8.15 Define Tier 3 data requirements, data quality objec-
D5611 Guide for Conducting a Sensitivity Analysis for a
tivesandcollectadditionalsite-specificinformationandupdate
Ground-Water Flow Model Application
the site conceptual model, as necessary, if further tier evalua-
D5612 Guide for Quality Planning and Field Implementa-
tion is warranted,
tion of a Water Quality Measurement Program
1.8.16 Developpoint(s)ofdemonstrationandTier3correc-
D5718 Guide for Documenting a Ground-Water Flow
tive action goals based on SSTL, SSEC, or ORMC, where
Model Application
appropriate;
D5880 Guide for Subsurface Flow and Transport Modeling
D6235 Practice for Expedited Site Characterization of Va-
1.8.17 Compare site conditions to the Tier 3 corrective
doseZoneandGroundWaterContaminationatHazardous
action goals,
Waste Contaminated Sites
1.8.18 If site conditions meet corrective action goals for
E978 Practice for Evaluating Mathematical Models for the
chemical(s) of concern, then no further action is warranted,
Environmental Fate of Chemicals
1.8.19 If site conditions do not meet corrective action goals
E1527 Practice for Environmental SiteAssessments: Phase
forchemical(s)ofconcern,thenoneofthefollowingactionsis
I Environmental Site Assessment Process
appropriate: 3
E1599 GuideforCorrectiveActionforPetroleumReleases
1.8.19.1 Implement interim remedial action to facilitate
E1689 Guide for Developing Conceptual Site Models for
reassessment of the tier evaluation;
Contaminated Sites
E1739 Guide for Risk-Based Corrective Action Applied at
1.8.19.2 Design and implement remedial action to achieve
Petroleum Release Sites
the corrective action goals.
E1903 Guide for Environmental SiteAssessments: Phase II
1.8.20 Develop and implement a monitoring plan based on
Environmental Site Assessment Process
thecorrectiveactiongoalstovalidatetheassumptionsusedfor
E1912 GuideforAcceleratedSiteCharacterizationforCon-
the tier evaluation and to demonstrate effectiveness of the
firmed or Suspected Petroleum Releases
remedial action, as applicable.
E1943 Guide for Remediation of Ground Water by Natural
1.9 For chemical release sites currently in corrective action,
Attenuation at Petroleum Release Sites
the user should review information and data available for the
site and determine the most appropriate entry point into the
3. Terminology
RBCA framework consistent with the general performance
3.1 The reader should review the definitions presented here
standards and sequence of events outlined in this guide.
prior to reviewing the guide, as many of the terms included in
1.10 This Guide is Organized as Follows— Section 2 lists
this guide may have different meanings than the specific
referenced documents, Section 3 defines terminology used in
regulatory definitions within existing federal, state or local
this guide, Section 4 describes the significance and use of this
programs.Thefollowingtermsarebeingdefinedtoreflecttheir
guide, Section 5 is a summary of the tiered approach, and
specificuseinthisguide.Theusershouldnotassumethatthese
Section 6 presents the RBCA procedures in a step-by-step
definitions replace existing regulatory definitions
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.