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ASTM E 2081 Document Information:
Title
Standard Guide for Risk-Based Corrective Action
ASTM International
Publication Date:
Apr 10, 2000
Scope:
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.
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.
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.
The general performance standard for this guide requires that:
Technical policy decisions be identified before beginning the process,
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,
Actions taken during the risk-based decision process will be
protective of human health and the
environment,
Applicable federal, state and local regulations will be followed (for
example, waste management
requirements, ground water designations, worker protection) and,
Remedial actions implemented will not result in higher risk levels
than existed before taking
actions.
ASTM standards are not federal or state regulations, they are
consensus standards that can
voluntarily be followed.
The RBCA process is not limited to a particular class of compounds.
This guide is intended to be a
companion to Guide E 1739, and does not supersede that document for
petroleum releases. If a
release site contains a mixture of releases of petroleum and other
chemicals, this guide should be
followed.
The United States Environmental Protection Agency (USEPA) has
developed guidance for human health
risk evaluation (see Appendix X8 for other resources). Many of the
components of this guidance have
been integrated into the RBCA framework. The science of ecological
evaluation and the process by
which the science is applied, however, are not as well defined and
agreed upon as human health risk
assessment. Therefore, the information provided in this guide for each
tier evaluation for relevant
ecological receptors and habitats is general. The user is referred to
Appendix X5, which provides
additional information regarding the development of a RBCA framework
for protection of ecological
resources.
The decision process described in this guide integrates exposure and
risk assessment practices with
site assessment activities and remedial action selection to ensure
that the chosen actions are
protective of human health and the environment. The following general
sequence of events is
prescribed in RBCA:
Perform an initial site assessment and develop the first iteration of
the site conceptual model. If
the information is sufficient to demonstrate that there are no
complete or potentially complete
exposure pathways, then no further action is warranted,
Evaluate the site (see definition of site 3.2.50) for response actions
(multiple sites at a single
facility may require different response actions and times),
Implement a response action that is appropriate for conditions found
at the site during the site
response action evaluation,
Define data requirements, develop data quality objectives, and perform
a site assessment for the
Tier 1 evaluation if the site conceptual model indicates that the
tiered evaluation is appropriate,
Conduct an exposure pathway analysis to determine if relevant
ecological receptors and habitats are
present and if complete and potentially complete exposure pathways are
present. If no relevant
ecological receptors or habitats or complete and potentially complete
exposure pathways exist, then
no further action for relevant ecological receptors and habitats is
warranted,
For potential human exposure pathways, identify the applicable Risk
Based Screening Levels (RBSL)
and for potential ecological exposure pathways, identify the
applicable Relevant Ecological
Screening Criteria (RESC). In addition, identify any Other Relevant
Measurable Criteria (ORMC), as
applicable. Collectively these are the Tier 1 corrective action goals
for the site;
Compare site conditions to the Tier 1 corrective action goals
determined to be applicable to the
site;
If site conditions meet the corrective action goals for chemical(s) of
concern then, no further
action is warranted,
If site conditions do not meet corrective action goals for chemical(s)
of concern then, one or more
of the following actions is appropriate:
Further tier evaluation;
Implement interim remedial action;
Design and implement remedial action to achieve the corrective action
goals.
Define Tier 2 data requirements, data quality objectives, collect
additional site-specific
information and update the site conceptual model, as necessary, if
further tier evaluation is
warranted,
Develop point(s) of demonstration and Tier 2 corrective action goals
based on Site-Specific Target
Levels (SSTL), Site-Specific Ecological Criteria (SSEC) or ORMC, where
appropriate, for complete
and potentially complete exposure pathways, including exposure
pathways for which no RBSL, RESC or
ORMC, as applicable, were determined;
Compare site conditions to the Tier 2 corrective action goals
determined to be applicable to the
site;
If site conditions meet corrective action goals for chemical(s) of
concern, then no further action
is warranted,
If site conditions do not meet corrective action goals for chemical(s)
of concern then, one or more
of the following actions is appropriate:
Further tier evaluation;
Implement interim remedial action;
Design and implement remedial action to achieve the corrective action
goals.
Define Tier 3 data requirements, data quality objectives and collect
additional site-specific
information and update the site conceptual model, as necessary, if
further tier evaluation is
warranted,
Develop point(s) of demonstration and Tier 3 corrective action goals
based on SSTL, SSEC, or ORMC,
where appropriate;
Compare site conditions to the Tier 3 corrective action goals,
If site conditions meet corrective action goals for chemical(s) of
concern, then no further action
is warranted,
If site conditions do not meet corrective action goals for chemical(s)
of concern, then one of the
following actions is appropriate:
Implement interim remedial action to facilitate reassessment of the
tier evaluation;
Design and implement remedial action to achieve the corrective action
goals.
Develop and implement a monitoring plan based on the corrective action
goals to validate the
assumptions used for the tier evaluation and to demonstrate
effectiveness of the remedial action,
as applicable.
For chemical release sites currently in corrective action, the user
should review information and
data available for the site and determine the most appropriate entry
point into the RBCA framework
consistent with the general performance standards and sequence of
events outlined in this guide.
This Guide is Organized as Follows - Section 2 lists referenced
documents, Section 3 defines
terminology used in this guide, Section 4 describes the significance
and use of this guide, Section
5 is a summary of the tiered approach, and Section 6 presents the RBCA
procedures in a step-by-step
process. Appendix X1 provides guidance on developing technical policy
decisions and building a RBCA
program, Appendix X2 provides examples of chemical properties and
effects data that may be useful
for a RBCA evaluation, Appendix X3 provides EXAMPLE development of
RBSL, Appendix X4 describes the
use of predictive modeling, Appendix X5 provides an outline of the
process of the ecological
evaluation, Appendix X6 provides information about activity and use
limitations, Appendix X7
includes illustrative examples of the application of the RBCA
framework, and Appendix X8 includes
references that may be helpful to the user. The Appendixes are
provided for additional information
and are NOT included as mandatory sections of this guide.
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