United States
          Environmental Protection
          Agency
vEPA
Office of Science and Technology
Standards and Applied Science Division
(4305)
EPA 823-B-97-004
March 1997
                    WATER QUALITY
                      STANDARDS
                       ACADEMY
                    Basic Course
                PARTICIPANT
                    MANUAL
                     1997 Edition
                        Office of Water
                   Office of Science and Technology

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             United States
             Environmental Protection
             Agency
Office of Science and Technology
Standards and Applied Science Division
(4305)
EPA 823-B-97-004
March 1997
vvEPA
                          WATER QUALITY
                             STANDARDS
                              ACADEMY
                          Basic Course
                     PARTICIPANT
                          MANUAL
                           1997 Edition

                               Office of Water
                         Office of Science and Technology
    This manual provides a basic overview of EPA's water quality standards program. These
    materials are for instructional purposes only. Water quality standards program requirements
    and acceptable options for meeting those requirements are expressed in the Agency's
    regulations, policy, and guidance referenced and outlined herein.

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                                      PREFACE

       This "Water Quality Standards Training Academy" provides structured training on the
objectives of the water quality standards and criteria programs, the interpretation and
application of the Water Quality Standards Regulation policies and program guidance, and the
relationship of water quality standards to other programs.  This is a basic introductory course.

       This is a 5-day course that consists of 23 individual training modules.  The course is
comprised of a variety of instructional activities, including lectures, case studies, class
exercises, problem-solving activities, role-play, and discussions.  Certificates will be awarded
upon successful completion.

       Two sets of manuals are used in this course:  the Participant Manual and the Basic
Course Reference Manual. This is the Participant Manual.  Each module contains  a
summary page that provides information on the objectives of the module, the format used to
teach the module, the length of the module, and references.  References are identified as
either Basic Course Reference Documents or Other Documents.  The Basic Course  Reference
Manual that accompanies this manual contains copies of the Clean Water Act, the Water
Quality Standards Regulation, reports, guidance, and other materials that supplement the
information provided in the modules. The other documents listed for each  module contain
additional references that you may wish to refer to in order to  receive further information
about a particular subject.

       After the summary page, you will find  an outline of the information to be presented in
the module. Following the outline, transcripts of videotapes and copies of handouts are
provided. Review questions are located at the end of most modules.
Water Quality Standards Academy                iii                             Participant Manual
                                                                               1996 Edition

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                 WATER QUALITY STANDARDS ACADEMY
                          PARTICIPANT MANUAL
                           TABLE OF CONTENTS
                                                                      page
PREFACE 	iii
AGENDA	iv

Training Module 1
   INTRODUCTIONS AND PARTICIPANT EXPECTATIONS
      Summary Page  	1-1
      Outline	1-3
      Handouts
         1-1:  Course Instructors	1-7

Training Module 2
   OVERVIEW OF EPA, THE CLEAN WATER ACT, AND THE WATER QUALITY
   STANDARDS PROGRAM
      Summary Page  	2-1
      Outline	2-3
      Handouts
         2-1:  EPA Organization Chart	2-19
         2-2:  Office of Water Organization Chart	2-21
         2-3:  OST Organization Chart	2-23
         2-4:  History   	2-25
         2-5:  CWA Provisions  	2-27
         2-6:  Schematic	2-29
         2-7:  Federal Definition	2-31
         2-8:  WQS Example	2-33
         2-9:  Transcript	2-43
      Review Questions	2-47
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                                                                              page

Training Module 3
   DESIGNATED USES
       Summary Page  	3-1
       Outline	3-3
       Handouts
          3-1:  State A — Use Classification	3-13
          3-2:  State B — Use Classification	3-15
          3-3:  State C — Use Classification	3-17
          3-4:  State D — Use Classification	3-19
          3-5:  State E — Use Classification	3-23
          3-6:  Points to Consider  	3-25
          3-7:  Removal  	3-27
       Review Questions	3-29

Training Module 4
   CONDUCTING USE ATTAINABILITY ANALYSES
       Summary Page  	4-1
       Outline	4-3
       Handouts
          4-1:  Physical	4-11
          4-2:  Chemical	4-13
          4-3:  Steps in a Use Attainability Analysis  	4-15
          4-4:  Steps in a Use Attainability Analysis (simplified version)	4-17
          4-5:  Summary Sheet  	4-19
          4-6:  Case Study	4-21
       Review Questions	4-29

Training Module 5
   PRINCIPLES OF TOXICOLOGY
       Summary Page  	5-1
       Outline	5-3
       Handouts
          5-1:  IRIS Record (to be distributed)	5-25
       Review Questions	5-43
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Training Module 6
   PRINCIPLES OF RISK ASSESSMENT
      Summary Page  	6-1
      Outline	6-3
      Handouts
         6-1:  Cadmium Toxicity Data	6-19
         6-2:  Selection of Critical Endpoint and Data Set	6-21
         6-3:  Determination of the Dose Corresponding to the NOAEL   	6-23
         6-4:  Calculation of the RfD	6-25
         6-5:  Lifetime Cancer Risk	6-27
         6-6:  Cadmium Exposure Exercise	6-29
      Review Questions	6-31

Training Module 7
   INTRODUCTION TO CRITERIA DEVELOPMENT
      Summary Page  	7-1
      Outline	*	7-3
      Handouts
         7-1:  "Priority" Pollutants  	7-11
         7-2:  Transcript	7-13

Training Module 8
   HUMAN HEALTH CRITERIA
      Summary	8-1
      Outline	8-3
      Handouts
         8-1:  Cadmium	8-11
         8-2:  FM Table	8-15
         8-3:  IRIS Record  	8-17
         8-4:  Carcinogenic Chemical Calculation	8-33
         8-5:  Uncertainty Factors	8-35
         8-6:  Non-Carcinogenic Chemical Calculation	8-37
         8-7:  Pollutant List	8-39
      Review Questions	8-61
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                                                                                page

Training Module 9
    AQUATIC LIFE CRITERIA
       Summary	9-1
       Outline	9-5
       Handouts
          9-1:  Statement	9-21
          9-2:  "Priority" Pollutants  	9-23
          9-3:  No Criteria	9-27
          9-4:  Proposed Criteria	9-31
          9-5:  "Non-Priority" Pollutants  	9-33
          9-6:  Recommended State Actions  	9-37
          9-7:  How Chart	9-39
          9-8:  Freshwater	9-41
          9-9:  Sample Calculation	9-43
          9-10:  Site-Specific Criteria Flow Chart	9-47
          9-11:  Class Exercise  	9-49
          9-12:  Video Transcript	9-53
       Review Questions	9-63

Training Module 10
    SEDIMENT CRITERIA
       Summary Page  	10-1
       Outline	10-5
       Handouts
          10-1:  Program Applications	10-17
          10-2:  Class Exercise	10-21
          10-3:  Instructions for Class Exercise  	10-23
          10-4:  Classification Methods  	10-25
       Review Questions	10-27
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Training Module 11
    BIOLOGICAL CRITERIA
       Summary Page  	11-1
       Outline	11-3
       Handouts
          11-1:  Maine  	11-31
          11-2:  Arkansas Narrative Criteria Example  	11-33
          11-3:  Numeric Criteria for Ohio	11-35
          11-4:  Model of the Process	11-37
          11-5:  Field Data Sheet	11-39
          11-6:  Index of Biotic Integrity  	11-43
          11-7:  Regional IBI Matrix	11-45
          11-8:  IBI Scoring Criteria	11-47
          11-9:  IBI Worksheet	11-49
          11-10:  Transcript	11-51
       Review Questions	11-57

Training Module 12
    PRINCIPLES OF ECOLOGICAL RISK ASSESSMENT
       Summary Page  	12-1
       Outline	12-3
       Handouts
          12-1:  Ecological Risk Assessment Framework   	12-23
          12-2:  Ecological Risk Assessment Case Study	12-25
          12-3:  Dan River Watershed Conceptual Model  	12-33
          12-4:  Hill's Criteria  	12-35
          12-5:  5 Case Study Brochures  (to be distributed)	12-37
       Review Questions	12-39

Training Module 13
    PRINCIPLES OF RISK COMMUNICATION
       Summary Page  	13-1
       Outline	13-3
       Handouts
          13-1:  Seven Cardinal Principles of Risk
                Communication (to be distributed)	13-21
          13-2:  Group Exercise (to be distributed) 	13-23
          13-3:  Instructions (to be distributed)  	13-27
          13-4:  Improving Dialoque with Communities (to be distributed)	  13-31
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Training Module 14
   ANTIDEGRADATION POLICY REQUIREMENTS
      Summary Page  	14-1
      Outline	14-3
      Handouts
         14-1:  Transcript	14-9
      Review Questions	14-15

Training Module 15
   VARIANCES
      Summary Page  .	15-1
      Outline	15-3
      Review Questions	15-9

Training Module 16
   ECONOMIC CONSIDERATIONS
      Summary	16-1
      Outline	16-3
      Handouts
         16-1:  Transcript	16-19
         16-2:  Case Study Scenario  	16-23
         16-3:  Case Study Summary	16-25
         16-4:  Case Study Worksheet  	16-27
         16-5:  Municipal Affordability Screener for
               Mesa City (to be distributed)  	16-31
         16-6:  Secondary Affordability Test (Financial Management
               Indicators for Mesa City) (to be distributed)	16-33
         16-7:  Socioeconomic Information  	16-35
      Review Questions	16-39

Training Module 17
   MIXING ZONES
      Summary Page  	17-1
      Outline	17-3
      Handouts
         17-1:  Case Study  	17-13
         17-2:  Case Study Questions	17-17
      Review Questions	17-19
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                                                                         Eigg

Training Module 18
   THE WATER QUALITY STANDARDS SUBMITTAL AND APPROVAL PROCESS
      Summary Page  	18-1
      Outline	18-3
      Handouts
         18-1:  Certification  	18-17
         18-2:  Federal Rulemaking	18-19
      Review Questions	18-25

Training Module 19
   THE ENDANGERED SPECIES ACT AND THE WATER QUALITY STANDARDS
   PROGRAM
      Summary Page  	19-1
      Outline	19-3
      Handouts
         19-1:  Key Terms  	19-13
         19-2:  Flow Chart	19-21
         19-3:  Summary of ESA Section 7 Consultations  	19-23
         19-4:  ESA Summary	19-25
      Review Questions	19-29

Training Module 20
   IMPLEMENTATION OF WQS
      Summary Page  	20-1
      Outline	20-3
      Handouts
         20-1:  Transcript	20-23
         20-2:  TMDL Calculations	20-31
         20-3:  Three Types of Pollutants	20-35
         20-4:  NPDES  	20-37
         20-5:  Levels of Technology	20-39
         20-6:  FOIA	20-41
         20-7:  Information List	20-43
      Review Questions	20-45
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 Training Module 21
   WATER QUALITY STANDARDS ON INDIAN RESERVATIONS
      Summary Page  	21-1
      Outline	21-3
      Handouts
         21-1: Transcript	21-13
      Review Questions	21-17

 Training Module 22
   WQS TERMINOLOGY
      Summary Page  	22-1
      Outline	22-3
Training Module 23
   WRAP-UP/FEED BACK
      Summary Page  	23-1
      Outline	23-3
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                         TRAINING  MODULE  5:
                          PRINCIPLES OF TOXICOLOGY
MODULE SUMMARY:

This module introduces basic principles and concepts of toxicology, including methods used to assess
chemical toxicity, with a focus on human health and aquatic life toxicity.
    NOTE:   This module contains technical information regarding the scientific underpinnings of
             environmental toxicology.  Participants are not expected to master this information
             upon completion of this module.  Follow-up training and technical support will be
             required for most participants who will be directly involved in the development of
             water quality criteria.  This module serves only as an introductory training session on
             principles of toxicology. Follow-up technical advisory support is available through
             EPA.
OVERALL OBJECTIVES:

To provide an understanding of the principles of toxicology, including techniques used to assess
toxicity, and how these principles relate to an understanding of the water quality standards and
criteria programs.
MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:
   •  List toxicologic endpoints of concern for humans and aquatic life
   •  Distinguish between acute and chronic toxicity, immediate and delayed toxicity, threshold and
      nonthreshold effects, and reversible and irreversible effects
   •  Explain how relationships between response and dose or concentration are used to quantify
      toxic effects
   •  Describe how data are evaluated in environmental toxicology
   •  List the pharmacokinetic processes that a toxicant undergoes in an organism
   •  Explain how chemical properties of the toxicant, conditions of exposure, and biological
      characteristics of the host can influence toxicity
   •  Describe the  advantages and disadvantages of various tests used to assess toxicity
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 Module 5
 LOGISTICS:

 Teaching Method:  Lecture (with slides).

 Approximate Presentation Time:  1% hours (Lecture—95 minutes; Review Questions—10
 minutes).

 Other Documents:

 General

    Amdur, M, et al. (1991) Casarett and Doull's Toxicology:  The Basic Science of Poisons, 4th
    Edition.

    Barnes, D.G., and M. Dourson. (1988) Reg. Toxicol. Pharmacol. 8:471-486. (Discussion  of
    Reference Dose methodology.)

    Public Health Service. (1990)  Draft Toxicological Profile for Cadmium. U.S. Department of
    Health and Human Services, Agency for Toxic Substances and Disease Registry (ATSDR).

    U.S. EPA. (1986) Ecological Risk Assessment.  U.S. Environmental Protection Agency, Office of
    Pesticide Programs. (EPA/540/9-85-001).

    Loomis, T.A. (1978) Essentials of Toxicology, 3rd Edition.

    U.S. EPA. (1987) The Risk Assessment Guidelines of 1986. U.S. Environmental Protection
    Agency, Office of Health and  Environmental Assessment.  (EPA/600/8-87/045).

Aquatic

    Coekerham, L.G., and B.S. Shane (eds). (1994)  Basic Environmental Toxicology. CRC Press,
    Boca Raton, FL.

    Eislee, R. (1985)  Cadmium hazards to fish, wildlife, and invertebrates: A Synoptic Review.
    U.S. Fish  and Wildlife Service. Biol. Rep.  85(1.2).

    Rand, G.M., (ed.). (1994).  Fundamentals of Aquatic Toxicology II:  Effects, Environmental Fate
    and Risk Assessment.  Taylor  & Francis, Bristol, PA.

    U.S. EPA. (1984).  Ambient Water Quality Criteria for Cadmium. U.S. Environmental Protection
    Agency, Office of Water, Washington, D.C.  (EPA 440/S-84-032).
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                             MODULE 5 - OUTLINE
                  PRINCIPLES OF  TOXICOLOGY
                             — INTRODUCTION —
The objective of the Clean Water Act is to restore and maintain the chemical, physical, and
biological integrity of the nation's water.
Water quality standards consist of three components:

   •  designated uses;

   •  criteria;  and

   •  antidegradation policy.
Toxicology is the study of poisons
(toxicants) and their effect on living
biological systems.
Slide 1:  Toxicology
Environmental toxicology is the branch of toxicology that studies the effects resulting from the
exposure of humans and other living organisms to chemicals in the environment.
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 Module 5
 Inhalation, ingestion, and passage
 through the skin are routes of exposure
 to toxicants in the environment.
Slide 2: Routes of Exposure
                                                 Routes
                                                 of
                                                 Exposure
                                                                              &EPA
Chemicals may cause adverse effects in organisms because they interact with the body's vital
functions. These interactions depend on the properties of the chemical compound and the amount of
chemical present.
Endpoints are adverse effects that can
be studied in the laboratory or in the
environment.
Slide 3:  Toxicologic Endpoints
                                                              TOXICOLOGIC
                                               •Lethality    [   ENDPOINTS   J
                                               •Carcinogenicity
                                               • Mutagenicity
                                               • Neurotoxicity
                                               • Immunotoxicity
                                               •Reproductive/Developmental Toxicity
                                               •Target Organ Toxicity
                                             v • Ecological Effects
Lethality is the ability of a toxicant to cause the death of exposed individuals or populations.
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                                                                       Principles of Toxicology
Carcinogenicity is the ability of a
toxicant to cause cancer.
Slide 4: Cancer in Fish
                                                     CANCER IN FISH       )
                                                                              *EPA
Mutagenicity is the ability of a toxicant to cause changes in the genetic material of cells.

Neurotoxicity refers to adverse effects of a chemical on the structure or function of the nervous system.

Immunotoxicity refers to adverse effects of a toxicant on the function of the immune system.

Reproductive toxicity refers to adverse effects on an adult's reproductive capability.
Developmental toxicity refers to adverse
effects on a growing organism.
Slide 5: Developmental Toxicology
                                              [     DEVELOPMENTAL
                                              I           TOXICITY
                                                                              &EPA
Target organ toxicity refers to adverse effects of a toxicant on a particular organ or tissue.

Ecological effects refer to adverse effects of a toxicant on populations or communities of species in a
natural ecosystem.
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 Module 5
 Ecological effects refer to adverse effects of a toxicant on populations or communities of species in a
 natural ecosystem.
  — TERMS USED TO DESCRIBE TOXICOLOGICAL EFFECTS —
Acute toxicity describes adverse effects
that occur after one or only a few
exposures to a chemical over a short
period of time.
Chronic toxicity refers to adverse
effects that appear only after repeated
or continuous exposure to a chemical,
usually over an extended period of
time.
Slide 6:  Acute vs. Chronic
  TYPES OF Toxic EFFECTS]
                                               Acute Toxicity
   Adverse Effects
   Occur After One
   or Only a Few
   Exposures
                   vs.
     Chronic Toxicity
    Adverse Effects
    Occur Only After
    Repeated Exposure
    (distinction based on extent of exposure)

   	& EPA-
Immediate toxicity refers to adverse
effects that occur right away.
Delayed toxicity refers to effects that
appear only after a time lag.
Slide 7:  Immediate vs. Delaved
                                               TYPES OF Toxic EFFECTS]
       Immediate
                                               Adverse Effects
                                               Appear Within
                                               Minutes, Hours, or
                                               or a Few Days
                                               Exposures
VS.
Delayed Toxicity
                        Adverse Effects
                        Appear Only after a
                        Time Lag of Several
                        Days, Weeks,
                        Months, or Years
                                                (distinction based on time between exposure)
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                                                                        Principles of Toxicology
If there is some dose level below which
a chemical generally does not cause an
adverse effect, the effect is said to have
a threshold.

Effects that occur even at
infinitesimally small exposures to a
chemical are referred to as
nonthreshold effects.
Slide 8: Threshold vs. Nonthreshold
   TYPES OF Toxic EFFECTS]

Threshold Effects
i Adverse Effects Do
• Not Occur Below
; Some Specified
Dose or
Concentration
VS. Nonthreshold
Adverse Effects Can
Occur as a Result of
Exposure to Even a
' Single Molecule of
the Toxicant
                                                 (distinction based on the presence or absence
                                                        of effects at very low doses)
Adverse effects that last only as long as
a person is exposed to the chemical are
called reversible effects.

Adverse effects that persist or intensify
even after exposure to the chemical has
ended are  called irreversible effects.
Slide 9:  Reversible vs. Irreversible
  TYPES OF Toxic EFFECTS]
      Reversible
                                                Adverse Effects
                                                Disappear When
                                                Exposure to the
                                                Chemical Ends
VS. ! Irreversible Effects
                         Adverse Effects
                         Persist Even After
                         Exposure to a
                         Chemical Ends
                                                (distinction based on permanence of effects)
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                                    1996 Edition
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Module 5
Cadmium is a useful example for
illustrating lexicological properties.
Slide 10: Cadmium Toxicity
 [      CADMIUM TOXICITY     )
                                                   Organism
                                                   WistarRat
                                                    Quail
                 Eiposure

                 Inhalation
                  24 hour,
                 high dose
                 Inhalation,
                Low to moderate
                  dose
                months toveais
                                                               Moderate dose,
                                                                 weeks
                                                                           Irritation of upper airway
                                                                           memoianes, chest pains,
                                                                             Kidney damage
                                                                              Lung cancer
                             Anemia, bone nunow
                              & heart damage
                                               Slide 11:  Cadmium Toxicity
                                                      CADMIUM TOXICITY     )
      Fish
     Fish
                                                                Exposure

                                                             Inhalation/lngestion
                                                              Percutaneous
                                                           High dose, hours to days

                                                             Inhalatkm/Ingestion/
                                                              Percutaneous
                                                             Low dose months to
                                                                 years
   Effect

 Gill damage
Intestine, kidney
  damage
                                                   Water Flea   Inhalation/lngestion/   Decreased reproduction
                                                              Percutaneous      Increased mortality
                                                           Low dose, days to weeks
                                                                                  &EPA
        — QUANTIFICATION OF TOXICOLOGIC EFFECTS —
For the majority of chemicals, the likelihood that adverse effects will occur increases as the dose of
the chemical and the period of exposure increase.
The relationship between the dose of a chemical and the degree of adverse effects that occur in an
animal is known as a dose-response relationship.


The relationship between the aqueous concentration of a chemical and the degree of adverse effects
that occur in aquatic organisms is known as a concentration-response relationship.
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                                                                             Principles of Toxicology
Dose-response (concentration-response)
curves plot the dose (concentration)
along the horizontal axis and the
percentage of exposed animals
exhibiting the adverse effect along the
vertical axis.
Slide 12: Dose-Response Relationships
       I        DOSE-RESPONSE
         (CONCENTRATION-RESPONSE)
       i        RELATIONSHIPS
                                                                i       10     100     1000
                                                                 Dose or Concentration (mg/kg)
                                                                                    &EPA
By plotting curves of two chemicals on
a single graph, it is possible to compare
the relative toxicity of the two
chemicals.
Slide 13: Interpreting Dose-Response Curves
       INTERPRETING DOSE-RESPONSE 1
       AND CONCENTRATION-RESPONSE I
                   CURVES             J
                                                             0.1      1      10     100
                                                                Dose or Concentration (mg/kg)
                                                                                       1000
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 Module 5
 LD50 tests with mammals or birds are used to measure the acute toxicity of a chemical by identifying
 the dose that kills 50 percent of the animals exposed to the chemical.
For chemicals that are present in water or air, a lethal concentration, or LC50, may be reported.
In an LD50 test, the adverse effect
plotted on the vertical axis of the dose-
response (concentration-response) graph
is death.
                                             Slide 14: Determination of the LD,
                                                                      50
                                                   DETERMINATION OF THE
                                                          LD50ORLCS
                                                                         '50
                                                           1      10      100     1000
                                                            Dose or Concentration (rag/kg*  __
                                                            	* EPA-
When toxicologists study endpoints
other than lethality, they often report
results as ED,0 or as ED,*, — or as
EC10 or ECjo values. In these values,
"ED" stands for "effective dose," while
"EC" stands for "effective
concentration."
                                             Slide 15: Quantification of Nonlethal Effects
                                                     QUANTIFICATION OF )
                                                    NONLETHAL EFFECTS]
                                                           0.1     1      10
                                                             Dose or Concentration (nig/kg)
                                                                               &EPA
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                                                                           Principles of Toxicology
Dose-response (concentration-response)
studies are also used to identify levels
of exposure to a chemical that can be
considered relatively safe.
Slide 16:  NOAEL/NOAEC
                 NOAEL
      No-Observed-Adverse-Effect Level
    Highest Experimentally Tested Dose of a
    Chemical That Does Not Produce Signs of
    Toxicity
                                                                NOAEC
                                                  No-Observed-Adverse-Effect Concentration
                                                   Similar to NOAEL, Except That
                                                 I  Chemical Concentration in Water or Air
                                                 i  Is Used in Place of an Administered Dose
                                                                                  &EPA
When it is not possible to determine a
NOAEL (or NOAEC), toxicologists
generally report the lowest dose or
concentration tested as the LOAEL (or
LOAEC).
                                               Slide 17:  LOAEL/LOAEC
                 LOAEL
      Lowest-Observed-Adverse-Effect Level
    Lowest Dose That Causes an Adverse Effect
                                                                LOAEC
                                                  i Lowest-Observed-Adverse-Effect Concentration
                                                  ! Similar to LOAEL, Except That Chemical
                                                  ! Concentration in Water or Air Is Used in
                                                  I Place of an Administered Dose
                                                                                  &ERA
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 Module 5
            — EVALUATION OF TOXICOLOGIC DATA —
Dose-response data can provide
important information, but there are
also some limitations.
Slide 18:  Limitations of Dose-Response Data

   ! LIMITATIONS OF DOSE-]
        RESPONSE DATA     ]
  • Paucity of Data
  • Endpoint Selection
  • Limits of the Dose-Response
   Model
                                                                   -&EPA-
Extrapolation is the process of using assumptions to form conclusions that extend beyond the realm
of experimental data.
One of the most common areas of
extrapolation in mammalian toxicology
is the use of animal data to predict
what effects a chemical will have in
humans.
Slide 19: Interspecies Extrapolation
                                                V^'
                                                                   &EPA
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                              1996 Edition
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                                                                         Principles of Toxicology
To account for uncertainties that are
inherent in efforts to apply
experimental data to a real world
situation, toxicologic values are usually
adjusted.
Slide 20: Uncertainty Factors
   I UNCERTAINTY FACTORS)
  An Uncertainty Factor of 1,3, or 10 is Assigned
  for Each of the Following:
  Use of Animal Data to Predict Human Responses or
  use of surrogate species to protect endangered species
  Individual Variability in the Population
  Use of Short-Term (90-day) Studies to Predict Effects
  of Long-term Exposure
  Use of a LOAEL Rather than a NOAEL to Calculate
  theRfD
  An Inadequate Data Base or a Data Base With Gaps
 "	& EPA—^
If variables are known that will affect
the likelihood of adverse effects,
modifying factors are applied.
Slide 21:  Modifying Factors
      MODIFYING FACTORS]
                                                A Modifying Factor of 1 to 10 May be Used to
                                                Account'for Known Variables, Such as:

                                                 • Known Differences in the Absorption of a
                                                  Chemical from Water Versus Food
                                                 • A Known Lack of a Sensitive Endpoint of
                                                  Toricity
                                                                               -&EPA—'
Water Quality Standards Academy
                               Participant Manual
                                    1996 Edition
                                            5-13

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 Module 5
The Reference Dose is an estimate of
the daily exposure to a noncarcinogenic
chemical that is  likely to be without
significant risk of harmful effects
during an individual's lifetime, taking
into account  all of the uncertainties in
the available data.

A Reference  Concentration or criterion
is calculated  in a similar manner for
aquatic organisms.
Slide 22: Calculation of the Reference Dose
         RfD  =
 NOAEL
UF xMF
   Where:
   RfD     = Reference Dose
   NOAEL = No-Observed-Adverse-Effect Level
   UF      = Uncertainty Factors
   MF     = Modifying Factors
Computerized mathematical models are now being used to evaluate chemical toxicity data.
One of the most widely used data bases containing toxicity information for humans is IRIS.
                           — PHARMACOKINETICS —
Pharmacokinetics is the area of
toxicology that studies the interactions
between a chemical and an organism
over time.
Slide 23: Phannacokinetic Processes
  I    Absorption
                                                    Elimination

                                                           J>
                           Metabolism
                                                                                 -A EPA-
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                                     1996 Edition

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                                                                             Principles of Toxicology
Absorption is how a chemical enters the bloodstream.
A chemical's bioavailability is the proportion of a chemical concentration or dose that crosses the
organism's body barriers and enters the bloodstream.
Distribution is the process of a chemical being carried by the blood to organs and tissue throughout
the body.
Metabolism or biotransformation is the structural changes to a chemical that occur in the body.
A metabolite is the changed form of a chemical.
The two processes of elimination are egestion (chemicals pass through the gastrointestinal tract
without being absorbed in the bloodstream) and excretion (removal after being absorbed in the
bloodstream).
Chemical concentration in the blood is
plotted on the vertical axis of a graph,
and the time after exposure  is plotted
on the horizontal axis.
Slide 24: Chemical Concentration Over Time
       CHEMICAL CONCENTRATION
                 OVERTIME
       =  loo-
       's   90-j
       |   «H

       11 60-j
       |5 50-1

       I5 30-,
       !   20
       5   10 -, •
           oj
                                                                        oncentration
                                                     One-Time  /I2345678!)
                                                     Exposure       Time After Exposure (Hours)
                                                                                    EPA
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                                 Participant Manual
                                      1996 Edition
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 Module 5
 One half-life is the time it takes for the
 peak chemical concentration to be
 reduced by 50 percent.
Slide 25:  Half-Life
                                                                  HALF-LIFE
                                                                    Ti»e Alter Exponn (Hmn)
                                                                                  -&EPA-
A chemical's pharmacokinetic profile
can affect the toxicity of a chemical.
Slide 26:  Cadmium Absorption
                                                         Pharmacokinetic
                                                         Properties of:


                                                         Absorption
                                                         • Occurs Mainly in the Lung or Gills After
                                                           Inhalation (Orally Ingested Cadmium is
                                                           Poorly Absorbed)
                                                         * A Similar Dose or Concentration Would be
                                                           More Toik if Inhaled than if Ingested
                                                         .	& EPA
                                                  Slide 27:  Cadmium Distribution
                                                         Pharmacokinetic
                                                         Properties of:  [^


                                                         Distribution
                                                         • Widely Distributed
                                                         • Over Time, More Reaches the Kidneys, Bones,
                                                           and Liver
                                                                                     &EPA
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                                        1996 Edition
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                                                                       Principles of Toxicology
                                            Slide 28:  Cadmium Metabolism
                                               Pharmacokinetic
                                               Properties of:
48
 Cd
 112.40
                                               Metabolism
                                               * Does Not Undergo Significant Metabolism
                                               " Forms Stable Complex with Metallothionein
                                                Renal Toxicity Occurs when Amount in Body
                                                Exceeds Binding Capacity of Metallothionein
                                            Slide 29:  Cadmium Elimination
                                             Pharmacokinetic
                                             Properties of: ^
                                             Elimination
                                             • Less than 0.01% is Excreted Each Day
                                             • Half-Life in the Human Body as a Whole =
                                               19-38 Years
                                             • Half-Life in Wildlife = Unknown
                                                                             &EPA
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                1996 Edition
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Module 5
            — FACTORS THAT INFLUENCE TOXICITY —
Factors that influence toxicity fall into
three categories.
Slide 30: Factor:; That Influence Toxicity
                                                   FACTORS THAT
                                               INFLUENCE TOXICITY
                                           • Chemical Properties of the Toxicant
                                           ' Conditions of Exposure
                                           • Biological Characteristics of the Exposed
                                            Individual

                                          	£ ERA.
Chemical properties that influence a
compound's toxicity profile fall into
different categories.
Slide 31:  Chemical Properties of the Toxicant
      f CHEMICAL PROPERTIES "j
      I   OF THE TOXICANT   J
                                               Chemical Form

                                                   CdO2
                                                   CdCl,
                                                  CdCO,
                                                 B	
                                                 lonization
                                                                       -&EPA-
Different forms of a chemical may differ in their ability to reach specific types of membranes.
A feature that influences the ability of a toxicant to cross biological membranes is its solubility in
lipid (fatty) substances.
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                                1996 Edition
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                                                                               Principles of Toxicology
lonization is the process by which electrically neutral salts separate into a positively charged ion and
a negatively charged ion when they are present in solution.
 A toxicant's ability to cause harmful effects is closely related to its chemical structure.
Another factor that influences a
chemical's toxicity profile is related to
the conditions under which exposure to
the toxicant occurs.
Slide 32:  Conditions of Exposure
  Conditions
  of
  Exposure^
   • Route of       /;
    Exposure     ( I [
   • Duration &   A:
    Frequency   V^ <
    of Exposure
                                                                                      &EPA-
A chemical's toxicity profile can also be influenced by the duration, route, and frequency of
exposure.
The third major category of factors that
influence a chemical's toxicity profile
are factors related to the biological
characteristics of the host.
Slide 33: Biological Characteristics of the Host

     BIOLOGICAL CHARACTERISTICS )
   [	OF THE HOST	I
                                                       Species Differences
                                                     • Bioconcentration
                                                     • Bioaccamulation
                                                     • Biotransfonnation
                         Individual Differences
                         • Genetic Difference
                         ' Dietary Factors
                         ' Gender and/or
                          Hormonal Status
                         " Age, Disease, and Stress
                                                                                      mEPA
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                                       1996 Edition

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 Module 5
 Bioconcentration is the net accumulation of a substance by an aquatic organism as a result of uptake
 directly from the ambient water through gill membranes or other external body surfaces.

 Bioaccumulation is the net accumulation of a substance by an organism as a result of uptake from all
 environmental sources.

 Metabolic differences (biotransformations) may make it difficult to form meaningful conclusions
 about a toxicant's risk to humans on the basis of animal data.

 Factors that account for intraspecies variability include:

    •   genetic differences;

    •   dietary factors;

    •   gender or hormonal status; and

    •   age, disease, and stress.


                 — STUDIES OF  CHEMICAL TOXICITY —
Evidence of a chemical's potential to produce adverse effects in humans is usually gathered in a
variety of ways.
Four types of studies are most
commonly used to characterize a
chemical's toxicity to humans.
Slide 34: Types of Toxicity Studies
            TYPES OF TOXICITY
                  STUDIES
                                                      Epidemiologic
                                                      or Ecological
                                                         Studies
                                                     In Vitro
                                                     Studies
                                                                       Animal Bioassays
                        Structure-Activity
                                                                                 &EPA
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                                     1996 Edition

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                                                                                 Principles of Toxicology
Epidemiology is the study of disease
and factors that contribute to disease in
humans.
Slide 35:  Epidemiologic Studies
                                                     Advantage:
                                                      Uses Human Data
                             Epidemiologic
                                 Studies
                                                     Limitations:         '
                                                     • Often Based on Accidental or Occupational
                                                      Exposures
                                                     • Don't Establish Causality
                                                     • Existing Studies are Not Well-Controlled
                                                     • Expensive to Conduct
                                                                                         &EPA
For terrestrial and aquatic wildlife, field
studies using ecological investigation
methods can help detect factors that
adversely affect these organisms, and
hence, cause disease.
Slide 36:  Epidemiologic Studies
                              Ecological
                               Studies
Advantage:
• Uses Data From Aquatic
 and Terrestrial Wildlife
 exposed in Situ
Limitations:        '
• Sources of Exposure can be Accidental,
 Deliberate, or Unknown.
• Can be Difficult to Distinguish Natural
 Variability from Effects of Anthropogenic
 Contaminants.
• Monitoring and Other Studies Need To Be
 Focused To Be of Most Value.
Water Quality Standards Academy
                                                 5-21
                                   Participant Manual
                                        1996 Edition

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 Module 5
 In an animal bioassay, known
 quantities of a toxicant are administered
 to laboratory animals and the animals'
 responses are monitored.
Slide 37: Animal Bioassays
                          Animal
                          Bioassays
Advantages:
• Can be Used to Generate
 Lethal, No- and
 Low-Effect Levels, and
 Chronic Toxicity Data
• Relatively Low Cost
• Convenience
• Precise Control Over Experimental Conditions
Limitation:
• Introduces Need for Interspecies Extrapolation
 (except in studies of aquatic organisms)
                                                                                     &EPA
Acute toxicity studies are conducted to examine the effects of exposure to one or a few large doses
of the test chemical.
Subchronic toxicity studies involve daily administration of low to moderate doses for an extended
period of time.
Chronic toxicity studies involve daily administration of a toxicant, usually at low doses, for a longer
period of time.
Bioconcentration studies involve continuous exposure of aquatic organisms to sublethal
concentrations of a toxicant.
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                                      1996 Edition
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                                                                              Principles of Toxicology
In whole-effluent toxicity tests, samples
of industrial or municipal effluents are
collected and diluted with varying
concentrations of uncontaminated water.
Slide 38: Animal Bioassays
              BIOASSAYS
                                                                                     &EPA
In vitro studies usually involve
observing a chemical's effects in a cell
culture or tissue preparation.
Slide 39: In Vitro Studies
                          In Vitro
                          Studies
Advantages:
• Offer Insight into
 Toxicant's Mechanism of
 Toxicity
• Rapid and Inexpensive
• Can be Used to Screen Potential Toxicants for
 Further Study

Limitations:
• Not Conducted in Living Animals
• Provide Supportive Rather than Conclusive
 Evidence of Toxicity
                                                                                    -&EPA
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                                 Participant Manual
                                      1996 Edition
                                               5-23

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 Module 5	

 Structure-activity studies compare the
 relative toxicity of structurally related
 compounds.
Slide 40: Structure-Activity Studies
/*
  Advantage:
  • Can be Used to Screen
   Chemicals and Predict
   tbe Toxicity of Unstudied
   Compounds

  Limitation:
  • Provide Supportive Rather than Conclusive
   Evidence of Toxicity
Structure-Activity
Studies
                                                                                     -&EPA-
In the weight-of-evidence approach,
elements of the data base are weighted
differently based on the extent to which
they contribute to a plausible and
consistent picture of toxicity.
Slide 41: Weight-of-Evidence Approach
      THE WEIGHT-OF-EVIDENCE
                           APPROACH
                                                                                  -&EPA-
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                                  Participant Manual
                                       1996 Edition
                                               5-24

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                                                                                  Review Questions
                                REVIEW QUESTIONS


 1. The toxicologic endpoint that refers to the ability of a toxicant to cause cancer is:
    a,     immunotoxicity
    b.     neurotoxicity
    c.     carcinogenicity
    d.     reproductive toxicity
2. Adverse effects that disappear when the toxicant is removed from the body are called:

   a.     reversible effects
   b.     irreversible effects
   c,     threshold effects
   d.     nonthreshold effects
3. Dose-response tests can provide information about all of the following properties of a chemical
   EXCEPT:

   a.     its relative potency
   b.     its lethal and nonlethal doses
   c.     its NOAEL/NOAEC and LOAEL/LOAEC
   d.     its concentrations in the environment
4. True or False.  To account for the uncertainties involved in applying experimental data to real
   world situations, toxicologists usually divide toxicologic values (such as the NOAEL or LOAEL)
   by one or more uncertainty factors.
5. True or False.  A toxicant's bioavailability is a measure of its rate of elimination from the body.
Water Quality Standards Academy                                                      Participant Manual
                                                                                      1996 Edition
                                              5-43

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 Module 5
 6.  Chemical properties that can influence the toxicity profile of a chemical include all of the
    following EXCEPT:

    a.     lipid solubility
    b.     tendency to ionize in solution
    c.     chemical structure and chemical form
    d.     route, duration, and frequency of exposure
 7.  True or False. The main advantage of epidemiologic studies is that well-controlled studies are
    usually very inexpensive to conduct.
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     1996 Edition
                                               5-44

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                                                                                  Review Questions
                                REVIEW QUESTIONS

 1.  True or False.  Risk is defined as the likelihood of injury, disease, or death under specified
    conditions, while risk assessment consists of efforts to quantify this risk.

 2.  Which of the following is NOT one of the four components of the NAS risk assessment
    paradigm?

    a. hazard identification
    b. dose-response assessment
    c. exposure assessment
    d. risk characterization
    e. risk communication

 3.  The goal of the hazard identification step in a risk assessment is to determine:

    a. whether a hazard exists
    b. how severe the hazard is
    c. how prevalent the hazard is
    d. how likely it is that the hazard will occur

 4.  True or False.  To ensure consistency across dose-response assessments, risk  assessors use  one
    method to analyze all dose-response data.

 5.  The two main types of studies used in exposure assessment are:

    a. epidemiologic and animal studies
    b. monitoring and modeling studies
    c. in vitro and structure-activity studies
    d. acute and chronic toxicity studies

 6.  True or False.  In a risk characterization  for a non-carcinogen, we are most concerned if the
    reference dose is higher than the estimated exposure dose (if  RfD > EED).
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     1996 Edition
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 Module 6
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     1996 Edition
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                        TRAINING MODULE 7:
               INTRODUCTION TO CRITERIA DEVELOPMENT
MODULE SUMMARY:

This module provides an introduction to the different types of water quality criteria and sets the stage
for the next four modules.
OVERALL OBJECTIVES:

To attain an understanding of the different categories of water quality criteria and how they work
together to achieve the objective of the Clean Water Act: "to restore and maintain the chemical,
physical, and biological integrity of the Nation's waters."
MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:
   •  Explain the relationship between water quality criteria and water quality standards
   *  Explain the difference between numeric and narrative criteria
   •  Identify the different categories of water quality criteria
   •  Explain how the different criteria work together to achieve the goals of the Clean Water Act
LOGISTICS:

Teaching Method: Lecture (with vugraphs); Video.

Approximate Presentation Time:  35 minutes (Lecture—20 minutes; Video—15 minutes).

Basic Course Reference Manual Documents:

1  Clean Water Act: sections 104(n)(l); 301; 303; 304(a); 402; 404.

4  Water Quality  Standards Handbook, Second Edition, August 1994.
      Appendix A: Water Quality Standards Regulation: 40CFR131.il.
      Appendix I:  List of EPA Water Quality Standards Criteria Documents.
      Appendix P:  List of 126 Section 307(a) Priority Toxic Pollutants.
Water Quality Standards Academy
                                         7-1
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    1996 Edition

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 Module 7

 Other Documents:

    Quality Criteria for Water (the Gold Book), Office of Water Regulations and Standards. 1987.
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                                                                                      1996 Edition
                                              7-2

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                                                                                  Review Questons
                                REVIEW QUESTIONS

 1.   Which of the following is not a typical element of a health assessment?

     a. exposure
     b. pharmacokinetics
     c. biological endpoints
     d. toxic effects
     e. criterion formulation

 2.   True or False, Section 304(a)(l) criteria are regulatory limits States are required to achieve.

 3.   True or False. The toxic effects section of health assessments includes data reviews on
     absorption, distribution, metabolism, and excretion.

 4.   True or False. The RfD is a threshold value below which noncarcinogenic toxic effects are
     unlikely to occur.

 5.   The Carcinogenic Potency Slope factor is	.
     a. RL
     b. RfD
     c. BCF
     d-Qi*
     e. BAF

6.   The uptake of a chemical through the food chain and water is the	.

     a. Food Chain Multiplier
     b. Bioaccumulation Factor
     c. Bioconcentration Factor
     d. RfD
     e.q,*

7.   True or False.  Even if an EPA criterion is not available, a reference ambient concentration
     (RAC) can be calculated.

8.   An electronic online data base of the U.S. EPA which is the accepted source for RfD values is
    a. BAF
    b. BCF
    c. RfD
    d. IRIS
    e.q,*
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     1996 Edition
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Module 8

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                                                                                               1996 Edition
                                                   8-62

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                                                                                 Review Questions
                                REVIEW QUESTIONS


   Which of the following is not necessary when deriving numerical water quality criteria for protection
   of aquatic life?

   a.  Aquatic toxicity tests that conform to ASTM standards
   b.  Hard copy documentation of all tests used
   c.  Carcinogenic rodent bioassays of material in question
   d.  Specific definition of chemical/material of concern
2.  Which of the following is true in regard to the calculation of the Final Chronic Value?

    a.  A Final Chronic Value can always be calculated
    b.  The Final Acute Value may be a component of the Final Chronic Value
    c.  The Final Chronic Value is equal to half the Final Acute Value
    d.  The Criterion Continuous Concentration always equates  to the Final Chronic Value
3. True or False.  If species sensitivity at a site is similar and physical or chemical properties affect
   bioavailability, the recalculation procedure is used.
4. Which of the following would not be a reason for establishing a site-specific criterion?

   a.  Water quality characteristics of a site are known to vary greatly from season to season.
   b.  The pollutant in question is a metal. The site in question has high levels of total organic carbon,
       which is known to bind various species of the metal pollutant being regulated.
   c.  A stream contains an aquatic invertebrate that is unusually resistant to various pollutants.
   d.  Physical and chemical characteristics at the site have no effect on the toxicity and bioavailability
       and the range of resident species  sensitivities is comparable to those species  in the national
       criterion document.
   e.  None of these (a-d) is a reason.
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     1996 Edition
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                       TRAINING  MODULE 10;
                              SEDIMENT CRITERIA
MODULE SUMMARY:

This module discusses the importance of sediment criteria, approaches to establishing sediment
criteria, and sections of the Clean Water Act where sediment criteria apply (or can apply).
OVERALL OBJECTIVES:

To provide an understanding of the methodology used to develop sediment criteria, and how
sediment criteria can be used to protect the aquatic environment.
MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:
      •  Define sediment
      •  Identify reasons why contaminated bottom sediments pose a severe environmental problem
      •  Identify six activities concerning contaminated sediments that should be addressed under a
         successful management program
      •  Explain the role of bioavailability in developing sediment quality criteria
      •  Define the equilibrium partitioning approach that EPA is using to develop sedimeni
         criteria
      *  List the classes of contaminated sediments that EPA's sediment criteria will initially
         delineate
      •  Identify potential-applications of sediment criteria
LOGISTICS:

Teaching Method:  Lecture (with vugraphs).

Approximate Presentation Time:   W* hour (Lecture—50 minutes, Class Exercise—20 minutes;
Review Questions—15 minutes).
                                                                        Participam Manual
                                                                           Update-1 1997

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Module 10
Basic Course Reference Manual Documents:

1  Clean Water Act:  sections 303; 304(a); 402; 404.

3  Water Quality Standards Handbook. Second Edition, September 1993, Chapter 3.

16 Briefing Report to Science Advisory Board on the Equilibrium Partitioning Approach to
   Predicting Metal Bioavailability in Sediment and the Derivation of Sediment Quality Criteria for
   Metals.  December 1994.

17 Memo to Carol Browner from SAB in regard to SAB review of Agency's Approach for the
   development of sediment criteria for 5 metals.  September 29. 1995.

18 Memo from Carol Browner to SAB in response to SAB Review of Agency's Approach for
   development of sediment criteria for 5 metals.  February' 2, 1996.


Other Documents:

   Briefing Report to the EPA Science Advisory Board on the Equilibrium Partitioning Approach to
   Generating Sediment Quality Criteria.  U.S. Environmental Protection Agency.  April 1989.  EPA
   440/5-89-002.

   Managing Contaminated Sediments:  EPA Decision-Making  Processes.  U.S. Environmental
   Protection Agency, Sediment Oversight Technical Committee.  December 1990. EPA 506/6-
   90/002.

   Sediment Classification  Methods Compendium.  U.S. Environmental Protection Agency,
   Watershed Protection Division.  September 1992, EPA 822-R-92-006.

   Contaminated Sediments:  Relevant Statutes and EPA Program Activities. U.S. Environmental
   Protection Agency, Sediment Oversight Technical Committee.  December 1990. EPA 506/6-
   90/003.

   Sediment Quality Criteria for the Protection of Benthic Organisms: ACENAPHTHENE,
   September 1993.  EPA-822-R-93-013.

   Sediment Quality Criteria for the Protection of Benthic Organisms: DIELDRIN.
   September 1993.  EPA-822-R-93-015.

   Sediment Quality Criteria for the Protection of Benthic Organisms: ENDRIN.
   September 1993.  EPA-822-R-93-016.

   Sediment Quality Criteria for the Protection of Benthic Organisms: FLUORANTHENE.
   September 1993.  EPA-822-R-93-012.


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                                                                             Sediment Criteria
Sediment Quality Criteria for the Protection of Benthic Organisms:  PHENANTHRENE.
September  1993.  EPA-822-R-93-014.

Report of the Sediment Criteria Subcommittee of the Ecological Processes and Effects Committee
- Evaluation of the Equilibrium Partitioning Approach for Assessing Sediment Quality.

Analytical Method for Determination of Acid Volatile Sulfide in Sediment (final draft).
U.S. Environmental Protection Agency.

Sediment Quality Criteria Methodology Validation:  Uncertainty Analysis of Sediment
Normalization Theory for Non-polar Organic Contaminants.  U.S. Environmental  Protection
Asencv.
  ~   .-

Guidelines  for Deriving Site-Specific Sediment Quality Criteria for the Protection of Benthic
Organisms. September, 1993. EPA-822-R-93-017.

Technical Basis for Deriving Sediment Quality Criteria for Non-ionic Organic Contaminants for
the Protection  of Benthic Organisms by Using Equilibrium Partitioning.  September 1993.  EPA-
822-R-94-01I.
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Module 10
                                                   10-4
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                      MODULE 10 - OUTLINE
                    SEDIMENT CRITERIA
                         INTRODUCTION
Contaminated sediments can pose
serious threats to human health and the
environment.
Vugraph 1: Discussion Topics
   SEDIMENT CRITERIA
                                    , DISCUSSION TOPICS
                                   ^ V' *•. • Applications of Sediment Criteria
                                   V| • Sediment Contamination and Its
                                       Effects on the Aquatic
                                       Environment    ^_^
                                   ;   • Research and Methodologies

Sediment consists of organic and nonorganic material that has settled at the bottom of a waterbody.
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                                                           Update-1 1997
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Module 10
Historically, point source discharges of
heavy metals, PCBs, pesticides,
dioxins, and other contaminants were
the main source of contaminants in
pollutants.
Vugraph 2: Point Source Categories
   POINT SOURCES or
         POLLUTION
 Include Discharges from:
  g^U Industries
  If Wastewater Treatment Plants
 OJA, Combined Sewers
                                                           &EPA
A more recent concern i& the impact of
pollutants derived from nonpoint
sources such as runoff from agricultural
activities, construction sites, and urban
areas.
Vugraph 3: Nonpoint Source Categories

   NONPOINT SOURCES
      OF POLLUTION
   Include Runoff from:
        Agricultural Activities
        Construction Sites
    [Ji| Urban Areas

                          & EPA
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                                                           Update-1 1997
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                                                            Sediment Criteria
The contamination of sediments is
influenced bv a number of variables.
Vugraph 4: Variables
                                            VARIABLES
                                   INFLUENCING SEDIMENT
                                        CONTAMINATION
                                   •Contaminant Source
                                   •Contaminant Type
                                   •Sedimentary and Hydrologic Environment
                                   •Grain Size Distribution and Composition
                                   •Aquatic Life
                                   •Historical Influences
                                   	&EPA-
Sediment contamination is not necessarily connected to poor water quality.
         — APPLICATIONS OF SEDIMENT CRITERIA —
The Clean Water Act provides EPA with the authority to develop sediment criteria.
Sediment criteria apply only to the
sediment itself and the interstitial
water.
Vugraph 5: Application of Sediment Criteria
     APPLICATION OF
  SEDIMENT CRITERIA
                                     I Water Column
                                   Sediment criteria are developed
                                    to protect organisms in the
                                   sediment, not tbe water column.
                                                       [filial water, often referred
                                                      fas pore water, is the water
                                                     between sediment particles
                                                             &EPA
                                 10-7
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                                                             Update-1 1997

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Module 10
             MANAGEMENT OF SEDIMENT ISSUES
Management programs need to consider
the entire "sediment package".
Vugraph 6: Management Program
                                     MANAGEMENT
                                        PROGRAM
                                   • Management Strategy
                                   • Users Guide
                                   • Sediment Criteria
                                   • Target Sites
                                   • Sediment Toxicity Testing
                                   • Guidance Document
                                   	&EPA
A comprehensive management program
includes 6 key activities.
Vugraph 7: Se:diment Management Activities
                                     MANAGEMENT
                                       ACTIVITIES
                                1. Finding Contaminated Sediments
                                2. Assessment of Contaminated Sediments
                                3. Prevention and Source Control
                                4. Remediation
                                5. Treatment of Removed Sediments
                                6. Disposal of Removed Sediments

                                	&EPA-
                    — CLASS EXERCISE —
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                                                               Sediment Criteria
 — BIOLOGICAL EFFECTS OF CONTAMINATED SEDIMENTS —
Research has determined that sediments in aquatic environments have the ability to accumulate or
absorb higher concentrations of pollutants than the overlying waters.
Aquatic organisms are exposed to
concentrations through a variety of
pathways.
Vugraph 8: Aquatic Environment
                                     Routes of
                                     Exposure
The primary technical difficulty that
must be overcome in establishing
sediment quality criteria is to determine
the extent of bioavailability of
sediment-associated chemicals.
Vugraph 9:  Bioavailability
      TOXICITY AND
    BIOAVAILABILITY
                                      Similar Concentrations of a
                                      Chemical Can Produce
                                      Widely Different Biological
                                      Effects in Different Sediments
                                                               •SB
                              EPA
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 Module 10
 The concentration-response curve for the biological effect of concern can be correlated not to the
 total sediment-chemical concentration, but to the interstitial water concentration.
                    — EQUILIBRIUM PARTITIONING —
Sediment criteria development activities have centered on evaluating and developing the equilibrium
partitioning approach.
Equilibrium partitioning involves the
balancing of a pollutant concentration
between the sediment and the
associated interstitial water.
Vugraph 10: HqP
         EQUILIBRIUM
        PARTITIONING
                                                  Water
                                                Column
                       Equilibrium Partitioning addresses the
                       relationship between pore water and
                       sediment (not the water column).

                       The equilibrium a established between
                       the toxics attached to the sediment 2nd
                       dissolved in the interstitial water.
                                                                              &EPA
Chemical components of water should be measured because these factors may affect the toxicity of
sediment contaminants.
The equilibrium partitioning method was selected because it has been shown to accurately predict
toxicity and environmental effects.
EPA has developed a methodology for deriving sediment quality criteria for non-ionic, or non-polar,
organic contaminants. Methodology and criteria for metals are currently under development.
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                                                                  Sediment Criteria
Numeric values for sediment quality
criteria (SQC) are derived by a back-
calculation from the chemical-specific
chronic water quality criterion (the
effects concentration of a chemical on
benthic organisms).
Vugraph 1 1 and 1 2:  Parameters Used to Calculate SQCs

   SQC CALCULATION
       PARAMETERS
                                            Specific chemical's octanol/water
                                            partitioning coefficient; a measure of the
                                            chemical's differential solubility in
                                            organic and aqueous solutions.

                                            Organic Carbon-normalized partitioning
                                            coefficient; a measure of a chemical's
                                            differential solubility between the
                                            sediment and the interstitial water.
                                                                  & EPA
                                         SQC CALCULATION
                                        PARAMETERS (cont'd.)
                                           :  Fraction Organic Carbon
                                        FCV: Final Chronic Value
                                                                  &EPA
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 Module 10
 Chronic water quality criteria are tho
 effects concentration from which a
 solid phase (organic carbon normalized)
 effects concentration can be calculated.
Vugraph 13:  Basic Calculation of SQCs
   SQC CALCULATION
                                             SQCOC = FCV x Koc

                                                       or

                                              SQC = (SQCJ(F J
                                                                 &EPA
The applicability of this methodology
depends on certain assumptions.
Vugraph 14:  Non-polar Organic Constituents

   NONPOLAR ORGANIC
I       CONSTITUENTS
        ASSUMPTIONS
                                       ' Pollutant Concentration in Sediment
                                        Participates Is at Equilibrium with
                                        Sediment Interstitial Water

                                       1 Absorption Controlled by Chemical
                                        and Physical Properties
                                                                 &EPA
Metals sediment quality criteria will be used with aquatic life criteria to protect aquatic organisms
and their environment.
EPA is focusing on identifying and understanding the role of acid volatile sulfides (AVS) and other
binding factors, such as organic carbon content, in controlling the bioavailability of metal
contaminants.
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                                                                 Sediment Criteria
In January 1994, EPA proposed the
following: dieldrin, endrin,
acenaphthene, flouranthene and
phenanthrene.
Vugraph 15: Schedule for Sediment Quality
Criteria (SQC) Non Ionic Organics
           PROPOSED
         JANUARY 1994
                                               > Dieldrin
                                               • Endrin
                                               >Acenaphthene
                                               >Flouranthene
                                               > Phenanthrene
                                                                  &EPA
In the Spring of 1997. EPA will
finalize criteria for dieldrin and endrin
only.
Vugraph 16: Schedule for Sediment Quality
Criteria (SQC) Non Ionic Organics (cont.)
                                                  FINALIZE
                                                 SPRING 1997
                                                   > Dieldrin
                                                   >£ndrin
                                                                 &EPA
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 Module 10
 Proposed SQC for PAH mixtures.
Vugraph  17:  Schedule for Sediment Quality
Criteria (SQC) Non Ionic Organics (cont.)
                                                     PROPOSE
                                                        1998
                                                'PAH Mixtures Criterion
                                                                    &EPA
EPA has developed a methodology for
developing sediment criteria for several
metal contaminants.
Vugraph 18:  SQC for Metals
        METHODOLOGY FOR

     DEVELOPING SEDIMENT   j
       CRITERIA FOR METAL    !

 	CONTAMINANTS
                                    i
  • Lead
  • Nickel
  • Copper
  • Cadmium
  • Zinc (divalent and cationic metals)
  • Focus on identifying/understanding role of Acid
    Volatile Sulfides (AVS)	 A __.
The application of sediment criteria may vary significantly from the application of water quality
criteria.
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                                                                Scdjincm Criteria
Initially, sediment criteria will be used
to delineate three classes of specific
sediments.
Vugraph 19:  Sediment Classes
   SEDIMENT CLASSES
                                      Sediments with Contaminant
                                      Concentrations:
                                        • Above Criteria Levels

                                        • Below Criteria Levels

                                        • At or Near Criteria Levels
                                                                 «EPA
Because the sediment quality criteria methodology relies on an empirical model, there is a level of
uncertainty.
All sediment evaluation procedures require some level of interpretation.
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Module 10
       — BIOCONCENTRATION/BIOACCUMULATION
Another impact from contaminated
sediment is bioconcentralion and
bioaccumulation.
Vugraph 20: Eiioconcentration/Bioaccumulation
 BIOCONCENTRATION/
  BIOACCUMULATION
                                Bioconcentration: accumulation
                                 of water-bourne contaminants
                                 through nondietary routes

                                Bioaccumulation: accumulation
                                 of toxics from exposure to
                                 contaminated sediment or
                                 through the food chain
                                	* EPA
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                                                                                 Review Questions
                                REVIEW  QUESTIONS

1. Why do contaminated bottom sediments potentially pose a severe environmental problem?

   a.  Because pollutants can accumulate at higher concentrations in sediments than in the water
       column.
   b.  Because pollutants remain available for re introduction into the water long after initial
       deposition.
   c.  Because pollutants multiply in bottom sediments.
   d.  Both a &  b.
   e.  All of these (a-c).


2. True or False. Sediment criteria are specifically contained in the Clean Water Act.


3. True or False. Nonpoint sources  contribute to sediment contamination.


4. Determining the	of a chemical is critical  in establishing sediment quality criteria.

   a.  Bioaccumulation
   b.  Bioavailability
   c.  Bioconcentration
5.  Sediment criteria development activities have centered on evaluating and developing the
   approach.
   a.  Non-polar complexation
   b.  Equilibrium partitioning
   c.  Tissue Residue
   d.  Biological effects
6.  EPA is in the process of developing a strategy for addressing bioaccumulative contamination in
   sediments and the water column by developing:

   a.  Prey quality criteria
   b.  Human life criteria
   c.  Toxic  quality criteria
   d.  Worm quality criteria
                                                                                Participant Manuu!
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Module 10
7.  The first sediment criteria developed will enable the user:

    a.  To delineate three specific levels of sediment contamination
    b.  To distinguish point source discharges
    c.  To distinguish nonpoint source pollutants
    d.  To fine polluters
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                       TRAINING MODULE 11:
                            BIOLOGICAL CRITERIA
 MODULE SUMMARY:
This module provides an overview of the biological criteria program.
OVERALL OBJECTIVES:

To provide an understanding of the meaning, value, and applications of biological criteria within
water quality management.


MEASURABLE OBJECTIVES:

After completing this module, the participants should be able to:
   •  Describe the relationship between biological criteria and other criteria programs
   •  Define biological criteria
   •  List the steps required to implement a biological criteria program
   •  Identify the components of research required to develop biological criteria


LOGISTICS:

Teaching Method:  Lecture (with slides);  Class exercise; Video.

Approximate Presentation Time: 1% hours (Lecture—60 minutes; Class Exercise—20 minutes;
Video—20 minutes; Review Time—15 minutes).

Basic Course Reference Manual Documents:

1  Clean Water Act:  sections 303; 304(a)(8).

4  Water Quality  Standards Handbook. Second Edition, August 1994.
      Chapter 3:    Water Quality Criteria
      Appendix C:  Biological Criteria:  National Program Guidance for Surface Waters, April
                  1990.~
      Appendix K:  Procedures for the Initiation of Narrative Biological Criteria, October 1992.
      Appendix R:  Policy on the Use of Biological Assessments and Criteria in the Water Quality
                  Program, May 1991.
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   Update-1 1997

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 Module 11
 Other Documents:

    Transmittal of Final Policy on Biological Assessments and Criteria (Memorandum).  U.S.
    Environmental Protection Agency, Office of Water.  From Tudor T. Davies, Director, Office of
    Science and Technology to Waste Management Division Directors, Regions I-X.  June 19,  1991.

    Biological Criteria:  State Development and Implementation Efforts.  U.S. Environmental
    Protection Agency. Office of Water.  July 1991.  EPA-440/.V91-003.

    Biological Criteria:  Research and Regulation—Proceedings of a Symposium.  U.S.
    Environmental Protection Agency, Office of Water.  July  1991.  EPA-440/5-91-005.

    Biological Criteria:  Guide to Technical Literature.  U.S. Environmental Protection Agency,
    Office of Water.  July 1991.  EPA/5-91-004.

    Rapid Bioassessment Protocols for Use in Streams and Rivers:  Benthic Macroinvertebrates and
    Fish.  U.S. Environmental Protection Agency, Office of Water.  May 1989.  EPA/444/4-89-001.

    Regionalization as a Tool for Managing Environmental Resources.  U.S. Environmental
    Protection Agency, Environmental Research Laboratory, Corvallis, OR. July 1989. EPA/600/3-
    89/060.
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                         MODULE 11 - OUTLINE
                     BIOLOGICAL CRITERIA
                          — INTRODUCTION —
Biological criteria are threshold levels
or regulator)' guidelines based on the
premise that the condition of biota
inhabiting waterbodies provides a
useful baseline measure of water
resource quality.
Slide !: Introduction
           MODULE 11
                           — BACKGROUND —
Comprehensive information about the
biological integrity of aquatic
environments is needed.
Slide 2: CWA Objectives
                                             CWA
                                         SECTION 101
                                        To Restore &
                                        Maintain the
                                        Chemical, Physical, &
                                        Biological Integrity of
                                        the Nation's Waters
                                            &EPA
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 Module 11
 Clean Water Act (CWA) section 3()3(c)(2)(A) — Requires adoption of water quality standards that
 serve the purpose of section 101.
 CWA section 303(c)(2)(E5) — Where numeric criteria are not available, States should adopt criteria
 based on biological assessment and monitoring methods.
Ecological integrity is ideally attained
when chemical, physical, and biological
integrity occur simultaneously.
Slide 3: Ecological Integrity
    ELEMENTS
         OF
  ECOLOGICAL
    INTEGRITY
                                                                                &EPA
Limits to chemical-specific criteria and
whole-effluent toxicity criteria.
Slide 4: 3 Elements with Current Criteria
                                                       EXISTING WVTER  I
                                                      QUALITY CRITERIA]
   Chemieal-SpeciSe Criteria
   Whole-Effluent Toxitity
   Convention] CrHeri*
                                                                           Cbemkal Integrity
                                                                           Pbyskil Integrity

                                                                           BioiogicMl Integrity
                                                                               &EPA
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                                                                                  Biolosical Criteria
 Analyses reflect the difficulty of
 protecting waterbodies when criteria
 cannot be developed for all possible
 chemicals.
Slide 5: Ohio Piechart
         OHIO COMPARISON OF
     BlOSURVEY WITH CHEMICAL
               EVALUATION
                                                 Chemical Evaluation
                                                 Indicates No
                                                 Impairment

                                                 Biosurvey Shows
                                                 '.Impairment
                                                 1 Biosurvey Shows No
                                                 Impairment

                                                 'Chemical Evaluation
                                                 Indicates
                                                 Impairment
                                 Chemical
                                 Prediction &
                                 Biosurvey Agree
                                                                                    »EPA
Biological assessment and criteria
provide an essential third element for
water quality management.
Slide 6: 3 Elements of Biological Criteria
           INCORPORATION OF
         BIOLOGICAL CRITERIA
^
                                                   Cbcmkal-SpeciCc Criteria

                                                   Whole-Effluent Toricit}

                                                   Conventional Criteria
                                                   Biological Criteru
                               Chemical Integrity

                               Physical Integrity


                               Biological Integrity


                               Biological Integrity


                               Chemical Integrity

                               Physical Integrity
                                                                                   &EPA
                                            -/
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 Module 11
 Biological criteria supplement, but do
 not replace, chemical and toxicological
 methods.
Slide 7: Independent Application
                                              THE PRINCIPLE OF
                                                 INDEPENDENT
                                                 APPLICATION
                                              It Is the Policy of EPA That
                                         Nonattainment of Water Quality Occurs
                                            When Any of the Three Forms of
                                         Criteria - Chemical, Whole-Effluent, or
                                                Biological - Are Not Met

                                         	& EPA
                  — STATUS OF STATE EFFORTS —
Several States already have biological
criteria programs in place.
Slide 8: Map of States
                                                                   &EPA
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                                                                    Biological Criteria
                CONCEPT OF BIOLOGICAL CRITERIA —
The structure and function of an
aquatic biological community provide
critical information about the quality of
surface waters.
Slide 9: Definition
    BIOLOGICAL CRITERIA]
                                          Definition:
                                          Narrative Expressions or
                                          Numerical Values That Describe
                                          the Biological Integrity
                                          of Aquatic Communities
                                          Inhabiting Water of a
                                          Given Designated Use
                                                                      &EPA
Biological integrity is measured by
both the structure and function of the
community.
Slide 10:  Functional Definition
           FUNCTIONAL
          DEFINITION OF
     BIOLOGICAL CRITERIA
                                          The Condition of the Aquatic
                                          Community Inhabiting the Essentially
                                          Unimpaired Waterbodies of a Specified
                                          Habitat as Measured by Community
                                          Structure & Function
                                                                      &EPA
If the measures of the existing aquatic community fail to meet the criteria, the designated use is
considered impaired.
Water Quality Standards Academy
                           Participant Manual
                              Update-1 1997

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 Module 11
 Narrative criteria establish a positive
 statement about what should occur
 within a waterbody.
Slide 11:  Narrative Biological Criteria
     NARRATIVE CRITERIA ]

  Definition:

  General Statements of Attainable or
  Attained Conditions of Biological
  Integrity and Water Quality for a
  Given Use Designation

  	&EPA
Narrative criteria can take a number of
forms but must possess essential
characteristics.
Slide 12: Check List
                                                  CHECKLIST FOR
                                            v NARRATIVE CRITERIA J

                                         L»f Protect the Particular Aquatic Life Use
                                         QTInclude Measurable Aquatic Community
                                           Characteristics
                                         ^ Promote Water Quality To Protect the
                                           Most Natural Community Possible
                                         ^Address Conflicting Multiple Uses
                                         3Trotect the Most Sensitive Use and
                                           Support Antidegradation
                                         *	Si EPA—
Several States currently use narrative criteria.
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                                                                     Biological Criteria
Narrative criteria can be used to refine
the aquatic life use classification for a
State.
Slide 13: Aquatic Life Uses
                                                REFINING AQUATIC
                                                      LIFE USE
                                                 CLASSIFICATIONS
                                           Data Collected in the Biological Criteria
                                           Program May Reveal Differences in
                                           Aquatic Communities that Warrant
                                           Separation into Different Use Classes

                                           	&EPA
To derive a numeric criterion, an
aquatic community's structure and
function are measured using
quantitative tools like metrics.
Slide 14:  Numeric Biological Criteria
      NUMERIC CRITERIA  )
   v                     .. _ _ ...__     J

  Definition:
  Specific Quantitative Indicators
  (e.g., Metrics) of Desired Biological
  Integrity

 	&EPA
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                              Update-1 1997
                                       11-9

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 Module 11
Numeric criteria may describe

community differences.
Slide 15: Communitv Differences
                                          RELATIVE MEASURES
                                             OF COMMUNITY
                                               DIFFERENCES
                                         Similarity Indices

                                         Coefficients of Community Loss

                                         Comparisons of Lists of
                                         Dominant Taxa
                                                                &EPA
Numeric criteria may describe

community structure.
Slide 16: Community Structure

/
                                            DIRECT MEASURES
                                             OF COMMUNITY
                                                STRUCTURE
                                         Species Richness

                                         Indicator Taxa

                                         Distribution of Trophic Feeding

                                         Groups
Development of numeric biological criteria requires careful assessments of community structure and

function.
Water Quality Standards Academy
                                   11-10
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                           Update-1 1997

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                                                                        Biological Criteria
The process for developing and
implementing biological criteria
requires a multistep approach.
Slide 17: Biological Criteria Process
                                                                PROCESS
                                                                FOR THE
                                                          DEVELOPMENT AND
                                                           IMPLEMENTATION
                                                                    OF
                                                              BIOLOGICAL
                                                                CRITERIA
                                                                        -«EPA-
                                          Slide 18:  Steps
                                              STEPS FOR DEVELOPING AND
                                              IMPLEMENTING BIOLOGICAL
                                                         CRITERIA
                                               1. Develop Standardized, Consistent Protocols
                                               2. Identify and Conduct Biosurveys at Unimpaired
                                                Reference Sites
                                               3. Establish Biological Criteria
                                               4. Conduct Biosurveys at Test Sites
                                               5. Analyze Results
                                               6. Monitor and Modify, as Necessary
                                                                         &EPA
Standardized, consistent protocols.
Slide 19: Step 1
                                                       BIOLOGICAL
                                                   CRITERIA PROCESS]

                                               1. Develop Standardized, Consistent
                                                Protocols (Test Protocol Sensitivity)
                                                                         &EPA
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                                Update-1 1997
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 Module 11
Establish reference conditions.
Slide 20:  Step 2
                                      c
                                                 BIOLOGICAL
                                             CRITERIA PROCESS
                                        2. Identify & Conduct Biosurveys at
                                           Unimpaired Reference Sites
                                                                   &EPA
Establish biological criteria.
Slide 21:  Step 3
                                                 BIOLOGICAL
                                             CRITERIA PROCESS]
                                        3. Establish Biological Criteria
                                                                  &EPA
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                                                                    Biological Criteria
Conduct site survevs.
Slide 22: Step 4
                                                   BIOLOGICAL     )
                                               CRITERIA PROCESS]
                                          4, Conduct Biosurveys at Test Sites
Perform impact testing and analysis.
Slide 23:  Step 5
                                                   BIOLOGICAL
                                               CRITERIA PROCESS]
                                                   5. Analyze Results
                                                 (Determine Condition)
                                            Impaired Condition
                       Not Impaired
                                             Diagnose Cause of    No Action Required
                                               Impairment      ; (Continue Monitoring)
                                            Implement Corrections (Continue Monitoring)
                                                                      &EPA
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Module 11
Continue biocriteria monitorine.
Slide 24: Step 6
                                                     BIOLOGICAL

                                                 CRITERIA PROCESS]

                                            6. Continue Biocriteria Monitoring
                                             System and Review Steps 1-5 for
                                             Possible Modifications as a Result of
                                             Data Developed:

                                             - Calibration of Metrics

                                             - Revised References, Protocol,
                                               Criteria Adjustments
                                           	&EPA
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                                                                   Biological Criteria
              COMPONENTS OF BIOLOGICAL CRITERIA:
                     1.  REFERENCE CONDITION —
 Reference conditions are needed for
 environmental assessments because
 standard experimental controls are
 rarelv available.
Slide 25: Component 1
f~
                                                COMPONENTS OF
                                             BIOLOGICAL CRITERIA
                                             Reference Condition
                                                                     »EPA
Establishing a reference condition
involves current investigations of
selected reference sites in the context
of historical conditions for these areas
and the best judgement of experienced,
objective biologists and natural
resource managers.
Slide 26: Reference Approaches
     APPROACHES TO THE
       DEVELOPMENT OF
   REFERENCE CONDITIONS
        Site-Specific Reference Sites
         or
        Regional Reference Sites
        Historical Data
        Model-Based Approach
        Expert Opinion
                                                                      &EPA
To develop the most comprehensive reference condition, ideally as much attention as is realistically
possible should be paid to the reference site data. However, this data must be evaluated in the
context of historical information and the collective judgment of regional experts. In some cases,
such as significantly  impaired areas, appropriate reference conditions must be derived primarily from
that historical data, models based on site-specific knowledge, or the judgment of these experts, in
order to prevent lowering the criteria by undue reliance on inappropriate reference sites.
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 Module 11
 It is important to select sites comparable in terms of habitat structure and other physical
 environmental parameters;.

 Adequate habitat evaluations need to be conducted to ensure that waterbodies with the same physical properties are
 compared.
 A habitat assessment matrix is an example of a
 habitat evaluation method.
Slide 27:  QHEI Graph
                                                   STREAM HABITAT vs.
                                                 BIOLOGICAL INTEGRITY]
                                                mi
       60 —

       50-

       40-

       30-

       20-

       10-
                                                              o O c 0 c x OO cocc oc    C2
                                                                                 s
                                                         30  40  5«  60  70 80 90 100
                                                                255	&EPA>
A site-specific reference condition is usually obtained from a nearby site on the same waterbody that
is not impacted by the point discharge of interest.
A site-specific reference condition is
difficult to establish when the entire
waterbody is impacted or physically
comparable sites are not available.
Slide 28:  Site-Specific References
           SITE-SPECIFIC
    REFERENCE CONDITIONS]
  Difficult To Establish When There Is:
  • Diffuse Nonpoint Source Pollution
  • Multiple Locations of Point Sources
  • Modification to Channel, Shoreline, or
    Bottom Substrate
  • Differences in Habitat between Reference
                                               and Impact Sites
                                                                            -A EPA—^
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                                                                           Biological Criteria
The use of site-specific reference
conditions is the method of choice for
point source dischargers.
Slide 29:  Drainage Pipe
The near field-far field reference
condition is effective for establishing a
reference condition in large lakes.
estuaries, and coastal waters.
Slide 30:  Near Field-Far Field
f
            SITE-SPECIFIC
    REFERENCE CONDITIONS]
                                              Near Field - Far Field
                                              Used in Estuaries and Lakes, When Large
                                              Enough To Provide for Gradient in Impact
                                              but Still Have Comparable Habitats
                                                                             &EPA
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                                          n-r
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 Module 11
 Regional reference conditions can also
 be established.
Slide 31: Pairec. Watersheds
                                               REGIONAL REFERENCE
                                                      CONDITIONS
                                                   • Paired Watersheds
                                                   • Ecoregions
                                                                          &EPA
Paired watershed reference conditions
are established to evaluate waterbodies
impacted by multiple sources.
Slide 32: Watershed
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                                Update-1  1997
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                                                                             Biolosical Criteria
Reference conditions can also be
developed on a larger scale.
Slide 33:  Ecoregion Reference Sites
                                                   REGIONAL REFERENCE
                                                           CONDITIONS
                                                  '-.^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

                                                 Ecoregions

                                                 Identifies Regions of Ecological Similarity
                                                 from Which To Select Reference Sites
                                                                               &EPA
Ecoregional reference sites should be as
unimpacted as possible and
representative of the region's
waterbodies.
Slide 34:  U.S. Ecoresions
                                                               Map
                                                                 \f-
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 Module 11
The use of ecoregions has been
instrumental in the development of
Slide 35: Ohic Ecoregions
 biological criteria.
       ECQREGIONS OF QffloJ
                                                                                 se EPA
Candidate watersheds can be selected
from appropriate maps.
Slide 36:  Aerial Photo
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                                                                  Biological Criteria
           — COMPONENTS OF BIOLOGICAL CRITERIA:
                      2.  BIOLOGICAL SURVEY —
 Biological surveys are used to conduct
 the investigations of subject
 waterbodies to determine whether
 criteria are met.
Slide 37: Component 2
         COMPONENTS OF
     BIOLOGICAL CRITERIAJ
                    Biological
                      Survey
                                                                    &EPA
Survey design must be scientifically rigorous and biologically relevant to detect problems of
regulatory concern.
Selecting community components.
Slide 38:  Bioassessment Components
                                            BIOLOGICAL SURVEYS]
                                          Target Species and Taxa
                                          • Serve as Effective Indicators of High
                                           Biological Integrity
                                          • Represent a Range of Pollution Tolerances
                                          • Provide Predictable, Repeatable Results
                                          • Are Readily Identifiable by State Personnel
                                                                  -&EPA-
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                                     11-21
                          Participant Manual
                             Update-1 1997

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Module 11
The most useful measures of biological
integrity have been

   •  number of specie?,

   *  degree of dominance, and

   •  organism size reduction.

Components chosen will vary
depending on the type of ecosystem.
Slide 39: Fish
  COMMUNITY COMPONENTS]
        Fish
Macroinvertebrates
                                                                         &EPA
Components should be measured in a
way that best describes the structure
and function of aquatic communities.
Structural metrics describe the
composition of a community.
Functional metrics describe the
ecological processes of the community.
Slide 40: Metrics Types
         METRICS TYPES    ]

   Structural:
    Community Composition
    (Species Number, Abundance, and Ratios
    of Tolerant and Intolerant Species)
   Functional:
    Describe Processes
    (Community Photosynthesis)
  	&EPA
                               [CLASS EXERCISE]
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                            Participant Manual
                               Update-1 1997

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                                                                         Biological Criteria
 Careful design and statistical protocols are required to reduce sampling error and to evaluate natural
 variability.
 Data collection protocols should
 incorporate:


    •   spatial scales and


    •   temporal scales.
Slide 41: Protocol Scales
      COMPONENTS OF DATA
    COLLECTION PROTOCOLS J

  Spatial Scales:
    Wide Variety of Subhabitats Within
    Surface Water Habitat

  Temporal Scales:
    Annual, Seasonal, Diurnal Changes in an
    Aquatic Community
                                                                           &EPA
Spatial scales refer to the wide variety of subhabitats that exist within any surface water habitat.
Temporal scales refer to aquatic community changes that occur over time and to life-cycle changes in
organism behavior.
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                                         11-23
                             Participant Manual
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 Module 11
 Rapid bioassessment protocols use
 standardized techniques to gather data
 quickly.
Slide 42:  Strean Sampling
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                                                 11-24
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                                                                 Biological Criteria
           — COMPONENTS OF BIOLOGICAL CRITERIA:
               3. IMPACT TESTING AND ANALYSIS —
The final component of biological
criteria development is impact testing
and analysis.
Slide 43:  Component 3
                                               COMPONENTS or
                                           BIOLOGICAL CRITERIAJ

                                            Impact Testing and
                                                   Analysis
Biological criteria are used to test
hypotheses about the degree of
biological impairment of surface
waters.
Slide 44: Impact Testing
        IMPACT TESTING   ~]

      Null Hypothesis:
         Use Is Not Impaired

      Alternative Hypothesis:
         Use Is Impaired

      	&EPA
Data are used to evaluate whether or not characteristics of biota are significantly different from
established criteria.  Hypothesis testing is an established approach for doing this. Analysis of
variance is another approach used by some States, but not described here.
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                            Update-1 1997
                                    11-25

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 Module 11
Use impaired.
Slide 45: Outcomes-1
                                                     OUTCOMES
                                           1.  The Use Is Impaired

                                              When Survey Design and Data Analysis
                                              Are Sensitive Enough To Detect
                                              Differences of Regulatory Importance,
                                              and Significant Differences Are
                                              Detected.
Criteria achieved.
Slide 46: Outcomes-2
                                                     OUTCOMES
                                          2. The Biological Criteria Are Met

                                              When Survey Design and Data Analysis
                                              Are Sensitive Enough To Detect
                                              Differences of Regulatory Importance,
                                              but No Differences Are Found.
                                                                       &EPA
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                                                                   Biological Criteria
 Outcome indeterminate.
Slide 47: Outcomes-3
                                                   OUTCOMES
                                         3. The Outcome Is Indeterminate
                                            When Survey Design and Data Analysis
                                            Are Not Sensitive Enough To Detect
                                            Differences of Regulatory Importance,
                                            and No Differences Are Detected.
                                                                     &EPA
 Impairment of a designated use requires
 a diagnosis of the probable cause.
Slide 48:  Diagnostic Questions
                                           DIAGNOSTIC QUESTIONS]

                                          1 What Are the Obvious Causes of
                                           Impairment?

                                           If No Obvious Causes Are
                                           Apparent, What Possible Causes
                                           Do the Biological Data Suggest?

                                          	&EPA
                  [VIDEO: Development of Biological Criteria]
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                           Participant Manual
                             Update-1  1997

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 Module II
Future Directions.
Slide 49:
                                                     FUTURE
                                                  DIRECTIONS
                                             - Lakes and Reservoirs
                                             - Estuaries and Coastal Marine Waters
                                             - Wetlands
                                             - Large Rivers
                                             - Coral Reefs
                                                                     &EPA
                                       Slide 50:
                                                     FUTURE
                                                  DIRECTIONS
                                                New Initiative
                                                Technical Assistance
                                                Pact Project
                                                                     &EPA
Note:  Slides 51 through 75 do not appear in the Participant Manual.
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                              Update-1 1997
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                                                                           Biological Criteria
 Summary.
Slide 76:  Applications
                                                    APPLICATIONS OF
                                                       BIOCRITERIA
                                               1) Refined Aquatic Life Criteria and Designated Uses
                                               2) Problem Identification
                                               3) Regulatory Assessments
                                               4) Management Planning
                                               5) Water Quality Project and Techniques Evaluation
                                               6) Status and Trends of Water Resources
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                                                    11-30
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                                                                                  Review Questions
                                 REVIEW QUESTIONS


   1. True or False.  Biological integrity is one principal objective of the Clean Water Act.
  2. Where numeric criteria for the 126 priority pollutants are not available, section 303(c)(2)(B)
     requires  States to adopt criteria based on what?

     a.    Single bioassays
     b.    Biological assessment and monitoring methods
     c.    Literature reviews
  3. The condition of the aquatic community inhabiting the unimpaired waterbodies of a specified
     type, as measured by community structure and function, is known as:

     a.    chemical integrity
     b.    physical integrity
     c.    biological integrity
  4. True or False.  Water quality programs in most States currently use comprehensive biological
     criteria to protect biological integrity.
  5. True or False.  EPA's goal is to develop national biological criteria for each waterbody type.
  6. True or False.  When developing biological criteria, any reference site may be chosen as long
     as standard sampling protocols are applied.
  7. Site-specific reference conditions are best applied to:

     a.     lakes and ponds
     b.     small rivers and streams
     c.     wetlands
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 Module 11
   8.  Which is not a difficult situation for application of site-specific reference conditions?

      a.     diffuse nonpoint source pollution throughout a waterbody
      b.     extensive channel or shoreline modifications
      c.     multiple point source locations
      d.     heavy point source contamination from one discrete release area
   9.  The two site-specific reference condition approaches are (circle the two that apply):

      a.     near field-far field
      b.     paired watersheds
      c.     upstream-downstream
      d.     ecoregions
 10.  True or False. The ecoregion maps have yet to be applied to State water quality programs.
 11.  True or False. Caution should be exercised when selecting minimally impacted sites for ecoregion
      reference conditions because many minimally impacted sites (e.g., spring-fed stream) are atypical of
      the region.
 12. Which of the following are essential characteristics for species to be selected as community
     components for a bioassessment? (Circle all that apply.)

     a.    Likely  to live in unimpaired waters
     b.    Previously not described by taxonomists
     c.    Readily identified by trained State personnel
     d.    Active  during only part of the year
 13. Types of metrics used in bioassessments include (circle all that apply):

     a.     structural measures, such as number of species
     b.     functional measures, such as plant productivity
     c.     economic value, such as monetary benefits of navigation
 14. True or False.  The Index of Biotic Integrity (IBI) is the total number of fish species collected in a
     standard sample.
 15. True or False.  Biological criteria are designed to replace chemical and whole-effluent criteria within
     water quality standards.
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                        TRAINING MODULE 12:
                        ECOLOGICAL RISK ASSESSMENT
 MODULE SUMMARY:

 This module will introduce basic principles and concepts of ecological risk assessment, as currently
 practiced under guidelines developed by EPA.

    NOTE:   This module is intended to serve only as an introductory training session on principles
             of ecological risk assessment.  Follow-up training and technical support will be
             required for most participants who will be directly involved in the development of
             water quality criteria.  Additional technical advisory support is available through
             EPA.

 OVERALL OBJECTIVES:

 To provide an understanding of the principles of ecological risk assessment, including quantitati%'e as
 well as qualitative aspects. These principles provide a basis for understanding the development and
 use of ambient water quality criteria and other risk information used in developing and implementing
 standards.

 MEASURABLE OBJECTIVES:

 After completing this module, participants will be able to:

    •  Define ecological risk assessment.
    •  Identify the differences between human health risk assessments and ecological risk
      assessments.
    •  Understand the statutory and regulator)' basis  for conducting ecological  risk assessments and
      the different types of such assessments that can be done.
    •  Understand the role of communication in the design and execution of ecological risk
      assessments.
    •  Identify the phases  of an ecological risk assessment and discuss the objectives of each phase.
    •  Distinguish between an assessment endpoint and a measure of effect.
    •  Understand that a variety of methods to evaluate causal associations and to quantify risk in
      ecosystems are available.
    •  Understand the importance of characterizing and communicating the uncertainties associated
      with the use of these methods for each assessment.
    •  Apply aquatic life, sediment, and biological criteria in an ecological  risk assessment, as well
      as determine when it is inappropriate to do so.
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                                           12-1

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 Module 12
 LOGISTICS:

 Teaching Method:  Lecture (with Slides); Class Exercise

 Approximate Presentation Time:  1  hour, 10 minutes (Lecture--30 minutes; Group Exercise—30
 minutes; Review Questions—10 minutes)

 Basic Course Reference Manual Documents:

 12 Framework for Ecological Risk Assessment. U.S. Environmental Protection Agency, Risk
    Assessment Forum. 1992.

 Other Documents:

    Calabrese, E. J.,  and L. A. Baldwin. 1993.  Performing Ecological Risk Assessments. Lewis
    Publishers, Boca Raton,  Florida.

    Hoffman, D. J., B. A. Rattner, G. A. Burton, Jr., and J. Cairns, Jr.  1994.  Handbook of
    Ecotoxicology. Lewis Publishers, Boca Raton, Florida.

    Howell, D. J.  1994. Ecology for Environmental Professionals.  Quorum Books, Westport,
    Connecticut.

    Landis, W. G., J. S. Hughes, and M. A. Lewis (eds.). 1993.  Environmental Toxicology and Risk
    Assessment. ASTM STP 1179.  American Society for Testing and Materials, Philadelphia.

    Landis, W. G., G. B. Matthews, R.  A. Matthews, and Anne Sergeant.  1994.  Application of
    multivariate techniques to endpoint determination, selection and evaluation in ecological risk
    assessment. Environmental Toxicology and Chemistry 13:1917-1927.

    Suter, G. W. II.  1993.  Ecological Risk Assessment.  Lewis Publishers., Boca Raton, Florida.

    USEPA.   1986.  Hazard Evaluation Division, Standard Evaluation Procedure: Ecological Risk
    Assessment. EPA-540/9-85-001.  U.S. Environmental Protection Agency, Office of Pesticide
    Programs, Washington, DC.

    USEPA.   1989.  Rapid Bioassessment Protocols for Use in Streams and Rivers: Benthic
    Macroinvertebrates and Fish.  EPA/444/4-89-001. U.S. Environmental Protection Agency, Office
    of Water, Washington, DC.

    USEPA.   1993 and 1994. A Review of Ecological Assessment Case Studies from a Risk
    Assessment Perspective.  Volume 1: EPA/630/R-92/005; Volume 2: EPA/630/R-94/003.  U.S.
    Environmental Protection Agency,  Risk Assessment Forum, Washington, DC.
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                          MODULE 12 - OUTLINE
              ECOLOGICAL RISK ASSESSMENT
                           — INTRODUCTION —
This module presents a brief overview
of ecological risk assessment. It ties
in with several other modules that have
been or will be presented.
                                        Slide 1:  Introduction.
                                           MODULE OVERVIEW
                                         • Define Ecological Risk Assessment
                                         • Differentiate Ecological Risk Assessment
                                           from Human Health Risk Assessment
                                         • Discuss Phases of an Ecological Risk
                                           Assessment
                                         • Demonstrate How an Ecological Risk
                                           Assessment Is Conducted
Efforts  are underway to develop appropriate methodologies for a risk-based approach to ecosystem
protection.
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 Module 12
 Ecological risk assessment is a process
 used to evaluate the likelihood that
 adverse effects may occur or are
 occurring as a result of exposure to one
 or more stressor.
                                          Slide 2: Definition.
                                          i DEFINITION OF ECOLOGICAL
                                          I       RISK ASSESSMENT
                                           • Process to Evaluate the Likelihood of
                                             Adverse Ecological Effects from
                                             Exposure to Stressors

                                           • Tool to Help Meet Management Goals

Ecological risk assessment can increase the probability of achieving a desired environmental result.

                                          Slide 3: Value of Ecological Risk Assessment.
Ecological risk assessments provide a
valuable addition to several
environmental programs and statutory
requirements.
                                              VALUE OF ECOLOGICAL
                                                 RISK ASSESSMENT

                                             Improve Use Attainability Analysis
                                             Aid in Interpretation and Use of Criteria
                                             Improve Watershed Protection
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                                                                       Ecological Risk Assessment
 There are three key groups of players
 in ecological risk assessment.
Slide 4: The Players.
                                                         THE PLAYERS
                                                       • Risk Managers

                                                       • Risk Assessors

                                                       • Stakeholders
The framework developed by EPA
provides guidance for conducting
ecological risk assessments.
Display: Ecological Risk Assessment Framework.
       ECOLOGICAL RISK
  ASSESSMENT FRAMEWORK
                                                    FnutMwork for brologteil Risk *
                                                                    c. USEFA Rule. AtMtrttnmt Fontm. 1992
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Module 12
There are three basic elements to the;
ecological risk assessment process.
                                         Slide 5: Process.
                                                   THE PROCESS
                                              1. Problem Formulation
                                             2. Analysis
                                              3. Risk Characterization
                                                                      &ER&
                     — PROBLEM FORMULATION —

The problem formulation phase of ecological risk assessment is when the people involved with water
quality standards are most likely to be involved.
There are five general components of
the problem formulation phase.
                                         Slide 6: Problem Formulation.
                                                  THE PROCESS
                                           1.  Problem Formulation
                                              •Articulate Management Goal
                                              •Assess Available Information
                                              •Develop Assessment Endpoints
                                              •Develop Conceptual Model
                                              •Develop Analysis Plan
                                          	—	•	& EfA-
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                                                                Ecological Risk Assessment
The first product of the problem
formulation phase is a management
goal.
 Slide 7: Management Goal.
                                               MANAGEMENT GOAL
                                           Who Is Involved in the Assessment?
                                               • Identify the Players

                                           Why Do an Ecological Risk Assessment?
                                               • Identify the Problem and Purpose
                                               • Determine the Type of Assessment
The  risk manager, in consultation with the stakeholders and risk assessors, examines the  situation
and identifies the need for a risk assessment.
The next part of the problem
formulation phase involves the
assessment of available relevant
information.
 Slide 8: Assessment of Available Information-1.
/	    ^^ — ^   ,                   ^
 ASSESSMENT OF AVAILABLE
          INFORMATION
                                            What Are the Problems?

                                                • Characterize What Is at Risk

                                                • Identify the Ecological Effects

                                                • Describe the Sources and
                                                  Characteristics of Stressors
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 Module 12
 Assessment of available information
 allows you to determine temporal and
 spatial limits of stressors.
                                        Slide 9: Assessment of Available Information-2.

                                        ASSESSMENT OF AVAILABLE
                                                 INFORMATION
                                            When do Problems Occur?
                                                • Set Temporal Limits

                                            Where do the Problems Occur?
                                                • Set Spatial Limits
Available information is used to determine ecologically-based endpoints.

Assessment endpoints are explicit              Slide 10:  Develop Assessment Endpoints.
expressions of the actual environmental        /-           —             •
values that are to be protected.
                                                   DEVELOP
                                         ASSESSMENT ENDPOINTS
                                           • Ecologically Relevent

                                           • Susceptible to the Stressor

                                           • Reflects Policy Goals and
                                             Societal Values
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                                                                Ecological Risk Assessment
Assessment endpoints must be
operationally-defined by a quantifiable
attribute.
Slide 11: Attributes of Assessment Endpoints.
                                         ASSESSMENT ENDPOINTS
                                                                             j
                                           Unambiguous Operational Definition
                                              - Ecological Component
                                              - Attribute of Component
                                           Subject to Prediction and Measurement
Measure of effect is a measurable
response to a stressor that is related to
the valued characteristics selected.
Slide 12: Measures of Effect.
                                            MEASURES OF EFFECT
                                                 Measurable Ecological
                                                 Characteristics

                                                 Related to the Assessment
                                                 Endpoint
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 Module 12
                                          Slide 13:  Examples of Ecological Risk Assessment
                                          Endpoints.
                                            EXAMPLE OF ECOLOGICAL
                                          RISK ASSESSMENT ENDPOINTS
                                              Assessment
                                               Endpoinl

                                              Sport Fish
                                               Abundance
                      Measure of
                        Effect

                     Fathead Minnow
                      LC50
                     Percent Mortality

                     Species Abundance

                     Spawning Behavior
Conceptual models are used to establish the focus of the risk assessment.
One type of conceptual model
graphically demonstrates the
interactions in an ecosystem.  This
elementary level model wouldn't be
appropriate in a risk assessment.
Slide 14: Conceptual Model-1.
      CONCEPTUAL MODEL I
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                                                                                        Ecological Risk Assessment
 A second type of conceptual model
 allows the risk assessor to identify
 possible exposure scenarios to link the
 stressors and effects to an appropriate
 endpoint.
Slide  15:  Conceptual Model-2.
        Conceptual  Model II
                                                          Stressors
                                                                       Agriculture
                                                          Stressors        Nutrients
                                                                   Algal Growth/Shading
                                                         Ecological    Periodic Dieoffs with
                                                           Effects    Lmv Dissolved Oxygen
                                                        Measurement
                                                         Endpoims
                                                         Assessment
                                                         Endpoints
          Primary Productivity
          in the Water Column
           Extent of Low DO
            Benthic Species
             Diversity and
                                                                                                           J
Abundance



         , Benthic Invertebrate p
           Species Diversity
            and Abundance
Threatened
                                                                                    Abundance
                                         Industry
                                         Effluent
                                          Toxic
                                       1 Chemicals
                                       Reduced Fish
                                        Populations
                                       Reduced Bird
                                      :  Populations
              Fish Tissue
             Contaminants
            Fish Population
              Abundances
              Laboratory
            Toxicity to Birds
            Fish-Eating Bird
           Species Abundance
Once information  is organized in a conceptual model, the risk assessor can  develop a series of risk
hypotheses.
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 Module 12
 The final step of the problem
 formulation phase is the development
 of an analysis plan.
Slide 16: Analysis plan.
     ANALYSIS PLAN      ]
                                            How Will the Assessment be Conducted?

                                                  •  Risk Hypotheses

                                                  •  Objectives/Measures

                                                  •  Data Quality and Quantity
                              [CLASS  EXERCISE]
                      — PROBLEM FORMULATION —
A successful problem formulation must
have assessment endpoints that reflect
the management goals and the
ecosystem they represent; conceptual
models that  show key relationships; and
an analysis plan.

Problem formulation requires dialogue
between the risk assessors and risk
managers.
Slide 17: Problem Formulation.
        Problem Formulation Phase

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                                                                   Ecological Risk Assessment
                        — MANAGEMENT GOALS —
When initiated by a stressor,
characteristics of the stressor provide
the foundation for development of
conceptual models and assessment
endpoints.

When initiated by an effect, the
assessment endpoint is established first
as the affected system.
Slide 18:  Risk Assessment Initiation.

     RISK ASSESSMENT
           INITIATION
What drives the risk assessment?
 • Source or stressor, e.g.,
    - toxic waste site
    - new chemical process or pesticide
 • Observed effect
    - decline of endangered species
 • Values of concern
    - protection or restoration of place (watershed,
      estuary, ecosystem)
    - protection or restoration of values
Management goals must be agreed to
by interested parties, clearly articulated
and have a way to measure success.
Slide 19:  Management Goals.
 MANAGEMENT GOALS  J
                                              Statutory goals (e.g., water quality
                                              standards, protection of endangered
                                              species)
                                              Goals agreed to by interested parties
                                              General goals must be translated as
                                              specific management objectives
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Module 12
An assessment endpoint is an explicit
expression of the environmental value
that is to be protected.

An assessment endpoint must be
susceptible to one or more stressors in
the risk assessment.
 Slide 20:  Criteria for Assessment Endpoints.
s                ~       —— ,  i^
        CRITERIA FOR
 ASSESSMENT ENDPOINTS
                                          • Ecological relevance
                                          • Susceptibility to known or potential
                                            stressors
                                          • Representation of management goals
A conceptual model is a set of risk
hypotheses that describe relationships
between stressors, exposure, and
assessment endpoint responses.
Slide 21:  Example of Conceptual Model; Part 1.


      CLINCH RIVER WATERSHED
         CONCEPTUAL MODEL
                                                                      -&EFA-
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                                                                  Ecological Risk Assessment
                                           Slide 22: Example of Conceptual Model; Part 2.

                                          '     CLINCH RIVER WATERSHED   "~
                                                   CONCEPTUAL MODEL
                                                                         &ER&-
                                           Slide 23: Develop Analysis Plan.
                                                        DEVELOP
                                                    ANALYSIS PLAN
                                             Develop Analysis Plan
                                              •  How to Evaluate Risk Hypotheses
                                              •  Availability of Data
                                              •  Uncertainty
                                              •  Relate Analysis to Ultimate Decisions
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 Module 12
                                        Slide 24: Topograpluic View of Watershed.
                     [CLASS EXERCISE - QUESTIONS]
                                           Display: Dan River Watershed.
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                                                                     Ecological Risk Assessment
                                             Display: Dan River Watershed Conceptual Model.

                                                      DAN RIVER WATERSHED     \
                                                i       CONCEPTUAL MODEL      I
                                      — ANALYSIS —
The second step in the ecological risk
assessment process is the analysis
phase.
Slide 25: Analysis.
                                                      THE PROCESS
                                                   2.  Analysis
                                                      •Exposure Characterization
                                                      •Ecological Effects
                                                       Characterization
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 Module 12
 The purpose of characterizing exposure
 is to measure or predict spatial and
 temporal distribution of a stressor.
Slide 26:  Exposure Characterization.
          EXPOSURE
   CHARACTERIZATION
                                           •  Predict Spatial Distribution

                                           •  Predict Temporal Distribution
The purpose of characterizing
ecological effects is to identify and
qualify the adverse effects caused by a
stressor and evaluate cause and effect
relationships.
Slide 21:  Ecological Effects Characterization.
  ECOLOGICAL EFFECTS
   CHARACTERIZATION
                                               Identify and Quantify
                                               Adverse Effects

                                               Evaluate Cause-and-Effect
                                               Relationships
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                                                              Ecological Risk Assessment
                    — RISK CHARACTERIZATION —
The final phase in an ecological risk
assessment is risk characterization.
There are many ways to estimate
ecological risks, including the quotient
method and stressor response curves.
Slide 28: Risk Characterization.
                                                 THE PROCESS
                                            3.  Risk Characterization
                                               •Estimate Risks
                                               • Evaluate Uncertainties
                                               • Summarize Risk
                                               •Document Significance of
                                                Threat
Slide 29:  Methods for Estimating Ecological Risks.
                                        METHODS FOR ESTIMATING
                                             ECOLOGICAL RISKS
                                               Quotient Method
                                               Stressor-Response Curves
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 Module 12
 The quotient method is a common
 quantitative screening technique.
Slide 30:  Quoiient Method.
                                                                                 ~-\
                                                 QUOTIENT METHOD
                                              Quotient Method =
                 EEC
                 WQC
                                              EEC = Concentration of chemical estimated
                                                    to occur in the environmental to which
                                                    ecological components are likely to be
                                                    exposed

                                              WQC = Estimated safe (no-effect) concentration
                                                    such as the chemical's water quality
                                                    criterion.
Stressor-response curves are developed
considering frequency, timing, and
duration of exposure are considered.
Slide 31: Stressor-Response Curve.
                                            STRESSOR-RESPONSE
                                                     PROFILES

                                                           Tutd*     100

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                                                                   Ecoloaical Risk Assessment
Another important phase of risk
characterization is evaluating the
uncertainty.
Slide 32:  Evaluating Uncertainty.
                                                     EVALUATING
                                                    UNCERTAINTY
                                                        •  Stochasticity

                                                        •  Ignorance

                                                        •  Human Error
                                                                          &EFA
                            — FINAL PRODUCT —

The final product of an ecological risk assessment is a report summarizing the ecological risks and
interpreting the ecological significance of the stressor.
The weight-of-evidence approach helps
increase confidence in the conclusion
of the assessment.
Slide 33: Weight-of-Evidence Approach.

  THE WEIGHT-OF-EVIDENCE
                      APPROACH
                                                                        &EPA-
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 Module 12
 After completing the ecological risk
 assessment, the risk manager will have
 to choose the appropriate options.
Slide 34:  Options
                                                          OPTIONS

                                                             No Action
                                                              Take Action
                                                          •   Modify an Action
                                                                              &EFA
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                                  Update-1 1997
                                            12-22

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                                                                                 Review Questions
                                REVIEW QUESTIONS
 1.  What is an ecological risk assessment?

    a.  A stud)' of the plants  and animals  in an ecosystem.
    b.  An evaluation of the likelihood of adverse effects resulting from exposure to a stressor.
    c.  The collection of data from a hazardous waste site.
2.  Ecosystems can be affected by
    of some of these stressors are:
               , as well as
_, types of stressors.  Examples
    a.  Sediment
    b.  Temperature
    c.  pH
    d.  Sunlight
    e.  AH of the above
3.  To evaluate exposure of organisms to different types of stressors, what types of studies might be
    used?
4.  True or False.  Ecological risk assessments are less likely to produce quantitative estimates of
    risk than are human health risk assessments.
5.  Fill in the blanks. The term
                         means an explicit expression of the actual
    environmental values that are to be protected by management decisions that will be based on the
    ecological risk assessment.  Data collected during the assessment should include measurable
    responses of this endpoint to the suspected stressor, and these responses are termed	
    	.  It is important  to	the assessment endpoints and measures of effect by
    developing a
model before the ecological risk assessment begins.
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                                                     Participant Manual
                                                         Update-1  1997
                                             12-39

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 Module 12
 6.  Uncertainty is everywhere, but what does this mean in an ecological risk assessment?

    a.  Somebody goofed somewhere.
    b.  Nothing.
    c.  Nature  is inherently random.
    d.  A lab test result always means the same thing as what is found in the field.
    e.  a and c.
 7.  Give two examples of why we should identify the uncertainties associated with an ecological risk
    assessment to the risk manager.
8.  What is the purpose of conducting an ecological risk assessment?
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   Update-1 1997
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                        TRAINING  MODULE 13:
                    PRINCIPLES OF RISK COMMUNICATION
 MODULE SUMMARY:

 This module presents basic risk communication principles. Participants apply those principles by
 developing a risk communication strategy for a hypothetical situation involving review of a water
 quality criterion.
OVERALL OBJECTIVES:

To raise awareness about how the public perceives risk, and to introduce participants to the basic
principles of risk communication and the considerations involved in developing a risk communication
strategy.  To help participants be better prepared to handle risk communication situations that might
arise during development and implementation of water quality standards.
MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:
   •  Identify situations that might induce public outrage
   •  Demonstrate understanding of some basic principles of risk communication
   •  Demonstrate understanding of basic components of a risk communication strategy
   •  Apply basic principles of risk communication in developing a risk communication strategy
LOGISTICS:

Teaching Method: Lecture (with slides): Group exercises: Discussion.

Approximate Presentation Time: 2 hours (Opening Presentation—60 minutes: Walk-through of
Case Study—10 minutes; Group Exercise—25 minutes; Wrap-up—25 minutes).

Other Documents:

   A Citizen's Guide to Understanding Health Risks and Reducing Exposure. U.S. Environmental
   Protection Agency, Office of Policy, Planning, and Evaluation.  1990.

   Resource Document for Workshop on Risk Communication.  U.S. Environmental Protection
   Agency,  Office of Policy, Planning, and Evaluation.  1989.
Water Quality Standards Academy
Participant Manual
   Update-! 1997

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 Module 13	

    Covello, V.T., D.B. McCallum, and M.T. Pavlova.  Effective Risk Communication:  The Role
    and Responsibility of Government and Nongovernment Organizations.  Plenum Press, New York.
    1989.

    NRC (National Research Council).  Improving Risk Communication. National Academy Press,
    Washington, D.C. 1989.
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                      MODULE 13 - OUTLINE
       PRINCIPLES OF RISK COMMUNICATION
                      — INTRODUCTION —


Any situation that involves public health also has the potential to arouse public concern.


                    [PARTICIPANT EXPERIENCES]



                — HAZARD VERSUS OUTRAGE —


The public perception of risk has been extensively studied in recent years.

                                  Slide 1: Risk Equation
                                    Risk = Hazard + Exposure
                                                           &EPA
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Participant Manual
  Update-1 1997

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 Module 13
 Hazard refers to the scientific
 component of risk perception.
Outrage refers to the emotional
component of risk perception.
Slide 2: Risk Perception
     Person = Hazard + Outrage I
                                                                                -&EPA-
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                                                          Principles of Risk Communication
Studies of risk communication have
shown that there are several outrage
factors.
Slide 3: Factors-1
                                              FACTORS AFFECTING
                                                RISK PERCEPTION
                                             "Less Risky"
                                              voluntary
                                               familiar
                                           controlled by self
                                                 fair
                       "More Risky"
                        involuntary
                         unfamiliar
                     controlled by others
                           unfair
                                         Sown: Ptal Slavic. Bmjcfa Fiahbog, Sroh Lkbanmrin
                                                                       &EPA
                                        Slide 4: Factors-2
                                              FACTORS AFFECTING
                                                RISK PERCEPTION   J
                                            "Less Risky"
                                             not memorable
                                             diffuse in time
                                               and space
                                               natural
                                               detectable
                 A	IS.
                 r—4
"More Risky"
  memorable
 focused in time
   and space
   artificial
  undetectable
                                                                      &EPA
                             [CLASS EXERCISES]
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                                       13-5
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                              Update-1 1997

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 Module 13
                   — THE SEVEN CARDINAL RULES
                     OF RISK COMMUNICATION —
Rule 1:
Accept and Involve the
Public as a Legitimate
Partner.
Slide 5: Rule 1
                                            ACCEPT AND INVOLVE THE
                                             PUBLIC AS A LEGITIMATE
                                                       PARTNER
                                            The goal of risk communication is to
                                            produce an informed public that
                                            participates in developing solutions to the
                                            problem.

                                            Involve the public early in the process,
                                            before decisions have been made.

                                            Involve all parties that may have an
                                            interest or stake in the outcome.
                                                                      &EPA
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                                                             Update-1 1997

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                                                        Principles of Risk Communication
Rule 2:   Plan Carefully, Evaluate
         Your Efforts, and Learn
         from Your Mistakes.
Slide 6: Rule 2-1
                                        PLAN CAREFULLY, EVALUATE
                                         YOUR EFFORTS, AND LEARN
                                            FROM YOUR MISTAKES
                                         • Begin with clear, explicit risk
                                           communication objectives.

                                         • Evaluate the risk information you
                                           have.
                                                                    &EPA
                                       Slide 7: Rule 2-2
                                         IPLAN CAREFULLY, EVALUATE}
                                          YOUR EFFORTS, AND LEARN
                                            FROM YOUR MISTAKES
                                          • Classify your audience and target
                                           communication strategies to the
                                           different subgroups.
                                          • Recruit spokespeople who are good at
                                           presentation and interaction.
                                                                  &EPA
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                             Update-1 1997
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 Module 13	

 Rule 3:   Listen to the Public's
         Specific Concerns.
Slide 8: Rule >1
                                           LISTEN TO THE PUBLIC'S
                                         I     SPECIFIC CONCERNS
                                           •  Try to put yourself in your audience's
                                             shoes.

                                           •  Don't assume you know what people
                                             know, think, feel, or want done about
                                             the risks.

                                           •  Take time to find out what people
                                             think.

                                          	.	.	A EpA.
                                        Slide 9:  Rule 3-2
                                           LISTEN TO THE PUBLIC
                                              SPECIFIC CONCERNS
                                 ,j
                                          • Listen to all parties that have an interest or
                                           stake in the issue.

                                          • Recognize and respect people's emotions.

                                          * Legitimize people's concerns.

                                          • Be calm.
                                                                     &EPA
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                              Update-1 1997
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                                                              Principles of Risk Communication
Listening is essential to building trust.
Slide 10: Active Listening-1
                                                     STEPS IN ACTIVE
                                                         LISTENING
                                                Listen for the main idea(s). Look for
                                                feelings. Pay attention to body language.

                                                Paraphrase the speaker's main ideas.
                                                Recognize the person's feelings. "I
                                                understand that..." "What you are saying
                                                is ..." "Let me make sure I understand.
                                                You think..."
                                                                           &EPA
                                           Slide 11: Active Listening-2
                                                   STEPS IN ACTIVE
                                                        LISTENING
                                      J
                                              Listen and look for confirmation of your
                                              understanding.

                                              If the speaker clarifies your
                                              understanding, paraphrase your new
                                              understanding.
                                                                           &EPA
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                                Update-1 199?
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 Module 13
There are advantages of active
(reflective) listening.
Slide 12: Advantages
                                              BENEFITS OF ACTIVE
                                         i  ^	LISTENING
                                           •  Defuse;; strong emotion.
                                         I  •  Recognizes and legitimizes people's
                                         I    feelings and concerns.
                                           •  Helps ensure accurate communication.
                                           •  Avoids defensiveness.
                                         :  '  Helps you remain objective.
                                                                        &EPA
Rule 4:   Be Honest, Frank, and Open.
Slide 13: Rule 4
                                              BE HONEST, FRANK,
                                                     AND OPEN
                                            •  If you don't know an answerer are
                                              uncertain, say so. Get back with an answer.
                                            •  Admit mistakes.
                                            •  Disclose risk information as soon as possible.
                                            •  Lean toward sharing more information, not
                                              less.
                                            •  Discuss data uncertainties, strengths, and
                                              weaknesses.
                                           	£ EPA _
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                               Update-1 1997
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                                                             Principles of Risk Communication
Not acknowledging uncertainty is a
sure way to lose trust and credibility.
Slide 14: Uncertainties-1
                                                ACKNOWLEDGE AND
                                                    DISCUSS DATA
                                                   UNCERTAINTIES
                                              Explain what the uncertainties are.

                                              Explain how the data were developed (e.g.,
                                              explain the risk assessment process).

                                              Explain that science is never completely
                                              certain and that the data provide a better
                                              basis for decision and action than guesswork.
                                                                          *EPA
                                          Slide 15: Uncertainties-2
                                                ACKNOWLEDGE AND
                                                     DISCUSS DATA
                                                   UNCERTAINTIES
                                              If data are highly uncertain, state:
                                               -What is known.

                                               -What steps will be taken to get better
                                                data.

                                               -What will be done in the meantime to
                                                reduce or protect against the risk.


                                             	&EPA
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                                Update-1  1997
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         Module 13
         Rule 5:   Coordinate and Collaborate
                  with Other Credible Sources.
Slide 16: Rule. 5
                                                     r~
                                                           COORDINATE AND
                                                     I COLLABORATE WITH OTHER]
                                                          CREDIBLE SOURCES
                                                    • Build bridges with other organizations.

                                                    • Determine who is best able to answer
                                                      questions about risk.

                                                    • Whenever possible, issue
                                                      communications jointly with other
                                                      trustworthy sources.
                                                                                 &EPA


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                               Update-1  1997
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                                                              Principles of Risk Communication
Rule 6:    Meet the Needs of the
          Media.
Slide 17: Rule 6-1
                                                MEET THE NEEDS OF
                                                        THE MEDIA
                                              \^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^_,____^^^^^^^^^

                                              • Be open with and accessible to reporters.
                                              ' Respect their needs and deadlines.
                                              • Provide background information on
                                                complex risk issues.
                                              • Follow up on stories with praise or criticism
                                                as warranted.
                                                                           &EPA
                                           Slide 18:  Rule 6-2
                                                MEET THE NEEDS OF
                                                       THE MEDIA
                                              • Try to establish long-term relationships of
                                               trust with specific editors and reporters.

                                              • Ask the media what they need.

                                              • Focus on the issues; avoid going off on
                                               tangents.
                                                                           &EPA
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                                Update-1 1997
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Module 13
Rule 7:   Speak Clearly and with
        Compassion.
Siide 19: Rule 7-1
                                          SPEAK CLEARLY ANDl

                                           WITH COMPASSION   1
                                      I   N^«^^^^^a^^^H^HMBMMMHIMHHHHHHHIV^^^^^^«^^^^^^^HMHMM4r
                                      I
                                      I
                                      \  * Use simple, nontechnical language.
                                        • Be sensitive to local customs, such as speech or
                                          dress.
                                          Acknowledge and respond to emotions and
                                          concerns.
                                     I
                                                                   »EPA
                                      Slide 20:  Rule 7-2
                                          SPEAK CLEARLY AND
                                           WITH COMPASSION   J

                                        • Discuss actions that are underway or can be
                                          taken.
                                        • Tell people what you can't do.
                                        • Promise only what you can do, and do it!
                                                                   &EPA
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                           Participant Manual
                             Update-1  1997
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                                                         Principles of Risk Communication
       — RISK COMMUNICATION STRATEGY EXERCISE —
Takes place in Newlandia, our 51st
State.
DPS is found in the effluent of the
arconalt industry.
Slide 21: DPS
                                                DIFESTYLONIUM (DFS)j
                                        II  • Found in many Newlandia surface
                                            waters.

                                           • Manmade chemical discharged by the
                                            Arconalt industry.

                                           • Regulated under Newlandia's WQS
                                            program.
                                                                     &EPA
DPS has been classified as a B2
carcinogen.
Slide 22:  DPS Properties
                                                   TOXICOLOGICAL
                                                  PROPERTIES OF DFS
                                              Immune system effects at relatively
                                              high levels of exposure.
                                             • A carcinogen in animal studies by oral
                                              exposure at high doses.

                                             • No human carcinogenicity data.

                                             • Classified as a B2 carcinogen
                                              (probable human carcinogen).

                                             —	——- & EPA -
Water Quality Standards Academy
                                      13-15
                           Participant Manual
                              Update-1 1997

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 Module 13
 The State has essentially adopted the
 Federal ambient water quality criterion.
Slide 23: Human Health Criterion
                                                     NEWLANDIA HUMAN
                                                     HEALTH CRITERION
                                                            FOR DFS
                                                 • Based on EPA's 304(a) Guidance
                                                  Criterion.

                                                 • Assumes daily consumption of 2 liters
                                                  untreated surface water and 6.5
                                                  grams (« 1/4 oz.) of fish.

                                                 • 3 fig/L standard based on 10s
                                                  incremental risk level.

                                                	ft EPA _
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                                        13-16
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                                Update-1 1997

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                                                           Principles of Risk Communication
 A team is reviewing the DPS criterion.
Slide 24: Review Process-1
                                                      DFS CRITERION
                                               3    REVIEW PROCESS

                                             •  DFS criterion is up for review.
                                               WQS team for the review consists of
                                               State representatives and one invited
                                               EPA Regional representative.
                                                                       &EPA
                                         Slide 25: Review Process-2
                                                      DFS CRITERION
                                                     REVIEW PROCESS
                                       i
                                     ]
                                               Informal meetings have been held
                                               With three parties representing:
                                               - Arconalt industry
                                               - Environmental group
                                               - Tourism industry
                                                                       &EPA
Water Quality Standards Academy
                                       13-17
                           Participant Manual
                              Update-1 1997

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 Module 13
The Newlandia Arconait Industry
Federation does not favor lowering the
criterion.
Slide 26: NAIF-1
         NEWLANDIA ARCONALT*'
         INDUSTRY FEDERATION
             (NAIF) POSITION
                                            NAIF Provided These Data:           I
                                             - Industry compliance costs associated  '
                                              with current DFS standard (set at 10'5 \
                                              risk level) = $350,000/cancer case
                                              avoided.

                                             ~ Industry compliance costs that would
                                              be associated with more stringent DFS -
                                              standard (set at 10* risk level) =      ••
                                              53,500,000/cancer case avoided.      '
                                            	& ERA --
                                       Slide 27: NAIF-2
                                               i NEWLANDIA ARCONALT
                                                INDUSTRY FEDERATION
                                                     (NAIF) POSITION
                                            • Does not want criterion lowered

                                            • Further controls would impose undue
                                             financial burden

                                            • 20,000 jobs threatened
                                                                     &EPA
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                              Update-1 1997
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                                                              Principles of Risk Communication
 The Newlandia Tourist Association is
 concerned with image.
Slide 28: NTA
                                                     NEWLANDIA TOURISM
                                                       ASSOCIATION (NTA)
                                                              POSITION
                                                 Concerned with image

                                                > State must be perceived as having high
                                                 quality surface water and a strong game
                                                 fisheries resource

                                                1 Fears that lowering the DFS criterion may
                                                 result in impairment of waterbodies and
                                                 additional fish consumption advisories
                                                                           &EPA
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                                Update-1  1997
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 Module 13
The Newlandia Sport Fishermen's
Association is concerned about the
health of its members.
Slide 29: Sport Fishermen-1
                                                NEWLANDIA SPORT
                                                    FISHERMEN'S
                                                ASSOCIATION (NSFA)
                                                      POSITION
                                          . Over 100,000 members (5% of
                                           Newlandia population) - some are
                                           commercial fishermen

                                          * Recent NSFA member survey indicates
                                           NSFA members and their families
                                           typically eat one-half pound offish per
                                           week per person
                                         	__	^ EPA -
                                      Slide 30: Sport Fishermen-2
                                                NEWLANDIA SPORT
                                                   FISHERMEN'S
                                                ASSOCIATION (NSFA)
                                                      POSITION
                                           Very concerned that the health of its
                                           members has been compromised

                                           Very concerned that the proposed
                                           standard will not be sufficiently
                                           protective

                                          	& EPA
        [DEVELOPMENT OF RISK COMMUNICATION STRATEGY]
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                          Participant Manual
                             Update-1 1997
                                    13-20

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                       TRAINING  MODULE 15:
                                    VARIANCES
MODULE SUMMARY:

This module provides an overview of the requirements for and uses of variances in the water quality
standards and criteria programs.
OVERALL OBJECTIVES:

To provide a basic understanding of a variance, how variances are used and how they differ from use
reclassification and site-specific criteria, and the limitations of variances.
MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:

   •  Define a variance
   •  Identify three key points regarding variances
      List factors in the Water Quality Standards Regulation that can be used to support a variance
   •  Explain the differences between variances and use reclassification or site-specific criteria
LOGISTICS:


Teaching Method:  Lecture (with slides).

Approximate Presentation Time: l/2 hour (Lecture—20 minutes; Review Questions—10 minutes).

Basic Course Reference Manual Documents:

1  Clean Water Act: sections 301(b)(0; 402(a)(l).

4  Water Quality Standards Handbook, Second Edition, August 1994.
      Chapter  5, Section 5.3: Variances from Water Quality Standards
      Appendix A: Water Quality Standards Regulation (40 CFR 131.10(g); 131.13).

5  U.S. EPA's  Environmental Appeals Board. NPDES Appeal 88-5. In the Matter of Star-Kist
   Caribe, Inc.  Decided May 26, 1992.
Water Quality Standards Academy
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    1996 Edition
                                         15-1

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 Module 15	

 6  EPA's Proposed Combined Sever Overflow Control Policy.  April  19, 1994.

 Other Documents:

    National Assessment of State Variance Procedures. U.S. Environmental Protection Agency,
    Office of Water Regulations and Standards, Criteria and Standards Division. November 1990.

Water Quality Standards Academy                                                     Participant Manual
                                                                                    1996 Edition
                                             15-2

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                        MODULE 15 - OUTLINE
                            VARIANCES
               DEFINITION AND KEY COMPONENTS
A variance should be used only when
there is uncertainty as to whether a
standard can be attained or when
compliance is deemed attainable in the
foreseeable future.
                                     Slide 1: Definition
           \kRIANCE
                                         A Short-Term Modification
                                          from Meeting Applicable
                                          Water Quality Standards
                                                               »EPA
There are several key points to
remember regarding variances.
Slide 2:  Key Points
                                            KEY POINTS OF
                                               VARIANCES
                                      1. Temporary Exemptions
                                      2. Provide Alternative to Downgrading
                                      3. Determine Permit Limits For
                                        Discharger
                                      4. Established by States -
                                        Approved/Disapproved by EPA
                                      5. Subject to Public Review
                                      6. Incorporated into Water Quality
                                        Standards
                                      7. Analyses Similar to UAAs
                                     	&EPA
Water Quality Standards Academy
                         Participant Manual
                             !996 Edition
                                   15-3

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 Module 15
          — REGULATORY OVERVIEW AND HISTORY —

40 CFR 131.13 — States may include variances in their water quality standards and policies.
The variance policy originated in an Office of General Counsel (OGC) opinion, number 58, dated
March 29, 1977.
           — FACTORS FOR JUSTIFYING VARIANCES —
40 CFR 131.10(g) — Factors to be
used for justifying variances.
Slide 3: Factors
                                       FACTORS JUSTIFYING
                                              VARIANCES
                                      1. Naturally Occurring Pollution
                                      2. Natural Low-Flow Conditions
                                      3. Irretrievable Human-Caused
                                         Conditions
                                      4. Hydrologic Modifications
                                      5. Physical Conditions
                                      6. Substantial and Widespread Economic
                                         and Social Impact
                                                                 &EPA
EPA reviews and approves both the overall State variance policy and individual variances.
Water Quality Standards Academy
                          Participant Manual
                             1996 Edition
                                    15-4

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                                                                        Variances
Variances differ from use
recJassification, site-specific criteria,
and water quality standards compliance
schedules.
Slide 4: Differences-1
         DIFFERENCES
                                         i VARIANCES
                                            - Short-Term Criteria Change
                                         '   - Basic WQS Remain
                                         ! SITE-SPECIFIC CRITERIA
                                            - Permanent Change in WQS
                                            - Designated Use Unchanged
                                         i USE RECLASSIFICATION
                                         I   - Permanent Change in WQS
                                         '   - Criteria Also Change
                                         I WQS COMPLIANCE SCHEDULES
                                         ;   - In Permit or BMP to Meet WQS
                                            - No Subsequent Change in WQS
                                         ^	— & EPA
Variances determine the permit limits for discharges.

                   — BENEFITS AND PROBLEMS —

Variances from standards should be used only as a temporary measure and only where justified.
Benefits.
Slide 5: Intended Benefits
                                       r
                                                  BENEFITS
                                           A Variance Allows Time to
                                            Evaluate Attainability of
                                           Standards Prior to Forcing
                                               Expensive Controls
                                                                    &EPA
Water Quality Standards Academy
                                     15-5
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Module 15
Problems.
Slide 6:  Problems
                                    f
                                         PROBLEMS WITH
                                              VARIANCES
                                    i  • Used to Describe Other Actions
                                      • Sometimes Taken Without
                                    ,   Public Review and Revision
                                       Vague
A national program assessment conducted by EPA in 1990 indicated that States do not routinely
grant variances.
Some States provide a generic exception for nonpoint sources of pollution.
Water Quality Standards Academy
                         Participant Manual
                             1996 Edition
                                   15-6

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                                                             Variances
                         — SUMMARY —
                                 Slide 7: Summary 1
                                           \kRIANCES
                                     Short-Term Modifications
                                     from Meeting Water Quality
                                     Criteria
                                     Discharger-Specific for Same
                                     Factors Used for
                                     Downgrading
                                                          &EPA
                                 Slide 8: Summary 2
                                         KEY POINTS
                                    Temporary
                                    Alternative to Downgrading
                                    Allow Legal Permit Limit
                                    State Adopted - EPA Review
                                    Require Public Review
                                    Legally Enforceable
                                   	mEPA
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                                                           1996 Edition
                                15-7

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 Module 15
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     1996 Edition
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                                                                                  Review Questions
                                 REVIEW QUESTIONS
    True or False. Water quality standards variances are specifically provided for in the Clean Water
    Act.
2.  Variances are provided for in section	of the Water Quality Standards Regulation.

    a.  131.13
    b.  131
    c.  #58
3.  Which of the following is not a viable basis for granting a discharger a variance?

    a.  naturally occurring pollution
    b.  natural low-flow conditions
    c.  existing hydrologic modifications
    d.  economic impact to the discharger
4.  Which of the following is not true of a variance?

    a.  A variance is a short-term modification to the applicable water quality standards for a
       discharger.

    b.  Adoption of a variance is one way to change basic water quality standards.

    c.  Variances provide a means to temporarily change water quality standards.


5.  True or False. EPA has the authority to review each individual variance.
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     1996 Edition
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 /i%                  TRAINING MODULE  16:
  ,4i J/                   ECONOMIC CONSIDERATIONS


MODULE SUMMARY:

This module provides a basic understanding of when it is appropriate to consider economic
conditions within the water quality standards process and how to evaluate claims of adverse
economic impacts.


OVERALL OBJECTIVES:

To provide a basic understanding of what information is needed from both private and public entities
to demonstrate that water quality standards requirements will result in substantial and widespread
social and economic impacts.


MEASURABLE OBJECTIVES:

After completing this module, participants will be able to:
   •  Identify the components of the water quality standards process that allow for the consideration
      of economic factors
   •  Define substantial and widespread social and economic impacts to dischargers and
      communities
   •  Demonstrate usage of four types of financial tests to determine a private entity's financial
      health and ability to pay for pollution controls
   •  Evaluate the social costs to the surrounding community when an entity complies with
      pollution reduction requirements
   •  Identify information that public entities must present to demonstrate that a publicly financed
      project will cause substantial and widespread economic impact


LOGISTICS:

Teaching Method:  Lecture; Slides; Case study [Video — optional].

Approximate Presentation Time:  (I'/z hours; Lecture — 35 minutes; Case Study — 45 minutes;
[Optional Video — 15 minutes]; Review Questions — 10 minutes.)
Water Quality Standards Academy                                                 Participant Manual
                                                                            Update-I 1997
                                          16-1

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 Module 16
 Basic Course Reference Manual Documents:

 4  Water Quality Standards Handbook, Second Edition, August 1994.
    Appendix A:  Water Quality Standards Regulation:  40 CFR 131.10;  131.12; and 131.13.
    Appendix M:  Interim Economic Guidance for Water Quality Standards — Workbook
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                      MODULE 16 - OUTLINE
              ECONOMIC CONSIDERATIONS
                      — INTRODUCTION —

         [OPTIONAL VIDEO: ECONOMIC CONSIDERATIONS IN
                   WATER QUALITY STANDARDS]
   — WATER QUALITY STANDARDS PROCESS OVERVIEW -

Federal regulations are not intended to result in water quality standards that are so stringent that
compliance would cause severe economic impacts on communities.
To demonstrate economic hardship,
applicants must demonstrate substantial
and widespread economic and social
impacts.
                                  Slide 1: Where Considered
                                     \T7 Wf^          -m
                                     WH-fcjJvli* UN IJUlj
                                 PROCESS ARE ECONOMICS
                                         CONSIDERED?
                                   Use Attainability Analysis
                                                         .^gcc~x.
                                   Variances
                                   Antidegradation
                                                           &EPA
Use Attainability Analyses are assessments of the environmental and economic factors affecting the
attainment of a designated use.
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 Module !6

 40 CFR  131.13 - Variances may be granted to a polluting entity only if economic hardship can be
 demonstrated.
40 CFR 131.12 - Economic considerations are also part of the ani:idegradation policy. States may
lower water quality only if it is necessary to accommodate important economic or social
development.
Wastewater dischargers must consider all alternatives.
To demonstrate economic hardship two
conditions must be demonstrated.
Slide 2: Economic Impact
                                            ECONOMIC IMPACT
                                           SUBSTANTIAL:  Discharger Unable to
                                                           Afford the Necessary
                                                           Pollution Reduction


                                           WIDESPREAD:  Significant Adverse
                                                           Economic and Social
                                                           Impacts to the
                                                           Surrounding
                                                           Community
                                                                       wEPA
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                                                               Economic Considerations
             — REVIEW OF SPECIFIC APPLICATIONS —
The distinction between public and
private entities is critical in an
economic impact analysis.
Slide 3: Applicant Types
 TYPES OF APPLICANTS
                                        PRIVATELY
                                          OWNED
                             POINT
                           SOURCES
                                                  DISCHARGERS


                                         PUBLICLY               NONPOINT
                                          OWNED                  SOURCES
                                                                     wEPA
Publicly owned entities include

   •  publicly owned sewage treatment works:

   •  regional sewage authorities;

   •  roads; and

   •  other municipal infrastructure.

Privately owned entities include

   •  manufacturing facilities;

   •  agricultural operations;

   •  shopping centers and other commercial developments;

   •  residential developments; and

   •  recreational developments.
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 Module 16
 States, dischargers, and the general
 public take part in the development and
 implementation of water quality
 standards.
Slide 4: Roles and Reviewers
r ~\
ROLES AND
REVIEWERS
Dischargers
Analysis
V
Community
Public
Hearings
States & EPA
Review
                    — SUBSTANTIAL IMPACTS —
Financial analysis requires calculation
of project costs on an annual basis.
Slide 5: Pollution Control Costs
                                        POLLUTION CONTROL
                                                    COSTS
 Capital
 (or
 Investment)
 Costs

 Operation
 and
 Maintenance
 Costs
                                                     Spread
                                                     over
                                                     Time
                                                                 Total
                                                               ^> Annualized
                                                                 Cost
                                                     Annually L
                                                     Recurring
                                                                  •&EPA-
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                                                       Economic Considerations
                      — PUBLIC ENTITIES —
To determine if a community can
afford a project, two indicators are
considered jointly.
Slide 6: Affordabilitv
   AFFORDABBLITY FOR
       COMMUNITIES
                                     • MUNICIPAL AFFORDABILITY
                                      SCREENER
                                        Ability to Pay, by Household

                                     • SECONDARY AFFORDABILITY
                                        Community Assessment Indicators
                                                            &EPA
The Municipal Affordability Screener
answers the question:  Can community
households afford to pay the total
annual pollution control costs?
Slide 7: Affordability Screener
          MUNICIPAL
AFFORDABILITY SCREENER
                                    Average Annualized Cost per Household
                                         Median Household Income

                                    Used to Evaluate Expected Impacts to
                                    Households
Little Impact
< 0.8%
i Mid-Range
Impact
| 0.8% -1.5%
Large Impact
; >i.s%
                                                            &EPA
                        [CLASS EXERCISE]
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 Module 16
The Secondary Affordability Test
incorporates other factors that affect
whether or not a community can afford
to meet water quality standards.
Slide 8: Secondary Affordability
         SECONDARY
 AFFORDABILITY TESTS
                                      Debt Indicators (2 measures)
                                      Socioeconomic Indicators (2 measures)
                                      Financial Management Indicators
                                      (2 measures)
                                                             &EPA
For each measure, a score of 1. 2, or 3
is assigned.
Slide 9: Assessment
                                             SECONDARY
                                       AFFORDABILITY TEST
                                    METHOD OF ASSESSMENT
                                    For Each Measure, Assign Score, Where:
                                    *
                                               rp Range = 2 '-s^'
                                                            Strong = 3
                                    Cumulative Secondary Affordability
                                    Score Equals the Weighted Average of
                                    These Scores.
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                                                           Economic Considerations
Bond rating.
Slide 10:  Bond Rating
SECONDARY
AFFORDABILITY TEST
DEBT INDICATORS

Measure 1: Bond Rating
Measures of Credit Worthiness of a Community
Source of
Rating
S&P
Moody's
Weak
below BBB
below Baa
Mid-Range
BBB
Baa
Strong
above BBB
above Baa
                                                                 &EPA
Net debt relative to market value of

taxable property.
Slide 11: Net Debt Ratio
                                                SECONDARY
                                         AFFORDABILITY TEST
                                            DEBT INDICATORS
                                       Measure 2:.
                 OveraU Net Debt
                                                Market Value of Taxable Property

                                       Measures Debt Burden on Residents within the
                                       Community
Weak
>5%
Mid-Range, Strong
2% -5% ! <2%
                                                                 &EPA
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Module 16
Unemployment rate.
Slide 12: Unemployment Rate
                                          SECONDARY
                                    AFFORDABBLITY TEST
                                  SOCIOECONOMIC INDICATORS
                                  Measure 1:  Unemployment Rate


                                  Measures the General Economic Health of the
                                  Community
Weak
Above State
Average
Mid-Range
State
Average
Strong
Below State
Average
                                                         &EPA
Median household income.
Slide 13: Median Household Income
                                          SECONDARY
                                    AFFORDABELITY TEST
                                  SOCIOECONOMIC INDICATORS
                                  Measure 2: Median Household Income


                                  Provides Overall Indication of Community
                                  Earning Capacity
Weak
Below State
Average
Mid-Range
State
Average
Strong
Above State
Average
                                                         &EPA
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                                                           Economic Considerations
Property tax revenue to market value of

taxable property.
Slide 14: Tax Revenue Ratio.
                                               SECONDARY
                                         AFFORDABELITY TEST
                                      FINANCIAL MANAGEMENT INDICATORS
                                      Measure 1:
               Property Ta^Revenue
                                               Full Market Value of Taxable Property


                                      Measures Funding Capacity Available To

                                      Support Dept Based on Community's Wealth
                                            Weak  'Mid-Range:  Strong
                                             >4%
              2% - 4%
                                                                 &EPA
Property tax collection rate.
Slide 15: Collection Rate.
                                               SECONDARY
                                         AFFORDABILITY TEST
                                      FINANCIAL MANAGEMENT INDICATORS
                                      Measure 2: Property Tax Collection Rate


                                      Measures How Well the Local Government Is

                                      Administrated
                                            Weak  Mid-Range  Strong
                                            <94%  94%-98%   >98%
                                                                 -EPA
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Module 16
When calculating the Cumulative
Secondary Affordability Score, all six
measures are given equal weight.
Slide 16:  Cumulative Assessment
  CUMULATIVE SECONDARY
     AFFORDABILITY TEST
           ASSESSMENT
                                         Average the Scores of All Measures
                                              Weak   iMid-Range,  Strong
                                               2.5
For Example:
                     1+3
                                                                  + 3 = 12
                                                                  12/6 = 2
                                          Community Falls within Mid-Range
                                                                   & EPA
The combination of the Secondary
Assessment Score and the Municipal
Affordability Screener indicates the
community's ability to pay for
proposed pollution control
Slide 17:  Matrix.
 ASSESSMENT OF SUBSTANTIAL
        IMPACTS MATRIX
Secondary
Assessment
Score
<1.5
1.5-2.5
>2.5
Municipal Affordability
Screener
<0.8% 1 0.8 -1.5%
? K
• ?
• •
>1.5%
*
X
9
                                         ? = Questionable affordability
                                         • = Community can afford the pollution control
                                         X = Community- cannot afford the pollution control
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                                                              Economic Considerations
                        — PRIVATE ENTITIES —
Four financial tests are commonly used
to measure different aspects of a
private entity's financial health-
Slide 18: Private Entities Tests
      TESTS To MEASURE
      ECONOMIC IMPACTS:
        PRIVATE ENTITIES
                                        LIQUIDITY - How Easily an Entity Can Pay Its
                                                   Short-Term Bills
                                        SOLVENCY - How Easily an Entity Can Pay Its
                                                   Fixed and Long-Term Bills
                                        LEVERAGE -How Much Money the Entity Can
                                                   Borrow
                                        EARNINGS - How Much the Entity's
                                           f-       Profitability Will Change with the
                                          '•"£\      Additional Pollution Control

                                        —^	&EPA-
The combined results of the financial tests are intended to answer the question of whether or not the
entity can afford to pay these costs.
Liquidity.
Slide 19:  Liquidity
                                             LIQUIDITY TEST
                                         CURRENT  _  Current Assets
                                           RATIO     Current Liabilities
                                             Should Be Greater Than 2
                                                                      EPA
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 Module 16
 Solvency.
Slide 20: Solvency
                                         SOLVENCY  TEST
                                     BEAVER'S _Cash flow per Given Year

                                      RATIO     Total Debt of the Entity
                                         > 0.20 Indicates Entity Is Solvent
                                      < 0.15 Indicates Entity May Go Bankrupt
                                                              &EPA
Leverage.
Slide 21: Leverage
                                         LEVERAGE  TEST
                                      DEBT-TO-
                                       EQUITY
                                        RATIO
                 Amount Firm Has
                  Borrowed (Debt)

                    Amount of
                Stockholders' Capital
                     (Equity)
                                     The Larger the Ratio, the Less Likely That
                                     the Entity Will Be Able To Borrow Funds

                                     	&EPA-
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                                                               Economic Considerations
Earnings.
Slide 22:  Earnings
                                              EARNINGS  TEST
                                          PRE-TAX
                                         EARNINGS
                    ANNUALIZED
               —    POLLUTION
                  CONTROL COST
                                           Compare Result with Entity's Revenues
                                          to Measure Post-Compliance Profit Rate
                                                                     &EPA
The results of the four tests should be considered jointly.
Ratios and tests should be compared over several years-
Financial ratios also should be compared against those of "healthy" entities.
The role the entity plays in a parent firm's operations should be considered.
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 Module 16
                   — WIDESPREAD IMPACT —
Three steps are involved in evaluating
the social costs of pollution control
requirements.
Slide 23: Social Costs

   STEPS TO EVALUATE
  COMMUNITY IMPACTS
                                     Define the Affected Community
                                     Evaluate Community's Current
                                     Characteristics
                                     Evaluate How Characteristics
                                     Would Change if Discharger Must
                                     Meet Water Quality Standards
                                                          &EPA
The interdependence of the entity and
the affected community is a major
factor in demonstrating that impacts are
not only substantial but also
widespread.
Slide 24: Contrbution
          ENTITY'S
 CONTRIBUTION TO THE
       COMMUNITY
                                     Contributes to Economic Base
                                   (Property Taxes and Employment)
                                    Provides Product or Service upon
                                     Which Other Businesses or the
                                         Community Depend
                                                          &EPA
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                                                                  Economic Considerations
 Factors that indicate the current health
 of the local economy may include
 information considered when
 calculating the Cumulative Secondary
 Affordabilitv Score.
Slide 25: Socioeconomic Health
  COMMUNITY'S CURRENT
 SOCIOECONOMIC HEALTH
                                           • Median Household Income
                                           • Unemployment Rate
                                           • Rate of Industrial Development
                                           • Developing and Declining Industries
                                           • Percent of Households Below Poverty Line
                                           • Ability of Community to Carry More Debt
                                           • Local & Regional Factors
                                                                         &EPA
Other applicable information on the local and regional economy should also be reviewed:

   •  the annual rate of population change;

   •  current financial surplus as a percentage of total expenditures;

   •  the percentage of property taxes actually collected:

   •  property tax revenues as a percentage of the market value of real property;

   •  overall debt outstanding as a percentage of market value of real property;

   •  overall debt per capita; and

   •  the percentage of outstanding debt due within 5 years.
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Module 16
The analysis should consider how the
community will be affected by
development of the project.
Slide 26: Adverse Impacts
     PROJECTED ADVERSE
  SOCIOECONOMIC IMPACTS
          OF PROJECT
                                        • Property Values
                                        • Employment Rate
                                        • Commercial Development Opportunities
                                        • Tax Revenues
                                        • Expenditure on Social Services
                                                                  &EPA
One of the most serious impacts to communities is the loss of employment.
Affected communities may be faced with impaired development opportunities.
State-level impacts include

   •  loss of revenues; and

   •  increased expenditures.
                            [CLASS EXERCISE]
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                                                                                  Review Questions
                                 REVIEW  QUESTIONS

 1.   True or False,  Social and economic impacts may be grounds for a change in a designated use
     of a waterbody or for a variance from water quality standards if they would  cause the
     discharger substantial hardship.
 2.   Which of the following are financial tests commonly used to measure different aspects of a
     private entity's financial health?

     a.   solvency
     b.   earnings
     c.   liquidity
     d.   leverage
     e.   all of these (a-d) are financial tests
     f.   a, c, and d only
3.   True or False.  A private entity can fail one of the financial tests yet still be financially strong
     and stable.


4.   What steps must a private entity undertake in evaluating the social impacts of pollution control
     requirements on the surrounding community?

     a.   define the affected community
     b.   evaluate the current characteristics of the community
     c.   evaluate how community characteristics would change if the private entity must meet
          water quality standards
     d.   all of these (a-c) are steps
5.   True or False.  Whether or not a publicly financed project will impose substantial and
     widespread economic and social impacts on the community  depends only on the ability of the
     public entity to finance the capital cost of the pollution control project.
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 Module 16
 6.    In the case of a publicly funded project, when conducting an analysis of the affected
      community, which of the following factors should be considered?

      a.    percentage of households below the poverty line
      b.    median household income
      c.    State, regional, local economic health
      d.    rate of industrial development
      e.    developing and declining industries
      f.    a, b, and c only
      g.    all of these (a-e) are factors
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                        TRAINING MODULE  18:
               THE WATER QUALITY STANDARDS SUBMITTAL
                            AND APPROVAL PROCESS
MODULE  SUMMARY:

This module presents an overview of the administrative process required for submission of State
water quality standards. Further, it describes the process by which EPA reviews State- and Indian
Tribe-adopted water quality standards, the types of approval possible, and Federal promulgation
procedures.
OVERALL OBJECTIVES:

To present laws and regulations pertaining to State and Tribal submittal of water quality standards;
requirements for State standards, including definitions: administrative procedures, such as conduct of
public hearings; and the implications of a State's failure to submit standards.  Additionally, to
provide an understanding of the process by which EPA reviews water quality standards and the
criteria used for approval.
MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:
   *  Identify when States are required to review water quality standards
   •  Identify formal hearing requirements
   •  List State and Tribal submittal requirements for water quality standards
   •  Identify EPA's options if a State fails to submit standards
   •  Identify the components checked by EPA when reviewing a State's water quality standards
   •  Describe State actions required when EPA disapproves water quality standards
   •  Describe the process of Federal promulgation of standards
   •  Define conditional and partial approval of water quality standards
LOGISTICS:

Teaching Method:  Lecture (with slides).

Approximate Presentation Time:  1 hour (Lecture—45 minutes; Review Questions—15 minutes).
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 Module 18
 Basic Course Reference Manual Documents:

 1   Clean Water Act: sections 101(a)(2): 106: 303 (a)(3)(C); 303(c)(l); 303(c)(2)(A); 303(c)(3).

 4   Water Quality Standards Handbook, Second Edition, August 1994.
       Chapter 6:    Procedures for Review and Revision of Water Quality Standards.
       Appendix A:  Water Quality Standards Regulation:  40 CFR 131.4; 131.5; 131.12; 131.13;
                     131.20; 13).21(c).

 Other Documents:

    40 CFR Part 130 (EPA's Water Quality Management Regulation).

    40 CFR Part 25 (EPA's  Public Participation Regulation).
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                    MODULE 18 - OUTLINE
  THE WATER QUALITY STANDARDS SUBMITTAL
               AND APPROVAL PROCESS
         — LEGAL/REGULATORY REQUIREMENTS —

Clean Water Act, section 303(c)(l)—States are required to review their water quality standards at
least once every 3 years.
CWA, section 303(c)(2)(A).
Slide 1: CWA
                                  CLEAN WATER ACT
                                  SECTION 303(c)(2)(A)
                                                      XJ--V '•'
                                  Whenever a State Revises or
                                  Adopts a New Wa|ef%iiality
                                        idard, pSiall Be
                                        Submitted to the
                                          Iministrator

                                              	«EPA
CWA, section 303(c)(3)—EPA has the responsibility for reviewing State-adopted water quality
standards.
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 Module 18
 40CFR 131.6 and 131.20 —

 Requirements for State submittaL
Slide 2: 40 CFR 131.20
                                                40 CFR  131.20
                                            STATES MUST:
                                                                    ^ '
                                            • Review Water Quality Standards at
                                             Least Once Every 3      '
                                             Sub
                                             Region-
                                                    Public Hearing
                  Results to the EPA
                  istrator
                                                                       &EPA
It is strongly recommended that the State meet with EPA regional staff.
                      — PUBLIC INVOLVEMENT
A minimum of one public hearing must be held.
Hearings must be conducted in accordance with State law, 40 CFR Part 130 (EPA's Water Quality

Management Regulation), and 40 CFR Part 25 (EPA's Public Participation Regulation).
40 CFR 13I.20(c) — Submittal to EPA.
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                                                    The WQS Submittal and Approval Process
Submittal must include

   •  Use Attainability Analysis (UAA) supporting analysis,

   •  site-specific criteria methodologies.


   *  general policies, and

   •  standard revisions.
Public hearings are required by EPA
regulations and the Clean Water Act.
Slide 3: Public Hearings
                                            PUBLIC HEARINGS
                                          A Public Hearing Must Be
                                          Held When a State Changes
                                          any Element of a
                                          Standard
                                                                     &EPA
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 Module 18
40 CFR Part 25 — EPA's Public
Participation Regulation.
Slide 4: Formal Hearings
   FORMAL HEARINGS

  A Formal Public Hearing Requires a Notice
  45 Days Prior to the Hearing, Whichs »-
  Includes:                    ^
                           /&-
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                                           The WQS Submittal and Approval Process
               — SUBMISSION REQUIREMENTS —
40 CFR 131.6 — Elements of             Slide 5: 40 CFR 131.6-1

Submittal.
                                  SUBMITTAL ELEMENTS

                                        40 CFR 131.6

                                  1. Use Designations Consistent with
                                    the Act            ^ ^
                                  2. Methods and Analyses Used
                                  3. Water Quality Criteria to
                                    Prolit Uses/':'
                                  4. Antide^radation Policy and
                                    Implementation Procedures
                                 Slide 6: 40 CFR 131.6-2
                                  SUBMITTAL ELEMENTS

                                        40 CFR 131.6
                                  5. Information to Support UsefNot
                                     Specified in Section 101(a)(2) of the
                                   6. General State Poficies Affecting
                                     Apf|ication said Implementation

                                   7- Attorney General Certification

                                                        •dSpi

                                                         &EPA
8. Informatv^i on Endangered Species ;
  Act
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 Module 18
                                CERTIFICATION
 EPA requires certification submitted by the State Attorney General to be assured that the standards
 under review legally apply in that State.
Certification is important because a State water quality standard remains in effect (even if EPA
disapproves it) until the State revises it or EPA promulgates a rule that supersedes it.
                          OTHER CONSIDERATIONS
If a State does not submit standards to EPA, the Agency will attempt to compel submission.  EPA
may also promulgate water quality standards for the State.

Two important components of State submittals are definitions and general information requested by
EPA.
                   — EPA REVIEW AND APPROVAL —

Both EPA regional offices and Headquarters review the draft and adopted State standards.
EPA checks to see that all seven elements of a standard have been submitted.
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                                           The WQS Submittal and Approval Process
EPA reviews State use classifications
for waterbodies.
Slide 7: Uses
                                     STATE STANDARDS
                                     SUBMISSION MUST
                                           INCLUDE:
                                    Use Classifications Consistent with
                                    the Act
                                    NOJWaste Transport or Waste
                                            n JJse Classification
                                  • Use Designations for All Waterbodies j
                                    AdequateWse Attainability Analysis I
                                                         &EPA
EPA reviews Use Attainability Analyses.


EPA reviews State-adopted criteria.
Slide 8: Criteria
                                     STATE STANDARDS
                                     SUBMISSION MUST
                                           INCLUDE:
                                                       rffi :
                                  Criteria Adequate to Protect
                                  Designated Uses    ^''""
                                   • Downstream Uses Protected

                                   • Adequate "Free-ifcom" Narrative Criteria

                                   • Adequara^nmeric Criteria

                                   • Criteria ffonferiority Toxic Pollutants

                                  	-&ERA-
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Module 18
EPA reviews State's antidegradation
policy.
Slide 9: Antidegradation
                                STATE STANDARDS
                                SUBMISSION MUST
                                     INCLUDE:
                               An Antidegradation Policy
                                     Meets Minimum
                                      uirements of
                                          131.12

                                                 &EPA
EPA reviews State's basis for
designating uses.
Slide 10: Analyses
                               STATE STANDARDS
                               SUBMISSION MUST
                                    INCLUDE:  ~
                              Information on Appropriate
                                  :hnical and Scientific
                               Daf&Mnalyses To Support
                              ChaniW in Designated Uses

                                       	—	-&EPA
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                                      The WQS Submittal and Approval Process
EPA also reviews general policies.
Slide 11: Policies
                                 STATE STANDARDS
                                 SUBMISSION MUST
                                      INCLUDE:  ^

                                 General Policies that Affect
                              Application and Implementation
                                            ; Zones
                                                   &EPA
                                       Low Flows

                                         nances
EPA reviews legal and administrative
procedures.
Slide 12: Legal
                                 STATE STANDARDS
                                 SUBMISSION MUST
                                      INCLUDE:  ^
                              Attorney General*! Certification
                               that^egal and Administrative  ;
                                 Procedures Were Followed
                                                   &EPA
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 Module 18
                      — REVIEW OPTIONS —
 The EPA review process is not subject
 to formal public review and comment.
Slide 13: Discussions
                                    EPA AND THE
                                       SHOULD C
                                  THROUGHjtHTREVIEW
                                                OCESS
                                                           &EPA
                               J
EPA reviews the time schedule
Slide 14: Schedule
                                        RE VIEW TIME
                                           SCHEDULE
                                   60 Days after Submittal - EPA Approves

                                   90 Days after Submittal - EPA Notifies
                                   State of Disapproval
                                   90 Days after Notification - State
                                   Must Revise Standards To Meet
                                   Requirements

                                   EPA Promulgation of Standards
                                   Will Be Prompt
                                                           &EPA
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                                          The WQS Submittal and Approval Process
A letter of disapproval will be sent to the Governor (or Governor's designee) specifying what
revisions must be adopted to obtain full approval.
Federal promulgation of standards
involves a rule-making action taken by
the EPA Administrator.
Slide 15:  Promulgation-!
 IF THE STATE FAILS TO
 REVISE ITS STANDARDS
                                      EPA Promulgates
                                      federal Standards
                                                        &EPA
                                Slide 16: PromuIgation-2
                                          FEDERAL
                                      PROMULGATION
                                         INCLUDES:
                                 Publication of Proposed Standard
                                 PubB| Hearings
                                 Public^mnients
                                 Publication of Final Standard

                                             —	——&EPA-
Water Quality Standards Academy
                      Participant Manual
                         1996 Edition
                               18-13

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Module 18

Conditional approvals can result in
standards that meet the requirements of
the CWA without Federal intervention.
Slide 17: Conditional
      CONDITIONAL
   APPROVAL MAY BE
        GRANTED/^

        IfThrfeAre
        oAeficiencies

           	&EPA
EPA may approve a portion of a
State's water quality standards.
Slide 18: Partial
                              PARTIAL APPROVALS
                               CAN BE GRANTED
                                 If a Portion^f the
                                    indards Meets
                                    Requirements
                                                 »EPA
Water Quality Standards Academy
                           18-14
                   Participant Manual
                      1996 Edition

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                                                    The WQS Submittal and Approval Process
                              — SUMMARY —
 Document submission.
Slide 19: Submission Summary
                                         WQS DOCUMENT
                                         SUBMISSION
                                          Provide
                                         Analyses to (
                                           Public
              Hold
             Public
             Hearing
                                                                NO REVISIONS

                                                               Submit Review Results
                                                                  to Regional
                                                                 Administrator
or
                                                                 ADOPT WQS
                                                                 REVISION

                                                               Submit WQS Revision,
                                                               Supporting infornutioD,
                                                               •ad Review Results to
                                                               Regional Administrator
                                                                     &EPA
Submission review.
Slide 20:  Review Summary
                                                WQS SUBMISSION
                                                                REVIEW
                                          EPA  L
                                         Reviews
             EPA Issues
             Conditional
              Approval
                                                     EPA Issues
                                                      Partial
                                                     Approval
                                                 lor    EPA    L |>  StjjteAdopts_J
                                                    Disapproves |— |0r
                                                                 > EPA Promulgates |

                                                                   — &EPA-
Water Quality Standards Academy
                                      18-15
                           Participant Manual
                               1996 Edition

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 Module 18
Water Quality Standards Academy
Participant Manual
      1996 Edition
                                                     18-16

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                                                                                  Review Questions
                                 REVIEW QUESTIONS

   1.    States are required by statute to review their water quality standards at least once every	
        years.

        a.  1
        b.  2
        c.  3
        d.  4
   2.   The State must submit the results of the review to the EPA regional review for approval
        within  	days after taking final  action.

        a.  15
        b.  30
        c.  60
        d.  90
   3.
Which of the following correctly completes this statement? The State Attorney General's
certification is important because if EPA disapproves a State's revised standards,	
       a.  The previously existing EPA-approved standards remain in place.
       b.  No standards are legally applicable until either the State revises the standards again or
           EPA promulgates Federal standards.
       c.  The State-adopted standards remain in effect until either revised by the State or
           superseded by a federally promulgated standard.
       d.  Federal standards automatically apply.
  4.   True or False.  It is possible in some States that a public hearing regarding water quality
       standards revisions will not be held.
  5.   True or False.  Definitions included in a State's water quality standard cannot be reviewed by
       EPA. because the Aaencv can review onlv standards that are defined as designated uses and
                          &   *              V                                 
-------
 Module 18
   6.   True or False.  EPA can promulgate State standards if the State does not submit adopted
        standards.
   7.   True or False.  EPA must either approve or disapprove the entire submission of State
       standards.
   8.   What information contained in the State's water quality standards does EPA review?

       a.  Uses and criteria only.
       b.  Uses, criteria, and antidegradation policy.
       c.  EPA reviews all information, including definitions.
   9.   True or False.  Unlike the State's review of standards, EPA's review of State standards and
       its decision to approve or disapprove is not subject to public notice and comment.
  10.   True or False.  When EPA disapproves standards, the State must submit a new standards
       package within 60 days.
  11.   When EPA allows the standards to go into effect but requires the State to perform specific
       actions in a timely manner, this is known as:

           a.  approval
           b.  partial approval
           c.  conditional approval
           d.  delayed approval
           e.  disapproval
Water Quality Standards Academy                                                      Participant Manual
                                                                                      1996 Edition

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                      TRAINING MODULE 19:
            ENDANGERED SPECIES ACT AND THE WATER QUALITY
                           STANDARDS PROGRAM
MODULE SUMMARY:

This module presents a brief overview of the Endangered Species Act (ESA) and how it relates to
the Water Quality Standards (WQS) Program.


OVERALL OBJECTIVES:

To provide an understanding of the relationships between the ESA and the WQS program and the
consultation requirements of the ESA.


MEASURABLE OBJECTIVES:

After completing this module, participants should be able to:

   •   Identify the responsibilities of the EPA and the states in the consultation process
   •   Describe the differences between formal and informal consultations
   •   Explain the importance of water quality for endangered species
   •   Define key terms related to the ESA
   •   Recognize potential problems associated with the coordination of the ESA and WQS


LOGISTICS

Teaching Method: Lecture with slides.

Approximate Presentation Time: 1 hour (Lecture—45 minutes; Review Questions—15 minutes).

Basic Course Reference Manual Documents:

15 Report to Congress:  Recovery Program - Endangered and Threatened Species.  1994. U.S.
   Department of the Interior. U.S. Fish and  Wildlife Service.
Water Quality Standards Academy
Participant Manual
    1996 Edition
                                      19-1

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 Module 19
Water Quality Standards Academy                                                            Participant Manual
                                                                                               1996 Edition
                                                    19-2

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                                                                     Handout 1-1: Course Instructors
                                COURSE INSTRUCTORS
 Charles Abernathy possesses a Ph.D. Degree from North Carolina State in physiology.  He
 completed a post doctoral program at Berkeley in toxicology.  For 10 years, Dr. Abernathy
 conducted research at the Veterans Administration on the pathophysiology of liver.

 Dr. Abernathy has worked in EPA's  toxic substances program and its drinking water program. He is
 currently a toxicologist in the Office  of Water. Dr. Abernathy has been a Water Quality Standards
 Academy Instructor since 1993.

 Kent Ballentine is one of the principle authors of the existing water quality standards regulation.
 Kent is Chief of EPA's Regulation and Policy Section in EPA's Standards and Applied Science
 Division in the Office of Water. He  conducts reviews of State and Indian Tribal water quality
 standards.  In addition, Kent provides guidance and assistance to EPA's 10  Regional Water Quality
 Standard Coordinators. Kent is trained both as an engineer and a lawyer.

 George Denning is an economist in the Engineering and Analysis Division within the Office of
 Science and Technology.  He conducts analyses on the economic impacts of effluent guidelines. In
 the past, he has  worked on the State Revolving Fund Program and on drinking water regulations.
 For the past 15 years, George has also served on the faculty of the Virginia Community College
 System;  he teaches microeconomics and macroeconomics to business leaders,  teachers, government
 executives, and undergraduate students.

 Frances A. Desselle is an employee of EPA. Her background is in education and the social
 sciences.  She is responsible for designing and implementing technical assistance,  training, education
 and other outreach and public information programs.  These programs are aimed at States, Indian
 Tribes, environmental, industrial and  other groups, including the public-at-large. She also provides
 technical expertise to other EPA program offices  and to other Federal agencies with respect to
 training, education and technical assistance activities.  Frances designed the Water Quality Standards
 Academy Basic  Course and she is charged with the responsibility for implementing it.

 George Gibson  possesses a Ph.D. Degree from Michigan State University in resource development
 and water resource management. Dr. Gibson has considerable experience in academia; he has been
 associated  with the University of Wisconsin, Michigan State University and the  University of
 Maryland.  Dr. Gibson is the coordinator or EPA's national biological criteria program.

 Susan Gilbertson is a program analyst at the EPA where she is responsible for reviewing State and
 Tribal Water Quality Standards, and developing guidance for use attainability  analyses.  She has
 Masters Degrees in cellular immunology from Michigan State University and  in public policy from
 the University of Chicago. Prior to joining EPA/HQ in 1996, she worked in EPA's Regional Office
 in Chicago. She has worked on a range of Great Lakes issues, including the Great Lakes Water
 Quality Guidance, Remedial Action Plans and Lakewide Management Plans.
Water Quality Standards Academy
                                             1-7
Participant Manual
   Update-1 1997

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 Module 1
 Russell Kinerson is Chief of the Exposure Assessment Branch in the Standards and Applied Science
 Division (SASD). Among his responsibilities in this branch are the technical aspects of the TMDL
 Program.  Russ came to the Office of Water (OW) in 1991 from the Office of Health and
 Environmental Assessment in the Office of Research and Development (ORD). Before that he ran
 the modeling program in the Office of Pollution Prevention and Toxics (OPPT). Before coming to
 EPA in 1980, Russ taught various ecology courses at the University of New Hampshire.  Ecology,
 mathematical modeling, human and environmental assessments;...that sounds like a total maximum
 daily load in its own right. Or is that an EMMHEA?

 Amy Leaberry is an  aquatic biologist at EPA.  She graduated from Bowling Green State University.
 Amy has worked with EPA's pretreatment program.  She currently develops national aquatic life
 criteria and she reviews site-specific criterion developed by States and Indian Tribes.  Amy has been
 a Water Quality Standards Academy Instructor since 1993.

 Edward V. Ohanian is a Chief Toxicologist and Technical Adviser within EPA's Office of Water.
 In this capacity, Dr. Ohanian provides expert guidance concerning multimedia risk assessment and
 science policy issues.  Prior to his current position, Dr. Ohanian managed the efforts of a
 multidisciplinary team of professions  responsible for conducting human risk assessments under the
 Safe Drinking Water Act and Clean Water Act.

 Before joining EPA in 1980, Dr. Ohanian was an Adjunct Clinical Associate Professor with the
 Health Sciences Center at the State University of New York at Stony  Brook and a Medical Scientist
 with the Environmental Health Sciences Program at Brookhaven National Laboratory.

 Dr. Ohanian received  his Bachelors in Biological Sciences from  Columbia University and his Masters!
 in Physiology from the New York Medical College. His Doctorate in Biomedical Sciences was
 obtained from Mount  Sinai School of Medicine in New York. His professional affiliations include
 the Society of Toxicology, Society for Risk Analysis, Society  for Environmental Geochemistry and
 Health (President, 1987-1989), and American Association for the Advancement of Science.

 Neil Patei manages economic and statistical  analyses support for the Water Quality  Standards and
 the Effluent Guidelines programs.  Prior to that he worked in EPA's Office of Pesticides and Toxic
 Substances and in the Office of Air and Radiation as the Senior  Chemical Engineer  supporting the
 Stratospheric Ozone Protection program.  Before joining EPA  in 1983, he worked for two major
 chemical companies for eight years as a senior product development/process engineer.

 Mary Reiley possesses a Masters Degree in environmental biology. For the first 6  1/2 years of
 Mary's tenure at EPA, she worked with EPA's National Pollutant Discharge Elimination Program
 (NPDES) enforcement program. Currently, she coordinates research in support of sediment quality
 criteria. She was involved in EPA's Endangered Species Act national consultation effort.

 Robert Shippen is an employee of the EPA.  He reviews water  quality standards  adopted by States
 and Indian Tribes. Prior to joining EPA, Bob worked in the monitoring program with the
government of the District of Columbia.  Bob has been an Instructor with the Water Quality
 Standards program since 1991.


Water Quality Standards Academy                                                    Participant Manual
                                                                                 Update-1 1997
                                             1-8

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                                                                      Handout 1-1:  Course Instructors
 Nortna Kay Whetzel is employed within EPA's Health and Ecological Criteria Division of the
 Office of Water. She is trained as a chemist. Her current responsibilities involve development of
 aquatic life criteria documents and she is a resident expert on metals issues.  Before joining the
 Office of Water, Norma worked in EPA's Office of Pesticides and Toxic Substances where she
 reviewed experimental data in support of pesticide registration and tolerance levels.  Norma has also
 worked as a bench chemist at the  National Institutes of Health in Bethesda, Maryland.
Water Quality Standards Academy                                                      Participant Manual
                                                                                    Update-1 1997
                                              1-9

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 To be distributed
                         Handout 5-1:  IRIS Record
                        IRIS RECORD FOR CADMIUM
0141
Cadmium:  CASEN 7440-43-9 (06/01/92)

Health risk assessment information on a chemical is included in IRIS only after a comprehensive
review of chronic toxicity data by work groups composed of U.S. EPA scientists from several
Program Offices. The summaries presented in Sections I and II represent a consensus reached in the
review process.  The other sections contain U.S. EPA information which is specific to a particular
Program Office. The regulatory actions in Section IV may not be based on the most current risk
assessment, or may be based on a current, but unreviewed, (e.g., treatment technology). When
considering the use of regulatory action data for a particular situation, note the date of the regulatory
action, the date of the most recent risk assessment relating to that action, and whether technological
factors were considered.  Background information and explanations of the methods used to derive the
values given in IRIS are provided in the five Background Documents in Service Code 5, which
correspond to Sections I through V of the chemical files.

STATUS OF DATA FOR  Cadmium
File On-Line 03/31/87

Category (section)

Oral RfD Assessment (LA)

Inhalation RfC Assessment (I.B)

Carcinogenicity Assessment (II.)

Drinking Water Health  Advisories (III.A)

U.S. EPA Regulatory Actions (IV.)

Supplementary Data (V.)
Status

on-line

pending

on-line

no data

on-line

no data
Last Revised

10/01/89



06/01/92



04/01/92
_ I.      CHRONIC HEALTH HAZARD ASSESSMENTS FOR NONCARCINOGENIC EFFECTS

_ LA.        REFERENCE DOSE FOR CHRONIC ORAL EXPOSURE (RfD)

Substance Name — Cadmium
CASRN - 7440-43-9
Last Revised - 10/01/89
Water Quality Standards Academy
                               Participant Manual
                                   1996 Edition
                                           5-25

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 Module 5
 The Reference Dose (RfD) is based on the assumption that thresholds exist for certain toxic effects
 such as cellular necrosis, but may not exist for other toxic effecr.s such as carcinogenicity. In
 general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily
 exposure to the human population (including sensitive subgroups) that is likely to be without  an
 appreciable risk of deleterious  effects during a lifetime.  Please refer to Background Document 1 in
 Service Code 5 for an elaboration of these concepts. RfDs can also be derived for the
 noncarcinogenic health effects  of compounds which are also carcinogens. Therefore, it is essential to
 refer to other sources of information concerning the carcinogenicity of this substance. If the U.S.
 EPA has evaluated this substance for potential human carcinogenicity, a  summary of that evaluation
 will be contained in Section II of this file when a review of that evaluation is  completed.

   I.A.1. ORAL RFD SUMMARY
Critical Effect
Significant
proteinuria
Human studies
involving chronic
exposures
Experimental Doses*
NOAEL (water): 0.005
mg/kg/day
NOAEL (food): 0.01
mg/kg/day
UF
10
10
MF
1
1
Rfd
5E-4
mg/kg/day
(water)
1E-3
mg/kg/day
(food)
U.S. EPA, 1985
'Conversion Factors: See text for discussion

«< Cadmium  >»

_ I.A.2. PRINCIPAL AND SUPPORTING STUDIES (ORAL RfD)

U.S. EPA.  1985. Drinking Water Criteria Document on Cadmium.  Office of Drinking Water,
Washington, DC. (Final draft)

A concentration of 200 jig cadmium (Cd)/gm wet human renal cortex is the highest renal level not
associated with significant proteinuria (U.S. EPA, 1985).  A toxicokinetic model is available to
determine the level of chronic human oral exposure (NOAEL) which results in 200 fig Cd/gm wet
human renal cortex; the model assumes that 0.01% day of the Cd body burden is eliminated per day
(U.S. EPA, 1985). Assuming 2.5% absorption of Cd from food or 5% from water, the toxicokinetic
model predicts that the NOAEL for chronic Cd exposure is 0.005 and 0.01  mg Cd/kg/day from water
and food, respectively (i.e., levels which would result in 200 ug Cd/gm wet weight human renal

Water Quality Standards Academy                                                    Participant Manual
                                                                                   1996 Edition
                                             5-26

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To be distributed
                                                           Handout 5-1: IRIS Record
cortex).  Thus, based on an estimated NOAEL of 0.005 mg Cd/kg/day for Cd in drinking water and
an UF of 10, an RfD of 0.0005 mg Cd/kg/day (water) was calculated; an equivalent RfD for Cd in
food is 0.001 mg Cd/kg/day (see Section VIA for references).

<«  Cadmium  »>

_ I.A.3.  UNCERTAINTY AND MODIFYING FACTORS (ORAL RfD)

UF = 10. This uncertainty factor is used to account for intrahuman variability to the toxicity of this
chemical in the absence of specific data on sensitive individuals.

MF= 1.

<«  Cadmium  >»

___ I.A.4.  ADDITIONAL COMMENTS (ORAL RfD)

Cd is unusual in relation to most, if not all, of the substances  for which an oral RfD has been
determined in that a vast quantity of both human and animal toxicity  data are available. The RfD is
based on the highest level  of Cd in the human renal cortex (i.e., the critical level) not associated with
significant proteinuria (i.e., the critical effect). A toxicokinetic model has been used to determine the
highest level of exposure associated with the lack of a critical effect.  Since the fraction of ingested
Cd that is absorbed appears to vary with the source (e.g., food vs. drinking water), it is necessary to
allow for this difference in absorption when using the toxicokinetic model to determine an RfD.

<«  Cadmium  >»

   I.A.5.  CONFIDENCE IN THE ORAL RfD
Study:
Data Base:
RfD:
Not applicable
High
High
The choice of NOAEL does not reflect the information from any single study.  Rather, it reflects the
data obtained from many studies on the toxicity of cadmium in both humans and animals. These
data also permit calculation of pharmacokinetic parameters of cadmium absorption, distribution,
metabolism and elimination. All of this information considered together gives high confidence in the
data base. High confidence in either RfD follows as well.

<« Cadmium »>
Water Quality Standards Academy
                                                                 Participant Manual
                                                                      1996 Edition
                                             5-27

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 Module 5
_ I.A.6. EPA DOCUMENTATION AND REVIEW OF THE ORAL RfD

U.S. EPA.  1985. Drinking Water Criteria Document on Cadmium.  Office of Drinking Water,
Washington, DC. (Final draft)
Agency RfD Work Group Review: 05/15/86, 08/19/86, 09/17/87, 12/15/87, 01/02/88, 05/25/88

Verification Date:   05/25/88
_ I.A.7. EPA CONTACTS (ORAL RfD)

Ken Bailey / ODW -- (202)260-5535 / FTS 260-5535

Warren Banks / OWRS -- (202)260-7893 / FTS 260-7893



_ I.B.    REFERENCE CONCENTRATION FOR CHRONIC INHALATION EXPOSURE (RfC)

Substance Name — Cadmium
CASRN - 7440-43-9


A risk  assessment for this substance/agent is under review by an EPA work group.



_ n.      CARCINOGENICITY ASSESSMENT FOR LIFETIME EXPOSURE

Substance Name — Cadmium
CASRN -- 7440-43-9
Last Revised - 06/01/92

Section n provides information on three aspects of the carcinogenic risk assessment for the agent in
question; the U.S.  EPA classification, and quantitative estimates of risk from oral exposure and from
inhalation exposure.  The classification reflects a weight-of-evidence judgment of the likelihood that
the agent is a human carcinogen. The quantitative risk estimates are presented in three ways.  The
slope factor is the  result of application of a low-dose extrapolation procedure and is presented as the
risk per (mg/kg)/day.  The unit risk is the quantitative estimate in terms of either risk per ng/L
drinking water or risk per ^g/cu.m air breathed.  The third form in which risk is presented is a
drinking water or air concentration providing cancer risks of 1 in  10,000, 1 in 100,000 or 1 in
1,000,000. Background Document 2 (Service Code 5) provides details on the rationale and methods
used to derive the  carcinogenicity values found in IRIS.  Users are referred to Section I for
information on long-term toxic effects other than carcinogenicity.
Water Quality Standards Academy                                                  Participant Manual
                                                                                1996 Edition
                                           5-28

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 To be distributed                                                          Handout 5-1: IRIS Record


 _ H.A.   EVIDENCE FOR CLASSIFICATION AS TO HUMAN CARCENOGENIOTY

 _ II.A. 1.     WEIGHT-OF-EVIDENCE CLASSIFICATION

 Classification — Bl; probable human carcinogen

 Basis — Limited evidence from occupational epidemiologic studies of cadmium is consistent across
 investigators and study populations. There is sufficient evidence of carcinogenicity in rats and mice
 by inhalation and intramuscular and subcutaneous injection.  Seven studies in rats and mice wherein
 cadmium salts (acetate, sulfate, chloride) were administered orally  have shown no evidence of
 carcinogenic response.

 <«  Cadmium  >»

 _ ILA.2.     HUMAN CARCINOGENICITY DATA

 Limited.  A 2-fold excess risk of lung cancer was observed in cadmium smelter workers.  The cohort
 consisted of 602 white males who had been employed in production work a minimum of 6 months
 during the years 1940-1969.  The population was followed to the end  of 1978. Urine cadmium data
 available for 261 workers employed after 1960 suggested a highly  exposed population.  The authors
 were able to ascertain that the increased lung cancer risk was probably not due to the presence of
 arsenic or to smoking (Thun et ah, 1985).  An evaluation by the Carcinogen Assessment Group of
\ these possible confounding factors has indicated that the assumptions and methods used in
 accounting for them appear to be valid. As the SMRs observed were  low and there is a lack of clear
 cut evidence of a causal relationship of the cadmium exposure only, this study is considered to
 supply limited evidence of human carcinogenicity.

 An excess lung cancer risk was also observed  in three other studies which were, however,
 compromised by the presence of other carcinogens (arsenic, smoking)  in the  exposure or by a small
 population (Varner, 1983; Sorahan  and Waterhouse, 198; Armstrong and Kazantzis, 1983).

 Four studies of workers exposed to cadmium dust or fumes provided evidence of a statistically
 significant positive association with prostate cancer (Kipling and Waterhouse, 1967; Lemen et ah,
 1976; Holden, 1980; Sorahan and Waterhouse,  1983), but the total number of cases was small in
 each  study. The Thun et ah (1985) study is an update of an earlier study (Lemen et ah, 1976) and
 does  not show excess prostate cancer risk in these workers. Studies of human ingestion of cadmium
 are inadequate to assess carcinogenicity.

 <«  Cadmium >»
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                                                                                   1996 Edition
                                             5-29

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 Module 5

 _ JI.A.3.    ANIMAL CARONOGENICITY DATA

 Exposure of Wistar rats by inhalation to cadmium as cadmium chloride at concentrations of 12.5, 25
 and 50 ug/cu.m for 18 months, with an additional 13-month observation period, resulted in
 significant increases in lung tumors (Takenaka et al., 1983).  Intratracheal instillation of cadmium
 oxide did not produce lung tumors in Fischer 344 rats but rather mammary tumors in males and
 tumors at multiple sites in males (Sanders and Mahaffey, 1984). Injection site tumors and distant
 site tumors (for example, testicular) have been reported by a number of authors as a consequence of
 intramuscular or subcutaneous administration of cadmium metal and chloride, sulfate, oxide and
 sulfide compounds of cadmium to rats and mice (U.S. EPA,  1985). Seven studies in rats and mice
 where cadmium salts (acetate, sulfate, chloride) were administered orally have shown no evidence  of
 a carcinogenic response.

 <« Cadmium  >»

 _ II.A.4.    SUPPORTING DATA FOR CARdNOGENICITY

 Results of mutagenicity tests in bacteria and yeast have been inconclusive. Positive responses have
 been obtained in mutation assays in Chinese hamster cells (Dom and V79 lines) and in mouse
 lymphoma cells (Casto, 1976; Ochi  and Ohsawa,  1983; Oberly et al., 1982).

 Conflicting results have been obtained in  assays of chromosomal aberrations  in human lymphocytes
 treated in vitro or obtained from exposed workers. Cadmium treatment in vivo or in vitro appears to
 interfere  with spindle formation and to result in aneuploidy in germ cells of mice and hamsters
 (Shimada et al.,  1976; Watanabe et al., 1979; Gilliavod and Leonard, 1975).
	<«  Cadmium »>—
_ H.B.   QUANTITATIVE ESTIMATE OF CARCINOGENIC RISK FROM ORAL EXPOSURE

Not available.  There are no positive studies of orally ingested cadmium suitable for quantification.
	<« Cadmium >»-
_ H.C.   QUANTIFICATION ESTIMATE OF CARCINOGENIC RISK FROM INHALATION
         EXPOSURE
   ILC.1.
SUMMARY OF RISK ESTIMATES
Inhalation Unit Risk - 1.8E-3 per ((ag/cu.m)
Water Quality Standards Academy
                                                              Participant Manual
                                                                   1996 Edition
                                           5-30

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 To be distributed
                                              Handout 5-1: IRIS Record
 Extrapolation Method —  Two stage; only first affected by exposure; extra risk
!
 Air Concentrations at Specified Risk Levels
  Risk Level
  Concentration
  E-4 (1 in 10,000)
  E-5 (1 in 100,000)
  E-6 (1 in 1,000,000)
 <« Cadmium >»
  6E-2 ug/cu.m
  6E-3 jjg/cu.m
  6E-4 jag/cu.m
_ ILC.2.    DOSE-RESPONSE DATA FOR CARCINOGENICITY, INHALATION EXPOSURE

Tumor Test -  lung, trachea, bronchus cancer deaths
Test Animals — human/white male
Route —  inhalation, exposure in the workplace
Reference  - Thun et al., 1985



No. of Expected
lung, Trachea
Observed No.
and Bronchus of Deaths (lung,
Cumulative
Exposure
(mg/day/cu.m)
less than or
equal to 584
585-2920

Median
Observation
280

1210

24 hour/jug/cu.m
Equivalent
168

727
Cancers
Assuming No
Cadmium Effect
3.77

4.61
trachea,
bronchus
cancers)
2

7
   greater than or
    equal to 2921
4200
2522
2.5
The 24-hour equivalent = median observation x 1E+3 x 8/24 x 1/365 x 240/365.

<« Cadmium >»

_ II.C.3.     ADDITIONAL COMMENTS  (CARCINOGENICITY, INHALATION EXPOSURE)

The unit risk should not be used if the air concentration exceeds 6ug/cu.m, since above this
concentration the unit risk may not be appropriate.

<« Cadmium >»
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                                                    Participant Manual
                                                         1996 Edition
                                           5-31

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 Module 5
_ II.C.4.     DISCUSSION OF CONFIDENCE (CARCINOGENICITY, INHALATION
             EXPOSURE)

The data were derived from a relatively large cohort.  Effects of arsenic and smoking were accounted
for in the quantitative analysis for cadmium effects.

An inhalation unit risk for cadmium based on the Takenaka et al. (1983) analysis is 9.2E-2 per
(ug/cu.m). While this estimate is higher than that derived from human data [1.8E-3 per (ng/cu.m)]
and thus more conservative, it was felt that the use of available human data was more reliable
because of species variations in response and the type of exposure (cadmium salt vs. cadmium fume
and cadmium oxide.)
   	<« Cadmium  »>-
_ II.D.   EPA DOCUMENTATION, REVIEW, AND CONTACTS (CARCINOGENICITY
         ASSESSMENT)

_ H.D. 1.     EPA DOCUMENTATION

U.S. EPA. 1985. Updated Mutagenicity and Carcinogenicity Assessment of Cadmium:  Addendum
to the Health Assessment Document for Cadmium (May 1981, EPA 600/B-B1-023). EPA 600/B-83-
025F.

The Addendum to the Cadmium Health Assessment has received both Agency and external review.

<« Cadmium >»

_ II.D.2 REVIEW (CARCINOGENICITY ASSESSMENT)

Agency Work Group Review  -  11/12/86

Verification Date -- 11/12/86


_ II.D.3.     EPA CONTACTS (CARCINOGENICITY ASSESSMENT)

William E. Pepelko / ORD -- (202)260-5904 / FTS 260-5904

David Bayliss / ORD - (202)260-5726 / FTS 260-5726
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                                                             Handout 5-1:  IRIS Record
_ ffl.     HEALTH HAZARD ASSESSMENTS FOR VARIED EXPOSURE DURATIONS

_ ffl.A.      DRINKING WATER HEALTH ADVISORIES

Substance Name — Cadmium
CASRN - 7440-43-9

Not available at this time
_ m.B.  OTHER ASSESSMENTS

Substance Name - Cadmium
CASRN -  7440-43-9

Content to be determined.
  IV.
US EPA REGULATORY ACTIONS
Substance Name — Cadmium
CASRN - 7440-43-9
Last Revised  --  04/01/92

EPA risk assessments may be updated as new data are published and as assessment methodologies
evolve.  Regulatory actions are frequently not updated at the same time.  Compare the dates for the
regulatory actions in this section with the verification dates for the risk assessments in sections I and
II, as this may explain inconsistencies. Also note that some regulatory actions consider factors not
related to health risk, such as technical or economic feasibility.  Such considerations are indicated for
each action.  In addition, not all of the regulatory actions listed in this section involve enforceable
federal standards.  Please direct any questions you may have concerning these regulatory actions to
the U.S. EPA contact listed for that particular action.  Users are strongly urged to read the
background information on each regulatory action in Background Document 4 in Service Code 5.

_IV.A.  CLEAN AIR ACT (CAA)

No data available.
      -<«  Cadmium >»-
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 _ IV.B.  SAFE DRINKING WATER ACT (SDWA)

 _ IV.B.I.    MAXIMUM CONTAMINANT LEVEL GOAL (MCLG) for Drinking Water

 Value (status)  --  0.005 mg/L  (Final, 1991)

 Considers technological or economic feasibility?  -  NO

 Discussion  —  Cadmium has been classed as a Category HI contaminant with an MCLG of 0.005
 mg/L based upon reports of renal toxicity in humans. The MCLG is based upon a DWEL of 0.018
 mg/L and an assumed drinking water contribution (plus aquatic organisms) of 25 percent.  An
 uncertainty factor of 10 was also applied.

 Reference -  56 FR 3526 (01/30/91)

 EPA Contact  -  Health and Ecological Criteria Division / OST / (202)260-7571 / FTS 260-7571; or
 Safe Drinking Water Hotline / (800) 426-4791

 <« Cadmium >»

_ IV.B.2.    MAXIMUM CONTAMINANT LEVEL (MCL) for Drinking Water

 Value (status)  -  0.005 mg/L (Final,  1991)

 Considers technological or economic feasibility?  --  YES

Discussion  --  EPA has promulgated an MCL equal to the established MCLG or 0.005 mg/L.

 Monitoring requirements  —  Ground water systems monitored every three  years; surface water
 systems monitored annually; systems out of compliance must begin monitoring quarterly until system
 is reliably and consistently below MCL.

 Analytical methodology --  Atomic absorption/ furnace technique (EPA 213.2; SM 304); inductively
coupled plasma (200.7): PQL= 0.002 mg/L.

Best available technology  — Coagulation/filtration; ion exchange; lime softening; and reverse
osmosis.

Reference -  56 FR 3526 (01/30/91)

EPA Contact  ~  Drinking Water Standards Division / OGWDW / (202)260-7575 / FTS 260-7575;
or Safe Drinking Water Hotline / (800)426-4791

<« Cadmium >»
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__ IV.B.3.    SECONDARY MAXIMUM CONTAMINANT LEVEL (SMCL) for Drinking Water

No data available.

<« Cadmium  >»

_ IV.B.4.    REQUIRED MONITORING OF "UNREGULATED" CONTAMINANTS

No data available.


	<« Cadmium  >»	
_ IV.C.  CLEAN WATER ACT (CWA)

_ IV.C. 1.    AMBIENT WATER QUALITY CRITERIA, Human Health

Water and Fish Consumption:  1E+1 ug/L

Fish Consumption Only: None

Considers technological or economic feasibility? — NO

Discussion  — The criteria is the same as the existing standard for drinking water.

Reference  --  45 FR 79318 (11/28/80)

EPA Contact  --  Standards and Applied Science Division / OWRS  (202)260-1315 / FTS 260-1315

<« Cadmium  »>

_ IV.C.2.    AMBIENT WATER QUALITY CRITERIA, Aquatic Organisms

Freshwater:

   Acute — 3.9E+0 |jg/L (1-hour average)
   Chronic  —  1.1E+0 ng/L (4-day average)

Marine:

   Acute — 4.3E+1 ug/L (1-hour average)
   Chronic  —  9.3E+0 fig/L (4-day average)
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 Module 5
 Considers technological or economic feasibility? --  NO

 Discussion ~ Criteria were derived from a minimum data base consisting of acute and chronic tests
 on a variety of species. The freshwater criteria are hardness de-.pendent. Values given here are
 calculated at a hardness of 100 mg/L CaCO3.  A complete discussion can  be found in the referenced
 notice.

 Reference  -  50 FR 30784 (07/29/85)

 EPA Contact  -  Criteria and Standards Division / OWRS (202)260-1315  / FTS 260-1315


 	<« Cadmium >»	
_ IV.D.  FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)

_ IV.D.1.    PESTICIDE ACTIVE INGREDIENT, Registration Standard

Status  — Voluntary Cancellation [cadmium chloride] (1990)

Reference - 55 FR 31227 (08/01/90)

EPA Contact --  Registration Branch / OPP / (703)557-7760 / FTS 557-7760

<« Cadmium >»

	IV.D.2.    PESTICIDE ACTIVE INGREDIENT, Special Review

Action - Termination of Special Review (1991)

Considers technological or economic feasibility?  —  YES

Summary of regulatory action  —  All uses of cadmium pesticides canceled.
Criterion of concern:  oncogenicity, mutagenicity, teratogenicity, and fetotoxicity.

Reference - 56 FR  14522 (04/10/91)

EPA Contact -  Special Review Branch / OPP (703)557-7400 / FTS 557-7400
	<«  Cadmium »>-
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 _ IV.E.   TOXIC SUBSTANCES CONTROL ACT (TSCA)

 No data available.
     —<« Cadmium  >»--
 _IV.F.   RESOURCE CONSERVATION AND RECOVERY ACT (RCRA)

 _ IV.F.1.   RCRA APPENDIX IX, for Ground Water Monitoring

 Status - Listed

 Reference  -- 52 FR 25942 (07/09/87)

 EPA Contact -- RCRA/Superfund Hotline (800)424-9346 / (202)260-3000 / FTS 260-3000
      --<« Cadmium  >»--
 _IV.G.  SUPERFUND (CERCLA)
>
 	IV.G.l.   REPORT ABLE QUANTITY (RQ) for Release into the Environment

 Value (status)  -  10 pounds (Final, 1989)

 Considers technological or economic feasibility?  — NO

 Discussion —  The RQ for cadmium is 10 pounds, based on potential carcinogenicity.  Available
 data indicate a hazard ranking of medium, based on a potency factor of 57.87/mg/kg/day and weight-
 of-evidence group Bl,  which corresponds to an RQ of 10 pounds. Cadmium has also been found to
 bioaccumulate in the tissues of aquatic and marine organisms, and has the potential to concentrate in
 the food chain.  Reporting of releases of massive forms of this hazardous substance is not required if
 the diameter of the pieces released exceeds 100 micrometers (0.004 inches).

 Reference - 54 FR 33418 (08/14/89)

 EPA Contract  --  RCRA/Superfund Hotline (800)424-9346 / (202)260-3000 / FTS 260-3000
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 Module 5	

 _ V.      SUPPLEMENTARY DATA

 Substance Name -- Cadmium
 CASRN -  7440-43-9

 Not available at this time.
_ IV.     BIBLIOGRAPHY

Substance Name -  Cadmium
CASRN  -  7440-43-9
Last Revised ~  10/01/89
   VI.A.  ORAL RfD REFERENCES

Foulkes, E.G. 1986.  Absorption of cadmium.  In: Handbook of Experimental Pharmacology, B.C.
Foulkes, Ed. Springer Verlag, Berlin. Vol. 80, p. 75-100.

Friberg, L., M. Piscator, G.F. Nordberg and T. Kjellstrom.  1974.  Cadmium in the environment, 2nd
ed. CRC Press, Inc., Boca Raton, FL.

Shaikh, Z.A. and J.C. Smith. 1980.  Metabolism of orally ingested cadmium in humans. In:
Mechanisms of Toxicity and Hazard Evaluation, B. Holmstedt et al., Ed. Elsevier Publishing Co.,
Amsterdam, p. 569-574.

U.S. EPA.  1985.  Drinking Water Criteria Document on Cadmium.  Office of Drinking Water,
Washington, DC. (Final  draft)

WHO (World Health Organization).  1972.  Evaluation of certain food additives and the
contaminants mercury, lead, and cadmium.  Sixteenth Report of the Joint FAO/WHO Expert
Committee on Food Additives.  WHO Technical Report Series No. 505, FAO Nutrition Meetings
Report Series No. 51. Geneva, Switzerland.

WHO (World Health Organization).  1984.  Guidelines for drinking water quality -
recommendations. Vol.  1. Geneva, Switzerland.
    —<« Cadmium >»-

_ VLB.  INHALATION RfD REFERENCES

None

	<« Cadmium >»	
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Handout 5-1: IRIS Record
_ VI.C.   CARCINOGENICITY ASSESSMENT REFERENCES

Armstrong, E.G. and G. Kazantzis.  1983. The mortality of cadmium workers. Lancet. June 25,
1983: 1425-1427.

Casto, B.  1976. Letter to Richard Troast, U.S. EPA.  Enclosing mutagenicity data on cadmium
chloride and cadmium acetate.

Gilliavod, N. and A. Leonard.  1975.  Mutagenicity tests with cadmium in the mouse. Toxicology.
5: 43-47.

Holden, H.  1980.  Further Mortality studies on workers exposed to cadmium fumes.  Presented at
Seminar on Occupational Exposure to Cadmium,  March 20,  1980.  London, England.

Kipling, M.D. and J.A.H. Waterhouse.  1967. Cadmium and prostatic carcinoma.  Lancet.  1: 730.

Lemen, R.A., J.S. Lee, J.K. Wagoner and H.P. Blejer.  1976. Cancer mortality among cadmium
production workers. Ann. N.Y. Acad. Sci.  271:  273.

Oberly, T., C.E. Piper and D.S. McDonald.  1982. Mutagenicity of metal salts in the L5178 Y
mouse lymphoma assay.  J. Toxicol. Environ. Health.  9: 367-376.

Ochi, T. and M. Ohsawa.  1983.  Induction of 6-thioguanine-resistant mutants and single-strand
scission DNA by cadmium chloride in cultured Chinese hamster cells.  Mutat.  Res. Ill: 69-78.

Sanders, C.L. and J.A. Mahaffey. 1984.  Carcinogenicity of single and multiple intratracheal
instillations of cadmium oxide in the  rat.  Environ. Res. 33: 227-233.

Shimada, T., T. Watanabe and A. Endo.  1976. Potential mutagenicity of cadmium in mammalian
oocytes.  Mutat. Res.  40: 389-396.

Sorahan, T. and J.A.H. Waterhouse.  1983.  Mortality study of nickel-cadmium battery workers by
the method of regression models in life tables.  Br. J. Ind. Med. 40: 293-300.

Takenaka, S., H. Oldiges, H. Konig, D. Hochrainer and G. Oberdoerster.  1983.  Carcinogenicity  of
cadmium aerosols in Wistar rats.  J. Natl. Cancer Inst.  70: 367-373.

Thun, M.J., T.M. Schnorr, A.B. Smith and W.E. Halperin.   1985.  Mortality among a cohort of U.S.
cadmium production workers: An update. J. Natl. Cancer Inst. 74(2): 325-333.

U.S. EPA.  1985.  Updated Mutagenicity  and Carcinogenicity Assessment of Cadmium.  Addendum
to the Health Assessment Document for Cadmium (EPA 600/B-B1-023).  EPA 600/B-83-025F.
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 Module 5
 Varner, M.O.  1983. Updated epiclemiologic study of cadmium smelter workers.  Presented at the
 Fourth International Cadmium Conference. Unpublished.

 Watanabe, T., T. Shimada and A. Endo. 1979. Mutagenic effects of cadmium on mammalian
 oocyte chromosomes. Mutat. Res. 67: 349-356.

 	<« Cadmium  »>	
  VI.D.  DRINKING WATER HA REFERENCES
None
  vir
REVISION HISTORY
Substance Name  —  Cadmium
CASRN  - 7440-43-9
Date
05/21/87
03/01/88
03/01/88
03/01/88
03/01/88
01/01/89
01/01/89
08/01/89
10/01/89
10/01/89
12/01/89
06/01/90
06/01/90
08/01/90
08/01/90
08/01/90
01/01/91
01/01/91
03/01/91
03/01/91
01/01/92
04/01/92
05/01/92
06/01/92
06/01/92
Section
n.c
II. A.I.
II.C.3.
II.C.4.
n.D.3.
IV.C.l.
IV.C.2.
VI.
LA.
VI.A.
I.B.
IV.A.l.
ILF.l
II.A.1.
II.A.2.
II.B.
II.
II.C.1.
II.A.1.
II.B.
rv.
IV.A.l.
n.c.2.
n.A.2.
n.A.3
Description
Slope factor corrected
Text added
Text revised
Confidence statement revised
Secondary contact changed
Water quality human health criteria added
Corrected marine acute criterion
Bibliography on-line
Oral RfD summary on-line
Oral RfD references added
Inhalation RfD now under review
Area code for EPA contact corrected
EPA contact changed
Basis statement revised
Text revised, paragraph 1
Text revised
Text edited
Inhalation slope factor removed (global change)
Text revised
Text revised
Regulatory actions updated
CAA regulatory action withdrawn
Number correction in data table
Text revised, paragraph 1
Text clarified
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SYNONYMS

Substance Name  —  Cadmium
CASRN -- 744-43-9
Last Revised  --  03/31/87

7440-43-9
C.I. 77180
Cadmium
KADMIUM
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              Module 5
I
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                                                                    Handout 9-10: Site-Specific Criteria
                                                                                        Flow Chart
              Decisions to Be Made Before the Procedures for
               Developing Site-Specific Criteria Are Initiated
           Verify that site-specific criteria are actually needed (e.g., the use of clean sampling and/or
                 analytical techniques did not result in the attainment of current standards).
                                     Define the site boundaries.
       Determine whether data (in the national
       criterion document or other sources)
       indicate that the range of sensitivity of the
       selected resident species to the material of
       interest is different from that in the
       national criterion document (The
       variation in physical/chemical
       characteristics of site water is not expected
       to be a factor.).
           Use the Recalculation Procedure.
Determine from the national criterion
document and other sources if physical
and/or chemical characteristics are known
to affect the bioavailability and/or toxicity
of the material of interest (The range of
sensitivity of resident species is similar to
that used for the national criterion
document)
                                             -
  Use the Water-Effect Ratio Procedure.
       If both of these conditions exist and are to be taken into account, use the Recalculation Procedure
                          in conjunction with the Water-Effect Ratio Procedure
                                              OR
                                 Use the Resident Species Procedure.
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                                                                     Handout 9-11:  Class Exercise
             DEVELOPMENT OF SITE-SPECIFIC  CRITERIA

NOTE:            This exercise provides a highly simplified example of some of the considerations
                   and processes States or dischargers need go through to develop site-specific
                   criteria.  For more complete step-by-step procedures and discussion of which
                   steps require prior U.S. EPA approval, please refer to Appendix L of the Water
                   Quality Standards Handbook, included as Tab 4 of your Reference Manual.

INSTRUCTIONS:  Read the following scenario and then the class will read the review questions.
                   together.  The instructor will call on individuals to answer the questions.

    Gob Bog, located near a former mining operation, in Newiandia (our 51st state) has been
monitored by the Newiandia Water Quality Agency quarterly for the last  5 years for water quality
parameters including both total and dissolved metals concentrations. Both the total and dissolved
concentrations of metallium have been found to consistently exceed the criterion continuous
concentration (CCC) listed in the national criterion document for metallium (5 ug/L). The national
CCC for metallium was calculated from the Genus Mean Acute Values (GMAVs) of salmonids,
catfish, amphipods, and mayflies and acute-to-chronic ratios. Newiandia does not yet have State
water quality criteria established.
    The bog is approximately 300 acres in size and has an average depth of 1 foot in the rainy
months, although it dries down in summer months. The bog does not provide habitat for any species
of bony fish for any part of their life cycles, and none of the species in the bog are considered to
have recreational or commercial importance. It does, however, provide critical habitat for several
aquatic insects, macroinvertebrates, and amphibians, including the endangered Sally's salamander
(Sallius salamanderus). The most notable water quality characteristics of this bog include a slightly
lowered pH (slightly acidic) and a hardness of 60 mg/L. (Average or default water hardness is
usually considered to be approximately 100 mg/L.)
    Sally Mander is a citizen of Newiandia who, in the  early 1900s, actually discovered and named
the now endangered Sally's salamander. Her son, a professor of biology  at Newiandia University,
oversees  graduate work conducted at the bog.  Because of her intimate involvement with this species,
Mrs. Mander has carefully tracked the  decline of the salamander for decades.  Mrs. Mander, her son,
and several graduate students have collected data and performed toxicity tests that demonstrate the
salamander's sensitivity to metallium and have sent the data to  U.S. EPA for approval.
1. There are at least three reasons why derivation of a site-specific criterion might be considered at
   this site. List as many as you can.
2. Our site is defined as the bog only.  Before the site-specific criterion derivation procedure is
   initiated, some data quality issues should be considered. What are these?

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3. It turns out that the quality of the water monitoring data for the Gob Bog is satisfactory. What
   procedures should we use to derive site-specific criteria in this case? Why?
4. If you selected the Recalculation Procedure (by itself or in conjunction with the Water-Effect
   Ratio fWER] Procedure), you should read through the simplified steps listed under this item
   number and answer the appropriate questions. Remember, if the two procedures are to be used
   together, the Recalculation Procedure should be completed first.

NOTE:    The National Toxics Rule does not allow the use of the Recalculation Procedure to
          develop site-specific criteria.  Newlandia is not within a National Toxics Rule jurisdiction.

   a. Make any U.S. EPA-approved corrections to the national data set. This is a requirement for
      the Recalculation Procedure.  No corrections are necessary at this time.

   b. Make U.S. EPA-approved additions to the national data set. Mrs. Mander started this process
      for Newlandia.  Newlandia has received approval from U.S. EPA on the GMAV and chronic
      value for Sally's salamander calculated at Newlandia University and published in the Ecotox
      Journal of Science.

   c. Apply the deletion process, if desired.  More than half of the national data set for metallium
      was composed of data for bony fish; however, no bony fish occur in this bog. Although the
      bog does not provide habitat for salmonids and a second fish family recommended as the
      minimum data set for freshwater criterion derivation, the variety of aquatic  invertebrates and
      amphibians is sufficient to allow us to meet the eight-family minimum data set; therefore, we
      can proceed with the Recalculation Procedure.  Do you think the deletion of bony fish from
      the national data set will result in a lowering or raising of the criterion?

   d. Determine the new CCC or criterion maximum concentration (CMC) or both.  The table
      below presents the revised data base at the genus level. Using what was presented in the
      module and in Handout 9-9, briefly describe the procedures used to determine the new CMC
      and CCC.
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                                                                        Handout 9-11: Class Exercise
Scientific name
Stylaria spp.
Tubifex spp.
Libellula spp.
Daphnia spp.
Amnicola spp.
Rana spp.
Bufo americanus
Sallius spp.
Common name
annelid worm
tubificid worm
dragonfly
daphnid
snail
pickerel frog (egg)
toad (egg)
Sally's salamander
(egg)
(N)ational or (S)ite
Data Set
N, S
N, S
N, S
N,S
N, S
N, S
N, S
S
Chronic
Value
available
N/A
available
available
N/A
N/A
N/A
available
GMAV
Rank
6
5
2
3
8 (highest)
7
4
1 (lowest)
    e.  Report all findings to U.S. EPA for approval.  Our resulting criterion for metallium is
       0.5 ug/L.

5.  If you selected the WER Procedure, you should read through the  simplified steps listed under this
    item number and answer the appropriate questions. The WER concept involves two side-by-side
    toxicity tests—one test using laboratory dilution water and the other using site water. The
    endpoint obtained using  site water is divided by the endpoint obtained using laboratory dilution
    water.  The quotient is the WER, which is multiplied by the national, state,  or recalculated
    aquatic life criterion to calculate the site-specific criterion.

    a.  Before initiating the  WER Procedure, it is extremely important that all attempts at clean
       sampling and analytical procedures have been made.  The WER Procedure often derives a
       ratio of 1 or very close to 1 (i.e., having little, if any,  effect on the national criteria) and is
       expensive to implement.  The WER procedure may be used with only certain metals.  For the
       purposes of our example, we will pretend that metallium is  one of these.

    b.  Second, a method of deriving WERs is selected.  The  following two methods are available:
       Method 1  for determining WERs for areas in or near plumes,  and Method 2 for determining
       WERs  for areas away from plumes.  Because the bog  is located near the former mining
       operation, the bog has been determined to be within the plume; therefore, we  will use
       Method 1.
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    c.  The following flow chart gives an indication of the actual procedures involved in the WER
       process.  Based on what you know about the Newlandia bog, do you think the WER will
       effectively raise or lower the criterion for metallium?
       If the site water endpoint was 2.0 ug/L and the laboratory water endpoint was 4.0 ug/L, what
       is the final resulting site-specific criterion based on the methods you selected?
                                      WER Imptemanation
                              Lab Procedures   \
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                                                                     Handout 9-12: Video Transcript
                          Developing Site-Specific Criteria
                                       Video Transcript
                                          36 minutes
U.S. EPA
Office of Water
Office of Science and Technology
Standards and Applied Science Division
In this presentation we will discuss the development of site-specific numeric criteria for aquatic life and
the role they play in the water quality standards and criteria process. As part of our discussion, we will
focus on the indicator species criteria, one of the procedures which may be used to develop numeric site-
specific criteria.

To bring more meaning to the discussion, we first need to understand a few of the  important aspects of
the water quality standards and criteria programs. Under the Clean Water Act, States, Territories and
Indian Tribes that are authorized to  administer the water quality standards are required to set water
quality standards. Throughout this presentation, when I say "States," I am also including Territories and
Indian Tribes that are authorized to administer the program.

Water quality standards are  laws or regulations that consist of the designated use of a waterbody, or
segment of a waterbody, and the water  quality  criteria necessary to protect the  designated use.  In
addition to uses and criteria, water quality standards must contain an antidegradation policy and a method
for implementing it.  Examples of uses  are:  public water supply; fishing,  swimming and boating,
agricultural and industrial water supply; navigation; and other such purposes.  Keep in mind, uses may
exist currently, or they may be goals that could be obtained in the future with improved water quality.
As mentioned, criteria are designed to protect and support the use or uses.

Criteria can be expressed as numeric concentration  limits on a particular chemical that protect and
support a use, or as a narrative  description of a condition of a waterbody that protects and supports a
use.  When criteria are met, the  quality of the water should be  such that it protects the designated uses.
Today, EPA has published criteria to protect both human health and aquatic life.
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 Today we'll be focusing on developing site-specific aquatic life criteria. EPA's guidance for aquatic life
 criteria is generally used by the States as the basis for developing water quality criteria in their water
 quality standards.   EPA's criteria guidance is based on a broad spectrum of data and  is generally'
 sufficient to protect the aquatic life in all waterbodies.

 These criteria, although broad, may be adjusted to reflect  localized site-specific conditions when the
 national criteria  appear to be either significantly over- or under-protective.  Water quality criteria
 developed for a specific area is referred to as site-specific criteria.  Later in this presentation, I'll discuss
 the definition of a site. It does not necessarily mean a small localized area.  The need for this  site-
 specific  approach  may be due to differences in pollution sensitivity  of an  indigenous biological
 community or in the water chemistry of a specific site as it affects toxicity of a chemical.

 States have a  choice of adopting EPA's water quality criteria or adopting other criteria which are
 scientifically defensible, including site-specific criteria.  Thus, local conditions can  be used to derive
 criteria for a given waterbody at the option of a State. The process for developing site-specific criteria
 evolves from  EPA's national criteria development methodology.  This presentation  is based on  site-
 specific toxicity testing. Because EPA's  national criteria is determined in clean water, as it is intended
 to provide criteria applicable to virtually all waters in the entire nation, it may be over-  or under-
 protective at any specific site.

 Keep in mind, some  naturally  occurring  substances and  some introduced substances  are able  to
 chemically combine with metals and probably other pollutants. This occurrence in the ambient water
 can affect the bioavailability of the pollutant.  In other words, we want to determine how the pollutant!
 affects the test organism in site water when compared with its affect in laboratory water as presented
 in EPA's criteria document.

 Assessing bioavailability and establishing site-specific criteria for a pollutant can only be done currently
 with the use of biologically-based approaches.  Scientific knowledge has not yet progressed to allow
 methods, for example chemically-based procedures.

The first step to establishing site-specific criteria is to look at species sensitivity.  To determine if the
 species present at the site are either  more sensitive or less sensitive than those included in the National
 Criteria Database used by EPA.  Thus,  a recalculation adjustment is based on the sensitivity of the
biological community at the site.  If the recalculation procedure is insufficient  or  inappropriate, the
 second step requires biological toxicity testing.

Let's  proceed  with our discussion of developing site-specific criteria.  Specifically, we're talking about
 scientifically determined site-specific numeric criteria to protect aquatic life.  We won't be covering the
 narrative-based criteria in this presentation.
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WaierQuahty Standards Academy                                                       Participant Man
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                                               9-54

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                                                                       Handout 9-12: Video Transcript
Water quality criteria generally apply statewide, depending on  the specificity with which each State
identifies the aquatic life to be protected and on the type of waterbody.  The physical, chemical or
biological characteristics of certain waterbodies within a State may be so different that the national or
statewide water quality criteria might be over- or, infrequently, under-protective.  In such situations,
States, at their option, may use numeric criteria  that are specific to each site.  Thus the site-specific
numeric criteria replace the statewide numeric standards for a specific waterbody.

Once again,  one  reason it may be  desirable to  develop site-specific criteria is that an aquatic life
community that occurs in a particular waterbody may be either more or less sensitive to a pollutant than
the aquatic organisms used to develop the state  of EPA criteria.  For example, the National Criteria
Database contains data for various species of trout for fresh waters and pennate  shrimp for marine
waters.   These species  represent aquatic  life families known  to  be especially sensitive to certain
chemicals.  However, these or other sensitive species may not occur naturally at a particular site. They
may not be representative of those species that do occur at the site.  Conversely, untested sensitive
resident species may exist at a site, and they may need to be protected because they may be ecologically
or economically important.

Another reason for developing site-specific criteria is because of differences in the physical and chemical
characteristics of the water itself.  For example, it may be demonstrated  in the laboratory that the
characteristics of the water increase or decrease the toxicity of chemicals in the water, as compared with
waters used in developing the national criteria.  This applies to freshwater and saltwater environments.
Such characteristics of water include hardness, concentrations of paniculate matter, or dissolved organic
matter.

Next, let's  look at how site-specific criteria are proposed.   Any person, municipality, corporation, or
organization  can  propose site-specific criteria to a State.  The entity making the proposal  needs to
provide that data, and other information justifying the proposed site-specific criterion.  Here's a very
important point:  after determining the site-specific criterion, you may find that the result is a numeric
limit that is equal to, more stringent  than, or less stringent than EPA's national recommendation. The
State must review the data in the proposal, and  review the procedures that were used to collect and
analyze the data.  The State must then make a determination whether or not to adopt the proposed site-
specific criterion.  If adopted, EPA  then must review and approve,  or disapprove, the site-specific
criterion.

Let's review the three procedures, or protocols, which may be used to develop the numeric site-specific
criteria. They are: the recalculation procedure, the indicator species procedure (also known as  the water
affect ratio procedure), and the resident species procedure. The resident species procedure may involve
significant  amounts  of toxicity testing almost equivalent to complete development of a criterion by
EPA's methodology, and is therefore beyond the  scope of this discussion.
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The recalculation procedure may be used in situations where data exist which indicate that the sensitivity
of the species that occur at the site may be different from the sensitivity of one or more of the s
used by EPA to develop national criteria.  This procedure does not directly consider the physical and/o;
chemical characteristics of the site's water.

The indicator species, or water affect ratio procedure, may be used in situations where the indigenous
aquatic species and the species used to develop EPA's national criteria exhibit similar sensitivity to
pollutants of concern; but where the physical and/or chemical characteristics of the site's water may
result in differences between the local site and EPA criteria in terms of bioavailability and/or toxicity
of the pollutant of concern.

The recalculation procedure and the water affect  ratio may be used together in certain situations.
However, the recalculation procedure must be performed first.

Please note:  site-specific criteria can be developed for both acute  and chronic criteria.  Acute criteria
protect aquatic life from rapidly induced affects, usually death, in a short period of time.  Chronic
criteria protect aquatic life from adverse stimulus that lingers or continues for a relatively long period
of time.

Before we go into more detail on the protocols, it's important to know and understand the definition of
a site.  A site may be an area affected by a single point source discharge, or it may be quite a large area
encompassing an entire segment of a waterbody, such as a stream  segment affected  by sev«
discharges.  It can even be an entire State. For example, large portions of a waterbody, such as
of the Chesapeake Bay, Lake Michigan,  or the Ohio River, may  be  considered sites.  They may be
considered as one site because we may find that their respective aquatic communities or water quality
characteristics may be similar. Unique populations, or less sensitive uses of a segment of a waterbody,
may justify a designation as a distinct site or sub-site.

Let's  look at a hypothetical example which is based on an actual site. Here's the situation:

    The site is a  waterbody we  will classify as a river basin.  The State examined the river site
    because high metal loadings to the river resulted in occasional exceedances of its water quality
    criteria for lead and zinc under design flow conditions. There  are two point source discharges
    of treated sewage located upstream from where water sampling will take place.  One publicly
    owned treatment work (POTW) discharges roughly 400,000 gallons per  day of treated sewage
    near the headwaters of the stream, 13.5 miles upstream from where water sampling will take
    place.  By the way, a POTW is a waste treatment facility owned by a State, local government
    or Indian Tribe to treat wastewater.  A second  POTW discharges 350,000 gallons per day of
    treated sewage to the river 9 miles upstream from the sampling area. Although water quality is
    degraded somewhat in  the immediate vicinity  of these pollutant sources as  the river flows
    downstream,  it recovers  to  support a valuable recreational  trout fishery.   There  is also a
                                                                                            inua^
Water Quality Standards Academy                                                      Participant Main
                                                                                      1996 Edition
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                                                                      Handout 9-12: Video Transcript
   manufacturing company within the study area that discharges metal containing treated processed
   water to the river.  The manufacturing facility cleans, draws and coats metal wire. Wastewater
   is generated  during  the  wire cleaning and  coating  processes.   The treated wastewater  is
   discharged intermittently to the river.  The company's NPDES permit is due for renewal. The
   NPDES (National Pollutant  Discharge Elimination System) of this  company  specifies  an
   allowable daily discharge limit for lead and zinc. NPDES permits limit the quantity of pollutants
   discharged to a body of water.

An evaluation  by the State indicated that given  the present level of lead and zinc in the industrial
discharge, in comparison to the State criteria for these metals, aquatic communities should show evidence
of impact downstream from the point of release. In the evaluation, acute and chronic State criteria for
lead and zinc, which were the same as the national criteria, were compared with calculated instream
concentrations of the same metals. These calculations were made for the design low flow condition.

In terms of instream  biota in  the control zone  "Cl" upstream  from the  study area, the biological
community can be characterized as diverse, with many species being classified as sensitive with respect
to pollution tolerance.  The combination of high species diversity and pollution sensitive species indicate
good water quality.

Downstream from the two POTW discharges the community composition and the  diversity of taxa
remained acceptable in comparison with the upstream  controlled community.   The downstream
community exhibited the effects of organic enrichment, but not toxicity. While the bottom dwelling
organism community downstream did not return to or recover from conditions present in  the upstream
control zone, it was deemed satisfactory. Thus, there was evidence that the State criteria failed to predict
the actual instream condition, so the  State decided to establish site-specific  criteria.

In order to evaluate the effect of the  site's water on the toxicity of lead and  zinc, it was decided to use
site-specific criteria modification protocol.  The indicator species procedure  was  chosen for this
evaluation.  Remember, the indicator species, or water- effect ratio procedure, assumes the sensitivity
of the aquatic species at the site to  the pollutant of concern is similar to that of the species used to
develop the EPA national criteria, and that physical and/or chemical characteristics of the site's water
may  result in differences in terms of bio-availability and/or toxicity of the pollutant.   Therefore, it
accounts for the effective toxicity of  a chemical as a function of site water quality parameters, such as
pH, hardness, dissolved organic materials, and the presence of other contaminants.
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In this hypothetical example, the organic materials discharged by the POTW seem to reduce the toxicity
of zinc and lead discharged by the industry. EPA's 1993 recommended approach for determining water-
effect  ratios for rnetals, recommends testing of a sensitive primary species on at least three separate'
occasions, with a confirmation  test on a secondary species on at least one of those occasions.  In our
example, the State used a daphnia species as the primary test and rainbow trout as  the confirmatory test.
Here's how:

    The river water was withdrawn from station Cl and transported back to the laboratory along with
    samples of the industrial dischargers effluent.  Toxicity tests with laboratory reared daphnia were
    conducted in simulated downstream river water and in laboratory water after climatizing the test
    organisms in each. Simulated  downstream water is site water prepared by mixing effluent  and
    upstream water in the same ratio as actually occurs in the waterbody. Lead and zinc were added
    separately to both and simulated downstream river water and the laboratory water.  Testing is
    done for zinc in  one set of tests and for lead in another set of tests.  Separate analyses were
    performed for each metal.  For each metal, a 48-hour static  acute toxicity test with measured
    toxicant concentrations in a laboratory  beaker was conducted with laboratory reared daphnia on
    three separate occasions. Similarly, 96-hour  flow through acute toxicity tests with measured
    concentrations of toxicants were also conducted.

In the  study with rainbow trout, lead and zinc concentrations were measured respectively in the test
waters at the beginning of the test, after 48 hours, and at 96 hours.  LC50  values were calculated based
on concentrations at  the end of the test. LC50 is defined as the concentration of material that is
to 50% of the test organisms over  the specific time of observation. Analyses of effluent samples
the company's waste treatment  system  indicates  that  lead  and zinc  were  present  at expected
concentrations.  In the various dilutions tested, the addition of metal salts  to the simulated downstream
and laboratory water were at concentrations less than, equal to, or greater than EPA and State acute and
chronic water quality criteria under design low flow conditions.

In terms of the toxicity testing, static bioassays were  conducted exposing daphnia to  zinc and lead.
Based  upon  measured concentrations, the 48-hour LC50 values were determined  for simulated
downstream river water and for laboratory water, each spiked with either lead or zinc.  Flow through
bioassays with  either zinc or lead were also conducted for rainbow trout.  Assuming for this example,
that at  the times of sample collection the streamflow was sufficiently close to design flow, a geometric
mean of the data for  daphnia was taken. Results of this procedure show these findings:  from this data,
it appears that zinc and lead as  less toxic in river water than in laboratory water.
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     1996 Edition
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                                                                      Handout 9-12:  Video Transcript
Next, we want to perform the calculations of water-effect ratios.  In  1994 EPA issued the Interim
Guidance on Determination and Use of Water-Effect Ratios for Metals. EPA's current recommended
procedure for determining water-effect ratios for metals is based on the calculation of a water-effect ratio
for a primary species, which in this example is daphnia.  The water effect-ratio determines a correction
factor to quantify the difference between the toxicity of a pollutant  in site water as compared with
laboratory or reference water.

The water-effect ratio for acute criteria for a given toxicant is defined as the pollutant concentration at
the LC50 value in the stream water, effluent mixture, or other appropriate endpoints such as the EC50
value divided by the pollutant concentration at the corresponding test endpoint value in laboratory water.
Measured LC50 values for a toxicant should be somewhat different in the site and laboratory dilution
waters to calculate a water-effect  ratio. Ratios very close to 1 may indicate that there  is really no
difference.

Results for this study of our river for daphnia include:   the zinc water-effect ratio of 2.25,  which is
calculated as 900 micrograms per liter, divided by 400 micrograms per liter.  The lead water-effect ratio
was 4.19, which was calculated as 1300 micrograms per liter, divided by 310 micrograms per liter.

Please note  that in these examples, the concentrations are expressed as total recoverable  metal.  The
testing could have been  done for dissolved metal if the State standards were expressed as dissolved
metal.  For comparative purposes, the rainbow trout results  for zinc were 1.50, and for lead 3.69.  The
Interim Guidance on Determination and Use of Water-Effect Ratios for Metals recommends the use of
a test organism whose sensitivity is equal to or slightly less than the EPA  criteria.  In this example,
daphnia was selected as the primary test species. Less sensitive species like trout generally yield lower
water-effect ratios.  Thus, the final instream site-specific  criteria for zinc and lead are based on daphnia
data.  However, the trout data, while lower, are similar and thus  substantiate that the daphnia data are
reasonable.

For zinc, EPA's and the State's acute criterion at 50 milligrams per liter of hardness, is 65 micrograms
per liter.  This is multiplied by the water-effect ratio of 2.25 to yield a site-specific acute criterion of
146.2 micrograms per liter as total recoverable zinc.

To determine the site-specific chronic criterion, we will utilize an approach taken from EPA's Guidelines
for Deriving Numeric Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses,
published in  1985. The acute criterion is equal to one-half of the final acute value (FAV).  The chronic
criteria can be determined by dividing the FAV by the final acute to chronic ratio (ACR).   Therefore,
by multiplying the site-specific acute criterion by 2, we can obtain a site-specific FAV. The site-specific
chronic criterion is equal to the site-specific FAV divided by the national final
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Module 9
acute to chronic ratio. The site-specific acute criterion for zinc, 146.2, is multiplied by 2 then divided
by EPA's national acute to chronic ratio of 2.208, yielding a site-specific chronic criterion .of 132.4 ^
micrograms per liter as total recoverable zinc.

Let me also mention that the use of the national acute to chronic ratio is the simplest approach, however,
chronic testing for a chronic water-effect ratio  could have been performed.

For lead, EPA's and the State's acute criterion at 50 milligrams per liter of hardness is 34 micrograms
per liter. This is multiplied by the water-effect ratio of 4.06, yielding a site-specific acute criterion of
138 micrograms per  liter  as total recoverable lead.  The site-specific acute criterion for lead, 138
micrograms per liter  is multiplied by  2, then divided by EPA's recommended acute to chronic ratio
51.29, yielding a site-specific chronic criterion of 5.38 micrograms per liter as total recoverable lead.

To convert these instream site-specific  criteria to permit limits, generally would proceed without further
consideration of chemical partitioning between the total recoverable metal and the biologically available
metal.  Permit limits are  almost  always  expressed  as  total  recoverable  metal, so that no  further
corrections are required. In some cases, however, it may be necessary empirically evaluate how the total
recoverable metal in  an effluent changes chemical form upon discharge to a receiving water.  Such
translation  would be required if the site-specific criteria were determined as dissolved  criteria.
Translation  of such dissolved  criteria to total recoverable  permit limits can  be done by acquiring
appropriate chemical data during the performance of the toxicity testing.  This would be accomplished
by analyzing both dissolved and total recoverable metals.

Now let's summarize the study:

    The results of conducting the toxicity tests indicate that this river's water reduces the toxicity of
    lead and zinc relative  to  laboratory  water.   The difference in measured toxicity  between
    laboratory and simulated downstream site water, expressed as the water-effect ratio, was used to
    calculate a State site-specific criterion by modifying the national or State criteria.  The extent to
    which the river water reduces  bio-availability and toxicity can be examined by determining a
    water-effect ratio.  The  water-effect ratio of 2.25 was calculated for zinc, and a water-effect ratio
    of 4.19 was calculated  for  lead. These results are substantiated by similar toxicity testing of
    rainbow trout and by analyses  of the results of  instream biological survey.

Let's look at a list of factors which are  important to  keep in mind when performing a site-specific study.
Each of EPA's recommended procedures are appropriate for particular situations. The indicator species
procedure, for example, may be the most appropriate when some aspect  of the water's  quality affects
a pollutant's toxicity.  In performing a water-effects ratio  study, the test organism should be chosen by
examining the site and by using EPA's or the State's database  While not required, it  is generally best
to use sensitive species in the test,  and preferably the species EPA used to  calculate the national criteria.
Water Quality Standards Academy                                                       Participant Manu
                                                                                       1996 Edition
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                                                                     Handout 9-12:  Video Transcript
Select the appropriate toxicity testing method or protocol.  EPA recommends using it's own protocols
or those of the American Society for Testing Materials (ASTM).  Other scientifically defensible protocols
are  acceptable, however.

Determine how much testing will be required and the  appropriate period of time that will be required
to derive the site-specific criterion. Remember, the toxicity testing phase includes chemical  analysis,
toxicity testing, data analysis, and water-effect ratio computation, along with QA/QC procedures.  Use
clean techniques when  collecting samples  and performing  chemical  analyses to  help minimize
contamination of the samples. The work necessary to develop a site-specific criterion may be conducted
by a third party, such as an independent laboratory or a consultant.  Municipalities, corporations, and
other organizations may also do the necessary work. The State must review and analyze data presented
by the third party and make a decision on whether to adopt the site-specific criterion.  The State-adopted
site-specific criterion is then subject to EPA review and approval.

A more complete discussion of development of site-specific criteria using indicator species or water-
effect ratio procedures, is contained in the Interim Guidance on Determination and Use of Water-Effect
Ratios for Metals.  It also contains recommendations for clean sampling and analytical procedures.

The development of site-specific criteria is important to the development of State water quality standards
because they reflect local environmental conditions that are primarily the result of differences in the
indigenous biological community or in water chemistry.  Site-specific criteria are not needed in all
situations, however.  Therefore, it is strongly recommended that any party interested in proposing site-
specific criteria should involve the State and  the appropriate EPA regional office at the start of the site-
specific project.  This can facilitate the process by fostering an agreement concerning data needs, sources
for  generating new data, testing procedures to be followed, and QA/QC procedures.

Additional information about the water quality standards and criteria programs, including technical
assistance, can be obtained from EPA Headquarter's Office of Science and Technology, or EPA Regions
1-10.
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                                                               Handout 10-1: Program Applications
                      POTENTIAL CLEAN WATER ACT
               APPLICATIONS FOR SEDIMENT  CRITERIA
Section 104(n)(l)
Section 304(a)(l)
Section 304(a)(2)
Section 301
Section 402
Section 404
Section 104(n)(l) authorizes the Administrator to
establish national programs that study the effects of
pollution in estuaries, including sedimentation, on
aquatic life.

Section 304(a)(l) directs the Administrator to develop
and publish criteria for water quality that accurately
reflect the latest scientific knowledge in a wide range
of technical areas, including information on the
factors affecting rates of organic and inorganic
sedimentation for varying types of receiving waters.

                    — and —

Section 304(a)(2) directs the Administrator to develop
and publish information on, among other things, "the
factors necessary for the protection and propagation of
shellfish, fish, and wildlife for classes and categories
of receiving waters ..."

To the extent that sediment criteria can be developed,
they could also be used in implementing other
sections of the Clean Water Act.

When monitoring discharges under section 301, which
establishes effluent limitations, the analyzed
contaminated sediments could be compared with
sediment criteria to determine if any adverse risk is
possible or if remediation activities should be
considered.

Under section 402,  the National Pollutant Discharge
Elimination System (NPDES) Program could use
sediment criteria to assist in modifying discharge
restrictions when  establishing permit limits to prevent
even low levels of permitted chemical discharges
from adding to the current sediment contaminant
loads.

Sediment criteria  also could be used to help
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Module 10
                                             implement section 404, which regulates the discharge
                                             of dredged or fill material (sediments and debris
                                             removed from the bottom of a waterbody by a
                                             scooping or  suction device) into waters of  the United
                                             States, by evaluating sediments proposed for dredging
                                             and redisposal at an aquatic disposal site or by
                                             evaluating the suitability of a site for disposal of
                                             dredged materials (or the incremental addition of
                                             pollutants).
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                                                                    Handout 10-1:  Program Applications
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                                            10-19
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                                                                      Handout 10-2:  Class Exercise
                                  CLASS EXERCISE
The City of Some Place Else in Newlandia (our 51st state) is on the shores of the Lake TranquiJ, one
of the largest lakes in the country.  The Camotop River runs through the city  and empties into the
lake.  The river has historically been used as a commercial fishing port, for fish packing, and for
boat maintenance. The city was  built prior to controls for stormwater runoff and there are several
CSOs discharging to the river. One mile upstream from the mouth of the river is the now-abandoned
Never Ready Battery Plant which went out of business 15 years ago.

The bottom of the river is composed of materials ranging from fine silty clay  to bedrock.  Most of
the river bottom is covered with  varying thicknesses of silt, clay, sand, or gravel, and some sections
are limestone bedrock. The velocity of the currents dictates the bottom constituents; i.e., the
backwater and protected areas near the shoreline are dominated by silty clay ooze, and the majority
of the moderate velocity areas are fine gravel or medium sand.  River sediments continuously shift
and change in areas where velocities are moderate to high, resulting in shoaling in the dredged
navigation channels and considerable downstream transport od sediment.

Sediments in the Camotop River  are heavily polluted by the following contaminants: arsenic,
cadmium, chromium, copper, cyanide,  iron, lead, manganese, mercury, nickel, zinc, PCBs,  and oil
and grease.

The city is  now faced with the need to address the contaminated sediment issue.  Due to shoaling,
navigation is being impeded and  the fishing vessels are continually resuspending the sediments.
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                                                      Handout 10-3: Instructions for Class Exercise
                 INSTRUCTIONS FOR CLASS EXERCISE
The Blue Group — discuss steps for finding the contaminated sediments and determine how these
sediments can be assessed for their impacts on the environment.

The Red Group — come up with recommendations for implementing prevention and source controls
to reduce and prevent sediment contamination through permitting and enforcement activities.

The Green Group — develop a framework for determining when, how, and what degree
contaminated sediments should be remediated.

The Yellow Group — select appropriate disposal methods for removed contaminated sediments.
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                                                                         Handout 10-4:  Classification Methods
                             SEDIMENT CLASSIFICATION
                                            METHODS
                                               Type
Method
Numerical
Descriptive     Combination
Concept
Bulk Sediment Toxicity
Spiked-Sediment
Toxicity
Interstitial Water
Toxicity
Equilibrium Partitioning
Tissue Residue
                                                Test organisms are exposed to sediments
                                                that may contain unknown quantities oi
                                                potentially loxic chemicals. Ai the end
                                                of a specified time period, the response
                                                of the test organisms is examined in
                                                relation to a specified biological
                                                endpoint.

                                                Dose-response relationships are
                                                established by exposing test organisms
                                                to sediments that have been spiked  with
                                                known amounts of chemicals  or
                                                mixtures of chemicals.

                                                Toxicity of interstitial water is quantified
                                                and specific procedures are applied to
                                                identify and quantify chemical
                                                components responsible for sediment
                                                toxicity. The  procedures  are
                                                implemented  in three phases to
                                                characterize interstitial water toxicity,
                                                identify the suspected toxicant, and
                                                confirm toxicant identification.

                                                A sediment quality value  for a given
                                                contaminant is determined by  calculating
                                                the concentration at which the sediment
                                                particles and interstitial water  are both  at
                                                effects concentrations  (SQC and SCV).
                                                Below this concentration, the chemical
                                                will not cause toxic effects; above it, it
                                                is expected to cause toxic effects.

                                                Safe sediment concentrations of specific
                                                chemicals are  established  by determining
                                                the sediment chemical concentration that
                                                will result in acceptable tissue residues.
                                                Methods to derive unacceptable tissue
                                                residues are based on chronic  water
                                                quality criteria and bioconcentration
                                                factors, chronic dose-response
                                                experiments or field correlations, and
                                                human health risk levels from the
                                                consumption of freshwater fish or
                                                seafood.
                                                  10-25
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Module 10
                                                 Type
 Method
Numerical
Descriptive     Combination
Concept
 Freshwater Benthic
 Community Structure


 Marine Benthic
 Community Structure


 Sediment Quality Triad
 Apparent Effects
 Threshold
 International Joint
 Commission"
                                                  Environmental degradation is measured
                                                  by evaluating alterations in freshwater
                                                  benthic community structure.

                                                  Environmental degradation is measured
                                                  by evaluating alterations in marine
                                                  benthic community structure.

                                                  Sediment chemical contamination,
                                                  sediment toxicity, and benthic infauna
                                                  community structure are measured on
                                                  the same sediment. Correspondence
                                                  between sediment chemistry, toxicity,
                                                  and biological effects is used to
                                                  determine sediment concentrations that
                                                  discriminate conditions of minimal,
                                                  uncertain, and major biological effects.

                                                  An AET is the sediment concentration
                                                  of a contaminant above which
                                                  statistically significant biological effects
                                                  (e.g.,  amphipod mortality in bioassays,
                                                  depressions in the abundance of benthic
                                                  infauna) would always be expected.
                                                  AET  values are empirically derived
                                                  paired field data for sediment chem
                                                  and a range of biological effects
                                                  indicators and identifies a correlation
                                                  between toxic effects  and a chemical.

                                                  Contaminated sediments are assessed in
                                                  two stages:  1) an initial  assessment that
                                                  is based on macrozoobenthic community
                                                  structure and concentrations of
                                                  contaminants in sediments and biological
                                                  tissues, and 2) a detailed assessment that
                                                  is based on a phased sampling of the
                                                  physical, chemical, and biological
                                                  aspects of the sediment, including
                                                  laboratory toxicity bioassays.
   The 1IC approach is an example of a sequential approach, or "strategy" combining a number of methods for the
   purpose of assessing contaminated sediments in the Great Lakes.
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                                                                           Handout 11-1:  Maine
         NARRATIVE CRITERIA  WITHIN THE AQUATIC  LIFE
                  CLASSIFICATION SCHEME FOR MAINE
       RIVERS AND
         STREAMS
MANAGEMENT PERSPECTIVE
    NARRATIVE CRITERIA
     Class AA
High-quality water for preservation
of recreational and ecological
interests.  No discharges of any
kind permitted. No impoundment
permitted.
Aquatic life shall be as naturally
occurs.
     Class A
High-quality water with limited
human interference. Discharges
restricted to noncontact process
water or highly treated wastewater
of quality equal to or better than the
receiving water.  Impoundment
allowed.
Aquatic life shall be as naturally
occurs.
     Class B
Good-quality water.  Discharges of
well-treated effluents with ample
dilution permitted.
Ambient water quality sufficient to
support life stages of all indigenous
aquatic species. Only
nondetrimental changes in
community composition may occur.
     Class C
Lowest-quality water.
Requirements consistent with
interim goals of the Federal Water
Quality Law (ftshable/ swimmable).
Ambient water quality sufficient to
support the life stages of all
indigenous fish species.  Changes in
species composition may occur but
structure and function of the aquatic
community must be maintained.
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 Module  II
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                                                    Handout 11-2; Arkansas Narrative Criteria Example
          NARRATIVE CRITERIA EXAMPLE FOR ARKANSAS

               Fisheries:  Streams:  Ozark Highlands Ecoregion

 Fisheries - This beneficial use provides for the protection and propagation of fish, shellfish, and other
 forms of aquatic life. It is further subdivided into the following subcategories:

 Streams - Water which  is  suitable for the protection and propagation of fish and other forms of
 aquatic life adapted to flowing water systems whether or not the flow is perennial.

Ozark Highlands Ecoregion - Streams supporting diverse communities of indigenous or adapted
species of fish and other forms of aquatic life. Fish communities are characterized by a
preponderance of sensitive species and normally dominated by a diverse minnow community
followed by sunfishes and darters.  The community may be generally characterized by the following
fishes:
       Key Species
       Duskystripe shiner
       Northern hogsucker
       Slender madtom
       "Rock" basses
       Rainbow and/or Orangethroat darters
       Smallmouth bass
Indicator Species
Banded sculpin
Ozark madtom
Southern redbelly dace
Whitetail shiner
Ozark minnow

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                                                        Handout 11-3: Numeric Criteria for Ohio
               INDEX OF BIOTIC  INTEGRITY  (IBI)
                           FIVE OHIO ECOREGIONS
50
40
HH
ffl »
I-H
20
10

:JLL pj n
: (\ 2=i \ (—1
i
-
-
: I 1 1 ! 1
Huron- Intend Eastetn- Western Eastera
Erie Plateau Ontario Allegheny Com
Lake Ute Plateiu Belt
Flam Plain Plains
         Frequency distribution of Index of Biotic Integrity (IBI) results from individual samples
         collected at reference sites in each of the five Ohio ecoregions.
                                   Huron-Erie
                                   Lake Plain
             Eastern
            Com Belt
              Plains
                                                             Eastern-Ontario
                                                               Lake Plain
                  Interior
                  Plateau
                                                    Western
                                                   Allegheny
                                                    Plateau
         Biological criteria (based on 25%ile IBI values) in Ohio WQS for Warmwater Habitat.
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                                                                       Handout 11-4:  Model of the Process
           PROCESS FOR DEVELOPING AND IMPLEMENTING
                                BIOLOGICAL CRITERIA
                                  Evaluate Biocriteria Program Concept   I
                                    Formulate Biocrfteri* Approach   I
                                     Define Expected Conditions   I
                                Select Reference Sites and/or Condition
                                 Appropriate to Targeted Assemblages
                                      Develop Standard Protocols
                  Test Protocol
              Address Technical Issues
                                                              Modify/Refine Protocols   I
                                  Characterize Biological Integrity of
                                 Reference Conditions from Data Base
                      \  Step 2
                                        Establish Biocriteria
                      -(  Step 3
             Evaluate both the Biological
             and Physicochemical Data
             within an Ecological Context
 j   If Needed, Revise Approach
 I    Based on Evaluation Data
                                   Conduct Biosurveys at Test Sites
                                     (Determine Impairment within
                                      the Revised Framework)
                         Step 4

                         StepS
          i   Impaired Condition Detected   I
  No Impaired Condition Detected   I
            Diagnose Cause of Impairment   I
              Implement Control and
               Continue Monitoring
     No Action Required;
Continued Monitoring Recommended
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                                                                                   Handout 11-5: Field Data Sheet
                  HABITAT ASSESSMENT FIELD DATA SHEET
                                 RIFFLE/RUN  PREVALENCE
                                                                Category
     Habitat Parameter
       Optimal
      Suboptimal
       Marginal
        Poor
  1.   Bottom substrate/
      instream cover (a)
Greater than 50% mix of
rubble, gravel, submerged
logs, undercut banks, or
other stable habitat.
                 16-20
30-50% mix of rubble,
gravel, or other stable
habitat. Adequate habitat.

                11-15
 10-30% mix of nibble,
 gravel, or other stable
 habitat. Habitat
 availability less than
 desirable.
                                                                                      6-10
Less than 10% rubble,
gravel, or other stable
habitat. Lack of habitat
is obvious.

                 0-5
  2.   Embeddedness (b)
Gravel, cobble, and
boulder particles are from
0-25% surrounded by fine
sediment.
                 16-20
Gravel, cobble, and
boulder particles are from
25-50% surrounded by
fine sediment.
                11-15
Gravel, cobble, and
boulder particles are from
50-75% surrounded by
fine sediment.
                 6-10
Gravel, cobble, and
boulder particles are
over 75% surrounded by
fine sediment.

                 0-5
3. <0.15cms (5 cfs)-»
Flow at rep. low



OR
>0.15 cms
(5 cfs)->
velocity/depth



4. Canopy cover
(shading)
(c) (d) (g)





Cold >0.05 cms (2 cfs)
Warm >0.15 cms
(5 cfs)

16-20

Slow (<0.3 m/s), deep
(>0.5 m): slow, shallow
(<0.5 m); fast (>0.3 m/s),
deep; fast, shallow
habitats all present.
16-20
A mixture of conditions
where some areas of
water surface fully
exposed to sunlight, and
other receiving various
degrees of filtered light.

16-20
0.03-0.05 cms
(1-2 cfs)
0.05-0.15 cms
(2-5 cfs)
11-15

Only 3 of the 4 habitat
categories present
(missing riffles or runs
receive lower score than
missing pools).
11-15
Covered by sparse
canopy; entire water
surface receiving filtered
light.



11-15
0.01-0.03 cms
(0.5-1 cfs)
0.03-0.05 cms (1-cfs)

6-10

Only 2 of the 4 habitat
categories present
(missing riffles or runs
receive lower score).

6-10
Completely covered by
dense canopy; water
surface completely shaded
OR nearly full sunlight
reaching water surface.
Shading limited to
<3 hours per day.
6-10
<0.01 cms (0.5 cfs)
<0.03 cms (1 cfs)


0-5

Dominated by 1
velocity/depth category
(usually pools).


0-5
Lack of canopy, full
sunlight reaching water
surface.




0-5
 5.  Channel alteration (a)
Little or no enlargement
of islands or point bars.
and/or no channelization.
                                         12-15
Some new increase in bar
formation, mostly from
coarse gravel; and/or
some channelization
present.
                 8-11
Moderate deposition of
new grave], coarse sand
on old and new bars;
and/or embankments on
both banks.
Heavy deposits of fine
material, increased bar
development; and/or
extensive
channelization.
                                                              4-7
                                       0-3
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                                                                           Category
     Habitat Parameter
         Optimal
       Suboptimal
        Marginal
         Poor
       Bottom scouring and
       deposition (a)
 Less than 5% of ihe
 bottom affected by
 scouring and/or
 deposition.
                                                12-15
 5-30% affected. Scour at
 constrictions and where
 grades steepen.  Some
 deposition in pools.
                                              8-11
30-50% affected.
Deposits and/or scour at
obstructions, constrictions,
and bends. Filling of
pools prevalent.

                     4-7
More than 50% of the
bottom changing
frequently.  Pools almost
absent due to deposition.
Only large rocks in riffle
exposed.
                    0-3
7. Pool/riffle, run/bend
ratio (a) (distance
between riffles
divided by stream
width)

Ratio: 5 — 7. Variety of
habitat. Repeat pattern of
sequence relatively
frequent.

12-15
7-15. Infrequent repeat
pattern. Variety of
macrohabitat less than
optimal.

8-11
15-25. Occasional riffle
or bend. Bottom contours
provide some habitat.

4-7

>25. Essentially a
straight stream.
Generally all flat water
or shallow riffle. Poor
habitat.
0-3
  8.   Lower bank channel
      capacity (b)
Overbank (lower) flows
rare.  Lower bank W/D
ratio <7.  (Channel width
divided by depth or
height of lower bank.)
                   12-15
Overbank (lower) flows
occasional. W/D ratio 8-
15.
                                                                           8-11
Overbank (lower) flows
common.  W/D ratio 15-
25.
                                               4-7
Peak flows not contained
or contained through
channelization.  W/D
ratio >25.

                    0-3
 9.   Upper bank stability
      (a)
Upper bank stable.  No
evidence of erosion or
bank failure.  Side slopes
generally <30°. Little
potential for future
problems.

                    9-10
Moderately stable.
Infrequent, small areas of
erosion mostly healed
over. Side slopes up to
40° on one bank.  Slight
potential in extreme
floods.
                     6-8
Moderately unstable.
Moderate frequency and
size of erosional areas.
Side slopes up to 60° on
some banks.  High
erosion potential during
extreme high flow.
                     3-5
Unstable.  Many eroded
areas.  "Raw" areas
frequent along straight
sections and bends.  Side
slopes >60° common.

                   0-2
  10.  Bank vegetative
      protection (d)
 OR
      Grazing or other
      disruptive pressure (b)
Over 90% of the
streambank surfaces
covered by vegetation.
                    9-10


Vegetative disruption
minimal or not evident.
Almost all potential plant
biomass at present stage
of development remains.
                                                9-10
70-89% of the streambank
surfaces covered by
vegetation.
                     6-8


Disruption evident but not
affecting community
vigor.  Vegetative use is
moderate, and at least
one-half of the potential
plant biomass  remains.

                     6-8
50-79% of the streambank
surfaces covered by
vegetation.
                     3-5
Disruption obvious; some
patches of bare soil or
closely cropped
vegetation present. Less
than one-half of the
potential plant biomass
remains.
                     3-5
Less than 50% of the
streambank surfaces
covered by vegetation.
                    0-2


Disruption of
streambank vegetation is
very high.  Vegetation
has been removed to 2
inches or less in average
stubble height.

                    0-2
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                                                                                             Handout 11-5:  Field Data Sheet
                                                                        Category
     Habitat Parameter
        Optima]
      Suboptimal
       Marginal
Poor
  11.  Streamside cover (b)    Dominant vegetation is
                            shrub.
                         Dominant vegetation is of  Dominant vegetation is
                         tree form.                 grass or forbs.
                                               9-10
                                             6-8
                                             3-5
                         Over 50% of the
                         streambank has no
                         vegetation and dominant
                         material is soil, rock,
                         bridge materials,
                         culverts, or mine
                         tailings.
                                            0-2
  12.  Riparian vegetative
      zone width (least
      buffered side)
      (e) (f) (g)
>! 8 meters.
Between 12 and 18
meters.
                   9-10
                    6-8
Between 6 and 12 meters.   <6 meters.
                                                                      3-5
                                            0-2
  Column Totals
                Score
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                                                                 Handout 11-6:  Index of Biotic Integrity
                          INDEX OF BIOTIC INTEGRITY
The Index of Biotic Integrity (IBI) is commonly used for fish community analysis. The original IBI contains
12 metrics:

6 metrics evaluate species richness and composition:
    number of species
    number of darter species
    number of sucker species
    number of sunfish species
    number of intolerant species
    proportion of green sunfish

3 metrics quantify trophic composition:
    proportion of omnivores
    proportion of insectivorous cyprinids
    proportion of piscivores

3 metrics summarize fish abundance and condition information:
    number of individuals in sample
    proportion of hybrids
    proportion of individuals with disease or anomalies
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                                                           Handout 11-7: Regional IBI Matrix
          IBI Metrics Used in Various Regions of North America


Variations in IBI Metrics
1. Total Number of Species
# native fish species
# salmonid age classes
2. Number of Darter Species
# sculpin species
# benthic insectivore species
# darter and sculpin species
# yearling salmonids (Individ.)
% round-bodied suckers
# sculpins (individuals)

3. Number of Sunfish Species
# cyprinid species
# water column species
# sunfish and trout species
# salmonid species
# headwater species
4. Number of Sucker Species
# adult trout species
# minnow species
# sucker and catfish species
5. Number of Intolerant Species
# sensitive species
# amphibian species
presence of brook trout
6. % Green Sunfish
7c common carp
% white sucker
% tolerant species
% creek chub
% dace species
7. % Omnivores
% yearling salmonids
8. % Insectivorous Cyprinids
% insectivores
% specialized insectivores
# juvenile trout
% insectivorous species


Midwest
X


X





X

X




X
X

X

X
X


X


X


X

X



X

New
England
X




X







X



X



X





X



X


X





Ontario

X




X







X





X



X





X
X







Central
Appalachia
X


X

























X

X



X


Colorado
Front
Range
X


X







X







X

X





X



X
X


X



Western
Oregon

X
X

X



X



X




X
X


X




X





X

X




Sacramento-
San Joaquin
X

X





X

X




X


X




X












X

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Variations in IBI Metrics
9. % Top Carnivores
% catchable salmonids
% catchable trout
% pioneering species
Density catchable wild trout
10. Number of Individuals
density of individuals
11. % Hybrids
% introduced species
% simple lithophils
# simple lithophilic species
% native species
% native wild individuals
12. % Individuals with Diseases or
Anomalies


Midwest
X


X

X

X

X
X


X


New
England
X





X
X





X



Ontario
X




X







X


Central
Appalachia





X







X

Colorado
Front
Range





X


X




X


Western
Oregon

X



X


X




X


Sacramento-
San Joaquin


X

X
X





X
X


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    Update-1  1997
                                                    11-46

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                                                                 Handout 11-8: IBI Scoring Criteria
                             IBI  SCORING CRITERIA
  Example.  Index of Biotic Integrity Metrics and Scoring Criteria based on fish community data from
            more than 300 reference sites throughout Ohio.  These criteria apply to boat sites only.
Category
Species composition





Trophic composition


Fish condition


Metric
Total species
% Round-bodied suckers
Sunfish species
Sucker species
Intolerant species
% Tolerant (number)
% Omnivores
% Insectivores
% Top carnivores
% Simple lithophils
% Anomalies
Total fish numbers'

5
>20
>38
>3
>5
>3
<15
<16
>54
>10
>50
<0.5a
>450
Scoring Criteria
3
10-20
19-38
2-3
3-5
2-3
15-27
16-28
27-54
5-10
25-50
0.5-3. Ob
450-200

1
<10
<19
<2
<3
<2
>27
>28
<27
<5
<25
>3.0
<200
 aOr >1 individual at sites with <200 total fish.
 bOr >2 individuals at sites with <200 total fish.
 cExcludes tolerant species; special scoring procedures are used when relative numbers are less
  than 200/km.
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                                                                      Handout 11-9: IBI Worksheet
                                  IBI WORKSHEET

      Example.  Evaluation of the fish community at two sites in the Upper Hocking River
                during August-September 1982, using the Index of Biotic Integrity modified
                for application to Ohio waters (boat sites).

                Scores are assigned based on whether the individual metric values (in
                parentheses) approximate (5), partially deviate (3), or strongly deviate (1) from
                what is expected in a least impaired stream or river.
Sampling Station (River Mile)
82.4 78.3
IBI Metrics Sample:
Total Species
% Round-bodied Suckers
Sunflsh Species
Sucker Species
Intolerant Species
% Tolerant (number)
% Omnivores
% Insectivores
% Top Carnivores
% Simple Lithophils
% Anomalies
Total Fish Numbers
(Individuals)
1
(6)_
(4) 	
(2) 	
(2)__
(0) 	
(85) 	
(70) 	
(22)_
(7) 	
(22) 	
(10) 	
(8) 	
2
(5) 	
(0)_
(1) 	
(D_
(0) 	
(86) 	
(67) 	
(19) 	
(7) 	
(7) 	
(4) 	
(12) 	
3
(4) 	
(4) 	
(2) 	
(2)__
(0)_
(92) 	
(76)_
(20) 	
<4)_
(8) 	
(5) 	
(4) 	
1
(16) 	
(19) 	
(4) 	
(3)_
(0)_
(60) 	
(53)_
(36) 	
(5) 	
(60)_
(0.2) 	
(87) 	
2
(14) 	
(32)_
(3)_
(5)_
(0)_
(44) 	
(41) 	
(54) 	
(4) 	
(72) 	
(0.4) 	
(106) 	
3
(14) 	
(34) 	
(4)_
(3) 	
(0) 	
(42) 	
(38) 	
(50) 	
(10) 	
(57)_
(0.2) 	
(130) 	
Index Value
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                                                                           Handout 11-10: Transcript
                                 VIDEO  TRANSCRIPT
                            Development  of Biological Criteria
                                     19 minutes, 30 seconds
    The principal objectives of the Clean Water Act are to "restore and maintain the chemical,
 physical, and biological integrity of the nation's waters."  Thus, the condition of specific waters—or
 waterbodies—is determined from the combined measures of physical, . . . chemical, and
 . . . biological characteristics of each type of waterbody . . .

    This presentation provides an overview of the biological criteria that States and Indian Tribes are
 to adopt to meet the objectives of the Clean Water Act. More specifically,  I will be discussing
 biological  criteria as they relate to the water quality standards program.

    States adopt biological criteria into their water quality standards, which are subject to EPA review
 and approval under the Clean Water Act.  When I refer to States, I am also referring to Indian Tribes
 because Indian Tribes may qualify for treatment as States in the water quality standards program.

    . . .  Let's begin with some background.

    Water quality standards are  laws or regulations which consist of the designated use or uses of a
 waterbody or segment of a waterbody, and the water quality criteria necessary to protect the
 designated use or uses of that waterbody.  Examples of uses are public water supplies, propagation of
 fish and wildlife, recreational purposes, agriculture,  industrial uses, navigation, and other such uses.

    Criteria are limits—or carefully defined guidelines—on a particular pollutant or on the conditions
 of a waterbody that are designed to protect and support a use.  When criteria are met, water quality
 is at a level to protect designated uses.  Water quality standards also contain an  antidegradation
 policy and a method for implementing  it.  The antidegradation policy sets minimum requirements
 which conserve, maintain, and protect existing uses  and water quality.

    As I mentioned, the objective of the Clean Water Act is to preserve the chemical, physical, and
 biological integrity of the nation's waters.  Chemical and physical characteristics have long  been
 used to measure water quality.  However, as we learned more about aquatic life, it became apparent
 that biological evaluations were also of great importance.

   Biological criteria, or biocriteria (as they are usually called), are based on direct measures of the
 biological integrity of surface waters . . . and thus they provide a valuable assessment tool for
 evaluating  the quality of our  nation's waters.  Biocriteria augment, but do not replace, the chemical
 and physical elements of water quality  programs.

   A primary strength of biological criteria is that they detect water quality  problems that other
 methods may miss or underestimate. Procedures for developing biological criteria apply to  all
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 Module 11
 waterbodies, including rivers, streams, lakes, wetlands, estuaries, and coastal waters.  Biocriteria are
 expressed in terras of "narrative" statements or as "numeric" values that describe the biological
 condition of aquatic communities that live in waters of a given  "use" category.  Narrative biocriteria
 are general statements of attainable conditions such as fish communities as naturally  occur.  Such a
 statement may be further refined by lists of species one expect?; to find in a particular body of water.
 In the case of a mountain stream, the list may include "trout, sunfish and minnows."  Numeric
 biocriteria (as the name implies) are specific quantitative indicators of a condition of a waterbody.

    Numeric biocriteria may be measures of "community structure," such as the number of species in
 the aquatic community, or they may be  measures of "community function," such as nutrient cycling
 or the presence of different feeding mechanisms, for example, filter feeding, leaf shredding,  and
 predation.

    Now that you know more about what biocriteria are, and about the role they play, it's time to talk
 about how they are developed and implemented.

    As we consider the development and implementation of biocriteria for use in water  quality
 standards, we find that five major steps  are required.  The first step is to apply standard protocols.
 The second step is to establish reference conditions. The third step is to establish biocriteria.  The
 fourth step is to conduct a site survey, and the fifth step is to analyze data for impact.

    Now, let's take a closer look, starting with step 1.  A protocol would include the detailed
 instructions and procedures to be used to obtain information on  the aquatic life in the waterbody.
 This protocol also ensures a consistent method of data collection to provide that information.
 Basically, to standardize the protocols, each State should validate proposed protocols through pilot
 studies.  These pilot studies help to ensure that the protocols for the biocriteria program will provide
 reliable measures  of the biological condition of the surface waters of the State, test for impacts on
 waterbodies, and determine any impairment of waterbodies.  To assure that the results are
 scientifically sound, it is essential that each step employs reliable, standardized methods for
 measuring and comparing the biological status and integrity of any given waterbody.

    The next step is to establish reference conditions.  This is an important step because establishing
 reference conditions helps to set the biological condition that can be expected for the waterbody that
 is to be evaluated. In most cases, the reference  condition will be based on a site (or  sites) that are
 the least impacted or disturbed—and that is the closest to a pristine condition that can be found
 within that ecological region.  If one is to evaluate a small stream, the reference site  should be
 another stream of the same size and with similar characteristics.  Similarly, if one is to evaluate a
 lake, the reference site should be a lake  of comparable geographic  origin and in a natural or
 minimally developed condition.  Thus, the  reference site establishes the unimpaired baseline for
 comparison with the site to be evaluated (which is often referred to as the "subject waterbody").

   The methods that are used to characterize the reference condition will be the foundation of the
 biocriteria that are to be established, and they will be used to evaluate the  subject  waterbody for the
 purpose of making a determination of whether the attainment of a designated  "use" has been
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                                                                            Handout 11-10: Transcript
 achieved.  By designated "use" I mean the type or quality of the fishery or aquatic life "use" to be
 protected.  Examples of two designated uses are a cold water stream that supports trout or a warm
 water lake that supports bass.

    Now, with the standard protocols developed and reference sites established, the next step is to
 establish the biocriteria. Biocriteria are established by applying the standard protocols to the
 appropriate reference sites for each type of aquatic life "use" designation and waterbody.  The results
 of the biological surveys of the reference sites are evaluated, and are used to  set quantifiable
 measures of the reference conditions.  They are the standard by which the subject waterbody is
 evaluated.  These measures of the reference conditions constitute the primary element of the
 biocriteria, but are not the only basis for the biocriteria for the type of use designated for the subject
 waterbody.  States may decide to improve the subject waterbody beyond the present condition of the
 reference site.

    So, after the biocriteria have been set, the  State or Indian Tribe conducts a site survey of the
 subject waterbody for subsequent comparison with the appropriate biocriteria that have been
 established in Step 3.  To do this, a habitat evaluation must also be conducted to determine whether
 the physical environment at the subject waterbody sampling  site is comparable to that of the
 reference site from which the biocriteria were derived.  Assuming that the habitats match, a
 biological site survey is conducted to determine whether the  biological integrity of the subject
 waterbody is consistent with the biocriteria.  Keep in mind that the survey of the subject site must
 use the same biosurvey procedures and protocols that were used at the reference site.

    The final step in developing and implementing biocriteria is to analyze data for an impact to the
 subject waterbody by comparing the data from the biological survey of the subject site with the
 established biocriteria.  This final step requires the use of appropriate statistical  or modeling
 approaches to determine the  impairment of the subject waterbody in terms of the attainment or
 nonattainment of the designated aquatic life use.

    So, to summarize this point, there are the 5 basic steps in developing biocriteria as a part of the
 State's water quality standards program. To support  the quality and reliability of the biocriteria
 process, we must  also take into consideration three very important activities.  The first is the
 selection and evaluation of reference sites to support  development of biological  criteria. The second
 is the  proper measurement of the structure and function of the  aquatic community at reference and
 subject sites of comparable habitats, and the third is the analysis of the results of the biological
 survey of the subject waterbody to determine  impact  and  to determine attainment or nonattainment of
 a designated use.

    Let's explore them in more detail, one at a time.  In selecting and evaluating reference sites, keep
 in mind  that reference conditions should embody the  characteristics of waterbody segments that are
 the least impaired by human activities, and should represent the attainable biological conditions
 required by the aquatic  use the State or Indian Tribe wishes to protect.
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 Module 11

    There are two main approaches to establishing a reference condition.  One is to use site-specific
 reference sites within the same waterbody.  This is the case, for example, when an upstream site is
 used as a reference for a downstream subject location or when a nearby undeveloped coastal area is
 compared to a similar subject site. Site-specific references are useful in controversial situations.
 However, the site-specific reference approach may be too expensive if used routinely for every site
 evaluated, and it may prove to be unsatisfactory with multiple discharges such as sewer pipes and
 nonpoint sources such as runoff from large land areas.  Therefore, EPA also recommends the
 adoption of a second approach, the use of a regional reference site or sites.  These ecologically
 similar regional references form an excellent basis for comparison of many waterbodies.  As with
 site-specific references, the process of selecting and evaluating regional references must be well
 planned to meet scientific requirements, to maximize information, and to minimize cost.

    The U.S. EPA is currently helping States in these efforts.  EPA consults with States and assists
 each State as it designs regional or ecoregional data bases to fit the State's particular needs. Of
 course, the effective characterization  of the biological reference condition must include the actual
 measurement of the structure and  function of the selected aquatic community. The design must
 incorporate data collection protocols that ensure the optimal characterization of the component that
 best represents the State's surface waters.  In biological surveys, data collection protocols should
 incorporate the spatial and temporal scales that are responsible for much of the natural variability of
 aquatic systems.  For example, samples taken before and after the seasonal emergence of aquatic
 insects cannot be directly compared.  Many measures of the community structure and function can be
 used to describe the components of choice. An evaluation of the number of species is the simplest.
 However, EPA recommends a multiple-measure approach.  Examples include the Rapid
 Bioassessment Protocols developed by EPA.  Integrated measures such as these can be used to  help
 set the actual biocriteria for incorporation into  State water quality standards.

    The third activity is the analysis of the results.  Proper analysis of the findings is as important as
 using the appropriate evaluation methods and techniques. A complete discussion of the analysis
 process is beyond the scope of this presentation. Nevertheless, let me say again that use of
 biocriteria in water quality standards  requires careful application of established scientific  principles,
 methods, and statistical tools.  When impairment of the designated use is found,  the next step is to
 make a diagnosis of the probable cause. Obvious cases, such as point source discharges, are
 generally readily identifiable, but keep in mind that there may be other sources contributing to the
 impairment, such as nonpoint sources.  In cases where no obvious cases are observed, the diagnostic
 procedure becomes a repeated process of investigating and testing until the  causes are determined.

   Now let's review.  The development of biological criteria adds another dimension to physical and
 chemical criteria for a more integrated assessment of water quality.  Biological assessments, when
 used in conjunction with traditional methods, will give a better assessment of the overall ecological
 integrity of the subject water.  Narrative and numeric biological criteria are statements of the
 condition of aquatic biota that are attainable in order to meet a designated use or uses.  A reference
 condition must be selected that is representative of the least disturbed waterbodies for each
 designated use.  Biological surveys of subject waterbodies  and of reference waterbodies must be
 conducted in a standardized fashion, so that ecologically relevant and  statistically rigorous
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                                                                           Handout 11-10: Transcript
 conclusions are drawn.  A finding of waterbody impairment based on biocriteria must be confirmed
 by testing whether the  habitats of the reference and subject sites are, indeed, the same.  And, when
 findings and analyses show that a designated use has not been attained, a process of diagnosis of the
 cause of the impairment is to be undertaken. Biocriteria are an important addition to a State's water
 quality management program.  This will become increasingly apparent as more States incorporate
 biocriteria into their water quality standards. The EPA develops technical guidance and other
 information to assist the States in meeting the requirements of the water quality standards program.
 These informational materials are augmented by technical assistance workshops and individual
 consultations. Additional information about the water  quality standards program may be obtained
 from this address and from the following EPA  locations . . .
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                                                 Handout 12-1: Ecological Risk Assessment Framework
                      ECOLOGICAL RISK
            ASSESSMENT  FRAMEWORK
                                     Ecological Rusk Assessment
                                          PROBLEM
                                         FORMULATION
                                          f
                                                  E
                                            RISK
                                       CHARACTERIZATION
Acquisition,
n, and Moni
                                       Discussion Between the
                                     Risk Asjeisor and Risk Manager
                                          (Results)
                                       Risk Management
             Source: Framework for Ecological Risk Assessment. USEPA Risk Assessment Forum. 1992
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 Module 12
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TO BE DISTRIBUTED
Handout 12-2: Ecological Risk Assessment Case Study
                            CASE  STUDY  - MODULE 12
    This case is based upon a hypothetical example.
 Location and Watershed Description

    The Dan River lies in the Appalachian region of the southeastern United States. The watershed
 and its tributaries cover about 1500 square miles of varying terrain characterized by mountain ridges
 interspersed with broad floodplain valleys with rich soils.  The Dan River is part of the headwater
 system of the Mattapan River that flows to the Atlantic (see map 1). Average precipitation in the
 Dan River watershed is about 35 inches annually, falling mostly as rain—since snow is infrequent,
 except in the highest elevations.

    The Dan River watershed is comprised of a mosaic of forested lands, agricultural croplands, and
 grazing lands.  The forests are owned privately, and by the state and Federal governments and are
 dominated by mixed pine as well as ridgeline hardwoods.  Dan's Mountain National Forest, with its
 granite outcroppings, is highly valued by hikers and birdwatchers.

    The watershed has two medium sized towns (each  -25,000 people). The towns, East Bend and
 Little Falls are  the sites of local commerce and employment as well as the location of the area's two
 biggest manufacturing plants.  The H&T Paper Company has been making paper at Little Falls since
 1890 and the Statesman Furniture Company has been milling wood for furniture and hardwood floors
 since 1855. Both companies derive all their wood  from forests in the region.  They are the major
 sites of non-agricultural employment in the region.

    Crop agriculture is second only to timber and pulp industry in economic importance to the area.
 Agricultural production  in the area focuses on soy bean, corn, lima bean, sweet potato and tobacco.
 The dairy industry, made up primarily of small family farms, is now shrinking because of
 competition from "agro-conglomerates" from outside of the state.

    Historically, coal has been extracted from the portions of the Allegheny Plateau in the
 westernmost part of the watershed using shaft mines. Limited metal ores were found in  the Ridge, in
 the eastern downstream  portion of the watershed and were removed long ago using open  pit mines.
 Mining activities in the  area ceased 25 years ago.

    Drinking water for the municipalities is surface  water from the Dan River.  Each municipality
 operates  a water treatment facility for treatment of waste water.  Treated waste water is discharged
 into the river at each facility.  In addition, the paper mill discharges effluent to the river.
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 Module 12
 The Ecological Setting

    •   Much of the bottomland and urban centers have been intensively managed or developed for
       over 200 years, but ridgeline forests and steep slopes in the mountainous areas remain
       isolated and provide habitat and connecting corridors for wildlife.

    •   The ridgeline is habitat for several endemic (native) plant species and one species of squirrel
       that is listed as endangered.

    •   Nesting perigrine falcons depend on both the  ridgelines and rock outcroppings for nest sites
       and upon the availability of songbirds in the valley fields and forests as prey.

    •   The Dan River below the dam contains refugia for remnants of yellow perch.  Striped bass
       have colonized the lake and are becoming recreationally important.  American shad were and
       important resource historically but no longer occur above the dam and spawning runs are now
       only a small remnant. Tributaries above the dam support several coldwater fish species,
       including native brook trout and European brown trout, that are important recreationally.
       Tributaries are habitat for the endangered Dan River Darter and the Mattapan Madtom.

Nature of the Issues

    Industrial, agricultural, forest products development, and the activities of the human population
have had a major effect on the ecology of the Dan River Valley over the last 200 years. Clearing of
the land for tillable agriculture,  dwellings, and other buildings have altered habitat excluding many
species or significantly reducing their range and population size.  Manufacturing of natural products
have historically and continue to produce air and water effluents.

    In each of the two communities within the watershed, publically owned  treatment works
(POTWs) also discharge effluents to the river. In some instances, habitat for aquatic species has
been altered physically as well—a mill dam at the pulp and paper plant constructed in 1890 blocked
the stream as a migration route for anadromous trout, American shad, Blueback herring, and  yellow
perch.  The same dam obliterated downstream riffles, rapids, and pools that were important to these
species and other non-migratory fish.  The re-establishment of these important recreational  species is
a priority of the State Fish and Game  Office.

    Runoff from tilled land and clear-cut forest has been a significant source of sediment loading to
the stream and clearing of the riparian vegetation as part of agricultural  practice has resulted  in the
loss of shading to the river and its tributaries.  The result  has been a warmer, slower, more sediment
and nutrient-laden  stream that is no longer able to support much of the historical flora and  fauna.
The species that depend on clear, cold, well-oxygenated waters have been replaced to varying extents
by species  more tolerant of the anthropogenic stresses.
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TO BE DISTRIBUTED
Handout 12-2: Ecological Risk Assessment Case Study
Some Stressor and Source Characteristics

    •   Several abandoned coal mines dot the western mountainsides resulting in chronic low-level
       discharges of acidic drainage.  Additional atmospheric deposition of metals, including
       mercury, may be attributable to an incinerator located in another state outside the watershed.

    •   The prevailing winds carry nitrogen  and sulphur byproducts into the watershed from power
       plants outside the watershed.

    •   Effluent from the pulp and paper mill contains traces of dioxin, fine particulates, organic
       loading and color.

    •   Effluents from the furniture mill are  primarily air emissions.  The air emissions include dust
       and particulates  from furniture sanding and milling as well as volatile organic compounds
       (VOCs) that evaporate from staining and finishing operations.  These compounds include
       organic materials from stains and wood sealers.  There is some evidence that spills or leakage
       may have occurred from storage tanks  out in the mill  yard.  These tanks contain solvents such
       as turpentine, stains, and finishes such  as polyurathane.

    •   Continued logging of slope and ridgetop forests would have significant effects on remaining
       migratory and resident species as well  as riparian corridors for species that nest elsewhere.

    •   Dairy cattle use  of riparian corridors along the Dan River and several of its tributaries
       contributes to the sediment,  nutrient  and fecal coliform loading to the river and ambient water
       temperature elevation.

Current Regulatory Activities

    •   An EPA Region  12 official is reviewing the EPA-issued water quality permit associated with
       the pulp mill located in the Dan River  Watershed.  She  must also consider whether
       consultation with the U.S. Fish and Wildlife Service is necessary due to potential impacts to
       threatened and endangered species from the effluent permitted.

       -   The amount  of effluent allowed under the pulp and paper mill permits  will determine the
           plants'  production capacities and  associated forest  product demand by the mills.

           The permits  must be written and  signed within 6 months to comply with a court order; the
           court order was the result of a suit  filed by the state which cited delays in EPA processing
           of effluent permits—EPA admits to backlogs due to staff shortages.

    •   The Department of the Environment  in the state is reviewing an air quality permit for the
       Statesmen Furniture Company.
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 Module 12

    •  The Federal Energy Regulatory Commission (FERC) license for the dam at H&T Paper is up
       for renewal in two years.  Currently, the Dam is used by the mill to generate a small amount
       of electricity, and a municipal water reservoir for Little Falls,

    *  East Bend is developing an industrial park to attract employers, and is requesting to double its
       withdrawal of drinking water from the Dan River, as well as an increase in effluent.

Stakeholders and Their Interests

    •  EPA Region 12 Division of Water
       (See Current Regulatory Activities)

    •  U.S. Fish and Wildlife Dan River Field Office

           The FWS is interested in protecting the endangered southern squirrel and is considering
       listing several species of songbirds which nest in the bottomland forest along the Dan River.
       They are also concerned about the recent decline of perigrine falcons.

    •  State Fish and Game Little Falls Field Office

           The State Fish and Game is interested in maintaining the recreational fisheries in the Dan
       River below the dam including white and yellow perch,  catfish, and striped bass  populations.
       Increases in temperature, sedimentation, and pollution from air and water emissions have  all
       adversely affected the fisheries.

    •   State Department of the Environment
       (See Current Regulatory Activities)

           The Natural Heritage Office within the Department of the Environment in the state is
       developing protection  programs for rare, endangered, threatened, and other endemic plant
       species.  They are in the process of acquiring riparian land containing bottomland hardwoods
       to designate as State Preserves.

    •   U.S. Department of Agriculture Extension Office

           The Extension Office is working with farmers to decrease nonpoint sources of pollution.

    •   U.S. Department of Agriculture Forest  Service

           The Forest Service is interested in protecting the Dan's Mountain National Forest
       ecosystem and is considering developing an ecosystem management plan for the  forest.

    •   Federal Energy and Regulatory Commission
       (See Current Regulatory Activities)
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TO BE DISTRIBUTED                                Handout 12-2: Ecological Risk Assessment Case Study

    •   Save Dan's Mountain Coalition

          The mission of the coalition is to provide for nonconsumptive wildlife viewing, hiking,
       and research in the Dan's Mountain area. They are concerned about the recent declines in
       perigrine falcon populations.

    •   H&T Paper Company

          H&T Paper Company is interested in a continued supply of wood from the forests  in the
       watershed and in the re-issuance of its water discharge permit without any expenditures in
       new equipment to reduce discharges of metals.

    •   University of the Southeast, Department of Biology

          The USE Department of Biology has been studying the ecology of both the terrestrial  and
       aquatic ecosystems for years.

    •   Dan River County Commissioners

          The commissioners are interested in addressing problems with the changing economy of
       the area.

          The Commission is comprised of the president of the Dan's River Chapter  of Ducks
       Unlimited; plant manager of H&T Paper; Charles Griffen of Griffen Logging; a dairy farmer;
       a developer from East Bend; and a retired city worker  from Little Falls.

    •   Charles Griffen, owner, Griffen Logging

          Mr. Griffen owns much of the private land in the Dan's Mountain National Forest  and
       would  like to continue logging in these areas.

    •   Statesman Furniture Company

          Statesman is very concerned about the renewal of their  air emission permit and is
       considering ways of reducing  pollution that do not involve  high costs.

    •   State Timber and Forestry Office

       The State Timber and Forestry Office is interested in maintaining the flow of revenue from
    logging leases but,  is  under pressure by  local groups to work with other agencies to address the
    natural resource problems of the area.
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 Module 12

 Statutory Requirements or Agreements

    •   The Region 12 water permitting program and nonpoint source grants are administered by EPA
        under authority of the Clean Water Act; the watershed is located in a non-delegated state,
        meaning that EPA is  responsible directly for all permit writing.

    •   The air permits associated with the off-watershed incinerator are issued by a delegated state in
        the region.

    •   The U.S. Fish and Wildlife Service (FWS), a branch of the Department of Interior, is the
        Federal agency responsible for administering the Endangered Species Act (ESA) of 1973 for
        most species.  EPA must consult, either formally or informally,  with the FWS if EPA
        determines that its action may affect  a threatened or endangered (listed) species or its
        designated critical habitat.  These EPA actions could include registration of a pesticide and
        any other decision authorized, funded, or implemented by EPA.   Also, EPA must confer with
        the FWS if its action  could affect a species or critical habitat that may be proposed for listing.
        If EPA  determines that there will be  no effect, consultation is not necessary.

    •  The Migratory Bird Act, protecting migratory species, and administered by FWS.

    •  The FERC has authority to issue permits for dams.

    •  The Dan River County Development Plan: stresses the continued stable economy supported
       by the widest range of economic inputs (e.g.,  farming, mining, forestry) while accommodating
       a long-term vision of quality public use and recreation on county lands.

    •  The U.S. Forest Management Act, which specifies timber management on federal forest lands
       and requires the maintenance of viable populations of native flora and fauna, while allowing
       for managed timber production.  The Federal  forest lands are managed by the U.S.  Forest
       Service.

    •  State Timber and Forestry Office - permits and regulates logging, sales and shipment of
       timber harvested from private forest land leases.
Water Quality Standards Academy
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   Update-1 1997
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TO BE DISTRIBUTED
Handout 12-2: Ecological Risk Assessment Case Study
Water Quality Standards Academy
                                                  12-31
                              Participant Manual
                                  Update-1 1997

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 Module 12
Water Quality Standards Academy
                                                    12-32
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    Update-1  1997

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                        Handout 12-3: Dan River Watershed Conceptual Model
        DAN RIVER WATERSHED
          CONCEPTUAL MODEL
       |
       I
       S

       1
        Integrity of F«t>«ld
       Invertebrate Axsembbgtt
Water Quality Standards Academy
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 Update-1 1997

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 Module 12
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                                                                    Handout 12-4:  Hill's Criteria
  HILL'S CRITERIA FOR EVALUATING CAUSAL ASSOCIATIONS


 1.  Strength: A high magnitude of effect is associated with exposure to the stressor.

 2.  Consistency: The association is repeatedly observed under different circumstances.

 3.  Specificity:  The effect is diagnostic of a stressor.

 4.  Temporality:  The stressor precedes the effect in time.

 5.  Presence of a biological gradient: A positive correlation exists between the stressor and
    response.

 6.  A plausible mechanism of action.

 7.  Coherence:  The hypothesis does  not conflict with knowledge of natural history and biology.

 8.  Experimental evidence.

 9.  Analogy:  Similar stressors cause  similar responses.
Not all of these criteria must be satisfied, but each incrementally reinforces the argument for
causality.  Negative evidence does not rale out a causal association but may indicate incomplete
knowledge of the relationship (Rothman, 1986).
Hill, A.B. 1965. The environment or disease: Association or causation? Proceedings of the Royal
Society of Medicine 58:295-300.

Rothman, K.J. 1986. Modern Epidemiology.  1st ed.  Little, Brown and Company, Boston, MA.
Water Quality Standards Academy                                                   Participant Manual
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 Module 12
Water Quality Standards Academy
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Participant Manual
    Update-1 1997

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 TO BE DISTRIBUTED
Handout 12-5: 5 Case Study Brochures
Water Quality Standards Academy
                 Participant Manual
                     Update-1 1997
                                                 12-37

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 Module 12
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                                                   12-38

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TO BE DISTRIBUTED
   Handout 13-1: Seven Cardinal
Principles of Risk Communication
Water Quality Standards Academy
                                                 13-21
             Participant Manual
                Update-1 1997

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 Module 13
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TO BE DISTRIBUTED DAY BEFORE MODULE IS TO BE TAUGHT	Handout 13-2: Group Exercise

                                GROUP EXERCISE:
            DESIGN A RISK COMMUNICATION STRATEGY
   You live in the 51st State of the United States of America. Newlandia, which has a population of
2 million. This State is known for its natural beauty and abundant natural resources.  Most of its
many lakes and rivers have been designated by the State as "fishable/swimmable."  The State has
also designated several waterbodies as "Outstanding National Resource Waters" (ONRWs).
Outstanding National Resource Waters include high-quality or ecologically unique waters such as
those  within state and national parks and wildlife refuges.  Recreational tourism is an important
industry in this State. Many people come to Newlandia to hike, fish, swim, and camp.

   One industrial pollutant found in many Newlandia surface waters is difestylonium (DPS). DPS is
a man-made chemical found in the effluent of the arconalt industry, one of the primary industries and
employers in Newlandia and neighboring states.

   DPS is regulated under Newlandia's water quality standards (WQS) program. The current WQS
includes an ambient water quality criterion (AWQC) for human health based on EPA's 304(a)
guidance criterion.  The EPA ambient water quality criteria document states that DPS appears to
have immune system effects at relatively high levels of exposure; however, it is not clear whether
these  effects have an adverse impact on human health. DPS is a carcinogen in animal studies where
the chemical was administered orally.  Fairly high doses of the chemical are required to cause cancer
in test animals.  There are no human data regarding the carcinogenicity of DPS. The chemical has
been classified as a B2 carcinogen (i.e., a probable human carcinogen) based on animal data for oral
ingestion.

   EPA's AWQC is based on the animal carcinogenicity data. The State has essentially adopted the
Federal AWQC.  This criterion assumes daily consumption of 2  liters of untreated surface water and
6.5 grams of fish from the surface water.  The State chose to adopt into its WQS a 10~s incremental
risk level. In other words, exposure to waters containing  DPS at the Newlandia standard (3  ug/L)
might increase the incidence of cancer by 1 in an exposed population of 100,000.

   (The state DPS criteria for aquatic life are higher than the human health criterion, so aquatic life
in Newlandia is presumed to be protected by application of the human health criterion where both
are applicable [e.g., for water designated as fishable, swimmable, etc.]).

   As you learned earlier, water quality standards must be reviewed every 3 years and revised as
necessary to meet the goals of the Clean Water Act.  The DPS criterion for protection of human
health is up for review.  You are part of a team for review of the DPS criterion.  This team consists
mostly of members of the Newlandia WQS program.  It also includes EPA's Regional WQS
Coordinator, who was invited to participate by the Newlandia Water Quality Agency. This team has
held informal meetings with the three parties that have a stake in the standard: the Newlandia
Arconalt Industry Federation (NAIF), the Newlandia Environmental Group (NEG), and the
Newlandia Tourism Association (NTA).

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 Module 13                	

    •  Newlandia Arconalt Industry Federation (NAIF). The NAIF does not want the criterion
       lowered.  Members of the organization claim that the pollution control necessary to meet
       National Pollutant Discharge Elimination System (NPDES) permit limits is already expensive,
       and any further controls would impose an undue financial burden that would effectively put
       their members at a competitive disadvantage with other arconalt plants in neighboring states.
       A more stringent criterion, they argue, would likely threaten the viability of the State's entire
       arconalt industry.

       The industry performed a cost-benefit analysis in which they analyzed the  pollution
       prevention and control costs as compared to the regulator/ benefits in terms of number of
       cancer cases avoided.  They divided the costs of regulatory compliance by the benefits of
       regulatory compliance (i.e., total number of cancer cases avoided).  They claim that
       compliance with the current DPS standard set at a 10'5 risk level (i.e., exposure to waters
       containing DPS at the current Newlandia standard might cause one additional cancer  case in
       an exposed population of 100,000) now costs the industry 5350,000/cancer case avoided.
       They project that compliance with a more stringent DPS standard set at a 10"6 risk  level (i.e.,
       exposure to waters containing DPS at that standard would be expected to cause one additional
       case of cancer in an exposed population of 1 million) would cost the industry $3.5
       million/cancer case avoided.  Because of the competitive disadvantage this type of  criterion
       would  cause, the industry estimates 20,000 jobs  would be lost  if the DPS criterion  were set at
       the 10'6 level.

    •  Newlandia Environmental  Group (NEG).  The NEG is the primary  watchdog environmental
       group in the State. It  wants to ensure that the standard does not become less stringent.

    •  Newlandia Tourism Association (NTA). The NTA is primarily concerned  with image.  This
       group wants to make sure  that, whatever the outcome, the State is still perceived as having
       high-quality surface water  and a strong game fisheries resource.  The NTA fears  that  lowering
       the DPS criterion might result in more impaired waterbodies and the likelihood of additional
       fish consumption advisories.

    After three informal meetings, all groups agree that  the current standard should be maintained.
The public hearing for revision of the standard has been scheduled for one week from today. It is
important that everything proceed on schedule to meet the EPA deadline for the DPS standard.  This
deadline has already been postponed once, and the political climate would make it very difficult to
postpone this deadline further.

    Your team has just received word that the director of the  Newlandia Water Quality Agency WQS
program, Ms. Staneria, was contacted yesterday afternoon by Mr. Fin, head of the Newlandia Sport
Fishermen's Association (NSFA), which has over 100,000 members, some of whom are  also
professional fishermen.  This  group has recently discovered, from an article in the Newland Times
(the most popular newspaper in  the  State), that the DPS standard is based on an exposure assumption
of 6.5 grams (approximately  1/4 ounce) of fish per day.  A recent NSFA member  survey indicates
that NSFA members and their families typically eat about one-half pound of fish per week per
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TO BE DISTRIBUTED DAY BEFORE MODULE IS TO BE TAUGHT
Handout 13-2: Group Exercise
person on average—about five times the exposure assumed in the standard.  The NSFA is very
concerned that the health of its members has been compromised by an underprotective State
standard.  The organization is also extremely concerned that the proposed standard is not sufficiently
protective and will further endanger its members' health.

   This morning, Ms. Staneria received a call from Senator Sinker's office in the U.S. Senate.
Senator Sinker is chairman of the congressional Wilderness Committee, which is concerned with
ensuring protection of wilderness areas.  The Senator, an  avid fisherman, was contacted by Mr. Fin
and is very concerned about the  situation.  Representatives from his office will be attending the
public hearing next week. Ms. Staneria also received a call this morning from a Newland Times
reporter.  The newspaper's chief editor, also a member of the NSFA, was contacted by Mr. Fin. The
reporter requested information and will be attending the public hearing next week.
                         LIST OF ACRONYMS FOR CASE STUDY

AWQC - ambient water quality criterion

DPS - difestylonium

NAIF - Newlandia Arconalt Industry Federation

NEG - Newlandia Environmental Group

NPDES - National Pollutant Discharge Elimination System

NSFA - Newlandia Sport Fishermen's Association

NTA - Newlandia Tourism Association

ONRW - Outstanding National Resource Waters

WQS - water quality standards
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 Module 13
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TO BE DISTRIBUTED
Handout 13-3:  Instructions
             INSTRUCTIONS FOR CASE STUDY  EXERCISE
   Working as a group representing the Newlandia water pollution control agency, design a
preliminary risk communication strategy for handling this situation. Brainstorm ideas and answers to
the following questions. Designate at least one person to record your answers and report your
findings to all participants at the end of the exercise. You will have about 20 minutes to complete
this exercise.

1. Audience. With what group or groups will you be communicating about risk and risk-related
   issues?
2. Audience Concerns/Questions. What types of questions are likely to be asked?  What kinds of
   concerns are these groups likely to have?
3. Goals. Why are you communicating?  What do you want to achieve through communication?
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TO BE DISTRIBUTED                                                      Handout 13-3: Instructions
6.  Communication Channels. In addition to the public hearing itself, what channels of
    communication might be appropriate to use in this situation?  Why?

SOME RISK COMMUNICATION CHANNELS

Additional public meetings

Citizen's advisory group

Door-to-door visits

Information trailer

Social and community networks  (e.g., voluntary, community-based, and professional organizations)

Public service announcements

Radio or TV advertisements

Interviews with press, radio, TV

Press releases

Press briefings

Speeches to local groups

Posted notices/posters

Fact sheets

Brochures, pamphlets

Hot line

Response  to incoming calls (i.e., in the absence of a formal hotline number)

Libraries

Health professionals

Videotapes

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                                                                                                         1
 Module 13
 7.  Timing.  When will you implement each of the various forms of communication you have
    decided on? (e.g., How  soon will you hold a public meeting or distribute a flyer?)
 8.  Expertise.  Who will be involved in each of the communication events?  What kind of expertise
    would you like to have for each of these events? (e.g., What types of people should represent
    your team at a public meeting?  Who should be involved in drafting and reviewing a fact sheet?)
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TO BE DISTRIBUTED
Handout 13-4: Improving Dialogue with Communities
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                                                                          Handout 14-1: Transcript
                                VIDEO TRANSCRIPT
   Antidegradation Policy:  A Means to Maintain and Protect Existing Uses and
                                       Water Quality
                                     13 minutes, 22 seconds

U.S. EPA
Office of Water
Office of Science and Technology
Standards and Applied Science Division

    If you were to read that a public hearing took place, and that in the hearing someone objected to
the proposed revisions to existing water quality standards because the revision violated the
requirements of the State's antidegradation policy, would  you  understand just what was being said?

    What is an antidegradation policy?  From where did it come? What role does it play in
protecting water quality?  And How does it work?

    In the next few minutes, we'll answer those questions, not in great detail, but in enough detail to
provide you with the basic idea of what the antidegradation policy is all about.

    In the late 1960s, when the first national effort to set water quality standards began, the quality of
many of our rivers, lakes, streams, and harbors was poor. However, much of our water was of very
high quality.

    As the country began an extensive and expensive national  cleanup of polluted waters, an
interesting problem arose: How do we protect the waters that already had a quality that exceeded
standards?  To answer that question, it's important to recognize that water quality standards define
the goals to be achieved in a waterbody—in terms of a use of the water—and  in terms of the quality
or criteria necessary to protect that use.

    When you're dealing with water of poor quality, the solution is straightforward: you set the
standards and clean up the water.

    But, when the water is already better than the standard, is it possible to allow the water quality to
be degraded down to the standard?  Such a notion appeared to be illogical and contrary to  the efforts
going on to clean up the nation's water. Thus, the concept of antidegradation was born.

    It was bom  in controversy and remains controversial, but its basic tenet of protecting existing use
and water quality has remained unchanged through the years.  The policy was  not explicitly
mentioned in the Clean Water Act until 1987, but the policy is rooted in  the goal of the act to restore
and maintain water quality.  The antidegradation  policy was established on February 9, 1968, by the
Department of the Interior, the predecessor agency to EPA. Through the years, the policy  has
undergone modification, and the regulatory requirements for the policy are in the Water Quality
Standards Regulation.
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 Module 14	

    An antidegradation policy is one of the minimum elements required to be included in a State's
 water quality standards. One of the interesting things to remember about antidegradation is that it
 does not prohibit degradation of water quality, except in a very limited circumstance.  Here's how it
 works: first of all, the antidegradation policy is not just one policy, but three separate policies rolled
 into one.

    Part One of the policy says  that any existing  use, and the water quality necessary to protect that
 use, must be maintained and protected.  You can call this the floor of water quality in the U.S.   In
 simpler terms, it means that whatever the existing use of the waterbody is, you are not allowed to
 make it worse.  If water quality needs to be improved to meet the standards, the control programs
 must be put in place to accomplish that. Consider that the concern of the  policy is the uses of water,
 including swimming, boating, drinking, irrigation, various kinds of aquatic life uses, and many other
 uses.  So, when a State sets a standard, it defines a use, and adopts water quality criteria to protect
 the use.

    Within a range, different levels of water quality can protect a use. While in theory any
 improvement  in water quality would improve a use, as a practical matter we cannot define uses that
 precisely, which is why the range is important.  So, Part Two of antidegradation says that if water
 quality is better than needed to  protect fishable/swimmable streams, the water quality can be allowed
 to deteriorate  to the level that is required to maintain a fishable/swimmable use.  This is what we call
 "Tier 2" of antidegradation, or high-quality water. For example: let's say a waterbody is classified
 by the State for fishable/swimmable purposes.  The criterion set by the State happens to be 5.0 mg/L
 for dissolved oxygen.  Someone goes out and monitors the actual water quality of the stream and
 finds out that the dissolved oxygen level is actually 6 mg/L.  In terms of the policy that's clearly
 better, and certainly will foster the preservation and propagation of fish, shellfish, and wildlife, which
 is what "fishable" really means.

    Of course, a State may allow the dissolved oxygen level of 6 to deteriorate to 5, which will meet
 the criterion and will still fully protect the  existing use. However, the State cannot allow the
 dissolved oxygen level to go lower than 5  because the State has to protect the existing use, which is
 covered in Part One of the antidegradation policy.

    It would not be unreasonable for people to say that it seems that we ought to keep the dissolved
 oxygen level at 6 because it represents better water quality. This brings us to the State's actual
 implementation of antidegradation, which requires the State to  ask the public: Do we want to allow
 the water quality of this waterbody to degrade?

    The State  may make a decision to allow the degradation, or it may decide not to allow it. In all
cases, the State is required to involve the public,  and other Federal agencies, as necessary.  The
 decision to allow deterioration in water quality is based on the finding that a lower water quality is
 necessary to support important economic and social development in the area in which the water is
 located.

    Also, before water quality can be considered for possible degradation, the  State municipalities
and industrial dischargers must meet all the technologically based requirements of the act and must
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                                                                           Handout 14-1:  Transcript
meet all cost-effective and reasonable best management practices for nonpoint source control.  The
point is that the antidegradation policy only required that the question about degradation be asked,
and that a public decision be made based on data for the waterbody in question. The policy is
neutral as to what the final decision should or should not be. Remember, the policy does not
prohibit degradation except in one situation, and that situation is where the quality of water is  exactly
equal to that necessary to support the existing use.

    A common question is:  if a State implements antidegradation,  is it a barrier against all economic
development?  The answer is no, because the public may decide that the economic development
justifies the degradation.  Of course, at other times the public decision will be that the economic
development is not worth the environmental costs.

    The Third Part of the antidegradation policy has to do with ONRW:  Outstanding National
Resource  Water. This is a use classification created by EPA, which does not allow any degradation
if the State classifies the waterbody as ONRW.

    There are a couple key points to understand: First, there is no  statutory or regulatory requirement
that a State has to designate any waterbodies as ONRWs.  And second, temporary water quality
degradation is allowed if "temporary" is defined in terms of weeks and months, and not years.  For
example, if a sewer pipe ruptures,  the water is likely to be fouled during the time it takes to make
the repairs.

    Now,  let's look at what waters are supposed to be designated ONRWs. The name,  Outstanding
National Resource Water, implies something of pristine quality, and such waters certainly are
candidates for the designation.  However, any  water of ecological significance can be a candidate.
For example, a swamp might be considered to be very  important ecologically, but the normal
standards, use classifications, and water quality criteria don't apply particularly well. So, the State
could designate the swamp as an ONRW and apply a special set of standards regarding it. And
that's really the point: an ONRW should be applied to waters needing special protection, whether or
not they actually have high-quality water.

    Before discussing a couple of other points, let's summarize what we've covered so far:
antidegradation began as a policy statement, not as a statutory requirement, but now it is contained in
the Clean Water Act and in the Water Quality Standards Regulation.

    The policy does not actually prohibit degradation except where the water quality actually matches
what is needed to protect the use.  In  high-quality water, water quality can be degraded if a public
decision is reached that determines that important economic and  social development needs to be
accommodated by lowering the water quality.  And for special waters, called ONRWs, the policy in
effect permits no water quality degradation at all.

    Another important issue has to do with the relationship between EPA and the States.  Simply put,
EPA establishes the regulatory requirements to be met by the States.  It is the State's policy  that
takes on the enforceable nature of a standard.  At present, policies vary somewhat State by State, but
EPA is working with the States to improve policy statements to bring them into direct compliance

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 Module 14
 with EPA's regulations. So, the actual implementation of antidegradation is done by the States.  It's
 the "how" aspect that is being brought into compliance. The States have been asked to develop an
 implementation method so that everyone knows how and when the policy will be applied and what
 decision-making criteria the State will use. This is where a lot of work remains to be done.

    To help with this work, EPA provides, free of charge, the Water Quality Standards Handbook,
 which contains the guidance EPA has for the policy, and Questions and Answers on Antidegradation.
 These books and other information about the water quality standards program may be obtained from
 the U.S. Environmental Protection Agency, Office of Science and Technology, Standards and
 Applied Science Division, 401 M Street, SW (4305), Washington, DC 20460.

    Information about the water quality standards program also may be obtained from EPA's
 Regional Offices at the addresses that follow.  Contact the Water Quality Standards Coordinator at
 the appropriate Regional Office.

 REGION 1

 Environmental Protection Agency
 John F. Kennedy Federal Building
 Boston, MA   02203
 (CONNECTICUT, MASSACHUSETTS, MAINE, NEW HAMPSHIRE, RHODE ISLAND,
 VERMONT)

 REGION 2

 Environmental Protection Agency
 26 Federal Plaza
 New York, NY   10278
 (NEW JERSEY, NEW YORK, PUERTO RICO, VIRGIN ISLANDS)

 REGION 3

Environmental Protection Agency
 841 Chestnut Street
 Philadelphia, PA   19107
 (DELAWARE, MARYLAND, PENNSYLVANIA, VIRGINIA, WEST VIRGINIA, DISTRICT OF
COLUMBIA)
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                                                                Handout 14-1: Transcript
 REGION 4

 Environmental Protection Agency
 345 Courtland Street, NE
 Atlanta, GA  30365
 (ALABAMA, FLORIDA, GEORGIA, KENTUCKY, MISSISSIPPI, NORTH CAROLINA, SOUTH
 CAROLINA, TENNESSEE)

 REGION 5

 Environmental Protection Agency
 230 South Dearborn Street
 Chicago, IL  60604
 (ILLINOIS, INDIANA, MICHIGAN, MINNESOTA, OHIO, WISCONSIN)

 REGION 6

 Environmental Protection Agency
 1445 Ross Avenue
 Dallas, TX  75202
 (ARKANSAS, LOUISIANA, NEW MEXICO, OKLAHOMA, TEXAS)

 REGION 7

 Environmental Protection Agency
 726 Minnesota Avenue
 Kansas City, KS  66101
. (IOWA, KANSAS,  MISSOURI, NEBRASKA)

 REGION 8

 Environmental Protection Agency
 999 18th Street
 Suite 500
 Denver, CO  80202-2405
 (COLORADO, MONTANA, NORTH DAKOTA, SOUTH DAKOTA, UTAH, WYOMING)
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 Module 14

 REGION 9

 Environmental Protection Agency
 75 Hawthorne Street
 San Francisco, CA  94105
 (ARIZONA, CALIFORNIA, HAWAII, NEVADA, AMERICAN SAMOA, GUAM, TRUST
 TERRITORY OF THE PACIFIC ISLANDS, COMMONWEALTH OF THE NORTHERN
 MARIANA ISLANDS)

 REGION 10

 Environmental Protection Agency
 1200 Sixth Avenue
 Seattle, WA   98101
 (ALASKA, IDAHO, OREGON, WASHINGTON)
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                                                                            Handout 16-1: Transcript
                                 VIDEO TRANSCRIPT
                 Economic Considerations in Water Quality Standards
                                     15 minutes, 47 seconds

      This presentation will focus on the economic factors that are considered in the Water Quality
Standards Process.  We'll discuss WHY economics  may be considered, describe WHERE, in the
process, economics are considered, and we'll discuss HOW economic considerations are used in the
water quality standards process. To appreciate WHY, WHERE, and HOW economic considerations
might be involved in the water quality standards process, we first need to understand a few of the
important aspects of water quality standards.

      Under the Clean Water Act, States, Territories, and Indian Tribes — that qualify for treatment
as States — are required to set water quality standards.  The purpose of these standards is to protect
public health, enhance the quality of the Nation's waters, maintain fish, shellfish, and wildlife
resources, and preserve the public's recreational  uses of the Nation's waters.

      There are several major elements of the water quality standards process:  States  select
waterbodies and designate the uses of the waterbodies — uses such as recreation and the  protection
of fish and wildlife. These uses may exist currently or they may be goals that could be attained in
the future — with improved water quality.

      Uses that are ultimately attainable are referred to as designated uses.  States define  their water
quality  standards in terms of these designated uses or goals, and in terms of scientifically determined
criteria that limit pollutants  to the level needed to protect the designated use.

      A water quality standard, then, by definition requires  a use and criteria to protect the use.
Water quality standards also contain an antidegradation policy and a method of implementing it.

      As part of the process, States develop water quality standards and hold public hearings to give
the public an opportunity  to review and comment on the proposed water quality standards.  States
hold public  hearings at least once every three years to review existing water quality standards, to
review proposed revisions to those standards, or  to review new standards before they are adopted.
After considering the information presented at the public hearings,  States formally adopt water
quality  standards.

      Then, the Environmental Protection Agency (EPA)  reviews the standards to ensure they meet
the requirements of the Clean Water Act.  When standards meet these requirements, EPA approves
them and States implement the standards.

      To comply with  water quality standards, anyone discharging  wastewater into  a waterbody may
need to install treatment technologies,  undertake  pollution prevention techniques, or adopt best
management practices.

      There may be circumstances in which meeting water quality  standards results in economic
hardship to dischargers or to communities.  In these situations, the  Federal regulation  governing

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 Module 16

 water quality standards allows States to consider the costs and economic impacts of meeting the
 standards. The rest of this presentation provides an overview of how dischargers go about
 demonstrating economic hardship and of how EPA reviews  State decisions regarding a determination
 of economic hardship.

      Now let's discuss WHY economics can be considered. Tie Federal regulation governing water
 quality standards is not intended to be so stringent that it would have severe economic impacts on
 communities. Thus, there are several places in the water quality standards process WHERE
 economic considerations may be grounds for setting or changing the designated use of a waterbody.

      In addition to economic considerations, there may be other reasons for changing standards,
 such as physical conditions that prevent the attainment of a use. The first place economic
 considerations are addressed  occurs when a State designates uses of a waterbody.  At this point in
 the process, a Use Attainability Analysis is performed. This analysis determines whether a
 designated use can realistically be achieved by studying the  physical, chemical, biological, and
 economic factors associated with achieving a use.

      To be more specific, a State may conduct a Use Attainability Analysis to remove a designated
 use — as long as it is not an existing use, and as long as it can be demonstrated that attaining the
 designated use is not feasible because the controls needed to meet the designated use will  result in
 substantial and widespread economic and social  impacts.

      The second place where economics can be considered occurs if a State grants a variance to
 water quality standards.  Variances are short-term exemptions from the standards that are used when
 the State is trying to determine whether the standard can be  attained.  The economic considerations
 for granting a variance are the same as those used when setting, modifying, or removing a designated
 uses — that is:  the dischargers must demonstrate that substantial and widespread economic and
 social impacts would occur as a result of adopting the pollution reduction technologies or techniques
 necessary to meet water quality standards.

      Federal regulation also allows economic impacts to be considered when States develop their
 antidegradation policy.  In the case of the antidegradation policy, States may lower water quality
only if the lower water quality is necessary to accommodate important economic or social
development in the area in which the waters are located.

      So far, we've focused on the State's and the discharger's roles in the water quality standards
process.  The public also has a responsibility.  You can attend public hearings when designated uses
are being reviewed, when an application is being made for a variance, or when changes in a
designated use are recommended. In addition, you have the right to submit comments on proposed
changes to a designated use or on variances from water quality standards. Public involvement and
participation are important aspects of the water quality standards process and are strongly encouraged
by EPA.

      Now, let's turn to HOW economic considerations are addressed. First, the State and the
discharger must consider all the alternatives that would allow the discharger to meet water quality
standards. These alternatives include pollution prevention, such as changing raw materials or
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                                                                             Handout 16-1: Transcript
 substituting process chemicals; recycling and reuse; as well as end-of-pipe treatment.  These
 alternatives are often associated with increased costs.

      When we think HOW economic considerations fit into the water quality standards process, a
 chief concern is WHO will bear the costs of complying with water quality standards.

      Although States are responsible for setting water quality standards, individual wastewater
 dischargers may seek relief from these standards because of their costs of compliance.  Dischargers
 may be either private entities or public entities.  By private entities, we mean operations like
 industrial facilities, recreational developments, and shopping centers.

      When we speak of public entities, the most common example is a sewage treatment plant.

      There are also situations in which  private entities (such as industrial facilities) discharge their
 waste to public sewage treatment plants.  In such  cases, both the private and public entities can
 suffer — and claim — economic hardship.  In addition, adverse economic impacts from compliance
 costs can affect both point and nonpoint sources of pollution.

      Point sources include discharges from a single point of origin.  Nonpoint sources are those that
 do not have a single point of origin, such as runoff from road construction or from a farm.

      As  I mentioned, to change water quality standards for economic reasons, the discharger must
 demonstrate that the economic impact of complying with  water quality standards will be "substantial"
 and "widespread."  The substantial part of "substantial and widespread" focuses on the cost of
 pollution  reduction and on the discharger's  ability to pay  for necessary pollution reductions.

      In considering the ability to pay, various aspects of the discharger's financial health  should be
 reviewed.  Does the discharger have ample financial resources?  Would the discharger have difficulty
 raising the money to make the capital investment  in pollution reductions?  And, how would the
 discharger's profitability be affected?

      For a private entity, like a manufacturer, raising the money might require a loan from a bank.
 For a public entity, like a municipality, raising the money might require an increase in sewer system
 user fees  or in local taxes.

      To  demonstrate that economic impacts will also be  "widespread," the discharger must show
 that complying with the water quality standards  will result in significant adverse impacts to the
 community — not just to the discharger.

      To  do this, the discharger must define what the affected community would be — by identifying
 who will bear the adverse impacts. The discharger must also evaluate the current characteristics of
 the community.

      Some examples of important characteristics  to consider include household income,
 unemployment, expenditures on social services,  and the amount of tax revenues currently paid to the
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 Module 16
 community by the discharger.  Next, the discharger needs to demonstrate what the impacts would be
 if the discharger were forced to meet water quality standards.  Would people lose their jobs?  Would
 other economic activities be affected? Will the community  lose out on development opportunities?
 Because these impacts are site-specific, the decision  as to whether the  impacts are "widespread" must
 be based on local conditions.

      The EPA can provide you with information on the data and financial indicators that dischargers
 should use to demonstrate economic hardship and that the States  and EPA use to evaluate the
 economic impact to the discharger.

      These financial indicators are standard analytic tools used by businesses and governments to
 make decisions  about their operations — such as when they evaluate potential investments or
 expansions.

      Measures of the impacts on the discharger and on the  community help the States and EPA
 understand the  complexity and specifics of each situation. With information about the financial and
 social costs, the States and EPA are better able to balance the need for pollution reductions with the
 other needs of the community.

      In summary, it's important to remember that Water Quality Standards are designed to protect
 public health, enhance the quality of the Nation's waters, maintain natural resources, and preserve the
 public's recreational uses.

      In addition, the important task of protecting water quality can include economic considerations,
 because Federal regulations require that costs and  impacts at specific sites be a factor in developing
 water quality standards.

      For additional information and to learn more about the water qualit> standards program and
 about the role economic considerations play in water quality standards, contact EPA or your State
 water pollution control agency — or its equivalent.  Educational materials and information can be
 obtained from the following addresses:
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                                                                 Handout 16-2:  Case Study Scenario
                  MESA CITY, NEWLANDIA, CASE STUDY


                                       SCENARIO

This case study is based on a variance request by Mesa City, Newlandia, which is located on the
Winding River.

The city council for Mesa City objects to the Winding River Use Attainability Analysis completed by
the state, claiming  that the water quality standards were overprotective.  City lawyers argue that the
effluent limitations needed to meet the water quality standards would be burdensome to the city. To
meet the water quality standards, Mesa City would have to upgrade its existing secondary treatment
plant.

Mesa City is now applying for a variance  from effluent limitations required to meet the Class 1
aquatic life classification for the Winding River.  The applicant is Mesa City, which operates the
Winding River Treatment Plant. The treatment plant is in violation of the standards based on the
concentration of ammonia present in its wastewater. The variance  requested is a reduction in the
stringency of the ammonia standards the treatment plant must meet.

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                                                                        Handout 16-3: Case Study Summary
                      MESA CITY, NEWLANDIA, SUMMARY
 Mesa City's Demographics

 Population (1990)

 Current Population (1996)

 Type of household moving away from Mesa City


 Number of households

 Median Household Income (U.S. Census,
 Census Designated Place)

 Median Household Income (Local Planning
 Board Estimates, City)

 Median Household Income (U.S. Census, State)

 Median Household Income (U.S. Census, County)

 Major Type of Employment

 Regional Economic Conditions

 Percentage of Total Wastewater Flow Attributable
 to Residential and Municipal Wastewater Flows

 Unemployment Rate (City)

 Unemployment Rate (County)

 Unemployment Rate (State)

 Mesa City's Financial History

 Property Tax Revenues (1990)

 Sales Tax and Miscellaneous Revenues (1990)

 Total Government Revenues (1990)

 Property Tax Revenues (FY 1995)

 Sales Tax and Miscellaneous Revenues (FY 1995)

 Total Government Revenues (FY 1995)
38,000

34,200 (decrease of 10% since 1989)

Single-person households and smaller two-income
families

12,100

515,000


$17,500


$17,400

$16,300

Oil industry, Service sector

Decline of oil industry

85%


6.1%

5.9%

5.6%



513,042,000

58,301,000

$21,343,000

$10,725,000

$5,775,000

$16,500,000
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 Module  16
 Current Market Value of Taxable
 Property (FY 1994)

 Property Tax Delinquency Rate

 Bond Rating — insured sewer

 Bond Rating — non insured sewer

 Overall Net Debt (FY 1995)

 Cost of Wastewater Treatment Upgrade

 Capital Improvements

        1990 dollars

        1994 dollars

 Annual Operating Costs

        1990 dollars

        1994 dollars


 Financing for Wastewater Treatment Upgrade

 Source of Financing

 Repayment Term, Vehicle

 Bond Rate

 Total Annual Cost of Existing Plant
$753,382,000


5.5% (up from 1% prior to 1988)

S&P rating of AAA

S&P rating of BBB

531,335,000
$2,5CO,000

$3,300,000 (using ENR capital cost index of 1.32)



$750,000

$802,500 (using ENR operating cost index of
1.07)



General obligation bond

20 years, property and sales tax revenues

8.45<7c (optimistic), 11% (realistic)

$2,950,500
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                                                              Handout 16-4:  Case Study Worksheet
          WORK SHEET FOR THE MESA CITY, NEWLANDIA
                                     CASE STUDY
I.   Calculating the Municipal Affordability Screener

     A.   Calculate Average Annualized Cost Per Household

          1.    Calculate the Total Annual Cost of the Project

                  Interest Rate for Financing (i) =

                  Time Period for Financing (ri) =
(expressed as a fraction)
                years
                 Annualization Factor
                                       (i »  1)"
                 Total Capital Cost of Project to be Financed =

                 Annual Operating Costs of Project =

                 Annualized Capital Cost  [(1) x (2)] =

                 Total Annual Cost of Project [(3) + (4)] =

          2.    Calculate the Total Annual Cost to Households

                 Total Annual Cost of Project (5) x Percentage of
                 Total Wastewater Flow Attributable to Residential
                 and Municipal Wastewater Flows =

                 Total Annual Cost of Existing Plant ($2,950,500)
                 x Percentage of Total Wastewater Flow Attributable
                 to Residential and Municipal Wastewater Flows =

                 Total Annual Cost to Households [(6) + (7)] =

          3.    Calculate the Average Annualized Cost Per Household

                  Total Annual Cost  to Households (8) __
                        Number of Households
      0.1052865    (1)


     $ 3.300.000    (2)

       $ 802.500    (3)

    	  (4)

    	  (5)
      $ 977.453   (6)
                  (7)
     $ 3.485.378   (8)
                  (9)
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     B.   Calculate Screener Value:
          Average Annualized Cost Per Household (9)
                   Median Household Income
          What type of impact does the Municipal Affordability
          Screener Indicate?

          Is there a need to proceed to the Secondary Affordability Test?
                                                                           % (10)
                                                                            impact
II.   Applying the Secondary Affordability Test

     A.   Evaluating the Debt Indicators:

           Bond Rating:

              What is Mesa City's Bond Rating?

              What is the resulting score? (Slide 15)
           Overall Net Debt to Market Value of Taxable Property:

              Mesa City's Overall Net Debt =

              Mesa City's Market Value of Taxable Property =
                       Overall Net Debt (12)
     B.
      Market Value of Taxable Property (13)

     What is the resulting score? (Slide 16)

Evaluating the Socioeconomic Indicators:

  Unemployment Rate:

     What is Mesa City's Unemployment Rate?

     Is this above or below the State's rate?

     What is the resulting score? (Slide 17)
                                                    x  100 =
                                                                  points (11)
                                                                $ 31.355.000  (12)

                                                               $ 753.382.000  (13)
                                                                           points (14)
                                                                           points (15)
Water Quality Standards Academy
                                           16-28
                                                                    Participant Manual
                                                                       Update-! 1997

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                                                                Handout 16-4:  Case Study Worksheet
           Median Household Income:

               What is Mesa City's Median Household Income?

               Is this above or below the State's rate?

               What is the resulting score? (Slide 18)    	
                                                                   points (16)
     C.
Evaluating the Financial Management Indicators:

 Property Tax Revenue to Full Market Value of Taxable Property:

     What is Mesa City's  Property Tax Revenue?                    $ 10.725.000  (17)

     What is the Full Market Value of Taxable Property?           $ 753.382.000  (18)
                        Property Tax Revenue (17)
                Full Market Value of Taxable Property (18)

               What is the resulting score? (Slide 19)

           Property Tax Collection Rate:
                                                          x  100 =
               What is the Property Tax Collection Rate of Mesa City?

               What is the resulting score? (Slide 20)   	
     D.   Calculate the Cumulative Secondary Affordability Test Score:

                (11) *  (14)  *  (15) *  (16) *  (19) * (20) _
                                                                   points (19)
                                                                   points (20)
                                                                                   points (21)
Water Quality Standards Academy
                                             16-29
                                                                     Participant Manual
                                                                        Update-1 1997

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 Module 16
 III. Assessment of Substantial Impacts Matrix

     The Municipal Affordability Screener (10) =                        _

     The Cumulative Secondary Affordability Test Score (21) =


     Where does Mesa City appear in the Substantial Impacts Matrix below?
         points
Secondary Assessment
Score
(Cumulative Secondary
Affordability Score)
< 1.5
1.5 — 2.5
>2.5
Municipal Affordability Screener
(Average Annualized Pollution Control
Cost as a Percentage of Median Household Income)
<0.8%
?
/
/
0.8%- 1.5%
X
7
/
>1.5%
X
X
7
     ? Questionable affordability
     /  Community can afford the pollution control
     X  Community cannot afford the pollution control

     Can Mesa City afford the upgrade to their facility?
Water Quality Standards Academy
                                            16-30
Participant Manual
   Update-1 1997

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                             Handout 16-5: Municipal Affordability
TO BE DISTRIBUTED                          Screener for Mesa City
    MUNICIPAL AFFORDABILITY
     SCREENER FOR MESA CITY
    ;    _ Average Annualized Cost per Household
    i    ~      Median Household Income
              $15,000.00

               1.92 %

Water Quality Standards Academy                        Participant Manual
                                     Update-1 1997
                    16-31

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 Module 16
Water Quality Standards Academy
                                                   16-32
Participant Manual
    Update-1 1997

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                               Handout 16-6: Secondary Affordability Test
TO BE DISTRIBUTED                   Financial Management Indicators for Mesa City
      SECONDARY AFFORDABILITY TEST
          FINANCIAL MANAGEMENT
                INDICATORS FOR
                   MESA CITY
        Measure 1

                   Property Tax Revenue
             Full Market Value of Taxable Property
                $10725.000
                $753,382,000 A
                 1,42 %
                                      EPA
Water Quality Standards Academy                          Participant Manual
                                          Update-1 1997
                       16-33

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 Module 16
Water Quality Standards Academy
                                                  16-34
Participant Manual
    Update-1 1997

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                                                          Handout 16-7: Socioeconomic Information
               SOURCES OF SOCIOECONOMIC INFORMATION
                      FOR WATER QUALITY STANDARDS
 Public Entitv
 For public entities, it is necessary to determine whether or not a community can afford a project.  To
 obtain information on the social and economic strength of the community, consider the following
 options.

 For information on bond ratings, contact:

 Standard & Poor's (S&P) Ratings Service Home Page
 S&P Service is the largest global bond rating agency. S&P via Internet:  http://www.mcgraw-
 hill.com/financial-markets/ratings/ratings/htm

 For information on debt/market value, contact:

 County Board of Taxation

 For information on unemployment and household income, contact:

     U.S. Bureau of the Census, Public Information Office, Room 2705, Building 3, Washington, DC
     20133; phone (301)763-4040.  U.S. Census Gopher Server via Internet: http://www.census.gov

     Bureau of Economic Analyses (BEA).  BEA measures and analyzes U.S. economic activity.
     BEA via Internet: http://www.doc.gov/resources/csd/csbea.html

     County or State Chamber of Commerce (request a relocation package or socioeconomics fact
     sheet)

     Local planning office or economic development office

     State Department of Labor

For information on taxes, property values,  and collection rates, contact:

     County Board of Taxation

     County or State Chamber of Commerce (request a relocation package or socioeconomics fact
     sheet)

     Local planning office or economic development office
     State Department of Labor
Water Quality Standards Academy                                                  Participant Manual
                                                                              Update-1 1997
                                          16-35

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 Module 16

 Private Entity

 For private entities, it is necessary to assess the entity's ability to pay for water pollution controls
 along with its financial health. To obtain information on the financial strength of the entity, ask for
 such items as cash, inventories, accounts receivable, accounts payable, accrued expenses, taxes, and
 the current portion of any long-term debts.

 For information to help perform the Liquidity Test (current assets divided by current liabilities);
 Solvency Test (cash flow per given year divided by total debt of the entity); Leverage Test (amount
 firm has borrowed divided by amount of stockholders' capital); or Earnings Test (annualized
 pollution control cost subtracted from pretax earnings), consider the following options:

     Obtain a copy of the entity's balance sheet.

     Obtain a copy of the annual report.

     With permission, call the entity's bank to request line of credit information.

     Commission  a credit bureau to run a credit analysis.

     Refer to Robert Morris  Associates' Annual Statement Studies or Moody's Industrial Manual.

 Community

 To demonstrate that economic impacts will be widespread, one must show that the surrounding
 community will  incur an adverse  impact.  To obtain information on the demographics and financial
 status of the community, consider the following options.

 For information  on the geographic area  of the affected community, purchase a map of the area from
 the U.S. Geological Survey, Rand-McNally, etc., or contact:

     U.S. Census Gopher Server Map Locator via Internet: http://www.census.gov

     County or State Chamber of Commerce

 For information  on population, contact:

     U.S. Bureau of the Census, Public Information Office, Room 2705, Building 3, Washington, DC
     20133; phone (301)763-4040.  U.S. Census Gopher Server via Internet: http://www.census.gov

     County or State Chamber of Commerce (request a relocation package or socioeconomics fact
     sheet)
Water Quality Standards Academy
                                             16-36
Participant Manual
   Update-1 1997

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                                                             Handout 16-7: Socioeconomic Information
For information on financial surplus as a percentage of total expenditures, contact:

     Local planning  office or economic development office

For information on tax revenues and property values, contact:

     County or State Chamber of Commerce (request a relocation package or socioeconomics fact
     sheet)

     Local Planning  Office or Economic Development Office

     The State's Department of Labor

For information on overall debt outstanding, contact:

     Local planning  office or economic development office

For information on employment/unemployment rates, contact:

     U.S. Bureau of the Census, Public Information Office, Room 2705, Building 3, Washington, DC
     20133; phone (301)763-4040. U.S. Census Gopher Server via Internet: http://www.census.gov

     Bureau of Economic Analyses (BEA). BEA measures and analyzes U.S. economic activity.
     BEA via Internet:  http://www.doc.gov/resources/csd/csbea.htmi

     County or State Chamber of Commerce (request a relocation package or socioeconomics fact
     sheet)

     Local planning  office or economic development office

     State Department of Labor

For additional assistance on any of the subjects above, you can call EPA, Office of Water, Office of
Science and Technology, Engineering and Analysis Division, Economic and Statistical Analysis
Branch, in Washington,  DC; phone (202)260-5397.
Water Quality Standards Academy                                                     Participant Manual
                                                                                  Update-1 1997
                                             16-37

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 Module  16
Water Quality Standards Academy
                                                   16-38
Participant Manual
    Update-1 1997

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                                                                   Handout 18-1: Certification
                ATTORNEY GENERAL'S CERTIFICATION
Governor    (Name)
   (City)   .    (State)
Dear Governor      :
   I have reviewed the proposed Amendments to the Rules and Regulations Establishing Surface
Water Criteria for the State of	, as adopted by the  (State Agency!  on   (date)
following a public hearing held by the Department on   (date)  . The amended rules and
regulations were duly adopted pursuant to the authority contained in the (State Act citation). The
hearing was held in accordance with the provisions of the (State Act citation).

   The proposed regulations amend the use classifications and certain criteria assigned to protect
those classifications previously approved by the Environmental Protection Agency on   (date)  __.
These proposed regulations apply to all navigable waters in  (State)  .

   On the basis of the above, I have concluded that  the Rules and Regulations Establishing Surface
Water Criteria for the State of	have been promulgated in accordance with State law and
that they will be legally enforceable in the State.

                      Signature
                       (Attorney General's name)
                         (STATEMENT MAY BE ADDRESSED TO
                         DEPARTMENT HEAD, GOVERNOR, OR
                           EPA REGIONAL ADMINISTRATOR)
Water Quality Standards Academy                                                 Participant Manual
                                                                              1996 Edition
                                          18-17

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 Module 18
Water Quality Standards Academy
Participant Manual
     1996 Edition
                                                   18-18

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                                                   Handout 18-2: Federal Rulemaking
     SUMMARY OF FEDERAL WATER QUALITY STANDARDS
                            RULEMAKINGS
                              (January 31, 1996)
STATE
1 . Kentucky





2. Arizona*

3. Nebraska

4. Mississippi



DATE
12/2/74




12/9/80
6/22176

6/6/78
7/26/82
4/30/79


4/4/86
ACTION
Final Rule




Withdrawal
Final Rule

Final Rule
Withdrawal
Final Rule


Withdrawal
REFERENCE
39 FR 41709




45 FR 81042
41 FR 25000
(40CFR 131.31)
43 FR 24529
47 FR 32128
44 FR 25223


51 FR 11581
DESCRIPTION
Established statement in WQS
giving EPA Administrator authority
to grant a temporary exception to
stream classification and/or criteria
after case-by-case studies. Also,
established statement that streams
not listed in the WQS are
understood to be classified as
Aquatic Life and criteria for this use
to be met.
Withdrew the Federal promulgation
action of 12/2/74 after adoption of
appropriate water quality standards
by the State.
Established nutrient standards for 1 1
streams.
Redesignated eight stream segments
for full body contact recreation and
three for partial body contact
recreation and the protection of fish
and wildlife.
Withdrew Federal promulgation
action of 6/6/78 after adoption of
appropriate water quality standards
by the State.
Established dissolved oxygen
criterion for all water uses
recognized by the State. Established
criterion for a daily average of not
less than 5.0 mg/1 with a daily
instantaneous minimum of not less
than 4.0 mg/1.
Withdrew the Federal promulgation
of 4/30/79 following State adoption
of requirements consistent with the
Federally promulgated standard.
Water Quality Standards Academy
                                   18-19
Participant Manual
    1996 Edition

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 Module 18
STATE | DATE
5. Alabama









6. Alabama













7. North
Carolina











11/26/79









2/14/80








11/26782




4/1/80







11/10/81




ACTION
Proposed Rule









Final Rule








Withdrawal




Final Rule







Withdrawal




REFERENCE
44 FR 67442









45 FR 9910








47 FR 53372




45 FR 21246







46 FR 55520




DESCRIPTION
Proposal to reestablish rule
previously approved use
classifications for segments of four
navigable waterways, Five Mile
Creek, Opossum Creek, Valley
Creek, Village Creek, and upgrade
the use designation of a segment of
Village Creek from river mile 30 to
its source. [This proposal was never
finalized or removed.]
Established beneficial stream use
classification for 16 streams: 8
were designated for fish and
wildlife, 7 were upgraded to a fish
and wildlife classification, 1 was
designated as agricultural and
industrial water supply. Proposed
streams classification ruiemaking for
7 streams withdrawn.
Withdrew the Federal promulgation
action of 2/14/80 following State
adoption of requirements consistent
with the Federally promulgated
standard.
Nullified a zero Carolina dissolved
oxygen standard variance in a
segment of Welch Creek and
reestablished the State's previous
standard of 5 mg/1 average, 4 mg/1
minimum, except for lower
concentrations caused by natural
swamp conditions.
Withdrew the Federal promulgation
action of 4/1/80 following State
adoption of a dissolved oxygen
criterion consistent with the
Federally promulgated standard.
Water Quality Standards Academy
                                                   18-20
Participant Manual
     1996 Edition

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                                                                           Handout 18-2: Federal Rulemaking
STATE
8. Ohio






















9. Idaho





















DATE
1 1/28/80

















2/16782




8/20/85






7/14/86







7/25/88






ACTION
Final Rule

















Withdrawal




Proposed Rule






Partial
Withdrawal of
Proposal





Completed
Withdrawal of
Proposal




REFERENCE
45 FR 79053

















47 FR 29541




50 FR 33672






51 FR 25372







53 FR 27882






DESCRIPTION
(1) Established water use
designation,
(2) established a DO criterion of 5
mg/1 for wantiwater use,
(3) designated 17 streams as
warm water habitat,
(4) placed 111 streams downgraded
by Ohio into modified warmwater
habitat.
(5) revised certain provisions
relating to mixing zones (principally
on Lake Erie),
(6) revised low flow and other
exemptions to standards.
(7) amended sampling and analytical
protocols, and
(8) withdrew EPA proposal to
establish a new cyanide criterion.
Withdrew Federal promulgation of
1 1/28/80 because it was based on a
portion of the water quality
standards regulation that has been
determined to be invalid.
Proposal to replace DO rule
criterion downstream from dams.
partially replace Statewide ammonia
criterion, replace ammonia criterion
for Indian Creek, and delete
categorical exemption of dams from
Anti-degradation Policy.
Withdrew portions of withdrawal
proposed rule to of replace DO
criterion proposal downstream from
dams and delete categorical
exemptions of dams from
antidegradation rule since State
adopted acceptable standards in both
instances.
Withdrew portion of withdrawal
proposed rule which of would have
established proposal a Statewide
ammonia criterion and a site-specific
ammonia criterion applicable to
lower Indian Creek since State
adopted acceptable standards.
Water Quality Standards Academy
                                                   18-21
Participant Manual
     19% Edition

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 Module 18
STATE
10. Kentucky







11. ColvilJe
Confederated
Tribes
Reservation*

12. 12 States
1 Territory
District of
Columbia


Washington












13. New Mexico






DATE 1 ACTION
3/20/87



4/3/91



7/6/89




12/22/92





7/6/93




5/4/95







10/18/94






Final Rule



Withdrawal



Final Rule




Final Rule





Partial
Withdrawal



Interim Final
Rule






Proposed Rule






REFERENCE
52 FR 9102



56 FR 13592



54 FR 28622
(40 CFR 131.35)



57 FR 60848
(40 CFR 131.36)




58 FR 36141




60 FR 2228







59 FR 52496






DESCRIPTION
Established a chloride criterion of |
600 mg/1 as a 30-day average, not to
exceed a maximum of 1,200 mg/1 at
any time. II
Withdrew the Federal promulgation
of 3/20/87 after adoption of
appropriate chloride criterion by the
State.
Established designated Confederated
(40 CFR 131.35) uses and criteria
for Tribes all surface waters on
Reservation the Reservation at the
Tribes' request.
Established numeric water quality
criteria for toxic pollutants (aquatic
life and human health) and certain
minimum implementing
requirements. Generally called
"National Toxics Rule."
Withdrew, in part, the withdrawal
applicability to the State of the
National Toxics Rule of 12/22/92
after adoption of some appropriate '
criteria by the State.
Converted metals criteria in National
Toxics Rule based on the total
recoverable form to criteria based on
dissolved form by the use of
laboratory-derived conversion
factors. This action was agreed to
pursuant to a partial settlement of
litigation.
Proposed to supersede a State
mixing zone provision that would
allow acute numeric criteria to be
superseded by biomonitoring. (This
Proposal is inactive as the State has
taken corrective action. See EPA's
Reg. Agenda at 60 FR 23969.)
Water Quality Standards Academy
                                                  18-22
Participant Manual
     1996 Edition

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                                                                                Handout 18-2: Federal Rulemaking
STATE
14. California*











15. Arizona








DATE
1/24/95






12/20/95




1/29/96








ACTION
Final Rule






Proposed Rule




Proposed Rule








REFERENCE
60 FR 4664
(40CFR 131.37)





60 FR 2766




61 FR 2766








DESCRIPTION
Established four sets of Federal
criteria to protect the habitat
conditions of the San Francisco Bay
- Sacramento and San Joaquin
Rivers Delta Estuary to protect
endangered species and other aquatic
life.
EPA has proposed to withdraw the
Bay/Delta rule because the State has
adopted requirements which are
judged to be equivalent to EPA's
rule.
EPA proposed, pursuant rule to a
U.S. District Court order, to remove
a mining exemption from the
definition of navigable waters, add
fish consumption to AZ's fishable
uses, nullify setting WQS on
analytical "practical quantitation
limits", and certain implementation
policies.
Note: Asterisk (*) indicates that the rule is still in effect and can be found at the citation provided in the Code of Federal
Regulations.
Water Quality Standards Academy
Participant Manual
      1996 Edition
                                                      18-23

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 xModule 18
Water Quality Standards Academy
Participant Manual
     1996 Edition
                                                    18-24

-------