United States
            Environmental Protection
            Agency
                 Office of
                 Solid Waste and
                 Emergency Response
           Publication 9345.0-11FSI
             EPA 540/F-95/037
             PB95-963323
             January 1996	
  SERA
ECO   Update
 Office of Emergency and Remedial Response
                                  Intermittent Bulletin
                                  Volume 3, Number 1
   Ecological  Significance  and
       Selection  of Candidate
       Assessment  Endpoints
      This   Bulletin  provides
 guidance   to  Superfund  risk
 assessors   and   risk
 managers  on  planning
 ecological   risk
 assessments   (ERAs)   at
 Superfund  sites.     This
 guidance   is  based   on  the
 experience  of  the Regional
 Biological   Technical
 Advisory   Groups  (BTAGs).
 Following  the  concepts
 advocated  in   this  Bulletin
 should  result  in  ERAs  that
 will  meet  the  needs  of
 Superfund program.
      IN THIS BULLETIN
Background
               1
Ecological  Significance  and  the
Risk Assessment Process  	 2
                     Ecological   Significance  and
                     Candidate  Assessment  Endpoint
                     Selection	 3

                     Conclusion  	 4

                     Reference	 5
Glossary	  5

Background

     In a 1994 OSWER Directive (No.
9285.7-17), Assistant Administrator Elliott Laws
stressed the importance of protecting ecological
receptors at Superfund sites through the
Ecological Risk Assessment (ERA) process. The
purpose for conducting the ERA was described
as characterizing threats from chemical
contaminants to the environment and identifying
clean-up levels that will protect the ecological
receptors atrisk. The information provided in the
ERA and the Human Health Risk Assessment
complete the Baseline Risk Assessment
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conducted during the Remedial Investigation It
is important to note ihat Superfimd ERAs may be
more focused than ERAs conducted by other
programs, in that only chemical stressors are
evaluated during the baseline risk assessment
process. Superfund risk managers, however, do
consider both chemical and non-chemical (e.g.,
habitat loss due to physical disturbances)
stressors when selecting a remedial alternative
that will be ecologically protective.
       A critical element in the ERA process
requires distinguishing important environmental
responses to chemical releases from those that
are inconsequential to the ecosystem in which the
site resides: in other words, determining the
ecological significance of past, current,
or projected site-related effects. Failure to make
this distinction may result in a risk assessment that
brings little value to the decision-making process.
       For the purpose of a Superfund ERA,
investigations should focus on endpoints most
likely to be affected given the fate and transport
mechanisms of the contaminants involved, the
ecotoxicological properties of the contaminants,
the habitats at the site, and the potential
ecological receptors. Additional endpoints may
be added to assist in risk communication. The
challenge then, for the risk assessor and the risk
manager, is to structure the ERA in such a
manner that potentially ecologically significant
risks will be addressed.
Ecological Significance  and The
Ecological Risk Assessment Procesjs

       The Superfund program accepts the
approach described in the Framework for
Ecological RiskAssessment(EPA/630/R-
92/001) as an appropriate conceptual model for
the ERA process. Superfund-specific guidance
is being prepared by both the Office of
Emergency and Remedial Response (OERR) and
some Regions that will complement this generic
Agency Framework.  However, the OERR
guidance is a process document that does not
address issues such as the ecological significance
of an observed or expected effect. Due to
inherent complexities in developing site-specific
ERAs, risk managers (e.g., Remedial Project
Managers and On-Scene Coordinators) should
coordinate with Regional ecological risk
assessment teams (BTAGs).
      The issue of ecological significance must
be addressed in at least two phases of the risk
assessment process. First, during the Problem
Formulation phase, the risk assessor and the risk
Ecological  Significance   must   be
addressed  during  two  phases  of a
Superfund ERA:

•     Problem Formulation, and

•     Risk Characterization.
manager should discuss and identify ecological
attributes associated with the site that may
function as assessment endpoints, which are
defined  as  explicit  expressions of  the
environmental value that is to be protected (EPA,
1992). During these planning discussions, it is
important to keep in mind the objectives of the
risk assessment and what it seeks to achieve. A
pertinent question to ask at this juncture is how
an assessment of the proposed ecological
endpoints will help determine whether or not to
remediate the site, and if so, to what  level.
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                              ECO Update

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       The issue of ecological significance arises
again during the Risk Characterization step. At
this time, the risk assessor presents the results of
the assessment to the risk manager and the results
are in turn presented to the general public. The
risk assessor must provide an interpretation of the
assessment in the context of the questions raised
intheProblemFormulation what is ihe nature of
the risk (likelihood, duration andmagnitude) to
the receptor(s) represented by the assessment
endpoint(s),   what  is  the  anticipated
spatial/temporal extent of the threads), and at
what chemical concentration would the
contaminant(s) of concern no longer pose a
threat.

Ecological Significance and Candidate
Assessment Endpoint Selection

       During Problem Formulation, the
significance of adverse toxicological, biological,
and ecological effects to receptors is considered
as part of the process in the selection of
assessment endpoints. The BTAG considers
individual, population, and community level
assessment endpoints appropriate at Superfund
sites. Examples of receptors at these levels of
organization include:

Individual Level

•      Endangered or threatened species
       known to be present (e.g., bald eagle,
       spotted owl, gopher tortoise)

Population Level
       A sensitive fish population
       Bird  populations   exposed
       contaminants of concern
to
        Community Level -

        •      Distribution and abundance of:

               -  fish and avian communities
               -  benthic community
               -  wetland plant community
               -  soil invertebrate communities

               This list does not encompass the
        complete array of potential ecological structural
        and functional attributes that could be assessed.
        Given the state of current ecosystem models and
        the relatively small physical size of most
        Superfund sites, however, the utility of
        ecosystem-type assessments is questionable for
        Superfund ERAs.
               For Superfund ERAs, at the population
        level of organization, "lite-table" parameters (e.g.,
        mortality, fecundity, age class distributions) are
        recommended as appropriate measures of
        response. It is suggested that community
        assessment endpoints should focus on structural
        characteristics such as productivity and diversity.
               Distinguishing potential and current
        adverse effects due to releases of contaminants
        from normal fluctuations in measurable
        population- and community-level parameters is
        the most contentious and complicating issue in the
        ERA.  Natural variability (e.g., population
        During  a  Superfund  ERA,   natural
        variability inherent in the ecosystem at
        a   site  must  be  addressed  as   an
        uncertainty, and factored into  the risk
        characterization.
                                             fluctuations, changes in presence/absence of
ECO Update
                             January 1996 • Vol. 3, No. 1

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species, abundance, diversity, biomass) is a
factor that must be addressed when selecting
assessment endpoints. Due to time constraints in
the Superfund process, it is unlikely that site-
specific studies will be conducted to determine
natural variability inherent in populations
associated with Superfund sites. Consideration
of whether the observed or estimated effect is
within the range of normal variability should be
addressed as an imcertainty, and factored into Ihe
risk characterization.
      Candidate assessment endpoints Ihat are
consistent with the Superfund ERA process
include (but are not limited to) the following

Population   Level   Assessment
Endpoints

•     Survival and reproduction of fish
•     Survival, growth, and reproduction of
      fish-eating birds and mammals
                Level   Assessment
Community
Endpoints
•      Stream benthic invertebrate species
       diversity and abundance
•      Survival of soil invertebrates
•      Productivity of wetland vegetation
•      Maintenance of song-bird population^

Additionally, candidate assessment endpoints for
endangered or threatened species, individuals, or
populations should include impacts on the
following:
      Physiological status
      Reproduction
      Growth
      Development
      Morbidity and mortality
                                            Conclusion

                                                   Choosing from candidate endpoints is a
                                            challengingprocess that requires site-specific
                                            information on species, communities, and
                                            functions; the mode of action (both direct and
                                            indirect) of the released contaminants; and
                                            exposure and sensitivity of the response of the
                                            receptors. It is important that Superfund ERAs
                                            address risks that are ecologically significant and
                                            relevant to the site. Decisions to remediate sites
                                            based upon poorly-designed ERAs that do not
                                            clearly define  site-specific needs are
                                            contradictory to the intent of CERCLA and
                                            compromise the integrity of the Superfund
                                            Program.
                                                   It may be argued that any discussion
                                            regarding the significance of an effect, the
                                            significance of a specific receptor, and the
                                            societal value of remediation all fall within the
                                            purview of risk management rather than risk
                                            assessment.  While it is important to not allow
                                            Regional  BTAG   Coordinators  can
                                            work with Superfund RPMs and other
                                            project managers to select appropriate
                                            assessment endpoints for ERAs.  This
                                            process will  increase  the  chance  that
                                            the  ERA will address risks that are
                                            ecologically significant and relevant to
                                            the site.
                                            the risk management process to force the
                                            assessment process in any predetermined
                                            direction (and thus compromise the integrity of
                                            the assessment), the risk assessor and risk
                                            manager must reach agreement on the issue of
                                            assessment endpoints prior to beginning any date
January 1996 • Vol. 3, No. 1
                                                                          ECO Update

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collection activities to confirm the projected
effects. When the results of the ERA are
provided to the risk manager, the significance of
the risks to the ecosystem should be discussed,
and die role of societal value can Ihen be weighed
as an aspect of risk management. Without this
coordination, there is no way to assure that the
ERA will be useful to the risk management
decision-making process.
        The Regional BTAG Coordinators can
work with the project manager to select the
appropriate assessment endpoints for the ERA.
Establishing explicit assessment endpoints very
early in the process greatly increases  the
likelihood that a successful ERA will be
accomplished.

Reference

U.S.  Environmental  Protection  Agency,  1992.
   Framework for  Ecological Risk Assessment.
   EPA/63O/R-92/001.  Risk Assessment Forum,
   U.S.  Environmental  Protection   Agency,
   Washington, DC.
GlOSSary (adapted from EPA, 1992)
assessment endpoint - An explicit expression of
the environmental value that is to be protected.

community - An assemblage  of populations of
different  species within a  specified location in
space or time.

direct effect - An effect where the stressor acts
on the  ecological component of interest itself, not
through  effects on  other  components  of the
ecosystem (compare with definition for indirect
effect).

ecological risk assessment - The process that
evaluates the likelihood that  adverse  ecological
effects may occur or are occurring as a result of
exposure to one or more stressors.
ecosystem - The biotic community and abiotic
environment within a specified location in space
and time.

exposure - Co-occurrence of or contact between
a stressor and an ecological component.

indirect effect  - An effect where the stressor
acts on supporting components of the ecosystem,
which in turn have an effect on the ecological
component of interest.

measurement  endpoint  -  A  measurable
ecological characteristic  that is  related to  the
valued  characteristic chosen as the assessment
endpoint.    Measurement  endpoints  are often
expressed  as  the   statistical   or   arithmetic
summaries of the  observations that comprise the
measurement.

population  -  An  aggregate  of individuals  of a
species within a  specified  location in space  and
time.

risk characterization - A phase of ecological risk
assessment  that   integrates  the results  of  the
exposure  and ecological  effects  analyses  to
evaluate  the  likelihood  of  adverse  ecological
effects associated with exposure to stressor.   The
ecological significance of the adverse effects is
discussed, including consideration of the types and
magnitudes  of the  effects,  their  spatial  and
temporal patterns, and the likelihood of recovery.

stressor  - Any physical, chemical, or biological
entity that can induce an adverse response.

xenobiotic  - A  chemical or other stressor  that
does not  occur  naturally  in the environment.
Xenobiotics  occur  as a result of anthropogenic
activities such as  the application of pesticides  and
the discharge of industrial chemicals to air, land, or
water.
ECO Update
                       January 1996 • Vol. 3, No. 1

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