EPA/630/R-94/003
                                                  July 1994
A REVIEW OF ECOLOGICAL ASSESSMENT CASE STUDIES

       FROM A RISK ASSESSMENT PERSPECTIVE


                     VOLUME H
                 Risk Assessment Forum
           U.S. Environmental Protection Agency
                 Washington, DC 20460
                                           Printed on Recycled Paper

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                                      DISCLAIMER

       This document has been reviewed in accordance with U.S. Environmental Protection
Agency policy and approved for publication. Mention of trade names or commercial products does
not constitute endorsement or recommendation for use.  Case study data and interpretations were
current as of the peer review workshops held in the fall of 1992.

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                                    CONTENTS

 Foreword	  	             jv

 Report. Contributors	.  . . .  .	           .  . .  v

 Summary	    ........      vi

 PART I.   CASE STUDIES OVERVIEW	   1

       1.  Introduction	   1

      2.  Guide to the Case Studies	  .  	   2

          2.1. Background	,	   2
          2.2. Case Study Highlights	   2

              2.2.1. Problem Formulation	   5
              2.2.2. Analysis	 .	   7

                    2.2.2.1.  Characterization of Exposure	 .   7
                    2.2.2.2.  Characterization of Ecological Effects	   8

              2.2.3. Risk Characterization   .	  9

      3.  Key Terms	         •..•„..   12

      4.  References	              13

PART II.   THE CASE STUDIES	; . .   14

      1.   Assessing the Ecological Risk of a New Chemical Under the Toxic Substances
          Control Act (Short Title:  New Chemical Case Study)  	  1-1

      2.  Risk Assessment for the Release of Recombinant Rhizobia at a Small-Scale
         Agricultural Field Site (Recombinant Rhizobia Case Study)  	  2-1

      3.  Ecological Risk Assessment of Radionuclides in the Columbia River System—
         A Historical Assessment (Radionuclides Case Study)  	  3-1

      4.  Effects of Physical Disturbance on Water Quality Status and Water Quality
         Improvement Function of Urban Wetlands (Wetlands Case Study)   .	  4-1

      5.  The Role of Monitoring in Ecological Risk Assessment:  An EMAP Example
         (EMAP Case Study)  .	  5-1
                                        in

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                                       FOREWORD

       Since 1990, the Risk Assessment Forum of the U.S. Environmental Protection Agency
(EPA) has sponsored activities to improve the quality and consistency of EPA's ecological risk
assessments.  Projects have included development of Agencywide guidance on basic ecological risk
assessment principles (Framework Report, U.S.  EPA, 1992) and evaluation of 12 ecological
assessment case studies from a risk perspective  (U.S. EPA, 1993).  To complement this original set
of case studies, several new case studies were recently evaluated to provide further insight into the
ecological risk assessment process.

       As with the original case studies, each of the five new case studies was evaluated by
scientific experts at EPA-sponsored workshops.  Two workshops were held in September 1992 (57
Federal Register 38504, August 25,1992); these workshops were chaired by Dr. Charles Menzie
and included reviewers from universities, private organizations, and industry.

       The new case studies expand the range of the first case study set by including different
kinds of stressors  (radionuclides, genetically engineered organisms, and physical alteration of
wetlands) and programmatic approaches (premanufacture notice assessments under the Toxic
Substances Control Act and the  EPA's Environmental Monitoring and Assessment Program).  In
addition, the authors and reviewers of the new case studies were able to use EPA's Framework
Report as background information. Both sets of case studies provide useful perspectives concerning
application of ecological risk assessment principles to "real world" problems.
                                                 Dorothy E. Patton, Ph.D.
                                                 Chair
                                                 Risk Assessment Forum
                                            IV

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                               REPORT CONTRIBUTORS

       Dr. William van der Schalie (EPA) and Dr. Charles Menzie (Menzie-Cura & Associates,
Inc.) prepared this report.  Mr. Thomas Waddell and Mr. James Morash (The Cadmus Group)
provided review comments on the draft case studies, and Mr. Morash also edited the case studies
following their revision after the workshops.  The workshops were organized by Dr. van der
Schalie and Mr. Waddell, with the assistance of Dr. Menzie and Ms. Deborah Kanter of Eastern
Research Group. Case study authors and peer reviewers are listed at the beginning of each case
study (part II).  R.O.W. Sciences, Inc., under the direction of Ms.  Kay Marshall, provided
editorial assistance in the preparation of this report.   The Cadmus Group, Eastern Research Group,
Menzie-Cura & Associates, and R.O.W. Sciences, Inc., were EPA contractors or subcontractors
for this effort.

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                                         SUMMARY

       As with the previous case studies report (U.S. EPA, 1993), this document uses case studies
to explore the relationship between the ecological risk assessment process and approaches used by
EPA (and others) to evaluate adverse ecological effects.  In contrast to the earlier report, the
authors and reviewers of these case studies were able to use EPA's Framework for Ecological Risk
Assessment (Framework Report, U.S. EPA, 1992) as background information.  However, even
though the case studies have been structured as described in the Framework Report, most were not
originally planned and conducted as risk assessments. This should be kept in mind when
considering each case study's strengths and limitations.

       Some of the contributions of the case studies in this report to a broader understanding of
the ecological risk assessment process are highlighted below.

       •      The application of the framework  approach to nonchemical stressors is explored.
               Examples include biological stressors (genetically engineered microorganisms),
               physical stressors (alteration of wetland function by a variety of physical
               disturbances), and radioactivity (radionuclides in water).

       •      The relationship of ecological risk assessment to a major EPA monitoring program
               (Environmental  Monitoring and Assessment Program—EMAP) is described.

       •      Regional scale assessments (EMAP, wetlands) are included.

       •      Conducting an ecological risk assessment in a tiered fashion starting with minimal
               exposure and effects data is illustrated by the premanufacture notice (PMN) review
               carried out under the Toxic Substances Control Act.

       While these cases are representative of the state of the practice in ecological assessments,
they should not be regarded as  models to be followed.  Rather, they should be used to attain a
better understanding of ecological risk assessment practices and principles.  These case studies and
others being prepared will be used along with the Framework Report to provide a foundation for
future Agencywide  guidelines for ecological risk assessment.
                                              VI

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                          PART I.  CASE STUDIES OVERVIEW
1.  INTRODUCTION
       .In 1990, the Risk Assessment Forum initiated an effort to develop Agencywide guidance for
conducting ecological risk assessments.  This effort consists of several parts, as described below.

       •     Basic principles and terminology for ecological risk assessment are described in the
              report Framework for Ecological Risk Assessment (Framework Report) that was
              published in 1992 (U.S. EPA, 1992).   • -I

       «     Scientific/technical background information for development of future EPA
              ecological risk assessment guidelines will be contained in a series of issue papers
              based on the Framework Report that are now in preparation.

       •     Case studies are being developed to provide "real world" examples of how
              ecological risk assessments can be conducted. The first set of 12 case studies has
              been published (U.S. EPA, 1993).

       This report includes five additional case studies that have been peer-reviewed and organized
according to the ecological risk assessment process as described in the Framework Report.  As with
the first case studies report, this document should be useful to EPA regional, laboratory, and
headquarters personnel conducting ecological risk assessments, as well as to interested individuals
from other federal and state agencies and the general public.  The Risk Assessment Forum plans to
continue development of other case studies as a means of illustrating the application of ecological
risk assessment principles.

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2.  GUIDE TO THE CASE STUDIES

2.1.  Background

       The case studies presented in part n of this report illustrate several types of ecological
assessments.  As summarized in table 1, these cases involve:

       •      studies done under several different federal environmental laws;

       •      spatial scales ranging from local impacts to national impacts;

       •      different types of stressors (chemical, physical, and biological);

       •      a variety of ecosystems, including aquatic (freshwater and marine), wetlands, and
              terrestrial; and

       *      measurement endpoints reflecting different levels of biological organization, ranging
              from effects on individual organisms up to and including effects on ecosystems.
              (See part I, section 3 for definitions of measurement and assessment endpoints.)

       These case studies expand the range of the first case study set (U.S. EPA, 1993) by
including different kinds of stressors (radionuclides, genetically-engineering organisms, and physical
alteration of wetlands) and programmatic approaches (Pre-Manufacture Notice assessments under
the Toxic Substances Control Act and the EPA's Environmental Monitoring and Assessment
Program).

2.2.  Case Study Highlights

       This section highlights some common themes and principles gleaned through development
and review of these case studies. This section is organized according to the framework for
ecological risk assessment provided in the Framework Report (U.S. EPA, 1992) (see figure 1):

       •      Problem formulation, which is a preliminary scoping process;

       •      Analysis, which includes characterization of both ecological effects and
              exposure; and

       »      Risk characterization, which highlights qualitative and quantitative conclusions,
              with special emphasis on data limitations and other uncertainties.

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Table 1.  Case Study Characteristics
No."
1
2
3
4
5
Short Title
New Chemical
Recombinant
Rhizobia
Radionuclides
Wetlands
EMAP
Relevant
Federal
Legislation1"
TSCA
TSCA
CERCLA/SARA,
CWA
CWA, EWRA
-
Spatial
Scale of
Assessment
National
Local
Local
Regional
Regional
Stressor
Type'
SC
B
CM
P, CM
P,CM
Ecosystem
Typed
A/F
T
A/F
W.A/F
A/M
Level of
Biological
Organization0
Individual
Individual
Individual
Ecosystem
Community
" Numbers 1-5 refer to the sections of part n of this report

b Legislation

  CERCLA/SARA: Comprehensive Environmental Response, Compensation, and Liability Act (1980)/
                  Superfund Amendments and Reauthorization Act (1987)
  CWA:           Clean Water Act (1977)
  EWRA:          Emergency Wetlands Resources Act (1986)
  TSCA:          Toxic Substances Control Act (1976)

c Stressor types

  B:     Biological                                     ;                  ,
  CM:   Mixture of chemicals
  P:     Physical Stressor
  SC:   Single chemical

d Ecosystem types

  A/F:   Aquatic—freshwater
  A/M:  Aquatic—marine or estuarine
  T:     Terrestrial :     •.
  W:    Wetlands

e Highest level of biological organization for the measurement endppints used.

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  Discussion
  Between the
 Risk Assessor
     and
 Risk Manager
   (Planning)
                       Ecological Risk Assessment
                                                i
                                  Characterization  ' Characterization
                                       of
                                     Exposure
|
   of
Ecological
 Effects
                                                                  '','
                            .~             ,,
                         RISK CHARACTERIZATION
                        '                    '
Data Acquisition; Ver
on and Monitoring
                                                                                 t
                                     Discussion Between the
                                  Risk Assessor and Risk Manager
                                           (Results)
                                       Rjsk Management'
Figure 1.  The framework for ecological risk assessment (U.S. EPA, 1992).  The ecological
          risk assessment framework is the product of a series of workshops and reviews that
          involved both EPA and outside scientists.  While the Framework Report has been a
          critical first step in developing ecological risk assessment concepts, evolution of the
          framework concepts is expected and encouraged.
                                          4

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       2.2.1.  Problem Formulation

       Problem formulation is an initial planning and scoping process for defining the feasibility,
breadth, and objectives for the ecological risk assessment. The process includes preliminary
evaluation of exposure and effects as well as examination of scientific data and data needs,
regulatory issues, and site-specific factors.  Problem formulation defines the ecosystems potentially
at risk, the stressors, and the measurement and assessment endpoints.  This information then may be
summarized in a conceptual model, which hypothesizes how the stressor may affect the ecological
components (i.e., the individuals, populations, communities, or ecosystems of concern).

       Two of the most important themes that emerged ;from a review of the 12 case studies (U.S.
EPA, 1993) and that were clearly evident in the review of the five case studies presented in this
document are as follows:

       •     Thorough formulation of the problem and development of the scope are essential
              first steps for a successful risk assessment.

       •     It is important to clearly articulate management issues at the beginning of an
              assessment.

       The strengths and limitations of the case studies '• often were related to the care  taken in
formulating the problem and articulating management issues at the beginning of the assessment.
Examples in this set of case studies that demonstrate careful implementation of these steps include
the New Chemical and Radionuclides case studies.
Monitoring Programs
Can Provide Data
Useful for Problem
Formulation
The ElMAP case study was unique in that it illustrated how monitoring
data can be used at the problem formulation stage of an assessment.
As indicated in figure 1, data acquisition and verification and
monitoring provide information that supports  all phases of ecological
risk assessment. The EMAP Near Coastal program in the Virginia
Biogeographic Province is an example of a provincewide monitoring
program in which data are collected using a systematic, probability-
based design that facilitates detection of spatially distributed events but
does not estimate intraannual variability or short-term episodic events.

The monitoring program obtains data throughout the province on a
variety of exposure and effects indicators. The indicators were chosen
based on past monitoring experience with regard to environmental
conditions in coastal systems.  Associations between exposure  and
effects indicators imply neither causality nor direct effects from
anthropogenic  stressors.  As noted in the EMAP case study, "It is
important to recognize that monitoring data alone will not be sufficient
for establishing the causal relationships necessary for developing a
complete analysis of ecological risk."  Taken along with other
evidence, however, associations between exposure and effects

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                           indicators can be used to direct further study and to aid in problem
                           formulation.
The Framework Can
Be Applied to Such
Diverse Stressors as
Radionuclides and
Genetically Engineered
Organisms
Iterative Approaches
Are Useful for Defining
Problems and
Allocating Resources
The EMAP case study also illustrates how information obtained from
provincewide monitoring can be used in the problem formulation
phase for more local or regional risk assessments.  The monitoring
tools and the design employed within EMAP can be applied to these
smaller spatial scales.

The previous review of 12 case studies (U.S. EPA, 1993) indicated
that the framework can be applied to chemical and physical stressors.
This was demonstrated further with the present set of five case studies,
which includes assessments of the environmental release of a new
chemical substance and physical modifications of wetlands.  The
Radionuclides case study showed that the framework is applicable to
radionuclides as well as to hazardous chemicals.

The authors and reviewers of the case study on the release of
recombinant rhizobia, a genetically engineered organism, concluded
that application of the framework to microbial stressors is possible.  It
was generally agreed, however, that  the unique properties and
complexities of a living, changing stressor should be acknowledged in
the framework and in subsequent case studies with a similar focus.
Stressors potentially associated with  the rhizobia were characterized as
either biological (i.e., pathogenicity,  altered legume growth, microbial
competition, and gene release) or chemical (i.e., toxins and detrimental
metabolites); the reviewers of the case study found this to be a useful
approach. The case study authors found it difficult to select endpoints
and to decide whether these represented assessment or measurement
endpoints.

As noted in the Framework Report (U.S. EPA, 1992), ecological risk
assessments are frequently iterative,  with data collection and analysis
performed in tiers of increasing complexity and cost The New
Chemical case study illustrates this process. Ecological risk
assessments are conducted for new chemical substances under the
Toxic Substances Control Act in EPA's Office of Pollution Prevention
and Toxics (OPPT).  In these assessments, there is a progression from
a simple screening approach to more resource-intensive evaluations
based on the results of the simpler analysis, consideration of associated
uncertainties, and identification of data gaps.   The  authors note that
because of the large number of PMNs received annually by OPPT, the
only practical approach is to use conservative  screening estimates
initially and to proceed to more detailed assessments 'only when
necessary.

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All Important Exposure
Scenarios Should Be
Considered
Exposure routes should be carefully considered during problem
formulation to ensure that the risk assessment is properly focused.
For example, in two of the case studies, the reviewers suggested that
additional routes of exposure could have been included in the risk
assessments.  In the New Chemical case study, exposure to suspended
sediments was suggested, while in the Radionuclides case study,
potential uptake from food could have been evaluated in addition to
direct uptake from water.
       2.2.2.  Analysis
       Analysis includes the technical evaluation of data on both potential exposure to stressors
(characterization of exposure) and the effects of stressors (characterization of ecological effects).
Characterizing exposure involves predicting or measuring the spatial and temporal distribution of a
stressor and its co-occurrence, or contact, with the ecological components of concern; <      8
characterizing ecological effects involves identifying and quantifying the effects elicited by a
stressor and, to the extent possible, evaluating cause-and-effect relationships.

       2.2.2.1.  Characterization of Exposure
Models Provided Useful
Tools for
Characterizing
Exposure
 "ReaUty Checks" Are
Important for Exposure
Estimates Based on
Models
As with the previous compendium of case studies, this set
demonstrates that simple as well as more complex models can help to
characterize the exposure field.  Selection of models should be based
on the goals of the assessment as well as the availability of data and
resources.  In the New Chemical case study, a simple dilution model
was  initially used to estimate exposure concentrations in receiving
water. Based on the results from this model, which showed that
exposures could result in risk to aquatic organisms, a more complex
model was used to provide a more accurate but less conservative
estimate of exposure.    ;

While exposure models  can be useful, some degree of model
verification is important to reduce uncertainty.  The Radionuclides
case study used a bioaccumulation model to estimate dose. When the
predicted doses were checked against a set of measurements, the
model was found to be conservative in some respects.  The reviewers
observed that exposure may not be reliably predicted from
radionuclide activity in water, given the high variance found in
bioconcentration factors. In the ReCombinant Rhizobia  case study,
field measurements conducted after the risk assessment  was completed
verified the literature-based predictions concerning off-site migration
of the rhizobia microorganisms.

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 Evaluating Exposure to
 Genetically Engineered
 Organisms Poses
 Special Problems
 Biological stressors were not addressed in the Framework Report, but
 are the subject of the Recombinant Rhizobia case study, which
 highlights some of the difficulties associated with predicting and
 monitoring the spread of a stressor that is a living organism. Exposure
 evaluation is most challenging because of the organism's capacity to
 interact with its environment and to evolve.  Moreover, because it is
 capable of growth and reproduction, the stressor can increase in
 amount over time as compared with amounts of chemical stressors,
 which are either conservative or decrease with time and/or distance
 from sources.
        2.2.2.2. Characterization of Ecological Effects
Effects Information Is
Developed From
Predictive Methods,
Literature Values,
Laboratory Studies, and
Field Programs
Most Effects
Information Is
Developed for
Individual Organisms
in Single-Species Tests
Multiple Stressors
Complicate Evaluations
of Causality
The case studies demonstrate the range in sources of information used
for characterizing ecological risks. The Radionuclides case study and
the Wetlands case study relied primarily on existing guidelines or
literature values to characterize effects. The potential effects of
rhizobia were based on greenhouse studies, while the EMAP case
study used a suite of field studies. The New Chemical case study
utilized quantitative structure-activity relationships (QSARs) based on
molecular weight and log K^ as one source of information concerning
toxicity. QSAR methods were particularly useful in this application
given the large number of PMNs that need to be evaluated by EPA.
This case study also relied on laboratory bioassays.  The author noted
that larger-scale studies (e.g., of mesocosms) have not been used   •
routinely because of cost considerations.  Nonetheless, OPPT is
initiating field mesocosm studies to evaluate the use of laboratory tests
for predicting effects in the field.

Most of the effects  information presented in the case studies is based
on small groups of organisms tested as individual species.  Because
effects data on  mortality, growth,  and reproduction are developed for
the individual, there is a general lack of information on effects at the
population  level.  Assessment endpoints, however, often are expressed
in terms of populations or communities of organisms.  Similarly, data
from single species of organisms are used to derive stressor levels that
will be protective of communities or ecosystems, without consideration
of indirect  effects or interspecies interactions. The use of such
extrapolations is a continuing area of controversy and discussion in
ecological risk assessment.

Individual stressors  do not occur in a vacuum in the real world.
Rather, accompanying the stressor of interest may be a host of other
chemical, biological, or physical stressors that may alter or.confound
the effects  and risks associated with the subject stressor. Thus the
EMAP case study noted that results of monitoring do not necessarily

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                           indicate causality.  Reviewers of the New Chemical case study noted
                           that the effects of the chemical could depend on the presence of other
                           chemicals in a complex effluent.  While the Radionuclide case study
                           concluded that radionuclides posed little risk to important fish species
                           in the Columbia River, the limited scope of the case precluded
                           consideration of other chemical and physical stressors that may pose a
                           much higher risk to fish populations.  The Wetlands case study
                           examined the effects on wetland water quality status of a range of
                           stressors, including physical and hydrologic disturbances and loss or
                           conversion of wetland habitat.  Several stressors were present at most
                           of the study  sites.  A multiple regression approach was used to relate
                           the effects of different stressors to water quality impacts.

       2.2.3.  Risk Characterization

       Risk characterization uses  the results of the exposure and ecological effects analyses to
evaluate the likelihood that adverse ecological effects are occurring or will occur in association
with exposure to a stressor. Essentially, a risk characterization highlights summaries  of the
assumptions, scientific uncertainties, and strengths and weaknesses of the analyses.  Additionally, a
risk characterization evaluates the ecological significance of the risks with consideration of the
types and magnitudes of the effects, their spatial and temporal patterns,  and the likelihood of
recovery.
Most of the Case
Studies Used the
Quotient Method to
Integrate Exposure and
Effects Estimates
 Risks to Populations
 Were Qualitatively
 Discussed
The Quotient Method was used in three of the five case studies:  New
Chemical, Wetlands, and Radionuclides.  While the Quotient Method
does not measure risk in terms of a likelihood of effects at the
individual or population level, it does provide a simple benchmark for
judging risk potential. As such, it has been widely used.  The most
common application of the Quotient Method in aquatic ecological risk
assessments is to compare an estimate of a maximum exposure
concentration to a water quality criterion for a chemical. While
reliance on the Quotient Method in the present set of case studies is
consistent with the previous set of 12 case studies (U.S. EPA, 1993),
development and use of other ecological risk integration techniques
that can provide actual risk estimates should be encouraged. When
the Quotient Method is used, at least a qualitative description of key
study uncertainties and limitations should be provided.

Both the previous and present set of case studies made only limited
attempts at directly estimating population-level risks.  Typically, risks
are assessed at the individual level, and  population-level risks then are
inferred from the presence of risks to individuals.  It is indeed
probable that when estimates indicate little or no risk to individuals,
there is little or no risk to the population. However, when there are
risks to individuals, there may or may not be risks to the population.
Thus the extrapolation from risks to individuals to risks to populations

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                            is frequently discussed as an area of uncertainty within the risk
                            assessments.
 Stressor-Response
 Models Are Useful in
 Both Predictive and
 Retrospective
 Assessments
Major Sources of
Uncertainty Should Be
Identified
A Weight-of-Evidence
Approach Can Be
Useful in Risk
Assessments
 The previous set of risk assessments (U.S. EPA, 1993) illustrated the
 value of stressor-response models in quantitative risk assessment.  In
 the present set, the Wetlands case study used regression techniques to
 develop stressor-response models for water quality impacts resulting
 from a wide range of physical stressors.  The reviewers of this case
 study noted that this empirical statistical model was a key feature of
 the case study and provided a predictive component. However,
 because this model is based on a particular set of physical and
 hydrological characteristics, predictions of the model may or may not
 be applicable to other urban wetlands.

 The EMAP case study was retrospective in nature because it examined
 the relationship between indicators of the status of ecological resources
 and an array of stressors. Although this case study was not a risk
 assessment, it clearly showed that an understanding of stressor-
 response relationships would be an important component of any future
 risk assessment that evaluated the causal links between sources,
 stressors, and observed effects.

 Uncertainties associated with the use of available data for risk
 assessments were mentioned in most of the case studies.  The New
 Chemical case study described the use of fixed "assessment factors" to
 deal with extrapolations between different types of data. The EMAP
 case study cautioned against assuming causality based on apparent
 associations derived from monitoring exposure and effects indicators.
 The authors and reviewers of the case studies frequently pointed out
 potential problems in extrapolating between species and from the
 laboratory to the field, in accounting  for the combined effects of
 multiple stressors,  and in interpreting the results of field tests.
 Although it is important to identify the major sources of uncertainty in
 a risk assessment, the presence of uncertainty does not necessarily
 preclude use of the risk assessment for risk management decisions.

 The availability of multiples sources of information can help to
 strengthen a risk estimate even when individual lines of evidence are
not conclusive. For example, in the Recombinant Rhizobia case study,
the reviewers felt that the data from the greenhouse studies and field
tests by themselves were not convincing.  However, the availability of
information characterizing the rhizobia strains and documenting the
effects of previous releases of other rhizobia helped strengthen the
overall risk assessment conclusion that the small-scale field test of the
recombinant rhizobia should proceed. The EMAP case study also uses
a weight-of-evidence approach in problem formulation (not risk
                                             10

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formulation (not risk characterization).  Stressor and effects
information derived from the monitoring program are used to identify
areas of greatest concern that may be candidates for ecological risk
assessment.
                  11

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3.   KEY TERMS (U.S. EPA, 1992)

assessment endpoint—An explicit expression of the environmental value that is to be protected.

characterization of ecological effects—A portion of the analysis phase of ecological risk assessment
       that evaluates the ability of a stressor to cause adverse effects under a particular set of
       circumstances.

characterization of exposure—A portion of the analysis phase of ecological risk assessment that
       evaluates the interaction of the stressor with one or more ecological components.  Exposure
       can be expressed as co-occurrence or contact, depending on the stressor and ecological
       component involved.

conceptual model—The conceptual model describes a series of working hypotheses  of how the
       stressor might affect ecological components.  The conceptual model also describes the
       ecosystem potentially at risk, the relationship  between measurement and assessment
       endpoints, and exposure scenarios.

ecological component—Any part of an ecological system,  including individuals, populations,
       communities,  and the ecosystem itself.

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.

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

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.

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 a 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.
                                              12

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4.  REFERENCES

U.S. Environmental Protection Agency.  (1992) Framework for ecological risk assessment.  Risk
       Assessment Forum, Washington, DC. EPA 630/R-92/001.

U.S. Environmental Protection Agency.  (1993) A review of ecological assessment case studies
      from a risk assessment perspective. Risk Assessment Forum, Washington, DC.
       EPA/630/R-92/005.                                         .......
                                          13

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                              PARTH.  THE CASE STUDIES
       Authors of the case studies
included in this section were asked to
follow the format shown in the box on
the right. As you read the case
studies, it is important to keep several
points in mind:

•      The original case studies
       were not necessarily
       developed as risk assessments
       as defined in the Framework
       Report.  EPA notes that the
       case studies are often partial
       risk assessments that focus on
       available information without
       discussing other relevant
       considerations such as the
       uncertainties defined by a
       limited data base.

       At the workshops, each case
       study was evaluated as  to
       whether it (1) effectively
       addressed the generally
       accepted components of an
       ecological risk assessment, or
       (2) addressed some but not all
       of these components or,
       instead, (3) provided an
       alternative approach to
       assessing ecological effects.
         Case Study Format

 Abstract. The abstract summarizes the
 major conclusions, strengths, and limitations
 of the case study.

 Risk Assessment Approach. This section
 clarifies any differences between the
 ecological risk assessment approach used in
 the case study and the general process
 described in the Framework Report.

 Statutory and Regulatory Background.  The
 statutory requirements for the study are
 described along with any pertinent
 regulatory background information.

 Case Study Description.  This  contains the
 background information and objective for the
 case study, followed by the technical
 information organized according to the
 ecological risk assessment framework:
problem formulation, analysis
 (characterization of exposure and
characterization of ecological effects), and
risk characterization. A comment box is
included at the end of each major section.

References.
      The strengths and limitations of each case study are highlighted in comment boxes at
      the end of the problem formulation, analysis, and risk characterization sections.
      Author's comments address issues raised in the preceding text or reviewer remarks from
      the peer review of the case study.  Reviewers' comments include strengths, limitations, and
      general observations concerning the case studies.

      The authors who compiled the case studies did not necessarily conduct the research
      upon which the case studies are based.  References to the original research are provided
      in each case study.
                                            14

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       The general characteristics of the case studies are summarized in table 1 (in part I). Case
studies are referenced by the section of this report in which they appear. (The corresponding short
titles of the case studies are given in table 1).
                                               15

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                 SECTION ONE
     ECOLOGICAL RISK ASSESSMENT CASE STUDY:
ASSESSING THE ECOLOGICAL RISKS OF A NEW CHEMICAL
    UNDER THE TOXIC SUBSTANCES CONTROL ACT

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                               AUTHORS AND REVIEWERS
 AUTHORS

 David G. Lynch
 Office of Pollution Prevention and Toxics
 U.S. Environmental Protection Agency
 Washington, DC

 Gregory J. Macek
 Office of Pollution Prevention and Toxics
 U.S. Environmental Protection Agency
 Washington, DC

 J. Vincent Nabholz
 Office of Pollution Prevention and Toxics
 U.S. Environmental Protection Agency
 Washington, DC

 COMPILED BY

 Donald Rodier
 Office of Pollution Prevention and Toxics
 U.S. Environmental Protection Agency
 Washington, DC

 REVIEWERS

 Richard E. Purdy (Lead Reviewer)
 Environmental Laboratory
 3-M Company
 St. Paul, MN

 Gregory R. Biddinger
 Exxon Biomedical Sciences, Inc.
 East Millstone, NJ

 Joel S. Brown
 Department of Biological Science
 University of Illinois at Chicago
 Chicago,  IL

Robert J. Huggett
Virginia Institute of Marine Science
The College of William and Mary
Gloucester Point, VA
 Scott M. Sherlock
 Office of Pollution Prevention and Toxics
 U.S. Environmental Protection Agency
 Washington, DC

 Robert Wright
 Office of Pollution Prevention and Toxics
 U.S. Environmental Protection Agency
 Washington, DC       '.
Freida B. Taub
School of Fisheries
University of Washington
Seattle, WA

Richard Weigert
Department of Zoology
University of Georgia
Athens, GA
                                           1-2

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                                  CONTENTS

ABSTRACT	  1-7

1.1. RISK ASSESSMENT APPROACH ................... . . .  . . .  . ......  1-8

1.2. STATUTORY AND REGULATORY BACKGROUND . ...... . . ...........  1-8

1.3. CASE STUDY DESCRIPTION	 .	..-. ... . .  . . .	   1-11

    1.3.1. Background Information and Objective	   1-12

          1.3.1.1. Chemistry Report	   1-12
          1.3.1.2. Engineering Report *.. j .....:.'	   1-12
          1.3.1.3. Environmental Exposure Assessment	   1-12
          1.3.1.4. Ecological Hazard Assessment	   1-12
          1.3.1.5. Ecological Risk Assessment	  .	   1-13

    1.3.2. Problem Formulation	   1-13

          1.3.2.1. Stressor Characteristics	   1-13
          1.3.2.2. Ecosystem Potentially at Risk  ...	:...;... .  , ... . .  , .   1-13
          1.3.2.3. Ecological Effects	 ,.. .... ........ ... .   1-13
          1.3.2.4. Assessment Endpoints	........:....   1-15
          1.3.2.5. Measurement Endpoints ... . . . . . . . . . , . ... . .  .........   1-15
          1.3.2.6. Conceptual Model		 .   i-15

    1.3.3. Analysis, Risk Characterization,  and Risk Management—1st Iteration   	   1-17

          1.3.3.1. Analysis:  Characterization of Exposure	   1-17
          1.3.3.2. Analysis:  Characterization of Ecological Effects	   1-18
          1.3.3.3. Risk Characterization	 . .	   1-19
          1.3.3.4. Risk Management	 .   1-20

    1.3.4. Analysis, Risk Characterization,  and Risk Management—2?d Iteration	   1-21

          1.3.4.1. Characterization of Ecological Effects	 .   1-21
          1.3.4.2. Characterization of Exposure	   1-21
          1.3.4.3. Risk Characterization	   1-21
          1.3.4.4. Risk Management	 .  ...  4 ... r ....   1-22

    1.3.5. Analysis, Risk Characterization,  and Risk Management—3rd Iteration   	   1-23

          1.3.5.1. Characterization of Ecological Effects   .........:......,,.   1-23
          1.3.5.2. Characterization of Exposure . .	 . .  . . .........  . .   1-24
                                      1-3

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                               CONTENTS (continued)

           1.3.5.3.  Risk Characterization: Risk Estimation and Uncertainty Analysis  . . .  1-24
           1.3.5.4.  Risk Management	  1-24

     1.3.6.  Analysis, Risk Characterization, and Risk Management—4th Iteration  	  1-24

           1.3.6.1.  Characterization of Exposure	  1-24
           1.3.6.2.  Risk Characterization	 ,	  1-24
           1.3.6.3.  Risk Management	  1-25

     1.3.7.  Analysis, Risk Characterization, and Risk Management—5th Iteration  	  1-25

           1.3.7.1.  Characterization of Exposure	  1-25
           1.3.7.2.  Risk Characterization—Risk Estimation	  1-25

     1.3.8.  Risk Management—Final Decision	  1-27

1.4.  REFERENCES		  1-33

APPENDIX A—QSARS BETWEEN NEUTRAL ORGANIC CHEMICALS
     AND FISH AND GREEN ALGAL TOXICITY  	  1-A1

APPENDIX B—INPUT AND OUTPUT PARAMETERS FOR EXAMS II	  1-B1
                                        1-4

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                                LIST OF FIGURES




Figure 1-1.  Structure of assessment for effects of a PMN substance ..... . . .........  1-9




Figure 1-2.  Flow chart and decision criteria for the ecological risk assessment of a

           PMN substance .,..'.. . . ;. . . . , . . 	 . .  . . . , ; ... ............  1-10


                                                i               t.      ,



                     : '"'   V      LIST OF TABLES   •—•'"..:';  '-'"-        ;




Table 1-1.  Physical/Chemical Properties of PMN Substance	  1-14




Table 1-2.  PECs for PMN Substance G*g/L)  . . . . . ....!... .".''../..........  1-19




Table 1-3.  PMN Substance Stressor-Response Profile  ........... . . . . ../.!...  1-20




Table 1-4.  Summary of Five Risk Characterization Iterations  . . . . . . . . .... .;. .... . .  i-21




Table 1-5.  PDM3 Analysis  . . .  ./.'. . . .	 . /.  . ... . f. . ... . .\. . . ; . .  1-23




Table 1-6.  (Estimated)  Stresspr-Ressponse Profile for Benthic Organisms . ..'. . . .;. ; . . . .  1-23




Table 1-7.  EXAMS II Analysis	 ... . ..........	  1-24
                     ' "*"           -                 "                ....



Table 1-8.  Stressor-Response Profile for Chironomus tentans	  1-26






                            LIST OF COMMENT BOXES




Comments on Problem Formulation	  1-16




Comments on Characterization of Exposure	  1-27




Comments on Characterization of Ecological Effects		  1-28




Comments on Risk Characterization  .	  1-30
                                        1-5

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  CBI




  CC




  ChV




  CSRAD
 EEB




 EETD




 EXAMS H




 HERD
 K™
 MATC




 OPPT




 PDM3




 PEC




 PMN




 QSAR




 SAR




 SNUR




POTW
               LIST OF ACRONYMS



  confidential business information



  concern concentration



  chronic value




  Chemical Screening and Risk Assessment Division



  median effect concentration



  Environmental Effects Branch




  Economics, Exposure and Technology Division



  exposure  analysis modeling system




 Health and Environmental Review Division




 soil/sediment organic carbon-water partition coefficient



 octanol-water partition coefficient



 median lethal concentration




 maximum acceptable toxicant concentration



 Office of Pollution Prevention and Toxics



 probabilistic dilution model




 predicted environmental concentration



 premanufacture notice




 quantitative structure-activity relationship



 structure activity relationship



 significant new use rule



publicly owned treatment works
                                           1-6

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                                         ABSTRACT

       This case study is an example of how the Office of Pollution Prevention and Toxics
(OPPT) conducts ecological risk assessments for new chemical substances.  The Toxic Substances
Control Act requires manufacturers and importers of new chemicals to submit a premanufacture
notice (PMN) to EPA 90 days before they intend to begin manufacturing or importing.  Because
actual test data are not required as part of a PMN submission, EPA uses structure-activity
relationships to estimate both ecological effects and exposure.

       The PMN substance is a neutral organic compound.  This class of compounds elicits a
simple form of toxicity known as narcosis.   The toxicity of neutral organic compounds can be
estimated through quantitative structure-activity relationships, which correlate toxicity with
molecular weight and the octanol-water partition coefficient (log Kow).  The subject PMN substance
has a log K,,w of 6.7.  Compounds with such a log K,,w are not expected to be acutely toxic (no
effects at saturation over short exposure durations) but are expected to elicit chronic effects.
Actual testing of the PMN substance confirmed these predictions.

       The manufacturer identified processing, use,  and disposal sites adjacent to rivers and
streams.   Because it was expected that the PMN. substance would be discharged to such
environments, pelagic and benthic aquatic populations and communities were considered to be
potentially at risk. Therefore,, the assessment, endpoint used in this case study was the protection of
aquatic organisms (e.g.,  algae, aquatic invertebrates, and fish).  Measurement endpoints used to
evaluate the risks to the assessment endpoint were mortality, growth and development, and
reproduction.

       Initial exposure concentrations were  estimated using a simple dilution model that divided
releases (kg/day)  by stream flow (millions of liters/day).  Subsequent exposure analyses used a
probabilistic dilution model (PDM3) and the exposure analysis modeling system (EXAMS II).
PDM3 was used to estimate the number of days a particular effect concentration would be
exceeded in 1 year, and EXAMS II was used to estimate concentrations hi the water column and
sediments using generic site data.                                   *

       In risk characterization, the quotient, method was used to compare exposure concentrations
with ecological effect concentrations.  A ratio of I or greater indicates a risk. The case study
presents five iterations of analysis and risk characterization.  The first four iterations identified an
ecological risk and resulted in the collection of additional ecological effects test data and more
information on potential exposure to the PMN  substance.   The, final outcome was that the PMN
substance could be used only at the identified sites because there was uncertainty as to whether the
concern level (1 /tg/L) might be exceeded at sites not identified  by the manufacturer.

       OPPT terminology differs from terminology in EPA-'s Framework for Ecological Risk    '  •
Assessment (Framework Report; U.S. EPA, 1992).  For example, OPPT uses "Hazard
Assessment" instead of "Characterization of Ecological Effects." Otherwise, the OPPT ecological
risk assessment procedure follows the approaches and concepts described in the first- and second-
order diagrams of the Framework Report.
                                             1-7

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 1.1.  RISK ASSESSMENT APPROACH

        This case study follows EPA's Framework Report (figure 1-1); that is, it is composed of
 three phases:  problem formulation, analysis, and risk characterization.

        The Office of Pollution Prevention and Toxics' (OPPT's) overall approach to assessing the
 risks of new chemicals is to compare exposure concentrations with ecological effect concentrations.
 The process often begins with simple stream flow dilution models that typically result in a worst-
 case scenario.  If a risk is ascertained, more detailed analyses are performed (figure 1-2).  Because
 of the paucity of data associated with premanufacture notice (PMN) submissions (see discussion
 under Statutory and Regulatory Background), there is a heavy reliance on the use of structure-
 activity relationships (SARs) to estimate ecological effects and develop a stressor-response profile.

        Figure  1-2 does not include risk management options.  In addition to obtaining additional
 exposure and ecological effects information,  risk management options can include  a variety of
 regulatory enforcement actions such as banning discharges to water or requiring pretreatment.  In
 any event, risk assessors must ascertain that a risk exists before risk managers can exercise their
 management options.

        The case study has the following strengths: (1) it relates measurement endpoints to an
 assessment endpoint; (2) it demonstrates that ecological risk assessments can be conducted with
 minimal ecological effect and exposure data; and (3) it demonstrates the usefulness of SARs in
 establishing a stressor-response profile.

        One weakness of the case study is the lack of a true quantification of the effects to the
 assessment endpoint (populations of aquatic organisms).   However, this is a weakness only  from
 the scientific point of view; it was not needed from the regulatory point of view.  Another
 weakness is that the risk assessors expected the PMN substance to bioconcentrate,  yet they  did not
 analyze the potential risks to predators that might ingest contaminated prey.

 1.2.  STATUTORY AND REGULATORY BACKGROUND

       The  Toxic  Substances Control Act (TSCA) provides for the regulation of chemicals not
 covered by other statutes (e.g., Food, Drug,  and Cosmetic Act; Federal  Insecticide, Fungicide, and
 Rodenticide  Act).  Enacted in 1976, TSCA regulates industrial chemicals such as solvents,
 lubricants, dyes, and surfactants. TSCA requires the assessment and, if necessary, regulation of all
 phases of the life cycle of industrial chemicals:  manufacturing, processing, use, and disposal.

       TSCA regulates two categories of industrial chemicals:   (1) chemicals  on the TSCA
 Chemical Substances Inventory List and (2) new chemicals.  The TSCA  Chemical  Substances
 Inventory includes  chemicals in commercial production between 1975 and 1979, and chemicals
 reviewed under the PMN program and commercially produced after 1979.  New chemicals  are
those substances that do not appear on the TSCA inventory.  Section 5 of TSCA requires
 manufacturers and  importers of new chemicals to submit  a PMN to EPA before they intend to
begin manufacturing or importing.  EPA has up to 90 days to evaluate whether the substance will
                                            1-8

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     Risk Assessment
    PROBLEM FORMULATION
    Stressors: Neutral organic compound.
    Ecosystem(s) at Risk: Freshwater rivers and streams.
    Ecological Components: Pelagic and benthic aquatic organisms, including
    fish, invertebrates, and algae.
    Endpoints: Assessment endpoint is protection of aquatic life from unreasonable
    adverse effects due to exposure to industrial chemicals. Measurement
    endpoints are effects on mortality, growth, development, and reproduction using
    surrogate species.
    ANALYSIS
             Characterization
               of Exposure
      Concentrations of the PMN
      substance in the water column were
      estimated with a simple dilution
      model and PDM3.  EXAMS II was
      used to estimate concentrations in
      the water column and sediments.
    Characterization of
     Ecological Effects

QSAR and test data for algae,
fish, daphnids, and chironomids
were used to establish a stressor
response profile.
    RISK CHARACTERIZATION

    The Quotient Method was used to integrate exposure and effects estimates.
    Ecological effect concentrations of concern were established by applying an
    uncertainty factor of 10 to the most sensitive measurement endpoint
    concentration.
                                  i
                    Risk Management
               Five iterations before
               final management
               decision
Figure 1-1. Structure of assessment for effects of a PMN substance

                                   1-9

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         Stepl. FOCUS MEETING
         •  Determine the most sensitive species and endpoint using actual
           test data or QSAR. Estimate a chronic value whenever possible.
         •  Apply an Uncertainty Factor to obtain a concern concentration (CC).
         •  Calculate a Predicted Environmental Concentration (PEC) using a
           simple stream flow dilution model as a worst case scenario for
           concentrations in the water column.
                                                           Drop from
                                                           Review
                                  Yes
         Step 2. STANDARD REVIEW
         •  Obtain more information about Production, Use, and Disposal of the
           PMN substance.
         •  Obtain additional ecotoxicological data (testing, analogs, QSAR).
         •  Estimate a chronic value (ChV) for the most sensitive species.
         •  Adjust the ChV with a margin of exposure (typically 10) to obtain a
           new CC.
         *  Use additional release data and the Probabilistic Dilution Model
           (PDM3) to estimate the number of days in one year that the CC is
           exceeded.  Further analyses could employ EXAMS II.
Additional
ecotoxicity
or fate
tests
Is the CC exceeded
more than 20 times
in one year?
Drop from
Review
         Step 3. RISK MANAGEMENT OPTIONS
         •  Control releases of the PMN substance pending additional testing.
         •  Ban manufacture or use under Section 5f of TSCA.
Figure 1-2. Flow chart and decision criteria for the ecological risk assessment of a PMN
         substance
                                   1-10

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 present an unreasonable risk of injury to human health or the environment.  With good cause, EPA
 can allow an extension of up to 180 days for the evaluation of the chemical.

        In addition to the short review time allowed, there are three major problems associated with
 evaluating PMNs.  The first is the confidential business information (CBI) protection afforded by
 TSCA.  Under this clause, manufacturers and importers can designate many characteristics of the
 PMN substance, such as chemical name, structure, intended uses, and site of manufacture and use,
 as CBI.  This information is not available to the public, and only personnel with TSCA CBI
 security clearance and members of Congress can access the information.  There are strict
 safeguards against disclosure of the CBI (see text box on page 1-12). The second problem is that
 manufacturers and importers submit approximately 2,000 Section 5 notices to EPA  annually.  The
 third and perhaps the most important problem is that only the following information must be
 submitted:  chemical identity; molecular structure; trade name; production volume,  use, and
 amount for each use; by-products and impurities;  human exposure estimates; disposal methods; and
 any test data that the submitter may have. The manufacturer does not have to initiate any
 ecological or human health testing prior to submitting a PMN. Only 4.8 percent of the PMNs
 reviewed to date contain ecological effects data, and most of those data consist of acute toxicity
 tests performed on fish (Nabholz,  1991; Nabholz et al., 1993a; Zeeman et al., 1993).

 1.3.  CASE STUDY DESCRIPTION

        This case study describes how OPPT evaluates the ecological risks of a PMN substance.
 The risk assessment begins with a worst-case analysis using a stream flow dilution model to
 estimate environmental concentrations. This is the typical approach taken by OPPT, and it results
 in very conservative estimates.  Investigators initially use SARs to assess ecological effects, and the
 quotient method to integrate exposure and effects estimates.

       Because the initial assessment identified a risk, additional analyses were performed using
 actual test data and PDM3.  The second risk characterization indicated risks to pelagic and benthic
 aquatic life; therefore,  investigators used the exposure analysis modeling system (EXAMS II)  and
 generic site data to estimate concentrations in both the water column and sediments.  Investigators
 estimated toxicity to benthic organisms using chronic test data for daphnids and assumed that the
 sediments would decrease toxicity by a factor of 10.  The results of these  analyses identified a risk.

       The manufacturer then supplied OPPT with more precise data on the use and disposal  of
the PMN  substance.  Investigators input this new information into EXAMS II,  and the results
indicated little risk to benthic organisms at the identified sites. OPPT was ready to issue a consent
order to restrict use of the PMN substance to the identified sites; however, the manufacturer chose
to perform an actual test on benthic organisms using chironomids as the surrogate species.  The
results of the tests indicated moderate toxicity and  little risk to benthic organisms at the identified
sites.  The final outcome was that EPA restricted the use of the PMN substance to the identified
sites because there was uncertainty as to whether the concern level (1 /ig/L) might be exceeded at
sites not identified by the manufacturer.
                                            1-11

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  Confidential Business Information (CBI)

         The CBI provisions ofTSCA are
  intended to protect manufacturers and
  processors.  Disclosure of chemical
  structures, uses, and even sites can
  provide competitors with proprietary
  information.  However, CBI is available to
  the personnel involved with processing and
  evaluating Section 5 notices. This case
  study cannot provide certain information
  because of the  CBI disclosure restrictions.
  Thus, this report does not reflect all
  available technical information,  because
  certain details  cannot be revealed to
  persons who are  not cleared for CBI.  For
  example,  the technical assessors know the
  chemical name and structure of the PMN
  as well as the uses, sites,  and releases,
  but such information cannot be revealed in
  this  case  study.  Therefore, CBI does not
  hamper the ecological risk assessment
  process by EPA scientists  who must be
  cleared initially for CBI before gaining
  access to such  information.  In addition,
  they must be certified on an annual basis
  to maintain their access to CBI.  Once
  personnel move to positions that no longer
  require access  to CBI, their clearance for
  access to such  information is terminated.
1.3.1.  Background Information and
       Objective

       OPPT performs the following analyses
in assessing the human and ecological risks of
PMN substances. For a more detailed
discussion of the process, see U.S. EPA
(1986), Nabholz (1991), and Nabholz et al.
(1993a).

       1.3.1.1.  Chemistry Report

       The Industrial Chemical Branch of the
Economics, Exposure and Technology
Division (EETD) evaluates PMNs to ensure
that:  (1) the chemical name matches
structure, (2) the chemical/physical properties
are accurate, (3) the information about
manufacturing and processing is accurate, and
(4) the uses are consistent with the chemical.

       1.3.1.2. Engineering Report

       The Chemical Engineering Branch of
EETD estimates worker exposure during the
life cycle of the chemical (manufacturing,
processing, use, and disposal) and estimates
releases of the chemical to the environment.

       1.3.1.3.  Environmental Exposure
                Assessment
                                                        The Exposure Assessment Branch of
                                                 EETD evaluates available fate, transport, and
abiotic and biotic fate parameters.  This is analogous to the exposure profile discussed in the
Framework Report.  The exposure assessment estimates the environmental concentrations likely to
occur during the life cycle of the PMN substance.  This includes an evaluation of potential
exposure from releases to surface waters, landfills, and land spray, as well as nonoccupational
exposures.  Environmental concentrations can be site-specific or generic.  PMN substances
frequently are discharged to water; therefore, most exposure assessments address aquatic
environments, chiefly rivers and streams.

       1.3.1.4.  Ecological Hazard Assessment

       Also known as  a toxicity assessment, the ecological hazard assessment is analogous to a
stressor-response profile and is performed by the Environmental Effects Branch (EEB) of the
                                            1-12

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  Health and Environmental Review Division (HERD).  The initial ecological hazard assessment
  evaluates the potential adverse ecological effects of a PMN substance and relies chiefly on SAR
  For many classes of discrete organic chemicals (about 50 percent of which are neutral organic
  chemicals), quantitative structure-activity relationships (QSARs) are available that permit an
  estimation of acute and chronic effects to surrogate species such as fish, aquatic invertebrates and
  algae (Auer et al., 1990; Clements, 1988; Nabholz et al., 1993a, b; Zeeman et al, 1993)  HERD
  will review the results of submitted test data and, if the results are valid, incorporate them into the
  hazard assessment.

        1.3.1.5.  Ecological Risk Assessment

        The Chemical Screening and  Risk Assessment Division (CSRAD) conducts both human
  health and ecological risk assessments. Ecological risk assessments are conducted in a tiered
  fashion (figure 1-2). Initial hazard and exposure assessments are evaluated at a FOCUS meeting to
  ascertain whether a potential risk exists. If the FOCUS meeting does not identify a risk the
  chemical may be dropped from further review. If a risk is identified, the PMN substance undergoes
  a more detailed assessment called a standard review. Alternatively, additional information may be
 requested immediately following the FOCUS meeting.  If a risk is still identified after all additional
 information has been submitted, then  risk management options are considered. Possible risk
 management options are:  (1) control options (such as no releases to water) pending further tests of
 the PMN substance, (2) issuance of a significant new use rule (SNUR), and (3) direct control under
 Section 5(f) (e.g., banning the manufacture or use of the PMN substance).

 1.3.2.   Problem Formulation

        1.3.2.1.  Stressor Characteristics

        Table 1-1 lists the physical/chemical properties  of the  subject PMN substance. The
 manufacturer declared the chemical identity, structure, intended uses, and sites of use as CBI  This
 particular example evaluated  only the  parent compound, because investigators  did not expect the
 PMN substance to degrade or be transformed into more toxic  metabolites.

        1.3.2.2.  Ecosystem Potentially at Risk

        The processing, use, and disposal sites are adjacent to  rivers and streams.  Investigators also
 expected the PMN substance  to be discharged to such rivers and streams.  Thus, pelagic and benthic
 aquatic populations and communities may be at risk.

        1.3.2.3. Ecological Effects

        The PMN substance belongs to a class of chemicals known as neutral organic compounds
These chemicals are nonelectrolyte and nonreactive and exert toxicity through a narcotic of
nonspecific mode of action (Auer et al., 1990; Lipnick,  1985; Veith and Broderius, 1990)  Neutral
organic compounds can exert  both acute and chronic effects.  The toxicity of neutral organic
compounds has been correlated with molecular weight and the logarithm of the octanol-
                                            1-13

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Table 1-1.  Physical/Chemical Properties of PMN Substance
 Property
                                            Measured or Estimated Value
 Chemical Class

 Chemical Name

 Chemical Structure

 Physical State

 Molecular Weight

 LogKow
  Water Solubility


  Vapor Pressure
Neutral Organic

CBI

CBI

Liquid

232

6.7a

6.56b

0.051 mg/L (estimated)0
0.30 mg/L  (measured)

 < 0.001 Torr @ 20°Cd
 "Estimated using CLOGP program (Leo and Weininger, 1985).
 "Estimated by a regression equation developed by Karickhoff et al. (1979). The average method error
  for the log K^ was 0.2 log K^ units over a log Koc range of 2 to 6.6.
 °Estimated by a regression equation developed by Banerjee et al.  (1980).
 Estimated by a regression equation cited in Grain (1982).

 water partition coefficient (Kow).  Experimental data have shown that neutral organics with a log
 K  of 5 0 or more do not exert pronounced acute effects (toxic effects such as mortality or
 immobilization within 4 days).  This is mainly, due to the low water solubility of such compounds,
 which results in decreased bioavailability to aquatic organisms.  Because of the decreased
 bioavailability, exposure durations of 4 days or less are insufficient to elicit marked acute effects
 (e g  as measured by a 96-hour LCso1 test).  Because of the high Kow of this PMN substance
 investigators expected only chronic effects to occur at or below the chemical's aqueous solubility
 limit.

         OPPT typically assesses ecological effects for three trophic levels:  primary producers
  (algae)  primary consumers (aquatic invertebrates), and forage/predator fish.  Investigators use the
  most sensitive species and toxicological effect for the initial risk assessment.  Unless only chronic
  effects  are expected, such as the PMN substance in this case study, OPPT usually assesses both
  acute and chronic effects.  The ecological effects characterization is based on effects on mortality,
  growth and development, and reproduction.  The rationale and approach used to assess these
  effects  are presented under Measurement Endpoints.
      lrThe LCso is the median lethal concentration.
                                               1-14

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        1.3.2.4.  Assessment EmHpoints

        TSCA was intended to prevent unreasonable risks to health and the environment as a result
 of the manufacture, processing, use, and disposal of industrial chemicals.  The assessment endpoint
 (Surer, 1990) used hi this case study is the protection of aquatic organisms  (algae, aquatic
 invertebrates, and fish).  The investigators assumed that any effects from the PMN substance
 would be exhibited at least up to the population level of organization.

        1.3.2.5. Measurement Endpoints

        Investigators used the following measurement endpoints (Suter, 1990) to assess the risks to
 the assessment endpoint:

        •      mortality;                            v     -  .
        •      growth and development;  and
        •      reproduction.

        Clements (1983) and U.S. EPA (1984) present the rationale for selecting these endpoints.
 To summarize,  documented evidence indicates that xenobiotics can adversely affect these endpoints
 both directly and indirectly. Since populations are governed by mortality, growth and
 development, and reproduction, Investigators presumed that adverse effects  to these measurement
 endpoints would manifest themselves at least up to the population level of ecological organization.
 Thus, there is a logical connection between the assessment endpoint (i.e., the protection of aquatic
 life, at least up  to the population level) and the measurement endpoints.

       OPPT uses a tiered approach when testing the toxicity of a given industrial chemical (U.S.
 EPA, 1983; Smrchek et al., 1993; Zeeman et al., 1993). The first tier consists of relatively
 Inexpensive short-term tests that measure  effects chiefly on mortality to fish and aquatic
 invertebrates and population growth for green algae (the three trophic levels discussed under
 Ecological Effects).   The first tier or "base set" consists oif a 96-hour fish acute test,  a 48-hour
 daphnid test, and a 96-hour algal test. Because the algal test represents exposure across  about
 eight generations of algal cells, OPPT considers the  algal test to be representative of chronic
 toxicity to algal populations. Additional tiers consist of chronic tests, such as the fish early life
 stage toxicity test that measures effects on mortality  and growth and development, and the daphnid
 chronic test that measures effects on survival and reproduction. Investigators must ascertain a risk
 before proceeding to these additional tests.

       1.3.2.6.  Conceptual Model

       Based on experience with neutral organic compounds and available QSARs, the high log
K,,w for the PMN substance indicated a risk of chronic toxicity to benthic and pelagic  aquatic
organisms.  Principal concerns were for effects on mortality, growth and development, and
reproduction.  Investigators  presumed that these effects would be manifested at  least up to the
population level of organization (Clements, 1983).
                                             1-15

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       A preliminary exposure profile was developed through the use of simple stream flow
models.  To characterize ecological effects, QSARs were used to develop an initial stressor-
response profile (Clements, 1988). The QSARs established which trophic level (i.e., algae, fish,
aquatic invertebrates) would be the most sensitive, and were developed from actual tests of neutral
organic compounds using surrogate species (U.S. EPA, 1982) that represented aquatic organisms in
rivers and streams.

       Assessment factors (U.S. EPA, 1984; Nabholz, 1991; Nabholz et al., 1993a) were used to
address uncertainties in extrapolating from laboratory to field effects.  Investigators used a quotient
method of ecological risk characterization to assess risk (Barnthouse et al.,  1986; Nabholz,  1991;
Rodier and Mauriello, 1993).  If the results of the risk characterization predicted an unreasonable
risk, investigators planned to perform a more in-depth analysis including fate and transport
modeling and ecological effects testing hi accordance with EEB ecological effect test guidelines
(U.S. EPA, 1985).  The PDM3 and EXAMS II models would further characterize and refine
exposure, and additional ecological effects testing of the PMN substance would be based on the
criteria established by OPPT (U.S. EPA, 1983).  Investigators would continue to use the quotient
method to characterize risks.
  Comments on Problem Formulation

  Strengths of the case study include:

         •      The process is scientific and judged to be adequate.

         •      The case study is a good example of the PMN process.

  Limitations include:

         •      Much of the information is confidential and is unavailable to the reviewers.

         •      The problem formulation section should present more detail on potential
                ecological effects.

         •      The PMN process appears to consider chemicals singly and not as part of a
                complex mixture in the environment.  Other chemicals might interact with the
                chemical of interest, thereby changing exposure and/or toxicity.

         •      There should be some discussion as to the potential for transformation products
                and what might be done if they were known to be produced.

  General reviewer comments:

         •      This case study addresses all components of a risk assessment listed in the
                EPA's Framework Report.

         •      Future PMN assessments should include fairfy realistic, yet simple,
                bioaccumulation models.
                                            1-16

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  Comments on Problem Formulation (continued)

  Author's comments:

         «     Using a general assessment endpoint, such as the protection of aquatic
                organisms, helps to communicate the significance of risks determined with
                measurement endpoints.  Risk managers might not be familiar with the surrogate
                species used in PMN testing or the significance of the test results (e.g., £C50,
                MATC).

         •     Given the volume ofPMNs received annually, the approach of using
                conservative methods initially and then proceeding to more detailed assessments,
                as necessary, is the only practical approach.

         «     Generic assessments cannot identify specific biota at risk. This often is
                considered a shortcoming; however, given the conservative exposure estimates
                provided by the stream flow models, the lack of information about biota at
                specific sites, and the use of assessment factors for projecting ecological effects,
                it is not unreasonable to assume that the risk assessment will protect a wide
                array of aquatic organisms.

         «     TSCA gives no legislative authority to regulate mixtures of chemicals.  TSCAis
                written to address each chemical individually.

         9     OPPT always considers potential transformation products during assessments.
                If a persistent and/or more toxic transformation product could be formed from a
                PMN substance, OPPT would assess the product in the same way as the parent
                compound was assessed.  In this case, no transformation products of concern
                were identified.

         9     PMN assessments do include bioaccumulation  models when they  are needed.
                Fish ingestion models by humans is a standard model run for all PMN
                substances.  Fish ingestion by predators is assessed if a potential concern has a
                likely probability of occurring.  In the early stages of this case, the assessor
                knew that food chain transport could be a problem.  Late in the  assessment, the
                company submitted fish bioconcentration data for a close analog, which showed
                that the measured fish bioconcentration factor of the PMN substance would be
                much lower than predicted. Therefore,  exposure to human populations and
               predators through fish ingestion was not evaluated further.
1.3.3.  Analysis, Risk Characterization, and Risk Management—1st Iteration

       1.3.3.1.  Analysis:  Characterization of Exposure

       Because the use of the PMN substance is CBI, only the terms Manufacturing, Processing,
Use, and Disposal are used to describe the life cycle of the compound.  The sites of manufacture,
                                            1-17

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use, and disposal are CBI, and this draft considers the actual releases that were used to calculate
concentrations of the PMN substance hi receiving rivers and streams as CBI.

       1.3.3.1.1. Stressor Characterization

       The compound has low water solubility and is not expected to volatilize from water because
of the low vapor pressure.  Photodegradation is negligible, and the compound is expected to sorb
strongly to sediments.  The half-life for aerobic degradation could be weeks; anaerobic degradation
could require months or longer.

       1.3.3.1.2. Exposure Analysis

       In the first iteration, investigators used a simple stream flow dilution model to calculate
predicted environmental concentrations (PECs).  The calculation was based on the following
algorithm:

       Concentration = Releases (kg/day) / Stream flow (millions of liters/day)

       The PEC calculations use both mean and low flow rates.  In addition, the initial OPPT
exposure analysis typically ranks stream flow rates and uses the 10 percent and 50 percent flow
rates. The measured solubility limit of 0.3 mg/L was  used.

       Investigators determined that there would be no significant releases during the manufacture
of this PMN substance. The most significant routes of exposure would result from the use and
disposal of the chemical. Effluents containing the PMN substance would first be treated in publicly
owned treatment works (POTW), which are wastewater treatment plants that include primary and
biological treatment of the incoming waste stream.  POTWs normally are  located off-site or
between the processing plant and the receiving river.  To assess the extent of removal of the PMN
substance by POTWs, investigators used data from laboratory-scale wastewater treatment
experiments and the output from mathematical wastewater treatment simulations.  The results
indicated that removal would be due largely to adsorption to sludge;  however, the analysis assumed
approximately 10 percent of the PMN substance released from treatment was in the effluent sorbed
to solids.  This assumption was based on typical solids removal for secondary wastewater treatment
systems.

       This study did not consider the fate and ecological effects of the PMN substance hi sludge.

       1.3.3.1.3.  Exposure Profile

       Table 1-2 lists the PECs for the PMN substance during manufacture, use, and disposal.

       1.3.3.2.  Analysis: Characterization of Ecological Effects

       OPPT initially used QSAR to estimate the ecological effects of the PMN substance. The
manufacturer contacted EPA prior to  submitting the PMN and was briefed on concerns about
                                            1-18

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 Table 1-2. PECs for PMN Substance
Process

Manufacture
Use
Disposal
Mean Flow
10%a
0.0
9.0
52.3

50%
0.0
0.5
0.7

10%
0.0
68.0
90.2
Low Flow
50%
0.0
4.0
6.1
 "Percentage of streams having flows equal to or less than the value used to calculate the PECs.
 chronic effects.  As a result, the manufacturer submitted a fish acute test and a fish early life stage
 test.

        1.3.3.2.1.  Stressor-Response Profile

        Table 1-3 summarizes the QSAR-derived effect concentrations and the results of the fish
 acute and fish early life stage tests.

        1.3.3.3.   Risk Characterization

        Five risk characterizations were performed in this case study.  Table 1-4 provides a brief
 summary of the  assumptions, estimations, and types of uncertainty for each of the five iterations.

        1.3.3.3.1.  Risk Estimation (Integration and Uncertainty Analysis)

        Investigators used the quotient method to estimate ecological risks.  A quotient of 1 or
greater indicates a risk. The algorithm is given below:

                                  Risk Quotient =  PEC/CC

        Normally, OPPT calculates the concern concentration (CC) by identifying the most
sensitive species and effect from the stressor-response profile and applying  an assessment factor.
In this case, investigators used the  measured chronic value (ChV) of 0.013  mg/L for the fathead
minnow rather than the estimated ChV of 0.004 mg/L for the daphnids (table 1-3).  To account for
the uncertainty between chronic effects noted in the laboratory and those that might occur in the
field, an assessment factor of 10 was used (see text box on page 1-22). The ChV was divided by
the assessment factor to yield a CC of 0.0013 mg/L, which was rounded off to 0.001 mg/L or
1
       In estimating risk, the CC of 1 /tg/L was compared to the PECs (table 1-2).  As can be
seen, the CC was exceeded at both low and mean flow for 10 percent of the streams, and at low
flow for 50 percent of the streams.  A risk was inferred based on mean flow.
                                            1-19

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Table 1-3.  PMN Substance Stressor-Response Profile
QSAR Estimated Toxicity"
Endpoint
Fish 96-hr LCJO
Daphnid 48-hr LC50
Green Algae 96-hr EC50b
Fish ChV°
Daphnid ChV
Algal ChV
Effect Concentration
No effect at saturation
No effect at saturation
No effect at saturation
0.002 mg/L
0.004 mg/L
No effect at saturation
Reference
Veith et al. (1983)
Hermens et al. (1984)
Appendix A
Appendix A
Hermens et al. (1984)
Appendix A
Actual Measured Toxicity
Fathead Minnow (Pimephales
r No effect at saturation
U.S. EPA (1993)
 promelas) 96-hr Acute Test

 P. promelas Early Life Stage   0.013 mg/L
 Test, 31-day ChV (growth,
 mean wet weight)

 P. promelas Early Life Stage   0.061 mg/L
 Test, 31-day ChV (survival,
 growth [length])
U.S. EPA (1993)
U.S. EPA (1993)
•Based on molecular weight and log Kow.
bMedian effect concentration.
The ChV is the geometric mean of the highest concentration for which no effects were observed
 and lowest concentration for which toxic effects were observed.  The ChV is essentially the
 geometric mean of the maximum acceptable toxicant concentration (MATC).
       It should be noted that the initial risk assessment evaluates risks to aquatic species in the
water column only.

       1.3.3.4. Risk Management

       Because the results of the initial risk characterization identified a potential unreasonable
risk, investigators requested a chronic daphnid test to complete the chronic tier tests. EPA  also
informed the submitter that a benthic test with contaminated sediments could be required if there
was a potential unreasonable risk to sediment-dwelling organisms. The concern for benthic
organisms was based on the high Kow, low vapor pressure, and low water solubility, which  indicate
that the PMN substance was likely to partition to the sediments of rivers and streams, resulting in
                                            1-20

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  Table 1-4.  Summary of Five Risk Characterization Iterations
Iteration
1
Estimates/Assumptions
Fish are the most sensitive suedes (
Uncertainty
Chronic \Vnrst-rras*» angltreio
     4


     5
effects at 1 /tg/L.  PMN substance mixes
instantaneously in water. No losses.

Actual test data for daphnids still indicate a ChV
of 1 /tg/L. Determine how often this
concentration is exceeded using PDM3.

Estimate risk to benthic  organisms using daphnid
ChV and mitigation by organic matter.  EXAMS
II used to estimate concentrations.


Site-specific data obtained on use and disposal.
EXAMS II rerun with new data.

Actual test data for benthic organisms obtained.
Worst-case analysis.
Other species may be
more sensitive.

Generic production
sites. Actual data for
benthic organisms not
available.

Estimated toxicity for
benthic invertebrates.

Best estimates for
identified sites. May
not hold for other sites
or uses.
 exposures of benthic organisms.  EPA also requested a coupled units test (40 CFR 796.3300) to
 simulate the effectiveness of a POTW in removing the PMN substance.

 1.3.4.  Analysis, Risk Characterization,  and Risk Management—2nd Iteration

        1.3.4.1. Characterization of Ecological Effects

        A daphnid chronic toxicity test was conducted and found to be acceptable (i.e., it followed
 OPPT guidelines and good laboratory practices).  The ChV for survival, growth, and reproduction
 was 0.007 mg/L.

        1.3.4.2. Characterization of Exposure

        The coupled units test is a measure of the ultimate biodegradation of the PMN substance
 under conditions that simulate treatment in  activated sludge.  The POTW simulation conducted by
 the manufacturer indicated that a POTW would remove from 95 percent to 99 percent of the PMN
 substance.

        1.3.4.3. Risk Characterization

       Investigators used PDM3  (U.S. EPA, 1988) to estimate the number of days out of 1 year
that the CC will be exceeded. Like the simple stream flow model, PDM3 assumes that the
                                            1-21

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Uncertainty Assessment Factors

     OPPTuses assessment factors to
attempt to address three types of
uncertainty:

•   Uncertainty regarding differences in
     species sensitivity to toxicants.

•   Uncertainty regarding the differences
     between concentrations eliciting acute
     effects and those causing chronic
     effects.

•   Uncertainty regarding comparisons of
     laboratory  studies to field conditions.

     Assessment factors range from 1 to
1,000.  The particular assessment factor
used for a chemical mil vary  inversely with
the amount and type of data available.
Examples are shown below. A complete
discussion can be found in U.S. EPA
(1984).

      Examples  of Assessment Factors
Available Data

Acute toxicity QSAR
or test data for one
species

QSAR or test data for
fish, algae, and
aquatic invertebrates

QSAR or chronic
toxicity data for fish
or aquatic
invertebrates

Actual field study
Assessment Factor
     1,000
       100
        10

         1
chemical will mix instantaneously with water
and no losses will occur through any
physical, chemical,  or biological
transformations.  Flow rates were obtained
from the U.S. Geological Survey.

       Investigators continued to use the CC
of 1 /ig/L, since the daphnid ChV of 0.007
mg/L divided by the assessment factor of 10
rounds off to 0.001  mg/L or 1 fig/L.  Table
1-5 presents the results of PDM3.

       1.3.4.3.1. Interpretation of
                  Ecological Significance

       As a matter of policy, OPPT infers an
unreasonable risk to aquatic organisms if a
CC for chronic effects exceeds  20 days or
more.  The 20-day criterion is derived from
partial life cycle tests  (daphnid  chronic and
fish early life stage tests) that typically range
from 21 to 28 days  in duration.  OPPT infers
a reasonable risk if the CC is exceeded less
than 20 days.  It  is  important to remember
that the PDM3 model estimates only the  total
number of days out of 1  year that the CC is
exceeded.  The days are not necessarily
consecutive, and  thus  the 20-day criterion is a
conservative one. This iteration showed  an
unreasonable risk to aquatic organisms from
the PMN substance because the CC was
exceeded 20 days for use and 39 days for
disposal (table  1-5).

       1.3.4.4.  Risk Management

       EPA notified the company that a
potentially unreasonable  risk to aquatic
organisms still existed.  A  meeting was held
to discuss possible benthic  toxicity tests and
to clarify unanswered questions regarding
releases of the PMN substance through use
and disposal.  It also was decided to evaluate
exposure further through the use of EXAMS
II (Burns,  1989).
                                          1-22

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 Table 1-5.  PDM3 Analysis*
  Process
Exceedance (days/year)
  Manufacture

  Use

  Disposal
 0

20

39
 "Releases to water considered CBI.  PMN substance was expected to be released 350 days/year,
 and a 95 percent removal from POTW was assumed.


 1.3.5. Analysis, Risk Characterization, and Risk Management—3rd Iteration

       1.3.5.1. Characterization  of Ecological Effects

       Currently, there are no  SARs for neutral organics and aquatic benthic organisms; however,
 SARs do exist for neutral organics with earthworms in artificial soil. To estimate the ecological
 effects of the PMN substance to aquatic benthic organisms, predictions from the fish 14-day LC50
 QSAR (Konemann, 1981) were compared with the earthworm 14-day LC50 QSAR.  The
 earthworm 14-day LC50 was about 10 times higher than the fish 14-day LCj0.  Investigators
 assumed that the organic matter (i.e., ground peat) in the artificial soil mitigates the toxicity of
 neutral organic chemicals by  about 10 times.

       Investigators further expected that the organic matter in natural sediments would mitigate
the toxicity of the PMN substance by at least a factor of 10, because natural organic  matter in
natural sediments should be more efficient at binding neutral organic chemicals than freshly ground
peat in artificial soil.  That is, sediment organic matter is likely to have a larger surface area-to-
volume ratio than ground peat and, therefore, have more sites to bind hydrophobic compounds.
Proceeding on the above assumption, the effective concentrations in the toxicity profile for water
column were multiplied  by 10 to produce the stressor-respdnse profile for benthic organisms  (table
 1-6).  This scenario used the best data available at the time for neutral organic compounds, and the
PMN submitter accepted the rationale for mitigation.

Table 1-6. (Estimated) Stressor-Response Profile for  Benthic Organisms
Organism
Invertebrate
Invertebrate
Vertebrate
Endpoint
14-day LC50
21-day ChV
31-day ChV
Effect Level
(mg/kg dry weight)
0.3
0.10
0.3 to 1.0
                                            1-23

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       1.3.5.2.  Characterization of Exposure

       A preliminary EXAMS II analysis at the worst site indicated concentrations ranging from
11.2 to 21.8 mg/kg dry weight of sediment after 1 year of releases of the PMN substance.
Appendix B presents  the critical input parameters for EXAMS II and an example of the output.

       1.3.5.3.  Risk Characterization:  Risk Estimation and Uncertainty Analysis

       The most sensitive endpoint was the invertebrate 21-day ChV of 0.1 mg/kg.  An
assessment factor of  10 was applied to derive a CC of 0.01 mg/kg or 10 /tg/kg.  The quotient
method was used.  As can be seen from .the initial EXAMS II analysis, the exposure concentrations
exceeded the CC by factors of 1,000 to 2,000.

       1.3.5.4.  Risk Management

       The manufacturer initiated an extensive site-specific evaluation of the  releases of the PMN
substance during uses and disposal, and submitted new exposure information to OPPT for
evaluation. The report is CBI.

1.3.6.  Analysis, Risk Characterization, and Risk Management—4th  Iteration

       1.3.6.1.  Characterization of Exposure

       OPPT used the additional information to conduct another EXAMS II analysis.  Table 1-7
summarizes the results for three representative sites.
Table 1-7. EXAMS H Analysis
Water Column
Site Otg/L)
1 0.004
2 0.001
3 0.008
Sediments
(mg/kg)
0.019
0.014
0.038
       1.3.6.2.  Risk Characterization

       There was not enough of a risk to benthic organisms to warrant a ban pending a testing
decision by OPPT.
                                            1-24

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        1.3.6.3.  Risk Management

        A decision was made to offer the company a consent order to allow manufacturing but
 require a benthic/sediment toxicity test to confirm the toxicity profile and thus the risk assessment.
 Prior to offering the consent order, the company volunteered to test with a benthic organism using
 contaminated sediment.  The submitter and OPPT agreed to a 28-day chironomid toxicity test.

 1.3.7.  Analysis, Risk Characterization,  and Risk Management—5th Iteration

        1.3.7.1.  Characterization of Exposure

        Table 1-8 presents the results! of the chironomid toxicity test.

        1.3.7.2.  Risk Characterization—Risk Estimation

        A CC of 2.0 mg/L was set for the  benthic community based on the most sensitive effect, a
 ChV of 23 mg/kg for survival and emergence.  The CC was 50 times higher than the highest PEC
 for sediments, and the ChV was 600 times higher.  Thus, there did not appear to be an
 unreasonable risk to benthic organisms as a result of the use and disposal of the PMN substance
 over 1 year.

        As can be seen  from table 1-7, concentrations of the PMN substance were three orders  of
 magnitude  lower than the concern level of  1 jig/L  for water column organisms at the specific sites
 of use and disposal.

        1.3.7.2.1. Uncertainty

        In this case study, the three main types of uncertainty with regard to ecological effects are
variations in species-to-species sensitivity, uncertainty regarding acute versus chronic effects, and
uncertainty regarding extrapolating laboratory-observed effects to those that might occur in the
natural environment.  U.S. EPA (1984) developed assessment factors specifically for establishing
concentrations of concern for PMN substances. Use of these factors is not intended to establish a
 "safe" level for a particular substance, but  rather to identify a concentration which, if equaled or
exceeded, could result in some adverse ecological effects.  Such a  finding provides the rationale for
requesting either actual  testing of the PMN substance or more specific information about fate and
exposure.  Naturally, there are other types  of uncertainty, such as the effects of the PMN
substance on adult rather than juvenile fish.  Such types of  uncertainty are research issues.

        In the case of the exposure profile,  an important aspect of uncertainty has to do with the
actual duration of exposure. The PDM3  model predicts only the number of days out of 1 year that
the CC will be exceeded (table 1-4).  These days are not necessarily consecutive days. Thus, only
flow rates could be used to account for seasonal variation.  The presence or absence of critical life
stages  of aquatic organisms cannot be accounted for with this type  of analysis. In addition, the
generic nature of the assessment precludes identification of specific biota.
                                             1-25

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Table 1-8. Stressor-Response Profile for Chironomus tentans
 Endpoint
Effect Level
(mg/kg dry weight sediment)
 14-day ChV
 21-day EC50 emergence
 25-day EC50 emergence

 28-day EC50 emergence

 28-day LC50 survival
 ChV survival
 ChV emergence
32

23

25

24

22

23

23
       1.3.7.2.2.  Risk Description—Ecological Risk Summary

       This case study demonstrates the validity of QSAR in establishing toxicity profiles for
water quality organisms (fish, invertebrates, and algae). In this case, the chemical structure
indicated that the PMN substance was closely analogous to chemicals known to behave like neutral
organic compounds.  The high Kow indicated that the compound would not be acutely toxic, and
this was confirmed by an actual test with a surrogate fish species. Actual chronic toxicity testing
confirmed the QSAR-predicted chronic toxicity (within an order of magnitude).  EPA's experience
with other high-Kow compounds such as hexachlorobenzene and chloroparaffins further confirms
the chronically toxic nature of such compounds. The predictions for chironomid toxicity  did not
agree with the actual test data.  QSARs have not been developed for benthic organisms simply
because not enough test data are available to permit such analyses.

       The use of QSAR is not limited to neutral organic compounds.  Currently, there are
QSARs available for compounds that show more specific modes of toxicity or excess toxicity over
the neutral  organics. Examples include acrylates, methacrylates, aldehydes, anilines,
benzotriazoles, esters, phenols,  and epoxides (Auer et al., 1990; Clements,  1988).

       Because the CCs were exceeded  enough times out of 1 year, the PDM3 model indicated  a
risk to aquatic organisms.  When actual sites were analyzed using EXAMS II, no unreasonable
risks were identified.

       1.3.7.2.3.  Ecological Significance

       There appears to be no unreasonable risks to pelagic and benthic organisms at the identified
use sites.  The potential risk posed by the PMN substance bioaccumulating through the aquatic
food web was thought not to be significant.
                                            1-26

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         1.3.7.2.4.  Spatial and Temporal Patterns of the Effects
        CBI restrictions preclude revealing the uses and specific sites for the PMN substance

 PiCK ,   teC^°al assessors ide°tified important river systems that could be affected by 'this
 PMN substance.  Thus, if there was a risk, the effects are not likely to be localized.

        1.3.7.2.5.  Recovery Potential


        The PMN substance is a neutral hydrophobic chemical.   This mode of toxicity is akin to a
 simple narcosis type of action (Auer et al., 1990; Veith and Broderius, 1990) that Slversible if
 exposure to the toxicant is terminated before lethality or death occurs.


            ? ""?* P°tential W3S n0t evaluated'  Short-term pulsed exposure is not likely to  cause

                                            1S
1.3.8. Risk Management— Final Decision


       The risk managers agreed that the PMN substance posed no unreasonable risks to pelagic

                 ^ the^cmc^s of use and disposal. However, there could be risks at ofher

                ^ ?d dlSP°Sal °f *e PMN SUbstanCe"  Therefore' the final di^ition was a
       PMM  I"/  f ^ SgamSt releashlg concentrati° suspended particle
               -* feeding or bioconcentration.
                                           1-27

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Comments on Characterization of Exposure (continued)
       •      The exposure analysis should have considered the fate of the sludge from the
              POTW. Such sludge is often applied to agricultural or forest land.

       •      More detail about the discharges should be given, even if it is something like
              "one  large" or "several small"
       •      For chemical products that are mixtures, there may be a large number of
              chemicals present, and this may  contribute to variability in estimates as well as
              measurements.  The mixture can result in exposure conditions in the
              environment different from those for the original material.

Author's comments:

       •     The simple stream flow model offers a conservative estimate of exposure by
              assuming instantaneous mixing and dispersion of the chemical.   The  model does
              not take into account any losses due to factors such as volatilization,
              partitioning, or chemical or biological degradation after release. Because of
              the paucity  of data and information about exposure,  the use of conservative
              models is justified.
       •     The PDM3  model is an improvement over the simple stream flow models in that
              the temporal nature of exposure can be evaluated.   Thus,  a risk manager can be
              advised as to how often a particular concentration is likely to be exceeded.

       •     The above two models estimate chemical concentrations in the water column
              onfy.  As demonstrated in the study, more in-depth models such  as EXAMS II
              can be used to estimate chemical concentrations both in the water column and
              sediments when sufficient data are available.
 Comments on Characterization of Ecological Effects

 Strengths of the case study include:

        •      The case study illustrates the iterative approach associated with the evaluation
               of a PMN chemical.

 Limitations include:

        •      Estimating a concern level for sediment organisms based on  earthworm data is
               not appropriate because earthworms exchange gases with air and sediment
               organisms exchange  gases with water.  The statement that sediment organic
               carbon will mitigate  toxidty 10 times more than soil or peat carbon  requires
               additional support.
                                            1-28

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Comments on Characterization of Ecological Effects (continued)
              The authors should give a good rationale for their approach to estimating
              sediment toxicity and tell why it is better than the equilibrium partitioning
              method other offices in EPA are using, or they should use the equilibrium
              partitioning method.

              The case study should not state that it demonstrates the validity ofQSAR in
              establishing toxicity profiles.  The estimated 21-day chronic value of 0.100 was
              230-fold lower than the test results (tables 1-6 and 1-8). A single case study
              would not be sufficient to demonstrate the validity of using QSAR to establish
              toxicity profiles, no matter what might have been shown.
Author's comments:
              The use ofSAR is commonplace within OPPT because TSCA does not require
              the completion of test data prior to the submission of a PMN.  The track record
              with SAR is extremely good (Nabholz et al., 1993b) and has resulted in dropping
              low-risk chemicals from review and regulating high-risk chemicals without
              measured data on the chemical. Provided sound expert judgment is employed,
              SAR can identify whether acute or chronic tests (or both) are needed.

              The use of surrogate species at different trophic levels (e.g., fish, daphnids,
              algae, benthic organisms) permits one to evaluate which organisms are most
              sensitive  to a given xenobiotic. While many argue that the commonly used
              surrogates may not be as sensitive as those in the wild, both industry and
              government agree that it is the most practical way to evaluate the ecological
              effects of chemicals.  Because many industrial chemicals are used in a wide
              array of industries as well as consumer products, identifying specific biota (at
              the species level) is often impossible.    \

              The cost  of larger scale studies such as laboratory microcosms and field
              mesocosms has precluded their use to assess the ecological effects of new
              chemicals. However, OPPT is initiating field mesocosm studies at EPA's Duluth
              Environmental Research Laboratory to evaluate how well laboratory tests
              predict effects in the field.
                                          1-29

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Comments on Characterization of Ecological Effects (continued)
       •      Comparing a fish 14-day LC50 with an earthworm 14-day LC50 value in an
              artificial soil was the only available way at" the time to estimate the effect that
              organic matter would have on the hioavailabilitv of an organic chemical in
              sediments.  It was known that (1) earthworms interacted intimately with soil
              pore water, (2) the toxicity of organic chemicals in soil toward earthworms
              could be predicted by relating molar concentration in soil pore water to the
              chemical's Kow (van  Gestel and Ma, 1990), (3) K^ was highly correlated with
              Koc, and (4) the amount of organic matter in sediments strongly influenced the
              amount of organic chemical that could be absorbed by sediments. It was a
              simple and valid extrapolation to use  earthworms as  a surrogate for benthic
              organisms.  In addition,  when the OPPT assessment  team conferred with the
              submitter's assessors, the submitter accepted OPPT's best estimate given the
              level of knowledge and available data that existed at the time.

        •     Sediment organic  matter was expected to be more efficient than the ground peat
              used in the artificial soil of the earthworm toxicity test because sediment organic
              matter is generally more finely divided due to more processing by invertebrates
              and partial degradation by microbes: Sediment organic matter was expected to
              have a much greater surface area to volume ratio than the peat and, therefore,
              a much greater absorptive area to reduce the bioavailability of organic
              chemicals with high  Kow values (i.e.,  >4.2).
 Comments on Risk Characterization

 Strengths of the case study include:

        •      The risk characterization  appeared to be adequate for a management decision.
                                                                              i
        •'     The case study illustrates the PMN risk assessment process.

 Limitations include:

        •      The summary table of the major assumptions and estimates used at various
               stages of the process (table 1-4) should have included some information on the
               magnitude of uncertainty associated with each of these  estimates or assumptions.

        •      The risk assessment methods employed do not distinguish  risks to individuals
               from risks to populations.  In some cases "individuals"  are the organizational
               level of interest, while in other cases it is the "population. "
                                            1-30

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 Comments on Risk Characterization (continued)

        «      // was pointed out that assessment factors were developed in 1984 and continued
               to evolve along with the PMN process.  The case study should include the
               method used to derive the assessment factors and a brief statement of the history
               of these factors.

        »      The case study should clarify the difference between "uncertainty" in the
               statistical sense and "uncertainty" as it is addressed by using "assessment
              factors."

        «     Assigning an assessment factor of "1" to field toxicity data is not appropriate
              because field data are site-specific,  and the data may not be directly
              transferable to other sites where the chemical might be used or released.

        •      The available  information suggested that risks to benthic organisms were
              probably  more important than those to pelagic organisms.  Yet, the process was
              carried out in a specific manner that emphasized the studies on pelagic
              organisms first.  It was pointed out  that this was policy.

        •     If disposal options were considered  along  with the risk assessment, then various
              options could have been considered early in the process.  Such  mitigation could
              be included as an  iteration.

        •     If "acceptable" concentrations were first identified,  then it would be possible to
              estimate acceptable loadings.

General reviewer comments:

        •     The case study description of interactions between risk assessors and risk
              managers led the reviewers to discuss the following:

                     Who is the  risk manager? It appears to be a manager at EPA, but the
                     manager at the company also can manage risk by deciding not to test
                    further and abandoning  the chemical,  or he could deal with potential
                     exposure by treating  the waste stream or making process changes.

             —      It might be useful to  develop a framework for risk managers similar to
                     that for risk assessors.  Both frameworks should contain  sections  on
                     interaction  with the other and on mitigation.

       •      The example chemical does not indicate how well the process works for other
             types of chemicals.   Narcoleptic chemicals are the easiest chemicals to model
             for toxicity. Reactive toxicants often cannot be modeled simply,  if at all, and
             they are usually more toxic or hazardous.
                                          1-31

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Comments on Risk Characterization (continued)
       •      Reviewers discussed the use of "probabilistic" risk assessment.  It was noted that
              this is the direction in which EPA is going.  A question was raised regarding
              whether these quantitative methods  would be understandable to the risk
              manager.  Some experience indicates  that they would.

Author's comments:

       •      The Quotient Method is the most common ecological risk assessment method
              used in OPPTfor new and existing chemicals.  It also is used  by the Office of
              Pesticide Programs.  The Quotient  Method is easy to use, is mutually accepted
              by industry and EPA, and is amenable to the ecological effects and exposure
              data available to OPPT under TSCA.
        •      One disadvantage of this method is the uncertainty about the degree of risk
              when quotients approach, but do not equal, 1. Also, it is difficult to quantify
              risks to assessment endpoints when most ecological risk assessments under TSCA
              are generic.  While the risks to measurement endpoints can be quantified,
              extrapolating such risks to the population or community level is impossible
              unless simulation models are employed.   OPPT is evaluating developmental
              versions of population and  ecosystem models for use with existing chemicals;
              however, due to the volume ofPMNs, their use is not practical at this time.
               This is particularly  true for ecosystem models that require mainframe or high-
              speed/high-memory computers.  Thus, only qualitative inferences can be made
              between measurement and assessment endpoints.
        •      Since  1979,  OPPT has assessed the environmental toxicity of over 24,000
               chemicals submitted under  Section 5 of TSCA. Although only 4.8 percent of
               those  chemicals had any environmental toxicity information submitted with them,
               OPPT has been able to use chemical structure and commonly  measured
              physical/chemical properties to model the aquatic toxicity of many classes of
               reactive toxicants, including 64 classes of organic chemicals that have some type
               of specific toxicity in addition to narcosis.
                                            1-32

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 1.4.  REFERENCES

 Auer, C.M.; Nabholz, J.V.; Baetcke, K.P. (1990) Mode of action and the assessment of chemical
        hazards in the presence of limited data: use of structure-activity relationships (SAR) under
        TSCA, Section 5. Environ. Health Perspect. 87:183-197.

 Banerjee, S.; Yalkowsky, S.H.; Valvani, S.C. (1980) Water solubility and octanol/water partition
        coefficients of organics. Limitations of the solubility-partition coefficient correlation.
        Environ. Science Technol.  14:1227-1229.

 Barnthouse, L.W.; Suter, G.W.; Bartell, S.M.; Beauchamp, J.J.;  Gardner, R.H.; Under, E.;
        O'Neill, R.V.; Rosen, A.E. (1986) User's manual for ecological risk assessment. Oak
        Ridge National Laboratory. ORNL Publ. No. 2679.

 Broderius, S.J.; Russom, C.L.  (1989) Mode of action-specific QSAR models for predicting acute
        and chronic toxicity of industrial chemicals to aquatic organisms. U.S. Environmental
        Protection Agency. Duluth, MN: Environmental Research Laboratory. Deliverable No
        81421.

 Burns, L.A. (1989) Exposure analysis modeling system: user's guide for EXAMS II version 2.94.
        Athens, GA: U.S. Environmental Protection Agency.

 Clements, R. (1983) Environmental effects of regulatory concern under TSCA—a position paper.
        Environmental Effects Branch, Health and Environmental Review Division (7403), Office
        of Toxic Substances, U.S. Environmental Protection Agency, Washington, DC.

 Clements, R. (1988) Estimating toxicity of industrial chemicals to aquatic  organisms using
        structure-activity relationships. U.S. Environmental Protection Agency,  Washington, DC.
        EPA 560-6-88-001. Available from: NTIS, Springfield, VA,  PB89-117592.

 Grain, C.F. (1982) Vapor pressure. In: Lyman,  W.J.; Reehl, W.;  Rosenblatt, D.H., eds.
       Handbook  of chemical property estimation methods, environmental behavior of organic
        compounds. New York, NY: McGraw-Hill Co.

 Hermens, J.; Canton, H.; Janssen, P.; DeJong, R. (1984) Quantitative structure-activity
       relationships and toxicity studies of mixtures of chemicals with anesthetic potency: acute
       lethal and sublethal toxicity to Daphnia magna. Aquat. Toxicol. 5:143-154. (also in
       jClements,  1988).

Karickhoff, S.W.; Brown, D.S.; Scott, T.A. (1979) Sorption of hydrophobic pollutants on natural
       sediments.  Water Res. 13:241-248.

Konemann, H. (1981) Quantitative structure-activity relationships in fish toxicity studies.  Part 1:
       relationship for 50 industrial pollutants. Toxicology 19:209-221.
                                            1-33

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Leo, A.; Weininger, D. (1985) CLOGP version 3.3. estimation of the n-octanol/water partition
       coefficient for organics in the TSCA industrial inventory. Claremont, CA: Pomona College.

Lipnick, R.L. (1985) Validation and extension of fish toxicity QSARs and interspecies comparisons
       for certain classes of organic chemicals. In: Tichy, M., ed. Toxicology and
       xenobiochemistry. 8:39-52.

Nabholz, J. V. (1991)  Environmental hazard and risk assessment under the United States Toxic
       Substances Control Act. The science of the total environment. 109/110:649-665.

Nabholz, J. V. (in preparation) Estimating toxicity of industrial chemicals to aquatic organisms
       using structure-activity relationships.

Nabholz, J.V.; Miller, P.; Zeeman, M. (1993a) Environmental and risk assessment of new
       chemicals under the Toxic Substances Control Act (TSCA) Section Five. In: Landis, W.G.;
       Hughes, J.S.; Lewis, M.A., eds. Environmental toxicology and risk assessment.  American
       Society for Testing and Materials, Philadelphia, PA. ASTM STP 1179.

Nabholz, J.V.; Clements, R.G.; Zeeman, M.G.; Osborn, K.C.; Wedge, R. (1993b)  Validation of
       structure-activity relationships used by EPA's Office of Pollution Prevention and Toxics for
       the environmental hazard assessment of industrial chemicals. In: Gorsuch, J.W.; Dwyer,
       F.J.; Ingersoll, C.G.; LaPoint, T.W., eds. Environmental toxicology and risk assessment.
       American Society for Testing and Materials, Philadelphia, PA. ASTM STP 1216.

Rodier, D.J.; Mauriello, D. (1993) The quotient method of ecological risk assessment and
       modeling under TSCA: a review. In: Landis, W.G.; Hughes, J.S.; Lewis, M.A, eds.
       Environmental toxicology and risk assessment. American Society for Testing and Materials,
       Philadelphia, PA. ASTM STP 1179.

Smrchek, J.; Clements, R.; Morcock, R.; Roberts, R. (1993) Assessing ecological hazard under
       TSCA: methods and evaluation of data. In: Landis, W.G.; Hughes, J.S.; Lewis,  M.A.,
       eds. Environmental toxicology and risk assessment. American Society for Testing and
       Materials, Philadelphia, PA. ASTM STP 1179.

Suter, G.W. (1990)  Endpoints for regional ecological risk assessment. Environ. Manage. 14:9-23.

TSCA. (1976) Toxic Substances Control Act, PL 94-46, October  11, 1976,  Stat. 90:2003.

U.S. Environmental Protection Agency. (1982) Surrogate species  workshop.  Environmental Effects
       Branch,  Health and Environmental Review Division (7403), Office of Toxic Substances,
       U.S. Environmental Protection Agency, Washington, DC.

U.S. Environmental Protection Agency. (1983) Testing for environmental effects under the Toxic
       Substances Control Act. Environmental Effects Branch, Health and Environmental Review
       Division (7403), Office of Toxic Substances, U.S. Environmental Protection Agency,
       Washington, DC.
                                           1-34

-------
 U.S. Environmental Protection Agency. (1984) Estimating concern levels for concentrations of
        chemical substances in the environment. Environmental Effects Branch, Health and
        Environmental Review Division (7403), Office of Toxic Substances, U.S. Environmental
        Protection Agency, Washington, DC.

 U.S. Environmental Protection Agency. (1985) Toxic Substances Control Act test guidelines final
        rules. Federal Register 50(188):39252-39516.

 U.S. Environmental Protection Agency. (1986) New chemical review process manual. Office of
        Toxic Substances, U.S. Environmental Protection Agency, Washington, DC. EPA 560/3-
        86-002.

 U.S. Environmental Protection Agency. (1988) User's guide to PDM3, final report.  EPA Contract
        No. 68-02-4254, Task No. 117. Exposure Assessment Branch, Exposure Evaluation
        Division (7403), Office of Toxic Substances, U.S. Environmental Protection Aeencv
        Washington, DC.

 U.S. Environmental Protection Agency. (1992) Framework for ecological risk assessment. Risk
        Assessment Forum, Washington, DC. EPA 630/R-92/001.
                                                    i
 U.S. Environmental Protection Agency. (1993) PMNEcotox Database: a data base of
        environmental toxidty studies which are protected by  confidential business information
        (CBI). Environmental  Effects Branch, Health and Environmental Review Division (7403),
        Office of Toxic Substances, U.S. Environmental Protection Agency, Washington,  DC.

 van Gestel, C.A.M.; Ma, W.-C. (1990) An approach to quantitative structure-activity relationships
        (QSARs) in earthworm toxici«y tests. Chemosphere 20:1023-1033.

 Veith, G.D.; Call, D.J.; Brooke, L.T. (1983)  Structure-activity relationships for the fathead
       minnow, Pimephales promelas: narcotic industrial chemicals. Can. J.  Fish. Aquat  Sci
       40:743-748. (also in Clements, 1988).

Veith, G.D.; Broderius, SJ. (1990) Rules for distinguishing toxicants that cause type I and type II
       narcosis syndromes. Environ. Health Perspect. 87:207-211.

Zeeman, M.; Nabholz, J.V.; Clements, R.G. (1993) The development of SAR/QSAR for the use
       under EPA's Toxic Substances Control  Act (TSCA): an introduction. In: Gorsuch, F.J.;
       Dwyer, F.J.; Ingersoll, C.G.; LaPoint, T.W.,  eds. Environmental toxicology and  risk '
      assessment: 2nd volume. American Society for Testing and Materials,  Philadelphia PA
      ASTM STP  1216.                                                           '
                                           1-35

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               APPENDIX A
QSARS BETWEEN NEUTRAL ORGANIC CHEMICALS
    AND FISH AND GREEN ALGAL TOXICITY
                 1-A1

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QSARS BETWEEN NEUTRAL ORGANIC CHEMICALS AND FISH CHRONIC VALUES
                           (Broderius and Russom, 1989)
      •     Log NOEC (mol/L) = -0.878 Log K,,,, - 2.40

            n = 20      r2 = 0.911     s = 0.335


      •     Log LOEC (mol/L) = -0.862 Log K,,w - 2.16

            n = 20      r2 = 0.913     s = 0.325


      •     Log ChV (mol/L) = -0.870 Log K,,w - 2.28

            n = 20     r2 = 0.914    s = 0.327


      •     Log ChV (mg/L) = antilog ChV (mol/L) * mw
     QSARS BETWEEN NEUTRAL ORGANIC CHEMICALS AND GREEN ALGAE
                  TOXICITY (GROWTH) (Nabholz, in preparation)
            Log ChV (mmol/L) = 0.036 - 0.634 Log

            n = 6       r2 = 0.99
      •     Log 96-h EC50 (mmol/L)  = 1.48 - 0.869 Log

            n = 22       r2 = 0.93

Please note: The QSARs referenced here and elsewhere in the report are now available as a
computer program called ECOSAR (EPA-748-F-93-002). Limited copies are available from the
National Center for Environmental Publications and Information, U.S. EPA, 26 West Martin
Luther King Drive, Cincinnati, OH 45268 (513-569-7985).  In addition, copies may be obtained
from:

      •     U.S. Government Printing Office, Superintendent of Documents, ATTN:
            Electronic Product Sales Coordinator, P.O. Box 37082, Washington, DC 20013-
            7082 (202-512-1530);
                                       1-A2

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Federal Bulletin Board, U.S. Government Printing Office of Electronic Information
Dissemination Services (202-512-1524); or

National Technical Information Service, U.S. Department of Commerce, 5285 Port
Royal Road, Springfield, VA 22161 (703-487-4650) (order as computer program
PB94-500485).
                            1-A3

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         APPENDIX B
INPUT AND OUTPUT PARAMETERS
        FOR EXAMS H
           1-B1

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                          INPUT PARAMETERS FOR EXAMS H

       EXAMS II estimates exposure, fate, and persistence of an organic chemical after being
released into an aquatic ecosystem (Burns, 1989).  EXAMS II requires input of data into three files
that describe the chemical, the environment, and the chemical loading to the environment.

       Critical inputs to the chemistry file for this example were the water solubility, octanol-
water partition coefficient (K<,w), soil/sediment organic carbon-water partition coefficient (K,,,.), and
biodegradation rate constant. These parameters  are important hi modeling the test chemical
partitions between the water column and sediments.  This particular analysis used a log Kow of
6.56.

       The environment file was culled from a  set of predefined or canonical environments.  Data
including stream geometry and surface water flow rates are included here.  Two important
parameters that were user-defined in this example were  the benthic and suspended sediment organic
carbon content and the concentration of microorganisms hi the sediments active in the
biodegradation of the compound.  The mass of test chemical released per unit time is entered into
the loading file.

                                 OUTPUT OF EXAMS H

       The EXAMS II output includes tables summarizing test chemical properties; environmental
characteristics; chemical loadings; steady-state mean, minimum, and maximum concentrations hi
various environmental compartments;  and an exposure analysis summary (see example below).

               EXAMPLE OUTPUT OF EXAMS (NOT CASE STUDY PMN)

Exposure (maximum steady-state concentrations'):

Water column:                      7.884E-03 mg/L  dissolved; total = 8.255E-03 mg/L
Benthic sediments:


Biota ftig/g dry weight):


Pate:

Total steady-state accumulation:


Total chemical load:
7.377E-03 mg/L dissolved in pore water; maximum total
concentration =  33.1 mg/kg (dry weight)

Plankton:  7.68E+03
Benthos:  7.18E+03
494 kg, with 0.29 percent hi the water column and 99.71
percent hi the benthic sediments.

27 kg/month.  Disposition:  0.00 percent chemically
transformed, 0.00 percent biotransformed,  0.00 percent
volatilized, and 100.00 percent exported via other pathways.
                                           1-B2

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Persistence:
After 16.0 months of recovery time, the water column had lost 65.82 percent of its initial chemical
burden; the benthic zone had lost 60.08 percent; systemwide total loss of chemical =  60.1 percent.
Five half-lives (>95 percent cleanup) thus require about 60 months.
                                           1-B3

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                     SECTION TWO


        ECOLOGICAL RISK ASSESSMENT CASE STUDY:
RISK ASSESSMENT FOR THE RELEASE OF RECOMBEVANT RfflZOBIA
        AT A SMALL-SCALE AGRICULTURAL FIELD SITE

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                             AUTHORS AND REVIEWERS
AUTHORS
Gwendolyn McClung
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
Washington, DC

Philip G. Sayre
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
Washington, DC

REVIEWERS

Joseph E. Lepo (Lead Reviewer)
Center for Environmental Diagnostics
  and Bioremediation
University of West Florida
Gulf Breeze, PL

Gregory R. Biddinger
Exxon Biomedical Sciences, Inc.
East Millstone, NJ

Joel S. Brown
University of Illinois at Chicago
Chicago, JJL
Herbert Grover
Benchmark Environmental Corporation
Albuquerque, NM

Thomas Sibley
Fisheries Research Institute
University Of Washington
Seattle, WA

Frieda B. Taub
School of Fisheries
University of Washington
Seattle, WA
                                          2-2

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                                    CONTENTS

ABSTRACT  .	'	  2-7

2.1.  RISK ASSESSMENT APPROACH . .  . . .	  2-8

2.2.  STATUTORY AND REGULATORY BACKGROUND	   2-10

2.3.  CASE STUDY DESCRIPTION	   2-11

     2.3.1.  Background Information and Objective  .  .	   2-11
     2.3.2.  Problem Formulation . .	 ,	   2-11

           2.3.2.1. Planning	!	   2-11
           2.3.2.2. Stressor Characteristics	   2-12
           2.3.2.3. Ecosystem Potentially at Risk	 .   2-16
           2.3.2.4. Endpoint Selection	 .   2-18

     2.3.3.  Analysis: Characterization of Exposure	   2-21

           2.3.3.1. Stressor Characterization	   2-22
           2.3.3.2. Ecosystem Characterization	   2-23
           2.3.3.3. Temporal Analysis	   2-24
           2.3.3.4. Exposure Analyses	• •  • •:	   2-24

     2.3.4.  Analysis: Characterization of Ecological Effects   	   2-26

           2.3.4.1. Evaluation of Effects Data	   2-26
           2.3.4.2. Evaluation of Causal Evidence	 .   2-26
           2.3.4.3. Effects Needing Study  in the Event of Significant Off-Site
                   Migration or Large-Scale Release	   2-26

     2.3.5.  Risk Characterization	   2-28

           2.3.5.1. Risk Estimation	   2-28
           2.3.5.2. Uncertainty	;	   2-29
           2.3.5.3. Risk Description	   2-29

2.4.  DISCUSSION BETWEEN RISK ASSESSOR AND RISK MANAGER  	   2-32

2.5.  RISK VERIFICATION	  . 2-32

     2.5.1.  Persistence	   2-32
     2.5.2.  Competitiveness	 .	   2-32
     2.5.3.  Dissemination From the Test Site	   2-33
     2.5.4.  Effect on Alfalfa Yield During Field Test  . .	   2-33
                                        2-3

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                          CONTENTS (continued)




2.6. KEY TERMS	  2-33




2.7. REFERENCES	  2-34




APPENDIX A—MONITORING AND ENUMERATION TECHNIQUES FOR RHIZOBIA  2-A1




APPENDIX B—PERSISTENCE IN THE RHIZOSPHERE AND NODULE OCCUPANCY  2-B1




APPENDIX C—RHIZOBIAL DISPERSION AND MIGRATION	  2-C1




APPENDIX D—STRAIN COMPARISON AND COMPETITION TESTS	  2-D1




APPENDIX E—RHIZOBIAL CULTURE VIABILITY 	  2-E1




APPENDIX F—ALFALFA YIELDS IN THE FIELD TESTS	  2-F1
                                  2-4

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                                   LIST OF FIGURES

 Figure 2-1.  Structure of assessment for small-scale field tests with recombinant rhizobia ...  2-9

 Figure 2-2.  PMN data/information,, components, and decisions made  . .	  .   2-13

 Figure 2-3.  Cassette diagram for RMB7103 with only primary sequences added	   2-15


                                    LIST OF TABLES

 Table 2-1.   Table of Recombinant Rhizobia for 1989-1990 Field Tests	   2-14

 Table 2-2.   Linkages Among Assessment Endpoints and Data Needs Relevant to Endpoint
            Evaluation	 . . . .	   2-17

 Table 2-3.   Linkages Among Stressor, Monitoring, andjData Needs Relevant to Endpoint
            Evaluation	,	   2-19


                              LIST OF COMMENT BOXES

Review Comments on Risk Assessment Approach	2-8

Comments on Problem Formulation  	2-19

Comments on Characterization of Exposure	2-25

Comments on Analysis: Characterization of Ecological Effects	2-27

Comments on Risk Characterization	2-29
                                          2-5

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                                 LIST OF ACRONYMS

DNA         deoxyribonucleic acid

EPA          U.S. Environmental Protection Agency

FA           fluorescent antibody

GEM         genetically engineered microorganism

MDL         minimum detection limit

MPN         most probable number

OPPT        Office of Pollution Prevention and Toxics

OTS          Office of Toxic Substances  ^

PMN         premanufacture notice
                                    t-
RDM         rhizobia-defined medium

TSCA        Toxic Substances Control Act
                                           2-6

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                                         ABSTRACT

        This ecological risk assessment concerns a small-scale field test of genetically engineered
RMzobiwn meliloti strains. The strains were submitted hi 1988 as part of a prernanufacture notice
(PMN) to the Office of Toxic Substances (OTS, currently the Office of Pollution Prevention and
Toxics, OPPT) for tests to be conducted hi 1989-1990.  The rhizobia were genetically modified by
the insertion of antibiotic resistance markers or by the addition of both antibiotic resistance and mf
genes to enhance nitrogen fixation.  R. meliloti form nodules and fix nitrogen hi alfalfa (Medicago
sativa), sweet clover (Melilotus), and fenugreek (Trigonella).  The surrounding agroecosystem near
Sun Prairie, Wisconsin, constituted the area of concern for ecological effects.  Literature accounts
of rhizobial movement,  field test site characteristics, and field test design indicated that the
microorganisms had only a minimal potential for migrating beyond the field test plot.  The primary
assessment endpoint examined during the small-scale field test was the potential for these
recombinants to alter top growth of alfalfa. The ecological concerns for large-scale releases of
recombinant rhizobia—such as increased growth of nontarget legumes, decreased growth of target
legumes, spread of antibiotic resistance genes, nitrogen cycling disruption, and  alteration of host
range—were of low concern for the agroecosystem around the test site.

       Actual data obtained from the small-scale field study confirmed the predictions hi the OTS
PMN risk assessment conducted hi 1988 and those hi this ecological risk assessment.  Little
horizontal, vertical, or aerial migration of R. meliloti occurred.  The rhizobia primarily moved
with the alfalfa root system. When compared with unmodified strains, recombinant rhizobia did
not cause significant changes hi nitrogen fixation, as measured indirectly by alfalfa yield.
Recombinant strains did not out-compete parental strains, alleviating the concern for displacement
of the indigenous  rhizobia.
                                            2-7

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2.1. RISK ASSESSMENT APPROACH

       This case study represents a typical risk assessment for a premanufacture notice (PMN)
received by the U.S. Environmental Protection Agency's (EPA's) Office of Pollution Prevention^
and Toxics (OPPT). OPPT effectively evaluates the potential risk using the paradigm of "Risk -
Hazard X Exposure" (Sayre, 1990).  This paradigm is consistent with the Framework for
Ecological Risk Assessment (U.S. EPA, 1992).  Figure 2-1 demonstrates how the assessment was
structured, using the framework report as guidance.

       Since the framework report focuses on physical and chemical rather than biological
stressors, the report does not adequately address certain aspects of this risk assessment.  These
include:

        •      the need for fate monitoring to build a data base of rhizobial behavior for larger-
               scale releases;

        •      the potential that in some cases the introduced deoxyribonucleic acid (DNA) might
               move from the genetically engineered microorganism (GEM) to other environmental
               recipients;

        •      consideration of field site design that limited microbial dissemination beyond the
               site, thereby alleviating the need for certain effects testing;

        «      the  evaluation of exposure resulting from culturing and transporting OEMs to the
               field site; and

        •      construct considerations.
   Reviewer Comments on Risk Assessment Approach

          •      As currently formulated, EPA's Framework for Ecological Risk Assessment does
                 not address fundamental differences between biological stressors and chemical
                 and physical stressors.  These differences include concerns unique to living
                 entities, such as replication, colonization, and genetic evolution.  This case
                 study should provide a useful model for assessing risks of future limited releases
                 of genetically engineered microorganisms in agroecosystems.

          •      This case study does not address more general ecological risks, nor does it
                 consider risks of large-scale or commercial release of OEMs.  However, the
                 study does serve as an important ground-breaking document because risk
                 assessments of OEMs released into agroecosy stems will become more common in
                 the near future.
                                              2-8

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                     a* Rifk: A9roecosystem site for field test of recombinant
                      involving larger spatial scales were of lesser concern

        aro?m ?nr phC°T-POnen?,: Na"Ve rhiz°bia'legumes within tne cross-inoculation
        group for Rhizobium meliloti, legumes outside the cross-inoculation qrouo
        nonlegumes affected by introduced sequences.         lol-uiail°n group,

        Endpoints: Assessment endpoints are listed in table 2-2. These also are
        cons.dered to be measurement endpoints since they can be measured directly.
        ANALYSIS
                   Characterization
                    of Exposure
          Exposure potential was evaluated by
          examination of literature on rhizobia,
          PMN laboratory data, and
          greenhouse data.  Field test
          procedures were developed to
          minimize exposure in the field test.
     Characterization of
      Ecological Effects
Effects were evaluated based on
the literature, PMN greenhouse
studies, and PMN construct data.
       RISK CHARACTERIZATION
       Risk characterization focused on the exposure data that limited risk
       S25?T ?Hri!?arily t0 smal|-scale issues- s"ch as effects on alfalfa yield,
       which could be examined easily in the field test.
       FIELD TESTING
       mt H t Hf  »!f  .aSSeSSment> moniton'ng for microorganism movement was
       mandated for the field test so that the test could be terminated if microbes
       moved off site ,n great numbers or if adverse effects were noted. The field
       test generally confirmed the predictions of the risk assessment. Dispersal
       studies showed little off-site movement of rhizobia                 •*«   .
Figure 2-1. Structure of assessment for small-scale field tests with recombinant rhizobia
                                        2-9

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 Reviewer Comments on Risk Assessment Approach (continued)

         •      The reviewers did not consider the application of the framework to microbial
                stressors an insurmountable barrier.  However, they agreed that both the
               framework report and similar future case studies should acknowledge the unique
               properties and complexities of a living, changing  stressor.  The reviewers
                suggested that applying the framework to biotechnological risks—such as the
                release of OEMs—might require providing  the framework audience with the
                biotechnological details needed for appraising the relative importance of the risk
               factors.
2.2. STATUTORY AND REGULATORY BACKGROUND

       The "Coordinated Framework for Regulation of Biotechnology" (Office of Science and
Technology Policy,  1986) explains that the Toxic Substances Control Act (TSCA) gives EPA the
authority to review certain classes of biotechnology products. Under the coordinated framework,
biotechnology products are regulated in accordance with the use of each product (Milewski,  1990).
Uses of microorganisms  not covered by other existing authorities (U.S. Department of Agriculture,
Food and Drug Administration, EPA's Office of Pesticide Programs) are reviewed by EPA's
OPPT under TSCA; thus, TSCA serves as a "gap-filling" statute.  TSCA's applicability follows
from the interpretation that microbes are chemical substances under TSCA. Candidates for review
are limited to those  commercial microorganisms that have been altered to contain genetic
information from dissimilar source organisms.  EPA describes as dissimilar those organisms
produced using DNA from different taxonomic genera.  Such microorganisms are considered
"intergeneric."  EPA does not regulate the use of naturally occurring rhizobial inoculants.

       TSCA applies only to products developed for commercial purposes, whether for contained
systems or environmental releases.  Under Section 5 of TSCA, manufacturers and importers of
intergeneric microorganisms  must submit a PMN at least 90 days prior to beginning manufacture
or import.  Under TSCA authority, OPPT can require information on microbial biotechnology
products in order to identify potential hazards and exposures. OPPT also can require testing a
microbial biotechnology product that may  present an unreasonable risk of injury to human health or
the environment or  that is produced in substantial quantities and may result in substantial
environmental release or substantial human exposure.  Finally, OPPT can restrict the production,
processing, distribution, use, and disposal of a microbial biotechnology product if it presents an
unreasonable risk of injury to human health or the environment.

       Because TSCA applies only to microorganisms developed for commercial purposes, EPA
currently requests that industry voluntarily comply with the PMN reporting requirements for any
commercial research and development field test that involves the release of intergeneric
microorganisms involving a TSCA use. As a result, the PMN  submission for the small-scale field
test of genetically engineered strains of Rhizobium  meliloti, the subject of this ecological risk
assessment, was submitted on a voluntary basis by Biotechnica  Agriculture, Inc., in 1988.
                                            2-10

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 Approval of the field test resulted in the issuance of a 5(e) Consent Order, which bound the
 company to the protocols, monitoring procedures, and data collection approved by EPA.

 2.3.  CASE STUDY DESCRIPTION

 2.3.1. Background Information and Objective

        This case study focuses primarily on the small-scale field testing of four recombinant
 strains of R. meliloti.  Rhizobia, a general term for various species of the genus Rfuzobium, are
 Gram-negative, motile, rod-shaped, aerobic bacteria that infect legume roots.  A symbiotic
 relationship forms in which the bacteria fix atmospheric nitrogen, providing ammonium for protein
 production hi the plant. In exchange, the bacteria obtain energy from the plant in the form of
 photosynthate, specifically dicarboxylates.

        The various species and biovars ofRhizobium have been designated according to the types
 of legume plants they infect, such as alfalfa, clovers, beans, vetch, or lotus.  The specificity of
 infection by certain  species or biovars ofRhizobium has led to the loose designation of "cross-
 inoculation" groups  (Alexander, 1977).  For example, the alfalfa group consists of R. meliloti,
 which is  capable of infecting not only alfalfa (Medicago), but sweet clover (Melilotus) and
 fenugreek (Trigonella).

        The symbiotic relationship between rhizobia and legumes is of great importance in
 agriculture, as legumes typically are not fertilized with nitrogen if rhizobia are  present.  In fact,
 high nitrogen contents in soils actually suppress nitrogen fixation by the nodules.  More important,
 symbiotic nitrogen fixation contributes greatly to the nitrogen cycle.  In association with alfalfa,
 rhizobia fix nitrogen vigorously, perhaps fixing between 125 and 335  kg of nitrogen per hectare
 each year (Alexander, 1977).

        This case study has two purposes. First, the case study will examine the information
 submitted and used during the OPPT risk assessment to  determine whether the framework
 assessment process can use the information as efficiently. Second, the case study will examine the
 data generated from  the field to determine how accurately the  risk assessment process predicted
 risks associated with the field test.

        The area of concern for possible adverse ecological impacts  is the surrounding
 agroecosystem.  Ecological concerns are contingent on the ability of the rhizobia to survive and
 spread beyond the immediate area of the field site.

2.3.2.   Problem Formulation

       2.3.2.1. Planning

       This risk assessment focused on determining the  potential adverse effects of conducting a
small-scale field test with recombinant rhizobia. However, the data gathered  from the field site
also may prove useful in projecting adverse effects that could result from a large- or commercial-
                                             2-11

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scale release.  Before such a release occurs, the potential ecological effects for a large-scale release
need to be addressed.

       The PMN submission supplied laboratory data on the microorganism identity, construct
information, and microorganism characteristics and behavior.  Greenhouse data addressed the
effects on alfalfa (yield data), survival, and competitiveness of the recombinant strains (nodule
occupancy).  These data contributed to the decision-making process for approval of the small-scale
field test.  Field test protocols and a site evaluation conducted prior to the field tests also helped
reach the decision to approve the small-scale field test of these recombinant rhizobia.

       Figure 2-2 illustrates the various components  of the risk assessment  process for PMNs,
from the data submissions through the decision-making processes prior to approval for commercial
release  The field test design included several approaches to evaluating adverse effects from small-
scale releases of recombinant rhizobia. Yields of alfalfa were an indirect measure of changes in
the nitrogen-fixing ability of rhizobial strains.  Nodule occupancy indicated  competitiveness of the
rhizobial strains with the indigenous rhizobial populations. The test design  also included plans to
measure the persistence of the microorganism in the rhizosphere.  Finally, to test  the prediction
that only limited dissemination of the recombinant microorganisms  beyond the site would occur,
the test design included monitoring both soil and air for the presence of these microorganisms.

        2.3.2.2. Stressor Characteristics

        The primary stressors in this case study are the recombinant rhizobia, as opposed to
 chemical or physical stressors.  In this study, the stressor has the potential to split into
 subcomponents of a biological nature (pathogenicity, altered legume growth resulting from the
 microbe) and subcomponents of a chemical nature (production of toxins,  detrimental metabolites,
 and overproduction of nitrate).

        As with chemical stressors, characterizing the recombinant microbes to predict their
 potential adverse effects constitutes a critical component for the risk assessment.  For the
 recombinant microorganism, characterization includes a description of the donor and recipient
 microorganisms, including their taxonomic derivation.  The phenotypic traits of most OEMs
 reviewed  in OPPT are encoded and analyzed with a PC-microcomputer version of the  Micro-IS
 software package; this data system was originally developed by the National Institutes of Health
 (Segal,  1988).  A description of the techniques used to construct the PMN  microorganism also
 contributes to characterization of the GEM.

         The final step for GEM identification involves verifying that GEM DNA contains the DNA
 of interest, along with additional  vector DNA. This analysis is based on PMN submission
 information that usually includes  the following:

     '    •      construction of the DNA cassette that codes for traits such  as enhanced  nitrogen
                fixation;

         •     a complete description of the integration site hi the R.  metiloti genome;
                                               2-12

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                                                    §
                                                   •o
                                                   •a
                                                   42

                                                   I
                                                   1
2-13

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       •      construction of the vector containing the cassette;

       •      introduction of the vector carrying the cassette into the recipient microorganism;
              and

       •      final construct and genetic stability of the PMN microorganism.

       OPPT reviewed data from restriction digests, DNA probe verification, and phenotypic
analysis of recombinants for this step of GEM characterization.  OPPT also used DNA sequence
data bases and software such as GENEMBL and DNA Star to examine introduced sequences.
These sequences are examined to determine functions of identified DNA and the potential for
unidentified DNA sequences (such as open reading frames) to encode known protein products.

       Table 2-1 summarizes the recombinant rhizobia tested in the  1989-1990 field tests.  The
genes inserted in the four recombinant  strains were  added to the same insertion site, the ino site.
Note that each wild-type R. meliloti  recipient contains the usual complement of nif genes necessary
for nitrogen fixation.

Table 2-1.  Table of Recombinant Rhizobia for 1989-1990 Field Tests

PMN No.
P88-1116
P88-1118
P88-1120
P89-280
Biotechnica
Agriculture,
Inc., Strain
RMB7101
RMB7201
RMB7401
RMB7103

Recipient
RCR2011"
PCb
UC445C
RCR2011

Modification
o/nega/strep/spec
omega/strep/spec
o/wega/strep/spec
omega/strep/spec/nif

Insertion Site
ino
ino
ino
ino
 *  Streptomycin-sensitive parent of R. meliloti strain Rml021. Strain Rml021  is a spontaneous
   streptomycin-resistant mutant arising from strain RCR2011. Strain RCR2011 is derived from a
   natural isolate, strain SU47 (Rothamsted Experimental Station collection).
 b  Natural isolate obtained in 1986 from a root nodule of inoculated alfalfa plant grown in soil from
   the Chippewa Agricultural Station, Pepin County, Wisconsin.
 c  California soil isolate (UC445 or  CA445) effective  in the alfalfa cultivar Hairy Peruvian.

        Each introduced sequence of the constructs was examined for the potential to cause adverse
 impact.  The insertion site, too, may disrupt recipient DNA. The altered or added DNA sequences
 are noted below, along with their potential ecological impact (see figure 2-3 for additional
 information about constructs):

        •     ino insertion site.  The ino sequence encodes genes responsible for the metabolism
               of myoinositol, a substrate usable as  a carbon source during saprophytic growth. If
               an introduced DNA sequence inactivates genes at this insertion site, rhizobia would
                                              2-14

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              promoterItePlnifH leader/nifA/omega/inp

ino = inositol region of R. meliloti located on megaplasmid pRmeSU47b

TiT2  = transcriptional terminator sequences from the rrriB gene that encodes the 5S rRNA of
Escherichia coli

nijD promoter = promoter derived from Bradyrhizobiumjaponicum

tet fragment =  200 bp of the tet* gene derived from pBR322

niJH = synthetic 21 bp oligomer linker with two added restriction sites plus the R.  meliloti nifHDNA
that encodes untranslated leader RNA of niJH gene

nifA  = R. meliloti nifA gene

omega = gene constructed by Prentki and Krisch (1984) derived from plasmid R100 originally
isolated from Shigellaflexineri; encodes a transcriptional terminator and resistance to streptomycin
and spectinomycin
Figure 2-3.  Cassette diagram for RMB7103 with only primary sequences added (serves as
            illustration of a gene cassette introduced into the ino site)
                                            2-15

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              have decreased survival in soil and senescing plant roots.  No other adverse effect
              would be expected.

       •      T^, nifH.  Because the T^ termination sequence halts the transcription of the
              introduced DNA into messenger RNA, this sequence limits the effects of the
              cassette on surrounding DNA.  Consisting of only a leader sequence for the nifA
              and other genes, nifH has little likelihood of causing adverse ecological effects.

       •      nifA niJD.  A regulatory gene, the nifA sequence controls the production of the
              nitrogenase enzyme, which brings about nitrogen fixation in alfalfa.  Altered
              nitrogenase production could lead to decreased growth of alfalfa or increased
              growth of weedy relatives.  The same concerns apply to the cassette's promoter
              sequence, nifD.

       •      tet, omega.  The omega fragment encodes resistance to streptomycin and
              spectinomycin.  Transfer of these genes from OEMs to human or animal pathogens
              would render them resistant to streptomycin and spectinomycin, but such resistance
              transfer  is not of concern in small-scale field trials.  The tet gene does not encode
              resistance to tetracycline because it is only a gene fragment.

       Essentially, the  construct analysis narrowed the concerns about Effects to the potential for
decreased yield in the target legume, alfalfa. The construct analysis did not eliminate concerns for
increased  competitiveness or survival of the recombinant rhizobia relative to the wild-type strains.

       The fate of the introduced DNA hi the GEM is an ecological concern.  Natural gene
transfer of this DNA from recombinant strains to environmental receptors could produce secondary
stressors.   However, in the  case of these OEMs, careful analysis of the constructs, available
literature, and laboratory data indicated little need to monitor for the existence of secondary
stressors.   For example, under optimal laboratory conditions, genetic transfer of the megaplasmid
containing the insertion point was  not detected at a detection limit of 10* (Finan et al., 1986).
These constructs cannot transfer by means  of transposition, because the omega fragment lacks
transposition functions.   Finally, data on RMB7101 indicated a reversion frequency to a
streptomycin-sensitive phenotype of less than 6.3 x 1O8 (Sayre, 1988).

       2.3.2.3.  Ecosystem Potentially at Risk

       The field test plots consisted of less than 1  acre in the northwest corner of a 14-acre parcel
leased from a 39-acre farm. This farm is  located in Dane County, Wisconsin, directly north of the
city of Sun Prairie and 12 miles east of Madison.  Sparsely populated agricultural land lies to the
north and east of the site.  Residential areas lie within a mile to the south and 1.5 miles to the
west.  Dane County is  approximately 80 percent farmland, with approximately 80 percent of this
land in crops: corn for gram and silage, alfalfa, other hay, oats, sweet  corn, and soybeans.

       Potential biotic components of the  agroecosystem include target and nontarget legumes
(including weedy legumes), rotational nonlegume crops, native rhizobia, and bacterial pathogens
that can acquire antibiotic resistance genes from the recqmbinant rhizobia (table 2-2).
                                              2-16

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 Table 2-2. Linkages Among Assessment Endpoints and Data Needs Relevant to Endpoint
            Evaluation
Assessment Endpoint
1.
2.
3.
4.
5.
6.
7.
8.
Decreased alfalfa growth
Decreased growth of legumes outside
cross-inoculation group
Decreased growth of nonlegume crop
plants
Unanticipated effects of introduced
DNA sequences
Effects of introduced DNA on
recipient DNA at insertion site
Unanticipated effects of recipient
microbe
Effects of antibiotic resistance genes
Competitive displacement of native
Predictive Risk Endpoints Future
Assessment Monitored in Large-
Onformation Small -Scale Scale
used)' Test Issues
GH X
TX, CA
GH, CA, TX
CA
CA
TX
BSAC
X
X
X
X


"

Y
         rhizobia if coupled with any hazards
         listed in 1-3 or 9-10

   9.     Increased/decreased growth of sweet
         clover

  10.     Increased/decreased growth of
         fenugreek

  11.     Effects of coumarin on cattle

  12.     Effects on nitrogen cycle
X


X


X

X
a Legend:
  BSAC = addressed by the EPA Subcommittee of the Biotechnology Science Advisory Board
  CA    = addressed by construct analysis
  GH    = addressed by PMN greenhouse data
  TX    = addressed by taxonomic analysis of recipient rhizobia
                                           2-17

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Displacement of the indigenous rhizobia by recombinants also may alter ecosystem structure.  Such
a change would adversely affect the ecosystem if the constructs have a lower nitrogen-fixing
capacity than native rhizobia.  For example, Bradyrhizobium japonicum strain 123, which fixes
nitrogen poorly in the field, has out-competed and displaced native strains in the Midwest, resulting
in decreased nitrogen fixation in soybean plants (Tiedje et al., 1989).  Displacement of native
rhizobia by recombinants having a greater nitrogen-fixing capacity also has the potential to affect
ecosystem function adversely.  Increased soil nitrogen might disrupt the nitrogen cycle balance or
lead to localized pollution of ground water by nitrates.

       2.3.2.4.  Endpoint Selection

       The assessment endpoints reflect the delineation of the ecosystem at risk: primary concern
focused on the area immediately surrounding the field plot, with some lessening concern for areas
farther removed from the field site.  If the monitoring  of the microorganisms during the field test
had shown significant off-site movement and spread (particularly if linked with decreased alfalfa
growth in the field or other adverse effects),  then the field test would have been terminated and the
risk assessment expanded to include larger-scale issues.

        In this ecological risk assessment, many of the 12 assessment endpoints listed in table 2-2
can be measured directly, eliminating the need to identify measurement endpoints for these
assessment endpoints.  Table 2-2 links the assessment endpoints to the data needed to evaluate
them. Data relating to assessment endpoints originate  from four sources:  the literature, laboratory
studies, greenhouse studies, and the field test. Literature information and laboratory studies
conducted for the PMN can at least partially address assessment endpoints 4 through 7 of table 2-2.
Greenhouse studies for the PMN provide information on assessment endpoints 1 and 3,  while the
small-scale field test concerns assessment endpoints 1 and 8. Assessment endpoints 1 through 3
and 8 through 12 concern information needed prior to  large-scale release.  Table 2-3 links the
OEMs to monitoring and data needs.
   Comments on Problem Formulation
   General reviewer comments:
                 The following factors in the current case study set it aside from risk assessments
                 of chemical and physical stressors:

                      the unique complexities of a microbial stressor;
                 -   the real and imagined risks of genetically engineered microorganisms; and
                 —   detecting off-site migration.
                 As risk assessment experience for microbial stressors accumulates, risk assessors
                 will gain facility in addressing  these factors.   The process should result in an
                 enhanced knowledge base that, can feed back into the risk assessment process
                 itself and can be implemented in the education of scientific and regulatory
                 communities as well as the general public.
                                              2-18

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Table 2-3.  Linkages Among Stressor, Monitoring, and Data Needs Relevant to Endpoint
            Evaluation
Exposure
Element"
Detection of GEM in nodule
Survival of GEM in soil,
rhizosphere
Monitoring of GEM in soil, air,
water
Monitoring of gene transfer
Risk Assessment
(information
used)b
GH
GH,L
F
L, CA
Measurement
Endpoints for
Small-Scale Test
X
X
X

Future Large-
Scale Issues



X
  Presence of the GEM or the introduced DNA in various media is necessary for linking the GEM
  with the assessment endpoints in table 2-2.
b Legend:  CA
           F
           GH
           L
= addressed by construct analysis
= , addressed by examination of field prior to GEM release
= addressed by PMN greenhouse data
= addressed by PMN laboratory data
  Comments on Problem Formulation (continued)

         •      Releases of genetically engineered rhizobia are probably the best available
                model for initial release of OEMs. Thus, although supporting data for low risk
                of small-scale field tests were weak (compromised or poorly designed
                greenhouse studies), other factors contributed to the decision  to issue consent for
                the study, including:

                    the knowledge base on the generally innocuous nature of the rhizobia, e.g.,
                    the history of their application worldwide in the enhancement  of symbiotic
                    nitrogen fixation;
                    site characteristics that would tend to inhibit spread of the introduced
                    strains; and
                    the nature of the  genetic construct in the OEMs.
                                            2-19

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Comments on Problem Formulation (continued)

       •      The case study set criteria for termination of the test and described monitoring
              procedures.  The authors may wish to point out the extent to which exotic
              rhizobia have already been introduced in the United States and the
              consequences.  The authors do describe how the introduction of a highly
              effective and competitive Bradyrhizobium japonicum  (strain 123) became
              problematic, out-competing  indigenous rhizobia with a greater capacity for
              nitrogen fixation.  The effectiveness data,  which addressed this particular kind
              of risk, proved inconclusive.  Although most introduced rhizobia have been
              harmless, the legume kudzu (and its symbiotic rhizobia) has become an infamous
              pest in the southern  United States.
       •     In the characterization of the stressors, the authors split risks  of the OEMs into
              biological (i.e., pathogenicity, altered legume growth,  microbial competition,
              gene release) and chemical (i.e., toxins, detrimental metabolites such as
              nitrate).   This approach  appears useful in addressing risks of plant-associated
              microbes.
       •      One category of secondary stressors consists of microbial recipients that could
              acquire introduced DNA by natural gene  transfer, such as through
              bacteriophages or conjugation.  Several reviewers pointed out that the antibiotic
              marker genes were likely to be of greater concern than the nif genes themselves.

       •      The review panel expressed interest in whether risk assessment for microbial
               releases into an agroecosystem also should consider risk in the broader context
               of general ecological effects; that is, should a more general range ofnontarget
               animals, plants,  microbes, or ecosystem function be incorporated as
               measurement endpoints for the general health of the ecosystem?  The case study
              focuses on decreased production in a commercially  important crop as  opposed
               to effects on surrounding ecosystems.  However,  a risk to surrounding
               ecosystems may not be a risk to the agroecosystem.  Although the study
               discussed broader ecological risks outside the field site, the study considered the
               risk of exposure  beyond the site as minimal
                                            2-20

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    Comments on Problem Formulation (continued)

    Authors'comments:

           •      At the time the Agency reviewed this proposed field test (1988), it was not
                  deemed necessary to assess risk in the broader context of general ecological
                  effects such as the general range ofnontarget animals, plants, microbes, or
                  ecosystem Junction for several reasons'.  First, the field test was a small-scale
                  test that was expected to remain small scale given the data available in  the
                  literature on rhizobial movement and specific site characteristics for this test.
                  Second,  there was no reason to expect that the genetic modifications made to the
                  recipient rhizobial strains would result in any broad ecological consequences.
                  The genetic alterations of (1) enhancing the existing trait of nitrogen fixation
                 and (2) insertion of antibiotic resistance genes to serve as markers for detection
                 were not expected to confer on these microorganisms the trait of pathogenicity
                 to plants or animals,  nor to alter the host range  of plants these rhizobia can
                 infect (nodulate).  Competitiveness  of the recombinant rhizobia relative to  the
                 parental strains and indigenous rhizobia was addressed in the field studies.
                 Similarly, in 1988, standardized validated protocols for assessing  disturbances
                 in ecosystem junction were not available.  Currently, the processes of (1)
                 identification of ecologically significant endpoints for assessing ecosystem
                 function, (2) the development of protocols/methodology for assessing those
                 endpoints, and (3) the interpretation of results from  such tests are all still in
                 their infancy.

          •      Because EPA's framework report did not address several aspects of an
                 ecological risk  assessment relevant to biological  stressors, addressing these
                 aspects proves difficult.  In this ecological risk assessment, two key facets in
                 particular were difficult to address:  (1) the  need to identify construct issues in
                 general and to  use the construct information to lessen the concerns for fate and
                 effects and (2) the need to monitor the  movement and survival of the OEMs in
                 different media.  The exposure elements in table 2-3  were critical to identifying
                 the ecosystem at risk,  but including  the table proved problematic within the
                 context of the framework guidance.

          •      In addition, it was difficult to decide which table 2-2 endpoints  to list and
                 whether these endpoints were assessment or measurement endpoints in this
                particular case study.
2.3.3. Analysis:  Characterization of Exposure

       The exposure profile in this case study can contain specific information because both the
intended number of microorganisms to be applied and the area of application are known.  The test
specified applying microorganisms by means of in-furrow spraying at the time of planting.  The
                                             2-21

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test
           a total of approximately 6 X 1012 microorganisms to approximately 0.8 acre.  The first
  each Burred" on May 24,  1989, consisted of 5.52 X  10- cells for a strain comparison
test  The second release, which took place on May 25,  1989, contained 5.52 X  10" cells for a
strain competition test.  Monitoring these microorganisms continued for 2 years,  collecting yield
data for alfalfa over two growing seasons.  Post-termination monitoring of recombmant rhizobia in
soil extended months beyond the last alfalfa harvest.

       Although the initial exposure is well characterized, uncertainty regarding  exposure over
time arises as a result of microbial death, reproduction,  and transport. Considerations Delude
survival in soil and root nodules and dissemination away from the planted rows within and beyond
the field plot as a result of vertical and horizontal movement through the soil or through wind-
vectoring of aerosolized microbes.

       2.3.3.1.  Stressor  Characterization

       Laboratory studies  showed that recombinants in bulk field soil underwent a 1-log  reduction
in survival over a 4-week period.  Literature on rhizobial survival in soil available at toe  time of
the PMN review indicated that only  limited horizontal and lateral movement of rhizobia in soil
would occur  Three studies indicated that lateral movement by wind, water, and bactenal motility
was on the order of only 2.5 to 5 cm (Kellerman and Fawcett,  1907; Robson and Loneragan
 1970- and Brockwell et al., 1972, as cited in Madsen and Alexander, 1982).  However some of
these studies have limited utility as a result of their qualitative nature, use of autoclaved soil, or
lack of proper controls.

        Aside from survival as intact cells in soil, rhizobia exist in a morphologically altered form
 (bacteroids) in root nodules. These  intranodal rhizobia can survive saprophytically at the end of
 the growing season, when the alfalfa senesces.  These populations can then reinfect alfalfa in the
 field the following year. Consequently, the rhizobial population in the soil shows  seasonal
 variations.

        The present case study needed to determine how well the recombinants could be  monitored
 in the field. The 1988 PMN presented minimum detection limits and recovery efficiencies for tte
 rhizobial strains, based  on the technologies available at that time.  At the time of this review ^ EPA
 considered the use of selective antibiotic media as the appropriate method for monitoring rhizobial
 numbers in this small-scale field test.

         In the data submitted with the PMN,  the company reported that use of selective antibiotic
 media gave an actual minimum detection limit (MDL)  between 2 x 104 and 2 x  itf cells/g soil.
 The use of fluorescent antibody (FA) technique lowered the MDL to 103 to 10* cells/g soil.
 Appendix A provides additional details of the monitoring and enumeration techniques.

         In circumstances with low rhizobial counts, such as horizontal dispersal studies  field tests
 may require a more sensitive detection limit.  To meet this need, a most probable number (MPN)
 enumeration procedure was developed.  This MPN technique involved  placing alfalfa plants in
 growth pouches and infecting their  roots with dilutions of soil  suspensions. Any plants in which  at
 least a single nodule formed was scored as a positive.  In some cases,  laboratory personnel
                                              2-22

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 identified the rhizobial strain present in nodules on the plants exposed to the highest dilution that
 resulted in nodule fonriation.  Although the MPN technique inherently has a high statistical error, it
 gives a minimum detection limit of approximately 10 cells/g soil using soil from the field test site.
 The MPN technique was more sensitive but less quantitative than the other enumeration methods.

        Prior to the field tests, the MPN technique was used to determine the number of indigenous
 rhizobia in the field site soil.  At the Sun Prairie site, the number of indigenous rhizobia was <10
 rhizobia/g soil.

        The PMN submission included both routine and emergency termination procedures, which
 received EPA approval prior to the field studies.  Routine termination procedures after completion
 of the field tests included plowing under the test plots and, if necessary, applying glyphosphate
 herbicide to kill any remaining alfalfa or weeds.  Severe adverse  effects such as die-off of the
 alfalfa, tremendous increases in population density, or movement off-site would indicate a need for
 emergency termination.  Emergency procedures included treatment of the test area with methyl
 bromide to rninimize the microbial populations. EPA did not specify the exact criteria that should
 have triggered emergency termination procedures. Instead, EPA advised the company to report anv
 "irregularities."                                                            v   j      v     j

        2.3.3.2. Ecosystem Characterization

        The ecosystem under consideration was a 0.8-acre (275 ft. x 300 ft.) field site plus the
 immediate surrounding agroecosystem in Dane County, Wisconsin (with lesser concern for areas
 farther removed from the site itself).  The test site lay 500 feet  from a road and was separated from
 it by a fence.  The majority of the field was Piano silt loam that consisted of deep, well to
 moderately drained soil on glaciated uplands.  The soil contained high levels of phosphorus,
 potassium, magnesium, manganese, iron, zinc, and copper.  Organic matter was 3.3 percent, and pH
 was 6.8. Organic nitrogen content was not supplied, but was roughly estimated at 0.19 percent.1
 In a later PMN submission, the company stated that a nitrogen content of 0.20 percent was limiting
 for alfalfa growth.                                                                         &

       The slope of the field was approximately 2 percent from east to west. Dane County
receives approximately 31 inches of rain each year. Although infrequent, some runoff from the test
plot was expected.  The runoff would drain into a ditch south of the site and then enter a culvert
that empties into Koshkonong Creek and eventually into Koshkonong Lake.  The study did not
monitor microorganisms in runoff water because their level was expected to be below detection
limits.  The site area had no  wells that could become contaminated by dispersing microorganisms.
 As a very rough estimate of organic nitrogen levels, one may assume a conversion factor of 1 724
 between organic matter and organic carbon (Broadbent, 1965).  Therefore, the organic carbon content
 should be approximately 3.3 percent/1.724 = 1.9 percent organic carbon.  Most agricultural surface
 soils have C:N ratios of approximately 10:1 (Breioner, 1965), suggesting that fee soil had a nitrogen
 content of approximately 0.19 percent,,
                                            2-23

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       To address concerns that R. meliloti might infect nontarget legumes, the 14-acre test area
and the ditch separating the test area from the road were scouted before and during the field trials
for the presence ofMettlotus (sweet clover) and weedy Medicago species.

       2.3.3.3. Temporal Analysis

       The field trials ran for a maximum of 2 years, but the company reserved the option to
terminate the trials earlier if it so desired.

       2.3.3.4. Exposure Analyses

       To determine the spatial and temporal distributions of the OEMs at the field site, several
studies were performed before the field test. These included laboratory studies on survival of the
OEMs in pure culture, survival in soil,  survival in rhizosphere soil in the greenhouse, and the
ability of the OEMs to infect alfalfa in greenhouse studies.

       The PMN included laboratory survival data of several recombinant rhizobial strains hi
soils.  Unfortunately, the studies employed soils obtained from areas other than the test site.  In
addition, some of the studies failed to include parental strains as controls.  R. meliloti strains
RMB7101  and RMB7201  showed a 1- to 2-log reduction in numbers over a period of 6 weeks hi
both Chippewa soil and hi soil obtained from another field.  Later studies  tested a streptomycin-
resistant spontaneous mutant of RCR2011 against the four recombinant strains used in the field
tests.  Approximately a 1-log reduction hi numbers for all the strains occurred over 4 weeks, with
no significant difference between strains.

       The PMN submission contained some data concerning the persistence of the recombinant R.
meliloti hi the rhizosphere. The rhizosphere samples were separated into two fractions, the inner
and outer rhizospheres. Soil aggregates that fell off the roots with vigorous shaking represented
the outer rhizosphere, while the inner rhizosphere consisted of the remaining root system and
associated soil.  Recombinant rhizobia /persisted in both soil fractions  and  hi nonrhizosphere soil,
with only slight declines hi numbers over the 3-week study.

       The PMN included two pilot tests of nodule  occupancy to study competitiveness of the
rhizobial strains. Competitiveness, hi this context, means the ability to form nodules hi alfalfa
roots when competing with another RMzobium strain. The presence of a strain hi a nodule suggests
that it is the strain that caused the nodule to form. In one study, the two parental strains,
RCR2011  and PC,  showed no significant differences in competitiveness when inoculated into
alfalfa hi a 1:1 ratio.  The second test indicated no significant difference hi competitiveness
between a naturally occurring and a recombinant strain that was not one of the stressors hi the test
study.

       EPA recommended including nodule occupancy as part of the field trials because of the
absence  of greenhouse nodule occupancy data for the OEMs  hi the field test.  Also, nodule
occupancy data can link altered alfalfa yield with the recombinant rhizobia. The field data on
nodule occupancy showed no significant differences  hi nodule occupancy between the recombinant
and the wild-type rhizobia (appendix D).
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       Monitoring the microbe at the field site can indicate whether the GEM is associated with
changes in alfalfa yield and can track OEMs beyond the field site. The study monitored vertical
horizontal, and aerial dispersal of lie recombinant rhizobia by means of the strain comparison test
described in appendix C.

       Analysis  of exposure also included a strain comparison test to determine the efficacy of the
inoculahts.                                                                         3
  Comments on Characterization of Exposure

  General reviewer comments:

         •      The technology for monitoring the spread of introduced strains from the
                inoculation site suffered from potential limitations of sensitivity and specificity.
                Newer, more sensitive and highly specific technologies (e.g., pofymerase chain
                reaction fPCRJ amplification of strain-specific sequences, strain-specific probes,
                marker cassettes) could be brought to bear on these problems.  The
                manufacturer also could provide quality assurance/quality control of the methods
                used to monitor these important endpoints (e.g., proper controls, background
               levels of native rhizobia).

        «     Further work on developing the idea of meaningful estimates of exposure to a
               microbiological stressor is needed. An examination of the uninoculated  alfalfa
               border plants for nodule occupancy by strains introduced within the field plots
               might give another indication of their spread.
 Authors' comments:                                \

        *      Newer, more sensitive methods such as gene probes, PCR, or marker cassettes
              for detection of microorganisms in environmental samples have been developed
               in recent years. However, at the time of this submission, in 1988, those
               techniques were not routine laboratory analyses, and these laboratory research
               techniques have just recently been refined for use in environmental matrices.
               The use of antibiotic-selective media,  supplemented with  the fluorescent antibody
               technique,  and the use of the MPN growth pouch technique were deemed
               appropriate by the Agency at the time of the review. The company was not
               required to submit actual QA/QC documents, but its use  of appropriate methods
              and protocols,  the use of proper controls as well as other aspects of its field
               experimental designs, and determination of background levels of rhizobia was
              reviewed by the Agency before the field test.
                                          2-25

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2.3.4. Analysis:  Characterization of Ecological Effects

       2.3.4.1.  Evaluation of Effects Data

       The primary effects data reviewed prior to the field test consisted of greenhouse studies that
examined alfalfa yields resulting from infection with recombinant rhizobia.  For these studies,
plants were grown in sterile vermiculite inoculated with RMB7103.  Because vermiculite is
nitrogen limiting,  nodule occupancy data were  probably not needed to show a causal link between
rhizobia in the nodules and top growth of plants. One study demonstrated that no significant
difference occurred in the growth of alfalfa plants inoculated with the parental strain, RCR2011,
and a recombinant strain, RMB7101.  Similarly, no significant difference in alfalfa yield occurred
for plants inoculated with parental strain RCR2011 or recombinant strain RMB7103.  In one study,
recombinant strain RMB7103 gave a yield increase of 7.0 percent compared with RMB7101.
Another study using these same recombinant strains showed no significant difference in their effect
on alfalfa yield.  Field yield studies also showed a lack of significant yield effects  (appendix F).

        However, the results of the greenhouse yield data were questionable for two reasons.
First, the studies reported data as fresh weight of alfalfa top growth rather than as  dry weight.
Secondly, the studies were  of short duration.  Harvest of the alfalfa plants occurred 3 weeks after
planting, but it usually takes 11 days for nitrogen fixation to begin.  Consequently, these data
demonstrated growth for only 10 days after the onset of nitrogen fixation hi the nodules,  making it
difficult to interpret the effects of the inserted  genes.

        The study did not collect data on the growth of sweet clover or fenugreek,  nor did the
 1989-1990 field test generate data on effects on nonlegumes or on legumes  outside the cross-
inoculation group. A 1987 PMN offered limited qualitative information that indicated a lack of
effects on such plants. The earlier PMN greenhouse studies exposed soybeans, peas, tender green
beans, and  clover to inoculation levels of 109 rhizobial cells/g of soil. Results indicated no adverse
effects.  Similarly, corn and ryegrass, crop plants commonly grown in rotation with alfalfa,
showed no  adverse effects from such exposures.

        2.3.4.2.   Evaluation of Causal Evidence

        This section evaluates the strength of the relationship between the stressor  and the
 measurement endpoint, yield of alfalfa. Problems associated with the greenhouse tests are noted in
 this section.  In addition to the problems already noted for the greenhouse studies, extrapolating
 from the greenhouse to the field also presents  difficulties.  For example, such an extrapolation
 must take into account that the greenhouse and the field differ in climate, soil, and pest species.

        2.3.4.3.   Effects Needing Study in the Event of Significant Off-Site Migration or
                  Large-Scale Release

        This risk assessment assumed that only limited off-site migration of the rhizobia would
 occur.  If,  however, this risk assessment had been conducted for large-scale releases or if large
 numbers of rhizobia moved off-site,  the risk assessment would need to address at least six main
 ecological concerns.
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             Increased competitiveness.  If large numbers of rhizobia moved off-site, then the
             risk assessment would need to examine whether the increased population resulted
             from enhanced competitiveness relative to native rhizobia.  Displacement of native
             rhizobia by increased competitiveness would be a concern if the GEM decreased the
             growth of alfalfa or increased the growth of weeds.

             Increased nitrogen production.  Increased nitrogen production by alfalfa and other
             legumes may increase soil nitrogen enough to contribute to nitrate pollution of soil
             or ground water.

             Alteration of host range.  Alteration of host range can result in effects on legumes
             other than those that R. mettloti is known to infect. However, host range alteration
             appears unlikely for the submitted OEMs because no manipulations occurred  in the
             loci important to host range specificity.

             Effects on nonlegumes.  Because naturally occurring rhizobia have no effect on
             nonlegumes, including those grown in rotation with alfalfa, effects on nonlegumes
             appear unlikely.  In addition, information about the constructs gives no reason to
             suspect such effects.

             Effects on sweet clover and fenugreek.   Increased growth of the sweet clover
             (Metilotus) when it occurs as a weed in another crop could adversely affect the
             agroecosystem by decreasing the quality of the planted crop or by increasing
             production of coumarin, a secondary metabolite found in the sweet clover plant that
             is hazardous to livestock.  Decreased growth of fenugreek or of sweet clover (when
             grown as a crop) also could adversely affect certain agroecosystems. The
             greenhouse and field data  on alfalfa yield would not be predictive of the effects of
             rhizobia on these other legumes.

             Spread of antibiotic resistance. Large-scale releases offer a greater opportunity for
             transfer of these resistances to bacterial pathogens of humans and animals.
Comments on Analysis:  Characterization of Ecological Effects

Strengths of the case study include:

       •       The body of knowledge on the effects of previous uses of rhizobia (rhizobial
               inoculation has been practiced for almost a century) and the well-characterized
               strains in the case study compensate, in part, for the weakness of monitoring
               effects.
                                           2-27

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  Comments on Analysis:  Characterization of Ecological Effects (continued)

  Limitations include:

          •      Neither the yield data from poorly designed and implemented greenhouse studies
                 nor the highly variable data from the field tests themselves could reliably
                 comment on the efficacy of the introduced genetically engineered rhizobia.

          •      Table 2-2 in the study lists 12 assessment endpoints and the sources of
                 information used to evaluate them, but only alfalfa growth was addressed in the
                 study.  Off-site migration was considered, and the field test itself contributed
                 data with regard to the  movement of rhizobia off-site.
2.3.5.  Risk Characterization

        2.3.5.1.  Risk Estimation

        The risk of conducting the small-scale field test was considered low.  The field test would
collect data on alfalfa yield and microorganism fate.  Decreased alfalfa yields, increased
competitiveness, or movement off-site could have triggered termination of the field test.

        The study did not evaluate several assessment endpoints because of the small likelihood of
off-site dispersal.  Both the characteristics of the field site and the test protocol supported this
position (see section 2.3.3.)  The field site's low slope minimizes surface water runoff,  and the site
contains no wells. In addition, the test protocol also limited movement off-site through  (1) the in-
furrow  spraying technique for rhizobial application, (2) on-site decontamination of equipment and
disposal of plant material, and (3) growth of rye grass and uninoculated alfalfa borders around test
plots.  Further, monitoring of soil and water evaluated off-site movement, while the test protocol
also established emergency termination procedures in the event that significant spread appeared
likely.  Data collected during the small-scale field test confirmed the prediction that only limited
off-site movement of rhizobia would occur.  Appendix C presents the results of the aerial, lateral,
and vertical dispersion studies.

        Even if dispersal had occurred,  the numbers of microorganisms required for legume
infection may have precluded effective nodulation of other legumes near the site.  The PMN
submission suggests  103 rhizobial cells/seed for agricultural application.  Others have noted
infection concentrations of 100 to 1,000 rhizobial cells/g soil for effective nodulation of legumes
(van Elsas et al., 1990).  Consequently, the assessment did not address large-scale effects such as
effects on the nitrogen cycle and the spread of clinically important antibiotic resistances.  To  assess
enhanced growth of weedy legumes, the study examined the 14-acre site for sweet clover and
weedy Medicago species (as noted in section 2.3.3).  The  study did not assess exposure to the
legume fenugreek because this crop  plant grows only in certain portions  of the United States.
                                             2-28

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        Appendix B presents the data on the competitiveness and survival of the rhizobial strains,
 as measured by nodule occupancy and persistence in the rhizosphere.  The low viability of some of
 the inoculant strains (appendix E)  affects the data in appendices B and C.  As predicted from the
 greenhouse data, the rhizobial strains became established and survived well in the rhizosphere.
 Nodule occupancy tests demonstrated that the inoculant strains were fairly competitive compared
 with indigenous rhizobial populations. The recombinant and naturally occurring strains showed no
 significant differences in survival or competitiveness.

        2.3.5.2.  Uncertainty

        Both effects and fate data and information in the PMN had elements of uncertainty.  For
 the greenhouse yield data, uncertainty resulted from the protocol, the alfalfa cultivar relative to the
 field trials, and the extrapolation to field results.  The alfalfa yield in the field may not have
 reflected the ability of the rhizobia to increase alfalfa growth because the test did not measure total
 nitrogen in the field soil, and high levels of nitrogen can inhibit nodulation by rhizobia. Heavy
 weed and leaf hopper  infestations also may have confounded the alfalfa yield data.

        Uncertainty also exists regarding the effects on weedy legumes and other crop legumes in
 the cross-inoculation group for R. meliloti. For the OEMs undergoing field testing, no data existed
 that would have indicated their competitive ability to nodulate alfalfa relative  to native  rhizobia.

       Fate data and information in the PMN also had elements of uncertainty associated with
 them.  Extrapolation from pure laboratory culture and greenhouse studies to the field is
 questionable.  How well the monitoring techniques could distinguish the released rhizobia from
 each other and from the indigenous rhizobia is also uncertain.

       2.3.5.3.  Risk Description

       After completion of the field test, the risk assessment indicates that the likelihood of
adverse effects occurring either in the field or beyond the field border  is considered low because of
limited dispersal from the site, site termination procedures, the number of rhizobia  needed to infect
alfalfa plants, competition from native rhizobia, and the natural decline in cell populations expected
in the absence of further alfalfa planting.  Other effects noted for large-scale release of rhizobia
will be addressed should large-scale releases become likely (see section 2.3.3).
  Comments on Risk Characterization

  Strengths of the case study include:
                The case study characterized as low the risk associated with limited release of
                genetically engineered rhizobia into a small-scale field site.  This assessment
                was based on the generally held view that rhizobia are fairly innocuous
                bacteria, that the site would effect adequate containment of the released
                bacteria, and that the genetic construct would preclude transfer of the
                introduced nif genes as well as the antibiotic resistance markers to other strains.
                The reviewers generally were satisfied with that assessment.
                                             2-29

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Comments on Risk Characterization (continued)

Limitations include:

       •      The effects data on efficacy were lacking, and there was considerable
              uncertainty in monitoring data because of the limitations of the chosen methods.
              Some attempt should have been made to address these shortcomings.

General reviewer comments:

       •      The case study should have included a table that addressed the uncertainties
              introduced by the assumptions made.  For example, the study assumed that the
              plate-counting technology used to estimate the spread of introduced strains can
              distinguish between the introduced strains and indigenous R. meliloti. Similarly,
              the study should either give a literature citation or acknowledge the following as
              an assumption:  an infective dose of l(f rhizobial cells/seed establishes a safe
              level of escaped rhizobia at less than 10*/g soil.

       •      The case study might formulate action thresholds that would trigger the
              termination of the small-scale field test.  These thresholds should consider the
              minimal infective dose and available data on persistence of the OEMs in the
              soil. For example, a test would be terminated when plate-counting on medium X
              detects more than 1,000 GEMs/g soil.

       •      As in all risk assessments, difficulty quantifying the hazard quotient leads
              assessors to argue for reduced exposure. Reviewers generally agreed that the
              risk assessors should attempt  to bring quantification of the risk components of
              stressors to state of the art.

       •      The reviewers also generally agreed that proper measurement endpoints should
              make possible a meaningful characterization of risk in the restricted small-scale
              test.
                                           2-30

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Comments on Risk Characterization (continued)

Authors' comments:

       •     It is inappropriate to establish a level of safety for escaped rhizobia at itf
              cells/g soil for several reasons.  First, it is impossible to establish a safety level
              of a certain number of microorganisms  that is below the detection limit for that
              microorganism.  Second, it is not known exactly how many rhizobia are needed
              for a nodule formation. As discussed in section 2.3.5.1, according to the PMN
              submission,  l(f cells/seed is the international standard inoculation rate for R.
              meliloti.  This rate is supposed to ensure that the inoculant strain will be able to
              outcompete  indigenous rhizobia. Another report in the literature suggested that
              Itf to Iff cells/g of soil are needed for effective nodulation of legumes (van
              Elsas et al., 1990); however, no data were supplied in this paper, and no
              reference was given for where these particular data could be obtained.   Third,
              knowledge of the ecology of rhizobia indicate that rhizobial numbers are
              greatest in the rhizosphere of leguminous plants and may drop off several orders
              of magnitude in the bulk soil away from the plant. Rhizobia populations are
              known to persist in soils at low numbers for long periods of time, but will
              increase dramatically if the leguminous  host plant is introduced into that soil
              Consequently, it is inappropriate to establish any specific number as a safe level
              of escaped rhizobia in soil, even if one defines the portion  of the soil that one is
              sampling, and even if one were to select a specific number that actually could
              be measured in this study.

       •      Knowledge of rhizobial ecology precludes the formation of "action thresholds"
             for rhizobia.  It is inappropriate to put exact quantitative values on what level is
              safe and what level would trigger emergency termination of the small-scale field
              tests because of (1) a general lack of knowledge of exactly  how many rhizobia
              are needed for infection, (2) the variability in population densities in the
              rhizosphere vs.  soil at increasing distance away from the plant roots, and (3) the
              ability to stimulate rhizobial growth even after several years by planting the
              suitable  leguminous host as discussed above.

       •      The reviewers again request that state-of-the-art methodology be used.  As
              discussed in  the  case study and above, at the time this review was conducted
              (1988), antibiotic-selective media supplemented  with the fluorescent antibody
              technique and the MPN growth pouch methods were deemed appropriate for
              these field tests.  Great advances in methodology for detection of
              microorganisms in the environment over the past few years  may allow for
              greater sensitivity in measurements for future studies.
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2.4. DISCUSSION BETWEEN RISK ASSESSOR AND RISK MANAGER

       The 5(e) Consent Order (DCO 50-899004545) summarized how to conduct the field test
and which data to collect.  The Consent Order specified the following items:

       »     The field test will use EPA-approved protocols that will describe test objectives,
              field site,  methods  of transport of microbes to site, methods to limit dissemination,
              methods for detection and identification, descriptions of sampling procedures, and
              analysis of data.

       •     The test will provide data on the following (with proper controls):  nodule
              occupancy for all four recombinant microbes; alfalfa yield effects of all four PMN
              microorganisms; persistence in the rhizosphere with RMB7101 and RMB7103;
              vertical dissemination of RMB7101 and RMB7103; horizontal dissemination of
              RMB7101  and RMB7103;  and aerial dissemination of RMB7101 and RMB7103
              beyond the test plot during inoculation and termination.

       •     The test will comply with applicable provisions of the Good Laboratory Practice
              Standards (40 CFR 792).

       •     Microorganisms not used in the test will be disposed of in accordance with the NIH
              Guidelines for Research Involving Recombinant DNA Molecules (51 FR 16958).

       •     Reports on progress of the field test will be provided every 3 months.

       •     The company will  terminate the test if an event occurs  indicating that the
               microorganisms have caused an adverse effect that EPA believes presents an
              unreasonable risk of injury to the environment.

2.5. RISK VERIFICATION

2.5.1. Persistence

       The small-scale field tests verified the risk assessment conducted for this PMN submission.
As expected from knowledge of rhizobial behavior and from greenhouse data, the recombinant
rhizobia  persist in the rhizosphere of alfalfa plants (see appendix B).  The recombinant strains that
the field trials investigated for persistence—strains RmSF38, RMB7101, and RMB7103—survived
at rates of lOMO6 cells/g dry root into the second year of the field study.

2.5.2. Competitiveness

       As an indication of competitiveness of the recombinant rhizobial strains relative to
unmodified strains, the study included nodule occupancy tests.  Those  conducted in the greenhouse
used recombinant strains  similar to the subject GEMs, while those subsequently conducted in the
field used subject GEM strains. Neither set  of occupancy tests indicated any significant difference
                                            2-32

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 in nodule occupancy for recombinant and parental strains (appendix C). However, in the strain
 competition trials, the recombinant strains appeared somewhat less competitive than the wild types.
 Interpretation of the data from this latter study proved difficult, however, because problems with
 culture viability prevented the desired ratio of 1:1 for the application rate of recombinant:parental
 strain (appendix E).                                    i

 2.5.3.  Dissemination From the Test Site

        Information in the literature suggested that little off-site movement of rhizobia would occur
 during the test studies. The various dispersal studies conducted during the field trials confirmed
 this prediction (appendix C).

 2.5.4.  Effect on Alfalfa Yield During Field Test

        Appendix E presents the alfalfa yield from the field studies and compares these with the
 greenhouse studies submitted as part of the PMN.  This  information is useful for validating both
 the risk assessment done by OPPT and this case study performed under the framework guidance.
 As predicted from the laboratory and the greenhouse studies, the construct analysis, and the
 literature, no adverse effects on alfalfa growth occurred with any of the rhizobial strains tested.
 Significant increases in yield also did not occur.  Most importantly, no significant differences
 occurred between the use of the wild-type  parental strains and the recombinant rhizobial strains.

 2.6.  KEY TERMS

 biovar—A group of bacterial strains that can be distinguished by special biochemical  or
       physiological properties that are consistent (but insufficient to justify a subspecies name for
       the group).

 cassette—Structural and regulatory DNA sequences introduced  into a GEM  that allow the GEM to
       express a phenotypic trait of interest to the PMN submitter.

 construct—1. (adj.) Information describing the DNA and genetic manipulations used to create the
       GEM.  Such information covers the cassette, site of cassette insertion, use of vector DNA,
       intermediate recipients, and final recipients of cassette sequences.  2.  (n.) The final genetic
       makeup of a GEM, including information noted for use of this term as an adjective.

cultivar—A group  of individual plants that  differ from others within the species due to certain
       consistent phenotypic traits (synonym:  "variety").

vector—DNA sequences such as plasmids used to move the DNA of interest (usually cassette
       DNA) from one organism to another.
                                             2-33

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2.7. REFERENCES

Alexander, M. (1977) Introduction to soil microbiology. New York, NY: John Wiley & Sons.

Bremner, J.M. (1965) Organic nitrogen in soils. In: Bartholomew, W.V.; Clark, F.E., eds. Soil
       nitrogen.  Agronomy No. 10. American Society of Agronomy, Madison, WI, pp. 93-149.

Broadbent, F.E.  (1965) Organic matter. In: Black, C.A.; Evans, D.D.; White, J.L.; Ensinger,
       L.E.; Clark, S.E., eds. Methods of soil analysis. Agronomy No. 9. American Society of
       Agronomy, Madison, WI, pp. 1397-1408.

Finan, T.M.; Kunkel, B.; DeVos, G.F.; Signer, E.R. (1986) Rhizobium meliloti genes required for
       C4-dicarboxylate transport and symbiotic nitrogen fixation are located on a megaplasmid. /.
       Bacterial. 170:927-934.

Kellerman, K.F.; Fawcett, E.H. (1907) Movements of certain bacteria in soils.  Science 25:806.

Madsen, E.L.; Alexander, M. (1982) Transport of Rhizobium arid Pseudomonas through soil. Soil
       Sci. Soc. Amer. J. 46:557-560.

Milewski, E. (1990) In: Nakas, J.P.; Hagedorn, C.,  eds. Biotechnology of plant-microbe
       interactions.  New York, NY: McGraw-Hill Publishing Company, pp. 319-340.

Office of Science and Technology Policy. (1986)  Coordinated framework for regulation of
       biotechnology; announcement of policy and notice for public comment. Federal Register
       51:23302-23393.

Prentki, P.; Krisch, H.M. (1984) In vitro insertional mutagenesis with a selectable DNA fragment.
       Gene 29:303-313.

Robson, A.; Loneragan,  J. (1970) Nodulation and growth of Medicago truncatula D on acid soils.
       Part 1. Effect of calcium carbonate and inoculation level on the nodulation of Medicago
       truncatula D on a moderately acid soil. Aust. J. Agric. Res. 21:427-434.

Sayre, P. (1988) Ecological hazard assessment and construct analysis for PMN submission P88-
        1115 through -1122.   Office of Toxic Substances, U.S. Environmental Protection Agency,
       Washington, DC.

Sayre, P. (1990) Assessment  of genetically engineered microorganisms under the Toxic Substances
       Control Act:  considerations prior to small-scale release. In: Gresshoff, P.M.; Roth, L.E.;
       Stacey, G.; Newton, W.E.,  eds. Nitrogen fixation: achievements and objectives. New
       York, NY: Chapman  & Hall, pp. 405-414.

 Segal, M. (1988) In: Shoemaker,  S.; Middlekauf, R.; Ottenbrite,  R., eds. The impact of chemistry
        on biotechnology. Washington,  DC: American Chemical Society, pp. 386-396.
                                            2-34

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Tiedje, J.M.; Colwell, R.K.; Grossman, Y.L.; Hodson, R.E.; Lenski, R.E.; Mack, R.N.; Regal,
       P.J. (1989) The release of genetically engineered organisms: a perspective from the
       Ecological Society of America. Ecology 70:298-315.

U.S. Environmental Protection Agency. (1992) Framework for ecological risk assessment. Risk
       Assessment Forum, Washington, DC. EPA 630/R-92/001.

van Elsas, J.; Heijnen, C.; van Veen, J. (1990) The fate of introduced genetically engineered
       microorganisms (OEMs) hi soil, hi microcosm, and the field: impact of soil textural
       aspects. In: MacKenzie, D.; Henry, S., eds. The biosafety results of field tests of
       genetically modified plants and microorganisms. Bethesda, MD: Agricultural Research
       Institute, pp. 67-79.
                                           2-35

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                    APPENDIX A
MONITORING AND ENUMERATION TECHNIQUES FOR RHIZOBIA
                      2-A1

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                                       APPENDIX A
          MONITORING AND ENUMERATION TECHNIQUES FOR RHIZOBIA

       The monitoring studies used only three strains: RmSF38, a spontaneously streptomycin-
resistant mutant of the parental strain RCR2011, and two recombinants, RMB7101 and RMB7103,
both of which are derivatives of RCR2011.

       Selective antibiotic media differentiate the parental from the recombinant and from the
indigenous rhizobial strains.  The basic medium proposed for enumeration of all rhizobial isolates,
RDM (rhizobia defined medium),  consisted of the following (g/L): potassium gluconate 5.0,
K2HPO4 0.22, MgSO4-7H2O 0.1, sodium glutamate 1.1, 1,OOOX trace elements, 1,OOOX vitamin
stock, and agar.  The parental strain RCR2011 was intrinsically resistant to kanamycin and
cinoxachi at 10 /ig/mL and 100 iiglroL, respectively. Medium A, proposed for enumeration of
RmSF38, consisted of RDM supplemented with kanamycin (10 /tg/mL), cinoxacin (100 j*g/mL),
and streptomycin (200 jtg/mL) as well as the antifungal agents cycloheximide and nystatin, both at
the rate of 75 jig/mL. Medium B, for enumeration of the recombinant strains RMB7101 and
RMB7103, was identical to Medium A except for addition of another antibiotic, spectinomycin
(100 /tg/mL). Spectinomycin was needed because both streptomycin and spectinomycin  resistances
were carried  on the 0 fragment that was inserted to make the recombinant strains.

       Recovery studies revealed that 51 to 90 percent of added rhizobia were recovered from the
Sun Prairie soil 1 hour after addition to the soil.  The PMN contained data from preliminary
laboratory studies indicating that indigenous rhizobia intrinsically resistant to the same  antibiotics as
the OEMs occurred in low numbers and did not increase greatly in the presence of plant roots.

       For the fluorescent antibody technique (and for future measurements during the field tests),
the study selected 20 colonies from each antibiotic plate to determine the  percentage of colonies
formed on that plate by the inoculant strain versus the indigenous rhizobial populations.
Multiplying this conversion factor by the total number of colonies on the plates corrected for the
inoculants and eliminated the indigenous rhizobia.

       Dr. E.L. Schmidt at the University of Minnesota prepared the immunofluorescent antibody
to the parental R. meliloti strain RCR2011  using antiserum collected from the first production bleed
of an immunized New Zealand white rabbit. The fluorescent antibody was a conjugate of the IgG
fraction of the antiserum to the fluorescent dye, fluorescein.  Dr. Schmidt's laboratory titered the
fluorescent antibody to determine the highest antibody dilution that provided an acceptable
homologous cross-reaction against strain RCR2011.  A 1:1 dilution of the antibody suspension in
glycerol was  diluted 1:2, 1:4, 1:8, and 1:16 in filtered saline, and each dilution was applied to
microscope slides containing rhizobial smears.  Cross-reactivity was rated as (-) = no reactivity, tr
— trace, and from (1+) to (4+) indicating very weak to strong cross-reactivity. The  1:16 dilution
exhibited cross-reactivity of 4+ with RCR2011 derivatives but no cross-reactivity with the other
rhizobial parental strains, their derivatives, or indigenous rhizobial populations.  Consequently, this
dilution was used for all further work.  Laboratory tests conducted prior to the field tests indicated
an MDL of 5 X 103 cells/g dry soil with this supplemental fluorescent antibody technique.
                                            2-A2

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       Colony morphology also distinguished between the RCR2011 derivatives and the indigenous
populations.  The indigenous rhizobia produced mucoid colonies, whereas the RCR2011 derivatives
were always nonmucoid.

       Although other aspects of population dynamics studies used all strains, dispersal monitoring
used only the RCR2011 derivatives.  Neither the PC parent or derivatives nor the UC445 parent or
derivatives had good enough antigenic properties to produce a fluorescent antibody usable for
detection.  In addition, the highly mucoid PC strains were indistinguishable from the indigenous
population. The RCR2011 strain and its derivatives served as an appropriate model for microbial
dispersal, making it unnecessary to investigate all strains.
                                          2-A3

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                    APPENDIX B
PERSISTENCE IN THE RfflZOSPHERE AND NODULE OCCUPANCY
                      2-B1

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Persistence in the Rhizosphere

       The 2-year study followed the establishment and persistence of three strains—a wild-type
strain, RmSF38, and two recombinant strains, RMB7101 and RMB7103—by means of selective
media plating.  All three strains were established hi the rhizosphere and remained stable through
the 1989 growing season at levels of approximately 10s hi the inner rhizosphere and 10s to 106
cells/g dry root hi the outer rhizosphere.  The first sampling hi April 1990 revealed rhizobial
numbers hi the inner and outer  rhizosphere similar to the levels for the last sampling of the 1989
season, indicating that the rhizobial steams either overwintered at these levels or recovered after
thawing hi the spring.  Although all three steams persisted hi the rhizosphere through day 376, the
levels of the two recombinant steams were approximately tenfold lower than the level of indigenous
rhizobia.  In summary, both the wild-type and the two recombinant steams became established hi
the rhizosphere and persisted into year 2, in general showing no population differences.

Nodule Occupancy

       The strain comparison trial on October 3, 1989, entailed nodule occupancy studies.  The
study measured the length of the root systems for 12 plants, with the root system being divided into
four sections:  crown, top middle, bottom middle, and distal.  A maximum of 24 nodules from
each section was screened for the presence of the inoculant. Unfortunately, the parental steam PC
and the indigenous rhizobia were indistinguishable.  However, the other parental steams and the
recombinants could be identified.  The data indicated that nodule occupancy ranged from 39 to 70
percent for the inoculated rhizobial steams, the remaining nodules being occupied by the indigenous
rhizobia.  The percent nodule occupancy by the inoculant decreased with increased distance from
the crown hi all cases.  No significant differences occurred between the wild-type  and recombinant
strains.  Plants collected hi the second year, 15 days prior to the second harvest, showed a decline
hi percent nodule occupancy  for all inoculated treatments.

        In the steam competition trial, parental and recombinant steams were inoculated together.
Nodule occupancy data showed that recombinant steams appeared somewhat less competitive than
the wild types.  Because problems with culture viability prevented the desired inoculation ratio of
 1:1, interpreting these data is difficult (appendix D).
                                             2-B2

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            APPENDIX C
RHIZOBIAL DISPERSION AND MIGRATION
               2-C1

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Aerial Dispersal

       Selective agar plates were mounted on posts located in all four compass directions at
various distances—4, 9, 50, 100, 200, and up to 500 feet—from the perimeter of the test plots on
days 0, 1, 2, 3, 4, and 6 after initiation of the strain comparison trial.  Additional plates were
placed between the four compass points.  No colonies appeared on the vast majority of plates
regardless of compass direction or distance. A total of 13 colonies appeared on Selective Medium
A over a cumulative exposure of 6 hours  on day 0 for all compass directions and distances even
though a moderate wind blew on the day  of application.  Later samplings were for 2-hour
exposures only.  On day 6, the number of colonies on Medium A from the west compass direction
(the direction with the highest counts) had dropped from  13 at the 4-foot distance to one colony at
both the 100- and 200-foot distances. Overall, little aerial  dispersion of the PMN microorganisms
occurred.  Likewise, aerial dispersion measurements taken at termination, when the fields were
being plowed, resulted in no detectable dispersal of inoculant from the test site.

Vertical Migration

       Movement of the recombinant rhizobia downward through the soil profile past the
rhizosphere was measured by plating out  soil obtained with a soil-coring device. Twelve-inch
cores were taken from control and treated plots hi an outside row, immediately adjacent to a plant
stalk.  The top 2 and bottom 2 niches of the soil core were homogenized and subsampled for the
presence of added rhizobia.

       Vertical monitoring used the plant MPN technique  for enumeration at various time points
up to 312 days.  Throughout the season, cell numbers ranged from 7 to > 138 cells/g  dry soil in
the top 2 inches and from 3 to >524 cells/g dry soil in the 10- to  12-inch depth.  Rhizobial
inoculants also occurred at a depth of 22  to 24 niches. Overall, only minimal movement occurred
beyond the root zone.  No differences occurred in the vertical movement of the recombinant strains
versus the wild-type strain.

Horizontal Dispersion

       The study monitored horizontal movement through the soil by sampling the top 2 inches of
the soil surface at a distance of 6 inches away from the edge of the plots in all four compass
directions on days 0,  11, and 34. Samples were examined for the presence of three strains:
RmSF38 and two recombinants, RMB7101 and RMB7103.  Using selective media supplemented
with the fluorescent antibody method, samples  contained no detectable inoculants.  With the more
sensitive MPN enumeration technique,  counts ranged from 0 to 57 cells/g dry soil.  Consequently,
all subsequent analyses used the MPN technique.  Up through day 123, cell counts never exceeded
250 cells/g dry soil, and nearly all counts dropped to 0 by  day 159.  These results indicate minimal
horizontal movement of the rhizobial inoculants throughout the study and no differences  in the
behavior of the recombinant strains versus the wild type.
                                            2-C2

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               APPENDIX D
STRAIN COMPARISON AND COMPETITION TESTS
                 2-D1

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                                        APPENDIX D
                   STRAIN COMPARISON AND COMPETITION TESTS

       The strain comparison test used four recombinant strains and a single alfalfa variety.  The
total area for the strain comparison trial was approximately 0.65 acre, with 0.07 acre treated with
recombinant rhizobia. The proposed design consisted of 13 treatments set up as a complete
randomized block design with six replicates.  Each treatment occupied a plot measuring 5 X  25
feet. A 5-foot wide buffer strip of ryegrass separated plots from each other.  A 5-foot wide border
of uninoculated alfalfa surrounded the experimental area. Alfalfa seeds were planted with a cone
planter in rows 6 inches apart and sown to a depth of approximately 0.25 to 0.5 inches.  A carbon
dioxide-propelled bicycle sprayer, calibrated to deliver  10 mL/linear foot, sprayed 3.0 L of
suspensions of each rhizobial strain on the alfalfa seeds in the open furrows.  The application rate
was approximately  10s bacteria per seed.  This rate corresponded to 2.3 X 10" seeds per plot, for
a total of 5.52 X 1012 recombinant R. meliloti cells.  Immediately following spraying of the
rhizobia, garden rakes were used to cover the furrows with soil.

       The strain competition experiments took place on a 0.09-acre portion of the same field (48
 X 78 feet).  The proposed design consisted of 22 treatments set up as a randomized complete block
design with four replications.  Each treatment consisted of one row, 6 feet long, with seeds spaced
every 0.5 to 1.0 inch. Rows were 3 feet apart.  Because of the experiments' short duration  (8
weeks),  the ryegrass borders were omitted.  As in the strain comparison trial,  a 5-foot wide  border
of uninoculated  alfalfa surrounded the entire test area.  A hand-held spray bottle sprayed 50  mL of
rhizobial suspension into each 6-foot furrow row.  At an inoculum rate of approximately 105
bacteria per seed, each treatment had a total of 1.2 x  1010 rhizobial cells.  This corresponded to a
total application of 5.52  x 1011 recombinant rhizobial cells. Then the furrows were covered with
soil.

        Although the test design called for applying R.  meliloti strains at a rate of 10s cells per seed
to obtain 100 times the international minimum standard for alfalfa of 103, the actual viable counts
 applied in the field were significantly lower.  For results of viability studies, see appendix E.
                                             2-D2

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        APPENDIX E
RHIZOBIAL CULTURE VIABILITY
           2-E1

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                                      APPENDIX E
                           RHIZOBIAL CULTURE VIABILITY
       To determine the actual application rate of the R. mettloti strains sprayed on the seeds,
aliquots of the rhizobial suspensions were plated onto selective media to measure culture viability.
The following table summarizes the results.
 Applied Strain
          % of Anticipated Viable Cells
Strain Comparison        Strain Competition
 RCR2011 (parent)
 RMB7101 (RCR2011 parent + fl)
 RMB7103 (RCR2011 parent + 0 + mf)
          97
         113
          89
60
10
20
 PC (parent)
 RMB7201 (PC parent + 0)
          49
          43
20
40
 UC445 (parent)
 RMB7401 (UC445 parent + 0)
          77
          50
 5
 5
       Note that in some cases the numbers obtained are much lower than the number of viable
cells intended for application.  This situation is particularly true for the strain competition trial.
Consequently, the strain competition trials often did not have the desired 1:1 ratios. The ratios of
parent: recombinant for recombinants RMB7101, RMB7201, RMB7401, and RMB7103 were
1:0.85, 1:1.1, 0.34:1, and 1:0.43, respectively.
                                          2-E2

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           APPENDIX F
ALFALFA YIELDS IN THE FIELD TESTS
             2-F1

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 Table Fl. Alfalfa Yields in Year One—First Cutting
Treatment

RCR2011
RMB7101 (RCR2011 parent + 0)
RMB7103 (RCR2011 parent + 0 + nij)

PC
RMB7201 (PC parent + 0)

UC445
RMB7401 (UC445 parent + 0)
Alfalfa Yield (kg/ha)

       3,295
       3,362
       4,707

       3,766
       3,071

       3,295
       3,676
       The naturally occurring and recombinant strains tested gave no significant differences in the
dry weight yield of alfalfa at the first cutting (coefficient of variance [C. V.] 42.45 percent).  This
result may have occurred, in part, because of the variable stand of alfalfa often observed the first
year after planting.  The test plots suffered heavy weed infestation (no preplant herbicide was
used),  and the alfalfa plants also suffered stunting and chlorosis as the result of a heavy leaf hopper
infestation in early July.  To allow for spraying for leaf hoppers, the first cutting occurred earlier
rather than the normal 10 percent bloom standard.

       The table below presents the dry weight yields of alfalfa for the second cutting, which
occurred 44 days  after the first cutting.
Table F2.  Alfalfa Yields in Year One—Second Cutting
Treatment
Alfalfa Yield (ke/ha)
RCR2011
RMB7101
RMB7103
PC
RMB7201
UC445
RMB7401
3,295
3,049
3,362
3,004
2,892
3,049
3,049
                                            2-F2

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        Again, the naturally occurring and the recombinant strains resulted in no significant
differences in the dry weight yield of alfalfa (C.V. 11.74 percent).  The test plots again showed
heavy weed infestation.

        Alfalfa was harvested twice in the second year of the field tests, once on June 6 and 7 and
again on July 24.  The table below presents data for dry weight yield.
Table F3. Alfalfa Yields in Year Two—First and Second Cuttings
Treatment
  Alfalfa Yield fkg/hal
1st Cutting    2nd Cutting
RCR2011
RMB7101
RMB7103
PC
RMB7201
UC445
RMB7401
C.V. (%)
4,304
4,102
4,416
4,281
4,506
4,304
4,438
11.50
6,052
6,232
6,590
6,254
6,590
6,209
6,276
6.95
       The second year of the strain comparison test showed no significant differences in alfalfa
dry weight yield with wild-type and recombinant R. meliloti strains. The second year's alfalfa
growth lacked much of the variation seen in the first year. Consistent trends, however, were not
evident.

       The field data showed no conclusive trends toward either increased or decreased growth of
alfalfa as compared with the parent strains.  Therefore, the field tests indicate that the recombinant
rhizobia posed little risk of decreasing alfalfa yields.  The greenhouse data, although faulty, also
indicated little potential for decreased growth of alfalfa from the OEMs.
                                             2-F3

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                    SECTION THREE
        ECOLOGICAL, RISK ASSESSMENT CASE STUDY:
EFFECTS OF RADIONUCLIDES IN THE COLUMBIA RIVER SYSTEM-
               A HISTORICAL ASSESSMENT

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                             AUTHORS AND REVIEWERS
AUTHORS
Stephen Li. Friant
Environmental Science Department
Battelle Pacific Northwest Laboratories
Richland, WA

Charles A. Brandt
Environmental Science Department
Battelle Pacific Northwest Laboratories
Richland, WA

REVIEWERS

Thomas Sibley (Lead Reviewer)
Fisheries Research Institute
University of Washington
Seattle, WA

Gregory R. Biddinger
Exxon Biomedical Sciences, Inc.
East Millstone, NJ

Joel S. Brown
University of Illinois
 at Chicago
Chicago, IL
Herbert Graver
Benchmark Environmental Corporation
Albuquerque, NM

Joseph E. Lepo
Center for Environmental Diagnostics
 and Bioremediation
University of West Florida
Gulf Breeze, FL

Frieda B. Taub
School of Fisheries
University of Washington
Seattle, WA
                                          3-2

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                                     CONTENTS

ABSTRACT	  3-7

3.1.  RISK ASSESSMENT APPROACH	,	  3-8

3.2.  STATUTORY AND REGULATORY BACKGROUND	  3-8

3.3.  CASE STUDY DESCRIPTION  	. .   3-10

     3.3.1.  Background Information and Objective	   3-10
     3.3.2.  Problem Formulation	3-12

           3.3.2.1.  Stressors	:	   3-12
           3.3.2.2.  Biological Fate of Radionuclides	   3-14
           3.3.2.3.  Ecosystem Potentially at Risk	.....'	   3-15
           3.3.2.4.  Endpoint Selection	   3-15
           3.3.2.5   Conceptual Model	   3-15

     3.3.3.  Analysis: Characterization of Exposure	   3-17

           3.3.3.1.  Sample Location . . .	   3-17
           3.3.3.2.  Data Analysis	   3-18
           3.3.3.3.  Exposure From Measured River Water Concentrations	   3-18
           3.3.3.4.  Calculation of Organism Dose  . . ]	   3-18
           3.3.3.5.  Dose From Water Exposure   . . ;	 .   3-23
           3.3.3.6.  Dose From Measured Tissue Concentrations	   3-23
           3.3.3.7.  Dose From Measured Sediment Concentrations  	   3-27

     3.3.4.  Analysis: Characterization of Ecological Effects	   3-27

     3.3.5.  Risk Characterization	   3-31

           3.3.5.1.  Acute Exposure to Ionizing Radiation	   3-31
           3.3.5.2.  Chronic Exposure to Ionizing Radiation	   3-32
           3.3.5.3.  Uncertainty	   3-32
           3.3.5.4.  Conclusions	   3-33

3.4.  REFERENCES	   3-36

3.5.  ADDITIONAL READING	j	   3-39

APPENDIX A—COLUMBIA  RIVER FISH SPECIES AND FOOD WEB	  3-A1
                                         3-3

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                         CONTENTS (continued)

APPENDIX B-CRITR2 CODE CALCULATIONS AND
           BIOACCUMULATION FACTORS	
3-B1
                                 3-4

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                                    LIST OF FIGURES

 Figure 3-1.   Structure of assessment for effects of radionuclides	   3-9

 Figure 3-2.   Location of the Hanford Reach of the Columbia River .	 .    3-11

 Figure 3-3.   Monthly concentrations for selected radionuclides in Columbia River grab
              samples, 1963	    3-20

 Figure 3-4.   Monthly concentrations for selected radionuclides in Columbia River grab
              samples, 1964	    3-21

 Figure 3-5.   Ranges of sensitivities of aquatic organisms to acute radiation exposure ....    3-29

 Figure 3-6.   Range of sensitivities of the early developmental stages of fish to acute
              exposures	    3-30

                                    LIST OF TABLES

 Table 3-1.     Summary of Water Quality Data, 1957-1973	    3-13

 Table 3-2.     Water Sampling Matrix (1963-1964)	    3-19

 Table 3-3.     Maximum Grab Sample Water Exposure Concentrations for 1963-1964 Time
              Period	    3-22

 Table 3-4.     CRITR2 Code Calculation of Organism Dose From Water Exposure to
              Various  Radionuclides	   3-24

 Table 3-5.     Calculated Dose Based, on Tissue Concentration for Selected Organisms of the
              Columbia River	;	   3-26

 Table 3-6.     Maximum Sediment Radionuclide Concentrations in the Hanford Reach and
              Dose to  an Organism Living in the Sediments	   3-28

 Table 3-7.     Hazard Quotient for Early Development Stage of Fish and Adult Fish  ....   3-32

                              LIST OF COMMENT BOXES

Comments on Problem Formulation	   3-17

Comments on Characterization of Exposure	   3-27

Commands  on Characterization of Ecological Effects	   3-31

Comments on Risk Characterization	   3-34
                                           3-5

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                                LIST OF ACRONYMS




BCF         bioconcentration factor




CERCLA     Comprehensive Environmental Response, Compensation, and Liability Act of 1980




DOE         Department of Energy




HQ          hazard quotient




NRDA       Natural Resource Damage Assessment




PNL         Pacific Northwest Laboratory




RM          River Mile




USGS        United States Geological Survey
                                         3-6

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                                         ABSTRACT

        In 1943, nuclear production activities began at the U.S. Department of Energy's (DOE)
 Hanfprd site in south-central Washington State.  These activities continued for many years.  During
 this time, the site discharged radioactive effluents into the Columbia River, which runs through the
 northern portion of the site and borders it on the east (the Hanford Reach).  The DOE requested
 the Pacific Northwest Laboratory (PNL) to conduct an ecological risk assessment to determine
 whether the ecological risk assessment framework (EPA, 1992) used for hazardous chemicals is
 applicable to radionuclides as stressors. PNL conducted this ecological risk assessment using
 historical Hanford site monitoring data, which had been collected to characterize human dose.  The
 data characterized exposure by measuring radioactivity in water, sediments, and biota.  The data
 used in the current investigation were collected during 1963-1964, a period of peak production of
 nuclear material.  During this time, the maximum number of eight reactors were operational.

        PNL employed two approaches in assessing ecological risk to Columbia River organisms.
 The first approach used environmental exposure data (water concentrations for radionuclides) to
 calculate dose to a variety of aquatic organisms,  including the most sensitive receptors (fish).  The
 second approach made use of measured tissue concentrations of selected aquatic organisms to
 calculate organism internal dose.

       PNL used dose to assess potential toxic effects and assess regulatory compliance.  Risk
characterization was developed by comparing dose levels in fish and other organisms found in the
Columbia River to known effect concentrations through a hazard quotient for acute dose and
possible developmental effects. The  assessment endpoint was protection of fishes in the Columbia
River, and the measurement endpoint was increases in mortality and sublethal  effects.  One of the
most sensitive ecological receptors was the early  developmental  stage of chinook salmon.

       The major conclusions of the study are:

       •      The ecological risk assessment paradigm is applicable to radionuclides as well as to
              hazardous chemicals,  as evidenced from the exposure, effect, and risk
              characterization.

       •      The most sensitive life stage of fish (i.e., salmon embryo) did not appear to be at
              risk from radionuclide exposure in sediments or water.

       •      During peak production at Hanford, releases of radionuclides did not result in any
              measurable risk to the Columbia River ecosystem, as evidenced by indicator species
              and regulatory benchmarks.

       •      Dose rates to Columbia River animals during the study period did not exceed the
              DOE standard of 1 rad/d per DOE Order 5400.5 (DOE, 1989).  Based on the
              computer code CRITR2, only crayfish and a plant-eating duck received a dose rate
              exceeding 1 rad/d.  However, this risk assessment did not include ducks, and the
              actual calculation of dose to crayfish from whole organism counts gave values
              considerably less than  both the modeled dose and 1 rad/d.
                                            3-7

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3.1. RISK ASSESSMENT APPROACH

       The ecological risk assessment follows the sequence of the U.S. Environmental Protection
Agency's Framework for Ecological Risk Assessment (EPA, 1992). This arrangement includes
problem  formulation, analysis, and risk characterization, respectively (figure 3-1).

       Exposure of aquatic organisms to radioactivity can elicit a toxic response depending on the
organism, level of dose, type of radionuclide, and habitat requirements of the exposed organism.
In this study, the assessment endpoint was defined as the maintenance of important recreational and
commercial fish populations in the Columbia River.  The measurement endpoint from radioactive
dose was toxicological response.  This assessment did not consider  elemental chemical toxicity of
each radionuclide.

       The major ecological components are benthic macroinvertebrates, zooplankton,
phytoplankton, and fish of the Columbia River. Fish species in the Columbia River are important
commercial, recreational,  cultural, and regional assets.

       Data analysis included exposure and effects characterization. Exposure characterization
consisted of an assessment of radioactivity at several river stations downstream from the Hanford
site. Measured river activity was used to calculate ionizing radiation dose from water to selected
organisms using bioaccumulation factors and computer modeling.  A second and more direct means
of estimating dose to aquatic  organisms used measured fish tissue concentrations.   Available
sampling data included sediments, water, and biota.

       Characterization of effects to aquatic organisms entailed using available toxicity data and
regulatory standards.  The characterization was conducted at the individual level,  qualitatively
interpreted, and applied to the population level of ecological organization.  Risk characterization
was based on a hazard quotient (HQ), defined as the ratio of radionuclide organism dose (exposure
or tissue value) to benchmark dose values.

3.2. STATUTORY AND REGULATORY  BACKGROUND

       Although federal regulations do not require quantitative ecological risk assessments, they
can be used effectively to  support regulatory requirements under nearly all of the major federal
environmental statutes (e.g., the Comprehensive Environmental  Response, Compensation, and
Liability Act, CERCLA).   Other potential applications include supporting compliance with federal
Executive Orders and with policy directives of various government agencies (e.g., DOE Orders).

       A number of federal statutes have promulgated risk-based and technology-based standards
for the protection of ecological  resources (e.g., water quality criteria under the Clean Water Act).
However, only one standard has been published for the protection of ecological resources from
exposure to radioactive materials.  DOE Order 5400.5 (DOE, 1989) stipulates that the interim dose
limit for native aquatic animal organisms "shall not exceed 1 rad per day from exposure to the
radioactive material in liquid wastes discharged to natural waterways."
                                             3-8

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   PROBLEM FORMULATION

   Stressprs: Ionizing radiation from radionuclides associated with the Hanford
   site.  Other chemical and physical stressors were not considered.

   Ecosystem(s) at Risk: Columbia River downstream of the Hanford Site,
   Richland, Washington

   Ecological Components: Fish, zooplankton, phytoplankton, and benthic
   macroinvertebrates in the Columbia River.

   Endpojnts: Assessment endpoint was the maintenance of important
   recreational and commercial fish populations in the Columbia River. The
   measurement endpoints included dose-response information for radiation and
   single species of aquatic organisms.
   ANALYSIS
             Characterization
               of Exposure

     Radioactivity of river water samples
     was measured and used to calculate
     ionizing radiation dose to selected
     species using bioaccumulation
     factors and models. Dose also was
     determined by direct measurement
     of fish tissues and sediments.
     Characterization of
     Ecological Effects
Radiation effects were evaluated
based on available laboratory
stresspr-response information on
mortality and developmental
effects and regulatory standards.
    RISK CHARACTERIZATION

    Hazard quotients were used to compare maximum exposure doses to the
    lowest reported doses causing adverse effects to aquatic organisms.  Major
    uncertainties associated with this approach were described.
Figure 3-1. Structure of assessment for effects of radionuclides
                                    3-9

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3.3.  CASE STUDY DESCRIPTION

3.3.1.  Background Information and Objective

        It is generally assumed that human health risk standards for radionuclides protect wildlife
sufficiently. However, under some circumstances the risk to wildlife from radionuclides may need
to be considered, such as managing risks, developing cleanup strategies, and identifying injury
under the Natural Resource Damage Assessment (NRDA) process. The objective of this case study
is to evaluate the applicability of the ecological risk assessment paradigm for radionuclides as
stressors in the Columbia River.

        The Hanford site, an area of slightly more than 1,400 km2 (560 mi2), straddles the
Columbia River just north of Richland, Washington.  Three northwest-southeast-trending basalt
ridges cross this broad, relatively level gravel plain.  The semiarid climate supports various
communities of shrubs—steppe and grassland.

        The Columbia River extends 1,954 km (1,214 mi) from its origin in Columbia Lake in
British Columbia to its mouth at Astoria, Oregon, making it the fourth-longest river in North
America. Typical flow rates of the Columbia River  at Priest Rapids Dam range from 2,800 to
3,400 cubic meters per second (cms), or 99,000 to 122,000 cubic feet per second (cfs) (Woodruff
et al., 1991).

        The Columbia River has eight primary uses:

       1.  River navigation through navigation locks from the Pacific Ocean to the Port of Benton
           in Richland.
      2.  Agricultural purposes, primarily irrigation. Approximately 6 percent of the Columbia
           Basin's water is diverted for agricultural use.
      3.  Nonagricultural irrigation.
      4.  Electric power generation, provided by the system of 11 dams along the Columbia
           River in the United States.
      5.  Flood control, also provided by the dams.
      6.  Fish and wildlife habitat, especially for anadromous salmon.   The Hanford Reach
           comprises the last major salmon and steelhead spawning area within the Columbia River
           proper.  The Columbia River also supports the vast majority of mesic terrestrial habitat
           in the semiarid Hanford Reach.
      7.  Water supplies to numerous municipalities and industries.
      8.  Recreational use.

       The Hanford Reach of the Columbia River runs from Priest Rapids Dam to just north of
the City of Richland and flows past the reactor areas  of the Hanford site (figure 3-2).  The average
annual flow of the Columbia River in the Hanford Reach, based on 65 years of record, is about
3,400 cms (120,100 cfs) (DOE, 1988).  Flows in the Hanford Reach vary widely, not only because
of the annual flood flow but also because of daily regulation by the upstream power-producing
Priest Rapids Dam. Flow rates during the late summer, fall, and winter may vary from a low of
                                            3-10

-------
                                                              Seattle   f       Spokane
                                                                  Washington
                                                          Vancouver
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                                                           Hanford
                                                           Town Site
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                                                                  Advanced Nuclear Fuels
                                                                  3QQQ Area

                                                                  1100 Area

                                                                  Rich]and Pumphouse
           Arid Lands Ecology Reserve
           Saddle Mountain
           National Wildlife Refuge
          Washington State
          Department of Game Reserve
Figure 3-2.  Location of the Hanford Reach of the Columbia River
                                           3-11

-------
1,100 cms (36,000 cfs) to as much as 4,800 cms (160,000 cfs) each day.  During the spring
runoff, peak flow rates from 4,800 to 20,000 cms (160,000 to 650,000 cfs) can occur.

       The Washington State Department of Ecology classifies the Columbia River water quality
as Class A (excellent) between Grand Coulee Dam and the mouth of the Columbia River (DOE,
1988). Table 3-1 shows water quality data  between Priest Rapids Dam  and Pasco, Washington, for
the years 1957-1973.  The dominant physical feature of the Columbia River through the Hanford
Reach is the high flow rate, which is subject to large, diurnal water-level fluctuations that change
the shoreline configuration and expose gravel substrate and periphyton to alternate periods of
wetting and drying. The Reach has a low level of suspended sediment,  1 to 7 mg/L.

       The river-bottom sediments from Priest Rapids Dam to several kilometers below the
confluence of the Snake and Columbia Rivers are primarily mixed sands and gravels with some
cobbles (maximum diameter « 20 cm). Coarser sediments predominate from Priest Rapids Dam
through the reactor areas (DOE, 1988).  The streambed near Richland consists of sand in deep
channels and a mixture of sand, silt,  and some clay in shallow areas (DOE,  1988).  Most of the
Hanford-produced cationic radionuclides are associated with suspended particulates and subsequent
fine sediments (Beasly and Jennings, 1984).

       Because  of the many dams on the Columbia River, the only free-flowing U.S. section
occurs between Priest Rapids Dam (River Mile [RM] 397) and McNary Reservoir (RM 351).  The
Priest Rapids Dam immediately upstream from the Hanford site regulates flow.  No significant
tributaries enter  the stream in this section, which lies mostly within the  Hanford site.

       The main channel of the Hanford Reach is braided around the island reaches and
submerged rock  ledges and gravel bars,  causing repeated pooling and channeling. The riverbed
material is mobile and dependent on river velocities; it typically is composed of sand, gravel, and
rocks up to 20 cm (8 in)  in diameter.  Small fractions of silts and clays  are associated with the
sands in areas of low-velocity deposition.

3.3.2. Problem Formulation

       3.3.2.1.  Stressors

       The release of radionuclides from Hanford operations is one of several possible stressors to
the ecosystems of the Columbia River.   Other possible stressors include thermal discharges from
Hanford reactors; varying river levels because of dams; the physical barrier to fish  migration  from
the dams; and heavy agricultural, commercial, and recreational activities along the river.
However, this assessment concerns only radionuclides as stressors of concern.

       The cooling effluents of Hanford reactors contain  over 60 radionuclides. Becker (1990)
has reported that during the period of maximum reactor production  (mid-1960s), the Hanford site
discharged over  300,000 curies per year to  the river.  Radioactive decay influenced the relative
abundance of different radionuclides in the  river (Becker,  1990).  In fact,  many of the
radionuclides discharged by the Hanford site have a short half-life and were not detected in the
effluent discharge.  Others could not be detected in the river after dilution. Becker (1990)
                                             3-12

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identified three radionuclides as being of concern because of their potential biological significance:
phosphorus-32, chromium-51, and zinc-65.  Together they account for over 90 percent of potential
radiological dose to aquatic organisms.  All are nuclear activation products that are activated as
Columbia River water cools the reactor core.  The potential for some radionuclides to
bioaccumulate in aquatic food webs causes concern with respect to both the human exposure
pathways and potential ecosystem effects.

       Among radionuclides, phosphorus-32 and zinc-65 are potential stressors because of their
biological importance and fate: they are essential elements for organism growth and are
incorporated into the aquatic food web. One study conducted in the Hanford Reach from 1961 to
1968 noted a seasonal pattern of uptake by algae, with higher radioactivity in winter and lower in
summer  (Becker, 1990).  This pattern  reflects concentration and dilution phenomena from river
flows.

       Unlike phosphorus-32 and zinc-65, chromium-51 is not considered a major biological
hazard.  This radionuclide has a short half-life, low biological mobility (i.e., it has no known
essential role in the physiology of organisms), and weak radiations.  It does  not accumulate to any
extent in aquatic organisms and is transported with river-suspended paniculate  material with little
dissolution (Becker,  1990).  However, the risk assessment included it because  it was a significant
activation product.

       The half-lives of the three radionuclides  considered in the risk assessment are:

        •      Phosphorus-32:  14.2 days
        •      Chromium-51:  27.8 days
        •      Zinc-65: 245.0 days

       Phosphorus-32 is a beta emitter (negatrons); chromium-51  emits gamma  radiation and
electrons; and zinc-65 is primarily a gamma emitter, but also emits positrons and electrons.

       3.3.2.2.  Biological Fate of Radionuclides

       Phosphorus, including phosphorus-32, is a building block of various  tissues and is a key
element  in many biochemical transformations, especially energy transduction (ATP, ADP, GTP,
etc.).  The element is comparatively scarce in the environment.  Organisms can concentrate
phosphorus,  including phosphorus-32, to levels that greatly exceed the concentration in the ambient
media.  Phosphorus has a bioconcentration factor (BCF) of 24,000 for freshwater plants and 8,000
for freshwater animals  (Becker, 1990).

       Terrestrial plants take up little chromium-51  from soils, <0.5 percent (Becker, 1990).  In
aquatic systems, this element sorbs to paniculate material and is transported along with it.  Becker
(1990) reported that in  biological systems chromium-51 has an affinity for the  blood of fish.

        Organisms accumulate a measurable fraction of zinc-65. In  aquatic  systems, this
radionuclide is transported through aquatic food webs. With chronic uptake, substantial tissue
accumulation can occur.  In the Pacific Ocean, Becker (1990) noted BCFs of up to 103 for algae
                                             3-14

-------
 and 10s for certain molluscs.  The BCF for plankton in the Columbia River ranges from 300 to
 19,000 (Gushing and Watson, 1966; Gushing, 1967a, b), with adsorption as the primary means of
 uptake.  Because of its long half-life and biological mobility,  zinc-65 can be transported through
 food webs.

        3.3.2.3.  Ecosystem Potentfedly at Risk

        The Columbia River supports a diversity of aquatic and terrestrial wildlife. The major
 ecological components are benthic macroinvertebrates, zooplankton, phytoplankton, and fish.
 Although a detailed description of the wildlife exceeds the scope  of this effort, appendix A lists the
 fish species and shows the generalized aquatic food web. This risk assessment focuses on the fish
 of the Columbia River because they are aquatic organisms sensitive to ionizing radiation and
 because the Columbia River supports a wide variety of fish, including several species that are
 commercial, recreational, and cultural assets of the region.

        3.3.2.4.  Endpoint Selection

        Exposure of aquatic organisms to radioactivity can elicit a toxic response depending on the
 dose level, the length of exposure, the particular species, and the life stage at the time of exposure.
 The magnitude of the response is proportional to radiological dose. In this study, the assessment
 endpoint was the health and condition of local populations of selected fish species that were of
 commercial,  recreational, and cultural interest.

        The risk assessment evaluated multiple measurement endpoints. They included literature
 investigations of adverse effects on fish, such as acute mortality and sublethal and developmental
 effects. Dose from ionizing radiation was evaluated in the maximally exposed individual fish and
 fish in early developmental stages during the study period.   Because no net increase occurred in the
 concentration of elements, the assessment considered only toxicity resulting from ionizing
 radiation, not toxicity resulting from chemical characteristics.

        3.3.2.5.  Conceptual Model

        Radionuclides in the Columbia. River are partitioned between river water, sediment,  and the
 aquatic food web.  Organisms become exposed through direct contact with river water, through
 contact or  ingestion of contaminated sediments,  or through food web incorporation of
 radionuclides.

        Two organism exposure pathways exist for ionizing  radiation.  In the external exposure
pathway, an organism receives a dose from its external environment,  such as ionizing radiation
from the water. If the energy of the radiation is high enough, it may penetrate the organism's
external tissue. In the internal exposure pathway,  an organism receives a dose of ionizing radiation
as a result  of uptake of a radionuclide.  Consequently, exposure occurs to internal organs and
tissues. The significance of each exposure pathway depends on the aquatic fate of the
radionuclide, its concentration, the energy of its radiation, and also on the pathway of
bioaccumulation.
                                             3-15

-------
       The level of organism dose from either external or internal exposure depends on the length
of time an organism spends in the Hanford Reach feeding and breeding habitats, the degree of
interaction with the sediments (i.e., living on or in the sediments), the discharged levels of
radionuclides, and the river flows. Potential dose to aquatic organisms equals the sum of the total
ionizing radiation dose from multiple radionuclides.

       Possible exposure scenarios include organisms living near or in reactor effluent discharges,
at various locations downriver of Hanford, and on or in contaminated sediments.  A resident fish,
such as whitefish, can spend its entire life in the Hanford Reach. The adult chinook salmon, on
the other hand, is present only during selected periods of the year.

       Generally, higher-level organisms such as fish have greater sensitivity to ionizing radiation
than lower-level organisms such as algae and invertebrates (Frank, 1973).  Consequently, fish can
serve as indicators or benchmarks of the health of fish populations and the ecosystem.  For fish,
sensitivity varies with developmental stage, (i.e., adult fish being less sensitive then juveniles),
amount of time required for various developmental stages, and number of fertilized eggs produced
(Whicker and Shultz,  1982). Species fecundity factors into extrapolating individual organism
effects to a population.  For example, species with high fecundity rates most likely will not
experience adverse effects to the  same degree as species with low fecundity rates.   In addition, the
exposure of organisms to low-level ionizing radiation can promote injury repair mechanisms.

       For Hanford, most of the available monitoring data for radionuclides were for river water
activity and tissue concentrations  of selected species  of fish, including mountain whitefish
(Prosopium williamsoni). One of the most fished species in the Columbia River, mountain
whitefish remains  resident throughout the year, making it a useful biomonitor of radionuclide
incorporation into the human food chain.  The food chain accumulation of radionuclides by
whitefish occurs in a three step process:

       Water -* Algae -*• Insects -* Whitefish

       Calculated dose to whitefish can be extrapolated to other fish species, such  as adult chinook
salmon that occur seasonally in the Hanford Reach of the Columbia River.   In the risk assessment,
whitefish served as an indicator or "generic" fish to  develop a potential exposure/dose scenario.
Where available, the risk assessment incorporated data for other fish species along with supportive
or ecosystem descriptive data for phytoplankton, snails, and crayfish.  Dose was estimated  from
exposure to measured radionuclides in the river to salmon embryos, identified as one of the most
sensitive organisms to ionizing radiation.
                                             3-16

-------
  Comments on Problem Formulation

  Strengths of the case study include:
                 This case study was well written and well organized.  It is an ideal case for the
                 application of the EPA Risk Assessment Framework because discrete stressors
                 are easily  identified and measured and substantial data are available on their
                 biological  impacts.  Assessment and measurement endpoints are identified and
                fit nicely into the risk assessment paradigm.
  Limitations include:
                Because the Columbia River ecosystem has been affected by many other factors,
                radiation may have a relatively small impact on salmon.  Therefore, although it
                may be valid to restrict the risk assessment to a single stressor that does not
                reflect the "real world" situation, other stressors on salmon should be identified.

                The authors should point out that data were developed for the specific case
                study, rather than for a full-ranging risk assessment that could consider other
                stressors.  DOE and EPA need to know whether radionuclides are a major
                problem or risk to the  ecosystem is negligible.

                The total biological community is not well characterized.
3.3.3. Analysis:  Characterization of Exposure

       Making use of the 1963-1964 data for sediments, water, and biota, the exposure
characterization employed two approaches to evaluate dose, which provided independent
assessments of dose.  The first approach evaluated river radioactivity at several stations
downstream of the Hanford site.  This  approach then modeled organism dose using biological
accumulation factors for several  "generic" aquatic organisms from measured radionuclide water
concentrations during the study period, 1963-1964.  The second approach used measured
radionuclide tissue concentrations to calculate dose to whkefish.  Directly measured tissue activity
has the advantage of considering all environmental pathways:  water and food uptake, excretion,
sediments, etc. However, this approach has the disadvantage of measuring selected radionuclides
only in fish muscle tissue.  As a result, the approach reflects the human pathway and places less
emphasis on effects to the fish.  For example, although organs and bones also accumulate
radionuclides, they were not included in the dose calculation.

       3.3.3.1.  Sample Location

       The initial exposure characterization was limited to the Richland Station (RM 344),
although ultimately all available data from the Hanford Reach were reviewed and considered.  The
U.S. Geological Survey (USGS,  1966)  indicated that the river is vertically and horizontally mixed
at this point.  This approach was used because of the potential for large spatial and temporal
                                            3-17

-------
 variability of radionuclide concentrations upstream.  This variability resulted from the discharge of
 eight production reactors with individual production schedules.  Once established, the relationship
 between exposure and potential effects can be applied to upstream locations.

        3.3.3.2.  Data Analysis

        The risk assessment reviewed three data sets to characterize exposure: measured
 radionuclide river concentrations, measured sediment concentrations, and measured fish tissue
 concentrations.  The data were collected during routine monitoring of radionuclide concentrations
 in the Columbia River system. River water was collected as composite, grab, or cumulative
 samples.  The sampling  scheme varied over the 2-year period (table 3-2).  Figures 3-3 and 3-4
 show the monthly water grab sample concentrations for selected radionuclides over the 2-year
 period. Water concentrations were generally highest during the winter and late fall and lowest in
 the spring and summer.

        3.3.3.3.  Exposure From Measured River  Water Concentrations

        Exposure concentrations were established by  reviewing  measured river activity data to
 determine the relationships among composite, grab, and continuous samples:  that is, to see
 whether one form of sampling yielded consistently higher water concentrations than another.  The
 results of this analysis showed that the highest river concentrations of radionuclides occurred in
 whole-water grab samples.

        An upper-boundary exposure concentration was derived by using the maximum  observed
 grab sample water concentration for the 2-year study period for each radionuclide shown in table
 3-3.  These concentrations were assumed to represent the maximum concentration for exposure of
 river organisms.  If the effect characterization indicated a potential risk, then  more typical exposure
 concentration scenarios could be developed.

        The maximum sediment concentration measured for each radionuclide was used to calculate
 organism  dose.

        3.3.3.4.  Calculation  of Organism Dose

        The internal total-body dose rate to an organism from water exposure  for a number (N) of
 radionuclides is given as:
                                             N
                                                                                        (3-D
where R<. is the dose rate to total body of organism c (rad d"1), bi(C is the specific body burden of
nuclide i in organism c (Bq kg'1), and Ei>0 is the effective absorbed energy rate for nuclide i per
unit activity in organism c (rad Ci"1 d"1):
                                             3-18

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Table 3-3. Maximum Grab Sample Water Exposure Concentrations for 1963-1964 Time
           Period (Dirkes, 1992; Nelson et al., 1964)
Radionuclide
As-76
Co-60
Cr-51
Cu-64
1-131
Na-24
Np-239
P-32
RE+Y
Sr-90
Zn-65
Concentration (pCi/L)
2,300
120
25,000
10,000
34
5,600
5,600
630
1,400
2.6
1,800
                           E:,. = eicMeV dis'1 X 3.70E10 dis s'1 Ci'1
                             1,C     I,C

                        86,400 sd'1 x  1.602E-11  rad'1 MeV = 5.12E4 ei;C

        (where e is the effective absorbed energy for nuclide i in organism c).

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                                         bi,c =  Ci,cBi>C
(3-2)
 where Q 0 is the concentration of nuclide i in the water to which organism c is exposed (Bq m'3)
 and Bi>c is the bioaccumulation factor for nuclide i and organism c (m3 kg'1).  Here the water
 concentration already has been corrected for dilution and radioactive decay during transit from the
 point of release into the receiving water body to the region of the organism's habitat.

        Combining equations 3-1 and 3-2 yields the dose rate in rad/d to the primary organism, as
 shown in equation 3-3 below.  The calculation of internal dose from tissue concentration is the
 same as equations 3-1 and 3-2, except the radionuclide-specific BCF is not used and correction for
 decay and dilution is unnecessary.
                                              3-22

-------
                                                                                        (3-3)
        For a secondary organism, such as an herbivore or carnivore, an expression can be written
 for a single radionuclide equating the change in body burden to the uptake and removal of the
 radionuclide.

        3.3.3.5.  Dose From Water Exposure

        Table 3-4 shows the CRITR2 code calculations of organism dose from water exposure to
 various radionuclides.  Appendix B provides a  more detailed listing of CRITR2 code calculations
 and bioaccumulation factors used.  Water concentrations were maximum values for the 2-year
 period.  Table 3-4 indicates internal dose, immersion or surface dose (external water dose), and
 sediment dose.  Internal exposure gave the maximum dose.  Since immersion and sediment doses
 made only minor contributions, they were not considered in the risk characterization.

        Table 3-4 summarizes dose for each organism. CRTTR2 default organisms are generic
 plants, fish, crayfish, and ducks that eat plants  and fish (DUCK-P and DUCK-F, respectively).
 Plant-eating ducks had the maximum dose rate, followed by plants, crayfish, fish, and fish-eating
 ducks.  The dose rates to the plant-eating duck  and crayfish exceeded the 1 rad/d level.  The
 maximally exposed fish had a dose rate of 0.42 rad/d.

       The dose to salmon eggs was estimated from measured river water radionuclide activities
 (table 3-3).  Bioconcentration  factors were estimated for salmon embryos from bioconcentration
 data reported for developing plaice (Pleuronectes platessd) embryos with respect to various fission
 product radionuclides (Woodhead, 1970).  Concentration factors for day 4 of embryonic
 development ranged from < 1 to  10 as a function of the radionuclide.  This assessment used a
 whole egg concentration factor of 10 for all radionuclides shown in table 3-3.  Dose calculations
 employed an overall egg diameter of 2 mm.  Dose to whole eggs was 0.00442 rad/d.

       3.3.3.6.  Dose From Measured Tissue Concentrations

       Table 3-5 lists calculated dose from measured tissue concentrations to selected organisms in
 the Columbia River.  Phytoplankton had the highest dose at 14 rad/d, followed by limpet hard
 parts (shell) at 0.39 rad/d and caddisfly at 0.38  rad/d. The maximally exposed fish dose was
 calculated to be 0.73 rad/d. For fish, table 3-5 concentrations  used to calculate dose represent the
 maximum values observed for whitefish during  1963-1964.  Dose was evaluated for other species,
 but whitefish had the highest body dose for the study period. Unfortunately, most of the fish data
 were muscle tissue concentrations and therefore underestimated whole-body burdens.
 Consequently, the assessment adjusted these values to whole-body values. Based on limited
Hanford data and published literature, the correction factors between whole body and muscle were
9:1 for phosphorus-32 and chromium-51 and 4:1 for zinc-65  (Poston and Strenge, 1989; U.S.
                                            3-23

-------
    Table 3-4. CRITR2 Code Calculation of Organism Dose From Water Exposure to Various
                Radionuclides (Baker and Soldat, 1992)
OUT File Name:  RMAX.OUT   Created:  09:52   18-MAY-92
USR File Name and Header:  RHAX.USR       RMAX.USR    Columbia River Max Concentrations
Version of Program used:   V 1.0  of 26-Mar-92
                                                                   18 May 92
                      *•*«•*  CR1TR2 -• Aquatic Biota Screening Dose Rates

TITLE:  Columbia River Max Concentrations --  Ecological Risk Assessment
          Release
Plant
                                Fish
                      Organism Dose Rates
                    Crayfish   Duck-P     Duck-F
ci/y
AS-76
CO-60
CR-51
CU-64
1-131
NA-24
NP-239
P-32
SR-90
ZH-65

Ci/y
AS-76
CO-60
CR-51
CU-64
1-131
NA-24
NP-239
P-32
SR-90
ZH-65

Ci/y
AS-76
CO-60
CR-51
CU-64
1-131
NA-24
NP-239
P-32
SR-90
ZN-65


3.9E-02
2.7E-03
2.7E-02
1.6E-01
1.3E-04
3. OE-02
1.8E-02
1.1E+01
4.6E-04
1.6E-01
15P+fl1
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9.3E-06
2.4E-05
5.6E-05
3.9E-07
7.9E-04
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3.9E-02
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** • £C U 1

3.0E-05
9.3E-06
2.4E-05
5.6E-05
3.9E-07
7.9E-04
2.9E-05
O.OE+00
O.OE+00
3.2E-05
97P-fli
• I C VH

2.9E-06
1.8E-04
6.5E-05
2.8E-06
3.0E-07
3.4E-05
6.9E-06
O.OE+00
O.OE+00
4.3E-04
7.1E-04
3.9E-02
2.9E-03
7.1E-03
2.8E-02
3.7E-05
2.2E-02
1.8E-03
2.2E+00
1.5E-05-
3.6E-02
?
Immersion or
1.5E-05
4.6E-06
' 1.2E-05
2.8E-05
1.9E-07
4. OE-04
1.4E-05
O.OE+00
O.OE+90
1.6E-05
4 OP* HA
• TC UH
. . . . C&/-J

5.9E-06
3.5E-04
1.3E-04
5.7E-06
6.0E-07
6.8E-05
1.4E-05
O.OE+00
O.OE+00
8.5E-04
1.4E-03
rna i i rac
3.1E-03
1.1E-03
1. OE-02
6.0E-03
1.4E-04
2.6E-03
6.2E-06
1.8E+01
4.8E-03
1.6E+00
1 OP+D1
1 . TC~W 1
Surface
1.7E-05
5.1E-06
1.3E-05
3.1E-05
2.1E-07
4.4E-04
1.6E-05
O.OE+00
O.OE+00
1.8E-05
_ , ...
'ment (r:
1.2E-06
7.1E-05
2.6E-05
1.1E-06
1.2E-07
1.4E-05
2.8E-06
O.OE+00
O.OE+00
1.7E-04
2.9E-04
VQJ 	 — 	 	
6.1E-03
7.3E-04
.OE-04
.5E-02
.6E-05
.1E-03
.OE-04
.2E-02
.6E-04
.OE-02
/ nc n?

iraa/a; --- — ............................
1.7E-05
5.1E-06
1.3E-05
3.1E-05
2.1E-07
4.4E-04
1.6E-05
O.OE+00
O.OE+00
1.8E-05
,.,_-. .

ia/a; .....................................
1.2E-06
7.1E-05
2.6E-05
1.1E-06
1.2E-07
1.4E-05
2.8E-06
O.OE+00
O.OE+00
1.7E-04
2.9E-04
Grand Totals >»»     1.2E+01    4.3E-01   2.4E+00    1.9£+01    5.OE-02
                                                     3-24

-------
      Table 3-4.  CRITR2 Code Calculation of Organism Dose From Water Exposure to Various
                   Radionuclides (continued)

OUT File Name:  RMAX.OUT   Created:   10:21   18-HAY-92

USS File Name:  RMAX.USR

Version of Program used:   V 1.0  of  26-Har-92
                                   Parameters and Water Concentrations
No dilution model used.
Bioaccumulation Factors for:  Fresh     No bioaccumulation factor corrections used.
Distance  (m) 	
Mixing Ratio 	
Radius (cm) 	
Mass (kg) 	
Intake rate (g/d) -
Diet	
Transit Time (h) --
 AS-76
 CO-60
 CR-51
 CU-64
 1-131
 NA-24
 HP-239
 P-32
 SR-90
 ZN-65
 H. L.

26.32 H
5.271 Y
27.704 D
12.701 H
8.04 0
15.00 H
2.355 D
14.29 0
29.12 Y
243.9 D
                    Release  Outfall
                           Concentration Plant    Fish    Crayfish Duck-P   Duck-F
                                 1
                               1
                               5.0
  1
1
5.0
  1
1
2.0
  1
1
5.0
1.0
100
 P
 0
  1
1
5.0
1.0
200
-f
 0
                              Water Concentrations ,  ( Decay during transit  included )
-i-i/y-
2
1
2
1
3
5
5
6
2
1
.3E-06
.2E-07
.5E-05
.OE-05
.4E-08
.6E-06
.6E-06
.3E-07
.6E-09
.8E-06
2.3E-06
1.2E-07
2.5E-05
1,, OE-05
3,,4E-08
5..6E-06
5..6E-06
6.3E-07
2..6E-09
1..8E-06
2.
1.
2.
1.
3.
5.
5.
6.
2.
1.
3E-06
2E-07
5E-05
OE-05
4E-08
6E-06
6E-06
3E-07
6E-09
8E-06
2
1
2
1
3
5
5
6
2
1
	 Ci/m3 or
.3E-06 2.3E-06
.2E-07 1.2E-07
.5E-05 2.5E-05
.OE-05 1. OE-05
.4E-08 3.4E-08
.6E-06 5.6E-06
.6E-06 5.6E-06
.3E-07 6.3E-07
.6E-09 2.6E-09
.8E-06 1.8E-06
uCi/mL 	 .-•- — 	 	
2.3E-Q6
1.2E-07
2.5E-05
1. OE-05
3.4E-08
5.6E-06
5.6E-06
6.3E-07
2.6E-09
1.8E-06
                                                     3-25

-------
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Chironimids
Dose, rad/d
                             «
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                          a Q
                                                   •   ON  .   co
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-------
 Congress, Joint Committee on Atomic Energy, 1959).  This correction introduces uncertainty into
 the effects characterization, but uncorrected muscle values could underestimate individual dose.

        3.3.3.7.  Dose From Measured Sediment Concentrations

        Table 3-6 shows the calculated dose from exposure to radioactivity reported in sediments of
 the Columbia River.  The calculated dose was quite small compared with other pathways.
  Comments on Characterization of Exposure

  Strengths of the case study include:

          •      The ability to evaluate the worst case (maximally exposed individual) at the most
                 sensitive life stage is an efficient method of screening for population-level
                 effects.  This study also  benefits from the availability of long-term data sets
                 collected on site.

  Limitations include:

          •      Analysis also should  consider potential uptake from food  rather than only
                 exposure or direct uptake from the water.  Large variance in BCF values
                 suggest that activity in water cannot  reliably predict exposure.

          •      In the computer model scenario,  algae, crayfish, and fish were not growing or
                 eating and did not accumulate a food chain dose.  Although the  computer code
                 included ducks, they  were not included in the ecological risk assessment because
                 of limited data and limited ability to  verify the model estimate.
3.3.4.  Analysis:  Characterization of Ecological Effects

        Characterization of effects was based on dose-response information for fish from available
toxicity data and also on regulatory standards. Conducted at the individual level, the
characterization was interpreted qualitatively and applied to the population level of ecological
organization.

        The general response of aquatic organisms to ionizing radiation occurs at both the cellular
and biochemical levels. Environmental factors also can affect the level of response.  An NCRP
(1991) report, Effects of Ionizing Radiation on Aquatic Organisms, provided the basis for stressor-
response relationships developed in this report.  Figures 3-5 and 3-6 were adapted from the NCRP
report and summarize the information on acute effects of ionizing radiation on aquatic organisms.

        One would expect different fish species to accumulate different concentrations of
radionuclides based on their feedings habits, age,  length of time spent at the site, and other factors.
Depending on the level of exposure, mortality can occur.  The threshold level of radiation dose
                                             3-27

-------
 Table 3-6.  Maximum Sediment Radionuclide Concentrations in the Hanford Reach and Dose
            to an Organism Living in the Sediments (Dirkes, 1992; Haushild et al., 1966;
            Nelson et al., 1964)
Nuclide
Cr-51
Co-60
Sc-46
Zn-65
Concentration
13,000
100
46
3,900
(pCi/Kg dry weight)"




*Total dose: Organism buried in sediment—0.16 rad/d.
            Organism on surface of sediment—0.08 rad/d.

that can cause acute mortality occurs at approximately 100 rad (1 Gy) for amphibians and 1,000
rad (10 Gy) for crustaceans and fish (figure 3-5).  Figure 3-5 summarizes the relationship between
organism dose and response and also shows the range for LD50s.  Under no circumstances did
calculated dose to fish or other organisms exceed the boundary dose where  acute effects would be
observed.  Dose calculations based on tissue concentrations for selected Columbia River organisms
confirmed this finding.  No aquatic  animal organism used in the risk assessment exceeded the DOE
dose limit of 1  rad/d.

        Few studies have evaluated the effects of chronic exposure to ionizing radiation.  However,
it is known that the early developmental stages of chinook salmon are especially sensitive to
ionizing radiation. NCRP (1991) reported that exposure to 5.1 rad/d (51 mGy/d)  for up to 69 days
produced no increase in mortality to chinook salmon embryos and alevins up to release as smolts.
Hershberger et al. (1978) reported lower return of spawning adult chinook salmon after exposure
of eggs and alevins at approximately 10 rad/d of gamma radiation. Gonadal development was
retarded in chinook salmon on exposure to 10 rad/d delivered to  embryos (Bonham and Donaldson,
1972).  Other laboratory research (Erickson, 1973) found that an exposure of 0.4 rad/d (4.0
mGy/d) reduced courting activity for male Poecilia reticulata exposed as embryos.  Chronic
gamma  radiation (190 days at an exposure of 18.5 rad/d) causes  sterility in young adult Ameca
splendens (Rackham and Woodhead, 1984).

        Based on available literature, the dose used in DOE Order 5400.5 appears sufficiently
conservative to protect most aquatic organisms.  Consequently, unless future data indicate
otherwise, this dose can be considered protective of populations and the ecosystem in general.  To
date, the sole qualifier is the work of Erickson (1973), who reported  reduced male guppy courting
activity  when exposed to 0.4 rad/d.  Little other information exists with regard to  behavioral
changes in fish exposed to ionizing radiation.

       Figure 3-6 summarizes the effects of acute irradiation on development of fish.   The
threshold for developmental effects on fish occurs at approximately 5 rad (0.05 Gy), as observed
for the one-cell-stage developing chinook salmon embryos. Radiosensitivity reportedly decreases
                                            3-28

-------
                10.000.0
                 1000.0
                 100.0
                  10.0
                  1.0
                  0.1
I
           I
I
                                  I
                          Freshwater   Amphibians  Crustaceans   Molluscs      Algae
                             fish
                                                 Organism
                      RadWien Mlwr hard x-ny or gamrnt.
Figure 3-5.  Ranges of sensitivities of aquatic organisms to acute radiation exposure (adapted
             from NCRP, 1991)
                                               3-29

-------
                   100.0
                    10.0


               5
               
-------
with increasing level of embryo development (Frank, 1973).  Laboratory studies with the Chinook
salmon identify early life stages as the most sensitive for fish. Damage occurred when the dose
reached 9.64 rad/d (4 mGy/h) over an 81-day development period (Hyodo-Taguchi, 1980).  Studies
have shown that 224 rad (2.24 Gy)  reduced female germ cells in chinook salmon; a dose of 600
rad (6 Gy) produced the same effect in rainbow trout.
  Comments on Characterization of Ecological Effects

  Strengths of the case study include:

         •      Direct experimental observations (dose^response curves) were provided to
                characterize effects.  Figures 3-5 and 3-6 include ranges of acute toxicity data
                for various taxonomc groups and different life stages of salmon.

  General reviewer comments:

         •      It was suggested that more sensitive measures than mortality  should be used to
                assess effects. Dose-response curves could be provided to indicate the
                conservative nature of the DOE regulatory limit.

         •      No data are presented to show that protecting salmon embryos protects the
                ecosystem.
3.3.5. Risk Characterization

       Ecological risk was characterized by assessing dose to fish and, as indicators of ecosystem
integrity, other aquatic organisms; by comparing doses to DOE Order 5400.5; and by comparing
doses to published toxicity data.

       3.3.5.1.  Acute Exposure to Ionizing Radiation

       The level of potential risk from ionizing radiation was assessed for fish under both acute
and chronic exposure scenarios.  The acute exposure considered mortality, while chronic exposure
considered developmental effects as measurement endpoints.

       To determine the potential risk to fish, both water and organism concentrations of
radionuclides were converted to dose (tables 3-4 and 3-5, respectively). A comparison of these
values (0.43 and 0.73 rad/d) to the range of acute toxicity (LD50) reported for fish shows that no
acute mortality would be expected from these levels.  To assess exposure effects on a developing
embryo, the whole egg dose was calculated to be 0.00442 rad/d.
                                            3-31

-------
       The characterization of the level of potential risk to fish during early developmental stages
and as adults was expressed as a hazard quotient (HQ), defined as the ratio of radionuclide
organism dose (exposure or tissue value) to a dose-response benchmark value:
                               HQ =
    Exposure Dose
Dose Benchmark Value
(3-4)
       If the HQ is equal to or greater than 1, the likelihood of an adverse effect or high risk
exists. The characterization was completed for the maximally exposed individual for the study
period.  It was assumed that if risk to the individual was low, the population was not at risk.

       The hazard quotients shown in table 3-7 for early developmental stages of fish  and adults
were compared with toxicity values and DOE Order 5400.5.  The  maximum hazard quotient was
0.73 for adult fish.  Assuming that this was the maximally exposed individual, the likelihood of an
adverse effect to an individual was low.

Table 3-7. Hazard Quotient for Early Development Stage of Fish and Adult Fish
                                               Minimum Effect
                        Maximum Exposure    Level
                               Hazard Quotient
Unfertilized ovum,
One-cell stage
Adult

0.00442
0.73

0.96," 0.4b
1

0.004,a0.11b
0.73a'c
"Based on recommendation of the NCRP (1991).
bBased on male courting activity in guppies (Erickson, 1973).
CDOE Order 5400.5.

       3.3.5.2.  Chronic Exposure to Ionizing Radiation

       Mortality from chronic exposure presented minimal risk to fish. Chronic exposure to 5.1
rad/d for up to 69 days did not produce any mortality to chinook salmon embryos or alevins
(NCRP, 1991).  Hershberger et al. (1978) reported lower return of spawning chinook salmon after
exposure of eggs and alevins to 10 rad/d and effects on gonadal development in chinook salmon
was reported to occur at 9.5  rad/d. Because the maximum dose rate to Columbia River adult fish
and developing embryos was 0.73  and 0.00442 rad/d respectively, no chronic effects or mortality
would be expected.  Applying the behavior response noted for guppy embryo exposure (Erickson,
1973), the benchmark concentration would be 0.4 rad/d with an HQ of 0.1.

       3.3.5.3.  Uncertainty

       Extrapolation of individual effects of radionuclides to populations and communities suffers
from the same constraints as similar extrapolations for hazardous chemicals.  The quantitative

                                            3-32

-------
 relationship between potential effects to fish or fish embryos and population and community
 response is not known.  However, the effects data available for radionuclides showed that the
 single-cell stage in salmon is one of the more sensitive indicators of irradiation effects in fish and
 that protection of this stage of development should be protective of the population. Although
 specific data were not available for salmon embryo, data for embryo development of plaice was
 used to estimate dose.

        The NCRP (1991) suggests that a "maximum dose rate 0.4 mGy/h (0.96 rad/d) would
 provide protection for endemic populations of aquatic organisms in environments receiving
 discharges of radioactive effluent." It further states, "adoption of a reference level of 0.4 mGy/h
 appears to represent a reasonable compromise based on current literature, i.e., considering both the
 nature of the effects observed at this dose rate and the limited amount of information on effects of
 radiation in natural populations, including interactions  between ionizing radiation and ecological
 conditions." This value is also  in agreement with DOE Order 5400.5.

        Because whitefish are resident species in the Columbia River and can accumulate
 radionuclides throughout their life cycle, the assessment assumed that the whitefish tissue dose
 would be sufficiently conservative to extrapolate dose levels to other adult fish, including salmon.
 Salmon, on the other hand, spend only a short period of time in the river and do not feed when
 present. In addition, during the spring and early fall when salmon are present, river concentrations
 of radionuclides were generally  the lowest.

        The risk characterization used  the maximally exposed individual to calculate organism dose.
 The risk characterization  assumed that if an organism dose is below any known effect level with
 some degree of certainty, then the likelihood of an adverse effect is  minimal. (The assessment
 endpoint was maintenance of important recreational fish populations  in the Columbia River
 measured by protection of fish populations and specifically salmon embryos.) Results indicate that
 this is a reasonable assumption.   Fish appear to be a suitable choice  of receptor for screening risk
 from ionizing radiation.  In addition, a fish dose of less than 1 rad/d should be protective of the
 ecosystem in general.  However, since CRITR2 indicate that ducks could have  received a dose
 higher than  1 rad/d, further studies are warranted.

        Another area of uncertainty in  the risk assessment is the extrapolation of muscle tissue
 concentration to whole fish concentrations for radionuclides.  The assumption that protection of the
 maximally exposed individual extrapolated to sensitive life stages constitutes an adequate measure
 of the assessment endpoint also is a source of uncertainty.  Alternatively, the hazard quotient is a
 reasonable approach for radionuclides for baseline or screening assessments.

        3.3.5.4.  Conclusions

        This study demonstrates that the ecological risk assessment paradigm  is  applicable to
radioactive substances.  However, stressor-response data were limited to acute exposures; few data
addressed chronic sublethal exposures.  Most endpoints used for hazardous chemicals are expected
to be equally appropriate for  radionuclides.  This study uncovered only one benchmark that
specifically addressed protecting aquatic organisms from exposure to radiation.  DOE  Order 5400.5
limits exposure to aquatic  animals to 1  rad/d.
                                             3-33

-------
        Risk characterization did not indicate any measurable risk to the most sensitive aquatic-
 organism (early life stage of chinook salmon) from exposure to radionuclides in sediments or water
 in the Columbia River. 'During peak production at Hanford, releases of radionuclides to the river
 did not result in a dose to fish that would exceed those specified in DOE Order 5400.5.

        Dose calculations for radionuclide exposure from water and tissue concentrations provide
 for two methods for assessing the potential risks.  This study investigated both methods and found
 that both provided reasonable results for fish, algae, and crayfish. Areas  of uncertainty included
 the relationship between muscle and whole fish concentrations, the lack of a strong data base for
 organism exposure to chronic radiation, and a quantitative measure of ecosystem-level response to
 radionuclides.  During the study period, the major thrust of monitoring at Hanford was to protect
 human health.  Few studies examined ecosystem structure and function. Another significant area
 of uncertainty was the use of adult whitefish tissue concentration as a surrogate for chinook
 salmon.  The study located no data suggesting that salmon accumulate a higher dose than whitefish,
which spend their whole lives in the Columbia River.  Although using fish data tends to increase
uncertainty, fish are particularly sensitive to ionizing radiation and should provide a reasonable
level of protection for fish populations and communities (figures 3-5 and 3-6) and a screen or
benchmark indicator of ecosystem-level effects.
  Comments on Risk Characterization

  Strengths of the case study include:
                The case study provides an opportunity to distinguish between screening
                assessments and more rigorous (realistic) assessments.  The CRITR2 computer
                model is intended to provide a first pass that can be refined if there appear to
                be significant concerns.
 limitations include:
                The hazard quotient should be described in more detail by addressing the
               potential range of values, the establishment of confidence intervals, the degree
                of confidence that the value of 1.00 is safe, etc.  This study uses the most
                sensitive individual  to be conservative, but the selection of the most sensitive or
                highest exposed individual biases the assessment.  The establishment of
                confidence bounds would result in a less biased measure of uncertainty.

               Many assumptions are chained together in this case study to obtain highly
                conservative assessments.  A table should be developed that specifies these
               assumptions  and the types of uncertainties jhey introduce.

                The focus on salmon limits an extrapolation to overall  ecosystem effects.
                                            3-34

-------
Comments on Risk Characterization (continued)

General reviewer comments:

       •      This section should emphasize that risk to the salmon populations is based on
              an anafysis of risk to the most sensitive individuals and that risk from chemical
              exposure or othe'r stressors was not evaluated. Nevertheless, risk from
              radionuclides is addressed adequately.

       •      It would be helpful to have additional emphasis placed on estimating and using
              variability and confidence intervals.  This could be the primary content for the
              section on uncertainty analysis.
                                          3-35

-------
 3.4.  REFERENCES
                     - *
 Baker, D.A.; Soldat, J.K. (1992) Methods far estimating doses to organisms from radioactive
        materials released into the aquatic environment. PNL-8150. Richland, WA: Pacific
        Northwest Laboratory.

 Beasley, T.M.; Jennings, C.D. (1984) Inventories of 239, 240Pu, 241 Am, 137Cs, and 60Co in
        Columbia River sediments from Hanford to the Columbia River Estuary. Environ. Sci.
        Technol 18:201-212.

 Becker, C.D. 0990) Aquatic bioenvironmental  studies: the Hanford experience 1944-84. New
        York, NY: Elsevier Science Publishers.

 Bonham, K.; Donaldson, L.R. (1972) Sex ratios and retardation of gonadal development in
        chronically gamma-irradiated chinook salmon smolts.  Trans. Am. Fish. Soc.  101(3):428-
        434.

 Gushing, C.E.  (1967a) Periphyton productivity and radionuclide accumulation  in the Columbia
        River, U.S.A. Hydrobiologia 24:121-139.

 Gushing, C.E.  (1967b) Concentration and transport of P-32 and Zn-65 by Columbia River
        plankton. Umnol  Oceanogr. 12:330-332.

 Gushing, C.E.; Watson, D.G. (1966) Accumulation and transport of radipnuclides by Columbia
        River biota. In: Guillon, A., ed. Disposal of radioactive wastes into seas, oceans and
        surface waters. Vienna, Austria: International Atomic Energy Agency, pp. 551-570.

 Dirkes, R.L. (1992) Columbia River monitoring data compilation. WHC-SD-EN-DP-024, Rev. O.
        Prepared by Pacific Northwest Laboratory for Westinghouse Hanford Company, Richland,
        WA.

 Erickson, R.C. (1973) Effects of chronic irradiation by tritiated water on Poecilia reticulata, the
        guppy. In: Radionuclides in ecosystems,  vol. 2. Proceedings of the Third National
        Symposium onRadioecology. May 10-12,  1971, Oak Ridge, TN. Nelson, D.J., ed.
       Washington, DC: U.S. Atomic Energy Commission, pp. 1091-1099.

 Frank, M.L. (1973) Sensitivity of carp (Cyprinus carpio) embryos to acute gamma radiation. In:
       Radionuclides in ecosystems, vol. 2. Proceedings -o}the Third National Symposium on
       Radioecology. May 10-12,  1971, Oak Ridge, TN.  Nelson, D.J., ed. Washington, DC: U.S.
       Atomic Energy Commission,  pp. 1106-1112.

Haushild, W.L.; Perkins, R.W.; Stevens, H.H.; Dempster, G.R.; Glenn, J,L. (1966) RadionucUde
       transport in the Pasco to Vancouver, Washington reach of the Columbia River, Jufy 1962 to
       September 1963. U.S. Department of the Interior,  Geological Survey. Portland, OR.
                                           3-36

-------
 Hershberger, W.K.; Bonkham, K.; Donaldson, L.R. (1978) Chronic exposure of Chinook salmon
        eggs and aleyins to gamma irradiation: effects on their return to freshwater as adults.
        Trans. Am. Fish. Soc. 107(4) :622-631,

 Hyodo-Taguchi, Y. (1980) Effects of chronic g-irradiation on spermatogenesis in the fish (Oryzias
        latipes), with special reference to regeneration of testicular stem cells. In: Egami, N., ed.
        Radiation effects on aquatic organisms. Baltimore, MD: University Park Press, pp. 91-104.

 National Council on Radiation Protection and Measurements. (1991) Effects of ionizing radiation
        on aquatic organisms. NCRP Report No. 109. Washington, DC.

 Nelson, J.L.; Perkins, R.W.; Nielsen, J.M. (1964) Progress in studies of radionuclides  in
        Columbia River sediments. HW-83614. Hanford Atomic Products Operation, General
        Electric Company, Richland, WA.

 Poston, T.M.; Strenge, D.L.  (1989) Estimation of sport fish harvest for risk and hazard assessment
        of environmental contaminants.  Presented at Sixth National RCRA/Superfund Conference
        and Exhibition, Hazardous Wastes and Hazardous Materials '89. New Orleans, LA.

 Rackham, B.D.; Woodhead, D.S. (1984) Effects of chronic 7-irradiation on  the gonads of adult
        Ameca splendens (Oste»^hthyes: Teleostei). Int. J. Radlat.  Biol. 45(6):645-656.

 U.S. Congress, Joint Committee on Atomic Energy. (1959) Hearings, vol. 2. 86th Cong., first
        session. Washington, DC:  U.S. Government Printing Office.

 U.S. Department of Energy. (1989) Order 5400.5: Radiation protection of the public and the
       environment.

 U.S. Department of Energy. (1988) Hazardous waste management plan. Defense Waste
       Management, DOE.R1-88-01, U.S. Department of Energy, Richland Operations Office,
       Richland, WA.

 U.S. Environmental Protection Agency. (1992) Framework for ecological risk assessment*
       Washington, DC. EPA/630/R-92/001.

 U.S. Geological Survey. (1966) Radionuclide transport of the Columbia River, Pasco to
       Vancouver, Washington Reach, July 1962 to September 1963. U.S. Geological Survey,
       Progress Report. Portland, OR.

Whicker, F.W; Schultz, V. (1982) Radioecology: nuclear energy and the environment, vol. 1.
       Boca Raton, FL: CRC Press.

Woodhead, D.S.  (1970) 'The assessment of the radiation dose to developing fish embryos due to the
       accumulation of radioactivity by the egg. Radiat. Res. 43:582-597.
                                           3-37

-------
Woodruff, R.K.; Hanf, R.W.; Hefty, M.G.; Lundgren, R.E., eds. (1991) Hanford site
       environmental report for calendar year 1990. PNL-7930. Richland, WA: Pacific Northwest
       Laboratory.
                                          3-38

-------
 3.5. ADDITIONAL READING

 Anderson, L.L.; Harrison, F.L. (1986) Effects of radiation on aquatic organisms and
        radiobiological methodologies for effects assessment.  U.S. EPA, Washington DC  EPA
        520/1-85-016.                                                          '    '

 Auerbach, S.I. (1971) Ecological considerations in siting nuclear power plants: the long-term biotic
        effects problem. Nuclear Safety 12(l):25-34.

 Blaylock, E.G. (1969) The fecundity of a Gambusia afflnis population exposed to chronic
        environmental radiation. Radial. Res. 37:108-117.

 Blaylock, B.C.; Trabalka, J.R. (1978) Evaluating the effects of ionizing radiation on aquatic
        organisms. In: Advances in radiation biology, vol. 7.  Lett, J.T.; Aider, H., eds. New
        York, NY: Academic Press, pp. 103-152.

 Dauble, D.D.; Watson, D.G. (1990) Spawning and abundance of fall chinook salmon
        (Oncorhynchus tashawytscha)  in the Hanford Reach of the Columbia River, 1948-1988
        PNL-7289. Richland, WA:  Pacific Northwest Laboratory.

 International Atomic Energy Agency. (1976) Effects of ionizing radiation on aquatic  organisms and
        ecosystems.  Technical Reports Series No. 172. Vienna, Austria: International Atomic
        Energy Agency.

 National Research Council of Canada. (1983) Radioactivity in the Canadian aquatic environment
        Pub.  No.  NRCC-19250. Ottawa, Canada.

 Nelson, J.L.; Perkins, R.W.; Nielsen, J.M. (1964) Progress in studies of radionuclides  in
        Columbia River sediments. HW-83614. Richland, WA: General Electric.

 Newcombe, H.B. (1972)  "Benefit"  and "harm" from exposure ofrvertebrate sperm to low doses of
        ionizing radiation. Health Phys. 25(7): 105-107.

 Ophel, L.L.; Hoppenheit, M.; Ichikawa, R.; Klimov, A.G.; Kobayashi, S.; Nishiwaki, Y.; Saiki,
       M.  (1976) Effects of ionizing radiations on aquatic organisms. In: Effects of ionizing
       radiation on aquatic organisms and ecosystems.  Technical Report Series No.  172. Vienna,
       Austria: International Atomic Energy Agency, pp. 57-86.

Pearce,  D.W.; Green, J.K., eds. (1965) Hanford radiological  sciences research and development
       annual report for 1964. BNWL-36. Richland, WA: Pacific Northwest Laboratory.

Rice, T.R.; Baptist, J.P. (1974) Ecologic effects of radioactive emissions from nuclear power
       plants. In: Sagan, L.A., ed. Human and ecologic effects of nuclear power plants.
       Springfield, IL: Charles C. Thomas, Publisher, pp. 373-439.
                                           3-39

-------
Templeton, W.L.; Nakatani, R.E.; Held, E.E. (1971) Radiation effects. Radioactivity in the
       marine environment. Washington, DC: National Academy of Sciences, pp. 223-239.

Templeton, W.L.; Bemhard, M; Blaylock, B.C.; Fisher, C.; Holden,  M.J.; Klimov, A.G.;
       Metalli, P.; Mukerjee, R.; Ravera, O.; Sztanyik, L.;  Van Hoeck, F. (1976) Effects of
       ionizing radiation on aquatic populations and ecosystems. Effects of ionizing radiation  on
       aquatic organisms and ecosystems. Technical Report Series No.  172. Vienna, Austria:
       International Atomic Energy Agency, pp.  89-102.

Walden, S.J. (1973) Effects of tritiated water on the embryonic  development of the three-spine
       stickleback Gasterosteus aculeatus linnaeus. In:  RadionucUdes in ecosystems, vol. 1.
       Proceedings of the Third National Symposium onRadioecology,  May 10-12,  1971, Oak
       Ridge, TN. Nelson, D.J., ed. Washington, DC:  U.S.  Atomic Energy Commission, pp.
       1087-1090.

Watson, D.G.; Gushing, C.E.; Coutant,  C.C.; Templeton, W.L. (1970) Radioecological studies on
       the Columbia River, Part II. BNWL-1377-PT2.  Richland, WA:  Pacific Northwest
       Laboratory.

Wilson, R.H., ed. (1963) Evaluation of radiological  conditions  in the vicinity ofHanford April -
       June, 1963. HW-78395. Richland, WA: General Electric.

Wilson, R.H., ed. (1963) Evaluation of radiological  conditions  in the vicinity ofHanford July -
       September, 1963. HW-79652. Richland, WA: General Electric.

Wilson, R.H., ed. (1964) Evaluation of radiological  conditions  in the vicinity ofHanfordfor 1963.
       HW-80991. Richland, WA: General Electric.

Wilson, R.H., ed. (1965) Evaluation of radiological  conditions  in the vicinity ofHanfordfor 1964.
       BNWL-90. Richland, WA:  Pacific Northwest Laboratory.
                                            3-40

-------
               APPENDIX A
COLUMBIA RIVER FISH SPECIES AND FOOD WEB
                  3-A1

-------
Table 3-A1.  Fish Species in the Hanford Reach of the Columbia River
 Common Name
Scientific Name
 White sturgeon
 Bridgelip sucker
 Largescale sucker
 Mountain sucker
 Pumpkinseed
 Bluegill
 Smallmouth bass
 Largemouth bass
 White crappie
 Black crappie
 American shad
 Prickly sculpin
 Mottled sculpin
 Piute sculpin
 Reticulate sculpin
 Torrent sculpin
 Chiselmouth
 Carp
 Peamouth
 Northern squawfish
 Longnose  dace
 Leopard dace
 Speckled dace
 Redside shiner
 Tench
 Burbot
Acipenser transmontanus
Catostomus columbianus
Catostomus macrocheilus
Catostomus platyrhynchus
Lepomis gibbosus
Lepomis macrochirus
Micropterus dolomieui
Micropterus salmoides
Pomoxis annularls
Pomoxis nigromaculatus
Alosa sapidissima
Cottus asper
Cottus bairdi
Cottus beldingi
Cottus perplexus
Cottus rotheus
Acrocheilus alutaceus
Cyprinus carpio
Mylocheilus caurinus
Ptychocheilus oregonensis
Rhinichthys cataractae
Rhinichthys falcatus
Rhinichthys osculus
Richardsonius  balteatus
Tinea tinea
Lota lota
                                           3-A2

-------
Table 3-A1.  Fish Species in the Hanford Reach of the Columbia River (continued)
 Common Name
Scientific Name
 Threespine stickleback
 Black bullhead
 Yellow bullhead
 Brown bullhead
 Channel catfish
 Yellow perch
 Walleye
 Sand roller
 Pacific lamprey
 River lamprey
 Lake whitefish
 Coho salmon
 Sockeye salmon
 Chinook salmon
 Mountain whitefish
 Cutthroat trout
 Rainbow trout (steelhead)
 Dolly Varden trout
Gasterosteus aculeatus
Ictalurus melas
Ictalurus natatis
Ictalurus nebulosus
Ictalurus punctatus
Percaflavescens
Stizosieclion vitreum vitreum
Percopsis transmontana
Entosphenus tridentatus
Lampetra ayresi
Coregonus  clupeafdrmis
Oncorhynchus  Tdsutch
Oncorhynchus  nerka
Oncorhynchus  tshawytscha
Prosopium  williamsoni
Oncorhynchus  clarld
Oncorhynchus  mykiss
Salvelinus malma
                                          3-A3

-------
                                                          Death and Feces
                                                        (Bacterial Breakdown)
                 xv    ^
                 /    Periphyton
                 (     t
                         Sediments
                     (Inorganic and Organic)
Figure 3-A1. Columbia River aquatic ecosystem
                                   3-A4

-------
                     APPENDIX B
CRITR2 CODE CALCULATIONS AND BIOACCUMULATION FACTORS
                        3-B1

-------
                        CRITR Code Calculation of Organism Dose  from
                        Water Exposure  to Various Radionuclides
CRITR OA Printout  •-•  User File: RMAX.USR

  No Dilution Model used.
Run of:  09:52   18-MAY-92
DFSUIH DFSED
3.5E-12 3.2E-11
INUC K NUKSYHS NS
1 1 AS-76 P
t 2 AS-76 F
t 3 AS-76 C
1 4 AS-76 P
1 5 AS-76 F
DFSUIH DFSED
2.1E-11 1.7E-10
INUC K NUKSYHS NS
2 1 CO-60 P
2 2 CO-60 F
2 3 CO-60 C
2 4 CO-60 P
2 5 CO-60 f
DFSUIH DFSED
2.6E-13 2.SE-12
INUC K NUKSYHS NS
3 t CR-51 P
3 2 CR-51 F
3 3 CR-51 C '
3 4 CR-51 .P
3 5 CR-51 F
DFSUIH DFSED
1.5E-12 1.4E-V,
INUC K HUKSYHS NS
4 1 CU-64 P
4 2 CU-64 F
4 3 CU-64 C
4 4 CU-64 P
4 5 CU-64 F
DFSUIH DFSED
3.1E-12 3.0E-11
INUC K NUKSYHS NS
5 1 1-131 P
5 2 1-131 F
5 3 1-131 C
5 4 1-131 P
5 5 1-131 F
DFSUIH DFSED
3.8E-11 2.6E-10
INUC K NUKSYHS NS
6 1 NA-24 P'
6 2 NA-24 F-
6 3 NA-24 C •.
6 4 NA-24 P
6 5 NA-24 F
DFSUIH DFSED
1.4E-12 1.4E-11
INUC K NUKSYHS NS
7 1 NP-239 P
7 2 NP-239 F
7 3 NP-239 C
7 4 NP-239 P
7 5 NP-239 F
FSOLD FRUF
6.9E-02 0.2
CONOR IT
8.5E+04 3
8.5E+04 3
8.5E+04 3
8.5E+04 3
8.5E+04 3
FSOLD FRUF
6.9E-02 0.2
CONCRIT
4.4E+03 1
4.4E+03 3
4.4E+03 2
4.4E+03 1
.- 4.4E+03 3
FSOLD FRUF
6.9E-02 0.2
CONCRIT
9.3E+05 4
9.3E+05 2
9.3E+05 2
TB

3.7E+02
BIO
.OE-01
.OE-01
.OE-01
.OE-01
.OE-01
TB
KB
1.000
1.000
1.000
1.000
1.000

3.7E+02
BIO
.OE+00
.3E-01
.OE+00
.OE+00
.3E-01
TB
3.7E+
BIO
.OE+00
.OE-02
.OE+00
9.3E+05 4. OE+00
9.3E+05 2
FSOLD FRUF
6.9E-02 0.2
CONCRIT
3.7E+05 2
3.7E+05 2
3.7E+05 4
3.7E+05 2
3.7E+05 2
FSOLD FRUF
6.9E-02 0.2
CONCRIT
1.3E+03 3
1.3E+03 5
1 .3E+03 1
.OE-02
TB
KB
1.000
1.000
1.000
1.000
1.000

02
KB
1.000
1.000
1.000
1.000
1.000

3.7E+02
BIO
.OE+00
.5E+00
.OE-01
.OE+00
.5E+00
TB
3.7E+
BIO
.OE-01
.OE-02
.OE-01
1.3E+Q3 3.0E-01
1 .3E+03 5
FSOLD FRUF
6.9E-02 0.2
CONCRIT
.OE-02
TB
3.7E+
BIO
2.1E+05 1.0E-01
2.1E+05 1
2.1E+05 1
2.1E+05 1
2.1E+05 1
FSOLD FRUF
6.9E-02 0.2
CONCRIT
2.1E+05 3
2.1E+05 2
2.1E+05 3
2.1E*05 3
2.1E+05 2
.OE-01
.OE-01
.OE-01
.OE-01
TB
3.7E+
BIO
.OE-01
.5E+00
.OE-02
.OE-01
.5E+00
KB
1.000
1.000
1.000
1.000
1.000

02
KB'
1.000
1.000
1.000
1.000
1.000

02
KB
1.000
1.000
1.000
1.000
1.000

02
KB
1.000
1.000
1.000
1.000
1.000
BUILDUP
1.6E+00
RINTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
3.4E+02
RINTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
4.0E+01
RINTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
7.6E-01
RINTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
1.2E+01
RINTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
9. OE-01
RINTAKE
0.000
0.000
0.000 .
0.100 '
0.200
BUILDUP
3.4E+00
RINTAKE
0.000
0.000
0.000
0.100
0.200
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
1.5E-08 280.0 5. OE-01
1.5E-08 280.0 5. OE-01
1.5E-08 280.0 5. OE-01
1.5E-08 280.0 5. OE-01
1.5E-08 280.0 5. OE-01
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
6.0E-09 9.5 3. OE-01
6.0E-09" 9.5 3. OE-01
3.3E-09 9.5 3. OE-01
6.0E-09 9.5 3. OE-01
6.0E-09 9.5 3>OE-01
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
7.3E-11 616.0 1. OE-01
7.3E-11 616.0 1. OE-01
3.8E-11 616.0 1. OE-01
7.3E-11 616.0 1. OE-01
7.3E-11 616.0 1. OE-01
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
2.1E-09 80.0 5. OE-01
2.1E-09 80.0 5. OE-01
1.9E-09 80.0 5. OE-01
2.1E-09 80.0 5. OE-01
2.1E-09 80.0 5. OE-01
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
3.4E-09 • 100.0 1. OE+00
3.4E^09 100.0 1. OE+00
2.9E-09 100.0 1. OE+00
3.4E-09 100.0 1. OE+00
3.4E-09 100.0 1. OE+00
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
1.5E-08 11.0 1. OE+00
1.5E-08 11.0 1. OE+00
1.1E-08 11.0 1. OE+00
1.5E-08 11.0 1. OE+00
1.5E-08 11.0 1. OE+00
TTRANS EXP
0. OE+00 1. OE+00
ECRIT TBIO F1
2. 9E-09 39000.0 1.0E-03
2. 9E-09 39000.0 1.0E-03
2.8E-09 39000.0 1.0E-03
2.9E-09 39000.0 1.0E-03
2. 9E-09 39000.0 1.0E-03


LAHC
0. OE+00
0. OE+00
0. OE+00
6.3E-01
6.3E-01


LAHC
0. OE+00
0. OE+00
0. OE+00
7.3E-02
7.3E-02


LAHC
0. OE+00
0. OE+00
0. OE+00
2.6E-02
2.6E-02


LAHC
0. OE+00
0. OE+00
0. OE+00
1.3E+00
1 .3E+00


LAHC
0. OE+00
O.OE+00
0. OE+00
9.3E-02
9.3E-02


LAHC
O.OE+00
O.OE+00
O.OE+00
1.2E+00
1.2E+00


LAHC
O.OE+00
O.OE+00
O.OE+00
2.9E-01
2.9E-01


MASS
0.0
0.0
0.0
1.0
1.0


HASS
0.0
b.o
0.0
1.0
1.0


HASS
0.0
0.0
0.0
1.0
1.0


HASS
0.0
0.0
0.0
1.0
1.0


HASS
0.0
0.0
0.0
1.0
1.0


MASS
0.0
0.0
0.0
1.0
1.0


MASS
0.0
0.0
0.0
1.0
1.0


DOSECRIT
3.9E-04
3.9E-04
3.9E-04
3. IE-OS
6.1E-05


DOSECRIT
2.7E-05
6.9E-06
2.9E-05
1.1E-05
7.3E-06


DOSECRIT
2.7E-04
1.4E-06
7.1E-05
1.0E-04
1.0E-06


DOSECRIT
1.6E-03
2.0E-03
2.8E-04
6.0E-05
1.5E-04


DOSECRIT
1.3E-06
2.1E-07
3.7E-07
1.4E-06
4.6E-07


DOSECRIT
3.0E-04
3.0E-04
2.2E-04
2.6E-05
5.1E-05


DOSECRIT
1.8E-04
1.5E-03
1.8E-05
6.2E-08
1.0E-06



PLANT
FISH
CRAUDAO
DUCK-P
DUCK-F



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FISH
CRAUDAD
DUCK-P
DUCK-F



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FISH
CRAUDAD
DUCK-P
DUCK-F



PLANT
FISH
CRAUDAO
DUCK-P
DUCK-F



PLANT
FISH
CRAUDAD
DUCK-P
DUCK-F



PLANT
FISH
CRAUDAD
DUCK-P
OUCK-F



PLANT
FISH
CRAUDAD
DUCK-P
DUCK-F



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eats
eats
eats
eats



eats
eats
eats
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eats
eats
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.
.
P
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P
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P
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.
P
F
                                            3-B2

-------
OFSUIN OFSEO FSOLD FRUF TB
O.OE*00 O.OE+00 6.9E-02 0.2 3.7E+02
INUC 1C NUKSYMS NS CONCRIT BIO KB
1 1 £"lf ? H6*04 5-OE*02 i.ooo
I 1 £"ff £ 'HE*04 1-7E-01 1.000
f / £"« ' £ 2.3E+04 1.06*02 1.000
I £ £"31 c 2.3E+04 5.0E+02 1.000
8 5 P-32 F 2.3E+04 1.7E-01 1.000
DFSWIM DFSED FSOLD FRUF TB
O.OE*00 O.OE+00 6.9E-02 0.2 3.7E+02
INUC K »UKSY« NS CONCRIT BIO KB
9 1 SR-90 P 9.6E+01 3.0E+00 1.000
9 2 SR-90 F 9.6E-01 5.0E-02 1.000
B ? !f'«2 C 9-6E+01 1.0E-01 1.000
9 4 SR-90 P 9.6E+01 3.0E+00 1.000
9 5 SR-90 F 9.6E+01 5.0E-02 1.000
OFSUIM OFSED FSOLD FRUF TB
4.8E-12 4.1E-11 6.9E-02 0.2 3.7g
INUC
10
10
10
10
10
K
1
2
3
i>
S
NUKSYMS
2N-65
ZN-65
ZN-65
ZN-65
ZN-65
NS
P
F
C
P
F
CONCRIT
6.7E+04
6.7E+04
6.7E+04
6.7E+04
6.7E+04
BIO
2.0E+01
6.4E-02
1.0E*01
2.0E+01
6.4E-02
+02
KB
1.000
1.000
1.000
1.000
1.000
BUILDUP
2.1E+01
R INTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
3.6E+02
R INTAKE
0.000
0.000
0.000
0.100
0.200
BUILDUP
2.3E+02
R INTAKE
0.000
0.000
0.000
0.100
0.200
TTRANS EXP
O.OE+00 1.0E+00
ECRIT TBIO F1
9.6E-09 257.0 8.0E-01
9.6E-09 257.0 8.0E-01
9.6E-09 257.0 8.0E-01
9.6E-09 257.0 8.0E-01
9.6E-09 257.0 8.0E-01
TTRANS EXP
O.OE+00 1.0E+00
ECRIT TBIO F1
1.6E-08 4000.0 3.0E-01
1.6E-08 4000.0 3.0E-01
1.6E:.08 4000.0 3.0E-01
1.6E-08 4000.0 3.0E-01
1.6E-08 4000.0 3.0E-01
LAHC
O.OE+00
O.OE+00
O.OE+00
5.1E-02
SilE-02
LAMC
O.OE+00
O.OE+00
O.OE+00
2.4E-04
2.4E-04
HASS
0.0
0.0
0.0
1.0
1.0
MASS
0.0
0.0
0.0
1.0
1.0
DOSECRIT
1.1E-01
3.8E-05
2.2E-02
1.8E-01
1.2E-04
DOSECRIT
4.6E-06
'7.6E-08
1.5E-07
4.8E-05
1.6E-06
PLANT
FISH
CRAWDAD
DUCK-P
DUCK-F
PLANT
FISH
CRAUDAO
DUCK-P
DUCK-F
TTRANS EXP
O.OE+00 1.0E+00
ECRIT
1.2E-09
1.2E-09
5.3E-10
1.2E-09
1.2E-09
TBIO
933.0
933.0
933.0
933.0
933.0
F1
5.0E-01
5.0E-01
5.0E-01
5.0E-01
5.0E-01
LAMC
O.OE-00
O.OE+00
O.OE+00
3.6E-03
3.6E-03
HASS
0.0
0.0
. 0.0
1.0
1.0
DOSECRIT
1.6E-03
5.0E-06
3.6E-04
1.6E-02
1.0E-04
PLANT
FISH
CRAUDAD
DUCK-P
DUCK-F
eats -
eats -
eats •
eats P
eats F
eats -
eats -
eats •
eats P
eats F

eats -
eats -
eats -
eats P
eats F
Notes C Units:

Hanford biofactors used.

Ho bfoaceutnulation factor corrections used.
LAMDA    Bad. Decay constant
DFSUIM   limterston DF
DFSEO   .Sediment DF
FSOLD    Nuctide sed. buildup rate
FRUF     Roughness factor
TB       Sed. Buildup time
BUILDUP  Sed. Buildup
TTRANS   Transport time
EXP      ....
   Vd
Sv/d per Bq
Sv/d per Bq
   m3/m2-d
         Fractional decay during trans.
    d
 Bq-d/Bq
    d
CONCRIT     Cone, in Water
BIO         Bioaccum factor
RINTAKE     Intake rate
ECRIT       Energy absorbed
TBIO        Biological half time
F1          Fraction to total  body
LAMC        Effective decay const.
HASS        Organism mass
DOSECRIT    Organism Dose
Bq/m3
m3/kg
kg/d
J/Bq-d
  d

 1/d
  kg
 Gy/d
                                                        3-B3

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                       SECTION FOUR


          ECOLOGICAL RISK ASSESSMENT CASE STUDY:
EFFECTS OF PHYSICAL DISTURBANCE ON WATER QUALITY STATUS AND
  WATER QUALITY IMPROVEMENT FUNCTION OF URBAN WETLANDS

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                              AUTHOR AND REVIEWERS
AUTHOR
Naomi Detenbeck
Environmental Research Laboratory-Duluth
U.S. Environmental Protection Agency
Duluth, MN
REVIEWERS

Richard Weigert (Lead Reviewer)
Department of Zoology
University of Georgia
Athens, GA

Gregory R. Biddinger
Exxon Biomedical Sciences, Inc.
East Millstone, NJ

Joel S. Brown
Department of Biological Science
University of Illinois at Chicago
Chicago, IL
Robert J. Huggett
Virginia Institute of Marine Science
The College of William and Mary
Gloucester Point, VA

Richard E. Purdy
Environmental Laboratory
3-M Company
St. Paul, MN

Freida B. Taub
School of Fisheries
University of Washington
Seattle, WA
                                          4-2

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                                       CONTENTS

 ABSTRACT   	                               4 ?

 4.1. RISK ASSESSMENT APPROACH	    4_g

 4.2. STATUTORY AND REGULATORY BACKGROUND	  4_g

 4.3. CASE STUDY DESCRIPTION	,	                4_10

      4.3.1.  Background Information and Objective   	            4_10

             4.3.1.1. Study Area	            4_10
             4.3.1.2. Site Selection	     4-12

      4.3.2.  Problem Formulation  . . ."	          4_12

             4.3.2.1. Stressor Characteristics	               4-12
             4.3.2.2. Ecosystem Potentially at Risk	   4_17
             4.3.2.3. Endpoint Selection	      4_lg
            4.3.2.4. Conceptual Model . .	      4_2Q

      4.3.3. Analysis:  Characterization of Exposure	   4_24

            4.3.3.1.  Stressor Characterization  .	   4_24
            4.3.3.2.  Ecosystem Characterization	 .	     4_24
            4.3.3.3.  Exposure Analysis	                  4.25
            4.3.3.4.  Exposure Profile	           4_2g

      4.3.4. Analysis:  Characterization of Ecological Effects  	                 4_29

            4.3.4.1.  Evaluation of Relevant Effects Data	  4-29
            4.3.4.2.  Ecosystem Response Analyses	  4_32
            4.3.4.3.  Analyses Relating Measurement and Assessment Endpoints  	  4-35
            4.3.4.4.  Stressor-Response Profile	  4.35

     4.3.5. Risk Characterization	              4_3g

            4.3.5.1. Risk Estimation	   4_3g
            4.3.5.2. Uncertainty	   4_4g
            4.3.5.3. Risk Description:  Summary and Interpretation of
                    Ecological Significance  . .	   4_4g

4.4.  REFERENCES 	       4_54
                                          4-3

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                                     LIST OF FIGURES
Figure 4-1.   Structure of assessment for physical or hydrological impacts on wetland water
             quality status and function in the eight-county Minneapolis/St. Paul
             metropolitan area	
Figure 4-2.  Map of eight-county Minneapolis/St. Paul, Minnesota, metropolitan area

Figure 4-3.  Path analysis diagram of cause/effect relationships	

Figure 4-4.  Frequency of disturbance regime by wetland type for study sites in
             Minneapolis/St. Paul metropolitan area	
 4-9

4-11

4-21


4-26
Figure 4-5a.  Cumulative frequency distribution of average mid-wetland turbidity values
              over the growing season.  Predisturbance turbidity distribution (P) is
              compared to peak-disturbance distributions for wetlands in watersheds with
              (C) and without  (NC) construction activity	•	
4-40
Figure 4-5b.  Cumulative frequency distribution of average mid-wetland turbidity values
              over the growing season.  Predisturbance turbidity distribution (P) is
              compared to first-year postdisturbance distributions for wetlands in
              watersheds with (C) and without (NC) construction activity	
 4-41
 Figure 4-6.   Regression line and 95 percent confidence interval for relationship between
              In (construction/wetland area) and springtime In (peak+postdisturbance
              pb/predisturbance pb) for urban wetlands affected by storm-water
              additions  	

 Figure 4-7a.  Isopleths for mid-wetland TP threshold values of 40 /ig P/L or 107 /*g P/L;
              predictions for springtime mid-wetland TP, depth change cases  	
 Figure 4-7b.  Isopleths for mid-wetland TP threshold values of 40 /ig P/L or 107 /ig P/L;
              predictions for growing season mid-wetland TP, depth change cases, target
              level of 40 /ig P/L	
 Figure 4-7c  Isopleths for mid-wetland TP threshold values of 40 /ig P/L or 107 /ig P/L;
              predictions for growing season mid-wetland TP, depth change cases, target
              level of 107 /xg P/L  	
 Figure 4-7d. Isopleths for mid-wetland TP threshold values of 40 /ig P/L or 107 /ig P/L;
              predictions for growing season mid-wetland TP, storm-water cases	

 Figure 4-8.  Isopleths for spring mid-wetland color target levels of 113 PCU, 268 PCU,
              and 583 PCU, based on predicted response of median predisturbance values
              and combinations of two stressors, depth change and change in
              watershed/wetland area ratios	
 4-43
 4-44
 4-45
 4-46
 4-47
 4-49
                                               4-4

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                                       LIST OF TABLES
   Table 4-1.   Characteristics of Wetland Disturbance Study Sites in the Minneapolis/St Paul
               Metropolitan Area	                           '


   Table 4-2.   Summary of Wetland Disturbance Intensities for Study Sites in the
               Minneapolis/St. Paul Metropolitan Area	
              Use
  Table 4-5.   Water Quality Values Associated with Mean Light Requirements of 21 4
              Percent Incident Radiation for Submerged Aquatic Vegetation in Northern
              Lakes  	;


  Table 4-6.   Summaty of Results of MANOVAs Testing for Significant Difference in
              Water Quality Change Among Disturbance Classes for Each of Four Time
              Periods	
 Table 4-7.   Equations Predicting Change in Mid-Wetland Water Quality as a Function of
             Disturbance Intensity  	
 Table 4-8.   Mean and Range of Growing Season Mid-Wetland Water Quality Values Prior
             to and Following Disturbance


 Table 4-9.   Uncertainties Affecting Measurement of Risk to Urban Wetland Water Quality
             Matus and Water Quality Improvement Function Related to Physical
             Hydrologic Disturbance	
              4-13



              4-15
  Table 4-3.   Endangered, Threatened, and Special Concern Species in the Upper Midwest
              That Are Associated With Wetland Habitats   	. . . .                4.19


  Table 4-4.   State of Minnesota Water Quality Criteria for Surface Waters by Designated
or
 Table 4-10.  Summary of Risk to Urban Wetland Water Quality Status and Water Quality
             Improvement Function Assessed Against Loss or Conversion of Wetland
             Habitat	
                                                                                        4-31
             4-31
                                                                                        4-33
                                                                                        4-36
             4-39
                                                                                       4-50
                                                                                       4-51
                               LIST OF COMMENT BOXES

Comments on Problem Formulation


Comments on Characterization of Exposure	


Comments on Characterization of Ecological Effects


Comments on Risk Characterization
            4-22


            4-28


            4-37


            4-53
                                           4-5

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DP




DOC




EPA




FTU




FWS



MANOVA




MNDNR




MPCA




NTU




NWI




NWP




PCU




SRP



TCMA




TDS




TP




TSS




U.S. ACOE
             LIST OF ACRONYMS




dissolved phosphorus




dissolved organic carbon




Environmental Protection Agency




formazin turbidity units




Fish and Wildlife Service




multivariate analysis of variance




Minnesota Department of Natural Resources




Minnesota Pollution Control Agency




nephelometric turbidity units




National Wetland Inventory




Nationwide Permit




platinum cobalt unit




soluble reactive phosphorus




Twin Cities metropolitan area




total dissolved solids




total phosphorus




total suspended solids




U.S. Army Corps of Engineers
                                            4-6

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                                           ABSTRACT

         This case study demonstrates an empirical approach to quantifying the regional risk to the
  water quality of wetlands and adjacent surface waters based on the frequency, type, and intensity
  of physical disturbances.  The case study describes an investigation, which began in the fall of
  1988, to determine the effects of physical and hydrological modifications on wetland water quality
  function in the eight-county Minneapolis/St. Paul metropolitan area. Investigators identified the
  incidence of potential stressors to wetland water quality function through surveys of the U S  Army
  Corps of Engineers (U.S. ACOE) 404 permits under the Clean Water Act, state and county
  agencies, and local watershed management organizations.

         The study addressed 33 wetland sites potentially affected by deposition of fill, dredging,
  imppundment, sedimentation, and storm-water or pumped ground-water inputs during the
  succeeding year.  Stressor intensities were quantified as wetland fill area, percentage wetland
  filled, change in water depth due to dredging or impoundment, changes in the ratio of watershed to
 wetland area, changes in the ratio of impervious surface area (urban or residential land use) to
 wetland area, and the ratio of construction area (bare earth)  in the watershed to wetland area.
 Assessment endpoints were potential water quality effects relative to wetland biota (reduced
 transparency, altered  ionic strength, low dissolved oxygen/high ammonia stress,  and lead toxicity)
 and potential water quality impacts on downstream surface waters (eutrophication, reduced
 transparency, nitrate/nitrite toxicity, and lead toxicity). Measurement endpoints  were changes
 between pre- and postdisturbance conditions in the following mid-wetland water quality parameters-
 temperature, dissolved oxygen, conductivity, turbidity, orthophosphate, nitrate plus nitrite,
 ammonia, dissolved and total nitrogen,  phosphorus,  organic carbon, total and volatile suspended
 solids, and total  extractable lead.  Sampling was conducted for up to 1  year prior to disturbance,
 during the peak-disturbance period, and over a 1- to 2-year postdisturbance or recovery period. '

        Investigators used a multiple regression approach to quantify stressor-response
 relationships.  Change in a water quality variable between pre- and postdisturbance or recovery
 periods was regressed against  measurements of disturbance intensity. The y-intercept in these
 regression equations represented annual changes in water quality in the  absence of disturbance
 (e.g., due to interannual climate variability), while the slope  of the relationship represented the
 response to increasing intensities of disturbance.

        Risk characterization required integrating cause-effect relationships identified through site-
 specific investigations  with information on regional distributions of stressor type and intensity,
 One of the greatest uncertainties associated with evaluating risks to wetland water quality in the
 study area was estimating the true incidence or intensity of unregulated  or incompletely regulated
physical or hydrologic disturbances, especially with respect to small, isolated headwater wetlands
Estimates of ecological risk to aquatic biota in wetlands also were hampered by problems in
extrapolating water quality standards derived primarily for different classes of surface  waters to
wetlands.
                                              4-7

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4.1. RISK ASSESSMENT APPROACH

       This case study represents a regional risk assessment of the impacts of physical and
hydrological disturbance on the water quality status and function of freshwater emergent wetlands
in the eight-county Minneapolis/St. Paul metropolitan area.  The study was not designed to fit the
complete U.S. Environmental Protection Agency (EPA)  ecological risk assessment framework
(U.S. EPA, 1992).  In particular, investigators could not fully identify or quantify stressor
characteristics during the problem formulation phase because of a  lack of good background
information.  Thus, problem formulation was refined in  conjunction with the stressor
characterization portion of the analysis phase.

       The study analyzed wetland water  quality status and function, i.e., ecosystem-level effects.
Ecological impacts on specific wetland biota were not the focus of the initial research, but
investigators were able to analyze ecological risks to wetland biota and biota of downstream surface
waters by comparing study area data with  state water quality criteria and critical effects levels
derived from the  literature for relevant wetland biota (U.S.  EPA,  1986).  Figure 4-1 provides a
summary  of the assessment approach used.

4.2. STATUTORY AND REGULATORY BACKGROUND

       One of the goals of the Clean Water Act is to restore and  maintain the chemical, physical,
and biological integrity of the waters of the United States.  A panel of wetland experts broadly
defined wetland integrity as ". . . the persistence of physical, chemical,  and biological conditions
that sustain the long-term processes and structure of the  regional wetland resource ..." (Adamus,
1989).  Similarly, the Emergency Wetlands Resources Act of 1986 promotes  "the conservation of
the wetlands of the nation in order to maintain the public benefits  they provide."  Wetland-related
activities within EPA focus on assessing and protecting wetland processes associated with water
quality, flood control, and habitat functions of wetlands  (Leibowitz et al., 1992).

       In practice, the only federal regulatory framework consistently applied to protect wetlands
is the program  established under Section 404 of the Clean Water Act, which controls the disposal
of dredge or fill material in wetlands.  Much of the wetland fill activity in urbanizing areas was
covered under Nationwide Permit (NWP)  26, which authorizes wetland fill of up to 10 acres in
isolated or headwater wetlands, with no predischarge notification required for fill of less than 1
acre.  Subsequently, as part of the 401 certification process, all NWP 26 applications filed in the
State of Minnesota must include a predischarge notification (U.S.  ACOE, 1992).

       In spite of the wide range of disturbances to which wetlands are subjected (Leslie and Clark
1990), the assessment of long-term impacts on inland wetlands has been restricted to the loss of
wetland area through fill or drainage (Tiner, 1984).  Urban wetlands in particular are exposed to a
wide range of physical modifications and hydrologic disturbances—filling, draining, dredging,
impoundment, and storm-water or pumped ground-water inputs—yet little research or synthesis of
information has been done to assess risks to these systems.
                                             4-8

-------
     PROBLEM FORMULATION
                                dredging, impoundment, storm water, pumped
     Ecosystem(s) at Risk: Wetlands in the Twin Cities (MN) metropolitan area
     Endpoints: Assessment endpoint is maintenance of wetland water quality
                  /urement endR°'nts are mid-wetland physical-chemical
                  (e.g., suspended solids, specific conductivity, organic carbon)
     ANALYSIS
                Characterization
                  of Exposure
       Natural resource managers were
       surveyed and 404 permit notices
       reviewed. Indices of disturbance
       measured were: fill area, % wetland
       filled, changes in water depth, ratio
       of watershed, urban/residential, or
       construction area to wetland area.
    Characterization of
    Ecological Effects
Mid-wetland water quality was
measured each season. Changes
among predisturbance, peak-
disturbance, 1st year post-
disturbance, and 2nd year
recovery phase were calculated.
     RISK CHARACTERIZATION

     Peak- or postdisturbance water quality conditions were compared to the
     predisturbance phase. Mid-wetland water quality was compared to state
     surface water quality criteria and tolerance levels cited in literature for dominant
     wetland vegetation. Rate of recovery of mid-wetland water quality was
     assessed.
Figure 4-1. Structure of assessment for physical or hydrological impacts on wetland water
          quality status and function in the eight-county Minneapolis/St. Paul metropolitan
          arpa                 -                                       r
          area
                                    4-9

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4.3. CASE STUDY DESCRIPTION

4.3.1.  Background Information and Objective

       The antidegradation clause in the Clean Water Act requires the maintenance of wetland
ecological integrity, while the Emergency Wetlands Resources Act promotes the conservation of
public benefits (i.e., functions) of wetlands.  A complete risk assessment of the impacts of physical
or hydrologic  disturbance on urban wetland status and function would require an examination of
effects on wetland hydrologic functions (flood control, ground-water recharge), habitat functions,
and water quality improvement functions.

       Traditionally, the loss of wetland function has been monitored as a net change in wetland
area (Dahl and Johnson, 1991).  Minnesota's 1990 report to Congress under Section 305(b) of the
Federal Water Pollution Control Act estimated that mitigation activities under the 404 permit
program resulted in a statewide net loss of 61 acres of wetlands (of the 5.02 million acre total)
during 1988-1989, with an additional 4,000 acres of wetlands restored or "enhanced" (MPCA,
1990).  Similarly, a comparison of previous rates of wetland loss from drainage with recent rates
shows a decrease. However, the loss of wetland function can occur through type conversions (with
no loss of wetland area) as well as through degradation  of existing conditions.  Therefore, this risk
assessment explicitly targets  an information gap—the potential degradation of wetland water quality
status and function due to common physical disturbances. Where possible, effects on wetland
habitat (loss or conversion) are discussed, but quantification of these impacts  was beyond the scope
of this study.

        The case study summarizes the results of a 3-year, $280,000 research project on the
impacts  on, and recovery of, mid-wetland water quality from physical or hydrologic disturbance in
the eight-county Minneapolis/St. Paul metropolitan area.  Stress-response curves derived from this
study were supplemented with literature- and permit-based surveys of the incidence of physical or
hydrologic disturbance activities hi this region. Investigators also supplemented water quality
criteria values with a literature review of tolerances of relevant wetland-dependent biota to
measured water quality parameters.  The Wetland Function Project (U.S. EPA Wetland Research
Program) provided funding for the original research.  At the time, the Wetland Function Project
focused on wetland water quality and water quality functions; therefore, site  investigations of
potential habitat effects were limited to qualitative descriptions of dominant plant species or cover
and to an assessment of changes in wetland type.

        4.3.1.1.  Study Area

        The study area encompasses both the 7,330 km2 Minneapolis/St. Paul metropolitan area and
 adjacent Wright County (figure 4-2). The population of the region is  over 2,000,000, with the
 heaviest densities in the central cities of Minneapolis and St. Paul.  Land use is 27 percent urban,
43 percent agricultural, and 30 percent open space (Ayers et al., 1985). Urbanization is rapidly
 spreading into agricultural and open areas, with greatest population increases now occurring in
 Anoka and northern Dakota Counties.
                                              4-10

-------
   N
10 KM
                                                                 Washington '•
                                                                   36
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Carver
                                                       '   40 3T
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                                              21
                                          24
                                                        27
                                    Dakota
                                                                         	i
Figure 4-2. Map of eight-county Minneapolis/St. Paul, Minnesota, metropolitan area
          (adapted from Detenbeck, et al. 1992).  Sites are listed by number and
          characterized in table 4-1.
                                     4-11

-------
        Omernik (1986) defines the Twin Cities metropolitan area (TCMA) as part of the North
Central Hardwood Forest ecoregion, with portions extending into the Western Cornbelt Plains.
Topography consists of gently undulating, glaciated uplands dissected by the St.  Croix, Minnesota,
Rum, and Mississippi River valleys.  The region is characterized by terminal moraines and glacial
outwash with wetlands in areas of high water tables, in glacial kettle depressions, and along major
rivers and associated tributaries (Ayers et al., 1985).  Agricultural and urbanization pressures
resulted in the filling or draining of many wetlands, and by 1969 only half of the presettlement
wetland area remained (Anderson and Craig, 1984).  Wetlands now  constitute about 7.6 percent of
the region (Owens and Meyer, 1978).

        4.3.1.2.  Site Selection

        The study design limited the selection process to those wetlands that could be sampled
before, during, and after disturbance within the two growing seasons of the original study time
frame (September 1988 to October 1990).  The lack of legal access eliminated only four of 53
wetlands identified as suitable for the project.  Investigators also eliminated wetland disturbances
adjacent to the St. Croix, Minnesota, and Mississippi Rivers because of the slight chance of
observing a measurable impact to the riparian wetlands of these large, lotic systems.  Impacts  on
water quality status and function of large riverine wetlands are better handled through cumulative
impact assessments than site-specific or population studies (e.g., Gosselink and Lee, 1989; Osborne
and Wiley, 1988).

        Investigators identified 31 wetlands for  the study by surveying wetland fill 404 permit
notices  and by requesting information on additional disturbance activities (dredging, impoundment,
draining, storm-water inputs) from the Minnesota Pollution Control Agency (MPCA), Minnesota
Department of Natural Resources (MN DNR),  county  (drainage)  ditch commissioners, and
watershed management  organizations.

4.3.2.   Problem Formulation

        4.3.2.1.   Stressor Characteristics

        Disturbance activities identified through surveys of area resource managers included
wetland fill (16), impoundment or dredging (9), and diversion of storm water or pumped ground
water into wetlands (14; table 4-1).  Construction activity in the watershed was quantified after the
fact, when monitoring demonstrated that severe sedimentation problems existed at some sites.
Investigators  calculated physical or hydrologic disturbance intensities for each site based on field
observations, 404 permit notices, and topographic maps combined with land-use maps derived by
classifying aerial photos (1:9600) taken before and after disturbance activities (table 4-2).

       In cases  of dredging or impoundment, the disturbance was defined as a step change in
water depth, based on field observations and design criteria contained in permit notices.
Investigators used Circular 39 (Shaw and Fredine, 1956) definitions to classify pre- and
postdisturbance wetland types.  The difference  in wetland types before and after disturbance was
used as a measure of the intensity of dredging or impoundment.  For example, a change from a
type 3 shallow marsh to a type 5 wetland pond  would have an intensity value of +2.  Nonriparian
                                             4-12

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 shrub-scrub (type 6) and woody (type 7) wetlands typically have water table levels equivalent to
 type 2 wet meadows and were assigned a hydrology factor of 2 on the intensity scale.      '

        Investigators measured the intensity of fill disturbances as fill area, the percentage of
 wetland area filled, and the distance from the sampling point to the nearest area of wetland filled.
 Public notices published as part of the U.S. ACOE  404(c) permit program provided information on
 area of fill. Wetland areas were obtained from 404(c) permit notices, watershed districts, or
 National Wetland Inventory (NWI) maps.  Distance from sampling point to nearest filled area was
 calculated from permit notice site maps, topographic maps, or NWI maps.

        Storm-water inputs to a wetland are related  to the degree of urbanization in the watershed.
 Increases in impervious surface area and point-source storm-sewer inputs increase the volume of
 storm water entering a wetland.  To  quantify the increase in urbanization, watersheds were gridded
 into 0.25- to 16-hectare cells on 1:25,000 U.S.  Geological Survey topographic maps  (depending on
 watershed size).  Using this map, investigators identified the number of cells classified as urban or
 residential before and after disturbance, based on an examination of aerial photos (Detenbeck et
 al., 1991a). The change in the ratio of urban and residential area in the watershed to the area of
 each study-site wetland was used as one indicator of storm-water disturbance intensity. Because
 the creation of storm-sewer systems can involve connecting previously isolated watersheds,  the
 change in watershed/wetland area was calculated as  an additional index of hydrologic disturbance.

        Investigators also used the gridded map to quantify erosion inputs. Construction zones with
 surfaces of freshly disturbed bare earth have the largest erosion potential.  Therefore,  the ratio of
 construction area in each watershed to postdisturbance wetland area was calculated for each
 wetland  site, based on an examination of aerial photos.

        Stressor impacts are determined not only by  the incidence and intensity of physical or
 hydrologic disturbances but also by the frequency and  duration of stressors, incidence of multiple
 stressors including increased chemical loadings from watershed development, and time since initial
 disturbance (recovery period).  Ecosystem response  also  depends on tolerances of existing species,
 which may be related to prior disturbance history, including both anthropogenic and natural
 (climatic) disturbance regimes.  Moderating factors include season, antecedent wetland type,
 vegetation,  watershed conditions, and the use of best management practices (e.g., preservation of
 vegetated [upland] buffer strips).

       4.3.2.2.  Ecosystem Potentially at  Risk

       Wetlands in this area can be classified by either water depth or predominant vegetation type
 (e.g., Shaw and Fredine,  1956; Cowardin et al., 1979).  Most of the freshwater wetland types
 identified by Cowardin occur in the study area (Owens and Myer, 1978; Werth et al., 1977),
 although bogs are extremely rare. Some calcareous  fens occur in Dakota  and Scott Counties in the
 southern part of the TCMA and contain plant species listed as endangered, threatened, or species
 of concern in Minnesota (Eggers  and  Reed,  1987).  While wetland vegetation communities have
been inventoried for the TCMA (Owens and Myer, 1978; Werth et al., 1977), few faunal
 inventories are available.  A number of amphibians and reptiles are found in the study region,
including eastern newts (Notophthalmus viridescens), tiger salamanders  (Ambystoma tigrinum),
                                             4-17

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leopard frogs (Rana pipiens), striped chorus frogs (Pseudacris triseriata), green frogs (Rana
clamitans),  wood frogs (Rana sylvatica), spring peepers (Hyla crucifer), snapping turtles (Chelydra
serpentina), painted turtles (Chrysemys pictd), and the smooth green snake (Opheodrys vernalis)
(Niering, 1985).  In all, 35 of the animal (27) or plant (8) species listed as endangered, threatened,
or of special concern within Minnesota are associated with wetland habitats (MN DNR,  1984); 18
of these species have ranges that overlap with the  study region (Niering, 1985; see table 4^3).

        Hydrologic classifications for wetlands in the study area include (a) isolated wetlands, with
no inlets or outlets; (b) intermittent-flow wetlands, with inlets and outlets that flow only during
snowmelt or major storm events; or (c) flow-through systems, with a fairly continuous movement
of surface water in and out of the wetland.  Distinct differences in water chemistry exist among
these hydrologic wetland types in the TCMA, with higher nutrient, carbon, and conductivity levels
in isolated wetlands; thus response may differ by wetland type (Detenbeck et ah, 1991a).
Therefore, impact analyses should consider  initial  (predisturbance) wetland water quality as a
reference condition.

        4.3.2.3.  Endpoint Selection

        Surface water inputs and outputs to wetlands often are intermittent and cannot be rigorously
quantified without intensive instrumentation  and monitoring (e.g., Brown, 1985).   Thus, mid-
wetland water quality variables were chosen as the best set of measurement endpoints to indicate
wetland condition and potential inputs to downgradient ground water or downstream surface
waters.

        Measurement endpoints were chosen as indicators of four components  of mid-wetland water
quality (transparency, trophic status, potential heavy metals toxicity, and redox status) and  three
components of downstream or downgradient surface water or ground-water quality (transparency,
eutrophication, and potential toxicity to humans [nitrate] or aquatic biota [lead]).  Within wetlands,
reduced transparency from high dissolved organic  carbon  (DOC) or suspended solids will limit the
growth of submerged macrophytes (Chambers and Kalff,  1985).  Sedimentation can inhibit
germination from seedbank sources (Galinato, 1985), which may already be depleted by dredge and
fill activities.  Qualitative records of dominant vegetation and plant cover at study-site wetlands
suggested that recovery of submerged aquatics was delayed by >2 years following initial impacts
(Detenbeck  et al., 1992). Regional or local declines in submerged aquatic communities elsewhere
have been attributed to eutrophication and reduced water clarity  (Dennison et al., 1993).
Phosphorus  often is the limiting nutrient  to primary producers  in metropolitan  area lakes, which are
already predominantly mesotrophic or eutrophic (Metropolitan Council, 1981); thus, any increased
loading to downstream lakes could be considered detrimental.  Productivity of area wetlands can be
either nitrogen- or phosphorus-limited; if it is  nitrogen-limited, then increased  nitrate loadings
would also have an impact on wetlands.

       Lead was chosen as a measurement endpoint because it is a common contaminant in urban
environments.  Lead levels are already elevated in metropolitan  area lakes to levels exceeding
water quality criteria (Metropolitan Council, 1981), and high lead levels are associated with urban
storm- water runoff in this region (time-weighted annual average = 39 /ig Pb/L; Johnston et al.,
                                             4-18

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Table 4-3.  Endangered, Threatened, and Special Concern Species in the Upper Midwest
            That Are Associated With Wetland Habitats (derived from MN DNR, 1984, and
            Niering,  1985)
 Scientific Name
 Common Name
 Podiceps auritus
 Pelecanus erythroorhynchos
 Botaurus lentiginosis
 Buteo lineatus
 Pandion hattaeteus
 Gray canadensis
 Rallus elegans
 Coturnicops noveboracensis
 Gallinula chloropus
 Phalaropis tricolor
 Sterna forsteri
 Asia flammeus
 Ammospiza caudacutus
 Homed grebe
 American white pelicanb
 American bittema>b
 Red-shouldered hawk3
 Osprey
 Sandhill crane
 King rail"
 Yellow rail
 Common moorhen3
 Wilson's phalarope
 Forster's tern
 Short-eared owl"
 Sharp-tailed sparrow
 Clemmys insculpta
 Chelydra serpentina
 Crotalus horridus
 Acris crepitans
 RarlU catesbiana
 Rana palustris
Wood turtle"
Snapping turtlea>b
Timber rattlesnake
Northern cricket frog
Bullfrog3
Pickerel frog3
 Clossianafrigga saga (Staudinger)
 Epidemia dorca dorcas (W. Kirby)
 Eribia disa mancinus (Doubleday and Hewitson)
 Oeneis jutta ascerta (Masters and Sorensen)
 Proclossiana eunomia dawsonii (Barnes and McDunnough)
Frigga fritillary
Dorcas copper
Disa alpine
Jutta arctic
Bog fritillary
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Table 4-3.  Endangered, Threatened, and Special Concern Species in the Upper Midwest
            That Are Associated With Wetland Habitats (continued)
 Scientific Name
Common Name
 Notropis emilae (Hay)

 Pofyodon spathula (Walbaum)
 Scaphirhynchus platorynchus  (Rafinesque)
Pugnose minnow

Paddlefish8

Shovelnose sturgeon"
 Arethusa bulbosa L.
 Cephalanthus occidentalis L.
 Decodon verticillatus (L.) Ell.

 Hydrocotyle americana L.

 Pinguicula vulgaris L.
Orchidaceae8

Rubiaceae8

Lythraceae

Apiaceae8

Lenibulariaceae*
"Occurring within study region according to range maps in Niering (1985).
bObserved at least once in study site(s).

1990).  Wetlands can efficiently retain paniculate lead, thereby protecting downstream lakes but
posing a potential risk to wetland biota (Detenbeck et al., 1991b).

        Nitrate was chosen as a measurement endpoint because denitrification is an efficient and
significant water quality improvement function associated with wetland ecosystems.  A buildup of
nitrate in urban wetlands would indicate a breakdown in normal wetland water quality function as
well as a risk to users of downstream surface waters or ground water.

        Measurement endpoints included changes in specific conductivity, temperature, dissolved
oxygen, and ammonia because any of these might affect the suitability of wetland habitats.  The
analysis did not  include measurements of sodium concentrations or ratios of monovalent to divalent
cations, which would be expected to increase with an influx of road salt and could have deleterious
effects on wetland phytoplankton or macrophyte vegetation (Wetzel, 1975).   In particular, inputs of
storm water to extremely dilute bogs or alkaline fens would be expected to  effect ecologically
significant changes in mid-wetland water quality (Rushton, 1991).

        4.3.2.4.   Conceptual Model

        Elements of the conceptual model  for this assessment  are listed in figure  4-1, and the path
diagram (figure 4-3) outlines the relationships between disturbance indices (stressors) and wetland
water quality response.  Construction activity is a potential source for sediment, phosphorus, and
nitrate supplies in urban wetlands, while wetland fill area can serve as a source of sediment or
phosphorus prior to revegetation. Construction activity also can increase loadings of dissolved
                                             4-20

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                                     Jill
                                     II §1
                                    P
                                    PH  U .3 U
4-21

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organic carbon by disrupting soil structure and promoting degradation of soil organic matter.  A
large fraction of lead in urban runoff is in paniculate form (paniculate toxicity), thus lead loadings
should be related to sediment inputs.  Impacts of nutrient, organic carbon, sediment, and lead
inputs are inversely proportional to wetland area; i.e., the same loadings will have a larger impact
on a small wetland than a large wetland. Internal loading of sediment and phosphorus may
increase as wetlands become shallower and resuspension increases, although development of
emergent vegetation in the shallow marsh zone and of submerged vegetation may limit
resuspension.

       Losses of sediment,  paniculate-associated contaminants (lead), and nutrients (phosphorus)
are controlled by hydraulic retention time (flow-through) and the time required for particles to
settle out of suspension (settling), which is a  function of particle size and wetland depth (Walker,
1987).   Flow-through rates are dependent on  runoff (a function of watershed area, percentage of
impervious area,  and precipitation) relative to wetland volume (surface area x depth).

       Within each wetland, transparency is  a  function  of dissolved organic carbon (color),
turbidity (suspended solids), and to some extent, chlorophyll a. Chlorophyll a probably plays a
lesser role in reducing water clarity in wetlands than in  lakes, because algal production in the water
column becomes  inhibited by light limitation  from suspended solids and water color. (Shading  by
floating algal mats would be an exception.)  High turbidity, color, and trophic status (high
chlorophyll a) within wetlands potentially limit the development or recovery of submerged
macrophytes by limiting the depths at which sufficient light is available for growth (Chambers and
Kalff,  1985; Dennison et al., 1993).

       Redox status within  the water column and surficial sediments will be reflected by levels of
dissolved oxygen and by the proportion of dissolved inorganic nitrogen as ammonia.  Under low
dissolved oxygen conditions, relative levels of nitrate will decrease because of denitrification
occurring in anaerobic sediments and because of inhibition of nitrification (conversion of ammonia
to nitrate).
  Comments on Problem Formulation

  Strengths of the case study include:
                 General information on regional wetland types and species composition was
                 summarized thoroughly.
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Comments on Problem Formulation (continued)

Limitations include:

       •      The risk assessment was based on research that was primarily focused on
               wetland water quality junction  and attendant protection of downstream surface
               waters. Insufficient information was available to fully assess the impacts on
               wetland biota.  An analysis of the biota found in specific study sites and an
               assessment of the relative sensitivity of different classes of biota would have
               strengthened the risk assessment.  These  data were not attainable given
               available  resources. Research is under way  to characterize the wetland
               macroinvertebrate communities that are affected by storm-water inputs in this
               region.

       •      Stressors and endpoints.  Water quality might not be an appropriate endpoint to
               evaluate the impacts of disturbance to wetland ecosystems.  For example,
              productivity is determined by the throughput, or turnover, of nutrients and can
               be affected without significant effects  on  standing stocks of free nutrients.
               Temperature is a relative factor; its impact depends on the system and its
               ground state.  Also, the presence or absence of individual species is unlikely to
               be a sensitive indicator because of prior  impact; however, changes  in abundance
               might signal important changes.

       •      Wetland values.  Wetlands are valuable for more reasons  than  serving as a
               buffer for downstream  water quality.  For example, wetlands provide habitat for
               migratory birds and ecotone species and help maintain ground-water levels.
               The case study  should indicate how the stressors affect variables such as these.
               It also should be noted that partial fill is a loss  of wetland habitat.

General reviewer comment:

       •     Although a path diagram is included  (figure 4-3), a statistical path  analysis
               could not be completed.   The ecological  literature tends to emphasize causality
               models that perform path analysis.  If the data  on wetlands  are numerous
               enough or amenable to such analyses, a  path analysis would be useful to
               decompose direct and indirect effects.  The resulting diagram would be useful by
               showing linkages between dependent and independent variables.  Rather than
              pattern hunting, statistics could be used to test specific hypotheses.   The path
               analysis diagram could be used as a basis for the conceptual model.
                                           4-23

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4.3.3.  Analysis:  Characterization of Exposure

        4.3.3.1.  Stressor Characterization

        Among the study sites, dredging impacts ranged from minimal (no change in water depth
class; e.g., Minnehaha site 39, type 5) to an increase in three depth units for site 36.  In the latter
case, a type 2 wetland was dredged to form a type 5 wetland pond.  Impoundment in the absence
of dredging was relatively rare, occurring at only two study sites, and resulted in a step change of
only one unit in the scale of relative water depth (1-5).

        Wetland fill area varied from 0.01  ha (Comma, site 38) to 2.0 ha (Colonial Pond, site 1),
with percent wetland area filled ranging from less than 1 percent (Comma) to 71 percent (Colonial
Pond).  The greatest potential erosion impacts occurred at Centerville (site 31), with a ratio of 120
for construction zone to wetland area, indicating a high potential loading of sediment per unit
surface area of wetland.

        New storm-water inputs were common in urbanizing regions as the area of impervious
surface increased and point-source storm sewers were built to divert storm water into wetlands.
The potentially greatest storm-water impacts occurred at JP-26W (site 29), with an increase in the
ratio of urban plus residential area to wetland area of 56.  In two cases, ground water also was
pumped into wetlands as a means to de-water adjacent construction sites.  These inputs were
temporary and sporadic and could not be quantified easily.

        4.3.3.2.  Ecosystem Characterization

        Wetlands ranged in size from 0.01  ha to over 112 ha, and watersheds varied from 3.3 ha to
8,864 ha. Predominant land use in each watershed was classified as agricultural, urban or
residential, or undeveloped or open space.  Overall land use ranged from 0 to 92 percent
agricultural, from 0 to 45 percent forested, from 0 to 48 percent urban, from 0 to 49 percent
residential, from 1 to 58 percent water (lake plus marsh), from 0 to 70 percent construction area,
and from 0 to 9 percent orchard in  any given watershed.  Average watershed slope varied from 1.4
percent for the Coon Creek watershed within the Anoka Sand Plain (site 23) to 13.2 percent  for
JP-25 (site 40) in the hilly terrain of Eagan.  Soil erodability varied from an average K-factor of
0.16 (Coon Creek watershed, site 23)  to an average K-factor of 0.33 in JP-68 (site 28) within
Eagan.

        Only a small proportion of the sites modified by physical or hydrological disturbance had
buffers of undisturbed  vegetation left surrounding the wetland.  Typically, construction extended to
the edge of or directly into the wetland.  Only six wetlands  had vegetated buffer zones left between
the impact and the sampling point; these buffers ranged in width from 3 to 8 meters.

        Effects of physical or hydrologic stressors will be moderated or exacerbated  by climate,
particularly the amount and temporal distribution of precipitation.  Climate in the TCMA is
continental, with mild, humid summers and relatively long,  severe winters.  Most rain comes in
frontal storms or warm-weather convective storms,  with May and June typically the wettest months
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  and February the driest (Brown, 1984).  Normal annual precipitation is 68.6 cm, including the
  water content of 111.8 cm average winter snowfall.  Annual precipitation varied greatly during the
  study.  In the drought year of 1989,  annual precipitation was only 59.2 cm, while heavy summer
  rains brought the 1990 total to 83.9 cm (U.S. Weather Service, 1991).

         Impacts on wetlands from physical and hydrologic disturbance depend in part on initial
  hydrologic and vegetation conditions at each site.  Investigators classified the range of wetland
  types in the study area using the definitions in Circular 39 (Shaw and Fredine, 1956).  Predominant
  vegetation in the wet meadows included reed canary grass (Phalaris arwdinacea),  smartweeds
  (Polygonwn spp.), and stinging nettle (Urtica dioicd).  Cattail (Typha spp.) dominated both shallow
  and deep marshes, with sizable inclusions of softstem bulrush (Scirpus validus), giant reed grass
  (Phrqgndtes australis), and arrowhead (Sagittaria latifolia).  Various pondweeds (Potamogeton
 spp.), coontail (Ceratophyllum demerusum), and water milfoil (Myriophyttum spp.) were common
 among submersed vegetation, with lotus (Nelumbo luted), yellow water lily (Nuphar variegata),
 white water lily (Nymphaea odorata), and duckweed (Lemna spp.) floating on the surface of
 wetland ponds.  Invasions of purple loosestrife (Lythrum salicarta) were found in scattered areas.
 Typical shrubs in type 6 wetlands included red osier dogwood (Cornus stolonifera), speckled alder
 (Alms rugosa),  and numerous willows (Salix spp.).   Of the species noted, seven were rated as
 moderately tolerant to turbidity and pollution by Kadlec and Wentz (1974), while only one species
 (Potamogeton natans) was rated as relatively intolerant. Typha spp. and Phragmites australis,
 common at many of the sites, are considered to be invasive species that often appear in disturbed
 areas.

        4.3.3.3.  Exposure Analysis

        Frequency of impacts due to physical or hydrologic disturbance to wetlands in the TCMA
 was quantified by two related survey  approaches. First, information on all impending physical or
 hydrologic disturbances to wetlands in the TCMA for the period of fall 1988 to fall 1990 was
 requested from area resource managers (see above).  Second, all individual and nationwide U.S.
 ACOE 404 permits requiring predischarge notification received in 1988 and 1989 by the St.  Paul
 District U.S. ACOE Office were reviewed for information on factors related to permit success
 (Taylor et al., 1992).

        The frequency of disturbance  regimes at sampling stations was tabulated by Circular 39
 wetland type (figure 4-4).  Most sites received multiple  impacts. Almost all study sites (79
 percent) were potentially affected by sedimentation from construction activity immediately
 surrounding the wetland or from physical modifications to existing wetlands. Nearly two-thirds of
 the study sites were partially filled or affected by storm-water or pumped ground-water inputs.
 Added water inputs were most common for wetland pond or deep marsh systems, while water level
 changes due to dredging or impoundment were most common for shallow marsh or wet meadow
 systems.

       A total of 114 fill permits were reviewed, of which 86 (75 percent) were approved.
Investigators identified 30 (35 percent) approved permits for which additional disturbances  at the
wetland site were anticipated, either as part of a construction project, mitigation action, or water
level manipulation for waterfowl management. Eighteen (60 percent) of the additional disturbances
                                            4-25

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       sedimentation
                                fill      water inputs  depth change
                           DISTURBANCE REGIME
                             Wetland type
      wet mead/seas'y fl
|     | pond
shallow marsh
shrub/woody
                                                            deep marsh
Figure 4-4.  Frequency of disturbance regime by wetland type for study sites in Minneapolis/
           St. Paul metropolitan area (Detenbeck et al., 1991a).  Physical or hydrologic
           disturbance regimes are categorized as sedimentation (i.e., erosion from
           construction activity  or resuspension), partial fill activity, storm-water or pumped
           ground-water inputs, and water depth changes due to dredging or impoundment.
           Wetland sampling stations are categorized by Circular 39 classifications:  wet
           meadow and seasonally flooded wetlands (types 1,  2),  shallow marsh (type 3),
           deep marsh (type 4), wetland ponds (type 5), and scrub-shrub or woody wetlands
           (types 6, 7).
                                      4-26

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 involved dredging open water areas, five (17 percent) involved new storm-water inputs, four (13
 percent) involved dredging channels, three (10 percent) involved impoundment but no dredging,
 and three (10 percent) involved wetland drainage (two cases of temporary drainage).

         Most of the wetland sites identified in this study received more than one physical or
 hydrologic disturbance, and many sites obviously had been affected by past alterations.   Without a
 longer term record, however, it was not possible to determine the frequency of disturbance to
 wetlands in the TCMA over time.  The season during which the physical activity creating physical
 or hydrologic disturbances ends is probably the most critical aspect of timing that will affect
 wetland recovery. At 34 (72 percent)  of the 47 mid-wetland stations monitored,  the physical
 activity producing the wetland disturbance ended outside of the growing season, i.e.,  in the fall,
 over the winter, or during snowmelt.

        It is clear that physical or hydrologic disturbances affect some wetlands in the TCMA more
 heavily than others.  However, there is no evidence that fill permit success is significantly
 associated with wetland type, adjacency to large wetland complexes, adjacency to calcareous fens
 (which have special protection status in the state of Minnesota),  or state-protected status  (types 3,
 4,  and 5 wetlands; Taylor et al., 1992).  Permits to fill wetlands immediately surrounded by
 industrial or commercial land or by open land (on the suburban fringe) are  significantly more likely
 to be approved than those for wetlands immediately surrounded by residential, mixed  residential, or
 agricultural land use  (Taylor et al., 1992). Storm water-related  disturbances  to wetlands are
 prevalent in the Eagan area (northern Dakota County), which has a relatively steep topography and
 a rapid rate of growth through residential development (figure 4-1).

        An exact percentage of the area of wetland resources in the TCMA affected annually by
 physical or hydrologic disturbance cannot be easily quantified until automated data are available
 from NWI map digitization.  Wetlands of 10 to 500 acres in size were partially catalogued in 1967
 by  MN DNR for fish and wildlife management (MN DNR,  1967).  According to their records,
 approximately 745 type 2, 3, 4, or 5 wetlands  were found in the TCMA. No quantitative
 inventory of smaller wetlands is available.  If 86 wetlands are partially filled  in a 2-year period, 30
 of which experience physical or hydrologic disturbances, this represents an incidence of
 approximately 11.5 percent of wetlands affected by partial fill and 4 percent of wetlands  affected
 by  additional physical or hydrologic disturbance over a 2-year period. This obviously is an
 overestimate,  however, because many of the wetlands affected by fill and related disturbances are
 much smaller than 10 acres in size,  and this fraction of the wetland resource has not been well
 quantified in the TCMA.

        Total wetland losses in Minnesota resulting from 404 permits (individual, general, and
nationwide) equaled approximately  1,196 acres out of a total of 5.02 million acres, or 0.024
percent per year in 1988-1989.  During the same period,  Minnesota also saw a gain due to
mitigation activities of 1,135 acres, for  a net loss rate of 0,0013 percent per year (MPCA, 1990).
In comparison, wetland losses due to drainage in a 10-county area during 1974-1980 were
estimated at 0.02 percent per year for wetland ponds, 0.6 percent per year for deep marshes, and
2.3  percent per year for shallow marshes (MPCA, 1990).  Loss of specific wetland types as the
result of conversions to other wetland types has not been quantified for this region of the country.
Nationwide, 0.1 percent and 1.3 percent of forested jpalustrine wetland area  (swamps)  have been
                                             4-27

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lost by conversion to nonvegetated wetlands (ponds) and marshes, respectively, while 0.2 percent
of marshes has been lost to conversion to ponds (Dahl et al., 1991).

       4.3.3.4.  Exposure Profile

       The most commonly recorded physical or hydrologic disturbances to wetlands in the
TCMA are, in order of frequency, sedimentation from excessive erosion, wetland fill, deepening
by dredging or impoundment, and storm-water impacts.  Up to 11.5 percent of wetlands in the
TCMA were  permitted for partial or complete filling over a 2-year period, with up to 4 percent of
all wetlands affected by additional physical or hydrologic disturbances. Wetlands on the suburban
fringe or those surrounded by industrial or commercial land uses are most likely to be filled.
Storm-water inputs are probably most common in areas of rapid residential growth and relatively
steep topography, but the use of wetlands for storm-water management is not well documented on a
regional basis.  Most disturbances to wetlands occur or terminate  during a period outside of the
growing season, thus maximizing potential recovery time.
  Comments on Characterization of Exposure

  Strengths of the case study include:

         •      Spatial and temporal variability in exposures is described.

         •      The causes of uncertainty in exposure estimates are documented.

  Limitations include:

         •      A complete exposure profile for the TCMA wetlands would require that the
                potential resources affected be better quantified in terms of wetland number,
                area, and type.  In addition,  a more complete sample of physical and
                hydrologic disturbance frequency and intensity, particularly for partially
                regulated or nonregulated disturbances (drainage, impoundment,  dredging,
                storm-water or pumped ground-water inputs) is needed.

         •      A more complete exposure profile also would include site-specific information
                on particular wetland populations and communities exposed to physical and
                hydrologic disturbance, as determined by the overlap of their temporal and
                spatial distributions.  Some of this information will be available from an
                ongoing study of effects of storm-water and nonpoint-source  pollution  on
                wetland macroinvertebrate  communities in the TCMA.
                                             4-28

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  4.3.4.  Analysis:  Characterization of Ecological Effects

         4.3.4.1.  Evaluation of Relevant Effects Data

         Investigators judged the relevance of the impacts  of disturbance on wetland water quality on
  the basis of (1) the statistical significance of effects and (2) the potential ecological significance of
  effects.  The statistical significance of changes in water quality was tested both as a verification of
  cause-and-effect relationships and as a means of comparing water quality values against a reference
  (predisturbance) condition.  Comparisons against reference conditions are appropriate when water
  quality varies regionally as  a  function of landscape or climatic conditions or when there is a high
  level of uncertainty associated with the magnitude of critical effect levels. For example, reference
  conditions by ecoregion have been used in deriving regional lake water quality standards for the
  State of Minnesota (Heiskary and Wilson, 1990). Water quality criteria provide critical effect
  levels, but these often are derived based on tests of nonwetland species and under testing conditions
  (high dissolved oxygen, low dissolved organic carbon, circumneutral pH) that are atypical of
 wetlands (Hagley and Taylor, 1991).

        The realism inherent in field-scale manipulations or observations is accompanied by spatial
 (geographic) variability among study sites as well as temporal (climatic) variability between pre-
 and postdisturbance periods. Analyses of predisturbance wetland water quality identified wetland
 type, hydrologic class, contact with sediment (pore water vs. surface water), season (snowmelt  vs.
 growing season),  and surrounding land use as factors with significant contributions to variability in
 wetland water quality variables (Detenbeck et al., 1991a). Thus, paired before-and-after
 comparisons were used to factor out spatial variability among sites.  Predisturbance conditions at
 each site served as a reference against which peak- or postdisturbance conditions were compared
 using a parametric multivariate analysis of variance (MANOVA).  A nonparametric Kruskal-Wallis
 test was used when data could not be normalized with log transformations* (Sokal and Rohlf,  1981).
 MANOVAs were used in place of paired t-tests to reduce the probability of Type II errors, which
 increases as the number of tests performed increases.  Repeated analysis of variance measures by
 variable type would be an ideal test to use here to determine time to recovery because these tests
 would correct for possible carry-over effects  (serial correlation), but the number of observations
 available without missing data for all of the time periods of interest was very low (n=8-9).

        The disadvantage of a paired before-and-after comparison approach is that interannual
 climatic variability can bias changes between pre- and postdisturbance periods.  Thus, only those
 water quality variables showing both (a) a significant change from predisturbance periods and (b) a
 significant difference in response among disturbance classes were considered to be affected by
 physical disturbances.  Alternatively, one could employ paired before-and-after  comparisons with
 sites distributed along a disturbance gradient,  somewhat analogous to an analysis of covariance
 approach.  This approach regresses the change in  mid-wetland water quality at each site against
 indices of disturbance intensity. Thus the y-intercept represents the expected change in water
 quality due to interannual climate variability alone, while the slope of the regression represents the
 response to increasing disturbance intensity.  A multiple regression approach can be used to factor
out the effect of multiple disturbances as long as colinearity (correlation among  dependent
variables) is not a problem.
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       Evaluation of levels of water quality variables (or changes in water quality) associated with
potential ecological effects was based on water quality criteria values (total lead, ammonia, total
phosphorus, nitrate, dissolved oxygen, temperature, conductivity, and turbidity) or on critical effect
levels derived from the literature (color, turbidity, total phosphorus, and conductivity).  Individual
states are still in the process of modifying narrative and numeric surface water quality criteria for
application to wetlands.  According to guidance provided to individual states by the EPA Office of
Wetlands Protection, initial narrative and numeric water quality standards for wetlands should be
developed or modified using existing information as much as possible, with a longer-term goal of
developing biocriteria for wetlands (U.S. EPA, 1991). Relevant water quality standards associated
with designated (protected) uses for surface waters in the State of Minnesota are listed in table 4-4.

       Changes in color, turbidity (suspended solids), and trophic state (total phosphorus [TP]) can
be evaluated based on their effects on wetland transparency and on the potential for successful
growth of submerged macrophyte communities.  Relatively few data have been published on light
requirements for submerged aquatic plants.  Data have been  compiled for sea grasses (Dennison et
al., 1993) and for submerged macrophytes in the littoral zone of northern lakes (Chambers and
Kalff, 1985).  Chambers and Kalff report an average minimal light requirement for freshwater
angiosperms in Canadian lakes corresponding to 21.4 ± 2.4 percent of surface light levels.
Corresponding color, turbidity, and chlorophyll a levels, which would reduce light  at the bottom of
a type 3, type 4,  or type 5 wetland to 21.4 percent of surface illumination, can be calculated (table
4-5).

        Calculations were based on the following relationships:

Equation 4-1 (Wetzel, 1975):

        Kd =  extinction coefficient
           =  In (Vy  x 1/z
           =  In (1/0.214) x
        where \ = incident radiation, \ = radiation at depth z

        SeccM depth = 1.65/K,, (Dennison et al., 1993)

 Equation 4-2 (Brezonik, 1978):

        1/S.D. = 0.106 + 0.128 (turbidity, nephelometric turbidity units [NTU]) + 0.0025 (color,
        platinum cobalt units [PCU])

 Equation 4-3:

        log10(Secchi depth, cm) = 2.07 - 0.13 Iog10(total P, ug/L)

        (Derived from data for colored lakes with average depth <2.4 m, in Beaver and Crisman,
        1991.)
                                              4-30

-------
Table 4-4.  State of Minnesota Water Qualify Criteria for Surface Waters by Designated Use
            (U.S. EPA, 1988c)
Water Quality
Variable
Total phosphorus

NO3 + NO2
NH4
Surficial dissolved
oxygen
Surficial water
temperature
Units
UgP/L

mgN/L
mgN/L
mg/L
degC
State of MN* or Other Numeric Water Quality Criteria
Recreation." 40 pg P/L for North Central Hardwood Forest
ecoregion
Consumption. >10 mgN/L
For NH3-N. Fisheries & Recreation. A: >0.016 mg/L; B: >0.04
mg/L
Fisheries & Recreation. 2A: >7 mg/L at all times. 2B, 2C:S5
mg/L at all times
Fisheries & Recreation. A: no material increase, 30°C max.
8B, C: no increase in monthly avg. of max. daily temp. >1.7°C in
 Total extractable lead   pg/L
 Specific conductivity

 Turbidity
umhos/cm

NTUd
lakes, 35°C max.

4-day average.  >1.3,3.2, or 7.7 pg/L at 50,100,200 mg CaCO3/L
hardness

Agr.& Wildlife. A: >700 mg/L TDSC

Fisheries & Recreation. A: >10; B, C: >25
"Depending on attainable use (Fisheries & Recreation or Agriculture & Wildlife).  Class A = associated with
 salmonid fisheries, Class B = supporting cool- and warm-water sport or commercial fisheries and associated
 aquatic community, Class C = supporting indigenous fish and associated aquatic community.
bBased on attainable lake trophic state for North Central Hardwood Forest ecoregion.
cApprox. 1,094 pmhos/cm. TDS = total dissolved solids.
dNTU = nephelometric turbidity units.


Table 4-5.  Water Quality Values Associated With Mean Light Requirements of 21.4
            Percent Incident Radiation for Submerged Aquatic Vegetation in Northern
            Lakes (Chambers and Kalff, 1985)
Wetland
Type
3
.4
5
Depth Range,
cm
15-60
60-120
120-240
K.m"
2.57
1.28
0.64
Secchi Depth,
meters
0.64
1.29
2.58
Turbidity,
FTUa
11.4
5.2
2.2
Color,
PCU
583
268
113
Total P, ug/ L
107
N/Ab
N/Ab
aFTU = formazin turbidify units.
"Secchi depths outside of range of observations used in deriving equation.
                                            4-31

-------
       Minnesota's standard of 40 pg P/L for TP in lakes within the North Central Hardwood
Forest is lower than the estimated requirement of 107  pg P/L to maintain sensitive submerged
aquatic macrophyte communities in type 3 wetlands. The lower standard is ecoregion based and is
designed to minimize the frequency of nuisance algal blooms.

       During predisturbance conditions, mean specific conductivity values for surface water (440
pmhos/cm) and ground water (610 pmhos/cm) were near the upper end of the range associated with
freshwater vegetation in the glaciated prairie region.  Stewart and Kantrud  (1971) list a range of
<40-500 pmhos/cm for normal climatic conditions  and a range of <40-700  pmhos/cm for extreme
(drought) conditions. Thus, 700 pmhos/cm was considered a threshold value for specific
conductivity for these wetlands.

       Investigators had  to apply dissolved oxygen criteria derived for other surface waters to study
area wetlands because of a lack of better literature values.  These criteria, however, were probably
overprotective since wetlands in the study area typically contain no fish or fish species extremely
tolerant of low dissolved oxygen (e.g., common carp [Cyprinus carpio], fathead minnow
[Pimephales promelas], and brook stickleback [Culaea inconstans]).  However, investigators
believed that the average level and diurnal fluctuations in both dissolved oxygen and temperature
could be critical in determining acceptable spawning habitat or refugia for  amphibians.

       4.3.4.2. Ecosystem Response Analyses

       Investigators could not use MANOVA to test categorical effects with the full complement of
study sites because data matrices were complete for a subset of sites; the power of these tests was
more limited than for regression analyses. However,  MANOVAs did demonstrate a significant
fivefold increase in soluble reactive phosphorus (SRP) and a threefold increase in dissolved
phosphorus (DP) at the peak of storm-sewer disturbance activities (after storm sewers were
connected and during watershed construction activity; table 4-6).  Threefold increases in SRP and
DP were still evident in storm water-impacted sites at 6 to 12 months and at 12 to 24 months
following peak disturbance.  Nitrate levels were strongly elevated, fortyfold in dredged or
impounded sites and eightfold in storm water-impacted sites during the peak of disturbance activity,
but no significant (categorical) increases were observed during subsequent time intervals (table 4-6).
All increases were significant at a probability level (a) of 0.05, some at a  probability level of 0.001.

        To assess further the long-term impacts of construction and residential development
surrounding  wetlands in  urbanizing areas, nonparametric Kruskal-Wallis tests were used to compare
different categories of wetlands.  Wetlands  in nondeveloping watersheds experienced declines in
 dissolved nitrogen between predisturbance and recovery periods, while those wetlands in developing
 watersheds experienced no change or a slight increase in dissolved nitrogen.  Construction activity
in the watershed was associated with increased In (total suspended solids [TSS]) within wetlands in
the second year following disturbance (Detenbeck et  al., 1992).

        Comparison of water quality changes among wetlands with or without vegetated buffers in
 watersheds with or without construction activity showed significant effects (p<0.05) only with
 respect to the initial impact period at the peak or immediately following disturbance. Wetlands
                                             4-32

-------
  Table 4-6.  Summary of Results off MANOVAs Testing for Significant Difference in Water
              Quality Change Among Disturbance Classes for Each of Four Time Periods
Average In Ratio (post/pre)a
(geometric mean)
{back-transformed 95% CI)
Variable
Aln soluble reactive
phosphorus

Aln dissolved
phosphorus

Aln nitrate


Aln dissolved
phosphorus

Aln soluble reactive
phosphorus

Aln dissolved
phosphorus

Aln dissolved
phosphorus

Time ;
Period1" N Depth Change Wetland Fill
1 19 -0.038 -O090

1 19 -0.37 -0.081

1 19 3.68d -0.30
(39.6)
(10.4 - 151)
3 16e 0.24 -6732~


4 14e 0.17 -0.44

4 14" 0.11 -0.48

4 21 0.16 -0.39

Storm Water
1.65C
(5.2)
(1.7-16)
1.21*
(3-4)
(1.6-7.2)
2.02d
(7.5)
(2.9 -19.7)
1 15°
(3.2)
(1.3 - 7.3)
1.09°
(3.0)
(1.2 - 7.6)
1.15°
(3.2)
(1.4-7.2)
0.71°.
(2.0)
(.1.1 -4.8)
"Differences in the change in water quality between disturbance classes were tested by Tukey's test to
 control for experimentwise error.  Categories not significantly different from each other are indicated
 by a line. Only variables demonstrating a. significant change in water quality and significant
 differences in response among disturbance regime categories are included here.

                                                                      (Notes continued on next page)
                                              4-33

-------
bl — Peak-disturbance vs. predisturbance.
 2 = 0-6 months postdisturbance vs. predisturbance.
 3 = 6-12 months postdisturbance vs. predisturbance.
 4 » 12-24 months postdisturbance vs.  predisturbance.
•Different from zero: p<0.05.
•"Different from zero: p<0.01.                                                                   .
'Only data for which both dissolved and total constituents were available (surface water samples) were included
 in the analysis.
                                                    4-34

-------
  without vegetated buffers in watersheds with construction activity had greater SRP levels than
  either wetlands associated with construction activity but surrounded by vegetated buffers or
  wetlands in watersheds without new construction activity.  There was no significant difference
  between peak or predisturbance SRP for wetlands in watersheds without new construction activity
  and those surrounded by vegetated buffers.  Nitrate levels followed the same pattern as SRP levels
  (Detenbeck et al.,  1992).

         DP was least in wetlands with no construction activity in the surrounding watershed but did
  not show significant differences between buffered and nonbuffered wetlands.  Dissolved nitrogen
  and water color were greater in nonbuffered wetlands than in watersheds without construction
  activity.  Longer-term effects of buffers were not detected for growing season averages of water
  quality variables in the first year following disturbance (p>0.05).

         4.3.4.3.  Analyses Relating Measurement and Assessment Endpoints

         The impact of physical or hydrologic disturbance on mid-wetland water quality depends on
 the ecological significance of the observed magnitude of change. In addition, potential impacts on
 biota of downstream surface waters  must be considered.  The impact of changes on water quality
 variables for which numeric water quality criteria exist or threshold values have been derived can
 be evaluated by  assessing the incidence of criteria or threshold value exceedance.

         4.3.4.4.   Stressor-Response Profile

         Investigators used stepwise multiple regression analysis to assess the effects of the intensity
 of physical or hydrologic disturbances on mid-wetland water quality.  The change in water quality
 between pre- and postdisturbance time periods was the dependent variable. Although numerous
 statistically significant relationships were found, this case study reports on a subset focusing on
 water quality variables for which threshold values were derived or criteria were available (table
 Tmi'i E^0nS  W6re reP°rted in gfeater detail by Detenbeck and colleagues in  earlier reports
 (1991a, 1992).

        Storm-water inputs, construction, dredging or impoundment, wetland fill, and increases in
 watershed area or area of urban or residential land use had a significant effect on mid-wetland
 water quality.  Construction, particularly within the buffer zone surrounding wetlands was
 correlated with increased concentrations of suspended solids, total lead, and nitrate in wetlands
 during the first year following disturbance.   Increased urbanization relative to wetland area tended
 to increase total nutrient levels and the fraction of nutrients associated with paniculate matter
 Paniculate nitrogen and phosphorus tended to increase as the area of wetland fill increased
 Storm-water  inputs (quantified as an increase in impervious surface area) tended to decrease
 dissolved nutrient levels in wetlands,  probably by decreasing the water retention time of the
wetlands (Detenbeck et al., 1992; Brown, 1985).  When predisturbance mid-wetland water quality
data were compared among sites, wetlands in isolated basins had significantly higher nutrient
dissolved organic carbon, and color values than did wetlands with intermittent or continuous  flow
In effect, connecting previously isolated wetlands with a storm-water sewer network can flush
nutrients downstream.  Deepening wetlands by impoundment or dredging tended to lessen some
                                             4-35

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 changes in mid-wetland water quality, probably by increasing retention time and sedimentation
 efficiency.

        Regression analyses also were used to determine the effect of disturbance intensity on
 recovery during the second year following disturbance. By that time, neither area of wetland filled
 nor percentage of wetland filled nor change in wetland type (water depth) had a discernible effect
 on mid-wetland water quality.  However, changes in watershed land use relative to either
 watershed  area or wetland area produced long-term effects on wetland water quality. Increases in
 urban or residential land use were associated with increases in dissolved nutrients (SRP  DP N
 and DOC)  and TP and decreases in surface dissolved oxygen.  An increase in the percentage of
 watershed  developed (percentage urban and residential) was associated with a long-term  increase in
 TP and decrease in surface water temperature.  Construction activity in the watershed was
 corrected with decreased SRP and increased levels of suspended  solids.  As relative watershed
 area (and flushing rate) increased, dissolved N  and P and  TP tended to decrease, offsetting some of
the increase due to accelerated nutrient loading.
  Comments on Characterization of Ecological Effects

  Strengths of the case study include:

         •      A statistical analysis of ecosystem responses was conducted, allowing estimates
                of response along a gradient of disturbance as well as categorical response.
                Uncertainties due to Type I errors can be quantified.

 Limitations include:

         •      Expected impacts due to water quality changes were derived in pan from
                criteria developed for surface waters other than wetlands.

         •      Habitat impacts were not measured directly.

         •      Only static  endpoints were used; ecological processes were not measured.

 General reviewer comments:

        •      EPA is developing biocriteria  to address ecological  effects, but these criteria
               are not yet available for wetlands.

        •      Indices of abiotic ecological quality, e.g.,  habitat destruction,  should be linked
               to biota.
                                           4-37

-------
4.3.5.  Risk Characterization

       43.5.1. Risk Estimation

       Investigators did not detect significant changes in mid-wetland specific conductivity,
temperature, dissolved oxygen, or ammonium levels between pre- and postdisturbance periods, nor
were any significant differences in response noted among disturbance categories by MANOVA.
Peak-, postdisturbance-, or recovery-period-specific conductivity levels exceeded the threshold value
of 700 urnhos-cm"1 in three cases, and temperature levels exceeded the absolute criteria for
Minnesota lakes (35°Q in one case (table 4-8). The change in surface water temperature (as
evidenced by the upward shift in minimum, mean, and maximum values between pre- and
postdisturbance conditions) was >1.7°C for most cases, but differences in temperature increase were
not noted among disturbance classes.  This level of temperature variability may be natural for
shallow wetland systems that are less resistant to temperature than are lakes.

        Surficial dissolved oxygen levels were occasionally below the lower limit criteria for Class
B and C waters for both predisturbance conditions (7 percent) and postdisturbance conditions (23
percent; table 4-8).  Under the range of pH values measured for similar wetlands in the
metropolitan area (pH 6-8; Detenbeck et al., 1991a) and the temperature range observed for these
wetlands (7-36°C), approximately 2 to 11 percent of total ammonia plus ammonium would be
present in the toxic (un-ionized) form (Thurston et al., 1974).  Levels of total ammonium in
wetlands during the predisturbance period were high enough to exceed Minnesota's water quality
 criteria for Class B and C fisheries and recreation surface waters (0.04 mg NH3-N/L; U.S. EPA,
 1988a) at  approximately 60 percent of sites under the highest pH and temperature conditions
 observed.  The proportion of sites at potential risk declined over the next 2 years to 5 to 15 percent
 following disturbance.

        Mid-wetland nitrate levels increased significantly immediately following depth changes due
 to impoundment or dredging (39.6x) or immediately following storm-water inputs (7.5x).  In no
 instance did nitrate levels exceed water quality criteria for drinking water standards; in general,
 nitrate levels were 1 to 3 orders of magnitude below the criteria of 10 mg N/L.  However, if these
 wetlands are nitrogen-limited, a sevenfold to fortyfold increase in nitrate could be expected to
 stimulate  productivity dramatically.

         For water quality variables showing a significant categorical response to disturbance, the
 change in risk to wetland water quality or potential water quality function can be expressed as a
 frequency of criteria exceedance for pre- and postdisturbance populations.  The majority of wetlands
 studied had predisturbance turbidity levels exceeding target levels for type  3 wetlands (64 percent
 >10 NTU) and type 4 wetlands (21 percent >5 NTU; figure 4-5a).  At the peak of disturbance, the
 frequency of sites exceeding target levels for type 3 wetlands decreased slightly for wetlands with
 no construction  activity in the watershed (to 58 percent) and increased slightly for wetlands with
 construction activity in the watershed (to 66 percent; figure 4-5a). However, in the first year
 following disturbance, average turbidity levels exceeded target levels for type 3 wetlands for 37
 percent of sites  with no construction activity, and turbidity levels exceeded the target level of  10
 NTU for 84 percent of sites exposed to construction activity (figure 4-5b).
                                              4-38

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PRE-DISTUR 3ANCE
           JSTRN
    CONST AUCTION
                                      10             15
                                     TURBIDITY, NTU
         25
  Figure 4-5a. Cumulative frequency distribution of average mid-wetland turbidity values over
              the growing season.  Predisturbance turbidity distribution (P) is compared to
              peak-disturbance distributions for wetlands in watersheds with (C) and without
              (NC) construction activity.  Proportions of the urban wetland population with
              turbidity at or below target levels of 5 or 10 NTU are indicated by the dotted
              lines.
                                           4-40

-------
                                      TURBIDITY, NTU
Figure 4-5b.  Cumulative frequency distribution of average mid-wetland turbidity values over
             the growing season.  Predisturbance turbidity distribution (P) is compared to
             first-year postdisturbaince distributions for wetlands in watersheds with (C) and
             without (NC) construction activity.  Proportions of the urban wetland
             population with turbidity at or below target levels of 5 or 10 NTU are  indicated
             by the dotted lines.
                                         4-41

-------
       Total extractable lead levels were quite high in the dry predisturbance period, possibly
because of increased availability of lead following oxidation of lead sulfides or increased chelation
by elevated dissolved organic carbon levels.  The predisturbance average for surface water was 9 ug
Pb/L, well above the criteria of 7.7 pg/L for chronic toxicity at a hardness level of 200 mg
CaCOa/L.  Maximum mid-wetland lead levels declined between the pre- and postdisturbance
periods, possibly due to increased precipitation and a lowering of redox levels.  However, the
magnitude of the inter-annual decrease in total lead decreased as a function of construction activity
in the period immediately following storm-water inputs (figure  4-6).

       The level of construction activity in the watershed associated with exceedance of the  water
quality criteria for chronic toxicity was calculated as a function of initial lead levels.  Figure  4-6
shows the level of the In (construction/wetland area) ratio associated with exceedance of the criteria
for chronic toxicity (3.2 ug/L at 100 mg/L CaCO3 hardness) corresponding to the 95th percentile,
75th percentile, and 50th percentile  (median) values of predisturbance lead levels.  Four of six sites
had construction activity greater than that associated with criteria exceedance for the upper 5
percent of predisturbance values, three sites had levels associated with criteria exceedance for the
upper 25 percent of predisturbance values, and two cases had construction activity (In ratio >2.9,
ratio >18.2) higher than that associated with exceedance for sites in the upper half of the
 predisturbance distribution. Similar predictions can be derived for other initial lead distributions.
 Predictions are based on mean response (In [post/pre] Pb); the  actual response is expected to fall
 within the 95 percent confidence interval for the regression.

        Mid-wetland TP levels exceeded target levels derived to protect clarity of type 3 wetlands
 (107 ppb P) and criteria for Minnesota lakes in the North Central Hardwood Forest ecoregion (40
 ppb P) in the majority of cases for  predisturbance, peak-disturbance, postdisturbance, and recovery
 periods (70 to 80 percent >107 ppb P, 94 to 100 percent >40 ppb P).  Based on results of
 regression analyses, potential increases in TP for storm water-impacted sites related to urbanization
 were offset by increased flushing rate related to increased watershed/wetland area ratios.

         Investigators used regression equations for mid-wetiand TP to predict stressor levels
 associated with criteria or threshold value exceedance for different percentiles of the population of
 predisturbance wetland conditions (figures 4-7a-d). For wetlands associated with the lower 50
 percent of predisturbance TP levels, springtime TP levels were expected to exceed target levels of
 40 ppb P and 107 ppb P for wetlands experiencing depth changes of <2.4 or <1.4 units, respectively
 (figure 4-7a). For the upper 75th percentile of sites, a target level of 40 ppb P could be achieved in
 cases of littie or no construction activity (construction/wetiand area <5) and a net decrease in
 watershed/wetland area (-13 to -30; figure 4-7b).  The lower 50th percentile of cases were expected
 to remain below the target level of 107 ppb P only for cases of limited construction activity (ratio
 of 0 to 8) and no change or a decrease in watershed/wetland area (figure 4-7c). For wetlands
 affected by storm water, the lowest 50th percentile could achieve the target level of 40 ppb P
 following disturbance for increases in the urbanization ratio of up to 8, but only if relative
 watershed size  (and flushing rate) was increased proportionately (figure 4-7d).

         Color levels were elevated during predisturbance (drought) conditions corresponding to
 high dissolved organic carbon levels (Detenbeck et al., 1991a). However, only 2 percent of sites
  had color levels exceeding the target of 583 PCU for type 3 wetlands, approximately 20 percent
                                               4-42

-------
      Stormwater, Spring, Pre vs. During and Post-Disturbance
            Y - -1 .8 + 0.46 ln(Constrn/Wtld area), r2=0.80
                   Target = 2.6 ppb Pb
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Figure 4-6.  Regression line and 95 percent confidence interval for relationship between In
           (construction/wetland area) and springtime In (peak+postdisturbance
           Pb/predisturbance Pb) for urban wetlands affected by storm-water additions.
           Construction activity levels corresponding to protection of wetlands in the 95th
           percentile, 75th percentile, and 50th percentile (median) of the full
           predisturbance mid-wetland lead distribution are shown.  Protection of mid-
           wetland water quality here is defined as a target level of  <;3.2 jig Pb/L.
                                     4-43

-------
                SPRINGTIME MIDWETLAND TOTAL P
                         DEPTH CHANGE CASES
Q
"O
     1-



   0.5-



     0
                      TARGET=40ppbP
                    TARGET=107ppbP
                                                                   50%
To         5
      dWSHD/WTLD
20
  Figure 4-7a. Isopleths for mid-wetland TP threshold values of 40 jig P/L or 107 /tg P/L;
             predictions for springtime mid-wetland TP, depth change cases.  Isopleths
             define the combinations of two stressors predicted to yield the target value of
             mid-wetland TP based on the 25th percentile, 50th percentile (median), or 75th
             percentile of predisturbance TP distributions.
                                     4-44

-------
          GROWING SEASON MIDWETLAND TOTAL P
                       DEPTH CHANGE CASES
                     TARGET = 40 PPBP
-35
0  -26  -22 -18 -U  -iQ  T  -2 '  £
                         d WSHDM/TLD
                                                   10   14   18  2226
Figure 4-7b. Isopleths for mid-wetland TP threshold values of 40 /*g P/L or 107 /tg P/L-
          predictions for growing season mid-wetland TP, depth change cases, target level
          of 40 fig P/L. Isopleths define the combinations of two stressors predicted to
          yield the target value of mid-wetland TP based on the 25th percentile, 50th
          percentile (median), or 75th percentile of predisturbance TP distributions
                                  4-45

-------
         GROWING SEASON MIDWETLAND TOTAL P
                      DEPTH CHANGE CASES
-25;
                                                                25%
                     TARGET =107 ppbP
0  -26  -22  -te -14 --10   -<3   -2  '  £   §
                          dWSHD/WTLD
                                                                      26
Figure 4-7c.  Isopleths for mid-wetland TP threshold values of 40 ng P/L or 107 fig P/L;
           predictions for growing season mid-wetland TP, depth change cases, target level
           of 107 fig P/L. Isopleths define the combinations of two stressors predicted to
           yield the target value of mid-wetland TP based on the 25th percentile, 50th
           percentile (median), or 75th percentile of predisturbance TP distributions.
                                   4-46

-------
         GROWING SEASON MIDWETLAND TOTAL P
                       STORMWATER CASES
 15-
 10-
-20
0  -26  -22  -18  -14  -10  -§   -2 '  £§    1'0   1'4   1'8  2!2
                          d WSHD/WTLD
Figure 4-7d.  Isopleths for mid-wetland TP threshold values of 40 jig P/L or 107 jig P/L;
           predictions for growing season mid-wetland TP, storm-water cases.  Isopleths
           define the combinations of two stressors predicted to yield the target value of
           mid-wetland TP based on the 25th percentile, 50th percentile (median), or 75th
           percentile of predisturbance TP distributions.
                                   4-47

-------
of wetlands had color >268 (target for type 4 wetlands), and 50 percent had color >113 PCU (target
for type 5 wetlands) during the predisturbance period.  Color alone probably is not limiting
submerged macrophyte production in these systems.  Maximum color levels for wetlands in fill and
storm-water disturbance categories decreased following disturbance activities but increased between
peak-disturbance and recovery periods for dredge or impoundment cases in response to increased
watershed/wetland area ratios.  Isopleth plots showing  combinations of depth change and change in
watershed/wetland for which target color levels could be achieved show that color levels are
relatively insensitive to changing watershed/wetland  area ratios and that the lowest target level for
color is achievable for the lower 50th percentile given a small increase in depth (figure 4-8).

       4.3.5.2.  Uncertainty

       Sources of uncertainty in this risk assessment include both qualitative errors (e.g., errors in
assumptions) and quantitative errors (e.g., measurement or prediction errors).  Table 4-9 lists the
main sources of uncertainty in  each phase of the risk assessment, along with an estimate of the
magnitude of uncertainties.

       Information gaps related to quantifying the total wetland resource in TCMA and the true
frequencies of physical or hydrologic disturbances to wetlands contributed to overestimation and
underestimation, respectively, of the true incidence of anthropogenic disturbance. Information gaps
on direct habitat loss or conversion rates and lack of (tested) water quality criteria specific to
wetlands limited the investigators'  ability to create a balanced assessment of impacts to the full
wetland  ecosystem as compared with impacts to downstream surface waters.
                                                                                               4
       Sources of uncertainty  in the empirical field study on impacts and recovery included the
interaction of effects of climatic variability between pre- and postdisturbance periods with effects of
anthropogenic physical or hydrologic disturbance. By using the paired comparison regression
approach, investigators were able to factor out potential additive effects of climatic differences
between years but were not necessarily able to factor out interactive (e.g., multiplicative) effects.
The design of the study would have been improved by including information from  paired
comparisons of undisturbed reference sites. Finally, the risk assessment could be improved by a
separate field validation of regression predictions based on a separate set of study sites. ,

        4.3.5.3.  Risk Description: Summary and Interpretation  of Ecological Significance

        Table 4-10 compares the risk to urban wetland water quality and water quality improvement
function from physical or hydrologic disturbance to potential loss or conversions of wetland habitat.
While neither dredging nor impoundment activity (water-depth change) caused many significant
long-term changes in mid-wetland water quality, these activities probably had the greatest effect on
wetland habitat. Wetland habitat is permanently removed by wetland fill activity and severely
modified by dredging operations.  Although emergent vegetation began to recover at disturbed
wetland sites within 1 year following disturbance, the recovery of submerged vegetation appeared to
be delayed by more than 2 years, especially where organic substrates had been removed (Detenbeck
et al., 1992). Similarly, storm-water additions create a significant long-term shift in hydrologic
regime,  which may affect vegetation succession patterns and spawning habitat for amphibians.
                                              4-48

-------
   0.2
   0.1-
     o-
LU
-0.2-
   -0.3-
   -0.4-
   •0.5
                SPRINGTIME MIDWETUMSID COLOR
                        DEPTH CHANGE CASES
                 TARGET=113PCU
               TARGET=268 PCU
                  TARGET=583 PCU
                                                            50%
                                                                50%
                                                                50%
       -26  -£2  -18  -U -iO  ^6   -2 '  ^   6   10   14  18  22  26
                             d WSHD/\AH"LD
  Figure 4-8. Isopleths for spring mid-wetland color target levels of 113 PCU, 268 PCU, and
           583 PCU, based on predicted response of median predisturbance values and
           combinations of two stressors, depth change and change in watershed/wetland
           area ratios
                                  4-49

-------
Table 4-9.  Uncertainties Affecting Measurement of Risk to Urban Wetland Water Quality
             Status and Water Quality Improvement Function Related to Physical or
             Hydrologic  Disturbance
             Phase of Risk Assessment
                                                             Level/Measure of Uncertainty
                                     Characterization of Exposure
 Total area, number of wetlands in metropolitan area


 Incidence of physical or hydrologic disturbances to
 metropolitan area wetlands over time
 Intensity of physical disturbances to wetlands in
 metropolitan region

 Conversion factors for wetlands in metropolitan
 region
                                                   Unknown certainty; no quantitative updated
                                                   inventory available
                                                   Unknown, especially for unregulated activities
                                                   Range, distribution of measured values


                                                   Unknown extrapolation error from nationwide trend
                                                   analysis
                                 Characterization of Ecological Effects
 Selection of threshold values or pertinent water
 quality criteria
                                                   Unknown certainty:  (a) surface water quality criteria
                                                   derived for clearwater lakes and streams, not
                                                   wetlands; (b) water quality threshold values to
                                                   protect transparency based on relationships derived
                                                   for colored lakes and macrophyte depth distributions
                                                   for relatively clearwater lakes

Estimate of relative risk due to habitat loss vs. water   Direct effects of habitat loss or conversion on
quality degradation                                  threatened or endangered species not measured

Measurement extrapolations                          Temperature and dissolved oxygen min./max. values
                                                   not recorded
 Precision/accuracy of water quality measurements

 Probability of Type I error in identifying significant
 changes in water quality

 Stressor-response analysis
                                                   Loadings to downstream surface waters not directly
                                                   measured

                                                   Relative error generally < 10 percent

                                                   p  ^0.05


                                                   Type I error ^0.05; uncertainty of predicted
                                                   response indicated by regression r2 values, 95
                                                   percent confidence intervals
                                                 4-50

-------
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                                        o
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                                        U
                  3
                  2
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                               4-51

-------
        Although the immediate effects of wetland fill on surface water quality are limited, the
 long-term cumulative effect of the loss or conversion of wetland area must be considered in
 determining risk to aquatic resources in this region.  Earlier studies demonstrated a relationship
 between the extent of wetlands and low total lead or high color in downstream lakes, and between
 proximal wetlands and lowered trophic status in downstream lakes,  or lowered suspended solids,
 fecal coliform, nitrate, and flow-weighted NH4 or TP in streams  of the TCMA region (Johnston et
 al., 1990; Detenbeck et al., 1991b, 1993).

        Given the high level of total extractable lead in wetlands during the predisturbance period,
 any increase in lead would be considered detrimental to both wetland biota and biota of
 downstream surface waters.   However, in the absence of disturbance activity, average total lead
 levels were predicted to decrease by 84 percent due to interannual climatic variation alone to levels
 just above detection limits.  There is a high degree of uncertainty as to the actual impact of total
 extractable lead in wetland systems for two reasons.  Surface water quality criteria were derived
 under standard testing conditions of low dissolved oxygen content, which may affect the availability
 of lead to biota. Second,  much of the lead trapped in wetlands is associated with paniculate
 matter, so that sediment concentrations and the  potential for bioaccumulation  need to be assessed
 (Stockdale, 1991).

        Long-term  categorical impacts on mid-wetland water quality were observed  in response to
 construction activity and storm-water inputs  (increased total and volatile suspended solids) or  in
 response to residential development in the watershed (increased dissolved nitrogen).  The
 proportion of wetlands with turbidity greater than identified thresholds for protection of submerged
 macrophyte communities increased over the  first year following construction activity.  The
 ecological significance of increased dissolved nitrogen in these systems is unknown at this point but
 could be very important if this change is an indicator of disruption of nitrogen cycling (Detenbeck
 etal., 1992).

        Changes in land use (residential and urban development) and watershed area relative to
 wetland area were associated with statistically significant impacts  on nutrients and water color in
 the first and second years  following disturbance. However, it  is clear that the trophic status of
 these wetlands is high due to prior loading.  For fully or partially impounded  wetlands, cumulative
 effects of wetland eutrophication may occur over time as loadings continue, but longer term studies
 are needed to assess these  effects (Kadlec, 1985).  Increased loadings of SRP or TP to wetlands
 converted from isolated potholes to components  of storm water networks that  experience
 intermittent or continuous flow probably create greater risks to downstream surface waters than to
 the wetlands themselves.  The inverse relationship between watershed/wetland area and mid-
 wetland phosphorus concentrations for storm-water wetlands suggests that increased  nutrient loads
 are being flushed downstream (Detenbeck et al., 1992).  Given the high proportion of eutrophic
 and phosphorus-limited lakes in the TCMA,  any additional inputs  of phosphorus to downstream
 lakes are likely to be detrimental to these systems  (Metropolitan Council, 1981).

       Best management practices,  such as the use of vegetated buffers, were only partially
protective of mid-wetland water quality. Storm  water represents a point-source input and is not
 filtered by vegetated zones surrounding wetlands.  Vegetated buffers were associated with lower
                                             4-52

-------
SRP and nitrate in wetlands with construction activity in the surrounding watershed, but this
moderating effect was only temporary.
  Comments on Risk Characterization

  Strengths of the case study include:
                Risk to wetland water quality is described both as a function of initial conditions
                (predisturbance water quality values) and as a junction of the intensity of
                disturbance.  Aspects of both temporal and spatial variability are addressed as
                they affect uncertainty estimates in risk analysis.

                A key feature of this case study is its predictive component:  a stress-response
                tool developed as an empirical statistical model  Additional discussion is
                needed, however, regarding  the representativeness of this data set for
                application to others.
 Limitations include:
                Although quantitative estimates are provided for some elements of uncertainty
                (e.g., probability of Type I errors,  experimental error values expressed as
                percent variance explained in regression analyses), most of the descriptions of
                uncertainty are qualitative.  A rigorous quantitative analysis of overall
                uncertainty is not possible given the level of available information.

                A discussion of the larger issues associated with wetland assessment (e.g.,
                landscape and wildlife aspects) is missing and could be included as a "lessons
                learned"  section.                       .

                Effects on organisms, especially mammals, are not discussed.

                The focus is on water quality impacts,  while habitat destruction is glossed over.

                The potential forecasting use of the case study was not portrayed clearly and
                should be emphasized.   Whether the study area wetlands are typical of those
               found in the area should be noted.  Empirical models can be misused if
                differences between the study area and a new area are not understood.
 General reviewer comment:
                With regard to mitigation, it is necessary to realize that virtually all wetlands
                were previously impacted, thus rendering it much less likely that perturbations
                of the kind reported here will result in farther extinctions.
                                            4-53

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4.4.  REFERENCES

Adamus, P. (1989) Wetlands and water quality: EPA's research and monitoring implementation
       plan for the years 1989-1994.  Environmental Research Laboratory, Office of Research and
       Development, U.S. Environmental Protection Agency, Corvallis, OR.

Anderson, J.P.; Craig, W.J. (1984) Growing energy crops on Minnesota's wetlands: the land use
       perspective. Center for Urban and Regional Affairs, University of Minnesota, Minneapolis,
       MN.

Ayers, M.A.; Brown, R.G.; Oberts, G.L. (1985) Runoff and chemical loading in small
       watersheds in the Twin Cities metropolitan area,  Minnesota.  U.S. Geological Survey,
       Water Resources Investigation Report 85-4122, St. Paul, MN.

Beaver, J.R.;  Crisman,  T.L.  (1991) Importance of latitude and organic color on phytoplankton
       productivity in Florida lakes.  Can. J. Fish. Aquat. Sci. 48(7): 1145-1150.

Brezonik, P.L. (1978) Effect of organic color and turbidity on Secchi disc transparency. /. Fish.
       Res. Board Can. 35:1410-1416.

Brown, R.G. (1984) Atmospheric deposition of selected chemicals and their effect on nonpoint-
       source pollution  in the Twin Cities metropolitan area, Minnesota.  U.S. Geological Survey,
       Water Resources Investigation Report 83-4195, St. Paul, MN.

Brown, R.G. (1985) Effects of wetlands on quality of runoff entering lakes in the Twin Cities
       metropolitan area, Minnesota.  U.S. Geological Survey, Water Resources Investigation
       Report 85-4170,  St. Paul, MN.

Chambers,  P.A.; Kalff,  J. (1985) Depth distribution and biomass of submersed aquatic macrophyte
       communities in relation to Secchi depth. Can. J. Fish. Aquat. Sci.  42:701-709.

Cowardin, L.M.;  Carter, V.; Golet, F.C.; LaRoe, E.T. (1979) Classification of wetlands and
       deepwater habitats of the  United States. Biological Services Program, U.S.  Fish and
       Wildlife Service. FWS/OBS-79-31.

Dahl, T.E.; Johnson, C.E. (1991) Status and trends of wetlands in the conterminous United States,
       mid-1970's to mid-1980's. U.S. Department of the Interior, Fish and Wildlife Service,
       Washington, DC.

Dennison, W.C.; Orth, R.J.; Moore, K.A.; Stevenson, J.C.; Carter, V.;   Kollar, S.; Bergstrom,
       P.W.;  Batiuk, R.A. (1993) Assessing water quality with submersed aquatic vegetation.
       Bioscience 43(2): 86-94.
                                            4-54

-------
 Detenbeck, N.E.; Johnston, C.A.; Taylor, D.L.; Lima, A.; Hagley, C.A.; Bamford, S. (1991a)
        Effects of disturbance on water quality junctions of wetlands: final report to the U.S. EPA.
        Environmental Research Laboratory-Duluth. Natural Resources Research Institute,
        University of Minnesota and AScI Corporation, Duluth, MN.

 Detenbeck, N.E.; Johnston, C.A.; Niemi, G.J.  (1991b) Use of a geographic information system to
        assess the effect of wetlands on lake water quality in the Minneapolis/St. Paul metropolitan
        area. In:  Proc. of the MNLake Management Conference. Brainerd, MN, October 7-9
        1990, pp. 81-85.

 Detenbeck, N.E.; Taylor, D.L.; Lima, A. (1992) Assessing recovery of freshwater wetland water
        quality from disturbance. Final report to U.S. EPA, Environmental Research Laboratory
        Duluth, MN.

 Detenbeck, N.E.; Johnston, C.A.; Niemi, G.J.  (1993) Wetland effects on lake water quality in the
        Minneapolis/St. Paul metropolitan area. Landscape Ecol. 8:39-61.

 Eggers, S.D.; Reed, D.M. (1987)  Wetland plants and plant communities of Minnesota and
        Wisconsin. U.S. Army Corps of Engineers, St.  Paul District.

 Galinato, M. (1985) Seed germination studies of dominant wetland species of the Delta Marsh.
        M.S. thesis, Dept. of Botany, Iowa State University, Ames, IA.

 Gosselink,  J.G.; Lee, L.C. (1989) Cumulative impact assessment in bottomland hardwood forests.
        Wetlands, vol. 9 (special issue),  174 pp.

 Hagley, C.A.; Taylor, D.L. (1991) An approach for evaluating numeric water quality criteria for
       wetlands protection.  Report to the U.S. EPA, Environmental Research Laboratory,
       Duluth, MN.

 Heiskary, S.A.; Wilson, C.B. (1990) Regional patterns  in lake water quality in Minnesota.  Lake
       Line 10(6):26-30.

Johnston, C.A.; Detenbeck,  N.E.;  Niemi, G.J. (1990) The cumulative effect of wetlands on stream
       water quality and  quantity: a landscape approach. Biogeochemistry 10:105-141.

Kadlec, R.H. (1985) Aging phenomena in wastewater wetlands. In: Godfrey, P.J.; Kaynor, E.R.;
       Pelczarski, S.; Benforado, J., eds. Ecological considerations in wetlands treatment of
       municipal wastewaters. Chapter 23. New York,  NY: Van Nostrand Reinhold Company.

Kadlec, J.A.; Wentz, W.A.  (1974) State-of-the-art survey and evaluation of marsh plant
       establishment techniques: induced and natural.  Volume I: Report of research. U.S. Army
       Corps of Engineers Waterways Experiment Station. Vicksburg, MS.
                                           4-55

-------
Leibowitz, S.; Preston, E.M.; Arnaut, L.Y.; Detenbeck, N.E.; Hagley, C.A.; Kentula, M.E.;
       Olson, R.K.; Sanville, W.D.; Sumner, R.R. (1992) Wetland research plan FY92-96: an
       integrated risk-based approach.  U.S. EPA, Environmental Research Laboratory, Corvallis,
       OR.  EPA/600/R-92/060.

Leslie, M.; Clark, E.H. II. (1990) Perspectives on wetlands loss and alterations. In: Bingham, G.;
       Clark, E.H. II; Haygood, L.V.; Leslie, M., eds. Issues in wetlands protection:  background
       papers prepared for the National Wetlands Policy Forum. Chapter 1. Washington, DC: The
       Conservation Foundation.

Metropolitan Council. (1981) A 1980 study of the water quality of 60 lakes in the Twin  Cities
       metropolitan  area. Publication 01-81-047. Metropolitan Council, St. Paul, MN.

Minnesota Department of Natural Resources (MN DNR). (1967) Metropolitan lake inventory.
       Bulletin 45. Minnesota Dept.  of Natural Resources, St. Paul, MN.

Minnesota Department of Natural Resources (MN DNR). (1984) Minnesota official list of
       endangered,  threatened, and  special concern plants and animals. Minnesota Dept. of
       Natural Resources, St. Paul, MN.

Minnesota Pollution Control Agency (MPCA). (1990) Minnesota water quality: water years 1988-
       1989.  1990 Report to Congress. Minnesota Pollution Control Agency,  St. Paul, MN.

Niering, W.A. (1985) The Audubon Society nature guides: wetlands. New York, NY: Alfred A.
       Knopf, Inc.

Omernik, J.M. (1986) Ecoregions of the conterminous United States map (scale 1:7,500,000). U.S.
       Environmental Protection Agency, Environmental Research Laboratory, Corvallis,  OR.

Osborne, L.L.; Wiley, M.J. (1988) Empirical relationships between land use/cover and  stream
       water quality in an agricultural watershed. /.  Environ.  Mgmt. 26:9-27.

Owens, T.;  Meyer, M. (1978) A wetlands survey of the Twin  Cities 7-county  metropolitan area-
       east half.  IAFHE FSL Research Report 78-2.  University of Minnesota, St. Paul, MN.

Rushton, B. (1991) Variation in field parameters in a  native wetland used for storm water
       treatment. In: Rushton, B.; Cunningham, J.; Dye, C., eds. Statewide  stormwater
       management  workshop, Octobers, 1991. Brooksville,  FL:  South Florida Water
       Management District, pp. 75-84.

Shaw, S.P.; Fredine, C.G. (1956) Wetlands of the United States. Circular 39. U.S. Dept. of the
       Interior, Fish and Wildlife Service. Washington, DC: U.S.  Government Printing Office,
       1971 (reissue).

Sokal, R.R.; Rohlf,  F.J.  (1981) Biometry: the principles and practice of statistics in biological
       research.  2nd ed. San Francisco, CA: W.H. Freeman  and Company.
                                            4-56

-------
  Stewart, R.E.; Kantrud, H.A. (1971) Classification of natural ponds, and lakes in the glaciated
         prairie region. Resource Publication 92. U.S. Dept. of the Interior, Fish and Wildlife
         Service. 57 pp.


  Stockdale, E.G. (1991)  Freshwater wetlands, urban stormwater, and nonpoint source pollution
         control.- a literature review and annotated bibliography. Washington State Department of
         Ecology.


  Taylor, D.L.; Detenbeck, N.E.; Lima, A. (1992) Patterns of wetland disturbance in the
         Minneapolis-St.  Paul metropolitan area: implications for policy makers. Unpublished
         manuscript.


  Thurston, R.V.; Russo,  R.C.; Emerson, K. (1974) Aqueous ammonia equilibrium calculations
         Technical Report Number 74-1. Fisheries Bioassay Laboratory, Montana State University
         Bozeman, MT. 18 pp.


 Tiner, R.W., Jr. (1984)  Wetlands of the United States: current status and recent trends. U S Dept
         of the Interior, Fish and Wildlife Service, Washington, DC.

 U.S. Army Corps of Engineers. (1992) Public Notice, 14 February 1992.  U.S  Army Corps of
        Engineers,  St. Paul District.


 U.S. Environmental Protection Agency. (1986) Hazard evaluation division standard evaluation
        procedure:  ecological risk assessment. Office of Pesticide Programs, Washington, DC.
            ~
 U.S. Environmental Protection Agency. (1988a) Nitrogen-ammonia/nitrate/nitrite: water quality
        standards criteria summaries: a compilation of state/federal criteria. EPA 440/5-88/029.

 U.S. Environmental Protection Agency. (1988b) State water quality standards summaries.  Office
        of Water Regulations and Standards, Washington, DC. EPA 440/5-88/031.

 U.S. Environmental Protection Agency. (1991) National guidance: water quality standards for
        wetlands. Office of Water Regulations and Standards, Office of Wetlands Protection
        Washington, DC. EPA 440/S-90-011.

 U.S. Environmental Protection Agency. (1992) Framework for ecological risk assessment. Risk
        Assessment  Forum,  Washington, DC. EPA/630/R-92/001.

 U.S. Weather Service.  (1991) Minneapolis-St. Paul Airport, MN. Personal communication.

Walker, W.  (1987) Phosphorus removal by urban runoff detention basins. Lake and Reservoir
       Management 3:314-326.
                                           4-57

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Werth, J.; Meyer, M.; Brooks, K. (1977) A wetlands survey of the Twin Cities 7-cowty
       metropolitan area-west half. IAFHE RSL Research Report 77-10. University of Minnesota,
       St. Paul, MN.

Wetzel, R.G. (1975) Limnology. Philadelphia, PA: W.B. Saunders Company.
                                           4-58

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                    SECTION FIVE
       ECOLOGICAL RISK ASSESSMENT CASE STUDY:
THE ROLE OF MONITORING IN ECOLOGICAL RISK ASSESSMENT:
                  AN EMAP EXAMPLE

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                              AUTHORS AND REVIEWERS
 AUTHORS
 John H. Gentile
 Environmental Research Laboratory - Narragansett
 U.S. Environmental Protection Agency
 Narragansett, RI

 K. John Scott
 Science Applications International Corporation
 Narragansett, RI

 John F. Paul
 Environmental Research Laboratory - Narragansett
 U.S. Environmental Protection Agency
 Narragansett, RI

 Rick A. Linthurst
 Atmospheric Research and Exposure  Assessment Laboratory
 U.S. Environmental Protection Agency
 Research Triangle Park, NC
REVIEWERS

Robert J. Huggett (Lead Reviewer)
Virginia Institute of Marine Science
The College of William and Mary
Gloucester Point, VA

Gregory R. Biddinger
Exxon Biomedical Sciences, Inc.
East Millstone, NJ
                                i>
Joel S. Brown
University of Illinois at Chicago
Chicago, IL
Richard E.  Purdy
Environmental Laboratory
3-M Company
St. Paul, MN

Frieda B. Taub
School of Fisheries
University of Washington
Seattle, WA

Richard Weigert
Department of Zoology
University of Georgia
Athens, GA
                                           5-2

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                                   CONTENTS

ABSTRACT		  5-6

5.1.  RISK ASSESSMENT APPROACH	. . . .	•'.'. . .  .  5-8

5.2.  STATUTORY AND REGULATORY BACKGROUND .	  5-8

5.3.  CASE STUDY DESCRIPTION		   5-10

     5.3.1. Problem Formulation	,.	   5-12

          5.3.1.1. Background	   5-12
          5.3.1.2. Site Description	   5-12
          5.3.1.3. Ecosystem Classification	 .  . .	   5-13
          5.3.1.4. Sampling Design	 . .  . . .   5-13
          5.3.1.5. Ecological Indicators	,	   5-14

     5.3.2. Conceptual Model Development	   5-17

          5.3.2.1. Ecological Effects	 .	   5-17
          5.3.2.2. Exposure	   5-21
          5.3.2.3. Exposure-Response Associations	   5-24
          5.3.2.4. Estuarine Class Conceptual Models	   5-26
          5.3.2.5. Problem Formulation Summary  .	   5-28

     5.3.3. EMAP and Regional Risk Assessments  . .	. . .  .	   5-30

          5.3.3.1. Regional Risk Assessment:  Problem Formulation	   5-31
          5.3.3.2. Regional Risk Assessment:  Analysis Phase		   5-31
          5.3.3.3. Regional Risk Assessment:  Risk Characterization	   5-32

5.4.  REFERENCES	   5-37
                                       5-3

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                                    LIST OF FIGURES

Figure 5-1.  Structure of assessment for EMAP Virginian Province 	  5-9

Figure 5-2.  EMAP Virginian Province base stations for 1990-1991	  5-11

Figure 5-3.  Contribution of EMAP data to problem formulation	  5-18

Figure 5-4.  Summary of Virginian Province response and exposure indicator values for the
            entire province, large tidal rivers, large estuaries, and small estuarine systems
            for 1990 and 1991 data, individually and combined   	  5-22

Figure 5-5.  EMAP estuaries indicator relationships, 1990 and 1991 base stations	  5-29


                                    LIST OF TABLES

Table 5-1.  Summary of EMAP Response and Exposure Indicator Data for 1990-1991   . . .  5-19

Table 5-2.  Indicator Associations:  The Percent Area of Degraded Benthos Co-occurring
            With Low Dissolved Oxygen and Sediment Toxicity for EMAP Base Stations
            for 1990-1991	  5'25


                                     COMMENT BOX

Comments on Problem Formulation, Conceptual Model
Development, and Regional Risk Assessments  	  5-33
                                             5-4

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                                LIST OF ACRONYMS




EMAP       Environmental Monitoring and Assessment Program




EPA         Environmental Protection Agency




ER-M        Effects Range-Median



GIS          geographic information system




HEP         Harbor Estuary Program




NEP         National Estuary Program



NOAA       National Oceanic and Atmospheric Administration




NPDES      National Pollution Discharge Elimination System




NRC         National Research Council



NS&T       National Status and Trends Program



ORD         Office of Research and Development




OTA         Office of Technology  Assessment



R-EMAP     Regional EMAP
                                          5-5

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                                         ABSTRACT

       Using data collected from the Environmental Monitoring and Assessment Program's
(EMAP's) Near Coastal program in the Virginian Biogeographic Province during July through
September 1990-1991, this paper describes the role and specific contributions of monitoring data in
the ecological risk assessment process.  This case study suggests that EMAP monitoring data can:

       •      contribute to the problem formulation phase of an ecological risk assessment;

       •      characterize areal and spatial extent of ecological resources;

       «      identify regional resources potentially at risk (e.g., degraded benthos); and

       •      provide initial information on the role of exposure and habitat characteristics.

       EMAP data were collected using a systematic probability-based sampling design that
facilitates detection of spatially distributed patterns but does not estimate intra-annual variability or
short-term episodic events.  The EMAP information was then used to develop a conceptual model
that described the areal extent of ecological resources at risk,  their spatial distribution, and
associated exposure and habitat information.  The assessment  endpoint was benthic community
integrity.  Resource condition, measured using a province-wide benthic index, was operationally
defined in terms of one or more anthropogenic stressors.  Currently, resource condition does not
discriminate anthropogenic from natural physical stress.

       In this case study, large  estuaries exhibited the lowest areal extent of degraded benthos,
16 ±7 percent; low dissolved oxygen was the exposure indicator most closely associated with
degradation.  In small estuarine  systems, 24±10 percent of the area exhibited degraded benthic
condition, nearly half (48 percent) of which was associated with sediment toxicity. For large tidal
rivers, 41 ±24 percent of the sampled area was degraded, and 45 percent of this degradation co-
occurred with low dissolved oxygen.  Co-occurrence of degradation and low dissolved oxygen was
confined to the mouths of the Potomac and Rappahannock  Rivers.   Although these associations
imply neither causality nor direct anthropogenic stress, they could, along with other evidence, be
used to direct further study.  In  this  regard, on a province  basis more than half of the area of
degraded benthos was not associated with any of the exposure indicators discussed.

       Data on spatial distribution indicated that degradation of benthic resources occurred mainly
in the upper Chesapeake Bay, the oligo-mesohaline portions of the five tidal river systems (e.g.,
Hudson-Raritan), and the associated small bays.  These bays are areas of intense demographic
pressure and extensive urban development.

       Although useful in identifying regional  areas of concern, EMAP province-scale data are not
sufficient  for conducting a complete  risk assessment at the  regional scale. Where local monitoring
data are too heterogeneous (relative to spatial, temporal, and ecological scales and methodologies)
to be usable in regional ecological risk assessments, investigators may need to acquire additional
data through:
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        •      an appropriately scaled monitoring program employing a random sampling design,
               such as the Regional EMAP [R-EMAP] program in EPA Region II;

        •      selection of the appropriate response, exposure, and habitat indicators to
               characterize the spatial extent of ecological problems and associated exposures; and

        •      incorporation of extant data (e.g., National Oceanic and Atmospheric
               Administration's [NOAA's] National Status and Trends [NS&T] Program, National
               Estuary Program [NEP], states, etc.).

        Monitoring data alone cannot establish  the causal relationships necessary to develop a
complete analysis of ecological risk.  Therefore,  ecological risk assessments should include
laboratory exposure-response information (e.g., ecotoxicity), effects of multiple stressors, and
measures of contaminant bioavailability to provide evidence for postulating potential causes of risk
to the region or to specific watersheds. Risks to specific watersheds can be examined initially by
using geographic information system  (GIS) and landscape methods  that describe the spatial
relationships and distribution of response, exposure, and habitat indicators (stressor-specific,
whenever possible). This information can then be overlaid with landscape information on
anthropogenic stressors and hydrologic features (e.g., transport and fate) in the surrounding
watershed.  Establishing causal relationships between sources and effects provides the basis for  •
instituting appropriate control strategies.  Ongoing local compliance (e.g., National Pollution
Discharge Elimination System [NPDES],  states, municipalities) and watershed assessment (e.g.,
R-EMAP, EMAP,  NS&T, NEP) monitoring programs can evaluate the effectiveness of the control
strategy.
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5.1. RISK ASSESSMENT APPROACH

       The U.S. Environmental Protection Agency's (EPA's) implementation of a risk-based
assessment, monitoring, and decision-making strategy requires the integration of the Office of
Research and Development's (ORD's) ecological risk assessment framework (U.S. EPA,  1992);
research, monitoring, and assessment programs under ORD's Environmental Monitoring and
Assessment Program (EMAP); and ORD's ecological risk assessment research programs.
Successfully implementing a risk-based approach for decision making for adoption throughout EPA
requires the integration of these three programs.  The framework and process for conducting
ecological risk assessment must not be separated from monitoring programs responsible for data
acquisition and verification nor from research programs responsible for developing the needed
methods and models.  The combination of these programs provides the template for all ecological
risk research, irrespective of specific programmatic applications, while ensuring that EPA can
respond directly  to the full spectrum of ecological risk assessment needs.

       This case study illustrates the roles and contributions of EMAP's Near Coastal Program to
the ecological risk assessment process as described by EPA's Framework for Ecological Risk
Assessment. The case study also examines the use of monitoring data to identify potential problems
for estuarine resources  and the potential use of biogeographic province-scale information in
regional assessments.  Since EMAP and other monitoring programs typically are not designed to
generate all the information required for a complete ecological risk assessment, this paper focuses
specifically on the use of monitoring data (e.g., EMAP Virginian Biogeographic Province data
from 1990 to 1991) in the problem formulation stage of the risk assessment process (figure 5-1).
The areal  extent and spatial patterns of ecological resources for the Virginian Province identify
specific regional areas potentially at risk. The case study uses the Hudson-Raritan estuary as an
example to illustrate the types of information needed for a complete ecological risk assessment.

5.2. STATUTORY AND REGULATORY BACKGROUND

       The EPA, U.S. Congress, and private environmental  organizations have long recognized
the need to improve our ability to document the condition of our environment and specifically our
ecological resources (National Research Council [NRC], 1990).  Federal, state, and local  agencies;
waste dischargers; and researchers all conduct marine environmental  monitoring.  Five federal
agencies conduct environmental quality monitoring activities in the coastal ocean.  Each agency's
programs  focus on different spatial scales, ranging from effluent discharges from individual  sources
(e.g., EPA's National Pollutant Discharge and Elimination System [NPDES] Program) to
measuring far-field, long-term effects of discharges from multiple sources (e.g., the National
Oceanic and Atmospheric Administration's [NOAA's] National Status and Trends [NS&T]
program, EPA's National Estuary Program [NEP]).  However, these programs do not, either
individually or taken together, constitute a comprehensive national status and trends monitoring
program focused on contributing information for identifying the potential risks to coastal
environmental resources (NRC, 1990).  Congressional hearings on the Monitoring Improvement
Act in 1984 (U.S. House of Representatives, 1984) concluded that, despite  considerable
expenditures on  monitoring,  federal agencies could assess neither the status  of ecological resources
nor the overall progress toward legally  mandated goals of mitigating or preventing adverse
ecological effects. In 1988, the EPA Science Advisory Board (U.S.  EPA,  1988), affirming the


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     PROBLEM FORMULATION

     Stressors: Low dissolved oxygen levels, metals, and organic chemicals in
     sediments

     Ecosystem(s) at Risk: Large and small estuaries and large tidal rivers in the
     Virginian Biogeographic Province

     Ecological Components: Benthic macroinvertebrates

     Endpoints: The assessment endpoint is benthic community integrity;
     measurement endpoints include the five indicators of benthic community
     structure that best distinguished between degraded and reference sites.
    ANALYSIS and RISK CHARACTERIZATION

    EMAP province-scale monitoring data alone cannot be used to complete the
    analysis and risk characterization phases of a risk assessment. However data
    needs and approaches for conducting such regional/watershed risk
    assessments are discussed.
Figure 5-1. Structure of assessment for EMAP Virginian Province
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existence of major gaps in environmental data and recognizing the broad base of support for better
environmental monitoring, recommended that EPA initiate a program to monitor ecological status
and trends of the nation's ecological resources. EMAP is EPA's response to these
recommendations.  This case study illustrates EMAP's contribution to the risk-based assessment
framework that is the cornerstone of EPA's decision-making process.

5.3.  CASE STUDY DESCRIPTION

       This case study describes the role and contribution of monitoring data in the ecological risk
assessment process.  The EMAP response, exposure, and habitat indicator data presented in this
case study were collected from the estuarine waters of the Virginian Biogeographic Province,
which extends from Cape Cod, Massachusetts, to Cape Henry, Virginia, at the mouth of the
Chesapeake Bay (figure 5-2).

       Information  from response, exposure, and habitat indicators constitutes the data acquisition
component  of ORD's Framework for Ecological  Risk Assessment and contributes directly to the
problem formulation stage of the risk assessment process.  The monitoring data specifically
contribute to the development of a conceptual model that delineates the spatial, temporal, and
ecological boundaries of the problem; the specific ecosystems and ecological components
potentially at risk; and the potential exposure pathways and co-occurrence with ecosystem
attributes/resources  of concern.

        This case study analyzed data collected during 1990-1991 by determining the cumulative
percent area (i.e., cumulative distribution function) for each ecological response and exposure
 indicator for the entire province and its component resource classes  (large estuaries, small  estuarine
 systems, and large tidal rivers).  Because the EMAP sampling design  is based upon a 4-year
 sampling cycle, the areal estimates based on 2 years of data reported in this case study for the
 response and exposure indicators must be viewed as examples of how  the data  can be used and
 should not be construed as  the most complete or accurate reflection of the power of the EMAP
 sampling design.  Since EMAP uses a probability-based design, the results from 2 years of
 sampling are likely representative of the remaining 2 years.  However, the additional data will
 improve the estimates  of central tendency,  decrease uncertainty, and increase the power to detect
 change.

        Analyses examined the associations between response and exposure indicators to explore
 the potential reasons for the observed changes in ecological condition.  The areal extent of resource
 change that co-occurred with the  exposure indicators was determined for the province as a whole
 and for each resource  class.  Information on exposure-response associations  focused attention on
 specific regional areas, such as the Delaware Bay and the Hudson-Raritan estuary.  For these
 areas a full ecological risk assessment-a  reiteration of problem formulation, the analysis of causal
 relationships, and the characterization of risks-can be conducted if the data warrant. Although
 these types of analyses are straightforward, their interpretation deserves discussion.

        A typical assumption implicit in interpreting results such as these is that changes in
 resource status (e.g., degraded or subnominal condition) result from anthropogenic  stress. One
 must view such interpretations with caution since these data are not designed to provide definitive
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information on causality or to separate anthropogenic from natural stressors.  Rather they provide a
"weight of evidence" approach, suggesting the direction for additional data acquisition and
research.  These data also are the basis for developing testable hypotheses to explain observations
regarding the status of ecological resources.  For example, low dissolved oxygen and physical
alterations of habitats may not have anthropogenic origin in certain situations; therefore, they
should not be associated with degradation, as defined by EMAP.  For this reason,  EMAP primarily
seeks to determine the status of ecological resources. Although a useful and important part of the
program,  understanding the reasons for changes in status is secondary.

       Although not explicitly part of this case study, a regional scale risk assessment could use
both historical data (e.g., NEP, states, EPA Regions, academia) and new data (e.g., Regional-
EMAP, EMAP) to characterize the magnitude and extent of the problem at the regional scale.  In
addition, changes  in ecological resources can be coupled to specific stressors.  Using geographic
information system (GIS) and landscape methods, these stressors can be linked to potential sources
associated with  land-based activities.  The overall effectiveness of control strategies applied to point
and nonpoint sources could then be evaluated by both compliance (e.g.,  NPDES, states,
dischargers) and long-term monitoring programs (e.g.,  R-EMAP, EMAP, states).  This case study
illustrates the application of a risk-based assessment and monitoring strategy that provides direct
and indirect evidence for inferring causal associations between the observed ecological effects and
specific stressors, thus enabling the manager to plan and evaluate remedial control strategy options.

5.3.1. Problem Formulation

       5.3.1.1.  Background

       Problem formulation, the initial phase of the ecological risk assessment process, consists of
the following components:  stressor and ecological effects characterization, identification of
ecosystems potentially at risk, selection of assessment and measurement endpoints, and
development of a  conceptual model (U.S. EPA, 1992).  The conceptual model  synthesizes the
information in each of these components  to describe the potential stressors and exposure pathways;
their co-occurrence, direct and indirect links with specific ecosystems and assessment endpoints of
concern; the spatial, temporal, and ecological boundaries of the risk assessment; and inferences as
to potential causal associations between stressors and ecological effects.   In this  case study, the
conceptual model  describes (1) the areal extent of degraded benthic resources, (2)  the areal extent
of exposure to  specific  categories of stressors, (3) the relationship between the areal extent of
degraded  benthic resources and exposure to categories of stressors,  (4) the relative importance of
different stressors in each  estuarine ecosystem, and (5) specific regional estuarine  systems with
degraded  benthic resources that could become  the subject of detailed regional risk  assessments.
The following sections  describe the EMAP indicators and analyze and interpret data for 1990 and
1991  to provide information for the conceptual model.

       5.3.1.2.  Site Description

       The data were collected from the estuarine waters of the Virginian Biogeographic Province,
which extends  from Cape  Cod, Massachusetts, to Cape Henry, Virginia, at the mouth of the
Chesapeake Bay.  Covering  approximately 23,573 km2, the province includes several large
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 estuarine systems (e.g., Chesapeake Bay, Delaware Bay, and Long Island Sound) as well as a
 substantial number of small estuarine systems and large tidal rivers (Holland, 1990).  Both the
 Labrador Current and the Gulf Stream affect the Virginian Province, which has a
 continental/subtropical climate.  Estuarine resources vary widely in size, shape, and ecological
 characteristics.  Many estuaries, like Chesapeake Bay,  are large, continuously distributed resources
 that consist of expansive regions with a broad variety of habitat types.  Other estuaries consist of
 relatively discrete resources composed predominantly of one habitat type.  For sampling  design
 purposes, the estuarine waters of the Virginian Province were classified into three categories:
 large estuarine systems, large tidal rivers, and small estuarine systems.

        5.3.1.3.  Ecosystem Classification

        Large estuarine systems are defined as systems  having surface areas greater than  260 km2
 and aspect  ratios (length/average width) less than 20. Application of these  criteria to the Virginian
 Province resulted in the identification of 12 large estuarine systems with a total surface area of
 16,096 km2, or 70 percent of the province's estuarine area. Large tidal rivers were defined as
 systems having surface areas greater than 260 km2 and  aspect ratios greater than 20. These criteria
 resulted in  the identification of five large tidal rivers—Hudson, Potomac, James, Delaware, and
 Rappahannock Rivers—with a total surface area of 2,840 km2, or 13 percent of the total province
 area.  Small estuarine systems were defined as systems having surface areas less than 260 km2 but
 greater than or equal to 2.6 km2.   Application of these criteria to the Virginian Province  resulted in
 the identification of 137 small estuarine systems with a  total surface area of 4,279 km2, or 17
 percent of the province.

        The classification process categorized estuaries into classes  (strata) for which a common
 sampling design  can be used. The process also ensured that selected components of estuarine
 resources were sampled sufficiently in different systems.  Further, the classification process
 facilitated the synthesis and integration of data into assessments for evaluating the effectiveness of
 management actions (Holland, 1990).

        5.3.1.4.  Sampling Design

        The EMAP sampling design provides unbiased estimates of the status and trends in
 indicators of ecological condition with known confidence.  There are four essential features of the
 EMAP sampling design as  applied to estuaries:  regionalization, classification, statistical sampling,
 and index period. A regionalization scheme partitions the estuarine and coastal resources of the
 United States into geographical areas with similar ecological properties.  The classification scheme
 defines certain populations of interest (e.g.,  large estuaries, small estuarine  systems, etc.) within
 large geographical areas that are functionally similar and can be  sampled using a common
 approach.  The value of the EMAP sampling design  is that it is both systematic in areal coverage
yet probabilistic relative to  the sampling strategy (Overton et al., 1991).  This design, therefore,
can determine areal extent (with confidence  intervals) and the spatial patterns of response,
exposure, and habitat indicators irrespective  of the characteristics of their statistical distributions.
The statistical sampling provides for the determination of unbiased estimates of the status  and
trends of the estuarine ecological resource classes. When fully implemented, EMAP will base its
status assessments on data collected over a 4-year baseline (Holland, 1990).   This multiyear cycle
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was chosen to dampen the year-to-year variability resulting from natural phenomena such as
extremely dry or wet years and hurricanes.  A consistent, probability-based sampling design is
employed within each EMAP resource group to facilitate future integrated assessments among
EMAP resource groups (e.g., estuaries, surface waters, forests).

       Fully characterizing natural seasonal variability or assessing status for all seasons is beyond
the scope of EMAP.  Because intra-annual variability is thought generally to exceed interannual
variability, an index period (July to September) was chosen to represent that portion of the year
when the measured parameters  are expected to show the maximum response to pollutant stress
(Council and Miller, 1984; Sprague, 1985; Mayer et al., 1989), dissolved oxygen concentrations
are lowest (Holland et al., 1987; U.S. EPA, 1984; Officer et al., 1984), fauna and flora are most
abundant, and within-season variability is expected to be minimal.  This sampling design may fail
to detect short-term, episodic events.  However, persistent unexplained degradation identified by
EMAP would certainly stimulate additional research in the area of concern.  This approach is
consistent with EMAP's goals of determining the long-term status and trends of ecological
resources,  with the status and trends then being used as the basis for intensive  site-specific research
to understand the reasons for the observed problems.

       Sampling sites in the large estuarine class were selected using a randomly placed systematic
grid.  The distance between the systematically spaced sampling points on the grid was
approximately 18 km.  The grid is an extension of the systematic grid proposed for use by all
EMAP resource groups (Overton et al., 1991).  For the Virginian Province, 54 sample  sites were
identified for the large estuaries for 1990, and 48 sites in  1991.  Sampling sites were limited to
waters >2 meters in depth; as  a result of this limitation, investigators were unable to sample ~5
percent of the province area. In all cases, the entire large estuarine resource is sampled each year
during the index period. A linear  analogue of the above design was used for sampling site
selection in the large tidal rivers.  A systematic linear grid was used to define  the spine of the five
large tidal rivers in the Virginian Province.  Randomly selected transects were placed along the
spine of the river within sequential 25-km segments, starting  at the mouth of the river and ending
at the head of the tide.  A total of 49 sample sites were selected for large tidal rivers in the
Virginian Province in 1990 and  1991.  The 137 small estuarine systems in the Virginian Province
were randomly sampled from the entire list frame of small systems.  They were ordered from
north to south by combining adjacent estuaries into groups of four.  One  system was selected
randomly from each group without replacement for each sampling year, yielding 62 sample sites
for 1990 and 1991 in the Virginian Province. The  location of the sample within each selected
small system was randomly selected.  Details of the design can be found in Holland (1990).

       5.3.1.5.  Ecological Indicators

       EMAP defines and uses three types of ecological indicators:  response, exposure,  and
habitat (Hunsaker and Carpenter, 1990). Ecological response indicators quantify the integrated
response of ecological resources to individual or multiple stressors.  Examples include
measurements of the condition of individuals (e.g., frequency of tumors), populations (e.g.,
abundance, biomass), and communities  (e.g., species composition, diversity).  Because benthic
communities play an important role in estuarine ecosystems (Holland et al., 1987, 1988; Rhoads et
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 al., 1978; Pearson and Rosenberg,  1978; Sanders et al., 1980; Boesch and Rosenberg,  1981), this
 case study uses the condition of benthic assemblages as its only response indicator.

        Characteristics of benthic assemblages have been used to measure and describe ecological
 status and trends of marine and estuarine environments for several decades (Sanders, 1956, 1960;
 Boesch, 1973; Pearson and Rosenberg,  1978; Holland et al., 1988). This literature has identified a
 diverse array of benthic assemblage attributes that can characterize ecological status and trends,
 including (1) measurements of biodiversity/species richness, (2) changes in species composition, (3)
 changes in the relative abundance or productivity of functional groups, (4) changes in relative
 abundance and productivity of "key" species, (5) changes in biomass, and (6) relative size of biota
 (Weisbergetal.,  1993).

        EMAP has operationally defined "degraded" or  "subnominal" to classify the status of
 benthic resources.  Three variables  are used to characterize sites as degraded:  sediment toxicity,
 sediment contaminants, and dissolved oxygen (Weisberg et al., 1993).  Fifty-eight different
 attributes of benthic assemblages were evaluated and used to develop a "benthic index" to measure
 ecological status and trends in the Virginian Province.  Of these, 28 benthic measurements differed
 significantly between degraded and  reference sites and were candidates for the discriminant
 analyses that led to the development of a benthic index.  While the operational definition of
 "degraded,"  as used by EMAP, assumes the presence of anthropogenic stress, alterations in benthic
 communities also can result from naturally  occurring physical stresses and low dissolved oxygen.
 Since EMAP does not have an exposure indicator for eutrophication or physical stressors, the
 current benthic index may not always discriminate between natural and anthropogenic effects. This
 limitation suggests a need for additional exposure indicators.  Finally, the term "degraded" also
 assumes some unique  property or characteristic of benthic assemblages when, in fact, stressed
 communities reflect changes in successional status.

        Using the  1990 data, five benthic measures (proportion of salinity-normalized expected
 number of species, number of amphipods, percent of total abundance as bivalves, number of
 capitellids, and average weight per individual polychaete) correctly differentiated reference sites
 from degraded sites with  about 90 percent certainty  (Weisberg et al., 1993).  This version of the
 benthic index was specifically developed for the entire Virginian Province  from 1990 data and may
 not be applicable outside  the province or in other years.  However,  the important point is not the
 specific composition of the current index but rather the process  of using discriminant analyses to
 identify .combinations of candidate benthic measurements  (measurement endpoints) that reliably
 distinguish between degraded and reference sites.  This approach resulted in the development of a
 benthic index for 1991 data in the Louisianian Province that is analogous to the index for the
 Virginian Province (Summers et al., 1993).

       Exposure indicators are physical, chemical, or biological measurements that quantify
pollutant exposure, habitat degradation, or other causes of degraded ecological condition.
Exposure indicators include direct measurements  of contaminant or dissolved oxygen concentration
in the water and sediments, contaminant concentrations in biological tissues,  biomarkers, and acute
toxicity of sediments.  The Virginian Province study used three types of exposure indicators to
infer changes observed in EMAP response indicators:  metals and organic contaminant
concentrations in sediments, sediment toxicity, and bottom dissolved oxygen.  Clearly, these are
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not the only exposure indicators that are operative in estuarine systems and potentially responsible
for ecological effects.

       Metals and organic chemicals from freshwater inflows and from point and nonpoint sources
concentrate in estuaries and accumulate in bottom sediments (Turekian,  1977; Forstner and
Wittmann, 1981; Schubel and Carter, 1984; Nixon et al., 1986).  These bottom sediments often
are contaminated to the point that they represent a threat to humans and ecological components
(Weaver, 1984;  Office of Technology Assessment [OTA], 1987; NRC, 1989).  While the extent
and magnitude of sediment contamination is only now becoming well described (NRC, 1989), it is
a potentially important exposure indicator.

       Whereas chemical measures of contaminant concentrations indicate the potential for
ecological effects, sediment toxicity tests provide an indirect measure  of contaminant
bioavailability.   A commonly used amphipod sediment toxicity test is well established and has been
employed in a variety of monitoring and  testing programs (Swartz, 1987, 1989; Chapman, 1988;
Scott and Redmond, 1989; Scott et al., 1990).

       Dissolved oxygen concentration is an important exposure indicator to both pelagic and
benthic marine biota. Low dissolved oxygen is one of the more important factors contributing to
fish and shellfish mortality in estuarine and coastal waters. Prolonged exposure to waters at less
than 60 percent saturation can result in altered behavior, reduced growth, adverse reproductive
effects, and mortality (Reish and Barnard, 1960; Vernberg, 1972).  Excessive nutrient input can
bring about low  dissolved oxygen by stimulating phytoplankton blooms.  Important as this indicator
is to EMAP, its measurement presents special problems because of the wide diurnal and tidal
fluctuations in concentrations.  To address this problem, continuous and point sampling techniques
currently  are being evaluated (Holland, 1990).

       Habitat  indicators  are physical,  chemical,  and  biological measurements that provide
information about the conditions (e.g., water depth, temperature,  sediment characteristics, salinity)
necessary to support ecological processes in the absence of pollutants.  In estuaries, salinity and
temperature are  among the most dominant factors controlling the distribution of flora and fauna and
the functioning of ecological processes (Remane and Schlieper, 1971). Sediment grain size has a
role in regulating benthic community composition, while organic carbon affects the bioavailability
of contaminants. Water depth itself can  influence the temperature regime, salinity distribution, and
dissolved oxygen concentration. These habitat variables are important for normalizing the
responses of the response and exposure indicators and for defining subpopulations (e.g., fine vs.
coarse-grained sediment, low vs. high salinity) for further analysis. In addition, these habitat
indicators can be used to postclassify indicator data for  a variety of analyses.   For example,
sediment toxicity data could be postclassified according  to grain size or total organic carbon, both
of which  are known to affect contaminant bioavailability. Grain size  also affects benthic
assemblages in that benthos occupying sandy substrates  are different from those dominated by silt-
clay. EMAP's Virginian Province 1990 Demonstration Project Report presents discussions and
examples of postclassification (Weisberg et al., 1993).
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5.3.2.  Conceptual Model Development

        The goal of the problem formulation phase is the development of a conceptual model that
identifies the potential relationships between valued ecosystem attributes (e.g., biotic integrity) and
human or natural attributes, functions!, or activities that are causes for concern (e.g., population
density, deforestation, sea level rise, volcanic eruption).  In the initial stages, problem formulation
focuses on defining the two ends of a conceptual model:  ecological responses in ecosystems
potentially at risk and exposure to  one or more stressors.  The conceptual model identifies the
potential exposure pathways by which stressors and ecosystem attributes may be connected to
define the spatial,  temporal, and ecological boundaries of the assessment and the ecosystems that
are potentially at risk.

        Figure 5-3 illustrates how monitoring data from the Virginian Province contributes to the
components of problem formulation and the development of the conceptual model.  As shown, the
assessment endpoint is benthic community integrity; measurement endpoints include five specific
benthic  community metrics.

        Analysis of areal extent for the status of each indicator represents only the area sampled
during 1990-1991 and is not scaled to the total 4-year area.  Presenting annual data provides a
picture of year-to-year variability.   In addition, unless otherwise noted, all data are presented as
mean estimates within the bounds of the  95 percent confidence limits.  Weisberg et al. (1993)
provide details on  these calculations.

       5.3.2.1.  Ecological Effects

       This case study characterizes ecological effects by determining the areal distribution  of
degraded benthos using the assessment and measurement  endpoints described above. Weisberg et
al. (1993) describe the algorithm and rationale for calculating numerical values for the benthic
index and the numerical cutpoint of <3.4 used to distinguish degraded from reference benthic
condition.  Cumulative distribution functions of benthic index values estimated the percent area of
degraded benthos (Weisberg et al., 1993).  Benthic  index data from 1990 and 1991  were analyzed
individually and then  combined for the Virginian Province and for large estuaries, small estuarine
systems, and tidal  rivers (table 5-1).

        •      Virginian Province: The stations sampled in 1990 and 1991 represented 40 percent
              of the provincial area.  Degraded benthic  assemblages occurred in 19+6 percent  of
              the province for the combined years and for each individual year (with slightly
              larger estimates of uncertainty).

        •      Large Estuaries: The stations sampled in 1990 and 1991  represented 40 percent  of
              the large estuarine area.  The study identified degraded benthic assemblages  in
              16+7 percent of the sampled area; there was little difference between years  1990
              and 1991  (15±10 percent in 1990 vs. 17±10 percent in 1991).

        •      Small  Estuaries:  Thirty-nine percent of the area found in small estuarine systems
              was sampled in the 2 years.  Of this area, 24+10 percent exhibited degraded
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       EMAP VIRGINIAN
    FRAMEWORK
         P
         tt
         0
         a
         L
         er
         M
                       EXPOSUREJMUCAIQB&
Sediment metals
Sediment organic*
Sediment toxicity
Dissolved oxygen
Add volatile su!fkfes(AVS)
Organic carbon
Grain size-percent silt day
                                                    EEEEGISJMD1CAIDBSL
                                                     • Spedas abundance
                                                     • Spedes composition
                                                     • Spedas blomasa
            • Large Estuaries
            » Small Estuaries
            * Large Tidal Rivers
                                  Assessment Enpdnts:
                                   • Benthte community Integrity
                                  Measurement Endpoints:
                                   • Proportion of expected number
                                     of spedss
                                   • Number of amphlpods
                                   • Percent abundance as bivalves
                                   • Number of capJtalllda
                                   • Mean weight per individual
                                     polychaete
                         • Large Tide! Rivera: Degraded benthos associated with
                           severe hypoxia. Toxksty/conJaminantion minimal.
                         • Small Estuaries: Sediment toxidty and chemical exceedences
                           of EHMhighest and associated with degraded benthos
                         • Large Estuaries: Low sediment toxidty;  localized low
                           dissolved oxygen associated with degraded benthos
                                    ESTUARINE CLASS AT RISK:
                                  Example: Small Estuarine Systems
                                   REGIONAL AREA OF CONCERN:
                                  Exampje: Hudson-Raritan Estuary
                                                         SCALE

Figure 5-3.  Contribution of EMAP data to problem formulation
                                               5-18

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Table 5-1. Summary of EMAP Response and Exposure Indicator Data for 1990-1991
Estuarine Classes
Indicators
Benthic index (1990-1991)
Number of stations
Sampled area (km2)
% Degraded area (B.I. < 3. 4)
Benthic index 1990
Number of stations
Sampled area (km2)
% Degraded area (B.I. < 3. 4)
Benthic index 1991
Number of stations
Sampled area (km2)
% Degraded area (B.I. < 3.4)
Dissolved oxygen (1990-1991)
Number of stations
Sampled area (km2)
% Degraded area (D.O.<2.0
ppm)
Dissolved oxygen (1990)
Number of stations
Sampled area (km2)
% Degraded area (D.O.<2.0
ppm)
Dissolved oxygen (1991)
Number of stations
Sampled area (km2)
% Degraded area (D.O. <2.0
ppm)
Province
(23,573 km2)

206
9,546
19±6

105
4,931
19+9

101
4,615
19 + 8

198
9,299
6+4

97
4,683
7±6

101
4,616
4±4
Large
(16,889 km2)

96
6,720
16+7

48
3,360
15+10

48
3,360
17+10

94
6,580
5+4

46
3,220
6+7

48
3,360
4±5
Small
(4,875 km2)

61
1,927
24±10

32
1,050
22+17

29
877
25+16

59
1,910
<1.0

30
1,032
<1.0

29
878
1+2
Tidal
(2,602 km2)

49
899
41+24

25
521
57+40

24
378
19+13

45
809
26+26

21
431
37+42

24
378
15 ±27
                                       5-19

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Table 5-1.  Summary of EMAP Response and Exposure Indicator Data for 1990-1991
           (continued)
Estuarine Classes
Indicators
Sediment toxicity (1990-1991)
Number of stations
Sampled area (km2)
% Degraded area (<80%
survival)
Sediment toxicity 1990
Number of stations
Sampled area (km2)
% Degraded area (<80%
survival)
Sediment toxicity 1991
Number of stations
Sampled area (km2)
% Degraded area (<80%
survival)
Sediment chemistry (1990-1991)
Number of stations
Sampled area (km2)
% Degraded area (>ERM)
Sediment chemistry (1990)
Number of stations
Sampled area (km2)
% Degraded area (>ERM)
Sediment chemistry (1991)
Number of stations
Sampled area (km2)
% Degraded area (>ERM)
Province
(23,573 km2)

172
7,832
17+6

84
3,716
10+7

88
4,116
22±10

202
9,450
7

104
4,908
8

98
4,542
6
Large
(16,889 km2)

76
5,320
14±8

34
2,380
3+5

42
2,940
24±13

96
6,720
4

48
3,360
4

48
3,360
4
Small
(4,875 km2)

52
1,661
28+13

26
820
38±25

26
820
19±14

59
1,861
16

332
1,050
23

27
811
8
Tidal
(2,602 km2)

44
852
8+7

24
516
6+11

20
335
10+7

47
869
13

24
498
5

23
371
24
                                        5-20

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              benthos; again the difference between years was small (22±17 percent in 1990 vs.
              25±16 percent in 1991).

       •     Large Tidal Rivers:  The 2-year sampling accounted for 34 percent of the tidal river
              area in the province.  Forty-one (±24) percent of the sampled area exhibited
              degraded benthos. The estimates of degraded condition showed large differences for
              the 2 years:  57±40 percent of the area in 1990 was degraded compared with 19±13
              percent in 1991.

       This case study used the bentbic index to classify the areal extent of degraded benthic
assemblages in the Virginian Province and its component resources classes.  Figure 5-4 shows a
pattern of increase in the percent area of degraded benthos across resource categories (1990-1991):
16 percent for the large estuaries, 24 percent for the small estuarine systems, and 41 percent for
tidal rivers.  Uncertainty estimates for area! extent of degraded benthos were within 6 percent for
the province, 7 percent for large estuaries, 10 percent for small estuarine systems, and 24 percent
for large tidal rivers.

       Although the benthic index used in this case study appears to work well for distinguishing
sites of differing environmental quality, other indices also may be effective.  First, covariance
among many of the candidate measurements was high, suggesting that several alternative
combinations could produce comparable results.  Second, index development was based  on only 33
indicator testing  sites that, although representative, did not represent all possible conditions.  Third,
the stepwise discriminate analysis may not have included important measurements of the benthic
assemblage.  Indicator development needs to be a flexible process: as other studies or the analysis
of large data bases suggest increased confidence in selected measurements, they can be incorporated
into the developing index through forced stepwise discriminate analysis.

       5.3.2.2. Exposure

       The case study characterized exposure by determining the area! distribution of each
exposure indicator:  low dissolved oxygen, sediment toxicity, and metals and organic contaminates
in the sediments.  Data for each exposure indicator, collected during the index period (My to
September), were analyzed individually and then combined for the Virginian Province and for large
estuaries, small estuarine systems, and large tidal rivers.  Critical values were selected for each
indicator: dissolved oxygen <2 pprn; sediment toxicity £80 percent control survival;  and sediment
chemistry values > Effects Range-Median (ER-M) (Long and Morgan, 1990).  The case  study did
not include estimates of bioavailability based on total organic carbon and acid volatile sulfides plus
simultaneously extractable metals (Di Toro et al., 1991, 1992). Cumulative distribution  functions
were used to calculate the percent area for exposure indicator values.  Note that it is  not the intent
of EMAP to characterize naturally occurring seasonal variability or to assess status for all seasons.
Table 5-1 summarizes data for dissolved oxygen, sediment toxicity, and sediment chemistry for
1990 and 1991 individually and for 1990-1991 combined.

       •     Virginian Province:  Bottom dissolved oxygen concentrations lower than 2.0 ppm
              occurred in 6+4 percent of the area of the province. The extent of area affected in
              1990 was similar (7±6 percent) to that in 1991 (4±4 percent). Toxic sediments
                                            5-21

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                                         5-22

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               occurred in 17 ±6 percent of the estuarine area, and more estuarine area showed
               toxicity in 1991 (22+10 percent) than in 1990 (10+7 percent).  Sediment
               contaminant concentrations exceeding the ER-M values of Long and Morgan (1990)
               were found in 7 percent of the estuarine area sampled over the 2 years; the extent
               of area exhibiting exceedances in each year was similar (8 percent in 1990, 6
               percent in 1991).

        •      Large Estuaries:  Low bottom dissolved oxygen occurred in 5 ±4 percent of the
               sampled area of large estuaries; the 2 years had similar estimates  for affected area:
               6 ±7 percent in 1990 and 4+5 percent in 1991. The amount of large estuarine area
               exhibiting toxic sediments was 14±8 percent.  An eightfold difference occurred in
               the extent of toxic sediments between 1990 (3+5  percent) and 1991 (24±13
               percent).  The  interannual difference in extent of  sediment toxicity was not reflected
               in Long and Morgan exceedances in chemical concentrations. The 2-year and
               single-year estimates of area affected by contaminant exceedances were all 4
               percent.

        •      Small Estuaries:  For small estuaries, the area with low dissolved oxygen did not
               exceed 1 percent for the 2-year or either of the single-year samples.  Conversely,
               toxic sediments were much more prevalent in small estuaries.  Twenty-eight (±13)
               percent of the area exhibited toxic  sediments over the 2 years. Nearly twice the
               sampled area was affected by toxic sediments in 1990 (38+25 percent) than in 1991
               (19±14 percent).  This pattern also was found for the extent of exceedances in
               contaminant concentrations, where 23 percent of the area in 1990 exhibited elevated
               contaminants compared with only 8 percent of the area in  1991.  The estimate for
               the affected area in the 2-year composite was 16 percent.

        •      Large  Tidal Rivers:  Low dissolved oxygen was most widespread  in the large tidal
               rivers with 26 ±26 percent of the area exhibiting dissolved oxygen concentrations
               < 2 ppm.   For 1990, the extent of area with low dissolved oxygen was over two
               times the value for 1991 (37±42 percent vs. 15±27 percent).  Toxic sediments
               occurred in 8±7 percent of the tidal river area over the 2 years; the affected area in
               either year did  not surpass  10 percent.  In contrast to small estuaries, the 1991
               value for the percent area having elevated contaminant concentrations exceeded the
               1990 value: 24 percent for 1991, as compared with 4 percent for 1990.  Overall, 13
               percent of the tidal river area was degraded relative to this  indicator.

       The percent area of low dissolved oxygen (<2 ppm) ranged from 1 percent (13 km2) in the
small estuarine systems to 4 to 6 percent (140 to 211 km2) in large estuaries and 15 to 37 percent
(56 to 159 km2) for large tidal rivers.  These data suggest that, based on percent area, low
dissolved oxygen presents a greater  problem in tidal rivers than in any other estuarine class (figure
5-4).  However, when compared on the basis of absolute area, tidal rivers  and large estuaries
appear quite similar.  In contrast, the percent area of sediment toxicity was consistently greater in
small systems,  28 percent (465 km2), than in large estuaries, 14 percent (745 km2), or tidal rivers,
8 percent (68 km2). However, when compared  on the basis of absolute area, the area of sediment
toxicity was almost twice as extensive in large estuaries than in small systems.  The sediment
                                            5-23

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chemistry data for 1990-1991 indicate that the small estuarine systems are at the greatest risk.
However, this type of degradation does not show consistent distribution between the 2 years (table
5-2). These data reinforce the need to use the entire 4-year data set to minimize uncertainty in the
description of estuarine condition.

       5.3.2.3.  Exposure-Response Associations

       An important aspect of the conceptual model is the development of qualitative and
quantitative associations or co-occurrences between exposure information and ecological effects
information. Such associations lead to the development of hypotheses that can explain the observed
changes in ecological responses and that can direct analyses in subsequent phases of the framework
and further research.  Because of the uncertainty inherent in this stage of the risk assessment
process (Layard and Silvers, 1989), these hypotheses may not indicate causality.  In fact, a
definitive statement of causality is not a prerequisite for a risk assessment (U.S. EPA, 1992). Four
areas of interest involve associations of benthic degradation with (1) low dissolved oxygen, (2)
sediment toxicity, (3) both of the exposure indicators, and (4) neither of the exposure indicators.
A separate analysis compares the co-occurrence  of degraded benthos with the percent area for one
or more sediment contaminants exceeding the ER-M values of Long and Morgan (1990).  Table
5-2 presents these analyses,  conducted for the Virginian Province, large estuaries, small estuarine
systems, and tidal rivers.

       »      Virginian Province:  In the Virginian Province, 20 percent of the total area has
               degraded benthos.  Of the 1,844  km2 with degraded benthic condition, 17 percent
               co-occurs with sediment toxicity, 21 percent co-occurs with low dissolved oxygen,
               < 1 percent have both, and 62 percent is not associated with either toxicity or low
               dissolved oxygen. These data suggest that low dissolved oxygen and sediment
               toxicity are almost equally associated with the  area of degraded benthos in the
               province and together co-occur with 40 percent of the degraded area.  The
               remaining 60 percent of degraded benthos is not associated with either exposure
               indicator.  The percent area of degraded benthos that co-occurred with ER-M
               exceedances was 16 percent for 1990-1991 combined, 24 percent for 1990, and 7
              percent for 1991.

       •     Large Estuaries:  In large estuaries, 16 percent of the total area has degraded
              benthos: 7 percent co-occurs with sediment toxicity, 20 percent co-occurs with low
              dissolved oxygen, and there is no overlap in co-occurrence with both exposure
              indicators.  These data indicate that 73 percent of the degraded benthos in large
              estuaries results from stressors other than sediment toxicity and low dissolved
              oxygen.  Low dissolved oxygen did co-occur with degraded benthos in 20 percent
              of the area of large estuaries,  principally in sections of Chesapeake Bay and Long
              Island Sound.  The percent  of degraded benthos that co-occurred with ER-M
              exceedances was 7 percent for 1990-1991.

       •      Small Estuaries:  Small estuarine systems present a somewhat different picture, with
              24 percent of their total area exhibiting degraded benthos. Forty-eight percent of
              the area with degraded benthos co-occurs with  sediment toxicity,  3 percent co-
                                             5-24

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                   occurs with low dissolved oxygen, 3 percent co-occurs with both, and 47 percent of
                   the area with degraded benthos is not associated with either low dissolved oxygen
                   or sediment toxicity. These data illustrate a stronger relationship between sediment
                   toxicity and degraded benthos in small estuarine systems. The data also suggest
                   that dissolved oxygen is a less important factor.  The percent degraded benthos
                   associated with ER-M exceedances was 50 percent for 1990-1991 combined, 67
                   percent for 1990,  and 25 percent for 1991.
    
            •      Tidal Rivers: Tidal rivers have the highest areal extent of degraded benthos, 40
                   percent of the total class.  In contrast to small estuaries, only 10 percent of the
                   degraded benthic area co-occurs with sediment toxicity.  However, 45 percent of
                   the degraded benthos co-occurs with low dissolved oxygen, zero percent co-occurs
                   with both exposure indicators, and the remaining 45 percent of the degraded benthic
                   area in the tidal rivers is not associated with either exposure  indicator.  The percent
                   degraded benthos  for the tidal rivers associated with ER-M exceedances was 8
                   percent for 1990-1991 combined, 5 percent for 1990, and 20 percent  for 1991.
    
            The above approach represents one way of conducting analyses for associations.  Other
    techniques are being explored (see Summers et al., 1993).
    
            5.3.2.4.  Estuarine Class Conceptual  Models
    
            In this case study, we have used only EMAP Virginian Province monitoring  data for
    postulating potential risks for each estuarine class. Because only 2 years of data (1990 and 1991)
    are available, one must be cautious in their interpretation.  The systematic, probabilistic sampling
    design includes 4 years of data collection to achieve complete coverage  of the province and
    estuarine classes. Consequently,  the areal estimates reported for both response and exposure
    indicators represent examples of how the data can be used and are not complete or accurate
    reflections of the power of the EMAP  sampling design. However, even though designed around a
    4-year sampling cycle, the estimates calculated from 2 years of data are representative of what
    would be expected for the whole  province after 4 years of sampling. With additional years of data,
    the uncertainty will decrease, increasing the power to detect changes in  areal extent.
    
            In addition to being  a monitoring program, EMAP is also a research program.
    Consequently, the choices of both response and exposure indicators must be viewed within the
    context of testable hypotheses.  For example, data analyzed in this case study suggest that the
    algorithm used for the benthic index may require modification.   However, since the benthic metrics
    (measurement endpoints) represent a consensus of what benthic ecologists deem important,
    variations in the index can be evaluated from the existing  data bases.  In fact, EMAP's indicator
    program is examining several other indices (Holland,  1990).
    
            The exposure-response associations examined in this case study do not imply  direct
    causality.  For example, low dissolved oxygen and sediment toxicity are indicators of an aggregate
    of stressors from potentially a variety of causes and sources. Likewise, the sediment chemistry
    values, which were not normalized for bioavailability, provide only circumstantial evidence for
    ecological effects.  The indicators used in this case study were never intended to assign causality.
                                                 5-26
    

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    Rather, they provide preliminary information from a weight-of-evidence perspective.  In
    conjunction with knowledge of other system properties (e.g., grain size, organic carbon, etc.),
    information from a weight-of-evidence perspective can identify potential problems.
    
           The following summarizes our understanding, to date, regarding the potential problems in
    the Virginian Province and its three estuarine classes.
    
           •      Virginian Province: The assessment endpoint used in these analyses, benthic
                   integrity/condition, was represented using a benthic index metric designed to
                   discriminate "degraded" sites from reference sites.  The data from 1990-1991
                   indicated that approximately 19 percent of the benthic area of the province was
                   degraded according to the criteria established for the benthic index.  Data from
                   exposure indicators show that 6 percent of the province area experienced dissolved
                   oxygen values <2 ppm, while 15 percent of the province area had toxic sediments.
                   Seventeen percent of the degraded benthic area co-occurred with sediment toxicity
                   (<80 percent control survival), while 20 percent co-occurred with low dissolved
                   oxygen and 62 percent of the degraded benthic area was not associated, with either
                   indicator.
    
           •      Large. Estuaries: For the most part, large estuarine systems are the downstream
                   repositories of the stressor inputs entering from both the large tidal rivers and small
                  estuarine systems.  Approximately 16 percent of the area of large estuaries in the
                  Virginian Province (1990-1991) exhibited degraded benthos.  Not unexpectedly, the
                  magnitude of sediment toxicity co-occurring with degraded benthos was only 7
                  percent.  Twenty percent of the area of degraded benthos co-occurred with low
                  dissolved oxygen. This area was restricted to the main stem of the Chesapeake Bay
                  north of the Potomac River.  In no areas of degraded benthos did low dissolved
                  oxygen and  sediment toxicity co-occur.
    
           •      Small Estuaries:  The areal  extent of degraded benthic communities  in small
                  systems for  1990-1991 was 24 percent.  Only 3 percent of the area of the small
                  estuarine systems with degraded benthos experienced hypoxic stress. In contrast, of
                  the 24 percent of small estuarine area experiencing degraded benthos, 48 percent
                  co-occurred with sediment toxicity. Approximately 50 percent of the area of small
                  estuarine systems experiencing degraded benthos also had one or more sediment
                  contaminant values exceeding the ER-M. Thus, a close correspondence exists in
                  the annual patterns of sediment toxicity and sediment chemistry (>ER-M) in the
                  small estuarine systems.
    
           •      Tidal Rivers:  Just under one-half of the estuarine area in the large tidal rivers (40
                  percent) had degraded benthos in 1990-1991.  Toxicity and hypoxic stressors rarely
                  co-occurred  at stations  in the Virginian Province, including those  in the large tidal
                  river systems.  Only 10 percent of the area with degraded benthos co-occurred with
                  sediment toxicity, which was restricted spatially to the  oligohaline headwaters
                  (<0.5 ppt) of the Rappahannock, Delaware, and Hudson Rivers.  In contrast, areas
                  of low dissolved oxygen (45 percent) occurred primarily in  the lower, mesohaline
                                                5-27
    

    -------
                  portions of the Potomac and Rappahannock Rivers. These data support current
                  understanding of sediment contaminant distributions in urbanized waterways and of
                  existing dissolved oxygen problems in the main stem of Chesapeake Bay.
                  However,  none of the five tidal rivers in the Virginian Province have areas of co-
                  occurrence of both  sediment toxicity and low dissolved oxygen.
    
           5.3.2.5.  Problem Formulation  Summary
    
           Of the three estuarine classes examined in this case study, large estuarine systems exhibited
    the lowest percent area of degraded benthos (16+7 percent), followed by the small estuarine
    systems (24+10 percent) and the tidal rivers (41+24 percent).  Although areal extent of
    degradation  is important, the spatial pattern (geographic distribution)  of resource degradation is
    particularly  important for  identifying specific regional ecosystems at risk (figure 5-5). These data
    clearly suggest that much  of the  degradation of benthic resources is closely associated with the five
    tidal river systems and their associated small estuaries.   The co-occurrence of exposure information
    on sediment chemistry, sediment toxicity, and  dissolved oxygen was used to  formulate hypotheses
    to suggest possible explanations for the observed spatial patterns of degraded benthos. Co-
    occurrence of low dissolved oxygen can be postulated as an explanation for 20 percent of the
    degraded benthos in large  systems, but only for 3 percent of the degraded benthos in small systems
    and for more than 45 percent of the degraded benthos in tidal rivers.  Conversely, co-occurrence
    of sediment toxicity can explain  only 7 percent of the degraded benthos in large systems,  10
    percent in tidal rivers, and 48  percent in  small estuaries.
    
           In addition, since hypoxia and toxicity  co-occur infrequently (<5 percent), one might
    expect them to represent differing system and source characteristics.  For example, toxicity was
    more prevalent in the lower salinity portions of these systems (mesohaline and oligohaline) than
    was low dissolved oxygen, suggesting a potential association with urban point sources in the upper
    reaches of estuaries.  Chemistry data on the exceedances of ER-M values for one or more chemical
    contaminants support this  interpretation.   Analysis  of these data suggests that toxicity problems
    within small estuarine systems are  localized in small tidal rivers and small embayments bordered
    by heavily industrialized urban areas.
    
           Hypoxia can result from municipal discharges in portions of tidal river systems independent
    of industrial discharges or from nutrient enrichment in those small systems deeper and more open
    to larger embayments. Poorly flushed small systems with high carbon  loads characteristic of
    sewage discharges would lead to high sediment oxygen demand and hypoxia.  Nonpoint runoff
    from agricultural land bordering small estuaries and coastal lagoons also may result in nutrient
    enrichment, subsequent algal blooms, and hypoxia. However, numerous  and extensive studies
    focus on explanations for the low dissolved oxygen in the large estuaries, especially in the main
    stem of the  Chesapeake Bay.
    
           The results from this case study indicate that, of the three exposure indicators, sediment
    contamination and toxicity are the primary risks in small estuarine systems while low dissolved
    oxygen presents  the primary risk in large systems and,  particularly, the tidal rivers.   These
    exposure data do not identify specific contaminant  stressors, nor do the data  imply that these are
    the only stressors of concern.  This conclusion is supported by the fact that more than 50 percent
                                                 5-28
    

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       5-29
    

    -------
     of the area of degraded benthos was not associated with any of the exposure indicators used in this
     case study.  Other unmeasured contaminants could cause the observed toxicity.  While it is not the
     intent of this case study to conduct an evaluation of the EMAP sampling design and indicator
     programs, the analysis of data used in this case study has resulted in several observations on its
     utility in the ecological risk assessment process (comment box).
    
     5.3.3. EMAP and Regional Risk Assessments
    
            The data presented above could lead to the formulation of several hypotheses regarding
     ecological condition at the provincial (biogeographic) scale and potential causes of degraded
     conditions.  For example, some hypotheses might address the relative effects of contaminants in
     small estuarine systems versus those due to low dissolved oxygen in large tidal rivers.  The
     provincial scale of EMAP sampling does not allow for adequate testing of hypotheses associating
     environmental exposure with ecological effect.  Thus, finer-scale regional studies are necessary to
     refine and focus EMAP-generated hypotheses in a way that will lead to the development of more
     definitive cause-effect data.  In addition to evaluating EMAP hypotheses, these assessments also
     should lead to more informed management decisions at the regional level. The following section
     presents an example of such an assessment.
    
            Having demonstrated the use of EMAP province-scale  information in the problem
     formulation phase  of the  risk assessment process, the next step would examine how the hypotheses
     developed at the province scale can be used to assess the regional risks to specific estuarine areas.
     The data and analyses presented above have focused on two types of information:  (1) the
     distribution of benthic resources over large biogeographic areas (i.e., the Virginian Province) and
     (2) the relationship of those benthic resources  to specific categories of exposure indicators.  EMAP
     uses this information for  characterizing and comparing the status of resources across provinces and
     within classes of estuaries. However, ecological resource data at the province scale have limited
     regulatory value; such data are not readily coupled to political boundaries and a control strategy via
     specific categories of stressors and defensible causal inferences. To optimize regulatory
     applicability, province-scale data must be placed within the context of regional assessments; that is,
     integrated into a risk-based decision framework that identifies the potential causal relationships
     between ecological resources and specific stressors and links the relationships to  land-based
     activities amenable to source control.
    
            EMAP data can identify  the status of estuarine resources (represented in this case study by
     benthic resources) and, more importantly, the  spatial patterns and extent  of resource degradation
     within the province.  These province-scale patterns can identify the types, spatial extent, and
     possible reasons for problems within various regional settings.  Figure 5-5 illustrates the spatial
     distribution of degraded benthos within the Virginian Province after 2 years of sampling and the
    use of province-scale data to identify potential areas for regional assessments.   Degradation
    generally is focused in the upper Chesapeake Bay, within the five tidal river systems  and their
    associated  small bays.  These are areas of intense demographic pressure, extensive urban
    development, and the source of anthropogenic  stress.  Considerable benthic degradation occurs
    throughout the Hudson, East,  and Raritan Rivers. This degradation is associated with sediment
    toxicity and elevated sediment chemistry values (figure 5-5).  Data suggest that EMAP information
    can help identify regional areas of degraded resources and provide preliminary associations with
                                                  5-30
    

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    exposure type. The probabilistic nature of the EMAP design also permits a determination of the
    relative magnitude of degradation, thereby focusing attention on areas with potentially the greatest
    problems.  Using the Hudson-Raritan. estuary and watershed as an example, the following sections
    briefly describe one approach for conducting a regional assessment that uses the EMAP design,
    indicator, and assessment concepts.
    
           5.3.3.1.  Regional Risk Assessment: Problem Formulation
                                                                                        i  •
           While useful in identifying regional problem areas, EMAP province-scale data are not
    collected in sufficient detail for conducting a complete regional risk assessment. Although,extant
    local monitoring data are usually available, they often are heterogeneous relative to spatial,
    temporal, and ecological scale and methodologies (e.g., type of sampling gear, analytical methods,
    etc.).  Within the Hudson-Raritan basin, decades of monitoring data are available from NOAA,
    states, and more recently the Harbor Estuary Program (HEP).  However, each of these programs
    has its own problem-oriented objectives and sampling and analysis goals. This heterogeneity in
    objectives makes it difficult, if not impossible, to satisfy the information needs of problem
    formulation and fully characterize the type and spatial extent of the ecological problems at a
    regional scale.
    
           The first step, then, in the regional risk assessment involves revisiting the problem
    formulation phase of the risk assessment process  to characterize the spatial extent of degraded
    resources and associated measures of exposure.  Data for this purpose can be acquired through (1)
    an appropriately scaled monitoring program employing a random sampling design (e.g., EPA
    Region II, R-EMAP);  (2) selection of the appropriate response, exposure, and habitat indicators to
    characterize the spatial  extent of ecological problems and associated exposures; (3) the
    incorporation of extant data, where possible, into a probabilistic sampling design analogous to that
    used by EMAP; or (4) through a combination of all three approaches.  The conduct of problem
    formulation at the regional scale will provide a detailed description and spatial representation of the
    types,  magnitude, spatial distribution, and areal extent of ecological problems.  These ecological
    effects can then be associated more closely with specific exposure and habitat indicators and
    stressors,  leading to the development of one or more conceptual models for the region or specific
    watershed within the region. Currently, ORD, in cooperation with EPA Region II, is conducting a
    Regional-EMAP project in the Hudson-Raritan estuary to develop just such a series of conceptual
    models for various areas within the estuary.
    
           5.3.3.2. Regional Risk Assessment: Analysis Phase
    
           The analysis phase of the ecological risk assessment process involves the development of
    detailed models describing the spatial and temporal patterns  of exposure and stressor-response
    models that illustrate the change in status of ecological response as  a function of incremental
    changes in exposure.  Monitoring programs  may collect some types of data that are relevant to a
    detailed analysis of ecological risks;  however, they do not normally collect the full spectrum of
    necessary data, nor do monitoring data provide the necessary uniform spatial coverage for the area
    of concern. Within a regional setting like the Hudson-Raritan,  where sediment toxicity and
    contaminated sediments are known to be associated with degraded benthic resources, the risk
    assessor would likely synthesize extant data from the ORD research laboratories, Region II, HEP,
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    NOAA, states, private sector, etc., to develop the causal relationships necessary to fully
    characterize the regional risks.
    
            Extant data for this area can prove particularly important in identifying possible causes for
    observed resource degradation.  For example, there is a history of PCS contamination in the
    Hudson River, dioxins hi the Raritan River, petroleum contamination in the Arthur Kill River, and
    organic enrichment in Jamaica Bay.  In addition, during the last several years NOAA has
    synthesized data on benthic community structure, sediment toxicity, and metal and organic
    contaminants in sediments and water in this  area.  Although not sampled probabilistically, these
    data help identify spatial patterns of problems and their potential causes in various sections of the
    estuary. A regional risk assessment can use these data, along with laboratory toxicity information
    and measures of contaminant bioavailability, to develop evidence needed for postulating causal
    inferences  for the region as a whole or for a specific watershed. The causal relationships may be
    quantitative or inferential, relying on weight-of-evidence and professional judgment.
    
            The contribution of the EMAP  design to the Hudson-Raritan basin study,  conducted by
    EPA Region II, will significantly strengthen inferences of risk within this watershed (National
    Governors Association, 1993).  In  addition, this R-EMAP project also will examine methods for
    incorporating extant data into the probabilistic EMAP design, further enhancing its utility.  Most
    likely, monitoring data alone will prove insufficient for establishing the causal relationships
    necessary for developing a complete risk assessment.  Nevertheless, the intent is to develop
    multiple, converging lines of evidence for linking observed ecological effects to one or more
    specific stressors or to stressor categories that are amenable to remediation.  The  extant data in the
    Hudson-Raritan basin  suggest that different stressor-response relationships may emerge for different
    watersheds.  This conclusion would lead to different source control management strategies for each
    watershed.
    
            5.3.3.3. Regional  Risk Assessment:  Risk Characterization
    
            The risk characterization phase  of the framework describes three methods for integrating
    exposure and effects information into a statement of the likelihood  of risk with associated
    uncertainties:  point comparisons,  distributional comparisons, and modeling.  Depending on  the
    type of data, any one or a combination  of these approaches can be  used with the types  of
    monitoring data presented here. GIS and landscape methods can provide initial descriptions of
    risks to specific watersheds. These methods can describe the spatial relationships and distribution
    of response, exposure, and habitat  indicators (stressor-specific whenever possible).  These
    descriptions can then be overlaid with landscape information on hydrologic features (e.g., transport
    and fate) in the surrounding watershed.   Descriptive approaches, using GIS and landscape methods,
    can integrate field data describing the spatial extent, magnitude, and degree  of association between
    response and exposure indicators.   However, descriptive approaches do not establish functional
    exposure-response relationships, Establishment of functional relationships requires the
    decomposition of measurements of "aggregate exposure" (e.g., sediment toxicity-related bioeffects
    from multiple stressors) into specific stressors using diagnostic biomarkers,  fractionation protocols,
    and laboratory ecotoxicity tests.
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            For example, overlays of response and exposure indicators indicate that there is a high
     degree of co-occurrence of benthic community degradation with sediment toxicity and specific
     sediment organic contaminants (e.g., dioxins and dibenzofurans) in the Raritan River.  This
     example suggests the potential for a strong causal relationship between specific stressors and
     ecological effects.  Literature data, additional in situ field testing along a gradient, or laboratory
     testing can evaluate the hypothesis.  As a clearer picture of the specific stressors emerges, GIS and
     landscape methods  can integrate (1) information  on the spatial distribution of specific contaminants,
     (2) areas of degraded benthos, (3) information on the discharges from land-based activities, and (4)
     hydrologic information from the surrounding watersheds.   Using available data and converging
     lines of evidence, a series of inferences can be developed regarding causal associations from
     response to exposure to stressors to sources.  Supporting these  initial inferences requires additional
     analyses such as site-specific studies on organism-residue  relationships, contaminant "spiked"
     laboratory sediment-residue and toxicity analyses, and site-specific field studies using natural
     contaminant gradients.  Together, these studies would focus on quantifying functional and causal
     relationships  and the uncertainties associated with each phase of this process.
    
            In summary, spatial models describing response-exposure-stressor-hydrologic relationships
     can be coupled with landscape models describing specific  watershed activities that are sources of
     anthropogenic inputs.  The establishment of the appropriate causal relationships between sources
     and effects provides the basis for the manager to institute  appropriate control strategies.  Existing
     local compliance (e.g., NPDES, states, municipalities) and watershed assessment (R-EMAP,
    EMAP, NS&T) monitoring programs can evaluate the effectiveness  of the control strategy.
      Comments on Problem Formulation, Conceptual Model Development, and Regional Risk
      Assessments
    
      General reviewer comments:
    
             •      The case study's introduction  and the background do a good job of setting the
                    stage for the problem formulation and of explaining the benefits and limitations
                    of the EMAP program.   The authors  refer to the use of EMAP in this fashion as
                    a "weight-of-evidence" approach.  Perhaps it would be more accurate to call it
                    a screening approach, because  "weight-of-evidence" has  a toxicological
                    interpretation  that implies real knowledge  of cause and effect for a stressor and
                    organisms.  In using the term "weight-of-evidence," EMAP is suggesting such a
                    relationship.
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    Comments on Problem Formulation, Conceptual Model Development, and Regional Risk
    Assessments (continued)
           •      The percent co-occurrence of degraded benthos with low dissolved oxygen does
                   not give the percent of degradation that can be attributed to low oxygen.  As
                   stated,  these co-occurrence data represent a contingency table that tests
                   association.  Consider the large estuaries where 7 percent of degraded benthos
                   is associated with sediment toxicity, despite the fact that 14 percent of the
                   estuaries have sediment toxicity.  The conclusion is (if significant) that sediment
                   toxicity tends to be associated with undegraded benthos.   For oxygen, the
                   respective figures are 20 percent and 5 percent,- hence, low  oxygen appears to
                   be quite strongly associated with degraded benthos.
    
                   There are a number of ways  of analyzing for associations in such data.  If one
                   can assume that samples are independent, then a log-linear  model of frequency
                   data might be appropriate.  In this case, sample size permitting, there could be
                  four levels:  riverine type, benthos condition  (degraded vs. undegraded),
                   sediment toxicity, and ER-M exceedance.  Such an analysis would determine
                   differences among riverine types in various conditions, associations of exposure
                   measures with effect measures, and associations among  the different exposures.
    
           •      The section on regional risk assessment refers to the association of degraded
                   areas with areas of "intense demographic pressure, extensive urban
                   development, and the source of anthropogenic stress. " Should these be
                   considered as pan of the exposure characterization?  Could sampling data be
                  further stratified by stressed areas within waterways  and by  stressed and
                   unstressed waterways?
    Authors' comments:
                                      EMAP Sdmplins Desien
    Strengths of the case study include:
                   Quantifies areal extent of indicator values.
                   Describes the spatial patterns and distribution of ecological resources and
                   associated habitat and exposure indicators.
                   Permits the estimation of uncertainties for indicator values.
                   Quantifies postremediation changes in areal extent of resources and exposures.
                   Scalable to regions and specific sites (e.g., bays, estuaries).
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     Comments on Problem Formulation (Continued)
    
     Limitations include:
    
            •      Limiting sampling to index period  (e.g., once per year) fails to address
                   seasonality and episodic events.
            •      Sampling design currently does not capture local spatial scale and short-term
                   temporal scale events.
            •      Incorporation of nonprobabilistic extant data with the EMAP'sprobabilistic
                   sampling design is currently not feasible and is a major limitation for risk
                   assessment applications.
                                         EMAP Indicators
    Strengths of the case study include:
                   Sites of exposure and habitat indicators are measured simultaneously with
                   response  indicator.
                   Response indicator is hierarchical in design, with clear links between assessment
                   endpoints, measurement endpoints, and metrics.                  :
                   Habitat indicators are directly related, facilitating the interpretation of response
                   and exposure indicator information.
    Limitations include:
                   Currently, EMAP has no response or exposure indicators for nutrient or carbon
                   enrichment (eutrophication).
                   Response indicators have been developed and applied only for benthic
                   resources.
                   Exposure indicators for physical stressors are lacking.
                   There is currently no systematic program for validating existing indicators.
                   Accurate measures  of bioavailability are needed for interpreting contaminant
                   exposure indicators.
                   The benthic index metric, sediment toxicity, and bioavailability indicators
                   require evaluation,  validation,  and revision.
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